Impact of a package of diagnostic tools, clinical algorithm, and training and communication on outpatient acute fever case management in low- and middle-income countries: protocol for a randomized controlled trial.

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.

Ethical qualms while treating diabetes in low-resource areas.

Diabetes care in low-resource rural areas is often compromised by access and finance barriers, leading to ethical dilemmas for physicians in diagnosis and treatment. Rural health workers should be educated on how poverty, disproportionate rural health infrastructure, and illiteracy impact diabetes care to facilitate a paradigm shift from blaming patients for poor adherence to improving health systems in order to address underlying structural care seeking barriers of cost, distance and social stigma. With these barriers urban, high resource protocols cannot be implemented and there is need for separate evidence-based protocols for rural, low resource populations. Having such set protocols coupled with continuous training and use of mobile/telemedicine technology could help shifting tasks to nurses and peripheral health workers. The National Programme For Prevention And Control Of Cancer, Diabetes, Cardiovascular Diseases & Stroke may benefit from this communitising care model by setting up PHC-level NCD clinics run by trained nurses and health workers with physician backup using technology as needed. This way of utilizing non-physician health workers to treat uncomplicated diabetes patients may not only allow physicians quality time and more resources to treat complicated diabetes patients but also provide good quality, accessible care within everyone's reach.

Exemplary operational research on an important public health problem.

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.

The ethics of compulsory notification of tuberculosis.

The Government of India has passed a notification making the non-reporting of tuberculosis (TB) by a clinical establishment a punishable offence. This article examines this move from an ethical standpoint. One of the main ethical concerns relates to the violation of patient confidentiality that may result from this. Also as regards improvement in patient care, there appears to be a poor cost-benefit ratio in terms of the actionable data obtained by this There may be possible adverse consequences by a limiting of access to care due to penalising of non-reporting. In terms of the bigger picture, the notification may lead to an increased tension between the private sector and Government. Moreover, it is the position of the authors that such a step distracts attention from the more important issues that plague TB care in India today.

Ultrasound in rural India: a failure of the best intentions.

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.

Sustaining for-profit emergency healthcare services in low resource areas.

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.

Issues in access to end-of-life care in low-resource areas.

Even though 1% of people require palliative and end-of-life care in low-resource situations, it remains an uncharted arena. Yet it is as important as curative care to alleviate suffering. Palliative care is not only a need in cancer and HIV disease; but is needed in a diverse group of illnesses ranging from tuberculosis, renal failures, paraplegia to chronic lung diseases. In a lower resource setting, the gaps in palliation may be the need for more technology and interventions or more healthcare professionals. Thus, palliative care will initially mean ensuring that life-prolonging treatment that most patients do not get is ensured to them. It is morally unacceptable to focus on comfort care as an alternative to advocating for patients' rights for appropriate life-prolonging treatments. If organised well and standard protocols are developed to support health workers, appropriate care can be provided for all people. Ethical principles of autonomy, nonmaleficence and benevolence will have to guide this development. We will have to prioritise for high value care which means choosing cheaper alternatives that are just as effective as more expensive diagnostic or therapeutic modalities. There is a need to settle the priorities between palliative and disease-modifying or curative treatments. Major roadblocks that limit access of the rural poor to palliative care relate mainly to the misconceptions among policy-makers and physicians, large gaps in health worker training and cultural mindsets of care-providers. A specific example of misplaced policies and regulations is the poor availability of opiates, which can make end-of-life care so much more dignified in illnesses that have chronic pain or breathlessness. A three-tiered structure is proposed with a central palliative care unit which will oversee several physicians and specially trained nurses for noncommunicable diseases, who will oversee primary healthcare centre-based nurses, who in turn, will oversee village health workers.