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Ethical considerations for allocation of scarce resources and alterations in surgical care during a pandemic.
No full textThe COVID-19 pandemic caused by SARS-CoV-2 is unprecedented in modern history. Its effects on social behavior and health care delivery have been dramatic. The resultant burden of disease and critical illness has outpaced the diagnostic, therapeutic, and health care professional resources of many clinics and hospitals. It continues to do so globally. The allocation of hospital beds and ventilators, personal protective equipment, investigational therapeutics, and other scarce resources has required difficult decisions. Clinical and surgical practices which are standard in normal times may not be standard or safe during the COVID-19 crisis. How can we best adapt as physicians and surgeons? What foundational ethical principles and systems of principle application can help guide our decision-making? Fortunately, a large body of work in medical ethics addresses these questions. Unfortunately, many surgeons and other health care professionals are probably not as familiar with these concepts. This brief communication is intended to provide a concise explanation of ethical considerations which readers may find helpful when addressing allocation of scarce resources and alterations in surgical care brought on by the current pandemic
Opening the black box of conservation philanthropy: A co-produced research agenda on private foundations in marine conservation
No full textIn the ‘new Gilded Age’ of mega-wealth and big philanthropy, academics are not paying enough attention to private foundations. Mirroring upward trends in philanthropy broadly, marine conservation philanthropy has more than doubled in recent years, reaching virtually every globally salient marine conservation issue in all corners of the planet. This paper argues that marine conservation philanthropy warrants a dedicated research agenda because private foundations are prominent, unique, and under-studied actors seeking to shape the future of a “frontier” space. We present a co-produced social science research agenda on marine conservation philanthropy that reflects the priorities of 106 marine conservation donors, practitioners, and stakeholders who participated in a research co-design process in 2018. These “research co-designers” raised 137 unique research questions, which we grouped into five thematic research priorities: outcomes, governance roles, exits, internal foundation governance, and funding landscape. We identify issues of legitimacy, justice, and applied best practice as cross-cutting research priorities that came up throughout the five themes. Participants from the NGO, foundation, and government sectors identified questions within all five themes and three cross-cutting issues, underscoring shared interest in this work from diverse groups. The research we call for herein can inform the practice of conservation philanthropy at a time when foundations are increasingly reckoning with their role as institutions of power in society. This paper is broadly relevant for social and natural scientists, practitioners, donors, and policy-makers interested in better understanding private philanthropy in any environmental context globally
A cross-sectional analysis of HIV and hepatitis C clinical trials 2007 to 2010: the relationship between industry sponsorship and randomized study design.
No full textBackgroundThe proportion of clinical research sponsored by industry will likely continue to expand as federal funds for academic research decreases, particularly in the fields of HIV/AIDS and hepatitis C (HCV). While HIV and HCV continue to burden the US population, insufficient data exists as to how industry sponsorship affects clinical trials involving these infectious diseases. Debate exists about whether pharmaceutical companies undertake more market-driven research practices to promote therapeutics, or instead conduct more rigorous trials than their non-industry counterparts because of increased resources and scrutiny. The ClinicalTrials.gov registry, which allows investigators to fulfill a federal mandate for public trial registration, provides an opportunity for critical evaluation of study designs for industry-sponsored trials, independent of publication status. As part of a large public policy effort, the Clinical Trials Transformation Initiative (CTTI) recently transformed the ClinicalTrials.gov registry into a searchable dataset to facilitate research on clinical trials themselves.MethodsWe conducted a cross-sectional analysis of 477 HIV and HCV drug treatment trials, registered with ClinicalTrials.gov from 1 October 2007 to 27 September 2010, to study the relationship of study sponsorship with randomized study design. The likelihood of using randomization given industry (versus non-industry) sponsorship was reported with prevalence ratios (PR). PRs were estimated using crude and stratified tabular analysis and Poisson regression adjusting for presence of a data monitoring committee, enrollment size, study phase, number of study sites, inclusion of foreign study sites, exclusion of persons older than age 65, and disease condition.ResultsThe crude PR was 1.17 (95% CI 0.94, 1.45). Adjusted Poisson models produced a PR of 1.13 (95% CI 0.82, 1.56). There was a trend toward mild effect measure modification by study phase, but this was not statistically significant. In stratified tabular analysis the adjusted PR was 1.14 (95% CI 0.78, 1.68) among phase 2/3 trials and 1.06 (95% CI 0.50, 2.22) among phase 4 trials.ConclusionsNo significant relationship was found between industry sponsorship and use of randomization in trial design in this cross-sectional study. Prospective studies evaluating other aspects of trial design may shed further light on the relationship between industry sponsorship and appropriate trial methodology
Understanding sexual and reproductive health among orphaned and separated adolescent girls in five low- and middle-income countries
No full textAdolescent girls' sexual and reproductive health (SRH) is a significant public health issue, but little is known about the SRH outcomes of orphaned and separated adolescent girls, who face a higher risk of abuse and neglect in the absence of parental guidance, underscoring the critical need for research. This study examines the SRH outcomes (early pregnancy and condom use) and their predictors among adolescent girls aged 15 to 21 in five low- and middle-income countries, including orphaned and separated children. We conducted a cross-sectional analysis of 933 participants during the latest round of data collection from a longitudinal cohort study to assess predictors of early pregnancy and condom use. We first used bivariable logistic regression to identify potential predictors of each outcome. Potential predictors included education level, abuse, working status, relationship status, and age. Predictors that were significant (p<=0.10) in crude analyses were added to a multivariable model to assess associations in the presence of other predictors. In bivariable analysis, we found that education, marital status, history of abuse, work status, and age are associated with early pregnancy. However, we did not find a significant association for condom use with any predictors. It should be noted that the findings may be imprecise due to the small sample sizes and exclusion of children under 16 years old. Further research is needed to explore targeted interventions aimed at reducing early pregnancy and promoting condom use. Addressing education, work, and relationship status may enhance the effectiveness of such interventions.</p
The strontium isotope fingerprint of phosphate rocks mining.
No full textHigh concentrations of metal(loid)s in phosphate rocks and wastewater associated with phosphate mining and fertilizer production operations pose potential contamination risks to water resources. Here, we propose using Sr isotopes as a tracer to determine possible water quality impacts induced from phosphate mining and fertilizers production. We utilized a regional case study in the northeastern Negev in Israel, where salinization of groundwater and a spring have been attributed to historic leaking and contamination from an upstream phosphate mining wastewater. This study presents a comprehensive dataset of major and trace elements, combined with Sr isotope analyses of the Rotem phosphate rocks, local aquifer carbonate rocks, wastewater from phosphate operation in Mishor Rotem Industries, saline groundwater suspected to be impacted by Rotem mining activities, and two types of background groundwater from the local Judea Group aquifer. The results of this study indicate that trace elements that are enriched in phosphate wastewater were ubiquitously present in the regional and non-contaminated groundwater at the same levels as detected in the impacted waters, and thus cannot be explicitly linked to the phosphate wastewater. The 87Sr/86Sr ratios of phosphate rocks (0.707794 ± 5 × 10-5) from Mishor Rotem Industries were identical to that of associated wastewater (0.707789 ± 3 × 10-5), indicating that the Sr isotopic fingerprint of phosphate rocks is preserved in its wastewater. The 87Sr/86Sr (0.707949 ± 3 × 10-6) of the impacted saline groundwater were significantly different from those of the Rotem wastewater and the background saline groundwater, excluding phosphate mining effluents as the major source for contamination of the aquifer. Instead, the 87Sr/86Sr ratio of the impacted water was similar to the composition of brines from the Dead Sea, which suggests that the salinization was derived primarily from industrial Dead Sea effluents with distinctive Sr isotope and geochemical fingerprints
Therapeutic plasma exchange in the management of immune checkpoint inhibitor-associated immune-related adverse effects: A review.
No full textAcute Adverse Events After Spinal Cord Injury and Their Relationship to Long-term Neurologic and Functional Outcomes: Analysis From the North American Clinical Trials Network for Spinal Cord Injury.
No full textObjectivesThere are few contemporary, prospective multicenter series on the spectrum of acute adverse events and their relationship to long-term outcomes after traumatic spinal cord injury. The goal of this study is to assess the prevalence of adverse events after traumatic spinal cord injury and to evaluate the effects on long-term clinical outcome.DesignMulticenter prospective registry.SettingConsortium of 11 university-affiliated medical centers in the North American Clinical Trials Network.PatientsEight-hundred one spinal cord injury patients enrolled by participating centers.InterventionsAppropriate spinal cord injury treatment at individual centers.Measurements and main resultsA total of 2,303 adverse events were recorded for 502 patients (63%). Penalized maximum logistic regression models were fitted to estimate the likelihood of neurologic recovery (ASIA Impairment Scale improvement ≥ 1 grade point) and functional outcomes in subjects who developed adverse events at 6 months postinjury. After accounting for potential confounders, the group that developed adverse events showed less neurologic recovery (odds ratio, 0.55; 95% CI, 0.32-0.96) and was more likely to require assisted breathing (odds ratio, 6.55; 95% CI, 1.17-36.67); dependent ambulation (odds ratio, 7.38; 95% CI, 4.35-13.06) and have impaired bladder (odds ratio, 9.63; 95% CI, 5.19-17.87) or bowel function (odds ratio, 7.86; 95% CI, 4.31-14.32) measured using the Spinal Cord Independence Measure subscores.ConclusionsResults from this contemporary series demonstrate that acute adverse events are common and are associated with worsened long-term outcomes after traumatic spinal cord injury
Prospective Randomized Control Trial to Compare the Role of Injection Cerebrolysin for 10 Days Duration Against Placebo in Operated Cases of Degenerative Cervical Myelopathy.
No full textStudy designProspective randomized control trial.ObjectiveTo analyze outcomes following the injection of cerebrolysin in surgically treated patients with degenerative cervical myelopathy (DCM).Summary of background dataPrevious research has concluded that superior functional outcomes are achieved with the use of cerebrolysin in surgically treated patients of DCM for 21 days. Our study has been conducted to analyze the use of this drug for a shorter duration (10 days) and compare its clinical efficacy.MethodsNinety operated cases of mild to severe DCM were randomized into two groups. Sixty patients received the injection Cerebrolysin for 10 days postoperatively. The remaining 30 patients received a placebo. Functional outcomes were measured using modified Japanese Orthopaedic Association (mJOA) scores and visual analogue scale (VAS). The American Spinal Injury Association (ASIA) scale was used to document neurological recovery. Hand function was assessed by measuring the grip strength and the upper limb function score the upper extremity motor mJOA plus upper extremity sensory mJOA score. Assessments were performed and preoperatively and postoperatively and at one-month, three-month, six-month, and one-year following surgery.ResultsPreoperative mJOA and VAS scores were comparable in both groups ( P >0.05). Both groups experienced an improvement in mJOA and VAS scores at all time-points during follow-up as compared with preoperative scores. However, the cerebrolysin group demonstrated significantly greater mJOA scores (16.37±1) when compared with the placebo (15.2±1.8) at one-year follow-up ( P ConclusionInjection cerebrolysin, when administered for 10 days postoperatively, can result in significantly greater neurological improvement and hand function in patients with DCM who also receive surgery
Understanding and Modeling Human Planners’ Strategy in Human-automation Interaction in Treatment Planning Using Deep Learning and Reinforcement Learning
No full textPurpose: Radiation therapy aims to deliver high energy radiation beam to eradicate cancer cells. Due to radiation toxicity to normal tissue, treatment planning process is needed to customize the radiation beam towards patient specific treatment geometry while minimizing radiation dose to the normal tissue. Treatment planning is often, however, a trial-and-error process to generate ultimate optimal dose distribution. Breast cancer radiation therapy is one of the most commonly seen treatment in modern radiation oncology department. Whole breast radiation therapy (WBRT) using electronic compensation is an iterative manual process which is time consuming. Our institution has been using artificial intelligence (AI) based planning tool for whole breast radiation therapy (WBRT) for 3 years. It is unclear how human planner interacts with AI in real clinical setting and whether the human planner can inject additional insight into well-established AI model. Therefore, the first aim of this study to model planners’ interaction with AI using deep neural network (NN). In addition, we proposed a multi-agent reinforcement learning based framework (MultiRL-FE) to self-interact with the treatment planning system with location awareness to improve plan quality via fluence editing.Methods: A total of 1151 patients have been treated since in-house AI-based planning tool was released for clinical use in 2019. All 526 patients treated with single energy beams were included in this study. The AI tool automatically generates fluence maps and creates “AI plan”. Then planner evaluates the plan and attempts manual fluence modification before physician’s approval (“final plan”). The manual-modification-value (MMV) of each beamlet is the difference between fluence maps in AI and “final plan”. The MMV was recorded for each planner. In the first aim, a deep NN using UNet3+ architecture was developed to predict MMV with AI fluence map, corresponding dose map and organ map in the beam’s eye view (BEV). Then the predicted MMV maps were applied on the initial “AI plan”s to generate AI-modified plans (“AI-m plan”). In the second aim, we developed MultiRL-FE to self-interact with a given plan to improve the plan quality. A simplified treatment planning system was built in the Python environment to train the agent. For each pixel in the fluence map, an individual agent was assigned to interact with the environment by editing fluence value and receive rewards based on projected beam ray’s dose profile. Asynchronous advantage actor critic (A3C) algorithm was used as the backbone for reinforcement learning agents’ training. To effectively train the agent, we developed the MultiRL-FE framework by embedding A3C in a fully convolutional neural network. To test the feasibility of the proposed framework, twelve patients from the same cohort were collected(6 for training and testing respectively). ”Final plans” were perturbed with 10% dose variation to evaluate the potential of the framework to improve the plan. The agent was designed to iteratively modify the fluence maps for 10 iterations. The modified fluence intensity was imported into the Eclipse treatment planning system for dose calculation. For both aims, plan quality was evaluated by dosimetric endpoints including breast PTV V95%(%), V105%(%), V110%(%), lung V20Gy(%) and heart V5Gy(%).
Results: In the first aim, the “AI-m plans” generated by HAI network showed statistically significant improvement (p<.05) in hotspot control compared with the initial AI-plan, with an average of -25.2cc volume reduction in breast V105% and -0.805% decrease in Dmax. The planning target volume (PTV) coverage were similar to AI-plan and “final plan”. In the second aim of MultiRL-FE testing, the RL modified plans showed a substantial hotspot reduction from the initial plans. The average PTV V105%(%) of testing set was reduced from 77.78(\pm2.78) to 16.97 (\pm9.42), while clinical plans’ was 3.34(\pm2.73). Meanwhile, the modified plans showed improved dose coverage over the clinical plans, with 70.45(\pm3.94) compared to 65.44(\pm5.39) for V95%(%).
Conclusions: In the first part of this study, we proposed a HAI model to enhance the clinical AI tool by reducing hotspot volume from a human perspective. By understanding and modeling the human-automation interaction , this study could advance the widespread clinical application of AI tools in radiation oncology departments with improved robustness and acceptability. In the second part, we developed a self-interactive treatment planning agent with multi-agents reinforcement learning. It offers the advantage of fast location-aware dose editing and can serve as an alternative optimization tool for intensity-modulated radiation therapy and electronic tissue compensation-based treatment planning.
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Novel Angular Measures of Cervical Deformity Account for Upper Cervical Compensation and Sagittal Alignment.
No full textStudy designThis is a retrospective review of a prospective multicenter database.ObjectiveThis study introduces 2 new cervical alignment measures accounting for both cervical deformity (CD) and upper cervical compensation.Summary of background dataCurrent descriptions of CD like the C2-C7 sagittal vertical axis (cSVA) do not account for compensatory mechanisms such as C0-C2 lordosis and pelvic tilt, which makes surgical planning difficult. The craniocervical angle (CCA) combines the slope of McGregor's line and the inclination from C7 to the hard palate. The C2-pelvic tilt (CPT) combines C2 tilt and pelvic tilt. Like the T1 pelvic angle, CPT is less affected by lower extremity and pelvic compensation.MethodsNovel and existing CD measures were correlated in 781 patients from a thoracolumbar deformity (TLD) database and 61 patients from a prospective CD database. CD patients were subanalyzed by region of deformity driver: cervical or cervico-thoracic junction. TLD patients were substratified according to whether or not they had CD as well, where CD was defined as cSVA>4 cm or T1 slope minus cervical lordosis mismatch (TS-CL) >20.ResultsTLD cohort: mean cSVA was 31.7±17.8 mm. Subanalysis of TLD patients with CD versus no-CD demonstrated significant differences in CCA (56.2 vs. 60.6, PConclusionsCCA and CPT account for both cervical sagittal alignment and upper cervical compensation and can be utilized in assessment of cervical alignment