How low should you go? The impact of including cross-sectional study designs on guideline recommendations

Article type
Authors
De Brier N1, Borra V2, Scheers H1, Vandekerckhove P3, De Buck E4
1Centre for Evidence-Based Practice, Belgian Red Cross
2Centre for Evidence-Based Practice, Belgian Red Cross; Cochrane First Aid
3Belgian Red Cross; Department of Public Health and Primary Care, Faculty of Medicine, KU Leuven
4Centre for Evidence-Based Practice, Belgian Red Cross; Department of Public Health and Primary Care, Faculty of Medicine, KU Leuven; Cochrane First Aid
Abstract
Background: It is not always easy to set selection criteria for study design when conducting a systematic review, especially if only limited evidence is available concerning the topic of interest. An example of such a topic is providing mental health first aid (MHFA) to someone who has experienced a traumatic event.

Objectives: In this context, we aimed to compare the evidence base when only including experimental studies versus also including observational studies when reviewing the effectiveness of MHFA for assisting people in the aftermath of a traumatic event. The review was performed as part of the development of evidence-based MHFA guidelines of the Belgian Red Cross.

Methods: Systematic literature searches were conducted in MEDLINE, PsycINFO and Embase. Previous systematic evaluations (Dieltjens 2014, Fox 2012) on this topic did not identify any evidence when only including controlled study designs. As a result, we also reviewed the body of evidence in studies with a cross-sectional approach. The certainty of evidence was appraised according to the GRADE methodology. The scientific evidence was evaluated by a multidisciplinary panel of mental health experts and patient representatives to formulate evidence-based recommendations.

Results: Out of 1724 articles, we were not able to identify experimental studies fulfilling the predefined selection criteria. Conducting controlled research activities during the aftermath of a traumatic event is difficult to perform since the timing and context are unpredictable and they may hamper the assistance to victims. When study designs of lower quality were screened for eligibility, 9 cross-sectional studies were included. This highlights the importance to search for study designs comprising the best available evidence for addressing the research question.

However, cross-sectional studies suffer from coexisting methodological limitations. No causal relationships could be inferred from the results since the relevant exposures and outcomes were collected simultaneously. The analyses of associations in the included studies were also subject to selection bias and confounding. Overall, the certainty of the evidence was very low because of the study type, risk of bias and imprecision.

Despite of these methodological issues, cross-sectional studies currently provide the best possible evidence for developing MHFA guidelines. The expert panel took the limitations of the body of evidence into account in formulating weak evidence-based recommendations.

Conclusions: Evidence-based recommendations can be formulated based on statistical associations inferred from cross-sectional studies when these associations were critically interpreted by the expert panel. When the search was limited to experimental studies, the guideline would only consist of good practice points based on expert opinion.

Patient or healthcare consumer involvement: Involving both mental health experts and patient representatives within an expert panel was critical to develop MHFA manual based on very low certainty evidence.