MHFS: Food Safety (2012-2013)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:

To assess and compare knowledge and self-reported formula handling practices of a sample of parents and child care workers living in Palermo, Italy against the WHO/FAO guidelines. Association with some socio-demographic variables was also evaluated.

Inclusion Criteria:
  • Full information on the study and its purposes was provided to participants
  • Completion of the questionnaire implied respondent consent to participate in the study
  • Ethical approval was not required for this study according to Italian regulations.
Exclusion Criteria:

Not described.

Description of Study Protocol:

Recruitment

Parents were asked to participate in the study by a written invitation from the child care workers of each center, who had been previously informed about the objectives of the investigation and the instructions to be given. Only one parent per child was allowed to fill in the questionnaire.

Design

Cross-sectional study.

Statistical Analysis
  • EpiInfo Software was used for data management and analysis
  • For descriptive statistics, analysis of frequency and central tendency and dispersion were calculated to describe demographic characteristics and formula-handling knowledge and self-reported practices
  • One-way analysis of variance (ANOVA or Kruskal-Wallis when appropriate) and cross-tabulation with chi-square statistics were used to evaluate the relationship between knowledge, self-reported practices and each demographic variable
  • In all analyses an alpha level of 0.05 or below was indicative of a statistically significant difference.

 

Data Collection Summary:

Timing of Measurements

A structured questionnaire was designed and self-administered to parents and child care workers.

 Dependent Variables

  • Formula handling practices were measured by a questionnaire. The questionnaire consisted of a first section on demographic characteristics and a second section that focused on the awareness and likelihood that microorganisms are in the formula and self-reported formula handling practices as compared to the procedure recommended by the WHO/FAO guidelines. 
  • For this portion of the survey a Likert Scale was used to measure the strength of the respondents feelings. For each statement a score of one, two, three, four or five was assigned to responses of strongly agree, agree, no opinion, disagree or strongly disagree. 

Independent Variables

Parents and child care workers in Palermo, Italy.

Description of Actual Data Sample:
  • Initial N: 983 parents invited to participate, 442 child care workers
  • Attrition (final N):  417 parents (90.8% female) and 314 child care workers (95.2% female) completed the questionnaire
  • Age: Mean age of parents was 35.09 years and mean age of child care workers was 44.04 years
  • Ethnicity: 93.5% of parents were Italian and 99.7% of child care workers were Italian
  • Other relevant demographics: Respondents within parents were more likely to be younger with eight years or less of education
  • Location: Palermo, Italy.
Summary of Results:

Key Findings

  • 42.4% of parents and 71.0% of child care workers filled in the questionnaire
  • Significant differences were found between parents and child care workers for age and education
  • While powdered infant formula is not a sterile product, 73.2% of parents vs. 84.4% of child care workers were confident that it was sterile (P<0.001)
  • Age and education significantly influenced the answers to the questionnaire of both parents and child care workers
  • Adherence to safe procedures when reconstituting and handling powdered infant formula was more frequently reported by child care workers than parents; such procedures included: 
    • Washing hands before preparing powdered infant formula
    • Sterilizing the equipment
    • Using pre-boiled water cooled to no less than 70°C
    • Immediate feeding
    • Re-warming bottles after storage in refrigerator
    • Throwing away reconstituted powdered infant formula after 24 hours
  • Only 47.1% of parents and 50.7% of child care workers were likely to be aware of risk of burns to the infant's mouth associated with heating bottles in a microwave oven.
Author Conclusion:
  • Parents and child care workers are generally unaware that powdered formulas may contain viable microorganisms. However, child care workers consistently chose safer options than parents when answering the questions about adherence to hygienic practices.
  • Infant formula needs to be handled in a way that reduces the chance of infection.
  • Industry and regulators should play the primary critical role in reducing the risk of illness from consumption of PIF and ensuring that it is as safe as possible. Improvements should start with the manufacturing process.
Funding Source:
University/Hospital: University, Via del Vespro, Palermo, Italy
Reviewer Comments:
  • The authors did identify some limitations, such as the limited non-probabilistic sampling generalization of the results.
  • Ethnicity of respondents was significantly slanted toward Italian persons.
  • It is likely that these issues would deserve closer attention in the future studies on infant feeding in private and public settings.
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? No
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
3. Were study groups comparable? Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) N/A
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) Yes
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? Yes
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? N/A
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? N/A
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) N/A
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? N/A
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? N/A
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? N/A
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? N/A
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? N/A
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? N/A
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? N/A
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? No
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? No
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? No
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? No
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? No
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes