NCCN Task Force Report: Specialty Pharmacy Schwartz, Rowena N; Eng, Kirby J; Frieze, Deborah A ...
Journal of the National Comprehensive Cancer Network
8 Suppl 4
Journal Article
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The use of specialty pharmacies is expanding in oncology pharmacy practice. Specialty pharmacies provide a channel for distributing drugs that, from the payor perspective, creates economies of scale ...and streamlines the delivery of expensive drugs. Proposed goals of specialty pharmacy include optimization of pharmaceutical care outcomes through ensuring appropriate medication use and maximizing adherence, and optimization of economic outcomes through avoiding unwarranted drug expenditure. In oncology practice, specialty pharmacies have become a distribution channel for various agents. The use of a specialty pharmacy, and the addition of the pharmacist from the specialty pharmacy to the health care team, may not only provide benefits for care but also present challenges in oncology practice. The NCCN Specialty Pharmacy Task Force met to identify and examine the impact of specialty pharmacy practice on the care of people with cancer, and to provide recommendations regarding issues discussed. This report provides recommendations within the following categories: education and training of specialty pharmacy practitioners who care for individuals with cancer, coordination of care, and patient safety. Areas for further evaluation are also identified.
To evaluate the measurement properties of the Wheelchair Use Confidence Scale for manual wheelchair users version 2.1 (WheelCon-M 2.1).
Cohort study.
Volunteer sample of 83 community-dwelling, ...experienced manual wheelchair users.
Participants completed the WheelCon-M 2.1 twice to assess retest reliability. Validity was assessed by evaluating hypothesized relationships between the WheelCon-M 2.1 and relevant variables. Responsiveness was assessed using the standard error of measurement (SEM) and smallest real difference (SRD).
The median (interquartile range) WheelCon-M 2.1 score was 84.6 (71.3-92.0) of a possible 0-100. The one-week retest intraclass correlation coefficient was 0.84 with 95% bias-corrected and accelerated confidence intervals of 0.77-0.90. Cronbach's alpha was 0.92. Correlations ranging from rs = -0.19 (p = 0.780) to rs = 0.58 (p < 0.001) were found between the WheelCon-M 2.1 and other relevant outcome measures with all correlations being statistically significant except for age (p = 0.780) and social support (p = 0.057). A statistically significant difference was not found between the sexes (p = 0.140). The SEM and SRM were 5.9 and 16.4, respectively.
WheelCon-M 2.1 has high internal consistency, strong retest reliability, and support for concurrent validity, construct validity and responsiveness. This new test holds promise as a clinical and research tool.
NCCN Task Force Report: Oral chemotherapy Weingart, Saul N; Brown, Elizabeth; Bach, Peter B ...
Journal of the National Comprehensive Cancer Network,
06/2008, Letnik:
6 Suppl 3
Journal Article
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Oral chemotherapy is emerging as a new option for well-selected patients who can manage potentially complex oral regimens and self-monitor for potential complications. If a choice between oral and ...parenteral therapy is available, patients may opt for oral chemotherapy because it is more convenient to administer, allows them to avoid multiple office visits, and gives them a sense of control over their own cancer care. Whether these potential advantages are maintained in regimens that combine oral and parenteral drugs is less clear. The use of oral chemotherapeutic agents profoundly affects all aspects of oncology, including creating significant safety and adherence issues, shifting some traditional roles and responsibilities of oncologists, nurses, and pharmacists to patients and caregivers. The financing of chemotherapy is also affected. To address these issues, the NCCN convened a multidisciplinary task force consisting of oncologists, nurses, pharmacists, and payor representatives to discuss the impact of the increasing use of oral chemotherapy.
The mitogen-activated protein kinase (MAPK) pathway signaling pathway is one of the most commonly mutated pathways in human cancers. In particular, BRAF alterations result in constitutive activation ...of the rapidly accelerating fibrosarcoma-extracellular signal-regulated kinase-MAPK significant pathway, leading to cellular proliferation, survival, and dedifferentiation. The role of BRAF mutations in oncogenesis and tumorigenesis has spurred the development of targeted agents, which have been successful in treating many adult cancers. Despite advances in other cancer types, the morbidity and survival outcomes of patients with glioma have remained relatively stagnant. Recently, there has been recognition that MAPK dysregulation is almost universally present in paediatric and adult gliomas. These findings, accompanying broad molecular characterization of gliomas, has aided prognostication and offered opportunities for clinical trials testing targeted agents. The use of targeted therapies in this disease represents a paradigm shift, although the biochemical complexities has resulted in unexpected challenges in the development of effective BRAF inhibitors. Despite these challenges, there are promising data to support the use of BRAF inhibitors alone and in combination with MEK inhibitors for patients with both low-grade and high-grade glioma across age groups. Safety and efficacy data demonstrate that many of the toxicities of these targeted agents are tolerable while offering objective responses. Newer clinical trials will examine the use of these therapies in the upfront setting. Appropriate duration of therapy and durability of response remains unclear in the glioma patient cohort. Longitudinal efficacy and toxicity data are needed. Furthermore, access to these medications remains challenging outside of clinical trials in Australia and New Zealand. Compassionate access is limited, and advocacy for mechanism of action-based drug approval is ongoing.
Although several clinician- and patient-reported outcome measures have been developed for trials in hidradenitis suppurativa (HS), there is currently no consensus on which measures are best suited ...for use in clinical practice. Identifying validated and feasible measures applicable to the practice setting has the potential to optimize treatment strategies and generate generalizable evidence that may inform treatment guidelines.
To establish consensus on a core set of clinician- and patient-reported outcome measures recommended for use in clinical practice and to establish the appropriate interval within which these measures should be applied.
Clinician- and patient-reported HS measures and studies describing their psychometric properties were identified through literature reviews. Identified measures comprised an item reduction survey and subsequent electronic Delphi (e-Delphi) consensus rounds. In each consensus round, a summary of outcome measure components and scoring methods was provided to participants. Experts were provided with feasibility characteristics of clinician measures to aid selection. Consensus was achieved if at least 67% of respondents agreed with use of a measure in clinical practice.
Among HS experts, response rates for item reduction, e-Delphi round 1, and e-Delphi round 2 surveys were 76.4% (42 of 55), 90.5% (38 of 42), and 92.9% (39 of 42), respectively; among patient research partners (PRPs), response rates were 70.8% (17 of 24), 100% (17 of 17), and 82.4% (14 of 17), respectively. The majority of experts across rounds were practicing dermatologists with 18 to 19 years of clinical experience. In the final e-Delphi round, most PRPs were female (12 85.7% vs 2 males 11.8%) and aged 30 to 49 years. In the final e-Delphi round, HS experts and PRPs agreed with the use of the HS Investigator Global Assessment (28 71.8%) and HS Quality of Life score (13 92.9%), respectively. The most expert-preferred assessment interval in which to apply these measures was 3 months (27 69.2%).
An international group of HS experts and PRPs achieved consensus on a core set of HS measures suitable for use in clinical practice. Consistent use of these measures may lead to more accurate assessments of HS disease activity and life outcomes, facilitating shared treatment decision-making in the practice setting.
Background. Confidence in one's ability to perform a given task can be a stronger predictor of performance than skill itself. There are currently no measures to assess confidence with manual ...wheelchair use. The objective of this study was to develop and assess the content validity of the Wheelchair Use Confidence Scale (WheelCon-M).
Method. A two-phase mixed-methods design was used. Semi-structured interviews were conducted to generate items, followed by a Delphi survey for item selection. Persons who use a wheelchair, health care professionals, and researchers participated in both phases of the study.
Results. An 84-item WheelCon-M was developed based on the qualitative data. After the Delphi survey, a final 62-item WheelCon-M was composed of the following six areas (number of items per area): Negotiating the Physical Environment (33 items), Activities Performed using a Manual Wheelchair (11 items), Knowledge and Problem Solving (6 items), Advocacy (4 items), Managing Social Situations (5 items) and Managing Emotions (3 items).
Conclusion. This article reports the development and content validation of the WheelCon-M. As a scale to measure confidence with wheelchair use was not available prior to this work, clinicians now have a method of identifying individuals who have low confidence with wheelchair use.
Purpose:
The use of radiation as a treatment modality for skin cancer has increased significantly over the last decade with standardized applicators. Utilizing 3D printing, the ability to make ...applicators specifically designed for each patient’s anatomy has become economically feasible. With this in mind it was the aim of this study to determine the dosimetric accuracy of a 3-D printed HDR brachytherapy applicator for the skin.
Methods:
A CT reference image was used to generate a custom applicator based on an anthropomorphic head and neck phantom. To create the applicator a 1cm expansion anteriorly with 0.5cmX0.5cm trenches on the outer surface that were spaced 1cm sup-inf to accommodate standard 6F flexible catheters. The applicator was printed using PLA material using a printrbot simple printer. A treatment plan optimized to deliver a clinically representative volume was created in Oncentra and delivered with a nucletron afterloader. Measurements were made using TLDs and EBT3 gafchromic film that were placed between the applicator and the phantom’s forehead. An additional piece of film was also used to qualitatively asses the dose distribution in the transverse plane. Using a standard vaginal cylinder and bolus, a standardized curve correlating TLD and film exposure-to-radiation dose was established by irradiating film to known doses (200,500,700 cGy) at a 3.5 cm radius distance.
Results:
Evaluated TLDs showed the absolute dose delivered to the skin surface using the 3-D printed bolus was 615cGy±6%, with a mean predicted TPS value in the measured area of 617.5±7%. Additionally, planar dose distributions had good qualitative agreement with calculated TPS isodoses.
Conclusion:
This work demonstrates patient specific 3-D printed HDR brachytherapy applicators for skin cancer treatments are practical and accurate in TPS calculations but additional measurements are needed to verify additional sites and dose at depth.
REMS are a particularly important issue for oncology and the National Comprehensive Cancer Network (NCCN). A disproportionate number of drugs with complex REMS are used in patients with cancer or ...hematologic disorders. REMS policies and processes within oncology may act as a model for other clinical areas. A breadth of experience and access to a wide knowledge base exists within oncology that will ensure appropriate development and consideration of the practical implications of REMS. NCCN is uniquely positioned to assume a leadership role in this process given its status as the arbiter of high-quality cancer care based on its world-leading institutions and clinicians. Notwithstanding the potential benefits, the successful design, implementation, and analysis of the FDA's recent requirement for REMS for some high-risk drugs and biologics will present significant challenges for stakeholders, including patients, providers, cancer centers, manufacturers, payors, health information technology vendors, and regulatory agencies. To provide guidance to these stakeholders regarding REMS challenges, the NCCN assembled a work group comprised of thought leaders from NCCN Member Institutions and other outside experts. The Work Group identified challenges across the REMS spectrum, including the areas of standardization, development and assessment of REMS programs, medication guides, provider knowledge and impact on prescribing, provider burden and compensation, and incorporation of REMS into clinical practice.
Background: Patients with sickle cell trait and concomitant systemic disease are known to be at risk for proliferative retinopathy. However, there are reports of retinopathy in patients with sickle ...cell trait without systemic disease. There are no population-based studies addressing the risk of sickle cell retinopathy in this group. We performed a study to clarify the relation between sickle cell trait and retinopathy in healthy subjects.
Methods: We reviewed the medical records of 100 children with sickle cell disease who attended the Sickle Cell Clinic at the Hospital for Sick Children, Toronto. We then contacted 200 parents with sickle cell trait, of whom 32 agreed to participate in the study. All participants were proven to have hemoglobin AS status with prior hemoglobin electrophoresis. An ophthalmologic history was obtained, and a complete ophthalmologic examination was performed. We defined sickle cell retinopathy as any salmon patch hemorrhages, iridescent spots, black sunbursts, retinal neovascularization or retinal detachment. The evaluation also included attempts to identify the more subtle signs of sickle cell retinopathy, such as optic nerve head vascular changes, vascular tortuosity, macular changes (e.g., microaneurysms and vascular loops) and peripheral arteriovenous anastamoses. Blood samples were obtained for complete blood count, reticulocyte count and smear.
Results: We found no cases of sickle cell retinopathy among the 32 subjects. Ten of 30 subjects had a high reticulocyte count (greater than 120 × 109/L); however, there were no associated eye findings in this subgroup.
Interpretation: Our results indicate that there is no increased risk of retinopathy in healthy people with sickle cell trait.
Contexte : Les patients porteurs du trait drépanocytaire et d'une maladie systémique concomitante sont reconnus comme étant à risque de rétinopathie proliférante. Certains rapports font cependant état de rétinopathie proliférante chez des patients drépanocytaires qui n'ont pas de maladie systémique. II n'y a par contre aucune étude démographique sur le risque de rétinopathie drépanocytaire chez cette population. Nous avons mené une étude pour préciser la relation entre le trait drépanocytaire et la rétinopathie chez des sujets en santé.
Méthodes : Nous avons examiné les dossiers médicaux de 100 enfants drépanocytaires qui s'étaient présentés à la clinique de drépanocytose de l'Hospital for Sick Children de Toronto. Parmi les 200 parents drépanocytaires que nous avons joints, 32 acceptèrent de participer à l'étude. On avait établi que les participants avaient tous un profil d'hémoglobine AS grâce a l'électrophorèse de l'hémoglobine. L'on a obtenu les antécédents ophtalmologiques et effectué des examens ophtalmologiques complets. Pour établir la rétinopathie drépanocytaire, nous avons tenu compte de toutes taches hémorragiques saumonées, des taches iridescentes, des voiles noirs et éclairs lumineux, de la formation de néo-vaisseaux et du décollement de la rétine. L'évaluation comprenait aussi le relèvement, dans la mesure du possible, des signes plus subtils de la rétinopathie drépanocytaire comme les modifications vasculaires de la papille optique, la tortuosité vasculaire, les modifications maculaires (p. ex., micro-anévrismes et anses vasculaires) et les anastamoses artério-veineuses périphériques. L'on a obtenu des prélèvements de sang pour établir la numération globulaire et le taux de réticulocytes, ainsi que des frottis.
Résultats : Nous n'avons trouvé aucun cas de rétinopathie drépanocytaire chez les 32 sujets. Dix sur 30 avaient un taux élevé de réticulocytes (supérieur à 120 × 109/L); mais l'on n'as pas trouvé de problèmes oculaires associés dans ce sous-groupe.
Interprétation : Nos résultats indiquent qu'il n'y a pas de risque accru de rétinopathie chez les personnes en santé porteuses du trait drépanocytaire.
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