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Strengths and weaknesses

of a paper

critical appraisal following CASP tool for systematic reviews

Journal

article

Clearly

focused question

1. Did the review address a clearly focused question ?

Review question

Objective: to determine whether feeding infants with hydrolysed formula reduces their risk of allergic or autoimmune disease

included studies of any hydrolysed formula of cows’ milk origin as the intervention of interest, compared with any non-hydrolysed cows’ milk formula, human milk, or another type of hydrolysed cows’ milk formula

studies of hydrolysed formula of milk other than cows’ milk, such as hydrolysed rice, goats’ milk, or soya formula were not included

Atopic and autoimmune outcomes were selected on the basis of their population prevalence in children and young adults in the UK and/or other affluent nations

included diseases with a prevalence of at least one in 1000 children/adolescents or young adults (aged <40)

Population

Intervention

Comparison

Outcome

Selection

of

papers

2. Did the authors look for the right type of papers?

Types of studies

Types of studies included

  • included all intervention trials classified as randomised controlled trials, quasi-randomised controlled trials and controlled clinical trials (they were analysed separately)

  • searched for observational studies but did not extract data from these because of the evidence from intervention trials

  • included studies of infant feeding between birth and 12 months of age and

excluded studies in which infants or their mothers were defined by the presence of a pre-existing

disease state, including very low birth weight or premature infants

  • included diseases with a prevalence of at least one in 1000 children/adolescents or

young adults (aged <40) but did not include rarer diseases

3. Do you think all important and relevant studies were included ?

Inclusion of relevant papers

Use of

databases

Use of bibliographic databases:

MEDLINE

EMBASE

Cochrane Library

Web of Science

LILACS

included all studies published up to that date and studies in progress or completed but unpublished identified through http://apps.who.int/trialsearch/

included all eligible publications, regardless of the language

summary

follow up from reference lists

unpublished as well as published studies

non-English language studies

hand search

personal contact with experts

perhaps could have looked in other databases?

perhaps could have looked at other grey literature?

4. Did the reviewers assess the quality of the included studies ?

Quality assessment

Quality assessment

Two authors assessed the quality of included studies using the Cochrane risk of bias tool

Fig 1. Summary of risk of bias and conflict of interest in included studies reporting allergic outcomes and type 1 diabetes mellitus, showing proportion of studies with high, low, or unclear risk of bias in each domain.

5. If the results of the review have been combined, was it reasonable to do so ?

Combination of results

Heterogeneity of studies?

reasons for any variations in results are discussed

results of all the included studies are clearly displayed

Table 1: Grades of Recommendation, Assessment, Development and Evaluation (GRADE) assessment and summary of key findings of review of studies of hydrolysed formula and risk of allergic or autoimmune disease

results of the studies have been combined

a meta-analysis was performed

forest plots

6. What are the overall results of the review?

Results of review

The details

Results

The original search identified 16 289 original titles.

Screening of titles, abstracts, and full text gave 52 studies - 37 intervention trials - of hydrolysed formula, including over 19 000 participants.

There were 28 randomised controlled trials, 6 quasi-randomised controlled trials, and 3 controlled clinical trials describing allergic or autoimmune outcomes.

7. How precise are the results ?

confidence intervals

Precision of results

95% confidence intervals

Fig 3 Summary of treatment effects of hydrolysed formula on different outcome measures:

Data shown are mean risk ratios (for allergic rhinitis at age 0-4; food allergy; allergic sensitisation; diabetes) or odds ratios (all other outcomes) with 95% confidence intervals for extensively hydrolysed formula compared with standard cows’ milk formula

Applicability

8. Can the results be applied to the local population ?

Limitations?

Limitations of the study?

In many cases study participants were infants with early full formula feeding

"so our findings might not be applicable to populations with more typical feeding patterns"

9. Were all

important outcomes considered ?

Consideration of all outcomes

Outcome discussion

all outcomes were considered and discussed in relation to the research question

Strengths of the study

Many studies of allergic outcomes included in this review had unclear or high risk of bias and evidence of conflict of interest, often because of inadequate methods of randomisation and treatment allocation (selection bias) and support of the study or investigators from manufacturers of hydrolysed formula.

Benefits

10. Should policy or practice change as a result of the evidence produced in this review?

Yes

- current recommendations to use hydrolysed formula in place of standard cows’ milk formula to prevent allergy in infants at high risk should be revised

- any future trials on hydrolysed formula should be prospectively registered, independently funded, and include adequate oversight to ensure that they do not negatively impact on breastfeeding in study participants

There is no consistent evidence to support the use of hydrolysed formula for the prevention of allergic or autoimmune disease.

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