Critical appraisal:Attwood SE, Lundell L, Hatlebakk JG, Eklund S, Junghard O, Galmiche JP, et al 2008

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Critical Appraisal

Article being appraised

Attwood SE, Lundell L, Hatlebakk JG, Eklund S, Junghard O, Galmiche JP, et al. Medical or surgical management of GERD patients with Barrett's esophagus: the LOTUS trial 3-year experience. J Gastrointest Surg 2008 Oct;12(10):1646-54; discussion 1654-5 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/18709511.


Applicable clinical question

Key Facts

Study Design

randomised controlled trial

Number of Patients:

60


Includes an economic evaluation

no

Evidence ratings

Level of evidence

IV

Risk of bias
Moderate risk of bias Comments: This study primarily compared surgery to medical therapy for reflux in patients who were suitable for either medical or surgical therapy. This analysis is a subgroup analysis with followup to 3 years and showed that 3/28 patients failed medical therapy compared with 1/30 surgical(ns). Its only value in determining appropriate medical systemic therapy is that long term followup of patients initially responding to medical therapy shows a low ((10%) failure rate.

Risk of bias assessment: randomised controlled trial

Was the trial double-blinded?
Outcomes not blinded, substantial side-effects, or not reported.
Was the treatment allocation schedule concealed?
No concealment or unclear (e.g. no approach described, open randomisation lists, person doing recruitment tossing a coin).
Were all randomised participants included in the analysis?
Exclusions not likely to cause bias (>80% follow-up for all groups, <5% difference in follow-up between groups)
The field below is not considered when calculating the risk of bias rating
How was the allocation schedule generated?
Adequate (e.g. random number table, computer random generator, coin tossing, card shuffling)
Size of effect
5 Reason for decision: The relevant part of the study is observaional
Relevance of evidence
3 Additional comments: The relevant evidence is observation of a subgroup in a trial of this group against another therapy. According to the NHMRC levels of evidence, RCT’s are rated as level II evidence. However, the level of evidence for this study was graded as level IV (case series) as only one arm of the RCT is relevant to medical systematic therapy
Result of appraisal

Jutta's tick icon.png Included



Comments

Observational analysis of a subgroup of a subgroup, but provides some evidence of durability of treatment in patients who are initially responsive.

Completed by

Associate Professor Geoffrey Hebbard


Jutta's tick icon.png This appraisal has been completed.


Article
Attwood SE, Lundell L, Hatlebakk JG, Eklund S, Junghard O, Galmiche JP, et al. Medical or surgical management of GERD patients with Barrett's esophagus: the LOTUS trial 3-year experience. J Gastrointest Surg 2008 Oct;12(10):1646-54; discussion 1654-5 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/18709511.
Assigned to
User:Geoffrey.hebbard
Topic area
Guidelines:Barrett's
Clinical question
Form
Form:Critical appraisal


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