Effectiveness of 3 per cent boric acid in 70 per cent alcohol versus 1 per cent clotrimazole solution in otomycosis patients: a randomised, controlled trial

AbstractObjectives:To compare the clinical effectiveness and adverse events for 3 per cent boric acid in 70 per cent alcohol versus 1 per cent clotrimazole solution in the treatment of otomycosis.Methods:A total of 120 otomycosis patients were randomly assigned to receive either 1 per cent clotrimazole solution (intervention group) or 3 per cent boric acid in 70 per cent alcohol (control group) at the Khon Kaen Hospital ENT out-patient department. Treatment effectiveness was determined based on the otomicroscopic absence of fungus one week after therapy, following a single application of treatment.Results:After 1 week of treatment, there were data for 109 participants, 54 in the clotrimazole group and 55 in the boric acid group. The absolute difference in cure rates between 1 per cent clotrimazole solution and 3 per cent boric acid in 70 per cent alcohol was 17.9 per cent (95 per cent confidence interval, 2.3 to 33.5; p = 0.028) and the number needed to treat was 6 (95 per cent confidence interval, 3.0 to 43.4). Adverse events for the two agents were comparable.Conclusion:One per cent clotrimazole solution is more effective than 3 per cent boric acid in 70 per cent alcohol for otomycosis treatment.

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Effect of Hope-oriented group counseling on mental health of infertile women with failed IVF cycles: a randomized controlled trial

BMC Psychiatry ◽

10.1186/s12888-021-03280-5 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Roya Rahimi ◽

Shirin Hasanpour ◽

Mojgan. Mirghafourvand ◽

Khalil Esmaeilpour

Keyword(s):

Mental Health ◽

Confidence Interval ◽

Group Counseling ◽

Controlled Trial ◽

Intervention Group ◽

Mean Difference ◽

Control Group ◽

The Mean ◽

And Control

Abstract Background Considering the prevalence of infertility in the community and the consequences of failure of infertility treatments on women’s mental health, interventions that can control stress, anxiety and depression in infertile women with a history of IVF failure will be very helpful. This study aimed to determine the effects of hope-oriented group counseling on mental health (primary outcome) and quality of life (QoL) (secondary outcome) of women with failed IVF cycles. Method This randomized controlled trial was conducted on 60 women with failed IVF cycles visiting Infertility Clinic at Al-Zahra Teaching Hospital of Tabriz- Iran. Participants were allocated to the intervention group (n = 30) and control group (n = 30) based on a randomized block design. Hope-oriented group counseling was provided to the intervention group in six 45–60 min sessions (once a week). The control group only received routine care to undergo another IVF cycle. The Depression Anxiety Stress Scale-21 (DASS-21) and the SF-12 Quality of Life Scale were filled out by interviewing the participants before the intervention and one week and one month after the intervention. After intervention 26 participants in each group were included in the analysis. Results There was no significant difference between the intervention and control groups in the socio-demographic profile of participants (P > 0.05). The post-intervention mean score of stress (adjusted mean difference = − 1.7, 95% confidence interval: − 3.2 to − 0.3, P = 0.018) and depression (adjusted mean difference = − 1.3, 95% confidence interval: − 4.7 to − 1.5, P < 0.001) was significantly lower in the intervention group compared to the control. Although the mean anxiety score was lower in the intervention group compared to the control, the difference between them was not statistically significant (adjusted mean difference = − 1.1, 95% confidence interval: − 2.6 to 0.4, P = 0.153). The mean score of QoL was significantly higher in the intervention group than that of the control group (adjusted mean difference = 6.9, 95% confidence interval: 5.1 to 8.8, P < 0.001). Conclusion Hope-oriented group counseling was effective in reducing stress and depression and improving QoL in women with failed IVF cycles. It is recommended to use this counseling approach, along with other methods, to improve the mental health of women with failed IVF cycles. Trial registration TCT Registration Number: TCTR 20191017003, registered on October 17, 2019.

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Effectiveness of online tailored advice to prevent running-related injuries and promote preventive behaviour in Dutch trail runners: a pragmatic randomised controlled trial

British Journal of Sports Medicine ◽

10.1136/bjsports-2016-097025 ◽

2017 ◽

Vol 52 (13) ◽

pp. 851-858 ◽

Cited By ~ 13

Author(s):

Luiz Carlos Hespanhol ◽

Willem van Mechelen ◽

Evert Verhagen

Keyword(s):

Randomised Controlled Trial ◽

Preventive Intervention ◽

Absolute Risk ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Number Needed To Treat ◽

Preventive Behaviour ◽

Randomised Controlled ◽

Tailored Advice

BackgroundTrail running is popular worldwide, but there is no preventive intervention for running-related injury (RRI).AimTo evaluate the effectiveness of adding online tailored advice (TrailS6) to general advice on (1) the prevention of RRIs and (2) the determinants and actual preventive behaviour in Dutch trail runners.MethodsTwo-arm randomised controlled trial over 6 months. 232 trail runners were randomly assigned to an intervention or control group. All participants received online general advice on RRI prevention 1 week after baseline. Every 2 weeks, participants in the intervention group received specific advice tailored to their RRI status. The control group received no further intervention. Bayesian mixed models were used to analyse the data.ResultsTrail runners in the intervention group sustained 13% fewer RRIs compared with those in the control group after 6 months of follow-up (absolute risk difference −13.1%, 95% Bayesian highest posterior credible interval (95% BCI) −23.3 to −3.1). A preventive benefit was observed in one out of eight trail runners who had received the online tailored advice for 6 months (number needed to treat 8, 95% BCI 3 to 22). No significant between-group difference was observed on the determinants and actual preventive behaviours.ConclusionsOnline tailored advice prevented RRIs among Dutch trail runners. Therefore, online tailored advice may be used as a preventive component in multicomponent RRI prevention programmes. No effect was observed on determinants and actual preventive behaviours.Trial registration numberThe Netherlands National Trial Register (NTR5431).

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A randomized controlled trial of a brief educational and psychological intervention for patients presenting to a cardiac clinic with palpitation

Psychological Medicine ◽

10.1017/s0033291702005536 ◽

2002 ◽

Vol 32 (4) ◽

pp. 699-706 ◽

Cited By ~ 11

Author(s):

R. MAYOU ◽

D. SPRIGINGS ◽

J. BIRKHEAD ◽

J. PRICE

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Educational Intervention ◽

Psychological Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Number Needed To Treat ◽

Treatment Needs ◽

Randomized Controlled

Background. We sought to determine whether a brief psycho-educational intervention reduced disability in patients with benign palpitation.Method. In a pragmatic randomized controlled trial within a cardiology clinic at a district general hospital, 80 consecutive patients diagnosed as having benign palpitation – either palpitation due to awareness of extrasystoles or sinus rhythm – with associated distress or disability were randomized to an intervention group (usual care plus nurse-delivered intervention based on cognitive-behavioural principles) or to a control group (usual care). Principal outcome was difference in proportion of participants with good or excellent researcher-rated activity levels at 3 months. Subsidiary outcomes were self-rated symptoms, distress and disability, researcher-rated unmet treatment needs.Results. The principal outcome showed a statistically and clinically significant benefit for the intervention group, with a number needed to treat of 3 (95% CIs 2 to 7). All but one subsidiary outcomes also showed a difference in favour of the intervention group, and several differences reached statistical significance. Significantly more of the control group had unmet treatment needs at 3 months.Conclusions. A brief, nurse-delivered, psycho-educational intervention, was an effective treatment for benign palpitation. Further evaluation, including assessment of cost-effectiveness, is needed. The findings have application to the care of patients presenting with other types of ‘unexplained’ medical symptoms.

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Targeting Sedentary Behavior in CKD

Clinical Journal of the American Society of Nephrology ◽

10.2215/cjn.12300720 ◽

2021 ◽

pp. CJN.12300720

Author(s):

Kate Lyden ◽

Robert Boucher ◽

Guo Wei ◽

Na Zhou ◽

Jesse Christensen ◽

...

Keyword(s):

Confidence Interval ◽

Sedentary Behavior ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Fat Percentage ◽

Clinical Trial Registry ◽

End Points ◽

Steps Per Day

Background and objectivesWe tested the feasibility of reducing sedentary behavior common in CKD.Design, setting, participants, & measurementsWe carried out a Sit Less, Interact, Move More intervention in a 24-week parallel-group, randomized controlled trial in patients with stages 2–5 CKD. In the intervention group (n=54), accelerometry performed at baseline and repeated every 4 weeks was used to develop and monitor adherence to individualized plans targeting sedentary and stepping durations. The control group (n=52) was provided national physical activity recommendations; accelerometry was performed at baseline and every 8 weeks. Between-groups changes from baseline to the average follow-up values at weeks 8, 16, and 24 of the sedentary and stepping durations were the coprimary end points.ResultsThe mean age was 69±13 years. Fourteen percent were on dialysis or received a kidney transplant. Eight percent of the control group and 17% of the intervention group were lost to follow-up. Sedentary and stepping durations did not change in the control group. Within the intervention group, the maximum decrease in sedentary duration (−43; 95% confidence interval, −69 to −17 min/d) and increase in stepping duration (16; 95% confidence interval, 7 to 24 min/d) and the number of steps per day (1265; 95% confidence interval, 518 to 2012) were seen at week 20. These attenuated at week 24. In mixed effects models, overall treatment effects between groups on sedentary (−17; 95% confidence interval, −43 to 8 min/d) and stepping (6; 95% confidence interval, −3 to 15 min/d) durations and the number of steps per day, a secondary end point (652; 95% confidence interval, −146 to 1449), were not significantly different. The intervention significantly reduced secondary end points of body mass index (−1.1; 95% confidence interval, −1.9 to −0.3 kg/m2) and body fat percentage (−2.1%; 95% confidence interval, −4.4% to −0.2%).ConclusionsIt is feasible to reduce sedentary duration and increase stepping duration in patients with CKD, but these were not sustained.Clinical Trial registry name and registration number:National Health and Nutrition Examination Survey (NHANES), NCT02970123

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Effect of therapeutic suggestions during general anaesthesia on postoperative pain and opioid use: multicentre randomised controlled trial

BMJ ◽

10.1136/bmj.m4284 ◽

2020 ◽

pp. m4284 ◽

Cited By ~ 1

Author(s):

Hartmuth Nowak ◽

Nina Zech ◽

Sven Asmussen ◽

Tim Rahmel ◽

Michael Tryba ◽

...

Keyword(s):

Postoperative Pain ◽

Confidence Interval ◽

General Anaesthesia ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Number Needed To Treat ◽

Opioid Use ◽

Number Of Patients ◽

Randomised Controlled

Abstract Objective To investigate the effect of therapeutic suggestions played to patients through earphones during surgery on postoperative pain and opioid use. Design Blinded randomised controlled study. Setting Five tertiary care hospitals in Germany. Participants 385 of 400 patients consecutively recruited from January to December 2018 who were to undergo surgery for 1-3 hours under general anaesthesia. In the per protocol analysis 191 patients were included in the intervention group and 194 patients in the control group. Intervention The intervention comprised an audiotape of background music and positive suggestions based on hypnotherapeutic principles, which was played repeatedly for 20 minutes followed by 10 minutes of silence to patients through earphones during general anaesthesia. Patients in the control group were assigned to a blank tape. Main outcome measures The main outcome was dose of opioid administered by patient controlled analgesia or nurse controlled analgesia within the first postoperative 24 hours, based on regular evaluation of pain intensity on a numerical rating scale (range 0-10, with higher scores representing more severe pain). Results Compared with the control group, the intervention group required a significantly (P=0.002) lower opioid dose within 24 hours after surgery, with a median of 4.0 mg (interquartile range 0-8) morphine equivalents versus 5.3 (2-12), and an effect size (Cohen’s d) of 0.36 (95% confidence interval 0.16 to 0.56). The number of patients who needed opioids postoperatively was significantly (P=0.001) reduced in the intervention group: 121 of 191 (63%, 95% confidence interval 45% to 70%) patients in the intervention group versus 155 of 194 (80%, 74% to 85%) in the control group. The number needed to treat to avoid postoperative opioids was 6. Pain scores were consistently and significantly lower in the intervention group within 24 hours after surgery, with an average reduction of 25%. No adverse events were reported. Conclusions Therapeutic suggestions played through earphones during general anaesthesia could provide a safe, feasible, inexpensive, and non-drug technique to reduce postoperative pain and opioid use, with the potential for more general use. Based on the finding of intraoperative perception by a considerable number of patients, surgeons and anaesthetists should be careful about background noise and conversations during surgery. Trial registration German Clinical Trial Register DRKS00013800.

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A Randomised Controlled Trial Evaluating the Effectiveness and Tolerability of Step-up and Step-down Varenicline Therapy for Smoking Cessation: A Study Protocol

The Journal of Smoking Cessation ◽

10.1017/jsc.2017.17 ◽

2017 ◽

Vol 13 (3) ◽

pp. 179-185

Author(s):

Aaron D. Drovandi ◽

Peta-Ann Teague ◽

Beverley D. Glass ◽

Bunmi Malau-Aduli

Keyword(s):

Smoking Cessation ◽

Adverse Events ◽

Outcome Measures ◽

Controlled Trial ◽

Intervention Group ◽

Withdrawal Symptoms ◽

Secondary Outcome ◽

Control Group ◽

Step Down

Background: Varenicline remains the most effective medication for smoking cessation; however, discontinuation as a result of adverse events negatively impacts medication adherence, and the likelihood of a quit attempt being successful. Post-treatment cravings and withdrawal symptoms may also occur, increasing the likelihood of treatment failure, due to lapse and relapse after achieving initial abstinence. This protocol details a trial investigating changes in the effectiveness and tolerability of varenicline, when an extended step-up and step-down regimen are used.Methods: A phase four, randomised, double-blinded, placebo-controlled single-centre study with a treatment period of 16 weeks, and follow-up period of 12 weeks will be conducted. Up to 201 participants will be enrolled and allocated in a 1:1:1 ratio to a placebo-matching control group, step-up, or step-down intervention group, all receiving behavioural counselling and quitting advice. Participants will be contacted weekly during treatment and fortnightly during follow-up. Eligible participants are smokers over 18 years old, willing to quit smoking, are able to attend clinic visits, and have no uncontrolled or serious medical issues. Primary outcome measures are comparisons of biochemically confirmed continuous abstinence rates, 7-day point prevalence abstinence rates, and the frequency, severity and duration of adverse events, cravings and withdrawal symptoms. Secondary outcome measures are participant adherence to the study medication throughout treatment, and comparisons of changes in smoking satisfaction and reward. Effects of each regimen on smoking cessation will be assessed by logistic regression, with survival analyses used for a more precise estimate of when cessation occurs. Primary endpoints will then be compared using a general linear model. Australian New Zealand Clinical Trials Registry: ACTRN12616000802404p

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Effect of Hope-Oriented Group Counseling on Mental Health of Infertile Women with Failed IVF Cycles: A Randomized Controlled Trial

10.21203/rs.3.rs-130529/v1 ◽

2021 ◽

Author(s):

Roya Rahimi ◽

Mojgan Mirghafourvand ◽

Khalil Esmaeilpour ◽

Shirin Hasanpour

Keyword(s):

Mental Health ◽

Confidence Interval ◽

Group Counseling ◽

Controlled Trial ◽

Intervention Group ◽

Mean Difference ◽

Control Group ◽

The Mean ◽

And Control

Abstract Background Considering the prevalence of infertility in the community and the consequences of failure of infertility treatments on women's mental health, interventions that can control stress, anxiety and depression in infertile women with a history of IVF failure will be very helpful. This study aimed to determine the effects of hope-oriented group counseling on mental health (primary outcome) and quality of life (QoL) (secondary outcome) of women with failed IVF cycles.Method This randomized controlled trial was conducted on 60 women with failed IVF cycles visiting Infertility Clinic at Al-Zahra Teaching Hospital of Tabriz- Iran. Participants were allocated to the intervention group (n = 30) and control group (n = 30) based on a randomized block design. Hope-oriented group counseling was provided to the intervention group in six 45–60 minute sessions (once a week). The control group only received routine care to undergo another IVF cycle. The author filled out the Depression Anxiety Stress Scale-21 (DASS-21) and the SF-12 Quality of Life Scale by interviewing the participants before the intervention and one week and one month after the intervention.Results There was no significant difference between the intervention and control groups in the socio-demographic profile of participants (P > 0.05). The post-intervention mean score of stress (modified mean difference=-1.7, 95% confidence interval: -3.2 to 0.3, P = 0.018) and depression (modified mean difference=-1.3, 95% confidence interval: -4.7 to -1.5, P < 0.001) was significantly lower in the intervention group compared to the control. Although the mean anxiety score was lower in the intervention group compared to the control, the difference between them was not statistically significant (modified mean difference= -1.1, 95% confidence interval: -2.6 to 0.4, P = 0.153). The mean score of QoL was significantly higher in the intervention group than that of the control group (modified mean difference= -1.1, 95% confidence interval: 5.1 to 8.8, P < 0.001).Conclusion Hope-oriented group counseling was effective in reducing stress and depression and improving QoL in women with failed IVF cycles. It is recommended to use this counseling approach, along with other methods, to improve the mental health of women with failed IVF cycles.Trial Registration TCT Registration Number: TCTR 20191017003, registered on October 17, 2019 (http://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=5369)

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Family psychoeducation for major depression: randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.110.078626 ◽

2011 ◽

Vol 198 (5) ◽

pp. 385-390 ◽

Cited By ~ 51

Author(s):

Kae Shimazu ◽

Shinji Shimodera ◽

Yoshio Mino ◽

Atsushi Nishida ◽

Naoto Kamimura ◽

...

Keyword(s):

Major Depression ◽

Expressed Emotion ◽

Hazard Analysis ◽

Controlled Trial ◽

Bipolar Affective Disorder ◽

Intervention Group ◽

Control Group ◽

Number Needed To Treat ◽

Family Psychoeducation ◽

Treatment As Usual

BackgroundThe value of family psychoeducation for schizophrenia has been well established, and indications for its use have recently expanded to include bipolar affective disorder. However, no study to date has adequately examined its use in depression.AimsTo examine family psychoeducation in the maintenance treatment of depression and to investigate the influence of the family's expressed emotion (EE) on its effectiveness.MethodOf 103 patients diagnosed with major depression and their primary family members, 57 pairs provided written informed consent. The pairs were randomly allocated to the intervention (n = 25) or control (n = 32). One family in the intervention group and two in the control group withdrew their consent after randomisation. The intervention group underwent four psychoeducation sessions consisting of didactic lectures about depression and group problem-solving focusing on how to cope in high-EE situations. Patients did not attend these sessions. Patients in both the intervention and control groups received treatment as usual. The families' EE levels were evaluated through Five-Minute Speech Samples. The primary outcome was relapse.ResultsTime to relapse was statistically significantly longer in the psychoeducation group than in the control group (Kaplan–Meier survival analysis, P = 0.002). The relapse rates up to the 9-month follow-up were 8% and 50% respectively (risk ratio 0.17, 95% CI 0.04–0.66; number needed to treat 2.4, 95% CI 1.6–4.9). In Cox proportional hazard analysis, baseline EE did not moderate the effectiveness of the intervention.ConclusionsFamily psychoeducation is effective in the prevention of relapse in adult patients with major depression.

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LO34: Does utilization of an intubation safety checklist reduce dangerous omissions during simulated resuscitation scenarios?

CJEM ◽

10.1017/cem.2018.96 ◽

2018 ◽

Vol 20 (S1) ◽

pp. S18-S19

Author(s):

C. Forristal ◽

K. Hayman ◽

N. Smith ◽

S. Mal ◽

M. Columbus ◽

...

Keyword(s):

Adverse Events ◽

Airway Management ◽

Human Error ◽

Controlled Trial ◽

Mean Difference ◽

Absolute Difference ◽

Control Group ◽

Error Type ◽

Average Percentage ◽

Significant Difference

Introduction: One of the most high-risk tasks regularly performed by emergency medicine (EM) physicians is airway management. Many studies identify an increase in adverse events associated with airway management outside of the operating theatre. Errors of omission are the single most common human error type. To address this risk, the checklist is becoming a common pre-intubation tool. Simulation is a safe setting in which to study the implementation of a new airway checklist. The purpose of this study was to determine if a novel airway checklist decreases practitioners rates of omission of important tasks during simulated resuscitation scenarios. Methods: This was a dual-centre, randomized controlled trial of a novel airway checklist utilized by EM practitioners in a simulated environment. The 29-item peri-intubation checklist was derived by experienced EM practitioners following a review of airway checklists in published and gray literature. Participants were EM residents or EM physicians who work more than 20 hours/month in an emergency department. Volunteers were recruited from two academic health centres to complete three simulated scenarios (two requiring intubation, one cricothyroidotomy), and were randomized to either regular care or checklist use. A minimum of two assessors documented the number of omitted tasks deemed important in airway management and the time until definitive airway management. Discrepancies between assessors were resolved by single-assessor video review. Results: Fifty-four EM practitioners participated. There was no significant difference in baseline characteristics between the two study groups. The average percentage of omitted tasks over the three scenarios was 45.7% in the control group (n=25) and 13.5% in the checklist group (n=29) an absolute difference of 32.2% (95% CI: 27.8%, 36.6%). Time to intubation (normally distributed) was significantly longer in the checklist group for the first two scenarios (mean difference 114.10s, 95% CI: 48.21s, 179.98s and 76.34s, 95% CI:31.35s ,121.33s), but there was no statistical difference in the third scenario where cricothyroidotomy was required (mean difference 33.75s, 95% CI: -28.14s, 95.65s). Conclusion: In a simulated setting, use of an airway checklist significantly decreased the omission rate of important airway management tasks, however it increased the time to definitive airway management. Further study is required to determine if these findings are consistent in a clinical setting and how they impact the rate of adverse events.

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Digital intervention increases influenza vaccination rates for people with diabetes in a decentralized randomized trial

npj Digital Medicine ◽

10.1038/s41746-021-00508-2 ◽

2021 ◽

Vol 4 (1) ◽

Author(s):

J. L. Lee ◽

L. Foschini ◽

S. Kumar ◽

J. Juusola ◽

J. Liska ◽

...

Keyword(s):

Influenza Vaccination ◽

Controlled Trial ◽

New Technology ◽

Intervention Group ◽

Vaccination Rate ◽

Control Group ◽

Number Needed To Treat ◽

Public Health Burden ◽

Vaccination Rates ◽

Increased Risk

AbstractPeople with diabetes (PWD) have an increased risk of developing influenza-related complications, including pneumonia, abnormal glycemic events, and hospitalization. Annual influenza vaccination is recommended for PWD, but vaccination rates are suboptimal. The study aimed to increase influenza vaccination rate in people with self-reported diabetes. This study was a prospective, 1:1 randomized controlled trial of a 6-month Digital Diabetes Intervention in U.S. adults with diabetes. The intervention group received monthly messages through an online health platform. The control group received no intervention. Difference in self-reported vaccination rates was tested using multivariable logistic regression controlling for demographics and comorbidities. The study was registered at clinicaltrials.gov: NCT03870997. A total of 10,429 participants reported influenza vaccination status (5158 intervention, mean age (±SD) = 46.8 (11.1), 78.5% female; 5271 control, Mean age (±SD) = 46.7 (11.2), 79.4% female). After a 6-month intervention, 64.2% of the intervention arm reported influenza vaccination, vers us 61.1% in the control arm (diff = 3.1, RR = 1.05, 95% CI [1.02, 1.08], p = 0.0013, number needed to treat = 33 to obtain 1 additional vaccination). Completion of one or more intervention messages was associated with up to an 8% increase in vaccination rate (OR 1.27, 95% CI [1.17, 1.38], p < 0.0001). The intervention improved influenza vaccination rates in PWD, suggesting that leveraging new technology to deliver knowledge and information can improve influenza vaccination rates in high-risk populations to reduce public health burden of influenza. Rapid cycle innovation could maximize the effects of these digital interventions in the future with other populations and vaccines.

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