There are increasing efforts towards improving the quality and safety of surgical care while decreasing the costs. In Washington state, there has been a regional and unique approach to surgical quality improvement. The development of the Surgical Care and Outcomes Assessment Program (SCOAP) was first described 5 years ago. SCOAP is a peer-to-peer collaborative that engages surgeons to determine the many process of care metrics that go into a “perfect” operation, track on risk adjusted outcomes that are specific to a given operation, and create interventions to correct under performance in both the use of these process measures and outcomes. SCOAP is a thematic departure from report card oriented QI. SCOAP builds off the collaboration and trust of the surgical community and strives for quality improvement by having peers change behaviors of one another. We provide, here, the progress of the SCOAP initiative and highlight its achievements and challenges.
The recent wave of the Ebola Virus Disease (EVD) in Western Africa and efforts to control the disease where the health system requires strengthening raises a number of ethical challenges for healthcare workers practicing in these countries. We discuss the implications of weak health systems for controlling EVD and limitations of the ethical obligation to provide care for patients with EVD using Nigeria as a case study. We highlight the right of healthcare workers to protection that should be obligatorily provided by the government. Where the national government cannot meet this obligation, healthcare workers only have a moral and not a professional obligation to provide care to patients with EVD. The national government also has an obligation to adequately compensate healthcare workers that become infected in the course of duty. Institutionalisation of policies that protect healthcare workers are required for effective control of the spread of highly contagious diseases like EVD in a timely manner.
BackgroundThe global interest in developing therapies for Ebola infection management and its prevention is laudable. However the plan to conduct an emergency immunization program specifically for healthcare workers using experimental vaccines raises some ethical concerns. This paper shares perspectives on these concerns and suggests how some of them may best be addressed.DiscussionThe recruitment of healthcare workers for Ebola vaccine research has challenges. It could result in coercion of initially dissenting healthcare workers to assist in the management of EVD infected persons due to mistaken beliefs that the vaccine offers protection. It could also affect equity and justice. For example, where people who are not skilled health care professionals but who provide care to patients infected with Ebola (such as in home care settings) are not prioritized for vaccination. The possibility of study participants contracting Ebola infection despite the use of experimental vaccine, and the standard of care they would receive, needs to be addressed clearly, transparently and formalized as part of the ethics review process. Future access to study products in view of current status of the TRIPS agreement needs to be addressed. Finally, broad stakeholder engagement at local, regional and international levels needs to be promoted using available communication channels to engage local, regional and international support. These same concerns are applicable for current and future epidemics.SummarySuccessful Ebola vaccine development research requires concerted efforts at public dialogue to address misconceptions, equity and justice in participant selection, and honest discussions about risks, benefits and future access. Public dialogue about Ebola vaccine research plans is crucial and should be conducted by trusted locals and negotiated between communities, researchers and ethics committees in research study sites.
Original Clinical Science-Liver Background. Bariatric surgery (BS) may be associated with significant malabsorption and nutritional deficiencies. Methods. Between March 1987 and January 2017, we performed 922 liver transplants (LT) at our institution; 33 had antecedent BS. We matched the BS cohort to LT recipients without BS (1:3 matching) based on exact matching for gender and cancer and inverse variance matching for age, LT body mass index, MELD score, and transplant date. Results. We analyzed outcomes in 132 LT recipients (33 BS; 99 non-BS). The BS cohort comprised 26 (79%) women with a mean age of 52.4 years. The BS procedures included 20 Roux-en-Y gastric bypass (61%), 6 jejunoileal bypass (18%), 3 gastric band (9%), 2 sleeve gastrectomy (6%), and 1 duodenal switch (3%). The primary indications for LT listing were alcoholic cirrhosis (9; 27%), nonalcoholic steatohepatitis (7; 21%), hepatitis C (8; 24%), and hepatocellular carcinoma (3; 9%). At LT, body mass index for the BS cohort was 29.6, and MELD was 24. Compared with matched controls, BS recipients did not have longer LT length of hospital stay (17.8 versus 15.7 d, P = 0.71), longer intensive care unit length of stay (5.3 versus 4.1 d, P = 0.16), or higher 30-day complication rate (76% versus 85%, P = 0.43). Overall patient survival was similar (1-and 3-y survival was 90.1% and 75.9% for BS; 90.9% and 76.4% for non-BS, P = 0.34). Conclusions. A history of BS does not portend a deleterious effect on LT outcomes.
Between 2004 and 2005, the first multi-sited clinical trial tested whether an existing, marketed antiretroviral drug, Tenofovir (TDF), could prevent HIV transmission. Referred to as pre-exposure prophylaxis (PrEP), most of these trial sites prematurely closed down. Two sites located in Cambodia and Cameroon received international media attention. But little attention was drawn to sites in Malawi and Nigeria, where university ethicists and research scientists extensively debated PrEP. This article focuses on events that took place in Malawi where there was a prolonged dispute over the scientific rationales of PrEP and not trial specific ethics referred to as 'bioethics'. Specifically, the article discusses debates pertaining to three PrEP trial protocols that were refused ethics approval in Malawi between 2004 and 2009. It is argued that HIV science debates in Malawi are embedded in postcolonial politics--geopolitical histories and state and household economic dispossessions that have created the structural possibilities for Malawi to become an offshore destination for HIV clinical research. As such, ethics in this case does not pertain to trial or bioethical 'failures'. Rather, ethics is located at the scale of imperial relations that give rise to multiple, often invisible, research concerns and constraints.
BackgroundThe current Ebola Virus Disease (EVD) outbreak in West Africa is the largest in history. As of February 18th 2015, 23,258 cases of EVD have been cumulatively reported from Nigeria, Senegal, Guinea, Liberia, Mali, Sierra Leone, Spain, the United Kingdom and the United States of America resulting in more than 9,000 deaths. It is therefore exigent to develop prevention and treatment therapies for EVD.DiscussionSeveral new EVD treatments are in clinical development at this time. Based on lessons learned, four critical processes need to be implemented before clinical trials begin. First, all global EVD research need to be coordinated to promote data sharing and synergistic overlap, while reducing unnecessary duplication of efforts. The World Health Organization is well-placed to undertake such an endeavor. Second, governments of affected nations where trials are being proposed need to lead discussions regarding immediate access to any proven medications for epidemics. Also, governments need to leverage international resources to support and expand existing national expertise to jointly conduct high-caliber clinical research; and resources must be used to enhance local technical skills and expand existing personnel. Third, ethics committees must review protocols, monitor the research process, and work closely with research scientists to insure the ethical integrity of research throughout the trials. Fourth, community advisory boards (CAB) need to be formed, linked with existing community leadership structures and organized in conjunction with trial implementation. These community structures should work together with ethics committees to facilitate the study design, informed consent process, and study implementation.SummaryWe must facilitate communication and mutual understanding between trial communities and research teams, and promote positive collaborations between all stakeholders engaged in EVD research. The community engagement process for EVD research is crucial to address myths and misconceptions, and to promote study volunteers’ understanding of the research details. The collaboration between all stakeholders is crucial for continued long term partnership to address EVD outbreak and none of the stakeholders should be left behind in ongoing efforts to develop EVD therapies.
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