Envisioning clinical trials as complex interventions

Stensland, Kristian; Damschroder, Laura J.; Sales, Anne; Schott, Anne F.; Skolarus, Ted A.

doi:10.1002/cncr.34357

Cited by 9 publications

(4 citation statements)

References 42 publications

(72 reference statements)

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“…Despite these advantages and investments, clinical trials frequently fail to reach their primary endpoints, commonly do not meet enrollment goals, and often take longer than anticipated to enroll and complete [ 4 – 7 ]. In these ways, clinical trials can be considered complex evidence-based interventions with significant benefits to both individuals and society although suffering from poor implementation [ 8 ]. The clinical trials system could benefit from implementation science approaches to address this evidence-to-practice gap.…”

Section: Introductionmentioning

confidence: 99%

Applying implementation frameworks to the clinical trial context

Stensland

Sales

Damschroder

et al. 2022

Implement Sci Commun

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Background Clinical trials advance science, benefit society, and provide optimal care to individuals with some conditions, such as cancer. However, clinical trials often fail to reach their endpoints, and low participant enrollment remains a critical problem with trial conduct. In these ways, clinical trials can be considered beneficial evidence-based practices suffering from poor implementation. Prior approaches to improving trials have had difficulties with reproducibility and limited impact, perhaps due to the lack of an underlying trial improvement framework. For these reasons, we propose adapting implementation science frameworks to the clinical trial context to improve the implementation of clinical trials. Main text We adapted an outcomes framework (Proctor’s Implementation Outcomes Framework) and a determinants framework (the Consolidated Framework for Implementation Research) to the trial context. We linked these frameworks to ERIC-based improvement strategies and present an inferential process model for identifying and selecting trial improvement strategies based on the Implementation Research Logic Model. We describe example applications of the framework components to the trial context and present a worked example of our model applied to a trial with poor enrollment. We then consider the implications of this approach on improving existing trials, the design of future trials, and assessing trial improvement interventions. Additionally, we consider the use of implementation science in the clinical trial context, and how clinical trials can be “test cases” for implementation research. Conclusions Clinical trials can be considered beneficial evidence-based interventions suffering from poor implementation. Adapting implementation science approaches to the clinical trial context can provide frameworks for contextual assessment, outcome measurement, targeted interventions, and a shared vocabulary for clinical trial improvement. Additionally, exploring implementation frameworks in the trial context can advance the science of implementation through both “test cases” and providing fertile ground for implementation intervention design and testing.

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Section: Introductionmentioning

confidence: 99%

Applying implementation frameworks to the clinical trial context

Stensland

Sales

Damschroder

et al. 2022

Implement Sci Commun

Self Cite

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“…Based on these promising results, the FSI was refined and scaled-up for implementation and evaluation of its clinical effectiveness in the FICUS cluster hybrid Randomized Controlled Trial (RCT) [ 6 ]. As recommended in implementation science, a clear delineation of implementation strategies in distinction to the intervention is necessary [ 42 , 43 ]. Therefore, based on the findings of the pilot-feasibility study, a set of implementation strategies was predefined, including ICU leadership endorsement, family nurse interventionist training with monthly case conferences and individual coaching and support, ICU team education about the FSI, nurse and physician champions, and local and central implementation facilitators [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

Tailored implementation of the FICUS multicomponent family support intervention in adult intensive care units: findings from a mixed methods contextual analysis

Verweij,

Oesch,

Naef

2023

BMC Health Serv Res

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Background The Family in Intensive Care UnitS (FICUS) trial investigates the clinical effectiveness of a multicomponent, nurse-led interprofessional family support intervention (FSI) and explores its implementation in intensive care units (ICUs). The local context of each ICU strongly influences intervention performance in practice. To promote FSI uptake and to reduce variation in intervention delivery, we aimed to develop tailored implementation strategies. Methods A mixed method contextual analysis guided by the Consolidated Framework for Implementation Research (CFIR) was performed from March to June 2022 on eight ICUs assigned to the intervention group. ICU key clinical partners were asked to complete a questionnaire on CFIR inner setting measures (i.e., organizational culture, resources, learning climate and leadership engagement) and the Organizational Readiness for Implementing Change (ORIC) scale prior to group interviews, which were held to discuss barriers and facilitators to FSI implementation. Descriptive analysis and pragmatic rapid thematic analysis were used. Then, tailored implementation strategies were developed for each ICU. Results In total, 33 key clinical partners returned the questionnaire and 40 attended eight group interviews. Results showed a supportive environment, with CFIR inner setting and ORIC measures each rated above 3 (scale: 1 low—5 high value), with leadership engagement scoring highest (median 4.00, IQR 0.38). Interview data showed that the ICU teams were highly motivated and committed to implementing the FSI. They reported limited resources, new interprofessional information exchange, and role adoption of nurses as challenging. Conclusion We found that important pre-conditions for FSI implementation, such as leadership support, a supportive team culture, and a good learning climate were present. Some aspects, such as available resources, interprofessional collaboration and family nurses’ role adoption were of concern and needed attention. An initial set of implementation strategies were relevant to all ICUs, but some additions and adaptation to local needs were required. Multi-component interventions are challenging to implement within complex systems, such as ICUs. This pragmatic, theory-guided, mixed methods contextual analysis demonstrated high readiness and commitment to FSI implementation in the context of a clinical trial and enabled the specification of a tailored, multifaceted implementation strategy.

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“…Clinical trials play a vital role in evidence-based medicine and have been instrumental in driving the development of healthcare (Stensland et al, 2022). To ensure transparency in the clinical trial process, the International Committee of Medical Journal Editors (ICMJE) reached a consensus in 2004 that all clinical trials should be registered in a public registry before recruiting patients (De Angelis et al, 2004).…”

Section: Introductionmentioning

confidence: 99%

Anti-PD-1/PD-L1 for nasopharyngeal carcinoma: a comprehensive analysis of registered trials on ClinicalTrials.gov

Dai,

Li,

Wang

et al. 2023

Front. Pharmacol.

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Objective: Clinical trials play an important role in the development of healthcare. However, the current status of clinical trials on anti-PD-1/PD-L1 for nasopharyngeal carcinoma remains unclear. Therefore, this study aims to provide a comprehensive analysis of the registered trials related to anti-PD-1/PD-L1 for nasopharyngeal carcinoma on ClinicalTrials.gov.Methods: A search was conducted on the ClinicalTrials.gov database to identify all registered trials related to anti-PD-1/PD-L1 for nasopharyngeal carcinoma up to 26 February 2023. The characteristics of the trials were examined, and the studied drugs, disease conditions, as well as details of trials with available results were analyzed. Publication status was assessed by a PubMed search using the ClinicalTrials.gov NCT number.Results: A total of 112 interventional clinical trials registered between 2015 and 2023 were included. Of the trials, 90 were carried out in Asia, 72 were in phase 2, and 31 trials had either companies or universities as sponsors/collaborators. The sample sizes across the trials varied greatly, with a median of 71.5 participants per trial. The majority of trials were recruiting participants, with only 6 had posted results. PD-1 inhibitors were preferred over PD-L1, and Toripalimab emerged as the most extensively studied drug. About one-third (33.9%) of the studies looked into recurrent/metastatic nasopharyngeal cancer.Conclusion: This study provides an overview of all registered trials of anti-PD-1/PD-L1 for NPC. It is needed to improve the completeness, outcome selection, randomization and masking of trials and to be transparent and timely in reporting of results.

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Envisioning clinical trials as complex interventions

Cited by 9 publications

References 42 publications

Applying implementation frameworks to the clinical trial context

Applying implementation frameworks to the clinical trial context

Tailored implementation of the FICUS multicomponent family support intervention in adult intensive care units: findings from a mixed methods contextual analysis

Anti-PD-1/PD-L1 for nasopharyngeal carcinoma: a comprehensive analysis of registered trials on ClinicalTrials.gov

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