DOI: 10.1097/DCR.0000000000004218

Short Title: Delphi Determined Prolapse Research

Brooke H. Gurland, M.D. • Sydni Au Hoy, B.S. • Liliana Bordeianou, M.D., M.P.H. • Alison Hainsworth, M.D. • Amy J. Thorsen, M.D. • Carlo Ratto, M.D. • Pedro Basilio, M.D., M.Sc. • Lucia Oliveira, M.D., Ph.D. • Margarita Murphy, M.D. • Shuqing Ding, Ph.D., LAc. E •

Jonathan King, M.P.H. • Pelvic Floor Consortium Volunteers Workgroup 2024 of the American Society of Colon and Rectal Surgeons • Craig Olson, M.D.

¹ General Surgery, Stanford University School of Medicine, Stanford, California, USA

² General Surgery, Stanford University School of Medicine, Stanford, California, USA

³ Department of Surgery, Pelvic Floor Disorders Center, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA

⁴ Guys and St Thomas’ Hospital, London, England, United Kingdom

⁵ University of Minnesota, Hopkins, Minnesota, USA

⁶ Isola Tibe rina, Gemelli Isola Hospital, Catholic University, Rome, Italy

⁷ Copa Star Hospital, RJ, Brazil

⁸ Casa de Saude Sao Jose, RJ, Brazil

⁹ Orlando Health Colorectal Institute, Florida State University, Orlando, FL, USA

¹⁰ Northwestern Health Science University, Bloomington, Minnesota, USA

¹¹ General Surgery, Stanford University School of Medicine, Stanford, California, USA

¹² Department of Surgery, Texas A&M University, Baylor Scott and White, TX, USA

Copyright © The American Society of Colon & Rectal Surgeons, Inc. Unauthorized reproduction of this article is prohibited

Funding/Support: None reported.

Financial Disclosures: None reported.

Quickshot presentation at the annual scientific meeting of the American Society of Colon and Rectal Surgeons, San Diego, CA, May 10 to 13, 2025.

Correspondence: Sydni Au Hoy, B.S., Stanford University School of Medicine, General Surgery, 300 Pasteur Drive, Palo Alto, California 94305. Email: sauhoy@stanford.edu

BACKGROUND:

There is limited understanding on how to focus research and resources to enhance care for individuals with rectal prolapse.

OBJECTIVE:

This study aimed to identify and prioritize clinical research themes for rectal prolapse with and without pelvic organ prolapse based on the perspective of clinician and patient stakeholders.

DESIGN:

This IRB-approved (73560) study utilized the Delphi method (>70% consensus) with an initial open response survey followed by three subsequent iterative clinician survey rounds. A patient survey was adapted from the final consensus themes.

SETTINGS:

Secure electronic data capture platform was used for online survey collection and an in-person consensus meeting was held at the 2024 Pelvic Floor Consortium.

PARTICIPANTS:

Surveys were distributed through the Pelvic Floor Consortium volunteer list.

MAIN OUTCOME MEASURES:

Three hundred seventy-two clinicians completed the first Pround and response rates were 69% and 64% for the second and third rounds, respectively.

RESULTS:

The majority of respondents were colorectal surgeons (67%). 56% of clinician responders reported 10 or more years in practice and 47% had academic affiliations. Clinician responders were primarily from the United States (54%) and Europe (18%). Round one included 45 themes, 1 9 themes reached consensus at the end of round three. The consensus meeting included 146 clinician attendees and 13 themes were reconsidered during the meeting, three of which reached consensus. The final consensus comprised 22 themes which were adapted into a patient survey; twenty-six women (> 50 years) from the United States completed the survey. Ten themes reached consensus with all stakeholders with long-term functional outcomes reaching nearly unanimous agreement.

LIMITATIONS:

Limitations include potential for clinician bias and lack of patient participation in the initial open-response survey design.

CONCLUSIONS:

Through an iterative process we have identified a list of themes that can guide international collaboration on outcomes research over the next decade. See Video

KEY WORDS:

Delphi survey; Pelvic organ prolapse; Rectal prolapse.

INTERNACIONAL ANTECEDENTES:

Existe un conocimiento limitado sobre cómo enfocar la investigación y los recursos para mejorar la atención a las personas con prolapso rectal.

OBJETIVO:

Este estudio tuvo como objetivo identificar y priorizar temas de investigación clínica para el prolapso rectal, con y sin prolapso de órganos pélvicos, desde la perspectiva deprofesionales clínicos y pacientes.

DISEÑO: Este estudio, aprobado por el Comité de Revisión Instit

ucional ( 73560), utilizó el método Delphi (consenso superior al 70 %) con una encuesta inicial de respuesta abierta, seguida de tres rondas iterativas de encuestas para profesionales clínicos. Se adaptó una encuesta para pacientes a partir de los temas de consenso finales.

CONFIGURACIÓN:

Se utilizó una plataforma electrónica segura de captura de datos para la recopilación de encuestas en línea y se celebró una reunión de consenso presencial en el Consorcio de Suelo Pélvico 2024.

PARTICIPANTES:

Las encuestas se distribuyeron a través de la lista de voluntarios del Consorcio de Suelo Pélvico. PRINCIPALES MEDIDAS DE RESULTADOS: Trescientos setenta y dos médicos c línicos completaron la primera ronda y las tasas de respuesta fueron del 69% y el 64% para la segunda y la tercera ronda, respectivamente.

RESULTADOS:

La mayoría de los encuestados eran cirujanos colorrectales (67%). El 56% de los médicos clínicos que respondieron reportaron 10 o más años de práctica y el 47% tenía afiliaciones académicas. Los médicos clínicos que respondieron provenían principalmente de Estados Unidos (54%) y Europa (18%). La primera ronda incluyó 45 temas, 19 de los cuales alcanzaron consenso al final de la tercera ronda. La reunión de consenso incluyó a 146 médicos clínicos asistentes y 13 temas se reconsideraron durante la reunión, tres de los cuales alcanzaron consenso. El consenso final comprendió 22 temas que se adaptaron a una encuesta para pacientes; veintiséis mujeres (> 50 años) de Estados Unidos completaron la encuesta. Diez temas alcanzaron consenso con todas las partes interesadas, y los resultados funcionales a largo plazo alcanzaron un acuerdo casi unánime. LIMITACIONES: Entre las limitaciones se incluyen el posible sesgo clínico y la falta de participación de los pacientes en el diseño inicial de la encuesta de respuesta abierta.

CONCLUSIONES:

Mediante un proceso iterativo, hemos identificado una lista de temas que pueden orientar la colaboración internacional en la investigación de resultados durante la próxima década. (AI-generated translation)

INTRODUCTION

Rectal prolapse (RP), with or without pelvic organ prolapse, significantly affects quality of life, self-esteem, and daily functioning. Patients often experience distressing symptoms such as difficult evacuation, fecal leakage, discomfort or pain, mucus discharge, and rectal bleeding. [1]While RP is most commonly reported in postmenopausal, multiparous women, it can affect individuals of all ages, including men. Additionally, certain subgroups—such as those with psychiatric disorders, benign hypermobility syndromes, and chronic constipation—may be predisposed to both internal and external rectal prolapse.[2]

Despite its substantial impact, there is a lack of high-quality evidence guiding preoperative evaluation, optimization strategies, and both surgical and non-surgical management. Surgery remains the primary treatment option for high-grade internal and external RP; however, best practices for this heterogeneous patient population are not well established. [3][4][5]Addressing these gaps in knowledge is essential for improving patient care and outcomes.

The Pelvic Floor Disorders Consortium (PFDC) (https://fascrs.org/healthcare-providers/education/pelvic-floor-disorders-consortium) was established as a multidisciplinary group of experts dedicated to advancing the clinical care of pelvic floor disorders. This volunteer organization includes colorectal surgeons, urogynecologists, urologists, gynecologists, gastroentero logists, radiologists, advanced care practitioners, and physical therapists—all committed to improving the diagnosis and management of pelvic floor conditions. The PFDC was created to bridge the gap between specialties and foster collaboration among practitioners.

Previously, this group developed core clinical descriptors for rectal prolapse [6], and a synoptic operative report [7], to establish a standardized language for research and clinical care. By leveraging expertise from across the PFDC, this initiative ensures the inclusion of clinical stakeholders experienced in RP. Furthermore, patients with rectal prolapse were recruited to provide their perspectives and share their priorities, ensuring that patient-centered concerns are addressed in future research and care strategies.

Aims/Purpose: There is a limited understanding of how to effectively direct research and resources to improve the care of individuals with rectal prolapse. This study aims to identify and prioritize key clinical research themes for RP, with and without pelvic organ prolapse, based on the perspectives of both clinician and patient stakeholders.

MATERIALS AND METHODS

This Institutional Review Board (IRB)-approved study (IRB #73560) was conducted from February 2024 to February 2025 and utilized a three-round multi-step Delphi consensus (>70% consensus used) methodology to identify and prioritize clinical research topics in rectal prolapse care. [8]

Collection of Stakeholder Perspectives

Survey 1: An anonymous, open-ended online questionnaire was administered via Research Electronic Data Capture (REDCap©) to PFDC volunteers. Participants were asked, ’What are your top five clinical research priorities or questions related to rectal prolapse?’ Responses were analyzed using qualitative content-analysis techniques by a study panel consisting of three physicians a nd one research coordinator trained in qualitative coding.

Survey 2: The first iterative Delphi round (Survey 2) invited PFDC volunteers worldwide to rank the identified clinical research topics. Volunteers were recruited through pelvic floor society email lists. Demographic data were collected, including practice environment (e.g., academic vs. private), medical specialty, level of training, years in practice, estimated annual prolapse cases, and geographic location. Following the Delphi consensus methodology, topics that received an overall score between 1-3 by > 70% of responders were considered low priority and removed from the list of research topics. Topics that received an overall score between 4-6 were considered moderate priority and moved to the second iterative Delphi round (Survey 3) to be revoted on. Topics that received an overall score between 7-9 by > 70% of respondents were considered high priority and advanced directly to the third iterative Delphi round (Survey 4) for a final consensus vote.

Survey 3: Survey 3 (the second iterative Delphi round) was restricted to participants who completed more than 50% of Survey 2. The same ranking system and scoring criteria were used, and topics receiving a score of 7-9 from >70% of respondents advanced to Survey 4 (the final Delphi round). Topics that did not reach consensus were removed.

Survey 4: Survey 4 invited all previous respondents who completed at least 50% of Surveys 2 and 3 to participate in a final ranking round. [Figure 1]

In-Person Consensus Meeting: A consensus meeting was held at the PFDC Annual Meeting, which was hosted by the American Society of Colon and Rectal Surgeons (ASCRS) during its Annual Meeting in Baltimore (2024). The consensus meeting was held to review survey results and re-vote on topics that narrowly missed the 70% consensus threshold. Findings were also presented at the International Continence Society (ICS) meeting in Madrid (2024) as part of a PFDC joint collaborative.

Survey 5 (Patient survey): The final consensus statements were adapted using the Flesch-Kincaid readability calculator into an 8-9th grade reading level for patients who self-reported a history of rectal prolapse. This anonymous survey was distributed among the previous clinician respondents. Clinicians who routinely see a high volume of pelvic organ prolapse cases were encouraged to offer participation to their patients.

Statistical Analysis: Separate analyses were conducted for each Delphi survey. Respondents to Survey 2 were considered valid if they provided a valid email address; however, only those who completed more than 50% of the Delphi research themes survey were included in the final analysis. For each survey, demographic variables were summarized as counts and percentages. Practice location was further detailed by region and specific country/state combinations. Responses categorized as ’Other’ for practice environment or profession were specified separately for all valid respondents. For surveys 2,3,4 the analysis report included a general summary of question outcomes presented as counts and percentages using the criteria mentioned above and bar graphs for each question that display the ranking distribution, grouped into low, medium, and high. For each question, percentages were calculated based on the number of participants who provided a response. Respondents who did not answer a specific question were excluded from percentage calculations for that question. Participants who were part of the analysis population but did not answer a question were not included in the calculated percentages for that specific question. The survey 4 analysis additionally included a summary of the five survey questions with the highest proportions of high-priority rankings, displayed as percentages, both overall and compared between different demographic subgroups. Subgroup comparisons were conducted for the following categories: practice location: USA vs. Other, profession: colorectal surgeons vs. other specialties, practice environment: academic institutions vs. other settings, and years in practice: < 10 years vs. ≥10 years. All data were stored in separate REDCap projects (Vanderbilt University, Nashville, Tennessee) and analyzed using SAS® version 9.4 (SAS Institute, Cary, NC)."

RESULTS

Two hundred twenty-eight open-ended suggestions were collected and then organized into 12 themes and 45 survey topics. A total of 372 clinicians completed Survey 2; however, only 331 clinicians were included in the final analysis, which did not include residents or fellows. The response rates for Survey 3 and Survey 4 were 70.9% and 65.2%, respectively. The majority of respondents were colorectal surgeons (67%), urogynecologists/urologists (14%), and pelvic floor physical therapists (12%). Most clinicians (56%) had ≥10 years of experience, and 47% were affiliated with an academic institution; 20% worked in private practice. Clinician respondents were from the United States (54%), Europe (18%), Latin America (12%), Asia (8%), and Australia/New Zealand (6%). The majority of clinician respondents performed between 10-20 cases per year (123, 37%) or less than 10 cases annually (89, 27%). Demographics are reported in Table 1.

A total of 45 topics were included in Survey 2, and by the conclusion of Survey 4, 19 topics had reached consensus. One hundred and forty-six clinicians attended the in-person consensus meeting, where 13 topics were reconsidered, and three additional topics achieved consensus (Table 2). Ultimately, 22 topics were finalized and adapted into an online patient survey. A total of 26 women aged 18-90 years from the United States completed a single patient survey. Ten themes reac hed consensus among all stakeholders.

Top-Rated Questions: The top five survey questions with the highest proportions of high rankings by clinicians included the following: Long-term functional and anatomic outcomes 97%, Prolapse recurrence treatment options 87%, Preoperative decision-making 82%, the benefit of pelvic floor physical therapy pre or post prolapse surgery 80%, and Mesh outcomes, types of material and complications 74%. Table 3 demonstrates subgroup differences when comparing results based on the responders from the USA vs international community, based on specialty, practice environment, and years in practice (Table 3). Clinician responses compared to patient responses are reported in Table 4.

DISCUSSION

The purpose of this initiative is to identify and prioritize key clinical research themes for RP, based on the perspectives of both clinician and patient stakeholders, utilizing a modified Delphi process. During the in-person meeting, we organized and grouped topics using an impact feasibility matrix. Themes were bucketed into categories of decision-making, gaps in care or unmet needs, surgical intervention, and innovation. This categorization aims to engage stakeholders in volunteer projects within these areas which could drive the Pelvic Floor Disorders Consortium over the next 5-7 years. “Long-term anatomic and functional outcomes” and “Prolapse recurrence treatment options” were identified as the most critical research priorities by both clinicians and patients and were considered high impact. The ability to compare surgical procedures, identify predictors of success or recurrence, and evaluate outcomes for multicompartment prolapse will depend on the systematic collection of long-term data. While previous initiatives led by the PFDC group have successfully implemented short-term follow-up quality improvement (QI) projects,[9] there remains a critical need to establish standardized long-term data collection. Notably, this group has already built a strong foundation for data standardization through the IMPACT survey, [1]Core

Descriptors,[6] and Synoptic Operative Report, [7] which provide an essential framework for research consistency. The feasibility of collecting long-term outcomes has logistical challenges, such as Data Use Agreements (DUAs) between sites may take up to a year to formalize, and given the timeline required for patient accrual and follow-up, this project could take 7-10 years to complete. Despite these challenges, the long-term impact of such a study could be transformative, offering high-quality evidence to guide surgical decision-making, optimize patient outcomes, and improve long-term care for individuals with rectal prolapse. To advance this initiative, we established a subcommittee within the ASCRS Steering Committee on Pelvic Floor Disorders to identify the necessary resources and infrastructure for a long-term patient outcome study.

Another critical discussion topic was the management of internal rectal prolapse, particularly in patients with obstructed defecation and/or fecal incontinence.[10] Due to the limited evidence base, this was recognized as an unmet clinical need across all levels of surgical experience. Based on its high feasibility, the group proposed an expert consensus and workgroup model to address this issue, with planned collaboration among international experts. Defining patient priorities achieved consensus in 74% of clinicians and 94% of patients, a topic that was emphasized during the in-person meeting. An anonymous patient-facing survey was conducted to capture the patient perspective, and also sought patients interested in participating in interviews for more qualitative evaluation. This qualitative approach will complement the patient facing survey which was initiated to gauge interest. During the ICS/Madrid meeting, participants discussed the best mechanisms for incorporating patient perspectives drawing on

models from the low anterior syndrome literature. Additionally, a volunteer group will be established to focus exclusively on integrating patient perspectives into research initiatives. Topics that did not meet consensus among clinicians included the development of patient educational tools, prolapse-specific surveys or scores, preoperative workup, diagnostic testing, informed consent, and shared decision-making. In contrast, 78.9% of patients agreed on the necessity of developing patient educational tools. Currently, patient-centered resources for specific pelvic floor disorders are often not readily accessible, and health literacy regarding these conditions remains low. Research has demonstrated that video animation can significantly enhance patients’ understanding of rectal prolapse. [11] Therefore, the development of such educational resources and the utilization of available platforms for educational consumption could be further explored when assessing patient priorities.

To better understand variations among practitioners we conducted a subgroup analysis and identified several differences in the top-rated questions between clinician subgroups. “Predictors of post-op function” was rated as high priority by participants based in the USA, while “Pelvic Floor Dyssynergia and Defecation disorders” received higher priority by participants from other countries. These differences may be attributed to variations in condition prevalence or the role of surgeons in managing pelvic floor dyssynergia.

Clinicians with less than 10 years in practice rated “Pelvic Floor Dyssynergia and Defecation disorders” and “Benefit of pelvic floor physical therapy pre or post prolapse surgery” as higher priority. In contrast, clinicians with at least 10 years of experience were more inclined to prioritize “Predictors/Risk factors for Prolapse Recurrence” and “Preoperative Decision-Making.” This difference may be attributed to a multitude of factors, including the fact that less experienced surgeons have had less exposure and understanding of the pathophysiology of these conditions, while more experienced surgeons have a better grasp of the long-term aspects of rectal prolapse and its treatment.

Clinicians p racticing in academic environments showed greater interest in “Predictors of Post-operative Function” whereas those in private practice rated “Predictors/Risk Factors For Prolapse Recurrence” as a higher priority. This variation may be influenced by the access to survey resources; academic settings often have the infrastructure for distribution, scoring and analyzing bowel functional surveys, making function a key area of interest. When functional scores are not available anatomic outcomes are of higher priority which could explain why private practitioners may be more interested in having the Pelvic Floor Disorders Consortium focus on developing predictive models to identify patients at risk for anatomic recurrence. Despite these nuances, PFDC members acknowledge that both function and recurrence are high priorities. One of our goals in bringing this discussion to an international society level is to ensure the inclusion of patients and clinicians from all practice models.

Furthermore, topics focusing on “preoperative decision-making” and “benefits of PFPT pre and post surgery” were deemed most relevant to colorectal surgeons. It is expected that decision-making during the perioperative period- including optimization, timing of surgery, and surgical technique- would be particularly pertinent to surgeons. The PFDC previously convened (2023) to discuss the role of physical therapy and acknowledged a significant deficit in the literature on this topic. For internal rectal prolapse and conditions such as obstructive defecation syndrome (ODS) and fecal incontinence (FI), PFPT is considered a prerequisite to surgery. [12]In contrast,

for external rectal prolapse, the offering of PFPT is more variable and the PFDC consensus was that PFPT should not delay surgery.

Finally, multicompartment surgery was identified as an ongoing research priority. A key focus is understandi ng the long-term outcomes of rectal prolapse surgery performed alone compared to those combined with vaginal surgery. While the collection of long-term data is essential, shorter term initiatives- such as expert opinion efforts or projects related to surgical efficiency- may be feasible in the interim.

A limitation of this study is the potential for clinician bias based on factors such as the predominant specialty of colorectal surgeons, practice type, location, and number of RP patients seen annually. We also acknowledge that our patient survey design has several limitations particularly since patients did not participate in the statement collection or Delphi process, and the IRB was limited to patients from a few institutions with a high volume of pelvic organ prolapse cases in the USA. As noted during the ICS/Madrid meeting, the patient survey has the potential to limit patient input by not allowing for qualitative and individualized feedback. The intention is for future studies to include more qualitative and thoughtful patient participation. Additionally, we recorded one programming glitch during the analysis of this study. During the transfer of high-priority research themes from survey 1 to survey 3, two themes, “Defining Success of Procedure” and “Comparing Different Prolapse Surgical Approaches” -were erroneously excluded. These two themes were presented and discussed at the in-person meeting, where consensus was ultimately reached.

CONCLUSION

Our findings underscore a multidisciplinary and international consensus on research priorities in rectal prolapse care. The high level of engagement from experienced specialists, along with diverse geographic representation enhances the validity of these results and establishes a framework for the PFDC for the next decade. The identification and presentation of these research priorities have already sparked important discussions and collaborative initiatives aimed at improvin g care for patients with RP.

Moreover, the alignment between clinician- and patient-identified priorities underscores the significance of integrating patient perspectives into research design. Future studies should aim to further validate these themes with larger and more diverse patient cohorts, as well as exploring strategies to translate these research priorities into actionable clinical guidelines and interventions.

References