Operational and resource management of an RCT: some of the pitfalls and lessons learned

Nurses frequently fulfil important functions within a research team involved in clinical trials. This paper describes the challenges inherent in developing and managing a large clinical trial involving the evaluation of homoeopathy and asthma. Teamwork, a clear and comprehensive understanding of the research protocol, marketing the project, and the ability to manage human resources within both a primary and secondary care environment are all essential aspects of clinical research. Our experience in establishing and managing this project has suggested to us that a high standard of clinical research demands an open approach to problem-solving as well as the realization that efficient research is as much about the management of people as it is about scientific rigour.     

An evidence-based approach to fall risk assessment, prevention, and management: lessons learned

Nurses at an academic medical institution undertook a fall safety initiative. Using an evidence-based approach, they created a risk stratification tool, developed a comprehensive protocol, investigated fall-prevention products and technologies, and piloted the protocol and products/technologies before the full implementation. This article describes their journey and lessons learned along the way, the most compelling of which is the need for a simple, guided, and time-efficient approach to implementing the best practices into clinical care.     

Risk management in transfusion medicine: a hospital transfusion service perspective

The hospital transfusion service has always been at the heart of the blood component therapy chain. It has had the multiple roles of not only maintaining an inventory of a wide range of blood components, monitoring their storage conditions and ensuring compatibility when appropriate, but also being the source of expertise in transfusion medicine, and attempting to follow up any adverse consequences of transfusion. Hospital transfusion medicine has been seen essentially as a scientific and technical specialty with a minimal component of medical input. This is now changing and transfusion medicine is becoming an all embracing specialty where the hospital transfusion service still remains at the heart of transfusion medicine, but a much higher level of understanding is necessary at the clinical and consumer level.     

Immersion in China: lessons learned

Students can learn a great deal from international experiences. Although one can learn about another culture from books and discussions, immersing oneself in a culture tends to have a greater impact on both intended and incidental learning. The authors describe the lessons learned and student outcomes during a faculty-led 5-week immersion trip to China.     

Trastuzumab cardio-oncology: lessons learned

Treatment with the humanized monoclonal antibody trastuzumab can significantly improve outcomes for patients with early or metastatic HER2-positive breast cancer. In a small proportion of patients, trastuzumab is associated with an increased risk of cardiac dysfunction. Although the mechanisms have yet to be fully established, trastuzumab may block HER2 signaling in cardiomyocytes, which is believed to be important for protecting the cardiomyocytes from stress such as that induced by treatment with anthracyclines. The risk of trastuzumab-associated cardiac dysfunction can be reduced if patients are evaluated thoroughly for risk factors before treatment (e.g., hypertension, low ejection fraction at onset, hyperglycemia, prior congestive heart failure). In addition, cardiac function must be assessed before and during the treatment period. If cardiac dysfunction occurs during treatment, early intervention can expand the possibilities of reinstitution of trastuzumab treatment. The integration of nonanthracycline adjuvant regimens offers opportunities for cardiac-compromised patients.     

Policy development in disaster preparedness and management: lessons learned from the January 2001 earthquake in Gujarat, India

INTRODUCTION: During the last decades, several humanitarian emergencies have occurred, with an increasing number of humanitarian organizations taking part in providing assistance. However, need assessments, medical intelligence, and coordination of the aid often are sparse, resulting in the provision of ineffective and expensive assistance. When an earthquake with the strength of 7.7 on the Richter scale struck the state of Gujarat, India, during the early morning on 26 January 2001, nearly 20,000 persons were killed, nearly 170,000 were injured, and 600,000 were rendered homeless. This study identifies how assigned indicators to measure the level of health care may improve disaster preparedness and management, thus, reducing human suffering. METHODS: During a two-week mission in the disaster area, the disaster relief provided to the disaster-affected population of Gujarat was evaluated. Vulnerability due to climate, geography, culture, religion, gender, politics, and economy, as each affected the outcome, was studied. By assigning indicators to the eight ELEMENTS of the Primary Health Care System as advocated by the World Health Organization (WHO), the level of public health and healthcare services were estimated, an evaluation of the impact of the disaster was conducted, and possible methods for improving disaster management are suggested. Representatives of the major relief organizations involved were interviewed on their relief policies. Strategies to improve disaster relief, such as policy development in the different aspects of public health/primary health care, were sought. RESULTS: Evaluation of the pre-event status of the affected society revealed a complex situation in a vulnerable society with substantial deficiencies in the existing health system that added to the severity of the disaster. Most of the civilian hospitals had collapsed, and army field hospitals provided medical care to most of the patients under primitive conditions using tents. When the foreign field hospitals arrived five to seven days after the earthquake, most of the casualties requiring surgical intervention already had been operated on. Relief provided to the disaster victims had reduced quality for the following reasons: (1) proper public health indicators had not yet been developed; (2) efficient coordination was lacking, (3) insufficient, overestimated, or partly irrelevant relief was provided; (4) relief was delayed because of bureaucracy; and (5) policies on the delivery of disaster relief had not been developed. CONCLUSION: To optimize the effectiveness of limited resources, disaster preparedness and the provision of feasible and necessary aid is of utmost importance. An appropriate, rapid, crisis intervention could be achieved by continual surveillance of the world's situation by a Relief Coordination Center. A panel of experts could evaluate and coordinate the international disaster responses and make use of stored emergency material and emergency teams. A successful disaster response will depend on accurate and relevant medical intelligence and socio-geographical mapping in advance of, during, and after the event(s) causing the disaster. More effective and feasible equipment coordinated with the relief provided by the rest of the world is necessary. If policies and agreements are developed as part of disaster preparedness, on international, bilateral, and national levels, disaster relief may be more relevant, less chaotic, and easier to estimate, thus, bringing improved relief to the disaster victims.     

Quality management in the transfusion service: case studies in process improvement

BACKGROUND: Laboratory‐based quality improvement (QI) initiatives can improve clinical outcomes and patient safety. STUDY DESIGN AND METHODS: We present three cases of QI that impact processes from the transfusion service (TS) laboratory to the patient's bedside. RESULTS: Case 1 was event discovery reporting (EDR). We were able to reduce our biologic product deviation reports from 41 (17%) of 238 EDRs to only 19 (7%) of 272 (p < 0.01) EDRs after implementation of a QI workflow process. Case 2 was antibody evaluation before elective surgery. We implemented process improvement strategies: 1) surgical safety checklist with confirmation of type‐and‐screen completion and antibody evaluation before patients can proceed to surgery; 2) specimen retention policy of 30 days to allow advance testing; and 3) daily review to identify specimens needed on day of surgery. After intervention, only 7 (0.3%) of 2298 patients required antibody evaluation on day of surgery, compared to 65 (0.75%) of 8656 patients (p < 0.01) before intervention. Case 3 was wrong blood in tube (WBIT). We have a two‐specimen requirement for blood type verification before transfusion. To determine whether trauma patients should be exempted, we reviewed WBIT errors. Six WBIT errors were from the emergency department (an error rate of 1:400) and nine WBIT specimens were institution‐wide. Three patients were transfused after correction of the WBIT error. Based on this analysis, our institution agreed that no clinical units shall be exempted from our policy. CONCLUSION: Successful QI in the TS improves processes that promote efficiency, effectiveness, and patient safety.     

门诊输液区的护理风险管理

目的探讨如何预防并降低门诊输液区护理风险,减少投诉和纠纷。方法将2005年1月至2006年12月护理风险管理干预前设为A组,将2007年1月至2008年12月风险管理干预后设为B组,投诉与纠纷的风险（差错与事故的风险）在医生环节、药房环节、收费环节、护士环节、病人或陪人环节、环境因素A组与B组比较研究。结果护理风险管理干预后10028例患者中发生5例纠纷,与护理风险管理干预前9365例患者中发生33例纠纷相比,有显著差异（χ^2=22．661,P〈0．01）。结论护理风险管理干预后门诊输液区护理风险降低,投诉与纠纷明显减少。     

New construction and renovation: lessons learned

Construction and renovation of an operating room suite is an expensive and challenging project. Perioperative managers must use their knowledge and expertise to ensure that the vision of the facility is realized. Managers may be unfamiliar with facility planning and design and lack understanding of how to communicate effectively with the architectural team. Important items to consider and how to avoid costly errors are discussed.