No frugal innovation without frugal evaluation: the Global IDEAL Sub-Framework.

Objective: The Global IDEAL Sub-Framework Study aimed to combine the intended effects of the 2009/2019 IDEAL (Idea, Development, Exploration, Assessment, Long-term study) Framework recommendations on evaluating surgical innovation with the vision outlined by the 2015 Lancet Commission on Global Surgery to provide recommendations for evaluating surgical innovation in low-resource environments. Design: A mixture of methods including an online global survey and semistructured interviews (SSIs). Quantitative data were summarized with descriptive statistics and qualitative data were analyzed using the Framework Method. Participants: Surgeons and surgical researchers from any country. Main outcome measures: Findings were used to suggest the nature of adaptations to the IDEAL Framework to address the particular problems of evaluation in low-resource settings. Results: The online survey yielded 66 responses representing experience from 40 countries, and nine individual SSIs were conducted. Most respondents (n=49; 74.2%) had experience evaluating surgical technologies across a range of life cycle stages. Innovation was most frequently adopted based on colleague recommendation or clinical evaluation in other countries. Four themes emerged, centered around: frugal innovation in technological development; evaluating the same technology/innovation in different contexts; additional methodologies important in evaluation of surgical innovation in low/middle-income countries; and support for low-income country researchers along the evaluation pathway. Conclusions: The Global IDEAL Sub-Framework provides suggestions for modified IDEAL recommendations aimed at dealing with the special problems found in this setting. These will require validation in a stakeholder consensus forum, and qualitative assessment in pilot studies. From assisting researchers with identification of the correct evaluation stage, to providing context-specific recommendations relevant to the whole evaluation pathway, this process will aim to develop a comprehensive and applicable set of guidance that will benefit surgical innovation and patients globally.

Point-Of-Care Ultra-Sound (POCUS) for suspected surgical abdominal conditions in rural India-a mixed-method health needs assessment.

INTRODUCTION: Evidence has shown a trend towards rising mortality from surgical abdominal conditions with increasing distance from hospitals in Eastern India. It has been claimed that imaging modalities such as portable ultrasound are ideal for use in rural areas of developing countries for diagnosis and management of a variety of acute abdominal conditions. This mixed-methods study aimed to explore the need for increased access to POCUS in rural, hard-to-reach populations within India, and to identify barriers that may exist to increasing this access. METHODS: This mixed-methods study utilized a health needs assessment framework. Quantitative data was extracted from medical records within two outreach camp organisations supporting hard-to-reach populations in Uttarakhand and Jharkhand to provide contextual background statistics. Qualitative data was collected using semi-structured interviews taken from employees of each outreach camp. A framework analysis was employed to analyse the qualitative data. Both datasets were analysed in parallel. RESULTS: Twelve semi-structured interviews were undertaken, and 3 months of medical records were reviewed. Themes that presented themselves from the data included the use of camps for case-finding of conditions amenable to routine surgery, a need for POCUS to help with this diagnostic process, a perceived high disease burden from renal calculi, and complex cultural and legislative barriers to POCUS specific to this setting. DISCUSSION: POCUS was considered a useful tool in expanding access to surgery for these settings and finding ways of overcoming cultural and legislative barriers to its use should be of high priority. POCUS should be highly portable, robust, easily repairable, and battery operated. For telemedicine to be fully utilised, signal quality will have to be proven to be reliable.

Cost-effectiveness of gasless laparoscopy as a means to increase provision of minimally invasive surgery for abdominal conditions in rural North-East India.

Laparoscopic surgery, a minimally invasive technique to treat abdominal conditions, has been shown to produce equivalent safety and efficacy with quicker return to normal function compared to open surgery. As such, it is widely accepted as a cost-effective alternative to open surgery for many abdominal conditions. However, access to laparoscopic surgery in rural North-East India is limited, in part due to limited equipment, unreliable supplies of CO2 gas, lack of surgical expertise and a shortage of anaesthetists. We evaluate the cost-effectiveness of gasless laparoscopy as a means to increase provision of minimally invasive surgery (MIS) for abdominal conditions in rural North-East India. A decision tree model was developed to compare costs, evaluated from a patient perspective, and health outcomes, disability adjusted life years (DALYs), associated with gasless laparoscopy, conventional laparoscopy or open abdominal surgery in rural North-East India. Results indicate that MIS (performed by conventional or gasless laparoscopy) is less costly and produces better outcomes, fewer DALYs, than open surgery. These results were consistent even when gasless laparoscopy was analysed using least favourable data from the literature. Scaling up provision of MIS through increased access to gasless laparoscopy would reduce the cost burden to patients and increase DALYs averted. Based on a sample of 12 facilities in the North-East region, if scale up was achieved so that all essential surgeries amenable to laparoscopic surgery were performed as such (using conventional or gasless laparoscopy), 64% of DALYS related to these surgeries could be averted, equating to an additional 454.8 DALYs averted in these facilities alone. The results indicate that gasless laparoscopy is likely to be a cost-effective alternative to open surgery for abdominal conditions in rural North-East India and provides a possible bridge to the adoption of full laparoscopic services.

Assessment of laparoscopic instrument reprocessing in rural India: a mixed methods study.

BACKGROUND: Laparoscopy is a minimally-invasive surgical procedure that uses long slender instruments that require much smaller incisions than conventional surgery. This leads to faster recovery times, fewer post-surgical wound infections and shorter hospital stays. For these reasons, laparoscopy could be particularly advantageous to patients in low to middle income countries (LMICs). Unfortunately, sterile processing departments in LMIC hospitals are faced with limited access to equipment and trained staff which poses an obstacle to safe surgical care. The reprocessing of laparoscopic devices requires specialised equipment and training. Therefore, when LMIC hospitals invest in laparoscopy, an update of the standard operating procedure in sterile processing is required. Currently, it is unclear whether LMIC hospitals, that already perform laparoscopy, have managed to introduce updated reprocessing methods that minimally invasive equipment requires. The aim of this study was to identify the laparoscopic sterile reprocessing procedures in rural India and to test the effectiveness of the sterilisation equipment. METHODS: We assessed laparoscopic instrument sterilisation capacity in four rural hospitals in different states in India using a mixed-methods approach. As the main form of data collection, we developed a standardised observational checklist based on reprocessing guidelines from several sources. Steam autoclave performance was measured by monitoring the autoclave cycles in two hospitals. Finally, the findings from the checklist data was supported by an interview survey with surgeons and nurses. RESULTS: The checklist data revealed the reprocessing methods the hospitals used in the reprocessing of laparoscopic instruments. It showed that the standard operating procedures had not been updated since the introduction of laparoscopy and the same reprocessing methods for regular surgical instruments were still applied. The interviews confirmed that staff had not received additional training and that they were unaware of the hazardous effects of reprocessing detergents and disinfectants. CONCLUSION: As laparoscopy is becoming more prevalent in LMICs, updated policy is needed to incorporate minimally invasive instrument reprocessing in medical practitioner and staff training programmes. While reprocessing standards improve, it is essential to develop instruments and reprocessing equipment that is more suitable for resource-constrained rural surgical environments.

Surgathon: a new model for creating a surgical innovation ecosystem in low-resource settings.

Innovation ecosystems and emerging technologies can potentially accelerate the access to safe, affordable surgical care in low-resource settings. There is a need to develop localised innovation ecosystems that can establish an initial culture and catalyse the creation, adoption and diffusion of innovation. The surgathon model outlines one approach to seeding surgical innovation ecosystems. International academic institutions collaborated on six global surgery, innovation and ethics-themed hackathons ('surgathons') across India and Rwanda between 2016 and 2019. Over 1598 local multidisciplinary students participated, learning about challenges in the delivery of surgical care and ideating solutions that could leverage appropriate technology and resources for impact. Pursuing student ideas and evaluating their implementation past the surgathons continues to be an active effort. Surgathons have unfolded in different permutations based on local faculty, institution and health system context. The surgathon model is a novel method of priority setting challenges in global surgery and utilises locally driven expertise and innovation capacity to derive ethical solutions. The model offers a path for low-resource setting students and faculty to learn, advocate and innovate for improved surgical care.