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Ways of coping questionnaire (WCQ) | WCQ is an established measure based on Lazarus and Folkman’s process-oriented stress and coping theory. It was originally developed with 68 items to identify the coping strategies people use in stressful situations | PMC10050170 | ||
Multidimensional scale of perceived social support (MSPSS) | MSPSS | PMC10050170 | ||
Perceived stress scale (PSS-10) | PSS-10 | PMC10050170 | ||
Spiritual well-being scale (SWBS) | SWBS | PMC10050170 | ||
Educational intervention programme | The intervention consisted of six face-to-face educational sessions held for the intervention group—which was divided into six subgroups. Each of the six weekly sessions lasted 1.5–2 h. The training programme is outlined in Table Content of educational session.All the educational content was provided to the control group after the analysis of the intervention. | PMC10050170 | ||
Data analysis | In both evaluation phases, histograms and the Kolmogorov–Smirnov test were first used to check the distribution and skewness of data. The dependent variables were all normally distributed, thus, chi-square, t-tests, and analyses of covariance (ANCOVA) were used to compare the data. All analyses were performed using SPSS version 23 software (SPSS Inc., Chicago, IL, USA). A | PMC10050170 | ||
Discussion | DECAY | This randomized controlled trial assessed the effect of an educational intervention based on the TMSC on stress management and coping skills among industrial workers in Iran. The results suggest that the educational intervention could significantly improve coping skills strategies, spiritual well-being, and perceived social support, and decrease perceived stress among industrial workers. This original study is the first to use an educational intervention based on the robust TMSC to help industrial workers cope with stress through the development of appropriate stress coping skills.The significant impact of the educational programme on coping skills in the present study aligns with previous research in other working populationsSeeking social support was another coping skill that was increased in the intervention group. This problem-focused coping skill intentionally pursues practical, informational and emotional support from relevant others to relieve the particular stressor which is challenging in one’s lifeThe present study showed a remarkable change in spiritual well-being when the measure was repeated after the intervention. Drawing upon one’s beliefs and understanding of the holistic purpose of life can be recognised as adaptive, and a positive coping strategy in the face of considerable sufferingOne of the most important results of the present study was that the educational programme reduced perceived stress even when measured three months after the intervention, suggesting some longevity to the principles of the TMSC programme. We acknowledge that an assertion that this programme could empower industrial workers to cope with stressors in the long term requires additional data collection, perhaps after two years, as it is well-known that there are skills decay over time, even when used regularlyThe present study is the first to describe the effect of an educational intervention based on the comprehensive and standard method of TMSC among industrial workers. This RCT study produced causal evidence of the role stress coping skills training can contribute to industrial workers’ well-being. In this study, we measured spiritual well-being in addition to eight coping skills of the TMSC model. The simultaneous use of face-to-face and virtual education is one of the other strengths of the study.Despite the strengths of the study, it also has some limitations. This study was conducted in one Iranian industrial company and may not generalize to other industrial work environments, or culturally diverse environments. Self-reported questionnaires were used to gather study variables, which may have been accompanied by some bias despite the full explanation provided to the participants at the beginning of the study as an attempt to gain their trust. The lack of long-term outcome assessment may also be considered another limitation of the present study. Finally, despite trying to prevent or mitigate contamination, selecting one work shift as the intervention group and the other as the control group might be contamination. | PMC10050170 | |
Acknowledgements | This work was supported by Shiraz University of Medical Sciences under Grant number: 98-01-04-21905. The authors would like to thank the employees for participating in the study. | PMC10050170 | ||
Author contributions | M.H.K.: conceptualization, methodology, supervision, , investigation, participant management, data assessment and curation, writing: original draft review and editing of the manuscript; F.M.: methodology, investigation, validation, data assessment and curation, writing: original draft review and editing; R.C.: methodology, writing: draft review and editing of the manuscript; H.M.: conceptualization, methodology, supervision, formal analysis, validation, writing: original draft review and editing of the manuscript, project administration, funding acquisition. All authors read and approved the final manuscript. | PMC10050170 | ||
Data availability | Data associated with this study is available upon reasonable request to the corresponding author. | PMC10050170 | ||
Competing interests | The authors declare no competing interests. | PMC10050170 | ||
References | PMC10050170 | |||
Methods | BPD, HC | A total of 1465 mother-child dyads were included. Ultrasound based fetal anthropometric parameters which included the head circumference (HC), abdominal circumference (AC), femur length (FL), biparietal diameter (BPD) and transcerebellar diameter (TCD) were collected at 26–28 weeks of gestation and their association with neurodevelopment at 24 months of age was examined. | PMC10745170 | |
Results | neurodevelopment impairment | Only the transcerebellar diameter z score was positively associated +0.54 units (95% CI: 0.15, 0.93) with motor composite score. When the neurodevelopment outcomes were analyzed as categorical, none of the fetal variables were associated with risk of moderate to severe neurodevelopment impairment. | PMC10745170 | |
Conclusion | The findings suggest that transcerebellar diameter could be useful for early prediction of neurodevelopmental outcomes in childhood. | PMC10745170 | ||
Clinical trial registration | Clinical trial registration of Women and Infants Integrated Interventions for Growth Study Clinical Trial Registry–India, #CTRI/2017/06/008908; Registered on: 23/06/2017, ( | PMC10745170 | ||
Data Availability | All relevant data are within the manuscript and its | PMC10745170 | ||
Introduction | PROLIFERATION | The largest number of under five children with impaired neurodevelopment are in sub-Saharan Africa followed by South Asia [The human brain starts developing early in pregnancy. During the second trimester, it tends to speed up with neuron proliferation axon and dendritic growth and synaptogenesis [Studies have used birth weight and gestational age at birth separately or together as indicators for later neurodevelopment [Findings from population-based studies with large samples aimed at identifying early fetal predictors of poor neurodevelopment using methods like ultrasound are needed, as ultrasound is widely available, noninvasive and a safe tool for fetal assessment in utero. Identification of early predictors like fetal anthropometric parameters would help in prioritizing infants at possible risk of developmental deficits. Studies have shown that targeted improvement in nutrition of pregnant women leads to better fetal growth [ | PMC10745170 | |
Materials and methods | PMC10745170 | |||
Study design and population | SECONDARY, DELHI | Secondary analysis of the data from a large community based randomized controlled trial (WINGS) conducted in low and middle socioeconomic urban and peri-urban population in South Delhi, India was done [Ultrasonography was done for fetal growth assessment for all pregnant women between 26–28 and 35–36 weeks of gestation, irrespective of their group allocation. The follow up continued till the children born were 24 months of age. Neurodevelopment assessment was done for these children at 24 months post-natal age.All pregnant women, whose ultrasonographic data was available at 26–28 weeks of gestation and their children, who had undergone neurodevelopment assessment at 24 months of age, were considered for this secondary analysis. Women who did not have an ultrasound at 26–28 weeks of gestation or children who were unavailable for neurodevelopment assessment at 24 months were excluded.Since we were looking at early predictors, and there is no ideal gestation when anthropometric measurements are most predictive of neurodevelopmental outcome we chose 26–28 weeks over 35–36 weeks. We were interested in utilizing data at a time which is earlier in the gestation so that interventions to promote fetal anthropometric growth (through addressing maternal risk factors) could be instituted | PMC10745170 | |
Ultrasonography and neurodevelopment assessment | During pregnancy trans-abdominal ultrasounds were done in all enrolled women at one of the three designated ultrasound centers. Between 9 and 13 weeks of gestation a dating ultrasound was done to estimate gestational age. Gestational age was calculated using fetal crown-rump length (CRL). In cases where the CRL was > 95 mm, gestational age was calculated using femur length and head circumference [Using the globally acceptable Bayley Scales of Infant and Toddler Development, 3 | PMC10745170 | ||
Exposure and outcome | cognitive, motor and language domains, neurodevelopmental impairment | Exposure was defined as z scores of ultrasound based fetal anthropometric parameters collected at 26–28 weeks of gestation. We had two outcomes; the first was continuous with composite scores for cognitive, motor and language domains. For the second outcome we considered a composite score of less than 85 on BSID-III to label a child as having moderate to severe neurodevelopmental impairment in cognitive, motor and language domains. | PMC10745170 | |
Data collection for other variables | A detailed description of the variables on which data were collected in the primary trial along with the methods adopted has been published previously [ | PMC10745170 | ||
Statistical analysis | BPD | Baseline characteristics of the mothers and their children were presented as means along with standard deviations (SD) for continuous and proportion for categorial variables. The measurements of HC, AC, FL, and BPD were converted to gestational age adjusted z scores using INTERGROWTH 21 calculator [ | PMC10745170 | |
Ethics | DELHI | The trial was conducted according to the guidelines outlined in the Declaration of Helsinki. It was approved by the ethics committees of the Society for Applied Studies, New Delhi (SAS/ERC/LG/2017); Vardhman Mahavir Medical College and Safdarjung Hospital (IEC/SJH/VMMC/PROJECT-2017/694), New Delhi; and WHO, Geneva (ERC.0002934).Prior to enrolment a written individual informed consent in the local language was obtained from participants. The form was read aloud for those who couldn’t read, and a thumb imprint was taken as witnessed by an impartial literate witness for those who couldn’t sign. | PMC10745170 | |
Results | Of the 4921 pregnancies identified at second randomization of the main trial, data for ultrasound parameters at 26–28 weeks were available for 4602 women and neurodevelopment assessment at 24 months was available for 1769 mother child dyads. Data for both ultrasound at 26-28weeks and neurodevelopment assessment at 24months was available for 1465 mother child dyads. For the analysis therefore data from 1465 mother child dyads was used. The characteristics of the children and their families at baseline are summarized in | PMC10745170 | ||
Association of fetal USG anthropometric parameters at 26–28 weeks of gestation and neurodevelopment at 24 months | TCD was positively associated with motor composite scores. Each unit increase in TCD was associated with +0.54 units (95% CI: 0.15, 0.93) increase in motor composite score ( | PMC10745170 | ||
Association between fetal ultrasonography anthropometric parameters and neurodevelopmental outcomes at 24 months of age. | BPD, neurodevelopment impairment, HC | HC: Head circumference, AC: Abdominal circumference, FL: Femur Length, BPD: Biparietal Diameter, TCD: Trans cerebellar diameter; *Statistically significant at P<0.05When we examined the association between the fetal anthropometric variables and risk of moderate to severe neurodevelopment impairment, there were no significant associations for any fetal anthropometric parameters in any domain of neurodevelopment ( | PMC10745170 | |
Discussion | The current analysis was done to understand the association between ultrasound based fetal anthropometric parameters and neurodevelopmental outcomes at 24 months of age. We did not find any significant association with parameters at 26–28 weeks gestation, except for a positive association of TCD with motor composite scores. None of the fetal anthropometric parameters were associated with a risk of moderate to severe development delay.Transcerebellar diameter is considered as a marker of cerebellar growth. Between 24 to 40 weeks of gestation the cerebellar volume increases by almost 500% [For some of the other fetal anthropometric parameters (AC, HC/AC, FL/BPD) measured in the second or third trimester, associations with neurodevelopment in early childhood have been found [In the Generation R study, an increase in AC z score and a decrease in HC/AC z score was associated with lesser risk of optimal neuromotor development [To the best of our knowledge, this is the only population based study done in South Asia which examines the association between fetal anthropometric variables and neurodevelopmental outcomes beyond infancy. A major strength of this study is that it was population based (in apparently healthy low risk women) with a large sample size of around 1500 mother child dyads. The fetal anthropometric variables were measured by well-trained sonographers using INTERGROWTH 21 standards. Trained psychologists conducted the neurodevelopmental assessments using the globally accepted Bayley-III scales. We carefully selected variables for adjustment in the model. However, there still remains a possibility that some factors such as postnatal nutrition, morbidity, quality of child care and parenting may have influenced the neurodevelopmental outcomes. | PMC10745170 | ||
Conclusion | The findings of our analysis indicate the possible usefulness of fetal ultrasound based transcerebellar diameter in the prediction of neurodevelopmental outcomes in early childhood. The findings also generate important questions regarding the associations particularly for the AC and the HC/AC ratio which need to be resolved through large studies with robust data collection and longer follow up. | PMC10745170 | ||
Supporting information | DELHI | (XLS)Click here for additional data file.We acknowledge the contribution and support of the enrolled women and their families. We are thankful to the community leaders for their cooperation and support. We also acknowledge the support of Hamdard Institute of Medical Sciences and Research and Associated Hakeem Abdul Hameed Centenary Hospital New Delhi, India: BR Diagnostics, New Delhi, India: Rahul Sachdev; Millennium Diagnostics, New Delhi, India: Omprakash Bansal; ML Agarwal Imaging Centre Private, New Delhi, India: Raghav Aggarwal. | PMC10745170 | |
Background | ICDs, PD, Parkinson’s disease | DISORDERS | Impulse control disorders (ICDs) are frequently encountered in Parkinson’s disease (PD). | PMC10511565 |
Objectives | We aimed to assess whether clonidine, an α2-adrenergic receptor agonist, would improve ICDs. | PMC10511565 | ||
Methods | PD, ICDs, movement disorder | MOVEMENT DISORDER | We conducted a multicentre trial in five movement disorder departments. Patients with PD and ICDs ( | PMC10511565 |
Results | MAY | Between 15 May 2019 and 10 September 2021, 19 patients in the clonidine group and 20 patients in the placebo group were enrolled. The proportion difference of success in reducing QUIP-RS at 8 weeks, was 7% (one-sided upper 90% CI 27%) with 42.1% of success in the clonidine group and 35.0% in the placebo group. Compared to patients in the placebo group, patients in the clonidine group experienced a greater reduction in the total QUIP-RS score at 8 weeks (11.0 points vs. 3.6). | PMC10511565 | |
Discussion | Clonidine was well tolerated but our study was not enough powerful to demonstrate significant superiority compared to placebo in reducing ICDs despite a greater reduction of total QUIP score at 8 weeks. A phase 3 study should be conducted. | PMC10511565 | ||
Trial Registration | The study was registered (NCT03552068) on clinicaltrials.gov on June 11, 2018. | PMC10511565 | ||
Supplementary Information | The online version contains supplementary material available at 10.1007/s00415-023-11814-y. | PMC10511565 | ||
Keywords | PMC10511565 | |||
Introduction | ICDs, hypersexuality, behavioural disorders, PD, Parkinson’s disease, binge eating, compulsive shopping | DYSFUNCTION, DISORDERS | Impulse control disorders (ICDs) are behavioural disorders frequently encountered in Parkinson’s disease (PD) treated by dopamine replacement therapies (DRT). The main ICDs are pathological gambling, binge eating, compulsive shopping, and hypersexuality [A recent study reported a 5‐year cumulative ICD incidence rate of 46% [The mechanism of ICDs is not entirely understood but dysfunction of the mesocorticolimbic dopaminergic pathway plays a key role and abnormal sensitization of the limbic dopaminergic system, combined with a relatively preserved dopaminergic mesocorticolimbic pathways and reduced dopamine transporter (DAT) expression in ventral striatum have been clearly shown [There is also evidence of a role of the noradrenergic system in decision-making and reward processes in rodents [In this context, we conducted a multicentre prospective, randomised, double-blind placebo-controlled trial to investigate the efficacy of clonidine on ICDs and its safety in PD patients in a phase 2b study in preparation for a phase 3 trial. | PMC10511565 |
Patients and methods | PMC10511565 | |||
Patients | Parkinson’s, PD, movement disorder | MOVEMENT DISORDER, DISORDERS, MOVEMENT DISORDER, -20 | Patients were screened in five university hospital movement disorder departments in France (Lyon, Clermont-Ferrand, Saint Etienne, Grenoble, and Nice). We included patients diagnosed with PD at least 1 year previously and in accordance with the Movement Disorder Society criteria, who were aged [30–80] years, and who weighed [40–95] kg. ICD symptoms had to start after PD onset and initiation of DRT. The Questionnaire for Impulsive-Compulsive Disorders in Parkinson’s Disease-Rating Scale (QUIP-RS) was used to assess the presence and severity of ICDs. The QUIP-RS is a screening instrument for ICDs [Approval from the institutional ethical standards committee on human experimentation (Comité de protection des personnes Ouest IV -Nantes) was obtained before study initiation and the trial was done in accordance with the Declaration of Helsinki and the International Conference on Harmonisation Good Clinical Practice Guidelines. All patients provided written informed consent before randomisation (EudraCT number 2019-000165-20). The study was registered (NCT03552068) on clinicaltrials.gov. | PMC10511565 |
Methods | PD, Depression | Patients received oral clonidine (75 µg twice a day, a morning and an evening) or a placebo for 8 weeks without any titration. Patients were instructed not to change their PD treatment (medications and/or DBS settings) during the study and treatment was checked at each visit. Randomisation and allocation to the trial group were carried out by a central computer system. Assignment was masked from the patients, study staff, investigators, and data analysts. The QUIP-RS was administered by a neuropsychologist specialised in PD. The neuropsychologists were trained before the beginning of the study in order to standardise, between centres, the administration of the questionnaire. When two sub-scores were equal, we the most disabling for the patient according to the neurologist was retained. Depression symptoms were assessed using the BDI II [ | PMC10511565 | |
Primary endpoint | The efficacy of the clonidine after 8 weeks of treatment was determined using the QUIP-RS. Success corresponded to a decrease of more than 3 points of the more elevated sub-score, without elevation of another sub-score of the QUIP-RS. This criterion was chosen to consider the most marked ICD for a given patient, which seemed more clinically relevant. | PMC10511565 | ||
Secondary endpoints | depression | MOVEMENT DISORDER, COMPLICATIONS | Change in ICD severity was assessed by the variation of the total QUIP-RS score between baseline and week 4 and between baseline and week 8. Secondary outcomes were the changes between baseline and week 8 of the Movement Disorder Society Unified Parkinson’s Disease Rating Scale MDS-UPDRS part I (Non-Motor Aspects of Experiences of Daily Living), part II (motor aspects of experiences of daily living), part III (motor symptoms), and part IV (motor complications) scores [Changes in depression symptoms were assessed using the BDI II [ | PMC10511565 |
Statistical analysis | The primary outcome was a reduction of QUIP-RS score between baseline and 8 weeks. We defined a success as a reduction by 3 points or more between baseline and 8 weeks of the highest QUIP-RS subscore at baseline, without any augmentation in the other QUIP-RS dimension. The minimal clinical difference was set at a 15% difference of success between placebo and clonidine. Using a confidence interval (CI) approach [ | PMC10511565 | ||
Role of the funding source | The funding sources had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author has full access to all the data and takes final responsibility to submit for publication. | PMC10511565 | ||
Results | MAY | Between 15 May 2019 and 10 September 2021, 41 patients were screened and 39 enrolled and randomly assigned. Nineteen received clonidine and 20 placebos (ITT population). One patient in the placebo arm decided to stop the study because of a personal issue independent of ICD. 19 patients in the clonidine arm and 19 patients in the placebo arm completed the study (PP population; Fig. Flow chartBaseline characteristics | PMC10511565 | |
Primary endpoint | The difference of success rate in reducing QUIP-RS at 8 weeks, was of 7% between groups (one-sided upper 90% CI 27%), with 8/19 patients experiencing success in the clonidine group (42.1%) and 7/20 in the placebo group (35.0%) in the ITT population. In the PP population, the proportion difference was of 10% (one-sided upper 90% CI 30.5) with 42.1% of success in the clonidine group and 31.6% in the placebo group. | PMC10511565 | ||
Secondary endpoints | At 4 weeks, compared to patients in the placebo arm, patients receiving clonidine had a larger reduction of the mean total QUIP-RS score (7.9 versus 2.9 points). At 8 weeks, this difference became greater; 11.0 points under clonidine versus 3.6 under placebo (Fig. QUIP-RS total score at baseline, 4 and 8 weeks for placebo and clonidine groupThe frequency of success in reducing QUIP-RS at 4 weeks did not differ between groups (4/20 in the placebo arm (20%) and 4/19 in the clonidine arm (21%).In the mixed effect model, the estimated mean difference of QUIP-RS evolution between clonidine and placebo groups was – 3.8 (95%CI [ – 7.2; 0.4]) (see details in supplemental data).There was no worsening of motor or non-motor manifestations under clonidine.The MDS UPDRS total and component scores, STAI-Y-A and B, ECMP, and the Epworth scale remained stable at 8 weeks in the ITT population. The PDQ39 score was better at 8 weeks than inclusion in the clonidine group and worse in the placebo group (Table Secondary objectives | PMC10511565 | ||
Adherence | Patients in the clonidine group had a good adherence monitored using capsule count; 74% of the patients received at least 75% of treatment doses for all periods between visits. | PMC10511565 | ||
Safety | ADVERSE EVENT | Overall, clonidine was well tolerated with no unexpected safety issues (Table Adverse events related to the treatment | PMC10511565 | |
Discussion | PD | CORTEX, PATHOPHYSIOLOGY | This study found that clonidine was well tolerated by PD patients, and the results indicate that a phase 3 trial should be conducted. Although the rate of success was not significantly different between groups, patients receiving clonidine had a greater and faster, reduction of the total QUIP-RS score at 8 weeks; it is of note that this phase 2b study was not calibrated to conclude on clonidine efficacy but on the conduct a phase 3 study. Of course, the pathophysiology of ICD in PD being still controversial and complex, we cannot exclude that targeting only the noradrenergic system could be insufficient to suppress ICD [Despite the randomisation, an imbalance was observed between groups for several variables, which, in turn, could have affected the results. Indeed, patients in the clonidine group had higher QUIP-RS total scores at baseline, meaning that they experienced more severe ICD. Moreover, patients in the clonidine groups were less systematically on agonist dopaminergic (78.9% vs 100% in the placebo group), which could, again, reflect more important ICD persisting despite the discontinuation of this treatment. Altogether, we cannot rule out that patients in the clonidine group may present more severe and more difficult to tackle ICD. It was however hard, because of the difficulty of recruiting these patients, to perfectly match them based on ICD score for this early-phase study. Although this could have affected our findings, we hypothesize that the differences of trends in terms of QUP-RS score reduction could have been more pronounced with better matching, which reinforces the need for a larger study to smooth out inter-group differences. In addition, with our mixed-effects model considering this difference, the difference in slopes remains statistically significant between the arms at the 10% alpha threshold (with The precise mechanisms of action of clonidine remain to be elucidated. It could, however, impact ICDs via the modification of noradrenergic transmission affecting, in turn, the inhibitory role of the prefrontal cortex; this lack of inhibitory and executive top-down control is one of the mechanisms of behavioural addictions in PD, in combination with aberrant motivation and reward circuits activations [ | PMC10511565 |
Supplementary Information | Below is the link to the electronic supplementary material.Supplementary file1 (DOCX 20 KB)Supplementary file2 (DOCX 14 KB) | PMC10511565 | ||
Author contributions | MH, TD | CL: design, execution, analysis, writing and editing of the final version of the manuscript. NT: analysis. AM: execution and editing of the final version of the manuscript. DDD: execution and editing of final version of the manuscript. CG: execution and editing of the final version of the manuscript. SM: execution and editing of final version of the manuscript. MH: execution. TD: execution and editing of final version of the manuscript. MA: design. HK: design, execution. TV: execution. MF: execution. CC: design, execution. MN: writing, analysis. PB: design and editing of the final version of the manuscript. CD: execution and editing of the final version of the manuscript. BB: design and editing of the final version of the manuscript. SP: execution and editing of the final version of the manuscript. SB: design, analysis, writing and editing of the final version of the manuscript. ST: design, execution, analysis, writing and editing of the final version of the manuscript. | PMC10511565 | |
Declarations | PMC10511565 | |||
Conflicts of interest | The authors have no competing interests to declare that are relevant to the content of this article. | PMC10511565 | ||
References | PMC10511565 | |||
Background | HIV infection, sexual behaviors | STIS, HIV INFECTION, SEXUALLY TRANSMITTED INFECTIONS | Men who have sex with men (MSM) who practice chemsex have a higher likelihood of engaging in risky sexual behaviors and higher rates of HIV infection and other sexually transmitted infections (STIs) than those who do not. | PMC9893729 |
Objective | This trial aimed to evaluate the effectiveness of a web-based intervention in reducing the sexual harms of chemsex among MSM. | PMC9893729 | ||
Methods | sexual behaviors | SECONDARY | The study was a 2-arm, assessor-blinded, randomized, parallel-group trial with a 3-month follow-up period. The study was conducted in the year 2021 in Hong Kong. Underpinned by the theory of planned behaviors and a harm reduction approach, the intervention consisted of interactive components and knowledge-based information about chemsex. Participants in the control group received brief information and content about sexual violence. The primary outcome was self-efficacy in refusing risky sexual behaviors and chemsex, as measured by the Condom Self-Efficacy Scale (CSES), Self-Efficacy for Sexual Safety (SESS) instrument, and Drug Avoidance Self-Efficacy Scale (DASES). The secondary outcomes included intentions to have chemsex, actual engagement in chemsex, HIV and other STI testing, and condom use in the last 3 months. All outcomes were self-reported. An online structured questionnaire was used to collect data. | PMC9893729 |
Results | In total, 316 MSM enrolled in the study. The intervention group demonstrated a significantly larger improvement in condom-use self-efficacy (as measured by CSES scores; time-by-group interaction: β=4.52, 95% CI 2.03-7.02; | PMC9893729 | ||
Conclusions | sexual behaviors | This study suggests that a web-based intervention with a harm reduction approach can enhance the self-efficacy of MSM in refusing risky sexual behaviors and chemsex and improve the uptake of HIV testing. We also provide initial evidence that such interventions can reduce both the intention of MSM to engage in chemsex and their actual engagement in chemsex. | PMC9893729 | |
Trial Registration | ISRCTN Registry ISRCTN20134522; https://www.isrctn.com/ISRCTN20134522. | PMC9893729 | ||
International Registered Report Identifier (IRRID) | RR2-10.1186/s12889-021-10742-8 | PMC9893729 | ||
Introduction | sexual behaviors, MSM | STIS, HIV INFECTION, HEPATITIS C INFECTION | “Chemsex” is defined as the use of psychoactive substances before or during planned sex to facilitate, initiate, prolong, sustain, or intensify the sexual encounter [Empirical studies have reported that the practice of risky sexual behaviors is prevalent among MSM who engage in chemsex. A systematic review reported that the prevalence of condomless sex ranged from 17% to 100% among MSM who engaged in chemsex [MSM who engage in chemsex experience higher rates of HIV infection, other STIs, and hepatitis C infection than those who do not [Globally, “undetectable equals untransmittable (U=U)” and pre-exposure prophylaxis (PrEP) have become important elements in HIV prevention programs [In addition, even though PrEP is a very effective HIV prevention method [eHealth, health services and information delivered electronically through the internet (eg, through a website) [Although several systematic reviews have provided robust evidence about the effectiveness of eHealth interventions in improving sexual health among MSM [We hypothesized that the web-based intervention could increase participants’ self-efficacy in refusing risky sexual behaviors and chemsex, reduce both the intention to engage in chemsex and actual chemsex behaviors, enhance consistent condom use, and increase the uptake of HIV and STI testing. | PMC9893729 |
Methods | PMC9893729 | |||
Study Design | This study was a 2-arm, assessor-blinded, randomized, parallel-group trial with a 3-month follow-up period. The trial protocol has been published [ | PMC9893729 | ||
Study Participants and Setting | The study participants were enrolled using convenience sampling from June 15, 2021, to November 5, 2021. To ensure that we could recruit the required number of study participants from diverse backgrounds, potential participants were approached using social media (eg, Instagram). Local nongovernmental organizations that target MSM populations in Hong Kong also helped recruit potential participants based on their existing networks. Participants were eligible for inclusion in the trial if they self-identified as cis-male MSM aged ≥18 years with internet access and the ability to read and understand Chinese. | PMC9893729 | ||
Screening, Baseline Assessment, and Randomization | An online screening questionnaire was used to screen the study participants for eligibility. Eligible participants were asked to sign an electronic consent form and use their email addresses to register for the study. They also needed to set a personal password to gain access to the study intervention. After completing these steps, the participants were asked to complete an online baseline questionnaire. After completing the baseline questionnaire, participants were randomly assigned to either the intervention group or the control group via a computer-generated block randomization procedure (with a block size of 4 with no stratification) with a 1:1 randomization ratio. The computer-generated sequence was created by the independent programmer who developed the online platform. The online platform conducted masking and allocation concealment. All participants and research team members were blinded to the allocation sequence before the allocation. After randomization, the study participants were automatically guided to the web content associated with their allocation. | PMC9893729 | ||
Interventions | STIS | The intervention was divided into 2 parts. The first part involved an interactive component. Enrolled participants were first invited to complete 2 quizzes to review their level of understanding of chemsex. The quizzes assessed how much the participants knew about chemsex. Each quiz contained 10 multiple-choice questions. The 2 sets of quizzes differed in terms of the level of difficulty. Participants received their score after completing the quiz. In the second part, participants were given knowledge-based information about chemsex and its potential risks and legal consequences. The side effects of different chemsex substances were also covered. Additionally, the participants were presented with information about how they could protect themselves from contracting HIV and other STIs and regarding local resources for emotional support and HIV and STI testing.The contents of the intervention were developed based on the theory of planned behaviors [The control group was offered brief information and educational content about sexual violence, which was not relevant to the chemsex intervention component. There was no interactive component in the control group. The details of the intervention and control groups are shown in Study participants had unlimited access to their allocated content during the study period. However, the content was only available to participants with a registered email address and password to minimize contamination between the intervention and control groups. | PMC9893729 | |
Outcomes | sexual behaviors | SECONDARY | The primary outcome was self-efficacy in refusing risky sexual behaviors and chemsex. As there was no well-established study instrument to specifically assess this primary outcome, the traditional Chinese version of the Condom Self-Efficacy Scale (CSES) [The CSES is a 14-item instrument covering 3 domains: (1) consistent condom use, (2) correct condom use, and (3) condom use communication. The total score ranges from 14 to 70, with a higher score indicating a higher level of condom use efficacy [The secondary outcomes included (1) an intention to have chemsex in the last 3 months, (2) actual engagement in chemsex in the last 3 months, and (3) HIV and other STI testing in the last 3 months. We assessed and evaluated participants’ intentions to have chemsex in the last 3 months because we wanted to supplement the outcomes relating to their actual engagement in chemsex. It is known that people who intend to have chemsex do not necessarily eventually engage in chemsex. Therefore, their intentions to have chemsex in the past 3 months were assessed. For participants who engaged in chemsex in the last 3 months, data were collected on the (4) practice of condomless sex during non-chemsex in the last 3 months and (5) practice of condomless sex during chemsex in the last 3 months.All study outcomes were self-assessed at baseline and 3-month follow-up interviews through an online structured questionnaire. The online questionnaire was pilot tested. A trained research assistant would send reminders (via email or instant messaging) to the study participants to ask them to complete the follow-up interview. There was no change to trial outcomes after the study commenced. | PMC9893729 |
Sample Size | To detect a small-to-moderate between-group difference (Cohen d=0.4) in the primary outcome through an independent samples | PMC9893729 | ||
Statistical Analysis | Descriptive statistics were used to summarize the sociodemographic characteristics and study outcomes of the participants at each time point. Baseline characteristics and study outcomes (1) between the intervention and control groups and (2) between participants who completed the study and those who did not (dropouts) were compared using Fisher exact tests for categorical variables or an independent samples The intention-to-treat principle was applied. Linear mixed effects models were used to assess the differential change in continuous outcomes (ie, scores on the CSES, SESS, and DASES). Similarly, generalized linear mixed effects models with logit links were used to analyze the binary outcomes (ie, intention to have chemsex, actual engagement in chemsex, undergone HIV testing, undergone other STI testing, practice of condomless sex during non-chemsex, and practice of condomless sex during chemsex in the last 3 months). Time, group, and interaction between group and time were included as independent variables. Mixed effects models can accommodate missing data and do not require imputation of missing observations, providing a natural way to deal with missing values or dropouts. For the main analysis, no covariates were put in the models. To supplement the main analysis, complete case analysis was conducted. Statistical analysis was performed using SPSS version 25.0 (IBM Corp, Armonk, NY). All statistical tests were 2-tailed, with a 5% level of statistical significance. The data set and analyses were checked by 2 researchers. | PMC9893729 | ||
Ethics | WEST | The study was approved by the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB; reference number: UW 20-650). Electronic informed consent was obtained from each study participant. Study information such as aims, nature of the study, and brief overview of the content of the intervention were provided in the consent form. This trial followed the CONSORT-EHEALTH statement ( | PMC9893729 | |
Results | In total, 316 participants were enrolled and randomized into intervention (n=158) and control (n=158) groups. However, 41 participants (22 participants in the intervention group and 19 participants in the control group) did not complete the follow-up survey. The overall dropout rate was 13.0%, (41/316), and there was no significant difference in the dropout rate between the intervention group and control group. CONSORT flow diagram. | PMC9893729 | ||
Secondary Outcomes | Participants in the intervention group demonstrated significantly larger reductions in the likelihood to have engaged in chemsex in the last 3 months (time-by-group interaction: OR=0.23, 95% CI 0.10-0.53; | PMC9893729 | ||
Discussion | PMC9893729 | |||
Principal Findings | primary HIV prevention, sexual behaviors, MSM | In this randomized controlled trial, we found that a web-based intervention with a harm reduction approach could enhance the self-efficacy of MSM in refusing risky sexual behaviors and chemsex. The intervention enhanced HIV testing but had no effects on other STI testing. Importantly, we found that the intention of MSM to engage in chemsex and their actual engagement in chemsex can also be reduced by the intervention. However, it should be noted that, given the small sample size of participants who reported engaging in chemsex in the last 3 months during the follow-up interviews, the findings related to condom use might not be reliable and should be interpreted with caution. Nonetheless, the clinical significance and academic merits of the findings are substantial because this study has provided one of the very first pieces of evidence on the effectiveness of eHealth interventions in reducing the sexual harm of chemsex among MSM, which echoes the recent review by Strong and colleagues [The intervention in the current trial was developed through a harm reduction approach because most qualitative evidence suggests that many MSM prefer reducing the harm associated with drug use (eg, by learning how to better manage their use) instead of abstaining altogether [Compared with the control group, the intervention group demonstrated statistically significant effects on the primary outcomes with a small-to-moderate effect size (in Even though PrEP has provided a new means of harm reduction (ie, primary HIV prevention) in the context of chemsex [Another important benefit of the current study is that the intervention was found to reduce the participants’ intention to have chemsex and their actual engagement in chemsex. Given that chemsex tends to be hidden and private and that those who practice chemsex are difficult to reach [This study found no significant effect on other STI testing, implying that future interventions should strengthen the components intended to encourage MSM to undergo regular STI testing. Nonetheless, the negative result could be explained by the substantial reduction in the availability of sexual health services during the COVID-19 pandemic [ | PMC9893729 | |
Limitations | sexual behaviors | SECONDARY, RECRUITMENT | There are several limitations and implications for further studies. First, social media, such as Instagram, was used to recruit participants. An online screening survey and electronic consent forms were also used in this study. Participants who were not technology-savvy may thus have been excluded in the recruitment phase. Therefore, the study findings may not be applicable to those who are not technology-savvy and those with low eHealth literacy. Second, study participants were not blinded to group allocation. The study might be subject to performance bias, as participant knowledge of group allocation may have affected their behaviors. Third, we only evaluated participants’ intention to have chemsex in the last 3 months. Further studies should assess their intention to have chemsex in the future such as in the next 3 months. Fourth, the study outcomes were measured 3 months after the baseline, so the long-term sustainability of the intervention remains unknown. Trials with a longer follow-up period are needed to evaluate the sustained effect of eHealth interventions in enhancing the self-efficacy of MSM in refusing risky sexual behaviors and chemsex. Also, an analysis of the cost-effectiveness of eHealth interventions for chemsex should be considered. Fifth, we did not record information about the study participants’ engagement, such as the duration or frequency of their visits. These parameters should be recorded in the future to further investigate how study engagement impacts the effectiveness of interventions. Sixth, during the follow-up interviews, the number of people who had engaged in chemsex in the last 3 months was small (n=31), which might have affected the statistical power and precision of some of the secondary outcomes. Seventh, qualitative interviews should be conducted to obtain qualitative feedback from study participants in the future. Finally, similar trials should be developed and tested in other geographic areas to provide more empirical evidence to support the effectiveness of such interventions in enhancing the self-efficacy of MSM in refusing risky sexual behaviors and chemsex. | PMC9893729 |
Conclusion | AIDS, sexual behaviors | AIDS | This study suggests that a web-based intervention with a harm reduction approach can enhance the self-efficacy of MSM in refusing risky sexual behaviors and chemsex and improve HIV testing in the 3-month follow-up interview. We also provide initial evidence that such interventions can reduce both the intention of MSM to engage in chemsex and their actual engagement in chemsex.The study was sponsored by the Council for the AIDS Trust Fund (reference number: MSS 338 R).This HIV/AIDS prevention part of the project/program is sponsored by the AIDS Trust Fund. The content of this article represents the opinion of our organization only. It does not represent the position of the AIDS Trust Fund. The AIDS Trust Fund is not responsible for any claims, demands, or liabilities whatsoever arising from or in connection with the use of any information contained in this article or the participation of the sponsored project/program.EPFC is supported by an Australian National Health and Medical Research Council (NHMRC) Emerging Leadership Investigator Grants (GNT1172873) outside of the submitted work.Conflicts of Interest: None declared.Content of the intervention and control groups.CONSORT-EHEALTH checklist (V 1.6.1).Comparisons of baseline characteristics and study outcomes between non-dropout and dropout participants.Mixed effects models for comparison of subscale scores of the Condom Self-Efficacy Scale.Mixed effects models for comparison of study outcomes with the results of between-group difference at each time point.Mixed effects models for comparison of study outcomes with an adjustment of baseline characteristics.Complete case analysis for comparison of study outcomes (n=275). | PMC9893729 |
Abbreviations | Condom Self-Efficacy ScaleDrug Avoidance Self-Efficacy Scalemen who have sex with menNational Health and Medical Research Councilpre-exposure prophylaxisSelf-Efficacy for Sexual Safetysexually transmitted infectionundetectable equals untransmittable | PMC9893729 | ||
Data Availability | The content of the web-based intervention, data sets generated during or analyzed during the current study, and related syntax are available from the corresponding author on reasonable request. | PMC9893729 | ||
1 Introduction | Peer review is the backbone of academia. As a means of pre-publication verification of scientific works, it has been widely adopted by conferences and journals across many fields of science. In addition to being the cornerstone for the dissemination of completed research, peer review nowadays plays a crucial role in shaping the directions of future research: it is used by funding bodies around the world (including US agencies NSF and NIH, and European Research Council) to distribute multi-billion dollar budgets through grants and awards. Given the considerable impact the peer-review process has on the progression of science, it is crucial to ensure that the process is designed in a principled manner and does not result in unintended consequences such as bias or inefficiency [ | PMC10337975 | ||
1.1 Discussion stage in scientific peer review | BOIL | In many journals (e.g., Nature and PNAS) reviewers do not communicate with each other, and decisions are made by editors based on independent opinions of reviewers. In contrast, many conferences (which in computer science are considered to be a final destination for research and typically ranked higher than journals) and grant committees (e.g., NSF) implement an additional discussion stage that takes place after reviewers submit their initial independent reviews. The purpose of the discussion stage is to allow reviewers to exchange their opinions about the submission and correct each other’s misconceptions. As a result of the discussion, reviewers are supposed to reach a consensus on the submission or boil their disagreement down to concrete arguments that can later be evaluated by chairs of the selection committee.Given that independent opinions of reviewers often demonstrate a substantial amount of disagreement [Importantly, lack of reliability in peer-review discussions may have far-reaching consequences not just for a particular submission, but also for career trajectories of researchers due to the widespread prevalence of the Matthew effect (“rich get richer”) in academia [ | PMC10337975 | |
2 Methods | In this section, we outline the design of the experiment we conducted to investigate the research question of this paper. | PMC10337975 | ||
2.1 Setting of the experiment | The experiment was conducted in the peer-review process of ICML 2020—a flagship machine learning conference that receives thousands of paper submissions and manages a pool of thousands of reviewers. The ICML peer review is organized in a double-blind manner and, similar to most other top machine learning and artificial intelligence conferences, follows the timeline outlined in | PMC10337975 | ||
Timeline of the peer-review process of typical machine learning and artificial intelligence conferences. | Upon the release of initial reviews, authors of papers have several days to write a response to reviewers, followed by the discussion stage. Finally, program chairs aggregate the results of the review process into final decisions. The duration of each stage varies across conferences, and this figure corresponds to the ICML 2020 review process with the duration of each stage rounded to weeks.Given our focus on the discussion dynamics, we describe the discussion process of ICML 2020 in more detail. During the discussion, reviewers (typically three or four per paper) and area chairs (one per paper; the role of area chairs is equivalent to that of associate editors in journal peer review) have access to the author feedback and are able to asynchronously communicate with each other (but not with authors) via a special online interface. The discussion between reviewers is anonymous (i.e., reviewers do not see each other’s names), but area chairs know identities of reviewers and vice versa. For the papers assigned to them, each reviewer is expected to carefully read the author rebuttal as well as the reviews written by the other reviewers, and participate in the discussion. | PMC10337975 | ||
3 Results of the experiment | In this section, we present the results of the experiment. First, we empirically check whether our treatment scheme satisfies requirements formulated in Section 2. In that, we begin with some general statistics on the discussion process to check satisfaction of Requirement 2 (Section 3.1). We then discuss the efficacy of the intervention we employed (Section 3.2) and confirm that Requirement 1 is well-satisfied. Finally, we conclude with the analysis of the research question we study in this work (Section 3.3). For brevity, for any paper, we use | PMC10337975 | ||
3.1 Preliminary analysis (data to check for satisfaction of Requirement 2) | We begin with providing data-based evidence which lets us verify whether our treatment scheme satisfies Requirement 2, that is, does not introduce differences across | PMC10337975 | ||
Comparative statistics on the discussion process. | Table notes: Comparison of some discussion statistics between two groups of papers (Looking closer at the most relevant parameters, we first focus on Rows 2 and 4 of that compare mean overall scores (the overall score takes integer values from 1 to 6 where larger values indicate higher quality) given by reviewers in the initial reviews, that is, before reviewers got to see the other reviews and the author feedback. Interestingly, mean initial scores given by reviewers who participate in the discussion (Row 4) appear to be lower than mean scores computed over all reviewers (Row 2), suggesting that those who give lower scores are more active in discussing papers (see also Rows 8 and 9). However, there is no significant difference between two groups of papers (Next, the activity of reviewers with the most positive (respectively, negative) initial opinion in the discussion (Rows 8 and 9) is similar across the two groups of papers. This observation supports the intuition that our treatment scheme does not introduce a difference across conditions in the distributions of reviewers who participate in the discussion. Finally, we note that most of the papers used in the experiment had some discussion (Row 5). Specifically, we see that the mean number of participants in a paper’s discussion and the length of a paper’s discussion is similar across the two conditions, where we measure the length as the number of messages in a paper’s discussion thread (Rows 6 and 7). With this observation, we conclude this section and note that data reported in | PMC10337975 | ||
3.2 Efficacy of the intervention (data to check for satisfaction of Requirement 1) | In the previous section we confirmed that our intervention did not introduce a difference across conditions in metrics such as intensity of discussions and the population of participating reviewers. This observation suggests that our treatment scheme satisfied Requirement 2 and indicates the appropriateness of our intervention. However, in order for the experiment to have sufficient power to detect the effect, the intervention needs to satisfy Requirement 1 and introduce a difference across conditions in the order in which reviewers join the discussion of the papers. Indeed, if all the emails we sent to reviewers were ignored (i.e., our attempt to impact the order failed), the subsequent analysis will not detect the phenomena even when the phenomena is present.
| PMC10337975 | ||
Does the intervention affect who initiates the discussion?. | Table notes: The impact of the intervention on who initiates the discussion. To compute values for Row 1, we use 1,140 papers for which (i) the discussion was initiated, and (ii) the discussion initiator was a reviewer (and not the area chair). For the last two rows, we use all papers including those with no discussion. Bootstrapped confidence intervals are constructed for the difference of the relevant quantities between conditions. All | PMC10337975 | ||
3.3 Main causal analysis | Having confirmed that the intervention we implemented in the experiment reasonably satisfies the necessary requirements, we now continue to the analysis directly related to the research question we study in this work. Specifically, as we explained in the introduction and in Section 2, if herding behaviour exists, we expect it to manifest in the final decisions being disproportionately influenced by the opinion of the discussion initiator. Hence, given that for the positive group of papers To understand the effect of the experiment, we first note the observed mean final scores in different sets of reviewers corresponding to groups
First, the data does not indicate a statistically significant difference between acceptance rates in the two groups of papers (Second, the data on the score updates suggests that in their final evaluations, reviewers tend to converge to the mean of initial independent opinions irrespective of the treatment we applied to a paper. Indeed, Row 2 demonstrates that the initiators of discussions update the scores towards the mean of all initial scores. Next, Rows 3 and 4 show that a significant update made by the discussion initiators is compensated by the update made by other reviewers, such that the overall amount of change in the mean scores is negligible. As expected, the outlined dynamics result in a significant decrease in the variance of scores per paper, but the effect is the same for both groups of papers (Row 5). | PMC10337975 | ||
Does the intervention affect the outcome of the papers?. | Table notes: The impact of the intervention on the final outcome of papers. For Row 2, we use 1,140 papers for which (i) the discussion was initiated, and (ii) the discussion initiator was a reviewer (and not the area chair). For Row 4, we use papers with discussion. For all other rows, we use all papers including those with no discussion. Bootstrapped confidence intervals are constructed for the difference of the relevant quantities between conditions. The Overall, we find no evidence of herding in the discussion phase of ICML 2020 peer review. We provide supporting information about the analysis in | PMC10337975 | ||
4 Discussion | arbitrariness | Past work has documented an undue influence of the first piece of information on the final decision [In this work, we focused on the manifestation of herding effect in peer-review discussions. In future work, it is of interest to understand whether the separate cognitive biases attributed to herding behavior such as anchoring bias [Regarding policy implications, the absence of the effect suggests that the absence of a unified approach towards discussion management does not result in an increased arbitrariness of the resulting decisions. Thus, the question of identifying the source of the spurious agreement between peer reviewers observed in past works [Finally, we urge the reader to be aware of the caveats that we listed in | PMC10337975 | |
Supporting information | PMC10337975 | |||
Caveats regarding the design and analysis of the experiment [ | (PDF)Click here for additional data file. | PMC10337975 | ||
Additional details on the experiment. | Fig 2. Timeline of the experiment. Day X is the day of the official discussion opening.(PDF)Click here for additional data file. | PMC10337975 | ||
Additional analysis. | (PDF)Click here for additional data file. | PMC10337975 |
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