How quality of life is measured in studies of nutritional intervention: a systematic review.

BACKGROUND: Nutrition care can positively affect multiple aspects of patient's health; outcomes are commonly evaluated on the basis of their impact on a patient's (i) illness-specific conditions and (ii) health-related quality of life (HRQoL). Our systematic review examined how HRQoL was measured in studies of nutritional interventions. To help future researchers select appropriate Quality of Life Questionnaires (QoLQ), we identified commonly-used instruments and their uses across populations in different regions, of different ages, and with different diseases. METHODS: We searched EMCare, EMBASE, and Medline databases for studies that had HRQoL and nutrition intervention terms in the title, the abstract, or the MeSH term classifications "quality of life" and any of "nutrition therapy", "diet therapy", or "dietary supplements" and identified 1,113 studies for possible inclusion.We then reviewed titles, abstracts, and full texts to identify studies for final inclusion. RESULTS: Our review of titles, abstracts, and full texts resulted in the inclusion of 116 relevant studies in our final analysis. Our review identified 14 general and 25 disease-specific QoLQ. The most-used general QoLQ were the Short-Form 36-Item Health Survey (SF-36) in 27 studies and EuroQol 5-Dimension, (EQ-5D) in 26 studies. The European Organization for Research and Treatment of Cancer Quality of life Questionnaire (EORTC-QLQ), a cancer-specific QoLQ, was the most frequently used disease-specific QoLQ (28 studies). Disease-specific QoLQ were also identified for nutrition-related diseases such as diabetes, obesity, and dysphagia. Sixteen studies used multiple QoLQ, of which eight studies included both general and disease-specific measures of HRQoL. The most studied diseases were cancer (36 studies) and malnutrition (24 studies). There were few studies focused on specific age-group populations, with only 38 studies (33%) focused on adults 65 years and older and only 4 studies focused on pediatric patients. Regional variation in QoLQ use was observed, with EQ-5D used more frequently in Europe and SF-36 more commonly used in North America. CONCLUSIONS: Use of QoLQ to measure HRQoL is well established in the literature; both general and disease-specific instruments are now available for use. We advise further studies to examine potential benefits of using both general and disease-specific QoLQ to better understand the impact of nutritional interventions on HRQoL.

Optimizing Diabetes Management Using a Low-Calorie Diet in Saudi Arabia: A Cost-Benefit Analysis.

BACKGROUND: Low-calorie diets, high in protein and low in carbohydrates, are commonly recommended for patients with pre-diabetes and type 2 diabetes. The objective of this study was to carry out a cost-benefit analysis (CBA) of a low-calorie versus a standard diet from the perspective of the Saudi Arabian health system. METHODS: The CBA compares costs and benefits of the two diet strategies over a 1-year time horizon. Costs included diet and diabetes treatment-related resources while benefits were measured in terms of the costs of diabetes complications avoided. Data on costs and benefits were collected from published literature and subject matter experts. Incremental costs were estimated as the cost difference between low-calorie and standard diet. Incremental benefits were estimated as cost difference from medical complications when following a low-calorie or standard diet. The incremental absolute cost-benefit ratio was calculated to show the difference between the costs and benefits of the low-calorie diet. Incremental relative cost-benefit ratio was calculated to show the cost per dollar of benefit obtained. Monte Carlo simulation modeled variability in outcomes due to variation in costs and uncertainty of diabetes complications. RESULTS: The 1 year cost of standard diet was US$2515 ± 156 compared to US$2469 ± 107 per patient for a low-calorie diet. Incremental benefit is estimated at US$21,438 ± 7367 per patient. The estimated incremental absolute cost-benefit ratio was US$ - 21,360 establishing that benefits are greater than costs, while the estimated incremental relative cost-benefit ratio is 0.0037, establishing that benefits are 270 times greater than costs. CONCLUSION: The low-calorie diet was the dominant strategy compared to the standard diet in modeled scenarios. These findings highlight the importance of a low-calorie diet as part of diabetes management programs for outpatients with type 2 diabetes.

Research is still limited on nutrition and quality of life among older adults.

Introduction: Globally, the number of older adults is growing exponentially. Yet, while living longer, people are not necessarily healthier. Nutrition can positively impact healthy aging and quality of life (QoL). Two decades ago, nutrition and diet were rarely viewed as key QoL domains, were not part of QoL screening, and QoL studies frequently used unvalidated tools. It is unclear how the nutrition and QoL research area may have since evolved. Methods: A scoping review was conducted in Pubmed of research with community-living older adults (aged ≥65) from developed economies that included 1 of 29 common, valid QoL instruments, nutrition indices, and was published between 1/2000-12/2022. The review followed published methodology guidance and used the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) flow diagram to document identified studies and record number of included/excluded studies (based on scoping review's pre-specified criteria). Results: Of 258 studies identified initially, 37 fully met scoping review inclusion criteria; only 2 were QoL studies, 30 focused on nutrition, 3 on measurement tool validation/testing, and 2 were other study types. Most studies (n = 32) were among populations outside of North America; majority were conducted in Europe (n = 22) where the EuroQol 5 Dimension (Eq5D) was used in >1/2 the studies. Of 5 North American studies, the 36-Item Short Form Survey (SF-36) was most frequently used (n = 4). Myriad nutrition indices described various aspects of eating, dietary intake, and nutrition status, making comparability between studies difficult. Studies included several different nutrition questionnaires; Mini Nutritional Assessment (MNA) (n = 8) or Mini Nutritional Assessment Short Form (MNA-SF) (n = 5) were used most frequently. The most frequent anthropometric measure reported was Body Mass Index (BMI) (n = 28). Nutrition-related biochemical indices were reported infrequently (n = 8). Discussion: The paucity of studies over the last two decades suggests research on nutrition and QoL among community-living older adults remains underdeveloped. Valid QoL instruments and nutrition indices are now available. To ensure greater comparability among studies it is important to develop consensus on core indices of QoL and particularly nutrition. Greater agreement on these indices will advance further research to support healthy aging and improve QoL for community-dwelling older adults.

Use of Conditionally Essential Amino Acids and the Economic Burden of Postoperative Complications After Fracture Fixation: Results from a Cost Utility Analysis.

Objective: To measure the economic impact of conditionally essential amino acids (CEAA) among patients with operative treatment for fractures. Methods: A decision tree model was created to estimate changes in annual health care costs and quality of life impact due to complications after patients underwent operative treatment to address a traumatic fracture. The intervention of interest was the use of CEAA alongside standard of care as compared to standard of care alone. Patients were required to be aged ≥18 and receive the surgery in a US Level 1 trauma center. The primary outcomes were rates of post-surgical complications, changes in patient quality adjusted life years (QALYs), and changes in cost. Cost savings were modeled as the incremental costs (in 2022 USD) of treating complications due to changes in complication rates. Results: The per-patient cost of complications under CEAA use was $12,215 compared to $17,118 under standard of care without CEAA. The net incremental cost savings per patient with CEAA use was $4902, accounting for a two-week supply cost of CEAA. The differences in quality-adjusted life years (QALYs) under CEAA use and no CEAA use was 0.013 per person (0.739 vs 0.726). Modeled to the US population of patients requiring fracture fixations in trauma centers, the total value of CEAA use compared to no CEAA use was $316 million with an increase of 813 QALYs per year. With a gain of 0.013 QALYs per person, valued at $150,000, and the incremental cost savings of $4902 resulted in net monetary benefit of $6852 per patient. The incremental cost-effectiveness ratio showed that the use of CEAA dominated standard of care. Conclusion: CEAA use after fracture fixation surgery is cost saving. Level of Evidence: Level 1 Economic Study.

Early enteral nutrition is associated with improved outcomes in critically ill mechanically ventilated medical and surgical patients.

BACKGROUND AND AIMS: Data suggest that guidelines for enteral nutrition (EN) initiation are not closely followed in clinical practice. In addition, critically ill mechanically ventilated (MV) patients have varying metabolic needs, which often increase and persist over time, requiring personalized nutrition intervention. While both over- and under-nutrition can impact patient outcomes, recent data suggest that targeted early EN delivery may reduce mortality and improve clinical outcomes. This study examined if early EN improves clinical outcomes and decreases costs in critically ill patients on MV. METHODS: Data from a nationwide administrative-financial database between 2018 and 2020 was utilized to identify eligible adult critical care patients. Patients who received EN within 3 days after intubation (early EN) were compared to patients who started EN after 3 days of intubation (late EN). Outcomes of interest included hospital mortality, discharge disposition, hospital and intensive care unit (ICU) length of stay (LOS), MV days, and total cost. After inverse-probability-of-treatment weighting, outcomes were modeled using a nominal logistic regression model for hospital mortality and discharge disposition, a linear regression model for cost, and Cox proportional-hazards model for MV days, hospital and ICU LOS. RESULTS: A total of 27,887 adult patients with early MV were identified, of which 16,772 (60.1%) received early EN. Regression analyses showed that the early EN group had lower hospital mortality (OR = 0.88, 95% CI, 0.82 to 0.94), were more likely to be discharged home (OR = 1.47, 95% CI 1.38 to 1.56), had fewer MV days (HR = 1.23, 95% CI, 1.11 to 1.37), shorter hospital LOS (HR = 1.43, 95% CI, 1.33 to 1.54) and ICU LOS (HR = 1.36, 95% CI, 1.27 to 1.46), and lower cost (-$21,226; 95% CI, -$23,605 to -$18,848) compared to the late EN group. CONCLUSIONS: Early EN within 3 days of MV initiation in real-world practice demonstrated improved clinical and economic outcomes. These data suggest that early EN is associated with decreased hospital mortality, increased discharge to home, and decreased hospital and ICU LOS, time on MV, and cost compared to delayed initiation of EN; highlighting the importance of early EN to optimize utcomes ando support the recovery of critically ill patients on MV.

Healthcare Burden Associated with Malnutrition Diagnoses in Hospitalized Children with Critical Illnesses.

Our primary study objectives were to (i) determine the proportion of children admitted to the Pediatric Intensive Care Unit (PICU) with malnutrition diagnoses, (ii) compare healthcare utilization by malnourished and non-malnourished PICU patients, and (iii) examine the impact of implementing malnutrition screening and coding practices at a major academic urban tertiary care medical center. Using patient records, we conducted a retrospective analysis of 4106 children admitted to the PICU for severe illnesses between 2011 and 2019. Patients were identified as malnourished if records showed an ICD-9 or ICD-10 code for malnutrition. We compared malnourished and non-malnourished patients by age, admitting diagnoses, number of comorbid conditions, and clinical outcomes (length of stay, hospital readmission). About 1 of every 5 PICU-admitted patients (783/4106) had a malnutrition diagnosis. Patients with malnutrition were younger (mean age 6.2 vs. 6.9 years, p < 0.01) and had more comorbid conditions (14.3 vs. 7.9, p < 0.01) than those without. Malnourished patients had longer hospital stays (26.1 vs. 10.0 days, p < 0.01) and higher 30-day readmission rates (10% vs. 7%, p = 0.03). Implementation of malnutrition screening and coding practices was associated with an increase in malnutrition diagnosis. In this study of children admitted to the PICU, malnourished patients had more comorbid diagnoses and used more healthcare resources (prolonged hospitalizations and higher 30-day readmission rates), leading to higher healthcare costs. Such findings underscore the need for policies, training, and programs emphasizing identification and treatment of malnutrition at hospitals caring for critically ill children.

Impact of nutritional compliance within ERAS protocols for hepatopancreatobiliary, radical cystectomy, and head and neck procedures: A case-matched analysis adjusted for major complications.

BACKGROUND: Enhanced recovery after surgery (ERAS®) pathways aim to improve patient outcomes by applying multimodal practices before, during, and after operative procedures. Compared with standard care before ERAS, we investigated whether compliance to ERAS guidelines for nutritional care, preoperative oral carbohydrate loading and postoperative oral nutrition, was associated with a decrease in hospital length of stay (LOS) after pancreaticoduodenectomy, distal pancreatectomy, hepatectomy, radical cystectomy, and head and neck tumor resection with reconstruction. METHODS: Compliance to ERAS nutrition recommendations was evaluated. Post-ERAS cohort was retrospectively analyzed. Pre-ERAS cohort consisted of case matched patients one year before ERAS: age more than or less than 65 years, body mass index (BMI) more than greater than or less than 30 kg/m2, diabetes mellitus, sex, and procedure. Each cohort consisted of 297 patients. Binary linear regressions evaluated the incremental effect of postoperative nutrition timing and preoperative carbohydrate loading on LOS. Multivariate regressions adjusted for postoperative complications. RESULTS: Compliance with preoperative carbohydrate loading for the post-ERAS cohort was 81.7%. Mean hospital LOS was significantly shorter for the post-ERAS cohort compared with pre-ERAS cohort (8.3 vs 10.0 days, p < 0.001). By procedure, LOS was significantly shorter for patients undergoing pancreaticoduodenectomy (p = 0.003), distal pancreatectomy (p = 0.014), and head and neck procedures (p = 0.024). Early postoperative oral nutrition was associated with a 3.75-day shorter LOS (p < 0.001); no nutrition was associated with a 3.29-day longer LOS (p < 0.001). CONCLUSION: Compliance with ERAS protocols for specific nutritional care practices was associated with a statistically significant decrease in LOS without subsequent increases in 30-day readmission rates and positive financial impact. These findings suggest that ERAS guidelines for perioperative nutrition are a strategic pathway to improved patient recovery and value-based care in surgery.

Evaluating the impact of using a wound-specific oral nutritional supplement to support wound healing in a rehabilitation setting.

Chronic wounds adversely affect patient quality of life, increase the risk of mortality, and impose high costs on healthcare systems. Since protein-energy malnutrition or specific nutrient deficiencies can delay wound healing, nutritionally focused care is a key strategy to help prevent or treat the occurrence of non-healing wounds. The objective of our study of inpatients in a rehabilitation hospital was to quantify the effect of daily wound-specific oral nutritional supplementation (WS-ONS) on healing chronic wounds. Using electronic medical records, we conducted a retrospective analysis of patients with chronic wounds. We identified records for (a) a treatment group who received standard wound care + usual hospital diet + daily WS-ONS for ≥14 days, and (b) a control group who received standard wound care + a usual hospital diet. We collected data for demographics, nutritional status, and wound-relevant health characteristics. We examined weekly measurements of wound number and sizes (surface area for superficial wounds or volume for non-superficial wounds). There were 341 patients identified, 114 with 322 wounds in the treatment group and 227 patients with 420 wounds in the control group. We found that rehabilitation inpatients who were given nutritional support had larger wounds and lower functional independence on admission. At discharge, wound area reduction (percent) was nearly two-fold better in patients who were given daily WS-ONS + usual hospital diet compared to those who consumed usual diet only (61.1% vs 34.5%). Overall, weekly wound improvement (lowered wound area or wound volume) was more likely in the WS-ONS group than in the Control group, particularly from the start of care to week 2. Inpatients with largest wounds and lowest functional independence on admission were most likely to be given WS-ONS, an indication that caregivers recognised the need for supplementation. Week-to-week improvement in wound size was more likely in patients who received WS-ONS than in those who did not. Specifically, wound areas and wound volumes were significantly lower at discharge among patients who were given specialised nutritional support. More research in this field is needed to improve care and reduce healthcare costs.

Young Child Nutrition: Knowledge and Surveillance Gaps across the Spectrum of Feeding.

The first 1000 days is a critical window to optimize nutrition. Young children, particularly 12-24 month-olds, are an understudied population. Young children have unique nutrient needs and reach important developmental milestones when those needs are met. Intriguingly, there are differences in the dietary patterns and recommendations for young children in the US vs. globally, notably for breastfeeding practices, nutrient and food guidelines, and young child formulas (YCFs)/toddler drinks. This perspective paper compares these differences in young child nutrition and identifies both knowledge gaps and surveillance gaps to be filled. Parental perceptions, feeding challenges, and nutrition challenges are also discussed. Ultimately, collaboration among academia and clinicians, the private sector, and the government will help close young child nutrition gaps in both the US and globally.

Role of Early Enteral Nutrition in Mechanically Ventilated COVID-19 Patients.

Current guidance recommends initiation of early enteral nutrition (early EN) within 24-36 hours of ICU admission in critically ill COVID-19 patients. Despite this recommendation, there is quite limited evidence describing the effect of early EN on outcomes in COVID-19 patients. The association between early EN (within 3 d post intubation) and clinical outcomes in adult COVID-19 patients requiring mechanical ventilation (within 2 d post ICU admission) was evaluated. DESIGN: We performed a nationwide observational cohort study using a nationwide administrative-financial database (Premier) in United States. SETTING: Information pertaining to all COVID-19 patients admitted to ICU from 75 hospitals between April and December 2020 was analyzed. PATIENTS: A total of 861 COVID-19 patients were included. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Clinical outcomes were assessed via regression models to control for patient and hospital characteristics. We identified 513 COVID-19 ICU patients (59.2%) requiring mechanical ventilation who received early EN and had similar baseline characteristics to late EN group. Compared with late EN group, the early EN group had shorter ICU (hazard ratio [HR], 1.39; 95% CI, 1.15-1.68) and hospital length of stays (LOS) (HR, 1.53; 95% CI, 1.23-1.91), fewer mechanical ventilation days (HR, 1.25; 95% CI, 1.01-1.54), and lower cost (-$22,443; 95% CI, -$32,342 to -$12,534). All comparisons were statistically significant (p < 0.05). CONCLUSIONS: In patients with COVID-19 requiring mechanical ventilation, early EN is associated with earlier liberation from mechanical ventilation, shorter ICU and hospital LOS, and decreased cost. Our results are among the first to support guideline recommendations for initiation of early EN in COVID-19 ICU patients. Further, our data show nearly 40% of critically ill COVID-19 patients fail to have early EN initiated, even at 3 d post initiation of mechanical ventilation. These results emphasize the need for targeted strategies promoting initiation of early EN, as this may lead to improved clinical and economic outcomes in severe COVID-19 patients.

Implementation of malnutrition quality improvement reveals opportunities for better nutrition care delivery for hospitalized patients.

BACKGROUND: Gaps in hospital-based nutrition care practices and opportunities to improve care of patients at risk of malnutrition or malnourished have been demonstrated by several US hospitals implementing quality improvement (QI) projects. This study examined the impact of nutrition care process improvements focused on better documentation of identification and diagnosis of malnutrition in 5 hospital services and differences between nutritionally targeted vs nontargeted services. METHODS: Data on malnutrition risk screening, nutrition assessment, malnutrition diagnosis, and nutrition care plan delivery were collected from 32,723 hospital encounters for patients admitted to the intensive care unit, pulmonology, oncology, urology, and general medicine services (targeted) as well as the rest of the nontargeted hospital services between 2017 and 2019. RESULTS: Higher rates of morbidity in targeted service patients compared with those in the patient population admitted in the nontargeted services were observed, including higher rates of malnutrition risk (37.43% vs 19.16%, P < .001), higher rates of moderate and severe malnutrition first identified by a registered dietitian nutritionist (20.27% vs 9.67%, P < .001), and malnutrition diagnosis confirmed by an admitting physician (16.72% vs 6.74%, P < .001). CONCLUSIONS: The findings suggest sustained improvements in confirmed rates of malnutrition identification and diagnosis are achievable. Targeting malnutrition QI efforts to hospital services with higher patient morbidity is an effective method for improving malnutrition diagnosis, in particular in hospitals with limited resources, which in turn can result in improved nutrition care delivery.

Identifying patients with malnutrition and improving use of nutrition interventions: A quality study in four US hospitals.

OBJECTIVE: This study investigated how specific nutrition interventions were implemented at four US hospitals, compared rates of malnutrition diagnosis and assessment between physicians and registered dietitian nutritionists (RDNs), and examined how these differences affected the nutrition intervention received during patients' hospital stay. METHODS: Data on patients' nutrition status and nutrition interventions were collected from 16 669 hospital inpatient records. Data on intervention utilization for patients with differing nutrition assessments and diagnoses from different health care practitioners were compared using descriptive statistics and χ2 tests. RESULTS: The study found high levels of agreement between physician diagnosis and RDN assessment of malnutrition (88%). Much of this agreement related to patients identified as not malnourished. Of patients identified as malnourished by either physician diagnosis or RDN assessment, agreement was reached in 55.5% of patients. Less than half (46.3%) of patients identified as malnourished had a documented nutrition intervention. Oral nutritional supplements (ONS) were the most commonly used intervention, with 5.1% of patients receiving them. Patients identified as malnourished by physician diagnosis, but not by RDN assessment, were more likely to receive enteral and parenteral nutrition. Patients identified as malnourished by RDN assessment, but not by physician diagnosis, were more likely to have received ONS, meals and snacks, counseling, and food/nutrition-related medication management. CONCLUSION: The high level of agreement on assessment and malnutrition diagnosis suggests positive levels of malnutrition care coordination at the study hospitals. However, significant room for improvement exists in providing interventions to inpatients diagnosed with malnourishment. Differences in interventions may reflect dissimilar approaches commonly used by different practitioners and should be a topic of future study.

Nutrition Care for Poorly Nourished Outpatients Reduces Resource Use and Lowers Costs.

BACKGROUND AND OBJECTIVES: Over 25% of United States (US) community-dwelling, older adults are at nutritional risk. Health and cost burdens of poor nutrition can be lowered by nutrition programs for hospital inpatients, but few studies have looked at the impact on outpatients. The objective of our study was to assess outcomes of a nutrition focused quality improvement program (QIP) on healthcare resource use and costs in poorly nourished outpatients. METHODS: This pre-post QIP study was implemented at 3 US healthcare system clinics. Included patients (n = 600) were ≥45 years old, had ≥2 chronic conditions, and were enrolled over a 15-month interval. For comparison, historical (n = 600) and concurrent control (n = 600) groups were used. Assessment of poor nutritional status was performed during each patient's baseline visit. Healthcare resource use (hospitalizations, emergency department visits, and outpatient clinic visits), medication use, and costs were determined for a 90-day interval. RESULTS: QIP patients (mean age 61.6 years) were predominantly female (62.5%) and overweight/obese (81.7%). The proportion of QIP outpatients presenting for healthcare services was significantly reduced compared to both historical and concurrent controls-relative risk reduction (RRR) versus historical (11.6%, P < .001) and versus concurrent (8.9%, P = .003). Of those who presented, RRR for healthcare resource use by QIP was significant in comparison with historical (12.9%, P = .022) but not concurrent controls. No significant differences were observed for medication usage. Lower resource use among QIP patients yielded total cost savings of $290 923 or per-patient savings of $485. CONCLUSIONS: Nutrition QIPs in outpatient clinics are feasible and can reduce healthcare resource use and cut costs. Such findings underscore benefits of nutritional interventions for community-dwelling outpatients with poor nutritional status.

How a Malnutrition Quality Improvement Initiative Furthers Malnutrition Measurement and Care: Results From a Hospital Learning Collaborative.

BACKGROUND: Malnutrition in hospitalized patients can adversely affect health outcomes and increase the cost of care. Real-world strategies are needed for prompt identification and treatment of patients at risk of malnutrition. OBJECTIVES: The aim of this quality improvement (QI) study was to measure the impact of a nutrition-focused program on the malnutrition care processes of participating hospitals. Secondary objectives were to determine whether improvements in these nutrition-related processes reduced hospital readmissions and length of stay (LOS) in patients ≥65 years. METHODS: A group of 27 US hospitals ("The Collaborative") implemented the Malnutrition Quality Improvement Initiative (MQii), as guided by a Malnutrition QI Toolkit and 4 electronic clinical quality measures (eCQMs), including (1) nutrition screening; (2) nutrition assessment following detection of malnutrition risk; (3) nutrition care plan for patients identified as malnourished after completed nutrition assessment; and (4) documentation of malnutrition diagnoses. Multivariate analyses identified the variables best correlated with patient outcomes. RESULTS: Improvements were observed for all 4 eCQMs. The greatest improvements were achieved as a result of timely nutrition assessment (P = .06) and malnutrition diagnosis (P = .02). Patients ≥65 years with a malnutrition diagnosis and nutrition care plan had a 24% lower likelihood of 30-day readmission but a longer mean LOS than did those without a care plan. CONCLUSIONS: In this study, the implementation of MQii practices significantly improved the identification of malnutrition. The prompt identification and treatment of patients at malnutrition risk can improve patient care and health, as well as reduce costly readmissions.

Impact of Early Incorporation of Nutrition Interventions as a Component of Cancer Therapy in Adults: A Review.

Malnutrition is prevalent among oncology patients and can adversely affect clinical outcomes, prognosis, quality of life, and survival. This review evaluates current trends in the literature and reported evidence around the timing and impact of specific nutrition interventions in oncology patients undergoing active cancer treatment. Previous research studies (published 1 January 2010-1 April 2020) were identified and selected using predefined search strategy and selection criteria. In total, 15 articles met inclusion criteria and 12/15 articles provided an early nutrition intervention. Identified studies examined the impacts of nutrition interventions (nutrition counseling, oral nutrition supplements, or combination of both) on a variety of cancer diagnoses. Nutrition interventions were found to improve body weight and body mass index, nutrition status, protein and energy intake, quality of life, and response to cancer treatments. However, the impacts of nutrition interventions on body composition, functional status, complications, unplanned hospital readmissions, and mortality and survival were inconclusive, mainly due to the limited number of studies evaluating these outcomes. Early nutrition interventions were found to improve health and nutrition outcomes in oncology patients. Future research is needed to further evaluate the impacts of early nutrition interventions on patients' outcomes and explore the optimal duration and timing of nutrition interventions.

Effective Market Exclusivity of New Molecular Entities for Rare and Non-rare Diseases.

BACKGROUND: Growth in development, approvals, and revenue of drugs treating rare diseases (orphan drugs) has been increasing over the last four decades, which has drawn substantial attention to these products. Much of this growth has been attributed to the incentives created by the Orphan Drug Act, which includes a seven-year exclusivity period for the approval of rare disease indications. OBJECTIVE: This study aims to compare the effective market exclusivity period of small molecule new molecular entities (NMEs) for rare (orphan) and non-rare (non-orphan) diseases approved by the U.S. Food and Drug Administration (FDA) from 2001-2012. While the overall length of a drug's effective market exclusivity period has been explored previously, there is little empirical research evaluating the differences in its duration between drugs for rare and non-rare diseases. METHODS: Data sources utilized in this analysis included the NME Drug and New Biologic Approvals Reports, Orange Book, Orphan Drug Product Designation Database, Drugs@FDA and IQVIA's National Sales Perspective. We computed the effective market exclusivity period for each NME as the time from NME approval until approval of the first generic competitor. We then regressed the effective market exclusivity period for each NME, on orphan disease status, and other NME market factors using a Cox proportional hazards model. Subsequently, we calculated regression-adjusted median effective market exclusivity periods for both orphan and non-orphan NMEs to estimate effective exclusivity extensions from orphan status. RESULTS: We find that only individual NMEs approved for the treatment of both orphan and non-orphan indications lower the hazard of generic entry (hazard ratio 0.464, p = 0.030) in comparison with non-orphan NMEs with a single indication. The associated additional median survival time for these NMEs is 1.9 years. CONCLUSIONS: NMEs' orphan status per se is not associated with a reduction in the hazard of generic entry and longer effective market exclusivity periods in comparison with non-orphan NMEs. Only NMEs that were approved for the treatment of both orphan and non-orphan diseases experience lower hazard of generic entry and longer exclusivity periods compared with non-orphan drugs with a single indication.

An Analysis of Follow-On Development in New Drug Classes, January 1986-June 2018.

Follow-on drugs-new medicines approved within an established drug class-provide incremental treatment improvements, additional choices for clinicians and patients, and potential price competition. We examine the timing, quantity, and product characteristics of within-class drug approvals for new drug classes approved by the US Food and Drug Administration since January 1986. We find that nearly two-thirds of first-in-class drugs do not face a subsequent follow-on product. Follow-on innovation within a drug class was more common and occurred more rapidly in the 1990s than during the 2000s. We also find that fewer drug classes have multiple competitors entering the market during the 2000s. First-in-class drugs treating rare disorders experienced lower rates of follow-on entry than drugs treating common medical conditions. The decreased pace of follow-on development likely results from greater industry focus on rare diseases and increasing reimbursement pressure on products lacking clear advantages over existing products.

Is the priority review voucher program stimulating new drug development for tropical diseases?

Congress created the tropical disease priority review voucher program to stimulate new drug development for tropical diseases. An analysis of the pharmaceutical pipeline indicates that the development of drugs for these tropical diseases has increased. However, the effects of the program are not uniform across all diseases, as malaria and tuberculosis have seen significant new drug development, while other diseases have not.

Patient Access in Restrictive Risk Management Programs: The Case of iPLEDGE.

BACKGROUND: The isotretinoin risk management program iPLEDGE places requirements on patients and providers to ensure that the benefits of isotretinoin therapy outweigh the risks. Such burdens have the possibility of limiting patient access through mechanisms such as lowered physician participation. METHODS: In this study, we utilized prescription claims data to examine changes in patient and provider participation in isotretinoin therapy with iPLEDGE implementation. We examined the change in utilization among patients not targeted by iPLEDGE (male patients) to assess the program's impact on access. We also examined whether provider participation in isotretinoin therapy varies by specialty and isotretinoin prescribing history. RESULTS: Patient access to isotretinoin decreased in the period immediately following iPLEDGE implementation, but recovered to pre-iPLEDGE levels in the succeeding months. In addition, therapy completion rates increased with iPLEDGE implementation, suggesting that patients less committed to isotretinoin therapy may be self-selecting out of therapy. Lastly, iPLEDGE resulted in decreased participation by low-volume, general practitioners, while high-volume, specialists' participation was largely unchanged. CONCLUSION: We found that participants responded to iPLEDGE's burdens in predictable ways. Insufficient anticipation of potential iPLEDGE rollout issues initially disrupted patient treatment and resulted in far fewer patients starting therapy. Over a longer term, isotretinoin utilization and therapy completion increased and isotretinoin prescribing shifted toward high-volume, specialist providers. We argue that these changes are predictable based on the burdens iPLEDGE imposes on patients and prescribers and may not be inconsistent with the goals of the risk management program.