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Showing posts with label medical research. Show all posts
Showing posts with label medical research. Show all posts

Friday, August 15, 2025

Trump Guts Healthcare on Global Scale

The Trump Administration while busy guilding everything in sight with gold and expanding the White House ballroom, has still managed to cause a massive curtailment in public health resources. Here is the list of his administration’s actions in order of priority, which are most deleterious to global health.   

Cutting billions in grants for medical research causing public universities and research groups to layoff thousands of scientists. These cuts include 16 billion in economic losses and 60,000 in jobs. Some of the research programs have been in existence for fifteen years and the lead investigators will take their programs to other countries to continue their work. France, Switzerland, and Canada are all global research centers. It is estimated the loss of these experts, value of medical technology and treatments generated by medical research will cause a permanent four percent reduction in GDP for the United States.

      Stopping the funding of USAID destined for disease prevention and treatment in the developing world, and demonically highlighted by the Trump Administration’s order to burn 9.7 million dollars of birth control products in Belgium, on August 7, 2025. This despite a U.S. based nonprofit’s offer to distribute the IUDs. hormonal implants, and birth control pills for free within the United States. Apparently, people in the Trump Administration are still confused on basic birth control, as none of these products were abortifants, the reason cited for their destruction. And where were these often life saving devices destined, to Africa, where lack of basic maternal health is rife and loss of life for mother and child is common. Albeit, thanks to the originalist conclusions of the U.S. Supreme Court, maternal deaths are on the rise here too. A further curtailment of Medicaid funding will only worsen the access for prenatal and postnatal care. Many maternal deaths occur after discharge from a hospital, where follow-up care is limited. When a tree falls in the forest and no one hears it, does it make a sound?

          Removal of clinical and scientific experts on the Food and Drug Agency (FDA) review board for approval of medical interventions, including drugs, which will result in more specious, extremely expensive, and dangerous treatments offered without due diligence in the United States. In June, HHS Secretary Kennedy fired all seventeen experts on the review board for vaccines, which were replaced by eight persons, including vaccine skeptics. (Mandavilli, 2025) This action undermines the credibility of the FDA for drug and treatment standards, which has been considered the gold standard globally.

      Direct cuts to public health programs including vaccine development, disease surveillance, and access to care will result in the closure of many clinics and hospitals in rural areas. The Trump Administration’s One Big Beautiful Bill Act (BBBA) disqualifies legal immigrants from Medicaid benefits eligibility and makes draconian cuts to Medicaid which will eviscerate coverage for 16 million people. (Mia Ives-Rublee, 2025) The crowning achievement of permanent tax breaks for the rich and claw-backs for the poor cuts Medicaid by a trillion dollars and only offers rural hospitals fifty billion in subsidies, which are not guaranteed and are subject to new constraints. Further the rural hospital subsidies are only budgeted for five years. Any state that reimburses more than the miserly Medicaid cap determined at the federal level will face funding cuts, further limiting resources and access to care. This is just another way for the Republicans to kill the Medicaid Expansion under the Patient Protection and Affordable Care Act, which has been adopted by 41 of the states. (Kaiser Family Foundation.org, 2025) It appears healthcare has been brought to its knees by nine predominately southern outlier states.

Republicans who voted for the bill essentially are ripping off their own people. It is estimated that 700 hospitals, about a third of all rural facilities will close. Here is a statewide list of rural hospitals that have the most at risk because of the shortsightedness of the Trump Administration Medicaid cuts. (Data is current as of July 2025)

 In this analysis, several states had no hospitals at risk of closure because of the BBBA.

 (Center for Healthcare Quality and Payment Reform, 2025)

Stopping the approval and funding of the highly effective Rna vaccines, which were developed quickly and saved thousands of lives during the Covid Pandemic, which was of course, preceded by appointing the anti-vaxer, with no medical background, Robert Kennedy, Jr. as Secretary of Health & Human Services. (Manadivilli, 2025)

          Further restrictions on access to birth control, reproductive rights, and maternal and child health, with a patchwork of state laws since the Trump appointed-Catholic dominated-Originalistic-Supreme Court overturned Roe-v-Wade in 2022. Women forced to fly outside their state of domicile to obtain urgent medical care during pregnancy complications, even those which are life threatening. Doctors are refusing to provide care for fear of losing their medical license in Idaho, Texas, and other states.

      Eviscerating healthcare savings to taxpayers if the healthcare entity donated to the Trump Campaign; case in point, overriding the Centers for Medicare and Medicaid decision not to reimburse for some of the outrageously costly and no more effective skin coverings for diabetic wound care. Because some of these products come under the biologic rulings, they are considered a new treatment and are more-or-less allowed to charge whatever they want, because the Medicare rules stipulate reimbursement at 6% of whatever the medical device company charges. Diabetic foot ulcers represent 16% of the total Medicare population, but the cost just for the skin coverings is over 10 billion annually for taxpayers. (Pinder, 2025) The Medicaid payment system does need reform, but allowing lobbyists in the medical supply sector to decide that outcome is not in the best interest of the nation. Other countries assess both the efficacy and the price of a medical treatment, weighed against what is currently available, for potentially less money before approval of a treatment device or drug. The U.S. government and the workers who contribute payroll taxes to pay for Medicare and Medicaid programs are not obligated to provide profitability for medical device, pharmaceutical, or medical supply companies. If the United States wants to reduce the cost of Medicare, it must adopt the evidence-based-practice recommendations for the most clinically and financially practical applications. Everyone does not drive a Rolls Royce or a Rivian and the government should not be expected to supply medical devices or applications that are unaffordable. Having a market rate reimbursement system saps resources from other primary health care needs, and for treatments which already have adequate substitutes.

 This article was written by independent journalist, Roberta Winter who received no compensation and is not intended to provide medical advice. Except, when agreeing to medical treatments of an inpatient variety, do stipulate that for which you consent and which you decline. If you do not have a medical directive or a POLST, get one. And this is the healthpolicymaven signing off.

References

Center for Healthcare Quality and Payment Reform. (2025). Rural Hospitals At Risk of Closure. Center for Healthcare Quality and Payment Reform. Center for Healthcare Quality and Payment Reform.org. Retrieved August 7, 2025, from ruralhospitals.chqpr.org

Kaiser Family Foundation.org. (2025, May). https://www.kff.org/statedata/collection/measures-to-identify-states-at-greater-risk-if-federal-medicaid-spending-is-reduced/. Retrieved August 7, 2025, from https://www.kff.org/affordable-care-act/state-indicator/state-activity-around-expanding-medicaid-under-the-affordable-care-act/?currentTimeframe=0&selectedDistributions=status-of-medicaid-expansion-decision&sortModel=%7B%22colId%22:%22Location%22,%22sort%

Manadivilli, A. (2025, August 7). On Vaccines, Kennedy Has Broken Sharply With the Mainstream. The New York Times. Retrieved August 7, 2025, from On Vaccines, Kennedy Has Broken Sharply With the Mainstream

Mandavilli, A. (2025, June 24). Vaccine Panel Gutted By Kennedy-Loses Member Ahead of First Meeting. The New York Times. Retrieved August 7, 2025, from https://www.nytimes.com/2025/06/24/us/politics/rfk-jr-cdc-vaccine-panel.html

Mia Ives-Rublee, K. M. (2025, July 3). The Truth About the One Big Beautiful Bill Act’s Cuts to Medicaid and Medicare. Progress.org. Retrieved August 7, 2025, from https://www.americanprogress.org/article/the-truth-about-the-one-big-beautiful-bill-acts-cuts-to-medicaid-and-medicare/#:~:text=The%20bill%20will%20put%20rural%20hospitals%20at%20risk&text=Rural%20hospitals%20have%20some%20of,risk%20when%20rural%20hospita

Pinder, J. (2025, July 21). https://clearhealthcosts.com/blog/2025/07/in-turnaround-administration-proposes-limits-on-skin-substitute-industry/. Clear Cut Costs. Retrieved August 7, 2025, from https://clearhealthcosts.com/blog/2025/07/in-turnaround-administration-proposes-limits-on-skin-substitute-industry/

 

Wednesday, September 18, 2024

Results from Scientific Studies Are Not Synomymous With Actual Value In Healthcare Practices

 

Results from scientific inquiry do not necessarily create value in health care practices. Read this article to understand why and what we should be doing differently to build population health and economic value.

Scientific studies and clinical trials do not necessarily equate to actual value in clinical practices for patients and health systems. Scientific inquiry is of course necessary, as are clinical trials, but even if these avenues of inquiry demonstrate statistical significance and adequate patient safety, there are other factors that must be considered to create value for population health and for each practice and unique patient. The most important thing in research to improve our health is to ask the right questions. Currently, in scientific inquiry, once an investigation question is identified, it is called the hypothesis, and methods are chosen for controls, measures, and reporting of the data. A randomized control trial is held to the highest standard for this inquiry process, with excellent controls, attempts to eliminate bias, and recognized quality standards. Following this process, if the science finds merit to conduct a clinical trial on patients, this is the next step. This all sounds good, except scientific studies and clinical trials do not reflect real world variables in medical care. There is a field of study, called Real World Effectiveness (RWE) which has been under research for several decades, and there are now improved methods to assess actual effectiveness before a health system adopts a new intervention in health care and it has nothing to do with profits.  Briefly, here are the reasons the current study methods do not provide the information patients and health systems need to optimize efficacy of treatment. (Porzsolt, 2024) (Franz Porzsolt M. W., 2024) Efficacy means the efficiency and the treatment or evidentiary value of an intervention.

1.  Scientific findings of statistical significance are not synonymous with value in the real-world practice of medicine.

2.  Scientific studies do not necessarily include patient populations which are similar in a medical practice, because patients may have multiple co-morbidities, which may exclude them from study participation.

3. Clinical trials attempt to show actual treatment effectiveness, but there is also bias in the patient selection for clinical trials, because the drug company or medical device manufacturer want to show their product works. Thus, clinical trials cherry-pick patients who will conform to the methodology restrictions, and not include a lot of other issues such as health comorbidities.

4. Real world medical practices have many more variables than clinical trials. This is primarily due to the intimate relationship the clinician has with the patient and the customized approach he or she may use to meet the best treatment paradigm for her patients. This phenomenon makes it nearly impossible to make uniform strategies for all the risk profiles.

Thankfully, there is a method for identifying real world impacts of treatments, which would allow health systems and most importantly, the patient, to identify whether a drug, medical device, or procedure is worth it. Just like anything else which informs a decision, the individual weighs risks, potential benefits, proven reliability, and the cost. Unfortunately, unless you work in medical research, are a clinician, or some policy expert, you will not have this information to inform your treatment process.  In many healthcare systems today, the person has more information up front on the vehicle they purchase, then a health care intervention. This practice needs to change and I outline how RWE works and can be applied in real clinical settings here.

The Cochrane strategy, which is the international standard for the highest degree of efficacy in research includes these three questions: (Franz Porzsolt, 2024) The first question is called the principle of proof (POP)and means, can the intervention work. The second question is does the intervention work and what is the real-world effectiveness (RWE) through pragmatic (clinical trial) or observational study (used where clinical trial is not an appropriate study method). Further study will either demonstrate effectiveness or not. But the third question that needs to be asked is does this intervention demonstrate enough value given other treatments currently available. All too often this is swept aside so that the new drug or treatment will supplant existing more economical ones, because of monetary incentives. The third question needs to be applied to any patient health intervention so that the best use of resources for each patient is considered. Currently, in the United States this comes into play based on the type of insurance a person has, because everything is driven by reimbursement, and volume of care. Providing more expensive care to people who can afford it does not mean their outcomes are necessarily better, especially from a population health standpoint. Benefiting a few outliers does not mean large populations would necessarily benefit. The solution is to observe the actual outcomes of care in a medical practice, which is somewhat like the Centers of Medicare and Medicaid Innovation Grant Programs. Unfortunately, there is often a rush to bring a drug or medical device, or practice into approval and adoption before the actual patient effectiveness has been vetted. This results in wasted money and patient harm in many instances, because organizations feel pressured to show their idea works and to receive recognition and of course financial remuneration.

Finally, why do we care about further refinement of experimental results and treatments, because we can treat more people optimally for less money if we include the question, Is it worth it, in our final decision model before adoption of the treatment. This requires decisions to be made at a systemic level, in clinical practice, and as an informed patient.  Only by including the last question and comparing results will we learn what is actually the best treatment for various patient groups. People are not a one-size-fits-all and we should not be using science to justify treatments for some as appropriate for all.

And this is the healthpolicymaven signing off, encouraging you not to sign blanket release forms when you have medical procedures, do stipulate that for which you agree and for which you decline. Also, it is a good idea to get a POLST document in place with your health system, which states your wishes for interventional treatment to extend your life. And this is not the same as a medical power of attorney, whom you have chosen, but it alerts EMT's and others in the care continuum.

Roberta Winter is a freelance journalist who accepts no money from health care entities for this column. Opinions expressed here are her own. Her guidebook to the U.S. healthcare system was published by Rowman & Littlefield in 2013. https://rowman.com/ISBN/9781442222977/Unraveling-U.S.-Health-Care-A-Personal-Guide

References

Franz Porzsolt, M. P. (2024). The Front-End Processor Developed By Engineers-A Useful Tool for Describing the Quality and Quantity of Progress in Healthcare. Qeois-Open Peer Review, 1-19.

Franz Porzsolt, M. W. (2024). Applying the Rule of Designers and Architects "Form Follows Function (FFF) Can Reduce Misinterpretations and Methodical Shortcomings in Healthcare. Trends in General Medicine, 2(1), 1-7. Retrieved September 2024, 2024

Porzsolt, F. (2024). An Evidence-based Hypothesis: Doctors Do Not Make Decisions Randomly but Based on Individual Patient's Risk Profiles. Private Research Insitute of Economics (PRICE), Ulm, Germany, 1-11.

 

 

Thursday, June 3, 2021

Biden's Proposal for New Government Agency On Disease Specific Research is a Bad Idea and Here's Why

 President Biden’s 2021 discretionary budget request includes 6.5 billion for the creation of a separate government healthcare research agency, outside the purview of Health and Human Services. The agency, entitled Advanced Research Projects Agency-Health (ARPA-H) is modeled after the defense agency DARPA. This analysis reviews why this proposal is a bad idea for healthcare, public spending and for governmental oversight. Here are the criteria the Biden Administration outlined for ARPA-H:

1. Research funding would not be subject to the normal Health and Human Services Agency grant vetting process

 2. The focus would be on research that would not necessarily have a foreseeable payoff

 3.  Initial research would focus on three diseases Alzheimer’s, Diabetes, and Cancer

The creation of ARPA-H balloons federal spending for an unnecessary healthcare agency with no clear mandate and porous accountability, while competing for resources from existing healthcare research initiatives, which have been vetted. Healthcare research in the U.S. is still largely funded by Health and Human Services (HHS) through grant awards mostly to universities and nonprofit research groups. The annual medical research allocation for all government agencies was 39.5 billion in 2017. (Research America An Alliance For Discoveries in Health, 2018) In 1991, the U.S. funded 83% of all biomedical research in the nation and by 2017 U.S. investment in scientific research had fallen to less than half. (Mervis, 2017)  Though the U.S. has always been the global leader in medical research, China is catching up, as well as other nations. It could be argued that the world’s leading scientists chose to open their labs in other countries due to the Trump Administration’s arcane immigration policies. Our neighbor to the north, Canada is a beneficiary of this short-sited policy and Toronto is now a hotbed for medical research.

The ARPA-H agency creation proposal is not even supported by many leading scientists, which are concerned that a huge introduction of funding without clear guidance and controls would be harmful to healthcare research initiatives. (Winter L. , 2021)

Top Causes of Death in the United States

Further, the number one killer in the U.S. is heart disease, which is largely preventable through public health education and early intervention. (Kenneth D. Kochanek, n.d.) Though cancer deaths rank number two for overall mortality, respiratory disease is third, meaning Chronic Obstructive Pulmonary Disease, people who can’t breathe because of their disease etiology which is linked to environmental pollution and smoking. Efforts to reduce particulate pollution caused from diesel vehicles have been shown to improve population health outcomes for those with respiratory disease. Why not throw the 6.5 billion into research to clear the air of climate warming health harming pollutants? Accidental injuries are the fourth cause of death for adults, so prevention of accidents through public education and resourcing would seem to be a good public health investment. Fifth place on the-cause-of-mortality list is stroke and there have been innovative ideas from the Centers for Disease Control and Prevention, an HHS Agency to reduce harmful impacts of stroke, by rapid administration of tPA (tissue plasminogen activator) to prevent long term health impairment. Alzheimer’s is the sixth leading cause of death and Diabetes is seventh, however kidney or nephritis is eighth on the all-cause mortality list and it is closely linked to long term Type 1 Diabetes. Pneumonia is ninth and frequently occurs in patients who have been hospitalized and is not always preventable.

Suicide, ranks as the tenth leading cause of death in the U.S. According to the Center for Health Statistics suicide rates for America’s young people increased by 57% between 2007 and 2018, including children as young as ten. If that isn’t enough to wake you up, I don’t know what hole there is where your heart should be. Even children can’t stand to live in the United States of America. This factoid should be considered a public health crisis and scarcely receives a mention. All we hear about are corporate profits and how we can’t afford to provide healthcare or school lunches for everyone.

Creating competition versus cooperation for funding resources among healthcare agencies is not in the best interest of public health. The tired idea that competition makes everything better and lowers costs in healthcare is not true. The U.S. has the most expensive healthcare system in the world, with results that are no better than other countries and it spends 40% more than most other industrialized nations. Yet, the U.S. doesn’t even provide healthcare to all of its people, including children, whose distribution is immorally dependent on their parentage and birthplace. The current profit-taking healthcare climate has produced nonprofit hospitals making so much money they have their own venture capital funds. (Drucker, 2020) This capitalistic climate has occurred in part because of increased government funding through the Affordable Care Act in 2010 and due to hospital consolidation in this sector. Hospital closures do have an adverse impact on community health, but often book a positive outcome for the financial statements of huge hospital corporations. The pandemic hospital bailouts exposed how poor rural hospitals were not given funds but rich hospital corporations received billions. (Winter R. , 2020)

Creating Effective Healthcare Investment

All investments and interventions in national healthcare should ask these three questions:

1.  Is this necessary?

2. Who does it harm?

3. Should we be doing it?

An amorphous healthcare agency without the same rules for government oversite is not the answer to improving population health for ALL of the American people, who actually finance all government endeavors. Before we saddle our children with another government agency, let’s fund and improve the ones we already have which have demonstrated their value.

 And this is the healthpolicymaven signing off encouraging you not to sign blanket releases when undergoing medical procedures, do stipulate that for which you consent and which you decline. This column has been in continuous publication since 2007 and accepts no money from any healthcare entity. All research and opinions are those of Roberta Winter, an independent journalist and healthcare advocate. Her guidebook on the U.S. healthcare system was published by Rowman and Littlefield in 2013, which focused on state health rankings, disparities in care, and discerning quality at the consumer level. https://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972

 References

Drucker, J. (2020, June 8). Wealthiest HospitalsGet Billions in Payouts for Struggling Providers. The New York Times.

Kenneth D. Kochanek, M. J. (n.d.). Mortality in the United States, 2019. (N. C. Statistics, Editor) Retrieved June 2, 2021, from Centers for Disease Control and Prevention: https://www.cdc.gov/nchs/products/databriefs/db395.htm

Mervis, J. (2017, March 9). Data check: U.S. government share of basic research funding falls below 50%. Retrieved June 2, 2021, from National Science Foundation: https://www.sciencemag.org/news/2017/03/data-check-us-government-share-basic-research-funding-falls-below-50

Research America An Alliance For Discoveries in Health. (2018, October 1). US Investments in Medical and Health Research Development 2013-2017. Retrieved June 2, 2021, from Research America.org: https://www.researchamerica.org/sites/default/files/Policy_Advocacy/2013-2017InvestmentReportFall2018.pdf

Winter, L. (2021, April 12). President Biden Proposes Creating Two DARPA-like Agencies. Retrieved from The Scientist.com: https://www.the-scientist.com/news-opinion/president-biden-proposes-the-creation-of-two-darpa-like-agencies-68660

Winter, R. (2020, October 13). Unintended Consequences of Pandemic Hospital Bailouts May Hasten Their Demise. Retrieved from Straight Talk on Health Care: http://healthpolicymaven.blogspot.com/2020/10/unintended-consequences-of-pandemic.html

 

 

Saturday, August 6, 2016

Clinical Economics-Healthcare Study Design and Optimizing Public Health Benefits



Clinical Economics-Changing Our Thinking about Clinical Study Design to Gain the Most Benefit for Public Health Improvements

The healthcare community is inundated with scientific information about new studies, often proclaiming specious benefits for improved health outcomes and a dearth in studies which actually improve public health in a real world setting. Private review boards and investigations done to promote medications are not uncommon. This article reviews clinical economics, a new field for evaluating the real-world application and effectiveness of health care interventions, which is fundamental to delivering value for health systems and patients. Dr. Franz Peszolt, head of the Institute for Clinical Economics in Ulm, Germany, states, “Scientists tell us what they see and clinicians tell us what they hope to see in their practices from clinical and pragmatic trials.”[1] In research, the scientific study tests hypothesis to follow a new line of inquiry for potential benefits and the gold standard for these are randomized control trials or RCT’s. The next phase of inquiry is to determine if the findings under ideal controlled scientific conditions can be replicated in a pragmatic trial, which determines how the intervention works in a real-world clinical environment.  However, both of these studies lack patient input in terms of the actual value of the intervention, their likelihood to continue with the treatment after the study concludes, and the absolute value to the patient. Dr. Norman Hadler has discussed this phenomenon in his book(s) and he always encourages patients to ask their doctor about absolute values when a treatment or intervention is encouraged. In real terms, this means, asking questions such as, “In a patient population has this treatment been shown to extend life expectancy and if so, by how much?”[2] For example, for cancer patients, a scientific finding which extends life by a few months may be valid, but not enough to motivate the actual patient to undergo an expensive and painful treatment. Chemotherapy comes to mind, as it may extend patient life, but nausea and susceptibility to infections are the side effects. Thankfully, more patients are now receiving palliative care information for end-of-life treatment, which incorporates comfort and patient values into the care process. Palliative care is an example of a health treatment which has a high utility value in clinical economics.
Scientific Findings in Real World Deployment Must Produce Significant Results
Examining scientific findings and their application in real world situations for individual patients can be confusing, so let’s examine prostate cancer treatment and see how clinical economics applies to treatment protocols. Prostate cancer can be slow growing and nonfatal, but treatment protocols vary little for the disease, chemotherapy and surgical interventions are the norm. This flies in the face of scientific evidence and the side effects (impotence).  Patient fear is a driver in the decision to pursue this drastic treatment. Genomic Health has developed a new blood test, which can show the efficacy of a treatment for patients, based on their genomic profile. This has the potential to improve patient’s quality of life, because the decision to use chemotherapy or a new drug regime can be tailored to the patient profile.  A blood test developed by Epic Sciences Inc. can detect a mutation in the blood which shows a poor response to two new cancer drugs, Xtandi and Zytiga. This has the potential to be a game changer for health systems as it provides insight into treatment which can avoid costly treatments which don’t improve outcomes for some prostate cancer patients.[3] Applying clinical economics can avoid over treatment and target optimization of results per patient.  In other words, one-size-doesn’t-fit-all.
The Difference Between Efficacy and Effectiveness
Efficacy is meant to determine if the hypothesis for a medical intervention shows a statistically significant scientific difference, as demonstrated through the randomized control trial. Effectiveness is the real world trial of a product with actual patients, called a pragmatic trial and is meant to show clinical effectiveness, in other words, does it work. In the actual clinical setting, there are many more variables than in a randomized control trial, so this can confound the expected results or mute the clinical benefits for the patient population. Sometimes in the pragmatic trial, harmful effects of the treatment are so significant the trial is stopped.[4]  
Dr. Porzsolt and his collaborators have outlined problems with reconciling findings from both randomized control trials and pragmatic trials and some methods to assure consistency for the purposes of adoption of treatment and deployment in a population. For example, one of the problems that has occurred with the advent of independent review boards, which function as for profit companies, is the tendency to stop a trial too early if some positive result is found. This makes the results weaker, but may be lucrative for the company which is funding the research, the future patent holder, by gaining FDA and CMS approval earlier. Secondly, before deployment of a medical intervention in a real world patient setting, the actual results must show scientific and clinical effectiveness, which is also not always the case. In pragmatic trials, patients are allocated to groups based on their preferences, which is not the case in a randomized control trial, which would cause bias in an RCT, but is a real element of variance in clinical practice. There are still concerns in the clinical community about proving real world value of some scientific studies, which have not adhered to all standards for bias control, published results too early in the trial, or published results that were only valid in the scientific trial (RCT) and not the pragmatic clinical test. For example, cost-benefit analysis done in a randomized trial isn’t necessarily applicable for a clinical trial, where there are many more patient and environmental variables.
Concerns About Proof of Clinical Value from Scientific Studies
In the United States, where a lot of the health system expenditures are paid by private companies and individuals, there are inherent conflicts between a cost reduction in one sector, which reduces revenue impacting cash flows for another aspect of patient care in the same system.  Changing the reimbursement method for health care services could alieve some of this dissonance. If a patient is able to find a lower cost treatment which generates desired clinical outcomes, this should be applauded as a health system advancement, not discouraged because it reduces revenues. Currently, the Centers for Medicare and Medicaid has chosen to pay a patient management fee for patients with targeted complex care diagnosis, but most of the reimbursement is merely based on the cost of the service. However, CMS has just announced an initiative to pay physicians more for care coordination, planning, and primary care.[5] One of the ways we can gauge the value of scientific studies and their potential worth in a real-world setting is to conduct meta-analysis on studies which are similar or heterogeneous to the targeted clinical setting.
In any quest for wisdom, the first step is to understand the questions, and from that we can better discern how to gauge articles about clinical studies and their actual value for a patient group. For more information on this topic health care professionals and policymakers may wish to read the following journal articles:
Porsolt, Frans, Galito Rocha, Natalia, Toledo-Arruda, Alessandra, et, al, Efficacy and effectiveness trials have different goals, use different tools, and generate different messages. Pragmatic and Observational Research, Dove Press, November 4, 2015
Metge CJ. What comes after producing the evidence? The importance of external validity to translating science to practice. Clin Ther. 2011; 33(5):578–580
Jüni P, Altman DG, Egger M. Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ. 2001; 323:42–46
Ioannidis JP. How to make more published research true. PLoS Med. 2014; 11: e1001747. doi: 10.1371/journal.pmed.1001747
Weiss AP, Guidi J, Fava M. Closing the efficacy-effectiveness gap: translating both the what and the how from randomized controlled trials to clinical practice. J Clin Psychiatry. 2009; 70:446–449

And this is the healthpolicymaven signing off wishing you truly informed consent, feel free to share this article virally. The healthpolicymaven is a trademark of Roberta E. Winter and Praevalere Inc., a Washington Corporation. She is the author of Unraveling U.S. Healthcare-A Personal Guide, published by Rowman & Littlefield in 2013. https://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972





[1] Frans Porzsolt, Natália Galito Rocha,  Alessandra C Toledo-Arruda, et, al,
 Efficacy and effectiveness trials have different goals, use different tools, and generate different messages, Observational Research, Dove Press, November 4, 2015
[2] Nortin M. Hadler, MD, The Citizen Patient-Reforming Health Care for the Sake of the Patient, Not the System, The University of North Carolina Press, Chapel Hill, 2013
[3] Ron Winslow, Test Helps Prostate Cancer Treatment, Wall Street Journal, July 7, 2016