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Evidence level based Medicine – what it means and what it costs

HeliR
By HeliR

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The Levels of Evidence in evidence-based medicine (EBM) are used to assess the quality and reliability of scientific studies. They are based on the type of study and the methodology.

EBM is a valuable tool, but frankly has extreme limitations when it comes to individual, rare or novel cases.

There is simply a severe discrepancy between EBM and the reality of a successful case in a doctor’s office or even the experience of a large clinic like Petros Kattou’s (he has about 60 patients per day).

One must not forget – creating such an evidence level is extremely costly, since we need university research, many patients, publication of studies, examinations, etc. –

A better EBM level can cost – according to GPT – up to 500 million euros!

Even publishing a “simple stupid case” and thus achieving EBM level 5 (= experience of a specialist) costs several thousand euros.

This means that the cool cases that we may experience in practice have no significance in the sense of EBM, since it is impossible for us to publish anything here and thus achieve EBM level 5.

We try to compensate for these weaknesses by showing, through lectures or CASE presentations (with video testimonials), what can be achieved with “non-guideline-compliant” treatments without a good level of evidence in some indications.

 

EBM Levels overview with patient numbers and physicians:

  1. Level 1: Highest evidence
    • Meta-analyses, RCTs
      • Patients: 1,000–10,000+
      • Physicians/researchers involved: 50–1,000
  2. Level 2: Moderate evidence
    • Cohort studies (prospective/retrospective)
      • Patients: 500–5,000
      • Physicians/researchers: 10-100
  3. Level 3: Lower evidence
    • Case-control studies
        • Patients: 100-1,000
        • Doctors/Researchers: 5-50
  4. Level 4: Low evidence
    • Case series and Individual case reports
      • Patients: 5–50
      • Doctors/researchers: 1–5
  5. Level 5: Lowest evidence
    • Expert opinions
      • Patients: none
      • Doctors/researchers: 1–3

 

so the “ridiculous” EBM Level 3 requires several hundred patients and many, many university professors and of course costs significantly more than a million euros!

 

beautiful AI image from ChatGPT

 

 

the individual EBM levels presented in detail

Level 1: Highest evidence

  1. Level 1a:
    • Systematic reviews (meta-analyses) of several high-quality randomized controlled trials (RCTs).
    • High consistency of results.
  2. Level 1b:
    • Individual well-conducted RCTs with narrow confidence intervals.
  3. Level 1c:
    • Evidence from “all-or-none” studies:
      • All patients die without the intervention, and all survive with the Intervention.

Level 2: Moderate evidence

  1. Level 2a:
    • Systematic reviews of high-quality cohort studies.
  2. Level 2b:
    • Individual high-quality cohort studies (prospective).
  3. Level 2c:
    • Results from observations such as outcome studies or analyses of clinical registers.

Level 3: Lower evidence

  1. Level 3a:
    • Systematic reviews of case-control studiesserve.
  2. Level 3b:
    • Single case-control studies.

Level 4: Low evidence

  • Case series and individual case reports:
    • Non-experimental studies or descriptive data.

Level 5: Lowest evidence

  • Expert opinion:
    • Expert reports, consensus papers or opinions without systematic data collection.

Additional systems (GRADE):

The GRADE system additionally categorizes evidence into very low, low, moderate and high, with quality being assessed based on factors such as study design, consistency, precision and publication bias.

Application:

  • Evidence levels help doctors and researchers make decisions based on the best possible data available. Higher levels (1a, 1b) are considered more reliable and should be preferred when available.

 

 

extreme costs for EBM are incurred - of course only large companies can bear them

Creating evidence levels in medicine is indeed associated with considerable costs. These depend heavily on the study design, the number of patients, the time period and the regulatory requirements. Here is a rough cost estimate for the main levels of evidence:

Level 1: Systematic reviews and RCTs

  • Systematic reviews (Level 1a):
    • Cost: $50,000 to $300,000+.
    • Main costs: Databases, expert teams, statistical analyses, publication costs.
  • Randomized controlled trials (Level 1b):
    • Cost: $1 to $100+ million, depending on:
      • Number of patients: Large multicenter studies (>1,000 patients) are particularly expensive.
      • Duration: Chronic diseases often require years of follow-up.
      • Regulatory requirements: Approvals and ethics protocols cost time and money.
      • Complexity: Interventions such as drugs or surgical procedures are more expensive than, for example, B. Behavioral studies.

Level 2: Cohort studies

  • Prospective cohort studies (Level 2a, 2b):
    • Cost: $100,000 to $10 million+.
    • Main factors:
      • Recruitment and follow-up of the cohort over years.
      • Data management and laboratory testing.
      • Multicenter studies cost considerably more.
  • Retrospective cohort studies (Level 2c):
    • Cost: $10,000 to $500,000+.
    • Retrospective analyses often use existing databases, which is less expensive.

Level 3: Case-control studies

  • Case-control studies (Level 3a, 3b):
    • Cost: $10,000 to $1 million+.
    • Main cost factors:
      • Access to high-quality data sources.
      • Statistical analyses and bias controls.

Level 4: Case series and Case reports

  • Case series (Level 4):
    • Cost: $5,000 to $50,000.
    • Lower cost because they are usually done retrospectively and without control groups.
    • Data are often available from routine clinical records.

Level 5: Expert opinions

  • Expert reports (Level 5):
    • Cost: $1,000 to $10,000.
    • Based on existing literature and clinical experience.
    • Publication costs in peer-reviewed journals are the largest items.

Additional cost factors for all levels:

  1. Ethics applications and regulations:
    • Can be $10,000 to $500,000 for large studies.
  2. Publication costs:
    • Articles in prestigious journals often cost $2,000 to $10,000+.
  3. Patient compensation:
    • Depending on region and study duration, participant payments can be very high.
  4. Monitoring and Quality assurance:
    • Needed for RCTs and cohort studies: $50,000 to $1 million+.

Examples of actual costs:

  • Big Pharma-supported RCTs for drug approval: $20 to $500 million+.
  • Academic studies (e.g. cohort studies): $100,000 to $10 million.
  • Systematic reviews: $100,000+, depending on complexity and data availability.

Conclusion:

The costs increase with the complexity and robustness of the evidence. Randomized controlled trials are the most expensive because they have to meet the highest methodological standards and regulatory requirements. Smaller retrospective or descriptive studies are considerably cheaper, but also provide lower levels of evidence.

 

Explanations of the study concepts

Different study concepts

  • Prospective: Observation from now into the future.
  • Retrospective: Analysis of the past, looking back at a group of patients
  • Experimental: Active intervention (e.g. testing therapy).
  • Non-experimental: Observations without intervention.
  • Systematic reviews: Summary and analysis of many studies.
  • Individual case reports/case series: Focus on a few or individual patients.

 

Summary of the usual study concepts

  1. Systematic reviews of high-quality cohort studies:
    • Collection and analysis of all available cohort studies on a question.
    • Goal: Reliable conclusions by summarizing large amounts of data.
  1. Cohort studies (prospective):
    • A group (cohort) is observed over a period of time in order to investigate future events (e.g. disease development).
    • Prospective: Starts in the present, events are only recorded in the future.
  1. Are there other cohort studies? than prospective?
    • Retrospective cohort studies:
      • Past data (e.g. from medical records) are analyzed to find correlations.
    • Ambispective cohort studies:
      • Combination of retrospective and prospective data analysis.
  1. Outcome studies:
    • Investigation of the results (outcomes) of treatments or interventions.
    • Example: How many patients recover after therapy?
  1. Analyses clinical registries:
    • Use large databases that collect information on treatments and diagnoses.
    • Use to identify patterns and trends in patient care.
  1. Systematic reviews of case-control studies:
    • Summary of several case-control studies to make reliable statements about risk factors or causes of disease.
  1. Case-control studies:
    • Comparison of a group with a disease (cases) with a group without a disease (controls) to identify possible causes.
    • Example: Comparison of smokers and non-smokers in Lung cancer.
  1. Case series:
    • Description of a small group of patients with a similar clinical picture or treatment.
    • Example: 10 patients who respond well to a new therapy.
  1. Individual case reports:
    • Description of a single patient case, often in rare or new diseases.
    • Example: First description of a rare tumor.
  1. Non-experimental studies:
    • Observational studies without active intervention by Researchers.
    • Example: Tracking patients with a specific disease without giving them new treatments.
  1. Descriptive data:
    • Descriptions without analysis or comparison.
    • Example: Statistics on the frequency of a disease in a region.
  1. Expert reports:
    • Summary of knowledge by professionals based on experience and literature.
    • Example: A specialist explains how he treats a rare disease.
  1. Consensus papers:
    • RecommendOpinions from expert groups based on existing literature and discussions.
    • Example: Guidelines for the treatment of diabetes.
  1. Opinions without systematic data collection:
    • Personal assessments or hypotheses without a systematic data basis.
    • Example: A doctor suspects a connection that has not yet been researched.

 

 

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