Efficacy and patient acceptability of the continence dish

Abstract Introduction and hypothesis The continence dish has been a treatment option since 2002 for women with stress urinary incontinence (SUI) who decline surgery, but few quantitative objective efficacy data are published. We aimed to determine the efficacy and acceptability of this device for pure SUI or mixed incontinence (MUI). Methods Prospective interventional cohort study of 100 women with SUI or stress-predominant MUI who were interested to use the device; International Consultation on Incontinence Questionnaire (ICIQ) was primary outcome measure; 24-h pad test and Incontinence Impact Questionnaire (IIQ) were secondary outcomes. Acceptability was determined by device retention for 4 weeks, adverse events and ability to self-insert the device. Results Of 100 suitable women, 9 were not actually fitted, and 27 did not complete (acceptability: 64/100). The rate of adverse events was 7.7%, with 62.5% of users able to self-insert the device: 22 (34%) had pure SUI; 66% had MUI. In SUI, 68% were ‘dry’ on ICIQ median value 4.0 (IQR 2.5–8.5); 88% were dry on 24-h pad test (median 0.0, IQR 0.0–8.5). The “dry rate” was lower in MUI: 36% for ICIQ (median 9.0, IQR 5.0–15.0) and 62% for 24-h pad test (median 6.2, IQR 0.95–19.7). A “good” response on IIQ occurred in 88% of SUI and 69% of MUI. Conclusion These new data showing strong objective benefits of the continence dish should be further validated by randomized trials, but this information should be made available to women seeking treatment options for SUI/MUI (particularly in view of concerns regarding mesh mid-urethral slings).

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Effectiveness of aripiprazole v. Haloperidol in acute bipolar mania

The British Journal of Psychiatry ◽

10.1192/bjp.187.3.235 ◽

2005 ◽

Vol 187 (3) ◽

pp. 235-242 ◽

Cited By ~ 122

Author(s):

Eduard Vieta ◽

Michel Bourin ◽

Raymond Sanchez ◽

Ronald Marcus ◽

Elyse Stock ◽

...

Keyword(s):

Primary Outcome ◽

Rating Scale ◽

Outcome Measure ◽

Treatment Options ◽

Manic Episode ◽

Primary Outcome Measure ◽

Young Mania ◽

Double Blind ◽

Number Of Patients ◽

To Receive

BackgroundDespite several treatment options, adherence to therapy is poor in patients with bipolar disorder.AimsA double-blind, controlled comparison of aripiprazole and haloperidol in patients with bipolar I disorder experiencing acute manic or mixed episodes.MethodPatients (n=347) were randomised to receive aripiprazole or haloperidol in this 12-week, multicentre study. The primary outcome measure was the number of patients in response (550% improvement from baseline in Young Mania Rating Scale score) and receiving therapy at week 12.ResultsAt week 12, significantly more patients taking aripiprazole (49. 7%) were in response and receiving therapy compared with those taking haloperidol (28. 4%; P<0. 001). Continuation rates differed markedly between treatments (week 12: aripiprazole, 50. 9%; haloperidol, 29. 1%). Extrapyramidal adverse events were more frequent with haloperidol than aripiprazole (62. 7% v. 24. 0%).ConclusionsAripiprazole showed superior levels of response and tolerability to haloperidol in the treatment of an acute manic episode for up to 12 weeks.

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Comparison of Percentage of Syllables Stuttered With Parent-Reported Severity Ratings as a Primary Outcome Measure in Clinical Trials of Early Stuttering Treatment

Journal of Speech Language and Hearing Research ◽

10.1044/2017_jslhr-s-16-0448 ◽

2018 ◽

Vol 61 (4) ◽

pp. 811-819 ◽

Cited By ~ 5

Author(s):

Mark Onslow ◽

Mark Jones ◽

Sue O'Brian ◽

Ann Packman ◽

Ross Menzies ◽

...

Keyword(s):

Clinical Trials ◽

Randomized Trials ◽

Primary Outcome ◽

Outcome Measure ◽

Primary Outcome Measure ◽

Analysis Of Covariance ◽

Data Sets ◽

Randomized Controlled ◽

Absolute Agreement

Purpose This report investigates whether parent-reported stuttering severity ratings (SRs) provide similar estimates of effect size as percentage of syllables stuttered (%SS) for randomized trials of early stuttering treatment with preschool children. Method Data sets from 3 randomized controlled trials of an early stuttering intervention were selected for analyses. Analyses included median changes and 95% confidence intervals per treatment group, Bland–Altman plots, analysis of covariance, and Spearman rho correlations. Results Both SRs and %SS showed large effect sizes from pretreatment to follow-up, although correlations between the 2 measures were moderate at best. Absolute agreement between the 2 measures improved as percentage reduction of stuttering frequency and severity increased, probably due to innate measurement limitations for participants with low baseline severity. Analysis of covariance for the 3 trials showed consistent results. Conclusion There is no statistical reason to favor %SS over parent-reported stuttering SRs as primary outcomes for clinical trials of early stuttering treatment. However, there are logistical reasons to favor parent-reported stuttering SRs. We conclude that parent-reported rating of the child's typical stuttering severity for the week or month prior to each assessment is a justifiable alternative to %SS as a primary outcome measure in clinical trials of early stuttering treatment.

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The CREST-E study of creatine for Huntington disease

Neurology ◽

10.1212/wnl.0000000000004209 ◽

2017 ◽

Vol 89 (6) ◽

pp. 594-601 ◽

Cited By ~ 34

Author(s):

Steven M. Hersch ◽

Giovanni Schifitto ◽

David Oakes ◽

Amy-Lee Bredlau ◽

Catherine M. Meyers ◽

...

Keyword(s):

Adverse Events ◽

Huntington Disease ◽

Primary Outcome ◽

Outcome Measure ◽

Functional Decline ◽

Primary Outcome Measure ◽

Creatine Monohydrate ◽

Rate Of Change ◽

Secondary Outcome ◽

Controlled Study

Objective:To investigate whether creatine administration could slow progressive functional decline in adults with early symptoms of Huntington disease.Methods:We conducted a multicenter, randomized, double-blind, placebo-controlled study of up to 40 g daily of creatine monohydrate in participants with stage I and II HD treated for up to 48 months. The primary outcome measure was the rate of change in total functional capacity (TFC) between baseline and end of follow-up. Secondary outcome measures included changes in additional clinical scores, tolerability, and quality of life. Safety was assessed by adverse events and laboratory studies.Results:At 46 sites in North America, Australia, and New Zealand, 553 participants were randomized to creatine (275) or placebo (278). The trial was designed to enroll 650 patients, but was halted for futility after the first interim analysis. The estimated rates of decline in the primary outcome measure (TFC) were 0.82 points per year for participants on creatine, 0.70 points per year for participants on placebo, favoring placebo (nominal 95% confidence limits −0.11 to 0.35). Adverse events, mainly gastrointestinal, were significantly more common in participants on creatine. Serious adverse events, including deaths, were more frequent in the placebo group. Subgroup analysis suggested that men and women may respond differently to creatine treatment.Conclusions:Our data do not support the use of creatine treatment for delaying functional decline in early manifest HD.Clinicaltrials.gov identifier:NCT00712426.Classification of evidence:This study provides Class II evidence that for patients with early symptomatic HD, creatine monohydrate is not beneficial for slowing functional decline.

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

Scientific Reports ◽

10.1038/s41598-021-88259-8 ◽

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.

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

The British Journal of Psychiatry ◽

10.1192/bjp.bp.117.198630 ◽

2017 ◽

Vol 211 (2) ◽

pp. 95-102 ◽

Cited By ~ 13

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.

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Erosive progression is minimal, but erosion healing rare, in patients with rheumatoid arthritis treated with adalimumab. A 1 year investigator-initiated follow-up study using high-resolution computed tomography as the primary outcome measure

Annals of the Rheumatic Diseases ◽

10.1136/ard.2008.097048 ◽

2008 ◽

Vol 68 (10) ◽

pp. 1585-1590 ◽

Cited By ~ 61

Author(s):

U M. Dohn ◽

A Boonen ◽

M L Hetland ◽

M S Hansen ◽

L S Knudsen ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Computed Tomography ◽

High Resolution ◽

Primary Outcome ◽

Outcome Measure ◽

Primary Outcome Measure ◽

High Resolution Computed Tomography ◽

Follow Up Study ◽

Erosive Progression

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

Archives of Disease in Childhood ◽

10.1136/archdischild-2019-318577 ◽

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.

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COMPARISON RESULTS OF SURGICAL TREATMENT LOCALIZED AND EXTENDED UTERINE CANCER

Clinical Practice ◽

10.17816/clinpract1356-61 ◽

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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