Grant 2008.
Methods | Randomised clinical trial | |
Participants | Country: United Kingdom Number randomised: 357 Post‐randomisation drop‐outs: not stated Revised sample size: 357 Average age: 46 years Females: 121 (33.9%) Barretts oesophagus: not stated Hiatus hernia: not stated Body mass index: 29 Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to two groups. Group 1: surgery (n = 178) Further details: Laparoscopic fundoplication as per surgeon preference. Group 2: medical treatment (n = 179) Further details: Medical treatment as per local protocol. | |
Outcomes | The outcomes reported were health‐related quality of life, GORD‐specific quality of life, proportion with heartburn, reflux, and dysphagia. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Random allocation was organised centrally by a secure system, using a computer‐generated sequence, stratified by clinical site, with balance in respect of age (18 ‐ 49 or ≥ 50), sex (men or women), and BMI (≤ 28 or > 29) secured by minimisation". |
Allocation concealment (selection bias) | Low risk | Quote: "Staff in the central trial office entered details of participants on the secure database, then notified participants and respective clinical sites of their allocation". |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "There was no subsequent blinding". |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "There was no subsequent blinding". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: An intention‐to‐treat analysis was performed. |
Selective reporting (reporting bias) | High risk | Comment: Treatment‐related complications were not reported adequately. |
Other bias | Low risk | Quote: "This study was funded by the NIHR Health Technology Assessment Programme (as part of project No 97/10/99)". |