scholarly journals How Are Emerging Data Translated Into Clinical Practice? A Mixed Methods Investigation of Coronavirus Disease 2019 Institutional Treatment Protocols

2021 ◽  
Vol 8 (4) ◽  
Author(s):  
Archana Asundi ◽  
Jack Resnik ◽  
Peter A Benedict ◽  
Marlena Shin ◽  
A Rani Elwy ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Practice ◽  
Clinical Care ◽  
Severity Of Illness ◽  
Scoring Systems ◽  
Evidence Base ◽  
Emerging Diseases ◽  
Treatment Protocols ◽  
Healthcare Facilities ◽  
Institutional Treatment

Abstract Background Early in the coronavirus disease 2019 (COVID-19) pandemic, there was minimal data to guide treatment, and we lacked understanding of how clinicians translated this limited evidence base for potential therapeutics to bedside care. Our objective was to systematically determine how emerging data about COVID-19 treatments was implemented by analyzing institutional treatment protocols. Methods Treatment protocols from North American healthcare facilities and recommendations from guideline-issuing bodies were collected. Qualitative data on treatment regimens and their applications were extracted using an adapted National Institutes of Health/US Food and Drug Administration experimental therapeutics framework. Structured data on risk factor and severity of illness scoring systems were extracted and analyzed using descriptive statistics. Results We extracted data from 105 independent protocols. Guideline-issuing organizations published recommendations after the initial peak of the pandemic in many regions and generally recommended clinical trial referral, with limited additional guidance. Facility-specific protocols favored offering some treatment (96.8%, N = 92 of 95), most commonly, hydroxychloroquine (90.5%), followed by remdesivir and interleukin-6 inhibitors. Recommendation for clinical trial enrollment was limited largely to academic medical centers (19 of 52 vs 9 of 43 community/Veterans Affairs [VA]), which were more likely to have access to research studies. Other themes identified included urgent protocol development, plans for rapid updates, contradictory statements, and entirely missing sections, with section headings but no content other than “in process.” Conclusions In the COVID-19 pandemic, emerging information was rapidly implemented by institutions into clinical practice and, unlike recommendations from guideline-issuing bodies, heavily favored administering some form of therapy. Understanding how and why evidence is translated into clinical care is critical to improve processes for other emerging diseases.

scholarly journals How to design and set up a clinical trial part 1: the research question

2019 ◽  
Vol 12 (3) ◽  
pp. 111-116
Author(s):  
Amarpreet Atwal ◽  
Philip E Benson
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Relevance ◽  
Clinical Care ◽  
Research Question ◽  
Relevant Information ◽  
Evidence Base ◽  
Human Participants ◽  
Set Up

Data from clinical trials involving human participants are essential in establishing an evidence base about the safety and effectiveness of our treatments. This first article describes the steps involved in designing and setting up a clinical trial, from establishing the research question(s) to searching the literature. Acquiring some knowledge about how to set up a clinical trial will allow the conscientious clinician to use the most relevant information to provide the highest possible standards of clinical care for his/her patients. CPD/Clinical Relevance: Even if a clinician is not, has never been, nor is ever planning to be involved in research, he/she should understand and be able to interpret the data from clinical trials.

scholarly journals Clinical characterization of Lassa fever: A systematic review of clinical reports and research to inform clinical trial design

2021 ◽  
Vol 15 (9) ◽  
pp. e0009788
Author(s):  
Laura Merson ◽  
Josephine Bourner ◽  
Sulaiman Jalloh ◽  
Astrid Erber ◽  
Alex Paddy Salam ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Trial Design ◽  
Clinical Care ◽  
Clinical Trial Design ◽  
Evidence Base ◽  
Lassa Fever ◽  
World Health ◽  
Treatment Recommendation ◽  
Presenting Symptoms

Background Research is urgently needed to reduce the morbidity and mortality of Lassa fever (LF), including clinical trials to test new therapies and to verify the efficacy and safety of the only current treatment recommendation, ribavirin, which has a weak clinical evidence base. To help establish a basis for the development of an adaptable, standardised clinical trial methodology, we conducted a systematic review to identify the clinical characteristics and outcomes of LF and describe how LF has historically been defined and assessed in the scientific literature. Methodology Primary clinical studies and reports of patients with suspected and confirmed diagnosis of LF published in the peer-reviewed literature before 15 April 2021 were included. Publications were selected following a two-stage screening of abstracts, then full-texts, by two independent reviewers at each stage. Data were extracted, verified, and summarised using descriptive statistics. Results 147 publications were included, primarily case reports (36%), case series (28%), and cohort studies (20%); only 2 quasi-randomised studies (1%) were found. Data are mostly from Nigeria (52% of individuals, 41% of publications) and Sierra Leone (42% of individuals, 31% of publications). The results corroborate the World Health Organisation characterisation of LF presentation. However, a broader spectrum of presenting symptoms is evident, such as gastrointestinal illness and other nervous system and musculoskeletal disorders that are not commonly included as indicators of LF. The overall case fatality ratio was 30% in laboratory-confirmed cases (1896/6373 reported in 109 publications). Conclusion Systematic review is an important tool in the clinical characterisation of diseases with limited publications. The results herein provide a more complete understanding of the spectrum of disease which is relevant to clinical trial design. This review demonstrates the need for coordination across the LF research community to generate harmonised research methods that can contribute to building a strong evidence base for new treatments and foster confidence in their integration into clinical care.

Clinical practice guidelines and risk management: a medicolegal perspective

Clinical Risk ◽  
2007 ◽  
Vol 13 (5) ◽  
pp. 169-172 ◽  
Author(s):  
Jo Samanta ◽  
Ash Samanta
Keyword(s):  
Risk Management ◽  
Clinical Practice ◽  
Clinical Guidelines ◽  
Clinical Care ◽  
Evidence Base ◽  
Medical Evidence ◽  
High Quality ◽  
Treatment Processes ◽  
The Relationship

Clinical guidelines are systematically developed statements created to assist clinicians in making decisions about the treatment and management of specific conditions. They are linked to the medical evidence base and aim to reduce unnecessary variations in treatment processes, thereby maintaining consistently high quality clinical care. Healthcare risk management is concerned with preventing harm to patients and this goal can be facilitated by clinical guidelines which enhance the quality of care. This paper explores the relationship between clinical guidelines and risk management from a medicolegal perspective.

scholarly journals How to design and set up a clinical trial part 2: protocols and approvals

2019 ◽  
Vol 12 (4) ◽  
pp. 145-150
Author(s):  
Amarpreet Atwal ◽  
Philip E Benson
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Relevance ◽  
Clinical Care ◽  
Relevant Information ◽  
Evidence Base ◽  
Human Participants ◽  
Set Up

Data from clinical trials involving human participants are essential in establishing an evidence base about the safety and effectiveness of our treatments. This second article describes the steps involved in designing and setting up a clinical trial, from writing a protocol to gaining the necessary approvals. Acquiring some knowledge about how to set up a clinical trial will allow the conscientious clinician to use the most relevant information to provide the highest possible standards of clinical care for his/her patients. CPD/Clinical Relevance: Even if a clinician is not, has never been, nor is ever planning to be involved in research, he/she should understand and be able to interpret the data from clinical trials.

scholarly journals 4494 Predictors of Reintubation After Cardiac Surgery

2020 ◽  
Vol 4 (s1) ◽  
pp. 50-50
Author(s):  
Robert Edward Freundlich ◽  
Gen Li ◽  
Jonathan P Wanderer ◽  
Frederic T Billings ◽  
Henry Domenico ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cardiac Surgery ◽  
High Risk ◽  
Query Language ◽  
Risk Estimation ◽  
Clinical Care ◽  
Model Development ◽  
Calibration Plot ◽  
Iterative Model ◽  
Strong Candidate

OBJECTIVES/GOALS: We modeled risk of reintubation within 48 hours of cardiac surgery using variables available in the electronic health record (EHR). This model will guide recruitment for a prospective, pragmatic clinical trial entirely embedded within the EHR among those at high risk of reintubation. METHODS/STUDY POPULATION: All adult patients admitted to the cardiac intensive care unit following cardiac surgery involving thoracotomy or sternotomy were eligible for inclusion. Data were obtained from operational and analytical databases integrated into the Epic EHR, as well as institutional and departmental-derived data warehouses, using structured query language. Variables were screened for inclusion in the model based on clinical relevance, availability in the EHR as structured data, and likelihood of timely documentation during routine clinical care, in the hopes of obtaining a maximally-pragmatic model. RESULTS/ANTICIPATED RESULTS: A total of 2325 patients met inclusion criteria between November 2, 2017 and November 2, 2019. Of these patients, 68.4% were male. Median age was 63.0. The primary outcome of reintubation occurred in 112/2325 (4.8%) of patients within 48 hours and 177/2325 (7.6%) at any point in the subsequent hospital encounter. Univariate screening and iterative model development revealed numerous strong candidate predictors (ANOVA plot, figure 1), resulting in a model with acceptable calibration (calibration plot, figure 2), c = 0.666. DISCUSSION/SIGNIFICANCE OF IMPACT: Reintubation is common after cardiac surgery. Risk factors are available in the EHR. We are integrating this model into the EHR to support real-time risk estimation and to recruit and randomize high-risk patients into a clinical trial comparing post-extubation high flow nasal cannula with usual care. CONFLICT OF INTEREST DESCRIPTION: REF has received grant funding and consulting fees from Medtronic for research on inpatient monitoring.

Edoxaban treatment of elderly patients with atrial fibrillation in routine clinical practice: 1-year results of the non-interventional Global ETNA-AF program

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Yamashita ◽  
C.C Wang ◽  
Y.-H Kim ◽  
R De Caterina ◽  
P Kirchhof ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Major Bleeding ◽  
Intracranial Haemorrhage ◽  
Clinical Care ◽  
Oral Anticoagulants ◽  
Clinical Event ◽  
Funding Source ◽  
Private Company ◽  
All Cause Mortality

Abstract Background The prevalence of atrial fibrillation (AF) and the need for appropriate anticoagulation increase with age. The benefit/risk profile of direct oral anticoagulants such as edoxaban in elderly population with AF in regular clinical practice is therefore of particular interest. Purpose Analyses of Global ETNA-AF data were performed to report patient characteristics, edoxaban treatment, and 1-year clinical events by age subgroups. Methods Global ETNA-AF is a multicentre, prospective, noninterventional program conducted in Europe, Japan, Korea, Taiwan, and other Asian countries. Demographics, baseline characteristics, and 1-year clinical event data were analysed in four age subgroups. Results Of 26,823 patients included in this analysis, 50.4% were ≥75 years old and 11.6% were ≥85 years. Increase in age was generally associated with lower body weight, lower creatinine clearance, higher CHA2DS2-VASc and HAS-BLED scores, and a higher percentage of patients receiving the reduced dose of 30 mg daily edoxaban. At 1-year, rates of ISTH major bleeding and ischaemic stroke were generally low across all age subgroups. The proportion of intracranial haemorrhage within major bleeding events was similar across age groups. All-cause mortality increased with age more than cardiovascular mortality. Conclusion Data from Global ETNA-AF support the safety and effectiveness of edoxaban in elderly AF patients (including ≥85 years) in routine clinical care with only a small increase in intracranial haemorrhage. The higher all-cause mortality with increasing age is not driven by cardiovascular causes. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Daiichi Sankyo

Discontinuation and relapse with paliperidone palmitate three-monthly for maintenance of schizophrenia: Two year follow-up of use in clinical practice

2021 ◽  
pp. 026988112110097
Author(s):  
Phoebe Wallman ◽  
Ivana Clark ◽  
David Taylor
Keyword(s):  
Clinical Practice ◽  
Treatment Duration ◽  
Maintenance Treatment ◽  
Clinical Care ◽  
Paliperidone Palmitate ◽  
Reduce Risk ◽  
Patient Refusal ◽  
Long Acting ◽  
Post Hoc

Background: The use of antipsychotic long-acting injections (LAI) aims to reduce risk of relapse and hospitalisation in patients with schizophrenia compared with oral medication. Paliperidone palmitate is currently the only LAI that can be administered at three-monthly intervals for maintenance treatment of schizophrenia. Aim: This prospective study aimed to evaluate relapse and continuation in licensed use of paliperidone palmitate three-monthly (PP3M) over a 2-year follow-up in clinical practice. Method: Non-interventional, observational study of patients treated in the South London and The Maudsley NHS Foundation Trust. Results: A total of 166 patients initiated on PP3M, 55 were excluded from the study (non-F20 diagnosis ( n = 43); F20 >65 years old ( n = 12)). Of the 111 patients included, 67 (60%) continued PP3M for 2 years. Overall 102 patients received more than one dose of PP3M and 92 (90%) remained on the same dose of PP3M for the whole of their treatment duration. Relapse (defined as a step-up in clinical care) occurred in eight patients (7%) while on PP3M. The most common reason for discontinuation was patient refusal and the most frequent medication prescribed after discontinuation was paliperidone palmitate one-monthly (PP1M). Post hoc, we analysed outcome in those continuing any form of PPLAI (those continuing with PP3M and those switching back to PP1M). Continuation over 2 years with any PPLAI formulation was 73% (81/111) and relapse was recorded in 9% (10/111). Conclusion: Overall, PP3M was an effective maintenance treatment for schizophrenia after stabilisation on PP1M in a clinical setting.

Quality Improvement in Otolaryngology–Head and Neck Surgery: Developing Registry-Enabled Quality Measures From Guidelines for Cerumen Impaction and Allergic Rhinitis Through a Transparent and Systematic Process

2021 ◽  
pp. 019459982110119
Author(s):  
Jeremy J. Michel ◽  
Seth R. Schwartz ◽  
Douglas E. Dawson ◽  
James C. Denneny ◽  
Eileen Erinoff ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Clinical Practice ◽  
Head And Neck ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Clinical Care ◽  
Quality Measures ◽  
Neck Surgery ◽  
Head And Neck Surgery ◽  
Quality Reporting

Background and Significance Quality measurement can drive improvement in clinical care and allow for easy reporting of quality care by clinicians, but creating quality measures is a time-consuming and costly process. ECRI (formerly Emergency Care Research Institute) has pioneered a process to support systematic translation of clinical practice guidelines into electronic quality measures using a transparent and reproducible pathway. This process could be used to augment or support the development of electronic quality measures of the American Academy of Otolaryngology–Head and Neck Surgery Foundation (AAO-HNSF) and others as the Centers for Medicare and Medicaid Services transitions from the Merit-Based Incentive Payment System (MIPS) to the MIPS Value Pathways for quality reporting. Methods We used a transparent and reproducible process to create electronic quality measures based on recommendations from 2 AAO-HNSF clinical practice guidelines (cerumen impaction and allergic rhinitis). Steps of this process include source material review, electronic content extraction, logic development, implementation barrier analysis, content encoding and structuring, and measure formalization. Proposed measures then go through the standard publication process for AAO-HNSF measures. Results The 2 guidelines contained 29 recommendation statements, of which 7 were translated into electronic quality measures and published. Intermediate products of the guideline conversion process facilitated development and were retained to support review, updating, and transparency. Of the 7 initially published quality measures, 6 were approved as 2018 MIPS measures, and 2 continued to demonstrate a gap in care after a year of data collection. Conclusion Developing high-quality, registry-enabled measures from guidelines via a rigorous reproducible process is feasible. The streamlined process was effective in producing quality measures for publication in a timely fashion. Efforts to better identify gaps in care and more quickly recognize recommendations that would not translate well into quality measures could further streamline this process.

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