Shortcomings in Design and Analysis of Clinical Studies on Bleeding and Thrombosis in Patients with Cirrhosis

2020 ◽  
Vol 46 (06) ◽  
pp. 665-672 ◽  
Author(s):  
Patrick Northup ◽  
Jessica Davis
Keyword(s):  
Best Practices ◽  
Study Design ◽  
Clinical Studies ◽  
Clinical Care ◽  
Decompensated Cirrhosis ◽  
Careful Study ◽  
Serious Adverse Events ◽  
Scientific Success ◽  
Standard Practices ◽  
Made In

AbstractSignificant gains have been made in our understanding of bleeding and thrombosis in patients with liver disease in recent years, with concurrent exponential growth in the scientific literature published in this realm. Clinical studies of this population are challenging for multiple reasons including some hurdles unique to this population. Cirrhosis patients as a whole, especially those with decompensated cirrhosis, are a high-risk and heterogeneous population prone to serious adverse events. Outcomes of bleeding and thrombosis are relatively rare and lack standardized, validated definitions. Standard practices for clinical care have evolved rapidly and rendered some control data uninformative. We aim to highlight these challenges and make recommendations for best practices for future study design and implementation. Multidisciplinary collaboration with proceduralists, careful study design including attention to validated clinically relevant outcomes, and aggressive pursuit of all funding streams will be key to continued scientific success in this burgeoning field.

Children’s assent within clinical care: A concept analysis

2020 ◽  
pp. 136749352097630
Author(s):  
Marjorie Montreuil ◽  
Justine Fortin ◽  
Eric Racine
Keyword(s):  
Clinical Care ◽  
Concept Analysis ◽  
Process Of Care ◽  
Deliberative Process ◽  
Ethical Implications ◽  
Rights Of The Child ◽  
Healthcare Decision Making ◽  
Psychological Harm ◽  
Practical Implications ◽  
Made In

Seeking children’s assent has been put forward as a way to foster children’s involvement in the healthcare decision-making process. However, the functions of the concept of assent within clinical care are manifold, and methods used to recognize children’s capacities and promote their involvement in their care remain debated. We performed an instrumentalist concept analysis of assent, with 58 included articles. Final themes were jointly identified through a deliberative process. Two distinct perspectives of assent were predominant: as an affirmative agreement for a specific decision and as part of a continuous, interactive process of care. Differing standards were provided as to how and when to apply the concept of assent. The concept of dissent was largely omitted from conceptions of assent, especially in situations for which children’s refusal would lead to severe health consequences. Ethical implications included fostering autonomy, reducing physical/psychological harm to the child, respecting the child as a human being, and fulfilling the universal rights of the child. There remain important gaps in the theory of assent and its desirable and possible practical implications. Practical standards are largely missing, and evidence supporting the claims made in the literature requires further investigation.

scholarly journals Payment Reforms for Prehospital Care Services in a Middle Income Country: Assessing Implementation and Patient Outcomes Using a Mixed-Methods Approach

2018 ◽  
Vol 2018 ◽  
pp. 1-10
Author(s):  
Paibul Suriyawongpaisal ◽  
Samrit Srithamrongsawad ◽  
Pongsakorn Atiksawedparit ◽  
Khanisthar Phooseemungkun ◽  
Krongkan Bunchaiyai ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Patient Care ◽  
Patient Outcomes ◽  
Prehospital Care ◽  
Clinical Care ◽  
Mixed Methods Approach ◽  
Time Flow ◽  
Care Systems ◽  
Pay System ◽  
Made In

Introduction. Financing health systems constitutes a key element of well-functioning healthcare system. Prior to 2015, two new financial arrangements (direct-pay and E-claim systems) were introduced on a voluntary basis which aimed to pool more financial resources and improve cash flow of prehospital care systems. The aims of this study were to (1) assess the effects of direct-pay system in terms of (a) timeliness of reimbursement to EMS agencies, (b) changes in clinical care processes, and (c) the outcomes of patient care as compared to previous system; (2) identify the reasons for or against EMS agencies to participate in direct-pay system mechanisms; (3) identify the emerging issues with potential to significantly further the advancement of EMS systems. Using a mixed-methods approach, retrospective datasets of 3,769,399 individual records of call responses from 2015 to 2017 were analyzed which compared EMS units with the direct-pay system against those without in terms of time flow of claim data and patient outcomes. For qualitative data, in-depth interviews were conducted. Results. EMS units participating in both systems had the highest percentages of financial claim being made in time as compared to those not participating in any (p=0.012). However, there were not any practically meaningful differences between EMS units participating and not participating in either of the payment systems in terms of patient care such as appropriateness of response time, airway management, and outcome of treatment. Analysis of data from focus-group and individual interviews ended up with a causal loop diagram demonstrating potential explanatory mechanisms for those findings. Conclusion. It is evident that progress has been made in terms of mobilising more financial inputs and improving financial information flow. However, there is no evidence of any changes in patient outcomes and quality of care. Furthermore, whether the progress is meaningful in filling the gaps of financial demands of the prehospital care systems is still questionable. Room for future improvement of prehospital care systems was discussed with implications for other countries.

scholarly journals Embedding surveillance into clinical care to detect serious adverse events in pregnancy

Vaccine ◽  
2015 ◽  
Vol 33 (47) ◽  
pp. 6466-6468 ◽  
Author(s):  
Anna C. Seale ◽  
Hellen C. Barsosio ◽  
Angela C. Koech ◽  
James A. Berkley
Keyword(s):  
Adverse Events ◽  
Clinical Care ◽  
Serious Adverse Events ◽  
In Pregnancy

scholarly journals Corrigendum: Nutritional Evaluation and Optimisation in Neonates (NEON) trial of amino acid regimen and intravenous lipid composition in preterm parenteral nutrition: a randomised double-blind controlled trial

2017 ◽  
Vol 3 (2) ◽  
pp. 81-82
Author(s):  
Sabita Uthaya ◽  
Xinxue Liu ◽  
Daphne Babalis ◽  
Caroline Dore ◽  
Jane Warwick ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Analysis Data ◽  
Secondary Outcome ◽  
Final Report ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Correct Treatment ◽  
Data Set ◽  
Study Results ◽  
Made In

Abstract During the uploading of data for submission to the EudraCT results database, a discrepancy was identified. It was noted that the number of deaths per group was not consistent with the number in the final report and trial publication. This discrepancy was found to relate to two randomisation numbers. During the trial, the randomisation database had been held separately from the trial database, with manual transcription of randomisation numbers from the randomisation database to the trial database. Two randomisation numbers had been entered incorrectly into the trial database and, although this was documented at the time, the correction had not been made in the analysis data set. The two infants in question received the correct treatment in accordance with their allocation, but were analysed according to the wrong treatment group. Following the identification of this error, all analyses were repeated. It was confirmed that this error had a negligible impact on the study results. Furthermore, the two infants in question had not been included in the primary and secondary outcome analyses, as one had died and the other had withdrawn prior to the primary end-point assessment, so the key study outcomes remain unchanged. The only changes to the results are in the number of serious adverse events and minor changes to the data in demographics tables mostly affecting decimal points and the CONSORT diagram. Our interpretation of the study results remains unchanged.

scholarly journals Time arrow in published clinical studies/trials indexed in MEDLINE: a systematic analysis of Retrospective vs Prospective study design, from 1960 to 2017.

2018 ◽  
Author(s):  
Michele M Ciulla ◽  
Patrizia Vivona
Keyword(s):  
Prospective Study ◽  
Study Design ◽  
Low Income ◽  
Clinical Studies ◽  
Human Subjects ◽  
Systematic Analysis ◽  
Time Line ◽  
Time Arrow ◽  
Prospective Study Design ◽  
Single Time Point

Clinical studies/trials are experiments or observations on human subjects considered by the scientific community the most appropriate instrument to answer specific research questions on interventions on health outcomes. The time-line of the observations might be focused on a single time point or to follow time, backward or forward, in the so called, respectively, retrospective and prospective study design. Since the retrospective approach has been criticized for the possible sources of errors due to bias and confounding, we aimed this study to assess if there is a prevalence of retrospective vs prospective design in the clinical studies/trials by querying MEDLINE. Our results on a sample of 1,438,872 studies/trials, (yrs 1960-2017), support a prevalence of retrospective, respectively 55% vs 45%. To explain this result, arandom sub-sample of studies where the country of origin was reported (n=1576) was categorized in high and low-income based onthe nominal Gross Domestic Product (GDP) and matched with the topic of the research. As expected, the absolute majority of studies/trials are carried on by high-income countries, respectively 86% vs 14%; even if a slight prevalence of retrospective was recorded in both income groups, nonetheless the most part of prospective studies are carried out by high-GDP countries, 85% vs 15%. Finally the differences in the design of the study are understandable when considering the topic of the research.

scholarly journals Intermittent Transfusions for Treatment of Thalassemia in the State of Georgia, 2007-2016

2021 ◽  
Vol 8 (4) ◽  
Author(s):  
Rollins MR ◽  
◽  
Boudreaux J ◽  
Eckman J ◽  
Branscomb J ◽  
...  
Keyword(s):  
Best Practices ◽  
Hospital Discharge ◽  
Study Design ◽  
Red Cell ◽  
Diagnosis Code ◽  
Provider Education ◽  
Discharge Data ◽  
Red Cell Transfusion ◽  
Transfusion Complications ◽  
Transfusion History

Background: Individuals with Non-Transfusion Dependent Thalassemia (NTDT) may require infrequent transfusions. Knowing transfusion history, while important, can be challenging in this subgroup. Study Design: Hospital discharge data in Georgia (2007-2016) was reviewed. Thalassemia patients were defined as ≥3 encounters with a thalassemia diagnosis code. Transfusion was defined by the presence of a diagnosis, CPT, revenue, or HCPCS code for red cell transfusion. Results: There were 428 patients identified; 57 received multi-site transfusions. Conclusion: Georgia hospitals provide intermittent transfusions to low volumes of probable NTDT patients. Patient and provider education may help assure adherence to best practices, avoiding serious transfusion complications.

ICT Based Performance Measurement and Benchmarking Methodology

2020 ◽  
pp. 188-196
Author(s):  
Nadja Yang Meng ◽  
Karthikeyan K
Keyword(s):  
Best Practices ◽  
Performance Measurement ◽  
Performance Metrics ◽  
Performance Enhancement ◽  
Performance Measurements ◽  
Know How ◽  
Performance Benchmarking ◽  
Measurement Framework ◽  
And Performance ◽  
Made In

Performance benchmarking and performance measurement are the fundamental principles of performance enhancement in the business sector. For businesses to enhance their performance in the modern competitive world, it is fundamental to know how to measure the performance level in business that also incorporates telling how they will performance after a change has been made. In case a business improvement has been made, the performance processes have to be evaluated. Performance measurements are also fundamental in the process of doing comparisons of performance levels between corporations. The best practices within the industry are evaluated by the businesses with desirable levels of the kind of performance measures being conducted. In that regard, it is fundamental if similar businesses applied the same collection of performance metrics. In this paper, the NETIAS performance measurement framework will be applied to accomplish the mission of evaluating performances in business by producing generic collection of performance metrics, which businesses can utilize to compare and measure their organizational activities.

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