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Patient Safety and Quality

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https://www.readbyqxmd.com/read/28650922/randomized-trial-of-reducing-ambulatory-malpractice-and-safety-risk-results-of-the-massachusetts-promises-project
#1
Gordon D Schiff, Harry Reyes Nieva, Paula Griswold, Nicholas Leydon, Judy Ling, Frank Federico, Carol Keohane, Bonnie R Ellis, Cathy Foskett, E John Orav, Catherine Yoon, Don Goldmann, Joel S Weissman, David W Bates, Madeleine Biondolillo, Sara J Singer
OBJECTIVE: Evaluate application of quality improvement approaches to key ambulatory malpractice risk and safety areas. STUDY SETTING: In total, 25 small-to-medium-sized primary care practices (16 intervention; 9 control) in Massachusetts. STUDY DESIGN: Controlled trial of a 15-month intervention including exposure to a learning network, webinars, face-to-face meetings, and coaching by improvement advisors targeting "3+1" high-risk domains: test result, referral, and medication management plus culture/communication issues evaluated by survey and chart review tools...
June 23, 2017: Medical Care
https://www.readbyqxmd.com/read/28650743/identifying-factors-and-root-causes-associated-with-near-miss-or-safety-incidents-in-patients-treated-with-radiotherapy-a-case-control-analysis
#2
Gregory D Judy, Prithima R Mosaly, Lukasz M Mazur, Gregg Tracton, Lawrence B Marks, Bhishamjit S Chera
PURPOSE: To identify factors associated with a near-miss or safety incident (NMSI) in patients undergoing radiotherapy and identify common root causes of NMSIs and their relationship with incident severity. METHODS: We retrospectively studied NMSIs filed between October 2014 and April 2016. We extracted patient-, treatment-, and disease-specific data from patients with an NMSI (n = 200; incident group) and a similar group of control patients (n = 200) matched in time, without an NMSI...
June 26, 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28649895/the-safety-and-efficacy-of-palbociclib-in-the-treatment-of-metastatic-breast-cancer
#3
Johannes Ettl, Nadia Harbeck
Palbociclib (Ibrance(®)) is the first-in-class CDK4/6 inhibitor which has been introduced into clinical practice for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC). It is an orally administered drug, which acts by selectively inhibiting cyclin-dependant kinases CDK4 and CDK6. Given together with anti-estrogens like letrozole and fulvestrant it enhances the antiproliferative effect of these drugs without compromising the favorable toxicity profile of endocrine therapy...
June 26, 2017: Expert Review of Anticancer Therapy
https://www.readbyqxmd.com/read/28649893/radium-223-dichloride-for-the-treatment-of-castration-resistant-prostate-cancer-with-symptomatic-bone-metastases
#4
Nicholas J Vogelzang
Castration-resistant prostate cancer (CRPC) is associated with the development of bone metastases, increased mortality, and a reduction in the patient's quality of life (QOL). The management of metastatic CRPC (mCRPC) has rapidly evolved over the past decade, with a number of available therapeutic agents improving overall survival. Radium-223 dichloride (radium-223), the first targeted alpha therapy, improves survival accompanied by QOL benefits with a favorable safety profile. It is approved in over 40 countries for the treatment of patients with CRPC with symptomatic bone metastases and no known visceral metastatic disease...
June 26, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28648618/patients-preference-of-trastuzumab-administration-subcutaneous-versus-intravenous-in-her2-positive-metastatic-breast-cancer-results-of-the-randomised-metaspher-study
#5
X Pivot, J P Spano, M Espie, P Cottu, C Jouannaud, V Pottier, L Moreau, J M Extra, A Lortholary, P Rivera, D Spaeth, H Attar-Rabia, C Benkanoun, L Dima-Martinez, N Esposito, J Gligorov
HannaH (NCT00950300) and PrefHer (NCT01401166) studies validated the subcutaneous (H-s.c.) formulation of trastuzumab as effective and safe as intravenous (H-i.v.) and highly preferred by patients in early breast cancer. The present randomised MetaspHer trial (NCT01810393) is the first study assessing patient's preference in metastatic setting. METHODS: Patients with HER2-positive metastatic breast cancer who completed a first line chemotherapy with trastuzumab and achieved a long-term response lasting more than 3 years were randomised to receive 3 cycles of 600-mg fixed-dose adjuvant H-s...
June 22, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28648417/effect-of-heart-failure-reversal-treatment-as-add-on-therapy-in-patients-with-chronic-heart-failure-a-randomized-open-label-study
#6
Rohit Sane, Abhijeet Aklujkar, Atul Patil, Rahul Mandole
OBJECTIVES: The present study was designed to evaluate effect of heart failure reversal therapy (HFRT) using herbal procedure (panchakarma) and allied therapies, as add-on to standard CHF treatment (SCT) in chronic heart failure (CHF) patients. METHODS: This open-label, randomized study conducted in CHF patients (aged: 25-65 years, ejection fraction: 30-65%), had 3-phases: 1-week screening, 6-week treatment (randomized [1:1] to HFRT+SCT or SCT-alone) and follow-up (12-week)...
May 2017: Indian Heart Journal
https://www.readbyqxmd.com/read/28648219/primary-care-collaboration-to-improve-diagnosis-and-screening-for-colorectal-cancer
#7
Gordon D Schiff, Trudy Bearden, Lindsay Swain Hunt, Jennifer Azzara, Jay Larmon, Russell S Phillips, Sara Singer, Brandon Bennett, Jonathan R Sugarman, Asaf Bitton, Andrew Ellner
BACKGROUND: Colorectal cancer (CRC) is a leading cause of cancer death, reducible by screening and early diagnosis, yet many patients fail to receive recommended screening. As part of an academic improvement collaborative, 25 primary care practices worked to improve CRC screening and diagnosis. METHODS: The project featured triannual learning sessions, monthly conference calls, practice coach support, and monthly reporting. The project phases included literature review and interviews with national leaders/organizations, development of driver diagrams to identify key factors and change ideas, project launch and practice team planning, and a practice improvement phase...
July 2017: Joint Commission Journal on Quality and Patient Safety
https://www.readbyqxmd.com/read/28648217/integrating-research-quality-improvement-and-medical-education-for-better-handoffs-and-safer-care-disseminating-adapting-and-implementing-the-i-pass-program
#8
Amy J Starmer, Nancy D Spector, Daniel C West, Rajendu Srivastava, Theodore C Sectish, Christopher P Landrigan
BACKGROUND: In 2009 the I-PASS Study Group was formed by patient safety, medical education, health services research, and clinical experts from multiple institutions in the United States and Canada. When the I-PASS Handoff Program, which was developed by the I-PASS Study Group, was implemented in nine hospitals, it was associated with a 30% reduction in injuries due to medical errors and significant improvements in handoff processes, without any adverse effects on provider work flow. METHODS: To effectively disseminate and adapt I-PASS for use across specialties and disciplines, a series of federally and privately funded dissemination and implementation projects were carried out following the publication of the initial study...
July 2017: Joint Commission Journal on Quality and Patient Safety
https://www.readbyqxmd.com/read/28646940/management-of-refractory-idiopathic-overactive-bladder-intradetrusor-injection-of-botulinum-toxin-type-a-versus-posterior-tibial-nerve-stimulation
#9
Hammouda Sherif, Mostafa Khalil, Rabea Omar
INTRODUCTION: To compare the safety and efficacy of posterior tibial nerve stimulation (PTNS) versus an intradetrusor injection of botulinum toxin type-A (BTX-A) 100 U in the management of refractory idiopathic overactive bladder (OAB). MATERIALS AND METHODS: We randomized 60 patients with refractory idiopathic OAB to receive an intradetrusor injection of BTX-A 100 U or PTNS. We assessed the patients at baseline, 6 weeks, 3 months, 6 months, and 9 months, and determined their clinical symptoms, overall OAB symptom score, urgency score, quality-of-life score, and urodynamic study parameters...
June 2017: Canadian Journal of Urology
https://www.readbyqxmd.com/read/28646936/surgical-flow-disruptions-during-robotic-assisted-radical-prostatectomy
#10
Christopher J Dru, Jennifer T Anger, Colby P Souders, Catherine Bresee, Matthias Weigl, Elyse Hallett, Ken Catchpole
INTRODUCTION: We sought to apply the principles of human factors research to robotic-assisted radical prostatectomy to understand where training and integration challenges lead to suboptimal and inefficient care. MATERIALS AND METHODS: Thirty-four robotic-assisted radical prostatectomy and bilateral pelvic lymph node dissections over a 20 week period were observed for flow disruptions (FD) - deviations from optimal care that can compromise safety or efficiency. Other variables - physician experience, trainee involvement, robot model (S versus Si), age, body mass index (BMI), and American Society of Anesthesiologists (ASA) physical status - were used to stratify the data and understand the effect of context...
June 2017: Canadian Journal of Urology
https://www.readbyqxmd.com/read/28646886/implementation-science-for-ambulatory-care-safety-a-novel-method-to-develop-context-sensitive-interventions-to-reduce-quality-gaps-in-monitoring-high-risk-patients
#11
Kathryn M McDonald, George Su, Sarah Lisker, Emily S Patterson, Urmimala Sarkar
BACKGROUND: Missed evidence-based monitoring in high-risk conditions (e.g., cancer) leads to delayed diagnosis. Current technological solutions fail to close this safety gap. In response, we aim to demonstrate a novel method to identify common vulnerabilities across clinics and generate attributes for context-flexible population-level monitoring solutions for widespread implementation to improve quality. METHODS: Based on interviews with staff in otolaryngology, pulmonary, urology, breast, and gastroenterology clinics at a large urban publicly funded health system, we applied journey mapping to co-develop a visual representation of how patients are monitored for high-risk conditions...
June 24, 2017: Implementation Science: IS
https://www.readbyqxmd.com/read/28646375/comparative-efficacy-and-safety-in-esa-biosimilars-vs-originators-in-adults-with-chronic-kidney-disease-a-systematic-review-and-meta-analysis
#12
REVIEW
Laura Amato, Antonio Addis, Rosella Saulle, Francesco Trotta, Zuzana Mitrova, Marina Davoli
BACKGROUND: Several Erythropoiesis-stimulating agents (ESAs) are available to treat anemia in patients with chronic kidney disease (CKD). Questions about the comparability of such therapeutic options are not purely a regulatory or economical matter. Appropriate use of originator or biosimilar in these patients need to be supported by clinical data. Regarding the prevention of blood transfusion, reduction of fatigue, breathlessness and mortality or cardiovascular events, a summary of the comparative efficacy and safety data of these drugs is lacking...
June 23, 2017: Journal of Nephrology
https://www.readbyqxmd.com/read/28645963/effectiveness-and-safety-of-moxibustion-treatment-for-non-specific-lower-back-pain-protocol-for-a-systematic-review
#13
Jungtae Leem, Seunghoon Lee, Yeoncheol Park, Byung-Kwan Seo, Yeeun Cho, Jung Won Kang, Yoon Jae Lee, In-Hyuk Ha, Hyun-Jong Lee, Eun-Jung Kim, Sanghoon Lee, Dongwoo Nam
INTRODUCTION: Many patients experience acute lower back pain that becomes chronic pain. The proportion of patients using complementary and alternative medicine to treat lower back is increasing. Even though several moxibustion clinical trials for lower back pain have been conducted, the effectiveness and safety of moxibustion intervention is controversial. The purpose of this study protocol for a systematic review is to evaluate the effectiveness and safety of moxibustion treatment for non-specific lower back pain patients...
June 23, 2017: BMJ Open
https://www.readbyqxmd.com/read/28645737/alfapump-system-vs-large-volume-paracentesis-for-refractory-ascites-a-multicenter-randomized-controlled-study
#14
Christophe Bureau, Danielle Adebayo, Mael Chalret de Rieu, Laure Elkrief, Dominique Valla, Markus Peck-Radosavljevic, Anne McCune, Victor Vargas, Macarena Simon-Talero, Juan Cordoba, Paolo Angeli, Silvia Rosi, Stewart MacDonald, Massimo Malago, Maria Stepanova, Zobair M Younossi, Claudia Trepte, Randall Watson, Oleg Borisenko, Sun Sun, Neil Inhaber, Rajiv Jalan
BACKGROUND AND AIMS: Patients with refractory ascites (RA) require repeated large volume paracenteses (LVP), which involves frequent hospital visits and is associated with poor quality-of-life. This study assessed safety and efficacy of an automated, low-flow pump (alfapump [AP]) compared with LVP [SoC]. METHODS: Randomized, controlled trial, in 7 centers, with 6M patient observation. Primary outcome was time to first LVP. Secondary outcomes included paracentesis requirement, safety, health-related quality-of-life (HRQoL), and survival...
June 20, 2017: Journal of Hepatology
https://www.readbyqxmd.com/read/28644984/current-practice-and-recommendations-in-uk-epilepsy-monitoring-units-report-of-a-national-survey-and-workshop
#15
Khalid Hamandi, Sandor Beniczky, Beate Diehl, Rosalind H Kandler, Ronit M Pressler, Arjune Sen, Juliet Solomon, Matthew C Walker, Manny Bagary
PURPOSE: Inpatient video-EEG monitoring (VEM) is an important investigation in patients with seizures or blackouts, and in the pre-surgical workup of patients with epilepsy. There has been an expansion in the number of Epilepsy Monitoring Units (EMU) in the UK offering VEM with a necessary increase in attention on quality and safety. Previous surveys have shown variation across centres on issues including consent and patient monitoring. METHOD: In an effort to bring together healthcare professionals in the UK managing patients on EMU, we conducted an online survey of current VEM practice and held a one-day workshop convened under the auspices of the British Chapter of the ILAE...
June 15, 2017: Seizure: the Journal of the British Epilepsy Association
https://www.readbyqxmd.com/read/28644771/biomarker-based-phase-ii-trial-of-savolitinib-in-patients-with-advanced-papillary-renal-cell-cancer
#16
Toni K Choueiri, Elizabeth Plimack, Hendrik-Tobias Arkenau, Eric Jonasch, Daniel Y C Heng, Thomas Powles, Melanie M Frigault, Edwin A Clark, Amir A Handzel, Humphrey Gardner, Shethah Morgan, Laurence Albiges, Sumanta Kumar Pal
Purpose Patients with advanced papillary renal cell carcinoma (PRCC) have limited therapeutic options. PRCC may involve activation of the MET pathway, for example, through gene amplification or mutations. Savolitinib (AZD6094, HMPL-504, volitinib) is a highly selective MET tyrosine kinase inhibitor. We report results of a single-arm, multicenter, phase II study evaluating the safety and efficacy of savolitinib in patients with PRCC according to MET status. Patients and Methods Patients with histologically confirmed locally advanced or metastatic PRCC were enrolled and received savolitinib 600 mg orally once daily...
June 23, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28644196/cebranopadol-a-novel-first-in-class-analgesic-drug-candidate-first-experience-in-patients-with-chronic-low-back-pain-in-a-randomized-clinical-trial
#17
Annette Christoph, Marie-Henriette Eerdekens, Maurits Kok, Gisela Volkers, Rainer Freynhagen
Chronic low back pain (LBP) is a common condition, usually with involvement of nociceptive and neuropathic pain components, high economic burden and impact on quality of life. Cebranopadol is a potent, first-in-class drug candidate with a novel mechanistic approach, combining nociceptin/orphanin FQ peptide and opioid peptide receptor agonism. We conducted the first Phase II, randomized, doubleblind, placebo- and active-controlled trial, evaluating the analgesic efficacy, safety, and tolerability of cebranopadol in patients with moderate to severe chronic LBP with and without neuropathic pain component...
June 21, 2017: Pain
https://www.readbyqxmd.com/read/28643733/a-prospective-randomized-controlled-study-of-cisplatin-versus-carboplatin-based-regimen-in-advanced-squamous-nonsmall-cell-lung-cancer
#18
Amr Shafik Saad, Ramy R Ghali, May Ahmed Shawki
BACKGROUND: The use of cisplatin (Cis) versus carboplatin (Carb) in the treatment of advanced nonsmall cell lung cancer (NSCLC) is controversial. The aim of the study was to compare the safety and efficacy of Cis versus Carb in squamous NSCLC. PATIENTS AND METHODS: A prospective, randomized, controlled, open-label study was conducted on advanced squamous NSCLC patients who were randomly assigned to receive Cis (40 mg/m 2 [day 1 and day 8]) or Carb (area under the curve = 5 [day 1]) combined with gemcitabine [Gem] (1000 mg/m 2 [day 1 and day 8]) of a 3-week schedule for six cycles...
April 2017: Journal of Cancer Research and Therapeutics
https://www.readbyqxmd.com/read/28643672/switch-from-agalsidase-beta-to-agalsidase-alfa-in-the-enzyme-replacement-therapy-of-patients-with-fabry-disease-in-latin-america
#19
Diego Ripeau, Hernán Amartino, Martín Cedrolla, Luis Urtiaga, Bella Urdaneta, Marilis Cano, Rita Valdez, Norberto Antongiovanni, Francisca Masllorens
There are currently two available enzyme replacement therapies for Fabry disease and little information regarding efficacy and safety of switching therapies. Between 2009 and 2012 there was a worldwide shortage of agalsidase beta and patients on that enzyme were switched to agalsidase alfa. This retrospective observational study assessed a 2-year period of efficacy and safety in a population of Fabry patients, in Argentina (30 patients) and Venezuela (3 patients), who switched therapies from algasidase beta to agalsidase alfa...
2017: Medicina
https://www.readbyqxmd.com/read/28643056/deep-neuromuscular-blockade-improves-surgical-conditions-during-low-pressure-pneumoperitoneum-laparoscopic-donor-nephrectomy
#20
D M D Özdemir-van Brunschot, A E Braat, M F P van der Jagt, G J Scheffer, C H Martini, J F Langenhuijsen, R E Dam, V A Huurman, D Lam, F C d'Ancona, A Dahan, M C Warlé
BACKGROUND: Evidence indicates that low-pressure pneumoperitoneum (PNP) reduces postoperative pain and analgesic consumption. A lower insufflation pressure may hamper visibility and working space. The aim of the study is to investigate whether deep neuromuscular blockade (NMB) improves surgical conditions during low-pressure PNP. METHODS: This study was a blinded randomized controlled multicenter trial. 34 kidney donors scheduled for laparoscopic donor nephrectomy randomly received low-pressure PNP (6 mmHg) with either deep (PTC 1-5) or moderate NMB (TOF 0-1)...
June 22, 2017: Surgical Endoscopy
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