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Celebrating 50 Years of PAs This PA Week

PAs have been moving healthcare forward since 1967, and that’s definitely something worth celebrating.

Each year, from October 6th through the 12th, Physician Assistants are recognized for their critical contributions to our nation’s healthcare, during what the American Academy of Physician Assistants has dubbed National PA Week. And this year’s PA Week is extra special, as it’s the 50th anniversary of the profession.

Since 1967, PAs have fought to move healthcare forward by increasing access and improving health outcomes for scores of Americans. 50 years later, they are the face of the future of healthcare. Seeing 70+ patients per week, on average, and filling gaps in care in rural areas—and, mind you, that’s all while fighting for full practice authority and constantly reminding people they’re Physician Assistants, not Physician’s Assistants—the need for PAs is glaringly obvious, and it just keeps growing—an expected growth of 30% from 2014 to 2024.

Trusted, essential, and ready for anything—we salute you, PAs, and hope you have a fabulous week celebrating all you have accomplished. It is truly something of which to be proud.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Do Pharma’s Claims On Drug Prices Pass The Smell Test? We Found 5 Stinkers.

The pharmaceutical industry fears major legislation that would curb prices and shrink profits, and has launched campaigns against it—but how honest are their claims?

By Jay Hancock

Drug companies launched an ad and publicity extravaganza this year right after President-elect Donald Trump said they “are getting away with murder” on sky-high pill prices.

More than it has in years, the pharmaceutical industry fears major legislation that would curb prices and shrink profits. TV spots lauding drug companies, quoting poet Dylan Thomas and showing heroic scientists have been hard to escape.

But the narrative from the Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group, is only the rosiest, most self-serving version of the tale, say critics, and numerous independent authorities question its assertions.

They say the campaign is misleading in these five ways:

1. Lowballing drugs’ cost to society.

For years, PhRMA said retail prescription drugs account for only 10 percent of America’s enormous health care bill. Lately, the group has been using a figure of 14 percent, counting chemotherapy and other drugs delivered in hospitals and doctor offices.

Both numbers downplay the expense of prescription meds. Arriving at the industry’s estimates requires lumping drug costs in with billions in public health spending, such as checking water and animals for pathogens, as well as nursing home care and other categories only loosely connected to the day-to-day job of healing the sick.

Retail drugs alone were 21 percent of the cost in 2014 for employer-sponsored health plans, often exceeding costs for inpatient hospital treatment. Add chemotherapy and other non-pharmacy drugs, and the portion is higher.

At CareFirst, a BlueCross BlueShield plan with members in Maryland, Virginia and the District of Columbia, total drug costs when chemotherapy and other hospital-administered medicines were added became a thumping 34 percent of the expense in the first half of 2017, says CEO Chet Burrell. By contrast, inpatient care, traditionally the most expensive health service, is about 20 percent of CareFirst’s costs.

“That tells you about the power of what’s going on with the drug prices and the degree of use of the drugs,” Burrell said.

2. Exaggerating drug development costs.

Inventing, testing and launching a drug costs $2.6 billion, calculates the Tufts Center for the Study of Drug Development. The industry substantially finances the center’s work, leading many to question its credibility. Drug companies use its conclusions to justify high prices and cite this figure at every turn.

Outside authorities criticize the research, saying it comes from untestable data, ignores enormous tax subsidies that reduce costs and inflates results with imaginary expenses, such as profits that could have been earned if drug companies invested research dollars elsewhere.

“These estimates are all based on secret, unverifiable numbers of unknown reliability from unknown companies about unnamed drugs,” said Donald Light, a health policy professor at Rowan University in New Jersey.

The Tufts results line up with publicly available data, counters Joseph DiMasi, economic analysis director for the Tufts Center. “If anything, they suggest our estimates are conservative,” he said.

But an independent study published in September using public filings found the median cost of developing 10 cancer drugs was $648 million, while the median revenue per drug was $1.7 billion.

Light and other critics especially object to counting, as part of development costs, the theoretical profit firms might have earned if they put research money into something other than inventing drugs — such as buying extra ads for existing products. That adds more than $1 billion to the supposed cost.

What settles the argument is drugmakers’ audited financial statements, which show that costs of all kinds are far below what they collect in revenue. Ten of the top publicly traded U.S. drug companies earned profits of $83.6 billion last year on revenue of $306 billion, regulatory filings show. That’s a 27 percent pretax profit margin — accomplished even after spending billions on TV ads and salespeople.

3. Cheering too loudly about a slowdown in drug costs.

Fueled partly by hepatitis C medicine costing as much as $1,000 a pill, retail prescription drug spending soared by 12 percent in 2014 and another 9 percent in 2015, according to government data. That was the biggest two-year increase in a decade.

So it’s no surprise growth is reverting to the mean now that there are fewer new blockbusters. Government figures aren’t in yet for 2016. But QuintilesIMS, which tracks wholesaler sales, says drug spending grew 4.8 percent last year.

“The slowest rate in years,” brags PhRMA, quoting a magazine. Actually, drug-spending growth was even lower from 2010 to 2013 before roaring back.

In any case, 4.8 percent is still twice the inflation rate for 2016 and greater than economic growth, which determines what the country can afford over the long term.

New drugs arriving to market, often involving living cells and gene therapy, look more expensive than ever. The announced cost for Novartis’ Kymriah therapy for kids with leukemia is $475,000 for a one-time treatment.

Drug companies seem to show concern about high prices only when there’s a danger Congress might do something about them. In January, AbbVie loudly promised to keep price increases under 10 percent this year. Now that political pressure has subsided, company executives said recently they have more “flexibility” to revert “to double-digit increases in 2018 and beyond,” according to a Sept. 22 report from Leerink, an investment research firm.

AbbVie subsequently said Leerink “incorrectly characterized” the remarks. The drugmaker promised to make “one, single-digit price increase” for 2018.

4. Exaggerating the role of generics.

“Nearly 90 percent of all medicines dispensed in the United States are generics,” says PhRMA, trying to argue drugs are cheap.

The group doesn’t mention that brand-name medicines are responsible for 74 percent of prescription costs and that drugmakers do everything in their legal power to keep pills from going generic after patents expire.

“PhRMA has fought for years to keep generics off the market,” said Robin Feldman, a law professor who researched the subject for a book, “Drug Wars,” published in June, which she co-authored. “The brunt of the pain of that is felt by U.S. citizens,” who pay more for medicine than anybody in the world, she said.

Industry tactics have included paying makers of generics not to make pills; filing dubious petitions opposing generics that cause months of delay; withholding samples that generics companies need to launch their own pills; and changing dosages or delivery mechanisms in tiny ways to get a new patent, Feldman said.

5. Exaggerating benefits from new drugs.

“Since 2000, biopharmaceutical companies have brought more than 500 new medicines to U.S. patients, resulting in significant progress against some of the most costly and challenging diseases,” says one of PhRMA’s promotions.

Rather than being breakthroughs, however, too many new drugs are “me-too” substances based on previous research, critics say. Many aren’t demonstrably better than cheaper, already available drugs yet get heavily promoted through expensive ads and salespeople.

Bernard Munos worked for years at Eli Lilly and now is a consultant and sits on the board of several small, drug-related companies. He credits the industry with creating drugs that “are superb and make a difference,” such as Gleevec, Novartis’ blood-cancer drug.

But there are not nearly enough of them, he says.

“One of the challenges of the industry is that, despite all of its efforts, it has not been successful in producing more of the really transformative drugs,” he said. “Mediocre drugs are starting to price themselves at almost the same level as the really innovative drugs. And this is a market failure.”

This story was produced by Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Feds Pay $8M+ to Promote ‘Diversity’ in STEM

The National Science Foundation recently issued 27 new grants totaling more than $8 million to promote “diversity and inclusion” in STEM fields.

from Campus Reform

The National Science Foundation has recently announced the launch of 27 new “diversity and inclusion” projects funded through grants of roughly $300,000 each through its NSF INCLUDES program, which seeks to develop STEM talent “from all sectors and groups in our society.”

Read More →

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

6 Bits of Inspiration from Ascend 2017

Here are a few key takeaways from this year’s Ascend conference, which therapy professionals can put into action whether or not they attended this past weekend.

from WebPT

The overarching theme of Ascend 2017—the fourth-annual installment of rehab therapy’s premier business summit—was, quite simply, “Think big.” But, based on what we learned from our esteemed group of speakers over the course of two inspiration-filled days in Washington, DC, a more accurate tagline for this year’s conference might have been, “Think differently.”

Read More →

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Happy National Physical Therapy Month!

October is the time to recognize the impact PTs and PTAs have on their patients’ lives and in their communities.

October is National Physical Therapy Month, as it has been dubbed by the American Physical Therapy Association, and the month serves as a time to recognize the impact PTs and PTAs have on their patients’ lives and in their communities.

One way to celebrate is by participating in the Global PT Day of Service on October 14th. Founded two years ago by a team of passionate PTs, PTDOS has seen over 8,000 PT and PTA volunteers make a difference across 42 countries around the globe. PTDOS encourages PTs and PTAs to give back to their communities by working in a pro bono physical therapy clinic, serving in a soup kitchen, cleaning up a community garden, or via any other means that contributes to the greater good.

PTs and PTAs, will you take the pledge to give back this year? If so, click here to pledge to serve.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

5 Takeaways From Congress’ Failure To Extend Funding For Children’s Coverage

Congress finally seems ready to take action on the Children’s Health Insurance Program after funding lapsed Sept. 30.

By Phil Galewitz

Congress finally seems ready to take action on the Children’s Health Insurance Program after funding lapsed Sept. 30.

Before the deadline, lawmakers were busy grappling with the failed repeal of the Affordable Care Act.

CHIP covers 9 million children nationwide. But until Congress renews CHIP, states are cut off from additional federal funding that helps lower- and middle-income families.

CHIP, which has enjoyed broad bipartisan support, helps lower- and middle-income families that otherwise earn too much to be eligible for Medicaid. Besides children, it covers 370,000 pregnant women a year. Like Medicaid, CHIP is traditionally paid for with state and federal funds, but the federal government covers most of the cost.

Though current authorization for spending has expired, states can use some of their unspent federal CHIP money. Still, several states are expected to run out of money before the end of 2017, and most of the rest will run out by next summer. CHIP has been in this fix only one other time since it was established in 1997. In 2007, CHIP went weeks without funding authorization from Congress.

Here’s a quick look at what may lie ahead for the program.

1. Will children lose coverage because Congress missed the deadline?

They could eventually, but not immediately. A few states facing the most immediate threat — including California and Arizona — have enough funding to last only until the end of the year.

No states have yet announced plans to freeze enrollment or alert families about any potential end in coverage. But if Congress fails to renew funding quickly, some states may begin taking steps to unwind the program in the next few weeks.

2. What are states doing in reaction to Congress missing the deadline?

Most states are doing little except reaching into their unspent federal funds.

However, Minnesota was among those most imperiled because it had spent all its funds. State officials said Tuesday that the federal Centers for Medicare & Medicaid Services (CMS) was giving Minnesota $3.6 million from unspent national funds to cover CHIP this month.

Emily Piper, commissioner of the Minnesota Department of Human Services, reported in a newspaper commentary last month that her state’s funds would be exhausted last Sunday.

Even without the last-minute infusion of funding from CMS, most of the children covered by CHIP would have continued to receive care under the state’s Medicaid program, but Minnesota would get fewer federal dollars for each child, according to Piper’s commentary. However, she added, those most at risk are the 1,700 pregnant women covered by CHIP, because they wouldn’t be eligible for Medicaid.

Utah has notified CMS that it plans to discontinue its CHIP program by the end of the year unless it receives more federal money. About 19,000 children are in the state’s CHIP program, state officials say. So far, though, the state said it is not moving to suspend service or enrollment or alert enrollees about any possible changes.

Nevada officials said if funding is not extended it might have to freeze enrollment on Nov. 1 and end coverage by Nov. 30.

California, which has 1.3 million children covered by CHIP, has the highest enrollment of any state running out of funding this year. But, so far, it’s continuing business as usual.

“We estimate that we have available CHIP funding at least through December 2017,” said Tony Cava, spokesman for California Department of Health Services. “Our CHIP program is open for enrollment and continues to operate normally.”

Oregon said it has enough CHIP funding to last through October for its program that covers 98,000 children.

3. When is Congress likely to act?

The Senate Finance and the House Energy and Commerce committees have scheduled votes Wednesday on legislation to extend CHIP funding. If both approve their individual bills, floor votes could come quickly, and then both houses would need to resolve any differences.

Senate Finance Committee Chairman Orrin Hatch (R-Utah) and the committee’s ranking Democrat, Sen. Ron Wyden of Oregon, announced an agreement in mid-September to renew CHIP funding. Under the proposed deal, federal CHIP funding would drop by 23 percentage points starting in by 2020, returning to its pre-Affordable Care Act levels. The agreement would extend the life of the CHIP program through 2022.

Hatch and Wyden did not provide any details on how they would pay for the CHIP extension.

The House Energy and Commerce Committee posted its bill just before midnight Monday. It mirrors the Senate Finance plan by extending funding for CHIP for five years and gradually phasing down the 23-percentage-point funding increase provided under Affordable Care Act over the next two years.

4. If CHIP is so popular among Republicans and Democrats, why hasn’t Congress renewed the program yet?

The funding renewal was not a priority among Republican leaders, who have spent most of this year trying to replace the Affordable Care Act and dramatically overhaul the Medicaid program. Some in Congress also thought the Sept. 30 deadline was squishy since states could extend their existing funds beyond that.

5. Who benefits from CHIP?

While CHIP income eligibility levels vary by state, about 90 percent of children covered are in families earning 200 percent of poverty or less ($40,840 for a family of three). CHIP covers children up to age 19. States have the option to cover pregnant women, and 18 plus the District of Columbia do so.

The program is known by different names in different states such as Hoosier Healthwise in Indiana and PeachCare for Kids in Georgia.

For families that move out of Medicaid as their incomes rise, CHIP is an affordable option that ensures continued coverage for their children. Many states operate their CHIP programs as part of Medicaid.

This story was produced by Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

KHN’s coverage of children’s health care issues is supported in part by a grant from The Heising-Simons Foundation.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Happy National Health IT Week!

October 2nd through 6th marks National Health IT Week and shines a spotlight on the value of health IT.

Monday, October 2nd, kicks off National Health IT Week, a nationwide awareness week developed by the Healthcare Information and Management Systems Society and the Institute for e-Health Policy to shine a spotlight on how healthcare IT produces value, especially in relation to improved treatment and clinical care. Scores of conferences and other events, such as the Pop Health Forum in Chicago and Health 2.0 in Santa Clara, will be taking place nationwide, as well as online, with webinars scheduled throughout the week and the month of October, which is Cybersecurity Awareness Month.

For a full list of events happening around the country, please click here.

Can’t attend? Stay up to date on the happenings of National Health IT Week via #NHITWeek on Twitter.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

The Nurse’s Role and Female Genital Mutilation

By Misbah Shah

Ethical issues involve gender inequality, unbalanced resource distribution, and danger to vulnerable populations. Although it is important to embrace other cultures, different beliefs can lead to ethical dilemmas. Global health encompasses a broad spectrum of problems, but one of the primary obstacles is morality. Female genital mutilation is one example which demonstrates a distinction in cultural behaviors. By injuring the female genitalia for non therapeutic purposes, women can suffer physically and psychologically. According to Simpson, Robinson, Creighton, and Hodes (2012), many Western civilizations view this practice as obscene, but individuals who reside in African countries such as Somalia, Ethiopia, Sudan, and Eritrea consider this action as tradition.

Not only is female genital mutilation a controversy which exhibits injustice amongst genders, but it also results in short and long term health complications. For instance, Reisel and Creighton (2015) mention several consequences which can develop when extracting and harming private parts of a female. “During and immediately following the procedure, the girl or woman is at significant risk of traumatic bleeding and infection including wound infection, septicaemia, gangrene and tetanus”. Several of these short term complications are due to the use of unsanitary instruments and lack of anesthesia. Therefore, along with pain, they are at high risk for infections which often remain untreated. In addition to the immediate effects, long term ramifications can occur. These can be categorized in three different sections. One division consists of gynecological issues, such as genital scarring, blood related infections, menstruation problems, and difficulty with conception (Reisel & Creighton, 2015). Another group involves pregnancy and childbirth complications. A few examples are prolonged labor, postpartum hemorrhage, perineal damage, and an increased risk for Cesarean section. Maintaining a pregnancy can be difficult with this condition, but even when the gestation is successful, there is a high risk for neonatal compromise (Reisel & Creighton, 2015). Along with the physical consequences, mental health considerations also play a role in genital mutilation. Gele, Kumar, Hjelde, and Sundby (2012) indicate that, “The practice is often performed on girls between the ages of 0-9 thus making it one of the most horrific child tortures of our time”. Since this operation occurs at such a young age, it can lead to psychosocial problems in the future including anxiety, depression, and post traumatic stress disorder (Reisel & Creighton, 2015). Female genital mutilation encompasses both physical and psychological consequences. Thus, it is unethical to place girls and women in an indecent situation which does not produce benefits.

Over 140 million females undergo genital mutilation. The majority of these individuals reside in African countries. However, Western countries and certain parts of Asia do manifest this action as well due to the immigrant population (Gele et al., 2012). When considering a cultural perspective, it is known that many Somalis practice Islam. Although the majority of Muslims worldwide recognize female circumcision as a sin, this African group classifies the practice as “sunna” which translates to tradition. It is a procedure that is performed as a custom in the Somali culture (Gele et al., 2012).

The primary reason I chose female genital mutilation as my topic is because I am interested in women’s health. Attempting to maintain a healthy pregnancy or avoid infections can be difficult especially for women who do not have proper medical services. Since several African countries are identified as underdeveloped, they do not always have access to the appropriate supplies and facilities. In addition to the third world country circumstances, performing female genital mutilation heightens the risk for pregnancy, childbirth, and menstruation problems.

Since this ethical dilemma involves tradition and culture, it would be challenging to minimize because the procedure revolves around a belief. However, healthcare professionals such as nurses play an essential role in educating patients and informing them of the negative effects the operation could potentially cause. Simpson, Robinson, Creighton, and Hodes (2012) explain ways nurses can identify females who are at risk for genital mutilation. For instance, one factor to consider is that the daughters of women who have had their genitalia harmed are in jeopardy. Since their mothers experienced the painful act, there is a chance that the tradition will continue in the family. Therefore, nurses must provide patient education and be aware of individuals who may be at risk (Simpson, Robinson, Creighton, and Hodes, 2012). In addition, for patients who have already undergone the circumcision or cutting should be referred to specialists who can assist them further. For instance, a women’s health nurse practitioner would be a helpful option to guide women who are suffering the short or long term outcomes of the procedure.

The African female population is at high risk for undergoing genital mutilation and circumcision. Although many Muslims worldwide categorize this practice as immoral, there are certain groups of people who recognize it as tradition. This operation is rare in Western civilization, but some immigrants carry on the “sunna”. Therefore, healthcare professionals must understand the consequences of the procedure and be able to identify females who are at risk for participating in this unethical act. Overall, female genital mutilation can be acknowledged as immoral because it portrays gender inequality and poor treatment to a vulnerable group of individuals.

Misbah Shah is a Registered Nurse, who graduated from St. Francis Medical Center School of Nursing in 2016, and is currently a student at The College of New Jersey.

References:

  1. Gele, A. A., Kumar, B., Hjelde, K. H., & Sundby, J. (2012). Attitudes toward female circumcision among Somali immigrants in Oslo: a qualitative study. International Journal of women’s Health, 4, 7.
  2. Reisel, D., & Creighton, S. M. (2015). Long term health consequences of Female Genital Mutilation (FGM). Maturitas, 80(1), 48-51.
  3. Simpson, J., Robinson, K., Creighton, S. M., & Hodes, D. (2012). Female genital mutilation: the role of health professionals in prevention, assessment, and management. BMJ, 344(e1361).

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

For Nurses, “Just” Is A Four-Letter Word

Words are powerful, and the words we use to describe ourselves, such as “I’m JUST a nurse,” can have far-reaching effects — for others, and within our own psyches.

From Nurse Keith’s Digital Doorway

If you’re a nurse, when was the last time you said, “Oh, I’m just a nurse” or “I’m not really an expert—I’m just a nurse“? If you stop to think about it, what are you really saying when you deny your expertise? Words are powerful, and the words we use to describe ourselves can have far-reaching effects — for others, and within our own psyches.

For a number of years, I’ve used the soapbox of this blog to cajole nurses to embrace their nurse identity while also embracing their individual and collective value as skilled clinicians.

Like I’ve said before, nurses have been voted the most trusted professionals in the United States every year for good reason, and that’s because, whether we feel like experts or not, the general public views us as honest and knowledgeable professionals with whom they trust their lives—and the lives of their loved ones.

Sadly, many nurses simply don’t feel like experts, and the common use of the above-mentioned phrase — “I’m just a nurse” — demonstrates for us the fact that nurses suffer from collective low self-esteem.

While some nurses are clearly more expert than others (or more educated, experienced or specialized in their practice), every nurse is an expert in some way, shape or form. Having survived nursing school, learned how to be a nurse, developed specialized assessment skills and been issued a license to practice, you deserve to call yourself an expert.

Face it, you’re a nurse and you’re an expert when it comes to being a nurse. And in the eyes of the general public, you’re part of a special breed whom they see as either angels, saints or some other superlative creature.

Of course, your nursing career itself is a creature that will only continue to grow and evolve, and that ongoing evolution is a wonderful thing. Nurses are required to participate in continuing education in order to maintain and renew their license, but many nurses also seek out education and specialization because they’re professionals who want to always be learning something new, increasing their level of knowledge, skill and expertise—and that’s a wonderful thing.

When I coach nurses, I try to instill in my clients the undeniable fact that they are indeed experts. I also make the demand that they never again say “I’m just a nurse.” Using that small “four-letter word” — just — is an affront to who you are and what you do. In this context, “just” is a diminishing term, a word whose purpose is to relieve you of authority, intelligence, and your undeniable importance.

You are not “just” a nurse. You’re a nurse, and nurses can be described as both the lifeblood and the backbone of the entire healthcare industry. Take away nurses, and the system as a whole would cease to function.

We’re not simple handmaidens to the all-knowing physicians (like it was in the bad old days). We’re skilled in the art and science of nursing, and this art/science is made more powerful by decades of research, practice, theory, skill-building and knowledge accumulation.

You are not “just” a nurse. You are a nurse. Period. And you deserve to erase that one particular four-letter word from your nursing vocabulary.

Keith Carlson, RN, BSN, NC-BC, is the Board Certified Nurse Coach behind NurseKeith.com and the well-known nursing blog, Digital Doorway. Please visit his online platforms and reach out for his support when you need it most.

Keith is co-host of RNFMRadio.com, a wildly popular nursing podcast; he also hosts The Nurse Keith Show, his own podcast focused on career advice and inspiration for nurses.

A widely published nurse writer, Keith is the author of “Savvy Networking For Nurses: Getting Connected and Staying Connected in the 21st Century,” and has contributed chapters to a number of books related to the nursing profession. Keith has written for Nurse.com, Nurse.org, MultiViews News Service, LPNtoBSNOnline, StaffGarden, AusMed, American Sentinel University, the ANA blog, Working Nurse Magazine, and other online publications.

Mr. Carlson brings a plethora of experience as a nurse thought leader, online nurse personality, podcaster, holistic career coach, writer, and well-known successful nurse entrepreneur. He lives in Santa Fe, New Mexico with his lovely and talented wife, Mary Rives.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

The Necessity of Continuing the Advancement of Clinical Trials

Despite vast patient benefits, clinical trials have struggled to recruit their target number of participants, with many recent studies failing to reach 33 percent of their original recruitment goal.

by Jennifer Landis

Clinical trials offer patients the opportunity to contribute to the development and approval of new therapies, drugs, treatments and medical devices. This research has the potential to improve the participating patient’s quality of life. In fact, recent advancements in the health care field over the past few decades can be attributed to clinical trial testing.

The vast patient benefits of participating in clinical trials include contributing to new research, access to the latest medical developments and positive effects on patient well-being. Despite this, clinical trials have struggled to recruit their target number of participants, with many recent studies failing to reach 33 percent of their original recruitment goal.

Patients decline to participate in clinical trials due to personal inconvenience and concerns with protocol, including using treatment methods unapproved by the FDA and conflicts with the research process. The development of programs that are focused more on patients rather than on statistical outcomes could increase the success of future programs.

Program Improvements

Clinical trials aren’t without fault. Improper reporting, misinterpreted outcomes, misleading reports and lost data are several of the items that skew trial results and occasionally render them unusable. Researchers can minimize these pitfalls by paying careful attention to detail, performing objective data analysis and reporting all trial results.

To encourage additional patient participation, trial administrators can work to develop programs specific to the outcomes relevant to patients in addition to clinician-reported outcomes. In the past, outcomes important to patients, such as death or outcomes, were considered to be of little value to completed studies or not reported at all.

Patient outcomes of interest include life expectancy, how they feel and how they function on a daily basis. Studies that share these metrics, as well as the symptoms and side effects experienced by participants, will garner more interest and be of more value to individuals suffering from the disease.

For successful trials to continue, qualified patients of all ages and backgrounds need to participate. A diverse trial group stands the best chance at representing the population that will be using the tested treatment options or devices.

Reduce Failure Rates

Approximately 50 percent of Phase III clinical trials fail by not exhibiting effective treatment outcomes, having severe or unexpected side effects or by not proving to be financially beneficial. Nearly 70 percent of Phase II clinical trials fail, though this is expected as these trials are in a more preliminary stage.

Patients who participate in Phase III trials are typically in late-stage conditions. These patients may have exhausted other treatments or have limited time available to find a successful option. Failed trials put them at risk for emotional distress and decreased quality of life.

The failure rate for Phase III trials can be reduced by defining specific protocol earlier on in the testing process, before beginning Phase II trials. A clear path forward during testing will reduce the number of treatment options that move to Phase III trials. This may increase the success rate of clinical trials and increase patient interest and involvement.

Future Possibilities

Remote clinical trials offer patients and clinicians a flexible option for participating in and conducting new research. Patients living in rural communities or patients that have difficulty commuting to a research facility have the option of participating in studies that otherwise might not have been available to them. Remote trials can solve the problem of patient participation as a larger audience can be reached.

Clinicians can ensure the integrity of trials by directing patients to one central location where specific protocols can be followed. Researchers can then work together to analyze and track the patient data being provided in one area. This reduces the potential for lost data or information being left out of analysis.

New apps have been developed that enable communications between patients and physicians directly. Patients can also track and record their progress through these apps and share this information with physicians through the app. This lessens the financial burden on patients as the number of visits to the clinical trial center and travel costs are reduced.

Registered reports are a new method to ensure clinical trial information is shared regardless of the outcome. In the first stage, the clinical trial process is peer-reviewed and sent back for revisions, if necessary. Once the protocol is accepted, the journal agrees to publish the results of the study regardless of the outcomes. This removes pressure for clinicians to leave out negative results and promotes trust among participants, since reviewed and defined processes will be followed.

Clinical trials are necessary to continue to make advancements in medical treatments. Reviewed, established protocol before beginning trials can ensure a higher success rate. This, along with a more patient-centric approach and remote trial options, can increase the number of participants.

Jennifer Landis is a freelance writer and healthy living blogger. She drinks tea in excess, has a collection of peanut butters, and is a super nerd at heart. Read more from Jennifer on her blog, Mindfulness Mama.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.