MHFS: Food Safety (2012-2013)

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

To implement a five-step model to assess the needs of people with HIV, develop education materials targeted to their needs and evaluate acceptance of the materials.

Inclusion Criteria:

HIV infection; no inclusion criteria specifically mentioned.

Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment

The needs assessment phase was conducted in 2002.  Individuals with HIV were recruited to participate in focus groups in Washington (four groups), Ohio (two groups) and Colorado (two groups) by flyers distributed by agencies and health care providers. In the evaluation phase, material evaluation sessions were conducted in 2003 in Washington with HIV-infected people and the recruiting procedure was similar to that used for needs assessment focus groups.

Design

Cross-sectional descriptive study.

Intervention

Eight needs assessment focus groups with 65-infected people and interviews with 18 health care providers were conducted to determine motivators and barriers to adopting food safety recommendations. Educational materials were developed using needs assessment data, literature on foodborne illnesses and the Health Belief Model. Acceptability of materials was evaluated by four focus groups with 32 HIV-infected people and a survey of 25 health care providers.

Statistical Analysis

  • Focus group sessions were transcribed verbatim and organized into grids by focus groups and discussion topic
  • Inter-coder reliability was deemed adequate (89% to 100%)
  • Responses to food safety attitude statements by needs assessment focus groups were coded from one to four
  • Survey data from focus group participants and health care providers and data from material rating forms were summarized using descriptive statistics.

 

Data Collection Summary:

Timing of Measurements

Eight needs assessment focus groups with 65 HIV-infected people and interviews with 18 health care providers were conducted to determine motivators and barriers to adopting food safety recommendations. Educational materials were developed using needs assessment data, literature on foodborne illnesses and the Health Belief Model. Acceptability of materials was evaluated by four focus groups with 32 HIV-infected people and a survey of 25 health care providers.

Dependent Variables

  • Focus group topics: Current concerns about foodborne illness, motivators and barriers to following food safety recommendations, and food safety information
  • All materials used for data collection, including the moderator's script, survey tools, education materials and the health care provider interview script, were extensively reviewed by the three-state research team as well as by external reviewers to ensure accuracy of content.

Independent Variables

Demographic questions and food safety attitude and behavior scales were part of a preliminary survey that was previously developed and validated by the research team.

 

Description of Actual Data Sample:

Initial N

Eight needs assessment focus groups with 65 HIV-infected people and interviews with 18 health care providers were conducted to determine motivators and barriers to adopting food safety recommendations. Educational materials were developed using needs assessment data, literature about foodborne illnesses, and the Health Belief Model. Acceptability of materials was evaluated by four focus groups with 32 HIV-infected people and a survey of 25 health care providers.

Attrition (final N)

As above.

Age

Primarily middle-aged men.

Ethnicity 

Most were white/non-Hispanic.

Anthropometrics

Participants in the material evaluation sessions had similar demographic characteristics to those in the needs assessment focus groups.

Location

Washington, Colorado and Ohio.

 

Summary of Results:

Other Findings

Needs assessment focus group participants expressed resistance to and confusion about many recommendations.

The attitude and behavior surveys administered before the focus groups indicated that participants generally had a weakly positive attitude about food safety, with most of the mean scores between 2.5 and 3.0 on a 4-point scale.

The preliminary survey showed that participants generally thought they were at higher risk than others for getting sick from unsafe food, recognized that foodborne illness could be a serious threat to their health, and understood that handling or cooking food safely was important to staying healthy.

The strongest motivators were a desire to know why certain foods should be avoided and prevention of foodborne illness.

Prototype materials were designed to address barriers and motivators:

  • A booklet with information about shopping, handling, preparing, storing and choosing safe foods
  • A booklet with food safety and nutrition information
  • A brochure with information about how to choose safe foods when eating out and traveling
  • A brochure about foodborne pathogens and control measures to avoid infections
  • A magnet listing foods to avoid.

HIV-infected people who reviewed the prototype materials in evaluation focus groups expressed positive attitudes about the materials, and most indicated willingness to follow recommendations.

Health care providers were interested in distributing the educational materials to their clients.

18 health care providers said that food safety was currently addressed in their clinic or agency, and 10 said they personally provided food safety education materials to their HIV/AIDS clients. 

Author Conclusion:

We conducted a multi-stage process of gathering information and developing, evaluating and refining food safety education materials for HIV-infected people. Throughout the process, the needs of the target audience were of primary consideration. Carefully listening to people from the target audience and their health care providers as well as detailed investigation of the literature on foodborne illnesses were essential components of the project and contributed to acceptance of the educational materials.

Funding Source:
Reviewer Comments:

Subjects in both needs assessment phase and materials evaluation phase were not well-described.

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? ???
  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? ???
  2.3. Were health, demographics, and other characteristics of subjects described? No
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
3. Were study groups comparable? ???
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) ???
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? ???
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) No
  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? N/A
  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? Yes
  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? Yes
  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? Yes
  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? N/A
  8.3. Were statistics reported with levels of significance and/or confidence intervals? N/A
  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)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? N/A
  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? N/A
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? No
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