Global Outreach Using a Systematic, Competency-Based Training Paradigm for Inguinal Hernioplasty

Key Points

Question  Can a structured training paradigm address the inconsistency in inguinal hernia operations performed worldwide?

Findings  In this prospective, observational study, 81 surgeon trainees at 16 hospitals in 5 countries underwent systematic training in Lichtenstein hernioplasty, a subset of whom became certified regional trainers. During the training series, improvements in operative performance were statistically significant for all countries and sites.

Meaning  Regional competency-based training provides a standard method to address the global burden of surgical disease.

Importance  Sustainable, capacity-building educational collaborations are essential to address the global burden of surgical disease.

Objective  To assess an international, competency-based training paradigm for hernia surgery in underserved countries.

Design, Setting, and Participants  In this prospective, observational study performed from November 1, 2013, through October 31, 2015, at 16 hospitals in Brazil, Ecuador, Haiti, Paraguay, and the Dominican Republic, surgeons completed initial training programs in hernia repair, underwent interval proficiency assessments, and were appointed regional trainers. Competency-based evaluations of technical proficiency were performed using the Operative Performance Rating Scale (OPRS). Maintenance of proficiency was evaluated by video assessments 6 months after training. Certified trainees received incentives to document independent surgical outcomes after training.

Main Outcomes and Measures  An OPRS score of 3.0 (scale of 1 [poor] to 5 [excellent]) indicated proficiency. Secondary outcomes included initial vs final scores by country, scores among surgeons trained by the regional trainers (second-order trainees), interval scores 6 months after training, and postoperative complications.

Results  A total of 20 surgeon trainers, 81 local surgeons, and 364 patients (343 adult, 21 pediatric) participated in the study (mean [SD] age, 47.5 [16.3] years; age range, 16-83 years). All 81 surgeons successfully completed the program, and all 364 patients received successful operations. Mean (SD) OPRS scores improved from 4.06 (0.87) before the initial training program to 4.52 (0.57) after training (P < .001). No significant variation was found by country in final scores. On trainee certification, 20 became regional trainers. The mean (SD) OPRS score among 53 second-order trainees was 4.34 (0.68). After 6-month intervals, the mean (SD) OPRS score among participating surgeons was 4.34 (0.55). The overall operative complication rate during training series was 1.1%.

Conclusions and Relevance  Competency-based training helps address the global burden of surgical disease. The OPRS establishes an international standard of technical assessment. Additional studies of long-term surgeon trainer proficiency, community-specific quality initiatives, and expansion to other operations are warranted.

The true global burden of inguinal hernia is unmeasured, but its worldwide prevalence approaches 8% according to previous reports.^1-3 Inguinal hernias jeopardize the productivity of the working population, especially in low- to middle-income countries, and their morbidity results in adverse socioeconomic effects for underserved patients and communities with poor access to care.^4,5

Despite a statement by the American College of Surgeons that low risks of recurrence and complication^6,7 make Lichtenstein hernioplasty (LH) the criterion standard treatment for inguinal hernia, as many as 80% of inguinal hernia operations in the developing world are tissue-based repairs.^2,8 In addition, pediatric inguinal herniorrhaphy (PH) is largely unavailable in developing nations, yet it is highly cost-effective in obviating disability-adjusted life-years.⁹ It is the mission of several humanitarian organizations to address these disparities by providing LH and PH to underserved communities.^4,5,8,9

Challenges to the effectiveness of surgical humanitarian missions include extensive mission scope, poor communication, logistical issues, and ethical considerations.^10,11 Short-term medical missions, in which participants provide care for a short duration in remote communities, risk poor outcomes and may not be cost-effective.^10,12 In contrast, long-term educational missions with a focused clinical scope may afford developing communities a cost-effective and sustainable means of improving care delivery.

In this study, we present an educational program developed by Hernia Repair for the Underserved (HRFU) to address the global disparity of care for inguinal hernia. Hernia Repair for the Underserved is a 501(c)(3) not-for-profit organization founded in 2004 by Charles Filipi, MD, with 10 physician and surgeon board members from Brazil, Germany, Italy, and the United States. The organization’s mission objectives are to offer underserved patients operations and perioperative care that are held to the same standards as those in developed nations, to train surgeons who will serve as local and regional expert trainers, and to assist institutions in establishing sustainable care delivery teams. We forged relationships with academic institutions and national health care administrations in developing and developed nations, constructed a training program for LH and PH, and launched this program as a regionally focused systematic training paradigm for surgeons in underserved communities in the Western hemisphere. We hypothesized that this paradigm would result in the delivery of sustainable, high-quality surgical care to meet the needs of currently underserved communities.

This study was performed from November 1, 2013, through October 31, 2015. Regional training hospitals in each country of operations (Table 1) were selected by members of HRFU based on perceived need, irrespective of prior institutional outcomes of inguinal hernia repairs. Local affiliate partners with established relationships among hospitals and health care professionals arranged patient recruitment, operating room coordination, scheduling, and postoperative care. Operations were performed in Brazil, Ecuador, Haiti, Paraguay, and the Dominican Republic. Training sessions in Brazil were performed at the designated São Paulo hospitals; in Dajabón, Santa Cruz de Mao, or Santiago, Dominican Republic; and in Archidona, Ecuador. In Haiti and Paraguay, trainings were hosted at the hospitals where surgeon trainees routinely practiced. This study was approved by the institutional review boards of the Faculdade de Ciências Médicas da Santa Casa de São Paulo in São Paulo, Brazil, and the University of California, Los Angeles. In Ecuador, Haiti, Paraguay, and the Dominican Republic, where studies are not subject to systematic institutional review, this study was approved for the use of human subjects by each country’s ministry of health. Written informed consent to participate was explicitly provided by surgeons participating in the educational program. Data were not deidentified because individual data were shared with participating surgeons as part of the educational program.

Training was provided by HRFU surgeon volunteers from Germany, Brazil, Italy, and the United States to licensed surgeons selected by the charity’s local affiliates in each location. Participating surgeon trainees had varying levels of experience with LH before this program. Trainees were selected irrespective of prior LH experience. Adult and pediatric patients with limited access to basic health care services and living in impoverished conditions were selected by local affiliates and approved by HRFU surgeon trainers to undergo LH or PH operations. Operations were provided at no cost to the patients. Board-certified pediatric surgeon trainers provided supervision, and pediatric anesthesia specialists provided general anesthesia for all PH operations. Anesthesia and perioperative nursing services were provided by board-certified HRFU volunteer anesthesiologists and nurses in Pignon, Dajabón, Santiago, Santa Cruz de Mao, Ouanaminthe, and Archidona and by the staff members of local hospitals in São Paulo, Port-au-Prince, and Paraguay.

All LH operations were performed with the patients under local anesthesia using the LH technique modified by Amid et al¹³ with polypropylene or polyester mesh reconstructions, specific attention to 3-nerve identification, and proper mesh sizing, positioning, and fixation. All PH operations were performed with high ligation of the hernia sac at the internal inguinal ring.¹⁴

An initial structured educational series was established to train surgeons in the LH technique. Each local surgeon trainee performed at least 3 LH operations, and local pediatric surgeon trainees participated in at least 1 PH operation, all with an HRFU surgeon trainer. The HRFU surgeon trainer performed the initial operation of each training series assisted by the trainee, emphasizing systematic identification of each of the ilioinguinal, iliohypogastric, and genital branch of the genitofemoral nerves; mesh positioning as modified by Amid et al¹³; inguinal floor reconstruction for large hernias; and management of scrotal hernias. In all subsequent cases, the trainee performed the operations assisted by the trainer. At the conclusion of each operation, the trainer evaluated the trainee’s performance using the Operative Performance Rating Scale (OPRS), a validated instrument that consists of 13 Likert scale parameters specific to LH or 12 specific to PH.^15,16 Using the OPRS, the surgeon trainer provided immediate feedback regarding areas of proficiency and opportunities for improvement. Surgeons were granted certificates of completion if they achieved an overall OPRS score of 3 or better by the end of training.

Hernia Repair for the Underserved surgeon trainers selected qualified individuals among the certified surgeon trainees to be designated independent trainers in their regions. These surgeons were instructed to select local surgeon trainees for a second-order LH training series using the same educational program described above. Second-order training series commenced on September 18, 2014. Training operations were tabulated, and the OPRS data were compiled by the independent trainers for the second-order trainees. Local surgeon trainees were granted certification with OPRS overall scores of 3 or greater.

Certified surgeons who elected to participate in interval assessments of maintained proficiency each received a high-definition camera with a head mount (GoPro Hero 3+; GoPro). Surgeons were instructed to independently perform an LH procedure 6 months after completion of the initial HRFU training program, record video via the head-mounted camera, and send the video electronically to HRFU staff for review. Certified trainees who completed the program before April 1, 2015, were included in this analysis to allow for the 6-month interval before conclusion of the study period. Hernia Repair for the Underserved surgeon trainers performed the OPRS assessments of the video-recorded LH operations via the Surgus web-based video review interface (CommentBubble Inc) and granted maintenance of proficiency to surgeons with overall scores of 3 or better.

An incentive structure was established to encourage surgeons certified by HRFU to maintain records of LH operations performed after training. Participating surgeons received a shipment of 20 pieces of donated synthetic polypropylene mesh specifically for use in future LH operations among underserved patients treated at their home institutions. Surgeons were instructed to record the date, time, and outcome of each operation performed. For every 20 operations recorded, HRFU delivered an additional 20 pieces of mesh to the participating surgeon.

Local clinicians affiliated with HRFU assessed patient outcomes at each participating institution on a continuous basis. Complications of training operations were reported and documented. Hernia Repair for the Underserved assumed costs of care for patients with complications from operations performed by surgeon trainers.

All OPRS scores were recorded in a web-based spreadsheet. An overall mean score of 3 or better (scale of 1 [poor] to 5 [excellent]) was defined as demonstrating technical proficiency. Training was considered successful if the trainee achieved and maintained technical proficiency by the final operation. Certificates and graphic score reports (Figure) were generated for each surgeon trainee demonstrating proficiency at completion of the course. Initial and final overall performance scores were compared by country and for all surgeons using 2-tailed paired t tests. Variations in score by country were analyzed via 1-way analysis of variance. Findings were considered statistically significant at P < .05.

A total of 20 surgeon trainers, 81 local surgeons, and 364 patients (343 adult, 21 pediatric) participated in the study (mean [SD] age, 47.5 [16.3] years; age range, 16-83 years). The inaugural round of initial training series at all sites resulted in successful completion by 42 surgeons. During the entire study period, the initial HRFU training course was successfully completed by 81 surgeon trainees across the 16 sites in 5 countries. Among the 81 surgeons, 75 received adult LH training only, 5 received training in LH and PH, and 1 received PH training only. The LH surgeon trainees performed a mean (SD) of 4.6 (1.1) operations, and the PH surgeon trainees performed a mean (SD) of 3.5 (1.4) operations.

All 81 surgeon trainees demonstrated technical proficiency throughout their LH and PH training courses. Table 2 summarizes the OPRS overall LH performance ratings by country and for all surgeons. Mean (SD) OPRS scores improved from 4.06 (0.87) before the initial training program to 4.52 (0.57) after training (P < .001). Significant improvement was found in overall performance scores in 3 of the 5 countries, with score improvement that did not achieve statistical significance in the other 2. Surgeons in all 5 countries received mean final scores of 4 or 5, signifying very good and excellent performance, respectively. No surgeon trainee sustained a decrease in the OPRS overall LH performance scores during the training program. Analysis of variance demonstrated significant variation in initial overall performance scores but no difference in final scores by country.

At the initiation of second-order training, 20 certified trainees were selected to become regional trainers (4 in Haiti and 16 in Brazil). Second-order regional trainees included 51 surgeons and 2 surgery residents who performed a mean (SD) of 3.1 (1.1) LH operations. All regional trainees achieved OPRS overall scores of technical proficiency, with mean (SD) scores of 4.3 (0.68).

By April 1, 2015, a total of 42 surgeons had completed the training program. Among them, 9 (21.4%) submitted interval operative videos within the overall study period. All 9 demonstrated technical proficiency on OPRS video review, with a mean (SD) overall performance score of 4.34 (0.55).

The LH outcomes after completion of training were independently documented by 11 (13.6%) of the 81 certified surgeons from the initial training program. All 11 received donations of mesh from HRFU in 14 shipments during the study period. A total of 173 independently performed LH operations were registered after completion of training, amounting to a mean of 15.7 operations (range, 0-16) per participating surgeon.

All 343 adult and 21 pediatric patients underwent successful hernia repair operations during the training program. Complications among adults included 2 postoperative hematomas (0.5%), 1 postoperative seroma (0.3%), and 1 hernia recurrence that required a subsequent operation (0.3%). Pediatric patients experienced no complications. Surgeons reported no complications in the 173 LH operations performed independently after completion of training.

The HRFU training paradigm was implemented in 16 sites in 5 countries. All 81 surgeon participants completed the program, demonstrating proficiency in the OPRS assessments. The program provided successful hernia repair operations for 537 patients: 364 in the initial training program, 173 documented by participants after completion of the program, and 177 supervised by participants who became trainers selected by HRFU. Rates of hernia recurrence and seroma formation were consistent with those reported from high-volume centers in the United States and Europe.^6,7,17

The OPRS is an invaluable instrument in providing objective data regarding the systematic conduct of the LH and PH techniques. The OPRS scores of surgeon performance demonstrated trends of improvement in the 5 participating countries, and although variance analysis revealed significant variation in initial performance scores by country, no significant variation was found in final performance scores. These results suggest that the OPRS captures common trends of improvement and establishes a standard of performance outcomes across several different countries, which was instrumental in vetting and recruiting participants to become regional expert trainers. Notably, surgeon trainees presented a spectrum of experience with LH before this training program; hence, no conclusions about technical proficiency may be drawn from initial OPRS scores. Rather, these scores serve only as a single standard indicator of variability, which we observed diminish after our training program. Interval video assessments of 21% of participating surgeons demonstrate that the technical proficiency observed at the conclusion of the training program is sustained 6 months later. All trained surgeons continued to practice at their local and regional hospitals, providing hernia repairs to patients in need.

This training paradigm was conceived to build surgical capacity while maintaining performance standards in needy communities. Although short-term medical missions may provide high-quality care, visiting practitioners are challenged in providing accountable care outside the finite construct of the mission scope.¹⁸ In recent evaluative studies,^10,11 short-term medical missions performed poorest in domains of education, efficiency, sustainability, and preparedness in providing care, whereas self-contained temporary platforms and specialized surgical centers are more cost-effective and result in improved outcomes. For this reason, solutions-based approaches to global surgical missions are advisable, with needs assessments individualized to the hosting communities.^12,19,20 By providing education to designated regional experts, accountability and ethical infractions are avoided, and the community develops an independently functional means of surgical care delivery.^21,22 Our program provides a focused surgical training program while cultivating relationships with regional health care organizations and governments to build surgical capacity in developing communities throughout the Western hemisphere. Among our participants, visiting health care professionals incurred the costs of their own travel, and the hosting states financed patient care in accordance with existing public health care policy. Industry sponsors donated equipment and materials used in the training series. The total cost of our program cannot be quantified; however, cost-effectiveness analysis is warranted in future studies to evaluate the degree to which our educational paradigm affects the financial burden of the disease process in our participant communities.

Several sustainable international surgical education partnerships^23-32 have been described recently (Table 3). In most cases, partnerships are established between a single international site and US academic institutions to foster bidirectional surgical education; however, discussions of these programs on residency websites are significantly more likely to feature benefits to residents from higher-income countries than to those from low- to middle-income countries.³³ Operation Smile has established robust global partnerships to offer cleft lip and cleft palate repairs in a variety of countries and now offers a fellowship in global surgery.²³ Other programs have also been developed by US institutions to provide sustainable surgical care by improving infrastructure and supporting the local workforce in hosting communities.^34,35 Operation Hernia has successfully established a regional center of excellence for inguinal hernia repair in Ghana.^5,36 These programs offer educational exchange, foster collaboration among international institutions, and may improve capacity and quality of surgical care delivery in their partnered communities. Our program shares these goals but with an additional strategy to increase the capacity of surgical education with an internationally standardized approach, compounding the reach of capable local surgeons. In this study, we demonstrate feasibility in generating sustainable surgical education programs in a variety of communities, whereas our systematic certification structure generates an international standard model of operative instruction.

In addition to the training program, our paradigm also establishes the foundations of clinical science and quality assessment in underserved communities. By tracking surgical outcomes, local surgeons are encouraged to evaluate their performance over time, investigate public health trends, and produce publications to engage global communities in the collective advancement of health care delivery. In fact, the rate of outcomes tracking was relatively low, reflecting the difficulties our program encountered in engaging regional surgeons in additional effort with a limited incentive structure. We anticipate this aspect of the HRFU mission objective will achieve a greater effect over time with expansion of our organization, increased adoption among developed communities, increased global awareness of health care quality standards, and increased participation of industry partners.

We have identified several components crucial to successful implementation of our training paradigm. As a foreign organization in participating communities, we found local coordinators to be a vital asset in arranging logistics and establishing relationships with individuals in our hosting communities. Financing was provided using a US-based donation structure; however, we recognize that local community-based philanthropic organizations may offer additional support to local surgical care professionals.¹⁹ In addition, support from enthusiastic local surgeon partners, hospitals, and public health administrations were crucial to the mission, as were low-cost data management and reporting systems. Computers, mobile telephones, and high-speed Internet access are valuable resources in making the educational program accessible with a relatively low degree of database maintenance. The program’s ultimate success relies on ongoing collaborative efforts of participating institutions, nations, and the global academic surgical community. With these elements, we believe that the regionalized training paradigm has significant potential to address the needs of underserved communities internationally and in the United States.

Our efforts are limited by several circumstances. Each participating community and institution has a unique set of needs and impediments to the delivery of high-quality care to its underserved population. Although HRFU and industry supporters provided supplies to serve these needs, not all needs could be met completely. In some settings, tissue-based repairs are performed frequently because prosthetic mesh is difficult to procure without humanitarian outreach efforts, and surgeons may only provide LH repairs when the patients purchase and present their own mesh at high individual cost. In these nations, donations of material resources alone may have a significant effect on delivery of high-quality care with appropriate institutional and governmental oversight. Alternatively, mesh supply may be augmented in resource-limited communities by engineering more cost-effective materials. A recent randomized, double-blind clinical trial found that, relative to commercial polypropylene mesh, low-cost polyethylene mesh used in LH in Uganda was associated with similar rates of recurrence and complications but at 1/125th of the cost.³⁷ For this reason, HRFU has partnered with industry sponsors to generate and distribute mesh in South America at a cost similar to that of mosquito netting. In other nations, information technology infrastructure is severely restricted, making basic communication, logistical arrangements, and data management cumbersome. Furthermore, each training site requires a well-cultivated series of institutional and interpersonal relationships, which may limit the initiation of shorter-duration programs in the future. Nevertheless, despite the differences in need for material resources among participating communities and institutions, the foundation of regional expertise in all participating sites improves the capacity to share experience in a safe and standard technique. To produce a sustainable and effective system, global health organizations, governments, and industry outreach leaders should aim to establish and support training programs, foster infrastructure investment, and maintain active relationships with underserved communities around the world.

The HRFU training program establishes a regional paradigm for the performance and training of adult and pediatric hernia repairs. Systematic training of qualified surgeons within their own underserved communities generates a sustainable model of surgical care delivery. Regional training should be the focus of public health and industry outreach campaigns to address the global burden of surgical disease.

Corresponding Author: David C. Chen, MD, Department of Surgery, David Geffen School of Medicine, University of California, Los Angeles, 10833 Le Conte Ave, 72-235 Center for Health Sciences, Los Angeles, CA 90095 (dcchen@mednet.ucla.edu).

Accepted for Publication: June 10, 2016.

Published Online: October 5, 2016. doi:10.1001/jamasurg.2016.3323

Author Contributions: Drs Wagner and Chen had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Wagner, Espinoza, Mellinger, Fitzgibbons, Campanelli, Cavalli, Reinpold, Filipi, Chen.

Acquisition, analysis, or interpretation of data: Wagner, Schroeder, Hiatt, Cusick, Fitzgibbons, Campanelli, Cavalli, Roll, Silva, Reinpold, Télémaque, Matthews, Chen.

Drafting of the manuscript: Wagner, Hiatt, Campanelli, Cavalli, Reinpold, Chen.

Critical revision of the manuscript for important intellectual content: All Authors.

Statistical analysis: Wagner, Schroeder, Roll.

Administrative, technical, or material support: Wagner, Schroeder, Espinoza, Cusick, Fitzgibbons, Campanelli, Cavalli, Roll, Reinpold, Filipi, Chen.

Study supervision: Espinoza, Hiatt, Fitzgibbons, Roll, Silva, Reinpold, Filipi, Chen.

Review of educational design elements and interpretation of educational outcomes data: Mellinger.

Conflict of Interest Disclosures: None reported.

Funding/Support:C. R. Bard Inc, Medtronic Covidien Ltd, Johnson & Johnson International Medical Assistance Programs, and Ethicon Inc provided financial support and surgical supplies.

Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Previous Presentation: This paper was presented at the 87th Annual Pacific Coast Surgical Association Meeting; February 16, 2016; Kohala Coast, Hawaii.

Additional Contributions: The American Pediatric Surgery Association and the UCLA (University of California, Los Angeles) Center for World Health provided recognition and academic affiliation. AmeriCares and Timmy Global Health provided logistical and humanitarian support. Thanks to all the local affiliates and hosting hospitals for the opportunity to develop this system together and to the donors of the Hernia Repair for the Underserved.