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Posts Tagged ‘defining patient experience’


US Responses to Coronavirus Outbreak Expose Many Flaws in Our Medical System

Curator: Stephen J. Williams, Ph.D.

The  coronavirus pandemic has affected almost every country in every continent however, after months of the novel advent of novel COVID-19 cases, it has become apparent that the varied clinical responses in this epidemic (and outcomes) have laid bare some of the strong and weak aspects in, both our worldwide capabilities to respond to infectious outbreaks in a global coordinated response and in individual countries’ response to their localized epidemics.

 

Some nations, like Israel, have initiated a coordinated government-private-health system wide action plan and have shown success in limiting both new cases and COVID-19 related deaths.  After the initial Wuhan China outbreak, China closed borders and the government initiated health related procedures including the building of new hospitals. As of writing today, Wuhan has experienced no new cases of COVID-19 for two straight days.

 

However, the response in the US has been perplexing and has highlighted some glaring problems that have been augmented in this crisis, in the view of this writer.    In my view, which has been formulated after social discussion with members in the field ,these issues can be centered on three major areas of deficiencies in the United States that have hindered a rapid and successful response to this current crisis and potential future crises of this nature.

 

 

  1. The mistrust or misunderstanding of science in the United States
  2. Lack of communication and connection between patients and those involved in the healthcare industry
  3. Socio-geographical inequalities within the US healthcare system

 

1. The mistrust or misunderstanding of science in the United States

 

For the past decade, anyone involved in science, whether directly as active bench scientists, regulatory scientists, scientists involved in science and health policy, or environmental scientists can attest to the constant pressure to not only defend their profession but also to defend the entire scientific process and community from an onslaught of misinformation, mistrust and anxiety toward the field of science.  This can be seen in many of the editorials in scientific publications including the journal Science and Scientific American (as shown below)

 

Stepping Away from Microscopes, Thousands Protest War on Science

Boston rally coincides with annual American Association for the Advancement of Science (AAAS) conference and is a precursor to the March for Science in Washington, D.C.

byLauren McCauley, staff writer

Responding to the troubling suppression of science under the Trump administration, thousands of scientists, allies, and frontline communities are holding a rally in Boston’s Copley Square on Sunday.

#standupforscience Tweets

 

“Science serves the common good,” reads the call to action. “It protects the health of our communities, the safety of our families, the education of our children, the foundation of our economy and jobs, and the future we all want to live in and preserve for coming generations.”

It continues: 

But it’s under attack—both science itself, and the unalienable rights that scientists help uphold and protect. 

From the muzzling of scientists and government agencies, to the immigration ban, the deletion of scientific data, and the de-funding of public science, the erosion of our institutions of science is a dangerous direction for our country. Real people and communities bear the brunt of these actions.

The rally was planned to coincide with the annual American Association for the Advancement of Science (AAAS) conference, which draws thousands of science professionals, and is a precursor to the March for Science in Washington, D.C. and in cities around the world on April 22.

 

Source: https://www.commondreams.org/news/2017/02/19/stepping-away-microscopes-thousands-protest-war-science

https://images.app.goo.gl/UXizCsX4g5wZjVtz9

 

https://www.washingtonpost.com/video/c/embed/85438fbe-278d-11e7-928e-3624539060e8

 

 

The American Association for Cancer Research (AACR) also had marches for public awareness of science and meaningful science policy at their annual conference in Washington, D.C. in 2017 (see here for free recordings of some talks including Joe Biden’s announcement of the Cancer Moonshot program) and also sponsored events such as the Rally for Medical Research.  This patient advocacy effort is led by the cancer clinicians and scientific researchers to rally public support for cancer research for the benefit of those affected by the disease.

Source: https://leadingdiscoveries.aacr.org/cancer-patients-front-and-center/

 

 

     However, some feel that scientists are being too sensitive and that science policy and science-based decision making may not be under that much of a threat in this country. Yet even as some people think that there is no actual war on science and on scientists they realize that the public is not engaged in science and may not be sympathetic to the scientific process or trust scientists’ opinions. 

 

   

From Scientific American: Is There Really a War on Science? People who oppose vaccines, GMOs and climate change evidence may be more anxious than antagonistic

 

Certainly, opponents of genetically modified crops, vaccinations that are required for children and climate science have become louder and more organized in recent times. But opponents typically live in separate camps and protest single issues, not science as a whole, said science historian and philosopher Roberta Millstein of the University of California, Davis. She spoke at a standing-room only panel session at the American Association for the Advancement of Science’s annual meeting, held in Washington, D.C. All the speakers advocated for a scientifically informed citizenry and public policy, and most discouraged broadly applied battle-themed rhetoric.

 

Source: https://www.scientificamerican.com/article/is-there-really-a-war-on-science/

 

      In general, it appears to be a major misunderstanding by the public of the scientific process, and principles of scientific discovery, which may be the fault of miscommunication by scientists or agendas which have the goals of subverting or misdirecting public policy decisions from scientific discourse and investigation.

 

This can lead to an information vacuum, which, in this age of rapid social media communication,

can quickly perpetuate misinformation.

 

This perpetuation of misinformation was very evident in a Twitter feed discussion with Dr. Eric Topol, M.D. (cardiologist and Founder and Director of the Scripps Research Translational  Institute) on the US President’s tweet on the use of the antimalarial drug hydroxychloroquine based on President Trump referencing a single study in the International Journal of Antimicrobial Agents.  The Twitter thread became a sort of “scientific journal club” with input from international scientists discussing and critiquing the results in the paper.  

 

Please note that when we scientists CRITIQUE a paper it does not mean CRITICIZE it.  A critique is merely an in depth analysis of the results and conclusions with an open discussion on the paper.  This is part of the normal peer review process.

 

Below is the original Tweet by Dr. Eric Topol as well as the ensuing tweet thread

 

https://twitter.com/EricTopol/status/1241442247133900801?s=20

 

Within the tweet thread it was discussed some of the limitations or study design flaws of the referenced paper leading the scientists in this impromptu discussion that the study could not reasonably conclude that hydroxychloroquine was not a reliable therapeutic for this coronavirus strain.

 

The lesson: The public has to realize CRITIQUE does not mean CRITICISM.

 

Scientific discourse has to occur to allow for the proper critique of results.  When this is allowed science becomes better, more robust, and we protect ourselves from maybe heading down an incorrect path, which may have major impacts on a clinical outcome, in this case.

 

 

2.  Lack of communication and connection between patients and those involved in the healthcare industry

 

In normal times, it is imperative for the patient-physician relationship to be intact in order for the physician to be able to communicate proper information to their patient during and after therapy/care.  In these critical times, this relationship and good communication skills becomes even more important.

 

Recently, I have had multiple communications, either through Twitter, Facebook, and other social media outlets with cancer patients, cancer advocacy groups, and cancer survivorship forums concerning their risks of getting infected with the coronavirus and how they should handle various aspects of their therapy, whether they were currently undergoing therapy or just about to start chemotherapy.  This made me realize that there were a huge subset of patients who were not receiving all the information and support they needed; namely patients who are immunocompromised.

 

These are patients represent

  1. cancer patient undergoing/or about to start chemotherapy
  2. Patients taking immunosuppressive drugs: organ transplant recipients, patients with autoimmune diseases, multiple sclerosis patients
  3. Patients with immunodeficiency disorders

 

These concerns prompted me to write a posting curating the guidance from National Cancer Institute (NCI) designated cancer centers to cancer patients concerning their risk to COVID19 (which can be found here).

 

Surprisingly, there were only 14 of the 51 US NCI Cancer Centers which had posted guidance (either there own or from organizations like NCI or the National Cancer Coalition Network (NCCN).  Most of the guidance to patients had stemmed from a paper written by Dr. Markham of the Fred Hutchinson Cancer Center in Seattle Washington, the first major US city which was impacted by COVID19.

 

Also I was surprised at the reactions to this posting, with patients and oncologists enthusiastic to discuss concerns around the coronavirus problem.  This led to having additional contact with patients and oncologists who, as I was surprised, are not having these conversations with each other or are totally confused on courses of action during this pandemic.  There was a true need for each party, both patients/caregivers and physicians/oncologists to be able to communicate with each other and disseminate good information.

 

Last night there was a Tweet conversation on Twitter #OTChat sponsored by @OncologyTimes.  A few tweets are included below

https://twitter.com/OncologyTimes/status/1242611841613864960?s=20

https://twitter.com/OncologyTimes/status/1242616756658753538?s=20

https://twitter.com/OncologyTimes/status/1242615906846547978?s=20

 

The Lesson:  Rapid Communication of Vital Information in times of stress is crucial in maintaining a good patient/physician relationship and preventing Misinformation.

 

3.  Socio-geographical Inequalities in the US Healthcare System

It has become very clear that the US healthcare system is fractioned and multiple inequalities (based on race, sex, geography, socio-economic status, age) exist across the whole healthcare system.  These inequalities are exacerbated in times of stress, especially when access to care is limited.

 

An example:

 

On May 12, 2015, an Amtrak Northeast Regional train from Washington, D.C. bound for New York City derailed and wrecked on the Northeast Corridor in the Port Richmond neighborhood of Philadelphia, Pennsylvania. Of 238 passengers and 5 crew on board, 8 were killed and over 200 injured, 11 critically. The train was traveling at 102 mph (164 km/h) in a 50 mph (80 km/h) zone of curved tracks when it derailed.[3]

Some of the passengers had to be extricated from the wrecked cars. Many of the passengers and local residents helped first responders during the rescue operation. Five local hospitals treated the injured. The derailment disrupted train service for several days. 

(Source Wikipedia https://en.wikipedia.org/wiki/2015_Philadelphia_train_derailment)

What was not reported was the difficulties that first responders, namely paramedics had in finding an emergency room capable of taking on the massive load of patients.  In the years prior to this accident, several hospitals, due to monetary reasons, had to close their emergency rooms or reduce them in size. In addition only two in Philadelphia were capable of accepting gun shot victims (Temple University Hospital was the closest to the derailment but one of the emergency rooms which would accept gun shot victims. This was important as Temple University ER, being in North Philadelphia, is usually very busy on any given night.  The stress to the local health system revealed how one disaster could easily overburden many hospitals.

 

Over the past decade many hospitals, especially rural hospitals, have been shuttered or consolidated into bigger health systems.  The graphic below shows this

From Bloomberg: US Hospital Closings Leave Patients with Nowhere to go

 

 

https://images.app.goo.gl/JdZ6UtaG3Ra3EA3J8

 

Note the huge swath of hospital closures in the midwest, especially in rural areas.  This has become an ongoing problem as the health care system deals with rising costs.

 

Lesson:  Epidemic Stresses an already stressed out US healthcare system

 

Please see our Coronavirus Portal at

https://pharmaceuticalintelligence.com/coronavirus-portal/

 

for more up-to-date scientific, clinical information as well as persona stories, videos, interviews and economic impact analyses

and @pharma_BI

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Ethics Behind Genetic Testing in Breast Cancer: A Webinar by Laura Carfang of survivingbreastcancer.org

Reporter: Stephen J. Williams, PhD

The following are Notes from a Webinar sponsored by survivingbreastcancer.org  on March 12,2020.

The webinar started with a brief introduction of attendees , most who are breast cancer survivors.  Survivingbreastcancer.org is an organization committed to supplying women affected with breast cancer up to date information, including podcasts, webinars, and information for treatment, care, and finding support and support groups.

Some of the comments of survivors:

  • being strong
  • making sure to not feel overwhelmed on initial diagnosis
  • get good information
  • sometimes patients have to know to ask for genetic testing as physicians may not offer it

Laura Carfang discussed her study results presented at  a bioethics conference in Clearwater, FL   on issues driving breast cancer patient’s  as well as at-risk women’s decision making process for genetic testing.  The study was a phenomenological study in order to determine, through personal lived experiences, what are pivotal choices to make genetic testing decisions in order to improve clinical practice.

The research involved in depth interviews with 6 breast cancer patients (all women) who had undergone breast cancer genetic testing.

Main themes coming from the interviews

  • information informing decisions before diagnosis:  they did not have an in depth knowledge of cancer or genetics or their inherent risk before the diagnosis.
  • these are my genes and I should own it: another common theme among women who were just diagnosed and contemplating whether or not to have genetic testing
  • information contributing to decision making after diagnosis: women wanted the option, and they wanted to know if they carry certain genetic mutations and how it would guide their own personal decision to choose the therapy they are most comfortable with and gives them the best chance to treat their cancer (the decision and choice is very personal)
  • communicating to family members and children was difficult for the individual affected;  women found that there were so many ramifications about talking with family members (how do I tell children, do family members really empathize with what I am going through).  Once women were tested they felt a great strain because they now were more concerned with who in their family (daughters) were at risk versus when they first get the diagnosis the bigger concern was obtaining information.
  • Decision making to undergo genetic testing not always linear but a nonlinear process where women went from wanting to get tested for the information to not wanting to get tested for reasons surrounding negative concerns surrounding knowing results (discrimination based on results, fear of telling family members)
  • Complex decision making involves a shift or alteration in emotion
  • The Mayo Clinic has come out with full support of genetic testing and offer to any patient.

Additional resources discussed was a book by Leslie Ferris Yerger “Probably Benign” which discusses misdiagnoses especially when a test comes back as “probably benign” and how she found it was not.

 

for more information on further Podcasts and to sign up for newsletters please go to https://www.survivingbreastcancer.org/

and @SBC_org

More articles on this Online Open Access Journal on Cancer and Bioethics Include:

Ethical Concerns in Personalized Medicine: BRCA1/2 Testing in Minors and Communication of Breast Cancer Risk

Tweets and Re-Tweets by @Pharma_BI ‏and @AVIVA1950 at 2019 Petrie-Flom Center Annual Conference: Consuming Genetics: Ethical and Legal Considerations of New Technologies, Friday, May 17, 2019 from 8:00 AM to 5:00 PM EDT @Harvard_Law

Genomics & Ethics: DNA Fragments are Products of Nature or Patentable Genes?

Study Finds that Both Women and their Primary Care Physicians Confusion over Ovarian Cancer Symptoms May Lead to Misdiagnosis

 

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Real Time Coverage @BIOConvention #BIO2019: Understanding the Voices of Patients: Unique Perspectives on Healthcare; June 4 11:00 AM

Reporter: Stephen J. Williams, PhD @StephenJWillia2

 

Description

The role of the patient has evolved dramatically over the past decade. Not only are patients increasingly more involved in their healthcare decision making, they are also passionate advocates who work tirelessly to advance drug development research and development and secure a public policy environment that is patient-centric. Join a discussion with patient advocates as they discuss their journeys to diagnosis and their viewpoints on our healthcare system. They will share their perspectives on what it means to be a patient and how they are advocating in their own unique ways to achieve a common goal: bringing new treatments to patients.

Speakers
Christopher Anselmo: affected by MS but did not understand why he should be involved in a study at the time or share your story but he saw others who benefited from both of these and now is fervent patient advocate. Each patient is worth their weight in gold as needed for other patient support.  The why needs to be asked of oneself before go out to other patients or into new trials. Might not see through to end if don’t have that discussion of why doing this.
Eve Bukowski:  she had stomach aches, went to hospital, and diagnosed with constipation, but had stage III colon cancer.  She was campaigning for Hillary Clinton but then started to campaign for her life.  She wound up having multiple therapies and even many I/O trials.  Fighting cancer is a mental challenge.   She has been fighting for eleven years but has an amazing strength and will.
Emily Kramer: cystic fibrosis patient.  Advocates for research as she has a mutant allele (nonsense mut) that is not targeted by the current new therapy against known mutants of CFTR.  So started Emily’s Entourage for this orphan of an orphan disease.  Funded $4 million in grants and helped develop a new startup and get early seed funding.  Noticed that the infrastructure to get these drugs to market was broken and also is investing to shore up these breaks in drug pipeline infrastructure for orphan diseases. For progressive diseases she would like drug developers to shift the timelines or speed with which they get to take a chance and try that new possibility. As a patient advocacy org, they want to partner every step of the way with biotech/pharma, they understand co’s and stakeholders can only do so much but let’s break out of convention.
Julie: many patient advocacy groups go person to person and make a support network.

Please follow LIVE on TWITTER using the following @ handles and # hashtags:

@Handles

@pharma_BI

@AVIVA1950

@BIOConvention

# Hashtags

#BIO2019 (official meeting hashtag)

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Multiple factors related to initial trial design may predict low patient accrual for cancer clinical trials

Reporter: Stephen J. Williams, Ph.D.

UPDATED 5/15/2019

A recently published paper in JCNI highlights results determining factors which may affect cancer trial patient accrual and the development of a predictive model of accrual issues based on those factors.

To hear a JCNI podcast on the paper click here

but below is a good posting from scienmag.com which describes their findings:

Factors predicting low patient accrual in cancer clinical trials

source: http://scienmag.com/factors-predicting-low-patient-accrual-in-cancer-clinical-trials/

Nearly one in four publicly sponsored cancer clinical trials fail to enroll enough participants to draw valid conclusions about treatments or techniques. Such trials represent a waste of scarce human and economic resources and contribute little to medical knowledge. Although many studies have investigated the perceived barriers to accrual from the patient or provider perspective, very few have taken a trial-level view and asked why certain trials are able to accrue patients faster than expected while others fail to attract even a fraction of the intended number of participants. According to a study published December 29 in the JNCI: Journal of the National Cancer Institute, a number of measurable trial characteristics are predictive of low patient accrual.

Caroline S. Bennette, M.P.H., Ph.D., of the Pharmaceutical Outcomes Research and Policy Program, University of Washington, Seattle, and colleagues from the University of Washington and the Fred Hutchinson Cancer Research Center analyzed information on 787 phase II/III clinical trials sponsored by the National Clinical Trials Network (NCTN; formerly the Cooperative Group Program) launched between 2000 and 2011. After excluding trials that closed because of toxicity or interim results, Bennette et al. found that 145 (18%) of NCTN trials closed with low accrual or were accruing at less than 50% of target accrual 3 years or more after opening.

The authors identified potential risk factors from the literature and interviews with clinical trial experts and found multiple trial-level factors that were associated with poor accrual to NCTN trials, such as increased competition for patients from currently ongoing trials, planning to enroll a higher proportion of the available patient population, and not evaluating a new investigational agent or targeted therapy. Bennette et al. then developed a multivariable prediction model of low accrual using 12 trial-level risk factors, which they reported had good agreement between predicted and observed risks of low accrual in a preliminary validation using 46 trials opened between 2012 and 2013.

The researchers conclude that “Systematically considering the overall influence of these factors could aid in the design and prioritization of future clinical trials…” and that this research provides a response to the recent directive from the Institute of Medicine to “improve selection, support, and completion of publicly funded cancer clinical trials.”

In an accompanying editorial, Derek Raghavan, M.D., Levine Cancer Institute, writes that the focus needs to be on getting more patients involved in trials, saying, “we should strive to improve trial enrollment, giving the associated potential for improved results. Whether the basis is incidental, because of case selection bias, or reflects the support available to trial patients has not been determined, but the fact remains that outcomes are better.”

###

Contact info:

Article: Caroline S. Bennette, M.P.H., Ph.D., cb11@u.washington.edu

Editorial: Derek Raghavan, M.D., derek.raghavan@carolinashealthcare.org

Other investigators also feel that initial trial design is of UTMOST importance for other reasons, especially in the era of “precision” or “personalized” medicine and why the “basket trial” or one size fits all trial strategy is not always feasible.

In Why the Cancer Research Paradigm Must Transition to “N-of-1” Approach

Dr. Maurie Markman, MD gives insight into why the inital setup of a trial and the multi-center basket type of  accrual can be a problematic factor in obtaining meaningful cohorts of patients with the correct mutational spectrum.

The anticancer clinical research paradigm has rapidly evolved so that subject selection is increasingly based on the presence or absence of a particular molecular biomarker in the individual patient’s malignancy. Even where eligibility does not mandate the presence of specific biological features, tumor samples are commonly collected and an attempt is subsequently made to relate a particular outcome (eg, complete or partial objective response rate; progression-free or overall survival) to the individual cancer’s molecular characteristics.

One important result of this effort has been the recognition that there are an increasing number of patient subsets within what was previously—and incorrectly—considered a much larger homogenous patient population; for example, non–small cell lung cancer (NSCLC) versus EGFR-mutation–positive NSCLC. And, while it may still be possible to conduct phase III randomized trials involving a relatively limited percentage of patients within a large malignant entity, extensive and quite expensive effort may be required to complete this task. For example, the industry-sponsored phase III trial comparing first-line crizotinib with chemotherapy (pemetrexed plus either carboplatin or cisplatin) in ALK-rearrangement–positive NSCLC, which constitutes 3% to 5% of NSCLCs, required an international multicenter effort lasting 2.5 years to accrue the required number of research subjects.1

But what if an investigator, research team, or biotech company desired to examine the clinical utility of an antineoplastic in a patient population representing an even smaller proportion of patients with NSCLC such as in the 1% of the patient population with ROS1 abnormalities,2 or in a larger percentage of patients representing 4%-6% of patients with a less common tumor type such as ovarian cancer? How realistic is it that such a randomized trial could ever be conducted?

Further, considering the resources required to initiate and successfully conduct a multicenter international phase III registration study, it is more than likely that in the near future only the largest pharmaceutical companies will be in a position to definitively test the clinical utility of an antineoplastic in a given clinical situation.

One proposal to begin to explore the benefits of targeted antineoplastics in the setting of specific molecular abnormalities has been to develop a socalled “basket trial” where patients with different types of cancers with varying treatment histories may be permitted entry, assuming a well-defined molecular target is present within their cancer. Of interest, several pharmaceutical companies have initiated such clinical research efforts.

Yet although basket trials represent an important research advance, they may not provide the answer to the molecular complexities of cancer that many investigators believe they will. The research establishment will have to take another step toward innovation to “N-of-1” designs that truly explore the unique nature of each individual’s cancer.

Trial Illustrates Weaknesses

A recent report of the results of one multicenter basket trial focused on thoracic cancers demonstrates both the strengths but also a major fundamental weakness of the basket trial approach.3

However, the investigators were forced to conclude that despite accrual of more than 600 patients onto a study conducted at two centers over a period of approximately 2 years, “this basket trial design was not feasible for many of the arms with rare mutations.”3

They concluded that they needed a larger number of participating institutions and the ability to adapt the design for different drugs and mutations. So the question to be asked is as follows: Is the basket-type approach the only alternative to evaluate the clinical relevance of a targeted antineoplastic in the presence of a specific molecular abnormality?

Of course, the correct answer to this question is surely: No!

– See more at: http://www.onclive.com/publications/Oncology-live/2015/July-2015/Why-the-Cancer-Research-Paradigm-Must-Transition-to-N-of-1-Approach#sthash.kLGwNzi3.dpuf

The following is a video on the website ClinicalTrials.gov which is a one-stop service called EveryClinicalTrial to easily register new clinical trials and streamline the process:

 

UPDATED 5/15/2019

Another possible roadblock to patient accrual has always been the fragmentation of information concerning the availability of clinical trails and coordinating access among the various trial centers, as well as performing analytics on trial data to direct new therapeutic directions.  The NIH has attempted to circumvent this problem with the cancer trials webpage trials.gov however going through the vast number of trials, patient accrual requirements, and finding contact information is a daunting task.  However certain clinical trial marketplaces are now being developed which may ease access problems to clinical trials as well as data analytic issues, as highlighted by the Scientist.com article below:

Scientist.com Launches Trial Insights, A Transformative Clinical Trials Data Analytics Solution

The world’s largest online marketplace rolls out first original service, empowering researchers with on demand insights into clinical trials to help drive therapeutic decisions

SAN DIEGO–(BUSINESS WIRE)–Scientist.com, the online marketplace for outsourced research, announced today the launch of Trial Insights, a digital reporting solution that simplifies data produced through clinical trial, biomarker and medical diagnostic studies into an intuitive and user-friendly dashboard. The first of its kind, Trial Insights curates publicly available data nightly from information hubs such as clinicaltrials.gov and customizes it to fit a researcher or research organization’s specific project needs.

Trial Insights, new clinical trial reporting solution, allows researchers to keep track of the evolving landscape of drugs, diseases, sponsors, investigators and medical devices important to their work.

Tweet this

“Trial Insights offers researchers an easy way to navigate the complexity of clinical trials information,” said Ron Ranauro, Founder of Incite Advisors. “Since Trial Insights’ content is digitally curated, researchers can continuously keep track of the evolving landscape of drugs, diseases, sponsors, investigators and medical devices important to their work.”

As the velocity, variety and veracity of data available on sites like clinicaltrials.gov continues to increase, the ability to curate it becomes more valuable to different audiences. With the advancement of personalized medicine, it is important to make the data accessible to the health care and patient communities. Information found on the Trial Insights platform can help guide decision making across the pharmaceutical, biotechnology and contract research organization industries as clinical trial data is a primary information source for competitive intelligence, research planning and clinical study planning.

“We are extremely excited to launch the first Scientist.com exclusive, original service offering to our clients in the life sciences,” said Mark Herbert, Scientist.com Chief Business Officer. “Our goal at Scientist.com is to help cure all diseases by 2050, and we believe solutions like Trial Insights, which greatly simplifies access to and reporting of clinical trial data, will get us one step closer to reaching that goal.”

source: https://www.businesswire.com/news/home/20190416005362/en/Scientist.com-Launches-Trial-Insights-Transformative-Clinical-Trials?utm_source=TrialIO+List

 

Other article on this Open Access Journal on Cancer Clinical Trial Design include:

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Factors in Patient Experience

Larry H. Bernstein, MD, FCAP, Curator

LPBI

Defining Patient Experience

http://www.theberylinstitute.org/?page=definingpatientexp

“The definition will allow me as a driver in improving the patient experience at our organization to include those key elements (interactions, current culture, perceptions, across the continuum of care) in our discussions to encourage a more integrated, quality experience that exceeds the expectations of each patient.”

To develop the Institute’s definition of patient experience, we formed a work group of patient experience leaders from a cross-section of healthcare organizations. The group shared perspectives, insights and backgrounds on what patient experience means to them and collaboratively created this definition. We believe it provides a terrific starting point for the conversation around this important issue.

Critical to the understanding and application of this definition is a broader explanation of its key elements:

Interactions Culture Perceptions Continuum of Care
The orchestrated touch-points of people, processes, policies, communications, actions, and environment The vision, values, people (at all levels and in all parts of the organization) and community What is recognized, understood and remembered by patients and support people. Perceptions vary based on individual experiences such as beliefs, values, cultural background, etc. Before, during and after the delivery of care

The History of Patient Experience

Hear perspectives from two leading Patient Experience thought leaders. Wendy Leebov, Partner at Language of Caring, and Mary Malone, President of Malone Advisory Services, discuss the history of patient experience and its growth in the healthcare industry. Perfect as tools to share with growing patient experience professionals or to reenergize efforts for experienced leaders, learn about the many influences that led to the existing patient experience movement and how we all have an impact in this emerging field.

Learn more about the history of patient experience in the PX Body of Knowledge History course where you will grasp the core foundation of patient experience and review the evolving role of patient experience in healthcare today.

https://youtu.be/_kwZ-xeOj8Y

Defining Patient Experience

Authors: Jason A. Wolf PhD, Victoria Niederhauser DrPH, RN, Dianne Marshburn PhD, RN, NE-BC, Sherri L. LaVela PhD, MPH, MBA
Publication: Patient Experience Journal

In recent years, perceptions of performance and quality of healthcare organizations have begun to move beyond examining the provision of excellent clinical care, alone, and to consider and embrace the patient experience as an important indicator. There is a need to determine the extent to which clear and formal definitions exist, have common overarching themes, and/or have unique, but important constructs that should be considered more widely. In this article, we provide a 14-year synthesis of existing literature and other sources (2000-2014) that have been used to define patient experience. A total of 18 sources (articles or organizational websites) were identified that provided a tangible, explicit definition of patient experience. A narrative synthesis was undertaken to categorize literature (and other sources) according to constructs of the definitions provided. The objectives of the synthesis were to: (1) identify the key elements, constructs, and themes that were commonly and frequently cited in existing definitions of ‘patient experience,’ (2) summarize these findings into what might be considered a common shared definition, and (3) identify important constructs that may be missing from and may enhance existing definition(s). The overarching premise was to identify and promote a working definition of patient experience that is applicable and practical for research, quality improvement efforts, and general clinical practice. Our findings identified several concepts and recommendations to consider with regard to the definition of patient experience. First, the patient experience reflects occurrences and events that happen independently and collectively across the continuum of care. Also, it is important to move beyond results from surveys, for example those that specifically capture concepts such as ‘patient satisfaction,’ because patient experience is more than satisfaction alone. Embedded within patient experience is a focus on individualized care and tailoring of services to meet patient needs and engage them as partners in their care. Next, the patient experience is strongly tied to patients’ expectations and whether they were positively realized (beyond clinical outcomes or health status). Finally, the patient experience is integrally tied to the principles and practice of patient- and family- centered care. As patient experience continues to emerge as an important focus area across healthcare globally, the need for a standard consistent definition becomes even more evident, making it critical to ensure patient experience remains a viable, respected, and highly embraced part of the healthcare conversation.

Patient Experience Journal 2014;  1:(1), Article 3.
Available at: http://pxjournal.org/journal/vol1/iss1/3

In practice and research the concept of patient experience has had varied uses and is often discussed with little more explanation than the term itself. Although very little has been published about the complexities with regard to defining patient experience, the 2009 HealthLeaders Media Patient Experience Leadership Survey 3 discovered that when it comes to defining patient experience, there are widely divergent views within the healthcare industry. They found that 35% of respondents agreed that patient experience equals “patient-centered care,” 29% agreed it was “an orchestrated set of activities that is meaningfully customized for each patient,” and 23% said it involved “providing excellent customer service.” The remaining responses reflected patient experience meant, “creating a healing environment,” being “consistent with what’s measured by HCAHPS,” or “other” than the options provided in the survey. In asking the question, “Does your organization have a formal definition of patient experience?” of healthcare organizations in its recent Patient Experience Benchmarking Study, The Beryl Institute discovered that on average 45% of US-based hospitals1 and 35% of non US-based healthcare organizations reported having a formal definition. The question this raises is that as patient experience is identified as a priority item, would healthcare efforts be best served by having a formally accepted definition of patient experience?

The efforts that shaped The Beryl Institute’s definition came from the voices of practice and a review of current research and use in 2010. A workgroup of healthcare leaders from a variety of patient experience roles identified the key elements shaping their work in the patient experience. Within individual organizations, inquiries were made of peers and patients to identify key themes and these larger concepts were pulled together in collective data that was aligned around main themes. The four themes that emerged were personal interactions, organization culture, patient and family perceptions, and across the care continuum. From the themes, a definition was created and then validated through the broader Institute community for further feedback and refinement. The definition is currently being used (with or without adaptations) by a number of healthcare facilities globally as their own definition of patient experience. However, there is much ground yet to be covered in moving towards alignment around a clear and shared definition of patient experience. The purpose of this article was to provide a 14-year synthesis of existing literature and other sources that have been used to define patient experience. Given the breadth and depth of information, we aimed to examine key concepts and compare/contrast multiple definitions, and ultimately to recommend a working definition that we feel can be used to across healthcare settings to capture the patient experience.

Need for Definition We identified 18 sources (websites or articles) that explicitly provide a definition for the patient experience (Table 1). The latest data from both the most recent HeathLeader’s survey and The Beryl Institute’s State of Patient Experience benchmarking research identified patient experience as a top priority; however they also identify there is a divergent nature of patient experience and need for a clear and concise definition. In the article “What is the Patient Experience”? from the Gallup Business Journal, the authors’ suggest that the ideal patient experience is created by meeting four basic emotional needs: confidence, integrity, pride and passion, ultimately asserting that experience is about engaging patients. The author offers in closing, “Engaged healthcare is better healthcare, for everyone. And that’s the best definition of the patient experience”.6

Continuum of Care Several authors argue that the patient experience is not just one encounter, but spans over time and includes many touch points. In a recent publication, Deloitte LLP’s Health Sciences Practice7 contends that organizations need to focus on the patient experience to gain and maintain a competitive advantage. They define the patient experience as much broader than the care itself, describing specific touch points or times when there is interaction with the organization and the patient. Their definition, “The Patient Experience refers to the quality and value of all of the interactions—direct and indirect, clinical and nonclinical—spanning the entire duration of the patient/provider relationship” represents a continuum of interactions. In a recent article, although Stempniak8 does not define patient experience directly, he does offer two quotes that provide some insight. The first from Pat Ryan, CEO of Press Ganey who said, “Let’s look at the patient experience in total as reducing suffering and reducing anxiety… across the entire continuum of care, from the first phone call to the patient’s being discharged.” The second is a statement from Dr. Jim Merlino, Chief Experience Officer at the Cleveland Clinic who admits, the biggest challenge in this effort is figuring out where to start, and defining exactly what the “patient experience” means. Pemberton & Richardson9 provide an overview of a development process of a patient experience vision, told through a story and framed by a series of six active steps a patient goes through during an episode of care, which included: reputation, arrival, contract, stay, treatment and after stay. While there is no direct statement of how they defined the patient experience, they identified the importance of culture and staff engagement in driving an effective patient experience effort.

Beyond Survey Results Several articles argue that the patient experience should be defined more broadly than just using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey domains.

Aligned with Patient-Centered Care Principles Other definitions focus on patient-centered care principles. Weiss and Tyink13 discuss the opportunity to provide the ideal patient experience through creating a patient-centric culture. The components of a patientcentric culture encompass competent, high-quality care, personalized care, timely responses, care coordination, and are reliable and responsive. They suggest that the patient experience is about a brand experience and is driven by what happens at the point of contact between the patient, the practice, and the provider.

Focus on Expectations

Focus on Individualized Care

More than Satisfaction

As our review of literature and sources showed, there is an absence of a commonly used definition around patient experience in healthcare. While there has been increasing numbers of articles, research and writing on the subject in recent years, little has been seen in the way of coalescing around an accepted statement. Much of this is due to the reality that in all but a few cases a truly concise, applicable and replicable definition was not offered. Other influences may be the competing interests that influence the day-today operations of healthcare overall.

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