Evidence Based Medicine & Outcomes Analysis – An

Evaluation

Dr. Suman Bhusan BhattacharyyaMBBS, ADHA, MBA

Presented at IAMI, Chandigarh-2003 Conference, October 19, 2003, PGI,

Chandigarh

An Evaluation

• What?

• Why?

• Where?

• How?

• Pain areas…

Evidence Based Medicine– What?

• Widely credited to have been coined by Dr. David Eddy of Kaiser Permanente

• It is believed that its philosophical base dates back to the sceptics of post-revolutionary France (Xavier Bichat, Pierre Louis, François Magendie)

• The conscientious, explicit and judicious use of current best evidence in making clinical decisions about the care of individual patients (Dr. David Sackett, 1996)

Evidence Based Medicine- When?

• There is evidence that something works, is good and benefits the patient, do it

• There is evidence that something does not work, is harmful, does not benefit the patient, do not do it

• There is insufficient evidence, be conservative, relying on individual clinician expertise

Evidence Based Practice- What?

Any practice that applies up-to-date information from relevant and valid research about the usefulness of various diagnostic tests or the predictive power of prognostic factors or the beneficence of a particular treatment method across healthcare, including education, practice management and health economics, it is said to be EBM-enabled.

Evidence Based Enablement, but…

Mere application of evidence based medicine is in itself simply not good enough. The end results need to be validated. This is done by performing outcomes analysis, preferably on a continuous basis

Outcomes Analysis – What?

• Outcomes are the result of efforts by healthcare providers to provide optimal care resulting in optimal outcomes (Avedis Donabedian, 1980)

• Outcomes analysis is a non-prejudiced analysis of the outcome of an event, episode or encounter.

• Not only are the outcomes of an event, but also the variances between different treatment methodologies are measured.

• In a clinical setting, it also allows one to find out how well a particular treatment method is faring.

Outcomes Analysis – What? [Contd.]

• Clinical. Was the care or service appropriate, and/or did it achieve desired results, such as restoration of function or reduction of physiological anomaly?

• Quality of Life. Did the care or service improve the psychosocial well-being of the patient and/or return the patient to his previous role in his personal life or work?

• Satisfaction. Was the patient satisfied with the care received, especially in the context of access, general perceived quality and cost-effectiveness, timeliness, etc.?

Outcomes Analysis – When?

• Continuously in realtime

Outcomes Analysis – Where?

• Wherever there is clinical data capture is done – both paper-based or electronic

Evidence Based Practice& Outcomes Analysis – Why?

• The old way of depending on a combination of informed guesswork, unsystematic observation, common sense, the consensus views of clinical experts, and the so-called “standard and accepted practice”, meaning the treatments and procedures used by most other clinicians in a local community – was fine, but with the addition of enormous amounts of information every day, things are threatening to “get out of control”.

• So, is this way “the only way”?

The Pain Areas… • 27 Kg of guidelines, • 3000+ new papers per day, • 1000 new Medline articles, • 46 randomized clinical trials• The number of biomedical journals alone doubling since 1970. • Average workload for a clinician of anything between 100 to 200

consultations a week resulting in 5000 to 10000 per year. • Add to it the difficulty of relying solely on experience while using 2

million pieces of information all stored in ones memory, ever increasing pressures to provide value-for-money services, raised patient demands and expectations, pressures due to a myriad of obtrusive and mostly confusing regulatory compliances, and rapidly altering business demands.

• Hmmm…

The Pain Areas… [Contd.]

• Every encounter with a patient identifies gaps in our knowledge about the etiology, diagnosis, prognosis, or therapy of their illness. Recent research reveals that even as seasoned clinicians we generate about five knowledge “needs” for every in-patient encounter, and two “needs” for every three out-patients encounters.

The Pain Areas… a plausible answer

• To bridge these gaps and fulfill the “needs”, we need to practice evidence based medicine, and to evaluate the best evidence that evidence based medicine is supposed to reveal we need to perform outcomes analysis

• Practicing medicine based on best evidence in the form of clinical protocols helps as a valid legal cover in malpractice suits

Best Evidence…

• Current best evidence is up-to-date information from relevant, valid research about the effects of different forms of healthcare, the potential for harm from exposure to particular agents, the accuracy of diagnostic tests, and the predictive power of prognostic factors.

Evidence Based Medicine – How? The way of seven A’s…

Assess the patient a clinical conundrum or question that arises out of the clinical examination

Ask the patient the care provider needs to construct a well-built clinical question from the findings in step 1

Access the information the appropriate resources needs to be selected and searched for the answer to the question framed in step 2

Appraise the evidence the information gathered in step 3 needs to be critically appraised using the various indices for its validity and applicability to the patient’s problems

Apply the findings the validated evidence needs to be integrated with clinical expertise and patient preferences and then applied as required

Assess the outcomes the performance of the evidence with the patient needs to be evaluated

Add the knowledge the information so gathered added to the clinician’s knowledge base for future reference to best evidence in similar problems

Evidence Based Medicine – The Types

• Diagnostic– Here the importance of various observations,

value of diagnostic tests, etc. are evaluated in ruling in or out a diagnosis

• Treatment– Here the value of a treatment method or the

necessity of a particular medication or procedure is determined

Evidence Based Balance Sheet

1. Examine the evidence that a treatment is effective.

2. If so, then determine the magnitude of its benefits, harms, and costs.

An evidence based balance sheet is an important tool that supports the practice of evidence based medicine.

Evidence Based Balance Sheet

• Display in a compact form the evidence as quantitative estimates of the effects of alternative treatments on all the important outcomes

• The decision-makers can more easily grasp the consequences of the different options they face.

• Specially useful for informed shared decision-making between physicians and patients.

Developing an Evidence Based Balance Sheet – The 4 Main Steps

1. Identification of the alternative treatments that are available to the patient

2. Identification of the health outcomes (i.e., the outcomes that can be experienced by, and are important to, the people who will receive the treatments) that are affected by the treatments

3. Estimation of the probabilities or magnitudes of each of the health outcomes, for each of the alternative treatments

4. Displaying the information in a table

EBM Balance Sheet – An ExampleOne-year probabilities of outcomes associated with Alendronate 5 mg vs. no drug, for a 55-year-old average-risk woman.

Item  No Drug Drug Difference NNT

Hip fracture .00046 .00032 .00014 7143

Wrist fracture .00316 .00223 .00093 1078

Spine fracture .00144 .00084 .0003 3322

Long-term benefits 0 ? ? ?

Inconvenience 1 0 1 1

Gastric distress 30% 0 30% 3

Long-term Harms 0 ? ? ?

Cost of drug $0 $308 +$308  

Expected cost of treatment $220 $203 -$17  

Net cost $220 $511 +$291  

Problems associated with Evidence Based Practice

Problems Solutions/Workarounds

Resources and commitments in terms of time and money that needs to be delivered away from actual patient care

Evaluate against opportunity cost, follow-on and abandonment option costs. Evidence based practice wins hands down as a strategic investment

Finding and evaluating the evidence is costly in terms of time Use EPR

Lack of skills in computer use and locating evidence Train personnel. This is not an issue with the generation next.

Resources needed to acquire and maintain databases Availability in electronic form and increased usage will bring the prices down

Searching may only result in discovering gaps in medical knowledge

One must seriously doubt our capabilities and question our insecurities

Poor indexing may lead to frustration of futile literature searches

Use online searches and make all literature available searchable online

The quality and quantity of research mostly unknown Use refined studies performed real-time using EPR

Demands a high degree of statistics knowledge Use EPR that have the calculations as well as their interpretations built-in

Viewed as a form of rationing Evidence based medicine is about improving the quality of patient care. It is just as likely to show that effective interventions are underused as to show that ineffective procedures are over-used

EBM in Clinical Protocols

• Clinical protocols need to be made based on the current best evidence

• These protocols must undergo continuous revalidation in order to continue to be relevant according to the current best evidence

• Protocols change according to triage assessments and specialty – so they need to be user and problem-specific

Artificially Intelligent Electronic Medical Records

• An electronic medical record solution that has the artificial intelligence to present the appropriate clinical data capture forms according to mandated clinical guidelines that are user as well as problem-specific

• Automatically “learns” to capture the necessary information according to the best evidence

Information Overload 2

Information @ Fingertips

Thank You!