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Journal Club

June 2010

Effect of smoking cessation intervention on results of acute fracture surgery: a randomized controlled trial.

• Authors: Nåsell H, Adami J, Samnegård E, Tønnesen H, Ponzer S.
• Institution: Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, S-118 83 Stockholm, Sweden
• Journal: J Bone Joint Surg Am. 2010 Jun;92(6):1335-42.
• Reviewed by: Terry Stephens | BSc(hons), MBBS, PhD | Unaccredited Orthopaedic Registrar

 

Introduction

Smokers

• Increased post operative complications (LEAP study, J OrthTrauma. 2005;19:151-7)
• Smoking cessation programs
  • Decrease post operative complications commenced prior telective knee and hip replacements. (Møller et al Lancet 2002;359:114-7)

Methodology

• a multicenter, single-blinded, randomized, controlled clinical trial.
• 105 smokers with a fracture
• acute surgical treatment
• randomized tan intervention group (n = 50) or a control group (n = 55).
• intervention group - standardised smoking cessation program for 6 weeks.
• patients were followed at 2, 3, 4, 6, 12  weeks.
• Exclusion criteria  
  • alcohol or drug abuse
  • pregnant
  • severe mental illness, including dementia
  • unable tread or understand Swedish
• Sample and power  
  • Power calculation
    • 30% reduction n=586
    • Unreasonable amount of time
    • Therefore trial ceased in Dec 2006    
    • 40% chance of detecting a 9% reduction
  • Statistics  
    • Nominal values
      • Chi square
    • Ratios and interval values
      • Mann U Whitney test
    • secondary analysis because of small numbers
      • Binary regression analysis

Results

• 298 eligible patients
• Completed study
  • 49 Control group
  • 55 treatment group
• 182 declined to participate
• 11 did not meet inclusion criteria
  

Complication frequency

• Intervention
  • 10/49 (20%) complication rate
• Control
  • 21/55 (38%) complication rate
• Superficial wound infection
  • Int – 4
  • Con – 11
• Plaster
  • Int – 1
  • Con – 6
• Number needed ttreat = 5.5
• Odds ratiof 2.51 (NS)
• Non intervention group
  • 42% complication rate
    
• Smoking Cessation
  
  • At 2 weeks
    • 24/48 intervention
    • 9/52 control (p = 0.001).
      
  • At 6 weeks
    • 19/44
    • 10/51 (p = 0.013).

Discussion

• No quantification of smoking
• Clinical relevance of complications
• Cost, increased clinic reviews
• Suggest primary and secondary outcome measures combined indicate decreased complication rates with smoking cessation program

Pros of Study

• Good design
• Good discussion of negatives
• Highlights difficulties in performing well controlled studies.

Cons of Study

• Underpowered
• Small numbers
• Low rate of participation
• Clinical relevance of complications
• Heterogeneous fractures
• Did not quantify smoking