With healthcare becoming digital, patients today are more empowered than ever before. As a result, digital health solutions have become the need of the hour to keep up with an increasing number of empowered patients participating in their own treatment decisions. Digital health encompasses various platforms and systems that apply technological solutions to enhance healthcare delivery. Digital therapeutics (DTx) is one such category of digital health solutions that provides evidence-based software-driven therapeutic interventions for the prevention and management of a medical disorder or disease. This review aims to provide a comprehensive overview of DTx, its functions and applications in healthcare, and associated regulatory aspects, among others.
Nicolau syndrome (NS) is a rare complication of an intramuscular injection characterized by severe pain, skin discoloration, and varying levels of tissue necrosis. The case outcomes vary from atrophic ulcers and severe pain to sepsis and limb amputation. We describe a case of a seven-year-old boy with diagnosis of NS after intramuscular benzathine penicillin injection to the ventrolateral aspect of the left thigh. Characteristic violaceous discoloration of skin and immediate injection site pain identified it as a case of NS. The case was complicated by rapid progression of compartment syndrome of the lower limb, proceeding to acute renal failure and death. Associated compartment syndrome can be postulated as a poor prognostic factor for NS.
Insomnia is a common condition that affects one's ability to sleep comfortably and consequently to work effectively. Its etiology is multifactorial and involves plethora of risk factors. Consequences can vary from mild sleepiness to more sever psychiatric disturbances and ischemic stroke. Despite several diagnostic criteria it is poorly diagnosed and less often treated. Benzodiazepines formed the mainline therapy for many years till the advent of newer nonbenzodiazepine group of drugs including zolpidem. Zolpidem is an imidazo-pyridine compound that enhances the GABA(A) receptor function by interaction with Omega-1 receptor subtype. Its pharmacokinetic profile allows the patients to use it later in the night when having trouble falling asleep without any residual cognitive impairment the next morning. It has rapid onset of action, improves total sleep duration, and reduces night-time awakenings. Its adverse effect profile is satisfactory as it appears to have low addiction potential. This review will focus on the current role of zolpidem in the management of insomnia.
Health economic studies provide information to decision makers for efficient use of available resources for maximizing health benefits. Economic evaluation is one part of health economics, and it is a tool for comparing costs and consequences of different interventions. Health technology assessment is a technique for economic evaluation that is well adapted by developed countries. The traditional classification of economic evaluation includes cost-minimization, cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis. There has been uncertainty in the conduct of such economic evaluations in India, due to some hesitancy with respect to the adoption of their guidelines. The biggest challenge in this evolutionary method is lack of understanding of methods in current use by all those involved in the provision and purchasing of health care. In some countries, different methods of economic evaluation have been adopted for decision making, most commonly to address the question of public subsidies for the purchase of medicines. There is limited evidence on the impact of health insurance on the health and economic well-being of beneficiaries in developing countries. India is currently pursuing several strategies to improve health services for its population, including investing in government-provided services as well as purchasing services from public and private providers through various schemes. Prospects for future growth and development in this field are required in India because rapid health care inflation, increasing rates of chronic conditions, aging population, and increasing technology diffusion will require greater economic efficiency into health care systems.
Real-world evidence (RWE) is clinical evidence on a medical product's safety and efficacy that is generated using real-world data (RWD) resulting from routine healthcare delivery. There are several sources of RWD, including electronic health records (EHRs), registries, claims/billing data, and patient-generated data, as well as those from mobile health applications and wearable devices. Real-world data from these sources can be collected and analysed through different study designs such as prospective and retrospective cohort studies, case-control studies, and pragmatic clinical trials. Real-world evidence in the form of post-marketing surveillance has been extensively used to generate pharmacovigilance data. Of late, it has been realised that, apart from safety, RWE has additional applications in different stages of the drug approval cycle, and can be used to optimize the design of randomised controlled trials (RCTs). There has been an increasing awareness and acceptance of RWE from different stakeholders, including physicians, pharmaceutical companies, payers, regulators, and patients. Several regulatory authorities have also created frameworks and guidelines for efficient harnessing of RWE while acknowledging several challenges in RWD collection and analysis. The purpose of this review is to offer an outline of the current information on RWE, its advantages and disadvantages, as well as the associated challenges and ways to overcome them, while also throwing some light on the future of RWE.
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