Developing recommendations for the safe handling of oral anti-cancer drugs in community pharmacies: A pan-Canadian consensus approach.

PURPOSE: To create a set of consensus-based and evidence-informed recommendations to provide guidance around the safe dispensing and handling of oral anti-cancer drugs in low-volume settings unique to the community pharmacy setting. METHODS: A review of published and grey literature (published in non-commercial domains such as national organizations and associations) documents and nine key informant interviews were conducted and a modified Delphi approach was taken to achieve consensus. The final list of 47 candidate recommendations was reviewed by a task force and validated by multi-disciplinary stakeholders. A draft of the statements was circulated broadly within the community pharmacy community in an effort to assess relevance and implementation feasibility. RESULTS: The final report included 44 recommendations that addressed 11 key areas germane to the safe handling of oral anti-cancer drugs in community pharmacies. Mean agreement increased from 70% to 95%. Early feedback from community pharmacy leaders during the external review suggests that many of the proposed recommendations can be feasibly implemented within a reasonable timeframe when released with appropriate education and resource materials. CONCLUSIONS: A modified-Delphi approach supplemented by key informant interviews and a comprehensive external review resulted in a set of evidence-informed, community-driven recommendations for community pharmacies. The recommendations address a gap in existing literature to improve understanding of the risks associated with handling and dispensing oral anti-cancer drugs for both community pharmacy staff and management and offer mitigating strategies to reduce those risks. Incorporating feasibility assessment actions early (through the key informant interviews) and late (through the external review) ensures recommendations are grounded in practicality and support broad and early knowledge translation strategies.

The effect of the angle of acuteness of additive manufactured models and the direction of printing on the dimensional fidelity: clinical implications.

The influence of the acuteness of the model angle and the direction of printing was investigated on different three-dimensional (3D) printers to understand the fidelity of 3D printing. A Polyjet printer and two fused deposition modeling printers were used in the present study. Computer-aided design (CAD) models were designed in the form of a triangular prism with a height of 15 mm and with varying angles of 60°, 45°, 30°, 20°, 10°, and 5°. From the CAD designs, additive manufacturing (AM) models were printed in three different directions by each of the three printers. To investigate the global fidelity of the 3D printers, the height and surface outlines of the AM model cross sections were measured. The fidelity of the AM models with increasingly acute angles was not accurately reproduced when 3D printed, and the surface outlines of the AM model cross sections were different in each direction of printing for each device. Printing technology and printing direction need to be considered if accurate reproduction of acute angles in fine AM structures in medical models is a necessity.

Alberta reconstructive technique (ART): An innovative approach using digital surgical design and simulation in advanced jaw reconstruction with occlusion-based prefabricated vascularized fibular flaps and primary osseointegrated implant installation.

The Alberta reconstructive technique (ART) is an innovative surgical procedure performed on patients undergoing primary jaw resection and reconstruction. The ART procedure was developed in collaboration with the Institute for Reconstructive Sciences in Medicine and the Division of Otolaryngology-Head and Neck Surgery, University of Alberta.

3D Printed Patient-Specific Cutting Guides for Bone Grafting in Reverse Shoulder Arthroplasty: A Novel Technique.

Glenoid bone loss remains a challenge in shoulder arthroplasty. Addressing substantial bone loss is essential to ensure proper function and stability of the shoulder prosthesis and to prevent baseplate loosening and subsequent revision surgery. Current options for creating and shaping glenoid bone grafts include free-hand techniques and simple reusable cutting guides that cut the graft at a standard angle. There is currently no patient-specific device available that enables surgeons to accurately prepare the bone graft and correct glenoid deformity. We present a novel surgical technique using three-dimensional (3D)-printed cutting guides to create a patient-specific bone graft to address glenoid deformity in the setting of reverse shoulder arthroplasty.

The Accuracy of 3D Surgical Design and Simulation in Prefabricated Fibula Free Flaps for Jaw Reconstruction.

The ideal jaw reconstruction involves the restoration and maintenance of jaw continuity, jaw relations, joint alignment, and facial contour, and, most importantly, dental occlusal reconstruction. One of the essential requirements of achieving a consistent functional outcome is to place the bony reconstruction in the correct three-dimensional position as it relates to the other jaw segments and dentition. A protocol of occlusion-driven reconstruction of prefabricated fibular free flaps that are customized to the patient with surgical design and simulation (SDS)-planned osseointegrated implant installation was developed by our institution. This innovation introduced significant flexibility and efficiency to jaw reconstructions, but functional and cosmetic outcomes were dependent on the accuracy of the final reconstructions when compared to the SDS plan. The purpose of this study was to examine the accuracy of the SDS-planned fibular flap prefabrication in a cohort of patients undergoing jaw reconstruction. All patients that had undergone primary jaw reconstruction with prefabricated fibular free flaps were reviewed. The primary outcome of this study was the accuracy of the postoperative implant positions as compared to the SDS plan. A total of 23 implants were included in the analysis. All flaps survived, there was no implant loss postoperatively, and all the patients underwent all stages of the reconstruction. SDS planning of fibular flap prefabrication resulted in better than 2 mm accuracy of osteointegrated implant placement in a cohort of patients undergoing jaw reconstruction. This accuracy could potentially result in improved functional and cosmetic outcomes.

Safety and immunogenicity of monovalent H7N9 influenza vaccine with AS03 adjuvant given sequentially or simultaneously with a seasonal influenza vaccine: A randomized clinical trial.

BACKGROUND: Influenza A/H7N9 viruses have pandemic potential. METHODS: We conducted an open-label, randomized, controlled trial of AS03-adjuvanted 2017 inactivated influenza A/H7N9 vaccine (H7N9 IIV) in healthy adults. Group 1 received H7N9 IIV and seasonal quadrivalent influenza vaccine (IIV4) simultaneously, followed by H7N9 IIV three weeks later. Group 2 received IIV4 alone and then two doses of H7N9 IIV at three-week intervals. Group 3 received one dose of IIV4. We used hemagglutination inhibition (HAI) and microneutralization (MN) assays to measure geometric mean titers and seroprotection (≥1:40 titer) to vaccine strains and monitored for safety. RESULTS: Among 149 subjects, seroprotection by HAI three weeks after H7N9 IIV dose 2 was 51% (95 %CI 37%-65%) for Group 1 and 40% (95 %CI 25%-56%) for Group 2. Seroprotection by MN at the same timepoint was 84% (95 %CI 72%-93%) for Group 1 and 74% (95 %CI 60%-86%) for Group 2. By 180 days after H7N9 IIV dose 2, seroprotection by HAI or MN was low for Groups 1 and 2. Responses measured by HAI and MN against each IIV4 strain three weeks after IIV4 vaccination were similar in all groups. Solicited local and systemic reactions were similar after a single vaccination, while those receiving simultaneous H7N9 and IIV4 had slightly more reactogenicity. There were no serious adverse events or medically-attended adverse events related to study product receipt. CONCLUSIONS: Adjuvanted H7N9 IIV was modestly immunogenic whether administered simultaneously or sequentially with IIV4, though responses declined by 180 days. IIV4 was immunogenic regardless of schedule. CLINICAL TRIALS REGISTRATION: NCT03318315.

The Modified Alberta Reconstructive Technique: A prospective cohort study.

INTRODUCTION: Jaw defect reconstructions have been transformed by the development of free tissue transfer using vascularized bone incorporating osseointegrated dental implants. We recently developed a modification our method this procedure and termed it the Modified Alberta Reconstruction Technique (MART). The objective of this study aimed to assess the soft tissue component and outcomes of the MART as compared to the Alberta Reconstructive Technique (ART) or conventional (BDD) reconstructions. PATIENTS AND METHODS: This was a prospective cohort study of adult patients who underwent jaw reconstruction with dental implant rehabilitation between 2000 and 2019 in Edmonton, Alberta. Patients were aged-matched and placed into a cohort based on the type of reconstruction they received. Outcomes were compared between the groups. Expert and aesthetic analyses were performed. Statistical analysis was conducted to determine significance. RESULTS: A total of 46 patients (15 BDD, 15 ART and 16 MART) were included. Demographics were similar between groups. There was no difference in complications. The soft tissue component of the MART cohort was more favourable to work with as judged by the occlusal reconstructive experts. The MART was rated as more aesthetically appealing in comparison to the BDD and ART (p = 0.049). CONCLUSIONS: The MART is a safe, effective, and aesthetically appealing procedure. It yields a good functional result and a clinically better soft tissue component for occlusal reconstructions. For a select group of patients requiring jaw reconstruction, the MART is an ideal reconstructive option as the modification provides good control of the soft tissue around the implants.

Prolonged moderate-intensity aerobic exercise does not alter apoptotic signaling and DNA fragmentation in human skeletal muscle.

Apoptosis in skeletal muscle plays an important role in age- and disease-related tissue dysfunction. Physical activity can influence apoptotic signaling; however, this process has not been well studied in human skeletal muscle. The purpose of this study was to perform a comprehensive analysis of apoptosis-related proteins/enzymes, DNA fragmentation, and oxidative stress in skeletal muscle of humans during an acute bout of prolonged moderate-intensity exercise. Eight healthy, recreationally active individuals (age 20.8 +/- 0.5 yr, Vo(2peak) 51.2 +/- 0.9 ml . kg(-1) . min(-1), BMI 21.5 +/- 0.8 kg/m(2)) exercised on a cycle ergometer at approximately 60% Vo(2peak) for 2 h. Muscle biopsies were obtained at rest as well as at 60 and 120 min of exercise. Although exercise was associated with a significant whole body and muscle metabolic response, there were no significant changes in the content of antiapoptotic (ARC, Bcl-2, Hsp70, XIAP) and proapoptotic (AIF, Bax, Smac) proteins, activity of proteolytic enzymes (caspase-3, caspase-8, caspase-9), DNA fragmentation, or TUNEL-positive nuclei in skeletal muscle. Furthermore, the protein levels of several antioxidant enzymes (catalase, CuZnSOD, MnSOD), concentrations of GSH and GSSG, and degree of ROS generation in skeletal muscle were not altered by exercise. Fiber type-specific analysis also revealed that ARC (P < 0.001) and Hsp70 (P < 0.05) protein were significantly higher in type I compared with type IIA and type IIAX/X fibers; however, protein levels were not affected by exercise. These findings suggest that a single bout of prolonged moderate-intensity aerobic exercise is not sufficient to alter apoptotic signaling in skeletal muscle of healthy humans.

The Alberta Reconstructive Technique: An Occlusion-Driven and Digitally Based Jaw Reconstruction.

OBJECTIVES/HYPOTHESIS: The free flap reconstructive protocols of the jaws have been refined over the years and presently are based on bone-driven approaches that generally use the lower border of the mandible or the anterior surface of the maxilla as the templates for reconstruction because these contours are deemed important to the eventual cosmetic outcomes of patients. The ultimate goal of functional jaw reconstruction, however, is the reconstruction of the dental occlusion and oral rehabilitation. The purpose of the present study was to evaluate the Alberta reconstructive technique (ART), which is a new approach of occlusion-driven jaw reconstruction with digitally planned immediate osseointegrated implant installation. STUDY DESIGN: Prospective cohort study. METHODS: This research study considers the ART's safety, effectiveness, accuracy, timeliness of reconstruction, aesthetic appeal, and cost-effectiveness in comparison with the standard bone-driven and delayed osseointegrated implant installation (BDD) protocol. RESULTS: The ART procedures were as safe and more effective at achieving full occlusal reconstruction and oral rehabilitation. The ART cohort of patients achieved oral rehabilitation in 21.4 month as compared to 73.1 months for the BDD cohort. There were no differences in the aesthetic appeal the two groups. The ART cost an average of $22,004 less than BDD and we calculated the quality adjusted life years gain to be between 2.14 and 4.04 in favour of ART. CONCLUSIONS: The ART is a good option for patients with jaw defects. It provides a safe, effective, accurate, aesthetic, and cost-effective reconstruction that restores form and function in a timely manner. LEVEL OF EVIDENCE: 2b Laryngoscope, 129:S1-S14, 2019.

From policy to practice: assessing the impact of staging policies for recording cancer stage across Canada.

In 1998, a survey of all hospitals in Canada by the National Cancer Institute (NCI) of Canada found that only 17% reported that stage was routinely recorded. Closely following the methodology of the 1998 study, an online questionnaire was sent to the chief executive officer of 201 institutions in Canada. Since the study in 1998, it was found that the staging rate in Canada has significantly increased from 17 to 36%. The implementation of a staging policy has had a significant impact on the practices of recording stage, but further policy initiatives, education and communication are required to improve institutional staging practices.

Intravenous Chemotherapy Compounding Errors in a Follow-Up Pan-Canadian Observational Study.

PURPOSE: Intravenous (IV) compounding safety has garnered recent attention as a result of high-profile incidents, awareness efforts from the safety community, and increasingly stringent practice standards. New research with more-sensitive error detection techniques continues to reinforce that error rates with manual IV compounding are unacceptably high. In 2014, our team published an observational study that described three types of previously unrecognized and potentially catastrophic latent chemotherapy preparation errors in Canadian oncology pharmacies that would otherwise be undetectable. We expand on this research and explore whether additional potential human failures are yet to be addressed by practice standards. METHODS: Field observations were conducted in four cancer center pharmacies in four Canadian provinces from January 2013 to February 2015. Human factors specialists observed and interviewed pharmacy managers, oncology pharmacists, pharmacy technicians, and pharmacy assistants as they carried out their work. Emphasis was on latent errors (potential human failures) that could lead to outcomes such as wrong drug, dose, or diluent. RESULTS: Given the relatively short observational period, no active failures or actual errors were observed. However, 11 latent errors in chemotherapy compounding were identified. In terms of severity, all 11 errors create the potential for a patient to receive the wrong drug or dose, which in the context of cancer care, could lead to death or permanent loss of function. Three of the 11 practices were observed in our previous study, but eight were new. Applicable Canadian and international standards and guidelines do not explicitly address many of the potentially error-prone practices observed. CONCLUSION: We observed a significant degree of risk for error in manual mixing practice. These latent errors may exist in other regions where manual compounding of IV chemotherapy takes place. Continued efforts to advance standards, guidelines, technological innovation, and chemical quality testing are needed.

Coordination Program Reduced Acute Care Use And Increased Primary Care Visits Among Frequent Emergency Care Users.

Many high utilizers of the emergency department (ED) have public insurance, especially through Medicaid. We evaluated how participation in Bridges to Care (B2C)-an ED-initiated, multidisciplinary, community-based program-affected subsequent ED use, hospital admissions, and primary care use among publicly insured or Medicaid-eligible high ED utilizers. During the six months after the B2C intervention was completed, participants had significantly fewer ED visits (a reduction of 27.9 percent) and significantly more primary care visits (an increase of 114.0 percent), compared to patients in the control group. In a subanalysis of patients with mental health comorbidities, we found that recipients of B2C services had significantly fewer ED visits (a reduction of 29.7 percent) and hospitalizations (30.0 percent), and significantly more primary care visits (an increase of 123.2 percent), again compared to patients in the control group. The B2C program reduced acute care use and increased the number of primary care visits among high ED utilizers, including those with mental health comorbidities.

The role of education, technique and equipment in pressure area care.

This paper aims to reflect on the successful management of pressure ulcer equipment within a district general hospital. Insight is given into what is considered an effective, efficient and economic use of static and dynamic mattress, underpinned by a fundamental education package into pressure ulcer management and prevention techniques.

Evaluation of test strips for the rapid identification of ethylenediaminetetraacetic acid (EDTA) specimens.

BACKGROUND: Identification of specimens that contain ethylenediaminetetraacetic acid (EDTA) is frequently necessary when investigating potentially mislabeled or improperly collected specimens. OBJECTIVE: To evaluate the performance of rapid EDTA detection test strips in clinical specimens. METHODS: We applied specimens to test strips designed to detect EDTA (QUANTOFIX EDTA) using a pipet (drop mode). Reactions were scored visually on a scale from red (no EDTA) to orange (low/indeterminate EDTA) to yellow (contains EDTA). RESULTS: Test strips reliably identified specimens from EDTA-containing tube types. Although test strips did not detect strong reactivity in other specimens, tubes containing NaFl/K-oxalate produced an orange (low/indeterminate EDTA) reaction. Bismuth and citrate levels were higher in specimens after we dipped test strips into solution (dip mode). CONCLUSIONS: Test strips detected the presence of EDTA in concentrations found in EDTA-containing primary tubes. Test strips were less effective in evaluating low-level EDTA concentrations expected with intravenous line contamination or backflow. Indeterminate reactions required further investigation. Dip mode can produce analytical problems for assays that measure (or are interfered by) the contents of test strips.

Evaluation of the accuracy of cone beam computerized tomography (CBCT): medical imaging technology in head and neck reconstruction.

BACKGROUND: With the introduction, development and commercialization of Cone Beam Computerized Tomography (CBCT) technologies in the field of head and neck reconstruction, clinicians now have increased access to the technology. Given the growth of this new user group, there is an increasing concern regarding proper use, understanding, quality and patient safety. METHODS: The present study was carried out to evaluate data acquisition of CBCT medical imaging technology and the accuracy of the scanning at three different machine warming times. The study also compared the accuracy of CBCT at 0.2 mm slice thickness and Computerized Tomography (CT) at 1 mm slice thickness. A control model was CT scanned at five random intervals, at 1 mm slice thickness and CBCT scanned at specialized intervals, at 0.2 mm slice thickness. The data was then converted and imported into a software program where a digital registration procedure was used to compare the average deviations of the scanned models to the control. RESULTS: The study found that there was no statistically significant difference amongst the three CBCT machine warming times. There was a statistically significant difference between CT scanning with 1 mm slice thickness and CBCT scanning with 0.2 mm slice thickness. CONCLUSIONS: The accuracy of the i-CAT CBCT scans used in the present study with a parameter at voxel size 0.2, will remain consistent and reliable at any warming stage. Also the difference between the CBCT i-CAT scans and the CT scans was not clinically significant based on suggested requirements of clinicians in head and neck reconstruction.

Pilot study: evaluation of the use of the convergent interview technique in understanding the perception of surgical design and simulation.

BACKGROUND: It is important to understand the perceived value of surgical design and simulation (SDS) amongst surgeons, as this will influence its implementation in clinical settings. The purpose of the present study was to examine the application of the convergent interview technique in the field of surgical design and simulation and evaluate whether the technique would uncover new perceptions of virtual surgical planning (VSP) and medical models not discovered by other qualitative case-based techniques. METHODS: Five surgeons were asked to participate in the study. Each participant was interviewed following the convergent interview technique. After each interview, the interviewer interpreted the information by seeking agreements and disagreements among the interviewees in order to understand the key concepts in the field of SDS. RESULTS: Fifteen important issues were extracted from the convergent interviews. CONCLUSION: In general, the convergent interview was an effective technique in collecting information about the perception of clinicians. The study identified three areas where the technique could be improved upon for future studies in the SDS field.

Exploratory benchtop study evaluating the use of surgical design and simulation in fibula free flap mandibular reconstruction.

BACKGROUND: Surgical design and simulation (SDS) is a useful tool to help surgeons visualize the anatomy of the patient and perform operative maneuvers on the computer before implementation in the operating room. While these technologies have many advantages, further evidence of their potential to improve outcomes is required. The present benchtop study was intended to identify if there is a difference in surgical outcome between free-hand surgery completed without virtual surgical planning (VSP) software and preoperatively planned surgery completed with the use of VSP software. METHODS: Five surgeons participated in the study. In Session A, participants were asked to do a free-hand reconstruction of a 3d printed mandible with a defect using a 3d printed fibula. Four weeks later, in Session B, the participants were asked to do the same reconstruction, but in this case using a preoperatively digitally designed surgical plan. Digital registration computer software, hard tissue measures and duration of the task were used to compare the outcome of the benchtop reconstructions. RESULTS: The study revealed that: (1) superimposed images produced in a computer aided design (CAD) software were effective in comparing pre and post-surgical outcomes, (2) there was a difference, based on hard tissue measures, in surgical outcome between the two scenarios and (3) there was no difference in the time it took to complete the sessions. CONCLUSION: The study revealed that the participants were more consistent in the preoperatively digitally planned surgery than they were in the free hand surgery.

On-ice sweat rate, voluntary fluid intake, and sodium balance during practice in male junior ice hockey players drinking water or a carbohydrate-electrolyte solution.

This study evaluated the repeatability of hydration and sweat measurements taken during on-ice hockey practices with players drinking only water, and determined whether having only a carbohydrate-electrolyte solution (CES) to drink during practices decreased fluid intake or affected other hydration and (or) sweat measures. All testing was conducted on elite players of an Ontario Hockey League team (+/-SE; mean age, 17.6 +/- 0.3 years; mean height, 182.9 +/- 1.4 cm; mean body mass, 83.0 +/- 1.7 kg). Players were studied 3 times over the course of 6 weekly on-ice practices (+/-SE; mean playing time, 1.58 +/- 0.07 h; mean temperature, 11.4 +/- 0.8 degrees C; mean relative humidity, 52% +/- 3%). There was strong repeatability of the measured hydration and sweat parameters between 2 similar on-ice practices when players drank only water. Limiting the players to drinking only a CES (as opposed to water) did not decrease fluid intake during practice (+/-SE; mean CES intake, 0.72 +/- 0.07 L.h-1 vs. mean water intake, 0.82 +/- 0.08 L.h-1) or affect sweat rate (1.5 +/- 0.1 L.h-1 vs. 1.5 +/- 0.1 L.h-1), sweat sodium concentration (72.4 +/- 5.6 mmol.L-1 vs. 73.0 +/- 4.4 mmol.L-1), or percent body mass loss (1.1% +/- 0.2% vs. 0.9% +/- 0.2%). Drinking a CES also improved sodium balance (-2.1 +/- 0.2 g.h-1 vs. -2.6 +/- 0.3 g.h-1) and provided the players with a significant carbohydrate (43 +/- 4 g.h-1 vs. 0 +/- 0 g.h-1) during practice. In summary, a single field sweat test during similar on-ice hockey practices in male junior hockey players is sufficient to evaluate fluid and electrolyte balance. Also, a CES does not affect voluntary fluid intake during practice, compared with water, in these players. The CES provided some salt to offset the salt lost in sweat, and carbohydrate, which may help maintain physical and mental performance in the later stages of practice.