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Journal of Clinical Medicine Dec 2022Current lung cancer clinical research focuses on biomarkers and personalized treatment strategies. Adaptive clinical trial designs have gained significant ground due to... (Review)
Review
Current lung cancer clinical research focuses on biomarkers and personalized treatment strategies. Adaptive clinical trial designs have gained significant ground due to their increased flexibility, compared to the conventional model of drug development from phase I to phase IV trials. One such adaptive approach is the seamless phase II/III design, which has been used to reduce the total sample size and drug development time. In this context, an algorithmic systematic search was conducted in MEDLINE (PUBMED), SCOPUS, EMBASE and Cochrane Central Register of Controlled Trials until 31 June 2022 in order to identify lung cancer trials of systematic treatments that have employed the seamless phase II/III methodology and to describe their characteristics. The search strategy yielded a total of 1420 records that were screened through their title and abstract; 28 eligible trials were included in the systematic review. Based on the study endpoints, the most common subtype included phase II/III trials with inefficacy/futility analyses (61%; 17/28), followed by dose escalation phase II/III trials (18%; 5/28), one multi-arm multi stage trial and 5 trials with other design (18%). Most eligible trials were open-label (71%; 20/27), included patients with non-small cell lung cancer (82%; 23/28), evaluated targeted therapies and/or immunotherapies (82%; 23/28) and recruited patients with advanced disease (89.3%; 25/28). In conclusion, the seamless phase II/III design is a feasible and suitable approach in lung cancer research, with distinct design subcategories according to study endpoints.
PubMed: 36498749
DOI: 10.3390/jcm11237176 -
The Cochrane Database of Systematic... Feb 2011Injury in the home is common, accounting for approximately a third of all injuries. The majority of injuries to children under five and people aged 75 and older occur at... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Injury in the home is common, accounting for approximately a third of all injuries. The majority of injuries to children under five and people aged 75 and older occur at home. Multifactorial injury prevention interventions have been shown to reduce injuries in the home. However, few studies have focused specifically on the impact of physical adaptations to the home environment and the effectiveness of such interventions needs to be ascertained.
OBJECTIVES
To determine the effect of modifications to the home environment on the reduction of injuries due to environmental hazards.
SEARCH STRATEGY
We searched The Cochrane Library, MEDLINE, EMBASE and other specialised databases. We also scanned conference proceedings and reference lists. We contacted the first author of all included randomised controlled trials. The searches were last updated to the end of December 2009, and were not restricted by language or publication status.
SELECTION CRITERIA
Randomised controlled trials.
DATA COLLECTION AND ANALYSIS
Two authors screened all abstracts for relevance, outcome and design. Two authors independently assessed methodological quality and extracted data from each eligible study. We performed meta-analysis to combine effect measures, using a random-effects model. We assessed heterogeneity using an I(2) statistic and a Chi(2) test.
MAIN RESULTS
We found 28 published studies and one unpublished study. Only two studies were sufficiently similar to allow pooling of data for statistical analyses. Studies were divided into three groups; children, older people and the general population/mixed age group. None of the studies focusing on children or older people demonstrated a reduction in injuries that were a direct result of environmental modification in the home. One study in older people demonstrated a reduction in falls and one a reduction in falls and injurious falls that may have been due to hazard reduction. One meta-analysis was performed which examined the effects on falls of multifactorial interventions consisting of home hazard assessment and modification, medication review, health and bone assessment and exercise (RR 1.09, 95% CI 0.97 to 1.23).
AUTHORS' CONCLUSIONS
There is insufficient evidence to determine whether interventions focused on modifying environmental home hazards reduce injuries. Further interventions to reduce hazards in the home should be evaluated by adequately designed randomised controlled trials measuring injury outcomes. Recruitment of large study samples to measure effect must be a major consideration for future trials. Researchers should also consider using factorial designs to allow the evaluation of individual components of multifactorial interventions.
Topics: Accidents, Home; Aged; Child; Controlled Clinical Trials as Topic; Housing; Humans; Interior Design and Furnishings; Randomized Controlled Trials as Topic; Wounds and Injuries
PubMed: 21328262
DOI: 10.1002/14651858.CD003600.pub3 -
BMC Medical Research Methodology Sep 2023Trial design plays a key role in clinical trials. Traditional group sequential design has been used in cardiovascular clinical trials over decades as the trials can...
BACKGROUND
Trial design plays a key role in clinical trials. Traditional group sequential design has been used in cardiovascular clinical trials over decades as the trials can potentially be stopped early, therefore, it can reduce pre-planned sample size and trial resources. In contrast, trials with adoptive designs provide greater flexibility and are more efficient due to the ability to modify trial design according to the interim analysis results. In this systematic review, we aim to explore characteristics of adaptive and traditional group sequential trials in practice and to gain an understanding how these trial designs are currently being reported in cardiology.
METHODS
PubMed, Embase and Cochrane Central Register of Controlled Trials database were searched from January 1980 to June 2022. Randomised controlled phase 2/3 trials with either adaptive or traditional group sequential design in patients with cardiovascular disease were included. Descriptive statistics were used to present the collected data.
RESULTS
Of 456 articles found in the initial search, 56 were identified including 43 (76.8%) trials with traditional group sequential design and 13 (23.2%) with adaptive. Most trials were large, multicentre, led by the USA (50%) and Europe (28.6%), and were funded by companies (78.6%). For trials with group sequential design, frequency of interim analyses was determined mainly by the number of events (47%). 67% of the trials stopped early, in which 14 (32.6%) were due to efficacy, and 5 (11.6%) for futility. The commonly used stopping rule to terminate trials was O'Brien- Fleming-type alpha spending function (10 (23.3%)). For trials with adaptive designs, 54% of the trials stopped early, in which 4 (30.8%) were due to futility, and 2 (15.4%) for efficacy. Sample size re-estimation was commonly used (8 (61.5%)). In 69% of the trials, simulation including Bayesian approach was used to define the statistical stopping rules. The adaptive designs have been increasingly used (from 0 to 1999 to 38.6% after 2015 amongst adaptive trials). 25% of the trials reported "adaptive" in abstract or title of the studies.
CONCLUSIONS
The application of adaptive trials is increasingly popular in cardiovascular clinical trials. The reporting of adaptive design needs improving.
Topics: Humans; Bayes Theorem; Cardiovascular Diseases; Computer Simulation; Data Collection; Death; Clinical Trials, Phase II as Topic; Randomized Controlled Trials as Topic
PubMed: 37679710
DOI: 10.1186/s12874-023-02024-1 -
BMJ Open Aug 2019Although adaptive e-learning environments (AEEs) can provide personalised instruction to health professional and students, their efficacy remains unclear. Therefore,... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Although adaptive e-learning environments (AEEs) can provide personalised instruction to health professional and students, their efficacy remains unclear. Therefore, this review aimed to identify, appraise and synthesise the evidence regarding the efficacy of AEEs in improving knowledge, skills and clinical behaviour in health professionals and students.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
CINAHL, EMBASE, ERIC, PsycINFO, PubMed and Web of Science from the first year of records to February 2019.
ELIGIBILITY CRITERIA
Controlled studies that evaluated the effect of an AEE on knowledge, skills or clinical behaviour in health professionals or students.
SCREENING, DATA EXTRACTION AND SYNTHESIS
Two authors screened studies, extracted data, assessed risk of bias and coded quality of evidence independently. AEEs were reviewed with regard to their topic, theoretical framework and adaptivity process. Studies were included in the meta-analysis if they had a non-adaptive e-learning environment control group and had no missing data. Effect sizes (ES) were pooled using a random effects model.
RESULTS
From a pool of 10 569 articles, we included 21 eligible studies enrolling 3684 health professionals and students. Clinical topics were mostly related to diagnostic testing, theoretical frameworks were varied and the adaptivity process was characterised by five subdomains: method, goals, timing, factors and types. The pooled ES was 0.70 for knowledge (95% CI -0.08 to 1.49; p.08) and 1.19 for skills (95% CI 0.59 to 1.79; p<0.00001). Risk of bias was generally high. Heterogeneity was large in all analyses.
CONCLUSIONS
AEEs appear particularly effective in improving skills in health professionals and students. The adaptivity process within AEEs may be more beneficial for learning skills rather than factual knowledge, which generates less cognitive load. Future research should report more clearly on the design and adaptivity process of AEEs, and target higher-level outcomes, such as clinical behaviour.
PROSPERO REGISTRATION NUMBER
CRD42017065585.
Topics: Computer-Assisted Instruction; Education, Medical; Health Personnel; Humans; Learning
PubMed: 31467045
DOI: 10.1136/bmjopen-2018-025252 -
The Cochrane Database of Systematic... Mar 2014Thalassaemia is a group of genetic blood disorders characterised by the absence or reduction in the production of haemoglobin. Severity is variable from less severe... (Review)
Review
BACKGROUND
Thalassaemia is a group of genetic blood disorders characterised by the absence or reduction in the production of haemoglobin. Severity is variable from less severe anaemia, through thalassaemia intermedia, to profound severe anaemia (thalassaemia major). In thalassaemia major other complications include growth retardation, bone deformation, and enlarged spleen. Blood transfusion is required to treat severe forms of thalassaemia, but this results in excessive accumulation of iron in the body (iron overload), removed mostly by a drug called desferrioxamine through 'chelation therapy'. Non-routine treatments are bone marrow transplantation (which is age restricted), and possibly hydroxyurea, designed to raise foetal haemoglobin level, thus reducing anaemia. In addition, psychological therapies seem appropriate to improving outcome and adherence to medical treatment.
OBJECTIVES
To examine the evidence that in people with thalassaemia, psychological treatments improve the ability to cope with the condition, and improve both medical and psychosocial outcomes.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register which comprises of references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Searches on the Internet were also performed.Date of the most recent search of the Group's Haemoglobinopathies Trials Register: 11 November 2013.
SELECTION CRITERIA
All randomised or quasi-randomised controlled trials comparing the use of psychological intervention to no (psychological) intervention in people with thalassaemia.
DATA COLLECTION AND ANALYSIS
No trials of psychological therapies have been found in the literature for inclusion in this review.
MAIN RESULTS
There are currently no results to be reported.
AUTHORS' CONCLUSIONS
As a chronic disease with a considerable role for self-management, psychological support seems appropriate for managing thalassaemia. However, from the information currently available, no conclusions can be made about the use of specific psychological therapies in thalassaemia. This systematic review has clearly identified the need for well-designed, adequately-powered, multicentre, randomised controlled trials assessing the effectiveness of specific psychological interventions for thalassaemia.
Topics: Adaptation, Psychological; Adult; Chelation Therapy; Child; Humans; Iron Chelating Agents; Psychotherapy; Transfusion Reaction; beta-Thalassemia
PubMed: 24604627
DOI: 10.1002/14651858.CD002890.pub2 -
Frontiers in Dentistry 2022Endocrown restorations were introduced for endodontically treated teeth as a conservative treatment. However, data about the effect of preparation design on marginal...
Endocrown restorations were introduced for endodontically treated teeth as a conservative treatment. However, data about the effect of preparation design on marginal integrity and fracture resistance of endocrowns are lacking. The purpose of this systematic review was to investigate the effect of preparation design of endocrown restorations on marginal integrity and fracture resistance. Based on PICO question and the search terms, PubMed, Embase, Scopus, and the Cochrane Library were searched. After including studies matched to predefined inclusion and exclusion criteria, the extracted data were tabulated in a table provided by the authors. Two reviewers assessed the methodological quality of each included study independently. Ten articles were selected for extracting the quantitative data. All included studies were in vitro. The potential risk of bias of the selected studies was assessed using the modified MINORS scale. Four studies assessed the marginal adaptation, five studies evaluated the fracture resistance and just one investigated both the marginal integrity and fatigue resistance of the specimens. The evaluated influencing items in preparation design were as follows: cavity depth, occlusal thickness, ferrule effect, internal divergence angle, type of finish line, and adding vents inside pulp chamber. Meta-analysis could not be done due to heterogeneity of preparation designs and evaluation methods. Marginal discrepancy of endocrowns is intensified with adding preparation features, higher cavity depth and increasing the divergence. Fracture resistance of endocrowns is increased with more occlusal reduction and cavity depth. However, it is still beyond the normal clinical force range.
PubMed: 36873612
DOI: 10.18502/fid.v19i37.11250 -
Korean Journal of Family Medicine Mar 2021Different scales have attempted to assess various aspects of family dynamics and structures. Good family function seems to allow for better prognoses for basic diseases...
BACKGROUND
Different scales have attempted to assess various aspects of family dynamics and structures. Good family function seems to allow for better prognoses for basic diseases and appears to be a predictor of depression. The aim of this study was to determine the association between family functionality and depression.
METHODS
This is a systematic review and meta-analysis including cross-sectional, cohort, and case-control studies using validated instruments such as the Family APGAR (Adaptability, Partnership, Growth, Affection, and Resolve) and Family Adaptability and Cohesion Evaluation Scale III. A search strategy was designed for the MEDLINE, Embase, Central, and LILACS databases along with data saturation through a search of unpublished literature from the onset of the databases to the present. The categorical variables are expressed in terms of odds ratios (OR), and the statistical analysis was carried out using Review Manager ver. 5.31 (The Cochrane Collaboration, Oxford, UK) using forest plots with corresponding 95% confidence intervals (CI). A fixed-effect model was used according to the expected heterogeneity, expressed in terms of I2 . The risk of bias was evaluated using the MINORS (methodological index for non-randomized studies) tool.
RESULTS
A total of 1,519 studies were found, of which 10 were selected for the qualitative synthesis and four were chosen for the meta-analysis. The result for the association between family dysfunction and depression yielded an OR (95% CI) of 3.72 (2.70 to 5.12) and I2 of 24%.
CONCLUSION
Family dysfunction and depression are strongly associated.
PubMed: 32521579
DOI: 10.4082/kjfm.19.0166 -
Clinical Psychology Review Aug 2022Mental imagery is recognised for its role in both psychological distress and wellbeing, with mental imagery techniques increasingly being incorporated into psychological... (Review)
Review
Mental imagery is recognised for its role in both psychological distress and wellbeing, with mental imagery techniques increasingly being incorporated into psychological interventions. In this systematic review and narrative synthesis (PROSPERO 2021: CRD42021240930), we identify and evaluate the evidence base for the phenomenon and phenomenology of mental imagery in people with intellectual disabilities, to ascertain the applicability of such interventions for this population. Electronic searches of nine databases and grey literature identified relevant publications. Two reviewers independently assessed titles and abstracts of retrieved records (n = 8609) and full-text articles (n = 101) against eligibility criteria. Data were extracted and quality appraised. Forty-onepapers met our eligibility criteria. The quality and designs were variable. Mental imagery was facilitated through ensuring participants understood tasks, providing opportunity to rehearse tasks (including using concrete prompts) and using scaffolding to help participants elaborate their responses. People with intellectual disabilities can engage with mental imagery, with appropriate adaptations, although the associated phenomenology has not been thoroughly investigated. Mental imagery interventions may be useful for people with intellectual disabilities with appropriate modifications.
Topics: Humans; Intellectual Disability
PubMed: 35738164
DOI: 10.1016/j.cpr.2022.102178 -
Heliyon Sep 2019This article reviews evaluation studies of interventions aimed at preventing and reducing incidents of suicide and self-harm among incarcerated individuals. Study... (Review)
Review
This article reviews evaluation studies of interventions aimed at preventing and reducing incidents of suicide and self-harm among incarcerated individuals. Study design, sample characteristics, intervention procedures, study measures, and relevant results of each study are reviewed. The outcomes of interest include severity and frequency of self-harm episodes and suicidal ideation, scores on adaptive coping methods, scoring on the Beck Hopelessness scale and risk scores. The six evaluated studies are peer-reviewed, published between 1990 and 2015, and took place in the United States, the United Kingdom, and Pakistan. Treatment modalities widely vary across studies and include cognitive behavioral therapy, dialectical behavioral therapy, peer programming, staff intervention training, and uniquely-designed courses that incorporate various aspects from other treatment modalities. Due to the nature of the studies, only one multi-randomized controlled trial was identified. All identified studies had a pre- and post-treatment design either lacking a comparison group or containing 1-2 comparison groups and conduct follow-up of varying times. While Cognitive Behavioral Therapy (CBT) interventions and uniquely-tailored intervention programs suggest promising results, the general absence of comparison groups, the shortage of relevant evaluation studies and the inconsistency of behavioral outcome measurements compromise the capacity of this review. Further, definitional variances, particularly for self-injury (self-harm, non-suicidal self-injury [NSSI], deliberate self-harm, suicidal behavior, etc.) affect the ability to synthesize study results. This article aims to synthesize the literature results to identify the most effective interventions that would benefit from additional research.
PubMed: 31517115
DOI: 10.1016/j.heliyon.2019.e02379 -
Nicotine & Tobacco Research : Official... Jun 2023Conversational agents (CAs; computer programs that use artificial intelligence to simulate a conversation with users through natural language) have evolved considerably... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Conversational agents (CAs; computer programs that use artificial intelligence to simulate a conversation with users through natural language) have evolved considerably in recent years to support healthcare by providing autonomous, interactive, and accessible services, making them potentially useful for supporting smoking cessation. We performed a systematic review and meta-analysis to provide an overarching evaluation of their effectiveness and acceptability to inform future development and adoption.
AIMS AND METHODS
PsycInfo, Web of Science, ACM Digital Library, IEEE Xplore, Medline, EMBASE, Communication and Mass Media Complete, and CINAHL Complete were searched for studies examining the use of CAs for smoking cessation. Data from eligible studies were extracted and used for random-effects meta-analyses.
RESULTS
The search yielded 1245 publications with 13 studies eligible for systematic review (total N = 8236) and six studies for random-effects meta-analyses. All studies reported positive effects on cessation-related outcomes. A meta-analysis with randomized controlled trials reporting on abstinence yielded a sample-weighted odds ratio of 1.66 (95% CI = 1.33% to 2.07%, p < .001), favoring CAs over comparison groups. A narrative synthesis of all included studies showed overall high acceptability, while some barriers were identified from user feedback. Overall, included studies were diverse in design with mixed quality, and evidence of publication bias was identified. A lack of theoretical foundations was noted, as well as a clear need for relational communication in future designs.
CONCLUSIONS
The effectiveness and acceptability of CAs for smoking cessation are promising. However, standardization of reporting and designing of the agents is warranted for a more comprehensive evaluation.
IMPLICATIONS
This is the first systematic review to provide insight into the use of CAs to support smoking cessation. Our findings demonstrated initial promise in the effectiveness and user acceptability of these agents. We also identified a lack of theoretical and methodological limitations to improve future study design and intervention delivery.
Topics: Humans; Smoking Cessation; Artificial Intelligence; Software; Delivery of Health Care; Communication
PubMed: 36507916
DOI: 10.1093/ntr/ntac281