Programmatic adaptations to acute malnutrition screening and treatment during the COVID-19 pandemic.

The COVID-19 pandemic presented numerous challenges to acute malnutrition screening and treatment. To enable continued case identification and service delivery while minimising transmission risks, many organisations and governments implemented adaptations to community-based management of acute malnutrition (CMAM) programmes for children under 5. These included: Family mid-upper arm circumference (MUAC); modified admission and discharge criteria; modified dosage of therapeutic foods; and reduced frequency of follow-up visits. This paper presents qualitative findings from a larger mixed methods study to document practitioners' operational experiences and lessons learned from these adaptations. Findings reflect insights from 37 interviews representing 15 organisations in 17 countries, conducted between July 2020 and January 2021. Overall, interviewees indicated that adaptations were mostly well-accepted by staff, caregivers and communities. Family MUAC filled screening gaps linked to COVID-19 disruptions; however, challenges included long-term accuracy of caregiver measurements; implementing an intervention that could increase demand for inconsistent services; and limited guidance to monitor programme quality and impact. Modified admission and discharge criteria and modified dosage streamlined logistics and implementation with positive impacts on staff workload and caregiver understanding of the programme. Reduced frequency of visits enabled social distancing by minimising crowding at facilities and lessened caregivers' need to travel. Concerns remained about how adaptations impacted children's identification for and progress through treatment and programme outcomes. Most respondents anticipated reverting to standard protocols once transmission risks were mitigated. Further evidence, including multi-year programmatic data analysis and rigorous research, is needed in diverse contexts to understand adaptations' impacts, including how to ensure equity and mitigate unintended consequences.

Between the city and the farm: food environments in artisanal mining communities in Upper Guinea.

OBJECTIVE: Artisanal and small-scale mining (ASM) is a widespread livelihood in low- and middle-income countries; however, many in ASM communities face high levels of poverty and malnutrition. The food environments in ASM communities have non-agricultural rural characteristics that differ from those in urban and agricultural rural areas examined in much existing food environment literature. DESIGN: We examine these complex external and personal food environments in ASM communities via a study using qualitative and quantitative methods. Market surveys and a cross-sectional household survey, plus qualitative mining site non-participant observations and in-depth structured interviews, were conducted in three waves. SETTING: Eighteen study sites in ASM communities in northern Guinea. PARTICIPANTS: Surveys covered mothers in mining households with young children (n 613); in-depth interviews engaged caregivers of young children (n 45), food vendors (n 40) and young single miners (n 15); observations focused on mothers of young children (n 25). RESULTS: The external food environment in these ASM communities combines widespread availability of commercially processed and staple-heavy foods with lower availability and higher prices for more nutritious, non-staple foods. Within the personal food environment, miners are constrained in their food choices by considerable variability in daily cash income and limited time for acquisition and preparation. CONCLUSIONS: We demonstrate that ASM communities have characteristics of both urban and rural populations and argue for greater nuance and appreciation of complexity in food environment research and resultant policy and programming.

Accelerating Advances in Cancer Care Research: A Lookback at the 21st Century Cures Act in 2020.

The 21st Century Cures Act (Cures Act), signed into law in 2016, was designed to advance new therapies by modernizing clinical trials, funding research initiatives, and accelerating the development and use of health information technology. To analyze the current issues in cancer care related to the implementation and impact of the Cures Act, NCCN convened a multistakeholder working group. Participants discussed the legislation's impact on the oncology community since enactment and identified the remaining gaps and challenges as experienced by stakeholders. In June 2020, the policy recommendations of the working group were presented at the virtual NCCN Policy Summit: Accelerating Advances in Cancer Care Research: A Lookback at the 21st Century Cures Act in 2020. The summit consisted of informative discussions and a multistakeholder panel to explore the recommendations and the future of the Cures Act. This article explores identified policy recommendations from the NCCN Working Group and the NCCN Policy Summit, and analyzes opportunities to advance innovative cancer care and patient access to data.

"If you don't find anything, you can't eat" - Mining livelihoods and income, gender roles, and food choices in northern Guinea.

Artisanal and small-scale mining (ASM) continues to grow as a viable economic activity in sub-Saharan Africa. The health and environmental impacts of the industry, notably linked to the use of potentially toxic chemicals, has been well documented. What has not been explored to the same extent is how pressures associated with ASM affect food choices of individuals and families living in mining camps. This paper presents research conducted in 18 mining sites in northern Guinea exploring food choices and the various factors affecting food decision-making practices. Two of the most influential factors to emerge from this study are income variability and gender roles. Results from this study suggest that through artisanal mining, women have the opportunity to earn a larger income that would otherwise be unavailable through agriculture. However, this benefit of potentially earning a larger income is often reduced or constrained by existing gender roles both at the mines and in the home, such as disparity in pay between men and women and increased pressures on women's time. This limits the potential benefit to household food decision-making that could have been gained from higher income. These results do not seek to establish one livelihood as superior; rather, they demonstrate that even when presented with opportunities to earn higher incomes, women still face many of the same barriers and challenges that they would in other economic activities. Additionally, while work and time demands on women change upon arrival in the mining camps, existing gender roles and expectations do not, further restricting women's decision-making capacity.

NCCN Policy Summit: Defining, Measuring, and Applying Quality in an Evolving Health Policy Landscape and the Implications for Cancer Care.

Quality measurement is a critical component of advancing a health system that pays for performance over volume. Although there has been significant attention paid to quality measurement within health systems in recent years, significant challenges to meaningful measurement of quality care outcomes remain. Defining cost can be challenging, but is arguably not as elusive as quality, which lacks standard measurement methods and units. To identify industry standards and recommendations for the future, NCCN recently hosted the NCCN Oncology Policy Summit: Defining, Measuring, and Applying Quality in an Evolving Health Policy Landscape and the Implications for Cancer Care. Key stakeholders including physicians, payers, policymakers, patient advocates, and technology partners reviewed current quality measurement programs to identify success and challenges, including the Oncology Care Model. Speakers and panelists identified gaps in quality measurement and provided insights and suggestions for further advancing quality measurement in oncology. This article provides insights and recommendations; however, the goal of this program was to highlight key issues and not to obtain consensus.

Food Security in Artisanal Mining Communities: An Exploration of Rural Markets in Northern Guinea.

The number of people engaged in artisanal and small-scale mining (ASM) has grown rapidly in the past twenty years, but they continue to be an understudied population experiencing high rates of malnutrition, poverty, and food insecurity. This paper explores how characteristics of markets that serve ASM populations facilitate and pose challenges to acquiring a nutritious and sustainable diet. The study sites included eight markets across four mining districts in the Kankan Region in the Republic of Guinea. Market descriptions to capture the structure of village markets, as well as twenty in-depth structured interviews with food vendors at mining site markets were conducted. We identified three forms of market organization based on location and distance from mining sites. Markets located close to mining sites offered fewer fruit and vegetable options, as well as a higher ratio of prepared food options as compared with markets located close to village centers. Vendors were highly responsive to customer needs. Food accessibility and utilization, rather than availability, are critical for food security in non-agricultural rural areas such as mining sites. Future market-based nutrition interventions need to consider the diverse market settings serving ASM communities and leverage the high vendor responsiveness to customer needs.

The State of Cancer Care in America: Impact of State Policy on Access to High-Quality Cancer Care.

Health policy in America has shifted rapidly over the last decade, and states are increasingly exercising greater authority over health policy decision-making. This localization and regionalization of healthcare policy poses significant challenges for patients with cancer, providers, advocates, and policymakers. To identify the challenges and opportunities that lay ahead of stakeholders, NCCN hosted the 2019 Policy Summit: The State of Cancer Care in America on June 27, 2019, in Washington, DC. The summit featured multidisciplinary panel discussions to explore the implications for access to quality cancer care within a shifting health policy landscape from a patient, provider, and lawmaker perspective. This article encapsulates the discussion from this NCCN Policy Summit.

Quality Measurement in Cancer Care: A Review and Endorsement of High-Impact Measures and Concepts.

Although oncology care has evolved, outcome assessment remains a key challenge. Outcome measurement requires identification and adoption of a succinct list of metrics indicative of high-quality cancer care for use within and across healthcare systems. NCCN established an advisory committee, the NCCN Quality and Outcomes Committee, consisting of provider experts from NCCN Member Institutions and other stakeholders, including payers and patient advocacy, community oncology, and health information technology representatives, to review the existing quality landscape and identify contemporary, relevant cancer quality and outcomes measures by reevaluating validated measures for endorsement and proposing new measure concepts to fill crucial gaps. This manuscript reports on 22 measures and concepts; 15 that align with existing measures and 7 that are new.

National Quality Forum Guidelines for Evaluating the Scientific Acceptability of Risk-adjusted Clinical Outcome Measures: A Report From the National Quality Forum Scientific Methods Panel.

: Quality measurement is at the heart of efforts to achieve high-quality surgical and medical care at a lower cost. Without accurate quality measures, it is not possible to appropriately align incentives with quality. The aim of these National Quality Forum (NQF) guidelines is to provide measure developers and other stakeholders with guidance on the standards used by the NQF to evaluate the scientific acceptability of performance measures. Using a methodologically rigorous and transparent process for evaluating health care quality measures is the best insurance that alternative payment plans will truly reward and promote higher quality care. Performance measures need to be credible in order for physicians and hospitals to willingly partner with payers in efforts to improve population outcomes. Our goal in creating this position paper is to promote the transparency of NQF evaluations, improve the quality of performance measurements, and engage surgeons and all other stakeholders to work together to advance the science of performance measurement.

A phase II study of imatinib mesylate and letrozole in patients with hormone receptor-positive metastatic breast cancer expressing c-kit or PDGFR-ß.

Background Imatinib mesylate is a potent inhibitor of the Abl, KIT and platelet derived growth factor (PDGF) receptor tyrosine kinases. Preclinical data suggest that combining imatinib mesylate with anti-estrogen therapy may be synergistic in hormone receptor-positive breast cancer. We report results of the first phase II trial evaluating the efficacy of the novel combination of imatinib mesylate and letrozole in the treatment of postmenopausal women with metastatic breast cancer. Patients and Methods 45 postmenopausal women with hormone receptor-positive metastatic breast cancer whose tumors demonstrated c-kit and/or PDGFR-ß positivity were treated with imatinib mesylate 400 mg PO twice daily and letrozole 2.5 mg PO once daily until disease progression or unacceptable toxicity. Results There were no complete responses and five partial responses for an objective response rate of 11%. An additional 16 patients had stable disease lasting at least 24 weeks for a clinical benefit rate of 46.7%. The median progression-free and overall survival was 8.7 months (95% confidence interval: 3.8-11.4 months) and 44.3 months (95% confidence interval: 34.0-55.3 months), respectively. The most common grade 3 or higher treatment related adverse events were fatigue and diarrhea, occurring in 9 (20%) and 7 patients (16%), respectively. Conclusion The combination of imatinib mesylate and letrozole is well tolerated but appears to have limited efficacy in the treatment of hormone receptor-positive metastatic breast cancer.

Redefining Quality Measurement in Cancer Care.

Quality measurement in oncology is increasing in significance as payment schemes shift from volume to value. As demand for quality measures increases, challenges in the development of quality measures, standardization across measures, and the limitations of health information technology have become apparent. Moreover, the time and financial burden associated with developing, tracking, and reporting quality measures are substantial. Despite these challenges, best practices and leaders in the field of quality measurement in oncology have emerged. To understand the current challenges and promising practices in quality measurement and to explore future considerations for measure development and measure reporting in oncology, NCCN convened the NCCN Policy Summit: Redefining Quality Measurement in Oncology. The summit included discussion of the current quality landscape and efforts to develop quality measures, use of quality measures in various programs, patient perspective of quality, and challenges and best practices for quality reporting.

Value-Based Breast Cancer Care: A Multidisciplinary Approach for Defining Patient-Centered Outcomes.

PURPOSE: Value in healthcare-i.e., patient-centered outcomes achieved per healthcare dollar spent-can define quality and unify performance improvement goals with health outcomes of importance to patients across the entire cycle of care. We describe the process through which value-based measures for breast cancer patients and dynamic capture of these metrics via our new electronic health record (EHR) were developed at our institution. METHODS: Contemporary breast cancer literature on treatment options, expected outcomes, and potential complications was extensively reviewed. Patient perspective was obtained via focus groups. Multidisciplinary physician teams met to inform a 3-phase process of (1) concept development, (2) measure specification, and (3) implementation via EHR integration. RESULTS: Outcomes were divided into 3 tiers that reflect the entire cycle of care: (1) health status achieved, (2) process of recovery, and (3) sustainability of health. Within these tiers, 22 patient-centered outcomes were defined with inclusion/exclusion criteria and specifications for reporting. Patient data sources will include the Epic Systems EHR and validated patient-reported outcome questionnaires administered via our institution's patient portal. CONCLUSIONS: As healthcare costs continue to rise in the United States and around the world, a value-based approach with explicit, transparently reported patient outcomes will not only create opportunities for performance improvement but will also enable benchmarking across providers, healthcare systems, and even countries. Similar value-based breast cancer care frameworks are also being pursued internationally.

Variations in Proton Therapy Coverage in the State of Texas: Defining Medical Necessity for a Safe and Effective Treatment.

PURPOSE: The definition of medical necessity and indications for coverage of proton beam therapy (PBT) for the treatment of cancer can vary greatly among different professional societies (PSs) and payors. Variations in policies introduce substantial inefficiencies and limit access for patients who may clinically benefit from PBT. The purpose of this study was to analyze differences in medical necessity and coverage policies among payors and a PS. MATERIALS AND METHODS: Peer-reviewed references and coverage decisions were abstracted from the coverage policies of each of the major payors in the state of Texas (Aetna-TX, UnitedHealthcare-TX, Blue Cross Blue Shield-TX) as well as from a representative PS, the Particle Therapy Cooperative Group. Differences in number and quality of references as well as coverage decisions were analyzed with descriptive statistics. RESULTS: Proton beam therapy coverage in the state of Texas varied among payors and the PS for several disease sites, including the central nervous system, eyes, and prostate. The PS cited more references and higher levels of evidence than payor policies (P < .01). Levels of evidence were inconsistent between policies. Interestingly, only 18% to 29% of cited references overlapped between policies. CONCLUSIONS: Payors and PSs have independent and nonstandardized processes for determining PBT coverage, which result in variations in both coverage and evidence cited. These differences can lead to clinical inefficiencies and may reduce access to PBT based on payor status rather than clinical utility. A collaborative approach among all stakeholders would help create a more consistent, equitable, and patient-centered PBT policy that could identify areas for further evidence development.

Assessing Compliance With Established Pneumonia Core Measures at a Comprehensive Cancer Center.

Healthcare organizations use Pneumonia Core Measures (PCMs) to ensure delivery of high-quality care. In this study, a multidisciplinary team was organized to optimize care and enhance compliance in a comprehensive cancer emergency center. We performed a four-phase study, three of which were interventional: intense education regarding PCM; microbiologic analysis of the pathogens responsible for the pneumonias; development and implementation of an institutional pneumonia algorithm and order set. In phase 4, we analyzed five PCMs. The percentage of pneumonia patients from whom blood cultures were obtained increased from 73% to 91% after intervention (p < .001); sputum cultures increased from baseline 24.6% to 51% (p = .004) post order-set implementation, and order-set utilization increased from 40% to 77%. We achieved the benchmark for only one PCM, PN 3a. More than 80% of patients met clinical and microbiological criteria for healthcare-associated pneumonia. We identified a gap between our patient population and some PCMs that relates to antibiotics selection. The treatment of cancer patients and pneumonia falls outside established guidelines for treating community-acquired pneumonia. Although the algorithm and order set implemented optimized care and minimized variation, national benchmarks for four of the PCMs were not met. Our findings provide information for policymakers considering pneumonia measurements for antibiotic selection in a cancer care setting.

Phase I and II Study of Gemcitabine and Vinorelbine in Heavily Pretreated Patients with Metastatic Breast Cancer and Review of the Literature.

BACKGROUND: Many phase II trials investigated the combination of Gemcitabine (G) and Vinorelbine (V) in the treatment of metastatic breast cancer (MBC) with variable outcomes. This study was conducted to explore whether this combination was effective and tolerable in MBC patients who were heavily pretreated with anthracyclines and taxanes. METHODS: A phase I study was conducted first to establish the maximum tolerated dose (MTD) of the G and V combination in MBC patients. Then, a phase II study evaluated the response rates, the median time to progression (TTP), the overall survival (OS) as well as the toxicities resulting from this combination at the MTD. RESULTS: Nine patients were enrolled in the phase I study. The MTD was identified as 700mg/m(2) of G on days 1 and 8 in combination with 15 mg/m(2) of V on days 2 and 9, every 21 days. Twenty-one of 25 patients involved in the phase II study were evaluable for response. No complete or partial responses were achieved; 6 patients (24.0%) had stable disease and 15 (60.0%) progressed. The median TTP was 2 months and the median OS 10 months. Grade 3/4 Neutropenia was the major hematologic toxicity, occurring in 52% of the cycles. The most common non-hematologic grade 3/4 toxicities were fatigue (18%), myalgias (17%) and arthralgias (13%). CONCLUSION: In heavily pretreated patients with MBC, the combination of G and V at the doses stated above was ineffective as it did not induce partial or complete responses. Other chemotherapy agents or combinations should be evaluated in future studies.

Opportunities for improvement: experience at one institution.

In spring of 2011, 11 NCCN Member Institutions were invited to participate in an opportunity to use the NCCN Breast Oncology Outcomes Database to identify opportunities for improvement in the quality of patient care in breast cancer and to implement measures that would target such improvement. The identified measures focused on the administration of treatment that is concordant with selected sections in the NCCN Clinical Practice Guidelines in Oncology for Breast Cancer or timely access to and administration of care. Each institution chose their project based on the individual opportunities specific to that institution.

Developing a system to track meaningful outcome measures in head and neck cancer treatment.

BACKGROUND: The health care industry, including consumers, providers, and payers of health care, recognize the importance of developing meaningful, patient-centered measures. This article describes our experience using an existing electronic medical record largely based on free text formats without structured documentation, in conjunction with tumor registry abstraction techniques, to obtain and analyze data for use in clinical improvement and public reporting. METHODS: We performed a retrospective analysis of 2467 previously untreated patients treated with curative intent who presented with laryngeal, pharyngeal, or oral cavity cancer in order to develop a system to monitor and report meaningful outcome metrics of head and neck cancer treatment. Patients treated between 1995 and 2006 were analyzed for the primary outcomes of survival at 1 and 2 years, the ability to speak at 1 year posttreatment, and the ability to swallow at 1 year posttreatment. RESULTS: We encountered significant limitations in clinical documentation because of the lack of standardization of meaningful measures, as well limitations with data abstraction using a retrospective approach to reporting measures. Almost 5000 person-hours were required for data abstraction, quality review, and reporting, at a cost of approximately $134,000. Our multidisciplinary teams document extensive patient information; however, data is not stored in easily accessible formats for measurement, comparison, and reporting. CONCLUSION: We recommend identifying measures meaningful to patients, providers, and payers to be documented throughout the patients' entire treatment cycle, and significant investment in the improvements to electronic medical records and tumor registry reporting in order to provide meaningful quality measures for the future.

Assessing the continuum of event-based biosurveillance through an operational lens.

This research follows the Updated Guidelines for Evaluating Public Health Surveillance Systems, Recommendations from the Guidelines Working Group, published by the Centers for Disease Control and Prevention nearly a decade ago. Since then, models have been developed and complex systems have evolved with a breadth of disparate data to detect or forecast chemical, biological, and radiological events that have a significant impact on the One Health landscape. How the attributes identified in 2001 relate to the new range of event-based biosurveillance technologies is unclear. This article frames the continuum of event-based biosurveillance systems (that fuse media reports from the internet), models (ie, computational that forecast disease occurrence), and constructs (ie, descriptive analytical reports) through an operational lens (ie, aspects and attributes associated with operational considerations in the development, testing, and validation of the event-based biosurveillance methods and models and their use in an operational environment). A workshop was held in 2010 to scientifically identify, develop, and vet a set of attributes for event-based biosurveillance. Subject matter experts were invited from 7 federal government agencies and 6 different academic institutions pursuing research in biosurveillance event detection. We describe 8 attribute families for the characterization of event-based biosurveillance: event, readiness, operational aspects, geographic coverage, population coverage, input data, output, and cost. Ultimately, the analyses provide a framework from which the broad scope, complexity, and relevant issues germane to event-based biosurveillance useful in an operational environment can be characterized.

Phase III trial evaluating weekly paclitaxel versus docetaxel in combination with capecitabine in operable breast cancer.

PURPOSE: We investigated whether capecitabine and docetaxel followed by fluorouracil, epirubicin, and cyclophosphamide (FEC) or weekly paclitaxel (WP) followed by FEC would improve relapse-free survival (RFS) in operable breast cancer. PATIENTS AND METHODS: In this single-institution study, patients with clinical stages I to IIIC breast cancer were randomly assigned on a 1:1 basis to WP 80 mg/m(2) for 12 weeks followed by fluorouracil 500 mg/m(2), epirubicin 100 mg/m(2), and cyclophosphamide 500 mg/m(2) (FEC-100) every 3 weeks for four cycles or docetaxel 75 mg/m(2) on day 1 and capecitabine (XT) 1,500 mg/m(2) on days 1 through 14 every 3 weeks for four cycles followed by FEC for four cycles and stratified by timing of chemotherapy (preoperative v adjuvant). Accrual was stopped short of 930 patients on the basis of a Bayesian predictive calculation that additional accrual would be unlikely to change the qualitative comparison of the two regimens. RESULTS: After enrollment of 601 patients and a median follow-up of 50 months, we observed no improvement in RFS between XT (87.5%; 95% CI, 82.7% to 91.1%) and WP (90.7%; 95% CI, 86.4% to 93.7%; P = .51). In the preoperative group, the pathologic complete response rate was 19.8% and 16.4% in the XT and WP arms, respectively (P = .45). Rates of breast-conserving surgery were similar between the two groups (P = .48). The XT arm had a significantly higher incidence of stomatitis (P < .001), hand-foot syndrome (P < .001), and neutropenic infection (P < .001). CONCLUSION: There was no difference in efficacy between WP and XT as used in this randomized phase III trial. XT was associated with higher GI, skin, and neutropenic-related toxicities.

Phase III randomized trial of dose intensive neoadjuvant chemotherapy with or without G-CSF in locally advanced breast cancer: long-term results.

OBJECTIVE: To compare the pathologic complete response (pCR) rate of patients treated with 5-fluorouracil (5-FU), doxorubicin, and cyclophosphamide (FAC) versus dose-intense FAC plus G-CSF in the neoadjuvant setting and to compare the delivered dose intensity, disease-free survival (DFS) and overall survival (OS) times, and toxicity between treatment arms in patients with breast cancer. METHODS: Patients were randomized to receive preoperative FAC (5-FU, 500 mg/m(2); doxorubicin, 50 mg/m(2); cyclophosphamide, 500 mg/m(2)) every 21 days for four cycles or dose-intense FAC (5-FU, 600 mg/m(2); doxorubicin, 60 mg/m(2); cyclophosphamide, 1,000 mg/m(2)) plus G-CSF every 18 days for four cycles. RESULTS: Two hundred two patients were randomly assigned. The median follow-up was 7.5 years. Patients randomized to FAC plus G-CSF had a higher pCR rate as well as clinical complete response rate; however, these differences were not statistically different from those with the FAC arm. Patients in the FAC + G-CSF arm had a higher delivered dose intensity of doxorubicin in the neoadjuvant and adjuvant settings than those in the standard FAC arm. DFS and OS times were not significantly different between the two groups. However, the OS and DFS rates were significantly higher for patients who achieved a pCR than for those who did not. Thrombocytopenia, febrile neutropenia, and infection rates were higher in the FAC + G-CSF arm. CONCLUSIONS: A higher delivered dose intensity of doxorubicin with the FAC + G-CSF regimen did not result in a statistically significant higher pCR rate. However, patients who achieved a pCR experienced longer DFS and OS times.