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RCT
ACE Report #7907

Early MRI useful in clinically suspected scaphoid fracture; no significant cost difference


Study Type:Economic Analysis
OE Level Evidence:2
Journal Level of Evidence:N/A

Costs analysis and comparison of usefulness of acute MRI and 2 weeks of cast immobilization for clinically suspected scaphoid fractures

Acta Orthop. 2015 Jun;86(3):303-9

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Synopsis

125 Norwegian patients, within a week of having acute wrist trauma requiring radiographic examination, were pseudo-randomized (based on the date of admission) to receive either early MRI treatment or standard treatment. The purpose of the study was to determine how early MRI compares with conventional management in treating suspected scaphoid fractures from a cost and efficacy perspective. Results indicated that the number of days absent from work and in a cast was significantly lower in the MRI group in patients without fractures, and no major difference was noted in the cost-minimization analysis.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
University of Bergen and the Norwegian Research Council
Conflicts:
None disclosed

Risk of Bias

4/10

Reporting Criteria

15/20

Fragility Index

N/A

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

1/4

Randomization

3/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

3/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

Conventional treatment of occult scaphoid fractures involves wrist immobilization with radiographic reassessment 2 weeks later and studies have shown that 4/5 patients are immobilized unnecessarily. Acute MRI of the wrist has become a proficient method for ruling out injuries otherwise over treated and has been shown to reduce immobilization time in patients with suspected scaphoid fractures. However, no consensus was present at the time of this study about whether early MRI in suspected scaphoid fractures saves money as compared with conventional management. Thus the present study sought to determine the difference between the two treatments from an economic perspective in a Norwegian setting.

What was the principal research question?

How does early MRI compare with traditional radiographs and conventional management in the treatment of clinically suspected scaphoid fractures, from a cost and efficacy standpoint, in Norwegian patients?

Study Characteristics -
Population:
125 patients aged 18-49 years, within a week of having an acute wrist trauma requiring radiographic examination were included in this study in Norway, from November 5, 2009 to November 4, 2010. Only patients with clinically suspected scaphoid fractures were included, with a clinical scaphoid score (CSS) equal to or greater than 3, with normal plain radiographs (124 completed follow-up).
Intervention:
MRI group: received acute MRI treatment as soon as possible after attending the clinic (Mean= 1 (0-7) days) and treatment according to MRI results at follow-up when results were available. The MRI protocol included 4 sequences and the scans were performed with a 1.5 T whole-body scanner with a wrist coil (n=61, Mean age= 29 (27-31), M=49%, F=51%).
Comparison:
Control group: received standard treatment with a below-elbow scaphoid cast for 2 weeks, after which a follow-up with repeated clinical examination, investigation, and treatment as with standard practice was performed. Radiography with extended wrist views and a series of 4 images including the distal part of the radius and the proximal part of the metacarpals was used (n=63, Mean age= 31 (29-33), M=60%, F=40%).
Outcomes:
Cost-minimization analysis (CMA) was used to estimate the cost of the 2 patient groups. Costs corresponded to expenses for social security, including healthcare provider costs and sick leave benefits combined with expenses for employers when employees are on sick leave. The time frame included both intended effects and unintended side effects. Direct and indirect costs were calculated and cost analysis was performed by comparing the cost of management of patients in the groups. The average cost of sick leave per day was calculated to be 242 euros, corresponding to an average daily income including tax of 14%.
Methods:
Prospective, single-centered, economic analysis, pseudo-randomized controlled trial.
Time:
Records at the department were reviewed 2 years after the inclusion of patients. Sick leave data was obtained from the start of the study until 6 months after inclusion.

What were the important findings?

  • 7 scaphoid fractures were diagnosed in the MRI group and 4 in the control group with the number of other fractures also being higher in the MRI group than the control (n=22 vs. n=8)
  • The numbers of consultations per patient were nearly identical between groups, and significant differences were found between the numbers of radiographs, the number of MRIs, and the numbers of elastic bandages used in the 2 groups
  • The total number of days using a cast was lower for patients in the MRI group compared to the control group (MD= 4.6, p=0.05) and significantly lower in the MRI group in patients without fracture (MD= 13, p<0.005, 95% CI [11-15]) or without scaphoid fracture (MD= 6.5, p<0.005, 95% CI [3-10])
  • In patients diagnosed with either scaphoid fractures (MD= 2.4, p=0.8) or other fractures (MD= 2.7, p=0.6), the number of days using a cast was similar
  • Number of days of absence from work was not significantly different, yet for patients with no fractures, significantly fewer sick leave days were found for the MRI group (MD= 8 (3-13), p=0.002)
  • No significant difference was present in the sum of all direct costs in the 2 groups (MRI group: 30,160 euros, Control group: 27, 997 euros) and the average direct medical cost of detecting/treating a patient with any occult wrist fracture was 1,160 euros in the MRI group and 2,545 euros in the control group
  • Similar indirect costs were noted for the 2 groups (MRI group: 147,404 euros, Control group: 186,550 euros), yet in patients in paid work with no fracture indirect cost in the MRI group was less than half of the control
  • Overall costs were marginally different between groups (MRI group: 177,564 euros, Control group: 214,548 euros)

What should I remember most?

The number of days in a cast and absence from work was significantly lower in the MRI group in patients without fractures. No major difference was noted in the cost-minimization analysis in terms of overall costs.

How will this affect the care of my patients?

In a Norwegian setting, early MRI was useful in patients with clinically suspected scaphoid fracture and normal radiographs as it ruled out wrist fracture and decreased days in a cast and days on sick leave. However, the cost-minimization analysis found only marginal differences in overall costs between the groups. Further studies are warranted in other population subsets to determine the applicability of these results in the general population.

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