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  1. 1. Prospective Study of Surgical Care Scale-Up in a Rural, Resource-Limited Setting<br />Selwyn Rogers, MD, MSc andDuncan Maru, MD, PHD<br />October 4, 2011Center for Surgery and Public Health<br />Nyaya Health<br />
  2. 2. Goals and Outline<br /><ul><li>Goal: to think through methodological issues in surgical research implementation; better metrics
  3. 3. Overview of Problem, Methods: 25 minutes
  4. 4. Group Discussion of Metrics: 60 minutes
  5. 5. Wrap-up: 5 minutes</li></ul>1<br />
  6. 6. Conflicts of Interest<br />We report no financial conflicts of interest. As with any scientific or service endeavor, we have significant intellectual interests at stake, though we hope to remain objective and self-reflective.<br />2<br />
  7. 7. The Need: Implementation Gap in Surgical Care<br /><ul><li> Two billlion people, a third of the global population, live in areas with less than one operating room per 100,000 people
  8. 8. Globally, approximately 11% of death and disability are attributable to surgical diseases</li></ul>3<br />
  9. 9. The Problem: Deploying Surgical Care<br /><ul><li> WHO has produced Integrated Management for Emergency and Essential Surgical Care, and this has been utilized in several sites
  10. 10. But: no studies have yet prospectively studied the implementation process</li></ul>4<br />
  11. 11. Our Proposal: A Prospective, Implementation Research Study<br /><ul><li>Prospectively study the implementation of an IMEESC-plus protocol at a district hospital in rural Nepal.
  12. 12. IMEESC: WHO’s current model
  13. 13. IMEESC-plus: includes community-based follow-up and hospital-based quality improvement methods
  14. 14. Study the process using mixed quantitative and qualitative methodologies at the hospital-, staff-, and patient levels
  15. 15. Focus on cesarean sections and soft-tissue injuries</li></ul>5<br />
  16. 16. Study Objectives<br />Rigorously study an innovative model for surgical care (IMEESC-plus)<br />Pilot an implementation research methodology that can be used in a larger multi-site study<br />Generate data for larger scale-up of surgical care worldwide<br />6<br />
  17. 17. Setting: Bayalpata Hospital<br />Infrastructure development and capacity building, not care provision alone<br />Government collaboration: Government partnership contract for 5 years signed June 2009 – June 2014, on a government-owned complex<br />Currently one of the highest levels of clinical care in the Far West (2 million people)<br />Over 75,000 patients seen to date<br />
  18. 18. The ease with which young people die in Achham and the ease with which it is accepted continues to horrify me. <br />-RumaRajbhandari, MD, MPH, March 22, 2011.<br />8<br />
  19. 19. Implementation science done well should be able to enhance, not compromise, both service and research quality.<br />9<br />
  20. 20. Good study design involves collecting the right amount of data, hopefully nothing less but certainly nothing more. <br />10<br />
  21. 21. Implementation Overview<br /><ul><li>Build off existing hospital + CHW network
  22. 22. MD-GP/generalist-run operative services
  23. 23. Not general anesthesia– only spinal, local, regional
  24. 24. Cases outside scope of practice referred 6-14 hours away</li></ul>11<br />
  25. 25. Study Objectives<br />Rigorously study an innovative model for Surgical Care (IMEESC-plus)<br />Pilot an implementation research methodology that can be used in a larger multi-site study<br />Generate data for larger scale-up of Surgical Care worldwide<br />12<br />
  26. 26. Specific Aim 1: Description of Implementation<br />To describe the logistics of the implementation process of IMEESC-Plus: the conditions with which patients present and the financial, staffing, pharmaceutical, and consumable supply inputs required to address these conditions. <br />What basic implementation parameters can one expect? What parameters matter for planning purposes?<br />13<br />
  27. 27. Specific Aim 1: Description of Implementation<br /><ul><li>Nature of surgical disease
  28. 28. Financial inputs
  29. 29. Human resource inputs
  30. 30. Pharmaceutical, consummable utilization
  31. 31. Qualitative description of the implementation process</li></ul>14<br />
  32. 32. Specific Aim 2: Measuring quality of the implementation<br />To assess the quality of the resulting IMEESC-Plus services during the course of the implementation process: adherence of staff to resuscitation and operating protocols, supply chain reliability, performance of morbidity and mortality conferences, patient follow-up rates, and rates of complications.<br />How do you measure and monitor quality of surgical service implementation? (Distinct from, was the implementation itself high-quality?)<br />15<br />
  33. 33. Specific Aim 2: Measuring quality of the implementation<br /><ul><li>Adherence to stocking and energy protocols
  34. 34. Adherence to resuscitation protocols
  35. 35. Adherence to surgical safety protocols
  36. 36. Community-based follow-up
  37. 37. Complication rates</li></ul>16<br />
  38. 38. Thoughts at this Juncture?<br />
  39. 39. Surgical Safety Measures: Background<br />Different surgical teams and contexts will bring different practices, tools, techniques<br />But: there should be a shared set of quality measures across these different contexts<br />Goal here is to develop some basic metrics that can be used for both internal QI and external monitoring/accountability.<br />All data will be collected as force-choice fields, nothing free-hand. Form itself would be site-specific, based on work-flows and local documentation systems.<br />18<br />
  40. 40. Surgical Safety Measures: Domains of Analysis<br />Emergency room/pre-op<br />Operating room/intra-op<br />Inpatient unit/post-op<br />Facilities and supplies systems<br />Community/follow-up<br />19<br />
  41. 41. Surgical Safety Measures: Pre-Op<br />Fetal heart rate documented [obstetrics]<br />Indication documented<br />Time from decision to incision<br />Pre-operative evaluation and documentation of airway <br />20<br />
  42. 42. Surgical Safety Measures: Intra-op<br />Time out performed prior to surgery<br />Pulse oximeter working throughout the case<br />Appropriate perioperative antibiotic use*<br />Appropriate size suture documented <br />21<br />
  43. 43. Surgical Safety Measures: Post-op<br />Vital signs recorded within 30 minutes post-op<br />Postoperative exam documented by nurse within 30 minutes<br />Appropriate postoperative antibiotic use<br />22<br />
  44. 44. Surgical Safety Measures: Facilities<br />X-ray machine in working order, with technician to operate it<br />Electricity present throughout duration of surgery<br />Number of days that the surgical theater is open^<br />Suction machine verified and working pre-operatively<br />Oxygen source verified and working pre-operatively<br />Documentation of appropriate temperature strip from autoclave of surgical instruments<br />23<br />
  45. 45. Surgical Safety Measures: Follow-up<br />Hours to reach hospital from home<br />Use of ambulance<br />Paid CHW available in patient’s ward<br />Number of deliveries at hospital, cesarean and non-cesarean<br />Successful follow-up by CHW within 72 hours<br />24<br />
  46. 46. Concluding Thoughts<br />Concluding Thoughts<br /><ul><li> Unmet research need in surgical service delivery
  47. 47. Huge barriers remain in implementing this research
  48. 48. Complementary roles of implementation (service) and implementation science (research)
  49. 49. Simplicity and flexibility are key
  50. 50. On Planners, Searchers, and NIH grants
  51. 51. My email: duncan@nyayahealth.org</li></li></ul><li>References<br />1. Abdullah F, Choo S, Hesse A, Abantanga F, Sory E, et al. (2010) Assessment of Surgical and Obstetrical Care at 10 District Hospitals in Ghana Using On-Site Interviews. J Surg Res. 2. Choo S, Perry H, Hesse A, Abantanga F, Sory E, et al. (2010) Assessment of capacity for surgery, obstetrics and anaesthesia in 17 Ghanaian hospitals using a WHO assessment tool. Trop Med Int Health. 3. Galukande M, von S, Wladis A, Mbembati N, de M, et al. (2010) Essential surgery at the district hospital: a retrospective descriptive analysis in three African countries. PLoS Med. 74. Kruk M, Wladis A, Mbembati N, Ndao-Brumblay S, Hsia R, et al. (2010) Human resource and funding constraints for essential surgery in district hospitals in Africa: a retrospective cross-sectional survey. PLoS Med. 75. Kushner A, Cherian M, Noel L, Spiegel D, Groth S, et al. (2010) Addressing the Millennium Development Goals from a surgical perspective: essential surgery and anesthesia in 8 low- and middle-income countries. Arch Surg. 145: 154-159.6. Contini S, Taqdeer A, Cherian M, Shokohmand A, Gosselin R, et al. (2010) Emergency and essential Surgical Care in Afghanistan: still a missing challenge. World J Surg. 34: 473-479.7. Bickler S, Spiegel D (2010) Improving surgical care in low- and middle-income countries: a pivotal role for the World Health Organization. World J Surg. 34: 386-390.8. Osen H, Chang D, Choo S, Perry H, Hesse A, et al. (2010) Validation of the World Health Organization Tool for Situational Analysis to Assess Emergency and Essential Surgical Care at District Hospitals in Ghana. World J Surg. 9. (2011/01/28) Integrated Management for Emergency and Essential Surgical Care Tool Kit. Available: http://www.who.int/surgery/publications/imeesc/en/index.html. Accessed 0/28/111.10. (2011/01/28) Monitoring and Evaluation Tool for Emergency and Essential Surgical Care. Available: http://www.who.int/surgery/publications/MonitoringEvaluationtoolwithEEE.pdf. Accessed 0/28/111.11. Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AHS, et al. (2009) A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med 360: 491-499.12. Luboga S, Macfarlane S, von S, Kruk M, Cherian M, et al. (2009) Increasing access to Surgical Care in sub-saharan Africa: priorities for national and international agencies recommended by the Bellagio Essential Surgery Group. PLoS Med. 613. (2011/01/28) Best Practice Protocols: Clinical Procedures Safety-- WHO Manual. Available: http://www.who.int/surgery/publications/BestPracticeProtocolsCPSafety07.pdf. Accessed 0/28/111.14. (2011/01/28) Surgical Care at the District Hospital - The WHO Manual. Available: http://www.who.int/surgery/publications/scdh_manual/en/index.html. Accessed 0/28/111.15. Schwarz D. Implementing a Hospital-Based Morbidity and Mortality Conference in Remote Rural Nepal (in preparation). 16. Surgical Care Wiki Page. Available: http://wiki.nyayahealth.org/SurgicalServices. Accessed 2/2/2011.17. X-Ray Wiki Page. Available: http:// http://wiki.nyayahealth.org/X-Ray/.18. Dindo D, Demartines N, Clavien P (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 240: 205-213.19. Data Management Wiki Page. Available: http://wiki.nyayahealth.org/DataManagement.<br />
  52. 52. Acknowledgements<br /><ul><li>The staff of Bayalpata Hospital & the people of Achham, Nepal
  53. 53. The volunteers and individual donors of Nyaya Health
  54. 54. Dr. Selwyn Rogers and Tess Panizales of the CSPH
  55. 55. The Nepali Ministry of Health & Achham District Health officials: Dr. Deepak Gaylal, Mr. SailendraShrestha, Mr. JhanakDhungana
  56. 56. Institutional Supporters: Abbot Laboratories, AMD and the Open Architecture Network, America Nepal Medical Foundation (ANMF), BWH COE in Quality and Safety, Buddha Air, Cents of Relief, Child Health Foundation, CIWEC Clinic (Menlha Nursing Home), Ella Lyman Cabot Trust, EquityEditors Association, Ford Foundation, Frederick Lovejoy Foundation, Google Grants, Nepal Ministry of Health and Population (MOHP), New Aid Foundation, Partners in Health, QBC Diagnostics, Quidel Corporation, Singapore Internet Research Center, Ten Friends, The Hunger Site, The International Foundation, The Shelley and Donald Rubin Foundation, Until There's a Cure Foundation, UpToDate, William Prusoff Foundation, Yale University</li>