Dennis 2005.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
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| Participants | 4023 participants; N = 2016 intervention (47% female; mean age 71 (SD 12)); N = 2007 usual care (46% female; mean age 71 (SD 13)) Inclusion criteria: people admitted with recent stroke, (first or recurrent stroke no more than 7 days before admission), if they passed swallow screen, the responsible clinician was uncertain whether to use oral nutritional supplements and the participant or relative consented to enrolment Exclusion criteria: subarachnoid haemorrhage Diagnostic criteria: stroke patients |
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| Interventions | Intervention group received normal hospital diet plus oral protein energy supplements (360 mL) prescribed on drug administration charts; usual care received normal hospital diet until discharge Number of trial centres: 125 hospitals in 15 different countries Treatment before trial: none |
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| Outcomes | Outcomes reported in abstract of publication: death, poor outcome (modified Rankin scale grade 3‐5) | |
| Study details |
Run‐in period: not stated Was trial terminated early: no |
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| Publication details |
Language of publication: English Funding: commercial/other funding‐ Health Technology Assessment Board of NHS Research and Development in the UK, the Stroke Association, the Chief Scientist Office of the Scottish Executive, and Chest, Heart and Stroke, Scotland Publication status: peer review journal |
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| Stated aim for study | Quote from publication: "to establish whether routine oral nutritional supplements improve outcome after stroke" | |
| Notes | The FOOD (feed or ordinary diet) trials consisted of three RCTs, sharing the same randomisation, data collection, and follow‐up systems, allowed co‐enrolment, and aimed to compare the outcomes of stroke patients in hospital. Dysphagic patients were enrolled into one or both of two trials: (1) early enteral tube feeding versus avoidance of tube feeding for at least 7 days; and (2) tube feeding via percutaneous endoscopic gastrostomy versus nasogastric tube. For this systematic review we describe the outcomes of participants who were able to swallow | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "the computer allocated the feeding regimen". Also, "A computer generated minimisation algorithm" was used |
| Allocation concealment (selection bias) | Low risk |
Quote from publication: "the computer allocated the feeding regimen" Comment: central allocation method ensured treatment allocation was concealed until intervention was given |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote from publication: "Neither the randomising clinician, the clinical team, nor patients were unaware of treatment allocation; doing so would have been very difficult" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote from publication: "Follow‐up was masked to treatment allocation (except when patients or carers inadvertently divulged it to an interviewer, which was unusual but not systematically recorded)" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: study attrition presented in a figure and all randomised participants accounted for |
| Selective reporting (reporting bias) | Low risk | Comment: all of the outcomes specified were reported |
| Other bias | Unclear risk | Comment: insufficient information to permit judgement of ‘Low risk’ or ‘High risk’ |