1. Prospective Study of Surgical Care Scale-Up in a Rural, Resource-Limited Setting Selwyn Rogers, MD, MSc andDuncan Maru, MD, PHD October 4, 2011Center for Surgery and Public Health Nyaya Health

3. Overview of Problem, Methods: 25 minutes

4. Group Discussion of Metrics: 60 minutes

5. Wrap-up: 5 minutes1

6. Conflicts of Interest 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. 2

8. Globally, approximately 11% of death and disability are attributable to surgical diseases3

10. But: no studies have yet prospectively studied the implementation process4

12. IMEESC: WHO’s current model

13. IMEESC-plus: includes community-based follow-up and hospital-based quality improvement methods

14. Study the process using mixed quantitative and qualitative methodologies at the hospital-, staff-, and patient levels

15. Focus on cesarean sections and soft-tissue injuries5

16. Study Objectives Rigorously study an innovative model for surgical care (IMEESC-plus) Pilot an implementation research methodology that can be used in a larger multi-site study Generate data for larger scale-up of surgical care worldwide 6

17. Setting: Bayalpata Hospital Infrastructure development and capacity building, not care provision alone Government collaboration: Government partnership contract for 5 years signed June 2009 – June 2014, on a government-owned complex Currently one of the highest levels of clinical care in the Far West (2 million people) Over 75,000 patients seen to date

18. The ease with which young people die in Achham and the ease with which it is accepted continues to horrify me. -RumaRajbhandari, MD, MPH, March 22, 2011. 8

19. Implementation science done well should be able to enhance, not compromise, both service and research quality. 9

20. Good study design involves collecting the right amount of data, hopefully nothing less but certainly nothing more. 10

22. MD-GP/generalist-run operative services

23. Not general anesthesia– only spinal, local, regional

24. Cases outside scope of practice referred 6-14 hours away11

25. Study Objectives Rigorously study an innovative model for Surgical Care (IMEESC-plus) Pilot an implementation research methodology that can be used in a larger multi-site study Generate data for larger scale-up of Surgical Care worldwide 12

26. Specific Aim 1: Description of Implementation 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. What basic implementation parameters can one expect? What parameters matter for planning purposes? 13

28. Financial inputs

29. Human resource inputs

30. Pharmaceutical, consummable utilization

31. Qualitative description of the implementation process14

32. Specific Aim 2: Measuring quality of the implementation 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. How do you measure and monitor quality of surgical service implementation? (Distinct from, was the implementation itself high-quality?) 15

34. Adherence to resuscitation protocols

35. Adherence to surgical safety protocols

36. Community-based follow-up

37. Complication rates16

38. Thoughts at this Juncture?

39. Surgical Safety Measures: Background Different surgical teams and contexts will bring different practices, tools, techniques But: there should be a shared set of quality measures across these different contexts Goal here is to develop some basic metrics that can be used for both internal QI and external monitoring/accountability. 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. 18

40. Surgical Safety Measures: Domains of Analysis Emergency room/pre-op Operating room/intra-op Inpatient unit/post-op Facilities and supplies systems Community/follow-up 19

41. Surgical Safety Measures: Pre-Op Fetal heart rate documented [obstetrics] Indication documented Time from decision to incision Pre-operative evaluation and documentation of airway 20

42. Surgical Safety Measures: Intra-op Time out performed prior to surgery Pulse oximeter working throughout the case Appropriate perioperative antibiotic use* Appropriate size suture documented 21

43. Surgical Safety Measures: Post-op Vital signs recorded within 30 minutes post-op Postoperative exam documented by nurse within 30 minutes Appropriate postoperative antibiotic use 22

44. Surgical Safety Measures: Facilities X-ray machine in working order, with technician to operate it Electricity present throughout duration of surgery Number of days that the surgical theater is open^ Suction machine verified and working pre-operatively Oxygen source verified and working pre-operatively Documentation of appropriate temperature strip from autoclave of surgical instruments 23

45. Surgical Safety Measures: Follow-up Hours to reach hospital from home Use of ambulance Paid CHW available in patient’s ward Number of deliveries at hospital, cesarean and non-cesarean Successful follow-up by CHW within 72 hours 24

47. Huge barriers remain in implementing this research

48. Complementary roles of implementation (service) and implementation science (research)

49. Simplicity and flexibility are key

50. On Planners, Searchers, and NIH grants

53. The volunteers and individual donors of Nyaya Health

54. Dr. Selwyn Rogers and Tess Panizales of the CSPH

55. The Nepali Ministry of Health & Achham District Health officials: Dr. Deepak Gaylal, Mr. SailendraShrestha, Mr. JhanakDhungana

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