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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
Goals and OutlineGoal: to think through methodological issues in surgical research implementation; better metrics
 Overview of Problem, Methods: 25 minutes
 Group Discussion of Metrics: 60 minutes
 Wrap-up: 5 minutes1
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
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
 Globally, approximately 11% of death and disability are attributable to surgical diseases3
The Problem: Deploying Surgical Care WHO has produced Integrated Management for Emergency and Essential Surgical Care, and this has been utilized in several sites
 But: no studies have yet prospectively studied the implementation process4
Our Proposal: A Prospective, Implementation Research StudyProspectively study the implementation of an IMEESC-plus protocol at a district hospital in rural Nepal.
IMEESC: WHO’s current model
IMEESC-plus: includes community-based follow-up and hospital-based quality improvement methods
Study the process using mixed quantitative and qualitative methodologies at the hospital-, staff-, and patient levels
Focus on cesarean sections and soft-tissue injuries5
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
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
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
Implementation science done well should be able to enhance, not compromise, both service and research quality.9
Good study design involves collecting the right amount of data, hopefully nothing less but certainly nothing more.  10
Implementation OverviewBuild off existing hospital + CHW network
MD-GP/generalist-run operative services
Not general anesthesia– only spinal, local, regional
Cases outside scope of practice referred 6-14 hours away11
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
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
Specific Aim 1: Description of ImplementationNature of surgical disease
Financial inputs

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Csph talk

  • 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.
  • 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
  • 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
  • 31. Qualitative description of the implementation process14
  • 32. Specific Aim 2: Measuring quality of the implementationTo 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
  • 33. Specific Aim 2: Measuring quality of the implementationAdherence to stocking and energy protocols
  • 35. Adherence to surgical safety protocols
  • 38. Thoughts at this Juncture?
  • 39. Surgical Safety Measures: BackgroundDifferent surgical teams and contexts will bring different practices, tools, techniquesBut: there should be a shared set of quality measures across these different contextsGoal 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 AnalysisEmergency room/pre-opOperating room/intra-opInpatient unit/post-opFacilities and supplies systemsCommunity/follow-up19
  • 41. Surgical Safety Measures: Pre-OpFetal heart rate documented [obstetrics]Indication documentedTime from decision to incisionPre-operative evaluation and documentation of airway 20
  • 42. Surgical Safety Measures: Intra-opTime out performed prior to surgeryPulse oximeter working throughout the caseAppropriate perioperative antibiotic use*Appropriate size suture documented 21
  • 43. Surgical Safety Measures: Post-opVital signs recorded within 30 minutes post-opPostoperative exam documented by nurse within 30 minutesAppropriate postoperative antibiotic use22
  • 44. Surgical Safety Measures: FacilitiesX-ray machine in working order, with technician to operate itElectricity present throughout duration of surgeryNumber of days that the surgical theater is open^Suction machine verified and working pre-operativelyOxygen source verified and working pre-operativelyDocumentation of appropriate temperature strip from autoclave of surgical instruments23
  • 45. Surgical Safety Measures: Follow-upHours to reach hospital from homeUse of ambulancePaid CHW available in patient’s wardNumber of deliveries at hospital, cesarean and non-cesareanSuccessful follow-up by CHW within 72 hours24
  • 46. Concluding ThoughtsConcluding Thoughts Unmet research need in surgical service delivery
  • 47. Huge barriers remain in implementing this research
  • 48. Complementary roles of implementation (service) and implementation science (research)
  • 50. On Planners, Searchers, and NIH grants
  • 51. My email: duncan@nyayahealth.orgReferences1. 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.
  • 52. AcknowledgementsThe staff of Bayalpata Hospital & the people of Achham, Nepal
  • 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