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When Phase III treatment effect is diluted from what was observed from Phase II results, we propose to determine the Bayesian sample size for a Phase III clinical trial based on the normal, uniform, and truncated normal prior distributions of the treatment effects on an interval, which starts from an acceptable treatment effect to the observed treatment effect from Phase II. After incorporating the prior information of the treatment effects, the Bayesian sample size is the number of patients of the Phase II...
Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials.
Clinical practice guidelines (CPGs) are significant tools for evidence-based health care quality improvement. The CPG program at King Saud University was launched as a quality improvement program to fulfil the international accreditation standards. This program was a collaboration between the Research Chair for Evidence-Based Healthcare and Knowledge Translation and the Quality Management Department. This study aims to develop a fast-track method for adaptation of evidence-based CPGs and describe results of...
The Partners Clinical Process Improvement Leadership Program provides quality improvement training for clinicians and administrators, utilizing graduates as volunteer peer coaches for mentorship. We sought to understand the factors associated with volunteer coach participation and gain insight into how to improve and sustain this program.
Although drug-based treatment is the primary intervention for malaria control and elimination, optimal use of targeted treatments remains unclear. From 2008 to 2016, three targeted programs on treatment were undertaken in Kachin Special Region II (KR2), Myanmar. Program I (2008-2011) treated all confirmed, clinical and suspected cases; program II (2012-2013) treated confirmed and clinical cases; and program III (2014-2016) targeted confirmed cases only. This study aims to evaluate the impacts of the three p...
The Royal College of Pathologists of Australasia Quality Assurance Programs introduced virtual microscopy cases into its cytopathology non-gynaecological program after a short pilot phase, to address the challenges of providing a purely glass slide-based external quality assurance program to multiple participants both locally and internationally. The use of whole slide image (WSI) cases has facilitated a more robust program in relation to standardised material and statistical analysis, with access to a wide...
Merck & Co., Inc. (Kenilworth, New Jersey) has recently published an integrated strategy for implementation of dried blood spots (DBS) in late-stage trials for population pharmacokinetic (PK) modeling. We applied this strategy for another late-stage clinical program: ubrogepant (MK-1602), a novel oral calcitonin gene-related peptide receptor antagonist for acute treatment of migraine. At the time of implementation, ubrogepant was entering phase 2 development. DBS was implemented to acquire PK information pr...
The main purpose of this study was compare the effects of resistance training (RT) performed two versus three times per week on phase angle (a cellular health indicator) in older women. Thirty-nine women (69.1±5.5 years) were randomly assigned to perform a RT program two (G2X) or three (G3X) days per week for 12 weeks. The RT was a whole-body program (8 exercises, 1 set, 10-15 repetitions). Phase angle, resistance, reactance, and total body water were assessed by bioimpedance spectroscopy. Intracellular wa...
As intraventricular thrombolysis for intraventricular hemorrhage (IVH) has developed over the last 2 decades, hemorrhagic complications have remained a concern despite general validation of its safety in controlled trials in the Clot Lysis: Evaluation of Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR-IVH) program.
To obtain a deeper understanding of how the e-learning program, Education in Dermatology (ED), affects the acquisition of dermatological knowledge and the underlying learning processes of medical students in their clinical phase.
The aim of the study was to evaluate a mentorship program for adjunct clinical faculty.
Assess patient adherence to radiologist recommendations in a clinical CT lung cancer screening program.
The Diabetes Prevention Program (DPP) demonstrated that lifestyle intervention programs were effective in preventing or delaying the onset of diabetes. The Group Lifestyle Balance (GLB) program translated the DPP curriculum into a 12-wk group intervention for those at risk for diabetes. This retrospective evaluation examined clinical outcomes for patients in the Diabetes Center of Excellence GLB program located at Wilford Hall Ambulatory Surgical Center from 2009 to 2013. Objectives included determining rat...
Animal-facilitated therapy (AFT) is a complementary medicine intervention. To the authors' knowledge, no study has investigated the benefits of an AFT program in an adult surgical oncology setting.
Illness Management and Recovery (IMR) is a psychosocial intervention with a recovery-oriented approach. The program has been evaluated in different settings; however evidence for the effects of IMR is still deficient. The aim of this trial was to investigate the benefits and harms of the IMR program compared with treatment as usual in Danish patients with schizophrenia or bipolar disorder.
The objective of this study is to assess the rates of infection-free achievement of hidradenitis suppurativa clinical response (HiSCR) using integrated data from 2 phase 3, placebo-controlled trials, PIONEER I and II.
This study examined the perceptions of benefits of and barriers to participating in a community-based diabetes program to improve program effectiveness. The Diabetes Prevention and Management (DPM) program was a twenty-two session, 1-year program, modeled after the evidence-based National Diabetes Prevention Program and AADE7 Self-Care Behaviors framework. Community-based participatory research approach was used to culturally tailor the curriculum. Participants included overweight or obese adults with dysgl...
Swallowing and swallowing-related quality of life studies following stroke were almost always performed by including both patients with brainstem and cortical involvement. It was aimed in this study to show the presence of dysphagia in patients with only cortical ischemic stroke and to investigate the interaction between dysphagia and quality of life as well as to evaluate the effect of a rehabilitation program in the acute phase. Seventy-two patients with cortical stroke (between 0 and 30 days) and dyspha...
The prevalence of an exaggerated exercise blood pressure (BP) response is unknown in patients with subacute stroke, and it is not known whether an aerobic exercise program modulates this response. The authors randomized 53 patients (27 women) with subacute stroke to 12 weeks of twice-weekly aerobic exercise (n = 29) or to usual care without scheduled physical exercise (n = 24). At baseline, 66% of the patients exhibited an exaggerated exercise BP response (peak systolic BP ≥210 mm Hg in men and ≥...
We evaluated outcomes of an online, self-directed REACH forgiveness intervention for community-based adults. Because many participants dropped out before program completion, predictors of program persistence were also examined.
This study evaluated a system thinking-based simulation program for the care of patients with congestive heart failure. Participants were 67 undergraduate nursing students from a nursing college in Seoul, South Korea. The experimental group was given a 4-hour system-thinking program and a 2-hour simulation program, whereas the control group had a 4-hour case study and a 2-hour simulation program. There were significant improvements in critical thinking in both groups, but no significant group differences be...
The impressive progress recently observed in adult cancers through the introduction of new drugs has not yet been translated to adolescents between 12 and 17 years of age. Currently adolescents are grouped with children, so their access to new, effective drugs already available for adults is delayed because paediatric drug development starts late relative to adult programmes. Moreover, specific early phase trials designed exclusively for adolescents in rare diseases recruit poorly, even if conducted interna...
We collected serum-cerebrospinal fluid (CSF)-paired samples during the acute phase of clinical episodes in MS and NMO patients, together with paired samples from non-MS/NMO patients, to compare the quotients of proteins and electrolytes among them. In NMO, the quotient of chloride was significantly higher in the acute phase of optic neuritis and brain lesions, but it was significantly lower in the acute phase of myelitis. Such findings were not observed in MS or in non-MS/NMO cases. With the coexistence of ...
The first Phase II and III clinical trials for treatments for Ebola Virus Disease were conducted during the west Africa (2013-16) outbreak. We report the operational practicalities of conducting a phase II clinical trial of TKM-130803 to international standards during this outbreak.
The purpose of this article is to review different x-ray phase-contrast breast imaging techniques and their potential application in clinical settings.