scholarly journals Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy study: a before−after study protocol

2020 ◽  
Vol 30 (1) ◽  
Author(s):  
Leonieke J. Breunis ◽  
Marlou L. A. de Kroon ◽  
Lyzette T. Laureij ◽  
Lieke de Jong-Potjer ◽  
Eric A. P. Steegers ◽  
...  
Keyword(s):  
Alcohol Use ◽  
Study Protocol ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Target Population ◽  
Primary Outcome Measure ◽  
Web Based ◽  
Maximum Duration ◽  
Secondary Outcomes ◽  
Group Sessions

AbstractDespite existing interventions, tobacco smoking and alcohol consumption during pregnancy are common. The Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy intervention combines monthly group sessions, access to a web-based platform and incentives upon biochemically validated cessation for a maximum duration of 6 months to promote cessation of smoking and alcohol use before and during pregnancy. To inform development of the SAFER pregnancy intervention, two focus groups with the target population were held beforehand, with results reported here alongside the final SAFER pregnancy study protocol. In a before−after study we aim to include 66 women who are pregnant or have a wish to become pregnant and who smoke and/or consume alcohol (i.e. target population of the SAFER pregnancy intervention). The primary outcome measure is cessation of smoking and/or alcohol use at 34−38 weeks of gestation, or after six group sessions if women did not become pregnant during the study period. Secondary outcomes focus on the barriers and facilitators for implementation of the SAFER pregnancy intervention.

scholarly journals Day hospital versus intensive out-patient mentalisation-based treatment for borderline personality disorder: multicentre randomised clinical trial

2019 ◽  
Vol 216 (2) ◽  
pp. 79-84 ◽  
Author(s):  
Maaike L. Smits ◽  
Dine J. Feenstra ◽  
Hester V. Eeren ◽  
Dawn L. Bales ◽  
Elisabeth M. P. Laurenssen ◽  
...  
Keyword(s):  
Borderline Personality Disorder ◽  
Personality Disorder ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Borderline Personality ◽  
Treatment Intensity ◽  
Day Hospital ◽  
Secondary Outcomes

BackgroundTwo types of mentalisation-based treatment (MBT) have been developed and empirically evaluated for borderline personality disorder (BPD): day hospital MBT (MBT-DH) and intensive out-patient MBT (MBT-IOP). No trial has yet compared their efficacy.AimsTo compare the efficacy of MBT-DH and MBT-IOP 18 months after start of treatment. MBT-DH was hypothesised to be superior to MBT-IOP because of its higher treatment intensity.MethodIn a multicentre randomised controlled trial (Nederlands Trial Register: NTR2292) conducted at three sites in the Netherlands, patients with BPD were randomly assigned to MBT-DH (n = 70) or MBT-IOP (n = 44). The primary outcome was symptom severity (Brief Symptom Inventory). Secondary outcome measures included borderline symptomatology, personality functioning, interpersonal functioning, quality of life and self-harm. Patients were assessed every 6 months from baseline to 18 months after start of treatment. Data were analysed using multilevel modelling based on intention-to-treat principles.ResultsSignificant improvements were found on all outcome measures, with moderate to very large effect sizes for both groups. MBT-DH was not superior to MBT-IOP on the primary outcome measure, but MBT-DH showed a clear tendency towards superiority on secondary outcomes.ConclusionsAlthough MBT-DH was not superior to MBT-IOP on the primary outcome measure despite its greater treatment intensity, MBT-DH showed a tendency to be more effective on secondary outcomes, particularly in terms of relational functioning. Patients receiving MBT-DH and MBT-IOP, thus, seem to follow different trajectories of change, which may have important implications for clinical decision-making. Longer-term follow-up and cost-effectiveness considerations may ultimately determine the optimal intensity of specialised treatments such as MBT for patients with BPD.

scholarly journals Efficiency and safety of ondansetron in preventing postanaesthesia shivering

2016 ◽  
Vol 98 (6) ◽  
pp. 358-366 ◽  
Author(s):  
k He ◽  
H Zhao ◽  
HC Zhou
Keyword(s):  
Lower Risk ◽  
Randomised Controlled Trials ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Meta Analysis ◽  
Primary Outcome Measure ◽  
Cochrane Library ◽  
Significant Difference ◽  
Secondary Outcomes ◽  
Randomised Controlled

Introduction Shivering is one of the most frequent complications of operation during the postanaesthesia period. Ondansetron has been proved to be valid in preventing postanaesthesia shivering (PAS) in several studies. However, its efficiency and safety are still disputable. We therefore performed an updated meta-analysis of randomised controlled trials (RCTs) for evaluation and to clarify this issue. Methods A literature search using the PubMed, Embase™ and Cochrane Library databases was performed (from inception to January 2015). RCTs that evaluated the efficiency and safety of ondansetron in the prevention of PAS were included in the meta-analysis. The primary outcome measure was incidence of PAS, and secondary outcomes included subgroup analysis and the side effects of ondansetron. Results A total of 8 RCTs containing 905 subjects were identified as suitable for this review. Compared with placebo, ondansetron was associated with a significant reduction of PAS (relative risk [RR]: 0.33, 95% confidence interval [CI]: 0.19–0.58, p=0.0001) while no difference was detected between ondansetron and pethidine (RR: 0.89, 95% CI: 0.41–1.94, p=0.78). There was no significant difference between ondansetron and placebo or pethidine in terms of risk of bradycardia but ondansetron was associated with a lower risk of hypotension (RR: 0.26, 95% CI: 0.08–0.79, p=0.020) than placebo. There was no difference in hypotension when ondansetron was compared with pethidine. Conclusions Ondansetron can prevent PAS effectively and reduce the risk of hypotension.

scholarly journals The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e015111 ◽  
Author(s):  
Mohamed Abdel-Fattah ◽  
Graeme MacLennan ◽  
Mary Kilonzo ◽  
R Phil Assassa ◽  
Kirsty McCormick ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Single Incision ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Female Stress Urinary Incontinence ◽  
Midurethral Slings ◽  
Secondary Outcomes ◽  
Randomised Controlled

IntroductionSingle-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up.Methods and analysisA pragmatic, multicentre, non-inferiority randomised controlled trial.Primary outcome measureThe primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months.Secondary outcome measuresThe secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit.Statistical analysisThe statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly.Ethics and disseminationThe North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations.Trial registration numberISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020.

Supporting self-management amongst young people with acne vulgaris: feasibility randomised trial of a web-based behavioural intervention (Preprint)

2020 ◽  
Author(s):  
Athena Ip ◽  
Ingrid Muller ◽  
Adam Geraghty ◽  
Kate Rumsby ◽  
Beth Stuart ◽  
...  
Keyword(s):  
Young People ◽  
Usual Care ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Randomised Trial ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Self Management ◽  
Web Based ◽  
Topical Treatments

BACKGROUND Acne is a common skin condition that is most prevalent in young people. It can have substantial impact on quality of life, which can be minimised with appropriate use of topical treatments. Nonadherence to topical treatments for acne is common often leading to treatment failure. OBJECTIVE The objective of this study was to develop a web-based behavioural intervention to support self-management of acne and to assess the feasibility of recruitment, retention and engagement in a parallel unblinded randomised trial of the intervention compared with usual care alone. METHODS The intervention was developed iteratively using LifeGuide software and following the Person-Based Approach (PBA) to intervention development. The target behaviour was ‘Appropriate use of topical treatments’ and barriers and facilitators identified from the qualitative research and evidence from the wider literature were used to identify techniques to improve and promote their use. Young people with acne aged 14-25 years who had received treatment for acne within the last 6 months were invited to participate through mail-out from primary care practices in the South of England. Participants were randomised to: (1) usual care, or (2) usual care plus access to web-based intervention. Usage data was collected and a series of questionnaires including the primary outcome measure for skin specific quality of life (Skindex-16) were collected at baseline, 4-weeks and 6-weeks follow-up. RESULTS A total of 1193 participants were invited and 53 young people with acne were randomised to usual care (n=27) or usual care plus intervention (n=26). The response rate for the primary outcome measure (Skindex-16) was 87% at 4-weeks, 6-weeks or both time points. The estimate of mean scores between groups (with 95% confidence) using linear regression showed a trend in the direction of benefit for the web-based intervention group in the primary outcome measure (Skindex-16), and secondary measures (Patient Health Questionnaire 4 and the Problematic Experiences of Therapy Scale). Intervention usage data showed a high uptake of the core module in the usual care plus web-based intervention group with 23 of 26 (88%) completing the module. Uptake of the optional modules were low with less than half visiting each (Myth-busting quiz: 27%; Living with spots or acne: 42%; Oral antibiotics: 19%; What are spots or acne: 27%; Other treatments: 27%; Talking to your GP: 12%). CONCLUSIONS This study demonstrated the feasibility of delivering a trial of a web-based intervention to support self-management for young people with acne. Additional work is needed prior to a full definitive trial including enhancing engagement with the intervention, recruitment and follow-up rates. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 78626638; https://doi.org/10.1186/ISRCTN78626638.

scholarly journals Nalmefene in the treatment of pathological gambling: multicentre, double-blind, placebo-controlled study

2010 ◽  
Vol 197 (4) ◽  
pp. 330-331 ◽  
Author(s):  
Jon E. Grant ◽  
Brian L. Odlaug ◽  
Marc N. Potenza ◽  
Eric Hollander ◽  
Suck Won Kim
Keyword(s):  
Pathological Gambling ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Symptom Control ◽  
Primary Outcome Measure ◽  
Controlled Study ◽  
Double Blind ◽  
Intention To Treat ◽  
Secondary Outcomes ◽  
Post Hoc

SummaryPathological gambling is a disabling disorder experienced by about 1% of adults. We randomised 233 participants (41.6% women) 1:1:1 to nalmefene (20 or 40 mg) or placebo. In analyses performed using an intention-to-treat (ITT) population, nalmefene failed to show statistically significant differences from placebo on primary and secondary outcomes. Post hoc analyses of only participants who received a full titration of the medication for at least 1 week demonstrated that nalmefene 40 mg/day resulted in significantly greater reductions on the primary outcome measure. These findings suggest that medication dosing may be an important consideration in achieving symptom control.

scholarly journals Clinical impact of left and right axis deviations with narrow QRS complex on 3-year outcomes in a hospital-based population in Japan

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yuta Seko ◽  
Takao Kato ◽  
Yuhei Yamaji ◽  
Yoshisumi Haruna ◽  
Eisaku Nakane ◽  
...  
Keyword(s):  
Cardiovascular Events ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Conduction Block ◽  
Primary Outcome Measure ◽  
Excess Risk ◽  
Major Adverse Cardiovascular Events ◽  
Prognostic Impact ◽  
Axis Deviation ◽  
The Right

AbstractWhile the prognostic impact of QRS axis deviation has been assessed, it has never been investigated in patients without conduction block. Thus, we evaluated the prognostic impact of QRS-axis deviation in patients without conduction block. We retrospectively analyzed 3353 patients who had undergone both scheduled transthoracic echocardiography and electrocardiography in 2013 in a hospital-based population, after excluding patients with a QRS duration of ≥ 110 ms, pacemaker placement, and an QRS-axis − 90° to − 180° (northwest axis). The study population was categorized into three groups depending on the mean frontal plane QRS axis as follows: patients with left axis deviation (N = 171), those with right axis deviation (N = 94), and those with normal axis (N = 3088). The primary outcome was a composite of all-cause death and major adverse cardiovascular events. The cumulative 3-year incidence of the primary outcome measure was significantly higher in the left axis deviation group (26.4% in the left axis deviation, 22.7% in the right axis deviation, and 18.4% in the normal axis groups, log-rank P = 0.004). After adjusting for confounders, the excess risk of primary outcome measure remained significant in the left axis deviation group (hazard ratio [HR] 1.44; 95% confidence interval [CI] 1.07–1.95; P = 0.02), while the excess risk of primary outcome measure was not significant in the right axis deviation group (HR 1.22; 95% CI 0.76–1.96; P = 0.41). Left axis deviation was associated with a higher risk of a composite of all-cause death and major adverse cardiovascular events in hospital-based patients without conduction block in Japan.

scholarly journals Computerised cognitive–behavioural therapy for adults with intellectual disability: randomised controlled trial

2017 ◽  
Vol 211 (2) ◽  
pp. 95-102 ◽  
Author(s):  
Patricia Cooney ◽  
Catherine Jackman ◽  
David Coyle ◽  
Gary O'Reilly
Keyword(s):  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundDespite the evidence base for computer-assisted cognitive–behavioural therapy (CBT) in the general population, it has not yet been adapted for use with adults who have an intellectual disability.AimsTo evaluate the utility of a CBT computer game for adults who have an intellectual disability.MethodA 2 × 3 (group × time) randomised controlled trial design was used. Fifty-two adults with mild to moderate intellectual disability and anxiety or depression were randomly allocated to two groups: computerised CBT (cCBT) or psychiatric treatment as usual (TAU), and assessed at pre-treatment, post-treatment and 3-month follow-up. Forty-nine participants were included in the final analysis.ResultsA significant group x time interaction was observed on the primary outcome measure of anxiety (Glasgow Anxiety Scale for people with an Intellectual Disability), favouring cCBT over TAU, but not on the primary outcome measure of depression (Glasgow Depression Scale for people with a Learning Disability). A medium effect size for anxiety symptoms was observed at post-treatment and a large effect size was observed after follow-up. Reliability of Change Indices indicated that the intervention produced clinically significant change in the cCBT group in comparison with TAU.ConclusionsAs the first application of cCBT for adults with intellectual disability, this intervention appears to be a useful treatment option to reduce anxiety symptoms in this population.

scholarly journals Telephone-guided self-help for mental health difficulties in neurological conditions: a randomised pilot trial

2021 ◽  
pp. archdischild-2019-318577
Author(s):  
Sophie D Bennett ◽  
Isobel Heyman ◽  
Anna E Coughtrey ◽  
Sophia Varadkar ◽  
Terence Stephenson ◽  
...  
Keyword(s):  
Mental Health ◽  
Young People ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Mental Health Problems ◽  
Pilot Trial ◽  
Primary Outcome Measure ◽  
Self Help ◽  
Mental Health Difficulties ◽  
Neurological Conditions

ObjectiveThis study aimed to conduct a randomised pilot trial to assess the feasibility of a randomised controlled trial (RCT) to investigate the effect of telephone-guided self-help for the treatment of mental health difficulties in children with neurological conditions.DesignPreliminary RCT. The primary outcome measure was the Strengths and Difficulties Questionnaire.SettingNeurology clinics in a national tertiary paediatric hospital.PatientsYoung people attending neurology clinics who met criteria for mental health difficulties according to the Development and Wellbeing Assessment.Interventions12 weeks of telephone-guided self-help based on a modular approach to psychological therapy for children delivered to children and/or their parents (n=17; eight males; mean age 12.04 years, SD=3.34) or a waiting list for telephone-guided self-help with no additional intervention over 12 weeks (n=17; nine males; mean age 10.53 years, SD=3.14).Results124 participants completed the DAWBA, and 34 children and young people were entered into the trial. 65% of those randomised to the intervention arm completed the full intervention, and the intervention was acceptable to those completing it. However, there were significant problems related to lack of data completion (38% data loss for primary outcome measure), choice of control comparator and outcome measures. Due to significant loss of data at follow-up, the effect size findings are considered unreliable.ConclusionsFurther feasibility work should be conducted to improve data completeness before progression to a definitive trial of guided self-help for mental health problems in children with neurological conditions can be recommended.Trial registration numberISRCTN21184717.

scholarly journals COMPARISON RESULTS OF SURGICAL TREATMENT LOCALIZED AND EXTENDED UTERINE CANCER

2010 ◽  
Vol 1 (3) ◽  
pp. 56-61
Author(s):  
I I Ushakov ◽  
E A Artoshina ◽  
P G Brousov ◽  
I V Nazvantsev ◽  
S A Levakov ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
High Risk ◽  
Adjuvant Radiotherapy ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Uterine Cancer ◽  
Primary Outcome Measure ◽  
Pelvic Lymphadenectomy ◽  
Peritoneal Washing ◽  
Comparison Results

We selected 145 patients with endometrial carcinoma who had been treated with standard surgery (hysterectomy and BSO, peritoneal washing, palpation pelvic and para-aortic nodes) and with complete systematic pelvic lymphadenectomy (n=30 patients) or combined pelvic and para-aortic lymphadenectomy (n=30). Patients at intermediate or high risk of recurrence were offered adjuvant radiotherapy. The primary outcome measure was results of the surgical therapy.

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