scholarly journals Evaluating the use of benzodiazepines following recent bereavement

2001 ◽  
Vol 178 (1) ◽  
pp. 36-41 ◽  
Author(s):  
James Warner ◽  
Chris Metcalfe ◽  
Michael King
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Negative Effect ◽  
Controlled Evaluation ◽  
Current Advice

BackgroundThere is no evidence to support current advice not to use benzodiazepines after bereavement.AimsTo determine the role of benzodiazepines in the management of bereavement.MethodWe conducted a randomised, double-blind, placebo-controlled evaluation of the use of diazepam after recent bereavement. Participants were randomised to either 2 mg diazepam or identically packaged placebo up to three times daily. The primary outcome measure was the Bereavement Phenomenology Questionnaire.ResultsThirty subjects were randomised. No evidence was found of an effect of benzodiazepines on the course of the first 6 months of bereavement (estimated mean difference of combined follow-up assessments=0.3 in favour of placebo; 95% CI –6.2 to +6.7).ConclusionWe found no evidence of a positive or negative effect of benzodiazepines on the course of bereavement.

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.

1136Prognostic impact of mineralocorticoid receptor antagonists in patients hospitalized for acute heart failure

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
H Yaku ◽  
T Kato ◽  
T Morimoto ◽  
Y Inuzuka ◽  
Y Tamaki ◽  
...  
Keyword(s):  
Heart Failure ◽  
Lower Risk ◽  
Mineralocorticoid Receptor ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Matched Cohort ◽  
Mineralocorticoid Receptor Antagonists ◽  
Receptor Antagonists

Abstract Background The favourable effect of mineralocorticoid receptor antagonists (MRAs) on mortality was established in patients with stable heart failure (HF) with reduced ejection fraction (EF). However, its prognostic effect of MRAs in acute decompensated heart failure (ADHF) including HF with preserved EF (HFpEF) was unclear. Purpose This study sought to investigate the long-term impact of MRA on the post-discharge outcomes in patients with ADHF. Methods From the consecutive 3717 patients hospitalized for ADHF and discharged alive in the KCHF registry, we developed the propensity score (PS) for MRA use and constructed the PS-matched cohort. We compared the effect of MRA use on the primary outcome measure of all-cause death or HF hospitalization. Results A total of 1678 patients (45%) received MRA at discharge from the index hospitalization. Median follow-up was 470 days with 96% 1-year follow-up rate. In the PS-matched cohort (N=1034 in each group), the cumulative 1-year incidence of the primary outcome measure was significantly lower in the MRA group than in the no MRA group (28.4% vs. 33.9%, P=0.003) (Figure 1). The cumulative 1-year incidence of HF hospitalization was significantly lower in the MRA group than in the no MRA group (18.7% vs. 24.8%, P<0.001), while there was no difference in mortality between the 2 groups (15.6% vs. 15.8%, P=0.85). There was no interaction between the effect of MRA and the 3 subgroups stratified by EF (EF <40%, EF 40–49%, EF ≥50%) (interaction P=0.12). Figure 1 Conclusion The use of MRA was associated with lower risk for the primary composite outcome of all-cause death or HF hospitalization in patients hospitalized for ADHF including HFpEF, which was mainly driven by the lower risk for HF hospitalization.

scholarly journals Therapist- and parent-guided Internet-delivered behaviour therapy for paediatric Tourette’s Disorder: a pilot randomised controlled trial with long-term follow-up

2018 ◽  
Author(s):  
Per Andrén ◽  
Kristina Aspvall ◽  
Lorena Fernández de la Cruz ◽  
Paulina Wiktor ◽  
Sofia Romano ◽  
...  
Keyword(s):  
Young People ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Behaviour Therapy ◽  
Tourette’S Disorder ◽  
Tourette's Disorder ◽  
Tic Severity ◽  
Randomised Controlled

Objective: Behaviour therapy (BT) for Tourette’s Disorder (TD) and Persistent Motor or Vocal Tic Disorder (PTD) is rarely available. We evaluated the feasibility of adapting two existing BT protocols for TD/PTD (habit reversal training [HRT] and exposure and response prevention [ERP]) into a therapist- and parent-guided online self-help format.Design: A pilot, single-blind, parallel group randomised controlled trial.Setting: A university hospital in Sweden.Participants: Twenty-three young people with TD/PTD, aged 8-16.Interventions: Two 10-week therapist- and parent-guided Internet-delivered programmes (called BIP TIC HRT and BIP TIC ERP).Outcome: The primary outcome measure was the Yale Global Tic Severity Scale (YGTSS). Blinded evaluators rated symptoms at baseline, post-treatment, and 3-month follow-up (primary endpoint). All participants were naturalistically followed-up to 12 months after treatment.Results: Patients and parents rated the interventions as highly acceptable, credible, and satisfactory. While both interventions resulted in reduced tic-related impairment, parent-rated tic severity, and improved quality of life, only BIP TIC ERP resulted in a significant improvement on the primary outcome measure. Within-group effect sizes and responder rates were, respectively: d=1.12 and 75% for BIP TIC ERP, and d=0.50 and 55% for BIP TIC HRT. The therapeutic gains were maintained up to 12 months after the end of the treatment. Adverse events were rare in both groups. The average therapist support time was around 25 minutes per participant per week.Conclusions: Internet-delivered BT has the potential to greatly increase access to evidence-based treatment for young people with TD/PTD. Further evaluation of the efficacy and cost-effectiveness of this treatment modality is warranted.Trial registration number: NCT02864589 (ClinicalTrials.gov).Funding: The trial was supported by the Stockholm County Council (PPG project 2016-0108).

No effect on functional outcome after repair of pronator quadratus in volar plating of distal radial fractures: a randomized clinical trial

2019 ◽  
Vol 101-B (12) ◽  
pp. 1498-1505 ◽  
Author(s):  
Jesper Sonntag ◽  
Linn Woythal ◽  
Per Rasmussen ◽  
Ulrik Branner ◽  
Per Hølmer ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Distal Radial Fracture ◽  
Radial Fracture ◽  
Volar Plating ◽  
Pronator Quadratus ◽  
Pronator Quadratus Muscle ◽  
Repair Group

Aims The aim of this study was to investigate the difference in functional outcome after repair and non-repair of the pronator quadratus muscle in patients undergoing surgical treatment for a distal radial fracture with volar plating. Patients and Methods A total of 72 patients with a distal radial fracture were included in this randomized clinical trial. They were allocated to have the pronator quadratus muscle repaired or not, after volar locked plating of a distal radial fracture. The patients, the assessor, the primary investigator, and the statistician were blinded to the allocation. Randomization was irreversibly performed using a web application that guaranteed a secure and tamper-free assignment. The primary outcome measure was the Patient Rated Wrist Evaluation (PRWE) after 12 months. Secondary outcomes included the Disabilities of the Arm, Shoulder and Hand (DASH) score, pronation strength, grip strength, the range of pronation and supination, complications, and the operating time. Results Of the 72 patients, 63 (87.5%) completed follow-up for the primary outcome measure: 31 (86.1%) from the non-repair group and 32 (88.9%) from the repair group. At the 12-month follow-up, the mean difference in PRWE of 5.47 (95% confidence interval (CI) -4.02 to 14.96) between the repair (mean 18.38 (95% CI 10.34 to 26.41)) and non-repair group (mean 12.90 (95% CI 7.55 to 18.25)) was not statistically significant (p = 0.253). There was a statistically significant difference between pronation strength, favouring non-repair. We found no difference in the other secondary outcomes. Conclusion We found that repairing pronator quadratus made no difference to the clinical outcome, 12 months after volar plating of a distal radial fracture. We conclude that there is no functional advantage in repairing this muscle under these circumstances and advise against it. Cite this article: Bone Joint J 2019;101-B:1498–1505

scholarly journals Therapist-guided and parent-guided internet-delivered behaviour therapy for paediatric Tourette’s disorder: a pilot randomised controlled trial with long-term follow-up

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e024685 ◽  
Author(s):  
Per Andrén ◽  
Kristina Aspvall ◽  
Lorena Fernández de la Cruz ◽  
Paulina Wiktor ◽  
Sofia Romano ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Behaviour Therapy ◽  
Tic Severity ◽  
Randomised Controlled

ObjectiveBehaviour therapy (BT) for Tourette’s disorder (TD) and persistent (chronic) motor or vocal tic disorder (PTD) is rarely available. We evaluated the feasibility of adapting two existing BT protocols for TD/PTD (habit reversal training (HRT) and exposure and response prevention (ERP)) into a therapist-guided and parent-guided online self-help format.DesignA pilot, single-blind, parallel group randomised controlled trial.SettingA specialist outpatient clinic in Sweden.ParticipantsTwenty-three young people with TD/PTD, aged 8–16.InterventionsTwo 10-week therapist-guided and parent-guided internet-delivered programmes (called BIP TIC HRT and BIP TIC ERP).OutcomeThe primary outcome measure was the Yale Global Tic Severity Scale. Blinded evaluators rated symptoms at baseline, post-treatment and 3-month follow-up (primary endpoint). All participants were naturalistically followed up to 12 months after treatment.ResultsPatients and parents rated the interventions as highly acceptable, credible and satisfactory. While both interventions resulted in reduced tic-related impairment, parent-rated tic severity and improved quality of life, only BIP TIC ERP resulted in a significant improvement on the primary outcome measure. Within-group effect sizes and responder rates were, respectively: d=1.12 and 75% for BIP TIC ERP, and d=0.50 and 55% for BIP TIC HRT. The therapeutic gains were maintained up to 12 months after the end of the treatment. Adverse events were rare in both groups. The average therapist support time was around 25 min per participant per week.ConclusionsInternet-delivered BT has the potential to greatly increase access to evidence-based treatment for young people with TD/PTD. Further evaluation of the efficacy and cost-effectiveness of this treatment modality is warranted.Trial registration numberNCT02864589; Pre-results.

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.

The rate of successful four-corner arthrodesis with a locking, dorsal circular polyether-ether-ketone (PEEK-Optima) plate

2013 ◽  
Vol 38 (7) ◽  
pp. 767-773 ◽  
Author(s):  
P. C. Rhee ◽  
A. Y. Shin
Keyword(s):  
Circular Plate ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Accurate Assessment ◽  
Polyether Ether Ketone ◽  
The Mean ◽  
Ether Ketone ◽  
Mean Time

The purpose of this study is to evaluate the rate of union after four-corner arthrodesis with a locking, dorsal circular plate comprised of polyether-ether-ketone. A retrospective review was conducted of all patients who underwent four-corner arthrodesis with a locking, dorsal circular plate at our institution from January 2005 to May 2009. The primary outcome measure was radiographic and clinical union. During the study period, 26 consecutive wrists underwent four-corner arthrodesis with a locking, dorsal circular plate. Twenty-three wrists were included. The mean clinical follow-up was 16 months (range 3–37). Union was achieved in 22 of 23 wrists at a mean time of 3 months (range 1–12). There was one partial union that underwent successful revision arthrodesis. In summary, four-corner fusion with a polyether-ether-ketone locking, dorsal circular plate results in high union rates. The use of a radiolucent plate allows for more accurate assessment of union with the biomechanical advantages of a fixed angle construct.

Double-Blind Randomized Placebo-Controlled Study of Homoeopathic Prophylaxis of Migraine

Cephalalgia ◽  
1997 ◽  
Vol 17 (5) ◽  
pp. 600-604 ◽  
Author(s):  
TE Whitmarsh ◽  
DM Coleston-Shields ◽  
TJ Steiner
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Migraine Prophylaxis ◽  
Controlled Study ◽  
Attack Frequency ◽  
Double Blind ◽  
Over The Counter ◽  
Ihs Criteria ◽  
The Uk

Homoeopathic remedies for migrane are widely available over the counter, statutorily offered by the national health service in the UK, and apparently popular with patients. Do they work? Sixty-three outpatients with migraine with or without aura b IHS criteria entered a 4-month randomized placebo-controlled, double-blind, parallel-groups trial of individualized homoeopathic prophylaxis, the first month being baseline with all patients on placebo. Three patients (4.8%) dropped out, leaving 30 in each treatment group. There were chance differences in attack frequency and severity between the groups at baseline (attacks were more frequent but less severe in the placebo group). Both groups improved on therapy but neither to a great extent on the primary outcome measure of attack frequency (verum: —19%; placebo: -16%). Reduction was mostly in mild attacks on placebo, more in moderate and severe attacks on homoeopathy. Few adverse events were reported. Overall, there was no significant benefit over placebo of homoeopathic treatment. The course of change differed between groups, and suggested that improvement reversed in the last month of treatment on placebo. On this evidence we cannot recommend homoeopathy for migraine prophylaxis, but cannot conclude that it is without effect.

scholarly journals Prognostic value of reduction in left atrial size during a follow-up of heart failure: an observational study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e044409
Author(s):  
Masayuki Shiba ◽  
Takao Kato ◽  
Takeshi Morimoto ◽  
Hidenori Yaku ◽  
Yasutaka Inuzuka ◽  
...  
Keyword(s):  
Heart Failure ◽  
Lower Risk ◽  
Left Atrial ◽  
Primary Outcome ◽  
Outcome Measure ◽  
No Reduction ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Group Change

ObjectiveThe association between sequential changes in left atrial diameter (LAD) and prognosis in heart failure (HF) remains to be elucidated. The present study aimed to investigate the link between reduction in LAD and clinical outcomes in patients with HF.DesignA multicentre prospective cohort study.SettingThis study was nested from the Kyoto Congestive Heart Failure registry including consecutive patients admitted for acute decompensated heart failure (ADHF) in 19 hospitals throughout Japan.ParticipantsThe current study population included 673 patients with HF who underwent both baseline and 6-month follow-up echocardiography with available paired LAD data. We divided them into two groups: the reduction in the LAD group (change <0 mm) (n=398) and the no-reduction in the LAD group (change ≥0 mm) (n=275).Primary and secondary outcomesThe primary outcome measure was a composite of all-cause death or hospitalisation for HF during 180 days after 6-month follow-up echocardiography. The secondary outcome measures were defined as the individual components of the primary composite outcome measure and a composite of cardiovascular death or hospitalisation for HF.ResultsThe cumulative 180-day incidence of the primary outcome measure was significantly lower in the reduction in the LAD group than in the no-reduction in the LAD group (13.3% vs 22.2%, p=0.002). Even after adjusting 15 confounders, the lower risk of reduction in LAD relative to no-reduction in LAD for the primary outcome measure remained significant (HR 0.59, 95% CI 0.36 to 0.97 p=0.04).ConclusionPatients with reduction in LAD during follow-up after ADHF hospitalisation had a lower risk for a composite endpoint of all-cause death or HF hospitalisation, suggesting that the change of LAD might be a simple and useful echocardiographic marker during follow-up.

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