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Feasibility study childhood Outcome Measures

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1 Feasibility study childhood Outcome Measures
Dr C Humphreys Specialist Registrar in Public Health

2 What will we learn? Information on obesity Using approach:
What cut-off to use for BMI? Using approach: Likely level of participation Likely data quality Experiences of Children Staff Parents Unexpected problems Costs

3 BMI in children Lack of evidence to support specific BMI cut-offs in children (NICE, 2006) Classification is aribtary and ‘not based on known medical risk’

4 1990 UK Centile charts Individual children: Populations:
91st & 98th centiles (overweight/obese) NICE (‘pragmatic’) SIGN Department of Health Populations: 85th & 95th centiles (overweight/obese) Historical use PSA targets (England) BMI 30, age 18 BMI 25, age 18 Source: Faculty of Public Health (2007) Lightening the Load Reproduced with kind permission from the Faculty of Public Health and The Child Growth Foundation Orange graphics not present in original

5 International Obesity Task Force
Age and sex specific cut offs (2-18 yrs) Relates to BMI 30 / 25, age 18 6 countries pooled data (Brazil, Great Britain, Hong Kong, Netherlands, Singapore, USA) Population monitoring Foresight Comparability Smooth transition European surveillance (proposed) High specificity (NICE) Risks (FPH) Possible underestimation esp. obese boys No underweight cut-off FPH (2007) Lightening the Load NICE (2006) Obesity: the prevention, identification, assessment and management of overweight and obesity in adults and children, section 2

6 WHO Growth standards Released 2007; use international data;
match with WHO 0-60 month charts (2006) Also proposed for European surveillance study Source: World Health Organization

7 Question? What cut-off to monitor population overweight/obesity
If feeding information back to family what form should this take? Wt / ht without BMI (as in England up to now) BMI with interpretation – what cut off? Supporting information?

8 Possible Study Outcomes
Response rate Parent refusal Child refusal Child unavailable Data quality Completeness of fields Face validity ‘impossible’ entries Feedback, routine, prospective: Child at time of measurement: Assessment by staff Verbal concern Non-verbal distress Self assessment (e.g. happy/sad faces for 5 year olds) School experience on day Any feedback from parents to school or measuring staff

9 Approaches to outcome measures
Agree on a single approach and apply uniformly Apply different approaches and compare outcomes Different approaches by Trust Cluster randomize schools within Trust? What to compare? Opt in vs opt out consent? Who takes the measures?

10 Numbers Primary School Secondary Other 5 yr olds* 11 yr olds*
Flintshire & Wrexham 84 12 3 3299 3474 Merthyr & Cynon** 58 10 1370 1603 Powys 109 13 1395 1692 Pembrokeshire 96 8 2 1355 1573 Total 347 43 5 7419 8342 *2005 population estimates. ONS **Cynon population estimates calculated using a conversion factor from total RCT population. Conversion factor based on 2001 census figures (ONS)

11 Power Response rate Weight Assuming 90% base (α 0.05; β 0.8):
To detect a difference of 2% (i.e. 90 vs 92%) 2,842 total Assuming 80% base: To detect a difference of 5%; (i.e. 80% vs 82%) 1,890 total To detect a difference of 2% (i.e. 80% vs 82%) 12,276 Weight Overweight: assuming 20% base in girls; to detect a difference of 1% (α 0.1; β 0.8) 4,500. 9,000 required Obesity assuming 5% base in boys/girls; to detect a difference of 1% (α 0.5; β 0.8) 1,830. 3,660 required R Williams (2007)

12 Questions What are the preferred outcome measures?
Should comparisons be used? If so, by what approach?

13 Thank you


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