Examples Of PICOT Questions And Statistical Analyses In Research Essay.

Understanding the PICOT Framework

1: You have just travelled to Thailand for a 4-week student exchange program, where you now have the opportunity to work with experts in a leading research institute in the country. During your visit, you observed that malaria remains a significant health issue, particularly among children and pregnant women. The Institute Director wants to reduce the number of child deaths and maternal mortality due to malaria in a particular endemic-community. She has proposed that insecticide-treated bed nets may be appropriate for use among children and pregnant women, and has asked for you to gather evidence to inform the development of a malaria prevention study.

a. Write a focused research question for this particular problem that will help you organise a search of the literature for an answer

b. Identify the PICO elements in your research question

2: Scott, a 78-year-old man with a history of hypertension and atrial fibrillation was discharged from the hospital following a fall. At a follow-up appointment in your GP practice, his wife Julie asks whether there is a better alternative to warfarin, a blood thinning medication, which he has been taking to prevent stroke. Her friend’s husband has recently been put on a newer blood-thinning medication (Rivaroxaban) which doesn’t require regular international normalisation ratio (INR) testing, a standardised measurement of the time it takes for blood to clot. Julie finds it difficult to get her husband to the pathology collection centre because he is quite immobile. She asks what whether the new blood-thinning medication could be an option for her husband in stroke prevention.

a. Write a focused research question for this particular problem that will help you organise a search of the literature for an answer

b. Identify the PICO elements in your research question

3: In the past 2 years, as a Consultant in Infectious Diseases in one of the tertiary hospitals in Sydney, you have attended to 15 migrant patients who were referred by their General Practitioners with symptoms not typical of pulmonary tuberculosis. After taking a detailed history and performing appropriate physical examinations, as well as reviewing a range of relevant investigations, you clinically diagnosed and microbiologically confirmed that those patients have multi-drug resistance pulmonary tuberculosis (MDR-TB). The Public Health Department was notified of disease and the patients were managed accordingly. Now, you and some colleagues from Western Sydney University want to investigate the risk factors for MDR-TB.

Examples of PICOT Questions

a. Write a focused research question for this particular problem that will help you organise a search of the literature for an answer
b. Identify the PICO elements in your research question

4: The Director of the Research and Strategic Policy Unit in New South Wales (NSW) Health has just read a non-government health report for Western Sydney, which indicates that the region has the highest burden of childhood obesity in Australia. You have been approached to gather evidence (to submit a research proposal) on patterns of overweight and obesity, and provide advice on strategies to reduce the burden of childhood obesity in the community because she wants an independent research facility to conduct a study to better understand the health issue.

a. Write a focused research question for this particular problem that will help you organise a search of the literature for an answer (use the PICO elements as appropriate).
b. Identify the PICO elements in your research question

5: Now choose ONLY ONE research question from any of the questions above (Q1–4) that will help you organise a search of the clinical literature for an answer. If you were to search Medline/PubMed/Web of science for original research on this question:
a. Describe what your search strategy would be, including keywords, MeSH terms, inclusion and exclusion criteria, as well as evidence of the Boolean operators used
b. Explain your rationale for taking this approach and explain your reasoning.
c. What type of study design would best be able to address your selected research question? State why.
d. Cite the best article from among those you find, using any referencing style of your choice.

6: Answer questions 6a-c based on the following information:
A total of 1500 children have a rapid strep test (RST) done by a standardized culture technique. Of the 1500 children, 1338 have a negative RST and 162 have a positive RST. In addition, a backup throat culture (gold standard) was done on all children. Of those children with a negative RST, 1302 have a negative throat culture. In the group with a positive RST, 159 have a positive throat culture.

6: Construct a 2x2 table using the information provided above, and answer the following questions (a-c):
a) Calculate the sensitivity of the RST
b) Calculate the specificity of the RST
c) Calculate the positive predictive value of the RST
d) In a test with high sensitivity, a negative result rules in the diagnosis [True/False]
e) In a test with high specificity, a positive result rules out the diagnosis [True/False]
f) The positive predictive value is dependent on all of the following: prevalence, incidence, sensitivity and specificity [True/False]
g) Using the image below, which value in the test result units is the point of maximum specificity?
a) 20
b) 15
c) 5
d) 30
e) 25

Keyword and MeSH Term Selection

7: Answer questions 7a-d based on the following information:
Saag et al. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med 2017; 377:1417-1427.
Background: Romosozumab is a monoclonal antibody that binds to and inhibits sclerostin, increases bone formation, and decreases bone resorption.
Methods: We enrolled 4093 postmenopausal women with osteoporosis and a fragility fracture and randomly assigned them in a 1:1 ratio to receive monthly subcutaneous romosozumab (210 mg) or weekly oral alendronate (70 mg) in a blinded fashion for 12 months, followed by open-label alendronate in both groups. The primary end points were the cumulative incidence of new vertebral fracture at 24 months and the cumulative incidence of clinical fracture (nonvertebral and symptomatic vertebral fracture) at the time of the primary analysis (after clinical fractures had been confirmed in ≥330 patients). Secondary end points included the incidences of nonvertebral and hip fracture at the time of the primary analysis. Serious cardiovascular adverse events, osteonecrosis of the jaw, and atypical femoral fractures were adjudicated.
Results: Over a period of 24 months, a 48% lower risk of new vertebral fractures was observed in the romosozumab-to-alendronate group (6.2% [127 of 2046 patients]) than in the alendronate-to-alendronate group (11.9% [243 of 2047 patients]) (P<0.001). Clinical fractures occurred in 198 of 2046 patients (9.7%) in the romosozumab-to-alendronate group versus 266 of 2047 patients (13.0%) in the alendronate-to-alendronate group, representing a 27% lower risk with romosozumab (P<0.001). The risk of nonvertebral fractures was lower by 19% in the romosozumab-to-alendronate group than in the alendronate-to-alendronate group (178 of 2046 patients [8.7%] vs. 217 of 2047 patients [10.6%]; P=0.04), and the risk of hip fracture was lower by 38% (41 of 2046 patients [2.0%] vs. 66 of 2047 patients [3.2%]; P=0.02). Overall adverse events and serious adverse events were balanced between the two groups. During year 1, positively adjudicated serious cardiovascular adverse events were observed more often with romosozumab than with alendronate (50 of 2040 patients [2.5%] vs. 38 of 2014 patients [1.9%]). During the open-label alendronate period, adjudicated events of osteonecrosis of the jaw (1 event each in the romosozumab-to-alendronate and alendronate-to-alendronate groups) and atypical femoral fracture (2 events and 4 events, respectively) were observed.
Conclusions: In postmenopausal women with osteoporosis who were at high risk for fracture, romosozumab treatment for 12 months followed by alendronate resulted in a significantly lower risk of fracture than alendronate alone.

7a. Construct a 2x2 table using the information in the abstract, and answer the following questions:
(i) What is the risk of developing clinical fractures in all patients included in the study? [2 marks]
(ii) What is the risk of developing clinical fractures in patients who received romosozumab-to-alendronate treatment [2 marks]?
(iii) What is the risk of developing clinical fractures in patients who received alendronate-to-alendronate treatment?
(iv) What is the relative risk of treatment with romosozumab-to-alendronate versus alendronate-to-alendronate with regard to experiencing clinical fractures? How would you interpret this relative risk estimate?

7b. If equal numbers of patients in the population received romosozumab-to-alendronate vs alendronate-to-alendronate treatment, what would be the expected population relative risk reduction (RRR) for romosozumab-to-alendronate treatment? How would you interpret this measure?

7c. How many patients need to be treated with romosozumab-to-alendronate regimen for one more patient to be benefit compared with the alendronate-to-alendronate regimen? What is this measure called? How would you interpret this measure?
7d. How does the measure in question 5b differ from question 5c?

8. What characteristics of the study would you consider in order to determine if its findings are valid? Include wider considerations of study quality/validity and give examples.

9. What characteristics of the findings would you consider, in order, to determine if they are clinically meaningful and statistically significant? Include examples.

10. What characteristics of the study would you consider, in order, to determine if it is generalizable to your context? Explain your answers and provide examples.

Understanding the PICOT Framework

PICO Question: Is the use of insecticide bed net amongst children and pregnant women effective in the prevention of malaria in reducing child and maternal mortality.

This PICOT question has been generated from the evidence research gathering I am to conduct as assigned by the Institute director during my travel to Thailand, using the PICOT framework the Problem (P), Intervention (I), Comparison (C) and Outcome (O) can be clearly shown as below:

P	Malaria
I	Insecticide treated bed nets
C	Other medical solution such as medicinal tablet
O	Reduced child and maternal mortality

PICOT Question: In stroke prevention does warfarin compared to rivaroxaban reduce regular international normalization ratio (INR)

This PICOT question has been generated from the question by July on blood thinning medication where she finds it difficult to take her husband Scott, a 75-year-old who is becoming immobile to pathology collection center during my GP practice, using the PICOT framework the Problem (P), Intervention (I), Comparison (C) and Outcome (O), below are the elements in my research question:

P	Stroke prevention
I	Warfarin (blood thinning medication)
C	Rivaroxaban (newer blood thinning medication)
O	No regular international normalization ratio (INR)

PICOT Question: In migrant patients what are the risk factors of multi-drug resistance pulmonary tuberculosis (MDR-TB) compared with pulmonary tuberculosis.

This research question was generated as an initiative between me and colleagues in Western Sydney university in investigating the risk factors of MDR- TB, using the PICOT framework the Population (P), Intervention (I), Comparison (C) and Outcome (O), below are the PICO elements:

P	Migrant patients
I	multi-drug resistance pulmonary tuberculosis (MDR-TB)
C	Pulmonary tuberculosis
O	Risk factors

PICOT Question: In the reduction of childhood obesity what are the patterns of overweight and obesity in Western Sydney, Australia.

This PICOT question was generated because of an approach to gather evidence on patterns or symptoms of overweight and obesity to reduce the childhood obesity in the community. Using the PICOT framework, the Population (P), Intervention (I), Comparison (C) and Outcome (O), below are the PICO elements:

P	Western Sydney, Australia
I	Patterns of overweight and obesity
C	****
O	Reduced childhood obesity

In this task my chosen PICOT question was derived form question two that states: In stroke prevention does warfarin compared to rivaroxaban reduce regular international normalization ratio (INR)

In doing a research of my question firstly I will select a suitable database that is based on the amount or quantity and the quality of relevant resources that it has amongst Medline, PubMed, Cochrane, WebMD, Google Scholar and Science Direct. My key words would be stroke prevention, warfarin, rivaroxaban, international normalization ratio (INR), my MeSH terms would be warfant, coumadin, rivaroxaban, Xarelto, stroke, apoplexy and cerebrovascular accident. But this would not be enough to produce my desired result so I would use the Boolean expression ‘AND’ in order to obtain the suitable and detailed articles that I require warfant and international normalization ratio (INR), warfant and stroke, rivaroxaban and stroke, rivaroxaban and international normalization ratio (INR), warfant and rivaroxaban and lastly warfarin and rivaroxaban and stroke.

Examples of PICOT Questions

The reason for searching the keywords is generally to obtain resources on the medicines and their uses but they do not provide an article that answers the question therefore the search has to be broadened by using key phrases at first, since this might end up without the provision of a single article the Boolean expression of combination ‘’AND” is used in an appropriate database (PubMed) that has a lot of medical articles on stroke and its prevention with these relevant medicines.

My research design was systematic review basing on cross sectional study where the study is based on statistics to compare the effect of both drugs to different groups.

After going through this process, I obtained an accurate and reliable article:

Halperin, J. L., Hankey, G. J., Wojdyla, D. M., Piccini, J. P., Lokhnygina, Y., Patel, M. R., ... & Paolini, J. F. (2014). Efficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the ROCKET AF trial. Circulation, CIRCULATIONAHA-113. https://doi.org/10.1161/CIRCULATIONAHA.113.005008 Circulation. 2014

In the question A total of 1500 children have a rapid strep test (RST) done by a standardized culture technique. Of the 1500 children, 1338 have a negative RST and 162 have a positive RST. In addition, a backup throat culture (gold standard) was done on all children. Of those children with a negative RST, 1302 have a negative throat culture. In the group with a positive RST, 159 have a positive throat culture.

Understanding that RST is a test that determines the presence of group A streptococci (GAS). Below is the table of the results:

	Present	Absent	Total
Positive RST	159	3	163
Negative RST	36	1302	1338
Total	195	1305	1500

KEY

In the below cases

FP = Total positive – total positive present

FN = Total negative – total negative absent

TPP represents total positive present

TNA represents total negative absent

TN represents total negative

TP represents total positive

PPV represents positive predictive value

1. Sensitivity

Sensitivity=TPP/ (TPP + FN)

Sensitivity=159/ (159 + 36)

Sensitivity= 159/195

Sensitivity = 0.815

In percentage 0.815 * 100 = 81.5%

Therefore, sensitivity = 81.5%

1. Specificity

Specificity =TNA/ (TNA + TN)

Specificity=1302/ (1302 + 3)

Specificity =1302/1305

Specificity=0.997

Percentage=0.997*100= 99.7%

Therefore, the specificity = 99.7%

1. Positive predictive value

   PPV = TP/ (TP + FP)

PPV=159/ (159 +3)

PPV =159/162

PPV=0.98*100

PPV=98%

1. d)  It is False that in a test of sensitivity negative results rules in the diagnosis
2. e)  It is False that in a test with high specificity a positive result rules out the diagnosis
3. f)   It is False that positive predictive value depends on prevalence, incidence, sensitivity and specificity sine positive predictive value is not dependent on incidence though it depends on sensitivity, specificity and prevalence.  
4. g) Using the table provide in the questions the value at the point of maximum in the text result unit is

“e” which is 25

Table using abstract information

		Vertebral fractures	Clinical fractures
Positive RST	Romosozumab to alendronate	127 (6.2%)	198 (9.7%)
	Alendronate to alendronate	243 (11.9%)	266 (13.0%)
Negative RST	Romosozumab to alendronate	178 (8.7%)	41 (2.0%)
	Alendronate to alendronate	217 (10.6%)	66 (3.2%)

a)

1. i) Risk of developing clinical fracture = 266+ 198 /total

Risk = 464/4093

Risk of clinical fracture = 0.1134

In percentage 0.1134*100

=11.34%

1. ii) Risk of developing clinical fractures for patients who received Romosozumab to alendronate treatment is 198/2046 which is 0.097

In percentage = 0.097*100

=9.7%

iii) Relative risk in developing clinical fracture for patients who received alendronate to alendronate treatment is 13%

1. iv) I will interpret the relative risk by comparison of the Romosozumab to alendronate vs alendronate to alendronate basing on clinical features

Keyword and MeSH Term Selection

Romosozumab to alendronate=9.7%

Alendronate to alendronate = 13%

9.7%/13%

Relative risk = 0.7462

In percentage=0.7462 * 100

=74.62%

1. b) Using a total population of 4092 in determining the population relative risk reduction for romosozumab to alendronate treatment if equal numbers were used. I would the take 100% - the relative risk percentage and multiply by the half of the total population.

100-74.62=25.38%

4092/2 = 2046

25.38% * 2046 = 520 women

1. c) I would know this by comparing the answer in b above to the same in the case of alendronate to alendronate

 1526/520 =3

3 patients need to be treated with romosozumab to alendronate for one patient of alendronate to alendronate to benefit.

1. d) The measure differs in that sensitivity is the responsiveness while specificity is ability of an instrument to be definite.

Questions on (Keenan et al., 2018) article

Internal validity is the extent in which the conditions causing the study are justified and it is determined by lack of errors and confusions, it is the basis of determining whether a research is sound.

In the case of Keenan et al., 2018 book on Azithromycin to reduce childhood mortality in sub Saharan Africa in this question I am going to consider the relevance of the findings focusing on internal validity.

This study is well planned and recorded carefully in a systematic order so that the findings are also systematic without errors due to additional qualitative research after the quantitative research that they have used in the calculation of statistics

One key factor that shows that is key in the determination of the researcher’s internal validity is the amount of time they have carried out their study due to their good planning, before the actual study they are able to organize themselves and communicate with the relevant authority, they do not engage in any activities that show rushed decisions that could lead to mistakes that would temper with the findings.

This study does not regress or retrogress towards the mean or an objective to the extent of using false means or methodology to reach the findings, it is clearly indicating the methods used to arrive at conclusion and not trying to reach the conclusion by unfair means guaranteeing the validity of the finding

Another guarantee of internal validity can be seen in the way they have followed several protocols during their study, in their study there is a clear method to follow and they have ensured that they have stick to the procedures as overall listed in the methods section

This study has provided detailed statistics which have added up to their total calculations that they have used in their interpretation their statistical analysis, the statistics that they have obtained during the study has been significant and relevant due to its accuracy. Their detailed work is reliable as seen in their provision of countries and specific sections of the country example they say lower Niger, details can also be seen when they provide counts in respect to a larger ratio example 16.5 death per 1000 deaths.

Boolean Expression for Better Search Results

The subject of the study has not changed a bit and this is evident in how they keep repeating and referring to their subject, this has helped the findings to be very relevant to the subject and their findings being relevant has been observed in their analysis, the fact that they have stuck to their subject could be due to the oversight committee and the presence of investigators form MORDOR group.

It can also be seen that the size of the subject population was very relevant to the findings in that they were to too much for the researchers to handle so that they could fail to cater for any of them instead all of them are catered for.

The instruments that were used during the study sensitivity can be noted to be good thus producing the best and relevant findings

External validity is the extent of application of data and theories to different section, the question is mostly on the applicability of the research on the outside world (out of the lab). This section on the contrary does not focus on external validity but on determining the clinical significance and the statistical significance during the study.

In looking at the statistical significance the focus is on the method or the means of obtaining the statistics and the range of the statistics. Beginning with the extent it is quite significant in the extent of the people involved beginning for the subjects to the researchers there is adequate number of researchers to carry out the study, these is seen in the division of the community onto sub groups as they assign themselves, the study also covers a large extent of the population as it can be seen as 95% in Tanzania,92% in Niger,95% in Malawi amongst other countries, this shows that the findings are valid reflection of the research in the areas that it is conducted.

In looking at the means or the method that have been used there can be no detection of error because in any case of difference, they are all highlighted, the fact that they provided health surveillance makes the quality of their findings outstanding and this can be used as a means of applauding the validity of their findings since they had health surveillance systems thus guaranteeing the clinical significance of the study.

In terms of the choice of population characteristics the subjects were chosen in a distributed manner with no concentration a single place so that it be said that there were any bias of any kind this helps in guaranteeing the statistics significance of the study.

Another factor that could be used in determining clinical significance is the availability of the necessary relevant machines to be used when the studying the article. It is quite clear that there were enough of this equipment that were used in the study.

In this section I will consider considerations that I will consider in determining if it can be relevant to my contest.

Fist I would consider the researcher and the experimental features, under this I would ask questions on the aim of the study and its objective and how the researchers have ensured that there is validity so that in my study I can stick to internal and external validity this study is therefore generalized in my practice .Secondly I would consider the subjects in the study and how they are relevant to my area of practice, despite the geographical difference the relevance is in the fact that the diagnosis and the diseased are the same and the means or method of carrying out this practices are the same.

I would also consider the protocols and the extent of changes that could be noted during the study and as it is evident there were no sudden changes or participant dropouts showing the effect or availability of good and complete protocols.

References

Halperin, J. L., Hankey, G. J., Wojdyla, D. M., Piccini, J. P., Lokhnygina, Y., Patel, M. R., ... & Paolini, J. F. (2014). Efficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the ROCKET AF trial. Circulation, CIRCULATIONAHA-113.

Keenan, J. D., Bailey, R. L., West, S. K., Arzika, A. M., Hart, J., Weaver, J., ... & Lebas, E. (2018). Azithromycin to Reduce Childhood Mortality in Sub-Saharan Africa. New England Journal of Medicine, 378(17), 1583-1592.