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Introduction to Clinical Epidemiology (401173)
 FINAL ASSIGNMENT
 Autumn, 2019
 Due date: 11.59pm , May 29 2019
 This assignment is based on the learning objectives and concepts as   described in the Unit Learning Guide. There are 9 questions worth a   total of 64 marks and this assignment will contribute 64% towards the   total assessment for this subject.
 Your assignment should be typed, with adequate space left between   questions. Assignments should be submitted via vUWS. Be as concise as   possible in your answers, and use the number of marks allocated to each   question as a guide for how much to write.
 Please note this is an individual exercise.
 Late assignments will not be accepted without prior approval.
 You are required to answer ALL questions (1-9)
 Page 1 of 7
 

Answer questions 1-2 based on the following scenarios:
 Q1: Fred, a 65-year-old obese man with a history of type 2 diabetes   mellitus and hypertension presents to the GP practice for a follow-up   appointment. During the consultation, he asks whether there is a better   medication to glicazide and metformin, his oral hypoglycemic   medications, which he has been taking to control his blood sugar. His   friend has recently been put on a newer oral hypoglycemic medication   (Liraglutide, a glucagon-like peptide-1 analogue), which has been shown   to help with weight management in patients with diabetes and obesity.   Fred has been finding it very difficult to lose weight for a few years   now as he has tried various lifestyle modifications. He asks whether  the  new oral hypoglycemic medications could be an option for him in  weight  reduction.
 

Task [2 marks]
 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
 Q2: In the past 2 years, as an Infectious Disease Specialist in one of   the tertiary hospitals in Australia, you have attended to 23 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.
 

Task [2 marks]
 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
 

Q3: Please select the single best answer for each of questions 3.I – VII
 I. Randomised controlled trials provide strong evidence that an  observed  effect is due to the intervention. One main reason is because  [1 mark]:
 a) When the study participants are randomised, many characteristics and   potential confounders are likely to be evenly distributed in the  groups
 b) It is easier to measure the outcome variable with great precision in   randomised controlled trials compared to other study designs.
 c) The exposure level and the outcome are measured at the same time
 d) The study participants are volunteers and therefore motivated to take part in the study
 e) None of the above
 II.Blinding is an important feature of a randomised controlled trials because [1 marks]:
 a) It helps prevent measurement bias – the biased assessment of outcomes
 b) It helps reduce contamination and compliance problems
 c) It helps reduce confounding and selection bias
 d) It is required to do an intention-to-treat analysis
 e) It helps improve chance event and reduce misclassification III. Which of the following is true [1 mark]?
 a) Loss to follow-up can lead to selection bias in cohort studies.
 b) Selection bias can arise from conditioning on the common effect of   the exposure and an uncontrolled independent risk factor for the   outcome.
 c) Case-control studies are no more prone to selection bias than are cohort studies.
 d) Loss to follow-up is not a major source of bias in cohort studies.
 e) None of the above.
 IV. When epidemiologists judge the evidence to establish a possible cause of a health outcome, they
 

consider [1 mark]:
 a) The strength of the association between an exposure and the outcome
 b) Evidence that the exposure of interest has appeared before the outcome.
 c) Evidence showing that reductions in the exposure level will reverse the risk of the outcome.
 d) A, B and C
 e) A and B only
 V. A double-blind study was designed to test the efficacy of a drug.  One  group of the patients consisting of 1227 participants were given a   placebo and the other group of patients consisting of 1220 were given   the active drug. Both groups were to be followed up for one year. After   6-months of the trial, 35% of participants in the placebo groups  dropped  out of the study and 4% of the participants taking the active  drug  dropped out of the study. What is the SINGLE BEST explanation for  this  occurrence [1 mark]?
 a) Failure of the active drug
 b) Insufficient information to interpret data
 c) Systematic error
 d) Chance event
 e) Breakdown of the double-blind study
 VI. The highest level of evidence provided for cancer treatment usually comes from: [1 mark]
 a) Randomised control trials
 b) Phase II clinical trials
 c) Phase III clinical trials
 d) Systematic reviews of observational studies
 e) Meta-analyses of intervention studies
 Page 3 of 7
 

VII. A recent study examined the association between tea consumption  and  ovarian cancer. The study included 414 women with primary  epithelial  ovarian, fallopian, or peritoneal cancer and 868 age-and  region-matched  women with non-neoplastic conditions. The adjusted odds  ratio was 0.39  for those drinking tea daily and 0.23 for those drinking  tea for 30  years, compared with non-tea drinkers. The study concluded  that  increasing frequency and duration of tea drinking, especially  green tea,  can reduce the risk of ovarian cancer.
 What type of study was conducted? [1 mark]
 a) Cross-sectional study
 b) Prospective cohort study
 c) Randomised controlled trial
 d) Retrospective cohort study
 e) Case control study
 Q4: Now select ONLY ONE research question from either Question 1 or 2   above that will help you organize 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 [4 marks].
 b. What type of study design would best be able to address your selected research question? State why [1 mark].
 c. Cite the best article from among those you find, using any referencing style of your choice [1 mark].
 

Q5: Answer questions 5a-b based on the following information:
 A total of 1800 patients have a screening test to identify a protein   called “FEN-59’ to determine patients at risk of lung carcinoma,   followed by a standardized lung biopsy procedure. Of the 1800 children,   1533 have a negative FEN-59 and 267 have a positive FEN-59. In  addition,  a lung biopsy (gold standard) was done on all patients. Of  those  patients with a negative FEN-59, 1491 have a negative lung  biopsy. In  the group with a positive FEN-59, 259 have a positive lung  biopsy.
 Construct a 2×2 table using the information provided above, and answer the following questions (a and b):
 a) Calculate the sensitivity of the FEN-59 [2 marks]
 b) Calculate the positive predictive value of the FEN-59 [2 marks]
 c) The negative predictive value is dependent on all of the following:   prevalence, incidence, sensitivity and specificity [True/False] [1  mark]
 Please select the SINGLE BEST answer in questions 5e to f
 d) Using the image below, which value in the test result units is the point of maximum specificity? [1 mark]
 a) 30
 b) 15
 c) 5
 d) 20
 e) 25
 e) A study was conducted in which 10,000 women participated. All women   underwent a cervical smear. 1,000 of 10,000 women had a positive smear.   Of these, 100 developed cervical cancer. 10 women who had negative  smear  developed cancer. What is the SINGLE most likely terminology to   describe the 10 women with negative results who developed cervical   cancer?  

The future of healthcare is focused upon improving patient outcomes and patient satisfaction. Through the application of research studies and theory, evidence based practice development will lead the profession of nursing into the future whereby knowledge and skills support the practice of providing quality care.

Locate one nursing theory and one non-nursing paper theory. Describe how two practitioners can bring these separate theories together to provide meaningful patient care.

at least 4 reference and 3 parragraf

Please review the Discussion Board Participation grading rubric under Course Resources. This is important information that will ensure that you earn maximum points. Your postings should be qualitative and provide substantive depth that advances the discussion. Please see the Academic Success Center located in the student portal for assistance with writing, APA, and online communication.
 [1 mark]
 a. True negative
 b. False negative
 c. True positive
 d. False positive
 e. Chance event
 

Q6: Answer questions 6a-d based on the following information:
 You have brought to the attention of the hospital medical services that  a  published trial reported reduced body weight in patients with morbid   obesity who were treated with liraglutide, a glucagon-like peptide-1   equivalent. You mentioned this published paper to your Director, and   given the evidence reported, he asked you to give a presentation about   the study findings during the weekly seminar series. In your   presentation, she has asked you to address the following questions   (6a-d) based on the results of the published paper (Edited abstract is   shown below):
 A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight   Management (Xavier Pi-Sunyer, M.D., Arne Astrup, M.D., D.M.Sc., Ken   Fujioka et al. N Engl J Med 2015;373:11-22.
 

DOI: 10.1056/NEJMoa1411892)
 Background: Obesity is a chronic disease with serious health   consequences, but weight loss is difficult to maintain through  lifestyle  intervention alone. Liraglutide, a glucagonlike peptide-1  analogue, has  been shown to have potential benefit for weight  management at a  once-daily dose of 3.0 mg, injected subcutaneously.
 Methods: We conducted a 56-week, double-blind trial involving 3731   patients who did not have type 2 diabetes and who had a body-mass index   of at least 30 or a BMI of at least 27 if they had treated or  untreated  dyslipidemia or hypertension. We randomly assigned patients  in a 2:1  ratio to receive once-daily subcutaneous injections of  liraglutide at a  dose of 3.0 mg (2487 patients) or placebo (1244  patients); both groups  received counselling on lifestyle modification.
 Results: At week 56, patients in the liraglutide group had lost a mean   of 8.4±7.3 kg of body weight, and those in the placebo group had lost a   mean of 2.8±6.5 kg (a difference of -5.6 kg; 95% confidence interval,   -6.0 to -5.1; P 0.001). A total of 63.0% of the patients in the   liraglutide group as compared with 37.0% in the placebo group lost at   least 5% of their body weight (P 0.001).
 Conclusion: In this study, 3.0 mg of liraglutide, as an adjunct to diet   and exercise, was associated with reduced body weight and improved   metabolic control.
 Q6a. Construct a 2×2 table using relevant figures shown in the abstract, and answer the following questions: [4 marks]
 (i) What is the risk of losing at least 5% of body weight in all patients included in the study?
 (ii) What is the risk of losing at least 5% of body weight in patients who were treated with liraglutide?
 (iii) What is the risk of losing at least 5% of body weight in patients who were treated with placebo?
 (iv) What is the relative risk of treatment with liraglutide verus   placebo with regard to weight management? How would you interpret this   relative risk estimate?
 Q6b. If equal numbers of patients in the population were treated with   liraglutide vs placebo treatment, what would be the expected population   relative risk reduction (RRR) for liraglutide treatment? How would you   interpret this measure? [4 marks]
 Q6c. How many patients need to be treated with liraglutide for one more   patient to benefit compared with the placebo? What is this measure   called? How would you interpret this measure [4 marks]?
 Q6d. How does the measure in question 5b differ from question 5c? [4 marks]
 

Read the attached original research article (Khorana et al., 2019), available in vUWS), and now answer Questions 7 to 9:

Epidemiology paper – Family Nurse Practitioner

Requirements:

This paper should clearly and comprehensively identify the chronic health disease: 

Alcohol Addiction, as this is a chronic disease that is in high prevalence here in Miami Florida that causes many health disparities for the community

The paper should be organized into the following sections:

Introduction (Identification of the problem) with a clear presentation of the problem as well as the significance and a scholarly overview of the paper’s content. No heading is used for the Introduction per APA current edition. 

Background and Significance of the disease, to include: Definition, description, signs and symptoms, and current incidence and/or prevalence statistics by state with a comparison to national statistics pertaining to the disease.  Create a table of incidence or prevalence rates by your geographic county/city or state with a comparison to national statistics. Use the APA text for formatting guidelines (tables). This is a table that you create using relevant data, it should not be a table from another source using copy/paste.

Surveillance and Reporting: Current surveillance methods and mandated reporting processes as related to the chronic health condition chosen should be specific.

Epidemiological Analysis: Conduct a descriptive epidemiology analysis of the health condition. Be sure to include all of the 5 W’s: What, Who, Where, When, Why. Use details associated with all of the W’s, such as the “Who” which should include an analysis of the determinants of health. Include costs (both financial and social) associated with the disease or problem.

Screening and Guidelines: Review how the disease is diagnosed and current national standards (guidelines). Pick one screening test (review Week 2 Discussion Board) and review its sensitivity, specificity, predictive value, and cost. 

Plan: Integrating evidence, provide a plan of how a nurse practitioner will address this chronic health condition after graduation. Provide three specific interventions that are based on the evidence and include how you will measure outcomes (how will you know that the interventions have utility, are useful?) Note:  Consider primary, secondary, and tertiary interventions as well as the integration of health policy advocacy efforts. All interventions should be based on evidence – connected to a resource such as a scholarly piece of research. 

Summary/Conclusion: Conclude in a clear manner with a brief overview of the keys points from each section of the paper utilizing integration of resources. 

The paper should be formatted and organized into the following sections which focus on the chosen chronic health condition.

Preparing the Paper:

Page length: 7-10 pages, excluding title page and references. 

APA format current edition

Include scholarly in-text references throughout and a reference list.

ASSIGNMENT CONTENT 

Identification of the Health Problem 

Comprehensively and succinctly states the problem/concern. Clear presentation of the problem as well as the significance with a scholarly overview of the paper’s content. 

Background and Significance of the Health Problem 

Background and significance is complete, presents risks, disease impact and includes a review of incidence and prevalence of the disease within the student’s state compared to national data. Evidence supports background. A student created table is included using APA format. 

Current Surveillance and Reporting Methods 

Current state and national disease surveillance methods are reviewed along with currently gathered types of statistics and information on whether the disease is mandated for reporting. Supported by evidence. 

Descriptive Epidemiological Analysis of Health Problem 

Comprehensive review and analysis of descriptive epidemiological points for the chronic health problem. The 5 W’s of epidemiological analysis should be fully identified. Supported by scholarly evidence. 

Screening, Diagnosis, Guidelines 

Review of current guidelines for screening and diagnosis. Screening tool statistics related to validity, predictive value, and reliability of screening tests are presented. 

Plan of Action 

Integrating evidence, provide a plan of how a nurse practitioner will address this chronic health condition after graduation. Provide three specific interventions that are based on the evidence and include how you will measure outcomes (how will you know that the interventions have utility, are useful?) Note:  Consider primary, secondary, and tertiary interventions as well as the integration of health policy advocacy efforts. All interventions should be based on evidence – connected to a resource such as a scholarly piece of research. 

Conclusion 

The conclusion thoroughly, clearly, succinctly, and logically presents major points of the paper with clear direction for action. Includes scholarly references 

Rubric

Introduction of Healthcare Problem/Concern

Comprehensively and succinctly states the problem/concern. Clear presentation of the problem as well as the significance with a scholarly overview of the paper’s content.

Background/Significance

Background and significance is complete, presents risks, disease impact and includes a review of incidence and prevalence of the disease within the student’s state compared to national data. Evidence supports background. A student created table is included.

Surveillance and Reporting

Current state and national disease surveillance methods are reviewed along with currently gathered types of statistics and information on whether the disease is mandated for reporting. All writing is supported by evidence.

Descriptive Epidemiology

Comprehensive review and analysis of descriptive epidemiological points for the chronic health problem. The 5 W’s of epidemiological analysis should be fully identified. Supported by scholarly evidence.

Screening, Diagnosis, Guidelines

Comprehensive review of current guidelines for screening and diagnosis. Screening tool statistics related to validity, predictive value, and reliability of screening tests are presented

Plan

Integrating evidence, provide a plan of how a nurse practitioner will address this chronic health condition after graduation. Provide three specific interventions that are based on the evidence and include how you will measure outcomes (how will you know that the interventions have utility, are useful?) Note:  Consider primary, secondary, and tertiary interventions as well as the integration of health policy advocacy efforts. All interventions should be based on evidence – connected to a resource such as a scholarly piece of research.

Summary/Conclusion

The conclusion thoroughly, clearly, succinctly, and logically presents major points of the paper with clear direction for action. Includes scholarly references.

Format

APA is consistently utilized according to the 6th edition throughout the paper.
 Q7. 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. (Q8 will address relevance,   and the next question will ask how to determine the importance of the   findings…for this question, focus on the internal validity of the  study)  [8 marks]
 Q8. What characteristics of the findings would you consider, in order,   to determine if they are clinically meaningful and statistically   significant? Include examples. (You’ve already addressed validity…for   this question, focus on how to determine the clinical significance and   statistical significance of an effect reported in the study) [8 marks]
 Q9. 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. (Questions 6 and 7 have asked how to determine if   the study is valid, and how important the findings are….for this   question, focus on how to determine if it is really relevant or   generalizable to your practice.) [8 marks]
 Note:
 0 Please do not list the characteristics in questions 8–10, but explain your answers succinctly.

  0  For assistance with finding sources, refer to the Current Peer-Reviewed, and Other Scholarly Citation Sources document. Carefully review the Grading Rubric for the criteria that will be used to evaluate your assignment.
 0 You can also download the article from the University Library using your student login details.