Skip to main content
. 2022 Jun 14;33(2):393–431. doi: 10.1007/s11065-022-09543-6

Table 1.

Five deviations from the Published Protocol and the Rationale for each Deviation

Protocol Deviation Rationale
We will consider a paper a ‘systematic review’ if it includes (1) a PICO statement expressed as a study objective or a research question, (2) a comprehensive search strategy and (3) inclusion of studies against clear criteria

We modified our criteria on what constituted a systematic review. 

Not all included systematic reviews fulfilled the specified criteria.

(1) All studies had some form of study objective or review question.

(2) A search strategy was not provided for one review (Liu et al., 2019).

(3) Inclusion criteria were not clearly provided in five reviews (Liu et al., 2019; Neurobehavioral Guidelines Working et al., 2006; Plantier et al., 2016; Maksimowski & Tampi, 2016; Yue et al., 2017).

The purpose of our umbrella review is to provide a thorough summary of the reviews completed to date. We felt it was important to be flexible with our inclusion criteria to ensure we included as many of the reviews conducted on this topic to-date.
Inclusion criteria – depression as primary outcome We did include reviews that examined studies for which depression was not the primary outcome (Plantier et al., 2016; Kreitzer et al., 2019; Reyes et al., 2019; Slowinski et al., 2019; Barker-Collo et al., 2013; Fann et al., 2009a). We did not extract data for these primary studies in to our review. We include this here as a point of clarification as it was not specified in the protocol. This change does not deviate from the inclusion criteria we set out in the protocol.
Inclusion criteria – adults 16 years and over

It was not explicitly stated in all reviews that only primary studies of adult patients would be included

For those reviews in which it was not explicitly stated in the eligibility criteria, information that the study comprised adult patients could be deciphered from the study characteristics tables or our knowledge of the included studies (Albrecht et al., 2015, 2019; Alway et al., 2016; Barker-Collo et al., 2015).

Reviews that included patients less than 16 years of age were included if the findings for those aged 16 years or older were provided separately (Maksimowski & Tampi, 2016).

We include this here as a point of clarification as it was not specified in the protocol. This change does not deviate from the inclusion criteria we set out in the protocol.
Systematic reviews of prophylactic (i.e. preventative) pharmacotherapy will be excluded

We excluded all systematic reviews that focussed only on prophylactic pharmacotherapy.

However, we did include reviews that included studies of both prophylactic pharmacotherapy and treatment pharmacotherapy.

We did exclude the prophylactic studies from the reviews where possible.

We retained the prophylactic studies if they were included in the only meta-analysis provided in a review. Removing the prophylactic studies in this context would have meant the review had no results.

The purpose of our umbrella review is to provide a thorough summary of the reviews completed to date. We did not wish to exclude reviews that had included prophylactic studies in their meta-analyses, as this would have resulted in excluding three reviews that we would have otherwise included.

Prophylactic studies still address the question of efficacy for pharmacotherapy for depression so we felt this was valid.

GRADE will be applied to assess the certainty of the evidence The GRADE approach will not be used. Based on heterogeneity in interventions, samples, methodology and outcomes, GRADE was deemed not to be appropriate for this umbrella review.

GRADE Grading of Recommendations, Assessment, Development and Evaluations, PICO Participants, Intervention, Comparator, Outcomes