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Archive for the ‘Patient Experience’ Category


Innovation + Technology = Good Patient Experience

Reporter: Gail S. Thornton

 

Following are a sampling of several relevant articles comprising health innovation and technology, which may ultimately lead to a good patient experience. 

When a health journalist found out her 4-year-old son had a brain tumor, her family faced an urgent choice: proven but punishing rounds of chemotherapy, or a twice-a-day pill of a new “targeted” therapy with a scant track record.

SOURCE

https://www.reuters.com/investigates/special-report/genomics-tumor/

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Paying for Tumor Testing

A recent U.S. government decision about coverage of tumor sequencing could affect cancer patients.

SOURCE

https://www.cancertodaymag.org/Pages/cancer-talk/Paying-for-Tumor-Testing.aspx

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Dr. Elaine Schattner has authored numerous articles on cancer — as a doctor and patient. She is a freelance journalist and former oncologist who lives in New York City. She is writing a book about public attitudes toward cancer.

A life-long patient with scoliosis and other chronic medical conditions, and a history of breast cancer, Elaine’s current interests include physicians’ health, cancer, and medical journalism.

SOURCE

https://www.elaineschattner.com/

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Speaking Up for Patient Preferences in Cancer Treatment Decisions.

Informed consent should include your input.

SOURCE

https://health.usnews.com/health-news/patient-advice/articles/2016-04-15/speaking-up-for-patient-preferences-in-cancer-treatment-decisions

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Breast Cancer, Risk And Women’s Imperfect Choices

SOURCE

https://www.npr.org/sections/health-shots/2013/05/15/184188710/breast-cancer-risk-and-womens-imperfect-choices

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A cancer researchers takes cancer personally: Dr. Tony Blau, who started All4Cure, an online platform for myeloma clinicians and researchers to interact directly with patients to come up with a customer treatment plan.

SOURCE

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Julia Louis-Dreyfus Acts Out: The actress on challenging comedy’s sexism, fighting cancer, and becoming the star of her own show.

SOURCE

https://www.newyorker.com/magazine/2018/12/17/julia-louis-dreyfus-acts-out

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Thanks to Wendy Lund, CEO of GCI Health (gcihealth.com)  and her team for compiling part of this list. 

Interoperability, patient matching could be fixed by smartphone apps, RAND says: Patients need quality information. A physician at George Washington University School of Medicine and Health Sciences believes that the healthcare community must improve reports by making them more accessible to patients.

SOURCE

https://www.healthcareitnews.com/news/interoperability-patient-matching-could-be-fixed-smartphone-apps-rand-says

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Sometimes Patients Simply Need Other Patients: Finding a support community is also getting easier, through resources like the Database of Patients’ Experiences, which houses videos of patients speaking about their experiences

 

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At These Hotels and Spas, Cancer is No Obstacle to Quality Care: A trend among spas and wellness resorts shows the increasing integration of safe wellness treatment options for cancer patients.

SOURCE

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The National Cancer Research Institute (NCRI) identified top 10 research priorities for people living with cancer to consider to improve treatment and quality of life. 

Reporter: Gail S. Thornton

By 2030 four million people in the UK will be living with the long-term consequences of cancer, but currently there is very little research on the problems they face and how these can be tackled. To help them live better lives, more focused research is needed.

To determine priorities for research that will help people live better with and beyond cancer, NCRI partnered with the James Lind Alliance on a Priority Setting Partnership. The two-year project involved two UK-wide surveys which attracted more than 3500 responses from patients, carers, and health and social care professionals. From these, we identified 26 key questions and distilled these down to 10 top research priorities.

This is the first time that clear research priorities have been identified in this area.

Questions 1 – 10 Questions 11 – 26

SOURCE

https://www.ncri.org.uk/lwbc/

 

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More than half of older Americans have “basic” or “below basic” health literacy. How do you make health care decisions when you don’t even understand what the doctor is saying?

From The New York Times

More than half of older Americans lack the skills to gather and understand medical information. Providers must simplify, researchers say.

Every time her parents pick up a new prescription at a Walgreens in Houston, they follow Duyen Pham-Madden’s standing instructions: Use the iPad she bought for them, log onto FaceTime, hold up the pill bottles for her examination.

Her mother, 79, and father, 77, need numerous medications, but have trouble grasping when and how to take them.

The label may say to take one pill three times a day, but “my dad might take one a day,” said Ms. Pham-Madden, 56, an insurance purchasing agent in Blue Springs, Mo. “Or take three at a time.”

So she interprets the directions for them, also reminding her mother to take the prescribed megadose of vitamin D, for osteoporosis, only weekly, not daily.

Part of their struggle, Ms. Pham-Madden believes, stems from language barriers. The family emigrated from Vietnam in 1975, and while her parents speak and read English, they lack the fluency of native speakers.

But recently, Ms. Pham-Madden said, her father posed a question that anyone grappling with Medicare drug coverage might ask: “What’s the doughnut hole?”

Researchers refer to this type of knowledge as “health literacy,” meaning a person’s ability to obtain and understand the basic information needed to make appropriate health decisions.

Can someone read a pamphlet and then determine how often to undergo a particular medical test? Look at a graph and recognize a normal weight range for her height? Ascertain whether her insurance will cover a certain procedure?

Most American adults — 53 percent — have intermediate health literacy, a national survey found in 2006; they can perform “moderately challenging” activities, like reading denser texts and handling unfamiliar arithmetic.

Just 12 percent rank as “proficient,” the highest category. About a fifth have “basic” health literacy that could cause problems, and 14 percent score “below basic.” Health literacy differs by education level, race, poverty and other factors.

And it varies dramatically by age. While the proportion of adults with intermediate literacy ranges from 53 to 58 percent in other age groups, it falls to 38 percent among those 65 and older. The percentage of older adults with basic or below basic literacy is higher than in any other age group; only 3 percent qualify as proficient.

Why is that? Compared to younger groups, the current generation of “older adults were less likely to go beyond a high school education,” said Jennifer Wolff, a health services researcher at Johns Hopkins University.

Moreover, “as adults age, they’re more likely to experience cognitive impairment,” she pointed out, as well as hearing and vision loss that can affect their comprehension.

Consider the recent experience of a retired 84-year-old teacher. All her life, “she was very detail-oriented” and competent, said her daughter, Deborah Johnson, who lives in Lansing, Mich.

But a neurologist diagnosed mild cognitive impairment last summer and prescribed a drug intended to ameliorate its symptoms. It caused a frightening reaction — personality changes, lethargy, dizziness, sky-high blood pressure.

Ms. Johnson thinks her mother might have overdosed. “She told me she thought, ‘This is going to fix me, and I’ll be O.K. So if I take more pills, I’ll be O.K. faster.’”

Yet health literacy can be particularly crucial for seniors. They’re usually coping with more complicated medical problems, including multiple chronic diseases, an array of drugs, a host of specialists. They have more instructions to decipher, more tests to schedule, more decisions to ponder.

Low health literacy makes those tasks more difficult, with troubling results. Studies indicate that people with low literacy have poorer health at higher cost. They’re less likely to take advantage of preventive tests and immunizations, and more apt to be hospitalized.

It may not help much that future cohorts of older adults will be better educated. “The demands of interacting with the health care system are increasing,” Dr. Wolff said. “Ask any adult child of a parent who’s been hospitalized. The system has gotten increasingly complex.”

That doesn’t mean patients deserve all the blame for misunderstandings and snafus. Rima Rudd, a longtime health literacy researcher at Harvard University, has persistently criticized the communications skills of health institutions and professionals.

“We give people findings and tell them about risk and expect people to make decisions based on those concepts, but we don’t explain them very well,” she said. “Are our forms readable? Are the directions after surgery written coherently? If it’s written in jargon, with confusing words and numbers, you won’t get the gist of it and you won’t get important information.”

A few years ago, Steven Rosen, 64, had spent more than two months at a Chicago hospital after several surgeries. Then a social worker came into his room and told his wife Dorothy, “You have to move him tomorrow to an L.T.A.C.”

“I don’t know what you’re talking about,” Ms. Rosen recalled saying. “What’s an L.T.A.C.?”

Question: Was she demonstrating inadequate health literacy, or should the social worker have clarified that L.T.A.C.s — long-term acute care hospitals — provide more care than nursing homes for very ill patients?

Aware of such issues, health care organizations are scrambling to try to make information more accessible and intelligible, and to help patients of all ages understand an often bewildering environment.

They’re hiring squadrons of care coordinators and navigators (sometimes too many), and redesigning and rewriting pamphlets and forms. They’re teaching medical students to communicate more clearly and to encourage patients’ questions.

They’re turning to technology, like secure websites where both patients and family members can see test results or ask questions.

“It’s not the silver bullet we hoped for,” said Amy Chesser, a health communications researcher at Wichita State University, pointing out that many patients are reluctant to turn to provider websites. But the potential remains.

For now, though, often the primary health literacy navigators for older people are their adult children, most commonly daughters and daughters-in-law.

“In the best of all worlds, she’d just be the daughter,” Dr. Chesser said. “But we need her to serve other roles — being an advocate, asking a lot of questions of the provider, asking where to go for information, talking about second opinions.”

The current cohort of people over 70 grew up in a more patriarchal medical system and asking fewer questions, Dr. Wolff pointed out. Her research shows that while most seniors manage their own health care, about a third prefer to co-manage with family or close friends, or to delegate health matters to family or doctors.

Duyen Pham-Madden plays the co-managerial role from hundreds of miles away, keeping spreadsheets of her parents’ drugs, compiling lists of questions for doctors’ appointments, texting photos to pharmacists when the pills in a refilled prescription look different from the last batch.

She’d probably score well in health literacy, but “sometimes even I get mixed up,” she said.

What’s the Medicare doughnut hole? “I had to look it up,” she said. Once she did, she wondered, “How do they expect seniors to understand this?”

SOURCE

 

 

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Live Conference Coverage @Medcitynews Converge 2018 Philadelphia: The Davids vs. the Cancer Goliath Part 2

8:40 – 9:25 AM The Davids vs. the Cancer Goliath Part 2

Startups from diagnostics, biopharma, medtech, digital health and emerging tech will have 8 minutes to articulate their visions on how they aim to tame the beast.

Start Time End Time Company
8:40 8:48 3Derm
8:49 8:57 CNS Pharmaceuticals
8:58 9:06 Cubismi
9:07 9:15 CytoSavvy
9:16 9:24 PotentiaMetrics

Speakers:
Liz Asai, CEO & Co-Founder, 3Derm Systems, Inc. @liz_asai
John M. Climaco, CEO, CNS Pharmaceuticals @cns_pharma 

John Freyhof, CEO, CytoSavvy
Robert Palmer, President & CEO, PotentiaMetrics @robertdpalmer 
Moira Schieke M.D., Founder, Cubismi, Adjunct Assistant Prof UW Madison @cubismi_inc

 

3Derm Systems

3Derm Systems is an image analysis firm for dermatologic malignancies.  They use a tele-medicine platform to accurately triage out benign malignancies observed from the primary care physician, expediate those pathology cases if urgent to the dermatologist and rapidly consults with you over home or portable device (HIPAA compliant).  Their suite also includes a digital dermatology teaching resource including digital training for students and documentation services.

 

CNS Pharmaceuticals

developing drugs against CNS malignancies, spun out of research at MD Anderson.  They are focusing on glioblastoma and Berubicin, an anthracycline antiobiotic (TOPOII inhibitor) that can cross the blood brain barrier.  Berubicin has good activity in a number of animal models.  Phase I results were very positive and Phase II is scheduled for later in the year.  They hope that the cardiotoxicity profile is less severe than other anthracyclines.  The market opportunity will be in temazolamide resistant glioblastoma.

Cubismi

They are using machine learning and biomarker based imaging to visualize tumor heterogeneity. “Data is the new oil” (Intel CEO). We need prediction machines so they developed a “my body one file” system, a cloud based data rich file of a 3D map of human body.

CUBISMI IS ON A MISSION TO HELP DELIVER THE FUTURE PROMISE OF PRECISION MEDICINE TO CURE DISEASE AND ASSURE YOUR OPTIMAL HEALTH.  WE ARE BUILDING A PATIENT-DOCTOR HEALTH DATA EXCHANGE PLATFORM THAT WILL LEVERAGE REVOLUTIONARY MEDICAL IMAGING TECHNOLOGY AND PUT THE POWER OF HEALTH DATA INTO THE HANDS OF YOU AND YOUR DOCTORS.

 

CytoSavvy

CytoSavvy is a digital pathology company.  They feel AI has a fatal flaw in that no way to tell how a decision was made. Use a Shape Based Model Segmentation algorithm which uses automated image analysis to provide objective personalized pathology data.  They are partnering with three academic centers (OSU, UM, UPMC) and pool data and automate the rule base for image analysis.

CytoSavvy’s patented diagnostic dashboards are intuitive, easy–to-use and HIPAA compliant. Our patented Shape-Based Modeling Segmentation (SBMS) algorithms combine shape and color analysis capabilities to increase reliability, save time, and improve decisions. Specifications and capabilities for our web-based delivery system follow.

link to their white paper: https://www.cytosavvy.com/resources/healthcare-ai-value-proposition.pdf

PotentialMetrics

They were developing a diagnostic software for cardiology epidemiology measuring outcomes however when a family member got a cancer diagnosis felt there was a need for outcomes based models for cancer treatment/care.  They deliver real world outcomes for persoanlized patient care to help patients make decisions on there care by using a socioeconomic modeling integrated with real time clinical data.

Featured in the Wall Street Journal, using the informed treatment decisions they have generated achieve a 20% cost savings on average.  There research was spun out of Washington University St. Louis.

They have concentrated on urban markets however the CEO had mentioned his desire to move into more rural areas of the country as there models work well for patients in the rural setting as well.

Please follow on Twitter using the following #hash tags and @pharma_BI 

#MCConverge

#cancertreatment

#healthIT

#innovation

#precisionmedicine

#healthcaremodels

#personalizedmedicine

#healthcaredata

And at the following handles:

@pharma_BI

@medcitynews

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Live Conference Coverage @Medcity Converge 2018 Philadelphia: Oncology Value Based Care and Patient Management

Reporter: Stephen J. Williams, Ph.D.

3:15 – 4:00 PM Breakout: What’s A Good Model for Value-Based Care in Oncology?

How do you implement a value-based care model in oncology? Medicare has created a bundled payment model in oncology and there are lessons to be learned from that and other programs. Listen to two presentations from experts in the field.

Moderator: Mahek Shah, M.D., Senior Researcher, Harvard Business School @Mahek_MD
Speakers:
Charles Saunders M.D., CEO, Integra Connect
Mari Vandenburgh, Director of Value-Based Reimbursement Operations, Highmark @Highmark

 

Mari: Building strategic partnerships with partners focused on population based health and evidence based outcomes. they provide data analytics and consultative services.  Incorporate risk based systems.  also looking at ancillary segments because they see cost savings.  True Performance is their flagship performance program and 11% lower ED (saving $18 million) rates and 16% lower readmissions ($200 million cost savings).  Also launched the Highmark Cancer care Program with Johns Hopkins.  They monitor the adherence pathways and if clinician shows good adherence they give reimbursements.

Charles:  Integra is a cloud based care platform focused on oncology and urology and allow clinicians to practice value based care. Providers must now focus on total cost including ER visits, end of life and therapies (which is half of total cost in US).  The actionable ways to reduce costs is by reducing ER visits.  What is working? Data on reimbursements models is very accurate so practices can dig into data and find effieciencies.  However most practices do not have the analytics to do this.

  • care navigation
  • care path based treatment choices
  • enhanced patient access and experience

What is not working

  • data not structured so someone has to do manual curation of records
  • flawed logic based on plurality of visits but physician doesn’t know who else they saw
  • target pricing not taking into account high prices of new therapies
  • lack of timely reporting either by patient or physician
  • insufficient reimbursements
  • technology limitations

 

4:10- 4:55 Breakout: What Patients Want and Need On Their Journey

Cancer patients are living with an existential threat every day. A panel of patients and experts in oncology care management will discuss what’s needed to make the journey for oncology patients a bit more bearable.

sponsored by CEO Council for Growth

Moderator: Amanda Woodworth, M.D., Director of Breast Health, Drexel University College of Medicine
Speakers:
Kezia Fitzgerald, Chief Innovation Officer & Co-Founder, CareAline® Products, LLC
Sara Hayes, Senior Director of Community Development, Health Union @SaraHayes_HU
Katrece Nolen, Cancer Survivor and Founder, Find Cancer Help @KatreceNolen
John Simpkins, Administrative DirectorService Line Director of the Cancer Center, Children’s Hospital of Philadelphia @ChildrensPhila

 

Kezia: was a cancer patient as well as her child getting treated at two different places and tough part was coordinating everything including treatments and schedules, working schedules

Katrece: had problem scheduling with oncologists because misdiagnosis and her imaging records were on CD and surgeon could not use the CD

John:  the above are a common frustration among patients at a time when they don’t need the confusion. He feels cancer centers need to coordinate these services better

Sara:  trying to assist people with this type of coordination is very tough even with all the resources

Kazia:  she needed to do all the research on her own because big dichotomy being an adult and a pediatric patient where pediatrics get more information and patient centered care. She felt she felt burdening the physicians if she asked the same questions.  How can we get more interaction with primary care physicians and feel comfortable with their interaction?

John: there is this dichotomy especially on wait times for adults is usually longer.  We can also improve patient experience with counseling patients

Katrece: Just working with a patient navigator is not enough.  The patient needs to take charge of their disease.

Sara: Patient communities can help as sometimes patients learn from other patients.

Amanda:  in breast cancer , navigators are common but must take care they are not only people patients see after a while

John:  at CHOP they also have a financial navigator.  On the adult side there are on call financial navigators.  Recent change of the high deductible plans are a major problem.  Although new families are starting to become comfortable with the financial navigator

Katrece:  guiding your children through your experience is important.  It was also important for her to advocate for herself as she had three different sites of cancer care to coordinate and multiple teams to coordinate with each other

Amanda:  A common theme seems to be hard trying to find the resources you need.  Why is that?

Kazia:  Sometimes it is hard to talk about your disease because it can be emotionally draining comforting other people who you told about the disease and they are being empathetic.  Sometimes they want to keep their ‘journey’ to themselves

John:  A relative kept her disease secret because she didn’t want to burden others…. a common cancer patient concern

Sara: Moderation of a social group is necessary to keep it a safe space and prevent trollers (like in Facebook support groups).

Kazia:  most group members will get together and force those trollers out of the group

Katrece: alot of anxiety after treatment ends, patient feels like being dropped on the floor like they don’t get support after treatment.  If there were survivorship navigators might be helpful

Amanda: for breast cancer they do a Survivor Care Package but just a paper packet, patients do appreciate it but a human coordinator would be a great idea

 

 

 

 

Please follow on Twitter using the following #hashtags and @pharma_BI

#MCConverge

#cancertreatment

#healthIT

#innovation

#precisionmedicine

#healthcaremodels

#personalizedmedicine

#healthcaredata

And at the following handles:

@pharma_BI

@medcitynews

 

Please see related articles on Live Coverage of Previous Meetings on this Open Access Journal

LIVE – Real Time – 16th Annual Cancer Research Symposium, Koch Institute, Friday, June 16, 9AM – 5PM, Kresge Auditorium, MIT

Real Time Coverage and eProceedings of Presentations on 11/16 – 11/17, 2016, The 12th Annual Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, Joseph B. Martin Conference Center, 77 Avenue Louis Pasteur, Boston

Tweets Impression Analytics, Re-Tweets, Tweets and Likes by @AVIVA1950 and @pharma_BI for 2018 BioIT, Boston, 5/15 – 5/17, 2018

BIO 2018! June 4-7, 2018 at Boston Convention & Exhibition Center

https://pharmaceuticalintelligence.com/press-coverage/

 

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  • More than 77 percent of patients in the REMfresh® Patient Reported Outcomes DURation (REMDUR) study reported achieving 6 or more hours of sleep after taking REMfresh®, the first continuous release and absorption melatonin (CRA-melatonin)
  • More than 91 percent experienced improvements in sleep onset, sleep maintenance and total sleep quality, after taking REMfresh® (CRA-melatonin)
  • Post-marketing, patient-reported outcomes data reinforces clinical trial evidence demonstrating the potential of non-prescription REMfresh®, as a new, non-prescription, drug-free hypnotic (sleep) product designed to achieve 7-hour sleep
  • New data confirms previously presented SLEEP 2017 study showing the patented Ion Powered Pump (IPP) technology in REMfresh® helps extend melatonin-targeted sleep maintenance levels in the body from 3.7 hours (with marketed immediate-release melatonin) to 6.7 hours, while mimicking the pattern of the body’s natural melatonin blood levels during the nightly sleep cycle

Real Time Coverage at SLEEP 2018 meeting, Baltimore.

Reporters: Aviva Lev-Ari, PhD, RN, and Gail S. Thornton, MA

BALTIMORE – (June 6, 2018) – A patient-reported outcomes study presented at SLEEP 2018 provides confirmatory real-world evidence of the previously peer-reviewed and presented data showing the 7-hour action of REMfresh®, a new product for sleep. REMfresh® Ion-Powered Melatoninis the first and only, continuous release and absorption melatonin (CRA-melatonin) to mimic the body’s own 7-hour Mesa Wave, the natural pattern of melatonin blood levels during a normal night’s sleep cycle. This induces sleep onset and provides lasting and restorative sleep for up to 7 hours.

This new data shows a correlative relationship between a 7-hour Mesa Wave pharmacokinetic (PK) profile and real-world evidence of improvements in sleep duration, onset, maintenance and sleep quality after taking REMfresh® (CRA-melatonin).

The post-marketing REMfresh® Patient Reported Outcomes DURation (REMDUR) study was presented at SLEEP 2018, the 32nd Annual Meeting of the Associated Professional Sleep Societies (APSS), LLC, a joint partnership of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS).

 

Brodner and Seiden

Pictured here is David C. Brodner, M.D., and David J. Seiden, M.D., FAASM, after presenting the latest study data which found REMfresh is the first and only continuous release and absorption melatonin™ to mimic the body’s own 7-hour Mesa Wave™.

 

In a sample of 500 patients on REMfresh® (CRA-melatonin) responding to an online survey, 77.6 percent achieved 6 or more hours of sleep compared to 23.6 percent who slept that duration prior to taking REMfresh® (p<.0001). A vast majority of respondents also reported a major or moderate improvement in sleep onset (91.6 percent, p<.0001), sleep maintenance (94.8 percent, p<.0001) and total sleep quality (97.2 percent, p<.0001). More than three-quarters (76.6 percent) of patients indicated they take REMfresh® (CRA-melatonin) nightly. The proportion of patients reporting nightly CRA-melatonin use was significantly greater than the proportion of patients with less than nightly use (p<.0001). Most importantly, over 98 percent of patients reported they were very likely or likely to continue taking REMfresh® (CRA-melatonin) to treat their sleep complaints.

“The real-world evidence reported today in REMDUR provides further confirmation that REMfresh® represents a significant advance in the use of melatonin as a baseline therapy for treating sleep complaints,” said David C. Brodner, M.D., a leading sleep specialist who is Double Board-Certified in Otolaryngology — Head and Neck Surgery and Sleep Medicine, founder and principle Physician at the Center for Sinus, Allergy, and Sleep Wellness, in Palm Beach County, Florida, and Senior Medical Advisor for Physician’s Seal, LLC®.

“REMfresh® Ion-Powered Melatoninhas been shown to be an effective drug-free solution that is now available to the millions of Americans in need of a good night’s sleep, many of whom seek new therapies that will induce sleep and keep them asleep until the morning, without causing residual effects they’ll feel the next day. With its unique delivery system that imitates the body’s own natural sleep pattern, REMfresh® has revolutionized the role of melatonin, when delivered in the CRA form. It is no longer just a treatment for jet lag, but the CRA-melatonin found in REMfresh® has been shown to provide substantial relief to individuals having nightly sleep challenges,” said Dr. Brodner.

The scientifically advanced, patented delivery system in REMfresh® (CRA-melatonin), called Ion Powered Pump (IPP™) technology, replicates the way in which the body naturally releases and absorbs melatonin, unlike conventional melatonin sleep products. Since REMfresh® is not a drug, there is no drug hangover.

Nearly one-third of U.S. adults sleep less than the recommended seven hours daily.[1],[2] Increasing evidence suggests an association between sub-optimal sleep duration and adverse health outcomes including a higher risk of diabetes, hypertension, heart attack, stroke, obesity and depression.[3] A pooled analysis of 16 studies and over one million patients found short sleep duration corresponded with greater risk of morbidity and mortality.[4]

 REMDUR Study Design

The post-marketing REMfresh® Patient Reported Outcomes DURation (REMDUR) study was designed to obtain real-world evidence about patients’ sleep patterns, duration of sleep before and after REMfresh® (CRA-melatonin), daily REMfresh® (CRA-melatonin) use, onset of action, sleep maintenance, quality of sleep, and overall satisfaction with REMfresh® (CRA-melatonin).

Patients with sleep disturbances in the general population who received a sample of CRA-melatonin (REMfresh®) from their physicians were invited to complete a 12-question survey. Survey responses were received from 500 patients.

Confirmation of the REMAKT Clinical Study

REMDUR confirmed clinical trial findings from REMAKT (REM Absorption Kinetics Trial), a U.S.-based randomized, crossover pharmacokinetic (PK) evaluation study in healthy, non-smoking adults that compared REMfresh® (CRA-melatonin) with a market-leading, immediate-release melatonin (IR-melatonin).[5]

The study results, peer-reviewed and presented last year at SLEEP 2017, showed that melatonin levels with REMfresh® (CRA-melatonin) exceeded the targeted sleep maintenance threshold for a median of 6.7 hours, compared with 3.7 hours with the leading IR-melatonin. Conversely, the levels of the market-leading IR-melatonin formulation dramatically increased 23 times greater than the targeted levels of exogenous melatonin for sleep maintenance and had a rapid decline in serum levels that did not allow melatonin levels to be maintained beyond 4 hours.

The REMfresh® (CRA-melatonin) studies build upon the body of evidence from prolonged-release melatonin (PR-M), marketed in Europe, which demonstrated in well-conducted, placebo-controlled studies, statistically significant improvement in sleep quality, morning alertness, sleep latency and quality of life in patients aged 55 years and older compared with placebo. REMfresh® (CRA-melatonin) was designed to overcome the challenges of absorption in the intestines, thereby extending the continual and gradual release pattern of melatonin through the night (known as the Mesa Wave, a flat-topped hill with steep sides). There was a fast time to Cmax, which is anticipated to result in improved sleep onset, while the extended median plateau time to 6.7 hours and rapid fall-off in plasma levels at the end of the Mesa Wave, may help to improve sleep maintenance and morning alertness.

Conventional melatonin products have had challenges at mimicking the profile of a Mesa Wave™. The scientific work behind REMfresh® (CRA-melatonin) sought to overcome these challenges by having the melatonin formulation in a matrix that maintains a patented, solubility-enhancing pH environment to help with the transport to the brush border of the gut and its subsequent absorption.

Designed as a hydrogel matrix tablet, REMfresh® (CRA-melatonin) provides rapid release of the melatonin from the surface of the tablet, as the hydrogel release-controlling matrix is setting up in the acidic environment (pH of 1 to 3.5) in the stomach. As the tablet moves into the higher pH (5.5 to 6.5) environment of the small-intestine, which is above the pKa of melatonin (~4.0), the acidic moiety in the tablet is designed to maintain the pH within the tablet below 4.0 for 7+ hours. The hydrogel matrix, after proper hydration, allows continuous release of the active melatonin and acidic moiety into the lumen of the intestines.

Melatonin: The Body’s Natural Sleep Ingredient

Melatonin is produced by the pineal gland in the brain and is the body’s natural sleep ingredient. Melatonin levels normally begin to rise in the mid-to late evening and remain high for the majority of the night. Levels begin to decline towards early morning, as the body’s wake cycle is triggered. As people age, melatonin levels can drop by as much as 70 percent[6] and their bodies may no longer produce enough melatonin to ensure adequate sleep.

Other available products, such as immediate-release melatonin, help initiate the onset of sleep but are usually unable to sustain prolonged sleep maintenance due to an immediate burst of melatonin, which is quickly degraded due to its relatively short half-life (60 minutes). Absorption in the lower digestive tract is limited by melatonin’s limited ability to be absorbed in a low acidity or neutral pH environment.

Importance of Sleep

Sleep is an essential part of every person’s life. The body requires a certain amount of sleep in order to properly rest, repair and renew itself. Sleep is customarily divided in four different stages, with each stage having a different effect. These four stages are:

N1, N2, deep sleep and REM sleep. The body moves among these four stages several times while asleep. If sleep is disrupted for any reason, a person’s body may not have a chance to properly restore itself, especially if it is struggling to get to the later stages, called deep sleep and REM sleep. Studies have shown that sound and sufficient sleep is important for learning, memory and a healthy immune system. A regular pattern of deep sleep and REM sleep will help a person begin the next day feeling refreshed and ready to go.

About Non-Prescription REMfresh®

REMfresh® (CRA-melatonin) is the first and only, continuous release and absorption formulation of UltraMel® melatonin (available as 2 mg and 5 mg and with a 0.5 mg anticipated in the second half of 2018). UltraMel® melatonin is a high-quality, 99 percent ultra-pure melatonin sourced from Western Europe exclusively for Physician’s Seal®.

REMfresh® (CRA-melatonin) is a dietary supplement and is regulated under the Federal Dietary Supplement Health and Education Act, which does not require pre-approval. Melatonin has been in common use for over two decades and has a well-established profile of safe use by millions of people around the world. As with all supplements, individual results may vary.

REMfresh® (CRA-melatonin) is non-habit forming and does not contain narcotics, hypnotics, barbiturates, sedatives, antihistamines, alcohol or other harsh or additive chemicals. The usual adult recommended dose is 1-2 tablets 30-60 minutes before bedtime. Follow specific dosing instructions found on the back of the box for proper use of supplements.

REMfresh® (CRA-melatonin) is available at Walmart, Rite Aid and CVS/pharmacy. In 2017 REMfresh® was ranked as  the #1 recommended brand for sleep management by sleep doctors[7].

About Physician’s Seal®

Physician’s Seal® is the innovator of REMfresh®, the first and only continuous release and absorption, 99 percent ultra-pure melatonin (CRA-melatonin) that mimics the way the body naturally releases and maintains melatonin over a 7-hour period. Physician’s Seal®, founded in 2015, is a privately held company based in Boca Raton, Florida. It is committed to bringing cutting-edge life science applications to doctors and their patients. For more information, visit www.remfresh.com and connect with us on Facebook and You Tube.

Its sister subsidiary, IM HealthScience® (IMH) is the innovator of IBgard® and FDgard® for the dietary management of Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), respectively. In 2017, IMH added Fiber Choice®, a line of prebiotic fibers, to its product line via an acquisition. IMH® is a privately held company based in Boca Raton, Florida. It was founded in 2010 by a team of highly experienced pharmaceutical research and development and management executives. The company is dedicated to developing products to address overall health and wellness, including conditions with a high unmet medical need, such as digestive health. The IM HealthScience® advantage comes from developing products based on its patented, targeted-delivery technologies called Site Specific Targeting® (SST®). For more information, visit www.imhealthscience.com to learn about the company, or www.IBgard.com,  www.FDgard.com,and www.FiberChoice.com.

This information is for educational purposes only and is not meant to be a substitute for the advice of a physician or other health care professional. You should not use this information for diagnosing a health problem or disease. The company will strive to keep information current and consistent but may not be able to do so at any specific time. Generally, the most current information can be found on www.remfresh.com. Individual results may vary.

Data Presented at SLEEP 2018 Poster Session on Sleep Maintenance/Sleep Quality

Tuesday, June 5, 2018, 5-7pm

  • (Abstract 0419, Poster Board #104) Improvement in Sleep Maintenance and Sleep Quality with Ion Powered Pump Continuous Release and Absorption Melatonin: Results from a Self-Reported Patient Outcomes Study
    • David J. Seiden, M.D., FAASM, David C. Brodner, M.D., Syed M. Shah, Ph.D.

Visit Physician’s Seal® at booth 220 to learn more about REMfresh®.

The abstract is published in an online supplement of the journal, Sleep, which is available at http://www.sleepmeeting.org/docs/default-source/default-document-library/abstractbook2018.pdf?sfvrsn=2

[1] Ford, E.S., Cunningham, T.J., & Croft, J.B. (2015, May 1). Trends in Self-Reported Sleep Duration among US Adults from 1985 to 2012. Sleep, 38(5):829-832. doi: 10.5665/sleep.4684.

[2] Watson, N.F., Badr, M.S., Belenky, G., Bliwise, D.L., Buxton, G.M., Buysse, D.,…Tasali, E. (2015). Joint Consensus Statement of the American Academy of Sleep Medicine and Sleep Research Society on the Recommended Amount of Sleep for a Healthy Adult: Methodology and Discussion. Journal of Clinical Sleep Medicine, 11(8):931-952. doi:10.1176/appi.ajp.158.11.1856.

[3] Colten, H.R., & Altevogt, B.M. (Eds). (2006). Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem.  Institute of Medicine (US) Committee on Sleep Medicine and Research. Washington, DC: National Academies Press (US). doi: https://doi.org/10.17226/11617.

[4] Cappuccio, F.P., D’Elia, L., Strazzullo, P.,&  Miller, M.A. (2010). Sleep duration and all-cause mortality: a systematic review and meta-analysis of prospective studies. Sleep, 33(5):585-592

[5] For this clinical trial, the head-to-head comparison was with the 5 mg form; a 2 mg form of the comparator was not available.

[6] Zisapel, N. (2010). Melatonin and sleep. The Open Neuroendocrinology Journal, 3: 85-95.

[7] Among primary care physicians with a certification in sleep disorders who recommended a brand of modified-release melatonin. Quintiles IMS ProVoice July-September 2017 survey.

REFERENCE/SOURCE

Physician’s Seal® and REMfresh® (www.remfresh.com)

Dr. David C. Brodner, Center for Sinus, Allergy, and Sleep Wellness (http://www.brodnermd.com/sleep-hygiene.html)

Other related articles published in this Open Access Online Scientific Journal include the following:

2017

Ultra-Pure Melatonin Product Helps Maintain Sleep for Up to 7 Hours

https://pharmaceuticalintelligence.com/2017/06/11/ultra-pure-melatonin-product-helps-maintain-sleep-for-up-to-7-hours/

2016

Sleep Science

Genetic link to sleep and mood disorders

https://pharmaceuticalintelligence.com/2016/02/27/genetic-link-to-sleep-and-mood-disorders/

2015

Sleep quality, amyloid and cognitive decline

https://pharmaceuticalintelligence.com/2015/10/31/sleep-quality-amyloid-and-cognitive-decline/

2013

Day and Night Variation in Melatonin Level affects Plasma Membrane Redox System in Red Blood Cells

https://pharmaceuticalintelligence.com/2013/02/23/httpwww-ncbi-nlm-nih-govpubmed22561555/

 

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Collaboration that corrected a major problem in Hip Replacement Surgery

Reporter:Irina Robu, PhD

British orthopedic surgeon, John Charnley performed an operation that almost miraculously restored pain-free movement and active lives to patients whose hip-joint damage had made even the simple act of walking across the room difficult.

However, with the advance in materials Charnley removed the damaged joint and replaced it with one made of Teflon. He cut off the top of the thigh bone and inserted the end of a rod like metal implant into its center, cementing it in place. The round head of the implant fits perfectly into the Teflon hip socket. The procedure seemed to work, but within some year complications arose. The routine movement of the balls in the sockets made the Teflon wear quickly, loosening the implants. Charnley was required to operate on nearly 300 patients after they developed an infection around the implant.
Charnley filled that need with a more-resistant material called high-density polyethylene, which he began using in a new version of the artificial hip joint in 1962. In 1974, a noted orthopedic surgeon at Massachusetts General Hospital had a patient who had replaced surgery but his X-ray showed that a large portion of his thigh bone had been eaten away. Even after further tests, it was confirmed that the patient was cancer free. Harris saw three similar cases that year and many more over the years and it was defined as a new disease, periprosthetic osteolysis.

The condition led not just to implant failures, hip fractures, femur fractures, and complex reoperations to install new implants. It would take decades to devise a solution, in the form of a new material , highly crosslinked polyethylene invented in the labs of Harris and his Massachusetts Institute of Technology collaborator, Edward Merrill. A few years after Harris described the condition, in 1976, another separate research effort drawn its cause to tiny particles of the cement that secured the metal thigh implant inside the femur. Those particles caused a massive immune reaction that in turn triggered osteoclasts, the only cell in the body capable of destroying bone.

The discovery led to the condition being called “cement disease,” warning the development in the early 1980s of porous-metal implants that allowed the bone to grow into the implant and hold it in place in the thigh bone. Further research displayed that particles were still there, but of the polyethylene that made up the hip socket. Nevertheless, the polyethylene was far more durable than Teflon, the even motion of the ball in the socket caused wear, producing particles that set off the same destructive immune reaction.

By that discovery, researchers finally understood what was happening in the body. With so many hip replacement surgeries ongoing around the world, what was needed was a material more durable as polyethylene. Harris had asked patients to donate implants for study after they died, and he worked with lab members to examine them under a scanning electron microscope. The long, skinny molecules of high-density polyethylene, which normally curl had become aligned in the direction of the back-and-forth motion of the joint.

Harris worked with Merrill who mentioned that he can created polyethylene into a new form: highly crosslinked polyethylene. Meanwhile in 1998, the first artificial hips using highly crosslinked polyethylene were put in patients and it shows a huge progress.

SOURCE
https://news.harvard.edu/gazette/story/2018/03/harvard-surgeon-publishes-vanishing-bone-conquering-a-stealth-disease-caused-by-total-hip-replacements/?utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Daily%20Gazette%2020180306

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