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External Validation of an Ethical Framework in Global Surgery Guilfoyle, Regan 2020-04

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Regan Guilfoyle, MD, FRCSC  SURG 560  MASTER OF GLOBAL SURGICAL CARE APRIL 2020  Academic Advisor. Abdullah Saleh, MD, University of Alberta Study Contributor: Alexander Morzycki, MD, University of Alberta  This project fulfills the Master of Global Surgical Care (MGSC) requirements for SURG 560 at the UBC Branch for International Surgical Care (BISC).              External Validation of an Ethical Framework in Global Surgery    1  Table of Contents Introduction .................................................................................................................................................. 2 Methods ........................................................................................................................................................ 3 Ethics Approval ......................................................................................................................................... 3 Research Design and Methodology .......................................................................................................... 3 Questionnaire Design and Development .............................................................................................. 3 Methods ................................................................................................................................................ 4 Inclusion Criteria: .................................................................................................................................. 4 Exclusion Criteria:.................................................................................................................................. 5 Data Analysis ............................................................................................................................................. 5 Results ........................................................................................................................................................... 5 Discussion.................................................................................................................................................... 11 Conclusion ................................................................................................................................................... 13 References .................................................................................................................................................. 14         2  External Validation of an Ethical Framework in Global Surgery Regan Guilfoyle, MD, Alexander Morzycki, MD, Abdullah Saleh, MD Introduction Since the publication of the Lancet Commission on Global Surgery in 2010 1, surgical care in low-middle income countries has garnered increasing attention. In response, many academic centers in high income countries have started to focus efforts on developing global surgical programs 2. These activities attempt to address the ever-increasing burden of global surgical disease and the gap in access to surgical care in low-income countries 3. However, there is little oversight in how best to conduct global surgical endeavours to ensure useful impact, sustainability, and cultural suitability 4. There is evidence to suggest that global surgical care can have negative consequences for both visiting and host members, particularly if little consideration is given to mitigate possible harmful consequences 5,6,7. Conscious of this concern, the Office of Global Surgery (OGS) at the University of Alberta, set out to develop an ethical framework in global surgery 8 that could be used as a guideline for academic centers wanting to participate in global surgical care. This framework was developed from a variety of research strategies including scoping literature review, a webinar series, panel discussions with biomedical ethicists, and a workshop class. This framework, though developed with contributions from surgeons, nurses, and ethicists from Europe, South America, North America, Africa, and Asia, has not been validated in a low-income setting. In order, to ensure that this framework is congruent with the beliefs, principles, and priorities of those working in 3  low-middle income settings, the OGS intends to provide an external validation of this framework through a cross sectional study using paper and online questionnaire.  Methods  Ethics Approval  Research ethics approval for this study was granted, prior to commencement, from the University of British Columbia Research Ethics Board and the University of Alberta Research Ethics Office. All study data was collected using Qualtrics Survey Software (Provo, Washington). No identifying information was ever collected, thus ensuring participants’ anonymity.  Research Design and Methodology  Questionnaire Design and Development  A questionnaire was designed to effectively capture the overarching themes outlined in the ethical framework. The design was based on a literature review conducted with the aid of a librarian at the University of Alberta. Based on the critique of 10 9-18 relevant articles, the questionnaire was developed using a two-step approach.   Major themes of the Ethical Framework in Global Surgery identified included patient care and delivery, research, teaching, partnerships/collaborations, donation, and environment. Questions were then developed according to these themes. A combination of Likert scale, rank order, and open-ended questions were employed. Questions were limited to a total of 16; 6 related to personal demographics and 10 related to framework content (Supplement 1).  4  The questionnaire was distributed to 5 academic expert panelists who had participated in developing the ethical framework. These expert panelists edited the questionnaire for content and comprehension. The revised questionnaire was then submitted for approval by University of British Columbia Ethics Board and the University of Alberta Research Ethics Office. Methods We employed an opportunistic sampling method for the purpose of this study. We aimed to recruit surgeons from low-and middle-income African countries who were in attendance at the Annual General Meeting of the College of Surgeons of East, Central, and Southern Africa (COSECSA).  This meeting was held in Uganda on December 6, 2019, and included a workshop on developing an ethical framework in global surgery. This allowed an opportunity to encourage participation from surgeons who were familiar with the complexities of global surgery and related collaborations. Individual members of COSECSA were contacted directly by email to request their participation and their help in the distribution of the online questionnaire to colleagues and allied health care professionals.  Inclusion Criteria: Included in the study were active surgical members of COSECSA who have been involved in international surgical collaborations at their respective centers and nurses and allied health care professionals invited by surgical members of COSECSA. Involvement was defined as:  o Time spent on a committee/board involved in working with an international academic partnership o Time spent with a visiting surgeon from an international center 5  o Participation in international health research o Training, at least in part, in an international setting o Direct interaction with international surgeons/collaborative projects while in practice Exclusion Criteria: Surgeons, nurses, allied health care professionals who had no experience with international collaborations Data Analysis Descriptive statistics, including frequencies of responses, were calculated. Continuous variables were presented by their means and standard deviations (SD). Likert scale data was displayed at median and interquartile range (IQR). Qualitative data was itemized and thematically analyzed to identify common themes in response to open-ended questions. Two independent reviewers were used to code responses.  Results   A total of 44 medical professionals responded with a response rate of 100% (44/44). Thirty-nine individuals attended the COSECSA workshop, all of whom completed the questionnaire. Nine of these surveys were removed as they did not meet criteria because the participants were not from a LMIC. Fourteen participants from previous webinar workshops were emailed directly and all responded but were ineffective at further distribution of the questionnaire. Ninety-five percent (42/44) were consultant surgeons or surgery residents/ registrars, of which 98% (43/44) lived in a low or middle-income country. Mean collaboration time with a high-income country was 4.43 year (SD=3.93).  6   Sixty-six percent (29/44) of respondents indicated that they had experienced an ethical conflict while working with a surgical team or academic collaboration from a high-income country. All surgeons (100%, 44/44) believed that a set of ethical guidelines would be useful in addressing ethical conflicts while working with a surgical team or academic collaboration from a high income country and believed that the development of a framework based on a set of guiding principles would be a useful tool for global surgical collaborations. Most respondents (86%, 36/42) believed that equal contributions from low and middle-income countries should guide the development for a framework in global surgery.   When asked to rank the importance of the following values in an equitable surgical partnership (Justice; Respect; Honesty; Compassion; Accountability), 44% (15/34) responded placed respect first, followed by accountability (18%, 6/34), and justice (15%, 5/34). Responses regarding general academic partnerships, surgical care, research, academic partnership planning, environmental impact, donations, and monitoring and evaluation are illustrated graphically (Figure 1-7).      7     Figure 1. Box and whisker plots of survey responses concerning general academic partnerships. Ratings are on an ordinal Likert scale, where 1 = Strongly disagree and 5 = Strongly agree. The box represents the interquartile range, and the whiskers the minimum and maximum values. Median values are displayed as separate lines in the box, but often overlap with interquartile values and are not displayed.     Figure 2. Box and whisker plots of survey responses concerning surgical care. Ratings are on an ordinal Likert scale, where 1 = Strongly disagree and 5 = Strongly agree. The box represents the interquartile range, and the whiskers the minimum and maximum values. Median values are displayed as separate lines in the box, but often overlap with interquartile values and are not displayed.  8    Figure 3. Box and whisker plots of survey responses concerning research. Ratings are on an ordinal Likert scale, where 1 = Strongly disagree and 5 = Strongly agree. The box represents the interquartile range, and the whiskers the minimum and maximum values. Median values are displayed as separate lines in the box, but often overlap with interquartile values and are not displayed.      Figure 4. Box and whisker plots of survey responses concerning academic partnership planning. Ratings are on an ordinal Likert scale, where 1 = Strongly disagree and 5 = Strongly agree. The box represents the interquartile range, and the whiskers the minimum and maximum values. Median values are displayed as separate lines in the box, but often overlap with interquartile values and are not displayed.  9   Figure 5. Box and whisker plots of survey responses concerning environmental impact. Ratings are on an ordinal Likert scale, where 1 = Strongly disagree and 5 = Strongly agree. The box represents the interquartile range, and the whiskers the minimum and maximum values. Median values are displayed as separate lines in the box, but often overlap with interquartile values and are not displayed.    Figure 6. Box and whisker plots of survey responses concerning environmental donations. Ratings are on an ordinal Likert scale, where 1 = Strongly disagree and 5 = Strongly agree. The box represents the interquartile range, and the whiskers the minimum and maximum values. Median values are displayed as separate lines in the box, but often overlap with interquartile values and are not displayed.   10   Figure 7. Box and whisker plots of survey responses concerning monitoring and evaluation. Ratings are on an ordinal Likert scale, where 1 = Strongly disagree and 5 = Strongly agree. The box represents the interquartile range, and the whiskers the minimum and maximum values. Median values are displayed as separate lines in the box, but often overlap with interquartile values and are not displayed.    In response to the open-ended question, “briefly describe an ethical conflict resulting from working with a surgical team or academic collaboration from a high-income country”, 25 provided descriptive texts. These responses could be categorized into four themes: patient care and safety, research, training, and respect. Fifty-two percent (13/25) recounted conflicts involving concerns with patient care, citing concerns such as: “Complications happened after visiting team left and local team had minimal capacity to handle it” and “Liability of visiting expert to use limited locally available equipment / resources”.   Ethical conflict in the area of research was described by 28% (7/25) of respondents. Experiences shared by participants included: “Publication of data generated from my country with no collaboration of the locals” and “Some teams have used the camp to collect specimen from patients that are not authorized!”.  Another 12% (3/25) of participants identified lack of training 11  for local staff as an ethical consideration. Comments reflecting these concerns included: “No skill transfer; Guests travel and work with their full teams” and “Failure to involve the local team to allow transfer of knowledge /skills for growth & sustainability”.  The last theme touched on by 8% (2/25) of participants was a lack of respect demonstrated by the visiting HIC team. The comments to this end: “Mainly communication and patronizing manner” and “There was a so-called ‘know-all attitude’ from HIC collaborating team, whereby any contradicting suggestions from the local was considered as ‘Non-Evidence-Based Medicine’ and not considered at all”.  Discussion Through direct input from surgeons and practitioners in low-middle income nations, we present compelling support of the ethical framework in global surgery. In addition to unanimous agreement in most domains, this study also describes areas requiring significant improvement. Although only 66% of respondents indicated that they had experienced an ethical conflict when working with a surgical team or academic collaboration from a high-income country, all believed that a set of ethical guidelines based on a set of guiding principles would be useful. This demonstrates overwhelming support for the concept of an ethical framework for global surgery. Five guiding principles were outline in the initial framework, these included: justice, respect, honesty, compassion, and accountability. Of these guiding principles, respect was given the highest priority by the greatest number of respondents (44%), followed by accountability (18%). This differed from a North American expert panel review which identified respect and justice as having paramount importance to guiding actions in global surgical endeavours.  12  The response to all Likert scale questions dealing with the major themes of patient care and delivery, research, teaching, partnerships/collaborations, donation, and environment were either in agreement or strong agreement. All whisper plots related to these questions had a median of either 4 (agree) or 5 (strongly agree). This degree of alignment points to a dramatic consensus regarding the content of the Ethical Framework in Global Surgery. Participant descriptions of an ethical conflict that had resulted from working with a surgical team or academic collaboration from a high-income country varied among four identified themes: patient care and safety, research, training, and respect.  These descriptions were echoed in previous webinars hosted by the Office of Global Surgery (OGS) while discussing the topic of ethics in global surgery. All of the themes highlighted in the descriptive texts have been captured within the current ethical framework proposed by the OGS in either guiding principles (justice, respect, honesty, compassion, and accountability) or major themes (patient care and delivery, research, teaching, partnerships/collaborations, donation, and environment). The response rate to our questionnaire was uncharacteristically high at 100%. This is likely the result of recruitment methodology, as participants were asked to complete the questionnaire either in person or via email following either a workshop or webinar series dedicated to the topic of ethics in global surgery. As such, the participants were selected opportunistically, having previous engagement with and commitment to the subject matter. Despite successful recruitment, our response size may pose issues with sampling bias, a limitation of this study. As a general consideration, a sample size 5 to 10 times the number of variables used in the questionnaire is adequate 19,20. Out of 16 questions herein, 10 were directly related to the topic theme, suggesting 50- 100 should have been recruited. 13  The genesis of the Ethical Framework of Global Surgery was built on the extensive engagement of all identified stakeholders including surgeons, anesthetists, and nurses representing both high and low income countries from around the globe. The purpose of this research was to further validate the content of the proposed framework giving a larger representation to those working in LMIC’s. Although the overall sample size of our research was smaller than projected and only recruited surgeons from Sub-Saharan Africa, the results and moreover the process by which they were obtained are critically important.  The findings of this research propel us one more step forward in developing a universally acceptable set of guidelines, while attempting to heed the instructions of our LMIC counterparts who have warned against adopting a “patronizing manner” and a “know-all attitude”.   Conclusion  The consistently positive results of our questionnaire lead us to believe that the Ethical Framework in Global Surgery proposed by the Office of Global Surgery at the University of Alberta is congruent with the beliefs, principles, and priorities of those working in low-middle income settings. This affirmation gives credibility to the framework and ensures that the process of developing a framework itself is representative of all stakeholders. Further dissemination of this questionnaire would enhance the power and statistical significance of this external validation. Once finalized, this document will help inform and guide global surgical collaborations to improve sustainability, mitigate harmful effects, and promote surgical care in to marginalized populations or to populations that do not have adequate access to safe and timely surgery.  14  References  1. Lozano R, Naghavi M, Foreman K, et al: Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: pp. 2095-2128 2. A.J. Dare, C.E. Grimes, R. Gillies, et al.Global surgery: defining an emerging global health field.Lancet, 384 (9961) (2014), pp. 2245-2247 3. Meara JG, Leather AJ, and Hagander L et al. Global Surgery 2030: evidence and solutions for achieving health, welfare, and economic development. Lancet. 2015, 386: 569–624.
  4. Farmer P. Rethinking Foreign Aid. Foreign Affairs. Published online. December 12, 2013 5. Martiniuk, A.L.C. etal. Brain Gains: a literature review of medical missions to low and middle-income countries. BioMedCentral Health Services Research, 2012, 12: 134. 6. Nouvet E., Chan E., and Schwartz L.J. Looking good but doing harm? Preceptions of short-term medical missions in Nicaragua. Global Public Health. online 20 Aug 2016. 7. Maine RG, Hoffman WY, Palacios-Martinez JH, Corlew DS, Gregory GA (2012) Comparison of fistula rates after palatoplasty for international and local surgeons on surgical missions in Ecuador with rates at a craniofacial center in the United States. Plastic and Reconstructive Surgery. 2012, 129:319–326. 8. Saleh A et al. An Ethical Framework in Global Surgery (2019) Unpublished manuscript.  9. Ciliberti R, Baldelli I, Gallo F et al. Physicians’ perception of the importance of ethical and deontological issues in a major Italian Province: pilot questionnaire and its validation. Acta Biomed. 2019. 90: 56-67. 10. Muamatsu T, Makamura M, Okada E, et al: The development and validation of the Ethical Sensitivity Questionnaire for Nursing Students. BMC. 2019. 215 (19): 1-8. 11. Falco-Pegueroles A, Lluch-Canut T, Guardia-Olmos J. Development process and initial validation of the Ethical Conflict in Nursing Questionnaire-Critical Care Version. BMC. 2013. 14 (22): 1-8. 12. Chughtai M, Jamil B, and Mahboob U. Developing and validating a questionnaire to Measure Ethical Sensitivity of Freshly Graduated Dentists. J Pak Med Assoc. 2019. 69 (4):  518- 522. 13. Crnjasnki T, Krajnovic D, Tadic I et al. An Ethical Issue Scale for Community Pharmacy Setting (EISP): Development and Validation. Sci Eng Ethics. 2016 22: 497-508. 14. Padilla-Walker L, Jensen L. Validation of the long- and short-form of the Ethical Values Assessment (EVA): A questionnaire measuring the three ethics approach to moral psychology. IJBD. 2016 40(2) : 181-192. 15. Junges J, Zoboli E, Schaefer R et al: Validation of the Comprehensiveness of an Instrument on Ethical Problems in Primary Care. Rev Gaucha Enferm. 2014. 35 (2): 157-160. 16. Pergert P, Bartholdson C, Wenemark M et al. Translating and culturally adapting the shortened version of the Hospital Ethical Climate Survey (HECS-S) – retaining or modifying validated instruments. BMC. 2018 19 (35): 1-9. 17. Steinman B, Nubold A, Maier G. Ethical Leadership at Work Questionnaire by Kalshoven et al. (2011). Frontiers in Psychology. 2016. 7(46): 1-17. 15  18. Suhonen R, Stolt M, Katajisto J. Validation of the Hospital Ethical Climate Survey for older people care. Nursing Ethics. 2015. 22(5): 517-532. 19. Cattel RB. The scientific use of factor analysis. Chapter 15. New York: New York Plenum; 1978. p. 1–10.  20. Hair JF, Anderson RE, Tatham RL, Black W. Multivariate data analysis. 5th Ed: Prentice Hall; 1998.      

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