Question 1

Example 1

Title: Impact of frequent intake of energy drink on malnutrition status among Pakistani children: a cross-sectional study

Background: Energy-dense drinks claim to have the macro- and micro-nutrients required to boost energy. No study has reported the impact of long-term consumption on growth of children.

Research Hypothesis/Hypotheses: Null hypothesis 1: Prevalence of malnutrition is the same for children who consume and do not consume energy-dense drinks; Alternate hypothesis 2: Prevalence of malnutrition among children is not associated with intake of energy drink

Study design: A cross-sectional study in Pakistan will be conducted in July 2017.

Sampling technique: Gender-stratified sampling technique of all children who live in Pakistan aged between 0 and 5 years old.

Data collection: Dietary intake, height and weight of the children will be collected using standardized stadiometer and weighing scale and dietary intake on the first day of every month.

Statistical analyses: Percentage of malnutrition will be reported. Association between malnutrition and consumption will be tested using Chi-squared test. The significance level will be set at 0.05.

Ethics application: Indian Board of Ethics

Limitations of the study: Will not include children who die prematurely, and hence their cause of death. Not able to deduce cumulative effect.

Significance of the study: This plan will provide a sustainable model to prevent ill health.
Has the title included the exposure and outcome factors?

a. Yes, the exposure factor is drink intake and the outcome factor is malnutrition.

b. Yes, the exposure factor is malnutrition and the outcome factor is drink intake.

c. Yes, the exposure factor is malnutrition and the outcome factor is children intake of drinks.

d. No, only the target population is stated in the title.

Question 2

Has the gap of knowledge been noted in the background section of Example 1?

Yes, it is to study malnutrition.

Yes, it is to study drink intake in Pakistan.

No, it is unclear which malnutrition status (stunted or wasted or both) will be investigated.

No, it is unclear if the gap lies around children in developing countries or children who live in rural areas of developed countries.

No, it is unclear if the lack of evidence is around the long-term impact of specific types of drink or children or both.

Question 3

Are the research hypothesis statements written clearly and correctly in Example 1?

a. Yes.

b. No, the alternate hypothesis needs to be stated too.

c. No, alternate hypothesis 2 should state that there is an association.

d. No, it is unclear if it can address the gap of knowledge.

e. Both c and d are correct.

Question 4

Is the proposed sampling technique in Example 1 appropriate to answer the gap of knowledge and the research hypothesis?

a. Yes.

b. Yes, if the gap of knowledge is around difference of impact by gender of the children.

c. No, a simple random sampling technique would be able to reduce selection bias that may occur in this setting.

d. No, a purposive sampling technique would be better to target the population of interest.

e. Both b and c could be correct if the gap of knowledge and the research hypothesis were communicated clearer.

Question 5

What is the validated tool that will be used to collect data in Example 1?

a. Height and weight measurements

b. Standardized stadiometer and weighing scale

c. Standardized stadiometer and weighing scale and dietary intake

d. Blood and urine analyses

Question 6 Are there any ethical concerns from Example 1?

a. Children who have allergies may be forced to consume the drinks.

b. The choice of the ethics committee does not exist.

c. All of the above

d. Unable to comment

Question 7 How would you improve the draft synopsis in Example 1?

a. State the gap of knowledge clearly

b. Reduce bias by revising the choice of study design in order to address the gap of knowledge

c. Revise the sampling technique in order to address the gap of knowledge

d. Align the data collection plan with the study design to address the gap of knowledge

e. Ensure the choice of ethics committee and ethical issues are considered

f. Revise the significance of the study so that there is no speculation of the results, not overpromising the outcome of the study and relate it to the gap of knowledge

g. All of the above

Question 8

1. Example 2

Title: Impact of long-term consumption of supplementary-meal drink on wellbeing of obese Indian females: a double-blind randomized controlled trial in New Delhi

Background: Formulated supplementary drinks may provide overweight consumers an easier way to consume the recommended dietary intake of macro- and micro-nutrients. There is lack of concluding evidence on long term consumption of such drinks on general wellbeing of obese Indian females.

Research Hypothesis/Hypotheses: Null hypothesis: Wellbeing of females who ever consumed the drink is the same as those who consumed it over a month and those who consumed it for more than 6 months on a daily basis.

Study design: A four-month double-blinded randomized controlled trial in India will be conducted from July 2017, with 3 groups of participants (control group: ever consumed drink in the past year but not in the current study; group 1: consume drink daily for a month; group 2: consume drink daily for a period of six months.

Sampling technique: Gender-stratified sampling technique of all obese adults (aged 18-35 years old) who live in New Delhi, India. Adults with allergies will be excluded.

Data collection: Dietary intake will be collected using a 3-day dietary record. Height, weight and blood samples (5mL) will be collected at clinic visits using standardized stadiometer, weighing scales and qualified clinicians with good rater reliability (>0.85). All data will be collected on the first day of every month.

Statistical analyses: Body mass index (BMI) will be calculated and its mean and standard deviation reported as the main descriptive statistics. Wellbeing of the participants will be compared using one-way ANOVA. The significance level will be set at 0.01.

Ethics application: New Delhi Central Ethics Committee on Human Research; Curtin University Human Research Ethics Committee

Limitations of the study: Not applicable.

Significance of the study: This plan will provide a sustainable model to prevent ill health.
Has the title included the exposure and outcome factors?

a. Yes, the exposure factor is ever consumption of supplementary-meal drink and the outcome factor is wellbeing.

b. Yes, the exposure factor is wellbeing and the outcome factor is ever consumption of supplementary-meal drink.

c. Yes, the exposure factor is consumption of supplementary-meal drink and the outcome factor is wellbeing of obese women.

d. No, only the target population are place of study are stated in the title.

Question 9

Is/are there anything missing from the background section of Example 2?

a. The gap of knowledge is not clearly stated.

b. There is no in-text citation.

c. All of the above

Question 10

Can you improve the study design in Example 2?

a. No, a double-blinded RCT is one of the best study designs that can be adopted.

b. No, there is no need to add further information to minimize the bias.

c. Yes, the duration of the study needs to be aligned with the research hypothesis.

d. Yes, there may be an opportunity to revise the condition for the groups or introduce a wait-list control group.

e. Both c and d may be adopted to improve the study design.

Question 11
In Example 2, is the proposed sampling technique appropriate to answer the gap of knowledge and the research hypothesis? Please justify your answer of ‘Yes' or ‘No'.

Question 12
1. How would you improve the data collection plan for Example 2?

a. Include urine analyses

b. Confirm the definition of ‘wellbeing' and align the plan to include all key variables.

c. Include collection of sociodemographic variables, their mental stress through telephone call by professionals from the Act-Belong-Commit team, and physical activity level through doctor's record.

d. All of the above

Question 13
Are there any ethical concerns from Example 2?

Children who have allergies may be forced to consume the drinks.

Improper choice of ethics committees.

Participants in the control group will not gain the benefit of long term consumption.

All of the above

Question 14
What are the limitations that were overlooked in Example 2?

a. Did not collect data on physical activity

b. Is susceptible to drop-outs and bias related to self-reported data

c. Did not measure wellbeing

d. All of the above

Question 15
How would you improve the draft synopsis in Example 2?