scholarly journals What Constitutes Sufficient Evidence for Case Formulation–Driven CBT for Psychosis? Cumulative Meta-analysis of the Effect on Hallucinations and Delusions

2020 ◽  
Vol 46 (5) ◽  
pp. 1072-1085 ◽  
Author(s):  
David T Turner ◽  
Simone Burger ◽  
Filip Smit ◽  
Lucia R Valmaggia ◽  
Mark van der Gaag

Abstract Objective Following 2 decades of research on cognitive behavioral therapy for psychosis (CBTp), it is relevant to consider at which point the evidence base is considered sufficient. We completed a cumulative meta-analysis to assess the sufficiency and stability of the evidence base for hallucinations and delusions. Method We updated the systematic search from our previous meta-analytic review from August 2013 until December 2019. We identified 20 new randomized controlled trials (RCTs) resulting in inclusion of 35 RCTs comparing CBTp with treatment-as-usual (TAU) or active controls (AC). We analyzed data from participants with psychosis (N = 2407) over 75 conventional meta-analytic comparisons. We completed cumulative meta-analyses (including fail-safe ratios) for key comparisons. Publication bias, heterogeneity, and risk of bias were examined. Results Cumulative meta-analyses demonstrated sufficiency and stability of evidence for hallucinations and delusions. The fail-safe ratio demonstrated that the evidence base was sufficient in 2016 for hallucinations and 2015 for delusions. In conventional meta-analyses, CBTp was superior for hallucinations (g = 0.34, P < .01) and delusions (g = 0.37, P < .01) when compared with any control. Compared with TAU, CBTp demonstrated superiority for hallucinations (g = 0.34, P < .01) and delusions (g = 0.37, P < .01). Compared with AC, CBT was superior for hallucinations (g = 0.34, P < .01), but not for delusions although this comparison was underpowered. Sensitivity analyses for case formulation, primary outcome focus, and risk of bias demonstrated increases in effect magnitude for hallucinations. Conclusions The evidence base for the effect of CBTp on hallucinations and delusions demonstrates sufficiency and stability across comparisons, suggesting limited value of new trials evaluating generic CBTp.

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e024886 ◽  
Author(s):  
Klaus Munkholm ◽  
Asger Sand Paludan-Müller ◽  
Kim Boesen

ObjectivesTo investigate whether the conclusion of a recent systematic review and network meta-analysis (Ciprianiet al) that antidepressants are more efficacious than placebo for adult depression was supported by the evidence.DesignReanalysis of a systematic review, with meta-analyses.Data sources522 trials (116 477 participants) as reported in the systematic review by Ciprianiet aland clinical study reports for 19 of these trials.AnalysisWe used the Cochrane Handbook’s risk of bias tool and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to evaluate the risk of bias and the certainty of evidence, respectively. The impact of several study characteristics and publication status was estimated using pairwise subgroup meta-analyses.ResultsSeveral methodological limitations in the evidence base of antidepressants were either unrecognised or underestimated in the systematic review by Ciprianiet al. The effect size for antidepressants versus placebo on investigator-rated depression symptom scales was higher in trials with a ‘placebo run-in’ study design compared with trials without a placebo run-in design (p=0.05). The effect size of antidepressants was higher in published trials compared with unpublished trials (p<0.0001). The outcome data reported by Ciprianiet aldiffered from the clinical study reports in 12 (63%) of 19 trials. The certainty of the evidence for the placebo-controlled comparisons should be very low according to GRADE due to a high risk of bias, indirectness of the evidence and publication bias. The mean difference between antidepressants and placebo on the 17-item Hamilton depression rating scale (range 0–52 points) was 1.97 points (95% CI 1.74 to 2.21).ConclusionsThe evidence does not support definitive conclusions regarding the benefits of antidepressants for depression in adults. It is unclear whether antidepressants are more efficacious than placebo.


2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 195-195
Author(s):  
Janine Wirth ◽  
Elaine Hillesheim ◽  
Lorraine Brennan

Abstract Objectives Poor sleep is increasingly seen as an issue of public health concern. The evidence to support the relationship between protein intake and sleep hygiene is limited and inconclusive. Therefore, the aim of this systematic review and meta-analysis was to examine the association between protein intake and subjective and objective sleep parameters in adults. Methods On June 22nd, 2020, five electronic databases were searched to identify relevant randomised controlled trials (Pubmed, Cochrane, Embase, Web of Science and CINAHL Plus). Risk of bias of included studies was assessed by outcomes using the Cochrane risk-of-bias 2.0 tool. Meta-analyses were performed for the outcomes sleep latency (SL), sleep efficiency (SE), and sleep quality (SQ). The quality of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. Results A total of 12 intervention studies from 10 articles were included. Meta-analyses showed no significant association between sleep outcomes (SQ = eight studies, SL = seven studies, SE = six studies) and increased protein intake, with very low certainty of evidence. However, results from sensitivity analyses excluding high-risk studies from parallel design trials suggest a small effect on SQ in favour of high protein intake (mean difference: −6.95; 95% CI: −12.52, −1.41; on a scale ranging from 0 to 100). Conclusions Our systematic review and meta-analysis indicate that there is no clear relationship between protein intake and sleep. However, the strength of the evidence is rather low. Further RCTs that focus on this specific research question are warranted, considering a more appropriate study design. This systematic review was registered with the International Prospective Register of Systematic Reviews, PROSPERO (CRD42020196021). Funding Sources This work was supported by: Marie Skłodowska-Curie Career Development Fellowship in the National Technology Centre Programme funded through a cofund with the European Union's Horizon 2020 and Enterprise Ireland; European Research Council (ERC); Brazilian Federal Agency for Support and Evaluation of Graduate Education (CAPES) as part of the Full PhD Abroad Program. Funding agencies had no role in the design, analysis, or writing of this article.


2020 ◽  
Vol 29 (12) ◽  
pp. 1019-1032 ◽  
Author(s):  
Ana Luisa Neves ◽  
Lisa Freise ◽  
Liliana Laranjo ◽  
Alexander W Carter ◽  
Ara Darzi ◽  
...  

ObjectiveTo evaluate the impact of sharing electronic health records (EHRs) with patients and map it across six domains of quality of care (ie, patient-centredness, effectiveness, efficiency, timeliness, equity and safety).DesignSystematic review and meta-analysis.Data sourcesCINAHL, Cochrane, Embase, HMIC, Medline/PubMed and PsycINFO, from 1997 to 2017.Eligibility criteriaRandomised trials focusing on adult subjects, testing an intervention consisting of sharing EHRs with patients, and with an outcome in one of the six domains of quality of care.Data analysisThe Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. Title and abstract screening were performed by two pairs of investigators and assessed using the Cochrane Risk of Bias Tool. For each domain, a narrative synthesis of the results was performed, and significant differences in results between low risk and high/unclear risk of bias studies were tested (t-test, p<0.05). Continuous outcomes evaluated in four studies or more (glycated haemoglobin (HbA1c), systolic blood pressure (SBP) and diastolic blood pressure (DBP)) were pooled as weighted mean difference (WMD) using random effects meta-analysis. Sensitivity analyses were performed for low risk of bias studies, and long-term interventions only (lasting more than 12 months).ResultsTwenty studies were included (17 387 participants). The domain most frequently assessed was effectiveness (n=14), and the least were timeliness and equity (n=0). Inconsistent results were found for patient-centredness outcomes (ie, satisfaction, activation, self-efficacy, empowerment or health literacy), with 54.5% of the studies (n=6) demonstrating a beneficial effect. Meta-analyses showed a beneficial effect in effectiveness by reducing absolute values of HbA1c (unit: %; WMD=−0.316; 95% CI −0.540 to −0.093, p=0.005, I2=0%), which remained significant in the sensitivity analyses for low risk of bias studies (WMD= −0.405; 95% CI −0.711 to −0.099), and long-term interventions only (WMD=−0.272; 95% CI −0.482 to −0.062). A significant reduction of absolute values of SBP (unit: mm Hg) was found but lost in sensitivity analysis for studies with low risk of bias (WMD= −1.375; 95% CI −2.791 to 0.041). No significant effect was found for DBP (unit: mm Hg; WMD=−0.918; 95% CI −2.078 to 0.242, p=0.121, I2=0%). Concerning efficiency, most studies (80%, n=4) found either a reduction of healthcare usage or no change. A beneficial effect was observed in a range of safety outcomes (ie, general adherence, medication safety), but not in medication adherence. The proportion of studies reporting a beneficial effect did not differ between low risk and high/unclear risk studies, for the domains evaluated.DiscussionOur analysis supports that sharing EHRs with patients is effective in reducing HbA1c levels, a major predictor of mortality in type 2 diabetes (mean decrease of −0.405, unit: %) and could improve patient safety. More studies are necessary to enhance meta-analytical power and assess the impact in other domains of care.Protocol registrationhttp://www.crd.york.ac.uk/PROSPERO (CRD42017070092).


Author(s):  
Beatrice Heim ◽  
Florian Krismer ◽  
Klaus Seppi

AbstractDifferential diagnosis of parkinsonian syndromes is considered one of the most challenging in neurology. Quantitative MR planimetric measurements were reported to discriminate between progressive supranuclear palsy (PSP) and non-PSP-parkinsonism. Several studies have used midbrain to pons ratio (M/P) and the Magnetic Resonance Parkinsonism Index (MRPI) in distinguishing PSP patients from those with Parkinson's disease. The current meta-analysis aimed to compare the performance of these measures in discriminating PSP from multiple system atrophy (MSA). A systematic MEDLINE review identified 59 out of 2984 studies allowing a calculation of sensitivity and specificity using the MRPI or M/P. Meta-analyses of results were carried out using random effects modelling. To assess study quality and risk of bias, the QUADAS-2 tool was used. Eight studies were suitable for analysis. The meta‐analysis showed a pooled sensitivity and specificity for the MRPI of PSP versus MSA of 79.2% (95% CI 72.7–84.4%) and 91.2% (95% CI 79.5–96.5%), and 84.1% (95% CI 77.2–89.2%) and 89.2% (95% CI 81.8–93.8%), respectively, for the M/P. The QUADAS-2 toolbox revealed a high risk of bias regarding the methodological quality of patient selection and index test, as all patients were seen in a specialized outpatient department without avoiding case control design and no predefined threshold was given regarding MRPI or M/P cut-offs. Planimetric brainstem measurements, in special the MRPI and M/P, yield high diagnostic accuracy for the discrimination of PSP from MSA. However, there is an urgent need for well-designed, prospective validation studies to ameliorate the concerns regarding the risk of bias.


2021 ◽  
Vol 5 (1) ◽  
pp. e001129
Author(s):  
Bill Stevenson ◽  
Wubshet Tesfaye ◽  
Julia Christenson ◽  
Cynthia Mathew ◽  
Solomon Abrha ◽  
...  

BackgroundHead lice infestation is a major public health problem around the globe. Its treatment is challenging due to product failures resulting from rapidly emerging resistance to existing treatments, incorrect treatment applications and misdiagnosis. Various head lice treatments with different mechanism of action have been developed and explored over the years, with limited report on systematic assessments of their efficacy and safety. This work aims to present a robust evidence summarising the interventions used in head lice.MethodThis is a systematic review and network meta-analysis which will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement for network meta-analyses. Selected databases, including PubMed, Embase, MEDLINE, Web of Science, CINAHL and Cochrane Central Register of Controlled Trials will be systematically searched for randomised controlled trials exploring head lice treatments. Searches will be limited to trials published in English from database inception till 2021. Grey literature will be identified through Open Grey, AHRQ, Grey Literature Report, Grey Matters, ClinicalTrials.gov, WHO International Clinical Trials Registry and International Standard Randomised Controlled Trials Number registry. Additional studies will be sought from reference lists of included studies. Study screening, selection, data extraction and assessment of methodological quality will be undertaken by two independent reviewers, with disagreements resolved via a third reviewer. The primary outcome measure is the relative risk of cure at 7 and 14 days postinitial treatment. Secondary outcome measures may include adverse drug events, ovicidal activity, treatment compliance and acceptability, and reinfestation. Information from direct and indirect evidence will be used to generate the effect sizes (relative risk) to compare the efficacy and safety of individual head lice treatments against a common comparator (placebo and/or permethrin). Risk of bias assessment will be undertaken by two independent reviewers using the Cochrane Risk of Bias tool and the certainty of evidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations guideline for network meta-analysis. All quantitative analyses will be conducted using STATA V.16.DiscussionThe evidence generated from this systematic review and meta-analysis is intended for use in evidence-driven treatment of head lice infestations and will be instrumental in informing health professionals, public health practitioners and policy-makers.PROSPERO registration numberCRD42017073375.


2021 ◽  
pp. 146531252110272
Author(s):  
Despina Koletsi ◽  
Anna Iliadi ◽  
Theodore Eliades

Objective: To evaluate all available evidence on the prediction of rotational tooth movements with aligners. Data sources: Seven databases of published and unpublished literature were searched up to 4 August 2020 for eligible studies. Data selection: Studies were deemed eligible if they included evaluation of rotational tooth movement with any type of aligner, through the comparison of software-based and actually achieved data after patient treatment. Data extraction and data synthesis: Data extraction was done independently and in duplicate and risk of bias assessment was performed with the use of the QUADAS-2 tool. Random effects meta-analyses with effect sizes and their 95% confidence intervals (CIs) were performed and the quality of the evidence was assessed through GRADE. Results: Seven articles were included in the qualitative synthesis, of which three contributed to meta-analyses. Overall results revealed a non-accurate prediction of the outcome for the software-based data, irrespective of the use of attachments or interproximal enamel reduction (IPR). Maxillary canines demonstrated the lowest percentage accuracy for rotational tooth movement (three studies: effect size = 47.9%; 95% CI = 27.2–69.5; P < 0.001), although high levels of heterogeneity were identified (I2: 86.9%; P < 0.001). Contrary, mandibular incisors presented the highest percentage accuracy for predicted rotational movement (two studies: effect size = 70.7%; 95% CI = 58.9–82.5; P < 0.001; I2: 0.0%; P = 0.48). Risk of bias was unclear to low overall, while quality of the evidence ranged from low to moderate. Conclusion: Allowing for all identified caveats, prediction of rotational tooth movements with aligner treatment does not appear accurate, especially for canines. Careful selection of patients and malocclusions for aligner treatment decisions remain challenging.


2021 ◽  
Vol 10 (13) ◽  
pp. 2760
Author(s):  
María León-López ◽  
Daniel Cabanillas-Balsera ◽  
Victoria Areal-Quecuty ◽  
Jenifer Martín-González ◽  
María C. Jiménez-Sánchez ◽  
...  

Aim. To conduct a systematic review and meta-analysis according to the following PICO question: in extracted human permanent teeth, does preflaring, compared with unflared canals, influence the accuracy of WL determination with EAL? Material and Methods. A systematic review was conducted according to the PRISMA checklist, using the following databases: PubMed, Science Direct, Scopus, and Web of Science. Studies related to WL determination using EAL both in preflared and unflared root canals of extracted human teeth were included. The outcome of interest was the accuracy of the electronic WL determination. A quality assessment of the included studies was performed, determining the risk of bias. The meta-analyses were calculated with the 5.4 RevMan software using the inverse variance method with random effects. PROSPERO registration: CRD42021243412. Results. Ten experimental studies fulfilled the inclusion criteria, and most of them found that preflaring increases the accuracy of the EALs in WL determination. The calculated OR was 1.98 (95% CI = 1.65–2.37; p < 0.00001; I2 = 10%), indicating that the determination of WL by EALs is almost twice as accurate in preflared canals. The accuracy of Root ZX in WL determination increases more than three times (OR = 3.25; p < 0.00001). Preflaring with Protaper files significantly increases the accuracy of EALs (OR = 1.76; p < 0.00001). The total risk of bias of the included studies was low. No obvious publication bias was observed. Conclusions. The results indicate a significant increase in the accuracy of WL determination with EAL after preflaring, doubling the percentage of exact measurements. Preflaring should be recommended as an important step during mechanical enlargement of the root canal, not only because it improves the access of the files to the canal, but also because it allows one to obtain more accurate electronic determinations of WL.


2021 ◽  
Vol 67 (1) ◽  
pp. 27-34
Author(s):  
Fernanda Cardoso ◽  
Jéssica Breder ◽  
Priscila Apolinário ◽  
Henrique Oliveia ◽  
Maria Saidel ◽  
...  

BACKGROUND: Plantago major is a medicinal plant that has been used for centuries to treat various health conditions including wounds. PURPOSE: To investigate the effectiveness of the topical use of P major in healing skin wounds in animal models. METHODS: Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a systematic review was conducted. Seven (7) electronic databases (Virtual Health Library, Public/Publisher MEDLINE, Scopus, Web of Science, Embase, Cumulative Index of Nursing and Allied Health Literature, and CAB Direct) were searched for controlled studies published in English from January 2006 to March 2020. The Collaborative Approach to Meta Analysis and Review of Animal Data from Experimental Studies tools guided the evaluation of the studies and determined their quality. The Systematic Review Center for Laboratory Animal Experimentation was used to assess the risk of bias. RESULTS: Of the 176 publications identified, 4 met the inclusion criteria. Studies included 20 to 100 animals and varying concentrations of P major. There were no reports of losses during research. Wound healing was assessed between 17 and 21 days following wounding. The best response in terms of wound contraction rate occurred with 10%, 20%, and 50% concentrations when compared with control groups. One (1) study did not have an animal ethics committee review. All studies had a high risk of bias and a lack of methodological rigor. CONCLUSION: The results of this review did not find evidence about the in vivo effectiveness of P major for wound healing. More rigorous preclinical studies with adequate sample sizes are required to identify the best concentrations and formulations as well as increase understanding about the mechanisms of action of P major in wound healing.


2018 ◽  
Vol 42 (4) ◽  
pp. 361 ◽  
Author(s):  
Richard Olley ◽  
Andrea Morales

Objective Dementia is one of the most common illnesses worldwide, and is one of the most important causes of disability in older people. Currently, dementia affects over 35 million people around the globe. It is expected that this number will increase to 65.7 million by 2030. Early detection, diagnosis and treatment to control the principal behaviour symptoms may help reduce these numbers and delay the progression to more advanced and dangerous stages of this disorder with resultant increase quality of life for those affected. The main goal of the present systematic literature review was to examine contemporary evidence relating to non-pharmacological therapy in the treatment of dementia. Methods To achieve the study goal, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was used. Results This study identified the five most common behaviours in patients with dementia as aggression, wandering, agitation, apathy and sleep disturbances. Two non-pharmacological therapies were the most studied treatment: music therapy and aromatherapy. Ten other non-pharmacological therapies were also identified, but these lack a sufficient evidence-base. Conclusion Although all the therapies identified could be used as part of the treatment of behavioural symptoms, there is insufficient evidence relating to the indications, appropriate use and effectiveness of these therapies to apply in each behavioural treatment. Thus, the present study has demonstrated a significant research gap. What is known about the topic? Despite the widespread use of many different types of therapies, there is limited evidence regarding the efficacy of non-pharmaceutical therapies deployed in the management of behaviours of concern manifested by some people who suffer with dementia in all its forms. What does this paper add? This systematic review examines contemporary evidence from the literature to determine whether there is an evidence base available that would underpin the use of these therapies. This report on a PRISMA systematic review of the available literature demonstrates that only two therapies have some evidence to underpin the use of these non-pharmaceutical therapies and that a significant research gap is exists. What are the implications for practitioners? The implications for practitioners is that significant research effort is required to determine the efficacy of many of the therapies that are currently deployed, and thus many of the therapies used lack an evidence base at this time.


BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e022142
Author(s):  
Jun Wang ◽  
Yin Wang ◽  
Hui Zhang ◽  
Ming Lu ◽  
Weilu Gao ◽  
...  

IntroductionOsteoarthritis is a common degenerative joint disease that eventually leads to disability and poor quality of life. The main symptoms are joint pain and mobility disorders. If the patient has severe pain or other analgesics are contraindicated, opioids may be a viable treatment option. To evaluate and compare the efficacy and safety of opioids in the treatment of knee or hip osteoarthritis, we will integrate direct and indirect evidence using a Bayesian network meta-analysis to establish hierarchies of these drugs.Methods and analysisWe will search the Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Web of Science and PsycINFO databases as well as published and unpublished research in international registries and regulatory agency websites for osteoarthritis reports published prior to 5 January 2018. There will be no restrictions on the language. Randomised clinical trials that compare oral or transdermal opioids with other various opioids, placebo or no treatment for patients with knee or hip osteoarthritis will be included. The primary outcomes of efficacy will be pain and function. We will use pain and function scales to evaluate the main outcomes. The secondary outcomes of safety will be defined as the proportion of patients who have stopped treatment due to side effects. Pairwise meta-analyses and Bayesian network meta-analyses will be performed for all related outcome measures. We will conduct subgroup analyses and sensitivity analyses to assess the robustness of our findings. The Grading of Recommendations, Assessment, Development and Evaluations framework will be used to assess the quality of the evidence contributing to each network assessment.Ethics and disseminationThis study does not require formal ethical approval because individual patient data will not be included. The findings will be disseminated through peer-reviewed publications or conference presentations.PROSPERO registration numberCRD42018085503.


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