Execution by organ procurement: Breaching the dead donor rule in China.

The dead donor rule is fundamental to transplant ethics. The rule states that organ procurement must not commence until the donor is both dead and formally pronounced so, and by the same token, that procurement of organs must not cause the death of the donor. In a separate area of medical practice, there has been intense controversy around the participation of physicians in the execution of capital prisoners. These two apparently disparate topics converge in a unique case: the intimate involvement of transplant surgeons in China in the execution of prisoners via the procurement of organs. We use computational text analysis to conduct a forensic review of 2838 papers drawn from a dataset of 124 770 Chinese-language transplant publications. Our algorithm searched for evidence of problematic declarations of brain death during organ procurement. We find evidence in 71 of these reports, spread nationwide, that brain death could not have properly been declared. In these cases, the removal of the heart during organ procurement must have been the proximate cause of the donor's death. Because these organ donors could only have been prisoners, our findings strongly suggest that physicians in the People's Republic of China have participated in executions by organ removal.

How did we reform our out of control massive transfusion protocol program?

BACKGROUND: The massive transfusion protocol (MTP) is designed to quickly provide blood products at a fixed ratio for the exsanguinating patient. At our academic medical center, the frequency of MTP activation increased over 10-fold between 2008 and 2015, putting inordinate stress on our transfusion service. STUDY DESIGN AND METHODS: Gathering a large number of relevant stakeholders, we performed a multidisciplinary root cause analysis (RCA) in response to the acute clinical need to reform our MTP. RESULTS: Through the RCA, we identified four principal opportunities for improvement (OFI) associated with our MTP: education, stewardship, process improvement, and communication. Through the deployment of new approaches to each of these OFI, we reduced MTP activations, blood product waste, and transfusion service technologist stress. CONCLUSION: The MTP is amenable to improvement, and, although time intensive, the RCA process yields significant favorable effects: improving communication with colleagues, reducing stress within the transfusion service, and improving resource utilization. Activation of the MTP at our institution is now more aligned with its primary purpose: rapidly providing large quantities of blood products to exsanguinating patients.

Analysis of official deceased organ donation data casts doubt on the credibility of China's organ transplant reform.

BACKGROUND: Since 2010 the People's Republic of China has been engaged in an effort to reform its system of organ transplantation by developing a voluntary organ donation and allocation infrastructure. This has required a shift in the procurement of organs sourced from China's prison and security apparatus to hospital-based voluntary donors declared dead by neurological and/or circulatory criteria. Chinese officials announced that from January 1, 2015, hospital-based donors would be the sole source of organs. This paper examines the availability, transparency, integrity, and consistency of China's official transplant data. METHODS: Forensic statistical methods were used to examine key deceased organ donation datasets from 2010 to 2018. Two central-level datasets - published by the China Organ Transplant Response System (COTRS) and the Red Cross Society of China - are tested for evidence of manipulation, including conformance to simple mathematical formulae, arbitrary internal ratios, the presence of anomalous data artefacts, and cross-consistency. Provincial-level data in five regions are tested for coherence, consistency, and plausibility, and individual hospital data in those provinces are examined for consistency with provincial-level data. RESULTS: COTRS data conforms almost precisely to a mathematical formula (which first appeared to be a general quadratic, but with further confirmatory data was discovered to be a simpler one-parameter quadratic) while Central Red Cross data mirrors it, albeit imperfectly. The analysis of both datasets suggests human-directed data manufacture and manipulation. Contradictory, implausible, or anomalous data artefacts were found in five provincial datasets, suggesting that these data may have been manipulated to enforce conformity with central quotas. A number of the distinctive features of China's current organ procurement and allocation system are discussed, including apparent misclassification of nonvoluntary donors as voluntary. CONCLUSION: A variety of evidence points to what the authors believe can only be plausibly explained by systematic falsification and manipulation of official organ transplant datasets in China. Some apparently nonvoluntary donors also appear to be misclassified as voluntary. This takes place alongside genuine voluntary organ transplant activity, which is often incentivized by large cash payments. These findings are relevant for international interactions with China's organ transplantation system.

Compliance with ethical standards in the reporting of donor sources and ethics review in peer-reviewed publications involving organ transplantation in China: a scoping review.

OBJECTIVES: The objective of this study is to investigate whether papers reporting research on Chinese transplant recipients comply with international professional standards aimed at excluding publication of research that: (1) involves any biological material from executed prisoners; (2) lacks Institutional Review Board (IRB) approval and (3) lacks consent of donors. DESIGN: Scoping review based on Arksey and O'Mallee's methodological framework. DATA SOURCES: Medline, Scopus and Embase were searched from January 2000 to April 2017. ELIGIBILITY CRITERIA: We included research papers published in peer-reviewed English-language journals reporting on outcomes of research involving recipients of transplanted hearts, livers or lungs in mainland China. DATA EXTRACTION AND SYNTHESIS: Data were extracted by individual authors working independently following training and benchmarking. Descriptive statistics were compiled using Excel. RESULTS: 445 included studies reported on outcomes of 85 477 transplants. 412 (92.5%) failed to report whether or not organs were sourced from executed prisoners; and 439 (99%) failed to report that organ sources gave consent for transplantation. In contrast, 324 (73%) reported approval from an IRB. Of the papers claiming that no prisoners' organs were involved in the transplants, 19 of them involved 2688 transplants that took place prior to 2010, when there was no volunteer donor programme in China. DISCUSSION: The transplant research community has failed to implement ethical standards banning publication of research using material from executed prisoners. As a result, a large body of unethical research now exists, raising issues of complicity and moral hazard to the extent that the transplant community uses and benefits from the results of this research. We call for retraction of this literature pending investigation of individual papers.

Impact of predictive analytics based on continuous cardiorespiratory monitoring in a surgical and trauma intensive care unit.

Predictive analytics monitoring, the use of patient data to provide continuous risk estimation of deterioration, is a promising new application of big data analytical techniques to the care of individual patients. We tested the hypothesis that continuous display of novel electronic risk visualization of respiratory and cardiovascular events would impact intensive care unit (ICU) patient outcomes. In an adult tertiary care surgical trauma ICU, we displayed risk estimation visualizations on a large monitor, but in the medical ICU in the same institution we did not. The risk estimates were based solely on analysis of continuous cardiorespiratory monitoring. We examined 4275 individual patient records within a 7 month time period preceding and following data display. We determined cases of septic shock, emergency intubation, hemorrhage, and death to compare rates per patient care pre-and post-implementation. Following implementation, the incidence of septic shock fell by half (p < 0.01 in a multivariate model that included age and APACHE) in the surgical trauma ICU, where the data were continuously on display, but by only 10% (p = NS) in the control Medical ICU. There were no significant changes in the other outcomes. Display of a predictive analytics monitor based on continuous cardiorespiratory monitoring was followed by a reduction in the rate of septic shock, even when controlling for age and APACHE score.

Telemedicine coverage for post-operative ICU patients.

Introduction There is an increased demand for intensive care unit (ICU) beds. We sought to determine if we could create a safe surge capacity model to increase ICU capacity by treating ICU patients in the post-anaesthesia care unit (PACU) utilizing a collaborative model between an ICU service and a telemedicine service during peak ICU bed demand. Methods We evaluated patients managed by the surgical critical care service in the surgical intensive care unit (SICU) compared to patients managed in the virtual intensive care unit (VICU) located within the PACU. A retrospective review of all patients seen by the surgical critical care service from January 1st 2008 to July 31st 2011 was conducted at an urban, academic, tertiary centre and level 1 trauma centre. Results Compared to the SICU group ( n = 6652), patients in the VICU group ( n = 1037) were slightly older (median age 60 (IQR 47-69) versus 58 (IQR 44-70) years, p = 0.002) and had lower acute physiology and chronic health evaluation (APACHE) II scores (median 10 (IQR 7-14) versus 15 (IQR 11-21), p < 0.001). The average amount of time patients spent in the VICU was 13.7 + /-9.6 hours. In the VICU group, 750 (72%) of patients were able to be transferred directly to the floor; 287 (28%) required subsequent admission to the surgical intensive care unit. All patients in the VICU group were alive upon transfer out of the PACU while mortality in the surgical intensive unit cohort was 5.5%. Discussion A collaborative care model between a surgical critical care service and a telemedicine ICU service may safely provide surge capacity during peak periods of ICU bed demand. The specific patient populations for which this approach is most appropriate merits further investigation.

There's no place like home: boarding surgical ICU patients in other ICUs and the effect of distances from the home unit.

BACKGROUND: Intensive care units (ICUs) function frequently at capacity, requiring incoming critically ill patients to be placed in alternate geographically distinct ICUs. In some medical ICU populations, "boarding" in an overflow ICU has been associated with increased mortality. We hypothesized that surgical ICU patients experience more complications when boarding in an overflow ICU and that the frequency of these complications are greatest in boarders farthest from the home unit (HU). METHODS: A 5-year (June 2005 to June 2010) retrospective review of a prospectively maintained ICU database was performed, and demographics, severity of illness, length of stay, and incidence of ICU complications were extracted. Distances between boarding patients' rooms and the HU were measured. Complications occurring in patients located in the same floor (BUSF) and different floor (BUDF) boarding units were compared and stratified by distance from HU to the patient room. Logistic regression was used to develop control for known confounders. RESULTS: A total of 7,793 patients were admitted to the HU and 833 to a boarding unit (BUSF, n = 712; BUDF, n = 121). Boarders were younger, had a lower length of stay, and Acute Physiology and Chronic Health Evaluation II and were more often trauma/emergency surgery patients. Compared with in-HU patients, the incidence of aspiration pneumonia (2.2% vs. 3.6%, p < 0.01) was greater in BUSF patients and highest in those farthest from the HU (odds ratio [OR], 2.39; p = 0.01). Delirium occurred less often in HU than in BUDF patients (3.3% vs. 8.3 %, p < 0.01), and both delirium (OR, 6.09, p < 0.01) and ventilator-associated pneumonia (OR, 4.49, p < 0.05) were more frequent in patients farther from the HU. CONCLUSION: Certain ICU complications occur more frequently in boarding patients particularly if they are located on a different floor or far from the HU. When surgical ICU bed availability forces overflow admissions to non-home ICUs, greater interdisciplinary awareness, education, and training may be needed to ensure equivalent care and outcomes. LEVEL OF EVIDENCE: Epidemiologic study, level III. Therapeutic study, level IV.