Chronic Anemia and Fatigue in Elderly Patients: Results of the First Randomized Double-Blind Placebo-Controlled Cross-Over Study with Epoetin Alfa.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 3553-3553
Author(s):  
P. Agnihotri ◽  
M. Ahuja ◽  
M. C. Telfer ◽  
A. Ahmed ◽  
C. M. Kozma ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Phase 1 ◽  
Community Dwelling ◽  
P Value ◽  
Elderly Persons ◽  
Phase 2 ◽  
Epoetin Alfa ◽  
Double Blind ◽  
Baseline Phase ◽  
Chronic Anemia

Abstract Background: Anemia is a common condition among elderly and its prevalence increases with age. Fatigue is well recognized as a prominent feature of chronic anemia and may be especially symptomatic in this population. In order to evaluate the effect of epoetin alfa (EPO) treatment on hemoglobin (Hb), fatigue, and health related quality of life (QOL) in elderly patients (pts) with chronic anemia a 32 week(w) randomized, double-blind, cross-over treatment trial among community-dwelling participants ≥65y was conducted. Pts were ambulatory and had anemia for ≥3 months with inclusion Hb ≤11.5g/dL. Pts with GI bleeding, active cancer, CKD (GFR<30), thrombocytopenia, iron deficiency, hypothyroidism, untreated depression, dementia, or expected survival ≤6months were excluded. Pts were randomized to receive either subcutaneous (sc) placebo or EPO weekly for 16w (Phase 1) and then crossed over to the other treatment (Phase 2). QOL was measured using the Functional Assessment of Cancer Therapy-Anemia (FACT-An) instrument, with specific focus on the Anemia and Fatigue subscales of the instrument. Hb was measured every 4w. Analyses of all efficacy endpoints were based on pts who had who had at least one Phase 1 (58/62) and one Phase 2 (55/58) visit (using analysis of covariance controlling for baseline values). Results: 62 pts, 85% women, and 95% African American with a mean (SD) age of 76.1y (±7.2). Mean baseline Hb was 10.5±0.9 g/dL (7.3–11.5); 75% had anemia of chronic disease and 25% had unexplained anemia. Common baseline comorbidities included hypertension, CHF, osteoarthritis, and Type 2 diabetes. Seven pts did not complete the study. There was 1 death, 1 stroke and 1 DVT on placebo and 1 death and 1 pulmonary embolus on EPO. None of the serious adverse events or deaths were considered treatment-related. Pts receiving EPO had significantly increased Hb compared to placebo at the end of phases 1 and 2 (p<0.0001; Table 1) and, significantly improved scores on the composite FACT-An (p<0.0107, phase 1; p=<0.0001, phase 2), FACT-An anemia subscale (p=0.0017, phase 1; p=0.0003, phase 2) and FACT-An fatigue subscale (p=0.0012, phase 1; p=0.0011, phase 2). Conclusion: A direct relationship exists between increasing Hb during EPO therapy, fatigue scores and corresponding QOL improvements among elderly persons with anemia. EPO was well tolerated in this trial among anemic elderly pts. Improving fatigue may enhance ability to perform daily activities in the elderly. Phase One - No Epo (n=25) Phase One-EPO(n=30) Variable LS mean Std Err LS Mean Std Err p-value* Difference in LS mean between groups * ANCOVA predicting last phase one study score controlling for baseline Phase 1 score Fatigue Subscale (0–52) 36.3 1.3 42.4 1.2 0.0012 6.1 Anemia Subscale (0–80) 56.1 1.5 63.1 1.4 0.0017 6.9 FACT-An (0–188) 138.0 3.0 148.9 2.8 0.0107 10.9 Hb (g/dl) 10.7 0.2 13.2 0.2 <0.0001 2.4 Phase Two- No EPO (n=30) Phase Two- EPO (n= 25) Variable LS Mean Std Err LS Mean Std Err p-value** Difference in LS mean between groups **ANCOVA predicting last phase two study score controlling for baseline (visit 17) score. Fatigue subscale (0–52) 34.2 1.6 42.8 1.8 0.0011 8.5 Anemia Subscale (0–80) 53.2 1.9 64.5 2.1 0.0003 11.3 FACT-An (0–188) 130.6 3.6 153.4 4.0 <0.0001 22.9 Hb (g/dl) 10.8 0.3 13.3 0.3 <0.0001 2.5

Phase 1b/2 study of enzalutamide (ENZ) with LY3023414 (LY) or placebo (PL) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) after progression on abiraterone.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5009-5009 ◽  
Author(s):  
Christopher Sweeney ◽  
Ivor John Percent ◽  
Sunil Babu ◽  
Jennifer Cultrera ◽  
Bryan Allyn Mehlhaff ◽  
...  
Keyword(s):  
Androgen Receptor ◽  
Phase 1 ◽  
Single Agent ◽  
Progression Free Survival ◽  
Primary Objective ◽  
P Value ◽  
Phase 2 ◽  
Castration Resistant Prostate Cancer ◽  
Double Blind ◽  
Phase 1B

5009 Background: Preclinical and phase 1 results suggest PI3K/mTOR pathway inhibition may enhance androgen receptor inhibition. We report the results of a double-blind, placebo-controlled, randomized Phase 1b/2 study of ENZ±LY (a dual PI3K/mTOR inhibitor) in pts with mCRPC who progressed on abiraterone. Methods: Phase 1b pts received single-agent LY 200 mg twice daily (BID) for 1 wk prior to starting LY+ENZ. Phase 2 pts were randomized 1:1 to 160 mg daily ENZ with PL or 200 mg BID LY on a 28-d cycle. The primary objective was progression-free survival (PFS: serological, radiographic [rPFS], or death) by PCWG2 criteria. Secondary objectives were rPFS, safety, decline in PSA, and PK. Exploratory biomarker analyses included outcomes by presence of androgen receptor variant 7 (AR-V7). 92 primary PFS events were needed for the study to have at least 80% power at one-sided alpha=0.20. Results: LY+ENZ was tolerable during Phase 1b with 1 dose limiting toxicity observed in 13 enrolled pts. Mean LY exposures remained in an efficacious range despite a 30% average decrease when combined with ENZ. In Phase 2, 129 pts were randomized to LY+ENZ (N=65) and PL+ENZ (N=64) (Table). Median PCWG2-PFS was 3.7 mos (LY+ENZ) vs 2.9 mos (PL+ENZ) (HR 0.66, 95% CI 0.43, 0.99; p-value 0.0208). Conclusions: Combination LY+ENZ had a clinically manageable safety profile. The primary end-point of PCWG2-PFS was met and is supported by a clinically meaningful delay in rPFS in AR-V7 negative pts. The biomarker data provide important insights to inform future development strategies. Clinical trial information: NCT02407054. [Table: see text]

scholarly journals Needs of patients with dementia and their caregivers in primary care: lessons learned from the Alzheimer plan of Quebec

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Vladimir Khanassov ◽  
Laura Rojas-Rozo ◽  
Rosa Sourial ◽  
Xin Qiang Yang ◽  
Isabelle Vedel
Keyword(s):  
Primary Care ◽  
Unmet Needs ◽  
Social Care ◽  
Phase 1 ◽  
Lessons Learned ◽  
Community Dwelling ◽  
Care Plan ◽  
Phase 2 ◽  
Care Needs ◽  
Health And Social Care

Abstract Background Persons living with dementia have various health and social care needs and expectations, some which are not fully met by health providers, including primary care clinicians. The Quebec Alzheimer plan, implemented in 2014, aimed to cover these needs, but there is no research on the effect this plan had on the needs and expectations of persons living with dementia. The objective of this study is to identify persons living with dementia and caregivers’ met and unmet needs and to describe their experience. Methods This is a sequential mixed methods explanatory design: Phase 1: cross-sectional study to describe the met and unmet health and social care needs of community-dwelling persons living with dementia using Camberwell Assessment of Need of the Elderly and Carers’ Assessment for Dementia tools. Phase 2: qualitative descriptive study to explore and understand the experiences of persons living with dementia and caregivers with the use of social and healthcare services, using semi-structured interviews. Data from phase 1 was analyzed with descriptive statistics, and from phase 2, with inductive thematic analysis. Results from phases 1 and 2 were compared, contrasted and interpreted together. Results The mean total number of needs reported by the patients was 5.03 (4.48 and 0.55 met and unmet needs, respectively). Caregivers had 0.52 met needs (3.16 unmet needs). The main needs for both were memory, physical health, eyesight/hearing/communication, medication, looking after home, money/budgeting. Three categories were mentioned by the participants: Persons living with dementia and caregiver’s attitude towards memory decline, their perception of community health services and of the family medicine practice. Conclusions Our study confirms the findings of other studies on the most common unmet needs of the patients and caregivers that are met partially or not at all. In addition, the participants were satisfied with access to care, and medical services in primary practices, being confident in their family. Our results indicate persons living with dementia and their caregivers need a contact person, a clear explanation of their dementia diagnosis, a care plan, written information on available services, and support for the caregivers.

Evaluation of the safety and pharmacodynamics of Hematide, a novel erythropoietic agent, in a phase 1, double-blind, placebo-controlled, dose-escalation study in healthy volunteers

Blood ◽  
2006 ◽  
Vol 108 (6) ◽  
pp. 1830-1834 ◽  
Author(s):  
Richard B. Stead ◽  
John Lambert ◽  
Dawie Wessels ◽  
Julie S. Iwashita ◽  
Kerstin K. Leuther ◽  
...  
Keyword(s):  
Synthetic Peptide ◽  
Phase 1 ◽  
Phase 2 ◽  
Healthy Male ◽  
Dose Escalation Study ◽  
Double Blind ◽  
Trade Name ◽  
Dose Dependent Increase ◽  
Dose Dependent ◽  
Support Phase

AbstractHematide is an investigational pegylated synthetic peptide that stimulates erythropoiesis in animal models and is being developed for the treatment of anemia associated with chronic renal failure and cancer. This study evaluated the safety and pharmacodynamics of single, intravenous doses (0.025, 0.05, and 0.1 mg/kg) of Hematide in 28 healthy male volunteers. All doses of Hematide were well tolerated, with safety profiles similar to those of placebo. Hematide showed a dose-dependent increase in reticulocytes. The 0.1-mg/kg dose was associated with a statistically significant increase in hemoglobin (Hgb) from baseline compared to the placebo group (13.6 ± 3.9 g/L [1.36 ± 0.39 g/dL] versus 3.9 ± 3.8 g/L [0.39 ± 0.38 g/dL]; P < .001) that was sustained for longer than 1 month. These results support phase 2 studies in patients with anemia associated with chronic kidney disease or cancer and suggest that Hematide administered as infrequently as once a month may result in a sustained elevation of Hgb levels. (Please note that Hematide is a proposed trade name; the compound does not yet have a nonproprietary name.)

Bleeding Phenotype with Various Bay 94-9027 Dosing Regimens: Subanalyses from the Protect VIII Study

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 1526-1526 ◽  
Author(s):  
Lisa N. Boggio ◽  
Walter Hong ◽  
Maria Wang ◽  
M. Elaine Eyster ◽  
Lisa A. Michaels
Keyword(s):  
Half Life ◽  
Hemophilia A ◽  
Phase 1 ◽  
P Value ◽  
Phase 2 ◽  
Dosing Regimen ◽  
On Demand ◽  
Dosing Regimens ◽  
Previously Treated ◽  
Dosing Intervals

Abstract Introduction: Factor VIII (FVIII) products with a longer half-life may allow for longer intervals between treatments for patients with hemophilia A and may facilitate prophylaxis tailored to an individual’s bleeding phenotype. BAY 94-9027, a PEGylated FVIII product, demonstrated an extended half-life in a phase 1 trial and was well tolerated and efficacious in a phase 2/3 study with dosing intervals up to every 7 days. In this subanalysis of the phase 2/3 trial, bleeding frequency calculated based on the BAY 94-9027 prophylactic dosing regimen during the study was compared with reported bleeding frequency in the 12 months before enrollment. Also, on-study annualized bleeding rates (ABRs) for joint, spontaneous, and trauma bleeds are presented by treatment group. Methods: PROTECT VIII was a multinational, partially randomized, open-label, 36-week study in previously treated patients aged 12–65 years with severe hemophilia A and no history of FVIII inhibitors. Patients received BAY 94-9027 for 36 weeks either on demand or prophylactically. Patients were assigned to 1 of 3 prophylaxis dosing regimens based on the number of bleeds observed during a 10-week run-in period, during which all patients in the prophylaxis arm were treated with 25 IU/kg BAY 94-9027 2x/week. Patients with ≤1 breakthrough bleed during the 10-week period were randomized 1:1 to BAY 94-9027 45–60 IU/kg every 5 days or 60 IU/kg every 7 days. Patients with ≥2 breakthrough bleeds received 30–40 IU/kg BAY 94-9027 2x/week. ABR and annualized joint bleeding rate (AJBR) for the 12 months before the study (collected retrospectively at screening) were compared with values calculated in patients previously treated with prophylaxis who used BAY 94-9027 prophylaxis during the study (weeks 0–36 for the combined prophylaxis groups [including the 10-week period]; weeks 10–36 for the 3 assigned prophylaxis dosing regimens). ABRs for joint, spontaneous, and trauma bleeds during the study were analyzed for the on-demand and combined prophylaxis groups (weeks 0–36) and in relation to patients’ BAY 94-9027 dosing regimen (weeks 10–36). Results: The intent-to-treat population comprised132 patients (prophylaxis, n=112; on demand, n=20). In patients previously treated with prophylaxis, median ABR and AJBR during BAY 94-9027 prophylaxis (weeks 0–36) were lower than corresponding prestudy values; ABR and AJBR during weeks 10–36 for every-5-day, every-7-day, and 2x/week BAY 94-9027 dosing were also lower than or comparable to prestudy values (Table). Median ABRs for joint, spontaneous, and trauma bleeds were lower for the combined prophylaxis groups (weeks 0–36) compared with the on-demand group (combined prophylaxis groups: 1.5, 1.4, and 0.0, respectively; on-demand group: 16.3, 14.3, and 9.1). In the prophylaxis arms (weeks 10–36), median ABRs for joint, spontaneous, and trauma bleeds were 2.1, 0.0, and 0.0 for 2x/week dosing; 1.9, 0.0, and 0.0 for every-5-day dosing; and 1.9, 1.9, and 0.0 for every-7-day dosing. Abstract 1526. Table. Bleeding Frequency During BAY 94-9027 Prophylaxis vs Prestudy Values Combined Prophylaxis, 2x/week, week 10–36 Every 5 Days, Every 7 Days, week 0–36(n=87)* Required† (n=9) Not Randomized‡ (n=6) week 10–36(n=34) week 10–36(n=37) ABR, median Prestudy 5 12 5.5 3 2 Study 2.82 8.7 0.75 1.48 2.88 P value 0.0015 0.2445 0.0766 0.0039 0.4981 AJBR, median Prestudy 2 9 3.5 2 2 Study 1.46 7.24 0 1.40 1.39 P value 0.0045 0.3484 0.0673 0.0131 0.4111 P values (paired Student’s t test) are nominal, as no multiplicity control was applied. *n=86 for AJBR. †Patients with ≥2 breakthrough bleeds in weeks 0–10. ‡Patients with ≤1 bleeds in weeks 0–10 who were not randomized (randomized arms were filled). Conclusions: BAY 94-9027 prophylaxis resulted in lower ABRs and AJBRs during the 36-week study period compared with prestudy values in patients previously treated with prophylaxis. Subgroup analyses based on prophylactic dosing regimens (including dosing intervals of up to every 7 days) showed that patients who were randomized based on bleeding phenotype during the 10-week run-in period achieved bleeding control that was better than or comparable to their prestudy levels, highlighting the value of individualized phenotype-based dosing with BAY 94-9027. In addition, prophylaxis with BAY 94-9027 resulted in reduced joint, spontaneous, and trauma bleeds compared with on-demand treatment. Disclosures Boggio: Bayer, Baxter, Novo Nordisk, CSL Behring, Grifols, and Pfizer: Consultancy. Hong:Bayer HealthCare: Employment. Wang:Bayer HealthCare Pharmaceuticals: Employment. Michaels:Bayer HealthCare Pharmaceuticals: Employment.

A phase 2 trial of lenvatinib 18 mg versus 14 mg once daily (QD) in combination with everolimus (5 mg QD) in renal cell carcinoma (RCC) after 1 prior VEGF-targeted treatment.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. TPS707-TPS707
Author(s):  
Hilary Glen ◽  
Javier Puente ◽  
Daniel Yick Chin Heng ◽  
Sun Young Rha ◽  
Di Li ◽  
...  
Keyword(s):  
Objective Response ◽  
Progression Free Survival ◽  
Final Analysis ◽  
The United States ◽  
Similar Efficacy ◽  
P Value ◽  
Phase 2 ◽  
Double Blind ◽  
Phase 2 Study ◽  
Grade 3

TPS707 Background: Based on findings from a randomized phase 2 study (Study 205), lenvatinib (LEN) + everolimus (EVE) was approved in the United States and European Union for patients (pts) with advanced RCC following 1 prior anti-angiogenic therapy. In that study, LEN 18 mg QD + EVE 5 mg QD significantly prolonged progression-free survival (PFS) compared with either monotherapy. In the LEN+EVE cohort, grades 3 and 4 treatment-emergent adverse events (TEAEs) occurred in 71% of pts. We report the design of an ongoing, multicenter, randomized, double-blind, phase 2 study (Study 218) to evaluate if a lower LEN starting dosage regimen provides similar efficacy with a better safety profile than LEN 18 mg + EVE 5 mg (NCT03173560). Methods: Eligible pts are aged ≥ 18 years with advanced clear cell RCC, 1 prior anti-VEGF therapy, ≥ 1 measurable target lesion per RECIST 1.1, a KPS score of ≥ 70, and prior nivolumab is allowed. Pts will receive LEN 18 mg or 14 mg QD + EVE 5 mg QD in 28-day cycles until disease progression, unacceptable toxicity, or withdrawal of consent. The LEN 14-mg dose will be escalated to 18 mg if no intolerable grade 2, or any grade ≥ 3 TEAEs requiring dose reduction occur in cycle 1. The primary endpoints are objective response rate (ORR) at week 24 (ORR24W) and the proportion of pts with intolerable grade 2 and any grade ≥ 3 TEAEs within 24 wks after randomization. Secondary endpoints include PFS and ORR. An estimated 306 pts will be randomized. Sample size is based on detecting noninferiority (NI) of ORR24W and superiority of the primary safety endpoint. Two interim analyses (IA) will be performed when 150 and 200 pts have completed 24 wks of follow-up or discontinue earlier. Each analysis will test NI and futility of the LEN 14-mg arm ORR24W vs the 18-mg arm ORR24W. An O’Brien-Fleming boundary will be used for NI. If the 1-sided P-value is ≤ 0.005 at the first IA, ≤ 0.014 at the second IA, or ≤ 0.045 at the final analysis, then NI in ORR24W will be claimed. If the futility boundary is crossed (ie, 1-sided P-value is ≥ 0.776 at the first IA or ≥ 0.207 at the second IA), then futility will be claimed. Clinical trial information: NCT03173560.

scholarly journals Safety, tolerability, and immunogenicity of a SARS-CoV-2 recombinant spike protein vaccine: a randomised, double-blind, placebo-controlled, phase 1-2 clinical trial (ABDALA Study).

2021 ◽  
Author(s):  
Francisco Hernandez-Bernal ◽  
Maria del Carmen Ricardo-Cobas ◽  
Yenima Martin-Bauta ◽  
Zadis Navarro-Rodriguez ◽  
Marjoris Pinera-Martinez ◽  
...  
Keyword(s):  
Placebo Group ◽  
Neutralizing Antibodies ◽  
Phase 1 ◽  
Vaccination Schedule ◽  
Phase 2 ◽  
Igg Antibodies ◽  
Protein Vaccine ◽  
Double Blind ◽  
Double Blind Placebo ◽  
The Third

Aim: To evaluate the safety and immunogenicity of a SARS-CoV-2 recombinant spike protein vaccine (Abdala), administered intramuscularly in different strengths and vaccination schedules. Method: A phase 1-2, randomized, double-blind, placebo-controlled trial was done. Subjects were randomly distributed in 3 groups: placebo, 25 and 50 μg RBD. The product was applied intramuscularly, 0.5 mL in the deltoid region. During the first phase, two immunization schedules were studied: short (0-14-28 days) and long (0-28-56 days). In phase 2, only the short scheme was evaluated. The main endpoints were: safety and proportion of subjects with seroconversion of anti-RBD IgG antibodies to SARS-CoV-2. Blood samples were collected in several points according to the corresponding vaccination schedule to determine the level of RBD-specific IgG antibodies (seroconversion rates and geometric mean of the titers), the percentage of inhibition of RBD-ACE-2 binding and levels of neutralizing antibodies. Results: The product was well tolerated. Severe adverse events were not reported. Adverse reactions were minimal, mostly mild and local (from the injection site), resolved in the first 24-48 hours without medication. In phase 1, at day 56 (28 days after the third dose of the short vaccination schedule, 0-14-28 days) seroconversion of anti-RBD IgG was seen in 95.2 % of the participants (20/21) for the 50 μg group and 81 % of the participants (17/21) for the 25 μg group, and none in the placebo group (0/22); whereas neutralizing antibodies to SARS-CoV-2 were seen in 80 % of the participants (8/10) for the 50 μg group and 94.7% of the participants (18/19) for the 25 μg group. For the long schedule, at day 70 (14 days after the third dose) seroconversion of anti-RBD IgG was seen in 100% of the participants (21/21) for the 50 μg group and 94.7% of the participants (18/19) for the 25 μg group, and none in the placebo group (0/22); whereas neutralizing antibodies to SARS-CoV-2 were seen in 95 % of the participants (19/20) for the 50 μg group and 93.8% of the participants (15/16) for the 25 μg group In phase 2, at day 56 seroconversion of anti-RBD IgG was seen in 89.2% of the participants (214/240) for the 50 μg group, 77.7% of the participants (185/238) for the 25 μg group, and 4.6% in the placebo group (11/239); whereas neutralizing antibodies to SARS-CoV-2 were seen in 97.3% of the participants (146/150) for the 50 μg group and 95.1% of the participants (58/61) for the 25 μg group. Conclusion: Abdala vaccine against SARS-CoV-2 was safe, well tolerated and induced humoral immune responses against SARS-CoV-2 among adults from 19 to 80 years of age.

scholarly journals A Mobile App Directory of Occupational Therapists Who Provide Home Modifications: Development and Preliminary Usability Evaluation

10.2196/14465 ◽  
2020 ◽  
Vol 7 (1) ◽  
pp. e14465
Author(s):  
An Thi Nguyen ◽  
Emily Kling Somerville ◽  
Sandra Martina Espín-Tello ◽  
Marian Keglovits ◽  
Susan Lynn Stark
Keyword(s):  
Older Adults ◽  
Phase 1 ◽  
Occupational Therapists ◽  
The United States ◽  
Mobile App ◽  
Community Dwelling ◽  
Phase 2 ◽  
Home Modifications ◽  
The Mean ◽  
Community Dwelling Older Adults

Background Home modifications provided by occupational therapists (OTs) are effective in improving daily activity performance and reducing fall risk among community-dwelling older adults. However, the prevalence of home modification is low. One reason is the lack of a centralized database of OTs who provide home modifications. Objective This study aimed to develop and test the usability of a mobile app directory of OTs who provide home modifications in the United States. Methods In phase 1, a prototype was developed by identifying OTs who provide home modifications through keyword Web searches. Referral information was confirmed by phone or email. In phase 2, community-dwelling older adults aged older than 65 years and OTs currently working in the United States were purposefully recruited to participate in a single usability test of the mobile app, Home Modifications for Aging and Disability Directory of Referrals (Home Maddirs). Participants completed the System Usability Scale (SUS) and semistructured interview questions. Interview data were coded, and themes were derived using a grounded theory approach. Results In phase 1, referral information for 101 OTs across 49 states was confirmed. In phase 2, 6 OTs (mean clinical experience 4.3 years, SD 1.6 years) and 6 older adults (mean age 72.8 years, SD 5.0 years) participated. The mean SUS score for OTs was 91.7 (SD 8.0; out of 100), indicating good usability. The mean SUS score for older adults was 71.7 (SD 27.1), indicating considerable variability in usability. In addition, the SUS scores indicated that the app is acceptable to OTs and may be acceptable to some older adults. For OTs, self-reported barriers to acceptability and usability included the need for more information on the scope of referral services. For older adults, barriers included high cognitive load, lack of operational skills, and the need to accommodate sensory changes. For both groups, facilitators of acceptability and usability included perceived usefulness, social support, and multiple options to access information. Conclusions Home Maddirs demonstrates good preliminary acceptability and usability to OTs. Older adults’ perceptions regarding acceptability and usability varied considerably, partly based on prior experience using mobile apps. Results will be used to make improvements to this promising new tool for increasing older adults’ access to home modifications.

scholarly journals Impact of a Standardized Treatment Guideline for Pediatric Iatrogenic Opioid Dependence: A Quality Improvement Initiative

2016 ◽  
Vol 21 (1) ◽  
pp. 54-65 ◽  
Author(s):  
Rima Abdouni ◽  
Teri Reyburn-Orne ◽  
Tarek H. Youssef ◽  
Imad Y. Haddad ◽  
Richard D. Gerkin
Keyword(s):  
Clinical Practice ◽  
Clinical Practice Guideline ◽  
Practice Guideline ◽  
Opioid Dependence ◽  
Phase 1 ◽  
Tertiary Care ◽  
Treatment Guideline ◽  
Quality Improvement Initiative ◽  
Phase 2 ◽  
Baseline Phase

OBJECTIVES: To determine whether utilization of a hospital-based clinical practice guideline for the care of pediatric iatrogenic opioid dependence (IOD) would promote a decrease in opioid exposure and improve management of opioid abstinence syndrome (AS). METHODS: This study is a retrospective chart review of critically ill patients from a tertiary care children's hospital. Inclusion criteria included mechanically ventilated patients up to 18 years of age who received continuous opioid infusions for at least 7 days and any length of methadone administration. Data on IOD patients from January 2005 to June 2010 was divided into 3 periods: baseline, phase 1, and phase 2. Primary outcome was decrease in opioid exposure, measured by methadone duration of use and any additional opioid bolus doses used in AS management. Documentation of additional opioid bolus doses was regarded as a surrogate measure of AS. Secondary outcomes included total cumulative fentanyl dose, continuous fentanyl infusion duration of use, and hospital and pediatric intensive care unit length of stay. RESULTS: There was a significant decrease in methadone duration of use in IOD patients from 15.3 ± 8.7 days at baseline to 9.5 ± 3.7 days during phase 1 (p = 0.002), to 8.1 ± 3.7 days on phase 2 (reduction not significant, p = 0.106) of this evaluation. Additional opioid bolus doses were significantly lower from baseline to phase 1 (5.5 ± 5.1 vs. 1.8 ± 2.3, p = 0.001) and from phase 1 to phase 2 (1.8 ± 2.3 vs. 0.2 ± 1.5, p = 0.003). For the remaining outcomes, differences were not observed among the evaluation periods, except for the total cumulative fentanyl dose, which was reduced from 2.8 ± 3.7 mg/kg at baseline to 1 ± 1 mg/kg only during phase 1 (p = 0.017). CONCLUSIONS: Introduction of a standardized, hospital-based clinical practice guideline for children with IOD reduced the length of exposure to opioids and improved opioid AS management.

scholarly journals PSII-5 Carcass characteristics and growth performance of market pigs fed reduced lysine diets in bedded hoop barns

2019 ◽  
Vol 97 (Supplement_2) ◽  
pp. 229-230
Author(s):  
Peter J Lammers ◽  
Chad A Stahl ◽  
Mark S Honeyman
Keyword(s):  
Growth Performance ◽  
Soybean Meal ◽  
Large Scale ◽  
Phase 1 ◽  
Stocking Density ◽  
Carcass Characteristics ◽  
Small Scale ◽  
P Value ◽  
Phase 2 ◽  
Des Moines

Abstract A 2 × 2 × 2 factorial design was used to compare the effect of SID Lys:ME concentration (current vs. reduced), stocking density (1.30 vs. 4.05 m2/pig), and harvest month (August vs. March) on pigs raised in bedded hoop barns in Western Iowa. For each harvest month, 420 pigs produced from the mating of Duroc boars (Choice Genetics; West Des Moines, IA) to Camborough females (PIC; Hendersonville, TN) were sorted into 12 pens. Six pens were inside 3 large-scale (9.1 × 18.3 m) hoop barns and were stocked with 64 pigs/pen (32 barrows and 32 gilts; 1.30 m2/ pig). Six pens were inside 3 small-scale (6.0 × 10.8 m) hoop barns and were stocked with 6 pigs/pen (3 barrows and 3 gilts; 4.05 m2/pig). Within each stocking density, pens were randomly assigned to 1 of 2 diets which were fed in 2 phases. Corn-soybean meal diets were formulated to deliver 2.94 or 2.34 g SID Lys per Mcal ME in phase 1 (72.6–95.0 kg) and 2.34 or 1.76 g SID Lys per Mcal ME in phase 2 (> 95.0 kg). Pigs were individually weighed every 28 days and feed disappearance was recorded. When pigs in a pen averaged 129.3 kg the entire pen of pigs were harvested. A single chop (last-rib location; 2.54 cm thick) was collected from each carcass to assess pork quality. Pigs harvested in the summer grew faster, more efficiently, and with more intramuscular fat than those harvested in winter (P-value ≤ 0.05) but had lower 10th rib pH (P-value < 0.0001). Pigs allotted 4.05 m2/pig grew more efficiently but had reduced last rib pH as compared to pigs stocked at 1.30 m2/pig (P-value < 0.05). Reducing SID Lys:ME did not impact growth performance or carcass characteristics (P-value > 0.10). Lower concentrations of SID Lys:ME may be adequate for pigs housed in bedded hoop barns but further study is warranted.

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