Natural experiments for orthopaedic trauma research: An introduction

Wall, Bryan Joost Marinus van de; Stadhouder, Agnita; Houwert, R Marijn; Öner, F. Cumhur; Beeres, Frank J. P.; Groenwold, Rolf H H

doi:10.1016/j.injury.2022.11.028

Cited by 8 publications

(18 citation statements)

References 23 publications

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“…Despite many trials on this topic, the optimal treatment for distal radius fractures in older patients remains debated, and regional preferences continue to influence the treatment chosen. This provides the perfect situation to perform a natural experiment [ 6 ]. The Let’s Agree to Disagree on Operative Versus Nonoperative radius study is a prospective international multicenter cohort study that will use a fairly new methodological study design [ 6 ].…”

Section: Discussionmentioning

confidence: 99%

“…This provides the perfect situation to perform a natural experiment [ 6 ]. The Let’s Agree to Disagree on Operative Versus Nonoperative radius study is a prospective international multicenter cohort study that will use a fairly new methodological study design [ 6 ]. One of the main benefits of this study design is that patients will be treated as per the local standards.…”

Section: Discussionmentioning

confidence: 99%

“…A natural experiment design uses existing variation in treatment allocation (eg, due to practice variation). Natural experiments are observational studies in which treatment allocation is determined by factors outside the control of the investigators but also (to a large extent) independent of patient characteristics [ 6 , 7 ]. We assume the decisions regarding the treatment of distal radius fractures are largely influenced by the training of the treating surgeons.…”

Section: Methodsmentioning

confidence: 99%

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Let’s Agree to Disagree on Operative Versus Nonoperative Treatment for Distal Radius Fractures in Older People: Protocol for a Prospective International Multicenter Cohort Study

van Veelen,

van de Wall,

Hoepelman

et al. 2024

JMIR Res Protoc

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Background Distal radius fractures are the most frequently encountered fractures in Western societies, typically affecting patients aged 50 years and older. Although this is a common injury, the best treatment for these fractures in older patients is still under debate. Objective This prospective study aims to compare the outcome of operatively and nonoperatively treated distal radius fractures in the older population. Only patients with distal radius fractures for which equipoise regarding the optimal treatment exists will be included. Methods This prospective international multicenter observational cohort study will be designed as a natural experiment. Natural experiments are observational studies in which treatment allocation is determined by factors outside the control of the investigators but also (largely) independent of patient characteristics. Patients aged 65 years and older with an acute distal radius fracture will be considered for inclusion. Treatment allocation (operative vs nonoperative) will be based on the local preferences of the treating hospital either in Switzerland or the Netherlands. Hence, the process governing treatment allocation resembles that of randomization. Patients will be identified after treatment has been initiated. Based on the radiographs and baseline information of the patient, an expert panel of 6 certified trauma surgeons from 2 regions will provide their treatment recommendation. Only patients for whom the experts disagree on treatment recommendations will ultimately be included in the study (ie, for whom there is a clinical equipoise). For these patients, both operative and nonoperative treatment of distal radius fractures are viable, and treatment choice is predominantly determined by personal or local preference. The primary outcome will be the Patient-Rated Wrist Evaluation score at 12 weeks. Secondary outcomes will include the Physical Activity Score for the Elderly, the EQ questionnaire, pain, the living situation, range of motion, complications, and radiological outcomes. By including outcomes such as living situation and the Physical Activity Score for the Elderly, which are not relevant for younger cohorts, valuable information to tailor treatment to the needs of the older population can be gained. According to the sample size collection, which was based on the minimal important clinical difference of the Patient-Rated Wrist Evaluation, 92 patients will have to be included, with at least 46 patients in each treatment group. Results Enrollment began in July 2023 and is expected to continue until summer 2024. The final follow-up will be 2 years after the last patient is included. Conclusions Although many trials on this topic have previously been published, there remains an ongoing debate regarding the optimal treatment for distal radius fractures in older patients. This observational study, which will use a fairly new methodological study design, will provide further information on treatment outcomes for older patients with distal radius fractures for which to date equipoise exists regarding the optimal treatment. International Registered Report Identifier (IRRID) DERR1-10.2196/52917

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Let’s Agree to Disagree on Operative Versus Nonoperative Treatment for Distal Radius Fractures in Older People: Protocol for a Prospective International Multicenter Cohort Study

van Veelen,

van de Wall,

Hoepelman

et al. 2024

JMIR Res Protoc

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“…10,[18][19][20]45,51 Eligible data is presented to an independent expert panel, blinded for the actual treatment and the expert panel should be representative of the two schools that are compared. 10,18,51 In this review one paper used an expert panel, 13 the other three studies did not. [31][32][33] When reviewing the 189 full text papers for inclusion in our review we noticed a high number of papers with a historical comparison group (see Figure 1).…”

Section: Discussionmentioning

confidence: 99%

“…13,31–33 A shorter duration of study time can be a contributing factor to conducting research in quickly developing specialties as orthopedic trauma and spine surgery. 18,49…”

Section: Discussionmentioning

confidence: 99%

Natural Experiments as a Study Method in Spinal Trauma Surgery: A Systematic Review

Stadhouder,

van Rossenberg,

Kik

et al. 2023

Global Spine Journal

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Study Design Systematic review. Objectives To determine if the natural experiment design is a useful research methodology concept in spinal trauma care, and to determine if this methodology can be a viable alternative when randomized controlled trials are either infeasible or unethical. Methods A Medline, Embase and Cochrane database search was performed between 2004 and 2023 for studies comparing different treatment modalities of spinal trauma. All observational studies with a natural experiment design comparing different treatment modalities of spinal trauma were included. Data extraction and quality assessment with the MINORS criteria was performed. Results Four studies with a natural experiment design regarding patients with traumatic spinal fractures were included. All studies were retrospective, one study collected follow-up data prospectively. Three studies compared different operative treatment modalities, whereas one study compared different antibiotic treatment strategies. Two studies compared preferred treatment modalities between expertise centers, one study between departments (neuro- and orthopedic surgery) and one amongst surgeons. For the included retrospective studies, MINORS scores (maximum score 18) were high ranging from 12-17 and with a mean (SD) of 14.6 (1.63). Conclusions Since 2004 only four studies using a natural experiment design have been conducted in spinal trauma. In the included studies, comparability of patient groups was high emphasizing the potential of natural experiments in spinal trauma research. Natural experiments design should be considered more frequently in future research in spinal trauma as they may help to address difficult clinical problems when RCT’s are infeasible or unethical.

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Does plate position influence the outcome in midshaft clavicular fractures? A multicenter analysis

Buenter,

Kremo,

Beeres

et al. 2024

Eur J Trauma Emerg Surg

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Purpose To date, it remains unclear whether superior or anterior plating is the best option for treating midshaft clavicular fractures. The aim of this study was to compare both techniques with regard to the incidence of implant removal due to implant irritation, risk of complications, time to union, and function. Methods In this retrospective cohort study, all midshaft clavicular fractures treated operatively between 2017 and 2020 in two hospitals in Switzerland were analyzed. The participating hospitals differed with regard to their standard practice; one offered superior plating only, while the other predominantly employed an anterior plate. The primary outcome was the incidence of implant removal for irritation. Secondary outcomes were time to union, complications, re-interventions, and range of motion during the follow-up period of at least 6 months. Results In total, 168 patients were included in the study of which 81 (48%) received anterior plating and 87 (52%) superior plating. The overall mean age was 45 years (SD 16). There was no significant difference between anterior and superior plating with regard to implant removal (58.5% versus 57.1%, p = 0.887), infection (5.7% versus 1.8%, p = 0.071), and time to union (median 48 weeks versus 52 weeks, p = 0.643). Data on range of motion were available in 71 patients. There was no significant difference in anteflexion (median 180 degrees anterior versus 180 degrees superior) and abduction (median 180 degrees anterior versus 180 degrees superior) between the two groups. Conclusion This retrospective cohort study did not find sufficient evidence to recommend one implant position over the other for midshaft clavicular fractures with regard to removal due to irritation. Time to union was similar and Infections were equally rare in both groups. Notably, a considerable number of patients in both groups had their implants removed due to irritation. Larger prospective studies are needed to determine how much plate position contributes to the occurrence of irritation and whether other patient or implant-related factors might play a role. Until this is clarified, implant position should be based on surgeons preference and experience.

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Natural experiments for orthopaedic trauma research: An introduction

Cited by 8 publications

References 23 publications

Let’s Agree to Disagree on Operative Versus Nonoperative Treatment for Distal Radius Fractures in Older People: Protocol for a Prospective International Multicenter Cohort Study

Let’s Agree to Disagree on Operative Versus Nonoperative Treatment for Distal Radius Fractures in Older People: Protocol for a Prospective International Multicenter Cohort Study

Natural Experiments as a Study Method in Spinal Trauma Surgery: A Systematic Review

Does plate position influence the outcome in midshaft clavicular fractures? A multicenter analysis

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