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Real World Evidence

April 21st, 2017 - 0 Comments

Let us look at the typical day of a physician when he or she sees several patients complaining of prolonged fever. Four of them had blood tests in the past few months, but there are no records in the charts of readings for these tests. How could the physician figure out if this was just an unusually bad day, or if there is a systematic problem in the office?

They could take a sample of charts for patients who had fever in the past year, and assess what percentage had a documented reading. If there is a significant percentage without readings, they could investigate further to figure out what went wrong and where the process failed.

The above example depicts the use of a chart audit to assess adherence to clinical protocol.

What is a Patient Chart Audit?

A chart audit is an examination of medical records (electronic and hard copy) to figure out what has been done and ascertain whether it could be possible in a better manner. Retrospective chart review studies are often required in the absence of suitable healthcare databases and/or other secondary sources of information. Chart review studies enable the rapid collection of clinical, safety, and healthcare resource utilization (HRU) data. Chart audits are characterized as small scale cycles of mediation connected to evaluation, with the objective to enhance the process, result, and efficiency of the complex systems of health care.

What are the Purposes of the Chart Audits?

  1. Collect data unavailable in claims/administrative databases
  2. Evaluate associations between patterns of care and clinical outcomes of interest
  3. Evaluate the real-world safety profile of marketed products
  4. Identify unmet clinical needs
  5. Inform clinical trial and other prospective study designs through cohort characterization and analyses of medical care variabilities

Why to Choose a Chart Audit?

Chart audits serve many purposes, from compliance to research to administrative to clinical. Chart audits can be conducted on virtually any aspect of care ordinarily documented in the medical record. Practices baffled with clinical processes that don’t function well can utilize chart audits to report that something isn’t right, spot the defect simultaneously and fix it. Perhaps the most beneficial use for a chart audit is to measure the quality of care so that it can be improved. Chart audits are often used as part of a quality improvement initiative. For instance, a practice may audit charts to perceive how regularly a specific vaccine is offered, given or declined. If the audit determines that the vaccine is not being offered or given as suggested, then there is scope for improvement. A similar practice could review the boards of individual doctors within the group to check whether they vary in performance on this measure and to give focus to their improvement efforts. Chart reviews are being used increasingly to generate Real World Evidence to perform economic analyses based on retrospective clinical practice.

Conclusion

Providing real value for all stakeholders means cutting down costs and improving patient outcomes. A collaborative effort is required to achieve this. Satisfying regulatory bodies and payers, and delivering value-based evidence that paves the way for patient access means better communication and understanding between all parties. It includes contending pharma brands. Accomplishing patient access for a tried tested and approved drug starts with powerful clinical trials and thoroughly investigated real life evidence. But, there must also be a strong business case to find disease solutions. Chart audits are fast proving themselves to be worth the extra expense incurred upfront, sharpening a brand’s competitive edge throughout the life cycle.

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