scholarly journals Effect of short-term psychological intervention on anxiety of pregnant women with positive screening results for chromosomal disorders: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Arezoo Bayat ◽  
Leila Amiri-Farahani ◽  
Mehdi Soleimani ◽  
Nooshin Eshraghi ◽  
Shima Haghani
Keyword(s):  
Pregnant Women ◽  
Trait Anxiety ◽  
Protocol Analysis ◽  
Psychological Intervention ◽  
Cognitive Behavioral ◽  
Control Group ◽  
Behavioral Training ◽  
Chromosomal Disorders ◽  
Intention To Treat ◽  
Post Trial

Abstract Background and aim Prenatal diagnosis of fetal abnormalities is a critical and stressful event for women. Most pregnant women are concerned about fetal abnormalities and screening tests. Due to the importance of anxiety reduction in pregnant women, this study was conducted to determine the effect of short-term psychological intervention on the anxiety of pregnant women with positive screening results for chromosomal disorders. Methods A randomized clinical trial was performed on women referred to Akbarabadi Hospital in Tehran, Iran, who had positive screening results for chromosomal abnormalities. Participants were selected from eligible individuals by a continuous method and were assigned to two groups of cognitive-behavioral training (n = 46) and control (n = 46), using the block balanced randomization method. Participants in the cognitive-behavioral training group received 4 sessions of individual counseling. The control group received routine pregnancy visits. The Spielberger State-Trait Anxiety Inventory was completed before the intervention and immediately at the end of the intervention (before receiving the amniocentesis result). The analysis of intervention effects was performed as intention-to-treat and per-protocol analysis. Results There was a statistically significant difference in post-intervention state anxiety scores and trait anxiety scores (p <  0.001) between the intervention and control groups, when their means were adjusted for pre-intervention scores for both intention-to-treat and per-protocol analysis. Also, there was a large effect size between the groups in terms of state (ITT: ηp2 = 0.63, PP: ηp2 = 0.71) and trait (ITT: ηp2 = 0.72, PP: ηp2 = 0.75) anxiety scores clinically for both intention-to-treat and per-protocol analysis. The intervention group had a statistically significant and large decrease in state and trait anxiety scores from pretrial to post-trial. In contrast, the control group had a statistically significant and medium increase in state and trait anxiety scores from pretrial to post-trial. Conclusion The results showed that cognitive-behavioral training reduced the anxiety of pregnant women with positive screening results for chromosomal disorders. According to the results, it is recommended to hold cognitive-behavioral training classes to reduce the anxiety of pregnant women with a positive screening result for chromosomal disorders. Trial registration IRCT.ir: IRCT20180427039436N7; date of registration: 24/08/2020 2020-08-24.

The effects of psychological counseling and acupressure based on couple therapy procedure for alleviation of vomiting and nausea in pregnant women in Iran country

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Sahar Saadatnia ◽  
Azita Tiznobaik ◽  
Amir Saber
Keyword(s):  
Pregnant Women ◽  
Couple Therapy ◽  
Psychological Intervention ◽  
Nausea And Vomiting ◽  
Control Group ◽  
Negative Effects ◽  
Psychological Counseling ◽  
Significant Difference ◽  
Group 2 ◽  
Short Time

Abstract Objectives Nausea and vomiting have psychological negative effects on some pregnant women during gestation. Different strategies have been used for the treatment of nausea and vomiting during pregnancy, such as acupressure and psychological interventions. This study was conducted to evaluate the effects of psychological counseling and acupressure based on couple therapy procedures on vomiting and nausea in pregnant women in Iran. Methods Two hundred and eight women were divided into four groups (n=52): 1) they did not any intervention (control group), 2) they received the psychological intervention, 3) they received acupressure intervention, and 4) they received a combination of psychological + acupressure interventions. To investigate the effects of interventions on nausea and vomiting, the Rhodes index of nausea, vomiting and retching were used. The counseling period has lasted for 4 weeks. The pressure intervention on the site was conducted in clockwise form for 1 min and anticlockwise form for another 1 min. Results Groups did not have a significant difference for abortion and income (p>0.05). The effects of counseling, and acupressure interventions on severity and period of vomiting and nausea were not significant (p>0.05), but the intervention based on counseling and acupressure decreased severity of vomiting and nausea (p<0.05). Conclusions The intervention based on counseling and acupressure could not reduce nausea and vomiting during the gestation, but the intervention based on a combination of both decreased nausea and vomiting. It can be suggested to apply an intervention based on a combination of counseling and acupressure in short-time period for decreasing nausea and vomiting in women during pregnancy.

Comparison of two different treatments in depressed pregnant women: fetal growth characteristics and neonatal outcomes

2018 ◽  
Vol 47 (1) ◽  
pp. 134-137
Author(s):  
Lisa Giardinelli ◽  
Lorenzo Lelli ◽  
Valentina Ugolini ◽  
Lisa Lazzeretti ◽  
Iuliia Burian ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Fetal Growth ◽  
Psychological Intervention ◽  
Growth Characteristics ◽  
Psychological Support ◽  
Prenatal Depression ◽  
Neonatal Outcomes ◽  
Control Group ◽  
Treatment Groups ◽  
Significant Difference

Abstract Background In this pilot study, the effects of selective serotonin reuptake inhibitors (SSRIs) and psychological intervention on fetal growth characteristics and neonatal outcomes were evaluated in two different groups of women affected by prenatal depression. Methods Forty-seven pregnant women diagnosed with major depression were divided into two different treatment groups according to the severity of their depression. The first group was treated with a combination of pharmacotherapy and psychological support. The second group (milder depression) was treated with psychological support only. The control group (CG) was made up of 26 healthy pregnant women. All of the patients and controls were assessed by means of a structured clinical interview and different self-reported questionnaires. Fetal ultrasonography assessments were performed in the second and third trimesters. Neonatal outcomes were evaluated at delivery. Results The infants of both treatment groups showed significant alterations in fetal biometry and a higher rate of low birth weight (LBW) with respect to controls. The infants of the patients treated with psychological support showed only a significantly higher rate of head circumference, <10th percentile with respect to controls. No significant difference was found between the two patient groups when fetal growth characteristics and neonatal outcomes were taken into account. Conclusion The data obtained from this study shed light on the effects of pharmacological and psychological treatment of prenatal depression on fetal growth.

scholarly journals The Feasibility and Acceptability of Project POWER: A Cognitive-Behavioral Mindfulness-Infused Group-Based Mental and Sexual Health Intervention Among Young Pregnant Women in Liberia

2021 ◽  
Author(s):  
Tamora A. Callands ◽  
Kandyce Hylick ◽  
Alethea Desrosiers ◽  
Shantesica M. Gilliam ◽  
Erica N. Taylor ◽  
...  
Keyword(s):  
Young Adult ◽  
Sexual Health ◽  
Health Outcomes ◽  
Pregnant Women ◽  
Repeated Measures ◽  
Cognitive Behavioral ◽  
Control Group ◽  
Depression Symptoms ◽  
Adult Women ◽  
Catchment Areas

Abstract Background Following 14 years of civil war in Liberia, war-exposure, gender-based violence, and extreme poverty have been identified as key challenges to the mental and sexual health of young pregnant women, and the health of their unborn children. Despite ongoing efforts to rebuild the country’s healthcare infrastructure, empirical research and interventions focused on addressing the consequences of war on the mental and sexual health of young pregnant women in Liberia are severely limited. To address these concerns, we developed Project POWER (Progressing Our Well-being, Emotions, and Relationships) (POWER), a mindfulness-infused cognitive-behavioral intervention for young adult pregnant women. This study sought to: 1) assess the feasibility and acceptability of POWER; and (2) determine the preliminary efficacy of POWER for improving mental and sexual health outcomes among Liberian war-exposed pregnant young adult women. Methods Eighty-seven women ages 18-25 years were recruited from three catchment areas in Monrovia, Liberia. Participants participated in one of two ten-session programs delivered over 5-weeks: POWER or a control group (a health education program). Feasibility and acceptability of POWER were examined using program log (e.g., the number of participants screened and enrolled, facilitator satisfaction, etc.) data from an exit interview. Results Preliminary efficacy of POWER’s effects on mental and sexual health outcomes was assessed using a series of four one-way repeated measures ANOVA with time and group as predictors. Analyses provided preliminary support for the feasibility and acceptability of POWER. Preliminary efficacy of POWER showed significant reductions in depression symptoms, PTSD symptoms, prenatal distress, and transactional sex over time. Conclusions Findings suggest that POWER may be a feasible and acceptable intervention to promote mental and sexual health for young adult pregnant women in Liberia. Future research is needed to determine the efficacy of POWER on a larger scale in Liberia.

Comparison of Two Different Treatment Protocols Using Systemic and Intratympanic Steroids with and without Hyperbaric Oxygen Therapy in Patients with Severe to Profound Idiopathic Sudden Sensorineural Hearing Loss: A Randomized Controlled Trial

2018 ◽  
Vol 23 (4) ◽  
pp. 199-207 ◽  
Author(s):  
Ilyoung Cho ◽  
Hyun-Min Lee ◽  
Sung-Won Choi ◽  
Soo-Keun Kong ◽  
Il-Woo Lee ◽  
...  
Keyword(s):  
Oxygen Therapy ◽  
Protocol Analysis ◽  
Controlled Trial ◽  
Sudden Sensorineural Hearing Loss ◽  
Oral Steroid ◽  
Control Group ◽  
Study Group ◽  
Intention To Treat ◽  
Hearing Recovery

Objectives: This study aimed to investigate the efficacy of simultaneous steroid and hyperbaric oxygen therapy (HBOT) in patients with severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL), which has a poor prognosis. Methods: Sixty patients diagnosed with severe to profound ISSNHL (≥70 dB HL) were randomly divided into two groups in a prospective controlled trial: an oral steroid + intratympanic steroid injection (ITSI) group (control group) and an oral steroid + ITSI + HBOT group (study group). Pure-tone audiometry (PTA) results and word discrimination scores (WDS) were compared between the two groups before treatment and 10 days and 1, 2, and 3 months after treatment. Hearing improvement was assessed using the modified American Academy of Otolaryngology-Head and Neck Surgery criteria. Analyses were by both intention to treat and per protocol. Results: A total of 58 patients completed the 3-month follow-up, and 2 patients in the study group were excluded due to follow-up loss in the per-protocol analysis. In the intention-to-treat and per-protocol analyses, the study group showed significantly better hearing levels than did the control group at 500 Hz (p < 0.05) 1 month after treatment and at 1 kHz (p < 0.05) 3 months after treatment. However, the average PTA values and PTA at 2, 4, and 8 kHz showed no significant difference. WDS improvement was significantly higher in the study group compared to the control group 3 months after treatment by both per-protocol (66.4 ± 13.3 and 56.7 ± 19.1%, respectively; p = 0.029) and intention-to-treat analyses (65.9 ± 14.1 and 56.7 ± 19.1%, respectively; p = 0.035). The sum of complete and partial hearing recovery for the study group was significantly higher than that for the control group by per-protocol analysis (60.7 vs. 33.3%; p = 0.037) and intention-to-treat analysis (60.0 vs. 33.3%; p = 0.038). Conclusion: These results demonstrate that the addition of HBOT to steroid combination therapy does not improve the average PTA values in severe to profound ISSNHL; however, it was associated with a better outcome at 500 Hz 1 month after treatment and, at 1 kHz, WDS 3 months after treatment. The sum of complete and partial hearing recovery was significantly higher for the study group than for the control group.

Acupuncture Vs Streitberger Needle in Knee Osteoarthritis – An Rct

2006 ◽  
Vol 24 (1_suppl) ◽  
pp. 15-24 ◽  
Author(s):  
Jorge Vas ◽  
Camila Méndez ◽  
Emilio Perea-Milla
Keyword(s):  
Protocol Analysis ◽  
Controlled Trial ◽  
Multiple Linear Regression Model ◽  
Chronically Ill ◽  
Visual Analogue Scale Pain ◽  
Control Group ◽  
Osteoarthritis Of The Knee ◽  
Clinical Variables ◽  
Intention To Treat ◽  
Treat Analysis

Aims To determine the effectiveness of acupuncture as a therapy complementary to the pharmacological treatment of osteoarthritis of the knee. Methods Randomised, single blind, placebo controlled trial. Patients with osteoarthritis of the knee were randomly assigned to either 12 sessions of true acupuncture or 12 sessions of placebo acupuncture (Streitberger needle), these sessions taking place once a week. A baseline measurement was carried out, followed by further observations at 4, 8, 12 and 16 weeks. The clinical variables were the WOMAC (Western Ontario and McMaster Universities Osteoarthritis) index, knee pain measured by a visual analogue scale (pain VAS), the weekly consumption of diclofenac and the Profile of the Quality of Life of the Chronically Ill (PQLC). The two groups were compared for each of the clinical variables per protocol and by intention to treat. A multiple linear regression model for the dependent variables was constructed. Results Ninety seven outpatients were selected, with 88 remaining for the per protocol analysis; the analysis of homogeneity concluded that the lost subjects were not significantly different from those that completed the study. The multivariate per protocol model for the relative pain VAS variable showed a difference in improvement of 43.7% (95% CI 29.4% to 58.0%) for acupuncture, compared with the control group. In an intention to treat analysis, the relative improvement was 32.4% (20.3% to 44.4%). In a per protocol analysis, the total WOMAC showed a relative decrease of 52.0% (34.3% to 69.6%) in favour of the acupuncture group, or 37.6% (22.4% to 52.8%) in an intention to treat analysis. Conclusions The group treated with acupuncture showed significantly better effects, both clinically and statistically, in the reduction of pain intensity as measured by pain VAS, on the WOMAC index and in decreased consumption of diclofenac.

scholarly journals Effects of relaxation exercises on the ways of coping with stress and anxiety level in primiparous pregnant women diagnosed with preterm labor

2017 ◽  
Vol 14 (4) ◽  
pp. 3158 ◽  
Author(s):  
Ayten Arıöz Düzgün ◽  
Emel Ege
Keyword(s):  
Pregnant Women ◽  
Trait Anxiety ◽  
Preterm Labor ◽  
Intervention Group ◽  
Control Group ◽  
State Trait Anxiety Inventory ◽  
Coping With Stress ◽  
Ways Of Coping ◽  
The Difference ◽  
Relaxation Exercises

This experimental study aims to evaluate the effects of relaxation exercises on the ways of coping with stress and anxiety level in primiparous women diagnosed with preterm labor. The study included a total of 60 pregnant women who were admitted to the outpatients clinics of the Department of Obstetrics and Gynecology at a tertiary setting between November 2012 and February 2014. Of these women, 30 were allocated into the intervention group and 30 were allocated into the control group. The Pregnant Women Identity Information Form, Ways of Coping with Stress Inventory, and State-Trait Anxiety Inventory were used as data collection tools.The pregnant women in the intervention group achieved higher scores in the State-Trait Anxiety Inventory in the first assessment and lower scores in the final assessment, and the difference from baseline was significantly different (p<0.005). The women in the control group achieved lower scores in the State-Trait Anxiety Inventory in the first assessment and higher scores in the final assessment, and the difference from baseline was significantly different (p<0.005). The scores of pregnant women in the intervention group in efficient ways of coping subscale increased as from the baseline (p<0.005), whereas there was an increase in the scores of women in the control group in inefficient ways of coping subscale and the difference was statistically significant (p<0.005). Our study results suggest that relaxation exercises are effective in reducing anxiety and coping with stress in pregnant women with imminent premature labor.

Effectiveness of brief-focused cognitive behavioral therapy in the reduction of cancer-related distress and emotive problems: A comparative study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e24169-e24169
Author(s):  
Alessandro Rossi ◽  
Maria Marconi ◽  
Stefania Mannarini ◽  
India Minelli ◽  
Silvia Bianchi ◽  
...  
Keyword(s):  
Cognitive Behavioral Therapy ◽  
Psychological Intervention ◽  
Behavioral Therapy ◽  
Statistical Significance ◽  
Distress Thermometer ◽  
Cognitive Behavioral ◽  
Control Group ◽  
Cohen’S D ◽  
Oncological Patients ◽  
Cohen's D

e24169 Background: In recent years, there was an increase of cognitive-behavioral therapy (CBT) oriented brief-focused psychological intervention protocols for the reduction of cancer-related emotive difficulties that oncological patients have to face almost every day and that could have a negative impact on medical treatment (Di Matteo, Lepper & Croghan, 2006; NCCN, 2015). Thus, this study aimed to determine the effectiveness of a 10-session brief CBT (B-CBT-P) compared with a control group (CG). Methods: Participants ( n = 67; mean age = 63.11, SD = 12.1, 35 female) enrolled at the Oncology Day Hospital at the “Presidio Ospedaliero” of Saronno, ASST Valle Olona, Italy who undertook (B-CBT-P: n = 34) or non-undertook (CG: n = 33) a psychotherapy intervention – with one of two different psychologists (authors MM and MI) to avoid potential biases. Participants were tested with the Distress Thermometer and the Problem List (DT&PL) at the baseline (T1; overall McDonald’s omega = .90), at the end of the 10-sessions B-CBT-P (T2; overall McDonald’s omega = .89). Results: A multilevel-multivariate repeated measure regression analysis was performed – controlling for age, type and localization of tumor, and therapist. In line with psychotherapy protocol, results showed no statistical significant changes for ‘practical problems’ ( p = 0.0497 ns), ‘spiritual problems’ ( p = 0.321 ns), and ‘physical problems’ ( p = 0.206). Results revealed a statistical significance reduction of ‘relationships problems’ ( p = 0.015; pooled Cohen’s d = 0.341), ‘emotive problems’ ( p = 0.012; pooled Cohen’s d = 0.349), and the distress thermometer ( p = 0.008; pooled Cohen’s d = 0.373). Conclusions: Considering that emotive and relational problems, as well as distress, occurs frequently among oncological patients, this study is into an important area. Results suggest that B-CBT-P is statistically and clinically effective to improve the emotive and relational sphere of oncological patients. However, the small effect sizes found suggest that these short protocols may not be sufficient to bring important changes in the patient's life. This study opens up to the idea of improving these protocols so that the cancer patient can improve his quality of life – even with a few psychotherapy sessions.

scholarly journals Bariatric surgery and the incidence of rheumatoid arthritis – a Swedish Obese Subjects study

Rheumatology ◽  
2019 ◽  
Vol 59 (2) ◽  
pp. 303-309 ◽  
Author(s):  
Cristina Maglio ◽  
Yuan Zhang ◽  
Markku Peltonen ◽  
Johanna Andersson-Assarsson ◽  
Per-Arne Svensson ◽  
...  
Keyword(s):  
Bariatric Surgery ◽  
Protocol Analysis ◽  
International Classification Of Diseases ◽  
Control Group ◽  
Intention To Treat ◽  
Classification Of Diseases ◽  
National Patient ◽  
Obese Subjects ◽  
Serum Crp

Abstract Objective The aim of this study was to determine the effect of bariatric surgery on the incidence of RA in participants of the Swedish Obese Subjects (SOS) study. Methods The SOS is a longitudinal study aiming to assess the effect of bariatric surgery on mortality and obesity-related diseases. This report includes 2002 subjects with obesity who underwent bariatric surgery and 2034 matched controls; none of them had RA at baseline. Cases of incident RA were identified through the Swedish National Patient Register by searching for International Classification of Diseases codes. Both intention-to-treat analyses and per-protocol analyses are reported. In the per-protocol analysis, participants from the control group who underwent bariatric surgery later on during follow-up were censored at the time of surgery. Results During follow-up, 92 study participants developed RA. The median follow-up was 21 years (range 0–29). Bariatric surgery was neither associated with the incidence of RA in the intention-to-treat analysis [hazard ratio (HR) 0.92 (95% CI 0.59, 1.46), P = 0.74], nor in the per-protocol analysis [HR 0.86 (95% CI 0.54, 1.38), P = 0.53]. Weight change at the 2 year follow-up, expressed as the change in BMI compared with baseline, did not associate with the development of RA. Higher serum CRP levels and smoking associated with the future development of RA independent of other factors. Conclusions We did not detect any association between bariatric surgery and the incidence of RA in subjects affected by obesity followed up for up to 29 years. ClinicalTrials.gov (http://clinicaltrials.gov): NCT01479452.

scholarly journals Effect of Cognitive Behavioral Therapy on Functional Outcomes in Patients with Stroke

2020 ◽  
Vol 11 (2) ◽  
pp. 2725-2730
Author(s):  
Abdul Allim Abdel Fattah Atteya ◽  
Ehab Shaker ◽  
Moataz Mohamed Talaat Elsemary ◽  
Hossam Mohammed Alsaid ◽  
Youssef Mohamed Elbalawy
Keyword(s):  
Physical Therapy ◽  
Upper Extremity ◽  
Functional Outcomes ◽  
Behavioral Therapy ◽  
Total Duration ◽  
Cognitive Behavioral ◽  
Control Group ◽  
Behavioral Training ◽  
Therapy Program ◽  
Physical Therapy Program

Upper extremity impairment is a common motor deϑicit after a stroke, and 30– 60% of stroke sufferers have disability and inability to use their affected upper extremity in their daily lives. Stroke survivors with cognitive dysfunctions are most likely to be dependent in activities of daily living. Further deterioration is possible as a result of limitation in activities. Psychiatric problems are also common among stroke survivors. This may delay recovery process and further impair cognitive function due to adaptations to unhealthy lifestyles or noncompliance to rehabilitation. Cognitive behavioral training (CBT) increase blood supply to 20% of different brain areas, and facilitation of internancial neurons activity. Cognitive behavioral training (CBT) act as Incentive therapy focuses on active participation, self-esteem, motivational features such as score keeping, and competition. The ultimate objective of physiotherapy is for patients to return to full independence and their former occupations.The purpose of this study was to investigate the effect of cognitive behavioral training on functional outcomes in stroke patients.Forty stroke patients from both sexes participated in this study 20 patients for each group. Random distribution for patients to 2 groups; Group (A) exposed cognitive behavioral therapy for 60 min and selected physical therapy program for 30 min, every other day for 24 sessions, total duration of session (90 min). Control group (B) received the same selected physical therapy program for 60 min, every other day for 24 sessions total duration of session (60 min). Changing in affected upper extremity motor impairment were measured (Dash scale, Wolf scale and Jammar hand dynamometer). The result of our study was improvement of motor functions were signiϑicantly greater in the study group than the control group (p=0.0001).

Ticagrelor monotherapy beyond 1 month versus standard dual antiplatelet therapy after drug-eluting coronary stenting: a pre-specified per-protocol analysis of the GLOBAL LEADERS trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
F Gragnano ◽  
M Zwahlen ◽  
P Vranckx ◽  
P Juni ◽  
D Heg ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Protocol Analysis ◽  
Dual Antiplatelet Therapy ◽  
Control Group ◽  
Funding Source ◽  
Intention To Treat ◽  
Protocol Population ◽  
All Cause Mortality ◽  
Drug Eluting ◽  
Experimental Group

Abstract Background In the GLOBAL LEADERS trial, the intention-to-treat (ITT) effect of ticagrelor monotherapy after 1 month of dual antiplatelet therapy (DAPT) was not superior to that of 12-month DAPT followed by aspirin alone in the prevention of 2-year all-cause mortality or new Q-wave myocardial infarction (MI) after coronary stenting. Intention-to-treat analyses can be affected by incomplete protocol adherence. We present a pre-specified per-protocol analysis. Purpose To determine whether 1 month of ticagrelor plus aspirin followed by 23 months of ticagrelor monotherapy is superior to 12 months of DAPT followed by aspirin alone in the per-protocol population of the GLOBAL LEADERS (NCT01813435). Methods The GLOBAL LEADERS compared two antiplatelet strategies after drug-eluting stenting for stable coronary artery disease or acute coronary syndromes. Per-protocol population consisted of randomized patients fulfilling enrollment criteria and receiving protocol-mandated treatment. Adherence to the allocated antiplatelet therapy was evaluated at discharge, 30 days, and 3, 6, 12, 18, and 24 months, with non-adherence reasons categorized following a hierarchical approach. A protocol-deviation was defined in the case of high perceived bleeding/thrombotic risk, a medical decision without evident clinical reason, patients unwilling to take study drugs, prescription error, logistical issues, unclear reasons. Baseline characteristics, including (but not limited to) age, sex, diabetes, prior PCI, were used to construct time-varying inverse probabilities for not deviation from the protocol to reconstruct a study population with no protocol-deviations. Protocol deviators were artificially censored at the time at which they deviated. The primary endpoint was the composite of 2-year all-cause mortality or non-fatal new Q-wave MI. We used a weighted pooled logistic regression to estimate the per-protocol rate ratio (RR) of experimental vs. control treatment for the primary endpoint. Results Of the 15,968 randomized patients, 805 out of 7,980 (10.1%) in experimental group and 537 out of 7,988 (6.7%) in control group were classified as protocol deviators and artificially censored by month 12, not contributing events in the second year. The events for the adherence-adjusted analysis were 279 in experimental group and 325 in control group (25 and 24 less than in ITT analysis, respectively). The estimated adherence-adjusted RR was 0.87 (95% CI: 0.74–1.02; p=0.09), comparable to the ITT RR (0.87; 95% CI: 0.75–1.01; p=0.07). Conclusion At per-protocol analysis, ticagrelor monotherapy after 1 month of DAPT was not superior to conventional treatment, in line with the previously reported ITT effect. Similar per-protocol and ITT effects can be accounted for similar per-protocol and ITT populations, as a substantial proportion of patients were non-adherent due to clinically grounded reasons (anticipated in the protocol) and, accordingly, not considered as protocol deviators. Funding Acknowledgement Type of funding source: Other. Main funding source(s): GLOBAL LEADERS was sponsored by the European Clinical Research Institute, which received funding from Biosensors International, AstraZeneca, and the Medicines Company.

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