SAGES Guidelines Development: Patient Engagement Update to Standard Operating Procedure

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Authors

Nisha Narula¹, Bethany J. Slater², Patricia Sylla³, Sunjay S. Kumar⁴, Elisa Calabrese^5,6, Joe Nadglowski⁷, Deborah S. Keller⁸

Abstract

Introduction: The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Guidelines Committee develops evidence-based surgical guidelines. Involvement of patient partners is important to ensure patient concerns and values are adequately addressed and incorporated. This standard operating procedure (SOP) for the process of patient partner involvement within the guidelines is described here.

Methods: This document outlines the SAGES Patient Partners SOP to involve patient partners in a consistent and reproducible manner.

Results: SAGES has now developed a SOP to include patient partners so that patient views are represented in current guidelines.

Conclusions: Guidelines must be patient-centric and in order to do so must include patient partners. The SAGES Guidelines Patient Engagement Update to Standard operating Procedure aims to provide an outline for systematically doing so.

Keywords: Patient engagement · Patient partner · Patients in the public interest · Guideline · Protocol

Introduction

The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) has a rigorous process in place for developing surgical clinical practice guidelines. Currently, this process involves completing a systematic review to investigate the current literature and establish evidence-based recommendations using a multidisciplinary team that includes surgeons, surgical trainees, other physicians, a research librarian, and a methodologist. While the process is quite robust, requiring significant time commitment from those developing them, until recently there has been no standardized process to deliberately incorporate the patient perspective. There is a paradigm shift globally as well as specifically within SAGES and the guideline development community towards a more patient-centric approach in surgery, aiming to improve outcomes, enhance patient satisfaction, and promote a sense of partnership between healthcare providers and patients. The patient-centered approach represents a change for patient representatives from the traditional role of passive “order taker” to active “team member” in all aspects of care. SAGES is committed to patient engagement more broadly, as well, not only as part of guidelines but in all educational products, annual meeting content, educational brochures, and research. In line with this, SAGES has a newly developed Patient Engagement Task Force as of 2024 to align with patient priorities to improve patient-centered care.

A patient partner is a person that has had the surgery or disease of interest or has provided support to a patient undergoing the intervention or disease of interest. Patient partners can include patients, service users, survivors, carers, and family members. As the patient partner has either experienced the intervention or provided support to a patient undergoing the intervention, they have the unique ability to serve as a subject matter expert from their lived experience of a specific disease, procedure/intervention, and healthcare delivery and management. As such, they can accurately advise on experience-based data that specifically relates to patients’ attitudes or points of view about their condition or its management. Patient representation is essential in all research to ensure the goals and outcomes for the investigators are aligned with patients’ expectations, needs and preferences [1]. The need for patient representation is highlighted in surgical guidelines to ensure appropriate representation of perceptions, goals, priorities, concerns, opinions, and preferences in the recommendations for practice. There are other societies, including European Association for Endoscopic Surgery (EAES) [2], European Hernia Society (EHS), and European Society of Coloproctology (ESCP) [3], that have successfully incorporated patient partners in their guidelines. However, there are minimal published formal materials on the specific process to include patients in society guidelines in a meaningful and sustained fashion.

SAGES has been at the forefront of researching, developing, and disseminating the guidelines for standards of practice in laparoscopic and endoscopic surgical procedures for 25 years. Currently, there is a process in place for guideline development, which includes a multidisciplinary team and public comment [4]. To meet the standards of a patient-centric approach, the SAGES Guidelines Committee has worked to update the existing process to ensure the patient perspective is well represented and incorporated into creating recommendations.  Thus, this standard operating procedure (SOP) aims to outline the approach to including patient partners in the SAGES guidelines.

Methods

This process is modeled on the SAGES Guideline Development Standard Operating Procedure [4]. A The process was developed with the current Guidelines Committee leadership, leadership for the SAGES Guidelines Patient Engagement Task Force, SAGES Patient Engagement Task Force leadership, and a patient partner.

Results

There is a current initiative to create a Patient Partners Network (PPN) within SAGES to enhance patient and public involvement. With collaboration across SAGES and other societies, patient and patient partners will be recruited so that when guidelines related to their interest or disease are being developed, they can be contacted. This will include patients, patient allies, and patient advocacy groups. Of those patients included in the PPN, if they are interested in contributing to guidelines, a member of the guidelines team will provide brief education and training to orient them to the guidelines process.

 Step 0: Project conception and team assignments

This step involves choosing the subject of the guideline and recruiting members to the project. During this step, it will be important to reach out to enough patient partners to ensure that there is sufficient patient representation and that there is diversity within the representation. We will aim for diversity in gender, race, ethnicity, language preference, socioeconomic status, health literacy level, and geographic location. To ensure this, we will have an optional demographic survey for patients to complete and thereby attempt to ensure a broad patient partner population within each guideline. Once patients have expressed their interest, the leads of the guideline will formally educate patients with an introduction to the project and their role as well as details about guidelines and guideline development. Leads of the guideline will also assure the appropriateness of the patient partners for the project and answer questions they may have.

Step 1: Key questions and Inclusion/Exclusion

This step involves generating the key questions in the PICO (population, intervention, comparison, outcome) framework. This is a crucial point in which patient partners will be actively involved. Their input will be sought and incorporated to ensure the key questions that are being asked are important to patients in addition to surgeons and especially that the outcomes for key questions are relevant to patients and patient partners. The specific PICO questions will be developed by the guideline panel and subject matter experts. The key questions and important and critical outcomes will be identified by the experts and then feedback from patient partners will be solicited. Patients will rank the outcomes in order of importance to them. Patient-reported outcome measures (PROMS) and patient-reported experience measures (PREMS) will be included if available.

 Step 2: Literature search

In this step, the research librarian and lead(s) of the guideline construct search criteria and then searches are conducted across multiple databases. If any questions or outcomes of particular interest to patients have minimal or no data that would be able to be reviewed, this will be noted as an important area of future research that should be investigated. In this step, there would be no significant involvement of patient partners.

 Steps 3-8

Abstract review, Full text review, Data extraction, Quality assessment, Data analysis/meta-analysis and follow up literature search, and Evidence tables and systematic review manuscript will have no patient partner involvement. See Rogers, et. al. for details of these steps [4].

 Step 9-10: Guidelines development and guidelines manuscript

During this step, the guideline panel will meet and follow the GRADE methodology to review the evidence to tables and formulate a description of the results taking a patient-centered approach and the previously discussed critical outcomes are taken into account. After this, the Evidence to Decision tables will be created that summarize the degree of desirable and undesirable effects, the certainty of the evidence, variation that exists between patients, the balance of effects, and the acceptability, with a final recommendation made. Other considerations, such as future areas of research, subgroup needs, implementation, and monitoring, will also be discussed. The patient partner will assist namely in providing perspective for acceptability for the intervention and comparator, subgroup needs, and any other additional considerations they feel need to be taken into account. In addition, the final recommendations will be discussed with patient partners. Their feedback and impressions will be incorporated into the manuscript.

Steps 11-12

Review by Chairs/Panel and Incorporation of Edits and Committee and Board Vote will have no patient partner involvement.

 Step 13: Member and Public Review

Guidelines are uploaded onto the SAGES website and membership can review. The patient partners will have the ability to access the guidelines at this time, as well, and provide any final feedback.

Step 14: End Product Publication

The Guideline will be submitted to Surgical Endoscopy and afterwards published on the SAGES website. The patient partners would be informed that the Guideline is published and thanked/acknowledged for their contribution.

Discussion

The SAGES Guidelines process is rigorous but until recently, there has been no standard process to include patient partners. This SOP aims to develop a standardized process to incorporate patient voices and integrate their perspective into surgical guidelines. In addition, this SOP will provide a process that others can also replicate.

From our experience of working with patients on a few guidelines, we have found it valuable and rewarding. It has led to modifications in our guidelines, and patient partners brought up suggestions that as clinicians we had not considered. Specifically, we had patient partners comment on key question relevance, appropriateness of outcome measures, acceptability of interventions, presence of additional subgroups, and provide any other concerns. The patient partners also brought up issues of cost/surprise billing for them, the importance of focus on long term outcomes rather than intraoperative or short-term outcomes, and re-emphasized that certain subgroups may prefer different treatment options. Notably, most of the patient partner comments were in line with what had already been done; most of the questions and outcomes were consistent with what the panel hoped to include, as well, which means that clinicians and patients are likely aligned on the importance of most issues. Going forward, much of the focus will be on choosing and ranking importance of outcomes to assure that appropriate balancing of desirable and undesirable outcomes is considered when creating recommendations.

There have been other societies that have incorporated the patient experience in the guideline process, including EAES, ESCP, and EHS [2, 3]. In one study, the majority of institutions reviewed noted the importance of including patients or their representatives, but less than half had a description of a process to incorporate patients [5]. In addition, a review of clinical practice guidelines showed that there was a greater focus on treatment effectiveness rather than patient preference. Only 4.6% of words focused on patient preferences [6]. In another review, only half of studies included patient preferences and only 42.9% included patients in multiple ways [7] Including patients in guidelines will help bring patient priorities to the forefront both for guideline recommendations and for areas of future research. Thus SAGES is not the first to include patients in guidelines, we are among the first to create a standardized operating procedure.

In addition, there have been various studies on the importance of including the patient experience in other aspects of research other than guidelines, including priorities for investigation. The main areas that have been published regarding patient engagement include diagnosis, treatment, hospital stay, follow up, needs for family members/caregivers, need for information, psychosocial needs, standards expected, other patient priorities, and importance of different symptom priorities, to name a few [8-13].

There are challenges in incorporating patient preferences into guidelines, as reviewed in a commentary by Montori, et. al.[14] such as recruitment, retention, maintaining engagement, and ensuring a diverse group of patients. However, it is clear that the patient perspective is important and further work needs to be done to continue to include their view; we hope that this SOP is a start to emphasizing the patient perspective in guidelines and creating a reliable process to incorporate the patients’ values within the guidelines.

Declarations

Funding: No funding to declare.

Disclosures: Nisha Narula has no conflicts of interest or financial ties to disclose. Bethany J. Slater received consulting fee from Hologic and is the SAGES Guideline Chair. Patricia Sylla received consulting fees from Ethicon, Stryker, Safeheal, Exero, Activ Surgical. Sunjay S. Kumar has no conflicts of interest or financial ties to disclose. Elisa Calabrese received SAGES guidelines research fellowship 2023-2025 with stipend from SAGES and Royal Australasia College of Surgeons (RACS). Joe Nadglowski is an employee of the Obesity Action Coalition (OAC). He is Obesity Care Advocacy Network former Co-Chair. OAC, his employer, receives support from a wide number of companies and organization interested in obesity care including obesity related pharma, surgical device and equipment manufacturers and behavioral treatment companies as well as the not for profit medical societies related to such care. OAC received fees from NovoNordisk and Boehringer Ingelheim for Patient centered clinical trial review. OAC received fees from Novo Nordisk, Amgen, Boehringer Ingelheim, Lilly, WondrHealth for Presentation honoraria. OAC received fees from WondrHealth Advisory Board and Boehringer Ingelheim Advisory Board. Deborah S. Keller has no conflicts of interest or financial ties to disclose.

References

1. Arumugam A, Phillips LR, Moore A, Kumaran SD, Sampath KK, Migliorini F, et al (2023) Patient and public involvement in research: a review of practical resources for young investigators. BMC Rheumatol 7(1):2.
2. Adamina M, Andreou A, Arezzo A, Christogiannis C, Di Lorenzo N, Gioumidou M, et al (2022) EAES rapid guideline: systematic review, meta-analysis, GRADE assessment, and evidence-informed European recommendations on appendicitis in pregnancy. Surg Endosc  36(12):8699-712.
3. Stabilini C, Muysoms FE, Tzanis AA, Rossi L, Koutsiouroumpa O, Mavridis D, et al (2023) EHS Rapid Guideline: Evidence-Informed European Recommendations on Parastomal Hernia Prevention-With ESCP and EAES Participation. J Abdom Wall Surg. 2:11549.
4. Rogers AT, Dirks R, Burt HA, Haggerty S, Kohn GP, Slater BJ, et al (2021) Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) guidelines development: standard operating procedure. Surg Endosc 35(6):2417-2427.
5. Selva A, Sanabria AJ, Pequeno S, Zhang Y, Sola I, Pardo-Hernandez H, et al (2017) Incorporating patients’ views in guideline development: a systematic review of guidance documents. J Clin Epidemiol 88:102-112.
6. Chong C, Chen I, Naglie G, Krahn MD (2009) How Well Do Guidelines Incorporate Evidence on Patient Preferences? J Gen Intern Med 24(8):977-982.
7. Kim C, Armstrong MJ, Berta WB, Gagliardi AR (2020) How to identify, incorporate and report patient preferences in clinical guidelines: A scoping review. Health Expect 23(5):1028-1036.
8. Tsianakas V, Maben J, Wiseman T, Robert G, Richardson A, Madden P, et al (2012) Using patients’ experiences to identify priorities for quality improvement in breast cancer care: patient narratives, surveys or both? BMC Health Serv Res 12:271.
9. Kent EE, Rowland JH, Northouse L, Litzelman K, Chou WY, Shelburne N, et al (2016) Caring for caregivers and patients: Research and clinical priorities for informal cancer caregiving. Cancer 122(13):1987-95.
10. Bower P, Roland M, Campbell J, Mead N (2003) Setting standards based on patients’ views on access and continuity: secondary analysis of data from the general practice assessment survey. BMJ 326(7383):258.
11. Tschiesner U, Sabariego C, Linseisen E, Becker S, Stier-Jarmer M, Cieza A, et al (2013) Priorities of head and neck cancer patients: a patient survey based on the brief ICF core set for HNC. Eur Arch Otorhinolaryngol 270(12):3133-3142.
12. Higginson IJ, Gomes B, Calanzani N, Gao W, Bausewein C, Daveson BA, et al (2014) Priorities for treatment, care and information if faced with serious illness: a comparative population-based survey in seven European countries. Palliat Med 28(2):101-110.
13. Martinez-Serna T, Tercero F, Jr., Filipi CJ, Dickason TJ, Watson P, Mittal SK, et al (1999) Symptom priority ranking in the care of gastroesophageal reflux: a review of 1,850 cases. Dig Dis 17(4):219-224.
14. Montori VM, Brito JP, Murad MH (2013) The optimal practice of evidence-based medicine: incorporating patient preferences in practice guidelines. JAMA  310(23):2503-2504.

Author Affiliations

Nisha Narula¹, Bethany J. Slater², Patricia Sylla³, Sunjay S. Kumar⁴, Elisa Calabrese^5,6, Joe Nadglowski⁷, Deborah S. Keller⁸

1. Department of Surgery, Rutgers, New Jersey Medical School, 185 South Orange Avenue, Medical Science Building, Room G‑506, Newark, NJ 07103, USA
2. Department of Surgery, University of Chicago, Chicago, IL, USA
3. Division of Colon and Rectal Surgery, Mount Sinai Health System, New York, NY, USA
4. Department of Surgery, Thomas Jefferson University Hospital, Philadelphia, PA, USA
5. Department of Surgery, University of California-East Bay, Oakland, CA, USA
6. Department of Surgery, University of Adelaide, The Queen Elizabeth Hospital, Adelaide, Australia
7. Obesity Action Coalition, Tampa, FL, USA
8. Division of Digestive Surgery, University of Strasbourg, Strasbourg, France

Corresponding Author: Nisha Narula, MD