PICO Questions, Eligibility, and Study Design for Diabetes Patients

This assignment presents a research study design for diabetes patients, employing the PICO framework to formulate clinical questions. The study focuses on the impact of medical nutrition therapy (MNT) on diabetic patients, comparing the effects of insulin and sugar levels across different age groups. It outlines eligibility criteria, recruitment strategies (including email and telephone), and the setting for data collection in Hobart, Australia. The intervention involves MNT, detailing its role in managing diabetes and preventing complications. The methodology includes random assignment to groups based on age and insulin levels, with allocation concealment and blinding procedures. Outcome measures are specified, emphasizing the importance of effective outcome measurements, and the study's duration is set at 1-2 years, with potential extensions based on patient outcomes. The conclusion highlights the significance of MNT in diabetes treatment, summarizing key elements of the study design and referencing relevant literature.

PICO

Table of Contents
INTRODUCTION...........................................................................................................................3
TASK 1............................................................................................................................................3
Write 3 PICO questions..............................................................................................................3
TASK 2............................................................................................................................................3
Eligibility criteria for participants (who will you include and exclude?)...................................3
Recruitment strategies (how will you invite people to participate in your RCT?).....................3
Setting (where data will be collected?).......................................................................................3
Interventions (provide enough detail for the interventions to be replicated by other podiatrists)
.....................................................................................................................................................4
How will you randomly assign people to groups?......................................................................4
How will you conceal your allocation sequence?.......................................................................4
Will you blind participants/therapists/outcome assessors?.........................................................4
Outcome measures (include description for the outcome measure, and by whom outcomes
will be measured)........................................................................................................................5
Duration of study (for how long will people have the intervention, and when will outcomes be
measured?)..................................................................................................................................5
CONCLUSION................................................................................................................................5
REFERENCES................................................................................................................................6

INTRODUCTION
PICO is mnemonic device that mainly used in the nursing to help an individual remember
components of better focused clinical questions. This strategy is used in first step of the Evidence
Based Practice (EBP) to be assess and ask when investigating to develop clinical questions.
There will be diabetes consider as health issue (Evert and et. al., 2019). The PICO questions will
be developed and address the intervention.
TASK 1
Write 3 PICO questions
 In diabetic patients, what is the effect of insulin on sugar level compared with healthy
individuals?
 Are diabetic patients, who have low sugar level are at high risk of dying as compared with
high sugar level after injecting peptide hormone (Insulin)?
 Is Medical nutrition therapy (MNT) more accurate in diagnosing low sugar level diabetic
patients compared with high sugar level diabetic patients for managing high risk of
death?
TASK 2
Eligibility criteria for participants (who will you include and exclude?)
There will be the diabetic patients of the low sugar level and the high sugar level chosen
on the basis of different age groups. The first age group will be the younger of 15 to 40 years and
the other one are the aged people of 50 to 65.
Recruitment strategies (how will you invite people to participate in your RCT?)
For invite the people to participant in RCT, recruitment strategies will be randomly
based. In this, researcher will informed the participants by using the email, telephone and the
other methods. Investigator will recruit only the diabetes patient because they can provide the
information accurately as well as in detailed manner (Grammatikopoulou and et. al., 2019).
Setting (where data will be collected?)
The data will be collected from the Hobart. In Australia, there are around 1.2 million of
Australians has the diabetes in year 2017-2018. for the every person that diagnosed with the

diabetes is usually family member or the carer who lives the the diabetes each day in support
role.
Interventions (provide enough detail for the interventions to be replicated by other podiatrists)
This intervention is provided on the basis of Is Medical nutrition therapy (MNT) more
accurate in diagnosing low sugar level diabetic patients compared with high sugar level diabetic
patients for managing high risk of death?. Medical intervention for Diabetic patient is Medical
nutrition therapy which play important role in preventing diabetes, managing existing diabetes as
well as in its prevention or least slowing rate of development diabetes complications. Because
there are several complications which diabetic patient feel and go through although it is
important to manage level of diabetes in proper manner (Romano and et. al., 2020). In addition
to this, it is important to manage diabetes at all the levels and prevent it is better manner.
Moreover, Medical nutrition therapy is also one of the integral component related to diabetes
self-management education related to diabetes. Along with this, position statement provides
evidence related recommendation as well as intervention which is related to Medical nutrition
therapy. In simple term it can be said that, managing high and low both diabetes level is essential
as it have negative impact on individual health as well as increase chances of death.
How will you randomly assign people to groups?
The people to the groups assign on random basis as per their age group and the level of
the insulin. As the different age group has the different insulin level.
How will you conceal your allocation sequence?
Some of the standards methods regarding assuring allocation concealment consist the
sequentially numbered, sealed envelopes and others. There will be the pharmacy controlled
randomization and the central randomisation considered (Theodoridis and et. al., 2019).
Will you blind participants/therapists/outcome assessors?
For collection of data and information regarding the diabetes related intervention, there
will be the diabetes patients and the therapists considered. The main reason behind selecting the
therapists is that they have the understanding about this health issue and the way to controlling
them in a better manner because it can cause death (Tsirou and et. al., 2019).

Outcome measures (include description for the outcome measure, and by whom outcomes will
be measured)
It is important to measure outcomes in effective manner because these will provide
assistance in treatment of diabetic patient in better manner. Along with this, Medical nutrition
therapy which play important role in preventing diabetes, managing existing diabetes as well as
in its prevention or least slowing rate of development diabetes complications. Because there are
several complications which diabetic patient feel and go through although it is important to
manage level of diabetes in proper manner (Romano and et. al., 2020). In addition to this,
recommended therapy goals is to make people feel good who are going through diabetes as well
as health care providers must be aware with the advantages of nutrition intervention. Moreover,
Medical nutrition therapy is also one of the integral component related to diabetes self-
management education related to diabetes. Along with this, position statement provides evidence
related recommendation as well as intervention which is related to Medical nutrition therapy.
Furthermore, it is needed to utilize suitable available scientific evidence while considering
treatment goals as well as strategies for accomplishing these goals and modifying particular
person with diabetes are willing and able to make changes.
Duration of study (for how long will people have the intervention, and when will outcomes be
measured?)
The duration will be 1 to 2 years. The outcomes will be measured after testing the
patients if there will issue arise again then the duration time can be enhanced.
CONCLUSION
It has been concluded from above mention report that there has been Medical nutrition
therapy consisted. It is related to provide the treatment to diabetic patients. There has been
considered about the Eligibility criteria for participants, recruitment strategies and essential
things regarding this report in detailed manner.

REFERENCES
Books & Journals
Evert, A.B. And et. al., 2019. Nutrition therapy for adults with diabetes or prediabetes: a
consensus report. Diabetes Care. 42(5). pp.731-754.
Grammatikopoulou, M. G. and et. al., 2019. AGREEing on guidelines for nutrition management
of adult severe burn patients. Journal of Parenteral and Enteral Nutrition. 43(4).
pp.490-496.
Romano, L. and et. al., 2020. Short Report–Medical nutrition therapy for critically ill patients
with COVID-19. Eur Rev Med Pharmacol Sci. 24(7). pp.4035-4039.
Theodoridis, X. and et. al., 2019. Nutrition Interventions in Pediatric Pancreatitis: Guidelines We
Can Trust. Journal of Pediatric Gastroenterology and Nutrition. 69(1). pp.120-125.
Tsirou, E. and et. al., 2019. Guidelines for medical nutrition therapy in gestational diabetes
mellitus: systematic review and critical appraisal. Journal of the Academy of Nutrition
and Dietetics. 119(8). pp.1320-1339.