Poustie 2006.
| Study characteristics | ||
| Methods | Randomised controlled trial.
Parallel design. Duration: 12 months. Location: multicentre in UK. |
|
| Participants | 102 children (54 males) aged 2 ‐ 15 years with CF and at least one of following criteria: BMI < 25th centile but > 0.4th centile; or no increase in weight over the previous 3 months; or 5% decrease in weight from baseline over a period of < 6 months. | |
| Interventions | Oral calorie supplements (range of different brands used, but daily amount to increase usual energy intake by 20%) plus routine dietetic advice compared with dietary advice alone. | |
| Outcomes | Change in BMI*
Change in BMI percentile*
Change in weight*
Change in height*
Change in weight percentile*
Change in height percentile*
Mid‐upper arm circumference*
Energy* and macro‐nutrient* intake
FEV₁ and FVC expressed as % predicted for age, sex and height*
Gastro‐intestinal symptoms* Outcomes measured at 3, 6 and 12 months. All participants were followed up to 12 months. |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Generation of the randomisation sequence used random number tables. |
| Allocation concealment (selection bias) | Low risk | Used sealed opaque envelopes. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Not possible to blind clinicians and participants, but the researcher undertaking the analysis of outcomes was masked as to the allocation groups. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Analysis was by ITT. All 102 randomised children completed the trial. However, unable to collect interim data on 2 children from the supplement group (owing to parental choice or illness) and 1 child from the standard care group (illness). Nine children failed to return the baseline diet diary, and 39 failed to return the 12‐month diet diary, so dietary intake data are based on the 58 children who completed both baseline and 12 month diaries. Spirometry data available for 70 of the 72 participants aged 5 and above. |
| Selective reporting (reporting bias) | Low risk | All outcomes described in the Methods section of the published paper (including adverse events) reported on. |
| Other bias | Low risk | No other potential source of bias identified. |
*Outcomes to be included in review BMI: body mass index CF: cystic fibrosis FEV₁: forced expiratory volume in 1 second ITT: intention‐to‐treat SD: standard deviation WFH: weight for height