title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
|---|---|---|---|---|
Trial Registration | ClinicalTrials.gov Identifier: | PMC10308298 | ||
Introduction | psychotic symptoms, Psychosis, First-episode psychosis, psychosis | REMISSION | First-episode psychosis is typically preceded by a prodrome characterized by nonspecific and attenuated psychotic symptoms and functional impairment. Ultrahigh risk criteria were introduced to prospectively identify this prodromal period.Unraveling the heterogeneity in the ultrahigh risk population is paramount to iden... | PMC10308298 |
Methods | PMC10308298 | |||
Study Design and Setting | The SMART design comprised 3 steps: open-label SPS (6 weeks), SPS vs CBCM (20 weeks), and CBCM with fluoxetine vs CBCM with placebo (26 weeks) (eFigure 1 in | PMC10308298 | ||
Participants | Prodromal Questionnaire-16 | Individuals seeking treatment were eligible for trial inclusion if they were aged 12 to 25 years, met ultrahigh risk criteria,Participants were screened using a standardized clinical assessment and the Prodromal Questionnaire-16 (PQ-16). | PMC10308298 | |
Randomization | Depression | REMISSION, BLIND | Randomization was based on computer-generated treatment allocations prepared by independent personnel. Participants who met remission criteria at the end of step 1 were randomized to SPS or monitoring; those who did not remit were randomized to CBCM or SPS. Assessors were blind to treatment allocation. Participants in ... | PMC10308298 |
Treatments | PMC10308298 | |||
Monitoring | Clinicians monitored participants’ mental state and risk at 3, 6, 9, and 12 months postentry to step 1. Any deterioration in mental health was appropriately managed. | PMC10308298 | ||
SPS | REMISSION | Manualized supportive counseling and problem-solving strategies were delivered within a positive psychology framework. Sessions were 30 to 50 minutes (weekly to fortnightly). In the relapse prevention and remission trial arm, participants received monthly SPS for up to 12 months. | PMC10308298 | |
CBCM | CBCM, a specialized manualized psychosocial intervention, consisted of cognitive behavioral therapy (CBT) provided within a case management framework. | PMC10308298 | ||
Medications | Step 3 comprised 1 capsule of fluoxetine, 20 mg per day, or placebo, increasing to 40 mg per day or 2 placebo capsules after 6 weeks if clinical response was insufficient as judged by the treating psychiatrist. At 12 weeks, a fast-fail option was available for participants who had deteriorated or had not responded to t... | PMC10308298 | ||
Outcome Measures | For power purposes and sample size calculation,Other outcome measures included the Brief Psychiatric Rating Scale (BPRS);Therapy sessions were audio recorded with consent and independently rated for fidelity. Based on the minimum number of sessions provided for each treatment at each step, | PMC10308298 | ||
Statistical Analysis | The study was powered to detect a small to medium effect size (Cohen | PMC10308298 | ||
Results | PMC10308298 | |||
Participant Flow | Of 1343 individuals considered, 342 were included (198 female; mean [SD] age, 17.7 [3.1] years) ( | PMC10308298 | ||
Sample Demographic Characteristics at Baseline | Depression, perceptual abnormalities | Abbreviations: BPRS, Brief Psychiatric Rating Scale; CAARMS, Comprehensive Assessment of At-Risk Mental States; MADRS, Montgomery-Åsberg Depression Rating Scale; PACE, Personal Assessment and Crisis Evaluation; SANS, Scale for the Assessment of Negative Symptoms; SPS, support and problem solving; SOFAS, Social and Occu... | PMC10308298 | |
CONSORT Diagram | Discontinuation rates were 17.8% (61 of 342; step 1), 47.7% (134 of 281; step 2), and 38.4% (53 of 138; step 3). Reasons for discontinuation are listed in eTable 1 in | PMC10308298 | ||
Hypothesis 1: Remission Rates | REMISSION | Remission rates (ie, sustained remission) across treatment arms at the end of steps 1, 2, and 3 were 8.5%, 10.3%, and 11.4%, respectively. The overall remission rate (ie, sustained remission at the end of at least one step) was 27.2%. There were no significant differences in remission rates between treatments at the en... | PMC10308298 | |
Hypothesis 2a: Effect of CBCM on Functioning and Clinical Measures | For the primary outcome, intent-to-treat analysis revealed no significant difference in mean scores on the Global Functioning: Social and Role scales between SPS and CBCM at 6 months ( | PMC10308298 | ||
General Linear Model Analysis Comparing Cognitive-Behavioral Case Management (CBCM) and Support and Problem Solving (SPS) at 6 Months and CBCM With Fluoxetine and CBCM With Placebo at 12 Months | Depression, perceptual abnormalities | INTERACTION | Abbreviations: AQoL, Assessment of Quality of Life; BPRS, Brief Psychiatric Rating Scale; CAARMS, Comprehensive Assessment of At-Risk Mental States; DACOBS, Davos Assessment of Cognitive Biases Scale; DS, disorganized speech; GF, Global Functioning Scale; MADRS, Montgomery-Åsberg Depression Rating Scale; NBI, nonbizarr... | PMC10308298 |
Hypotheses 2b and 2c: Effect of Baseline Cognitive Biases or Vulnerabilities on Remission and Treatment Outcome | While this hypothesis was intended to be restricted to the CBCM group, CBCM did not produce superior outcomes or greater improvement on cognitive biases or vulnerabilities than SPS (The correlation between baseline DACOBS total and 6-month outcomes and between change in DACOBS total and change in outcomes among those w... | PMC10308298 | ||
Hypothesis 3: Effect of Antidepressant Medication on Clinical Outcome | Both treatment arms (CBCM with fluoxetine and CBCM with placebo) showed improvement by the end of step 3, with no significant difference on any measure ( | PMC10308298 | ||
Changes in Mean Symptom and Functioning Scores From Baseline to the End of Step 3 | Depression | Circles represent individual participant data. Fluoxetine or placebo commenced at 6 months (start of step 3). AQoL indicates assessment of quality of life; BPRS, Brief Psychiatric Rating Scale; CBCM, cognitive-behavioral case management; DACOBS, Davos Assessment of Cognitive Biases Scale; MADRS, Montgomery-Åsberg Depre... | PMC10308298 | |
Hypothesis 4: Relapse Rates and Outcomes of Participants Who Remitted | Six-month relapse rates were higher in the SPS group (59.8%) than monitoring (16.9%) among participants who remitted at step 1 (Six-month SOFAS scores significantly differed between SPS and monitoring among participants who remitted at step 1 (effect size, 0.91; 95% CI, 0.95-19.6; | PMC10308298 | ||
Transition to Psychosis | The Kaplan-Meier–estimated 12-month transition rate was 13.5% (95% CI, 9.1-18.0). The log-rank test indicated no significant difference between groups at 6 and 12 months ( | PMC10308298 | ||
Overall Treatment Effect and Complete-Case and Per-Protocol Analyses | Across the entire sample, small to medium effect sizes were found at 6 and 12 months on measures of symptoms and functioning (eTable 6 in | PMC10308298 | ||
Treatment Adherence and Fidelity | The mean (SD) number of sessions attended was 2.3 (1.5) and 5.7 (3.9) for SPS at steps 1 and 2, respectively, and 6.2 (3.7) at step 2 and 6.0 (4.2) at step 3 for CBCM. A total of 199 recordings (65 participants; 24 clinicians) were rated for fidelity, a mean (SD) of 3.1 (2.1) per participant and 8.3 (9.3) per clinician... | PMC10308298 | ||
Adverse Events | ADVERSE EVENTS | Few adverse and serious adverse events occurred. No significant group differences were observed (eTable 17 in | PMC10308298 | |
Discussion | STAR*D, Depression, psychosis | SECONDARY, REMISSION | This is the first SMART trial to be conducted in the ultrahigh risk population. The primary outcome of functioning at the end of step 2 was selected for sample size and power calculations; however, results should be considered as a whole, spanning all steps. For the primary outcome, there was no difference between CBCM... | PMC10308298 |
Strengths and Limitations | psychosis | To our knowledge, this is the largest ultrahigh risk for psychosis trial to date, reflecting the utility of primary care youth mental health platforms, particularly when recruiting medication-naive participants. However, the treatment provided was insufficient for a large proportion of our sample. Despite high dropout ... | PMC10308298 | |
Conclusions | REMISSION | Enhancing the intensity of treatment with psychological interventions or medications was challenging to implement with fidelity and adherence in this largely primary care-based sample but nevertheless could not be demonstrated to produce any benefit over and above continuing a simpler form of care. Low remission and hi... | PMC10308298 | |
References | REMISSION | Trial protocolClick here for additional data file.eMethodseTable 1. Reasons for treatment discontinuation (%)eTable 2. Pearson correlation between baseline DACOBS total and 6-month outcomes and between change in DACOBS total and change in outcomes (Step 1 non-remitters)eTable 3. 12-month outcomes of the fast-fail group... | PMC10308298 | |
Methods | We leveraged the Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) trial, a randomized double-blind placebo-controlled trial of antimicrobial therapy with azithromycin and nitazoxanide provided quarterly to infants from 6 to 15 months of age. We tested 5,479 stool samples at time points... | PMC10734999 | ||
Results | There was substantial carriage of enteropathogens in stool. Azithromycin administration led to reductions in | PMC10734999 | ||
Conclusion | infections | INFECTIONS | The antimicrobial intervention of quarterly azithromycin plus or minus nitazoxanide led to only transient decreases in enteric infections with | PMC10734999 |
Data Availability | All relevant data are within the paper and its | PMC10734999 | ||
Introduction | infections | CNS INFECTIONS, INFECTIONS | Early enteric infections in children in low-resource settings are an established risk factor for poor growth [This background formed the rationale for the Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) trial, a randomized double-blind placebo-controlled trial of antimicrobial therapy... | PMC10734999 |
Methods | PMC10734999 | |||
Study enrollment and interventions | The ELICIT study methods have been previously reported in detail [ | PMC10734999 | ||
Data and sample collection | Use of non-study antibiotics by study children, defined as any antibiotic that was not part of the study intervention, was identified using a standardized questionnaire at monthly visits. Child lengths using measuring boards and weights using digital scales were measured every three months. Stool samples were collected... | PMC10734999 | ||
Stool testing | Procedures for sample extraction and testing have been previously detailed [ | PMC10734999 | ||
Statistical analysis | enteric infection | REGRESSION | Pathogens with an overall prevalence of at least 5% were included in the analyses of pathogen carriage. At a prevalence of 5% in the placebo arm, we had 80% power to detect a prevalence in the antimicrobial arm of 1.8%, a 3.2% difference; at a prevalence of 20%, we had 80% power to detect a prevalence of 13.6% in the a... | PMC10734999 |
Results | The baseline characteristics of the children in this study are summarized in | PMC10734999 | ||
Sample testing by qPCR, receipt of non-study antibiotics, and anthropometry by intervention arm. | There was substantial detection of enteric pathogens as we have noted previously [ | PMC10734999 | ||
Overall pathogen prevalence in the stool of ELICIT children at 6, 12, and 18 months by qPCR. | enteropathogen, enteroaggregative | Y axis shows prevalence or proportion positive. EAEC = enteroaggregative We examined the effect of receiving study antimicrobial versus placebo on enteropathogen carriage. | PMC10734999 | |
Difference in enteropathogen detection in the antibiotic versus placebo arms at 6, 6.5, 12, 12.5, and 18 months. | PENICILLINS | X axis is the absolute difference in pathogen prevalence between the antibiotic and placebo arms. Negative values to the left of 0.0 represent lower carriage in the active arm.Because children frequently received non-study antibiotics, we examined the effect of receiving such antibiotics on pathogens as well. Penicilli... | PMC10734999 | |
Difference in pathogen detection in children that recently received non-study antibiotics. | X axis is the absolute difference in those that received non-study antibiotics during the month prior to 6, 12, and 18 months versus those that did not receive non-study antibiotics. Negative values to the left of 0.0 represent lower carriage with receipt of non-study antibiotics.We examined whether a growth benefit wa... | PMC10734999 | ||
Difference in 3 month growth outcomes by treatment arm stratified by pathogen detection at 6 and 12 months of age. | Shown are the subset of children at 6 and 12 months with We also tested for carriage of antimicrobial resistance genes by qPCR within this customized TAC card. Receiving antimicrobials rather than placebo slightly increased the risk of detecting the macrolide resistance genes | PMC10734999 | ||
Discussion | ETEC diarrhea, intestinal infections, infections, reinfections, ETEC | INFECTIONS, INTESTINAL INFECTIONS | The ELICIT trial administered single-dose azithromycin plus or minus nitazoxanide quarterly to infants under the hypothesis that antibiotic treatment of the intestinal infections associated with poor growth could reduce child stunting. In the primary analysis no effect on childhood growth or stunting was seen at 18 mon... | PMC10734999 |
Supporting information | PMC10734999 | |||
Pathogens and gene targets tested by PCR in this study. | (DOCX)Click here for additional data file. | PMC10734999 | ||
Complete ELICIT TAC data. | (CSV)Click here for additional data file. | PMC10734999 | ||
ELICIT TAC data dictionary. | (CSV)Click here for additional data file. | PMC10734999 | ||
Difference in pathogen detection in the nicotinamide versus placebo arms at 6, 6.5, 12, 12.5, and 18 months. | X axis is the absolute reduction in pathogen prevalence between the nicotinamide–placebo. Negative values to the left of 0.0 represent reduction with nicotinamide. 95% confidence intervals are included.(DOCX)Click here for additional data file. | PMC10734999 | ||
Prevalence of non-study antibiotic use by drug class and month. | (DOCX)Click here for additional data file. | PMC10734999 | ||
References | PMC10734999 | |||
Background | ’ learning | Medical trainees often encounter situations that trigger emotional reactions which may hinder learning. Evidence of this effect on medical trainees is scarce and whether it could be counteracted is unclear. This study investigated the effect of negative emotions on medical residents’ learning and whether cognitive reap... | PMC9883942 | |
Methods | Ninety-nine medical residents participated in a three-phase experiment consisting of: (1) | PMC9883942 | ||
Results | Study time significantly varied between conditions ( | PMC9883942 | ||
Conclusion | Negative emotions can adversely affect medical residents’ learning. The effect of emotions was not counteracted by cognitive reappraisal, which has been successfully employed to regulate emotions in other domains. Further research to examine emotion regulation strategies appropriate for medical education is much needed... | PMC9883942 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12909-022-03996-2. | PMC9883942 | ||
Keywords | PMC9883942 | |||
Background | anger, ’ learning | Emotionally difficult situations are unavoidable in medical training. Students and doctors have reported experiencing negative emotions such as sadness when watching a patient’s suffering, fear of making mistakes, or anger when witnessing colleagues’ unprofessional behaviour [How could emotions affect residents’ learni... | PMC9883942 | |
Methods | PMC9883942 | |||
Design | This study was an experiment consisting of three tasks: (I) an Experiment design and tasks flow | PMC9883942 | ||
Participants | Participants were ninety-nine first-year internal medicine residentsAll participants signed informed consent forms. The study protocol was approved by the Research Ethics Committee of the São Paulo University (659.347 in 21/05/2014). | PMC9883942 | ||
Materials and procedure | The study was presented to the participants as two separate, unrelated studies, from two different institutions. The emotion induction procedure was presented as a study on the use of fictitious videoclips in medical education whereas the learning task and the test were purportedly a study on the suitability of new med... | PMC9883942 | ||
Emotion induction procedure | We opted to use a vicarious experience to induce negative emotions for ethical reasons. Experimental research has commonly employed films to elicit standardized emotional responses [After watching the videoclip, participants answered 6 questions to check if our manipulation worked (Additional file Subsequently, partici... | PMC9883942 | ||
Learning task | SCHMIDT, CARDIAC ARREST | After completing the above-mentioned tasks (purportedly, Study 1) participants were requested to open the second envelope (purportedly, Study 2), which contained a 930-word text on oxidative damage during cardiac arrest. The text was prepared to by considering the participants’ prior knowledge to avoid ceiling effects ... | PMC9883942 | |
Testing task | After completing the learning task, the participants were requested to write down everything that they could remember from the text. Learning about a certain topic progresses through the enrichment of the semantic network of concepts related to that topic stored in the person’s memory. The more effective the learning, ... | PMC9883942 | ||
Data analysis | Sample uniformity between the three experimental conditions with respect to gender and age was checked by performing, respectively, a chi-square test and a one-way ANOVA. Participants’ familiarity with the situation portrayed in the videoclips (item #1 Additional file Two measurements checked our manipulation: the aver... | PMC9883942 | ||
Discussion | ’ learning [, cognitive reappraisal, ’ | This experimental study had a two-fold purpose: (1) examining whether the finding of a previous study [What concerns the first study purpose, these results are in line with findings of a previous study that showed participants under the influence of negative emotions to invest less time to study the learning material a... | PMC9883942 | |
Conclusion | ’ learning | Summing up, the present study replicates previous findings that negative emotions adversely impact medical residents’ subsequent learning. To get a better understanding of how to manage this effect, further research is called for. Apparently, these emotional states are harder to regulate than we assumed. Our ER interve... | PMC9883942 | |
Acknowledgements | This study could not have been performed without the help and cooperation of the medical residents at the School of Medicine at University of Sao Paulo, Brazil (2017) for their participation and effort in completing the study tasks.We also thank Dr Chin An Lin for his valuable advice and cooperation and the preceptors ... | PMC9883942 | ||
Authors’ contributions | TK contributed to the conception and design of the study, the data collection, analysis and interpretation, drafted the first version of the manuscript and revised the manuscript. SM contributed to the conception and design of the study, the data analysis and interpretation, critically revised the manuscript for import... | PMC9883942 | ||
Authors’ information | Erasmus, psychiatric | SCHMIDT | Telma Kremer, MSc, PhD is a clinical psychologist graduated at São Paulo University, with a Master in Health Professions Education from Maastricht University and a PhD at the Institute of Medical Education Research Rotterdam, Erasmus MC, The Netherlands.Sílvia Mamede, MD, PhD, is associate professor at the Institute of... | PMC9883942 |
Funding | None. | PMC9883942 | ||
Availability of data and materials | The data analysed during the present study are available from the corresponding author upon reasonable request. | PMC9883942 | ||
Declarations | PMC9883942 | |||
Ethics approval and consent to participate | All participants signed informed consent forms. The study protocol was approved by the Research Ethics Committee of the São Paulo University (659.347 in 21/05/2014). All methods were performed in accordance with the relevant guidelines and regulations. | PMC9883942 | ||
Consent for publication | Not applicable. | PMC9883942 | ||
Competing interests | The authors declare that they have no competing interests. | PMC9883942 | ||
References | PMC9883942 | |||
Background | emphysema | LUNG, EMPHYSEMA | Lung volume reduction surgery (LVRS) and bronchoscopic lung volume reduction (BLVR) with endobronchial valves can improve outcomes in appropriately selected patients with emphysema. However, no direct comparison data exist to inform clinical decision making in people who appear suitable for both procedures. Our aim was... | PMC10133584 |
Methods | airflow obstruction, lung volume reduction, dyspnoea | DISEASE | This multicentre, single-blind, parallel-group trial randomised patients from five UK hospitals, who were suitable for a targeted lung volume reduction procedure, to either LVRS or BLVR and compared outcomes at 1 year using the i-BODE score. This composite disease severity measure includes body mass index, airflow obst... | PMC10133584 |
Results | 88 participants (48% female, mean± | PMC10133584 | ||
Introduction | death, lobar atelectasis, COPD, heterogeneous emphysema | COPD | COPD is a common and often disabling condition which is now the third largest cause of death worldwide [An alternative lung volume reduction approach is endobronchial placement of valves to the airways supplying the most emphysematous lobe causing it to deflate. This form of bronchoscopic lung volume reduction (BLVR) c... | PMC10133584 |
Methods | PMC10133584 | |||
Study design and participants | airflow obstruction, COPD | COPD | The CELEB study was a multicentre, randomised controlled, parallel-group superiority trial in which patients with COPD who were considered by a lung volume reduction multidisciplinary team (MDT) meeting to be suitable candidates for both forms of targeted lung reduction therapy, and who did not have collateral ventilat... | PMC10133584 |
Randomisation and masking | Randomisation to the treatment arm occurred only after the MDT meeting and once participants had undergone a fibreoptic bronchoscopy to allow for assessment of the presence of collateral ventilation using the Chartis system. People who were collateral ventilation-positive exited the study as valves would not be effecti... | PMC10133584 | ||
Procedures | LVRS, to remove the most emphysematous part of the target lung, was carried out by a thoracic surgeon under general anaesthesia, primarily using either unilateral video-assisted thoracoscopic surgery or unilateral robot-assisted surgery. Where required, an open thoracotomy was performed at the discretion of the surgeon... | PMC10133584 | ||
Outcomes | airflow obstruction | DISEASE | The primary outcome for the trial was the between-group difference in i-BODE score from baseline to 12 months post-procedure. This composite measure of disease severity is made up of body mass index (BMI), airflow obstruction (FEV | PMC10133584 |
Statistical analysis | Sample size calculation was based on a study comparing change in BODE score 3 months post-LVRS between survivors and non-survivors at 5 years [Changes in outcome measures between groups were analysed using independent t-tests where normally distributed, otherwise the Wilcoxon rank-sum (Mann–Whitney) test was used. Trea... | PMC10133584 | ||
Results | death, illness or injury, pneumothorax, atelectasis, lung volume reduction, disability/incapacity, deaths, COPD, coronavirus disease 2019 | SUBCUTANEOUS EMPHYSEMA, CORONAVIRUS DISEASE 2019, PNEUMOTHORAX, ADVERSE EVENTS, ATELECTASIS, COMPLICATION, ACUTE EXACERBATION OF COPD, COPD, SECONDARY, EVENTS, COMPLICATIONS | Between 16 September 2016 and 22 July 2019, 163 patients were assessed for their eligibility to be enrolled in the trial. Of 149 patients who were screened and thought on the basis of their CT scan to be collateral ventilation-negative, 38 (26%) were collateral ventilation-positive on Chartis assessment and nine (6%) h... | PMC10133584 |
Discussion | death, emphysema, COPD, pulmonary hypertension, hyperinflation | ADVERSE EVENTS, DISEASE, EMPHYSEMA, COPD, SECONDARY, PULMONARY HYPERTENSION | The CELEB trial is the first randomised controlled trial to compare the effects of LVRS with BLVR. We found that surgery was not substantially superior to bronchoscopic treatment in patients with intact fissures and that both were similarly safe. Both approaches produced a clinically meaningful reduction in hyperinflat... | PMC10133584 |
Conclusions | COPD | COPD | The results of this study do not support the hypothesis that LVRS is a substantially superior treatment compared with BLVR, in terms of health outcomes achieved 1 year post-procedure. These broadly similar results at 12 months were obtained with a longer length of stay initially for LVRS but with less need for subseque... | PMC10133584 |
Shareable PDF | COPD | COPD, THORACIC | This one-page PDF can be shared freely online.Shareable PDF Full list of study investigators on the CELEB trial: Royal Brompton Hospital (London): Sara C. Buttery, Winston Banya, Simon Jordan, Samuel V. Kemp, Adam Lewis, Pallav L. Shah, Nicholas S. Hopkinson, Sofina Begum, Michael I. Polkey, Matthew Pavitt, Karthi Srik... | PMC10133584 |
References | PMC10133584 | |||
Introduction | muscle mass, fatigue | BLOOD, DISEASE, CONTRACTIONS | In recent years, electrical muscle stimulation (EMS) devices have been developed as a complementary training technique that is novel, attractive, and time-saving for physical fitness and rehabilitation. While it is known that EMS training can improve muscle mass and strength, most studies have focused on the elderly or... | PMC10586320 |
Materials and Methods | PMC10586320 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.