Accounting for quality improvement during the conduct of embedded pragmatic clinical trials within healthcare systems: NIH Collaboratory case studies

As healthcare systems emerge from the COVID-19 and begin the process of recovery and rebuilding, it is more important than ever to find systematic ways to ensure that all healthcare staff are focusing on their wellbeing, are able to reflect on new ways of working and find methods to improve their experience at work. This article, the second in a three-part series on the practical application of quality improvement in healthcare, presents four case studies that demonstrate the learning from four healthcare systems that have been applying both quality improvement and the Institute for Healthcare Improvement's ‘joy in work’ framework to enhance staff wellbeing and experience. These case studies demonstrate the benefits of involving staff deeply in the process of understanding factors that impact on experience at work, developing and testing creative ideas that can make a difference. The ideas that emerged were diverse and highly contextualised to the local service. Ideas related most strongly to four areas: wellness and resilience, daily improvement, camaraderie and teamwork, and recognition and reward. The systematic approach that quality improvement brings is potentially replicable across all healthcare settings, and can provide a way for all teams to have greater ownership and control over their wellbeing and experience at work.

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Quality Improvement in the Fabrication of Railway Components-Case Studies

Indian Welding Journal ◽

10.22486/iwj.v27i3.148242 ◽

1994 ◽

Vol 27 (3) ◽

pp. 16

Author(s):

N. K. Sarkar

Keyword(s):

Quality Improvement ◽

Case Studies

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Improving pragmatic clinical trial design using real-world data

Clinical Trials ◽

10.1177/1740774519833679 ◽

2019 ◽

Vol 16 (3) ◽

pp. 273-282 ◽

Cited By ~ 4

Author(s):

Susan M Shortreed ◽

Carolyn M Rutter ◽

Andrea J Cook ◽

Gregory E Simon

Keyword(s):

Clinical Trials ◽

Trial Design ◽

Suicide Attempts ◽

Real World Data ◽

Electronic Health Record Data ◽

Pragmatic Clinical Trial ◽

Pragmatic Clinical Trials ◽

Sample Size Calculations ◽

Record Data ◽

Electronic Health

Background Pragmatic clinical trials often use automated data sources such as electronic health records, claims, or registries to identify eligible individuals and collect outcome information. A specific advantage that this automated data collection often yields is having data on potential participants when design decisions are being made. We outline how this data can be used to inform trial design. Methods Our work is motivated by a pragmatic clinical trial evaluating the impact of suicide-prevention outreach interventions on fatal and non-fatal suicide attempts in the 18 months after randomization. We illustrate our recommended approaches for designing pragmatic clinical trials using historical data from the health systems participating in this study. Specifically, we illustrate how electronic health record data can be used to inform the selection of trial eligibility requirements, to estimate the distribution of participant characteristics over the course of the trial, and to conduct power and sample size calculations. Results Data from 122,873 people with patient health questionnaire (PHQ) responses, recorded in their electronic health records between 1 July 2010 and 31 March 2012, were used to show that the suicide attempt rate in the 18 months following completion of the questionnaire varies by response to item nine of the PHQ. We estimated that the proportion of individuals with a prior recorded elevated PHQ (i.e. history of suicidal ideation) would decrease from approximately 50% at the beginning of a trial to about 5%, 50 weeks later. Using electronic health record data, we conducted simulations to estimate the power to detect a 25% reduction in suicide attempts. Simulation-based power calculations estimated that randomizing 8000 participants per randomization arm would allow 90% power to detect a 25% reduction in the suicide attempt rate in the intervention arm compared to usual care at an alpha rate of 0.05. Conclusions Historical data can be used to inform the design of pragmatic clinical trials, a strength of trials that use automated data collection for randomizing participants and assessing outcomes. In particular, realistic sample size calculations can be conducted using real-world data from the health systems in which the trial will be conducted. Data-informed trial design should yield more realistic estimates of statistical power and maximize efficiency of trial recruitment.

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An evaluation of the implementation of quality improvement (QI) in primary care dentistry: a multi-method approach

BMJ Open Quality ◽

10.1136/bmjoq-2019-000839 ◽

2021 ◽

Vol 10 (2) ◽

pp. e000839

Author(s):

Heather Cassie ◽

Vinay Mistry ◽

Laura Beaton ◽

Irene Black ◽

Janet E Clarkson ◽

...

Keyword(s):

Primary Care ◽

Quality Improvement ◽

Case Studies ◽

Quality Care ◽

Theoretical Domains Framework ◽

Team Members ◽

Knowledge And Skills ◽

Scottish Government ◽

The Impact

ObjectivesEnsuring that healthcare is patient-centred, safe and harm free is the cornerstone of the NHS. The Scottish Patient Safety Programme (SPSP) is a national initiative to support the provision of safe, high-quality care. SPSP promotes a coordinated approach to quality improvement (QI) in primary care by providing evidence-based methods, such as the Institute for Healthcare Improvement’s Breakthrough Series Collaborative methodology. These methods are relatively untested within dentistry. The aim of this study was to evaluate the impact to inform the development and implementation of improvement collaboratives as a means for QI in primary care dentistry.DesignA multimethod study underpinned by the Theoretical Domains Framework and the Kirkpatrick model. Quantitative data were collected using baseline and follow-up questionnaires, designed to explore beliefs and behaviours towards improving quality in practice. Qualitative data were gathered using interviews with dental team members and practice-based case studies.ResultsOne hundred and eleven dental team members completed the baseline questionnaire. Follow-up questionnaires were returned by 79 team members. Twelve practices, including two case studies, participated in evaluation interviews. Findings identified positive beliefs and increased knowledge and skills towards QI, as well as increased confidence about using QI methodologies in practice. Barriers included time, poor patient and team engagement, communication and leadership. Facilitators included team working, clear roles, strong leadership, training, peer support and visible benefits. Participants’ knowledge and skills were identified as an area for improvement.ConclusionsFindings demonstrate increased knowledge, skills and confidence in relation to QI methodology and highlight areas for improvement. This is an example of partnership working between the Scottish Government and NHSScotland towards a shared ambition to provide safe care to every patient. More work is required to evaluate the sustainability and transferability of improvement collaboratives as a means for QI in dentistry and wider primary care.

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Clinical Trials, Case Studies, and Oral Care R&D: Inclusivity, Consistency, and Other Atypical Evidence

Journal of Evidence Based Dental Practice ◽

10.1016/j.jebdp.2009.12.003 ◽

2010 ◽

Vol 10 (1) ◽

pp. 10-12 ◽

Cited By ~ 1

Author(s):

Robert W. Gerlach

Keyword(s):

Clinical Trials ◽

Case Studies ◽

Oral Care

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Optimizing the Impact of Pragmatic Clinical Trials for Veteran and Military Populations: Lessons From the Pain Management Collaboratory

Military Medicine ◽

10.1093/milmed/usab458 ◽

2021 ◽

Author(s):

Joseph Ali ◽

Margaret Antonelli ◽

Lori Bastian ◽

William Becker ◽

Cynthia A Brandt ◽

...

Keyword(s):

Clinical Trials ◽

Pain Management ◽

Pragmatic Trial ◽

Dissemination And Implementation ◽

Large Network ◽

Military Health ◽

Healthcare Needs ◽

Unmet Healthcare Needs ◽

Pragmatic Clinical Trials ◽

The Impact

ABSTRACT Pragmatic clinical trials (PCTs) are well-suited to address unmet healthcare needs, such as those arising from the dual public health crises of chronic pain and opioid misuse, recently exacerbated by the COVID-19 pandemic. These overlapping epidemics have complex, multifactorial etiologies, and PCTs can be used to investigate the effectiveness of integrated therapies that are currently available but underused. Yet individual pragmatic studies can be limited in their reach because of existing structural and cultural barriers to dissemination and implementation. The National Institutes of Health, Department of Defense, and Department of Veterans Affairs formed an interagency research partnership, the Pain Management Collaboratory. The partnership combines pragmatic trial design with collaborative tools and relationship building within a large network to advance the science and impact of nonpharmacological approaches and integrated models of care for the management of pain and common co-occurring conditions. The Pain Management Collaboratory team supports 11 large-scale, multisite PCTs in veteran and military health systems with a focus on team science with the shared aim that the “whole is greater than the sum of the parts.” Herein, we describe this integrated approach and lessons learned, including incentivizing all parties; proactively offering frequent opportunities for problem-solving; engaging stakeholders during all stages of research; and navigating competing research priorities. We also articulate several specific strategies and their practical implications for advancing pain management in active clinical, “real-world,” settings.

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Analysis of the tendency of development of biosensors based on GaN

Nanotechnology : the development , application - XXI Century ◽

10.18127/j22250980-202102-02 ◽

2021 ◽

Author(s):

S.I. Agasieva ◽

E.A. Smetanin ◽

A.R. Vechkanov ◽

A.V. Gubanov

Keyword(s):

Clinical Trials ◽

Infectious Diseases ◽

Diagnostic Tests ◽

Diagnostic Testing ◽

Healthcare Systems ◽

Clinical Analysis ◽

Molecular Diagnostic ◽

Economic Damage ◽

Disease Research ◽

Local Healthcare

Statement of the problem of this article - one of the most important problems is protection from especially dangerous infectious diseases. The use of biosensors in clinical trials will significantly reduce the time for obtaining the results of analyzes, thereby speeding up the appointment of treatment to patients. The purpose of the article is to present modern designs of biosensors based on gallium nitride, the possibilities of their application and characteristics. Consider the principles of operation, areas of application and characteristics. As a result, the design of modern biosensors and modern trends in their use from various sources of literature in recent years are shown. Biosensors, principles of their action, areas of application and characteristics are considered, which will reduce the possible socio-economic damage from temporary disability for sick citizens due to the rapid and timely implementation of anti-epidemic measures. Practical value: the proposed biosensors are of interest as devices for detecting diseases. The use of biosensors in clinical disease research has several potential advantages over other clinical analysis methods, including increased analysis speed and flexibility, multipurpose analysis capability, automation, reduced diagnostic testing costs, and the ability to integrate molecular diagnostic tests into local healthcare systems.

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