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Cardiovascular drugs - relationship of heart & Brain

10/2/2022

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by Rose Rohloff
There are many classifications of drugs used for cardiac and vascular (CV) issues. A 2007 report Neuropsychiatric Consequences of Cardiovascular Medications, by Dr. Jeff C. Huffman* is cited below, with his overviews by drug classification.  
The full article can be read with this link.
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"The use of cardiovascular medications can have a variety of neuropsychiatric consequences."  Therefore, the following highlights are good review for anyone prescribed a CV drug, especially for the elderly, those with other conditions such as liver or kidney insufficiency, and/or also being prescribed psychiatric medications.  

Angiotensin-converting enzyme inhibitors

"Bottom line: ACE inhibitors and angiotensin II receptor antagonists are associated with low rates of neuropsychiatrie side effects, though mood symptoms, psychosis, and delirium have been reported."

Beta-adrenergic blocking agents or Beta (β)-Blockers

"​Bottom line: β-Blockers as a class are not clearly associated with depression; there is the most evidence for a propranolol-depression link, but even this relationship is equivocal. In contrast, β-blockers are associated with increased rates of fatigue."

Calcium channel blockers (CCBs)

​"Bottom line: CCBs may be associated with fatigue in some patients, but otherwise cause few neuropsychiatrie symptoms."

Diuretics

"Bottom line: Diuretics most often cause neuropsychiatrie symptoms indirectly, through electrolyte abnormalities (thiazides) or vitamin deficiencies (loop diuretics). Acetazolamide is associated with fatigue and with delirium in renal failure." 

Doctors should always monitor electrolyte levels (sodium/Na and potassium/K+) of their patients taking diuretics.

Centrally acting agents - ​Antiadrenergic agent

"Bottom line: Clonidine is consistently associated with fatigue and sedation; delirium is infrequently associated with its use. (Clonidine) is also commonly used to reduce symptoms of opiate withdrawal.
​

Bottom line: Methyldopa is clearly associated with fatigue and sedation. In contrast to early studies linking methyldopa with depression, later reviews and studies have found this association to be relatively weak. Other neuropsychiatrie symptoms are uncommon.

Bottom line: Reserpine is associated with both sedation and daytime fatigue. Incidence of depression may be elevated among patients taking reserpine. However, other (generally more recent) reports question this association."

​α-Adrenergic agents

"Bottom line: Fatigue is the most common neuropsychiatrie side effect associated with -adrenergic antagonists; other neuropsychiatrie side effects are infrequent."

Vasodialtors

"Bottom line: Vasodilators are generally associated with low rates of neuropsychiatrie consequences. Hydralazine is a leading cause of drug-induced lupus, but this syndrome affects the central nervous system much less commonly than the idiopathic form of the disorder."

Antiarrhythmic medications

"Bottom line: Most Class I Antiarrthymic agents have been associated with psychosis and delirium in case reports. The syndrome of cinchonism associated with quinidine may include sensory changes along with delirium, and procainamide is a cause of drug-induced lupus.

Bottom line: Class III Amiodarone is associated with thyroid abnormalities in 15% of patients, and untreated thyroid dysregulation can lead to a variety of mood, cognitive, and psychotic symptoms. In contrast, direct neuropsychiatrie effects of amiodarone are uncommon.

Bottom line: Digoxin is associated with delirium and other cognitive effects, especially in toxicity. Visual changes and hallucinations may also occur with digoxin use, even at normal serum levels."

Conclusion by Author

"... numerous cardiovascular medications can have neuropsychiatrie side effects, ranging from mood symptoms to cognitive effects to psychosis, and though a given agent may not consistently cause neuropsychiatrie symptoms in the general population, idiosyncratic reactions are possible." More specific studies are needed for, "clinicians ... to make fully-informed prescribing decisions for their patients."

Patients and their families know the cognitive baseline of individuals being prescribed medications, and therefore, should always monitor for any neuropsych impact seen if CV drugs are used, on an individual basis for what is safe per person. Any and all side effects should be know, along with contradictions to other drugs, for all medication being taken. 
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* Dr Huffman is a professor of psychiatry at Harvard Medical School and the director of the Cardiac Psychiatry Research Program in the Massachusetts General Hospital (MGH) Division of Psychiatry and Medicine. He also serves as the associate chief for clinical services in the Department of Psychiatry at MGH.

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Vanco awareness

9/24/2022

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What should you be aware of regarding Vancomycin?

by Rose Rohloff
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​Vancomycin (Vanco) is an antibiotic, in the classification of Glycopeptide used for gram (+) bacteria, typically used for: 
Methicillin Resistant Staphylococcus Aureus (MRSA); Clostridium Difficile (commonly called C-diff), a potentially deadly infectious 
proliferation of the intestines (often after antibiotic use); and some hospitals are using as the standard protocol for elderly in the emergency room, for asymptomatic pneumonia, and other infections.

​
​Clinicians (nurses, doctors, physician assistants, etc.) are supposed to do comprehensive history and physicals (H&Ps) before using any drugs or treatments. And, it is important to know underlying conditions before using Vanco, because it can raise glucose levels, especially in diabetics, and/or cause kidney (renal) insufficiency, especially in elderly. 
The following use case is regarding an admitted primary care doctor as the patient.
"I don't know what the average "lay person" does when they don't have all this information, and without a medical person to look out for them."
"This article is 
exactly why they stopped Vanco when he had his MRSA infection. His kidneys were starting to get compromised, so they immediately stopped it and started him on a different antibiotic, Daptomycin, which worked just as well and had less side effects for his kidneys and diabetes. Thankfully they caught it very early because of the blood tests they were doing to see what was happening. The new antibiotic was infused only once a day as opposed to twice a day Vanco, and there weren't all the extra blood draws to make sure the kidneys and glucose were doing okay. God is really in control and watching out for us, because the medical field doesn't always do that, even with a fellow medical person."

Vanco and high glucose/hyperglycemia

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Vanco and kidney (renal) failure

Changes in vancomycin use in renal failure Stefaan J Vandecasteele 1, An S De Vriese pub in 2010
Abstract A progressive increase in vancomycin resistance with consequent treatment failure has been observed in staphylococci. Therefore, new dosing guidelines advocating much higher vancomycin doses have been issued. Target trough levels of 15-20 microg/ml are proposed. Whether and how these targets can be achieved in patients with chronic kidney disease or those on dialysis are still under evaluation. The higher vancomycin doses to achieve these treatment targets carry a substantial risk for nephrotoxicity. This risk is incremental with higher trough levels and longer duration of vancomycin use. Critically ill patients, patients receiving concomitant nephrotoxic agents, and patients with already compromised renal function are particularly at risk for vancomycin-induced nephrotoxicity.
Elderly patients are more prone to vancomycin toxicity with IV administration due to age-related changes in renal function, the volume of distribution, and accumulation. These patients need to be carefully monitored and require a more conservative dosage regimen. NIH 2022

Acute kidney injury during daptomycin versus vancomycin treatment in cardiovascular critically ill

Conclusions: Daptomycin appears to be safer than vancomycin in terms of AKI risk in ICU patients treated for cardiovascular procedure-related infection. Daptomycin could be considered as a first line treatment to prevent AKI in high-risk patients. NIH 2019
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1974 National research act - Why you should know

9/24/2022

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by Rose Rohloff

​On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects
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​The 1974 Research Act was created in entirety from the Belmont report, and put into place to prevent the Government, it agencies or representatives, military and private companies, from violating an individual's freedom: by forcing, tricking or coercing persons for research, testing and administration of unknown injections/materials, and experimental procedures. This law was enacted after a century long track record of precedence including, and not limited to, the following:
  • Dichlorodiphenyltrichloroethane (DDT) wide use (1940s-1972);
  • Nuremberg War Tribunals (1947);
  • Thalidomide with massive birth defects (1950s-60s) which led to the Kefauver Amendment (1962) "... to the Food, Drugs, and Cosmetic Act, also known as the Drug Efficacy Amendments of 1962, was signed by President John F. Kennedy and requires that all new drug applications demonstrate substantial evidence of the drug’s efficacy for the marketed indication, in addition to the existing requirement of demonstrating the drug’s safety ... In addition, the Amendment required drug advertising to disclose accurate information about side effects and efficacy of treatments.;
  • Lysergic Acid Diethylamide (LSD) experiments (1950s-60s);
  • the Radiation experiments (injection of radioactive elements, including polonium, plutonium, and uranium, into civilian patients around the country, (April 1945 and July 1947);
  • Tuskegee Syphilis Experiment (1930s-70s);
  • Declaration of Helsinki in 1964 (updated 2000) built upon the Nuremberg code as the basis for Good Clinical Practices;
  • Chester M. Southam, MD, a noted immunologist at Sloan-Kettering Institute, obtained funding from the government and injected live cancer cells into 14 patients with advanced cancer and into healthy convicts at Ohio State Prison, and injected live cancer cells into 22 elderly patients at Jewish Chronic Disease Hospital in Brooklyn (1954-1963) “Every human being has an inalienable right to determine what shall be done with his own body. These patients then had a right to know the contents of the syringe: and if this knowledge was to cause fear and anxiety or make them frightened, they had a right to be fearful and frightened and thus say NO to the experiment. (Oxford Textbook of Clinical Research Ethics, 2008)”
  • Operation Crimson Mist, Rwanda (1994) electromagnetic augmentation (5G)
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The law may not be negated, overwritten, or manipulated to force participation in experiments - by the government, employers,  or companies, especially pharmaceutical companies - for whom the law was written to protect us; especially by labeling Emergency Use (EU). EU is  for emergency circumstances with Informed Consent as part of Right to Try, if there are no other options for a patient.  EU cannot supersede or try to negate the law especially regarding being fully informed with the Right To Say No - and the Right to Try alternative treatments. ​
the_belmont_report_hhs.gov.pdf
File Size: 259 kb
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Demonstrated lack of Respect for Persons and their protections in violation of 1974 law.
1- Autonomous agents, individuals capable of deliberation about personal goals and of acting under the direction of such deliberation. The Government and companies have to give weight to autonomous persons' considered opinions and choices, and cannot obstruct their actions and judgments, nor deny individual freedom to act on considered judgments, and cannot withhold information necessary to make a considered judgment. Necessary information includes - but not limited to - all medical opinions by established, industry experts, health status, the necessary assessments, labs, with close monitoring of physical lab and test follow ups of each and every autonomous persons as part of clinical research and testing, along with full documentation of testing, efficacy, use of chimera for research and testing, any and all conceivable side effects, and interactions of conditions.​
COVID-19 clinical protocols
Nov 2020
Phase I not completed until after 2022
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Nov 2020 Protocols
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2- persons with diminished autonomy are entitled to added protections.
Violators to the law have been marketing to the most vulnerable, including the immature and the incapacitated who were in need of extra, added protections, even to the point of excluding them from any injections or procedures which may harm them; violating added safety precautions for children, elderly, or those with diminished capacity. 

Informed consent - must include full disclosure of ALL contents to be injected, any and ALL possible side effects (which can be several pages long), how those persons are individually to be closely monitored, safety guidelines, and above all the right to say no before or at any time, and full reporting of all individuals regarding their safety monitoring/labs/assessments, and any and all side effects. By promoting COVID shots all still under clinical trial/research, and coercing with careers/jobs, inability to travel, etc. in order to take the shots, this law is being violated through: lack of informed consent, lack of protections of autonomous persons, and/or illegally acting as IRSB board members marketing to those not autonomous and capable of self-determination, with higher standards of protection to be invoked, and assuming the role for their safety.

The maxim "do no harm" has long been a fundamental principle of medical ethics. Claude Bernard extended it to the realm of research, saying that one should not injure one person regardless of the benefits that might come to others. 

An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence. 

Undue influence also includes offers of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable as in the case of targeting children, persons with limited capacity, and elderly with elements of mental defect, or instilling fear.

Short term morbidity and mortality cases from the shots are well reported and known, such as death, myocarditis along with spontaneous cardiac arrest with no warning, debilitating neurological conditions, etc. And, there is no means yet to determine mid and long term effects because Phase I trials have not been competed, let alone Phase II and III - which is vital information in order to determine informed consent.

Injustice has been performed with companies and government representatives, by involving vulnerable subjects, including the young, those unable to fully comprehend with all necessary information, and scaring parents with compromised capacity for free consent. In addition to lack of individual, tightly scheduled, continual monitoring and follow ups, autopsies of all persons involved in this trial participation should be conducted for reporting by the pharmaceuticals companies for any and all persons who received the shots, as well as labs determining efficacy and detriments (as examples, antigen creation, D-dimer, Pulse Cardiac and Troponin Tests) for all those who were coerced or unduly influenced to participate in research. 

This law was created to protect people from government abuse through experimentation. The government cannot arbitrarily dismiss components, create resolutions or stipulations to supersede the law, as to invalidate its protection of individuals from them, including, but not limited to Health and Human Services (HHS) Center for Disease Control (CDC), Food and Drug Administration (FDA), National Institute for Health (NIH), etc. and pharmaceutical companies, etc.  

Persons have been illegally acting as members of, or bypassing, IRSB safety review and monitoring of each and every person receiving injections, with open undue influence and coercion, to participate in Covid injections. Coercion has been especially directed to the diminished autonomous, children and elderly, through TV ads, library recordings, verbal encouragement, schools or other public venues acting as government agents, and/or clinical researcher recruiting participants, and/or illegally as untrained IRSB member who is not following up to ensure safety of the people they recruited, coerced or used undue influence.

Overall lack of informed consent has become too often common practice across the healthcare industry, including people being given consent forms hours or minutes prior to surgery; no alternative treatments or lifestyle-nutrition changes prior to medications begin prescribed, and undue influence to intubate or perform surgery on patients in lieu of alternative treatments.​
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What is a normal temp? Expounding on a WSJ Article

1/24/2020

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by Rose Rohloff
Championing care: knowing your individual baselines, understanding trending deviations, influencing factors.

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A Wall Street Journal (WSJ) article https://lnkd.in/e9awgQT 1/24/2020 posted wrote: 
     
"Nearly 150 years ago, a German physician analyzed a million temperatures from 25,000 patients and concluded that normal human body temperature is 98.6 degrees Fahrenheit. That standard has been published in numerous medical texts and helped generations of parents judge the gravity of a child’s illness. But at least two dozen modern studies have concluded the number is too high. Or was it?

​In a new study, researchers from Stanford University argue that Wunderlich’s number was correct at the time but is no longer accurate because the human body has changed. Today, they say, the average normal human-body temperature is closer to 97.5 degrees Fahrenheit."
Championing your own health is about understanding your healthy baselines. Just as individuals have a variable "healthy" baseline for their blood pressure and heart rate, why would an individual not have an individualized, normal baseline for their temperature? And, temperatures are now measured using different methods:
forehead-ear-mouth-rectal, producing deviations based upon how the temperature is obtained. It is important to understand, compare what mechanism was used to take the temperature.

Is your normal 98 degrees, while another may run 97 degrees? Is the person normally running 97 degrees now have a temp of 99 along with malaise, dehydration because they are fighting a virus or bacteria? Assessment/vital sign numbers provide more information for clinicians (Doctor, PA, Nurse, etc.) when provided in context of associations, trends, baselines and influencing factors.  ​
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Population Health: has the focus on big data, populations & large systems caused the loss of individuals?

5/29/2018

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by Rose Rohloff
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​A Memorial Day quote yesterday regarding veterans also exemplifies much of what has happened in healthcare over the last 10 years, regarding the focus on Population Health, meaningful use reporting, value based analysis, big data analytics-claims data, and mergers of health systems with large EMRs, with focus on reporting.
“We are arguing over a statistical analysis. This is the challenge that we face in society today ,,, we are quantifying numbers because it’s easy to look at a number, and it’s not easy to look at the value of a human life. I would say to you today that (losing) one a day, one a year is too many.”
                                 Kyle Reyes, CEO, The Silent Partner Marketing
When the primary focus is on data (the multiple of numbers/records-statistics), singular records and numbers or outliers are not worth the time and effort of analysts and executives. And yet, they should be as each record is a real patient, a friend, a loved one. 
The solution is bringing analysis down to the most base level of management with front line analysis, to coincide with first-hand observation, the voice of the patient & their caregivers/champions, and reducing the ever growing administrative overhead. Bigger is not better for addressing health and care of populations, when the focus is shifted upward with large systems where individuals are lost: Especially when the individual issues are indicative of the core problems that need to be addressed for quality care delivery.
The need for P&P Reviews
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NARC Party - opioid crisis and Surgeon General advisory

4/7/2018

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by Rose Rohloff
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Naloxone is an emergency medication; it is temporary and doesn't stop or eliminate opioid abuse, addiction.

This week, reports were released in the media that 
US homes need Narcan to aid in opioid overdose epidemic, surgeon general advises​

Dr. Delos Marshall "Toby" Cosgrove, the previous CEO of Cleveland Clinic, spoke to a room of healthcare leaders from across the country about the Opioid Crisis in April 2017. The discussion centered around the abuse of taking prescribed medications - legally and illegally - with the current trend of NARC Parties. He explained that NARC Parties entail the supply of Naloxone (the common brand name is Narcan, used by hospital-emergency personnel as the medication to temporarily counteract a narcotic or heroine overdose.) He continued that having Naloxone allowed people to overdose, the person(s) were then given Narcan in order to continue partying.

The general public needs to be aware: Naloxone has been reported to foster increased abuse of drugs by allowing revival of overdosing for continuing to take more drugs. Naloxone is the generic of Narcan. Just as EpiPen is only the delivery system and not the generic drug Epinephrine, It is important to know the difference between the brand name versus the generic drug name.  

The danger of advising the untrained public to distribute emergency medicine

"A serious problem is many doctors and many more nurses are unaware of the different mode of metabolism of Fentanyl and Methadone. With various dosages of Fentanyl and Heroin or combinations of other opioids, the efficacy of Naloxone or Naltrexone is compromised. The general public (let alone many new doctors and nurses) do not have a working understanding of the differences in these competitive antagonists." "There may not be any impact for at least 30 minutes with a basic spray." 45 year RN, BSN, NP, MSN, Committee Member Opioid Crisis, Board of Directors Health Facility

Many clinicians, let alone the general public, are not specifically trained in the proper dosage and treatment with Naloxone for the various forms and dosages of opioids and heroin. 
FDA Advisory Committee on the Most Appropriate Dose or Doses of Naloxone to Reverse the Effects of Life-threatening Opioid Overdose ... Sept 2016
"The effectiveness of naloxone, and thus the exposure required, will depend on the opioid dose, the potency of the opioid in binding receptors, the lipophilicity of the opioid in crossing into the CNS system and the elimination half-life of the opioid, together with patient factors (7, 26). Appendix [2] and [2a] includes further information on naloxone pharmacology. The complex pharmacology of appropriate dosing is further compounded as often the fentanyl involved is illicitly manufactured without normal procedures or controls and may be introduced surreptitiously into heroin or prescription painkillers. Reports from the field confirm the need for additional naloxone doses to reverse opioid overdoses including those involving more potent fast onset synthetic opioids."

Narcan (Naloxone HCL) Use in Opiod Overdose: A Perspective

4/10/2018
An important point for the general public who is not used to or trained in emergency medicine, this “rescue” drug is only the first step in the opioid crisis ... not the end all and be all of treatment. I would like to respond to this “advisory report” from the Surgeon General as a pharmacist, an Emeritus Professor, Pharmacy Practice from a College of Pharmacy, former President/Chair of the Michigan Pharmacist Association (MPA) and Fellow of this Association; and lastly as a chronic pain patient.

I have used opioids now for chronic pain management after a car accident almost twenty-years ago. I will admit, I was taken aback by my family physician about a month ago being given a prescription for Narcan (generic name Naloxone) as a “precautionary measure” for my chronic opioid use.  The form I was prescribed is a nasal formulation vs. the oral/injection form. When I took it to a pharmacy to be filled, I had to undergo “special counseling” by a pharmacist (even with my credentials) which consisted of a video on proper use and a warning that after use, 911 had to be called and I was to be taken to the emergency room for follow-up. This is the proper follow-up when someone is prescribed any rescue medication for a drug reaction. The Naloxone is only to be given when a known opioid (i.e. codeine and it’s derivatives; Fentanyl, Meperidine, etc...) is given or taken in life-threatening incidences. I was instructed, "Were you aware that Naloxone has two elimination half-lives because this drug has an active metabolite; and, were you aware that Naloxone and Naltrexone are different agents, but are easily confused."

I believe giving someone this agent for overdose situations is giving a false sense of security that nothing else needs to be done. Nasal Naloxone is like putting a bandage on a cut artery.  You may stop the blood flow at the moment, but the wound will continue to bleed if the wound isn’t sutured properly.  Without appropriate emergency room follow up of an opioid overdose the person may die from that overdose.

Many opioids vary in dose, strength, predictability and most of all drug half-life. Knowing the half-life of drugs is essential to know how long the drug is going to last in your body. Drug half-life’s, drug absorption, distribution and elimination is well covered in Colleges of Pharmacy in courses such as pharmacology, pharmacokinetics and pharmacotherapeutics. Pharmacists do not know the pharmacokinetics on every drug substance out there by memory, and we are called the drug experts. Physicians do not have nearly as much education on medications as pharmacists, yet they are the first line of treating drug overdoses in emergency situations along with the nurses, Physician Assistants and Nurse Practitioners.

The general public is being provided a false sense of security by the media to carry this drug in their homes to address the opioid crisis. The public needs to be AWARE there is more to treating an opioid overdose than just squirting this agent up their nose. 

Joan M. Rider-Becker, BS, PharmD, FMPA
Retired, Emeritus Professor, Pharmacy Practice Ferris State University College of Pharmacy
Education/Training
B.S. Pharmacy-Ferris State University College of Pharmacy-1987
Pharmacy Practice Residency-Bronson Hospital Kalamazoo, MI-1987-1988
Doctor of Pharmacy (PharmD), University of Michigan-College of Pharmacy Ann Arbor, MI 1990
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5 thoughts on healthcare consumerism, interview with Rose Rohloff by Morgan Haefner, Becker's hospital review

9/2/2016

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A research letter published in JAMA Internal Medicine claimed patient satisfaction-based ratings are associated with patient outcomes, but a recently released study from Quantros disagreed, saying the letter's findings are misleading and may lead patients toward poor clinical outcomes.
​

Ms. Rohloff, a 35-year healthcare veteran with experience in nursing, business and information systems, spoke with Becker's Hospital Review about providing consumers with more detailed evaluation of quality care delivery. [read more]
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We love M&Ms, now it is time for P&Ps

5/27/2016

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The healthcare industry has used perioperative morbidity and mortality reviews (M&Ms) for blunt evaluations, to continuously improve the understanding of and performance in surgical intervention. Since the industry touts Population Health and Patient Engagement as top initiatives, health systems can use the successful process of M&Ms to perform Population Health and Patient Engagement reviews (P&Ps) of individual cases, for ensuring quality care processes. [read more]
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