Showing papers by "Amy P. Abernethy published in 2009"

Systematic Review: Reliability of Compendia Methods for Off-Label Oncology Indications

Abstract: The Centers for Medicare & Medicaid Services (CMS) limit coverage of cancer drugs for off-label indications to those indications listed in specified drug compendia. This systematic review of 14 off...

Decision making and quality of life in the treatment of cancer: a review.

Abstract: Introduction Complexity in decision making for cancer treatment arises from many factors. When considering how to treat patients, physicians prioritize factors such as stage of disease, patient age, and comorbid illnesses. However, physicians must balance these priorities with the patient’s preferences, quality of life, social responsibilities, and fear of uncertainty. Although these factors are important, physicians are often unable to effectively judge their patients’ preferences. Patients are often unable to fully understand their prognoses and the treatment intent.

Researching breathlessness in palliative care: consensus statement of the National Cancer Research Institute Palliative Care Breathlessness Subgroup.

Abstract: Breathlessness is common in advanced disease and can have a devastating impact on patients and carers. Research on the management of breathlessness is challenging. There are relatively few studies, and many studies are limited by inadequate power or design. This paper represents a consensus statement of the National Cancer Research Institute Palliative Care Breathlessness Subgroup. The aims of this paper are to facilitate the design of adequately powered multi-centre interventional studies in breathlessness, to suggest a standardised, rational approach to breathlessness research and to aid future ‘between study’ comparisons. Discussion of the physiology of breathlessness is included.

Changes in anticholinergic load from regular prescribed medications in palliative care as death approaches.

Abstract: Although there is an understandable emphasis on the side effects of individual medications, the cumulative effects of medications have received little attention in palliative care prescribing. Anticholinergic load reflects a cumulative effect of medications that may account for several symptoms and adverse health outcomes frequently encountered in palliative care. A secondary analysis of 304 participants in a randomised controlled trial had their cholinergic load calculated using the Clinician-Rated Anticholinergic Scale (modified version) longitudinally as death approached from medication data collected prospectively by study nurses on each visit. Mean time from referral to death was 107 days, and mean 4.8 visits were conducted in which data were collected. Relationships to key factors were explored. Data showed that anticholinergic load rose as death approached because of increasing use of medications for symptom control. Symptoms significantly associated with increasing anticholinergic load included dry mouth and difficulty concentrating (P < 0.05). There were also significant associations with increasing anticholinergic load and decreasing functional status (Australia-modified Karnofsky Performance Scale; and quality of life (P < 0.05). This study has documented in detail the longitudinal anticholinergic load associated with medications used in a palliative care population between referral and death, demonstrating the biggest contributor to anticholinergic load in a palliative care population is from symptom-specific medications, which increased as death approached.

Does palliative home oxygen improve dyspnoea? A consecutive cohort study.

Abstract: Palliativeoxygenfor refractorydyspnoea isfrequently prescribed, even when the criteria for long-term home oxygen (based on survival, rather than the symptomatic relief of breathlessness) are not met. Little is known about how palliative home oxygen affects symptomatic breathlessness. A 4 -year consecutive cohort from a regional community palliative care service in Western Australia was used to compare baseline breathlessness before oxygen therapy with dyspnoea sub-scales on the symptom assessment scores (SAS; 0–10) 1 and 2 weeks after the introduction of oxygen. Demographic and clinical characteristics of people who responded were included in a multi-variable logistic regression model. Of the study population (n = 5862), 21.1% (n = 1239) were prescribed oxygen of whom 413 had before and after data that could be included in this analysis. The mean breathlessness before home oxygen was 5.3 (SD 2.5; median 5; range 0–10). There were no significant differences overall at 1 or 2 weeks (P = 0.28) nor for any diagnostic sub-groups. One hundred and fifty people (of 413) had more than a 20% improvement in mean dyspnoea scores. In multi-factor analysis, neither the underlying diagnosis causing breathlessness nor the demographic factors predicted responders at 1 week. Oxygen prescribed on the basis of breathlessness alone across a large population predominantly with cancer does not improve breathlessness for the majority of people. Prospective randomised trials in people with cancer and non-cancer are needed to determine whether oxygen can reduce the progression of breathlessness compared to a control arm. Palliative Medicine (2009); 23 :3 09–316

Defining distinct caregiver subpopulations by intensity of end-of-life care provided.

Abstract: Interventions designed to assist informal caregivers who serve individuals at or near the end of life have predominantly focused on caregiving spouses. Can we define other caregiver subpopulations ...

Use of tablet personal computers for sensitive patient-reported information

Abstract: Notebook-style computers (e/Tablets) are increasingly replacing paper methods for collecting patient-reported information. Discrepancies in data between these methods have been found in oncology for sexuality-related questions. A study was performed to formulate hypotheses regarding causes for discrepant responses and to analyze whether electronic data collection adds value over paper-based methods when collecting data on sensitive topics. A total of 56 breast cancer patients visiting Duke Breast Clinic (North Carolina) participated by responding to 12 subscales of 5 survey instruments in electronic (e/Tablet) format and to a paper version of 1 of these surveys, at each visit. Twenty-one participants (38%) provided dissimilar responses on paper and electronic surveys to one item of the Functional Assessment of Cancer Therapy-General (FACT-G) Social Well-Being scale that asked patients to rate their satisfaction with their current sex life. Among these 21 patients were 8 patients who answered the question in the electronic environment, and 13 patients who answered both paper and electronic versions but with different responses. Eleven patients (29%) did not respond to the item on either e/Tablet or paper; 45 patients (80%) answered it on e/Tablet; and 37 patients (66%) responded on the paper version. The e/Tablet electronic system may provide a "safer" environment than paper questionnaires for cancer patients to answer private or highly personal questions on sensitive topics such as sexuality.

Improving the methodologic and ethical validity of best supportive care studies in oncology: lessons from a systematic review

Abstract: Purpose To systematically review the best supportive care (BSC) literature and to evaluate the ethical and methodologic validity issues by using widely acknowledged criteria. Methods Two search strings that included both cancer and supportive as terms (with random article type, or review or meta-analysis) explored databases from 1966 to 2008. Citations, abstracts, and papers were reviewed for inclusion criteria, and relevant data were extracted by two independent researchers. Data were validated for accuracy. Ethical and methodologic validity were evaluated by using the criteria derived from the Helsinki Requirements of the WMA; CONSORT statements for the evaluation of reports of randomized, controlled trials; and the universal requirements for ethical clinical research. Results Forty-three published papers were identified that described 32 studies, 20 of which incorporated the design of treatment plus supportive care (SC) versus SC alone, and 12 of which incorporated the design of treatment versus SC. Mo...

Detailing of gastrointestinal symptoms in cancer patients with advanced disease: new methodologies, new insights, and a proposed approach.

Abstract: PURPOSE OF REVIEW This review summarizes recent developments in the palliative management of gastrointestinal symptoms experienced by advanced cancer patients and provides a framework for detailing that encompasses education, assessment and monitoring, and treatment. RECENT FINDINGS Although many viable treatment options exist, gastrointestinal symptoms, particularly nausea and vomiting, constipation, and diarrhea, continue to challenge both patients and clinicians. New medications, such as skin patch delivery of granisetron for nausea or methylnaltrexone for constipation, show promise of better symptom management, and are advancing alongside an increasing emphasis on prevention. The integration into care plans of complementary and alternative therapies, such as relaxation techniques and electroacupuncture, may also assist with symptom relief. Accurate assessment is essential but often problematic, especially as the patient's experience of gastrointestinal distress is often incommensurate with objective measures. New methodologies that harness technology to collect patient-reported outcomes may improve the accuracy of assessment, better capture the patient's experience of gastrointestinal symptoms, and provide a means to simultaneously monitor symptoms, educate patients, and collect longitudinal data. SUMMARY Palliative management of gastrointestinal symptoms in advanced cancer patients requires a multipronged approach that entails effective assessment, judicious use of latest evidence-based approaches, and monitoring that incorporates both clinical measures and patient-reported outcomes. In combination with refinements in the overall clinical approach to symptom management, the deployment of standardized instruments that streamline data collection and enable data warehousing will support better symptom management.

Advances in the pharmacological management of breathlessness.

Abstract: Purpose of review To explore advances in the pharmacological treatment of refractory breathlessness and the physiological evidence for treatments. Recent findings The evidence for the role of oral and parenteral opioids in the reduction of breathlessness continues to strengthen from individual studies and from systematic reviews. Importantly, more data are emerging about a lack of lowering in oxygenation or carbon dioxide retention with opioid therapy. In healthy volunteers and those with refractory dyspnoea, nebulized frusemide appears to be worthy of further investigation with adequately powered phase III studies. Summary Opioids prescribed regularly can help to predictably and safely reduce breathlessness for people with a range of end-stage illnesses.

A Pilot Study on the Influence of an Individualized and Experiential Training on Cancer Caregiver’s Self-Efficacy in Home Care and Symptom Management

Abstract: The aim of this pilot study was to investigate if an individualized and experiential training can promote family caregiver's confidence (self-efficacy) in home care and symptom management. The study was conducted in a hematology/oncology unit in a southeastern regional medical center. Twenty informal cancer caregivers participated in the study. The individualized and experiential training was conducted at the bedside prior to patient's hospital discharge. Self-efficacy in home care and cancer symptom management was measured using the Cancer Caregiver Self-Efficacy Measure before and after training, and at 1 week after hospital discharge of cancer patients. Results of the study showed mean Cancer Caregiver Self-Efficacy Measure increased by 41.1 points immediately after the training (z = 4.49, p < 0.001) and was 31.7 points higher at 1-week follow-up (z = 3.22, p < 0.01). The findings of this study suggest that individualized and experiential training may be another avenue for nurses, including home care nurses, to support family home caregiving. By helping family members in home care, favorable patient outcomes may be achieved, enabling older patients with cancer to stay longer in the comfort of their homes.

Longitudinal patterns of chemotherapy use in metastatic colorectal cancer.

Abstract: Multiple agents and combination therapies available to patients with advanced colorectal cancer have significantly improved survival and provided an opportunity for individualization of care, allowing clinicians and patients to prioritize risks and benefits of comparable regimens.

Poor documentation prevents adequate assessment of quality metrics in colorectal cancer.

Abstract: To standardize oncology clinical practice and improve patient outcomes, multiple organizations have developed cancer-specific metrics on the basis of a systematic background review, expert guidance, and fundamental elements of cancer care—staging and treatment.

Horizon Scan: To What Extent Do Changes in Third-Party Payment Affect Clinical Trials and the Evidence Base?

Abstract: Background The principles of evidence-based medicine increasingly govern healthcare policy and practice in the United States. The hallmark of the evidence-based approach is research data generated through clinical trials, and particularly through “gold standard” randomized controlled trials (RCTs). Healthcare policy increasingly relies on evidence furnished by RCTs. It is therefore of paramount importance that investigators are able to execute RCTs, and that those trials include a fair representation of the general population, as well as of the specific populations of relevance to topics being studied. Currently, valid concerns surround low rates of participation in clinical trials and disparities in clinical trial participation. Various factors might influence patients’ interest and willingness to participate in clinical trials. Financial repercussions, which depend upon the payment policies of third-party insurers, may be an important element in patients’ decisions regarding whether or not to participate in a clinical trial, as well as whether patients stay in the trial once initiated. Payment policies may exert an influence on clinical trials in other ways, impacting not only recruitment and retention, but also conduct of the trial and the subsequent quality of the evidence base. Purpose The Duke Center for Clinical Health Policy Research and Duke Cancer Care Research Program conducted this study, supported by a contract with the Agency for Healthcare Research and Quality (AHRQ), to ascertain whether, and to what extent, payment policies may be influencing participant recruitment to clinical trials, rates of participation, and retention in clinical trials. A further objective was to gather input on the issue of whether or not payment policies, through influencing clinical trial participation, may have a deleterious effect on the resulting evidence base. This report will help to inform the Centers for Medicare and Medicaid Services (CMS) if there is causal relationship between the timing of initiating coverage for new therapeutic technologies and beneficiary participation in clinical trials to provide evidence of effectiveness of these new technologies in the elderly and disabled Medicare population. Design We employed a variety of strategies to gather data and experiences relevant to the topic. These strategies were: (1) a nationally selected Advisory Panel to provide expert input; (2) a systematic literature review of MEDLINE and ClinicalTrials.gov ; (3) a Public Forum held on the CMS campus in Baltimore, MD, to gather public input; and, (4) a series of teleconferences with “key informants” representing diverse stakeholders including government, industry sponsors, third-party insurers, clinical trials investigators and staff, and patient advocates. Flexibility in the study design permitted iterative expansion of the inquiry based on information and insights gathered during the exploratory process. Results Published data are virtually non-existent to quantify the difficulties encountered by trials with recruitment and retention, as it pertains to third party payment policies. However, in practice several large-scale clinical trials have encountered substantial difficulties due to the deterrent effect of payment policy on participation. Medical device trials have been more affected by these issues than have drug trials. Lack of a common understanding of which costs should be assumed by which party (sponsor, site, third-party payer), and lack of common definitions of “standard of care” versus “research-related” costs complicate payment policy and likely impact enrollment. To ensure that trials get completed, investigators are developing creative solutions to assure participants’ coverage on-trial. To ensure that payment policy does not result in a financial loss, sites are analyzing financial impact and may decide not to initiate trials if the financial prospects are negative. Poor coordination among government agencies, industry, third party payers, patients, and researchers is contributing to the difficulties. Conclusion Payment policy does bear an impact on clinical trial participation, though this impact is difficult to quantify and unevenly felt across different types of studies, stage of trials, and study populations. The issue of payment policy is closely related to issues of access to care and disparities in care. Payment policies do affect evidence development, in that their impact on clinical trial enrollment results in slower accrual, longer time to completion of studies, and sometimes early termination of studies due to lack of sufficient sample size. Better coordination among government agencies, and between government, third-party payers, sponsors, and sites is necessary. Presuming that participation in clinical trials is a good thing for individual patients and the public at large, a coherent strategy that stipulates when coverage should be initiated, specifies which costs should be covered, and assigns responsibility for those costs to specific payers, coordinated to maximize clinical trials enrollment and retention, could help to (1) rationalize the process of reimbursement when patients are enrolled in clinical trials, (2) ensure equal access to clinical trials for patients interested in participating, and (3) facilitate the generation of high-quality evidence to support future policy-making and clinical practice.

Management of dyspnea in patients with chronic obstructive pulmonary disease

Abstract: A progressive and debilitating illness, chronic obstructive pulmonary disease (COPD) has major worldwide impact In addition to the care for underlying causes of disease, COPD treatment involves palliative intervention to address associated symptoms; in later stages of disease, when the underlying disease has been maximally treated, symptom management assumes primacy as the goal of care Dyspnea is the most distressing symptom experienced by COPD patients When dyspnea cannot be relieved by traditional COPD management strategies (ie, "refractory dyspnea"), the goal of care shifts from prolonged survival to minimized symptoms, improved function, and enhanced quality of life Numerous pharmacologic and non-pharmacologic interventions are available to achieve these goals, but supporting evidence is variable This review summarizes options for managing refractory dyspnea in COPD patients, referring to the available evidence and highlighting areas for further investigation Topics include oxygen, opioids, psychotropic drugs, inhaled frusemide, Heliox28, nutrition, psychosocial support, and breathing techniques

Quality management of potential chemotherapy-induced neutropenic complications: evaluation of practice in an academic medical center

Abstract: Management of the risk of potential chemotherapy-induced neutropenic complications such as febrile neutropenia (FN) and severe neutropenia (SN) is a quality of care priority. How frequently does care at our institution conform to established guidelines? This retrospective chart review study included a random sample of 305 cancer patients receiving care at a single US academic medical center. Abstracted data included demographics, risk factors, and outcome variables (e.g., development of FN/SN, administration of myeloid growth factors). To evaluate quality of care, we assessed conformance between actual practice and established clinical practice guidelines for the use of myeloid growth factors from the National Comprehensive Cancer Network (NCCN). Of the 305 cases reviewed, 8% were classified as low risk ( 20%), using the risk classifications in the NCCN guidelines modified to accommodate illness and other risk factors. Thirty-four percent received prophylactic administration of myeloid growth factors. Half of the cases had adequate documentation of mid-cycle absolute neutrophil count to determine whether FN/SN developed. Among these cases with adequate documentation, 21% developed FN/SN. Use of growth factors did not conform to established quality guidelines. Overall, 77 of 133 (58%) high-risk cases received myeloid growth factors, whereas six of 25 (24%) low-risk cases received myeloid growth factors. Routine clinical practice in this academic oncology setting was poorly aligned with established guidelines; there is substantial opportunity to standardize clinical strategies and increase conformance with evidence-based guidelines.

Electronic patient-reported data capture as the foundation of a learning health care system

Abstract: 6522 Background: In a “learning healthcare system” clinical decisions are supported by accurate information delivered at point of care; information gathered today iteratively informs future care an...

Glossary of Abbreviations

Abstract: The following abbreviations are sometimes used: BCa Bias corrected and accelerated BFI Bartlett’s first identity cgf Cumulant generating function EDF Empirical distribution function IM Information matrix JB Jarque-Bera KLIC Kullback-Liebler information criterion MLE Maximum likelihood estimation NB Negative binomial NTA Neyman type-A pdf Probability density function P-IG Poisson-inverse Gaussian pgf Probability generating function pmf Probability mass function QMLE Quasi maximum likelihood estimation rv Random variable SA Simulated annealing

Haloperidol for nausea and vomiting

Abstract: . Timely and important studies are reviewed and commentaries provided by leading palliative care clinicians. Symptoms, interventions, and treatment-related adverse events addressed in this issue are haloperidol for nausea and vomiting; transdermal fentanyl and cachexia; drugs impact on opioid efficacy; denosumab for bone metastases; and cognitive behavioral insomnia therapy.

Survivorship care planning needs in diffuse large B-cell lymphoma (DLBCL)

Abstract: e20703 Background: Cancer survivorship care plans inform and direct care in the survivorship setting. These care plans should be tailored to individual medical information, needs, and circumstances, as providing excess information can be overwhelming. According to survivors of DLBCL, what are important components of care plans? Methods: We developed a 22-question survey to define and rate important survivorship health and psychosocial concerns; items were developed based upon literature review and experience in survivorship clinics. Through the tumor registry, 178 patients were identified who had been treated with curative intent (including stem cell transplant) without evidence of recurrence since 1/2006 and who continue to receive care at Duke University Medical Center. Results: Sixty-five survivors consented and returned a completed IRB approved survey (response rate 37%). Responders: 58% female, 88% white, and 75% from North Carolina, with mean age at diagnosis of 59.7 years; 42% had stage four diseas...

Ideas whose times have come.

Abstract: The burden of breathlessness is not new, and a century ago there were already established attempts to relieve the sensation of dyspnoea. The need for symptomatic treatment at this time was clear – there were few things to modify the underlying causes of breathlessness across the population. Today, despite advances unparalleled in human history, especially in the past 50 years, for many people there will be a point in the disease trajectory when – alone or together with disease modifying treatment – the focus becomes symptomatic control of breathlessness.