Overcoming Challenges in Multisite Trials

Smith, Laureen H.; Tan, Alai; Stephens, Janna; Hibler, David; Duffy, Sonia A.

doi:10.1097/nnr.0000000000000324

Cited by 13 publications

(19 citation statements)

References 32 publications

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“…While single hospital sites have dominated the research to date, multisite studies may afford diverse experiences, larger recruitment, increased generalizability, external validity, high scientific rigor, and reliability to transform clinical practice and inform ultrasound PIVC policies and guidelines. 38 Greater portability and miniaturization of ultrasound devices afford investigation on their use and benefits for PIVCs in prehospital and nonspecialty areas. Adoption of this technology into prehospital, hospital-in-the-home, older adult care, general practice, community, and regional and remote settings warrants further investigation.…”

Section: Study Characteristicsmentioning

confidence: 99%

Handheld Ultrasound Devices for Peripheral Intravenous Cannulation

Ray-Barruel,

Pather,

Schults

et al. 2024

Journal of Infusion Nursing

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Ultrasound-guided insertion of peripheral intravenous catheters (PIVCs) is recommended for patients with difficult intravenous access, but access to ultrasound equipment is often limited to specialty departments. Compact, affordable handheld ultrasound devices are available, but the extent of their clinical adoption and impact on patient outcomes is unknown. This scoping review aimed to explore evidence regarding handheld and pocket ultrasound devices for PIVC insertion. Databases were searched for studies published in English between January 2000 and January 2023 evaluating handheld or pocket ultrasound devices weighing ≤3 kg for PIVC insertion. Data were extracted using standardized forms and summarized using descriptive statistics. Seventeen studies reporting the use of handheld or pocket ultrasound devices were identified. Most studies were conducted in adult inpatient facilities; 3 included pediatrics, and 2 reported out-of-hospital use. Participants with difficult intravenous access featured in 9 studies. Ultrasound training programs were described in 12 studies, with competency defined by number of successful PIVC insertions. Five studies reported clinician and/or patient perspectives. Ultrasound for PIVC insertion is not widely accessible in nonspecialist areas, but more compact and affordable handheld models could provide a solution, especially for patients with difficult access. More research evidence using handheld ultrasound is needed.

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Section: Study Characteristicsmentioning

confidence: 99%

Handheld Ultrasound Devices for Peripheral Intravenous Cannulation

Ray-Barruel,

Pather,

Schults

et al. 2024

Journal of Infusion Nursing

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“…In addition, a multisite setting features better external validity, which may result in findings that are more generalisable across different settings and circumstances. 15,16 Despite the advantages, multisite studies tend to be more complicated to conduct compared to single-site studies. It is necessary to take these complexities into account from the start of the design of a trial.…”

Section: Multisite Settingmentioning

confidence: 99%

“…The multisite setting of both trials was necessary to meet their sample size requirement. In addition, a multisite setting features better external validity, which may result in findings that are more generalisable across different settings and circumstances 15,16 . Despite the advantages, multisite studies tend to be more complicated to conduct compared to single‐site studies.…”

Section: Multisite Settingmentioning

confidence: 99%

Lessons learned from two clinical trials on nutritional supplements to reduce aggressive behaviour

Bles

Gast

Slot

et al. 2022

Evaluation Clinical Practice

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Background: Setting up and conducting a randomised controlled trial (RCT) has many challenges-particularly trials that include vulnerable individuals with behavioural problems or who reside in facilities that focus on care as opposed to research. These populations are underrepresented in RCTs.Approach: In our paper, we describe the challenges and practical lessons learned from two RCTs in two care settings involving long-stay psychiatric inpatients and people with intellectual disabilities. We describe five main difficulties and how these were overcome: (1) multisite setting, (2) inclusion of vulnerable participants,(3) nutritional supplements and placebos, (4) assessment of behavioural outcomes, and (5) collecting bio samples.Conclusions: By sharing these practical experiences, we hope to inform other researchers how to optimally design their trials, while avoiding and minimising the difficulties that we encountered, and to facilitate the implementation of a trial. Both trials were registered in the Clinical Trials Register

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“…Descriptive epidemiological studies are necessary to inform clinical practice and policy and guide future research; they can assess the overall burden and distribution of a disease or condition as well as variability in clinical practices (Fox et al, 2022; Weiss et al, 2014). To successfully capture populations and practices conducted at the point of care, multisite studies are often needed to obtain larger, more diverse samples (Smith et al, 2019). However, to conduct multisite studies, investigators face multiple issues related to site recruitment and selection, approvals, differences in clinical practices/documentation across sites, staff training, and data integrity (Smith et al, 2019; Weiss et al, 2014).…”

mentioning

confidence: 99%

“…To successfully capture populations and practices conducted at the point of care, multisite studies are often needed to obtain larger, more diverse samples (Smith et al, 2019). However, to conduct multisite studies, investigators face multiple issues related to site recruitment and selection, approvals, differences in clinical practices/documentation across sites, staff training, and data integrity (Smith et al, 2019; Weiss et al, 2014). Addressing these issues a priori can mitigate the limitations of descriptive study designs and improve the rigor and reproducibility of the research (Smith et al, 2019; Snyder et al, 2016).…”

mentioning

confidence: 99%

Using a Cascading Approach to Improve Multisite Study Procedures

et al. 2023

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Background: Multisite studies offer larger, more diverse samples to successfully capture populations and clinical practices of interest at the point of care. However, investigators face challenges with site recruitment and sampling, differences in clinical practices across sites, and data integrity. Addressing these issues a priori can improve the rigor and reproducibility of the research.Objective: This article aims to describe a cascading approach to multisite research. An exemplar is provided of a study using this approach, which aimed to evaluate the prevalence of pain and the pain management practices provided to critically ill children in pediatric intensive care units in the United States.Methods: The cascading approach includes two or more pilot study procedures with a progressively increasing number of sites prior to a full-scale study. Following each pilot, study procedures are evaluated; feedback was obtained from site personnel and content experts; procedures were revised accordingly; approvals were obtained; sites were trained; and the revised procedures are repeated with a larger, more diverse number of sites.Results: In the exemplar provided, improvements in the efficiency and integrity of data collection were noted for the full-scale study following the pilots. All sites that completed the agreements and approvals for study participation were retained for the duration of the two pilots and full-scale study.Discussion: Borrowing from principles of process improvement, the cascading approach allows knowledge to be gained regarding site differences and informs the revision of study procedures while potentially maximizing efficiency and data integrity, minimizing site burden, and maintaining site engagement for multisite studies.

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Overcoming Challenges in Multisite Trials

Cited by 13 publications

References 32 publications

Handheld Ultrasound Devices for Peripheral Intravenous Cannulation

Handheld Ultrasound Devices for Peripheral Intravenous Cannulation

Lessons learned from two clinical trials on nutritional supplements to reduce aggressive behaviour

Using a Cascading Approach to Improve Multisite Study Procedures

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