Development of a Contextualized Patient Safety Bundle for Operating Rooms in North Kivu, DRC: A Consensus-Based Approach | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Development of a Contextualized Patient Safety Bundle for Operating Rooms in North Kivu, DRC: A Consensus-Based Approach Jacques Fadhili Bake, Katya Loban, Elisabeth Mishika, Masoda Nyamalyongo Maurice, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7361454/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 7 You are reading this latest preprint version Abstract Background : Operating rooms are complex, high-risk environments where preventable harm is frequent, especially in resource-limited settings such as North Kivu, a province in eastern Democratic Republic of Congo (DRC). Although global patient safety interventions exist, adapting these strategies to local realities remains challenging. This study aimed to develop a practical patient safety bundle specifically tailored to enhance the safety culture in operating rooms within North Kivu hospitals. Methods : A modified nominal group technique (NGT) was used to gather and prioritize strategies from a multidisciplinary panel of nine stakeholders, including healthcare professionals and patients from Goma hospitals. Participants reviewed evidence, shared perspectives, and ranked strategies to improve patient safety culture in local operating rooms. Results : The implementation of the WHO Surgical Safety Checklist was identified as the most effective and feasible strategy, supported by regular team training, leadership engagement, patient involvement, and continuous monitoring. Other themes included leadership and team culture; Continuous training and improvement; Patient-centered care and Organizational processes. The resulting patient safety bundle reflects consensus-driven, context-sensitive interventions tailored to North Kivu’s unique challenges. Conclusion : This study provides the first consensus-based patient safety bundle for operating rooms in North Kivu, offering a practical foundation for future implementation and effectiveness research. The approach can inform similar initiatives in other low-resource settings. Trial registration: Not applicable Patient safety Operating room WHO Surgical Safety Checklist Low-resource settings North Kivu Consensus Figures Figure 1 Figure 2 Introduction Patient safety remains a paramount concern in surgical care worldwide, with operating rooms recognized as complex, high-risk environments where preventable harm can occur frequently [1,2]. It is estimated that hundreds of thousands of patients globally suffer adverse events in hospitals each year due to errors that could have been avoided [3]. The dynamic and fast-paced nature of surgical settings, coupled with multiple interacting team members and high-stakes procedures, creates numerous opportunities for mistakes, ranging from patient misidentification to equipment failures and communication breakdowns [4]. Effective risk management strategies in the operating room extend beyond individual vigilance to encompass system-wide approaches that promote safety-conscious behaviors and minimize errors [3,5,6]. These strategies include standardized protocols for patient identification, surgical site verification, instrument counts, and patient handoffs, all designed to reduce variability and enhance reliability [7,8]. Moreover, fostering a culture of open communication and teamwork among surgeons, anesthesiologists, nurses, and technicians is critical to ensuring that safety protocols are followed and that concerns are promptly addressed [9–11]. While patient safety interventions such as checklists, time-outs, and briefing/debriefing sessions have shown promise in reducing surgical complications, their successful implementation depends heavily on local context, including resource availability, organizational culture, and staff engagement [12,13]. In low-resource contexts such as North Kivu province in eastern Democratic Republic of Congo (DRC), factors including inadequate infrastructure, hierarchical team structures, irregular training, and ongoing armed conflict hinder the development and maintenance of a strong patient safety culture [14–17]. Despite acknowledgment of these barriers, evidence for effective, context-specific strategies to improve patient safety culture in operating rooms within this region remains scarce. Additionally, the perspectives of multidisciplinary healthcare professionals and patients are often overlooked in developing tailored interventions [18]. Addressing this gap is crucial for creating feasible, culturally sensitive, and sustainable patient safety initiatives aligned with local realities. This study aimed to identify and prioritize strategies to enhance the patient safety culture in operating rooms in North Kivu hospitals, with the ultimate goal of developing a practical patient safety bundle tailored for operating rooms in this context. Methods Study Design Leveraging the inherent adaptability and modifiability of the nominal group technique (NGT) [19,20], a modified NGT was employed to facilitate consensus on strategies to improve patient safety culture in the operating rooms of hospitals in North Kivu, eastern DRC. The NGT process was adapted such that the session began with the structured presentation of relevant research findings, which served as the foundation for idea generation and subsequent group discussion. To enhance participant engagement and ensure clarity regarding the process and modifications, a dedicated WhatsApp group was established prior to the session, enabling participants to familiarize themselves with the NGT methodology and planned adaptations. Participants Purposive sampling was used to select participants for this study. Individuals were chosen specifically for their relevant expertise and ability to contribute a range of perspectives aligned with the research objectives [21]. Selection criteria included: Experience: Priority was given to individuals with demonstrable experience in patient care delivery, safety initiatives, or quality improvement within Goma hospitals. Knowledge: Participants were required to possess a strong understanding of the local healthcare context, including its challenges and resource limitations. Communication Skills: Individuals with strong communication and collaboration skills were selected to facilitate effective participation in group discussions. Alongside healthcare professionals, two adult patients who underwent surgery at a regional hospital within the same month were included to offer a patient-centered perspective. Both were literate and able to engage meaningfully in discussion. This approach recognizes that patients’ lived experiences provide valuable insights that enhance understanding of their needs and support holistic care planning [18]. Structure of the Modified Nominal Group Discussion The NGT typically involves four key stages: silent idea generation, round-robin sharing, clarification and discussion of ideas, and voting or ranking [19,21]. Its flexibility allows adaptations by various researchers to meet specific study objectives [20,22–25]. In this study, the NGT was conducted through five structured stages designed to facilitate consensus on improving patient safety culture (PSC) in operating rooms. Introduction and Presentation of Research Findings: The session began with the facilitator welcoming the nine participants and outlining the session’s purpose and objectives. The central question guiding the discussion was: “What are the most effective strategies to improve PSC in operating rooms in North Kivu, considering local challenges and available resources?” Rather than employing the traditional silent idea generation phase, the facilitator provided an evidence-based synthesis to establish a shared knowledge base. This presentation included results from a local Hospital Survey on patient safety culture (HSOPSC)-based survey assessing patient safety culture in operating rooms of North Kivu hospitals [26] and data on the use of the WHO (World Health Organization) Surgical Safety Checklist in the region [17]. Four evidence-based strategies were then presented as options for discussion: (1) WHO Surgical Safety Checklist implementation [7,27–29], (2) Safe Surgery 2020 interventions [30,31], (3) Non-Technical Skills for Surgeons (NOTSS) training [32,33], and (4) multidisciplinary safety training and quality improvement initiatives (e.g., Lifebox McCaskey Fellowship) [34]. This comprehensive introduction ensured all participants had a common understanding of relevant evidence and context before sharing their views. Round-Robin Sharing: Following the presentation, participants were invited, in turn, to articulate their views and preferences regarding the proposed strategies. The facilitator recorded each contribution verbatim, ensuring that every voice was heard equally. This round-robin format promoted balanced participation, minimized dominance by any individual, and encouraged diverse perspectives grounded in both evidence and local experience. While participants could note new ideas inspired by others, discussion and critique were deferred to the next stage. Clarification and Group Discussion: The group then engaged in an open discussion to clarify and elaborate on the proposed strategies. Participants sought and provided explanations, consolidated overlapping ideas, and addressed practical considerations and contextual challenges relevant to North Kivu. This collaborative process refined the strategies and fostered mutual understanding of their potential benefits and implementation barriers. Ranking and Voting: Each participant independently ranked the four proposed strategies from 1 (most effective) to 4 (least effective) according to their perceived suitability for improving PSC in operating rooms locally. Rankings were submitted anonymously to reduce social bias and encourage honest prioritization. Aggregation and Feedback: The facilitator aggregated the rankings, calculated mean scores for each strategy, and presented these results back to the group. This transparent feedback enabled participants to reflect on collective priorities and contributed to consensus-building. Data Analysis Descriptive statistics (mean rank) were used to summarize participant preferences for each strategy. Qualitative data from the group discussion were thematically analyzed to capture key recommendations and contextual insights. The final patient safety bundle was developed based on the consensus reached during the NGT session. Ethical Considerations The research protocol was reviewed and approved by the Ethics Committee of the University of Goma (UNIGOM/CEM/006/2024). Written informed consent was obtained from all participants prior to their involvement. Participants' confidentiality was strictly maintained throughout the study. Trial registration Not applicable Results The study included nine participants, representing a diverse range of experiences and professional backgrounds. The final group consisted of a general surgeon, an anesthetist, an operating room nurse, a public health specialist, a patient safety and quality improvement expert from the provincial health division, a medical director, a general practitioner, and two patients (Refer to table 1 for the participants' characteristics). This composition enabled comprehensive insights into the research topic from both clinical and patient perspectives. Table 1. Participants' characteristics Participants Gender Length of experience Medical director M 11 years General surgeon M 7 years Anesthetist M 13 years Operating room nurse M 9 years Public health specialist M 11 years Quality improvement expert F 6 years General practitioner M 4 years Patient 1 F 1 week from surgery Patient 2 M 4 weeks from surgery The implementation of the WHO Surgical Safety Checklist emerged as the most promising strategy (mean rank = 2.00), followed by NOTSS (2.44), Safe Surgery 2020 (2.56), and Multidisciplinary Training (2.78). (see figure 1) The group confirmed consensus around the WHO Surgical Safety Checklist as the preferred strategy for implementation. Thematic Analysis of Group Discussion The group discussion revealed several interconnected themes central to the effective implementation of the WHO Surgical Safety Checklist and the broader improvement of patient safety culture in North Kivu’s operating rooms. 1. Team Culture and Leadership A prominent theme that emerged was the critical importance of open and effective communication among healthcare professionals. Participants consistently emphasized that the successful implementation of the surgical checklist relied on fostering an environment where all team members, irrespective of hierarchy or role, felt empowered to speak up and contribute freely. This collaborative atmosphere was considered essential not only for patient safety but also for cultivating trust within surgical teams. Participants often likened teamwork to that of a sports team, where everyone must be willing to adapt roles for the collective success: “Operating room teamwork shouldn’t be defined by titles alone. Like a football team, each member has a role, but must also be ready to step in wherever needed to ensure success—rather than letting the team falter for the sake of sticking strictly to roles” (Public health specialist) Leadership engagement and clear accountability structures were identified as vital enablers of sustained improvements. The commitment of hospital management was underscored, exemplified by the assertion: “When hospital leaders aren’t involved… nothing gets done. If leadership doesn’t engage or grasp the importance of an initiative… it stalls” (Quality improvement expert). The idea of appointing dedicated “checklist champions” responsible for monitoring compliance was also highlighted as key to maintaining momentum: "While training is essential, ongoing follow-up is equally important—particularly with a designated individual responsible for overseeing the checklist’s use in the operating room. This process should also be evaluated regularly during each operating room team meeting" (Medical director). 2. Continuous Training and Improvement Participants stressed the importance of continuous learning as a cornerstone for enhancing PSC. Regular morbidity and mortality meetings were recognized as valuable forums to reflect on adverse events, disseminate lessons learned, and initiate quality improvement measures. The integration of patient safety principles into medical education was proposed as a strategic approach to embed safe practices from the outset of professional training: “Post-study training is helpful, but introducing patient safety culture during studies and encouraging student discussion early on could improve its later application” (general practitioner). Additionally, participants emphasized the need for training programs tailored to the specific challenges and contexts of different health care settings: “Training should be tailored to the facility’s context… since hospitals and health centers face different challenges, a one-size-fits-all approach isn’t effective” (Anesthetist). Comprehensive documentation of patient information was consistently noted as crucial for coordination and continuity of care: "To ensure patient safety, all relevant information must be documented in the patient's file, so that even in our absence, the care team remains fully informed of the most recent updates" (Public health specialist). 3. Patient-Centered Care The active involvement of patients emerged as a vital theme for enhancing safety and quality of care. Participants advocated for listening attentively to patients and encouraging their participation in care decisions wherever feasible, viewing this as both empowering and safety-enhancing: “Patients should always be encouraged to speak, and their illness shouldn’t lead health professionals to dismiss their knowledge or perspective” (Public health specialist). Patients themselves noted the potential for their engagement to prevent errors, such as wrong-site surgery, by being active partners in the perioperative process: “A patient can help prevent errors—like surgery on the wrong site—if they are allowed to speak up or asked to identify the problem area while they’re alert before the procedure” (Patient 1). The importance of transporting patients with comprehensive medical records to the operating room was also highlighted: “The patient should arrive at the Operating Room with a complete file detailing their condition for review before surgery… all relevant information must always be documented” (Operating room nurse). 4. From Hierarchy to Inclusivity Participants identified hierarchical structures as a potential barrier to cultivating a robust safety culture. To counteract this, they recommended deliberate efforts to flatten hierarchies in the operating room, ensuring that every team member's voice is valued throughout surgical care phases. Using individuals’ names rather than formal titles was suggested as a practical measure to reduce intimidation and encourage speaking up: “Referring to operating room staff by name instead of titles like ‘professor’ or ‘chief’ can help reduce hierarchy… encouraging team members to speak up—even when unsure—if they sense something may be wrong” (Medical director). Moreover, participants underlined the importance of a non-punitive culture to foster open communication, recognizing that blame inhibits speaking up: “Blame culture discourages people from speaking up… fear of being blamed again keeps them silent” (Quality improvement expert). Finally, the willingness of leaders to recognize team weaknesses and actively participate in training was acknowledged as crucial: “A leader should identify their team’s weaknesses, organize appropriate training, and participate alongside them” (Medical director). Summary of the Patient Safety Bundle for Operating Rooms Based on the consensus of multidisciplinary stakeholders and patients, this study developed a practical patient safety bundle tailored to the unique needs and challenges of operating rooms in North Kivu hospitals. The bundle integrates evidence-based strategies and local insights to promote a culture of safety, teamwork, and continuous improvement in surgical care (see figure 2). Discussion The present study identified the implementation of the WHO SSC as the top-ranked and most feasible strategy for improving patient safety culture in the operating rooms of North Kivu hospitals, a low-resource region in eastern DRC. This finding is consistent with a substantial body of evidence demonstrating that the checklist is a low-cost, high-impact intervention, particularly effective in resource-limited and high-risk environments [28,35,36]. In such settings, the checklist has been shown to reduce postoperative complications and mortality, improve team communication, and foster a culture of safety despite persistent infrastructural and workforce constraints [13,35,37]. Participants in this study emphasized that the checklist’s success is not solely dependent on its introduction, but rather on its integration within a broader framework of open communication, teamwork, and leadership engagement. This aligns with previous research indicating that the checklist acts as both a technical and cultural intervention, prompting teams to engage in safety-critical conversations and flatten hierarchical barriers that can impede speaking up and error reporting [7,37–39]. In North Kivu, where hierarchical structures and resource shortages are pronounced [14,40,41], the checklist was perceived as a practical tool to standardize safety practices and empower all team members to participate actively in patient care. Leadership commitment and accountability were highlighted as crucial for sustaining checklist use and broader safety improvements. The appointment of a “checklist champion” and regular monitoring were suggested as effective mechanisms to ensure adherence and address challenges as they arise. This is supported by studies showing that visible leadership engagement and ongoing feedback are key determinants of successful checklist implementation and sustainability, especially in low-income settings [42,43]. Continuous training and improvement were also identified as essential. Participants recommended regular refresher sessions and morbidity and mortality meetings to reinforce best practices and adapt to evolving challenges. Existing literature supports this approach, noting that ongoing education is necessary to maintain staff engagement and competence, particularly where baseline training may be limited [44–46]. Patient-centered care emerged as an additional priority. Engaging patients as active partners in their care and fostering open, transparent communication are powerful strategies to build trust and minimize errors. At the same time, meticulous documentation is essential for ensuring seamless continuity and effective coordination among healthcare providers. Together, these practices form the foundation of a comprehensive safety culture, as highlighted in multiple studies [47–51]. Despite its proven efficacy, the checklist’s adoption in low-resource settings faces persistent barriers, including lack of equipment, time pressures, and cultural resistance [28,42]. Participants acknowledged these obstacles but also noted that the simplicity and adaptability of the checklist made it particularly suitable for environments like North Kivu. Importantly, the checklist’s visible use was perceived by patients as a marker of professionalism and care, further supporting its acceptance and impact [52]. Study Limitations This study employed a rigorous modified nominal group technique to prioritize patient safety strategies in North Kivu, requiring 5-9 participants. However, several limitations should be acknowledged. The panel size (n=9), though purposeful, limits generalizability and may not reflect the full diversity of regional healthcare perspectives. Participant selection based on accessibility may have introduced selection bias, and despite the NGT’s structured format, group dynamics and social desirability could have influenced contributions. Modifying the traditional silent idea-generation phase by presenting prior research may have narrowed the range of spontaneous insights. Moreover, the findings are context-specific to North Kivu’s healthcare system—with unique cultural, structural, and resource constraints—and may require adaptation before application elsewhere. Importantly, this study focused on consensus-building rather than implementation. Nonetheless, it lays the groundwork for future implementation-effectiveness research and marks a critical first step in incorporating stakeholder perspectives into patient safety policy in the region. Conclusion This study identified and prioritized context-specific strategies to enhance patient safety culture in operating rooms, culminating in the development of a practical patient safety bundle. The findings highlight the central role of the WHO Surgical Safety Checklist, supported by regular team training, leadership engagement, patient involvement, and continuous quality improvement. By integrating multidisciplinary perspectives and adapting global best practices to local realities, this bundle offers a feasible and scalable approach for strengthening surgical safety in resource-limited settings. Future research should focus on the implementation and evaluation of this bundle to further advance patient safety outcomes. Abbreviations DRC: Democratic Republic of Congo HSOPSC: Hospital Survey on patient safety culture NGT: Nominal group technique NOTSS: Non-Technical Skills for Surgeons PSC: Patient safety culture SS2020: the Safe Surgery 2020 intervention, WHO SSC: World Health Organization Surgical Safety Checklist, WHO: World Health Organization Declarations Ethics approval and consent to participate The research protocol was reviewed and approved by the Ethics Committee of the University of Goma (UNIGOM/CEM/006/2024). Written informed consent was obtained from all participants prior to their involvement. The study was carried out in accordance with the Declaration of Helsinki [53]. The research adhered to applicable guidelines ensuring the protection of participants' rights, privacy, and wellbeing. No animal subjects were involved in this study. Consent for publication Not applicable Availability of data and materials All data analysed during this study are included in this published article Competing interests The authors declare that they have no conflict of interest Funding None Authors' contributions JFB : Conceptualization, Formal analysis, Investigation, Methodology, Project administration, Resources, Software, Validation, Visualization, Writing - original draft, Writing - review & editing, KL : Methodology, Validation, Visualization, Writing - review & editing, EM : Writing - review & editing and validation, KMC : Supervision, Writing - review & editing and validation, TKZ : Conceptualization, Supervision, Writing - review & editing and validation, MNM : Writing - review & editing and validation, DP : Conceptualization, Methodology, Supervision, Validation, Visualization, Writing - review & editing. Acknowledgements Not applicable References Wahr JA. 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Ferorelli D, Benevento M, Vimercati L, Spagnolo L, De Maria L, Caputi A, et al. Improving Healthcare Workers’ Adherence to Surgical Safety Checklist: The Impact of a Short Training. Front Public Heal. 2022;9(February):1–5. Etheridge JC, Moyal-Smith R, Yong TT, Lim SR, Sonnay Y, Lim C, et al. Transforming Team Performance Through Reimplementation of the Surgical Safety Checklist. JAMA Surg. 2024;159(1):78–86. Higginson J, Walters R, Fulop N. Mortality and morbidity meetings: An untapped resource for improving the governance of patient safety? BMJ Qual Saf. 2012;21(7):576–85. Bombard Y, Baker GR, Orlando E, Fancott C, Bhatia P, Casalino S, et al. Engaging patients to improve quality of care: A systematic review. Implement Sci. 2018;13(1). Sharkiya SH. Quality communication can improve patient-centred health outcomes among older patients: a rapid review. BMC Health Serv Res. 2023;23(1):1–14. Alsalim DS, Alanazi WS, Almutairi M, Abdullah A, Al-jabri IA, Alruhaymi AA. Accurate and Detailed Clinical Documentation is Essential for Quality Patient Care. Int J Innov Res Med Sci [Internet]. 2020;8(1):1–5. Available from: https://www.ijirmps.org/papers/2020/1/231296.pdf Rahman AIA El, Ibrahim MM, Diab GM. Quality of Nursing Documentation and its Effect on Continuity of patients’ care. Menoufia Nurs J [Internet]. 2021;6(2):1–18. Available from: https://menj.journals.ekb.eg Khatri R, Endalamaw A, Erku D, Wolka E, Nigatu F, Zewdie A, et al. Continuity and care coordination of primary health care: a scoping review. BMC Health Serv Res [Internet]. 2023;23(1):1–13. Available from: https://doi.org/10.1186/s12913-023-09718-8 Bergs J, Lambrechts F, Desmedt M, Hellings J, Schrooten W, Vlayen A, et al. Seen through the patients’ eyes: Surgical safety and checklists. Int J Qual Heal Care. 2018;30(2):118–23. The World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. 2008;(June 1964):1–5. Available from: https://www.wma.net/wp-content/uploads/2016/11/DoH-Oct2008.pdf Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Reviews received at journal 13 Sep, 2025 Reviewers agreed at journal 12 Sep, 2025 Reviewers invited by journal 05 Sep, 2025 Editor invited by journal 18 Aug, 2025 Editor assigned by journal 14 Aug, 2025 Submission checks completed at journal 14 Aug, 2025 First submitted to journal 13 Aug, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7361454","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":511495412,"identity":"1dde2047-e07f-4825-bfef-5ed253a1f1c8","order_by":0,"name":"Jacques Fadhili Bake","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA6UlEQVRIiWNgGAWjYBAC9gYGM4aEAokEBh4GxgdAAR4+Qlp4DoC0GIC1MBuABNiI0sJgwADSwiYBEiGshf3wtgcPDCzy+HsOH6v8mmMnw8bA/PDRDXxaeNLKDYAOK5Y425Z2W3ZbMtBhbMbGOXi02DPkmEkAtSQ2nOcxuy25jRmohYdNGp8WHv43EC3zz/N/K5bcVk+EFgmoLRvO9rAxftx2mBgtz8pAWooNzxwzlmbcdpyHjZmAX3j4k7dJ/qioy5M7k/zw489t1fb87M0PH+PTggKYecAkscpBgPEHKapHwSgYBaNgxAAAWOdBvJwk/DoAAAAASUVORK5CYII=","orcid":"","institution":"University of Goma","correspondingAuthor":true,"prefix":"","firstName":"Jacques","middleName":"Fadhili","lastName":"Bake","suffix":""},{"id":511495413,"identity":"bfe8a0bf-f049-4bed-816a-ccd6dfb8c70f","order_by":1,"name":"Katya Loban","email":"","orcid":"","institution":"McGill University","correspondingAuthor":false,"prefix":"","firstName":"Katya","middleName":"","lastName":"Loban","suffix":""},{"id":511495414,"identity":"30bf1957-518f-471c-ab1b-0ad03a3c49a1","order_by":2,"name":"Elisabeth Mishika","email":"","orcid":"","institution":"Quality Control","correspondingAuthor":false,"prefix":"","firstName":"Elisabeth","middleName":"","lastName":"Mishika","suffix":""},{"id":511495415,"identity":"b2c85234-8a93-4473-a954-d0ec7dec1213","order_by":3,"name":"Masoda Nyamalyongo Maurice","email":"","orcid":"","institution":"University of Goma","correspondingAuthor":false,"prefix":"","firstName":"Masoda","middleName":"Nyamalyongo","lastName":"Maurice","suffix":""},{"id":511495416,"identity":"e6e5452b-a6a1-4fb5-a4ce-d180b9e56f74","order_by":4,"name":"Kasereka Masumbuko Claude","email":"","orcid":"","institution":"Catholic University of Graben","correspondingAuthor":false,"prefix":"","firstName":"Kasereka","middleName":"Masumbuko","lastName":"Claude","suffix":""},{"id":511495417,"identity":"53ac345b-29fb-4db4-925a-61f9b6b885d0","order_by":5,"name":"Tsongo Kibendelwa Zacharie","email":"","orcid":"","institution":"University of Kisangani","correspondingAuthor":false,"prefix":"","firstName":"Tsongo","middleName":"Kibendelwa","lastName":"Zacharie","suffix":""},{"id":511495418,"identity":"ac47194b-ce59-4fa4-b128-1b21a0bdc647","order_by":6,"name":"Dan Poenaru","email":"","orcid":"","institution":"McGill University","correspondingAuthor":false,"prefix":"","firstName":"Dan","middleName":"","lastName":"Poenaru","suffix":""}],"badges":[],"createdAt":"2025-08-13 06:23:52","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7361454/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7361454/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":91190527,"identity":"8d2230f7-57bd-4266-801b-00463daf3313","added_by":"auto","created_at":"2025-09-12 14:35:46","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":85152,"visible":true,"origin":"","legend":"\u003cp\u003eResult from the ranking and voting stage\u003c/p\u003e\n\u003cp\u003eWHO SSC: World Health Organization Surgical Safety Checklist, SS2020: the Safe Surgery 2020 intervention, NOTSS: Non-Technical Skills for Surgeons\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-7361454/v1/5413b72bcc8c8008f09eeaae.png"},{"id":91190523,"identity":"26ff62fe-fb0d-4adc-b69b-36233b39d505","added_by":"auto","created_at":"2025-09-12 14:35:46","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":329676,"visible":true,"origin":"","legend":"\u003cp\u003eSummary of the Patient Safety Bundle for Operating Rooms\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-7361454/v1/f038ade03705894f4f47ec21.png"},{"id":91194327,"identity":"140e7e09-dea1-4a90-b26a-70fba94d01fb","added_by":"auto","created_at":"2025-09-12 14:51:46","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1109284,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7361454/v1/5df44207-4361-45c0-91e8-f9f8d5e88547.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Development of a Contextualized Patient Safety Bundle for Operating Rooms in North Kivu, DRC: A Consensus-Based Approach","fulltext":[{"header":"Introduction","content":"\u003cp\u003ePatient safety remains a paramount concern in surgical care worldwide, with operating rooms recognized as complex, high-risk environments where preventable harm can occur frequently [1,2]. It is estimated that hundreds of thousands of patients globally suffer adverse events in hospitals each year due to errors that could have been avoided [3].\u0026nbsp;The dynamic and fast-paced nature of surgical settings, coupled with multiple interacting team members and high-stakes procedures, creates numerous opportunities for mistakes, ranging from patient misidentification to equipment failures and communication breakdowns [4].\u003c/p\u003e\n\u003cp\u003eEffective risk management strategies in the operating room extend beyond individual vigilance to encompass system-wide approaches that promote safety-conscious behaviors and minimize errors [3,5,6]. These strategies include standardized protocols for patient identification, surgical site verification, instrument counts, and patient handoffs, all designed to reduce variability and enhance reliability [7,8].\u0026nbsp;Moreover, fostering a culture of open communication and teamwork among surgeons, anesthesiologists, nurses, and technicians is critical to ensuring that safety protocols are followed and that concerns are promptly addressed\u0026nbsp;[9\u0026ndash;11].\u003c/p\u003e\n\u003cp\u003eWhile patient safety interventions such as checklists, time-outs, and briefing/debriefing sessions have shown promise in reducing surgical complications, their successful implementation depends heavily on local context, including resource availability, organizational culture, and staff engagement [12,13].\u0026nbsp;In low-resource contexts such as North Kivu province in eastern Democratic Republic of Congo (DRC), factors including inadequate infrastructure, hierarchical team structures, irregular training, and ongoing armed conflict hinder the development and maintenance of a strong patient safety culture [14\u0026ndash;17].\u003c/p\u003e\n\u003cp\u003eDespite acknowledgment of these barriers, evidence for effective, context-specific strategies to improve patient safety culture in operating rooms within this region remains scarce. Additionally, the perspectives of multidisciplinary healthcare professionals and patients are often overlooked in developing tailored interventions [18]. Addressing this gap is crucial for creating feasible, culturally sensitive, and sustainable patient safety initiatives aligned with local realities. This study aimed to identify and prioritize strategies to enhance the patient safety culture in operating rooms in North Kivu hospitals, with the ultimate goal of developing a practical patient safety bundle tailored for operating rooms in this context.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eStudy Design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eLeveraging the inherent adaptability and modifiability of the nominal group technique (NGT) [19,20], a modified NGT was employed to facilitate consensus on strategies to improve patient safety culture in the operating rooms of hospitals in North Kivu, eastern DRC. The NGT process was adapted such that the session began with the structured presentation of relevant research findings, which served as the foundation for idea generation and subsequent group discussion. To enhance participant engagement and ensure clarity regarding the process and modifications, a dedicated WhatsApp group was established prior to the session, enabling participants to familiarize themselves with the NGT methodology and planned adaptations.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParticipants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePurposive sampling was used to select participants for this study. Individuals were chosen specifically for their relevant expertise and ability to contribute a range of perspectives aligned with the research objectives [21]. Selection criteria included:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eExperience: Priority was given to individuals with demonstrable experience in patient care delivery, safety initiatives, or quality improvement within Goma hospitals.\u003c/li\u003e\n \u003cli\u003eKnowledge: Participants were required to possess a strong understanding of the local healthcare context, including its challenges and resource limitations.\u003c/li\u003e\n \u003cli\u003eCommunication Skills: Individuals with strong communication and collaboration skills were selected to facilitate effective participation in group discussions.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eAlongside healthcare professionals, two adult patients who underwent surgery at a regional hospital within the same month were included to offer a patient-centered perspective. Both were literate and able to engage meaningfully in discussion. This approach recognizes that patients\u0026rsquo; lived experiences provide valuable insights that enhance understanding of their needs and support holistic care planning [18].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStructure of the Modified Nominal Group Discussion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe NGT typically involves four key stages: silent idea generation, round-robin sharing, clarification and discussion of ideas, and voting or ranking [19,21]. Its flexibility allows adaptations by various researchers to meet specific study objectives [20,22\u0026ndash;25]. In this study, the NGT was conducted through five structured stages designed to facilitate consensus on improving patient safety culture (PSC) in operating rooms.\u003c/p\u003e\n\u003col start=\"1\" type=\"1\"\u003e\n \u003cli\u003eIntroduction and Presentation of Research Findings: The session began with the facilitator welcoming the nine participants and outlining the session\u0026rsquo;s purpose and objectives. The central question guiding the discussion was: \u0026ldquo;What are the most effective strategies to improve PSC in operating rooms in North Kivu, considering local challenges and available resources?\u0026rdquo; Rather than employing the traditional silent idea generation phase, the facilitator provided an evidence-based synthesis to establish a shared knowledge base. This presentation included results from a local Hospital Survey on patient safety culture (HSOPSC)-based survey assessing patient safety culture in operating rooms of North Kivu hospitals [26] and data on the use of the WHO (World Health Organization) Surgical Safety Checklist in the region [17]. \u0026nbsp;Four evidence-based strategies were then presented as options for discussion: (1) WHO Surgical Safety Checklist implementation [7,27\u0026ndash;29], (2) Safe Surgery 2020 interventions [30,31], (3) Non-Technical Skills for Surgeons (NOTSS) training [32,33], and (4) multidisciplinary safety training and quality improvement initiatives (e.g., Lifebox McCaskey Fellowship) [34]. This comprehensive introduction ensured all participants had a common understanding of relevant evidence and context before sharing their views.\u003c/li\u003e\n \u003cli\u003eRound-Robin Sharing: Following the presentation, participants were invited, in turn, to articulate their views and preferences regarding the proposed strategies. The facilitator recorded each contribution verbatim, ensuring that every voice was heard equally. This round-robin format promoted balanced participation, minimized dominance by any individual, and encouraged diverse perspectives grounded in both evidence and local experience. While participants could note new ideas inspired by others, discussion and critique were deferred to the next stage.\u003c/li\u003e\n \u003cli\u003eClarification and Group Discussion: The group then engaged in an open discussion to clarify and elaborate on the proposed strategies. Participants sought and provided explanations, consolidated overlapping ideas, and addressed practical considerations and contextual challenges relevant to North Kivu. This collaborative process refined the strategies and fostered mutual understanding of their potential benefits and implementation barriers.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eRanking and Voting: Each participant independently ranked the four proposed strategies from 1 (most effective) to 4 (least effective) according to their perceived suitability for improving PSC in operating rooms locally. Rankings were submitted anonymously to reduce social bias and encourage honest prioritization.\u003c/li\u003e\n \u003cli\u003eAggregation and Feedback: The facilitator aggregated the rankings, calculated mean scores for each strategy, and presented these results back to the group. This transparent feedback enabled participants to reflect on collective priorities and contributed to consensus-building.\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003e\u003cstrong\u003eData Analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDescriptive statistics (mean rank) were used to summarize participant preferences for each strategy. Qualitative data from the group discussion were thematically analyzed to capture key recommendations and contextual insights. The final patient safety bundle was developed based on the consensus reached during the NGT session.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical Considerations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe research protocol was reviewed and approved by the Ethics Committee of the University of Goma (UNIGOM/CEM/006/2024). Written informed consent was obtained from all participants prior to their involvement. Participants\u0026apos; confidentiality was strictly maintained throughout the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eThe study included nine participants, representing a diverse range of experiences and professional backgrounds. The final group consisted of a general surgeon, an anesthetist, an operating room nurse, a public health specialist, a patient safety and quality improvement expert from the provincial health division, a medical director, a general practitioner, and two patients (Refer to table 1 for the participants\u0026apos; characteristics). This composition enabled comprehensive insights into the research topic from both clinical and patient perspectives.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1. Participants\u0026apos; characteristics\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"436\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.8716%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eParticipants\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.4312%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGender\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 36.6972%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eLength of experience\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.8716%;\"\u003e\n \u003cp\u003eMedical director\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.4312%;\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 36.6972%;\"\u003e\n \u003cp\u003e11 years\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.8716%;\"\u003e\n \u003cp\u003eGeneral surgeon\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.4312%;\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 36.6972%;\"\u003e\n \u003cp\u003e7 years\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.8716%;\"\u003e\n \u003cp\u003eAnesthetist\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.4312%;\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 36.6972%;\"\u003e\n \u003cp\u003e13 years\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.8716%;\"\u003e\n \u003cp\u003eOperating room nurse\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.4312%;\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 36.6972%;\"\u003e\n \u003cp\u003e9 years\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.8716%;\"\u003e\n \u003cp\u003ePublic health specialist\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.4312%;\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 36.6972%;\"\u003e\n \u003cp\u003e11 years\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.8716%;\"\u003e\n \u003cp\u003eQuality improvement expert\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.4312%;\"\u003e\n \u003cp\u003eF\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 36.6972%;\"\u003e\n \u003cp\u003e6 years\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.8716%;\"\u003e\n \u003cp\u003eGeneral practitioner\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.4312%;\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 36.6972%;\"\u003e\n \u003cp\u003e4 years\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.8716%;\"\u003e\n \u003cp\u003ePatient 1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.4312%;\"\u003e\n \u003cp\u003eF\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 36.6972%;\"\u003e\n \u003cp\u003e1 week from surgery\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 45.8716%;\"\u003e\n \u003cp\u003ePatient 2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17.4312%;\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 36.6972%;\"\u003e\n \u003cp\u003e4 weeks from surgery\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eThe implementation of the WHO Surgical Safety Checklist emerged as the most promising strategy (mean rank = 2.00), followed by NOTSS (2.44), Safe Surgery 2020 (2.56), and Multidisciplinary Training (2.78). (see figure 1)\u003c/p\u003e\n\u003cp\u003eThe group confirmed consensus around the WHO Surgical Safety Checklist as the preferred strategy for implementation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eThematic Analysis of Group Discussion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe group discussion revealed several interconnected themes central to the effective implementation of the WHO Surgical Safety Checklist and the broader improvement of patient safety culture in North Kivu\u0026rsquo;s operating rooms.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1. Team Culture and Leadership\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA prominent theme that emerged was the critical importance of open and effective communication among healthcare professionals. Participants consistently emphasized that the successful implementation of the surgical checklist relied on fostering an environment where all team members, irrespective of hierarchy or role, felt empowered to speak up and contribute freely. This collaborative atmosphere was considered essential not only for patient safety but also for cultivating trust within surgical teams. Participants often likened teamwork to that of a sports team, where everyone must be willing to adapt roles for the collective success:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;Operating room teamwork shouldn\u0026rsquo;t be defined by titles alone. Like a football team, each member has a role, but must also be ready to step in wherever needed to ensure success\u0026mdash;rather than letting the team falter for the sake of sticking strictly to roles\u0026rdquo;\u003c/em\u003e (Public health specialist)\u003c/p\u003e\n\u003cp\u003eLeadership engagement and clear accountability structures were identified as vital enablers of sustained improvements. The commitment of hospital management was underscored, exemplified by the assertion:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;When hospital leaders aren\u0026rsquo;t involved\u0026hellip; nothing gets done. If leadership doesn\u0026rsquo;t engage or grasp the importance of an initiative\u0026hellip; it stalls\u0026rdquo;\u003c/em\u003e (Quality improvement expert).\u003c/p\u003e\n\u003cp\u003eThe idea of appointing dedicated \u0026ldquo;checklist champions\u0026rdquo; responsible for monitoring compliance was also highlighted as key to maintaining momentum:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;While training is essential, ongoing follow-up is equally important\u0026mdash;particularly with a designated individual responsible for overseeing the checklist\u0026rsquo;s use in the operating room. This process should also be evaluated regularly during each operating room team meeting\u0026quot;\u0026nbsp;\u003c/em\u003e(Medical director).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2. Continuous Training and Improvement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants stressed the importance of continuous learning as a cornerstone for enhancing PSC. Regular morbidity and mortality meetings were recognized as valuable forums to reflect on adverse events, disseminate lessons learned, and initiate quality improvement measures. The integration of patient safety principles into medical education was proposed as a strategic approach to embed safe practices from the outset of professional training:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;Post-study training is helpful, but introducing patient safety culture during studies and encouraging student discussion early on could improve its later application\u0026rdquo;\u003c/em\u003e (general practitioner).\u003c/p\u003e\n\u003cp\u003eAdditionally, participants emphasized the need for training programs tailored to the specific challenges and contexts of different health care settings:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;Training should be tailored to the facility\u0026rsquo;s context\u0026hellip; since hospitals and health centers face different challenges, a one-size-fits-all approach isn\u0026rsquo;t effective\u0026rdquo;\u003c/em\u003e (Anesthetist).\u003c/p\u003e\n\u003cp\u003eComprehensive documentation of patient information was consistently noted as crucial for coordination and continuity of care:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026quot;To ensure patient safety, all relevant information must be documented in the patient\u0026apos;s file, so that even in our absence, the care team remains fully informed of the most recent updates\u0026quot;\u003c/em\u003e (Public health specialist).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3. Patient-Centered Care\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe active involvement of patients emerged as a vital theme for enhancing safety and quality of care. Participants advocated for listening attentively to patients and encouraging their participation in care decisions wherever feasible, viewing this as both empowering and safety-enhancing:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;Patients should always be encouraged to speak, and their illness shouldn\u0026rsquo;t lead health professionals to dismiss their knowledge or perspective\u0026rdquo;\u003c/em\u003e (Public health specialist).\u003c/p\u003e\n\u003cp\u003ePatients themselves noted the potential for their engagement to prevent errors, such as wrong-site surgery, by being active partners in the perioperative process:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;A patient can help prevent errors\u0026mdash;like surgery on the wrong site\u0026mdash;if they are allowed to speak up or asked to identify the problem area while they\u0026rsquo;re alert before the procedure\u0026rdquo;\u003c/em\u003e (Patient 1).\u003c/p\u003e\n\u003cp\u003eThe importance of transporting patients with comprehensive medical records to the operating room was also highlighted:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;The patient should arrive at the Operating Room with a complete file detailing their condition for review before surgery\u0026hellip; all relevant information must always be documented\u0026rdquo;\u003c/em\u003e (Operating room nurse).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e4. From Hierarchy to Inclusivity\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants identified hierarchical structures as a potential barrier to cultivating a robust safety culture. To counteract this, they recommended deliberate efforts to flatten hierarchies in the operating room, ensuring that every team member\u0026apos;s voice is valued throughout surgical care phases. Using individuals\u0026rsquo; names rather than formal titles was suggested as a practical measure to reduce intimidation and encourage speaking up:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;Referring to operating room staff by name instead of titles like \u0026lsquo;professor\u0026rsquo; or \u0026lsquo;chief\u0026rsquo; can help reduce hierarchy\u0026hellip; encouraging team members to speak up\u0026mdash;even when unsure\u0026mdash;if they sense something may be wrong\u0026rdquo;\u003c/em\u003e (Medical director).\u003c/p\u003e\n\u003cp\u003eMoreover, participants underlined the importance of a non-punitive culture to foster open communication, recognizing that blame inhibits speaking up:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;Blame culture discourages people from speaking up\u0026hellip; fear of being blamed again keeps them silent\u0026rdquo;\u003c/em\u003e (Quality improvement expert).\u003c/p\u003e\n\u003cp\u003eFinally, the willingness of leaders to recognize team weaknesses and actively participate in training was acknowledged as crucial:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;A leader should identify their team\u0026rsquo;s weaknesses, organize appropriate training, and participate alongside them\u0026rdquo;\u003c/em\u003e (Medical director).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSummary of the Patient Safety Bundle for Operating Rooms\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBased on the consensus of multidisciplinary stakeholders and patients, this study developed a practical patient safety bundle tailored to the unique needs and challenges of operating rooms in North Kivu hospitals. The bundle integrates evidence-based strategies and local insights to promote a culture of safety, teamwork, and continuous improvement in surgical care (see figure 2).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe present study identified the implementation of the WHO SSC as the top-ranked and most feasible strategy for improving patient safety culture in the operating rooms of North Kivu hospitals, a low-resource region in eastern DRC. This finding is consistent with a substantial body of evidence demonstrating that the checklist is a low-cost, high-impact intervention, particularly effective in resource-limited and high-risk environments [28,35,36]. In such settings, the checklist has been shown to reduce postoperative complications and mortality, improve team communication, and foster a culture of safety despite persistent infrastructural and workforce constraints [13,35,37].\u003c/p\u003e\n\u003cp\u003eParticipants in this study emphasized that the checklist\u0026rsquo;s success is not solely dependent on its introduction, but rather on its integration within a broader framework of open communication, teamwork, and leadership engagement. This aligns with previous research indicating that the checklist acts as both a technical and cultural intervention, prompting teams to engage in safety-critical conversations and flatten hierarchical barriers that can impede speaking up and error reporting [7,37\u0026ndash;39]. In North Kivu, where hierarchical structures and resource shortages are pronounced [14,40,41], the checklist was perceived as a practical tool to standardize safety practices and empower all team members to participate actively in patient care.\u003c/p\u003e\n\u003cp\u003eLeadership commitment and accountability were highlighted as crucial for sustaining checklist use and broader safety improvements. The appointment of a \u0026ldquo;checklist champion\u0026rdquo; and regular monitoring were suggested as effective mechanisms to ensure adherence and address challenges as they arise. This is supported by studies showing that visible leadership engagement and ongoing feedback are key determinants of successful checklist implementation and sustainability, especially in low-income settings [42,43].\u003c/p\u003e\n\u003cp\u003eContinuous training and improvement were also identified as essential. Participants recommended regular refresher sessions and morbidity and mortality meetings to reinforce best practices and adapt to evolving challenges. Existing literature supports this approach, noting that ongoing education is necessary to maintain staff engagement and competence, particularly where baseline training may be limited [44\u0026ndash;46].\u003c/p\u003e\n\u003cp\u003ePatient-centered care emerged as an additional priority. Engaging patients as active partners in their care and fostering open, transparent communication are powerful strategies to build trust and minimize errors. At the same time, meticulous documentation is essential for ensuring seamless continuity and effective coordination among healthcare providers. Together, these practices form the foundation of a comprehensive safety culture, as highlighted in multiple studies [47\u0026ndash;51].\u003c/p\u003e\n\u003cp\u003eDespite its proven efficacy, the checklist\u0026rsquo;s adoption in low-resource settings faces persistent barriers, including lack of equipment, time pressures, and cultural resistance [28,42]. Participants acknowledged these obstacles but also noted that the simplicity and adaptability of the checklist made it particularly suitable for environments like North Kivu. Importantly, the checklist\u0026rsquo;s visible use was perceived by patients as a marker of professionalism and care, further supporting its acceptance and impact [52].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy Limitations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study employed a rigorous modified nominal group technique to prioritize patient safety strategies in North Kivu, requiring 5-9 participants. However, several limitations should be acknowledged. The panel size (n=9), though purposeful, limits generalizability and may not reflect the full diversity of regional healthcare perspectives. Participant selection based on accessibility may have introduced selection bias, and despite the NGT\u0026rsquo;s structured format, group dynamics and social desirability could have influenced contributions.\u003c/p\u003e\n\u003cp\u003eModifying the traditional silent idea-generation phase by presenting prior research may have narrowed the range of spontaneous insights. Moreover, the findings are context-specific to North Kivu\u0026rsquo;s healthcare system\u0026mdash;with unique cultural, structural, and resource constraints\u0026mdash;and may require adaptation before application elsewhere.\u003c/p\u003e\n\u003cp\u003eImportantly, this study focused on consensus-building rather than implementation. Nonetheless, it lays the groundwork for future implementation-effectiveness research and marks a critical first step in incorporating stakeholder perspectives into patient safety policy in the region.\u0026nbsp;\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis study identified and prioritized context-specific strategies to enhance patient safety culture in operating rooms, culminating in the development of a practical patient safety bundle. The findings highlight the central role of the WHO Surgical Safety Checklist, supported by regular team training, leadership engagement, patient involvement, and continuous quality improvement. By integrating multidisciplinary perspectives and adapting global best practices to local realities, this bundle offers a feasible and scalable approach for strengthening surgical safety in resource-limited settings. Future research should focus on the implementation and evaluation of this bundle to further advance patient safety outcomes.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n"},{"header":"Abbreviations","content":"\u003cp\u003eDRC: Democratic Republic of Congo\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eHSOPSC: Hospital Survey on patient safety culture\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNGT: Nominal group technique\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNOTSS: Non-Technical Skills for Surgeons\u003c/p\u003e\n\u003cp\u003ePSC: Patient safety culture\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSS2020: the Safe Surgery 2020 intervention,\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWHO SSC: World Health Organization Surgical Safety Checklist,\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWHO: World Health Organization\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe research protocol was reviewed and approved by the Ethics Committee of the University of Goma (UNIGOM/CEM/006/2024). Written informed consent was obtained from all participants prior to their involvement. The study was carried out in accordance with the Declaration of Helsinki [53]. The research adhered to applicable guidelines ensuring the protection of participants\u0026apos; rights, privacy, and wellbeing. No animal subjects were involved in this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll data analysed during this study are included in this published article\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no conflict of interest\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNone\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eJFB\u003c/strong\u003e: Conceptualization, Formal analysis, Investigation, Methodology, Project administration, Resources, Software, Validation, Visualization, Writing - original draft, Writing - review \u0026amp; editing, \u003cstrong\u003eKL\u003c/strong\u003e: Methodology, Validation, Visualization, Writing - review \u0026amp; editing, \u003cstrong\u003eEM\u003c/strong\u003e: Writing - review \u0026amp; editing and validation, \u003cstrong\u003eKMC\u003c/strong\u003e: Supervision, Writing - review \u0026amp; editing and validation, \u003cstrong\u003eTKZ\u003c/strong\u003e: Conceptualization, Supervision, Writing - review \u0026amp; editing and validation, \u003cstrong\u003eMNM\u003c/strong\u003e: Writing - review \u0026amp; editing and validation, \u003cstrong\u003eDP\u003c/strong\u003e: Conceptualization, Methodology, Supervision, Validation, Visualization, Writing - review \u0026amp; editing.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eWahr JA. 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Available from: https://doi.org/10.1016/j.jamcollsurg.2021.04.006\u003c/li\u003e\n\u003cli\u003eLin Y, Scott JW, Yi S, Taylor KK, Ntakiyiruta G, Ntirenganya F, et al. Improving Surgical Safety and Nontechnical Skills in Variable-Resource Contexts: A Novel Educational Curriculum. J Surg Educ [Internet]. 2018;75(4):1014\u0026ndash;21. Available from: http://dx.doi.org/10.1016/j.jsurg.2017.09.014\u003c/li\u003e\n\u003cli\u003eAbahuje E, Bartuska A, Koch R, Youngson G, Ntakiyiruta G, Williams W, et al. Understanding Barriers and Facilitators to Behavior Change After Implementation of an Interdisciplinary Surgical Non-Technical Skills Training Program in Rwanda. J Surg Educ [Internet]. 2021;78(5):1618\u0026ndash;28. Available from: https://doi.org/10.1016/j.jsurg.2021.01.011\u003c/li\u003e\n\u003cli\u003eNegash S, Starr N, Mesfin S, G. Weiser T, Negussie TM. A novel global safe surgery mentorship program using a multidisciplinary team approach. World J Surg. 2024;48(7):1609\u0026ndash;15. \u003c/li\u003e\n\u003cli\u003eBielka K, Kuchyn I, Frank M, Sirenko I, Kashchii U, Yurovich A, et al. WHO Surgical Safety Checklist and Anesthesia Equipment Checklist efficacy in war-affected low-resource settings : a prospective two-arm multicenter study. Anaesthesiol Intensive Ther [Internet]. 2023;291\u0026ndash;6. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC10691456/pdf/AIT-55-51723.pdf\u003c/li\u003e\n\u003cli\u003eWhite MC, Randall K, Ravelojaona VA, Andriamanjato HH, Andean V, Callahan J, et al. Sustainability of using the WHO surgical safety checklist : a mixed- methods longitudinal evaluation following a nationwide blended educational implementation strategy in Madagascar. 2018;1\u0026ndash;10. \u003c/li\u003e\n\u003cli\u003eEyob B, Boeck MA, Fasioen P, Cawich S, Kluger MD. Ensuring safe surgical care across resource settings via surgical outcomes data \u0026amp; quality improvement initiatives. Int J Surg [Internet]. 2019;72(June):27\u0026ndash;32. Available from: https://doi.org/10.1016/j.ijsu.2019.07.036\u003c/li\u003e\n\u003cli\u003eJones A, Williams W, Soelling S, Abahuje E, Alayande B, Robertson JM, et al. Why the checklist works: the interplay of non-technical skills and the WHO surgical safety checklist in variable resource healthcare settings. BJS Acad [Internet]. 2024;1\u0026ndash;4. Available from: https://doi.org/10.58974/bjss/azbc046%0AAnnabelle\u003c/li\u003e\n\u003cli\u003eFudickar A, H\u0026ouml;rle K, Wiltfang J, Bein B. The Effect of the WHO Surgical Safety Checklist on Complication Rate and Communication. Dtsch Arztebl Int [Internet]. 2012;109(42):695\u0026ndash;702. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC3489074/pdf/Dtsch_Arztebl_Int-109-0695.pdf\u003c/li\u003e\n\u003cli\u003eLabat F, Sharma A. Qualitative study exploring surgical team members\u0026rsquo; perception of patient safety in conflict-ridden Eastern Democratic Republic of Congo. BMJ Open. 2016;6(4):1\u0026ndash;10. \u003c/li\u003e\n\u003cli\u003eShin MK, Tshimbombu TN. Strengthening Healthcare Delivery in the Democratic Republic of Congo through Adequate Nursing Workforce. 2024;10\u0026ndash;3. \u003c/li\u003e\n\u003cli\u003eMunthali J, Pittalis C, Bijlmakers L, Kachimba J, Cheelo M, Brugha R, et al. Barriers and enablers to utilisation of the WHO surgical safety checklist at the university teaching hospital in Lusaka, Zambia: a qualitative study. BMC Health Serv Res [Internet]. 2022;22(1):1\u0026ndash;9. Available from: https://doi.org/10.1186/s12913-022-08257-y\u003c/li\u003e\n\u003cli\u003eCowie J, Nicoll A, Dimova ED, Campbell P, Duncan EA. The barriers and facilitators influencing the sustainability of hospital-based interventions: A systematic review. BMC Health Serv Res. 2020;20(1):1\u0026ndash;27. \u003c/li\u003e\n\u003cli\u003eFerorelli D, Benevento M, Vimercati L, Spagnolo L, De Maria L, Caputi A, et al. Improving Healthcare Workers\u0026rsquo; Adherence to Surgical Safety Checklist: The Impact of a Short Training. Front Public Heal. 2022;9(February):1\u0026ndash;5. \u003c/li\u003e\n\u003cli\u003eEtheridge JC, Moyal-Smith R, Yong TT, Lim SR, Sonnay Y, Lim C, et al. Transforming Team Performance Through Reimplementation of the Surgical Safety Checklist. JAMA Surg. 2024;159(1):78\u0026ndash;86. \u003c/li\u003e\n\u003cli\u003eHigginson J, Walters R, Fulop N. Mortality and morbidity meetings: An untapped resource for improving the governance of patient safety? BMJ Qual Saf. 2012;21(7):576\u0026ndash;85. \u003c/li\u003e\n\u003cli\u003eBombard Y, Baker GR, Orlando E, Fancott C, Bhatia P, Casalino S, et al. Engaging patients to improve quality of care: A systematic review. Implement Sci. 2018;13(1). \u003c/li\u003e\n\u003cli\u003eSharkiya SH. Quality communication can improve patient-centred health outcomes among older patients: a rapid review. BMC Health Serv Res. 2023;23(1):1\u0026ndash;14. \u003c/li\u003e\n\u003cli\u003eAlsalim DS, Alanazi WS, Almutairi M, Abdullah A, Al-jabri IA, Alruhaymi AA. Accurate and Detailed Clinical Documentation is Essential for Quality Patient Care. Int J Innov Res Med Sci [Internet]. 2020;8(1):1\u0026ndash;5. Available from: https://www.ijirmps.org/papers/2020/1/231296.pdf\u003c/li\u003e\n\u003cli\u003eRahman AIA El, Ibrahim MM, Diab GM. Quality of Nursing Documentation and its Effect on Continuity of patients\u0026rsquo; care. Menoufia Nurs J [Internet]. 2021;6(2):1\u0026ndash;18. Available from: https://menj.journals.ekb.eg\u003c/li\u003e\n\u003cli\u003eKhatri R, Endalamaw A, Erku D, Wolka E, Nigatu F, Zewdie A, et al. Continuity and care coordination of primary health care: a scoping review. BMC Health Serv Res [Internet]. 2023;23(1):1\u0026ndash;13. Available from: https://doi.org/10.1186/s12913-023-09718-8\u003c/li\u003e\n\u003cli\u003eBergs J, Lambrechts F, Desmedt M, Hellings J, Schrooten W, Vlayen A, et al. Seen through the patients\u0026rsquo; eyes: Surgical safety and checklists. Int J Qual Heal Care. 2018;30(2):118\u0026ndash;23. \u003c/li\u003e\n\u003cli\u003eThe World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. 2008;(June 1964):1\u0026ndash;5. Available from: https://www.wma.net/wp-content/uploads/2016/11/DoH-Oct2008.pdf\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Patient safety, Operating room, WHO Surgical Safety Checklist, Low-resource settings, North Kivu, Consensus","lastPublishedDoi":"10.21203/rs.3.rs-7361454/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7361454/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: Operating rooms are complex, high-risk environments where preventable harm is frequent, especially in resource-limited settings such as North Kivu, a province in eastern Democratic Republic of Congo (DRC). Although global patient safety interventions exist, adapting these strategies to local realities remains challenging. This study aimed to develop a practical patient safety bundle specifically tailored to enhance the safety culture in operating rooms within North Kivu hospitals.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: A modified nominal group technique (NGT) was used to gather and prioritize strategies from a multidisciplinary panel of nine stakeholders, including healthcare professionals and patients from Goma hospitals. Participants reviewed evidence, shared perspectives, and ranked strategies to improve patient safety culture in local operating rooms.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: The implementation of the WHO Surgical Safety Checklist was identified as the most effective and feasible strategy, supported by regular team training, leadership engagement, patient involvement, and continuous monitoring. Other themes included leadership and team culture; Continuous training and improvement; Patient-centered care and Organizational processes. The resulting patient safety bundle reflects consensus-driven, context-sensitive interventions tailored to North Kivu’s unique challenges.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e: This study provides the first consensus-based patient safety bundle for operating rooms in North Kivu, offering a practical foundation for future implementation and effectiveness research. The approach can inform similar initiatives in other low-resource settings.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration: \u003c/strong\u003eNot applicable\u003c/p\u003e","manuscriptTitle":"Development of a Contextualized Patient Safety Bundle for Operating Rooms in North Kivu, DRC: A Consensus-Based Approach","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-12 14:35:41","doi":"10.21203/rs.3.rs-7361454/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2025-09-13T17:06:15+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"21156994696530989955760629331701341462","date":"2025-09-12T10:31:47+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-09-05T10:37:28+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-08-18T05:13:22+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-08-15T01:23:20+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-08-15T01:23:04+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Health Services Research","date":"2025-08-13T06:15:56+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"
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