LEBANON, NH – The foundation of evidence-based research has eroded and the trend must be reversed so patients and clinicians can make wise shared decisions about their health, say Dartmouth researchers in the journal Circulation: Cardiovascular Quality and Outcomes.
Drs. Glyn Elwyn and Elliott Fisher of The Dartmouth Institute for Health Policy & Clinical Practice are authors of the report in which they highlight five major problems set against a backdrop of "obvious corruption." There is a dearth of transparent research and a low quality of evidence synthesis. The difficulty of obtaining research funding for comparative effectiveness studies is directly related to the prominence of industry-supported trials: "finance dictates the activity."
The pharmaceutical industry has influenced medical research in its favor by selective reporting, targeted educational efforts, and incentivizing prescriber behavior that influences how medicine is practiced, the researchers say. The pharmaceutical industry has also spent billions of dollars in direct-to-consumer advertising and has created new disease labels, so-called disease-mongering, and by promoting the use of drugs to address spurious predictions.
Another problem with such studies is publication bias, where results of trials that fail to demonstrate an effect remain unpublished, but trials where the results are demonstrated are quickly published and promoted.
"We do not know when healthcare decisions are guided by sound interpretations of the evidence and whether patients are engaged in the process," say Elwyn and Fisher. "Rather we observe that in the United States, one of the most highly developed healthcare systems, consumer demand for healthcare is manufactured and manipulated, driving up cost, waste and harm."
And even if the synthesis is competent, they say, more evidence remains inaccessible and presented in a way that is difficult to translate into effective communication about harms and benefits.
"The problems of greatest concern to patients are often left uninvestigated, with emphasis given to research that expands market share," say Elwyn and Fisher.
The authors offer possible solutions:
Problem: Weak Research Foundation
Solution: Regulators should require that trials be compared against the best current therapy rather than placebos; measure outcomes that matter to patients; and have a registry that requires publication of all trial protocols, making it possible to track studies that have not reported results. Also, research outputs should have prominent warnings when the trial design, management and analysis were not done independently of a company who stood to profit by the outcomes.
Problem: Low-Quality Evidence Synthesis
Solution: Conflicts of interests must be made transparent and minimized where possible.
Problem: Evidence Remains Inaccessible to Those Who Need It
Solution: Redesign the tools of synthesis so the guidelines are shorter and understood by patients and clinicians so they may engage in a meaningful dialogue about the harms and benefits in order to make a shared decision about the course of treatment.
Problem: Ineffective Performance Measurement and Accountability
Solution: Measuring volumes while not paying attention to quality leaves patients vulnerable. Two broad initiatives have emerged. One is focused on payment reforms, such as bundled payments and accountable care organizations; the other on advancing performance measurements, such as patient reported outcomes that include improved function, quality of life and meaningful engagement in decision making.
Problem: Manufacturing Consumer Demand Solution: These issues defy an easy solution. The public and the media need to be more skeptical of industry claims and be wary of hype that over promises.
"Solutions to these problems are visible but will be difficult to introduced unless there is a much wider recognition that healthcare has become less about well-founded, trusted relationships between healthcare professionals and patients," Elwyn and Fisher say. "Rather it looks more like a profit-driven service industry, where commercial interests have influence the value chain."
To view the article, go to http://circoutcomes.ahajournals.org/
The Dartmouth Institute for Health Policy & Clinical Practice was founded in 1988 by Dr. John E. Wennberg as the Center for the Evaluative Clinical Sciences (CECS). Among its 25 years of accomplishments, it has established a new discipline and educational focus in the Evaluative Clinical Sciences, introduced and advanced the concept of shared decision-making for patients, demonstrated unwarranted variation in the practice and outcomes of medical treatment, developed the first comprehensive examination of US health care variations (The Dartmouth Atlas), and has shown that more health care is not necessarily better care.