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Role of personality disorder in randomised controlled trials of pharmacological interventions for adults with mood disorders: a protocol for a systematic review and meta-analysis.

ABSTRACT: INTRODUCTION:Remission rates for mood disorders, including depressive and bipolar disorders, remain relatively low despite available treatments, and many patients fail to respond adequately to these interventions. Evidence suggests that personality disorder may play a role in poor outcomes. Although personality disorders are common in patients with mood disorders, it remains unknown whether personality disorder affects treatment outcomes in mood disorders. We aim to review currently available evidence regarding the role of personality disorder on pharmacological interventions in randomised controlled trials for adults with mood disorders. METHODS AND ANALYSIS:A systematic search of Cochrane Central Register of Controlled Clinical Trials (CENTRAL) via cochranelibrary.com, PubMed via PubMed, EMBASE via embase.com, PsycINFO via Ebsco and CINAHL Complete via Ebsco databases will be conducted to identify randomised controlled trials that have investigated pharmacological interventions in participants aged 18 years or older for mood disorders (ie, depressive disorders and bipolar spectrum disorders) and have also included assessment of personality disorder. One reviewer will screen studies against the predetermined eligibility criteria, and a second reviewer will confirm eligible studies. Data will be extracted by two independent reviewers. Methodological quality and risk of bias will be assessed using the Cochrane Risk of Bias tool. A systematic review, and if sufficient evidence is identified, a meta-analysis will be completed. Meta-analysis will be conducted using the standardised mean difference approach and reported with 95% CIs. A random effects model will be employed and statistical heterogeneity will be evaluated using the I2 statistic. Prespecified subgroup analyses will be completed. ETHICS AND DISSEMINATION:As this systematic review will use published data, ethics permission will not be required. The outcomes of this systematic review will be published in a relevant scientific journal and presented at a research conference. TRIAL REGISTRATION NUMBER:CRD42018089279.

SUBMITTER: Kavanagh BE

PROVIDER: S-EPMC6502230 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Role of personality disorder in randomised controlled trials of pharmacological interventions for adults with mood disorders: a protocol for a systematic review and meta-analysis.

Kavanagh Bianca E BE Brennan-Olsen Sharon Lee SL Turner Alyna A Dean Olivia M OM Berk Michael M Ashton Melanie M MM Koivumaa-Honkanen Heli H Williams Lana J LJ

BMJ open 20190501 4

<h4>Introduction</h4>Remission rates for mood disorders, including depressive and bipolar disorders, remain relatively low despite available treatments, and many patients fail to respond adequately to these interventions. Evidence suggests that personality disorder may play a role in poor outcomes. Although personality disorders are common in patients with mood disorders, it remains unknown whether personality disorder affects treatment outcomes in mood disorders. We aim to review currently avai ...[more]

PMID: 31048431

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Project description:BackgroundDrugs are widely used in borderline personality disorder (BPD) treatment, chosen because of properties known from other psychiatric disorders ("off-label use"), mostly targeting affective or impulsive symptom clusters.ObjectivesTo assess the effects of drug treatment in BPD patients.Search strategyWe searched bibliographic databases according to the Cochrane Developmental, Psychosocial and Learning Problems Group strategy up to September 2009, reference lists of articles, and contacted researchers in the field.Selection criteriaRandomised studies comparing drug versus placebo, or drug versus drug(s) in BPD patients. Outcomes included total BPD severity, distinct BPD symptom facets according to DSM-IV criteria, associated psychopathology not specific to BPD, attrition and adverse effects.Data collection and analysisTwo authors selected trials, assessed quality and extracted data, independently.Main resultsTwenty-eight trials involving a total of 1742 trial participants were included. First-generation antipsychotics (flupenthixol decanoate, haloperidol, thiothixene); second-generation antipsychotics (aripirazole, olanzapine, ziprasidone), mood stabilisers (carbamazepine, valproate semisodium, lamotrigine, topiramate), antidepressants (amitriptyline, fluoxetine, fluvoxamine, phenelzine sulfate, mianserin), and dietary supplementation (omega-3 fatty acid) were tested. First-generation antipsychotics were subject to older trials, whereas recent studies focussed on second-generation antipsychotics and mood stabilisers. Data were sparse for individual comparisons, indicating marginal effects for first-generation antipsychotics and antidepressants.The findings were suggestive in supporting the use of second-generation antipsychotics, mood stabilisers, and omega-3 fatty acids, but require replication, since most effect estimates were based on single studies. The long-term use of these drugs has not been assessed.Adverse event data were scarce, except for olanzapine. There was a possible increase in self-harming behaviour, significant weight gain, sedation and changes in haemogram parameters with olanzapine. A significant decrease in body weight was observed with topiramate treatment. All drugs were well tolerated in terms of attrition.Direct drug comparisons comprised two first-generation antipsychotics (loxapine versus chlorpromazine), first-generation antipsychotic against antidepressant (haloperidol versus amitriptyline; haloperidol versus phenelzine sulfate), and second-generation antipsychotic against antidepressant (olanzapine versus fluoxetine). Data indicated better outcomes for phenelzine sulfate but no significant differences in the other comparisons, except olanzapine which showed more weight gain and sedation than fluoxetine. The only trial testing single versus combined drug treatment (olanzapine versus olanzapine plus fluoxetine; fluoxetine versus fluoxetine plus olanzapine) yielded no significant differences in outcomes.Authors' conclusionsThe available evidence indicates some beneficial effects with second-generation antipsychotics, mood stabilisers, and dietary supplementation by omega-3 fatty acids. However, these are mostly based on single study effect estimates. Antidepressants are not widely supported for BPD treatment, but may be helpful in the presence of comorbid conditions. Total BPD severity was not significantly influenced by any drug. No promising results are available for the core BPD symptoms of chronic feelings of emptiness, identity disturbance and abandonment. Conclusions have to be drawn carefully in the light of several limitations of the RCT evidence that constrain applicability to everyday clinical settings (among others, patients' characteristics and duration of interventions and observation periods).

Project description:IntroductionTherapeutic recommendations for hidradenitis suppurativa (HS) have recently shifted towards non-invasive pharmacological options. Recent evidence has shown promising efficacy for specific treatments. However, data regarding the comparative efficacy of these treatments in patients with HS are still limited. Therefore, we plan to conduct a systematic review and network meta-analysis (NMA) to summarise the benefits and harms of different pharmacological interventions for treating people living with HS.Methods and analysisWe will search electronic databases, including Medline, Embase, PubMed, Web of Science, Scopus, CINAHL and Cochrane Library beginning from their inception dates with no language restrictions. A grey literature search will be performed to supplement the electronic databases. Both randomised trials and non-randomised studies using validated measurement tools that investigated the benefits and harms of pharmacological interventions among people living with HS will be included. The predefined primary outcomes will include treatment responses that reflect the patient's perspective and all-cause discontinuation. Screening, selection, extraction, assessment of the risk of bias and analysis of the strength of the evidence will be performed independently by a pair of reviewers. A two-step approach of traditional pairwise and NMA will be performed. Based on a random-effects model, standardised weighted mean differences and ORs with corresponding 95% CIs will be pooled as effect estimates for the continuous and categorical endpoints, respectively. Statistical and methodological heterogeneities will be assessed. Preplanned subgroup analyses and univariate meta-regression will be conducted to quantify the potential sources of heterogeneity. Evidence-based synthesis will be based on the magnitudes of effect size, evidence certainty and the surface under the cumulative ranking curve values.Ethics and disseminationEthical approval is not required because this study is based on existing published data. These findings will be disseminated through scientific meetings and publications in peer-reviewed journals.Prospero registration numberCRD42022302795.

Project description:INTRODUCTION:The effectiveness of complex interventions for the management of musculoskeletal disorders has been estimated in many randomised clinical trials (RCTs). These trials inform which interventions are the most effective, however they do not always inform how an intervention achieved its clinical outcomes, nor how and what elements of an intervention were delivered to patients. Such information is useful for translating findings into clinical practice. A few process evaluation studies have been conducted alongside RCTs and a variety of methods have been used. To gain a better understanding of current practices of process evaluation in RCTs in musculoskeletal disorders, this systematic review is designed to answer the following research question: How are process evaluation of complex interventions tested in RCTs in musculoskeletal disorders being conducted? METHODS AND ANALYSIS:We will systematically search seven electronic databases (MEDLINE, SCOPUS, CINAHL, PsycINFO, EMBASE, Web of Science and Cochrane database) from the date of inception to August 2018 for studies on process evaluation of RCTs on non-surgical and non-pharmacological management of musculoskeletal disorders. We will include qualitative and quantitative studies conducted alongside RCTs, reported with the RCTs or separate studies that assessed interventions for musculoskeletal disorders. Two reviewers will screen abstracts and apply prespecified inclusion criteria to identify relevant studies, extract the data and assess the risk of bias within included studies. We will follow recommendations from the 'Cochrane Qualitative and Implementation Methods Group Guidance Series' when assessing methodological strengths and limitations of included studies. We will use a narrative synthesis to describe findings. ETHICS AND DISSEMINATION:Ethical approval is not required as this review will not collect original data. Findings from this systematic review will be presented at a scientific conference and published in a peer reviewed journal. PROSPERO REGISTRATION NUMBER:CRD42018109600.

Project description:ObjectivesTo evaluate the completeness of descriptions of non-pharmacological interventions in randomised trials, identify which elements are most frequently missing, and assess whether authors can provide missing details.DesignAnalysis of consecutive sample of randomised trials of non-pharmacological interventions.Data sources and study selectionAll reports of randomised trials of non-pharmacological interventions published in 2009 in six leading general medical journals; 133 trial reports, with 137 interventions, met the inclusion criteria.Data collectionUsing an eight item checklist, two raters assessed the primary full trial report, plus any reference materials, appendices, or websites. Questions about missing details were emailed to corresponding authors, and relevant items were then reassessed.ResultsOf 137 interventions, only 53 (39%) were adequately described; this was increased to 81 (59%) by using 63 responses from 88 contacted authors. The most frequently missing item was the "intervention materials" (47% complete), but it also improved the most after author response (92% complete). Whereas some authors (27/70) provided materials or further information, other authors (21/70) could not; their reasons included copyright or intellectual property concerns, not having the materials or intervention details, or being unaware of their importance. Although 46 (34%) trial interventions had further information or materials readily available on a website, many were not mentioned in the report, were not freely accessible, or the URL was no longer functioning.ConclusionsMissing essential information about interventions is a frequent, yet remediable, contributor to the worldwide waste in research funding. If trial reports do not have a sufficient description of interventions, other researchers cannot build on the findings, and clinicians and patients cannot reliably implement useful interventions. Improvement will require action by funders, researchers, and publishers, aided by long term repositories of materials linked to publications.

Project description:INTRODUCTION:Stroke is among the leading causes of death and disability worldwide. Poststroke cognitive impairment is a common sequela of stroke. The burden of cognitive impairment poststroke has significant impacts on the individual poststroke, their family and wider society. Despite the prevalence and associated burden of poststroke cognitive impairment, the optimal approach to rehabilitate cognitive deficits poststroke has yet to be established. A range of conservative interventions for cognitive impairment poststroke exist including self-efficacy training, physical activity interventions, neuropsychological interventions, electronic interventions, music therapy and occupational therapies. This systematic review aims to explore the totality of evidence with regard to non-pharmacological rehabilitation interventions wherein the primary or secondary aim is to improve cognitive function in individuals poststroke. METHODS AND ANALYSIS:A systematic review of randomised controlled trials which investigate the effectiveness of interventions wherein the primary or secondary aim is to improve cognitive function in individuals poststroke will be conducted (August 2019). The following electronic databases will be searched: PubMed, Embase, CINAHL, CENTRAL and PsycInfo. Reference lists of all identified studies will be reviewed to identify additional studies for inclusion. Titles and abstracts will be screened independently by two review authors for inclusion and exclusion. Any disagreement regarding inclusion will be resolved by discussion or by referral to a third assessor if necessary. Methodological quality will be assessed using the Cochrane Risk of Bias Tool for Randomised Controlled Trials. Meta-analyses will be performed if studies are sufficiently homogeneous. The review will be reported in accordance to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. ETHICS AND DISSEMINATION:As this systematic review will collect secondary data only, ethical approval is not required. Findings will be disseminated through presentations and peer-reviewed journals. TRIAL REGISTRATION NUMBER:CRD42019125289.

Dataset Information

Role of personality disorder in randomised controlled trials of pharmacological interventions for adults with mood disorders: a protocol for a systematic review and meta-analysis.

Publications

Role of personality disorder in randomised controlled trials of pharmacological interventions for adults with mood disorders: a protocol for a systematic review and meta-analysis.

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