1. What is empirical treatment approach?
In therapeutics, depending on the condition of the patient the treatment strategy is decided. It can either be empirical, semi-empirical or evidence based. The empirical treatment aims at comforting the patients and providing symptomatic relief which can stabilize the patient e.g. if the patient is running high fever and treated with anti-pyretic drugs, these drugs bring down the raised body temperature to the normal and offers relief from fever. However, it does not address the cause of the fever. The empirical treatment also depends on guess of disease and treatment initiated on observing the symptoms. For example, if the patient is reported with fever and chills, the treatment initiated with anti-malarial drug if malaria is prevalent in the community. In case the patient does not respond to the anti-malarial drugs, the patient may be having enteric fever and treatment started for enteric fever with fluoroquinolone antibiotics. Even the patient fails to respond then the patient may have some liver diseases.
2. What is semi-empirical treatment?
In Semi-empirical method, the patient is diagnosed by observations of subjective, objective evidence which are established for a particular disease condition. For example, in type 2 diabetes diagnosing the health of eye, neurons, heart and kidney helps in early detection of a developing pathology as diabetes is an established risk factor for above casualties.
3. What is evidence based medicine (EBM)?
EBM is a systematic approach for decision making in providing therapeutic services. The evidence is of past documented evidences organized in a systematic manner for retrieval. The amount of information documented being described as big data it is highly impractical to retrieve the data by manual search. The evidence gathered is updated in a continuous fashion in which the information gets refined. It is in the interest of the patient to apply the latest available information for making a decision. In this context, the EBM is an approach which depends upon gathering and review the relevant information in decision making. For example, in EBM if the patient is having a bacterial infection, the treatment with antibiotics should be based on culture & sensitivity reports.
4. What are the tools for EBM?
The EBM depends upon the data published and organized into databases which can be easily accessed and understood within the time-frame available. The randomized clinical trials are the primary evidence which are free of bias. On the other hand, the observational studies are alternative but are less trustworthy. The secondary tools of EBM consists of meta-analyses and systematic reviews which are collective evidence of similar RCTs.
Figure-1: Tools of EBM
5. What is the scope of Randomized controlled trials in EBM?
Randomized controlled trials are designed to minimize the various types of bias and establish the fact depicted by data. The RCTs are tested by a null hypothesis which establishes the evidence of a clinical statement tested in RCT. All the EBM borrows the evidence established in RCTs, meta-analyses and systematic reviews. The meta-analyses and systematic reviews are conducted on RCTs available in clinical trials database.
6. What is the scope of Meta analyses in EBM?
The meta-analyses comprises of summary of evidence gathered from several clinical trials conducted in the past having similarity on patient demographics and data. The meta-analyses can be considered as a collective evidence of RCTs. In meta-analyses, the results give a comparative qualitative and quantitative account of various RCTs agreeing/not agreeing with a clinical question asked. The healthcare professionals shall be able to get a comprehensive information regarding the evidence which helps them to take appropriate decisions in therapeutics. The meta-analysis being a statistical protocol of evidence derived from RCTs, the collective evidence helps in practice of EBM.
7. What is the scope of systematic reviews in EBM?
Systematic reviews being a thorough description of various evidences gathered by RCTs in a classical manner keeping in mind the requirements of various healthcare professionals. A systematic review is a thorough, comprehensive, and explicit way of interrogating the medical literature. For example, It typically involves several steps
* asking an answerable question
* identifying one or more databases to search
* developing an explicit search strategy
* selecting titles, abstracts, and manuscripts based on explicit inclusion and exclusion criteria, and
* abstracting data in a standardized format.
Hence, the systematic reviews are frequently referred and are highly resourceful in practice of EBM.
8. What is the limitation of Randomized controlled trials in EBM?
The randomized trial is an account of evidence of single study. The evidence available in literature in various clinical trials may not be uniform or identical. There can be variations of evidence among clinical trials, hence relying on a single isolated clinical trial may not be an appropriate while it is possible to get more comprehensive evidence.
9. What is the limitation of Meta analyses in EBM?
The major limitation of evidence from meta-analyses may be due to inclusion of several small studies rather than a big sound study. As a result of this, the quality of EBM may result in biased evidence. The publication bias in meta-analyses can result from insufficient literature survey and also due to poor publications of negative findings in RCTs. The personal bias is due to deliberate attempt by researchers who want to prove his point of view selects the studies which go in favor of his belief.
10. What is the limitation of systematic reviews in EBM?
The evidence generated in systematic reviews are likely to be affected by bias included in clinical trials and meta-analyses. There is a concern to reexamine and adapt stringent quality control on statistics applied in conducting the systematic review.
11. What are the popular database resources for EBM?
The Cochrane collaboration is the only independent database with no financial endorsement by pharmaceutical industry. The Cochrane collaboration was established on call for establishing a database which shall be critical, systematic, up-to-date RCTs in healthcare for the benefit of medical research and patient care. The center for reviews and dissemination and the University of York, UK, evidence based practice center funded by agency for healthcare research and quality of USA are the other agencies supporting evidence based practice.
12. What is Network meta-analyses?
The meta-analyses has traditionally been used to combine data on clinical outcomes e.g. efficacy, mortality and ADRs across published studies. One of the major drawback of meta-analyses is the evidence gathered after publication date is not included in the evidence of meta-analyses. To make meta-analyses more effective and latest, the approach of gathering evidence by well-identified experts of clinical practice is added to the evidence of published meta-analyses. This is called network meta-analyses.
13. What is the infrastructure required for implementing EBM?
The practice of EBM thrives on team work of different experts who contribute to the ongoing therapy in a network fashion. Fundamental requirement is equity of all healthcare professionals along with human resource expertise in data mining and drug information specialists.
14. What are the skills required for practice of EBM?
The professionals are to be in constant touch on patient condition along with active participation in patient care. The care-giver should focus on the economic and quality of life outcomes along with clinical outcomes. The challenge of providing the evidence for the ongoing treatment has to be met all along the patient stay in the hospital. IT skills along with knowledge of pharmacy is essential to provide the drug-related information in therapeutics.
15. How the clinical pharmacy practice contributes to practice of EBM?
The clinical pharmacy practice objective is to provide support to the therapeutic team in matters concerning medicines. In order to meet this objective the clinical pharmacist participate in ward rounds, manages drug information services, ADR monitoring and poison information center. All these services are needed in order to practice EBM.
16. What are the advantages of collaboration of clinical pharmacist and doctors?
The clinical pharmacist working with doctors to achieve and manage the best patient safety practices and involved in good therapeutic outcomes is only possible when a clinical pharmacist gives inputs regarding the knowledge of drug-drug interactions, dosage corrections and therapeutic drug-monitoring which helps the doctors to achieve a well-defined therapeutic outcome.
17. How the cost of treatment is justified for additional expenditure for implementing EBM?
The treatment which is not based on evidence is likely to be based on individual clinical experience and experimentation. The outcomes of non-EBM treatment are not predictable and are biased, hence it is considered as best practice to utilize the established evidence available.
The EBM being scientific and rational can be definitive in good outcomes.
18. How EBM is different from rational therapy?
EBM is based on evidence available in clinical trials, meta-analyses and systematic reviews where rational therapy is based on agreed, logical, established opinion with scientific evidence.
19. What is the importance of EBM in management of infectious diseases?
The infectious diseases therapeutics mainly comprises of use of broad spectrum and narrow spectrum antibiotics. The EBM of infectious diseases demands cultural sensitivity reports as evidence to treat the infection with an appropriate antibiotic. The infectious diseases has also an issue of emergence of resistance which is linked to treatment of infections by inadequate duration. For example, the tuberculosis multi drug resistance is attributed to poor patient compliance after the symptoms of the disease stops to bother the patient. The EBM stresses upon the complete course of treatment to prevent reinfection by multi-drug resistant bacteria.
20. Can EBM be integrated with smart drug therapies?
Smart drug therapies are intelligent, targeted drug-delivery systems aiming at highest efficacy and safety of the patients. The evidence based medicine is also having the objective of achieving highest efficacy and patient safety. The difference between the EBM and smart drug therapy is the EBM is based on information technology whereas the smart drug therapy is a technical product. The integration of both shall make the treatment more safe and efficacious.
21. How health technology assessments (HTA) can help EBM?
The HTAs are comprehensive protocol based on policy research that examines short and long-term consequences of the application of drugs, devices, medical procedures and support systems like drug formulary etc. The protocol based assessment will bring out clarity on aspects of clinical efficacy, pharmacoeconomic implications and its impact on quality of life of a particular decision. The EBM also analyses a clinical application and its value which helps in decision making, hence the HTA can support the practice of EBM with more clarity and evidence.