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At least 55 records · Page 3

Human Systems Integration: Managing Risk in Anesthesia

The practice of anesthesia relies on clinicians’ ability to safely manage increasingly complex equipment. Devices such as ventilators, drug infusion pumps, and physiologic monitors use sophisticated algorithms to deliver care, but most clinicians are only trained to manage automated systems during normal operation. Few if any receive training on how to manage system failures. Although manufacturers are required to consult with human factors engineers as part of the equipment design process, most pieces of equipment are ultimately brought to market without extensive input from clinicians. Systems in the operating room can be as simple as an oxygen tank, or as complex as a multi-institutional healthcare organization. Humans are also a complex system, and play a critical role in the domains of operations, design, fabrication, maintenance, repair, and ultimately, dismantling and closeout. HSI seeks to provide a means for advocating the human side of the system. Human Systems Integration (HSI) is the cross disciplinary process used as part of the Systems Engineering process to reduce risk in systems. HSI professionals consider the human, hardware, and software elements of system design to optimize system performance and improve safety. HSI professionals work in domains of study that include training, management, human factors engineering, safety, and occupational health, among others. This article discusses the role of systems in the practice of anesthesia, and how consideration of the human during all phases of the system life cycle helps manage risks and promote a better patient outcome.

Human Factors↗

Adjuvant Hepatic Arterial Infusion Pump Chemotherapy After Resection of Colorectal Liver Metastases: Results of a Safety and Feasibility Study in The Netherlands

Background: The 10-year overall survival with adjuvant hepatic arterial infusion pump (HAIP) chemotherapy after resection of colorectal liver metastases (CRLMs) was 61% in clinical trials from Memorial Sloan Kettering Cancer Center. A pilot study was performed to evaluate the safety and feasibility of adjuvant HAIP chemotherapy in patients with resectable CRLMs. Study Design: A phase II study was performed in two centers in The Netherlands. Patients with resectable CRLM without extrahepatic disease were eligible. All patients underwent complete resection and/or ablation of CRLMs and pump implantation. Safety was determined by the 90-day HAIP-related postoperative complications from the day of pump placement (Clavien–Dindo classification, grade III or higher) and feasibility by the successful administration of the first cycle of HAIP chemotherapy. Results: A total of 20 patients, with a median age of 57 years (interquartile range [IQR] 51–64) were included. Grade III or higher HAIP-related postoperative complications were found in two patients (10%), both of whom had a reoperation (without laparotomy) to replace a pump with a slow flow rate or to reposition a flipped pump. No arterial bleeding, arterial dissection, arterial thrombosis, extrahepatic perfusion, pump pocket hematoma, or pump pocket infections were found within 90 days after surgery. After a median of 43 days (IQR 29–52) following surgery, all patients received the first dose of HAIP chemotherapy, which was completed uneventfully in all patients. Conclusion: Pump implantation is safe, and administration of HAIP chemotherapy is feasible, in patients with resectable CRLMs, after training of a dedicated multidisciplinary team.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

Detectors Ensure Function, Safety of Aircraft Wiring

Pedro Medelius waited patiently in his lab at Kennedy Space Center. He had just received word that a colleague was bringing over a cable from a Space Shuttle solid rocket booster to test Medelius new invention. Medelius was calm until his colleague arrived, with about 30 other people. "Talk about testing under pressure," says Medelius. "There were people there from the Navy, the Air Force, and the Federal Aviation Administration." After the group s arrival, Medelius took a deep breath and connected his Standing Wave Reflectometer (SWR) to the cable. He wiggled the cable around, and the display showed a fault (a short or open circuit in wire) about an inch and a half inside the connector on the cable. His colleague questioned the results, because he had already checked that area on the cable. Medelius used the SWR to check again but got the same result. "That is when we took the cable apart and looked inside," Medelius says. "Lo and behold, that was exactly where the fault was." The impetus for Medelius new wire inspection technology came about in 1999 when one of the space shuttles lost power due to a fault somewhere in its more than 200 miles of electrical wiring. "The backup circuit was activated and prevented a major dysfunction, but nevertheless, there was a problem with the wiring," Medelius describes. Even though technicians used a device called a multimeter to measure the electrical current to find which wire had a fault, it could not pinpoint exactly where on the wire the fault was located. For that, technicians had to visually inspect the wire. "Sometimes they would have to remove the whole wire assembly and visually inspect every single wire. It was a very tedious operation because the wires are behind cabinets. They go all over the place in the shuttle," says Medelius. "NASA needed an instrument capable of telling them exactly where the faults were occurring." To meet NASA s needs for a highly precise device to inspect electrical power bundles, wires, and connectors, Medelius devised the SWR. "It came down to what was affected when a wire is short circuited or opened," he says. "We worked out a few equations based on physical principles." The SWR proved very sensitive, and the technology was patented.

Source record↗

Neurogenic orthostatic hypotension: a double-blind, placebo-controlled study with midodrine

PURPOSE: To investigate the efficacy and safety of midodrine for treatment of patients with orthostatic hypotension due to autonomic failure. PATIENTS: Ninety-seven patients with orthostatic hypotension were randomized in a 4-week, double-blinded, placebo-controlled study with a 1-week placebo run-in period. Patients ranged in age from 22 to 86 years (mean: 61 years). METHODS: After a 1-week run-in phase, either placebo or midodrine at a dose of 2.5 mg, 5 mg, or 10 mg was administered three times a day for 4 weeks. Both the placebo group and the 2.5-mg midodrine group received constant doses throughout the double-blind phase. The patients receiving 5 mg or 10 mg of midodrine were given doses that were increased at weekly intervals by 2.5-mg increments until the designated dose was reached. Efficacy evaluations were based on an improvement at 1-hour postdose in standing systolic blood pressure and in symptoms of orthostatic hypotension (syncope, dizziness/lightheadedness, weakness/fatigue, and low energy level). RESULTS: Midodrine (10 mg) increased standing systolic blood pressure by 22 mm Hg (28%, p < 0.001 versus placebo). Midodrine improved (p < 0.05) the following symptoms of orthostatic hypotension compared to placebo: dizziness/lightheadedness, weakness/fatigue, syncope, low energy level, impaired ability to stand, and feelings of depression. The overall side effects were mainly mild to moderate. One or more side effects were reported by 22% of the placebo group compared with 27% of the midodrine-treated group. Scalp pruritus/tingling, which was reported by 10 of 74 (13.5%) of the midodrine-treated patients, was most frequent. Other reported side effects included supine hypertension (8%) and feelings of urinary urgency (4%). CONCLUSION: We conclude that midodrine is an effective and well-tolerated treatment for moderate-to-severe orthostatic hypotension associated with autonomic failure.

NASA Discipline Number 14-10↗

Hypofractionated Radiation Therapy to the Prostate Bed With Intensity-Modulated Radiation Therapy (IMRT): A Phase 2 Trial

Postoperative radiation therapy (RT) is a common therapy used for patients with prostate cancer. Although clinical trials have established the safety and efficacy of hypofractionation as a primary therapy, there are limited data in a postoperative setting. We conducted a prospective trial to evaluate the safety and feasibility of postoperative hypofractionated RT to the prostate bed.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

Trends in Regional Nodal Management of Breast Cancer Patients with Low Nodal Burden

Background: American College of Surgeons Oncology Group Z0011 confirms the safety of omitting axillary lymph node dissection (ALND) and regional nodal irradiation (RNI) in breast cancer patients with one to two positive sentinel lymph nodes (SLNs), without compromising disease-free survival (DFS) and overall survival (OS). In contrast, the NCIC MA20 trial showed improved DFS in node-positive patients undergoing ALND and RNI. We sought to examine how these data have influenced the management of patients with limited nodal burden. Methods: Using the National Cancer Database, patients diagnosed between 2010 and 2015 and who met the criteria for Z0011 were identified. Logistic regression was used to analyze factors associated with practice patterns. The Cox proportional hazards model was used to assess the association of ALND and RNI with OS. Results: Omission of ALND in Z0011-eligible patients reached 89.2% in 2015. This Z0011-compliant group was more likely to undergo RNI compared with the non-compliant group (36.4% vs. 31.3%; p < 0.05), with RNI increasing to 43.8% by 2015. Factors associated with the use of RNI included later year of diagnosis [odds ratio (OR) 1.8, 95% confidence interval (CI) 1.6–2.1], hormone receptor-negative tumor (OR 1.2, 95% CI 1.1–1.4), grade 3 tumor (OR 1.2, 95% CI 1.1–1.3), treatment at a non-academic site (OR 1.2, 95% CI 1.1–1.3) and two versus one positive SLN (OR 2.0, 95% CI 1.8–2.2). With 43 months median follow-up, RNI was not associated with improved OS. Conclusion: Since the publication of Z0011, the omission of ALND has become widespread; however nearly half of these women now receive RNI. The optimal radiation therapy approach for this low nodal burden population warrants further study.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

Knocking out barriers to engineered cell activity

Engineered T cell therapies are revolutionizing cancer treatment by achieving long-lasting remission in blood-related cancers, such as leukemia and lymphoma. These therapies involve removal of patient T cells, “reprogramming” them to attack cancer cells, and then transferring them back into the patient. Targeted gene inactivation (knockout) using CRISPR-Cas9 can enhance T cell activity (1, 2) and has the potential to expand cell therapy applications. Until now, it has been unknown whether CRISPR-Cas9–edited T cells would be tolerated and thrive once reinfused into a human. On page 1001 of this issue, Stadtmauer et al. (3) present data from a phase 1 clinical trial (designed to test safety and feasibility) on the first cancer patients treated with CRISPR-Cas9–modified T cells. The findings represent an important advance in the therapeutic application of gene editing and highlight the potential to accelerate development of cell-based therapies.

60 APPLIED LIFE SCIENCES↗

Phase 3 Randomized Trial of Topical Steroid Versus Placebo for Prevention of Radiation Dermatitis in Patients With Head and Neck Cancer Receiving Chemoradiation

Radiation dermatitis is one of the most common acute toxicities induced by chemoradiation therapy (CRT) for head and neck cancer (HNC). The benefit of topical steroids in the management of radiation dermatitis is still unclear. This phase 3, multi-institutional, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of topical steroids for radiation dermatitis in patients with locally advanced HNC receiving CRT.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

Exercise Therapy and Radiation Therapy for Cancer: A Systematic Review

Exercise therapy (ET) is shown to improve toxicity and surrogates of survival for patients receiving chemotherapy. Current National Comprehensive Cancer Network (NCCN) guidelines lack recommendations for concurrent radiation therapy (RT) and ET. The main objective was to determine the impact of concurrent ET + RT with respect to (1) acceptability, feasibility, safety; and (2) to demonstrate how incorporating ET in cancer treatment can enhance patient-reported outcomes (PROs) and physical function—defined as strength or exercise capacity.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

Safety of Single-Site Laparoscopic Surgery Requiring Perioperative Heparinization in Colorectal Cancer: Propensity Score-Matched Analysis

Background: We assessed the feasibility and safety of single-site laparoscopic surgery for patients with colorectal cancer who required perioperative heparinization. Methods: This retrospective study reviewed the medical records of 390 patients who underwent single-site laparoscopic surgery for colorectal cancer from January 2010 to December 2016. Antithrombotic drugs were stopped preoperatively and heparin was administered according to the operative risk of each patient, based on consultation with the cardiologist physician or neurosurgeon. Propensity score modeling was utilized to adjust for baseline characteristics. Results: Of 390 patients, 29 were treated with standard bridging intravenous heparin therapy. Propensity matching identified 119 patients: 22 patients in the heparinization group and 97 in the control group. The matched groups were not significantly different in operation times, bleeding volumes, or conversion rate. The mean postoperative hospital stay was 17.9 days in the heparinization group and 9.5 days in the control group (p = 0.034). Postoperative bleeding was observed in 4 patients (18.2%) in the heparinization group and 11 patients (11.4%) in the control group (p = 0.646), while other complications were similar in the two study groups (p = 0.502). Of these other complications, thromboembolic events were observed in two patients in the heparinization group and one patient in the control group. Conclusions: We found that single-site laparoscopic surgery for colorectal cancer with heparinization was feasible and safe. Heparinization did not increase the risk of postoperative bleeding complications, but postoperative hospital stay was prolonged.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

Medical-Information-Management System

Medical Information Management System (MIMS) computer program interactive, general-purpose software system for storage and retrieval of information. Offers immediate assistance where manipulation of large data bases required. User quickly and efficiently extracts, displays, and analyzes data. Used in management of medical data and handling all aspects of data related to care of patients. Other applications include management of data on occupational safety in public and private sectors, handling judicial information, systemizing purchasing and procurement systems, and analyses of cost structures of organizations. Written in Microsoft FORTRAN 77.

Alterescu, Sidney↗

Safety in the operating theatre--part 1: interpersonal relationships and team performance

The authors examine the application of interpersonal human factors training on operating room (OR) personnel. Mortality studies of OR deaths and critical incident studies of anesthesia are examined to determine the role of human error in OR incidents. Theoretical models of system vulnerability to accidents are presented with emphasis on a systems approach to OR performance. Input, process, and outcome factors are discussed in detail.

Non-NASA Center↗

Clinical Outcomes of a Randomized Trial of Adaptive Plan-of-the-Day Treatment in Patients Receiving Ultra-hypofractionated Weekly Radiation Therapy for Bladder Cancer

Hypofractionated radiation therapy can be used to treat patients with muscle-invasive bladder cancer unable to have radical therapy. Toxicity is a key concern, but adaptive plan-of the day (POD) image-guided radiation therapy delivery could improve outcomes by minimizing the volume of normal tissue irradiated. The HYBRID trial assessed the multicenter implementation, safety, and efficacy of this strategy.

62 RADIOLOGY AND NUCLEAR MEDICINE↗

Personal Interventions for Reducing Exposure and Risk for Outdoor Air Pollution: An Official American Thoracic Society Workshop Report

Poor air quality affects the health and wellbeing of large populations around the globe. Although source controls are the most effective approaches for improving air quality and reducing health risks, individuals can also take actions to reduce their personal exposure by staying indoors, reducing physical activity, altering modes of transportation, filtering indoor air, and using respirators and other types of face masks. A synthesis of available evidence on the efficacy, effectiveness, and potential adverse effects or unintended consequences of personal interventions for air pollution is needed by clinicians to assist patients and the public in making informed decisions about use of these interventions. To address this need, the American Thoracic Society convened a workshop in May of 2018 to bring together a multidisciplinary group of international experts to review the current state of knowledge about personal interventions for air pollution and important considerations when helping patients and the general public to make decisions about how best to protect themselves. From these discussions, recommendations were made regarding when, where, how, and for whom to consider personal interventions. In addition to the efficacy and safety of the various interventions, the committee considered evidence regarding the identification of patients at greatest risk, the reliability of air quality indices, the communication challenges, and the ethical and equity considerations that arise when discussing personal interventions to reduce exposure and risk from outdoor air pollution.

63 RADIATION, THERMAL, AND OTHER ENVIRON. POLLUTAN↗

A Phase 1 Dose-Escalation Trial of Radiation Therapy and Concurrent Cisplatin for Stage II and III Triple-Negative Breast Cancer

Patients with triple-negative breast cancer (TNBC) experience higher local-regional recurrence rates than those with luminal or HER2-positive tumors. This prospective, phase 1B trial was designed to assess the safety and to establish the maximum tolerated dose (MTD) of cisplatin with radiation therapy for women with early-stage TNBC.

62 RADIOLOGY AND NUCLEAR MEDICINE↗