Wyers 2013.
| Study characteristics | ||
| Methods | RCT. Parallel design with two treatment arms. Duration: 3 months. Location: multicentre in Maastricht, Heerlen and Sittard, The Netherlands. |
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| Participants |
Inclusion criteria: adults (> 55 years) admitted for surgical treatment of hip fracture. Exclusion criteria: pathological/periprosthetic fracture, disease of bone metabolism, estimated life expectancy < 1 year, oral nutritional supplements before hospital admission, unable to speak Dutch, outside region or bedridden by fracture, dementia or cognitively impaired (Abbreviated Mental Test score < 7). Number randomised: 152 participants: intervention group, n = 73; control group, n = 79. Attrition: 7 participants died (intervention group, n = 3; control group, n = 4), 7 participants withdrew (intervention group, n = 3; control group, n = 4). Gender split: intervention female 54, male 19; control female 54, male 25. Age: mean(SEM), intervention 77 (1.2) years; control 76 (1.1) years. Nutritional status: assessed by MNA, intervention number (%) with no malnutrition 46 (63), number at risk of malnutrition 27 (37); control number (%) with no malnutrition 41 (52), number at risk of malnutrition 38 (48). |
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| Interventions |
Intervention: participants received dietary advice and ONS in the form of frequent dietary counselling (2x during hospital stay and 3x at home (1, 2 and 6 weeks after discharge) plus calls at home at 3, 4, 5, 8 and 10 weeks after discharge) and consumption of 2x oral nutritional supplement each day (Cubitan, Nutricia: providing 500 kcal and 40 g protein per 500 mL) for 3 months. Control: participants received no dietary advice and no ONS in the form of usual care i.e. oral nutritional supplements only if doctor provided them (13%) and 28% received dietetic counselling. |
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| Outcomes | Weight, QALYs (EQ‐5D‐3L), cost (Euros). | |
| Publication details |
Language: English. Funding: The Netherlands Organisation for Health Research and Development; oral nutritional supplements provided by Nutricia Advanced Medical Nutrition (Danone Research, Wageningen, The Netherlands). Publication status: peer‐reviewed journal. |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: randomized according to a concealed computer‐generated random‐number sequence list after pre‐stratification for hospital, gender and age (55 ‐ 74 years versus 75 years and above) with an allocation ratio of 1:1. |
| Allocation concealment (selection bias) | Unclear risk | Blinded for the reseacher, according to a computer generated random‐numbersequence list |
| Blinding (performance bias and detection bias) Clinical outcomes | Low risk | Study dietitian was not blinded but assessment of mortality unlikely to be affected. |
| Blinding (performance bias and detection bias) Functional outcomes | Low risk | The study did not address functional outcomes. |
| Blinding (performance bias and detection bias) Nutritional outcomes | High risk | Study dietitian was not blinded. Assessment of weight may have been influenced by lack of blinding. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded and likely that researchers and participants were aware of group allocation as this was a nutritional intervention. It is possible that assessment of some outcomes was influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Assessment of some outcomes likely to be affected by lack of blinding. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition fully reported and reasons were similar for both groups. There were 4/73 (5.5%) deaths in the intervention group and 3/79 (4%) in the control group. 3/73 (4%) withdrew from the intervention group and 4/79 (5%) withdrew from the control group. |
| Selective reporting (reporting bias) | High risk | Published protocol identified (Wyers et al 2010); however, not all stated outcomes have been reported. |
| Other bias | Low risk | Baseline characteristics reported and groups similar at baseline. |
* outcomes included in this review if data usable
ADL: activities of daily living ANZCTR: Australia and New Zealand Clinical Trials Registry BASDEC: brief assessment schedule depression cards BIA: bioelectric impedence analysis BMI: body mass index CDAI: Crohn's disease activity index CF: cystic fibrosis COPD: chronic obstructive pulmonary disease CVD: cardiovascular disease DEXA: dual energy X‐ray absorptiometry DRAQ: Disease‐Related Appetite Questionnaire EORTC: European Organisation for Research and Treatment of Cancer FAACT: Functional Assessment of Anorexia/Cachexia Therapy FEV1: forced expiratory volume in 1 second FVC: forced vital capacity GDS: geriatric depression score GEE: generalized estimating equation GFR: glomular filtration rate GI: gastro‐intestinal Hb: haemoglobin HIV: human immunodeficiency virus IADL: instrumental activities of daily living IBW: ideal body weight IDDM: insulin‐dependent diabetes mellitus IQR: interquartile range ITT: intention‐to‐treat MAC: mid‐arm circumference MAMA: mid‐arm muscle area MAMC: mid‐arm muscle circumference MCT: medium chain triglycerides MMSE: mini mental state examination MNA: mini nutritional assessment MUAC: mid‐upper arm circumference NRS: nutritional risk screening PG‐SGA: patient‐generated subjective global assessment PU: pressure ulcer PUSH: Pressure Ulcer Scale for Healing QALY: quality adjusted life year QoL: quality of life RCT: randomised controlled trial REE: resting energy expenditure SD: standard deviation SE: standard error SGA: subjective global assessment SNAQ65+:short nutritional assessment questionnaire for home living older persons TIBC: total iron binding capacity TSF: triceps skinfold thickness VAS: visual analogue score vs: versus