A multicentre randomized controlled trial on trans-generational attention deficit/hyperactivity disorder (ADHD) in mothers and children (AIMAC): an exploratory analysis of predictors and moderators of treatment outcome

2019 ◽  
Vol 47 (1) ◽  
pp. 49-65 ◽  
Author(s):  
Charlotte Jaite ◽  
Betteke Maria van Noort ◽  
Timo D. Vloet ◽  
Erika Graf ◽  
Viola Kappel ◽  
...  
Keyword(s):  
Treatment Outcome ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Specific Treatment ◽  
Externalizing Symptoms ◽  
Control Treatment ◽  
Comorbid Depression ◽  
Adhd Treatment ◽  
Mothers And Children ◽  
Maternal Adhd

Abstract. Objective: We examined predictors and moderators of treatment outcome in mothers and children diagnosed with ADHD in a large multicentre RCT. Method: In total, 144 mother-child dyads with ADHD were randomly assigned to either a maternal ADHD treatment (group psychotherapy and open methylphenidate medication, TG) or to a control treatment (individual counselling without psycho- or pharmacotherapy, CG). After maternal ADHD treatment, parent-child training (PCT) for all mother-child dyads was added. The final analysis set was based on 123 dyads with completed primary outcome assessments (TG: n = 67, CG: n = 56). The primary outcome was the change in each child’s externalizing symptoms. Multiple linear regression analyses were performed. Results: The severity of the child’s externalizing problem behaviour in the family at baseline predicted more externalizing symptoms in the child after PCT, independent of maternal treatment. When mothers had a comorbid depression, TG children showed more externalizing symptoms after PCT than CG children of depressive mothers. No differences between the treatment arms were seen in the mothers without comorbid depression. Conclusions: Severely impaired mothers with ADHD and depressive disorder are likely to need additional disorder-specific treatment for their comorbid psychiatric disorders to effectively transfer the contents of the PCT to the home situation (CCTISRCTN73911400).

scholarly journals Predictors and moderators of treatment outcome in patients receiving multi-element psychosocial intervention for early psychosis: Results from the GET UP pragmatic cluster randomised controlled trial

2017 ◽  
Vol 210 (5) ◽  
pp. 342-349 ◽  
Author(s):  
Antonio Lasalvia ◽  
Chiara Bonetto ◽  
Jacopo Lenzi ◽  
Paola Rucci ◽  
Laura Iozzino ◽  
...  
Keyword(s):  
Treatment Outcome ◽  
Psychosocial Intervention ◽  
Controlled Trial ◽  
A Priori ◽  
Specific Treatment ◽  
Cluster Randomised Controlled Trial ◽  
Random Regression ◽  
First Episode ◽  
Treatment As Usual ◽  
Treatment Type

BackgroundThe GET UP multi-element psychosocial intervention proved to be superior to treatment as usual in improving outcomes in patients with first-episode psychosis (FEP). However, to guide treatment decisions, information on which patients may benefit more from the intervention is warranted.AimsTo identify patients' characteristics associated with (a) a better treatment response regardless of treatment type (non-specific predictors), and (b) a better response to the specific treatment provided (moderators).MethodSome demographic and clinical variables were selecteda priorias potential predictors/moderators of outcomes at 9 months. Outcomes were analysed in mixed-effects random regression models. (Trial registration: ClinicalTrials.gov, NCT01436331.)ResultsAnalyses were performed on 444 patients. Education, duration of untreated psychosis, premorbid adjustment and insight predicted outcomes regardless of treatment. Only age at first contact with the services proved to be a moderator of treatment outcome (patients aged ≥35 years had greater improvement in psychopathology), thus suggesting that the intervention is beneficial to a broad array of patients with FEP.ConclusionsExcept for patients aged over 35 years, no specific subgroups benefit more from the multi-element psychosocial intervention, suggesting that this intervention should be recommended to all those with FEP seeking treatment in mental health services.

scholarly journals A how-to guide for conducting retrospective analyses: example COVID-19 study

2020 ◽  
Author(s):  
Michael Powell ◽  
Allison Koenecke ◽  
James Brian Byrd ◽  
Akihiko Nishimura ◽  
Maximilian F. Konig ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Specific Treatment ◽  
Control Treatment ◽  
Practical Implementation ◽  
Medical Specialties ◽  
Health Care Data ◽  
Randomized Controlled ◽  
Use Of Time

In the urgent setting of the COVID-19 pandemic, treatment hypotheses abound, each of which requires careful evaluation. A randomized controlled trial generally provides the strongest possible evaluation of a treatment, but the efficiency and effectiveness of the trial depend on the existing evidence supporting the treatment. The researcher must therefore compile a body of evidence justifying the use of time and resources to further investigate a treatment hypothesis in a trial. An observational study can help provide this evidence, but the lack of randomized exposure and the researcher’s inability to control treatment administration and data collection introduce significant challenges for nonexperimental studies. A proper analysis of observational health care data thus requires an extensive background in a diverse set of topics ranging from epidemiology and causal analysis to relevant medical specialties and data sources. Here we provide 10 rules that serve as an end-to-end introduction to retrospective analyses of observational health care data. A running example of a COVID-19 study presents a practical implementation of each rule in the context of a specific treatment hypothesis. When carefully designed and properly executed, a retrospective analysis framed around these rules will inform the decisions of whether and how to investigate a treatment hypothesis in a randomized controlled trial.

scholarly journals The Probiotic VSL#3® Does Not Seem to Be Efficacious for the Treatment of Gastrointestinal Symptomatology of Patients with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2021 ◽  
Vol 14 (10) ◽  
pp. 1063
Author(s):  
Elena P. Calandre ◽  
Javier Hidalgo-Tallon ◽  
Rocio Molina-Barea ◽  
Fernando Rico-Villademoros ◽  
Cristina Molina-Hidalgo ◽  
...  
Keyword(s):  
Abdominal Pain ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Specific Treatment ◽  
Response To Treatment ◽  
Secondary Outcome ◽  
Outcome Variable ◽  
Controlled Clinical Trial

Background: Gastrointestinal symptomatology is frequent among patients with fibromyalgia, which increases disease burden and lacks specific treatment, either pharmacological or non-pharmacological. We aimed to evaluate the efficacy and tolerability of a multi-strain probiotic, VSL#3®, for the treatment of fibromyalgia-associated gastrointestinal manifestations. Methods: This randomized, placebo-controlled trial included 12 weeks of probiotic or placebo treatment followed by 12 weeks of follow up. The primary outcome variable was the mean change from the baseline to the endpoint in the composite severity score of the three main gastrointestinal symptoms reported by patients with fibromyalgia (abdominal pain, abdominal bloating and meteorism). Secondary outcome variables were the severity of additional gastrointestinal symptoms, fibromyalgia severity, depression, sleep disturbance, health-related quality of life and patients’ overall impression of improvement. Results: No differences were found between VSL#3® (n = 54) and the placebo (n = 56) in the primary outcome (estimated treatment difference: 1.1; 95% confidence interval [CI]: −2.1, 4.2; p = 0.501), or in any of the secondary outcomes. However, responders to VSL#3 were more likely to maintain any improvement during the follow-up period compared to responders in the placebo arm. Overall, VSL#3 tolerability was good. Conclusion: Our data could not demonstrate any beneficial effects of VSL#3® either on the composite score of severity of abdominal pain, bloating and meteorism or in any of the secondary outcome variables. More research is needed to elucidate specific factors that may predict a favourable response to treatment in patients with fibromyalgia.

scholarly journals Effectiveness of Optional Videoconferencing-Based Treatment of Alcohol Use Disorders: Randomized Controlled Trial

2017 ◽  
Vol 4 (3) ◽  
pp. e38 ◽  
Author(s):  
Kristine Tarp ◽  
Anders Bo Bojesen ◽  
Anna Mejldal ◽  
Anette Søgaard Nielsen
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Outcome ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Alcohol Use Disorders ◽  
Treatment As Usual ◽  
Treatment Termination ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
The Difference

Background Treatment of alcohol use disorders (AUDs) is characterized by an adherence rate below 50%. Clinical research has found that patient adherence enhances treatment effect; hence, health authorities, clinicians, and researchers strive to explore initiatives contributing to patients receiving treatment. Concurrently, videoconferencing-based treatment is gaining ground within other addiction and psychiatric areas. Objective The aim of this study was to test whether optional videoconferencing increases adherence to and effectiveness of AUD treatment in a randomized controlled trial (RCT). We hypothesized that the intervention would decrease premature dropout (the primary outcome), as well as increase successful treatment termination, treatment duration, and treatment outcome (secondary outcomes). Methods We conducted this study in the public outpatient alcohol clinic in Odense, Denmark, between September 2012 and April 2013. It was an RCT with 2 groups: treatment as usual (TAU) and treatment as usual with add-on intervention (TAU+I). The TAU+I group had the option, from session to session, to choose to receive treatment as usual via videoconferencing. Data consisted of self-reported responses to the European version of the Addiction Severity Index (EuropASI). We collected data at baseline, at follow-up at 3, 6, and 12 months, and at discharge. Results Among consecutive patients attending the clinic, 128 met the inclusion criteria, and 71 of them were included at baseline. For the primary outcome, after 180 days, 2 of 32 patients (6%) in the TAU+I group and 12 of 39 patients (31%) in the TAU group had dropped out prematurely. The difference is significant (P=.008). After 365 days, 8 patients (25%) in the TAU+I group and 17 patients (44%) in the TAU group had dropped out prematurely. The difference is significant (P=.02). For the secondary outcomes, significantly more patients in the TAU+I group were still attending treatment after 1 year (P=.03). We found no significant differences between the 2 groups with regard to successful treatment termination and treatment outcome. Conclusions The results indicate that offering patients optional videoconferencing may prevent premature dropouts from treatment and prolong treatment courses. However, the small sample size precludes conclusions regarding the effect of the intervention, which was not detectable in the patients’ use of alcohol and severity of problems. Trial Registration The Regional Health Research Ethics Committee System in Denmark: S-20110052; https://komite.regionsyddanmark.dk/wm258128 (Archived by WebCite at http://www.webcitation.org/6tTL3CO6u)

scholarly journals A Randomized Controlled Trial of an Integrated Brain, Body, and Social Intervention for Children With ADHD

2016 ◽  
Vol 24 (5) ◽  
pp. 780-794 ◽  
Author(s):  
Stephanie D. Smith ◽  
Lawrence A. Vitulano ◽  
Liliya Katsovich ◽  
Shuaixing Li ◽  
Christina Moore ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Behavior Management ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Memory Task ◽  
Verbal Working Memory ◽  
Secondary Outcome ◽  
Significant Treatment ◽  
Children With Adhd ◽  
Adhd Treatment

Objective: This study evaluated the efficacy of an Integrated Brain, Body, and Social (IBBS) intervention for children with ADHD. Treatment consisted of computerized cognitive remediation training, physical exercises, and a behavior management strategy. Method: Ninety-two children aged 5 to 9 years with ADHD were randomly assigned to 15 weeks of IBBS or to treatment-as-usual. Primary outcome measures included blinded clinician ratings of ADHD symptoms and global clinical functioning. Secondary outcome measures consisted of parent and teacher ratings of ADHD and neurocognitive tests. Results: No significant treatment effects were found on any of our primary outcome measures. In terms of secondary outcome measures, the IBBS group showed significant improvement on a verbal working memory task; however, this result did not survive correction for multiple group comparisons. Conclusion: These results suggest that expanding cognitive training to multiple domains by means of two training modalities does not lead to generalized improvement of ADHD symptomatology.

The effect of feedback-informed cognitive behavioral therapy on treatment outcome: A randomized controlled trial.

2020 ◽  
Vol 88 (9) ◽  
pp. 818-828
Author(s):  
Pauline D. Janse ◽  
Kim de Jong ◽  
Carola Veerkamp ◽  
Maarten K. van Dijk ◽  
Giel J. M. Hutschemaekers ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Outcome ◽  
Cognitive Behavioral Therapy ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled

scholarly journals Cervical arthroplasty: what does the labeling say?

2017 ◽  
Vol 42 (2) ◽  
pp. E2 ◽  
Author(s):  
Mazda K. Turel ◽  
Mena G. Kerolus ◽  
Owoicho Adogwa ◽  
Vincent C. Traynelis
Keyword(s):  
Outcome Measures ◽  
Revision Surgery ◽  
Controlled Trial ◽  
Neck Disability Index ◽  
Specific Treatment ◽  
The United States ◽  
Cervical Disc ◽  
Cervical Arthroplasty ◽  
Single Level ◽  
Level Group

OBJECTIVE The aim of this paper was to comprehensively review each of the Food and Drug Administration (FDA)–approved labels of 7 total cervical disc replacements, assess the exact methodology in which the trial was conducted, and provide a broad comparison of these devices to allow each surgeon to determine which disc best suits his or her specific treatment goals based on the specific labels and not the studies published. METHODS The FDA-approved labels for each of the 7 artificial discs were obtained from the official FDA website. These labels were meticulously compared with regard to the statistical analysis performed, the safety and efficacy data, and the randomized controlled trial that each artificial disc was involved in to obtain the FDA approval for the product or device. Both single-level and 2-level approvals were examined, and primary and secondary end points were assessed. RESULTS In the single-level group, 4 of the 7 artificial discs—Prestige LP, Prestige ST, Bryan, and Secure-C—showed superiority in overall success. Prestige ST showed superiority in 3 of 4 outcome measures (neurological success, revision surgery, and overall success), while the other aforementioned discs showed superiority in 2 or fewer measures (Prestige LP, neurological and overall success; Bryan, Neck Disability Index [NDI] and overall success; Secure-C, revision surgery and overall success; Pro-Disc C, revision surgery). The PCM and Mobi-C discs demonstrated noninferiority across all outcome measures. In the 2-level group, Prestige LP and Mobi-C demonstrated superiority in 3 outcome measures (NDI, secondary surgery, and overall success) but not neurological success. CONCLUSIONS This paper provides a comprehensive analysis of 7 currently approved and distributed artificial discs in the United States. It compares specific outcome measures of these devices against those following the standard of care, which is anterior cervical discectomy and fusion. This information will provide surgeons the opportunity to easily answer patients' questions and remain knowledgeable when discussing devices with manufacturers.

scholarly journals Oral insulin immunotherapy in children at risk for type 1 diabetes in a randomised controlled trial

Diabetologia ◽  
2021 ◽  
Author(s):  
Robin Assfalg ◽  
Jan Knoop ◽  
Kristi L. Hoffman ◽  
Markus Pfirrmann ◽  
Jose Maria Zapardiel-Gonzalo ◽  
...  
Keyword(s):  
Immune Response ◽  
Type 1 Diabetes ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Antibody Responses ◽  
Oral Insulin ◽  
Cell Responses ◽  
Randomised Controlled

Abstract Aims/hypothesis Oral administration of antigen can induce immunological tolerance. Insulin is a key autoantigen in childhood type 1 diabetes. Here, oral insulin was given as antigen-specific immunotherapy before the onset of autoimmunity in children from age 6 months to assess its safety and immune response actions on immunity and the gut microbiome. Methods A phase I/II randomised controlled trial was performed in a single clinical study centre in Germany. Participants were 44 islet autoantibody-negative children aged 6 months to 2.99 years who had a first-degree relative with type 1 diabetes and a susceptible HLA DR4-DQ8-containing genotype. Children were randomised 1:1 to daily oral insulin (7.5 mg with dose escalation to 67.5 mg) or placebo for 12 months using a web-based computer system. The primary outcome was immune efficacy pre-specified as induction of antibody or T cell responses to insulin and measured in a central treatment-blinded laboratory. Results Randomisation was performed in 44 children. One child in the placebo group was withdrawn after the first study visit and data from 22 insulin-treated and 21 placebo-treated children were analysed. Oral insulin was well tolerated with no changes in metabolic variables. Immune responses to insulin were observed in children who received both insulin (54.5%) and placebo (66.7%), and the trial did not demonstrate an effect on its primary outcome (p = 0.54). In exploratory analyses, there was preliminary evidence that the immune response and gut microbiome were modified by the INS genotype Among children with the type 1 diabetes-susceptible INS genotype (n = 22), antibody responses to insulin were more frequent in insulin-treated (72.7%) as compared with placebo-treated children (18.2%; p = 0.03). T cell responses to insulin were modified by treatment-independent inflammatory episodes. Conclusions/interpretation The study demonstrated that oral insulin immunotherapy in young genetically at-risk children was safe, but was not associated with an immune response as predefined in the trial primary outcome. Exploratory analyses suggested that antibody responses to oral insulin may occur in children with a susceptible INS genotype, and that inflammatory episodes may promote the activation of insulin-responsive T cells. Trial registration Clinicaltrials.gov NCT02547519 Funding The main funding source was the German Center for Diabetes Research (DZD e.V.) Graphical abstract

scholarly journals Chemical, Mechanical, and Heat Cleaning to Decontaminate Hospital Drains Harboring Carbapenemase-Producing Enterobacteriales

2020 ◽  
Vol 41 (S1) ◽  
pp. s466-s467
Author(s):  
Alainna Juliette Jamal ◽  
Rajni Pantelidis ◽  
Rachael Sawicki ◽  
Angel Li ◽  
Wayne Chiu ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Group Versus ◽  
Brain Heart Infusion ◽  
Standard Of Care ◽  
Rt Pcr ◽  
Comparator Group ◽  
Carbapenemase Gene ◽  
Cleaning Intervention

Background: Carbapenemase-producing Enterobacteriales (CPE) outbreaks have been linked to contaminated wastewater drainage systems in hospitals. The optimal strategy for CPE decontamination of drains is unknown. In this randomized controlled trial, we aimed to determine whether combining chemical, mechanical, and heat cleaning was superior to routine cleaning for drain decontamination. Methods: We enrolled CPE-contaminated hospital drains at 2 geographic locations. Eligible drains were those initially found to be culture positive in a 2017 study and that remained positive (by RT-PCR) when retested twice in August 2018. Drains were stratified by type (sink versus shower) and randomized with a 1:1 allocation ratio (as per computer-generated randomization) to standard-of-care cleaning (comparator) or combined chemical, mechanical, and heat cleaning (intervention) on day 0. Drain tail pieces were swabbed on days 0 (before administration of the intervention), 1, 2, 3, 7, and 14, and at months 1, 2, 3, 4, 5, and 6. Swabs were placed into brain heart infusion with 10% Dey-Engley neutralizing broth and incubated overnight. Direct RT-PCR was performed to detect KPC, VIM, NDM, OXA-48–like, IMP, GES, and SME genes. The primary outcome was drain decontamination, defined as no detectable carbapenemase gene in the drain from day 1 to 7 (inclusive). Results: Overall, 33 CPE-contaminated drains were enrolled (7 sink and 26 shower); 17 and 16 drains were randomized to the intervention and comparator, respectively. Moreover, 12 (36%) drains met the primary outcome of decontamination, 18 (55%) remained contaminated, and 3 (9%) could not be assessed. Among drains that could be assessed, 11 of 15 (74%) in the intervention group met the primary outcome of decontamination compared to 1 of 15 (7%) in the comparator group (P = .0005). Of the 11 drains in the intervention group that were decontaminated, the carbapenemase gene present at enrollment was subsequently detected in 10 (91%): 1 (10%) at day 14, 3 (30%) at month 1, 4 (40%) at month 3, 1 (10%) at month 4, and 1 (10%) at month 6. The median time to a swab yielding CPE was 1 day in the comparator group versus 14 days in the intervention group (Fig. 1). Overall, 24 drains (73%) had a carbapenemase gene (that was not detectable at enrollment) appear in the follow-up. Of patients identified as CPE colonized or infected during this study, none occupied rooms with these drains. Conclusions: Chemical, mechanical, and heat cleaning were superior to standard cleaning for CPE decontamination of hospital drains at 7 days, but these trends were not sustained. Such cleaning may be useful if applied repeatedly.Funding: NoneDisclosures: Allison McGeer reports funds to her institution for studies for which she is the principal investigator from Pfizer and Merck as well as consulting fees from Sanofi-Pasteur, Sunovion, GSK, Pfizer, and Cidara.

scholarly journals Effects of different thermal insulation methods on the nasopharyngeal temperature in patients undergoing laparoscopic hysterectomy: a prospective randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Guanyu Yang ◽  
Zefei Zhu ◽  
Hongyu Zheng ◽  
Shifeng He ◽  
Wanyue Zhang ◽  
...  
Keyword(s):  
Thermal Insulation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Laparoscopic Hysterectomy ◽  
Control Group ◽  
Prospective Randomized Controlled Trial ◽  
Warming Blanket ◽  
Group A ◽  
Insulation Effect ◽  
Group B

Abstract Background This study explored the comparison of the thermal insulation effect of incubator to infusion thermometer in laparoscopic hysterectomy. Methods We assigned 75 patients enrolled in the study randomly to three groups: Group A: Used warming blanket; group B: Used warming blanket and infusion thermometer; group C: Used warming blanket and incubator. The nasopharyngeal temperature at different time points during the operation served as the primary outcome. Results The nasopharyngeal temperature of the infusion heating group was significantly higher than that of the incubator group 60 min from the beginning of surgery (T3): 36.10 ± 0.20 vs 35.81 ± 0.20 (P<0.001)90 min from the beginning of surgery (T4): 36.35 ± 0.20 vs 35.85 ± 0.17 (P<0.001). Besides, the nasopharyngeal temperature of the incubator group was significantly higher compared to that of the control group 60 min from the beginning of surgery (T3): 35.81 ± 0.20 vs 35.62 ± 0.18 (P<0.001); 90 min from the beginning of surgery (T4): 35.85 ± 0.17 vs 35.60 ± 0.17 (P<0.001). Regarding the wake-up time, that of the control group was significantly higher compared to the infusion heating group: 24 ± 4 vs 21 ± 4 (P = 0.004) and the incubator group: 24 ± 4 vs 22 ± 4 (P = 0.035). Conclusion Warming blanket (38 °C) combined infusion thermometer (37 °C) provides better perioperative thermal insulation. Hospitals without an infusion thermometer can opt for an incubator as a substitute. Trial registration This trial was registered with ChiCTR2000039162, 20 October 2020.

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