This document proposes a prospective study to scale up surgical care at a rural hospital in Nepal using the WHO's Integrated Management for Emergency and Essential Surgical Care (IMEESC) model plus additional community follow-up and quality improvement methods. The study aims to rigorously evaluate this innovative model, pilot an implementation research methodology, and generate data to inform larger scale-up of surgical care worldwide. Specific objectives include describing the implementation process and measuring quality through adherence to protocols, follow-up rates, and complication rates. Metrics are proposed for evaluating pre-op, intra-op, post-op, facilities/supplies, and community follow-up. The study seeks to provide needed research on deploying surgical care in low-

1. Prospective Study of Surgical Care Scale-Up in a Rural, Resource-Limited SettingSelwyn Rogers, MD, MSc andDuncan Maru, MD, PHDOctober 4, 2011Center for Surgery and Public HealthNyaya Health

2. Goals and OutlineGoal: to think through methodological issues in surgical research implementation; better metrics

3. Overview of Problem, Methods: 25 minutes

4. Group Discussion of Metrics: 60 minutes

5. Wrap-up: 5 minutes1

6. Conflicts of InterestWe 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

7. The Need: Implementation Gap in Surgical Care Two billlion people, a third of the global population, live in areas with less than one operating room per 100,000 people

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

9. The Problem: Deploying Surgical Care WHO has produced Integrated Management for Emergency and Essential Surgical Care, and this has been utilized in several sites

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

11. Our Proposal: A Prospective, Implementation Research StudyProspectively study the implementation of an IMEESC-plus protocol at a district hospital in rural Nepal.

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 ObjectivesRigorously study an innovative model for surgical care (IMEESC-plus)Pilot an implementation research methodology that can be used in a larger multi-site studyGenerate data for larger scale-up of surgical care worldwide6

17. Setting: Bayalpata HospitalInfrastructure development and capacity building, not care provision aloneGovernment collaboration: Government partnership contract for 5 years signed June 2009 – June 2014, on a government-owned complexCurrently 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

21. Implementation OverviewBuild off existing hospital + CHW network

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 ObjectivesRigorously study an innovative model for Surgical Care (IMEESC-plus)Pilot an implementation research methodology that can be used in a larger multi-site studyGenerate data for larger scale-up of Surgical Care worldwide12

26. Specific Aim 1: Description of ImplementationTo 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

27. Specific Aim 1: Description of ImplementationNature of surgical disease

28. Financial inputs