TECHNOLOGY AS ENABLER FOR EVIDENCE BASED MEDICINE PRACTICE

TECHNOLOGY AS ENABLER FOR EVIDENCE BASED MEDICINE PRACTICE

1 Dr. Arti Thapliyal, 2 Bappaditya Mallick

1 Industry & Innovation Lead, Health & Public Services, Accenture ATCI

2 Managing Director & Health Practice Lead, Accenture, ATCI

Abstract: Evidence based medicine is the integration of clinical practice with patient values and the best available clinical evidence derived from high quality clinical research aiding in appropriate clinical decision making. It is an ongoing process, where providers get opportunity to take a clinically informed decision for their patient. The treatment plan based on evidence-based medicine is in line with providing the best outcome with a cost-effective approach. It not only focuses on resolving the present issues and improving quality of life of patient but also emphasizes on the principles of ‘no harm’ inclusive of abreast modalities which are available and practiced at that point of time by other health care providers. To make this clinical decision-making process robust, an amalgamation of Evidence based medicine with technology is a must.

This study focuses on bringing forth the importance of technology in implementation of evidence-based medicine. Technology can play a major role in making evidence-based medicine approach accessible for all by helping in integration and organization of health care data derived from core healthcare stakeholders, e.g., providers, payers, public health organizations, pharmacies and other ancillary players like pharmaceutical companies, genetics companies, wearable manufacturers and nutritionists who are involved in the care process of an individual. This data then can help in bringing the major revolution in healthcare by channelizing our focus on advancements like personalized care and shared decision making which would ultimately lead to reduction in misses and errors and will result in best possible care outcomes for the patient.

Index Terms: Evidence-based medicine, Clinical evidence, Clinical decision making, Technology, Healthcare stakeholders, Personalize clinical care

**********************************************************************

?I.????????INTRODUCTION

Currently treatment plans for patients are developed based on historical understanding of what works best for treating a disease, but not what would be the best treatment approach looking at the patient holistically leveraging all potential data sets from diverse health care delivery systems.

With the rapid advances in the field of medicine & technology, it is necessary for clinicians to be well versed with the interdisciplinary approach of Evidence-based medicine to make informed decisions for the patient, aiding in favorable clinical outcome. The essentials of EBM include asking a clinical question, searching for evidence, critically evaluating the evidence for validity and relevance in respect of clinical question, applying the said result in clinical practice and evaluating the results obtained 1. Inability to bring EBM into practice leads to compromised treatment planning often called as medical error resulting in poor care outcomes.

Medical error may be defined as an undesirable or unintended outcome resulting due to a flaw in treatment planning, deviation or a failure during its execution that may or may not result into patient harm. Preventable medical error is accountable for 1 million injuries and approximately 44000 to 98,000 deaths in US alone 2. These were incidences which were recorded but issues like high cost related to negligence, malpractice or medical ignorance owing to explosions in fields of medicines still needs to be explored in detail.

Peter R. Orszag, director of the Congressional Budget Office, noted that if healthcare costs continue to grow at the same rate as they have over the past four decades, by 2050 Medicare and Medicaid spending alone would account for 20 percent of the total U.S. economy—an amount roughly equivalent to the entire size of the federal budget in 2007 4. One of the major reasons for this cost inflation is preventable medical errors and if the causes and probable solution for these are identified, the expenses can be diverted to other important areas like focusing on quality parameters and approach diversification from cure of a disease to wellness.

This paper will focus on the preventable errors related to medical field which may get reduced in number by practicing Evidence based medicine backed by technology. The study will also stress upon the challenges associated with it. The paper further discusses and puts emphasis on pivotal use of technology that would help integrate the vast amount of data from all the stakeholders of healthcare industry and hence ease EBM practice. This integrated data when combined with the technologies like AI and ML can help the clinicians to adopt and practice the best available clinical solutions well supported with evidence to achieve the desired care outcomes.

A.???Problem Statement

Challenges faced by the clinicians while practicing evidence-based medicine

Currently the patient care plan is derived based on traditional treatment modalities for a disease and the intuition of the physician based upon his/her experience in the field. Since the approach is generalized for all the patients & the individual patient’s need or values are not considered, there are chances of misses, errors, and related high cost.

There is an eminent need of technology-based solutions to help the clinicians during decision making process

II.????????LITERATURE REVIEW

A.???Need of Evidence based medicine

With the implementation of EBM in the patient’s treatment plan, favorable outcome may be attained complemented with a significantly reduced cost, one such use case that could be cited is, the usage of?angiotensin-converting enzyme inhibitors & angiotensin receptor blockers in a clinical trial for the patients suffering with diseases like diabetic nephropathy, end-stage renal disease and hypertension based on the guidelines of the ‘American Diabetes Association’ in the management of hypertension and microalbuminuria in type 2 diabetes and overt diabetic nephropathy and ‘Joint National Committee’ on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. This treatment plan adopted in clinical trial not only helped in prolongation of life of the patients but also improved their quality of life 5. If these types of clinical guidelines could be developed and applied into clinical practice, the healthcare industry will be benefited, and EBM could prove to be a significant tool to achieve this.

B.????Evidence based medicine-a tool to prevent medical errors

According to the report of ‘Agency for Healthcare Research and Quality ’?there?was a significant emphasis on quality measures in the time duration of 2010 to 2014 in US, which resulted in 17 percent decline in hospital acquired infection and a whooping saving of $ 19.8 billion in health care cost 6. These measures can be implemented in large scale, and it is only possible when we have evidence of its impact, and it can be achieved through

evidence based medicine; it can serve as the baseline for the healthcare organizations which are aspiring to deliver quality healthcare delivery ensuring patient safety. To make it accessible and easy to practice, technology can play a major role.

A study published in BMJ quotes, medical error qualifies for the third position in the reasons for death in US population 7. A significant effort should be made to reduce the medical errors and it may be achieved if the clinical practice aligns with the evidence-based medicine.

Thus, there is a pressing need to understand which treatment works for whom and it may be achieved with increased consumer information and keeping pace with latest medical advances & technology.

C.???Impact of Evidence based Medicine

1.????Reduction in Medication errors and cost associated with it

Medication error is a grave error, which is preventable and avoidable. Since healthcare industry is already face the crunch in human resources owing to growing population, exponential increase in number of lifestyle diseases and new diseases, there is a need where the work environment is made such that the likelihood of the errors is less.

If the health care organizations can analyze the practices followed by other healthcare organizations who are successful in reducing or preventing these types of errors, the number of errors globally can be reduced. This can only be achieved through evidence-based medicine and data analysis. The data pointers for both health care organizations, one striving to reduce the error rates and the other one who is successful in doing it can be compared and the root cause analysis may be done, to find out the causes. The significant steps that are helping the organization with less of such incidents can be marked and adopted leading to reduced number of errors, reduced cost and increase patient safety.

2.????Prevention of medication Prescription errors

In US alone 1 in 3 people are prescribed inappropriate medicines leading to poor health outcomes. Between 1993 & 2010 unsafe drugs were prescribed more than 100M times in the US before being recalled 8. This is mainly due to lack of insights on patients’ medical history, past prescriptions, socio-economic context, and lifestyle. If the above-mentioned data pointers are considered while designing medication regimen for the patient it would improve medication adherence & efficacy of the drug.

3.????Insights to Pharma companies on the performance of a particular drug new/existing

As all data that affects medication therapy is in silos, there is lack of holistic 360-degree view of all factors that affect efficacy of medication for a patient and treatment outcomes. If these data could be shared with pharma companies, the eminent issues with drug could be addressed and the measures to improve the end customer experience, that is patient could be implemented.

4.????Devising cost effective treatment plans-Insurance

Under the CMS innovation center, Bundled Payments for Care Improvement Initiative are developed.

CMS actively monitors and ensure that the beneficiaries get the cost-effective latest care plan. For this they continuously assess the claims, process outcomes, process improvements in healthcare 9. They continuously look for changes in any quality parameters or factors that would lead to same or higher level of patient outcome in lower cost.

Evidence based medicine, it can serve as the baseline for the healthcare organizations, and in making it accessible and easy to practice, technology can play a major role.

5.????Evidence-based public health (EBPH)

Decisions in public health is often influenced by crisis, concern of a particular group and political interest. EBM has an inherent role to play here since, public health practitioners should incorporate latest scientific evidence in selecting and implementing programs, developing policies, and evaluating progress otherwise it will give rise to issues like inequities in health and poor outcomes of implemented health plans 10.

D.???Use case example of EBM in India

MOHFW, AIIMS and ICMR have jointly issued an advisory for rationale use of a Remdesivir for Covid-19 treatment based on various clinical trials conducted by WHO all over the globe to stop irrational use/over prescription of this drug 11.

This decision making was done based on the evidence-based medicine keeping into account the actual outcome of the drug and the huge cost associated with it.

E.????Technology and EBM

Technology has a pivotal role to play in success of Evidence based medicine. If the healthcare settings are well-equipped with modern technologies like data analytics, AI and ML, the decision making can be improved and the plan suiting the individual need of patient can be deployed.

The traditional, textbook way of diagnosing and treating patients cumbersome and may get outdated with time. It is expected out of a physician that they should always be equipped with the most updated treatment protocol for any random diseases but is unjustified keeping into account the vast medical information available and exponential advancement in medical care and technology. This generates the urgency of technology which can improve the decision making and can help devise a treatment plan suiting the individual need of patient keeping abreast with the latest clinical practice which is well supported and researched.

F.????Challenges in practicing EBM

1.????Transparency and morality issues with EBM

Practicing EBM has fraught with its own risks, stakeholders are bulldozing their views to promote their products without concern for integrity and morality of fair practice.

2.????Interoperability between the stakeholders

Organizations use different clinical terminologies, have unique technical specifications, and functional capabilities. These differences make?it difficult to create one standard interoperability format for sharing data. This creates an issue of interoperability, which is a huge hinderance in implementing evidence-based medicine practices.

???????????????III.????????METHODOLOGY

A.????Study Universe

The study analyzed the market and research activities on Evidence based medicine and the advanced technologies affecting and aiding them.

B.??????Stakeholder Analysis

Data driven approaches which combine real-world data from sources such as electronic health records, registries, hospital records, health insurance company data, Pharmacy company data etc. of individuals or group to identify the best clinical guidelines currently practiced and making probable solutions that would positively impact a wide gamut of stakeholders :

·??????Patients: Availability of choice in treatment plan best suiting the need based on detailed analysis.

·??????Hospitals/Health care providers: Data led strategies to help in decision making for better clinical outcomes.

·??????Insurance Companies: It can prove out to be a boon for health insurance companies for cost reduction and minimization of fraud, abuse, and waste.

·??????Pharmaceutical & Medical equipment companies- Pharmaceuticals & Medical equipment companies will be able to gain insights on how their products are working outside the test environment thus saving on ???huge cost before launch.

IV.????????SOLUTION, ANALYSIS & DISCUSSION

A.???Solution Approach

Present treatment plan or medication regimen, takes a “one size fits all” approach. Most treatment plan fail to factor for the variability in genetic makeup, socio-economic conditions, past medical history of individuals which impacts disease progression. Healthcare organizations wants to become more accurate, precise, proactive, and impactful for everyone that comes under their care but due to lack of resources like time and human resource, physicians often follow the traditional approach of treatment based upon their instinct and practical experience ensuring patient safety. The need of the hour is Evidence based medicine impregnated with technology which may help to endeavor cost effective treatment plans which is at par or better than the existing treatment plan. It will not only benefit the patient but will also prove out to be an important tool for hospitals, insurance companies and public health organizations. One of the major obstacles in following evidence-based medicine is accessibility. The clinicians are ever short in number to match with the exponential population and it becomes difficult for them to keep abreast with the new treatment methodologies/protocols practiced in the other corners of the world.

To bridge this gap in practicing evidence-based medicine, technology may emerge as a one stop solution. Information comprising of integrated data of an individual/ population can be made accessible to the health care organizations leveraging technology. This will make them well equipped with the information about the patient and the treatment measure taken all over the world for the similar disease, which will be effective in treating the ailment and may also offer other advantages like increased patient safety, low risk carrying approach and cost effectiveness to name a few.

For implementing this solution, we would need to gather data for an individual/ population. The data may be gathered from various sources like EHR, genomic data, SDOH, past medical history profile and its interaction with various treatment modalities he is undergoing. Side by side we will have to make the organizations robust in information handling and processing via technology and interoperability. To do so, we would have to have tools in place which can integrate the data from various stake holders and retrieve the relevant information required.?

B.????Solution Analysis

After the data is collected from various stakeholders, the data will be cleaned and will be formulated into a modelled data, which would be easily understandable and would enable interoperability between the various stakeholders.

The data then may be used to derive useful information and insights regarding existing treatment options, associated risks, procedure protocols and patient safety measures that may yield better outcomes. Further, this structured data alone can help the health care organizations indecision making but this when combined with sophisticated technologies like AI & ML can give greater insights and can work as assistive tool during critical clinical decision making.

When this structured modelled data combines with AI and the insight derived from it is fed into deep-learning recommender system, it would be able to recommend a hyper-personalized, sustainable, accessible, and cost-effective treatment modalities/ medication regimen which would lead to higher probability of medication adherence.

This technology will be ever evolving, the more data it engulfs, it becomes more robust an able in assisting the health care givers.

This insight can be fed into a deep-learning recommender system, which would recommend a hyper-personalized, sustainable, accessible, affordable, and culturally relevant diet for an individual which would lead to higher probability of acceptance of the dietary recommendations and positive nutrition intervention.

C.???Solution Discussion

It can help predict the potential outcomes for critical diseases, where prognosis is uncertain. It can also help in comparing the various treatment options available, weighing the risk each option. This then can be used by clinicians in planning treatment plans and government is implementing healthcare policies.

Benefits of evidence-based medicine backed by technology

1.?????Assistance in accurate decision making

Medical data are often unstructured, but with deep learning algorithms, data can be systematized into a usable form, assisting clinicians in diagnosing faster and better.

2.?????Higher safety margin and better patient outcome

Since evidence-based medicine keeps patient value/ interest at utmost importance and always looks for advance methodologies with better outcome. The patient is benefitted, the transparency in the process, gives patient also an edge to ask questions regarding the treatment plan, which guarantees a better outcome.

3.?????3. It can pave a way for precision medicine?

It is a new frontier for healthcare combining genomics, big data analytics, and population health. The ingredients required for personalizing medicine are electronic health records, genomics, big data analytics, population health and supercomputing. It will be easier to verify the preliminary outcomes since entire database from clinical trials, experimental lab notes, and patients’ health history will be available for clinicians.

4.?????Early recognition of rare diseases and disease risk assessment

If the relation could be established between the diseases and health patterns, it will be easier to recognize the disease and measures can be taken to recognize and prevent its spread. Data analysis supported with technologies like AI & ML can help in early diagnosis and monitoring effect of the treatment given.

5.?????Reduction in regulatory compliance penalties for all the stakeholders

Hospitals and insurance companies often face monetary and goodwill loss for not meeting expected care outcomes since they are unable to provide care under value-based care payment construct. Evidence based medicine with technology can provide an interoperability platform for all the stakeholders ensuring best possible outcome.

6.?????Reduction Insights regarding new/existing drug which may change a medication regimen/improve adherence

These insights will allow public health organizations, pharma industry and other care delivery organizations to plan, produce and advocate medication regimen for diverse populations and may also help to design medication regimen catering individual as well as a population’s unique context.

V. CHALLENGES ASSOCIATED WITH PROPOSED SOLUTION

?1. Requirement of In-depth industry knowledge

In depth knowledge of healthcare industry in correlation with meaningful use of technology to solve for medical errors is extremely critical for successfully identifying use cases or areas for intervention that would enable EBM practice for better care outcomes. SME knowledge is critical in identifying data attributes, healthcare systems and business processes that needs to be looked upon to gather evidence for better care planning.

2.????Accessibility of reliable Data

As the data resides in different formats in every organization, it makes collation and harmonization of data difficult for easy analysis. This challenge can be overcome by good data engineering practices.

3.????Data Privacy

To ensure zero data compromise, best in class data security and storage practices must be adopted by following regulations like HIPAA and GDPR to ensure data protection with a formal consent.

4.????Generalized analytical models

Collected data could be generalized which can be fixed by conducting experimentation with a larger group of patients, which would allow the models to learn and become better at personalizing insights and recommendations.

5.?????Interoperability

The solution platform must be standardized to enable interoperability between stakeholders considering functional, legal, and technical aspects of their organizations.

VI. SEGMENTATION & TARGETING

A.???Segmentation

·????Areas with poor/moderate clinical outcomes

·????Developed countries where there is increased consumer demand for personalized treatment

·????Developing countries with socio-economic diversities where personalized plan benefits are needed to cater to diversified healthcare needs of populations.

·????Geographies with higher rate of epidemics

·????States with lower medication adherence rate

·????States which strive to achieve optimum patient safety accompanied with higher care outcomes.

·????Countries lacking in healthcare infrastructure can make use of this platform for resource optimization.

B.????Targeting

·????Clinicians practicing precision medicine.

·????Patients suffering from chronic diseases and seeking wellness services.

·????Health Insurance companies who are looking to introduce context relevant personalized care plans.

·????Hospitals to leverage technology for EBM practice for better care outcomes.

·????Government agencies and public health organizations that want to ensure the success of their implemented policies.

·????Pharmaceutical companies to use EBM insights for better R&D of drugs.

·????Medical equipment companies to evolve product designs based on care outcome.

????????VII.????????Recommendations

·?Public health organizations and government agencies must include EBM while planning and implementing health policies to improve acceptability of the intervention programs and to improve outcomes.

·??Health Insurance companies can design cost effective treatment plans for their consumers based on EBM which would further help in reduction of high-priced claims.

·?Hospitals can improve the care outcomes for their patients by making their clinical decision-making process accurate. Tailored made care plans can be devised to reduce hospital readmissions.

·?Pharma industry can leverage EBM based data insights to produce personalized drugs for certain geographies and populations to meets unique needs.

???????VIII.????????CONCLUSION

As the healthcare costs shows exponential rise, it is the need of the hour to leverage evidence-based medicine practice that provides safe, effective, and affordable care. Amalgamation of technology with evidence-based medicine will help in bridging the gap in care delivery. It will support the healthcare organizations who envision to be leaders in patient safety while providing most advanced treatment. This will shape the future of precision health which is redefining the healthcare delivery through hyper personalized care leveraging newer technologies like digital twin, quantum computing and advanced analytics in predicting best possible outcome driven cost-effective care.

?I.????????REFERENCES

[1] D L Sackett, W M Rosenberg, J A Gray, R B Haynes, W. S. R. (1996). Evidence based medicine: what it is and what it isn’t. National Library of Medicine. https://doi.org/https://doi.org/10.1136/bmj.312.7023.71 ?

[2] John Loannidis; Joseph Lau. (n.d.). Evidence on Interventions to Reduce Medical Errors. JGIM.

[3] Rajeev B Ahuja. (2013). Ethical practice of evidence-based medicine: A review for plastic surgeons. Indian Journal of Plastic Surgery. https://www.researchgate.net/figure/The-evidence-based-medicine-triad-Source-Florida-state-university-college-of-medicine_fig1_255986863

[4] Institute of Medicine (US) Roundtable on Evidence-Based Medicine. (2010). The Healthcare Imperative: Lowering Costs and Improving Outcomes: Workshop Series Summary. National Academies Press.

[5] SONYA J. LEWIS, B. I. O. (2004). The Importance and Impact of Evidence-Based Medicine. Supplement to Journal of Managed Care Pharmacy, 10.

[6] Agency for Healthcare Research and Quality. (2018). Saving Lives and Saving Money: Hospital-Acquired Conditions Update. https://www.ahrq.gov/hai/pfp/interimhacrate2014.html

[7] Martin Makary; Michael Daniel. (2016). Medical error—the third leading cause of death in the US. Bmj Medicine. https://doi.org/10.1136/bmj.i2139

??[8] ???McCormick, S. S. S. W. D. U. H. 2; D. B. 3; D. (2016). Unsafe Drugs Were Prescribed More Than One Hundred Million Times in the United States Before Being Recalled. PubMed.Gov.

[9] LeadingAge Center for Aging Services Technologies. (2016). Shared Care Planning and Coordination for Long-Term and Post-Acute Care: A PRIMER AND PROVIDER SELECTION GUIDE.

[10]??Ross C. Brownson, Elizabeth Anne Baker, Anjali D. Deshpande, K. N. G. (2018). Evidence-based Public Health (Third Edit). Oxford University Press.

[11] MOHFW, A. and I. (2021). Advisory for Rational use of Remdesivir for COVID-19 Treatment.

[12] H, S. (2018). Evidence-Based Medicine and Clinical Research: Both Are Needed, Neither Is Perfect. Annals of Nutrition and Metabolism.