Duloxetine versus ‘active’ placebo, placebo or no intervention for major depressive disorder; a protocol for a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis

Abstract Background Major depression significantly impairs quality of life, increases the risk of suicide, and poses tremendous economic burden on individuals and societies. Duloxetine, a serotonin norepinephrine reuptake inhibitor, is a widely prescribed antidepressant. The effects of duloxetine have, however, not been sufficiently assessed in earlier systematic reviews and meta-analyses. Methods/design A systematic review will be performed including randomised clinical trials comparing duloxetine with ‘active’ placebo, placebo or no intervention for adults with major depressive disorder. Bias domains will be assessed, an eight-step procedure will be used to assess if the thresholds for clinical significance are crossed. We will conduct meta-analyses. Trial sequential analysis will be conducted to control random errors, and the certainty of the evidence will be assessed using GRADE. To identify relevant trials, we will search Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, PsycINFO, Science Citation Index Expanded, Social Sciences Citation Index, Conference Proceedings Citation Index—Science and Conference Proceedings Citation Index—Social Science & Humanities. We will also search Chinese databases and Google Scholar. We will search all databases from their inception to the present. Two review authors will independently extract data and perform risk of bias assessment. Primary outcomes will be the difference in mean depression scores on Hamilton Depression Rating Scale between the intervention and control groups and serious adverse events. Secondary outcomes will be suicide, suicide-attempts, suicidal ideation, quality of life and non-serious adverse events. Discussion No former systematic review has systematically assessed the beneficial and harmful effects of duloxetine taking into account both the risks of random errors and the risks of systematic errors. Our review will help clinicians weigh the benefits of prescribing duloxetine against its adverse effects and make informed decisions. Systematic review registration PROSPERO 2016 CRD42016053931

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Exercise for patients with major depression: a systematic review with meta-analysis and trial sequential analysis

BMJ Open ◽

10.1136/bmjopen-2016-014820 ◽

2017 ◽

Vol 7 (9) ◽

pp. e014820 ◽

Cited By ~ 34

Author(s):

Jesper Krogh ◽

Carsten Hjorthøj ◽

Helene Speyer ◽

Christian Gluud ◽

Merete Nordentoft

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Adverse Events ◽

Sequential Analysis ◽

Trial Sequential Analysis ◽

Depression Severity ◽

Serious Adverse Events ◽

Secondary Outcomes

ObjectivesTo assess the benefits and harms of exercise in patients with depression.DesignSystematic reviewData sourcesBibliographical databases were searched until 20 June 2017.Eligibility criteria and outcomesEligible trials were randomised clinical trials assessing the effect of exercise in participants diagnosed with depression. Primary outcomes were depression severity, lack of remission and serious adverse events (eg, suicide) assessed at the end of the intervention. Secondary outcomes were quality of life and adverse events such as injuries, as well as assessment of depression severity and lack of remission during follow-up after the intervention.ResultsThirty-five trials enrolling 2498 participants were included. The effect of exercise versus control on depression severity was −0.66 standardised mean difference (SMD) (95% CI −0.86 to −0.46; p<0.001; grading of recommendations assessment, development and evaluation (GRADE): very low quality). Restricting this analysis to the four trials that seemed less affected of bias, the effect vanished into −0.11 SMD (−0.41 to 0.18; p=0.45; GRADE: low quality). Exercise decreased the relative risk of no remission to 0.78 (0.68 to 0.90; p<0.001; GRADE: very low quality). Restricting this analysis to the two trials that seemed less affected of bias, the effect vanished into 0.95 (0.74 to 1.23; p=0.78). Trial sequential analysis excluded random error when all trials were analysed, but not if focusing on trials less affected of bias. Subgroup analyses found that trial size and intervention duration were inversely associated with effect size for both depression severity and lack of remission. There was no significant effect of exercise on secondary outcomes.ConclusionsTrials with less risk of bias suggested no antidepressant effects of exercise and there were no significant effects of exercise on quality of life, depression severity or lack of remission during follow-up. Data for serious adverse events and adverse events were scarce not allowing conclusions for these outcomes.Systematic review registrationThe protocol was published in the journalSystematic Reviews: 2015; 4:40.

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Eversion technique versus conventional endarterectomy with patch angioplasty in carotid surgery: protocol for a systematic review with meta-analyses and trial sequential analysis of randomised clinical trials

BMJ Open ◽

10.1136/bmjopen-2019-030503 ◽

2020 ◽

Vol 10 (4) ◽

pp. e030503 ◽

Cited By ~ 1

Author(s):

Martijn S. Marsman ◽

Jorn Wetterslev ◽

Patrick W.H.E. Vriens ◽

Ronald L.A.W. Bleys ◽

Abdelkarime Kh. Jahrome ◽

...

Keyword(s):

Systematic Review ◽

Sequential Analysis ◽

Risk Of Bias ◽

Low Risk ◽

Trial Sequential Analysis ◽

Serious Adverse Events ◽

Symptomatic Carotid ◽

Patch Angioplasty ◽

Symptomatic Carotid Stenosis ◽

Meta Analyses

IntroductionTraditional carotid endarterectomy is considered to be the standard technique for prevention of a new stroke in patients with a symptomatic carotid stenosis. Use of patch angioplasty to restore the arterial wall after longitudinal endarterectomy is, to date, not unequivocally proven to be superior to eversion technique. A systematic review is needed for evaluation of benefits and harms of the eversion technique versus the traditional endarterectomy with patch angioplasty in patients with symptomatic carotid stenosis.Methods and outcomesThe review will be conducted according to this protocol following the recommendations of the ‘Cochrane Handbook for Systematic Reviews’ and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Randomised clinical trials comparing eversion technique versus endarterectomy with patch angioplasty in patients with a symptomatic stenosis of the internal carotid artery will be included. Primary outcomes are all-cause mortality rate, health-related quality of life and serious adverse events. Secondary outcomes are 30-day stroke and mortality rate, symptomatic arterial restenosis or occlusion and non-serious adverse events. The databases Cochrane Central Register of Controlled Trials, PubMed/MEDLINE and EMBASE will be searched (November 2019). We will primarily base our conclusions on meta-analyses of trials with overall low-risk of bias. We will use trial sequential analysis to assist the evaluation of imprecision in Grading of Recommendations, Assessment, Development and Evaluation. However, if pooled point estimates of all trials are similar to pooled point estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the trial sequential analysis adjusted precision of the estimate achieved in all trials as the result of our meta-analyses.Ethics and disseminationThe proposed systematic review will collect and analyse data from published studies, therefore, ethical approval is not required. The results of the review will be disseminated by publication in a peer-review journal and submitted for presentation at conferences.PROSPERO registration numberCRD42019119361.

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Carotid endarterectomy with primary closure versus patch angioplasty in patients with symptomatic and significant stenosis: protocol for a systematic review with meta-analyses and trial sequential analysis of randomised clinical trials

BMJ Open ◽

10.1136/bmjopen-2018-026419 ◽

2019 ◽

Vol 9 (4) ◽

pp. e026419 ◽

Cited By ~ 3

Author(s):

Martijn S Marsman ◽

Jørn Wetterslev ◽

Abdelkarime Khodadade Jahrome ◽

Christian Gluud ◽

Frans L Moll ◽

...

Keyword(s):

Systematic Review ◽

Primary Closure ◽

Sequential Analysis ◽

Risk Of Bias ◽

Low Risk ◽

Trial Sequential Analysis ◽

Serious Adverse Events ◽

Point Estimates ◽

Patch Angioplasty ◽

Meta Analyses

IntroductionUse of patch angioplasty in carotid endarterectomy (CEA) is suggested to reduce the risk of restenosis and recurrent ipsilateral stroke. The objective is to conduct a systematic review with meta-analysis and trial sequential analysis as well as Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessments comparing the benefits and harms of CEA with primary closure of the arterial wall versus CEA with patch angioplasty in patients with a symptomatic and significant carotid stenosis.Methods and analysisThe review shall be conducted according to this published protocol following the recommendations of the ‘Cochrane’ and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Randomised clinical trials comparing CEA with primary closure of the arterial wall versus CEA with patch angioplasty (regardless of used patch materials) in human adults with a symptomatic and significant carotid stenosis will be included. Primary outcomes are all-cause mortality at maximal follow-up, health-related quality of life and serious adverse events. Secondary outcomes are symptomatic or asymptomatic arterial occlusion or restenosis, and non-serious adverse events. We will primarily base our conclusions on meta-analyses of trials with overall low risk of bias. However, if pooled point estimates of all trials are similar to pooled point estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the precision achieved in all trials as the result of our meta-analyses.Ethics and disseminationThe proposed systematic review will collect and analyse secondary data from published studies therefor ethical approval is not required. The results of the systematic review will be disseminated by publication in a peer-review journal and submitted for presentation at relevant conferences.PROSPERO registration numberCRD42014013416.

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Pharmacological interventions for prevention and management of delirium in intensive care patients: a systematic overview of reviews and meta-analyses

BMJ Open ◽

10.1136/bmjopen-2018-024562 ◽

2019 ◽

Vol 9 (2) ◽

pp. e024562 ◽

Cited By ~ 8

Author(s):

Marija Barbateskovic ◽

Sara Russo Krauss ◽

Marie Oxenboell Collet ◽

Laura Krone Larsen ◽

Janus Christian Jakobsen ◽

...

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Intensive Care ◽

Adverse Events ◽

Pharmacological Interventions ◽

Serious Adverse Events ◽

Icu Patients ◽

Pharmacological Prevention ◽

Meta Analyses

ObjectivesWe assessed the evidence from reviews and meta-analyses of randomised clinical trials on the effects of pharmacological prevention and management of delirium in intensive care unit (ICU) patients.MethodsWe searched for reviews in July 2017 in: Cochrane Library, MEDLINE, Embase, Science Citation Index, BIOSIS Previews, CINAHL and LILACS. We assessed whether reviews were systematic according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and assessed the methodological quality using ROBIS.Outcome measuresPrimary outcomes: all-cause mortality, serious adverse events, prevention of delirium and management of delirium. Secondary outcomes: quality of life; non-serious adverse events and cognitive function.ResultsWe included 378 reviews: 369 narrative reviews, eight semisystematic reviews which failed on a maximum of two arbitrary PRISMA criteria and one systematic review fulfilling all 27 PRISMA criteria. For the prevention of delirium, we identified the one systematic review and eight semisystematic reviews all assessing the effects of alpha-2-agonists. None found evidence of a reduction of mortality (systematic review RR 0.99, 95% CI 0.79 to 1.24). The systematic review and three semisystematic reviews found no evidence of an effect for the prevention of delirium (systematic review RR 0.85, 0.63 to 1.14). Conversely, four semisystematic reviews found a beneficial effect. Serious adverse events, quality of life, non-serious adverse events and cognitive function were not assessed. We did not identify any systematic or semisystematic reviews addressing other pharmacological interventions for the prevention of delirium. For the management of manifest delirium, we did not identify any systematic or semisystematic review assessing any pharmacological agents.ConclusionBased on systematic reviews, the evidence for the use of pharmacological interventions for prevention or management of delirium is poor or sparse. A systematic review with low risk of bias assessing the effects of pharmacological prevention of delirium and management of manifest delirium in ICU patients is urgently needed.PROSPERO registration numberCRD42016046628.

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Major Mistakes and Errors in the Use of Trial Sequential Analysis in Systematic Reviews or Meta-analyses – Protocol for a Systematic Review

10.21203/rs.3.rs-900530/v1 ◽

2021 ◽

Author(s):

Christian Gunge Riberholt ◽

Markus Harboe Olsen ◽

Joachim Birch Milan ◽

Christian Gluud

Keyword(s):

Systematic Review ◽

Systematic Reviews ◽

Clinical Guidelines ◽

Methodological Quality ◽

Sequential Analysis ◽

Trial Sequential Analysis ◽

Type I ◽

Research Waste ◽

Meta Analyses

Abstract Background: Adequately conducted systematic reviews with meta-analyses are considered the highest level of evidence and thus directly defines many clinical guidelines. However, the risk of type I and II errors in meta-analyses are substantial. Trial Sequential Analysis is a method for controlling these risks. Erroneous use of the method might lead to research waste or misleading conclusions. Methods: The current protocol describes a systematic review aimed to identify common and major mistakes and errors in the use of Trial Sequential Analysis by evaluating published systematic reviews and meta-analyses that include this method. We plan to include all studies using Trial Sequential Analysis published from 2018 to 2021, an estimated 400 to 600 publications. We will search Medical Literature Analysis and Retrieval System Online (MEDLINE) and the Cochrane Database of Systematic Reviews (CDSR), including studies with all types of participants, interventions, and outcomes. The search will begin in July 2021. Two independent reviewers will screen titles and abstracts, include relevant full text articles, extract data from the studies into a predefined checklist, and evaluate the methodological quality of the study using the AMSTAR 2 (Assessing the methodological quality of systematic reviews). Discussion: This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P). The identified mistakes and errors will form the basis of a reviewed guideline for the use of Trial Sequential Analysis. Appropriately controlling for type I and II errors might reduce research waste and improve quality and precision of the evidence that clinical guidelines are based upon.

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Psychotherapy versus treatment as usual and other control interventions in children and adolescents with overweight and obesity: a protocol for systematic review with meta-analysis and Trial Sequential Analysis

BMJ Open ◽

10.1136/bmjopen-2019-036058 ◽

2020 ◽

Vol 10 (11) ◽

pp. e036058

Author(s):

Rajeeb Rashid ◽

Laura Condon ◽

Christian Gluud ◽

Janus C Jakobsen ◽

Jane Lindschou ◽

...

Keyword(s):

Systematic Review ◽

Adverse Events ◽

Children And Adolescents ◽

Sequential Analysis ◽

Meta Analysis ◽

Overweight And Obesity ◽

Trial Sequential Analysis ◽

Serious Adverse Events ◽

Treatment As Usual

IntroductionThe prevalence of children with overweight and obesity is increasing worldwide. Multicomponent interventions incorporating diet, physical activity and behavioural change have shown limited improvement to body mass index (BMI). However, the impact of psychotherapy is poorly explored. This systematic review aims to assess the effects of psychotherapeutic approaches for children with all degrees of overweight.Methods and analysisWe will include randomised clinical trials involving children and adolescents between 0 and 18 years with overweight and obesity, irrespective of publication type, year, status or language up to April 2020. Psychotherapy will be compared with no intervention; wait list control; treatment as usual; sham psychotherapy or pharmaceutical placebo. The following databases will be searched: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, MEDLINE, Embase, PsycINFO, PubMed, Web of Science, CINAHL and LILACS. Primary outcomes will be BMI z-score, quality of life measured by a validated scale and proportion of patients with serious adverse events. Secondary outcomes will be body weight, self-esteem, anxiety, depression and proportion of patients with non-serious adverse events. Exploratory outcomes will be body fat, muscle mass and serious adverse events. Study inclusion, data extraction and bias risk assessments will be conducted independently by at least two authors. We will assess risk of bias according to Cochrane guidelines and the Cochrane Effective Practice and Organisation of Care guidance. We will use meta-analysis and control risks of random errors with Trial Sequential Analysis. The quality of the evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation Tool. The systematic review will be reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Cochrane guidelines.Ethics and disseminationAs individual patient data will not be included, we do not require ethics approval. This review will be published in a peer review journal.PROSPERO registration numberCRD42018086458.

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The effects of adding glucocorticosteroids to standard care for children with sepsis. A systematic review of randomized clinical trials with meta-analysis and Trial Sequential Analysis

10.21203/rs.3.rs-275296/v1 ◽

2021 ◽

Author(s):

Steven Kwasi Korang ◽

Sanam Safi ◽

Christian Gluud ◽

Janus C Jakobsen

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Adverse Events ◽

Standard Care ◽

Sequential Analysis ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Trial Sequential Analysis ◽

Serious Adverse Events ◽

Meta Analyses

Abstract Background: Glucocorticosteroids are widely used to treat severe sepsis in pediatric intensive care units. However, the evidence on the clinical effects is unclear.Objective: To assess the benefits and harms of glucocorticosteroids for children with sepsis. Data Sources: We conducted a systematic review of randomized clinical trials with meta-analysis and Trial Sequential Analysis (TSA) (PROSPERO CRD42017054341). We searched CENTRAL, MEDLINE, Embase, LILACS, SCI-Expanded, and more. Study Selection: Randomized clinical trials assessing the effects of adding glucocorticosteroids to standard care for children with sepsis. Data Extraction: Two independent reviewers screened studies and extracted data. Evidence was assessed by GRADE according to our published protocol.Data Synthesis: We included 24 trials randomizing 3073 participants. Meta-analyses showed no evidence of an effect of adding glucocorticosteroids for children with sepsis with a mixed focus for any of our outcomes. Meta-analyses suggested evidence of a beneficial effect of dexamethasone for children with meningitis when assessing serious adverse events (risk ratio (RR) 0.68, 95% confidence interval (CI) 0.53 to 0.86; P = 0.001, very low certainty of evidence) and ototoxicity (RR 0.63, 95% CI 0.45 to 0.88; P = 0.007, low certainty of evidence). TSAs showed that we did not have sufficient data to confirm or reject these results. We found insufficient evidence to confirm or reject an effect on mortality or our other outcomes. No trials reported quality of life or organ failure. Most trials were at high risks of bias. We found high clinical heterogeneity between participants. None of our TSAs showed benefits, harms or futility. Conclusions: Generally, we found no evidence of an effect of glucocorticosteroids for children with sepsis without meningitis. Dexamethasone for sepsis in children due to meningitis may decrease serious adverse events and ototoxicity.

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Measurable Indicators of CRPD for People with Intellectual and Developmental Disabilities within the Quality of Life Framework

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17145123 ◽

2020 ◽

Vol 17 (14) ◽

pp. 5123

Author(s):

Laura E. Gómez ◽

Asunción Monsalve ◽

Mª Lucía Morán ◽

Mª Ángeles Alcedo ◽

Marco Lombardi ◽

...

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Developmental Disabilities ◽

Citation Index ◽

Intellectual And Developmental Disabilities ◽

Russian Science ◽

Persons With Disabilities ◽

Russian Science Citation Index ◽

Meta Analyses

This article proposes the quality of life (QOL) construct as a framework from which to develop useful indicators to operationalize, measure, and implement the Articles of the Convention on the Rights of Persons with Disabilities (CRPD). A systematic review of the scientific literature on people with intellectual and developmental disabilities (IDD) was carried out, with the aim of identifying personal outcomes that can be translated into specific and measurable items for each of the CRPD Articles aligned to the eight QOL domains. Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, the systematic review was conducted across the Web of Science Core Collection, Current Contents Connect (CCC), MEDLINE, KCI-Korean Journal Database, Russian Science Citation Index and SciELO Citation Index, for articles published between 2008 and 2020. A total of 65 articles focusing on people with IDD were selected. The results were grouped into four broad categories: conceptual frameworks used to monitor the CRPD; instruments used to assess the rights set out in the CRPD; recommendations on the use of inclusive research; and indicators or personal outcomes associated with specific rights contained in the CRPD.

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Tricyclic antidepressants versus ‘active placebo’, placebo or no intervention for adults with major depressive disorder: a protocol for a systematic review with meta-analysis and Trial Sequential Analysis

Systematic Reviews ◽

10.1186/s13643-021-01789-0 ◽

2021 ◽

Vol 10 (1) ◽

Author(s):

Caroline Kamp Jørgensen ◽

Sophie Juul ◽

Faiza Siddiqui ◽

Marija Barbateskovic ◽

Klaus Munkholm ◽

...

Keyword(s):

Systematic Review ◽

Major Depressive Disorder ◽

Depressive Disorder ◽

Sequential Analysis ◽

Tricyclic Antidepressants ◽

Meta Analysis ◽

Trial Sequential Analysis ◽

Major Depressive ◽

Serious Adverse Events ◽

Harmful Effects

Abstract Background Major depressive disorder is a common psychiatric disorder causing great burden on patients and societies. Tricyclic antidepressants are frequently used worldwide to treat patients with major depressive disorder. It has repeatedly been shown that tricyclic antidepressants reduce depressive symptoms with a statistically significant effect, but the effect is small and of questionable clinical importance. Moreover, the beneficial and harmful effects of all types of tricyclic antidepressants have not previously been systematically assessed. Therefore, we aim to investigate the beneficial and harmful effects of tricyclic antidepressants versus ‘active placebo’, placebo or no intervention for adults with major depressive disorder. Methods This is a protocol for a systematic review with meta-analysis that will be reported as recommended by Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols, bias will be assessed with the Cochrane Risk of Bias tool—version 2, our eight-step procedure will be used to assess if the thresholds for clinical significance are crossed, Trial Sequential Analysis will be conducted to control random errors and the certainty of the evidence will be assessed with the Grading of Recommendations Assessment, Development and Evaluation approach. To identify relevant trials, we will search both for published and unpublished trials in major medical databases and trial registers, such as CENTRAL, MEDLINE, EMBASE and ClinicalTrials.gov from their inception to 12 May 2021. Clinical study reports will be applied for from regulatory authorities and pharmaceutical companies. Two review authors will independently screen the results from the literature searches, extract data and perform risk of bias assessment. We will include any published or unpublished randomised clinical trial comparing tricyclic antidepressants with ‘active placebo’, placebo or no intervention for adults with major depressive disorder. The following interventions will be assessed: amineptine, amitriptyline, amoxapine, butriptyline, cianopramine, clomipramine, desipramine, demexiptiline, dibenzepin, dosulepin, dothiepin, doxepin, imipramine, iprindole, lofepramine, maprotiline, melitracen, metapramine, nortriptyline, noxiptiline, opipramol, protriptyline, tianeptine, trimipramine and quinupramine. Primary outcomes will be depressive symptoms, serious adverse events and quality of life. Secondary outcomes will be suicide or suicide-attempts and non-serious adverse events. If feasible, we will assess the intervention effects using random-effects and fixed-effect meta-analyses. Discussion Tricyclic antidepressants are recommended by clinical guidelines and frequently used worldwide in the treatment of major depressive disorder. There is a need for a thorough systematic review to provide the necessary background for weighing the benefits against the harms. This review will ultimately inform best practice in the treatment of major depressive disorder. Systematic review registration PROSPERO CRD42021226161.

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Psychological and Cognitive Aspects of Borderline Intellectual Functioning

European Psychologist ◽

10.1027/1016-9040/a000293 ◽

2017 ◽

Vol 22 (3) ◽

pp. 159-166 ◽

Cited By ~ 2

Author(s):

Bastianina Contena ◽

Stefano Taddei

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Intellectual Functioning ◽

Clinical Impact ◽

Review Of The Literature ◽

Borderline Intellectual Functioning ◽

General Quality ◽

Meta Analyses ◽

Over Time

Abstract. Borderline Intellectual Functioning (BIF) refers to a global IQ ranging from 71 to 84, and it represents a condition of clinical attention for its association with other disorders and its influence on the outcomes of treatments and, in general, quality of life and adaptation. Furthermore, its definition has changed over time causing a relevant clinical impact. For this reason, a systematic review of the literature on this topic can promote an understanding of what has been studied, and can differentiate what is currently attributable to BIF from that which cannot be associated with this kind of intellectual functioning. Using Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) criteria, we have conducted a review of the literature about BIF. The results suggest that this condition is still associated with mental retardation, and only a few studies have focused specifically on this condition.

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