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Organizations that fund research to address global development challenges are increasingly interested in measuring the social and economic outcomes of research. However, traditional metrics for measuring research outputs are often insufficient for capturing the outcomes targeted by international assistance organizations. To address this, the Center for Development Research (CDR), part of the U.S. Global Development Lab at the United States Agency for International Development (USAID), has designed a new tool: the Program and Policy Change (PPC) framework for tracking and quantifying the influence of research on program and policy change in international development. The framework draws on existing conceptual frameworks of evidence uptake and the literature on policy change. This article describes the design of the PPC framework and presents the results of applying the framework to two USAID research programs. The benefits of the framework include applicability across research sectors, focus on evidence-informed policy at various levels of geographical influence, and inclusion of a numeric scoring system that enables quantification of outcomes.

BackgroundAdding modified FOLFOX6 (folinic acid, fluorouracil, and oxaliplatin) after chemoradiotherapy and lengthening the chemoradiotherapy-to-surgery interval is associated with an increase in the proportion of rectal cancer patients with a pathological complete response.ObjectiveThe purpose of this study was to analyze disease-free and overall survival.DesignThis was a nonrandomized phase II trial.SettingsThe study was conducted at multiple institutions.PatientsFour sequential study groups with stage II or III rectal cancer were included.InterventionAll of the patients received 50 Gy of radiation with concurrent continuous infusion of fluorouracil for 5 weeks. Patients in each group received 0, 2, 4, or 6 cycles of modified FOLFOX6 after chemoradiation and before total mesorectal excision. Patients were recommended to receive adjuvant chemotherapy after surgery to complete a total of 8 cycles of modified FOLFOX6.Main outcome measuresThe trial was powered to detect differences in pathological complete response, which was reported previously. Disease-free and overall survival are the main outcomes for the current study.ResultsOf 259 patients, 211 had a complete follow-up. Median follow-up was 59 months (range, 9-125 mo). The mean number of total chemotherapy cycles differed among the 4 groups (p = 0.002), because one third of patients in the group assigned to no preoperative FOLFOX did not receive any adjuvant chemotherapy. Disease-free survival was significantly associated with study group, ypTNM stage, and pathological complete response (p = 0.004,

BACKGROUND: Patients with locally advanced rectal cancer who achieve a pathological complete response to neoadjuvant chemoradiation have an improved prognosis. The need for surgery in these patients has been questioned, but the proportion of patients achieving a pathological complete response is small. We aimed to assess whether adding cycles of mFOLFOX6 between chemoradiation and surgery increased the proportion of patients achieving a pathological complete response. METHODS: We did a phase 2, non-randomised trial consisting of four sequential study groups of patients with stage II-III locally advanced rectal cancer at 17 institutions in the USA and Canada. All patients received chemoradiation (fluorouracil 225 mg/m(2) per day by continuous infusion throughout radiotherapy, and 45·0 Gy in 25 fractions, 5 days per week for 5 weeks, followed by a minimum boost of 5·4 Gy). Patients in group 1 had total mesorectal excision 6-8 weeks after chemoradiation. Patients in groups 2-4 received two, four, or six cycles of mFOLFOX6, respectively, between chemoradiation and total mesorectal excision. Each cycle of mFOLFOX6 consisted of racemic leucovorin 200 mg/m(2) or 400 mg/m(2), according to the discretion of the treating investigator, oxaliplatin 85 mg/m(2) in a 2-h infusion, bolus fluorouracil 400 mg/m(2) on day 1, and a 46-h infusion of fluorouracil 2400 mg/m(2). The primary endpoint was the proportion of patients who achieved a pathological complete response, analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00335816. FINDINGS: Between March 24, 2004, and Nov 16, 2012, 292 patients were registered, 259 of whom (60 in group 1, 67 in group 2, 67 in group 3, and 65 in group 4) met criteria for analysis. 11 (18%, 95% CI 10-30) of 60 patients in group 1, 17 (25%, 16-37) of 67 in group 2, 20 (30%, 19-42) of 67 in group 3, and 25 (38%, 27-51) of 65 in group 4 achieved a pathological complete response (p=0·0036). Study group was independently associated with pathological complete response (group 4 compared with group 1 odds ratio 3·49, 95% CI 1·39-8·75; p=0·011). In group 2, two (3%) of 67 patients had grade 3 adverse events associated with the neoadjuvant administration of mFOLFOX6 and one (1%) had a grade 4 adverse event; in group 3, 12 (18%) of 67 patients had grade 3 adverse events; in group 4, 18 (28%) of 65 patients had grade 3 adverse events and five (8%) had grade 4 adverse events. The most common grade 3 or higher adverse events associated with the neoadjuvant administration of mFOLFOX6 across groups 2-4 were neutropenia (five in group 3 and six in group 4) and lymphopenia (three in group 3 and four in group 4). Across all study groups, 25 grade 3 or worse surgery-related complications occurred (ten in group 1, five in group 2, three in group 3, and seven in group 4); the most common were pelvic abscesses (seven patients) and anastomotic leaks (seven patients). INTERPRETATION: Delivery of mFOLFOX6 after chemoradiation and before total mesorectal excision has the potential to increase the proportion of patients eligible for less invasive treatment strategies; this strategy is being tested in phase 3 clinical trials. FUNDING: National Institutes of Health National Cancer Institute.

Background: The delivery of healthcare services has changed significantly as a result of the rapid development of technology in the healthcare sector. An innovative strategy that uses technological intervention systems to boost patients’ physical and mental health is called the Development and Application of a Service Model for Health. Objectives: 1. Awareness about the current and upcoming technology becomes critical in the healthcare sector, especially in Indian scenarios hence understanding awareness of technology or tools used for monitoring health among respondents was one of the objectives. 2. The challenges faced by the patients and their criteria for healthcare provider/service selection. 3. Awareness about the government initiatives for technological interventions in the Indian healthcare sector. Method: This study comprises primary and secondary research on the development and use of a service model for health in Indian scenarios; setting up technological intervention systems to support patients’ psychological and physical health. A questionnaire that was created by the researcher was used for primary research. The questionnaire was created following an extensive secondary study on the subject. The study’s sample size is 218 people. Newspapers, research papers, and articles were consulted online for secondary research data sources. Excel and Power BI were used to undertake data analysis using descriptive statistics. Results: Technology interventions can help to improve the quality of patient care by providing accurate diagnoses, personalized treatment plans, real-time monitoring of progress, and streamlined communication between medical professionals and patients. From the primary research wearable devices, self-monitoring apps and tele-medicine have the potential to solve all problems. These technologies can help handle data and provide personalized care. There is a positive response to the adaptability of technology in the Indian healthcare system which should attract investors and innovators. Conclusion: It is possible to enhance patient outcomes, lower healthcare costs, and give patients individualized and efficient care by creating and implementing a service model for health that combines technological intervention systems. [ABSTRACT FROM AUTHOR]

Recurrent hypoglycemia leads to impaired awareness of hypoglycemia where the blood glucose threshold that elicits the counterregulatory response is lowered. Hypoglycemia‐induced oxidative stress is hypothesized to contribute to impaired awareness of hypoglycemia development and hypoglycemia‐associated autonomic failure. Our group conducted a randomized, double‐blinded, placebo‐controlled, crossover study in healthy individuals undergoing experimentally induced recurrent hypoglycemia to evaluate the impact of intravenous N‐acetylcysteine (NAC) during experimental hypoglycemia to preserve the counterregulatory response to subsequent hypoglycemia. The work presented herein aimed to characterize the NAC pharmacokinetics and its effects on oxidative stress. Whole blood and plasma samples were collected at specified time points during separate NAC and placebo infusions from 10 healthy volunteers. Samples were analyzed for NAC, cysteine, and glutathione (GSH) concentrations. A 2‐compartment population NAC pharmacokinetic model was developed. Estimates for central compartment clearance and volume of distribution were 19.8 L/h, and 12.2 L, respectively, for a 70‐kg person. Peripheral compartment clearance and volume of distribution estimates were 34.9 L/h and 13.1 L, respectively, for a 70‐kg person. The PK parameters estimated here were different from those reported in the literature, suggesting a higher NAC clearance during hypoglycemic episodes. NAC leads to a significant increase in circulating cysteine concentration in a NAC concentration‐dependent manner, suggesting rapid biotransformation. A transient decrease in plasma GSH was observed, supporting the hypothesis that NAC can act as a reducing agent displacing glutathione from the disulfide bond allowing for increased clearance and/or distribution of GSH. [ABSTRACT FROM AUTHOR]