Periodic Report Summary 4 - COST - AFRICA (Clinical Officer Surgical Training in Africa)
Project Context and Objectives:
Five billion people are without access to safe, affordable surgical and anaesthetic care with Low and Middle Income Countries (LMICs) worst affected. Only 6% of needed surgery takes place in the poorest countries; and 33 million people endure catastrophic expenditure in paying for essential, often life-saving surgery (1). In many sub-Saharan Africa (SSA) countries, elective and emergency surgery is only available in the few hospitals in urban areas that are staffed by specialist surgeons (2). Where district hospitals deliver emergency obstetrical interventions (caesarean sections) and limited general surgery, these are often undertaken by non-physician clinicians (NPCs) such as clinical officers who have variable training, limited support and usually work with no supervision(3).
Clinical officers (COs) are a form of non-physician clinician (NCP), also known as associate clinicians and ‘non-surgeons’, who have been the backbone of clinical care services for rural dwellers in Africa for decades, working at health centres and district hospitals. Task-shifting of major surgery for common conditions to non-physician clinicians has taken place in over 30 LMICs. However, the case for promoting surgical task shifting is neither generally accepted nor has it been adequately justified as a mainstream model for making surgery accessible in rural settings that lack specialist surgeons, even if it is often a life-saving measure, as in the case of obstetrical emergencies, strangulated hernias and some acute abdominal emergencies in remote and rural areas.
If trained to do surgery, NPCs often work in an uncertain legal and regulatory environment, their services are not quality assured and may not be safe (4). However, they are often the only accessible source and means for rural populations to get elective surgery and life-saving emergency surgery. There is good evidence that the provision of essential surgery is cost effective (5); that it can be expanded safely and effectively (6); and that high quality surgery is affordable and feasible in low resource settings (6). Clinical Officer Surgical Training for Africa (COST-Africa), funded under the European Union’s Seventh Framework Programme (grant agreement 266417), is a 5-year trial, 2011-16. It aims to design, implement and evaluate a scalable surgical training programme so as to demonstrate the effectiveness, cost-effectiveness and feasibility of COs delivering major surgery at district hospitals in Malawi and Zambia, trained and supervised by specialist surgeons.
* references available
Objectives
1. (a) Work with national policy makers and other national stakeholders to ensure that COST-Africa becomes embedded within and helps to support national policy priorities for surgical training of clinical officers in Malawi and Zambia.
(b) Conduct a situational analysis to map the distribution and types of current district level surgical services; measure surgical capacity and gaps to be addressed; and establish surgical information systems at district hospitals for measuring surgical outcomes in Zambia and Malawi.
2. Design and implement ethically reviewed surgical training interventions for Clinical Officers which include centralised training, in-service training, supervision and quality control, leading to the scale-up of elective and essential emergency surgical care in district and rural hospitals.
3. Measure the effectiveness and impact of the intervention at the levels of health worker, patient, health facility and district population, using a cluster randomised controlled trial design where similar hospitals are paired and one of each randomly assigned to intervention and control arms.
4. Establish the cost-effectiveness of the intervention.
5. Support national and regional policy makers in developing career paths and retention strategies aimed at surgically trained Clinical Officers and specialist surgeon-trainers.
Project Results:
A surgical training programme for NPCs/COs/MLs has been developed, successfully delivered to a cohort of trainees and evaluated in Malawi and Zambia for impact, feasibility and cost-effectiveness. By prioritising engagement with national ministries of health and alignment with national training programmes, COST-Africa is now embedded at national policy levels in Malawi and Zambia. It has accredited and rolled out a national BSc in Surgery for COs in Malawi, with two further cohorts now being trained using local resources. Its support resulted in the accreditation of a BSc for COs in Zambia, into which three cohorts have been admitted and are undergoing training. Thereby, COST-Africa has played a major role in establishing a sustainable response to the need for a surgically trained workforce to deliver essential surgery in districts and rural areas. Despite the challenges – government-requested scale ups from 1/3rd to 2/3rds of Malawi’s districts and increase in coverage from 3 to 8 provinces in Zambia, in a politically challenging environment, COST-Africa has sustained a rigorous programme of ethically approved research.
Data collection tools are located on http://www.costafrica.eu/data-collection.html). They include the baseline situation analysis Tool A, an Annex A tool to collect 12 months of retrospective data on major surgery from all intervention and control hospital operating theatre (OT) registers; and Tool B1 – an extended OT register used by COs to record and transmit an expanded set of monthly surgical data from intervention hospitals. A B3 ‘critical event’ tool was developed to capture hospital factors that enabled or obstructed district hospital surgery. A B4 ‘adverse event’ tool recorded intra- or post-operative mortality and surgical complications, which were reviewed by supervising surgeons, who were responsible for ensuring patient safety.
Period 4, comprising the period October 2015 to end of March 2016, included:
• completion of data collection on surgical outputs in intervention and control hospitals (end of December 2015),
• hospital visits for data verification and validation (December 2015 to February 2016),
• completion of follow up telephone surveys on quality of life post hernia repair; and follow up post Caesarean Sections,
• completion of data collection for costing studies at a provincial and district hospital in Zambia; and
• in-depth interviews with NPCs, surgeon supervisors, hospital managers and national stakeholders, to bring their interpretation and insights to the research findings.
The final 12 months of the project, including the six-month no cost extension (April to end September 2016), has comprised analyses of data, which fed into outputs that have been disseminated and presented to key national, regional and global stakeholders to promote research into policy and practice. A correspondence letter was published in Lancet Global Health: “The evidence needed to make surgery a Global Health priority”; and a manuscript outlining the study design is still under review with the journal TRIALS.
Three major dissemination events and opportunities were successfully completed:
1) oral presentations at the COSECSA scientific conference in Blantyre, Malawi, December 2015, attended by regional and global stakeholders, where a session was devoted to surgical needs in under-served populations.
2) Oral and poster presentations at an April 2016 scientific meeting in Dublin: Global Health Partnerships: Innovations in Surgery, Education & Research, attended by regional and global stakeholders,
3) a high level meeting on 8-9 September in Lusaka, organised by COST-Africa, where findings were presented and discussed with senior Ministry of Health officials from Zambia, Malawi and Tanzania.
Four manuscripts have been circulated with a further eight planned. Overall achievements are described below.
Potential Impact:
(i) District hospital and patient end points
(i) (a) surgical outputs
Significant increases in trends in numbers of index major surgical procedures in intervention versus control hospitals in Malawi (general surgery) and Zambia (c sections).
(i) (b) appropriate surgical referrals
Early analyses of referral data in Malawi suggest improved quality and appropriateness of referrals in district intervention hospitals.
(i) (c) mortality and morbidity – patient level data:
Patient outcomes observational study in Malawi demonstrated comparable (no differences) improvements in quality of life at 60 days post-op in patients who underwent hernia repairs at 4 district and two central hospitals. Follow-up post-C sections
(i) (d) surgical task shifting
‘Task-shifting’ was achieved at the hospital level where clinicians who would otherwise do emergency surgery were relieved from these duties by surgically trained CO/MLs.
(i) (e) quality of care process measurements:
COST Africa trainees not directly involved in cases where poor management contributed to adverse events. In-depth interviews confirmed that most adverse events were due to lack of supplies (mostly availability of blood), non-functioning equipment and lack of training.
(i) (f) District and central hospital costs of conducting surgery:
Comparisons of costs of district and tertiary referral hospital surgery; estimates of costs of surgery as a proportion of total district hospital cost; quantification of main cost drivers; identification of possibilities to achieve more efficiency (economies of scale); calculation of unit costs of selected index procedures (cost per case); and estimates of cost implications of scaling up surgery at district hospitals. Also estimates of direct and indirect cost for households / patients seeking and obtaining surgery.
(ii) Clinical officer / Medical Licentiate end points and stakeholder perspectives
(ii) (a) CO/ML baseline and follow up survey showed that surgical confidence of COs in Malawi doubled after the first year of the intervention.
(ii) (b) Qualitative findings show high support among COs/MLs, surgeons, hospital managers and national stakeholders of the COST-Africa training and supervision model and the potential career paths.
(ii) (c) Cost of training and supervision of CO/ML: cost of surgical training per trainee (Malawi and Zambia), cost of supervisory visits by senior surgeons (Zambia).
(iii) Patient health outcomes
See (i) (c) above.
Socioeconomic impact and societal implications:
COST-Africa has delivered, tested and demonstrated the impact and cost-effectiveness of a feasible and sustainable model for delivering safe emergency and essential elective surgery to district and rural populations, especially pregnant women, in Malawi and Zambia. The model is contributing to a realistic career path and the potential to retain a cadre of clinician that is the cornerstone of district hospital clinical services in many African countries – the non-physician clinician (NPC). The project has put in place (in Malawi) and supported (in Zambia) BSc programmes, incorporating a surgical education syllabus developed by the project, that have each recruited two (M) or three (Z) further cohorts of students, using local resources.
Lessons on how to deliver affordable supervision of district clinician-surgeons and the potential benefits on clinician decision-making and patient referral decisions have been developed and incorporated into a new Horizon 2020 project proposal – Scaling up Safe Surgery for Rural and District populations (SURG-Africa). The COST-Africa project has demonstrated the cost-effectiveness and comparable long-term surgical outcomes in district versus referral hospital surgery, which will inform national policies and budget decisions for optimal use of scarce resources in Africa. Many of the lessons are being incorporated into new National Surgical Obstetric, and Anaesthesia Plans, as in Zambia (2017-2021).
List of Websites:
www.costafrica.eu
Five billion people are without access to safe, affordable surgical and anaesthetic care with Low and Middle Income Countries (LMICs) worst affected. Only 6% of needed surgery takes place in the poorest countries; and 33 million people endure catastrophic expenditure in paying for essential, often life-saving surgery (1). In many sub-Saharan Africa (SSA) countries, elective and emergency surgery is only available in the few hospitals in urban areas that are staffed by specialist surgeons (2). Where district hospitals deliver emergency obstetrical interventions (caesarean sections) and limited general surgery, these are often undertaken by non-physician clinicians (NPCs) such as clinical officers who have variable training, limited support and usually work with no supervision(3).
Clinical officers (COs) are a form of non-physician clinician (NCP), also known as associate clinicians and ‘non-surgeons’, who have been the backbone of clinical care services for rural dwellers in Africa for decades, working at health centres and district hospitals. Task-shifting of major surgery for common conditions to non-physician clinicians has taken place in over 30 LMICs. However, the case for promoting surgical task shifting is neither generally accepted nor has it been adequately justified as a mainstream model for making surgery accessible in rural settings that lack specialist surgeons, even if it is often a life-saving measure, as in the case of obstetrical emergencies, strangulated hernias and some acute abdominal emergencies in remote and rural areas.
If trained to do surgery, NPCs often work in an uncertain legal and regulatory environment, their services are not quality assured and may not be safe (4). However, they are often the only accessible source and means for rural populations to get elective surgery and life-saving emergency surgery. There is good evidence that the provision of essential surgery is cost effective (5); that it can be expanded safely and effectively (6); and that high quality surgery is affordable and feasible in low resource settings (6). Clinical Officer Surgical Training for Africa (COST-Africa), funded under the European Union’s Seventh Framework Programme (grant agreement 266417), is a 5-year trial, 2011-16. It aims to design, implement and evaluate a scalable surgical training programme so as to demonstrate the effectiveness, cost-effectiveness and feasibility of COs delivering major surgery at district hospitals in Malawi and Zambia, trained and supervised by specialist surgeons.
* references available
Objectives
1. (a) Work with national policy makers and other national stakeholders to ensure that COST-Africa becomes embedded within and helps to support national policy priorities for surgical training of clinical officers in Malawi and Zambia.
(b) Conduct a situational analysis to map the distribution and types of current district level surgical services; measure surgical capacity and gaps to be addressed; and establish surgical information systems at district hospitals for measuring surgical outcomes in Zambia and Malawi.
2. Design and implement ethically reviewed surgical training interventions for Clinical Officers which include centralised training, in-service training, supervision and quality control, leading to the scale-up of elective and essential emergency surgical care in district and rural hospitals.
3. Measure the effectiveness and impact of the intervention at the levels of health worker, patient, health facility and district population, using a cluster randomised controlled trial design where similar hospitals are paired and one of each randomly assigned to intervention and control arms.
4. Establish the cost-effectiveness of the intervention.
5. Support national and regional policy makers in developing career paths and retention strategies aimed at surgically trained Clinical Officers and specialist surgeon-trainers.
Project Results:
A surgical training programme for NPCs/COs/MLs has been developed, successfully delivered to a cohort of trainees and evaluated in Malawi and Zambia for impact, feasibility and cost-effectiveness. By prioritising engagement with national ministries of health and alignment with national training programmes, COST-Africa is now embedded at national policy levels in Malawi and Zambia. It has accredited and rolled out a national BSc in Surgery for COs in Malawi, with two further cohorts now being trained using local resources. Its support resulted in the accreditation of a BSc for COs in Zambia, into which three cohorts have been admitted and are undergoing training. Thereby, COST-Africa has played a major role in establishing a sustainable response to the need for a surgically trained workforce to deliver essential surgery in districts and rural areas. Despite the challenges – government-requested scale ups from 1/3rd to 2/3rds of Malawi’s districts and increase in coverage from 3 to 8 provinces in Zambia, in a politically challenging environment, COST-Africa has sustained a rigorous programme of ethically approved research.
Data collection tools are located on http://www.costafrica.eu/data-collection.html). They include the baseline situation analysis Tool A, an Annex A tool to collect 12 months of retrospective data on major surgery from all intervention and control hospital operating theatre (OT) registers; and Tool B1 – an extended OT register used by COs to record and transmit an expanded set of monthly surgical data from intervention hospitals. A B3 ‘critical event’ tool was developed to capture hospital factors that enabled or obstructed district hospital surgery. A B4 ‘adverse event’ tool recorded intra- or post-operative mortality and surgical complications, which were reviewed by supervising surgeons, who were responsible for ensuring patient safety.
Period 4, comprising the period October 2015 to end of March 2016, included:
• completion of data collection on surgical outputs in intervention and control hospitals (end of December 2015),
• hospital visits for data verification and validation (December 2015 to February 2016),
• completion of follow up telephone surveys on quality of life post hernia repair; and follow up post Caesarean Sections,
• completion of data collection for costing studies at a provincial and district hospital in Zambia; and
• in-depth interviews with NPCs, surgeon supervisors, hospital managers and national stakeholders, to bring their interpretation and insights to the research findings.
The final 12 months of the project, including the six-month no cost extension (April to end September 2016), has comprised analyses of data, which fed into outputs that have been disseminated and presented to key national, regional and global stakeholders to promote research into policy and practice. A correspondence letter was published in Lancet Global Health: “The evidence needed to make surgery a Global Health priority”; and a manuscript outlining the study design is still under review with the journal TRIALS.
Three major dissemination events and opportunities were successfully completed:
1) oral presentations at the COSECSA scientific conference in Blantyre, Malawi, December 2015, attended by regional and global stakeholders, where a session was devoted to surgical needs in under-served populations.
2) Oral and poster presentations at an April 2016 scientific meeting in Dublin: Global Health Partnerships: Innovations in Surgery, Education & Research, attended by regional and global stakeholders,
3) a high level meeting on 8-9 September in Lusaka, organised by COST-Africa, where findings were presented and discussed with senior Ministry of Health officials from Zambia, Malawi and Tanzania.
Four manuscripts have been circulated with a further eight planned. Overall achievements are described below.
Potential Impact:
(i) District hospital and patient end points
(i) (a) surgical outputs
Significant increases in trends in numbers of index major surgical procedures in intervention versus control hospitals in Malawi (general surgery) and Zambia (c sections).
(i) (b) appropriate surgical referrals
Early analyses of referral data in Malawi suggest improved quality and appropriateness of referrals in district intervention hospitals.
(i) (c) mortality and morbidity – patient level data:
Patient outcomes observational study in Malawi demonstrated comparable (no differences) improvements in quality of life at 60 days post-op in patients who underwent hernia repairs at 4 district and two central hospitals. Follow-up post-C sections
(i) (d) surgical task shifting
‘Task-shifting’ was achieved at the hospital level where clinicians who would otherwise do emergency surgery were relieved from these duties by surgically trained CO/MLs.
(i) (e) quality of care process measurements:
COST Africa trainees not directly involved in cases where poor management contributed to adverse events. In-depth interviews confirmed that most adverse events were due to lack of supplies (mostly availability of blood), non-functioning equipment and lack of training.
(i) (f) District and central hospital costs of conducting surgery:
Comparisons of costs of district and tertiary referral hospital surgery; estimates of costs of surgery as a proportion of total district hospital cost; quantification of main cost drivers; identification of possibilities to achieve more efficiency (economies of scale); calculation of unit costs of selected index procedures (cost per case); and estimates of cost implications of scaling up surgery at district hospitals. Also estimates of direct and indirect cost for households / patients seeking and obtaining surgery.
(ii) Clinical officer / Medical Licentiate end points and stakeholder perspectives
(ii) (a) CO/ML baseline and follow up survey showed that surgical confidence of COs in Malawi doubled after the first year of the intervention.
(ii) (b) Qualitative findings show high support among COs/MLs, surgeons, hospital managers and national stakeholders of the COST-Africa training and supervision model and the potential career paths.
(ii) (c) Cost of training and supervision of CO/ML: cost of surgical training per trainee (Malawi and Zambia), cost of supervisory visits by senior surgeons (Zambia).
(iii) Patient health outcomes
See (i) (c) above.
Socioeconomic impact and societal implications:
COST-Africa has delivered, tested and demonstrated the impact and cost-effectiveness of a feasible and sustainable model for delivering safe emergency and essential elective surgery to district and rural populations, especially pregnant women, in Malawi and Zambia. The model is contributing to a realistic career path and the potential to retain a cadre of clinician that is the cornerstone of district hospital clinical services in many African countries – the non-physician clinician (NPC). The project has put in place (in Malawi) and supported (in Zambia) BSc programmes, incorporating a surgical education syllabus developed by the project, that have each recruited two (M) or three (Z) further cohorts of students, using local resources.
Lessons on how to deliver affordable supervision of district clinician-surgeons and the potential benefits on clinician decision-making and patient referral decisions have been developed and incorporated into a new Horizon 2020 project proposal – Scaling up Safe Surgery for Rural and District populations (SURG-Africa). The COST-Africa project has demonstrated the cost-effectiveness and comparable long-term surgical outcomes in district versus referral hospital surgery, which will inform national policies and budget decisions for optimal use of scarce resources in Africa. Many of the lessons are being incorporated into new National Surgical Obstetric, and Anaesthesia Plans, as in Zambia (2017-2021).
List of Websites:
www.costafrica.eu