Role Of Patient Advocacy Research Articles

Patient-Centered Drug Approval: The Role of Patient Advocacy in the Drug Approval Process.

There is no funding to disclose. Mattingly reports advisory board fees from Summit Therapeutics and an educational grant from ALK, outside of this article. Simoni-Wastila has nothing to disclose. Mattingly took the lead in conceptualizing this Viewpoint article and writing the manuscript, along with Simoni-Wastila. Both authors contributed equally to manucript revision.

Correlation between the Nurses, Moral Sensitivity and the Observance of Patients' Rights in ICUs

Correlation between the Nurses, Moral Sensitivity and the Observance of Patients' Rights in ICUs

Designing and Testing the Model of Precedents and Outcomes of Islamic Work Ethics

Designing and Testing the Model of Precedents and Outcomes of Islamic Work Ethics

SC31.02 The Role of Patient Advocacy Groups

The role of Patient Advocacy organizations in the oncology health care delivery ecosystem is ever evolving and has moved well beyond its original role of solely advocating for services, research, care and understanding. The current field of patient advocacy has its roots in the patient rights movement of the 1970’s with groups like The National Welfare Rights Organization being instrumental in getting a patient bill of rights accepted by the Joint Commission on Accreditation of Healthcare Organizations in 1972.1 The transformation was further accelerated in 1991 with the formation of the FDA Patient Representative Program and has continued to expand over time with patient advocates now being involved in the entire care continuum. In this presentation I will focus my attention on examples of the ever evolving and expanding role of patient advocacy highlighted by projects developed and led by “partner” foundations the Bonnie J. Addario Lung Cancer Foundation (ALCF) and the Addario Lung Cancer Medical Institute (ALCMI). The disparities in lung cancer treatment and outcomes among underserved populations are well documented.2 Further, 80% of cancer patients are treated in the community hospital setting yet may not receive the same level of care as those treated at leading academic centers. The ALCF Community Hospital Centers of Excellence (COE) program addresses this unmet need. The COE program is a patient-centric model for lung cancer that establishes a standard of care for community hospitals which often treat underserved patient populations. The COE program, which currently includes 13 hospitals in regions of high unmet need, aims to improve the standard of care, patient experience and patient outcome by offering patients and caregivers the same type of multi-disciplinary and comprehensive care provided at leading academic centers. ALCF also provides lung cancer education and services to patients, caregivers and the community. The COE program tracks patient process data longitudinally for multiple quality-of-care metrics, including disease stage at diagnosis; molecular testing; tumor board review; time from diagnosis to treatment; treatment type; and clinical trial participation. Site data will also be monitored to provide a contextual picture of the program including total patients seen, demographics, insurance mix, rates and outcomes of molecular testing among other metrics. Data is analyzed across the COE community and against comparator groups to demonstrate impact of the COE program.3 The U.S. National Institutes of Health database currently lists over 45,000 cancer-related clinical trials worldwide.4 Unfortunately, more than 20% of these trials will never complete, for reasons unrelated to the effectiveness of the intervention that’s being tested. The most common reason for 20% of all clinical trials never finishing is poor patient accrual. One of the most common reasons for low accrual is procedural inefficiencies such as complexities in enrolling in the trial itself and the informed consent process. In 2014, ALCMI launched a prospective study to characterize somatic and germline genomics of adolescents and young adult (AYA) patients.5 It is estimated that less than 2% of those newly diagnosed with lung cancer globally are AYA, thus presenting a striking recruitment challenge. To address this challenge, ALCMI's study workflow included building a dedicated website3 enabling remote screening and e-consenting so patients could participate from their homes anywhere in the world while, in parallel, ALCF employed social media to educate patients on the importance of comprehensive genomic profiling and increasing awareness of the study via grass-roots patient blogging. Together, ALCMI and ALCF bring “research to the patient.” Accrual opened July 23, 2014 and in the first 5 weeks of the study, 37 subjects consented. Of the 37 initially consented, 35 enrolled via the remote web-portal. As of June 15 2016, 104 subjects are enrolled (128 consented) in the study from 10 countries following a social media campaign. Of the 104 subjects enrolled to date, 49% entered the study via the remote study portal with the balance recruited locally by participating ALCMI study sites. As briefly outlined above, patient advocacy organizations have moved well beyond their original patient supportive role and have become key players in the oncology healthcare delivery and clinical research ecosystems. As the healthcare system continues to evolve and become more complex so will the role of patient advocacy organizations. To address these challenges, there will be even greater need for innovation, sharing of data and resources, increased infrastructure and mission sophistication, the need to avoid overlap and duplication, and a laser focus on providing meaningful improvement in the availability, transparency and affordability of healthcare.

Ethical Crossroads: Expanded Access, Patient Advocacy, and the #SaveJosh Social Media Campaign

Expanded access programs raise complex ethical dilemmas regarding the use of experimental medicines to treat life-threatening medical conditions – issues for which there are no simple, monolithic solutions. Beyond the risks to an individual, how does society or a company balance the immediate needs of a critically ill individual versus the potential needs of many future patients? This article offers insights into and learning experiences from the case of a 7-year-old boy whose family sought access to an experimental antiviral medicine being developed by Chimerix, where the author was Chief Executive Officer. The high-profile #SaveJosh social media campaign helped to catalyze and crystalize the international debate on issues of ethics and equity in expanded access, raising questions regarding the role of patient advocacy and the impact of social media on healthcare and the biopharmaceutical industry. Additionally, the #SaveJosh campaign demonstrated how easily thoughtful dialogue can be overwhelmed by a hyper-immediacy that increases the intensity and scrutiny under which these issues must be addressed. Given that the decision to grant an expanded access request lies solely with the leadership of the company developing the experimental medicine, management must evaluate and balance a request against what is known about the safety and efficacy of the compound, where it is in its testing pathway, and any other complexities or risks identified during the development process. Furthermore, companies must craft and be prepared to explain their rationale, including the right not to make an experimental medicine available, to regulators, legislators, patient advocates, and patients in need.

What are the roles and valued attributes of a Trial Steering Committee? Ethnographic study of eight clinical trials facing challenges.

BackgroundClinical trials oversight by a Trial Steering Committee (TSC) is mandated by Good Clinical Practice. This study used qualitative methods to explore the role and valued attributes of the TSC to inform planned updates of Medical Research Council guidance and TSC terms of reference.MethodsAn ethnographic study was conducted during 2013–2014. TSC and Trial Management Group meetings from eight trials were observed and audio-recorded, and semi-structured interviews conducted with purposively sampled key informants: independent and non-independent TSC members, trial sponsor representatives, funder representatives and chief investigators. The selected trials were currently recruiting and dealing with challenging scenarios. Data were analysed thematically and findings triangulated and integrated to give a multi-perspective account of the role and valued attributes of a TSC.ResultsEight TSC meetings and six Trial Management Group meetings were observed. Sixty-five interviews were conducted with 51 informants. The two main roles played by the TSC were quality assurance and patient advocacy. Quality assurance involved being a ‘critical friend’ or a provider of ‘tough love’. Factors influencing the ability of the TSC to fulfil this role included the TSC Chair, other independent TSC members and the model of the TSC and its fit with the trial subject. The role of the TSC as an advocate for patient well-being was perceived as paramount. Two attributes of TSC members emerged as critical: experience (of running a trial, trial oversight or in a clinical/methodological area) and independence. While independence was valued for giving impartiality, the lack of consensus about its definition and strict requirements of some funders made it difficult to operationalise.ConclusionsWe found tensions and ambiguities in the roles expected of TSCs and the attributes valued of TSC members. In particular, the requirements of independence and experience could conflict, impacting the TSCs’ quality assurance role. Concerns were raised regarding whose interests are served by funders’ criteria of independence; in particular, funders’ selection of TSC members was thought to potentially inhibit TSCs’ ability to fulfil their patient advocacy role. These findings should be incorporated in revising guidance and terms of reference for TSCs.

Rocking the boat: the link between transformational leadership and advocacy

This paper aims to develop and explore certain leadership skills in particular with regard to the notion of patient advocacy, as detailed in the case study (Appendix 1). The paper will initially investigate definitions and theories of leadership models, with specific attention focused on the ‘transformational’ model of leadership. The role of patient advocacy will then be examined and the author intends to establish links between the qualities in transformational leadership skills and the idealised role of patient's advocate. The article will conclude with the proposals related to future education and development, and the completion of the action plan (Appendix 2).

Organization, teamwork, and advocacy: Important skills needed by hospice family caregivers who manage medications.

121 Background: In the home hospice setting, family caregivers (CGs) often assume medication administration responsibilities traditionally performed by licensed nurses. Little is known about how to assess and support CG medication management skills. As part of an ongoing study of nurse-caregiver interactions in home hospice, we gathered data on CG medication management needs. Methods: A longitudinal, multicenter study of home hospice nurse visits captured audiorecorded communication between nurses and CGs. Participants included patients with cancer and their self-identified CGs who were recruited upon home hospice enrollment. The current sub-study included participants aged ≥65 and their family CGs from 7 hospice agencies. Two investigators independently coded transcriptions of the first audio recorded nurse home visit using a directive content analytic approach to map conversations to a previously published, interview-derived, framework for hospice medication management by CGs. Results: A total of 18 patients (mean age 76.5 [SD 10.7], 56% female) and their CGs (mean age 59.6 [SD13.4], 78% female) were included. Content analysis revealed that CG skills needed for medication management are not limited to drug knowledge. Complicated organizational skills are needed to track medication acquisition and dosing, record the use of short- and long-acting drugs with similar modes of action, and coordinate medication administration by multiple CGs. Teamwork skills are needed to help coordinate medication prescribing between specialist, primary, and hospice physicians. CGs also need symptom management skills regarding the proper selection of medications, as well as skills to manage side effects, inadvertent errors, and possible medication related-emergencies. CGs play a vital role in patient advocacy, alerting providers to the burden and quality of life issues related to medication use, including whether medications have intended or unintended effects, or are potentially unnecessary or causing harm. Conclusions: CGs must have multiple skills to effectively manage medications in home hospice. A systematic approach and intervention is needed to support CGs’ medication management skills.

Whole exome or genome sequencing: nurses need to prepare families for the possibilities.

A discussion of whole exome sequencing and the type of possible results patients and families should be aware of before samples are obtained. To find the genetic cause of a rare disorder, whole exome sequencing analyses all known and suspected human genes from a single sample. Over 20,000 detected DNA variants in each individual exome must be considered as possibly causing disease or disregarded as not relevant to the person's disease. In the process, unexpected gene variants associated with known diseases unrelated to the primary purpose of the test may be incidentally discovered. Because family members' DNA samples are often needed, gene variants associated with known genetic diseases or predispositions for diseases can also be discovered in their samples. Discussion paper. PubMed 2009-2013, list of references in retrieved articles, Google Scholar. Nurses need a general understanding of the scope of potential genomic information that may be revealed with whole exome sequencing to provide support and guidance to individuals and families during their decision-making process, while waiting for results and after disclosure. Nurse scientists who want to use whole exome sequencing in their study design and methods must decide early in study development if they will return primary whole exome sequencing research results and if they will give research participants choices about learning incidental research results. It is critical that nurses translate their knowledge about whole exome sequencing into their patient education and patient advocacy roles and relevant programmes of research.

Perceptions of health professionals towards the management of back pain in the context of work: a qualitative study.

BackgroundMusculoskeletal complaints have a significant impact on work in terms of reduced productivity, sickness absence and long term incapacity for work. This study sought to explore GPs’ and physiotherapists’ perceptions of sickness certification in patients with musculoskeletal problems.MethodsEleven (11) GPs were sampled from an existing general practice survey, and six (6) physiotherapists were selected randomly using ‘snowball’ sampling techniques, through established contacts in local physiotherapy departments. Semi-structured qualitative interviews were conducted with respondents lasting up to 30 minutes. The interviews were audio recorded and transcribed verbatim, following which they were coded using N-Vivo qualitative software and analysed thematically using the constant comparative methodology, where themes were identified and contrasted between and within both groups of respondents.ResultsThree themes were identified from the analysis: 1) Approaches to evaluating patients’ work problems 2) Perceived ability to manage ‘work and pain’, and 3) Policies and penalties in the work-place. First, physiotherapists routinely asked patients about their job and work difficulties using a structured (protocol-driven) approach, whilst GPs rarely used such structured measures and were less likely to enquire about patients’ work situation. Second, return to work assessments revealed a tension between GPs’ gatekeeper and patient advocacy roles, often resolved in favour of patients’ concerns and needs. Some physiotherapists perceived that GPs’ decisions could be influenced by patients’ demand for a sick certificate and their close relationship with patients made them vulnerable to manipulation. Third, the workplace was considered to be a specific source of strain for patients acting as a barrier to work resumption, and over which GPs and physiotherapists could exercise only limited control.ConclusionWe conclude that healthcare professionals need to take account of patients’ work difficulties, their own perceived ability to offer effective guidance, and consider the ‘receptivity’ of employment contexts to patients’ work problems, in order to ensure a smooth transition back to work.

Abstract P5-10-01: A systems approach to combine genomics and emerging therapeutics to discover new treatments for TNBC

Abstract Genomic analyses of patient tumors have unearthed an overwhelming number of recurrent somatic alterations in genes that undoubtedly have dramatic effects on breast tumor biology, clinical outcomes and responses to therapeutics. In triple negative breast cancer (TNBC), there is an urgent need to translate this emerging patient genomic data into new therapeutic paradigms. To develop genotype-specific therapies, we have established an isogenic cell-line drug screen that measures the impact of gene activation on a panel of emerging, clinically relevant compounds targeting a variety of cancer pathways. We seek to uncover genotype-dependent sensitivity to drugs, synthetic lethal relationships, and validate in breast cancer cells and in vivo mouse models. We focused on emerging compounds that are already approved or in testing for human use and we expect that this work will serve as a prelude to one or more clinical trials in TNBC. RESULTS: We have developed a synthetic-lethal interaction mapping strategy to uncover the impact of gene activation on responses to a panel of emerging therapeutics. We believe that this approach can identify core synthetic lethal interactions which underlie drug sensitivity and can be used as a foundation to identify patient populations that will selectively respond to drug treatments. We have developed a high-throughput screening platform that can rapidly and accurately assess the proliferative capacity of cell lines in response to a panel of inhibitors. We have generated a panel of isogenic cell lines which closely mimic the impact of recurrent gene mutations and overexpression common in breast cancer. We have currently generated 23 cell lines expressing wild-type and/or mutant forms of these genes. To date we have screened 12 known oncogenes against our panel of 94 emerging therapeutic compounds. Using this systems approach, the resulting interaction map highlights both known and novel connections between oncogene activation and drug responses and provides a modular roadmap for the exploration of synthetic lethal relationships. Based on the coordinate activity of multiple drugs targeting the same pathway, we identified oncogenes that can drive resistance to EGFR inhibitors and PI3K/AKT inhibitors. We also recapitulated a known synthetic lethal relationship between MYC and CDK inhibition which we have previously described and we are now evaluating in a clinical trial. Therefore, our approach identified both resistance and synthetic lethal relationships that have been independently described, indicating that this platform is a good model for predicting synthetic lethality in vivo. Several novel and previously uncharacterized connections were also uncovered, including novel connections between MYC activity and several promising drugs in clinical development. Synthetic-lethal interactions discovered using this chemical-genetic systems approach and their mechanistic validation will be described in the presentation. Furthermore, the important role of patient advocacy in developing this project will be described. CONCLUSION: A novel systems biology approach that uses chemical-genetic maps of oncogenes and emerging therapeutics can define synthetic-lethal interactions and actionable therapeutics for breast cancer. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P5-10-01.

Causes of Erroneous Fifth Edition Ratings

Abstract The application of the processes defined in the AMA Guides to the Evaluation of Permanent Impairment (AMA Guides) should result in reliable impairment ratings, ie, reproducible impairment ratings when the AMA Guides is applied appropriately. This article reviews some of the causes of erroneous impairment ratings based on misapplication of the fifth edition. The first two chapters of the AMA Guides provide the principles of assessing impairment, a key of which is that physicians must be independent and unbiased. Treating physicians cannot be unbiased because they inherently have a patient advocacy role, and they may use approaches that will increase the patient's impairment rating. Clinical and causation errors are common in evaluations; the greatest source of error is examiner inexperience. Evaluations should take place only when the patient is at maximum medical improvement, and evaluators must distinguish between impairment related to the alleged injury and that due to other injury, degenerative disease, or illness, not self-reports. A box shows common causes of erroneous impairment ratings based on the fifth edition. Both the rating physician and the party requesting the rating should recognize the high likelihood of error and should become knowledgeable about the AMA Guides, and the evaluating physician should have had formal training regarding use of the AMA Guides and should possess demonstrated competency in assessing impairment.

Barriers to the Patient Advocacy Role: An Integrative Review of the Literature

Barriers to the Patient Advocacy Role: An Integrative Review of the Literature

Patient advocacy

The role of patient advocate has long fallen under the purview of nurses and we should continue to take a leadership role in patient advocacy.

Nursing Advocacy in North Carolina

To identify the ways oncology nurses in one state advocate for patients, as well as the resources they use to do so. Descriptive, cross-sectional survey. North Carolina. 141 RNs in North Carolina who were members of the Oncology Nursing Society (ONS). Subjects completed a two-page, self-administered questionnaire comprised of fixed-choice and open-ended questions. Demographics, frequency of advocating for patient services, and awareness of ONS resources. Nurses in North Carolina advocate for patients in a variety of ways. A need exists to develop ongoing methods to keep nurses up to date on advocacy issues, as well as to establish mentoring opportunities for them. Nurses believe that they are most challenged in addressing patients' financial and insurance concerns. Oncology nurses frequently advocate for patients' needs. The findings provide direction for future initiatives to educate nurses about their role in patient advocacy and available resources. Ongoing education and research are needed to enhance the role of oncology nurses as patient advocates.

Developing a mid‐range theory of patient advocacy through concept analysis

The aim of this paper is to clarify and refine the concept of patient advocacy through synthesizing the advocacy literature in nursing and to establish a theoretical basis for future studies on patient advocacy in nursing. Patient advocacy is an essential component of the Registered Nurse professional role. During the past 30 years, the patient advocacy role has become more important, but the concept of patient advocacy lacks a consistent definition and research into nurses' patient advocacy roles is limited. There have been few quantitative empirical studies on patient advocacy in nursing. Walker and Avant's method of concept analysis was used as a guideline in examining the concept of patient advocacy through synthesizing the advocacy literature in English (1974-2006). A mid-range theory of patient advocacy emerges during the process of synthesizing and analysing the advocacy literature. Three core attributes of the concept of patient advocacy are identified: (1) safeguarding patients' autonomy; (2) acting on behalf of patients; and (3) championing social justice in the provision of health care. They reflect nurses' patient advocacy roles at both macro- and micro-social levels. Antecedents of patient advocacy occur at both macro- and micro-social levels and call for nurses' advocacy roles in the healthcare system. Consequences produced by nurses' patient advocacy behaviours are contextual. Nurses' patient advocacy behaviours not only can positively influence the patients, other nurses and the nursing profession, but also can cause negative consequences for nurses who take action to advocate for patients. The proposed mid-range theory may be useful in guiding advocacy practice in nursing and in guiding research in the advocacy area. The proposed theory needs to be furthered refined and tested in the future.

Patient Advocacy in the Perioperative Setting

A descriptive study was undertaken to define patient advocacy and perioperative nurses' role as advocates and to investigate perioperative nurses' perceptions of behaviors that represent advocacy in the perioperative setting. A purposive sample of 163 perioperative RNs from upstate New York was invited to participate in the study. A total of 57 responses were returned, and 33 individuals participated in audiotaped interviews. The four overarching themes that emerged from the interviews include protection, communication/giving voice, doing, and comfort and caring. These interrelated, overlapping themes represent nurses' definition, role, and experiences of patient advocacy in the perioperative setting.

A Matter of Principle: the Nearest Relative under the Mental Health Act 1983 and Proposals for Legislative Reform

Social Role Valorisation theory, advanced to enhance the lives of disadvantaged groups of people, has addressed community care and lay advocacy for patients and users but has ignored the roles of relatives and carers. [In this article, the term ‘patient’ is used to describe a person who is detained under the Mental Health Act, liable to be detained, or in hospital on an informal basis. The term ‘service user’ describes someone receiving psychiatric services but who is neither hospitalised nor subject to compulsion.] The nearest relative was introduced as a legal category under the Mental Health Act 1959 without a theoretical base, although it was perceived as a safeguard and a way of supporting advocacy for patients. If recent proposals to reform legislation come into force, the role of patient advocacy will be enhanced whilst the nearest relative will be replaced by the new roles of nominated person and carer. This paper reinforces the importance of using governing principles to guide legislation, as supported by the most comprehensive in‐depth research recently conducted into the nearest relative role.

Spirituality and medicine: a proposal.

Dissatisfaction with medical care has increased among patients and providers, despite unprecedented medical successes.1-3 This paradox may be caused by a number of possible reasons, including a higher degree of patient education, improved access to information, criticism of the profession by the media, emergence of alternative forms of medicine that make unrealistic promises, increased cost of care, fragmentation of care into specialties and subspecialties, and divestment of primary care of its original role of patient advocacy.

Diffusion of the Concept of Patient Advocacy

To examine the growth and diffusion through the USA and UK literature of nurses claims to patient advocacy. A bibliometric analysis of articles cited under the key descriptor "patient advocacy" in the International Nursing Index (INI) was undertaken. Analysis included output in 5-year accumulations from 1976 to 1995, and was focused on quantity of output and exposition of concerns through interpretation of the titles. Citation mapping was undertaken to trace dominant influences in the diffusion process. Titles and countries of origin of the journal along with year of publication were organized into a database to provide quantitative material on comparative output from the USA and the UK. Citation profiles of key influencing authors were examined. A role in patient advocacy was proposed in the American nursing literature in the late 1970s and in the British literature a decade later. Support for the role was evident in its use in professional organizations and schools. The pattern of dissemination illustrates the influence of American nursing on the professional role of nurses in the UK. On the basis of a stages model for diffusion of an innovation, patient advocacy has reached only preliminary stages of acceptance as an innovation in nursing.