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Posts Tagged ‘defining patient experience’


 

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

Reporter: Stephen J. Williams, Ph.D.

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.”

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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:

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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