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AHRQ Study Eligibility Criteria
- 1. Study Eligibility Criteria Prepared for: The Agency for Healthcare Research and Quality (AHRQ) Training Modules for Systematic Reviews Methods Guide www.ahrq.gov
- 2. Systematic Review Process Overview
- 23. Exercise 1: PICOTS Population What constitutes an adolescent? What constitutes a diagnosis of autism spectrum disorder (ASD)? Intervention How is transition support defined? Comparator Do we compare to no transition support or directly compare types of support? Outcome What are the goals for adolescents with ASD as they transition to adulthood? Timing How quickly should the outcomes be apparent? Setting Is transition support provided in multiple settings, such as schools, clinics, and the community?
Notas del editor
- Study Eligibility Criteria
- Systematic Review Process Overview This slide illustrates the steps in the systematic review process. This module focuses on study eligibility criteria.
- Learning Objectives
- Study Selection Criteria Selection criteria, also known as eligibility or inclusion/exclusion criteria, are used to set appropriate limits by which studies are included in a review. References : Dickersin K, Scherer R, Lefebvre C. Identifying relevant studies for systematic reviews. BMJ 1994;309:1286-91. http://www.ncbi.nlm.nih.gov/pubmed/7718048 McPheeters ML, Briss P, Teutsch SJ, et al. Systematic reviews in public health. In: Brownson RC and Petitti DB, eds. Applied epidemiology. New York: Oxford University Press; 2006. p. 99-124.
- Some Sample Criteria Examples of criteria include setting limits around a population (e.g., limiting to women or men, or to community-dwelling women); the intervention (which should be very specific); the country or other geographic limit; the specific setting where one would expect to have the intervention implemented; the size of the study population; and potentially the study design.
- Using Broad Criteria Criteria range from being very broad to very narrow and reflect the goals of the particular review, as well as the content area of the research.
- Using Narrow Criteria
- Refining Criteria The overarching goal of setting criteria is to minimize bias related to which studies are selected. In doing so, review teams must balance the need to obtain adequate information to answer a given review question with the potential to include too much extraneous information.
- Bias in This Context Decisions about eligibility criteria may bias the review, possibly resulting in an overestimation or underestimation of the true treatment effect. When bias is discussed in this context, it is defined as “distortion of the estimate of effect that comes from how studies are selected” and may affect how applicable the review will be in practice.
- Examples of Bias in This Context For example, the included studies may not have been conducted in the patient population that is the focus of the review. In another example, the use of studies of twin pregnancies in a review of preterm labor management for low-risk women may not provide applicable information for the target population. In still another example, limiting a review to randomized controlled trials (RCTs), especially when there are few of them, is likely to provide data on only a highly specific group of individuals that may not reflect common practice. This could result in an overestimate of the effect of an intervention if its effectiveness in practice is lower than that seen in RCTs.
- Selecting Criteria Broader criteria are often set at the abstract review phase and refined to be more specific for the full-text review phase, so this process is likely to occur twice in the review. Sometimes it is helpful for the team to set criteria, then do a sample set of reviews, and reconvene to discuss whether the criteria are meeting the goals of the review. Criteria can be refined at this point if needed but then should be adhered to henceforth.
- Tie Criteria to PICOTS Because we will be discussing the use of PICOTS (population, intervention, comparator, outcome, timing, and setting) as a framework for setting criteria, please review the meaning of PICOTS before proceeding. It is helpful to use the PICOTS framework in setting criteria. Specifically, consider each of the PICOTS components individually and determine with the team whether criteria associated with each are warranted.
- Other Consideration for Setting Criteria Other potential considerations are the inclusion of specific study designs, studies published in foreign languages, and studies from other countries (those published in English); the use of grey or fugitive literature; and whether dates of publication should be limited (e.g., to include only studies published after a certain year if that marks a point at which practice changed, a new technique emerged, or a new medication was developed).
- Types of Studies To Be Included Limiting a review to randomized controlled trials is appropriate for questions of efficacy but may preclude understanding broader effectiveness of an intervention. If observational studies are included, teams may decide to include only certain subtypes (e.g., prospective and retrospective cohorts but not case series). There may also be situations in which case series provide important information, especially in emerging fields or for identifying harms.
- Observational Studies (I)
- Observational Studies (II)
- Non-English–Language Study Reports The question of whether to include studies that were published in languages other than English depends on both methodologic considerations and logistical ones. It may be impractical to obtain translation services within the context of a review. However, positive findings may be more likely to be published in high-profile English-language journals, and some researchers have suggested that to include only English-language studies may overestimate the positive effect of an intervention. Empirically, the bias associated with limiting a review to English-language publications, however, has been shown to be small. References: Gregoire G, Derderain F, Le Lorier J. Selecting the language of the publication included in a meta-analysis: is there a Tower of Babel bias? J Clin Epidemiol 1995;48:159-63. http://www.ncbi.nlm.nih.gov/pubmed/7853041 Moher D, Pham B, Klassen TP, et al. What contribution do languages other than English make on the results of meta-analyses? J Clin Epidemiol 2000; 53:964-72. http://www.ncbi.nlm.nih.gov/pubmed/11004423
- Grey or “Fugitive” Literature Reference: McAuley L, Pham B, Tugwell P, et al. Does the inclusion of grey literature influence estimates of intervention effectiveness reported in meta-analyses? Lancet 2000;356:1228-31. http://www.ncbi.nlm.nih.gov/pubmed/11072941
- Year of Publication
- Using the Criteria
- Exercise 1
- Exercise 1: Basic PICOTS Questions We can use these questions to operationalize the PICOTS (population, intervention, comparators, outcomes, timing, and setting) into practical questions for establishing criteria.
- Exercise 1: PICOTS Here are examples of further specification of the PICOTS (population, intervention, comparator, outcome, timing, and setting). These are only examples, and the review team should think through as many issues as are relevant to the particular review.
- Exercise 1: What Would You Do With … Sometimes we set criteria and then find that exceptions arise, or papers are found that do not fit nicely into them. For example, if we were conducting this review of adolescents with autism spectrum disorder (ASD), what would we do with a paper that said it included “individuals over 10 years of age.” Adolescents, and potentially adults, would have been included in the review, but so would children under 13 years of age. By the same token, a paper might be selected that included not only individuals with ASD, but also some with other developmental disabilities.
- Exercise 1: No “Right” Answers There are no “right” answers to these questions. The team should clearly define how eligibility criteria are operationalized and record these decisions throughout the review.
- Exercise 2: Selecting Criteria for a Narrow Research Question Here is an example of a research question that, by its nature, led to very narrow selection criteria. Notice that the question focuses on “efficacy” (which suggests the inclusion of randomized controlled trials only) and on women at low risk of preterm birth (which would exclude women with a previous preterm birth or with multiple birth).
- Exercise 2: Implications of a Question That Requires Narrow Criteria In a real review, these narrow criteria led to the identification of only 11 studies.
- Exercise 3: Selecting Criteria for a Broad Research Question In another example—a review of the management of overactive bladder among women—the team faced several challenges. First, overactive bladder is a difficult condition to define, making it challenging to put bounds around the “right” population. Treatments vary and include drugs, surgery, and behavioral interventions. It is critical for teams to justify and document their decisions about selection criteria as these decisions are made. Later, this becomes an important part of the report that increases transparency in the methods.
- Exercise 3: Impact of Study-Size Criteria on Excluded Studies Based on expert opinion and a preliminary review of the literature, the team set a minimum sample size of 50 for the review on overactive bladder. A total of 79 studies out of more than 2,000 were excluded on the basis of study size.
- Exercise 3: Impact of Gender in Studies on Selection Criteria Recall that this review was to focus on the management of overactive bladder in women. However, many studies of treatment included some men, and the team determined that to exclude all of these studies might create a loss of important information. On the other hand, the fact that men who had bladder-related issues likely had a different etiology for those issues and could have a different response to treatment could bias the overall estimate of effect. Based on expert opinion and the size and scope of the literature, the team included only studies whose sample had at least 75 percent women. This resulted in the exclusion of 40 studies. Had the team limited the review to studies that included only women, another 27 studies would have been excluded. The team looked carefully at the excluded studies and, with the help of technical experts, determined that exclusion of studies with less than 75 percent women was appropriate for reducing the possibility of obtaining a biased estimate.
- Example in a Maternal-Fetal Surgery Technical Brief In a technical brief on the use of maternal-fetal surgery, the purpose was to describe the state of the literature, rather than to present estimates of outcomes. Only three randomized controlled trials were available in all of the literature, and most of the observational studies were case series. Case series were included because this area of research is very new and the purpose was to describe the state of the field, rather than the outcomes of the different surgeries.
- Example 2: Systematic Review of Cesarean Delivery In response to the rising rate of cesarean deliveries, the National Institutes of Health Office of Medical Applications of Research planned a State-of-the-Science Conference on the maternal and neonatal outcomes of cesarean delivery on maternal request, which was defined as cesarean delivery in the absence of maternal or fetal indications.
- Example 2: The Challenge in the Systematic Review on Cesarean Delivery From preliminary reviews of the literature, the National Institutes of Health was aware that no studies compared outcomes of cesarean delivery on maternal request (CDMR) to other modes of delivery. As a proxy, they suggested that the review include studies comparing cesarean delivery for breech to other modes of delivery, but this body of evidence was also small and limited in applicability — that is, breech delivery was a reasonable proxy for CDMR for maternal outcomes, but not for neonatal outcomes, where fetal indications have been a confounding factor for both breech delivery and poor neonatal outcomes. With an urgent need for actionable evidence, and in the absence of data on the intervention of interest, the Research Triangle Institute – University of North Carolina Evidence-based Practice Center decided to expand the list of proxies and weight the evidence appropriately.
- Example 2: The Solution in the Systematic Review on Cesarean Delivery A crucial element of the comparison between cesarean delivery on maternal request (CDMR) and alternatives is the planned aspect of delivery. The Research Triangle Institute – University of North Carolina Evidence-based Practice Center (RTI-UNC EPC) included studies that compared planned vaginal delivery to planned cesarean delivery (for maternal and neonatal indications) as lower-rung evidence. As lowest-rung evidence, the RTI-UNC EPC also included comparisons of actual modes of delivery.
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