P: Planning
Time - requires about 18 months of preparation “…to find out about a healthcare intervention it is worth searching research literature thoroughly to see if the answer is already known. This may require considerable work over many months…” (Cochrane Collaboration)
The suggested timeline for a Cochrane review is:
Team - you need to be working with: subject experts to help clarify issues related to the topic; librarians who can develop the comprehensive search strategies and identify the appropriate databases to search; reviewers who can screen abstracts and read the full text; statistician who can assist with the appropriate analysis of the data; and project leader who will coordinate and write the final report
Written protocol - you need a written protocol that outlines the methodology, including the rationale for the systematic review, key questions broken into PICO components, inclusion/exclusion criteria, and literature search for both published and unpublished literature, data abstraction and data management, assessment of methodological quality of individual studies, data synthesis, and grading the evidence for each key question.
Registered protocol- After you write the protocol, you should register it with PROSPERO, an International Prospective Register of Systematic Reviews. Registration is free and open to anyone undertaking systematic reviews of the effects of interventions and strategies to prevent, diagnose, treat, and monitor health conditions, for which there is a health related outcome.
Literature searching - you need to first identify systematic reviews that may already address the key questions; then identify the appropriate databases and conduct a comprehensive and detailed literature search that can be documented and duplicated;
Citation management - you need working knowledge of EndNote or other software package to help manage the citations from the literature search
Guidelines for reporting - you need to use the appropriate guideline for reporting your review for publication.
See I: Identifying under the UTHealth School of Public Health Library Systematic Review Resources : Steps of Review (PIECES ) Libguide
P: Protocol
A major cause of bias in a systematic review is answering a different question to that being originally asked. This is why it is important to develop a review plan or protocol to determine the inclusion and exclusion criteria you will use. Inclusion criteria is everything that a study must have in order to be included in your review. Exclusion criteria are the factors that would make a study ineligible to be included in your review. These criteria can include dates, how a study was designed, population, outcomes, etc.
The benefits of having a protocol before the beginning of a review:
The protocol should include:
It is recommended that you register your systematic review protocol prior to conducting your review. This will improve transparency and reproducibility, but will also ensure that other research teams do not duplicate efforts. If you are working with the Cochrane or Campbell Collaborations, you will publish your protocol with those organizations. If you are working independently, consider registration with:
PROSPERO: An international database of prospectively registered systematic reviews in health and social care. Key features from the review protocol are recorded and maintained as a permanent record.
Official Protocol Resources:
Inclusion/Exclusion Criteria: You need to identify the criteria that will be used to determine which research studies will be included. These inclusion and exclusion criteria must be decided before you start the review. This is to ensure that your search targets articles that will provide an answer to your review question, allowing you to exclude any irrelevant ones. Criteria that should be considered include:
Type of studies: It is important to select articles with an appropriate design for the research question.
Type of participants: If focusing on a patient population, it is important to define their age, gender, diagnosis, as well as any other relevant factors.
Types of intervention: Describe the intervention that you are investigating. You may want to consider whether to include interventions carried out all over the world or just in the US. The Cochrane Collaboration recommends finding all available studies from all over the world. As before, the interventions that are to be excluded may also need to be described here.
Types of outcome measures: Outcome measures usually refer to measurable outcomes or ‘clinical changes in health’. For example, these could include body structures and functions like pain and fatigue, activities as in functional abilities and participation or quality of life questionnaires.
I: Identifying
Examine your topic to identify the major concepts you need to conduct the best searches. Some useful ways to do this include:
Focus-in by using the PICO(T) method to further develop one or more specific questions
What is PICO(T)?
PICO is a tool commonly used in medical and health research to help researchers formulate a question. The difficulty in creating a question is often underestimated and PICO can help us parse out the important keys a good question should contain. This is just a tool, not a rigid structure in which all questions must fit.
P = Patient, Population, and/or Problem
I = Intervention
C = Comparison (not always applicable)
O = Outcome
T = *Type of Study (what study design is most appropriate to answer the question?)
Sometimes you will see PICO TT where the additional T stands for the type of question you are asking which you do need to know to determine the best study design.
*In some PICO(T) models you will see T stand for time. This only works if your question includes a concept of time.
After you have composed your research question, it's important to search if the question has been asked before. You will sometimes find that you may need to adjust your question based on the research found. See Searching for Prior Reviews.