Reflections 1 Year Into the 21-Center National Institutes of Health–Funded WRIST Study: A Primer on Conducting a Multicenter Clinical Trial

Chung, Kevin C.; Kim, H. Myra; Haase, Steven C.; Lawton, Jeffrey N.; Özer, Kağan; Waljee, Jennifer F.; Nellans, Kate W.; Malay, Sunitha; Shauver, Melissa J.; Rozental, Tamara D.; Appleton, Paul; Rodriguez, E. Valente; Herder, Lindsay; Wagner, Katiri; Blazar, Philip E.; Earp, Brandon E.; Floyd, Waldo E.; Pico, Katherine S.; Richards, Marc J.; Ruch, David S.; Finley, Suzanne; Kalliainen, Loree K.; Fletcher, James; Heinrich, Cherrie A.; Ward, Christian M.; Hill, Brian W.; Bamberger, Brent H.; Robinson, Carla; Palmer, Brandi; Ring, David; Jupiter, Jesse B.; Reddy, Rajesh Kumar; Dennison, David G.; Shin, Alexander Y.; Scrabeck, Tyson L.; Hoyen, Harry A.; Malone, Kevin J.; Sandeep, Sebastin; Tay, Poh Ling; Gaston, Glenn; Connell, Benjamin; Neumeister, Michael W.; Berry, Nada; Bueno, Reuben A.; McAndrew, Mark P.; Koechle, Jennifer; Perey, Bertrand H.; Zomar, Mauri; Wolf, Jennifer Moriatis; Rodner, Craig M.; Côté, M.-C.; Clark, Tod A.; Lehman, Thomas; Carl, Kathy; Bozentka, David J.; Levin, S; Steinberg, David; Horan, Annamarie D.; Knox, Denise; Hammert, Warren C.; McIntyre, Allison W.; Friedrich, Jeffrey B.; Allan, Christopher H.; Hanel, Douglas P.; Huang, Jerry I.; Ko, Jason H.; Vedder, Nicholas B.; Boman, David M.; Cooper, C; Grewal, Ruby; MacDermid, Joy C.; Kelly, Kate; Millman, Kristie; Zhong-yu, LI; Koman, Andrew; Smith, Beth; Bullard, Debra

doi:10.1016/j.jhsa.2013.02.027

Cited by 16 publications

(7 citation statements)

References 31 publications

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“…The full study has been described in detail previously. 15 Participants of WRIST were enrolled at 24 sites in the United States, Canada, and Singapore from April 10, 2012, to December 31, 2016. Data used in these analyses were collected from April 24, 2012, to February 28, 2018.…”

Section: Methodsmentioning

confidence: 99%

Assessment of Distal Radius Fracture Complications Among Adults 60 Years or Older

et al. 2019

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Key Points Question Do rates or types of complications after distal radius fractures depend on treatment type? Findings In this secondary analysis of a randomized clinical trial of 304 adults from 24 health systems, the method of treatment participants received was associated with the rate or type of complications. Compared with participants who received internal fixation, participants who received any other treatments experienced complications at significantly higher rates. Meaning Choice of distal radius fracture treatment method in older patients should be specific to individual goals to minimize complication risks and improve outcomes.

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Section: Methodsmentioning

confidence: 99%

Assessment of Distal Radius Fracture Complications Among Adults 60 Years or Older

et al. 2019

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“…Detailed protocols of the study design, enrollment, study flow diagram, and results of WRIST have been illustrated previously ( Supplement 1 ). 13 Written consent was obtained from all participants, and the WRIST protocol was approved by each center. This study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) reporting guideline.…”

Section: Methodsmentioning

confidence: 99%

Modifiable Factors Associated With Chronic Pain 1 Year After Operative Management of Distal Radius Fractures

et al. 2020

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Key Points Question What are modifiable preoperative factors associated with developing chronic pain after distal radius fracture surgery? Findings In this secondary analysis of a randomized clinical trial with 146 participants, each 10-point increase in preoperative pain score was associated with 17% increased odds of chronic pain, and a 1-week delay in surgical intervention was associated with more than triple the odds of experiencing chronic pain. Internal fixation was associated with decreased risk of chronic pain compared with external fixation or pinning. Meaning In this study, earlier time to surgery, adequate preoperative pain control, and internal fixation were associated with lower risk of chronic pain development among patients with distal radius fracture who were treated surgically.

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“…Other multisite studies have reported timelines of up to a year to obtain approval. 5–7 These data are evidence of the challenges investigators encounter while initiating trauma studies and the need for guidance.…”

Section: Introductionmentioning

confidence: 99%

Regulatory challenges in conducting human subjects research in emergency settings: the National Trauma Research Action Plan (NTRAP) scoping review

Villarreal

Price

Moreno

et al. 2023

Trauma Surg Acute Care Open

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The complexity of the care environment, the emergent nature, and the severity of patient injury make conducting clinical trauma research challenging. These challenges hamper the ability to investigate potentially life-saving research that aims to deliver pharmacotherapeutics, test medical devices, and develop technologies that may improve patient survival and recovery. Regulations intended to protect research subjects impede scientific advancements needed to treat the critically ill and injured and balancing these regulatory priorities is challenging in the acute setting. This scoping review attempted to systematically identify what regulations are challenging in conducting trauma and emergency research. A systematic search of PubMed was performed to identify studies published between 2007 and 2020, from which 289 articles that address regulatory challenges in conducting research in emergency settings were included. Data were extracted and summarized using descriptive statistics and a narrative synthesis of the results. The review is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. Most articles identified were editorial/commentary (31%) and published in the USA (49%). Regulatory factors addressed in the papers were categorized under 15 regulatory challenge areas: informed consent (78%), research ethics (65%), institutional review board (55%), human subjects protection (54%), enrollment (53%), exception from informed consent (51%), legally authorized representative (50%), patient safety (41%), community consultation (40%), waiver of informed consent (40%), recruitment challenges (39%), patient perception (30%), liability (15%), participant incentives (13%), and common rule (11%). We identified several regulatory barriers to conducting trauma and emergency research. This summary will support the development of best practices for investigators and funding agencies.

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Reflections 1 Year Into the 21-Center National Institutes of Health–Funded WRIST Study: A Primer on Conducting a Multicenter Clinical Trial

Cited by 16 publications

References 31 publications

Assessment of Distal Radius Fracture Complications Among Adults 60 Years or Older

Assessment of Distal Radius Fracture Complications Among Adults 60 Years or Older

Modifiable Factors Associated With Chronic Pain 1 Year After Operative Management of Distal Radius Fractures

Regulatory challenges in conducting human subjects research in emergency settings: the National Trauma Research Action Plan (NTRAP) scoping review

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