GRADE guidance 37: rating imprecision in a body of evidence on test accuracy.

OBJECTIVES: To provide guidance on rating imprecision in a body of evidence assessing the accuracy of a single test. This guide will clarify when Grading of Recommendations Assessment, Development and Evaluation (GRADE) users should consider rating down the certainty of evidence by one or more levels for imprecision in test accuracy. STUDY DESIGN AND SETTING: A project group within the GRADE working group conducted iterative discussions and presentations at GRADE working group meetings to produce this guidance. RESULTS: Before rating the certainty of evidence, GRADE users should define the target of their certainty rating. GRADE recommends setting judgment thresholds defining what they consider a very accurate, accurate, inaccurate, and very inaccurate test. These thresholds should be set after considering consequences of testing and effects on people-important outcomes. GRADE's primary criterion for judging imprecision in test accuracy evidence is considering confidence intervals (i.e., CI approach) of absolute test accuracy results (true and false, positive, and negative results in a cohort of people). Based on the CI approach, when a CI appreciably crosses the predefined judgment threshold(s), one should consider rating down certainty of evidence by one or more levels, depending on the number of thresholds crossed. When the CI does not cross judgment threshold(s), GRADE suggests considering the sample size for an adequately powered test accuracy review (optimal or review information size [optimal information size (OIS)/review information size (RIS)]) in rating imprecision. If the combined sample size of the included studies in the review is smaller than the required OIS/RIS, one should consider rating down by one or more levels for imprecision. CONCLUSION: This paper extends previous GRADE guidance for rating imprecision in single test accuracy systematic reviews and guidelines, with a focus on the circumstances in which one should consider rating down one or more levels for imprecision.

Support interventions to reduce psychological distress in families experiencing stillbirth in high income countries: A systematic review.

BACKGROUND: Previous research indicates disparities in the care of bereaved parents and siblings following a stillbirth in the family. The aim of this systematic review was to assess the effects of interventions aimed at reducing psychological distress among parents or siblings in high-income countries after experiencing a stillbirth. METHODS: The databases CINAHL, Medline, PsycInfo, Cochrane Library, and EMBASE were searched in August 2022. RESULTS: Four intervention studies from the United States (US), the United Kingdom (UK), Finland, and Australia, met the inclusion criteria. The interventions comprised a perinatal grief support team; a perinatal counselling service; a grief support program; and a support package including contacts with peer supporters and health care staff. No studies of interventions for siblings were found. The results could not be synthesised due to disparities in interventions and outcome measures. The risk of bias was assessed as high in all four studies and the certainty for all outcomes was rated as very low. CONCLUSION: More controlled trials with rigorous methods are needed to evaluate the effect of bereavement support interventions in parents and siblings after stillbirth. Future studies should include a core outcome set to make them more comparable. Most of the studies in this review were assessed to have an overall high risk of bias, mainly due to problems with missing outcome data; thus, future studies could specifically target this problem.

Identification of depression and anxiety during pregnancy: A systematic review and meta-analysis of test accuracy.

INTRODUCTION: Depression and anxiety are significant contributors to maternal perinatal morbidity and a range of negative child outcomes. This systematic review and meta-analysis aimed to review and assess the diagnostic test accuracy of selected screening tools (Edinburgh Postnatal Depression Scale [EPDS], EPDS-3A, Patient Health Questionnaire [PHQ-9]-, PHQ-2, Matthey Generic Mood Question [MGMQ], Generalized Anxiety Disorder scale [GAD-7], GAD-2, and the Whooley questions) used to identify women with antenatal depression or anxiety in Western countries. MATERIAL AND METHODS: On January 16, 2023, we searched 10 databases (CINAHL, Cochrane Library, CRD Database, Embase, Epistemonikos, International HTA Database, KSR Evidence, Ovid MEDLINE, PROSPERO and PsycINFO); the references of included studies were also screened. We included studies of any design that compared case-identification with a relevant screening tool to the outcome of a diagnostic interview based on the Diagnostic and Statistical Manual of Mental Disorders, fourth or fifth edition (DSM-IV or DSM-5), or the International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10). Diagnoses of interest were major depressive disorder and anxiety disorders. Two authors independently screened abstracts and full-texts for relevance and evaluated the risk of bias using QUADAS-2. Data extraction was performed by one person and checked by another team member for accuracy. For synthesis, a bivariate model was used. The certainty of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE). REGISTRATION: PROSPERO CRD42021236333. RESULTS: We screened 8276 records for eligibility and included 16 original articles reporting on diagnostic test accuracy: 12 for the EPDS, one article each for the GAD-2, MGMQ, PHQ-9, PHQ-2, and Whooley questions, and no articles for the EPDS-3A or GAD-7. Most of the studies had moderate to high risk of bias. Ten of the EPDS articles provided data for synthesis at cutoffs ≥10 to ≥14 for diagnosing major depressive disorder. Cutoff ≥10 gave the optimal combined sensitivity (0.84, 95% confidence interval [CI]: 0.75-0.90) and specificity (0.87, 95% CI: 0.79-0.92). CONCLUSIONS: Findings from the meta-analysis suggest that the EPDS alone is not perfectly suitable for detection of major depressive disorder during pregnancy. Few studies have evaluated the other instruments, therefore, their usefulness for identification of women with depression and anxiety during pregnancy remains very uncertain. At present, case-identification with any tool may best serve as a complement to a broader dialogue between healthcare professionals and their patients.

Care and support when a baby is stillborn: A systematic review and an interpretive meta-synthesis of qualitative studies in high-income countries.

INTRODUCTION: Approximately 2 million babies are stillborn annually worldwide, most in low- and middle-income countries. Present review studies of the parental and healthcare providers' experiences of stillbirth often include a variety of settings, which may skew the findings as the available resources can vary considerably. In high-income countries, the prevalence of stillbirth is low, and support programs are often initiated immediately when a baby with no signs of life is detected. There is limited knowledge about what matters to parents, siblings, and healthcare providers when a baby is stillborn in high-income countries. OBJECTIVES: This systematic review and interpretive meta-synthesis aim to identify important aspects of care and support for parents, siblings, and healthcare professionals in high-income countries from the diagnosis of stillbirth throughout the birth and postpartum period. METHODS: A systematic review and qualitative meta-synthesis were conducted to gain a deeper and broader understanding of the available knowledge about treatment and support when stillbirth occurred. Relevant papers were identified by systematically searching international electronic databases and citation tracking. The quality of the included studies was assessed, and the data was interpreted and synthesised using Gadamer's hermeneutics. The review protocol, including qualitative and quantitative study approaches, was registered on PROSPERO (CRD42022306655). RESULTS: Sixteen studies were identified and included in the qualitative meta-synthesis. Experiences of care and support were interpreted and identified as four fusions. First, Personification is of central importance and stresses the need to acknowledge the baby as a unique person. The parents became parents even though their baby was born dead: The staff should also be recognised as the individuals they are with their personal histories. Second, the personification is reinforced by a respectful attitude where the parents are confirmed in their grief; the baby is treated the same way a live baby would be. Healthcare professionals need enough time to process their experiences before caring for other families giving birth. Third, Existential issues about life and death become intensely tangible for everyone involved, and they often feel lonely and vulnerable. Healthcare professionals also reflect on the thin line between life and death and often question their performance, especially when lacking collegial and organisational support. Finally, the fusion Stigmatisation focused on how parents, siblings, and healthcare professionals experienced stigma expressed as a sense of loneliness, vulnerability, and being deviant and marginalised when a baby died before or during birth. GRADE CERQual ratings for the four fusions ranged from moderate to high confidence. CONCLUSIONS: The profound experiences synthesised in the fusions of this meta-synthesis showed the complex impacts the birth of a baby with no signs of life had on everyone involved. These fusions can be addressed and supported by applying person-centred care to all individuals involved. Hence, grief may be facilitated for parents and siblings, and healthcare professionals may be provided with good conditions in their professional practice. Furthermore, continuing education and support to healthcare professionals may facilitate them to provide compassionate care and support to affected parents and siblings. The fusions should also be considered when implementing national recommendations, guidelines, and clinical practice.

GRADE guidance 36: updates to GRADE's approach to addressing inconsistency.

OBJECTIVES: To update previous Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidance by addressing inconsistencies and interpreting subgroup analyses. STUDY DESIGN AND SETTING: Using an iterative process, we consulted with members of the GRADE working group through multiple rounds of written feedback and discussions at GRADE working group meetings. RESULTS: The guidance complements previous guidance with clarification in two areas: (1) assessing inconsistency and (2) assessing the credibility of possible effect modifiers that might explain inconsistency. Specifically, the guidance clarifies that inconsistency refers to variability in results, not in study characteristics; that inconsistency assessment for binary outcomes requires consideration of both relative and absolute effects; how to decide between narrower and broader questions in systematic reviews and guidelines; that, with the same evidence, ratings of inconsistency may differ depending on the target of certainty rating; and how GRADE inconsistency ratings relate to a statistical measure of inconsistency I2 depending on the context in which one views results. The second part of the guidance illustrates, based on a worked example, the use of the instrument to assess the credibility of effect modification analyses. The guidance explains the stepwise process of moving from a subgroup analysis to assessing the credibility of effect modification and, if found credible, to subgroup-specific effect estimates and GRADE certainty ratings. CONCLUSION: This updated guidance addresses specific conceptual and practical issues that systematic review authors frequently face when considering the degree of inconsistency in estimates of treatment effects across studies.

Internet-delivered psychological treatment as an add-on to treatment as usual for common mental disorders: A systematic review with meta-analysis of randomized trials.

BACKGROUND: Psychological treatments for common mental disorders are increasingly being delivered remotely via the internet. Evidence suggests that internet-delivered cognitive behavioural therapy (iCBT) is superior to waitlist. However, the benefits are unclear of using this treatment modality as an add-on to treatment as usual (TAU) in regular healthcare. METHODS: The literature was systematically searched up to August 2021 for randomized trials of internet-delivered psychological treatments using TAU as the comparator. Eligible participants were diagnosed with depressive, anxiety, obsessive-compulsive, or trauma- and stress-related disorders. Outcomes of interest were symptoms, functioning, quality of life, healthcare utilization, and negative effects. Results were synthesized using random-effects meta-analyses. Quality of evidence was assessed using GRADE. RESULTS: The included studies evaluated iCBT for adults with depression (k = 9), depressive or anxiety disorders (k = 4), and post-traumatic stress disorder (k = 2) and were conducted in primary care or similar settings. For depression, low-certainty evidence suggested beneficial short-term effects on symptoms (g = -0.23; 95 % CI: = -0.37, -0.09), response rate (OR = 2.46; 1.31, 4.64), and remission (OR = 1.70; 1.19, 2.42;). The certainty of evidence was very low for long-term effects, other outcomes, and other disorders. LIMITATIONS: TAU varied across studies and was often insufficiently described. CONCLUSIONS: iCBT as a complement to usual care for adult with depression may result in a small incremental effect, which potentially could be clinically important. Studies are lacking for several common disorders and for children, adolescents, and the elderly. More robust studies of long-term effects are also needed, to better inform clinical decision-making.

GRADE Guidance 34: update on rating imprecision using a minimally contextualized approach.

OBJECTIVES: The aim of this study is to provide updated guidance on when The Grading of Recommendations Assessment, Development and Evaluation (GRADE) users should consider rating down more than one level for imprecision using a minimally contextualized approach. STUDY DESIGN AND SETTING: Based on the first GRADE guidance addressing imprecision rating in 2011, a project group within the GRADE Working Group conducted iterative discussions and presentations at GRADE Working Group meetings to produce this guidance. RESULTS: GRADE suggests aligning imprecision criterion for systematic reviews and guidelines using the approach that relies on thresholds and confidence intervals (CI) of absolute effects as a primary criterion for imprecision rating (i.e., CI approach). Based on the CI approach, when a CI appreciably crosses the threshold(s) of interest, one should consider rating down two or three levels. When the CI does not cross the threshold(s) and the relative effect is large, one should implement the optimal information size (OIS) approach. If the sample size of the meta-analysis is far less than the OIS, one should consider rating down more than one level for imprecision. CONCLUSION: GRADE provides updated guidance for imprecision rating in a minimally contextualized approach, with a focus on the circumstances in which one should seriously consider rating down two or three levels for imprecision.

GRADE guidance 35: update on rating imprecision for assessing contextualized certainty of evidence and making decisions.

OBJECTIVES: Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidance to rate the certainty domain of imprecision is presently not fully operationalized for rating down by two levels and when different baseline risk or uncertainty in these risks are considered. In addition, there are scenarios in which lowering the certainty of evidence by three levels for imprecision is more appropriate than lowering it by two levels. In this article, we conceptualize and operationalize rating down for imprecision by one, two and three levels for imprecision using the contextualized GRADE approaches and making decisions. METHODS: Through iterative discussions and refinement in online meetings and through email communication, we developed draft guidance to rating the certainty of evidence down by up to three levels based on examples. The lead authors revised the approach according to the feedback and the comments received during these meetings and developed GRADE guidance for how to apply it. We presented a summary of the results to all attendees of the GRADE Working Group meeting for feedback in October 2021 (approximately 80 people) where the approach was formally approved. RESULTS: This guidance provides GRADE's novel approach for the considerations about rating down for imprecision by one, two and three levels based on serious, very serious and extremely serious concerns. The approach includes identifying or defining thresholds for health outcomes that correspond to trivial or none, small, moderate or large effects and using them to rate imprecision. It facilitates the use of evidence to decision frameworks and also provides guidance for how to address imprecision about implausible large effects and trivial or no effects using the concept of the 'review information size' and for varying baseline risks. The approach is illustrated using practical examples, an online calculator and graphical displays and can be applied to dichotomous and continuous outcomes. CONCLUSION: In this GRADE guidance article, we provide updated guidance for how to rate imprecision using the partially and fully contextualized GRADE approaches for making recommendations or decisions, considering alternate baseline risks and for both dichotomous and continuous outcomes.

GRADE guidelines 33: Addressing imprecision in a network meta-analysis.

OBJECTIVE: This article describes GRADE guidance for assessing imprecision when rating the certainty of the evidence from network meta-analysis. STUDY DESIGN AND SETTING: A project group within the GRADE working group conducted iterative discussions, computer simulations, and presentations at GRADE working group meetings to produce and obtain approval for this guidance. RESULTS: When addressing imprecision of a network estimate, reviewers should consider the 95% confidence or credible interval, and the optimal information size. If the 95% confidence or credible interval crosses a pre-specified threshold, reviewers should rate down the certainty of the evidence. If the 95% confidence interval does not cross any pre-specfied threshold, reviewers should consider the optimal information size. Because addressing the optimal information size may be challenging, reviewers can use the effect size to decide if any calculations are necessary. When the size of the effect is modest or the optimal information size is met, reviewers should not rate down for imprecision. CONCLUSION: Reviewers should use this guidance when to appropriately address imprecision in the context of the assessment of certainty of evidence from network meta-analysis.

GRADE guidelines 32: GRADE offers guidance on choosing targets of GRADE certainty of evidence ratings.

OBJECTIVE: To provide practical principles and examples to help GRADE users make optimal choices regarding their ratings of certainty of evidence using a minimally or partially contextualized approach. STUDY DESIGN AND SETTING: Based on the GRADE clarification of certainty of evidence in 2017, a project group within the GRADE Working Group conducted iterative discussions and presentations at GRADE Working Group meetings to refine this construct and produce practical guidance. RESULTS: Systematic review and health technology assessment authors need to clarify what it is in which they are rating their certainty of evidence (i.e., the target of their certainty rating). The decision depends on the degree of contextualization (partially or minimally contextualized), thresholds (null, small, moderate or large effect threshold), and where the point estimate lies in relation to the chosen threshold(s). When the 95% confidence interval crosses multiple possible thresholds (i.e., including both large benefit and large harm), it is not worthwhile for authors to determine the target of certainty rating. CONCLUSION: GRADE provides practical principles to help systematic review and health technology assessment authors specify the target of their certainty of evidence rating.

GRADE Guidance: 31. Assessing the certainty across a body of evidence for comparative test accuracy.

OBJECTIVES: This article provides GRADE guidance on how authors of evidence syntheses and health decision makers, including guideline developers, can rate the certainty across a body of evidence for comparative test accuracy questions. STUDY DESIGN AND SETTING: This guidance extends the previously published GRADE guidance for assessing certainty of evidence for test accuracy to scenarios in which two or more index tests are compared. Through an iterative brainstorm-discussion-feedback process within the GRADE working group, we developed a guidance accompanied by practical examples. RESULTS: Rating the certainty of evidence for comparative test accuracy shares many concepts and ideas with the existing GRADE guidance for test accuracy. The rating in comparisons of test accuracy requires additional considerations, such as the selection of appropriate comparative study designs, additional criteria for judging risk of bias, and the consequences of using comparative measures of test accuracy. Distinct approaches to rating certainty are required for comparative test accuracy studies and between-study (indirect) comparisons. CONCLUSION: This GRADE guidance will support transparent assessment of the certainty for a body of comparative test accuracy evidence.

GRADE guidelines: 21 part 1. Study design, risk of bias, and indirectness in rating the certainty across a body of evidence for test accuracy.

OBJECTIVES: This article provides updated GRADE guidance about how authors of systematic reviews and health technology assessments and guideline developers can assess the results and the certainty of evidence (also known as quality of the evidence or confidence in the estimates) of a body of evidence addressing test accuracy (TA). STUDY DESIGN AND SETTING: We present an overview of the GRADE approach and guidance for rating certainty in TA in clinical and public health and review the presentation of results of a body of evidence regarding tests. Part 1 of the two parts in this 21st guidance article about how to apply GRADE focuses on understanding study design issues in test accuracy, provide an overview of the domains, and describe risk of bias and indirectness specifically. RESULTS: Supplemented by practical examples, we describe how raters of the evidence using GRADE can evaluate study designs focusing on tests and how they apply the GRADE domains risk of bias and indirectness to a body of evidence of TA studies. CONCLUSION: Rating the certainty of a body of evidence using GRADE in Cochrane and other reviews and World Health Organization and other guidelines dealing with in TA studies helped refining our approach. The resulting guidance will help applying GRADE successfully for questions and recommendations focusing on tests.

GRADE guidelines: 21 part 2. Test accuracy: inconsistency, imprecision, publication bias, and other domains for rating the certainty of evidence and presenting it in evidence profiles and summary of findings tables.

OBJECTIVES: This article provides updated GRADE guidance about how authors of systematic reviews and health technology assessments and guideline developers can rate the certainty of evidence (also known as quality of the evidence or confidence in the estimates) of a body of evidence addressing test accuracy (TA) on the domains imprecision, inconsistency, publication bias, and other domains. It also provides guidance for how to present synthesized information in evidence profiles and summary of findings tables. STUDY DESIGN AND SETTING: We present guidance for rating certainty in TA in clinical and public health and review the presentation of results of a body of evidence regarding tests. RESULTS: Supplemented by practical examples, we describe how raters of the evidence can apply the GRADE domains inconsistency, imprecision, and publication bias to a body of evidence of TA studies. CONCLUSION: Using GRADE in Cochrane and other reviews as well as World Health Organization and other guidelines helped refining the GRADE approach for rating the certainty of a body of evidence from TA studies. Although several of the GRADE domains (e.g., imprecision and magnitude of the association) require further methodological research to help operationalize them, judgments need to be made on the basis of what is known so far.

GRADE guidelines 26: informative statements to communicate the findings of systematic reviews of interventions.

OBJECTIVES: Clear communication of systematic review findings will help readers and decision makers. We built on previous work to develop an approach that improves the clarity of statements to convey findings and that draws on Grading of Recommendations Assessment, Development and Evaluation (GRADE). STUDY DESIGN AND SETTING: We conducted workshops including 80 attendants and a survey of 110 producers and users of systematic reviews. We calculated acceptability of statements and revised the wording of those that were unacceptable to ≥40% of participants. RESULTS: Most participants agreed statements should be based on size of effect and certainty of evidence. Statements for low, moderate and high certainty evidence were acceptable to >60%. Key guidance, for example, includes statements for high, moderate and low certainty for a large effect on intervention x as: x results in a large reduction…; x likely results in a large reduction…; x may result in a large reduction…, respectively. CONCLUSIONS: Producers and users of systematic reviews found statements to communicate findings combining size and certainty of an effect acceptable. This article provides GRADE guidance and a wording template to formulate statements in systematic reviews and other decision tools.

Defining ranges for certainty ratings of diagnostic accuracy: a GRADE concept paper.

OBJECTIVE: The objective of the study was to clarify how the Grading of Recommendations Assessment, Development and Evaluation (GRADE) concept of certainty of evidence applies to certainty ratings of test accuracy. STUDY DESIGN AND SETTING: After initial brainstorming with GRADE Working Group members, we iteratively refined and clarified the approaches for defining ranges when assessing the certainty of evidence for test accuracy within a systematic review, health technology assessment, or guideline. RESULTS: Ranges can be defined both for single test accuracy and for comparative accuracy of multiple tests. For systematic reviews and health technology assessments, approaches for defining ranges include some that do not require value judgments regarding downstream health outcomes. Key challenges arise in the context of a guideline that requires ranges for sensitivity and specificity that are set considering possible effects on all critical outcomes. We illustrate possible approaches and provide an example from a systematic review of a direct comparison between two test strategies. CONCLUSIONS: This GRADE concept paper provides a framework for assessing, presenting, and making decisions based on the certainty of evidence for test accuracy. More empirical research is needed to support future GRADE guidance on how to best operationalize the candidate approaches.

Defining certainty of net benefit: a GRADE concept paper.

Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology is used to assess and report certainty of evidence and strength of recommendations. This GRADE concept article is not GRADE guidance but introduces certainty of net benefit, defined as the certainty that the balance between desirable and undesirable health effects is favourable. Determining certainty of net benefit requires considering certainty of effect estimates, the expected importance of outcomes and variability in importance, and the interaction of these concepts. Certainty of net harm is the certainty that the net effect is unfavourable. Guideline panels using or testing this approach might limit strong recommendations to actions with a high certainty of net benefit or against actions with a moderate or high certainty of net harm. Recommendations may differ in direction or strength from that suggested by the certainty of net benefit or harm when influenced by cost, equity, acceptability or feasibility.

Pharmacological Treatment in Forensic Psychiatry-A Systematic Review.

Background: Pharmacological treatment is of great importance in forensic psychiatry, and the vast majority of patients are treated with antipsychotic agents. There are several systematic differences between general and forensic psychiatric patients, e.g. severe violent behavior, the amount of comorbidity, such as personality disorders and/or substance abuse. Based on that, it is reasonable to suspect that effects of pharmacological treatments also may differ. The objective of this systematic review was to investigate the effects of pharmacological interventions for patients within forensic psychiatry. Methods: The systematic review protocol was pre-registered in PROSPERO (CRD42017075308). Six databases were used for literature search on January 11, 2018. Controlled trials from forensic psychiatric care reporting on the effects of antipsychotic agents, mood stabilizers, benzodiazepines, antidepressants, as well as pharmacological agents used for the treatment of addiction or ADHD, were included. Two authors independently reviewed the studies, evaluated risk of bias and assessed certainty of evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE). Results: The literature search resulted in 1783 records (titles and abstracts) out of which 10 studies were included. Most of the studies included were retrospective and non-randomized. Five of them focused on treatment with clozapine and the remaining five on other antipsychotics or mood stabilizers. Five studies with a high risk of bias indicated positive effects of clozapine on time from treatment start to discharge, crime-free time, time from discharge to readmission, improved clinical functioning, and reduction in aggressive behavior. Psychotic symptoms after treatment were more pronounced in the clozapine group. Mainly due to the high risk of bias the reliability of the evidence for all outcomes was assessed as very low. Conclusion: This systematic review highlights the shortage of knowledge on the effectiveness of pharmacological treatment within forensic psychiatry. Due to very few studies being available in this setting, as well as limitations in their execution and reporting, it is challenging to overview the outcomes of pharmacological interventions in this context. The frequent use of antipsychotics, sometimes in combination with other pharmacological agents, in this complex and heterogeneous patient group, calls for high-quality studies performed in this specific setting.

Mapping Systematic Reviews on Forensic Psychiatric Care: A Systematic Review Identifying Knowledge Gaps.

Background: Forensic psychiatric care treats mentally disordered offenders who suffer mainly from psychotic disorders, although comorbidities such as personality disorders, neurodevelopmental disorders, and substance abuse are common. A large proportion of these patients have committed violent crimes. Their care is involuntary, and their caregivers' mission is complex: not only to rehabilitate the patient, but also to consider their risk for reoffending and their risk to society. The objective of this overview of systematic reviews is to identify, appraise, and summarize the existing knowledge in forensic psychiatric care and identify knowledge gaps that require further research. Methods: We undertook a systematic literature search for systematic reviews in five defined domains considered important in daily clinical practice within the forensic psychiatric care: (1) diagnostic assessment and risk assessments; (2) pharmacological treatment; (3) psychological interventions; (4) psychosocial interventions, rehabilitation, and habilitation; and (5) restraint interventions. The target population was mentally disordered offenders (forensic psychiatric patients aged >15 years). Each abstract and full text review was assessed by two of the authors. Relevant reviews then were assessed for bias, and those with moderate or low risk of bias were included. Results: Of 38 systematic reviews meeting the inclusion criteria, only four had a moderate risk of bias. Two aimed to incorporate as many aspects of forensic psychiatric care as possible, one investigated non-pharmacological interventions to reduce aggression in forensic psychiatric care, and one focused on women with intellectual disabilities in forensic care. However, most of the primary studies included in these reviews had high risks of bias, and therefore, no conclusions could be drawn. All of our identified domains must be considered knowledge gaps. Conclusion: We could not answer any of our research questions within the five domains because of the high risk of bias in the primary studies in the included systematic reviews. There is an urgent need for more research on forensic psychiatric care since all of our studied domains were considered knowledge gaps.

Experiences of living with fetal alcohol spectrum disorders: a systematic review and synthesis of qualitative data.

AIM: To identify and assess available evidence from qualitative studies exploring experiences of individuals living with fetal alcohol spectrum disorders (FASD) or those living with a child with FASD, as well as experiences of interventions aimed at supporting individuals with FASD and their families. METHOD: A systematic literature search was conducted in six electronic databases: PubMed, Embase, Cochrane Library, CINAHL, PsycINFO, and Scopus. Included studies were analysed using manifest content analysis. Methodological limitations and confidence in the evidence were assessed using a modified version of the Critical Appraisal Skills Programme and the Grading of Recommendations, Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative Research approach respectively. RESULTS: Findings from 18 studies show that individuals with FASD experience a variation of disabilities, ranging from somatic problems, high pain tolerance, destructive behaviour, hyperactivity, and aggressiveness, to social problems with friendship, school attendance, and maintenance of steady employment. Most studies reported parents' experiences with FASD; parenting was viewed as a lifelong engagement and that the whole family is isolated and burdened because of FASD. People with FASD feel that their difficulties affect their daily life in a limiting way and make them feel different from others. INTERPRETATION: From the perspective of primarily parents, individuals with FASD and their parents face many different difficulties, for which they need societal support. WHAT THIS PAPER ADDS: Individuals with fetal alcohol spectrum disorders (FASD) feel their difficulties make them different from others. Parents think of their parenting as a lifelong engagement. There is a shortage of studies investigating experiences of children with FASD. There is a shortage of studies investigating experiences of interventions given to individuals with FASD.