The role of data and safety monitoring boards in implementation trials: When are they justified?

Fiscella, Kevin; Sanders, Mechelle; Holder, Tameir; Carroll, Jennifer K.; Luque, Amneris E.; Cassells, Andrea; Johnson, Brent A.; Williams, Stephen; Tobin, Jonathan N.

doi:10.1017/cts.2020.19

Cited by 10 publications

(3 citation statements)

References 21 publications

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“…Pragmatic and implementation randomized clinical trials have natural areas of overlap. For example, multisite pragmatic and implementation trials grapple with similar regulatory issues [ 10 – 12 ]. Pragmatic and implementation trials may be designed to target both individual patient effectiveness and provider-level practice change outcomes [ 5 , 7 , 8 , 13 – 15 ].…”

Section: Introductionmentioning

confidence: 99%

Integrating pragmatic and implementation science randomized clinical trial approaches: a PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) analysis

Zatzick

Palinkas²,

Chambers

et al. 2023

Trials

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Background Over the past two decades, pragmatic and implementation science clinical trial research methods have advanced substantially. Pragmatic and implementation studies have natural areas of overlap, particularly relating to the goal of using clinical trial data to leverage health care system policy changes. Few investigations have addressed pragmatic and implementation science randomized trial methods development while also considering policy impact. Methods The investigation used the PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) and PRECIS-2-Provider Strategies (PRECIS-2-PS) tools to evaluate the design of two multisite randomized clinical trials that targeted patient-level effectiveness outcomes, provider-level practice changes and health care system policy. Seven raters received PRECIS-2 training and applied the tools in the coding of the two trials. Descriptive statistics were produced for both trials, and PRECIS-2 wheel diagrams were constructed. Interrater agreement was assessed with the Intraclass Correlation (ICC) and Kappa statistics. The Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) qualitative approach was applied to understanding integrative themes derived from the PRECIS-2 ratings and an end-of-study policy summit. Results The ICCs for the composite ratings across the patient and provider-focused PRECIS-2 domains ranged from 0.77 to 0.87, and the Kappa values ranged from 0.25 to 0.37, reflecting overall fair-to-good interrater agreement for both trials. All four PRECIS-2 wheels were rated more pragmatic than explanatory, with composite mean and median scores ≥ 4. Across trials, the primary intent-to-treat analysis domain was consistently rated most pragmatic (mean = 5.0, SD = 0), while the follow-up/data collection domain was rated most explanatory (mean range = 3.14–3.43, SD range = 0.49–0.69). RAPICE field notes identified themes related to potential PRECIS-2 training improvements, as well as policy themes related to using trial data to inform US trauma care system practice change; the policy themes were not captured by the PRECIS-2 ratings. Conclusions The investigation documents that the PRECIS-2 and PRECIS-2-PS can be simultaneously used to feasibly and reliably characterize clinical trials with patient and provider-level targets. The integration of pragmatic and implementation science clinical trial research methods can be furthered by using common metrics such as the PRECIS-2 and PRECIS-2-PS. Future study could focus on clinical trial policy research methods development. Trial registration DO-SBIS ClinicalTrials.gov NCT00607620. registered on January 29, 2008. TSOS ClinicalTrials.gov NCT02655354, registered on July 27, 2015.

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Section: Introductionmentioning

confidence: 99%

Integrating pragmatic and implementation science randomized clinical trial approaches: a PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) analysis

Zatzick

Palinkas²,

Chambers

et al. 2023

Trials

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“…13 describe practice facilitation as an important implementation strategy to communicate shared project goals and monitor practice behaviors, while Sterling et al, 15 examine the role of a specific group of neglected stakeholdershome care workers. Fiscella et al 16 discussed the role of data and safety monitoring boards (DSMBs) in implementations trials, raising the question about whether monitoring for differences in effectiveness is necessary or appropriate, and whether additional systems-level implementation outcomes should be monitored, such as impact on workflow and workforce that could create strain on the staff or increase access to care barriers.…”

Section: Broad Themes From Papers Published In This Jcts Special Issumentioning

confidence: 99%

Introduction to the JCTS special issue on Dissemination and Implementation Sciences

Stevens¹,

Tobin

2020

J. Clin. Trans. Sci.

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“…Fiscella, et al [ 6 ] have argued that data safety monitoring boards (DSMB) may have limited applicability for implementation studies, as NIH does not generally require DSMBs for minimal risk trials. Further, typical implementation study features (e.g.…”

Section: Introductionmentioning

confidence: 99%

Do no harm: the impact of implementing cancer prevention strategies on other preventive health measures

Emmons,

Pelton-Cairns,

Gundersen

et al. 2024

Implement Sci Commun

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Background Translational efforts to increase uptake of evidence-based practices typically look at those outcomes in isolation of their impact on other aspects of care delivery. If we are in fact to “do no harm”, we must consider the possible negative impact of improving use of one practice on other quality measures. Alternatively, a focus on one practice could lead to spread of effective strategies to other practices, which would be highly beneficial. We studied the impact of a colorectal cancer (CRC) screening initiative on delivery of other preventive care measures. Methods We used an interrupted time series design with implementation year as the interruption point. The initiative was conducted between 2015 and 2020, with three staggered cohorts. Main outcomes were quality measures for colorectal cancer screening, cervical cancer screening, hypertension management, diabetes management, weight screening and follow-up, tobacco use screening and cessation treatment, and depression screening and follow-up. Results The initiative was associated with an increase in CRC screening (OR = 1.67, p ≤ 0.01; average marginal effect = 12.2% points), and did not reduce performance on other quality measures in the year of CRC program implementation or a change in their respective secular trends. Conclusions The initiative led to a clinically meaningful increase in CRC screening and was not associated with reductions in delivery of six other preventive services. Quality improvement (QI) initiatives typically approach implementation with an eye towards reducing unintended impact and leveraging existing staff and resources. Implementation research studies may benefit from considering how QI initiatives factor in the local context in implementation efforts.

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The role of data and safety monitoring boards in implementation trials: When are they justified?

Cited by 10 publications

References 21 publications

Integrating pragmatic and implementation science randomized clinical trial approaches: a PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) analysis

Integrating pragmatic and implementation science randomized clinical trial approaches: a PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) analysis

Introduction to the JCTS special issue on Dissemination and Implementation Sciences

Do no harm: the impact of implementing cancer prevention strategies on other preventive health measures

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