Background The management of acute febrile illnesses places a heavy burden on clinical services in many low- and middle-income countries (LMICs). Bacterial and viral aetiologies of acute fevers are often clinically indistinguishable and, in the absence of diagnostic tests, the ‘just-in-case’ use of antibiotics by many health workers has become common practice, which has an impact on drug-resistant infections. Our study aims to answer the following question: in patients with undifferentiated febrile illness presenting to outpatient clinics/peripheral health centres in LMICs, can we demonstrate an improvement in clinical outcomes and reduce unnecessary antibiotic prescription over current practice by using a combination of simple, accurate diagnostic tests, clinical algorithms, and training and communication (intervention package)? Methods We designed a randomized, controlled clinical trial to evaluate the impact of our intervention package on clinical outcomes and antibiotic prescription rates in acute febrile illnesses. Available, point-of-care, pathogen-specific and non-pathogen specific (host markers), rapid diagnostic tests (RDTs) included in the intervention package were selected based on pre-defined criteria. Nine clinical study sites in six countries (Burkina Faso, Ghana, India, Myanmar, Nepal and Uganda), which represent heterogeneous outpatient care settings, were selected. We considered the expected seasonal variations in the incidence of acute febrile illnesses across all the sites by ensuring a recruitment period of 12 months. A master protocol was developed and adapted for country-specific ethical submissions. Diagnostic algorithms and choice of RDTs acknowledged current data on aetiologies of acute febrile illnesses in each country. We included a qualitative evaluation of drivers and/or deterrents of uptake of new diagnostics and antibiotic use for acute febrile illnesses. Sample size estimations were based on historical site data of antibiotic prescription practices for malarial and non-malarial acute fevers. Overall, 9 semi-independent studies will enrol a minimum of 21,876 patients and an aggregate data meta-analysis will be conducted on completion. Discussion This study is expected to generate vital evidence needed to inform policy decisions on the role of rapid diagnostic tests in the clinical management of acute febrile illnesses, with a view to controlling the rise of antimicrobial resistance in LMICs. Trial registration Clinicaltrials.gov NCT04081051. Registered on 6 September 2019. Protocol version 1.4 dated 20 December 2019
The Pre-Conception and Pre-Natal Diagnostic Techniques Act was written to prevent societally unacceptable harms including intentional sex selection. The pragmatism required to enforce this law has profound effects on the ability of rural Indians to access diagnostic ultrasonography. In so doing, it may have inadvertently placed a heavier burden on the poorest and worsened health inequity in India, creating serious ethical and justice concerns. It is time to re-examine and update the law such that diagnostic ultrasonography is widely available in even the most peripheral primary health and community health centres. Shorter, more accessible ultrasonography training courses should be offered; collaboration between radiologists and rural practitioners and facilities should be encouraged. Finally, modern ultrasound machines can carefully record all images via a "silent observer" modality. With some modifications to previously used silent observer modalities, this technology allows both greater access and better policing of potential misuse of ultrasound technology.
The Bawaskars in their Comment "Emergency care in rural settings: Can doctors be ethical and survive?" raise a context-specific question about the sustainability of emergency care in rural, low resource areas. This could be broadened to "What efforts are needed to sustain emergency care systems run by the private sector in rural, low resource areas without catastrophically affecting patients or healthcare providers?" There are enough constitutional, legal and ethical imperatives to state that all emergency care should be available to everyone irrespective of paying capacity. The State should be responsible for providing emergency care via the public sector or for strategically purchasing it from private providers. Even if that arrangement is not viable, private sector providers cannot expect the community to underwrite the sustainability of such services and the return on investment in their training. Finally, we suggest that the principles of ethics cannot be invoked for justifying the financial viability and sustainability of the private sector in an unequal world.
Rabies is a fatal disease once contracted, and a serious public health problem. Immunisation was unaffordable and inaccessible for most affected people in India. Omesh Bharti’s operational research allows us to reduce the unit dose needed for life saving rabies immunoglobulin (RIG) for class 3 rabid animal bites thereby raising hopes that access to this drug will improve. This study also suggests how public health research should question established guidelines that are rooted in impractical biomedicine without considering sociopolitical realities. The randomised controlled trial as a standard of research methodology is not only impractical but unnecessary. We discuss some of the challenges such as stockout of life saving medicines like RIG and suggest possible solutions. There is still a need to determine the correct RIG dose and the best technique for administering, storage and timing of this important drug.
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