PH671 Instructions Impact of Community Centered Health Care Programs on The Treatment of HIV Positive Drug and Substance Abuser Please research models for a good study protocol paper, starting with the Wilson et al. (2013) article that you read during Module 1 at the beginning of the course. Use the example(s) you find as a guide to develop your own study protocol paper that conforms to the following formatting guidelines: ▪ ▪ ▪ ▪ ▪ 6-8 pages, Microsoft Word Single-spaced 12-point standard font Moderate or normal margin settings APA-style references and reference list Program Learning Outcomes ▪ ▪ ▪ ▪ PLO 1. Evaluate collaborative health promotion and disease prevention programs/interventions using biostatistics, epidemiological principles and other evidence-based research as a source for appropriate planning and implementation strategies. PLO 2. Conduct evidence-based research to improve the health and wellbeing of the public and to advance the public health profession. PLO 3. Convey prevention and intervention strategies across diverse communities and populations with the goal of improving health outcomes using culturally appropriate communication and technology. PLO 5. Impact the health outcomes of communities through the use of data gained from the appraisal of their essential services, systems, and public policies. Course Learning Outcomes ▪ CLO 1. Apply skills, abilities, and models of practice/frames of reference gained across experiences both in the seminar and the field to solve problems or explore issues in health promotion and disease prevention (Aligns with PLO 1). ▪ ▪ ▪ ▪ ▪ CLO 2. Demonstrate the ability to construct a problem statement with evidence of the most relevant contextual factors as it relates to health promotion and disease prevention (Aligns with PLO 1). CLO 3. Evaluate the effectiveness of interventions observed during fieldwork to hypothesize solutions to improve public health outcomes (Aligns with PLO 2). CLO 4. Develop conceptual abilities such as critical thinking; problemsolving; policy and practice understanding; encouragement and facilitation of community organizing, involvement and education (Aligns with PLO 3). CLO 5. Develop a culturally appropriate communication plan to disseminate fieldwork experience/recommendations among affected communities and/or populations (Aligns with PLO 3). CLO 7. Employ practitioner skills for application in fieldwork/professional contexts, such as focused research, presentations, writing for multiple audiences, communications and analysis (Aligns with PLO 5). Module Learning Outcomes ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ MLO 2. Summarize the relevance of a selected public health research problem and identify appropriate analytical tools to examine it (Aligns with CLO 1). MLO 3. Find, use and interpret sources of public health data that utilizes multiple research methods to inform the development of problem statement (Aligns with CLO 2). MLO 4. Collect data and information from varied sources with enough interpretation/evaluation to develop a coherent analysis plan and recommendations to improve a public health problem (Aligns with CLO 3). MLO 5. Appraise community health needs in relation to selected public health research problem (Aligns with CLO 4). MLO 6. Summarize evidence-based and community-informed solutions to observed public health problem identified during fieldwork placement (Aligns with CLO 4). MLO 7. Explain the critical components of effective communication targeted at community and/or population affected by the activities of fieldwork organization (Aligns with CLO 5). MLO 10. Develop a research protocol to guide Capstone Research (Aligns with CLO 7). MLO 11. Present Capstone research problem statement, its public health relevance and analysis plan to an audience of peers (Aligns with CLO 7). PH671 Instructions Impact of Community Centered Health Care Programs on The Treatment of HIV Positive Drug and Substance Abuser Please research models for a good study protocol paper, starting with the Wilson et al. (2013) article that you read during Module 1 at the beginning of the course. Use the example(s) you find as a guide to develop your own study protocol paper that conforms to the following formatting guidelines: ▪ ▪ ▪ ▪ ▪ 6-8 pages, Microsoft Word Single-spaced 12-point standard font Moderate or normal margin settings APA-style references and reference list Program Learning Outcomes ▪ ▪ ▪ ▪ PLO 1. Evaluate collaborative health promotion and disease prevention programs/interventions using biostatistics, epidemiological principles and other evidence-based research as a source for appropriate planning and implementation strategies. PLO 2. Conduct evidence-based research to improve the health and wellbeing of the public and to advance the public health profession. PLO 3. Convey prevention and intervention strategies across diverse communities and populations with the goal of improving health outcomes using culturally appropriate communication and technology. PLO 5. Impact the health outcomes of communities through the use of data gained from the appraisal of their essential services, systems, and public policies. Course Learning Outcomes ▪ CLO 1. Apply skills, abilities, and models of practice/frames of reference gained across experiences both in the seminar and the field to solve problems or explore issues in health promotion and disease prevention (Aligns with PLO 1). ▪ ▪ ▪ ▪ ▪ CLO 2. Demonstrate the ability to construct a problem statement with evidence of the most relevant contextual factors as it relates to health promotion and disease prevention (Aligns with PLO 1). CLO 3. Evaluate the effectiveness of interventions observed during fieldwork to hypothesize solutions to improve public health outcomes (Aligns with PLO 2). CLO 4. Develop conceptual abilities such as critical thinking; problemsolving; policy and practice understanding; encouragement and facilitation of community organizing, involvement and education (Aligns with PLO 3). CLO 5. Develop a culturally appropriate communication plan to disseminate fieldwork experience/recommendations among affected communities and/or populations (Aligns with PLO 3). CLO 7. Employ practitioner skills for application in fieldwork/professional contexts, such as focused research, presentations, writing for multiple audiences, communications and analysis (Aligns with PLO 5). Module Learning Outcomes ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ MLO 2. Summarize the relevance of a selected public health research problem and identify appropriate analytical tools to examine it (Aligns with CLO 1). MLO 3. Find, use and interpret sources of public health data that utilizes multiple research methods to inform the development of problem statement (Aligns with CLO 2). MLO 4. Collect data and information from varied sources with enough interpretation/evaluation to develop a coherent analysis plan and recommendations to improve a public health problem (Aligns with CLO 3). MLO 5. Appraise community health needs in relation to selected public health research problem (Aligns with CLO 4). MLO 6. Summarize evidence-based and community-informed solutions to observed public health problem identified during fieldwork placement (Aligns with CLO 4). MLO 7. Explain the critical components of effective communication targeted at community and/or population affected by the activities of fieldwork organization (Aligns with CLO 5). MLO 10. Develop a research protocol to guide Capstone Research (Aligns with CLO 7). MLO 11. Present Capstone research problem statement, its public health relevance and analysis plan to an audience of peers (Aligns with CLO 7). PH671MPH Presentation Grading Rubric Criteria Assessed Exemplary Proficient Developing Needs Improvement Content The presentation thoroughly addresses each of the required topics and objectives for the assignment, as outlined in the syllabus. The presentation shows comprehension of the relevant research on the topic, and all sources used for the assignment are reliable and peer-reviewed. The presentation sufficiently addresses each of the required topics and objectives for the assignment as outlined in the syllabus. The presentation shows adequate comprehension of the relevant research on the topic, and most sources used for the assignment are reliable and peerreviewed. The presentation addresses some of the required topics and objectives for the assignment, as outlined in the syllabus, but some areas require further elaboration. In addition, comprehension may seem limited for some topics presented. Some sources are peer-reviewed and reliable, but others may not be. The presentation may address some of the required topics and objectives for the assignment, but many important points are missing, making the presentation incomplete. Relevant and peerreviewed research is lacking to support the material presented. The presentation may show a lack of comprehension in many areas. The presentation demonstrates superior presentation skills. The presenter(s) is(are) consistently professional, well-prepared, show comfort speaking, and adhere to the time limit. The presentation demonstrates adequate presentation skills. There may be an area for improvement, such as less reading from notes, adhering to the time limit, speed or volume of speaking, etc. The presentation may demonstrate some adequate presentation skills, but more than one area needs significant improvement. Points to improve may include less reading from notes, adhering to the time limit, speed or volume of speaking, etc. The presentation demonstrates significant need for improvement across several types of presentation skills. This may include several of the following: less reading from notes, adhering to the time limit, speed and volume of speaking, etc. The presentation demonstrates exceptional creativity and use of a variety of modalities to complete the presentation, such as activities, games, multimedia, etc. The presentation demonstrates adequate creativity and use of at least the required modalities to complete the presentation, such as activities, games, multimedia, etc. The presentation may demonstrate some creativity; however, the presentation does not meet the minimum level of creativity assigned for the presentation, and more creativity is desired for effective delivery of information. The presentation demonstrates little or no creativity. The presentation does not meet the minimum level of creativity assigned for the presentation, and significantly more creativity is desired for effective delivery of information. Thoroughly addresses all required topics and objectives, and evidence of adequate research. 50% of grade Presentation Skills Voice/volume, professionalism, speaking (not reading) to class, and adherence to time limits. 30% of grade Creativity Using more than one mode to deliver information, such as role plays, visual aids, PowerPoint, etc. 20% of grade Combatting Childhood Obesity 1 Combatting Childhood Obesity in Children with Autism Spectrum Disorder: An Assessment and Evaluation of the Modifiable Risk Factors and CHANGE Intervention A Study Protocol Paper Presented to Example ONLY Combatting Childhood Obesity 2 Protocol Outline Protocol Title: Combatting Childhood Obesity in Children with Autism Spectrum Disorder: An Assessment and Evaluation of the Modifiable Risk Factors and CHANGE Intervention Protocol Version: Version 1 Protocol Date: December 11, 2017 Principal Investigator: Crystal Marie Smith I. Abstract Summary of the study background, aims, and design. II. Background and Significance/Preliminary Studies Current environment that is the basis for the proposed research. Evaluation of current knowledge and preliminary studies related to the proposed research and describe how this proposal will enhance this knowledge. III. Study Aims Purpose of the study, including identification of specific primary objectives/hypotheses and secondary objectives/hypotheses. IV. Administrative Organization Setting description V. Study Design a. Experimental design of the study b. Study population general description c. Sample size determination d. Study outcomes VI. Study Procedures a. Subject selection procedures i. Sampling plan including Inclusion/Exclusion criteria ii. Recruitment procedures 1. Where will recruitment occur? 2. Where and when will consent be obtained? 3. Who will obtain consent? 4. What is the advertising plan? 5. What recruitment materials will be provided to the potential participant? Combatting Childhood Obesity iii. Screening procedures 1. What procedures are required for screening? 2. What is the screening schedule? 3. Which screening tests/procedures are part of standard care and which are for research purposes only? 4. What happens with screen failures? b. Randomization procedures c. Study Intervention 1. Active intervention description 2. Control group, if applicable d. Study Assessments and Activities i. Description of study procedures, assessments, and subject activities ii. Provide a schedule of all study assessments and subject activities VII. Analysis Plan Describe statistical analysis methods as appropriate. VIII. Ethical Considerations Description of ethical considerations related to the study IX. Anticipated Outcomes X. Literature Cited 3 Combatting Childhood Obesity 4 Abstract Many studies have concluded that there is a direct correlation between modifiable risk factors, such as dietary intake and physical activity, and obesity in children with autism spectrum disorder, however despite the availability of guidelines for the prevention, assessment, and treatment of obesity in children without ASD, no such guidelines or obesity programs exist for children who have been diagnosed with autism spectrum disorder. The purpose of this study will be to assess the modifiable risk factors for obesity in children with autism spectrum disorder and evaluate the feasibility of the Changing Health in Autism through Nutrition, Getting Fit, and Expanding variety (CHANGE) intervention created by researchers at the Marcus Autism Center. The manual consists of a set of effective techniques designed to increase dietary diversity and promote physical activity, packaged into a parent as co-therapist intervention. A feasibility study will be conducted to test efficacy and eventual dissemination. The study design will utilize the randomized control trial in which 11 children age 5-12 who are both autistic and obese will receive the intervention. The study will analyze data collected at baseline, week 12, week 16, and week 20 to determine if the children will see a reduction in BMI and an increase in both frequency and duration of physical activity. Data collected will include anthropometric parameters, 3 day food diaries, analysis of food selectivity, behavioral observations, and parent ratings of child behavior and caregiver stress. Paired T tests will be used to determine if there is a statistical significance from baseline to week 20 on variables of interest. It is anticipated that study participants will see both a reduction in BMI ratio and an increase in both the frequency and duration of physical activity. Background Obesity is expanding at alarming rates in pediatric populations. In the US, as many as 32% of children between the ages of 2 and 19 years are overweight and 16% are obese (Ogden, Carroll, Kit, & Flegal, 2012). Childhood obesity is associated with a number of detrimental health outcomes, including impaired glucose tolerance, Type 2 diabetes, and an increased risk for cardiovascular and non-alcoholic fatty liver disease (Wang & Lobstein, 2006). In addition to these physical comorbidities, obese children also experience low self-esteem and have a negative self-image. 52% of these obese children become obese adults who have an increased risk of developing cardiovascular disease and cancer, along with experiencing the same adverse psychological effects. Childhood obesity has significant health, social, and financial consequences. “The national cost of childhood obesity is estimated at approximately $11 billion for children with private insurance and $3 billion for those with Medicaid annually” (Thomson MedStat Research Brief, 2006). If rates continue to increase at this rapid pace, “the total healthcare costs attributable to obesity/overweight in the U.S. would double every decade to $860.7– 956.9 billion by 2030, accounting for 16– 18% of total US health-care costs” (Wang, Liang, Caballero, & Kuman, 2008). Such staggering individual and societal costs underscore treatment of childhood obesity as a worldwide public health priority, particularly among vulnerable pediatric subgroups. Growing evidence suggests that children with autism spectrum disorder (ASD) are significantly more likely to be obese compared with the general pediatric population. The estimated prevalence of obesity in children with ASD ranges from 10% to 31.8% (Whitely, Phillips), with odds ratios ranging from 1.16 to 4.83. Given that ASD affects as many as 14.7 children per 1000, the increased risk of obesity in this population poses a public health challenge. Combatting Childhood Obesity 5 Significance Modifiable factors are seen as critical to combatting childhood obesity. Schools and communities were targeted in the mid 1990’s when the Centers for Disease Control and Prevention provided guidelines for health promotion. In 1996, the Centers for Disease Control and Prevention published the Guidelines for School Health Programs to Promote Lifelong Healthy Eating and in 1997 the Guidelines for School and Community Programs to Promote Lifelong Physical Activity among Young People was subsequently published. Surveillance on obesity rates are conducted via the Behavioral Risk Factor Surveillance System (BRFSS), National Health and Nutrition Examination Survey (NHANES), and the Youth Risk Behavior Surveillance System (YRBSS). In 2001, the Surgeon General’s Call to Action to Prevent and Decrease Overweight and Obesity was published by the United States Department of Health and Human Resources. This document targeted diet, nutrition education, physical education, and parental influence. The Surgeon General’s Call to Action to Prevent and Decrease Overweight and Obesity suggested families incorporate physical activity into their regular, everyday routines, as well as at playtime, with a goal of at least 60 minutes per day. In addition, it advocated for an increase in the amount of time allocated and quality of physical education offered at schools, and the provision of healthy foods and beverages served on campus and during events held at schools. Despite the availability of guidelines for the prevention, assessment, and treatment of obesity in children without autism spectrum disorder, currently none are specifically developed for children with autism spectrum disorder. Results from studies where children who don’t have autism may not be applicable to those who do, mainly because autistic children have a combination of behavioral, developmental, and social deficits associated with the disease. Autistic children are more likely to suffer from feeding disorders, more specifically, food selectivity. Their diet typically consists of a strong affinity for starch and processed foods, while being biased towards to fresh fruit and vegetables. In addition, attempts to introduce new foods are often met with tantrums and adverse behavior. This combination complicates the application of current obesity interventions that promote the consumption of nutrient dense meals. In order to develop an effective intervention to combat childhood obesity in children with autism spectrum disorder, a multidisciplinary approach in the form of treatment of food selectivity, nutrition management, and behavioral analysis must be taken. This approach resulted in the development of CHANGE (Changing Health in Autism through Nutrition, Getting Fit, and Expanding Variety). Research Questions What are the modifiable risk factors for obesity in children with autism spectrum disorder? Is obesity in children with autism spectrum disorder medically induced or a result of food selectivity and physical inactivity? How effective is the CHANGE intervention in combatting childhood obesity in children with autism spectrum disorder? Study Aims Combatting Childhood Obesity 6 The overall aim of this paper is to assess the modifiable risk factors associated with childhood obesity in children diagnosed with autism spectrum disorder, and evaluate the effectiveness of the CHANGE intervention in utilizing parents as co-therapists and agents of change. Objectives Primary Objective: To assess the modifiable factors associated with obesity in children with autism spectrum disorder to determine if obesity is medically induced or a result of food selectivity and physical inactivity Secondary Objective: To evaluate the effectiveness of the CHANGE intervention in treating autistic children who have a BMI >=95th percentile. Administrative Organization This study was conducted at the Marcus Autism Center in the Pediatric Feeding Disorders Department. This department is well equipped to conduct this proposed research as it currently has the equipment and resources in place to implement and evaluate the treatment of chronic food aversion. The program treats over 80 patients per week for feeding and other identified nutritional problems. The staff consists of behavioral psychologists, registered dietitians, speech and language pathologists, occupational therapists, and a pediatric gastroenterologist. Study Design A. Open trial/randomized control trial B. 11 children age 5-12 who have been clinically diagnosed with autism spectrum disorder and who have a BMI>=95th percentile. C. This sample size is sufficient for feasibility. D. This trial will test the impact of the CHANGE intervention on the key outcome variables of BMI ratio, frequency of physical activity, and duration of physical activity. Sampling Plan Inclusion: Boys and girls who are age 5-12 who have been clinically diagnosed as autistic; Mild food selectivity as evidenced by a diet consisting of at least 6 food items with at least one being a fruit or vegetable; Clinically diagnosed as obese (BMI >= 95th percentile); Primary caregiver consents to participating in treatment sessions and can read, write, and understand English Combatting Childhood Obesity 7 Exclusion: Children with severe feeding disorders; Children who are currently taking medication to gain weight; Children being treated for adverse behavior Recruitment: Participants were recruited through an open trial via crossover from other studies and community organizations. Rolling recruitment will take place over the course of six months. A minimum of two participants per month is expected. Over 5,000 children per year are seen at the Marcus Autism Center, so meeting the participant threshold is possible. Consent will be obtained during the screen by the research coordinator. Advertising Plan: Flyers were distributed during health fairs, at partner facilities, and during community events. Screening Procedures: During screening, participants will receive an autism diagnosis. This will be completed via the use of the Autism Diagnostic Observation Schedule (ADOS), Vineland, and cognitive testing. These tests are part of the standard of care and not for research purposes only. Parents of eligible participants will be invited to return for baseline to confirm participants meet inclusion/exclusion criteria. Participants assigned will be asked to return for assessment, immediately following treatment and 1 month post-treatment. Screen fails will be notified and given the option to participate in another study. Randomization: Each participant will be assigned a 5 digit number when their data is input into Marcus’ data exchange system known as DEX. The participants going forward will then be identified by that number. Once the DEX system assigns each participant a number, the numbers will then be allocated to either the treatment group or the control group. Intervention: CHANGE (Changing Health in Autism through Nutrition, Getting Fit and Expanding Variety); manual that provides techniques to increase dietary diversity and promote physical activity while using parents as co-therapists. Aim is to provide a cost-effective, exportable intervention to combat childhood obesity in autistic children. Study Assessments and Activities: Bambi: 18-item parent rated measure of mealtime behavior Three Day Food Diary: Completed by parents to record the child’s daily intake. Registered dietitian will tally intake of pre-identified macro and micronutrients. Nutritional status is evaluated by assessing the levels of these macro and micronutrients. Food Preference Inventory (FPI): 154-item parent rated item that measures food selectivity. The FPI includes seven categories of food which consisted of fruits, vegetables, protein, starch, dairy, Combatting Childhood Obesity 8 snacks, and combination foods. Score is determined by number of foods reported as never consumed/154x100 Growth Status: Obtained by staff. Anthropometric data is collected and BMI is calculated. Physical Activity Logs: Parents track date, type, and duration of exercise Meal Observations: Rated by trained observers. The child’s caregiver is instructed to present the child with small bites in intervals of 30 seconds. Non-preferred fruit and vegetables are utilized during the observation. Outcomes evaluated include acceptance of the food item, swallowing, and grams consumed Parenting Stress Index Short Form (PSI): 36-item survey that measures parental stress Data was collected at screen/baseline, week 12, week, 16, and week 20. This data was then input into the DEX software system for analysis. Utilized literature reviews to collect data regarding the risk factors for autistic children who are obese. Data include categorized into two categories: Obese due to medication or Obese due to diet/physical activity ADOS and Vineland tests were used during screen. Subsequent data was collected from the remaining assessments during baseline, week 12, week 16, and week 20. Data Analysis Plan Paired T tests will be used to examine the change in primary outcomes before and after treatment. Ethical Considerations: Participants will be de-identified. After participants have been accepted into the study, they will be assigned a 5 digit number known as the DEX ID number. All documentation related to the participants will utilize the DEX ID. Researchers are required to obtain consent and will advise participants of their right to drop out of the study at any time. Anticipated Outcomes I anticipate the results of this study to show that participants in the treatment group of the CHANGE intervention will see a reduction in BMI ratio and increased frequency and duration of physical activity. In addition, the results will promote research on the use of manual-based, interdisciplinary intervention to improve weight management in children diagnosed with autism spectrum disorder. The development of a treatment manual with corresponding decision Combatting Childhood Obesity algorithm matrix will also support randomized control trials, which have not been implemented to treat obesity in the autism spectrum disorder population. 9 Combatting Childhood Obesity 10 References Bandini, L. G., Anderson, S. E., Curtin, C., Cermak, S., Evans, E. W., Scampini, R., Maslin, M., & Must, A. (2010). Food selectivity in children with autism spectrum disorders and typically developing children. The Journal of Pediatrics, 157(2), 259–264. http://doi.org/10.1016/j.jpeds.2010.02.013 Cermak, S. A., Curtin, C., & Bandini, L. G. (2010). Food selectivity and sensory sensitivity in children with autism spectrum disorders. Journal of the American Dietetic Association, 110(2), 238–246. http://doi.org/10.1016/j.jada.2009.10.032 Curtin, C., Jojic, M., & Bandini, L. G. (2014). Obesity in children with autism spectrum disorders. Harvard Review of Psychiatry, 22(2), 93–103. http://doi.org/10.1097/HRP.0000000000000031 Griswold, A. (2016). Side effects of meds weigh heavily on children with autism. Retrieved from https://spectrumnews.org. Hill, A. P., Zuckerman, K. E., & Fombonne, E. (2015). Obesity and Autism. Pediatrics, 136(6), 1051–1061. http://doi.org/10.1542/peds.2015-1437 Ogden, C.L., Carroll, M.D., Kit, B.K., & Flegal, K.M. (2012). Prevalence of obesity and trends in body mass index among US children and adolescents, 1999-2010. Journal of the American Medical Association, 307(5), 483-490. Phillips, K.L., Schieve, L.A., Visser, S., et al. (2014). Prevalence and impact of unhealthy weight in a national sample of US adolescents with autism and other learning and behavioral disabilities. Maternal and Child Health Journal, 18(8), 1964–1975. Thomson MedStat Research Brief. (2006). Childhood obesity: Costs, treatment patterns, disparities in care and prevalent medical conditions. Retrieved from http:// www.medstat.com/pdfs/childhood_obesity.pdf. Wang, Y., Beydoun, M., Liang, L., Caballero, B., & Kuman, S. (2008). Will all Americans become overweight or obese? Estimating the progression and cost of the U.S. obesity epidemic. Obesity, (16), 2323-2330. Wang, Y., Lobstein, T. (2006). Worldwide trends in childhood overweight and obesity. International Journal Pediatric Obesity, 1, 11–25. Whitely, P., Dodou, K., Todd, L., et al. (2004). Body mass index of children from the United Kingdom diagnosed with developmental disorders. Pediatrics International, 46(5), 531–533. Wright, J. (2015). Obesity takes heavy toll on children with autism. Retrieved from https://spectrumnews.org. Zuckerman, K. E., Hill, A. P., Guion, K., Voltolina, L., & Fombonne, E. (2014). Overweight and obesity: Prevalence and correlates in a large clinical sample of children with autism spectrum Combatting Childhood Obesity disorder. Journal of Autism and Developmental Disorders, 44(7), 1708–1719. http://doi.org/10.1007/s10803-014-2050-9 . 11 Protocol # & Version date A GUIDE TO WRITING A RESEARCH PROTOCOL The purpose of this template is to assist investigators and study personnel in planning and conducting their research projects. It is important to note that: ➢ A well-written and complete protocol is essential for achieving a high quality research study. ➢ Time spent on writing a detailed protocol will avoid problems during the study conduct, and will make publishing the results easier. ➢ A complete protocol is also essential for the study to be approved by the ethics committee. The following is a tool to facilitate the development of a Research Protocol. It is by no means a definitive layout for a protocol but more to provide guidance to the kind of things expected. Not all of these sections will be relevant for every protocol and the exact form of your protocol will depend on the specific study research design. It is recommended that the section headings in the Research Protocol should not be deleted. An * indicates sections that should appear in all protocols. General comment ✓ Make sure to include page numbering in the form of “X of Y” (1 of 10, 2 of 10 etc.) in the footer of the document – as shown in this document ✓ Indicate the date of the draft, or once it has been formally submitted for approval, the date of the version in the header or footer ✓ Always use the same Research Protocol title throughout your document and all related documents such as Informed Consent, submission applications etc. ✓ Italic content is for reference only and must be deleted from the final Research Protocol Document ✓ Once done, update “Table of Content” by clicking on the table of content and clicking on Update Table, then click on Update Entire Table Page 1 of 6 Protocol # & Version date “Title of Research Protocol / Project” Investigators & personnel Indicate the principal investigator Other investigators and /or Study Personnel and their affiliations Institution(s) responsible for the running of the study Contents 1. Synopsis................................................................................................................................................. 3 2. Abbreviations and Acronyms ................................................................................................................ 3 3. Introduction / Background * ................................................................................................................. 3 4. Objectives *........................................................................................................................................... 3 5. Study Methodology * ............................................................................................................................ 3 6. Study population ................................................................................................................................... 4 7. Study procedure * ................................................................................................................................. 4 8. Data Management * ............................................................................................................................. 4 9. Adverse Event Reporting ...................................................................................................................... 5 10. Statistical Analysis ............................................................................................................................ 5 11. Quality assurance, monitoring & safety............................................................................................ 5 12. Ethical Issues ..................................................................................................................................... 5 13. Finance and resource use* ............................................................................................................... 5 14. Dissemination of Results and Publication policy .............................................................................. 5 15. References *...................................................................................................................................... 6 16. Appendices ........................................................................................................................................ 6 Page 2 of 6 Protocol # & Version date 1. Synopsis This is similar to an abstract and should be about the same length (250-300 words). It acts as a stand alone summary of the study and should be present in large protocols. It generally consists of 1-2 sentences background then the concise objective or aim followed by a brief outline of description of participants, intervention, methods, outcome measures and proposed analysis. 2. Abbreviations and Acronyms List Abbreviations and Acronyms 3. Introduction / Background * This should include the following: ➢ Introduction to the topic of interest. ➢ What is known already - literature review of relevant findings (Brief and focused) ➢ Highlight area where there is missing information in the literature ➢ State the aims of this study– what the study is going to find out, and in one sentence how this is going to be achieved. ➢ Impact - this is where you indicate how the study will substantially add to science, change practice, save money and best of all save lives or improve quality of life in substantial numbers of people. Include an economic impact if possible. (note impact is sometimes placed at the end of the protocol) ➢ A handful of relevant references The background should not be an exhaustive literature review. At the end the reader should have a clear idea of what is the research question, an understanding that it is original and relevant, and how this research will help fill the gap in the literature. 4. Objectives * ➢ Clear statement of primary and secondary objectives of the study ➢ If relevant include a clearly defined hypothesis here 5. Study Methodology * ➢ Describe study * • Type of study • Where is it going to be carried out (also known as setting) • Sample size calculation or justification of numbers (Should be based on previous data ) ➢ Study comparison & intervention * • What interventions are you comparing? If you are doing a cohort study or survey then what are the exposures or predictors of interest? • Details of the interventions – this has to be very detailed if you are planning a drug / device study. Page 3 of 6 Protocol # & Version date 6. Study population ➢ Subjects * • Source of participants - where and when are you going to recruit them? • How many participants? • Inclusion/Exclusion criteria 7. Study procedure * ➢ Patient informed consent process, if applicable ➢ Details on how interventions are going to be delivered if applicable Who is going to deliver them? Blinding For randomized studies; how patients are going to be randomized (a simple diagram showing treatment arms is often useful here) ➢ Other details of particular ways the subject will be treated during the study independent to the specific intervention(s) (for example will other drugs not be allowed or will patient’s diet or environment be controlled) ➢ Outcome * (Note there should be only one primary outcome) • What are the primary and secondary outcomes • Details of the outcome measures used ➢ Data collection * • What data are you going to collect, how is it collected, who collects it and when? ✓ Details of intervention data ✓ Details of outcome data ✓ Details of all demographic data and other potentially confounding data ✓ Details of safety data and adverse events ➢ Further subject follow-up, if applicable • When and for what? Especially for adverse events • How often? • What data is collected at each time point? ➢ Study timelines: Expected duration of the study& start times, stages of the study such as screening, treatment phase (Visit numbers), etc ➢ Patients withdrawal • Are there any conditions that will cause a patient to be withdrawn from the study? • What happens if a patient wishes to withdraw consent? ➢ Risk / benefit 8. Data Management * ➢ Where and how is data going to be stored? Page 4 of 6 Protocol # & Version date • Case record forms • Database ➢ Will there be any attempts to de-identify data? ➢ Privacy and Confidentiality 9. Adverse Event Reporting ➢ Provide a definition of an Adverse Event (AEs) and Serious Adverse Event (SAEs) based on the study ➢ Include methods and timings for assessing, recording, and managing adverse events and safety parameters ➢ Also include how will you report these procedures and stopping rules for a study participant 10. Statistical Analysis ➢ Analysis plan • Details on how the primary and secondary outcomes will be analysed. • Statistical methods to be used • Who is going to carry out the analysis? 11. Quality assurance, monitoring & safety Any external committees overseeing the study such as Study Steering Committees or Data and Safety Monitoring Committees? ✓ Will there be an interim analysis? ✓ How will adverse events be identified and acted upon? ✓ Are there any specific safety measures or is there important safety data being collected? 12. Ethical Issues ✓ ✓ ✓ ✓ 13. Have interventions been used before? What goes beyond standard practice? Identify and justify any dual relationships, coercion or inducement Identify and justify any non-negligible risk or burden Finance and resource use* Details of funding bodies Budget including direct and indirect costs 14. Dissemination of Results and Publication policy The protocol should specify not only dissemination of results in the scientific media, but also to the community and/ or the participants, and consider dissemination to the policy makers where Page 5 of 6 Protocol # & Version date relevant. Publication policy should be clearly discussed- for example who will take the lead in publication and who will be acknowledged in publications, etc. 15. References * 16. Appendices Page 6 of 6
Purchase answer to see full attachment