A protocol is a document that serves as a work plan for your knowledge synthesis. It is important to write one to help guide you through the process, even if things change along the way. If your methods do change, it is important to document those changes in your final manuscript as well. For example, Cochrane reviews have a section called ‘Differences between protocol and review’ in their completed reviews.
The PRISMA guidelines for the transparent reporting of systematic reviews and meta-analyses define a protocol as a document that "describes the rationale, hypothesis, and planned methods of the review. It should be prepared before a review is started and used as a guide to carry out the review."
For systematic reviews, the PRISMA website provides several sources of guidance on writing a protocol
For scoping reviews, the Joanna Briggs Institute provides guidance for writing a protocol in section 11.2 of their chapter on scoping reviews.
In general, your protocol should have the following elements:
- Background literature review
- Review question
- Criteria for inclusion/exclusion of studies
- Types of studies, populations, interventions/exposures, outcome measures
- Search strategy for identification of studies
- Study selection methods
- Assessment of methodological quality [if applicable]
- Data extraction and synthesis
- Timeframe for conducting the review
[Adapted from: Booth, A., Sutton, A. and Papaioannou, D. [2016]. Defining the scope. Systematic Approaches to a Successful Literature Review, 2nd edition.]
1. World Health Organization. Obesity and overweight - Fact sheet [Internet]: World Health Organization, 2016. //www.who.int/mediacentre/factsheets/fs311/en/ [Google Scholar]
2. Afshin A, Forouzanfar MH, Reitsma MB, et al. . Health effects of overweight and obesity in 195 Countries over 25 Years. N Engl J Med 2017;377:NEJMoa1614362 10.1056/NEJMoa1614362 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
3. Barshop NJ, Francis CS, Schwimmer JB, et al. . Nonalcoholic fatty liver disease as a comorbidity of childhood obesity. Ped Health 2009;3:271–81. 10.2217/phe.09.21 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
4. Félix DR, Costenaro F, Gottschall CB, et al. . Non-alcoholic fatty liver disease [Nafld] in obese children- effect of refined carbohydrates in diet. BMC Pediatr 2016;16:187 10.1186/s12887-016-0726-3 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
5. Pulgarón ER. Childhood obesity: a review of increased risk for physical and psychological comorbidities. Clin Ther 2013;35:A18–A32. 10.1016/j.clinthera.2012.12.014 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
6. Kalarchian MA, Marcus MD. Psychiatric comorbidity of childhood obesity. Int Rev Psychiatry 2012;24:241–6. 10.3109/09540261.2012.678818 [PubMed] [CrossRef] [Google Scholar]
7. Cohen AK, Rai M, Rehkopf DH, et al. . Educational attainment and obesity: a systematic review. Obes Rev 2013;14:989–1005. 10.1111/obr.12062 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
8. Miller AL. Neurocognitive processes and pediatric obesity interventions. Pediatr Clin North Am 2016;63:447–57. 10.1016/j.pcl.2016.02.006 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
9. Pizzi MA, Vroman K. Childhood obesity: effects on children’s participation, mental health, and psychosocial development. Occup Ther Health Care 2013;27:99–112. 10.3109/07380577.2013.784839 [PubMed] [CrossRef] [Google Scholar]
10. Buttitta M, Iliescu C, Rousseau A, et al. . Quality of life in overweight and obese children and adolescents: a literature review. Qual Life Res 2014;23:1117–39. 10.1007/s11136-013-0568-5 [PubMed] [CrossRef] [Google Scholar]
11. Tsiros MD, Olds T, Buckley JD, et al. . Health-related quality of life in obese children and adolescents. Int J Obes 2009;33:387–400. 10.1038/ijo.2009.42 [PubMed] [CrossRef] [Google Scholar]
12. Kelsey MM, Zaepfel A, Bjornstad P, et al. . Age-related consequences of childhood obesity. Gerontology 2014;60:222–8. 10.1159/000356023 [PubMed] [CrossRef] [Google Scholar]
13. Wofford LG. Systematic review of childhood obesity prevention. J Pediatr Nurs 2008;23:5–19. 10.1016/j.pedn.2007.07.006 [PubMed] [CrossRef] [Google Scholar]
14. van Hoek E, Feskens EJ, Bouwman LI, et al. . Effective interventions in overweight or obese young children: systematic review and meta-analysis. Child Obes 2014;10:448–60. 10.1089/chi.2013.0149 [PubMed] [CrossRef] [Google Scholar]
15. Pearce M, Webb-Phillips S, Bray I. Changes in objectively measured BMI in children aged 4-11 years: data from the National Child Measurement Programme. J Public Health 2016;38:459–66. 10.1093/pubmed/fdv058 [PubMed] [CrossRef] [Google Scholar]
16. Middleton P, Crowther CA, Simmonds L. Cochrane Pregnancy and Childbirth Group. Different intensities of glycaemic control for pregnant women with pre-existing diabetes Middleton P, Cochrane database of systematic reviews. Chichester, UK: John Wiley & Sons, Ltd, 2016;83 10.1002/14651858.CD008540.pub4 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
17. Whitaker DJ, Le B, Karl Hanson R, et al. . Risk factors for the perpetration of child sexual abuse: a review and meta-analysis. Child Abuse Negl 2008;32:529–48. 10.1016/j.chiabu.2007.08.005 [PubMed] [CrossRef] [Google Scholar]
18. Kelly RK, Magnussen CG, Sabin MA, et al. . Development of hypertension in overweight adolescents: a review. Adolesc Health Med Ther 2015;6:171 10.2147/AHMT.S55837 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
19. Deshmukh-Taskar P, Nicklas TA, Morales M, et al. . Tracking of overweight status from childhood to young adulthood: the Bogalusa Heart Study. Eur J Clin Nutr 2006;60:48–57. 10.1038/sj.ejcn.1602266 [PubMed] [CrossRef] [Google Scholar]
20. Guo SS, Chumlea WC. Tracking of body mass index in children in relation to overweight in adulthood. Am J Clin Nutr 1999;70:145S-148S. [PubMed] [Google Scholar]
21. Juonala M, Magnussen CG, Berenson GS, et al. . Childhood adiposity, adult adiposity, and cardiovascular risk factors. N Engl J Med 2011;365:1876–85. 10.1056/NEJMoa1010112 [PubMed] [CrossRef] [Google Scholar]
22. Engeland A, Bjørge T, Tverdal A, et al. . Obesity in adolescence and adulthood and the risk of adult mortality. Epidemiology 2004;15:79–85. 10.1097/01.ede.0000100148.40711.59 [PubMed] [CrossRef] [Google Scholar]
23. Pandita A, Sharma D, Pandita D, et al. . Childhood obesity: prevention is better than cure. Diabetes Metab Syndr Obes 2016;9:83–9. 10.2147/DMSO.S90783 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
24. Vandenbroeck IP, Goossens J, Clemens M. Foresight tackling obesities: future choices — obesity system atlas. London, UK, 2007. [Google Scholar]
25. WHO Commission on Ending Childhood Obesity. Ending childhood obesity. Geneva, 2016. [Google Scholar]
26. Spruijt-Metz D. Etiology, Treatment and Prevention of Obesity in Childhood and Adolescence: A Decade in Review. J Res Adolesc 2011;21:129–52. 10.1111/j.1532-7795.2010.00719.x [PMC free article] [PubMed] [CrossRef] [Google Scholar]
27. Biro FM, Wien M. Childhood obesity and adult morbidities. Am J Clin Nutr 2010;91:1499S–505. 10.3945/ajcn.2010.28701B [PMC free article] [PubMed] [CrossRef] [Google Scholar]
28. Hill JO, Wyatt HR, Peters JC. Energy balance and obesity. Circulation 2012;126:126–32. 10.1161/CIRCULATIONAHA.111.087213 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
29. National Institute for Health and Care Excellence [NICE]. Lifestyle weight management services for overweight or obese children and young people overview - NICE Pathways [Internet]. //pathways.nice.org.uk/pathways/lifestyle-weight-management-services-for-overweight-or-obese-children-and-young-people#content=view-node%3Anodes-developing-a-tailored-plan.
30. HM Government. Childhood obesity a plan for action. London, UK, 2016. [Google Scholar]
31. Centers for Disease Control and Prevention [CDC]. Nutrition, physical activity, and obesity prevention strategies [Internet]. Prevention strategies & guidelines. //www.cdc.gov/obesity/resources/strategies-guidelines.html.
32. Government of Canada. Curbing childhood obesity a federal, provincial and territorial framework for action to promote healthy weights: Government of Canada, 2010. [Google Scholar]
33. European Commission - High Level Group on Nutrition and Physical activity. EU action plan on childhood obesity 2014-2020. Brussels, Belgium: European Commission, 2014. [Google Scholar]
34. Connelly JB, Duaso MJ, Butler G. A systematic review of controlled trials of interventions to prevent childhood obesity and overweight: a realistic synthesis of the evidence. Public Health 2007;121:510–7. 10.1016/j.puhe.2006.11.015 [PubMed] [CrossRef] [Google Scholar]
35. Wickremasinghe D, Kuruvilla S, Mays N, et al. . Taking knowledge users' knowledge needs into account in health: an evidence synthesis framework. Health Policy Plan 2016;31:527–37. 10.1093/heapol/czv079 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
36. Arksey H, O’Malley L. Scoping studies: towards a methodological framework. Int J Soc Res Methodol 2005;8:19–32. 10.1080/1364557032000119616 [CrossRef] [Google Scholar]
37. Burrows T, Golley RK, Khambalia A, et al. . The quality of dietary intake methodology and reporting in child and adolescent obesity intervention trials: a systematic review. Obes Rev 2012;13:1125–38. 10.1111/j.1467-789X.2012.01022.x [PubMed] [CrossRef] [Google Scholar]
38. Khambalia AZ, Dickinson S, Hardy LL, et al. . A synthesis of existing systematic reviews and meta-analyses of school-based behavioural interventions for controlling and preventing obesity. Obes Rev 2012;13:214–33. 10.1111/j.1467-789X.2011.00947.x [PubMed] [CrossRef] [Google Scholar]
39. Mallonee LF, Boyd LD, Stegeman C. A scoping review of skills and tools oral health professionals need to engage children and parents in dietary changes to prevent childhood obesity and consumption of sugar-sweetened beverages. J Public Health Dent 2017;77[Suppl 1]:S128–S135. 10.1111/jphd.12237 [PubMed] [CrossRef] [Google Scholar]
40. Rivera J, McPherson A, Hamilton J, et al. . Mobile apps for weight management: a scoping review. JMIR Mhealth Uhealth 2016;4:e87 10.2196/mhealth.5115 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
41. Waters E, de Silva-Sanigorski A, Burford BJ, et al. . Interventions for preventing obesity in children Waters E, Cochrane database of systematic reviews. Chichester, UK: John Wiley & Sons, Ltd, 2011;165 10.1002/14651858.CD001871.pub3 [PubMed] [CrossRef] [Google Scholar]
42. Boff RM, Liboni RPA, Batista IPA, et al. . Weight loss interventions for overweight and obese adolescents: a systematic review. Eat Weight Disord 2017;22:211–29. 10.1007/s40519-016-0309-1 [PubMed] [CrossRef] [Google Scholar]
43. Al-Khudairy L, Loveman E, Colquitt JL, et al. . Diet, physical activity and behavioural interventions for the treatment of overweight or obese adolescents aged 12 to 17 years Rees K, Cochrane database of systematic reviews. Chichester, UK: John Wiley & Sons, Ltd, 2017;32 10.1002/14651858.CD012691 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
44. Mead E, Brown T, Rees K, et al. . Diet, physical activity and behavioural interventions for the treatment of overweight or obese children from the age of 6 to 11 years. Cochrane Database Syst Rev 2017;24 10.1002/14651858.CD012651 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
45. Levac D, Colquhoun H, O’Brien KK. Scoping studies: advancing the methodology. Implement Sci 2010;5:69 10.1186/1748-5908-5-69 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
46. The Joanna Briggs Institute. The Joanna Briggs Institute Reviewers’ manual 2015 - methodology for JBI scoping reviews. Adelaide, South Australia, 2015. [Google Scholar]
Page 2
Data extraction framework
| Main category | Subcategory | Description |
| 1. Authors | ||
| 2. Title | ||
| 3. Journal | ||
| 4. Year of publication | ||
| 5. Objective[s] of the review | Describe the stated objectives of the review | |
| 6. Type of review | Specify eg, if systematic review, meta-analysis, scoping review, narrative review or other | |
| 7. Number of studies included in the review | Indicate the number of primary studies included in the review | |
| 8. Years of publication of the studies included in the review | Specify the range of the years of publications of the studies included in the review | |
| 9. Countries where the studies included in the review were conducted | Specify the geographical areas covered by the studies included in the review | |
| 10. Type of studies included in the review | Specify if the review includes specific types of studies [eg, RCTs, cost-effectiveness analyses, qualitative studies, modelling studies] | |
| 11. Description of the intervention[s] | Type of intervention | Specify the type[s] of the interventions on which the review focuses [eg, lifestyle interventions, weight management programmes and sugar taxes] |
| Delivery of the intervention | Describe how and by whom the intervention is delivered | |
| Length and intensity of the intervention | Describe for how long the intervention is delivered and its intensity | |
| 12. Definition of overweight/obesity | Specify the definition of overweight/obesity used in the review | |
| 13. Description of the study population | Target population | Specify if the intervention [i] targets individuals within subpopulation groups or [ii] the broad population [eg, in case of interventions on the built environment, national policies and regulation] |
| By BMI [preintervention] | Specify the distribution of the study population by BMI preintervention | |
| By age | Specify the age groups covered by the review | |
| By sex | Specify if the review focuses on interventions targeting specifically boys or girls, or indicate the distribution of study participants by sex | |
| By ethnic background | Specify if the review focuses on interventions targeting specific ethnic groups [eg, South Asians], or indicate the distribution of study participants by ethnic groups | |
| By socioeconomic background | Specify if the review focuses on interventions targeting children living in deprived areas, or indicate the distribution of study participants by socioeconomic background | |
| By other characteristics of the study population [eg, disability, comorbidity] | Specify if the review focuses on specific populations [eg, children with disabilities] | |
| 14. Setting of the intervention[s] | Specify if the review focuses on interventions delivered in school-based, family-based or community-based settings | |
| 15. Reported outcomes | Describe the intervention outcomes reported in the review [eg, weight, BMI, self-efficacy] | |
| 16. Effectiveness | Describe the results reported in the review [eg, change in BMI] | |
| 17. Impact | Describe the distribution of the study population by BMI [or other relevant outcomes] postintervention | |
| 18. Facilitators | Describe the factors that support or enable the implementation of the intervention reported in the review | |
| 19. Barriers | Describe the factors that inhibit the implementation of the intervention reported in the review |