Why can't we improve turnover time? A systematic review.

BACKGROUND: Despite substantial efforts to reduce operating room (OR) turnover time (TOT), delays remain a frustration to physicians, staff, and hospital leadership. These efforts have employed many systems and human factor-based approaches with variable results. A deeper dive into methodologies and their applicability could lead to successful and sustained change. The aim of this study was to conduct a systematic review to evaluate relevant research focused on improving OR TOT and clearly defining measures of successful intervention. MATERIAL AND METHODS: A systematic review of OR TOT interventions implemented between 1980 through October 2022 was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology. Research databases included: 1) PubMed; 2) Web of Science; and 3) OVID Medline. RESULTS: A total of 38 articles were appropriate for analysis. Most employed a pre/post intervention approach (29, 76.3%), the remaining utilized a control/intervention approach. Nine intervention methods were identified: the majority included a process redesign bundle (24, 63%), followed by overlapping induction, dedicated unit/team/space feedback, financial incentives, team training, education, practice guidelines, and redefinition of roles/responsibilities. Studies were further categorized into one of two groups: (1) those that utilized predetermined interventions based on anecdotal experience or prior literature (18, 47.4%) and (2) those that conducted a prospective analysis on baseline data to inform intervention development (20, 52.6%). DISCUSSION: There are significant variability in the methodologies utilized to improve OR TOT; however, the most effective solutions involved process redesign bundles developed from a prospective investigation of the clinical work-system.

Defining Properly Collected Urine: Thresholds to Improve the Accuracy of Urinalysis for Microscopic Hematuria Evaluation in Women.

PURPOSE: Microscopic hematuria is one of the most common office consults for urologists. While revised guidelines have risk-stratified patients to reduce unnecessary screening, they do not provide guidance concerning specimen quality. We sought to define "properly collected" specimens using catheterized urine samples as a reference to improve the utility of hematuria screening in women. MATERIALS AND METHODS: We prospectively acquired same-visit voided and catheterized urine samples from 46 women referred for microscopic hematuria from September 2016 to March 2020. Characteristics of pre-referral urinalysis were compared to the matched specimens. True microscopic hematuria was defined as ≥3 red blood cells per high power field on catheterization. RESULTS: Catheterized urinalyses had significantly fewer red blood and squamous epithelial cells in comparison to both referral urinalyses (p=0.006, p=0.001, respectively) and same-day void urinalyses (p=0.02, p=0.04, respectively). As no catheterized sample had >2 squamous epithelial cells, we applied this squamous epithelial cell threshold to referral urinalyses for analysis. Addition of this criterion for "properly collected specimen" increased the positive predictive value of referral urinalyses from 46.1% to 68.8% for true microscopic hematuria. Fewer than 2 squamous epithelial cells with elevated RBC was a significant predictor for true microscopic hematuria (p=0.003). CONCLUSIONS: Voided specimens in the urology clinic had significantly lower red blood cells than referral samples, indicating improved collection technique may reduce false positive urinalyses. Matched collection suggested that repeat collection by catheterization in women who present with >2 squamous epithelial cells per high power field on referral urinalysis may prevent unnecessary future work-up.

Barriers to safety and efficiency in robotic surgery docking.

BACKGROUND: The introduction of new technology into the operating room (OR) can be beneficial for patients, but can also create new problems and complexities for physicians and staff. The observation of flow disruptions (FDs)-small deviations from the optimal course of care-can be used to understand how systems problems manifest. Prior studies showed that the docking process in robotic assisted surgery (RAS), which requires careful management of process, people, technology and working environment, might be a particularly challenging part of the operation. We sought to explore variation across multiple clinical sites and procedures; and to examine the sources of those disruptions. METHODS: Trained observers recorded FDs during 45 procedures across multiple specialties at three different hospitals. The rate of FDs was compared across surgical phases, sites, and types of procedure. A work-system flow of the RAS docking procedure was used to determine which steps were most disrupted. RESULTS: The docking process was significantly more disrupted than other procedural phases, with no effect of hospital site, and a potential interaction with procedure type. Particular challenges were encountered in room organization, retrieval of supplies, positioning the patient, and maneuvering the robot. CONCLUSIONS: Direct observation of surgical procedures can help to identify approaches to improve the design of technology and procedures, the training of staff, and configuration of the OR environment, with the eventual goal of improving safety, efficiency and teamwork in high technology surgery.

A Human Factors Approach to Vaginal Retained Foreign Objects.

STUDY OBJECTIVE: This study aimed to apply a structured human factors analysis to understand conditions contributing to vaginal retained foreign objects (RFOs). DESIGN: All potential vaginal RFO events from January 1, 2000, to May 21, 2019, were analyzed by trained human factors researchers. Each narrative was reviewed to identify contributing factors, classified using the Human Factors Analysis and Classification System for Healthcare. SETTING: An 890-bed, academic medical center in Southern California. PATIENTS: Patients who underwent a vaginal procedure in which a vaginal RFO-related event occurred were included in this study. However, no patient information was included, and only the relevant details from their procedures were included. INTERVENTIONS: No interventions were developed or implemented. MEASUREMENTS AND MAIN RESULTS: Over the 19-year period, 45 events were reported. The most common items were vaginal packing and vaginal sponges (53.33%). Less frequently retained items involved broken instruments (20.20%). Most cases were laparoscopic hysterectomies or vaginal deliveries. Based on the Human Factors Analysis and Classification System, 75 contributing factors were identified, consisting primarily of preconditions for unsafe acts (communication challenges, coordination breakdowns and issues with the design of tools/technology) and unsafe acts (errors). CONCLUSION: Although rare, vaginal RFOs do occur. The top 2 contributing factors were skill-based errors and communication breakdowns. Both types of errors can be addressed and improved with human factors interventions, including simulation, teamwork training, and streamlining workflow to reduce the opportunity for errors.

Human Factors Integration in Robotic Surgery.

OBJECTIVE: Using the example of robotic-assisted surgery (RAS), we explore the methodological and practical challenges of technology integration in surgery, provide examples of evidence-based improvements, and discuss the importance of systems engineering and clinical human factors research and practice. BACKGROUND: New operating room technologies offer potential benefits for patients and staff, yet also present challenges for physical, procedural, team, and organizational integration. Historically, RAS implementation has focused on establishing the technical skills of the surgeon on the console, and has not systematically addressed the new skills required for other team members, the use of the workspace, or the organizational changes. RESULTS: Human factors studies of robotic surgery have demonstrated not just the effects of these hidden complexities on people, teams, processes, and proximal outcomes, but also have been able to analyze and explain in detail why they happen and offer methods to address them. We review studies on workload, communication, workflow, workspace, and coordination in robotic surgery, and then discuss the potential for improvement that these studies suggest within the wider healthcare system. CONCLUSION: There is a growing need to understand and develop approaches to safety and quality improvement through human-systems integration at the frontline of care.Precis: The introduction of robotic surgery has exposed under-acknowledged complexities of introducing complex technology into operating rooms. We explore the methodological and practical challenges, provide examples of evidence-based improvements, and discuss the implications for systems engineering and clinical human factors research and practice.

Work-system interventions in robotic-assisted surgery: a systematic review exploring the gap between challenges and solutions.

BACKGROUND: The introduction of a robot into the surgical suite changes the dynamics of the work-system, creating new opportunities for both success and failure. An extensive amount of research has identified a range of barriers to safety and efficiency in Robotic Assisted Surgery (RAS), such as communication breakdowns, coordination failures, equipment issues, and technological malfunctions. However, there exists very few solutions to these barriers. The purpose of this review was to identify the gap between identified RAS work-system barriers and interventions developed to address those barriers. METHODS: A search from three databases (PubMed, Web of Science, and Ovid Medline) was conducted for literature discussing system-level interventions for RAS that were published between January 1, 1985 to March 17, 2020. Articles describing interventions for systems-level issues that did not involve technical skills in RAS were eligible for inclusion. RESULTS: A total of 30 articles were included in the review. Only seven articles (23.33%) implemented and evaluated interventions, while the remaining 23 articles (76.67%) provided suggested interventions for issues in RAS. Major barriers identified included disruptions, ergonomic issues, safety and efficiency, communication, and non-technical skills. Common solutions involved team training, checklist development, and workspace redesign. CONCLUSION: The review identified a significant gap between issues and solutions in RAS. While it is important to continue identifying how the complexities of RAS affect operating room (OR) and team dynamics, future work will need to address existing issues with interventions that have been tested and evaluated. In particular, improving RAS-associated non-technical skills, task management, and technology management may lead to improved OR dynamics associated with greater efficiency, reduced costs, and better systems-level outcomes.

Challenges With Robot-Assisted Surgery Setup for Complex Minimally Invasive Upper Gastrointestinal Surgery.

BACKGROUND: The utilization of robot-assisted approaches to surgery has increased significantly over the last two decades. This has introduced novel complexities into the operating room environment, requiring management of new challenges and workflow adaptation. This study aimed to analyze challenges in the surgical setup for complex upper gastrointestinal robot-assisted surgery (UGI-RAS) and identify opportunities for solutions. METHODS: Direct observations of surgical setup processes for UGI-RAS were performed by a trained Human Factors researcher at a non-profit academic medical center in Southern California. Setup tasks were subdivided into five phases: (1) before wheels-in; (2) patient transfer and anesthesia induction; (3) patient preparation; (4) surgery preparation; and (5) robot docking. Start/end times for each phase/task were documented along with workflow disruption (FD) narratives and timestamps. Setup tasks and FDs were analyzed using descriptive statistics. RESULTS: Twenty UGI-RAS setup procedures were observed between May-November 2023: sleeve gastrectomy +/- hiatal hernia repair (n = 9, 45.00%); para-esophageal hernia repair +/- fundoplication (n = 8, 40.00%); revision to Roux-en-Y gastric bypass (n = 2, 10.00%); and gastric band removal (n = 1, 5.00%). Frequent FDs included planning breakdowns (n = 20, 29.85%), equipment/supply management (n = 17, 25.37%), patient care coordination (n = 8, 11.94%), and equipment challenges (n = 8, 11.94%). Eleven of 20 observations were first-start cases, of which 10 experienced delayed starts. DISCUSSION: Interventions aimed at improving workflows during UGI-RAS setup include performing pre-operative team huddles and conducting trainings aimed at team coordination and equipment challenges. These solutions could result in improved teamwork, efficiency, and communication while reducing case start delays and turnover time.

The impact of resident training on robotic operative times: is there a July Effect?

It is unknown whether the July Effect (a theory that medical errors and organizational inefficiencies increase during the influx of new surgical residents) exists in urologic robotic-assisted surgery. The aim of this study was to investigate the impact of urology resident training on robotic operative times at the beginning of the academic year. A retrospective chart review was conducted for urologic robotic surgeries performed at a single institution between 2008 and 2019. Univariate and multivariate mix model analyses were performed to determine the association between operative time and patient age, estimated blood loss, case complexity, robotic surgical system (Si or Xi), and time of the academic year. Differences in surgery time and non-surgery time were assessed with/without resident presence. Operative time intervals were included in the analysis. Resident presence correlated with increased surgery time (38.6 min (p < 0.001)) and decreased non-surgery time (4.6 min (p < 0.001)). Surgery time involving residents decreased by 8.7 min after 4 months into the academic year (July-October), and by an additional 5.1 min after the next 4 months (p = 0.027, < 0.001). When compared across case types stratified by complexity, surgery time for cases with residents significantly varied. Cases without residents did not demonstrate such variability. Resident presence was associated with prolonged surgery time, with the largest effect occurring in the first 4 months and shortening later in the year. However, resident presence was associated with significantly reduced non-surgery time. These results help to understand how new trainees impact operating room times.

Demands of surgical teams in robotic-assisted surgery: An assessment of intraoperative workload within different surgical specialties.

BACKGROUND: Current approaches to assessing workload in robotic-assisted surgery (RAS) focus on surgeons and lack real-world data. Understanding how workload varies by role and specialty aids in identifying effective ways to optimize workload. METHODS: SURG-TLX surveys with six domains of workload were administered to surgical staff at three sites. Staff reported workload perceptions for each domain on a 20-point Likert scale, and aggregate scores were determined per participant. RESULTS: 188 questionnaires were obtained across 90 RAS procedures. Significantly higher aggregate scores were reported for gynecology (Mdn â€‹= â€‹30.00) (p â€‹= â€‹0.034) and urology (Mdn â€‹= â€‹36.50) (p â€‹= â€‹0.006) than for general (Mdn â€‹= â€‹25.00). Surgeons reported significantly higher scores for task complexity (Mdn â€‹= â€‹8.00) than both technicians (Mdn â€‹= â€‹5.00) (p â€‹= â€‹0.007), and nurses (Mdn â€‹= â€‹5.00). CONCLUSIONS: Staff reported significantly higher workload during urology and gynecology procedures, and experienced significant differences in domain workload by role and specialty, elucidating the need for tailored workload interventions.

Understanding ultrarare adverse events - Lessons learned from a twelve-year review of intraoperative deaths at an academic medical center.

BACKGROUND: Intraoperative death (ID) is rare, the incidence remains challenging to quantify and learning opportunities are limited. We aimed to better define the demographics of ID by reviewing the longest single-site series. METHODS: Retrospective chart reviews, including a review of contemporaneous incident reports, were performed on all ID between March 2010 to August 2022 at an academic medical center. RESULTS: Over 12 years, 154 IDs occurred (∼13/year, average age: 54.3 years, male: 60%). Most occurred during emergency procedures (n = 115, 74.7%), 39 (25.3%) during elective procedures. Incident reports were submitted in 129 cases (84%). 21 (16.3%) reports cited 28 contributing factors including challenges with coordination (n = 8, 28.6%), skill-based errors (n = 7, 25.0%), and environmental factors (n = 3, 10.7%). CONCLUSIONS: Most deaths occurred in patients admitted from the ER with general surgical problems. Despite expectations for incident reporting, few provided actionable information on ergonomic factors which might help identify improvement opportunities.

Identifying Workflow Disruptions in Robotic-Assisted Bariatric Surgery: Elucidating Challenges Experienced by Surgical Teams.

PURPOSE: Bariatric surgery is an effective and durable treatment for weight loss for patients with extreme obesity. Although traditionally approached laparoscopically, robotic bariatric surgery (RBS) has unique benefits for both surgeons and patients. Nonetheless, the technological complexity of robotic surgery presents new challenges for OR teams and the wider clinical system. Further assessment of the role of RBS in delivering quality care for patients with obesity is necessary and can be done through a human factors approach. This observational study sought to investigate the impact of RBS on the surgical work system via the study of flow disruptions (FDs), or deviations from the natural workflow progression. MATERIALS AND METHODS: RBS procedures were observed between October 2019 and March 2022. FDs were recorded in real time and subsequently classified into one of nine work system categories. Coordination FDs were further classified into additional sub-categories. RESULTS: Twenty-nine RBS procedures were observed at three sites. An average FD rate of 25.05 (CI = ± 2.77) was observed overall. FDs were highest between insufflation and robot docking (M = 29.37, CI = ± 4.01) and between patient closing and wheels out (M = 30.00, CI = ± 6.03). FD rates due to coordination issues were highest overall, occurring once every 4 min during docking (M = 14.28, CI = ± 3.11). CONCLUSION: FDs occur roughly once every 2.4 min and happen most frequently during the final patient transfer and robot docking phases of RBS. Coordination challenges associated with waiting for staff/instruments not readily available and readjusting equipment contributed most to these disruptions.

Using flow disruptions to understand healthcare system safety: A systematic review of observational studies.

This systematic review provides information on the methodologies, measurements and classification systems used in observational studies of flow disruptions in clinical environments. The PRISMA methodology was applied and authors searched two databases (PubMed and Web of Science) for studies meeting the following inclusion criteria: (a) were conducted in a healthcare setting, (b) explored systems-factors leading to deviations in care processes, (c) were prospective and observational, (d) classified observations, and (e) were original research studies published in peer-reviewed journals. Thirty studies were analyzed and a variety of methods were identified for observer training, data collection and observation classification. Although primarily applied in surgery, comparable research has been successfully conducted in other venues such as trauma care, and delivery rooms. The findings of this review were synthesized into a framework of considerations for conducting rigorous methodological studies aimed at understanding clinical systems.

A Novel Approach for Engagement in Team Training in High-Technology Surgery: The Robotic-Assisted Surgery Olympics.

INTRODUCTION: There is ongoing interest in the development of technical and nontechnical skills in healthcare to improve safety and efficiency; however, barriers to developing and delivering related training programs make them difficult to implement. Unique approaches to training such as "serious games" may offer ways to motivate teams, reinforce skill acquisition, and promote teamwork. Given increased challenges to teamwork in robotic-assisted surgery (RAS), researchers aimed to develop the "RAS Olympics," a game-based educational competition to improve skills needed to successfully perform RAS. METHODS: This pilot study was conducted at an academic medical center in Southern California. Robotic-assisted surgery staff were invited to participate in the "RAS Olympics" to develop their skills and identify opportunities to improve processes. Impact of the activity was assessed using surveys and debriefs. RESULTS: Sixteen operating room team members participated and reacted favorably toward the RAS-Olympics (average score, 4.5/5). They enjoyed the activity, would recommend all staff participate, felt that it was relevant to their work, and believed that they practiced and learned new techniques that would improve their practice. Confidence in skills remained unchanged. Participants preferred the RAS Olympics to traditional training because it provided an interactive learning environment. CONCLUSIONS: The successful implementation of the RAS Olympics provided insight into new opportunities to engage surgical staff members while also training technical and nontechnical skills. Furthermore, this shared experience allowed surgical staff members to gain a greater appreciation for their teammates and an understanding of the current challenges and methods to improve teamwork and communication while promoting safety and efficiency in RAS.

A better way: training for direct observations in healthcare.

Direct observation is valuable for identifying latent threats and elucidating system complexity in clinical environments. This approach facilitates prospective risk assessment and reveals workarounds, near-misses and recurrent safety problems difficult to diagnose retrospectively or via outcome data alone. As observers are an instrument of data collection, developing effective and comprehensive observer training is critical to ensuring the reliability of the data collection and reproducibility of the research. However, methodological rigour for ensuring these data collection properties remains a key challenge in direct observation research in healthcare. Although prior literature has offered key considerations for observational research in healthcare, operationalising these recommendations may pose a challenge and unless guidance is also provided on observer training. In this article, we offer guidelines for training non-clinical observers to conduct direct observations including conducting a training needs analysis, incorporating practice observations and evaluating observers and inter-rater reliability. The operationalisation of these guidelines is described in the context of a 5-year multisite observational study investigating technology integration in the operating room. We also discuss novel tools developed during the course our project to support data collection and examine inter-rater reliability among observers in direct observation studies.

Room Size Influences Flow in Robotic-Assisted Surgery.

The introduction of surgical technology into existing operating rooms (ORs) can place novel demands on staff and infrastructure. Despite the substantial physical size of the devices in robotic-assisted surgery (RAS), the workspace implications are rarely considered. This study aimed to explore the impact of OR size on the environmental causes of surgical flow disruptions (FDs) occurring during RAS. Fifty-six RAS procedures were observed at two academic hospitals between July 2019 and January 2021 across general, urologic, and gynecologic surgical specialties. A multiple regression analysis demonstrated significant effects of room size in the pre-docking phase (t = 2.170, df = 54, ß = 0.017, p = 0.035) where the rate of FDs increased as room size increased, and docking phase (t = -2.488, df = 54, ß = -0.017, p = 0.016) where the rate of FDs increased as room size decreased. Significant effects of site (pre-docking phase: p = 0.000 and docking phase: p = 0.000) were also demonstrated. Findings from this study demonstrate hitherto unrecognized spatial challenges involved with introducing surgical robots into the operating domain. While new technology may provide benefits towards patient safety, it is important to consider the needs of the technology prior to integration.

Patient and Provider Experience with Telemedicine in a Urology Practice: Identifying Opportunities for Improvement.

INTRODUCTION: As a result of COVID-19, several clinics have adopted telemedicine to safely deliver care. However, the introduction of a new technology into an already complex system creates new challenges that have the potential to negatively impact patient and provider experience. We aimed to use a human factors approach (the science concerned with understanding the interactions between humans and other elements in a complex system) to identify where systemic vulnerabilities may exist throughout the patient/provider experience with telemedicine. METHODS: A total of 23 patients scheduled for telemedicine consults were observed during visits with providers. A trained human factors observer documented disruptions to system efficiency (eg communication breakdowns, connectivity problems and interruptions) and invited patients and providers to take a survey investigating perceptions of telemedicine technology usability, satisfaction with the experience and opportunities to improve the process. RESULTS: Visits lasted an average of 17 minutes, 20 seconds and each visit had an average of 6 disruptions. Inefficiencies were categorized into 13 categories consisting mainly of interruptions (21, 15.22%), Internet connectivity issues (21, 15.22%), nonoptimal device setup (19, 13.77%) and repeat communication (18, 13.04%). Provider satisfaction with the system was 3.72/5.00 and perceived usability was 63.15 (68 is considered acceptable). Patient satisfaction was 4.80/5.00 and perceived usability was 85. CONCLUSIONS: These findings highlight opportunities for a multifaceted intervention, including the development of an informational sheet/video for patients, a telemedicine "best practices" guideline for physicians, a standardized training process and checklist for front office staff and an in-service training for the entire care team.

Applying a Human Factors Approach to Improve Patient Experience with Sacral Neuromodulation.

OBJECTIVES: To apply a human factors approach, the study of interactions between humans and complex systems, to investigate patient preparedness, satisfaction, and perceived usability with sacral neuromodulation (SNM) and develop interventions aimed at improving patient experience. MATERIALS AND METHODS: Ten patients with overactive bladder undergoing staged SNM were observed, and data including pre-operative preparedness, satisfaction, perceived usability and barriers impacting patient experience were collected. Interventions were developed and an additional ten patients were observed. All patients were English-speaking and at least 18 years of age. RESULTS: Pre-intervention patients had difficulty understanding the risks of the procedure, did not know what to expect post-operatively and were unsatisfied with pre-operative materials. Interventions included: A pre-procedure educational video and informational sheet, detailed discharge instructions; and a nursing inservice. Pre-operative preparedness (Stage I: U = 100, z = 3.785, P = .000; Stage II: U = 80, z = 2.864, P = .003), post-operative satisfaction (Stage I: U = 100, z = 3.788, P = .000; Stage II: U = 77.5, z = 2.665, P = .006.) and perceptions of usability (Stage I: U = 77.00, z = 2.056, P = .043.; Stage II: U = 80.50, z = 2.308, P = .019) increased significantly after the intervention. CONCLUSION: Our observations highlight the value of implementing a human factors approach to identify and mitigate barriers impacting patient experiences with SNM. Through the implementation of systems-level interventions (ie, interventions that impact the non-clinical aspects of surgery such as patient and/or staff education), significant improvements can be made.

IMACTIV: A Pilot Study of the Impact of Unrestricted Activity Following Urethral Sling Surgery.

OBJECTIVES: To compare continence outcomes and health-related quality of life (HRQOL) among women with limited activity restrictions vs traditional restrictions following mid-urethral sling (MUS) surgery. METHODS: Thirty-six women who underwent MUS surgery were randomized: (1) the Restrictions group was given traditional postoperative restrictions for 6 weeks while (2) the Limited Restrictions group was instructed to resume normal activities other than pelvic rest. Patients undergoing concomitant surgery for Stage III and IV prolapse were excluded. Participants completed questionnaires related to urinary symptoms (UDI-6, IIQ-7) for continence outcomes and HRQOL (SF-12) at baseline, 1 to 6 weeks, 3 months, 6 months, and at least 1 year after surgery. RESULTS: There was no difference in mean scores on the UDI-6 or IIQ-7 between groups at baseline or any time after surgery. The Limited Restrictions group reported better scores than the Restrictions group on the SF-12 mental health component at 1 week (56.7 vs 50.2, P = .01) and 4 weeks (58.4 vs 53.3, P = .04). The Restrictions group reported better SF-12 physical health scores at 5 weeks (55.7 vs 53.0, P = .02) but there was no difference in HRQOL scores between the two groups at any other time. CONCLUSION: In this pilot study, there was no difference in continence outcomes for women with traditional vs limited activity restrictions following MUS surgery. There were differences in HRQOL in the early post-operative period, but these differences were not sustained. Larger prospective studies are needed, but it appears that activity restrictions after MUS surgery may not be necessary.

Identifying Opportunities to Improve Patient Experience With Sacral Neuromodulation: A Human Factors Approach.

OBJECTIVES: To use a human factors approach to conduct a needs assessment of patient preparedness, education, device usability, and satisfaction regarding all stages of sacral neuromodulation therapy and identify opportunities for improvement. Sacral neuromodulation, though minimally invasive, involves an initial testing phase that requires active patient participation. This process is relatively complex and, if a patient does not receive adequate preprocedure education, can be difficult to conceptualize. MATERIALS AND METHODS: Candidates were recruited to participate before undergoing staged sacral neuromodulation. Ten patients were observed, and their experiences were evaluated at 4 phases: (1) date of test implant (Stage I), (2) 5 days following Stage I, (3) date of permanent implant (Stage II), and (4) 3 months following Stage II. Administered questionnaires focused on preoperative preparedness, postoperative satisfaction, and usability. RESULTS: While every patient reported that their symptoms were at least "a little better" postoperatively, they generally had difficulty understanding the risks of the planned procedure, did not know what to expect postoperatively and were unsatisfied with the preoperative materials. Patients struggled with adjusting the settings for their implant devices and usability was considered "below average." Despite overall objective success, 30% of patients indicated that they would not recommend this treatment to friends/family. CONCLUSION: This pilot needs analysis demonstrates several opportunities for improvement in the experience of patients undergoing sacral neuromodulation. These findings highlight the opportunities for a multifaceted intervention to improve patient understanding through the testing phase.

Unsupervised Machine Learning Approaches Reveal Distinct Phenotypes of Perceived Bladder Pain: A Pilot Study.

Interstitial cystitis/bladder pain syndrome (IC/BPS) is defined as an unpleasant sensation perceived to be related to the bladder with associated urinary symptoms. Due to difficulties discriminating pelvic visceral sensation, IC/BPS likely represents multiple phenotypes with different etiologies that present with overlapping symptomatic manifestations, which complicates clinical management. We hypothesized that unique bladder pain phenotypes or "symptomatic clusters" would be identifiable using machine learning analysis (unsupervised clustering) of validated patient-reported urinary and pain measures. Patients (n = 145) with pelvic pain/discomfort perceived to originate in the bladder and lower urinary tract symptoms answered validated questionnaires [OAB Questionnaire (OAB-q), O'Leary-Sant Indices (ICSI/ICPI), female Genitourinary Pain Index (fGUPI), and Pelvic Floor Disability Index (PFDI)]. In comparison to asymptomatic controls (n = 69), machine learning revealed three bladder pain phenotypes with unique, salient features. The first group chiefly describes urinary frequency and pain with the voiding cycle, in which bladder filling causes pain relieved by bladder emptying. The second group has fluctuating pelvic discomfort and straining to void, urinary frequency and urgency without incontinence, and a sensation of incomplete emptying without urinary retention. Pain in the third group was not associated with voiding, instead being more constant and focused on the urethra and vagina. While not utilized as a feature for clustering, subjects in the second and third groups were significantly younger than subjects in the first group and controls without pain. These phenotypes defined more homogeneous patient subgroups which responded to different therapies on chart review. Current approaches to the management of heterogenous populations of bladder pain patients are often ineffective, discouraging both patients and providers. The granularity of individual phenotypes provided by unsupervised clustering approaches can be exploited to help objectively define more homogeneous patient subgroups. Better differentiation of unique phenotypes within the larger group of pelvic pain patients is needed to move toward improvements in care and a better understanding of the etiologies of these painful symptoms.