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J. Pers. Med., Volume 5, Issue 2 (June 2015) – 13 articles , Pages 50-228

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Open AccessReview
Market Access Advancements and Challenges in “Drug-Companion Diagnostic Test” Co-Development in Europe
J. Pers. Med. 2015, 5(2), 213-228; https://doi.org/10.3390/jpm5020213 - 12 Jun 2015
Cited by 9 | Viewed by 5822
Abstract
The pharma ecosphere is witnessing a measured transformation from the one-size-fits-all or blockbuster model of drugs to more informed and tailored personalized treatments that facilitate higher safety and efficacy for a relevant sub-population. However, with several breakthroughs still in a nascent stage, market [...] Read more.
The pharma ecosphere is witnessing a measured transformation from the one-size-fits-all or blockbuster model of drugs to more informed and tailored personalized treatments that facilitate higher safety and efficacy for a relevant sub-population. However, with several breakthroughs still in a nascent stage, market access becomes a crucial factor for commercial success, especially when it comes to co-creating value for pertinent stakeholders. This article highlights diverse issues from stakeholder perspectives in Europe, specifically the ones which require immediate resolution. Furthermore, the article also discusses case studies articulating potential solutions for the issues discussed. Full article
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Open AccessReview
Do Health Professionals Need Additional Competencies for Stratified Cancer Prevention Based on Genetic Risk Profiling?
J. Pers. Med. 2015, 5(2), 191-212; https://doi.org/10.3390/jpm5020191 - 09 Jun 2015
Cited by 5 | Viewed by 5813
Abstract
There is growing evidence that inclusion of genetic information about known common susceptibility variants may enable population risk-stratification and personalized prevention for common diseases including cancer. This would require the inclusion of genetic testing as an integral part of individual risk assessment of [...] Read more.
There is growing evidence that inclusion of genetic information about known common susceptibility variants may enable population risk-stratification and personalized prevention for common diseases including cancer. This would require the inclusion of genetic testing as an integral part of individual risk assessment of an asymptomatic individual. Front line health professionals would be expected to interact with and assist asymptomatic individuals through the risk stratification process. In that case, additional knowledge and skills may be needed. Current guidelines and frameworks for genetic competencies of non-specialist health professionals place an emphasis on rare inherited genetic diseases. For common diseases, health professionals do use risk assessment tools but such tools currently do not assess genetic susceptibility of individuals. In this article, we compare the skills and knowledge needed by non-genetic health professionals, if risk-stratified prevention is implemented, with existing competence recommendations from the UK, USA and Europe, in order to assess the gaps in current competences. We found that health professionals would benefit from understanding the contribution of common genetic variations in disease risk, the rationale for a risk-stratified prevention pathway, and the implications of using genomic information in risk-assessment and risk management of asymptomatic individuals for common disease prevention. Full article
Open AccessArticle
Perspectives of the Breast Cancer Survivorship Continuum: Diagnosis through 30 Months Post-Treatment
J. Pers. Med. 2015, 5(2), 174-190; https://doi.org/10.3390/jpm5020174 - 28 May 2015
Cited by 10 | Viewed by 5000
Abstract
This study explored breast cancer survivors’ perspectives regarding their experiences of the survivorship continuum from diagnosis through 30 months post-treatment. The sample included women (N = 379) with newly-diagnosed breast cancer undergoing treatment at a Midwestern university-affiliated cancer center. Semi-structured interviews were [...] Read more.
This study explored breast cancer survivors’ perspectives regarding their experiences of the survivorship continuum from diagnosis through 30 months post-treatment. The sample included women (N = 379) with newly-diagnosed breast cancer undergoing treatment at a Midwestern university-affiliated cancer center. Semi-structured interviews were conducted using the Lymphedema and Breast Cancer Questionnaire at time of diagnosis, post-operatively, quarterly during the first year, and then semi-annually thereafter through 30 months post-treatment. A mixed-methodology was used to analyze participants’ comments. Themes central to long-term survivorship experiences included social support, positive worldviews, breast cancer and lymphedema health literacy, religious/spiritual beliefs, self-empowerment, and recovery expectations. These themes were consistent with a psychoneuroimmunological model of health in which psychosocial variables mediate stress and influence health outcomes. Qualitative data showed that social support and positive worldviews were the two themes with the most significant impact on long-term breast cancer survivorship experiences. Survivors expressed a need to advance their health care literacy in order to share ownership of breast cancer and lymphedema treatment decisions. Since breast cancer is an immune-mediated disease, long-term survivorship planning should address psychosocial factors that influence the long-term psychological distress associated with immune dysfunction. Full article
(This article belongs to the Special Issue Long-term Cancer Survivorship)
Open AccessArticle
Barriers Prevent Patient Access to Personalized Therapies Identified by Molecular Tumor Profiling of Gynecologic Malignancies
J. Pers. Med. 2015, 5(2), 165-173; https://doi.org/10.3390/jpm5020165 - 21 May 2015
Cited by 6 | Viewed by 4410
Abstract
Objective. This study was designed to evaluate the ability of commercial molecular tumor profiling to discover actionable mutations and to identify barriers that might prevent patient access to personalized therapies. Methods. We conducted an IRB-approved retrospective review of 26 patients with gynecologic [...] Read more.
Objective. This study was designed to evaluate the ability of commercial molecular tumor profiling to discover actionable mutations and to identify barriers that might prevent patient access to personalized therapies. Methods. We conducted an IRB-approved retrospective review of 26 patients with gynecologic malignancies who underwent commercial tumor profiling at our institution during the first 18 months of test availability. Tumor profiles reported targeted therapies and clinical trials matched to patient-specific mutations. Data analysis consisted of descriptive statistics. Results. Most patients who underwent tumor profiling had serous epithelial ovarian, primary peritoneal, or fallopian tube carcinoma (46%). Patients underwent profiling after undergoing a median of two systemic therapies (range 0 to 13). A median of one targeted therapy was suggested per patient profile. Tumor profiling identified no clinically actionable mutations for seven patients (27%). Six patients sought insurance approval for a targeted therapy and two were declined (33%). One patient (4%) received a targeted therapy and this was discontinued due to tumor progression. Conclusions. There are formidable barriers to targeted therapy for patients with gynecologic malignancies. These barriers include a dearth of FDA-approved targeted agents for gynecologic malignancies, lack of third party insurance coverage and limited geographic availability of clinical trials. Full article
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Open AccessArticle
Establishing and Sustaining a Prospective Screening Program for Breast Cancer-Related Lymphedema at the Massachusetts General Hospital: Lessons Learned
J. Pers. Med. 2015, 5(2), 153-164; https://doi.org/10.3390/jpm5020153 - 20 May 2015
Cited by 23 | Viewed by 4746
Abstract
There has been an increasing call to prospectively screen patients with breast cancer for the development of breast cancer-related lymphedema (BCRL) following their breast cancer treatment. While the components of a prospective screening program have been published, some centers struggle with how to [...] Read more.
There has been an increasing call to prospectively screen patients with breast cancer for the development of breast cancer-related lymphedema (BCRL) following their breast cancer treatment. While the components of a prospective screening program have been published, some centers struggle with how to initiate, establish, and sustain a screening program of their own. The intent of this manuscript is to share our experience and struggles in establishing a prospective surveillance program within the infrastructure of our institution. It is our hope that by sharing our history other centers can learn from our mistakes and successes to better design their own prospective screening program to best serve their patient population. Full article
(This article belongs to the Special Issue Long-term Cancer Survivorship)
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Open AccessArticle
Phenotype-Driven Plasma Biobanking Strategies and Methods
J. Pers. Med. 2015, 5(2), 140-152; https://doi.org/10.3390/jpm5020140 - 14 May 2015
Cited by 5 | Viewed by 5188
Abstract
Biobank development and integration with clinical data from electronic medical record (EMR) databases have enabled recent strides in genomic research and personalized medicine. BioVU, Vanderbilt’s DNA biorepository linked to de-identified clinical EMRs, has proven fruitful in its capacity to extensively appeal to numerous [...] Read more.
Biobank development and integration with clinical data from electronic medical record (EMR) databases have enabled recent strides in genomic research and personalized medicine. BioVU, Vanderbilt’s DNA biorepository linked to de-identified clinical EMRs, has proven fruitful in its capacity to extensively appeal to numerous areas of biomedical and clinical research, supporting the discovery of genotype-phenotype interactions. Expanding on experiences in BioVU creation and development, we have recently embarked on a parallel effort to collect plasma in addition to DNA from blood specimens leftover after routine clinical testing at Vanderbilt. This initiative offers expanded utility of BioVU by combining proteomic and metabolomic approaches with genomics and/or clinical outcomes, widening the breadth for potential research and subsequent future impact on clinical care. Here, we describe the considerations and components involved in implementing a plasma biobank program from a feasibility assessment through pilot sample collection. Full article
(This article belongs to the Special Issue Biobanking and EHR/EMR)
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Open AccessArticle
Maternal Health Phone Line: Saving Women in Papua New Guinea
J. Pers. Med. 2015, 5(2), 120-139; https://doi.org/10.3390/jpm5020120 - 27 Apr 2015
Cited by 10 | Viewed by 5088
Abstract
This paper presents the findings of a research project which has involved the establishment of a maternal health phone line in Milne Bay Province of Papua New Guinea (PNG). Mobile phones and landline phones are key information and communication technologies (ICTs). This research [...] Read more.
This paper presents the findings of a research project which has involved the establishment of a maternal health phone line in Milne Bay Province of Papua New Guinea (PNG). Mobile phones and landline phones are key information and communication technologies (ICTs). This research study uses the “ICTs for healthcare development” model to ascertain benefits and barriers to the successful implementation of the Childbirth Emergency Phone. PNG has a very high maternal mortality rate. The “three stages of delay” typology was developed by Thaddeus and Maine to determine factors that might delay provision of appropriate medical treatment and hence increase risk of maternal death. The “three stages of delay” typology has been utilised in various developing countries and also in the present study. Research undertaken has involved semi-structured interviews with health workers, both in rural settings and in the labour ward in Alotau. Additional data has been gathered through focus groups with health workers, analysis of notes made during phone calls, interviews with women and community leaders, observations and field visits. One hundred percent of interviewees (n = 42) said the project helped to solve communication barriers between rural health workers and Alotau Provincial Hospital. Specific examples in which the phone line has helped to create positive health outcomes will be outlined in the paper, drawn from research interviews. The Childbirth Emergency Phone project has shown itself to play a critical role in enabling healthcare workers to address life-threatening childbirth complications. The project shows potential for rollout across PNG; potentially reducing maternal morbidity and maternal mortality rates by overcoming communication challenges. Full article
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Open AccessTechnical Note
The Da Vinci European BioBank: A Metabolomics-Driven Infrastructure
J. Pers. Med. 2015, 5(2), 107-119; https://doi.org/10.3390/jpm5020107 - 22 Apr 2015
Cited by 3 | Viewed by 5229
Abstract
We present here the organization of the recently-constituted da Vinci European BioBank (daVEB, https://www.davincieuropeanbiobank.org/it). The biobank was created as an infrastructure to support the activities of the Fiorgen Foundation (http://www.fiorgen.net/), a nonprofit organization that promotes research in the field of pharmacogenomics and personalized [...] Read more.
We present here the organization of the recently-constituted da Vinci European BioBank (daVEB, https://www.davincieuropeanbiobank.org/it). The biobank was created as an infrastructure to support the activities of the Fiorgen Foundation (http://www.fiorgen.net/), a nonprofit organization that promotes research in the field of pharmacogenomics and personalized medicine. The way operating procedures concerning samples and data have been developed at daVEB largely stems from the strong metabolomics connotation of Fiorgen and from the involvement of the scientific collaborators of the foundation in international/European projects aimed to tackle the standardization of pre-analytical procedures and the promotion of data standards in metabolomics. Full article
(This article belongs to the Special Issue Biobanking and EHR/EMR)
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Open AccessReview
Linking a Population Biobank with National Health Registries—The Estonian Experience
J. Pers. Med. 2015, 5(2), 96-106; https://doi.org/10.3390/jpm5020096 - 16 Apr 2015
Cited by 14 | Viewed by 5199
Abstract
The Estonian population-based biobank, with 52,000 participants’ genetic and health data, is the largest epidemiological cohort in the Baltic region. Participants were recruited through a network of medical professionals throughout Estonia (population 1.34 million). Unique legislation as well as a broad consent form [...] Read more.
The Estonian population-based biobank, with 52,000 participants’ genetic and health data, is the largest epidemiological cohort in the Baltic region. Participants were recruited through a network of medical professionals throughout Estonia (population 1.34 million). Unique legislation as well as a broad consent form give the Estonian Genome Center, a research institute of the University of Tartu, permission to re-contact participants and to retrieve participants’ data from national registries and databases. In addition to two re-contacting projects to update the health data of participants, extensive clinical characterizations have been retrieved from national registries and hospital databases regularly since 2010. Acquiring data from electronic health records and registries has provided a means to update and enhance the database of the Genome Center in a timely manner and at low cost. The resulting database allows a wide spectrum of genomic and epidemiological research to be conducted with the aim of benefitting public health. Future plans include linking the genome center database with the national health information system through X-road and exchanging data in real time, as well as using the genetic data and the technical infrastructure available for piloting personalized medicine in Estonia. Full article
(This article belongs to the Special Issue Biobanking and EHR/EMR)
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Open AccessCommunication
A Patient-Centered Perspective on Cancer Survivorship
J. Pers. Med. 2015, 5(2), 91-95; https://doi.org/10.3390/jpm5020091 - 15 Apr 2015
Cited by 1 | Viewed by 4495
Abstract
Survivorship is a complicated notion because people often confuse a process of survivorship with a mythic identity of being a cancer survivor. This confusion may be a distraction to addressing the real-life struggles and challenges experienced by all people diagnosed with cancer. A [...] Read more.
Survivorship is a complicated notion because people often confuse a process of survivorship with a mythic identity of being a cancer survivor. This confusion may be a distraction to addressing the real-life struggles and challenges experienced by all people diagnosed with cancer. A more expansive perspective of survivorship, one that attends to patients’ physical, psychological, social, spiritual, and existential challenges throughout a continuum of care, would be more in line with what is known empirically about people’s experiences with cancer. In an effort to gain a patient-centered perspective on cancer, and one that emphasizes multiple dimensions of cancer survivorship, the author reports findings from a non-scientific social media poll (via Facebook and personal emails) in which survivors and colleagues working in the field of cancer survivorship answered the question: What does cancer survivorship mean to you? The comments are enlightening and useful for guiding the development of a patient-centered, and, thus, more comprehensive, approach to caring for people affected by cancer. Full article
(This article belongs to the Special Issue Long-term Cancer Survivorship)
Open AccessArticle
Neurocognitive Outcomes and School Performance in Solid Tumor Cancer Survivors Lacking Therapy to the Central Nervous System
J. Pers. Med. 2015, 5(2), 83-90; https://doi.org/10.3390/jpm5020083 - 10 Apr 2015
Cited by 7 | Viewed by 4673
Abstract
School performance in patients who have received therapy for childhood cancers has been studied in depth. Risk factors have historically included cranial radiation, intrathecal chemotherapy, and high doses of chemotherapy, including methotrexate and cytarabine. Leukemia and brain tumor survivors who receive such therapy [...] Read more.
School performance in patients who have received therapy for childhood cancers has been studied in depth. Risk factors have historically included cranial radiation, intrathecal chemotherapy, and high doses of chemotherapy, including methotrexate and cytarabine. Leukemia and brain tumor survivors who receive such therapy have been the primary focus of this area of investigation. Extracranial solid tumor cancer patients lacking such risk factors have historically been expected to have normal school performance. We examined the medical records of 58 young pediatric extracranial solid tumor patients who lacked CNS-directed therapy or other known risk factors for cognitive impairment to evaluate the incidence of reported difficulties or abnormalities in neuropsychological testing. Thirty-one percent of patients were found to have at least one reported difficulty or abnormality. Of note, 34% of patients with Wilms tumor possessed difficulties compared to 23% of patients with other extracranial solid tumors. Extracranial solid tumor cancer survivors without known risk factors for school performance difficulties appear to have a higher incidence of problems than expected. Full article
(This article belongs to the Special Issue Long-term Cancer Survivorship)
Open AccessArticle
Perspectives on Genetic and Genomic Technologies in an Academic Medical Center: The Duke Experience
J. Pers. Med. 2015, 5(2), 67-82; https://doi.org/10.3390/jpm5020067 - 03 Apr 2015
Cited by 9 | Viewed by 5376
Abstract
In this age of personalized medicine, genetic and genomic testing is expected to become instrumental in health care delivery, but little is known about its actual implementation in clinical practice. Methods. We surveyed Duke faculty and healthcare providers to examine the extent of [...] Read more.
In this age of personalized medicine, genetic and genomic testing is expected to become instrumental in health care delivery, but little is known about its actual implementation in clinical practice. Methods. We surveyed Duke faculty and healthcare providers to examine the extent of genetic and genomic testing adoption. We assessed providers’ use of genetic and genomic testing options and indications in clinical practice, providers’ awareness of pharmacogenetic applications, and providers’ opinions on returning research-generated genetic test results to participants. Most clinician respondents currently use family history routinely in their clinical practice, but only 18 percent of clinicians use pharmacogenetics. Only two respondents correctly identified the number of drug package inserts with pharmacogenetic indications. We also found strong support for the return of genetic research results to participants. Our results demonstrate that while Duke healthcare providers are enthusiastic about genomic technologies, use of genomic tools outside of research has been limited. Respondents favor return of research-based genetic results to participants, but clinicians lack knowledge about pharmacogenetic applications. We identified challenges faced by this institution when implementing genetic and genomic testing into patient care that should inform a policy and education agenda to improve provider support and clinician-researcher partnerships. Full article
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Open AccessArticle
Atrophic Vaginitis in Breast Cancer Survivors: A Difficult Survivorship Issue
J. Pers. Med. 2015, 5(2), 50-66; https://doi.org/10.3390/jpm5020050 - 25 Mar 2015
Cited by 31 | Viewed by 5638
Abstract
Management of breast cancer includes systematic therapies including chemotherapy and endocrine therapy can lead to a variety of symptoms that can impair the quality of life of many breast cancer survivors. Atrophic vaginitis, caused by decreased levels of circulating estrogen to urinary and [...] Read more.
Management of breast cancer includes systematic therapies including chemotherapy and endocrine therapy can lead to a variety of symptoms that can impair the quality of life of many breast cancer survivors. Atrophic vaginitis, caused by decreased levels of circulating estrogen to urinary and vaginal receptors, is commonly experienced by this group. Chemotherapy induced ovarian failure and endocrine therapies including aromatase inhibitors and selective estrogen receptor modulators can trigger the onset of atrophic vaginitis or exacerbate existing symptoms. Symptoms of atrophic vaginitis include vaginal dryness, dyspareunia, and irritation of genital skin, pruritus, burning, vaginal discharge, and soreness. The diagnosis of atrophic vaginitis is confirmed through patient-reported symptoms and gynecological examination of external structures, introitus, and vaginal mucosa. Lifestyle modifications can be helpful but are usually insufficient to significantly improve symptoms. Non-hormonal vaginal therapies may provide additional relief by increasing vaginal moisture and fluid. Systemic estrogen therapy is contraindicated in breast cancer survivors. Continued investigations of various treatments for atrophic vaginitis are necessary. Local estrogen-based therapies, DHEA, testosterone, and pH-balanced gels continue to be evaluated in ongoing studies. Definitive results are needed pertaining to the safety of topical estrogens in breast cancer survivors. Full article
(This article belongs to the Special Issue Long-term Cancer Survivorship)
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