Tag: pubmed

JMIR Res Protoc. 2022 Dec 29;11(12):e42526. doi: 10.2196/42526.

ABSTRACT

BACKGROUND: Research suggests that the rapid increase in worldwide antidepressant use is mainly due to a rise in long-term and potentially inappropriate use. It has been suggested that 1 in 3 antidepressant users among general practice patients are no longer experiencing clinical benefits from their medication and should commence deprescribing. However there are many barriers to antidepressant deprescribing for both patients and clinicians, which adds to the complex nature of reducing or ceasing the medication. As such, antidepressant deprescribing does not routinely occur in clinical practice. Evidence-based supports and interventions for safe and successful antidepressant deprescribing are needed to assist patients and their doctors. Interventions should also include an understanding of how an intervention works, why it works, and whom it is for.

OBJECTIVE: This study aims to evaluate how the WiserAD approach to antidepressant deprescribing works, whom it is for, and the underlying circumstances by (1) examining the experiences and perceptions of WiserAD among antidepressant users, (2) identifying the underlying mechanisms of the WiserAD approach to antidepressant deprescribing, and (3) describing in what contexts and to what extent the underlying mechanisms of WiserAD are suited for antidepressant users.

METHODS: A mixed methods case study with realist evaluation will be conducted among participants in the WiserAD randomized controlled trial for antidepressant deprescribing. Quantitative data will be obtained from up to 12 participants from the intervention and control arms at baseline and 3-month follow-up. Baseline data will be used to characterize the sample using descriptive statistics. Paired samples t tests will also be performed to compare responses between baseline and 3-month follow-up for participant self-management, skills, confidence and knowledge, beliefs about medicines, current emotional health, and well-being symptoms. Qualitative data from the same participants will be collected via narrative interview at 3-month follow-up. Quantitative and qualitative data will be converged to form a “case,” and analysis will be conducted within each case with comparisons made across multiple cases.

RESULTS: Recruitment of participants commenced in October 2022 and will be completed by March 2023. Analysis will be completed by June 2023.

CONCLUSIONS: To our knowledge, this will be the first realist evaluation of an antidepressant deprescribing intervention in general practice. Findings from this evaluation may assist in the implementation of the WiserAD approach to antidepressant deprescribing in routine clinical practice.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/42526.

PMID:36580362 | DOI:10.2196/42526

JMIR Res Protoc. 2022 Dec 29;11(12):e39319. doi: 10.2196/39319.

ABSTRACT

BACKGROUND: The management of infected metaphyseal nonunion of the tibia is devastating, especially when associated with significant bone loss, poor soft tissues, draining sinuses, axial deformity, knee or ankle joint stiffness, limb discrepancy, and multiresisted pathogens. A systematic review, performed recently by the primary investigators but not yet published, yielded the lack of studies in the field and the huge heterogeneity of the presented results. We found several bias and controversies such as no clear definition of the exact part of the tibia where the nonunion was located, the pathogen causing the fracture-related infection, the number of previous interventions and time to presentation, and the exact type of treatment methods including the use of muscle flaps or bone grafting. Time to final union as a functional score is another important but missing data.

OBJECTIVE: The proposed study is designed to evaluate a sufficient number of patients with infected metaphyseal tibial nonunions using various general health, functional, and bone scores.

METHODS: This prospective clinical trial study, with a minimum follow-up period of 36 months, focuses on the effectiveness of the Ilizarov method after radical nonunion debridement and targeted antibiotic therapy in patients with infected metaphyseal tibial nonunions. The primary outcomes would be the definite healing of nonunion and infection-free results. Secondary outcomes would be limb alignment and discrepancy, alteration in the patient’s quality of life, and functional results. A power analysis calculated a minimum of 11 patients to obtain statistical power, but we aim to include at least 25 patients. Limb discrepancy, clinical validation of infection eradication and fracture healing, radiographic validation, and patient-reported outcome measures will be highlighted and correlated. Statistical analysis of the results will offer data missing from the literature so far. Measurements are scheduled at specific times for each patient: preoperatively, 3 and 6 months postoperatively, 1 month after Ilizarov frame removal, and once per semester afterward until the end of the follow-up period (minimum 36 months). Laboratory evaluation will be assessed once per month. Any complication will be reported and treated when it occurs.

RESULTS: The trial has already started. It was funded in June 2020. As of May 2022, 19 participants have been recruited and no major complications have been noticed yet. Data analysis will be performed after data collection ends, and results will be published afterward.

CONCLUSIONS: An infected metaphyseal tibial nonunion is a rare condition with limited treatment options and many controversies. There is no consensus in the literature about the best treatment strategy, and this lack of evidence should be fulfilled.

TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 30905788; https://www.isrctn.com/ISRCTN30905788.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39319.

PMID:36580353 | DOI:10.2196/39319

JAMA Netw Open. 2022 Dec 1;5(12):e2248817. doi: 10.1001/jamanetworkopen.2022.48817.

ABSTRACT

IMPORTANCE: Acupuncture is a promising therapy for irritable bowel syndrome (IBS), but the use of subjective scales as an assessment is accompanied by high placebo response rates.

OBJECTIVES: To preliminarily test the feasibility of using US Food and Drug Administration (FDA)-recommended end points to evaluate the efficacy of acupuncture in the treatment of IBS.

DESIGN, SETTING, AND PARTICIPANTS: This pilot, multicenter randomized clinical trial was conducted in 4 tertiary hospitals in China from July 1, 2020, to March 31, 2021, and 14-week data collection was completed in March 2021. Individuals with a diagnosis of IBS with diarrhea (IBS-D) were randomized to 1 of 3 groups, including 2 acupuncture groups (specific acupoints [SA] and nonspecific acupoints [NSA]) and a sham acupuncture group (non-acupoints [NA]) with a 1:1:1 ratio.

INTERVENTIONS: Patients in all groups received twelve 30-minute sessions over 4 consecutive weeks at 3 sessions per week (ideally every other day).

MAIN OUTCOMES AND MEASURES: The primary outcome was the response rate at week 4, which was defined as the proportion of patients whose worst abdominal pain score (score range, 0-10, with 0 indicating no pain and 10 indicating unbearable severe pain) decreased by at least 30% and the number of type 6 or 7 stool days decreased by 50% or greater.

RESULTS: Ninety patients (54 male [60.0%]; mean [SD] age, 34.5 [11.3] years) were enrolled, with 30 patients in each group. There were substantial improvements in the primary outcomes for all groups (composite response rates of 46.7% [95% CI, 28.8%-65.4%] in the SA group, 46.7% [95% CI, 28.8%-65.4%] in the NSA group, and 26.7% [95% CI, 13.0%-46.2%] in the NA group), although the difference between them was not statistically significant (P = .18). The response rates of adequate relief at week 4 were 64.3% (95% CI, 44.1%-80.7%) in the SA group, 62.1% (95% CI, 42.4%-78.7%) in the NSA group, and 55.2% (95% CI, 36.0%-73.0%) in the NA group (P = .76). Adverse events were reported in 2 patients (6.7%) in the SA group and 3 patients (10%) in NSA or NA group.

CONCLUSIONS AND RELEVANCE: In this pilot randomized clinical trial, acupuncture in both the SA and NSA groups showed clinically meaningful improvement in IBS-D symptoms, although there were no significant differences among the 3 groups. These findings suggest that acupuncture is feasible and safe; a larger, sufficiently powered trial is needed to accurately assess efficacy.

TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2000030670.

PMID:36580333 | DOI:10.1001/jamanetworkopen.2022.48817

JAMA Netw Open. 2022 Dec 1;5(12):e2248836. doi: 10.1001/jamanetworkopen.2022.48836.

ABSTRACT

IMPORTANCE: Approximately 1 in 4 women experience intimate partner violence (IPV) or nonpartner sexual violence during their lifetime. Mothers exposed to IPV are more likely to experience depressive symptoms and to discipline their children harshly, which may affect their children’s socioemotional development; however, there is limited evidence on these outcomes.

OBJECTIVE: To examine the association between IPV, maternal depressive symptoms, harsh child discipline, and child stimulation with child socioemotional development.

DESIGN, SETTING, AND PARTICIPANTS: This study used cross-sectional follow-up data collected from February 19 to October 10, 2014, from a birth cohort of children aged 18 to 36 months who were enrolled in a randomized, double-blind, placebo-controlled trial of neonatal vitamin A supplementation in the Morogoro region of Tanzania. Data analysis occurred between September 10, 2019, and January 20, 2020.

EXPOSURES: Lifetime experience of IPV was assessed using an abbreviated module of the Tanzania Demographic and Health Survey, maternal depressive symptoms were assessed with the Patient Health Questionnaire, and data on harsh child discipline and maternal stimulation of their children were collected using modules of the United Nations Children’s Fund Multiple Indicator Cluster Survey.

MAIN OUTCOMES AND MEASURES: Child socioemotional development was measured by the Caregiver-Reported Early Childhood Development Instruments.

RESULTS: A total of 981 mother-child dyads were included in the analytic sample; 388 children (39.6%) were between ages 18 and 24 (mean [SD] age, 27.06 [6.08]) months, and 515 (52.5%) were male children. A negative association was observed between maternal report of physical IPV only (mean difference, -0.022; 95% CI, -0.045 to -0.006) and physical and sexual IPV (mean difference, -0.045; 95% CI, -0.077 to -0.013) with child socioemotional scores, but neither was statistically significant after including depressive symptoms in the model, which is consistent with mediation. Furthermore, a negative association was observed between maternal mild to severe depressive symptoms and child socioemotional development, including adjustment for IPV (mean difference, -0.073; 95% CI, -0.103 to -0.043). Harsh disciplinary practices and stimulation were not associated with child socioemotional development after adjusting for IPV, maternal depressive symptoms, and other factors.

CONCLUSIONS AND RELEVANCE: The findings of this study suggest that maternal depressive symptoms may explain the negative association between IPV and child socioemotional development.

PMID:36580331 | DOI:10.1001/jamanetworkopen.2022.48836

JAMA Netw Open. 2022 Dec 1;5(12):e2248972. doi: 10.1001/jamanetworkopen.2022.48972.

ABSTRACT

IMPORTANCE: Lockdown measures and the stress of the COVID-19 pandemic are factors associated with increased risk of violence, yet there is limited information on trends in emergency department (ED) encounters for sexual assault.

OBJECTIVE: To compare changes in ED encounters for sexual assault during the COVID-19 pandemic vs prepandemic estimates.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective, population-based cohort study used linked health administrative data from 197 EDs across Ontario, Canada, representing more than 15 million residents. Participants included all patients who presented to an ED in Ontario from January 11, 2019, to September 10, 2021. Male and female individuals of all ages were included. Data analysis was performed from March to October 2022.

EXPOSURES: Sexual assault, defined through 27 International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, procedure and diagnoses codes.

MAIN OUTCOMES AND MEASURES: Ten bimonthly time periods were used to compare differences in the frequency and rates of ED encounters for sexual assault between 2020 to 2021 (during the pandemic) compared with baseline prepandemic rates in 2019. Rate differences (RDs) and age adjusted rate ratios (aRRs) and Wald 95% CIs were calculated using Poisson regression.

RESULTS: From January 11, 2019, to September 10, 2021, there were 14 476 656 ED encounters, including 10 523 for sexual assault (9304 [88.4%] among female individuals). The median (IQR) age was 23 (17-33) years for female individuals and 15 (4-29) years for male individuals. Two months before the pandemic, ED encounters increased for sexual assault among female individuals (8.4 vs 6.9 cases per 100 000; RD, 1.51 [95% CI, 1.06 to 1.96]; aRR, 1.22 [95% CI, 1.09 to 1.38]) and male individuals (1.2 vs 1.0 cases per 100 000; RD, 0.19 [95% CI, 0.05 to 0.36]; aRR, 1.19 [95% CI, 0.87 to 1.64]). During the first 2 months of the pandemic, the rates decreased for female individuals (4.2 vs 8.3 cases per 100 000; RD, -4.07 [95% CI, -4.48 to -3.67]; aRR, 0.51 [95% CI, 0.44 to 0.58]) and male individuals (0.5 vs 1.2 cases per 100 000; RD, -0.72 [95% CI, -0.86 to -0.57]; aRR, 0.39 [95% CI, 0.26 to 0.58]). For the remainder of the study period, the rates of sexual assault oscillated, returning to prepandemic levels during the summer months and between COVID-19 waves.

CONCLUSIONS AND RELEVANCE: These findings suggest that lockdown protocols should evaluate the impact of limited care for sexual assault. Survivors should still present to EDs, especially when clinical care or legal interventions are needed.

PMID:36580330 | DOI:10.1001/jamanetworkopen.2022.48972

JAMA Netw Open. 2022 Dec 1;5(12):e2249342. doi: 10.1001/jamanetworkopen.2022.49342.

ABSTRACT

IMPORTANCE: The Conséquences de la pandémie de COVID-19 sur la santé mentale des étudiants (COSAMe) survey was conducted among university students in France during the COVID-19 pandemic and found that although there was a slight decrease in anxiety, depression, and stress between the first lockdown (T1) and 1 month after it ended (T2), the prevalence of suicidal ideation had increased between these periods and 1 in 5 students had probable posttraumatic stress disorder (PTSD) at T2. These results emphasize the need to explore the long-term consequences of the COVID-19 pandemic.

OBJECTIVES: To measure the prevalence of mental health symptoms among university students in France 15 months after the first lockdown (T3) and to identify factors associated with outcomes.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study reports data from the third measurement time of the repeated COSAMe survey, which took place from July 21 to August 31, 2021, through an online questionnaire sent to all French university students.

MAIN OUTCOMES AND MEASURES: The prevalence of suicidal thoughts, PTSD (PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders [Fifth Edition] [PCL-5]), stress (Perceived Stress Scale), anxiety (State-Trait Anxiety Inventory), and depression (Beck Depression Inventory) at T3 were gender- and degree-standardized and compared with prevalence rates at T1 and T2. Multivariable logistic regression analyses identified risk factors.

RESULTS: A total of 44 898 students completed the questionnaires. They were mainly women (31 728 [70.7%]), and the median (IQR) age was 19 (18-21) years. Standardized prevalence rates of stress, anxiety, depression, suicidal thoughts, and PTSD were 20.6% (95% CI, 20.2%-21.0%), 23.7% (95% CI, 23.3%-24.1%), 15.4% (95% CI, 15.1%-15.8%), 13.8% (95% CI, 13.5%-14.2%), and 29.8% (95% CI, 29.4%-30.2%), respectively. Compared with the decreased prevalence rates at T2, there was an increase at T3 for stress (2.5% increase), anxiety (13.9% increase), and depression (22.2% increase). The prevalence of suicidal ideation continued to increase from T1 (10.6%) to T3 (13.8%), and the prevalence of probable PTSD increased from 1 in 5 students to 1 in 3 students between T2 and T3. Female and nonbinary participants; participants without children and living in an urban area; and those with financial difficulties, a chronic condition, psychiatric history, COVID-19 history, social isolation, and low perceived quality of information received were at risk of all poor outcomes at T3 (eg, stress among women: adjusted OR, 2.18; 95% CI, 2.05-2.31; suicidal thoughts among nonbinary respondents: adjusted OR, 5.09; 95% CI, 4.32-5.99; anxiety among students with children: adjusted OR, 0.68; 95% CI, 0.56-0.81; depression among students living in a rural area: adjusted OR, 0.80; 95% CI, 0.75-0.85).

CONCLUSIONS AND RELEVANCE: These results suggest severe long-lasting consequences associated with the pandemic on the mental health of students. Prevention and care access should be a priority.

PMID:36580328 | DOI:10.1001/jamanetworkopen.2022.49342

JAMA Otolaryngol Head Neck Surg. 2022 Dec 29. doi: 10.1001/jamaoto.2022.4112. Online ahead of print.

ABSTRACT

IMPORTANCE: The number of olfactory dysfunction cases has increased dramatically because of the COVID-19 pandemic. Identifying therapies that aid and accelerate recovery is essential.

OBJECTIVE: To determine the efficacy of bimodal visual-olfactory training and patient-preferred scents vs unimodal olfactory training and physician-assigned scents in COVID-19 olfactory loss.

DESIGN, SETTING, AND PARTICIPANTS: This was a randomized, single-blinded trial with a 2-by-2 factorial design (bimodal, patient preferred; unimodal, physician assigned; bimodal, physician assigned; unimodal, patient preferred) and an independent control group. Enrollment occurred from February 1 to May 27, 2021. Participants were adults 18 to 71 years old with current olfactory loss defined as University of Pennsylvania Smell Identification Test (UPSIT) score less than 34 for men and less than 35 for women and duration of 3 months or longer. Olfactory loss was initially diagnosed within 2 weeks of COVID-19 infection.

INTERVENTIONS: Participants sniffed 4 essential oils for 15 seconds with a 30-second rest in between odors for 3 months. Participants in the physician-assigned odor arms trained with rose, lemon, eucalyptus, and clove. Participants randomized to the patient-preferred arms chose 4 of 24 available scents. If assigned to the bimodal arm, participants were shown digital images of the essential oil they were smelling.

MAIN OUTCOMES AND MEASURES: The primary end point was postintervention change in UPSIT score from baseline; measures used were the UPSIT (validated, objective psychometric test of olfaction), Clinical Global Impressions Impression-Improvement (CGI-I; self-report improvement scale), and Olfactory Dysfunction Outcomes Rating (ODOR; olfaction-related quality-of-life questionnaire).

RESULTS: Among the 275 enrolled participants, the mean (SD) age was 41 (12) years, and 236 (86%) were female. The change in UPSIT scores preintervention to postintervention was similar between the study arms. The marginal mean difference for change in UPSIT scores preintervention to postintervention between participants randomized to patient-preferred vs physician-assigned olfactory training was 0.73 (95% CI, -1.10 to 2.56), and between participants randomized to bimodal vs unimodal olfactory training was 1.10 (95% CI, -2.92 to 0.74). Five (24%) participants in the control arm had clinically important improvement on UPSIT compared with 18 (53%) in the bimodal, patient-preferred arm for a difference of 29% (95% CI, 4%-54%). Four (19%) participants in the control group self-reported improvement on CGI-I compared with 12 (35%) in the bimodal, patient-preferred arm for a difference of 16% (95% CI, -7% to 39%). The mean change in ODOR score preintervention to postintervention was 11.6 points (95% CI, 9.2-13.9), which was not deemed clinically important nor significantly different between arms.

CONCLUSIONS AND RELEVANCE: Based on the change in UPSIT scores, this randomized clinical trial did not show any difference between intervention arms, but when exploring within-patient change in UPSIT as well as self-reported impression of improvement, active interventions were associated with larger improvement than controls with a potential advantage of bimodal intervention. While not definitive, these results suggest that patients with COVID-19 olfactory loss may benefit from bimodal visual-olfactory training with patient-preferred scents.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04710394.

PMID:36580304 | DOI:10.1001/jamaoto.2022.4112

Circ Genom Precis Med. 2022 Dec 29:e003542. doi: 10.1161/CIRCGEN.121.003542. Online ahead of print.

ABSTRACT

BACKGROUND: The 10-year Atherosclerotic Cardiovascular Disease risk score is the standard approach to predict risk of incident cardiovascular events, and recently, addition of coronary artery disease (CAD) polygenic scores has been evaluated. Although age and sex strongly predict the risk of CAD, their interaction with genetic risk prediction has not been systematically examined. This study performed an extensive evaluation of age and sex effects in genetic CAD risk prediction.

METHODS: The population-based Norwegian HUNT2 (Trøndelag Health Study 2) cohort of 51 036 individuals was used as the primary dataset. Findings were replicated in the UK Biobank (372 410 individuals). Models for 10-year CAD risk were fitted using Cox proportional hazards, and Harrell concordance index, sensitivity, and specificity were compared.

RESULTS: Inclusion of age and sex interactions of CAD polygenic score to the prediction models increased the C-index and sensitivity by accounting for nonadditive effects of CAD polygenic score and likely countering the observed survival bias in the baseline. The sensitivity for females was lower than males in all models including genetic information. We identified a total of 82.6% of incident CAD cases by using a 2-step approach: (1) Atherosclerotic Cardiovascular Disease risk score (74.1%) and (2) the CAD polygenic score interaction model for those in low clinical risk (additional 8.5%).

CONCLUSIONS: These findings highlight the importance and complexity of genetic risk in predicting CAD. There is a need for modeling age- and sex-interaction terms with polygenic scores to optimize detection of individuals at high risk, those who warrant preventive interventions. Sex-specific studies are needed to understand and estimate CAD risk with genetic information.

PMID:36580301 | DOI:10.1161/CIRCGEN.121.003542

J Vis. 2022 Dec 1;22(13):8. doi: 10.1167/jov.22.13.8.

ABSTRACT

Reliability-weighted averaging of multiple perceptual estimates (or cues) can improve precision. Research suggests that newly learned statistical associations can be rapidly integrated in this way for efficient decision-making. Yet, it remains unclear if the integration of newly learned statistics into decision-making can directly influence perception, rather than taking place only at the decision stage. In two experiments, we implicitly taught observers novel associations between shape and color. Observers made color matches by adjusting the color of an oval to match a simultaneously presented reference. As the color of the oval changed across trials, so did its shape according to a novel mapping of axis ratio to color. Observers showed signatures of reliability-weighted averaging-a precision improvement in both experiments and reweighting of the newly learned shape cue with changes in uncertainty in Experiment 2. To ask whether this was accompanied by perceptual effects, Experiment 1 tested for forced fusion by measuring color discrimination thresholds with and without incongruent novel cues. Experiment 2 tested for a memory color effect, observers adjusting the color of ovals with different axis ratios until they appeared gray. There was no evidence for forced fusion and the opposite of a memory color effect. Overall, our results suggest that the ability to quickly learn novel cues and integrate them with familiar cues is not immediately (within the short duration of our experiments and in the domain of color and shape) accompanied by common perceptual effects.

PMID:36580296 | DOI:10.1167/jov.22.13.8

Musculoskelet Surg. 2022 Dec 29. doi: 10.1007/s12306-022-00770-x. Online ahead of print.

ABSTRACT

In 1983, Fulkerson introduced a technique of tibial tubercle osteotomy performed according to an inclined plane with respect to frontal plane. Due to obliquity of the osteotomy plane, this procedure allows both anterior and medial transfer of the tibial tubercle. The purpose of the study was to investigate the influence of the different degrees of the oblique plane of osteotomy on anterior displacement and the contact surface area of tibial tubercle. Synthetic bones were used for the study. An osteotomy of the tibial tubercle (TT) was performed in each specimen. Specifically, 3 different degrees of osteotomy planes relative to the reference frontal plane were examined: 20°, 30° and 40°. On each sample, tibial tubercle medial transposition of 5 mm, 10 mm and 15 mm was performed. Anterior displacement was measured with a caliper. Further, the bone contact surface was calculated for each sample and each transposition. Finally, the measured data were statistically compared with a geometric model. At 5 mm of medial TT transposition, the anterior displacement (AD) was 0.1 mm when the osteotomy was performed at 20°. It increased of 1.5 mm and 2.7 mm, respectively at 30° and 40°. At 15 mm of TT transposition, the AD was 3.4 mm at 20°, 7.6 mm at 30° and 10.0 mm at 40°. Concerning the amount of medialization, it was observed a decrease in the overall contact surface passing from 5 to 15 mm of TT transposition. In addition, regarding the oblique plane of the osteotomy, it was observed an increase in the contact surface area passing from 20° to 40°. The main result of the present study is that the amount of anteriorization and medialization of the tibial tubercle could be predicted by the degrees of oblique plane of osteotomy. An increase in medialization significantly reduces the contact surface area at low degrees of osteotomy plane, potentially increasing the risk of non-union.

PMID:36580268 | DOI:10.1007/s12306-022-00770-x