Recording of patient-reported outcomes (PROs) enables direct measurement of the experiences of patients with cancer. In the past decade, the use of PROs has become a prominent topic in health-care ...innovation; this trend highlights the role of the patient experience as a key measure of health-care quality. Historically, PROs were used solely in the context of research studies, but a growing body of literature supports the feasibility of electronic collection of PROs, yielding reliable data that are sometimes of better quality than clinician-reported data. The incorporation of electronic PRO (ePRO) assessments into standard health-care settings seems to improve the quality of care delivered to patients with cancer. Such efforts, however, have not been widely adopted, owing to the difficulties of integrating PRO-data collection into clinical workflows and electronic medical-record systems. The collection of ePRO data is expected to enhance the quality of care received by patients with cancer; however, for this approach to become routine practice, uniquely trained people, and appropriate policies and analytical solutions need to be implemented. In this Review, we discuss considerations regarding measurements of PROs, implementation challenges, as well as evidence of outcome improvements associated with the use of PROs, focusing on the centrality of PROs as part of 'big-data' initiatives in learning health-care systems.
The role of real‐world evidence (RWE) in regulatory, drug development, and healthcare decision‐making is rapidly expanding. Recent advances have increased the complexity of cancer care and widened ...the gap between randomized clinical trial (RCT) results and the evidence needed for real‐world clinical decisions. Instead of remaining invisible, data from the >95% of cancer patients treated outside of clinical trials can help fill this void.
Summary Background Patients with advanced cancer frequently experience anorexia and cachexia, which are associated with reduced food intake, altered body composition, and decreased functionality. We ...assessed anamorelin, a novel ghrelin-receptor agonist, on cachexia in patients with advanced non-small-cell lung cancer and cachexia. Methods ROMANA 1 and ROMANA 2 were randomised, double-blind, placebo-controlled phase 3 trials done at 93 sites in 19 countries. Patients with inoperable stage III or IV non-small-cell lung cancer and cachexia (defined as ≥5% weight loss within 6 months or body-mass index <20 kg/m2 ) were randomly assigned 2:1 to anamorelin 100 mg orally once daily or placebo, with a computer-generated randomisation algorithm stratified by geographical region, cancer treatment status, and weight loss over the previous 6 months. Co-primary efficacy endpoints were the median change in lean body mass and handgrip strength over 12 weeks and were measured in all study participants (intention-to-treat population). Both trials are now completed and are registered with ClinicalTrials.gov , numbers NCT01387269 and NCT01387282. Findings From July 8, 2011, to Jan 28, 2014, 484 patients were enrolled in ROMANA 1 (323 to anamorelin, 161 to placebo), and from July 14, 2011, to Oct 31, 2013, 495 patients were enrolled in ROMANA 2 (330 to anamorelin, 165 to placebo). Over 12 weeks, lean body mass increased in patients assigned to anamorelin compared with those assigned to placebo in ROMANA 1 (median increase 0·99 kg 95% CI 0·61 to 1·36 vs −0·47 kg –1·00 to 0·21, p<0·0001) and ROMANA 2 (0·65 kg 0·38 to 0·91 vs −0·98 kg –1·49 to −0·41, p<0·0001). We noted no difference in handgrip strength in ROMANA 1 (−1·10 kg –1·69 to −0·40 vs −1·58 kg –2·99 to −1·14, p=0·15) or ROMANA 2 (−1·49 kg –2·06 to −0·58 vs −0·95 kg –1·56 to 0·04, p=0·65). There were no differences in grade 3–4 treatment-related adverse events between study groups; the most common grade 3–4 adverse event was hyperglycaemia, occurring in one (<1%) of 320 patients given anamorelin in ROMANA 1 and in four (1%) of 330 patients given anamorelin in ROMANA 2. Interpretation Anamorelin significantly increased lean body mass, but not handgrip, strength in patients with advanced non-small-cell lung cancer. Considering the unmet medical need for safe and effective treatments for cachexia, anamorelin might be a treatment option for patients with cancer anorexia and cachexia. Funding Helsinn Therapeutics.
Minimization of Heatwave Morbidity and Mortality Kravchenko, Julia, MD, PhD; Abernethy, Amy P., MD; Fawzy, Maria, MHA ...
American journal of preventive medicine,
03/2013, Letnik:
44, Številka:
3
Journal Article
Recenzirano
Abstract Global climate change is projected to increase the frequency and duration of periods of extremely high temperatures. Both the general populace and public health authorities often ...underestimate the impact of high temperatures on human health. To highlight the vulnerable populations and illustrate approaches to minimization of health impacts of extreme heat, the authors reviewed the studies of heat-related morbidity and mortality for high-risk populations in the U.S. and Europe from 1958 to 2012. Heat exposure not only can cause heat exhaustion and heat stroke but also can exacerbate a wide range of medical conditions. Vulnerable populations, such as older adults; children; outdoor laborers; some racial and ethnic subgroups (particularly those with low SES); people with chronic diseases; and those who are socially or geographically isolated, have increased morbidity and mortality during extreme heat. In addition to ambient temperature, heat-related health hazards are exacerbated by air pollution, high humidity, and lack of air-conditioning. Consequently, a comprehensive approach to minimize the health effects of extreme heat is required and must address educating the public of the risks and optimizing heatwave response plans, which include improving access to environmentally controlled public havens, adaptation of social services to address the challenges required during extreme heat, and consistent monitoring of morbidity and mortality during periods of extreme temperatures.
Learning Objectives
Describe the experiences of insured cancer patients requesting copayment assistance in order to better understand the challenges of underinsurance.
Describe the impact of costs on ...the well being of insured cancer patients.
Evaluate the impact of costs on the treatment received by insured cancer patients.
Purpose.
Cancer patients carry rising burdens of health care‐related out‐of‐pocket expenses, and a growing number of patients are considered “underinsured.” Our objective was to describe experiences of insured cancer patients requesting copayment assistance and to describe the impact of health care expenses on well‐being and treatment.
Methods.
We conducted baseline and follow‐up surveys regarding the impact of health care costs on well‐being and treatment among cancer patients who contacted a national copayment assistance foundation along with a comparison sample of patients treated at an academic medical center.
Results.
Among 254 participants, 75% applied for drug copayment assistance. Forty‐two percent of participants reported a significant or catastrophic subjective financial burden; 68% cut back on leisure activities, 46% reduced spending on food and clothing, and 46% used savings to defray out‐of‐pocket expenses. To save money, 20% took less than the prescribed amount of medication, 19% partially filled prescriptions, and 24% avoided filling prescriptions altogether. Copayment assistance applicants were more likely than nonapplicants to employ at least one of these strategies to defray costs (98% vs. 78%). In an adjusted analysis, younger age, larger household size, applying for copayment assistance, and communicating with physicians about costs were associated with greater subjective financial burden.
Conclusion.
Insured patients undergoing cancer treatment and seeking copayment assistance experience considerable subjective financial burden, and they may alter their care to defray out‐of‐pocket expenses. Health insurance does not eliminate financial distress or health disparities among cancer patients. Future research should investigate coverage thresholds that minimize adverse financial outcomes and identify cancer patients at greatest risk for financial toxicity.
The experiences of insured cancer patients requesting copayment assistance and the impact of health care expenses on well‐being and treatment are examined. Insured patients undergoing cancer treatment and seeking copayment assistance were found to experience considerable subjective financial burden and were found to alter care to defray out‐of‐pocket expenses.
Patients with chronic obstructive pulmonary disease (COPD) commonly suffer from breathlessness, deconditioning, and reduced health-related quality of life (HRQL) despite best medical management. ...Opioids may relieve breathlessness at rest and on exertion in COPD.
We aimed to estimate the efficacy and safety of opioids on refractory breathlessness, exercise capacity, and HRQL in COPD.
This was a systematic review and metaanalysis using Cochrane methodology. We searched Cochrane Central Register of Controlled Trials, MEDLINE, and Embase up to 8 September, 2014 for randomized, double-blind, placebo-controlled trials of any opioid for breathlessness, exercise capacity, or HRQL that included at least one participant with COPD. Effects were analyzed as standardized mean differences (SMDs) with 95% confidence intervals (CIs) using random effect models.
A total of 16 studies (15 crossover trials and 1 parallel-group study, 271 participants, 95% with severe COPD) were included. There were no serious adverse effects. Breathlessness was reduced by opioids overall: SMD, -0.35 (95% CI, -0.53 to -0.17; I(2), 48.9%), by systemic opioids (eight studies, 118 participants): SMD, -0.34 (95% CI, -0.58 to -0.10; I(2), 0%), and less consistently by nebulized opioids (four studies, 82 participants): SMD, -0.39 (95% CI, -0.71 to -0.07; I(2), 78.9%). The quality of evidence was moderate for systemic opioids and low for nebulized opioids on breathlessness. Opioids did not affect exercise capacity (13 studies, 149 participants): SMD, 0.06 (95% CI, -0.15 to 0.28; I(2), 70.7%). HRQL could not be analyzed. Findings were robust in sensitivity analyses. Risk of study bias was low or unclear.
Opioids improved breathlessness but not exercise capacity in severe COPD.
To establish a baseline for care and overall survival (OS) based upon contemporary first-line treatments prescribed in the era before the introduction of immune checkpoint inhibitors, for people with ...metastatic non-small cell lung cancer (NSCLC) without common actionable mutations.
Using a nationally representative electronic health record data from the Flatiron dataset which included 162 practices from different regions in US, we identified patients (≥18 years old) newly diagnosed with stage IV NSCLC initiating first-line anticancer therapy (November 2012- January 2015, with follow-up through July 2015). Patients with documented epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) translocation were excluded. Anti-cancer drug therapy and overall survival were described overall, and by histology.
A total of 2,014 patients with stage IV NSCLC without known EGFR or ALK genomic tumor aberrations initiated systemic anticancer therapy, 22% with squamous and 78% with nonsquamous histology. Their mean (SD) age was 67 (10) years, 55% were male, and 87% had a smoking history. In nonsquamous NSCLC, carboplatin plus pemetrexed either without (25.7%) or with bevacizumab (16%) were the most common regimens; 26.6% of nonsquamous patients receiving induction therapy also received continuation maintenance therapy. In squamous NSCLC, carboplatin plus paclitaxel (37.6%) or nab-paclitaxel (21.1%) were the most commonly used regimens. Overall median OS was 9.7 months (95% CI: 9.1, 10.3), 8.5 months (95% CI: 7.4, 10.0) for squamous, and 10.0 months (95% CI: 9.4, 10.8) for nonsquamous NSCLC.
The results provide context for evaluating the effect of shifting treatment patterns of NSCLC treatments on patient outcomes, and for community oncology benchmarking initiatives.