Controlled Intervention Trial Research Articles

Identifying and Categorizing Adverse Events in Trials of Digital Mental Health Interventions: Narrative Scoping Review of Trials in the International Standard Randomized Controlled Trial Number Registry.

To contextualize the benefits of an intervention, it is important that adverse events (AEs) are reported. This is potentially difficult in trials of digital mental health interventions, where delivery may be remote and the mechanisms of actions less understood. We aimed to explore the reporting of AEs in randomized controlled trials of digital mental health interventions. The International Standard Randomized Controlled Trial Number database was searched for trials registered before May 2022. Using advanced search filters, we identified 2546 trials in the category of mental and behavioral disorders. These trials were independently reviewed by 2 researchers against the eligibility criteria. Trials were included where digital mental health interventions for participants with a mental health disorder were evaluated through a completed randomized controlled trial (protocol and primary results publication published). Published protocols and primary results publications were then retrieved. Data were extracted independently by 3 researchers, with discussion to reach consensus when required. Twenty-three trials met the eligibility criteria, of which 16 (69%) included a statement on AEs within a publication, but only 6 (26%) reported AEs within their primary results publication. Seriousness was referred to by 6 trials, relatedness by 4, and expectedness by 2. More interventions delivered with human support (9/11, 82%) than those with only remote or no support (6/12, 50%) included a statement on AEs, but they did not report more AEs. Several reasons for participant dropout were identified by trials that did not report AEs, of which some were identifiable or related to AEs, including serious AEs. There is significant variation in the reporting of AEs in trials of digital mental health interventions. This variation may reflect limited reporting processes and difficulty recognizing AEs related to digital mental health interventions. There is a need to develop guidelines specifically for these trials to improve future reporting.

A randomised controlled trial of volitional and motivational interventions to improve cervical cancer screening uptake

Objective.Cervical cancer is the fourth most common cancer to occur in women worldwide. In the UK, the NHS cervical screening programme invites eligible individuals to take part in screening every 3–5 years. At present, around 70% of individuals attend screening when invited. The present study aimed to test the effectiveness of a volitional and a motivational intervention alone and in combination on screening uptake at 16-week follow up.Methods.14,536 participants were recruited from the list of eligible participants invited for screening in Yorkshire, Humber and the North East regions of England in December 2021. They were randomised to a social norm-based motivational intervention (SNA); implementation intention-based Volitional Help Sheet (VHS); combined intervention (SNA + VHS); or treatment as usual control. The primary outcome was screening uptake measured via patient screening records at 16 weeks.Results.Of the 14,466 participants with eligible data for analysis, 5793 (40.0%) attended for cervical cancer screening in the 16 weeks after the intervention mailing. Both age and deprivation influenced screening uptake, with lower uptake in the youngest individuals and those from more deprived areas. Compared to control, there was no evidence of any benefit from the VHS implementation intervention alone (Adj.OR = 0.99, 95% CI 0.90 to 1.10), the SNA motivational intervention alone (Adj.OR = 0.89; 95% CI: 0.80 to 0.99), or the combined intervention (Adj.OR = 0.96, 95% CI 0.86 to 1.06).Conclusion.The study did not support any benefit of either VHS or SNA interventions alone or in combination on cervical cancer screening uptake. It did demonstrate alarmingly low levels of screening uptake at 16 weeks which were well below the average rate. Future research needs to urgently investigate and understand the barriers to uptake following on from the COVID-19 pandemic.

Perceptions of prognosis and end-of-life care outcomes in patients with advanced lung and gastrointestinal cancer

Background: Many patients with advanced cancer have misperceptions of their prognosis, which may impact end-of-life decision-making. Data regarding associations between prognostic perceptions over time and end-of-life care outcomes are lacking. Aim: To describe patients’ perceptions of their prognosis with advanced cancer and examine associations between these perceptions and end-of-life care outcomes. Design: Secondary analysis of longitudinal data from a randomized controlled trial of a palliative care intervention for patients with newly diagnosed incurable cancer. Setting/Participants: Conducted at an outpatient cancer center in the northeastern United States and patients were within 8 weeks of a diagnosis with incurable lung or non-colorectal gastrointestinal cancer. Results: We enrolled 350 patients in the parent trial, of which 80.5% (281/350) died during the study period. Overall, 59.4% (164/276) of patients reported they were terminally ill, and 66.1% (154/233) reported that their cancer was likely curable at the assessment closest to death. Patient acknowledgment of terminal illness was only associated with lower risk of hospitalizations in the last 30 days of life (OR = 0.52, p = 0.025). Patients who reported their cancer as likely curable were less likely to utilize hospice (OR = 0.25, p = 0.002) or die at home (OR = 0.56, p = 0.043), and they were more likely to be hospitalized in the last 30 days of life (OR = 2.28, p = 0.011). Conclusions: Patients’ perceptions of their prognosis are associated with important end-of-life care outcomes. Interventions are needed to enhance patients’ perceptions of their prognosis and optimize their end-of-life care.

Protocol for a systematic review of reporting standards of lower limb endovascular interventions in peripheral arterial disease

IntroductionTechniques and devices for the endovascular treatment of peripheral arterial disease (PAD) are continuously evolving. High-quality clinical trials limit the variation in how endovascular interventions are described, performed and reported.The aim of this systematic review is to assess the quality of reporting standards in randomised controlled trials (RCTs) of endovascular lower limb interventions against the Consolidated Standards of Reporting Trials for Non-Pharmacologic Treatments (CONSORT-NPT) and template for intervention description and replication (TIDieR) framework.MethodsRandomised trials including participants with peripheral arterial disease undergoing any infra-inguinal lower limb endovascular arterial intervention, searched from Medline, Embase and Cochrane Library databases from inception to December 2021, will be included. All study data, including details of the procedure investigated, will be extracted in keeping with the CONSORT-NPT and TIDieR checklist. Descriptive statistics will be used to summarise general study details and reporting standards of the trials.DiscussionThe results will be used to inform the design of future RCTs in this area by optimising the way the interventions are described, standardised, and monitored. The systematic review will be disseminated via peer-reviewed manuscripts and presentations at relevant conferences.Systematic review registrationPROSPERO CRD42022288214

Fruit and vegetable consumption as a preventative strategy for non-communicable diseases.

A high intake of fruit and vegetables (FV) has consistently been associated with a reduced risk of a number of non-communicable diseases. This evidence base is largely from prospective cohort studies, with meta-analyses demonstrating an association between increased FV intake and reduced risk of both CHD and stroke, although the evidence is less certain for cancer and diabetes. Controlled intervention trials examining either clinical or intermediate risk factor endpoints are more scarce. Therefore, evidence that FV consumption reduces the risk of disease is so far largely confined to observational epidemiology, which is hampered by some methodological uncertainties. Although increased FV intake is promoted across all dietary guidelines, national surveys confirm that dietary intakes are suboptimal and are not increasing over time. A range of barriers to increasing FV intake exist, including economic, physical and behavioural barriers that must be considered when exploring potential opportunities to change this, considering the feasibility of different approaches to encourage increased FV consumption. Such interventions must include consideration of context, for example, challenges and uncertainties which exist with the whole food system.

User Experiences in a Digital Intervention to Support Total Skin Self-examination by Melanoma Survivors: Nested Qualitative Evaluation Embedded in a Randomized Controlled Trial.

Melanoma is a relatively common cancer type with a high survival rate, but survivors risk recurrences or second primaries. Consequently, patients receive regular hospital follow-up, but this can be burdensome to attend and not optimally timed to detect arising problems. Total skin self-examination (TSSE) supports improved clinical outcomes from melanoma via earlier detection of recurrences and second primaries, and digital technology has the potential to support TSSE. Recent research with app-based interventions aimed at improving the well-being of older adults has found that they can use the technology and benefit from it, supporting the use of digital health care in diverse demographic groups. Thus, the Achieving Self-directed Integrated Cancer Aftercare (ASICA) digital health care intervention was developed. The intervention provided melanoma survivors with a monthly prompt to perform a TSSE as well as access to a dermatology nurse who provided them with feedback on photographs and descriptions of their skin. We aimed to explore participants' attitudes, beliefs, and experiences regarding TSSE practices. Furthermore, we explored how participants experienced technology and how it influenced their practice of TSSE. Finally, we explored the practical and technical experiences of ASICA users. This was a nested qualitative evaluation within a dual-center randomized controlled trial of the ASICA intervention. We conducted semistructured telephone interviews with the participants during a randomized controlled trial. The participants were purposively sampled to achieve a representative sample with representative proportions by age, sex, and residential geography. Interviews were transcribed verbatim and analyzed using a framework analysis approach applied within NVivo 12. A total of 22 interviews were conducted with participants from both groups. In total, 40% (9/22) of the interviewed participants were from rural areas, and 60% (13/22) were from urban areas; 60% (13/22) were from the intervention group, and 40% (9/22) were from the control group. Themes evolved around skin-checking behavior, other people's input into skin checking, contribution of health care professionals outside ASICA and its value, ideas around technology, practical experiences, and potential improvements. ASICA appeared to change participants' perceptions of skin checking. Users were more likely to report routinely performing TSSE thoroughly. There was some variation in beliefs about skin checking and using technology for health care. Overall, ASICA was experienced positively by participants. Several practical suggestions were made for the improvement of ASICA. The ASICA intervention appeared to have positively influenced the attitudes and TSSE practices of melanoma survivors. This study provides important qualitative information about how a digital health care intervention is an effective means of prompting, recording, and responding to structured TSSE by melanoma survivors. Technical improvements are required, but the app offers promise for technologically enhanced melanoma follow-up in future. ClinicalTrials.gov NCT03328247; https://clinicaltrials.gov/ct2/show/NCT03328247?term=ASICA&rank=1. RR2-10.1186/s13063-019-3453-x.

Quality of life among colorectal cancer survivors participating in a pilot randomized controlled trial of a web-based dietary intervention with text messages

PurposeWe aimed to estimate the effect of a 12-week web-based dietary intervention with text messages on quality of life (QoL) among colorectal cancer (CRC) survivors.MethodsBetween 2017 and 2018, 50 CRC survivors were randomized (1:1) to receive a 12-week web-based dietary intervention with daily text messages or wait-list control. Health-related QoL was assessed using the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Core 30 (QLQ-C30) and colorectal quality of life module (QLQ-CR29) at baseline, 12, and 24 weeks. Within- and between-group mean changes in health-related QoL with 95% confidence intervals (CI) were calculated for both arms.ResultsCompared to the controls, participants receiving the intervention had an improvement in emotional functioning (mean change: 14.3; 95% CI: 3.0, 25.6) at 12 weeks and social functioning (mean change: 13.8; 95% CI: 2.1, 25.5) at 24 weeks. A decrease of fatigue from baseline was also observed in the intervention arm (mean change: − 9.1; 95% CI: − 17.1, − 1.1) at 24 weeks. No other changes in QoL scores were associated with the intervention.ConclusionCRC survivors randomized to receive a web-based dietary intervention with text messages experienced higher emotional and social functioning. Further study with a larger population may be warranted.Trial registrationclinicaltrials.gov, NCT02965521. Registered 16 November 2016, https://clinicaltrials.gov/ct2/keydates/NCT02965521

Project MOVE: A randomized controlled trial of interventions for initiating and maintaining physical activity in depressed individuals

ObjectiveTo test interventions for increasing aerobic exercise in depressed individuals. MethodsWe conducted a 3-arm randomized controlled trial aimed at increasing minutes of moderate-to-vigorous physical activity (MVPA) in depressed adults (N = 242). Each successive arm included an added component that might serve to increase and maintain physical activity. Arms were: 1) Brief advice (BA) to aerobic exercise; 2) BA + supervised and home-based aerobic exercise (SHE) + health education (HE); and 3) BA + SHE + cognitive-behavioral sessions focused on increasing and maintaining aerobic exercise (CBEX). HE was intended to serve as a control for CBEX. Assessments were conducted at baseline, Month 1.5, end of intervention (Month 3), Month 6, and Month 9. The primary outcome of MVPA was assessed via accelerometry. Secondary outcomes included self-reported MVPA, depression severity, and other aspects of mood and affect. ResultsAt 3 months (the pre-designated primary outcome timepoint), the simple effect of treatment was statistically significant (F2, 569.0 = 4.17, p = .016), with BA + SHE + CBEX being superior to BA. We did not observe differences between BA + SHE + HE and either of the other arms. There were no statistically significant differences between treatment groups at 6- or 9-months. Treatment effects were not statistically significant for secondary outcomes. ConclusionsSupervised and home-based exercise, when combined with a cognitive-behavioral exercise intervention, is effective in increasing aerobic exercise in depressed adults in the short-term, although the impact diminishes post-intervention period. Trial registrationclinicaltrials.gov NCT02691845.

A blended face-to-face and smartphone intervention to improve suicide prevention literacy and help-seeking intentions among construction workers: a randomised controlled trial

PurposeIn Australia and elsewhere, suicide rates among construction workers remain high. Construction workplaces are thus an important setting for targeted suicide prevention programs. This study aimed to compare suicide prevention literacy and help-seeking intentions among participants receiving face-to-face suicide prevention training, with those receiving face-to-face training augmented by a smartphone application.MethodsA two-arm randomised controlled trial of a smartphone suicide prevention intervention was conducted among construction workers in four Australian states (trial registration number: ACTRN12619000625178). All participants received face-to-face training and were randomised to the control condition (face-to-face only, n = 575), or MATESmobile condition (face-to-face + smartphone application,n = 509). Surveys administered at baseline and 3-month follow-up measured suicide prevention literacy and help-seeking intentions for personal/emotional problems and suicidal thoughts. A mixed-model repeated measures (MMRM) analysis included all 1084 randomised participants.ResultsOutcomes did not differ significantly for suicide prevention literacy, nor help-seeking intentions from formal sources, informal sources outside the workplace, or no one (did not intend to seek help from anyone). However, relative to those in the control condition, those in the MATESmobile group showed greater increase in help-seeking intentions for emotional problems from a MATES worker/Connector (mean difference 0.54, 95% CI 0.22–0.87) and help-seeking intentions for suicidal thoughts from a workmate (mean difference 0.47, 95% CI 0.10–0.83) or MATES worker/Connector (mean difference 0.47, 95% CI 0.09–0.85).ConclusionResults indicate that the MATESmobile application, together with face-to-face training, is beneficial in enhancing help-seeking intentions from MATES workers/Connectors and workmates to a greater extent than face-to-face training only. While this research provides some evidence that smartphone applications may support suicide prevention training, further research is needed.

Randomized controlled trial of prepregnancy lifestyle intervention to reduce recurrence of gestational diabetes mellitus

Preconception lifestyle intervention holds potential for reducing gestational diabetes mellitus, but clinical trial data are lacking. This study aimed to determine the effects of a prepregnancy weight loss intervention on gestational diabetes mellitus recurrence in women with overweight/obesity and previous gestational diabetes mellitus. A 2-site, randomized controlled trial comparing a prepregnancy lifestyle intervention with educational control was conducted between December 2017 and February 2022. A total of 199 English- and Spanish-speaking adults with overweight/obesity and previous gestational diabetes mellitus were randomized to a 16-week prepregnancy lifestyle intervention with ongoing treatment until conception or educational control. The primary outcome was gestational diabetes mellitus recurrence. Analyses excluded 6 participants who conceived but did not have gestational diabetes mellitus ascertained by standard methods. In the 63 (33%) women who conceived and had gestational diabetes mellitus ascertained (Ns=38/102 [37%] intervention vs 25/91 [28.0%] control; P=.17), those in the intervention group had significantly greater weight loss at 16 weeks compared with controls (4.8 [3.4-6.0] vs 0.7 [-0.9 to 2.3] kg; P=.001) and a greater proportion lost ≥5% of body weight (50.0% [17/34] vs 13.6% [3/22]; P=.005). There was no significant difference in the incidence of gestational diabetes mellitus recurrence between the intervention (57.9% [ns=23/38]) and the control group (44.0% [ns=11/25]; odds ratio, 1.8 [0.59-5.8]). Independent of group, greater prepregnancy weight loss predicted 21% lower odds of gestational diabetes mellitus recurrence (odds ratio, 0.79 [0.66-0.94]; P=.008). A ≥5% weight loss before conception reduced the odds of gestational diabetes mellitus recurrence by 82% (odds ratio, 0.18 [0.04-0.88]; P=.03). Lifestyle intervention produced considerable prepregnancy weight loss but did not affect gestational diabetes mellitus rates. Given that the conception rate was 50% lower than expected, this study was underpowered.

Study protocol for a multisite randomized controlled trial of a peer navigator intervention for emergency department patients with nonfatal opioid overdose

BackgroundPatients presenting to emergency departments (EDs) after a nonfatal opioid-involved overdose are at high risk for future overdose and death. Responding to this risk, the New York City (NYC) Department of Health and Mental Hygiene operates the Relay initiative, which dispatches trained peer “Wellness Advocates” to meet patients in the ED after a suspected opioid-involved overdose and follow them for up to 90 days to provide support, education, referrals to treatment, and other resources using a harm reduction framework. MethodsIn this article, we describe the protocol for a multisite randomized controlled trial of Relay. Study participants are recruited from four NYC EDs and are randomized to receive the Relay intervention or site-directed care (the control arm). Outcomes are assessed through survey questionnaires conducted at 1-, 3-, and 6-months after the baseline visit, as well as through administrative health data. The primary outcome is the number of opioid-related adverse events, including any opioid-involved overdose or any other substance use-related ED visit, in the 12 months post-baseline. Secondary and exploratory outcomes will also be analyzed, as well as hypothesized mediators and moderators of Relay program effectiveness. ConclusionWe present the protocol for a multisite randomized controlled trial of a peer-delivered OD prevention intervention in EDs. We describe how the study was designed to minimize disruption to routine ED operations, and how the study was implemented and adapted during the COVID-19 pandemic. This trial is registered with ClinicalTrials.gov [NCT04317053].

To Act or Not to Act-a Sense of Control Is Important for People With Chronic Obstructive Pulmonary Disease to Increase Physical Activity: Grounded Theory Study.

Among people with chronic obstructive pulmonary disease (COPD), low level of daily physical activity (PA) is the main risk factors for developing cardiovascular, metabolic, and musculoskeletal comorbidities. Increasing PA in people with COPD is complex as PA behavior itself is complex and multifaceted, including personal, physiological, and psychological elements as well as social and environmental factors. Although eHealth solutions such as web-based support or websites have shown positive effects on PA in people with COPD, the results are inconclusive, and it is still unclear how eHealth solutions might be used to support positive changes in PA behavior in people with COPD. This study aimed to explore the perceptions of increasing objective PA when using a web-based eHealth tool among people with COPD. This study was part of a pragmatic randomized controlled trial with in-depth interviews between the 3- and 12-month follow-ups. The methodology used was constructivist grounded theory. All sampling included participants from the randomized controlled trial intervention group, that is, participants who had access to the eHealth tool in question and agreed to be contacted for an in-depth interview. Inclusion of participants continued until data saturation was reached, resulting in an inclusion of 13 (n=7, 54% women) participants aged between 49 and 84 years and living in 8 municipalities in Middle and Northern Sweden. Two interviews were conducted face-to-face, and the remaining interviews were conducted via telephone. All interviews were recorded using a Dictaphone. The analysis resulted in 3 main categories: welcoming or not welcoming action, having or lacking resources, and lowering the threshold. The first 2 categories contain barriers and facilitators, whereas the third category contains only facilitators. The categories lead to the more latent theme Perceiving enough control to enable action, meaning that it seems that perceiving the right amount of control is essential to maintain or increase the level of PA when using an eHealth tool among patients with COPD. However, the right amount of control seemed to depend on the individual (and context) in question. The core category indicates that a need for a certain sense of control was interpreted as necessary for increasing the PA level as well as for using an eHealth tool to help increase the PA level. The eHealth tool seemed to strengthen or weaken the perception of control by either providing support or by being too demanding on the user. Perceptions varied depending on other environmental factors. The Fogg Behavior Model illustrated how motivational levels, ability levels, and functional triggers interact within our findings. Thus, this study provides further evidence for the importance of empowering the patients to boost their level of agency and their ability to improve PA levels. RR2-10.1136/bmjopen-2019-030788.

Project ASPIRE: A feasibility randomized controlled trial of a brief intervention for reducing risk of depression and alcohol-related harms among South African adolescents

Objective: Brief interventions could reduce adolescents’ risk of depression and alcohol-related harms, but evidence of their feasibility and acceptability for low-and middle-income countries is lacking. To address this gap, we conducted a feasibility trial of the ASPIRE intervention, a four-session multi-component counselling intervention for South African adolescents. Method: We recruited 117 adolescents who met our inclusion criteria. Participants were randomly assigned to the ASPIRE intervention or a comparison condition. Outcomes were assessed at baseline, six-week, and three-month post-randomization time points. Primary outcomes were based on feasibility of study procedures and intervention delivery (assessed on seven predetermined progression criteria). Clinical outcomes (risk of depression and alcohol harms) were secondary. Results: Despite modifications to all study procedures arising from Covid-19 restrictions, five of the seven key progression criteria were fully met, including: feasibility of data collection and outcome measures, counsellor competencies, randomization and blinding, adverse advents, and acceptability of the intervention. The progression criterion for recruitment and intervention retention were not fully met. Conclusion: Findings suggest that the ASPIRE intervention was generally feasible to deliver and acceptable to adolescents. However, modifications to the trial design and intervention delivery are needed to optimize the validity of a definitive randomized controlled trial of the ASPIRE intervention.

Triangulating on developmental models with a combination of experimental and nonexperimental estimates.

Plausible competing developmental models show similar or identical structural equation modeling model fit indices, despite making very different causal predictions. One way to help address this problem is incorporating outside information into selecting among models. This study attempted to select among developmental models of children's early mathematical skills by incorporating information about the extent to which models forecast the longitudinal pattern of causal impacts of early math interventions. We tested for the usefulness and validity of the approach by applying it to data from three randomized controlled trials of early math interventions with longitudinal follow-up assessments in the United States (Ns = 1,375, 591, 744; baseline age 4.3, 6.5, 4.4; 17%-69% Black). We found that, across data sets, (a) some models consistently outperformed other models at forecasting later experimental impacts, (b) traditional statistical fit indices were not strongly related to causal fit as indexed by models' accuracy at forecasting later experimental impacts, and (c) models showed consistent patterns of similarity and discrepancy between statistical fit and models' effectiveness at forecasting experimental impacts. We highlight the importance of triangulation and call for more comparisons of experimental and nonexperimental estimates for choosing among developmental models. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Study protocol for a randomised controlled trial of a virtual antenatal intervention for improved diet and iron intake in Kapilvastu district, Nepal: VALID

IntroductionDespite evidence that iron and folic acid (IFA) supplements can improve anaemia in pregnant women, uptake in Nepal is suboptimal. We hypothesised that providing virtual counselling twice in mid-pregnancy, would...

WITHDRAWN: Evidence Synthesis to Advance Clinical Practice and Scientific Research: A CGH Pillar

WITHDRAWN: Evidence Synthesis to Advance Clinical Practice and Scientific Research: A CGH Pillar

Pilot randomized controlled clinical trial of an adherence social norms intervention for adolescents with epilepsy

ObjectiveNon-adherence to anti-seizure medications (ASMs) is common for adolescents with epilepsy, with potentially devastating consequences. Existing adherence interventions in epilepsy do not meet the unique challenges faced by adolescents. Leveraging social norms capitalizes on the increased importance of peer influence while simultaneously targeting the low motivation levels of many adolescents. The current study examined the feasibility, acceptability, and satisfaction of a social norms adherence intervention in adolescents with epilepsy. MethodsA pilot RCT of a mHealth social norms intervention was conducted with adolescents with epilepsy who demonstrated non-adherence (≤95% adherence) during baseline. Adolescents were randomized to either (1) mHealth social norms (reminders, individualized and social norms adherence feedback) or (2) control (reminders and individualized adherence feedback). Primary outcomes included feasibility, acceptability, and satisfaction. Exploratory outcomes included electronically monitored adherence, seizure severity, and health-related quality of life (HRQOL). ResultsOne hundred four adolescents were recruited (53% female; Mage = 15.4 ± 1.4 years; 81% White: Non-Hispanic; 5% Black, 10% Bi/Multiracial; 2% White: Hispanic; 1% Other: Hispanic; 1% Bi/Multiracial-Hispanic). Forty-five percent screen-failed due to high adherence, 16% withdrew, and 38% were randomized to treatment (n = 19) or control (n = 21). Recruitment (75%), retention (78%), and treatment satisfaction were moderately high. Engagement with the intervention was moderate, with 64% of participants engaging with intervention notifications. Exploratory analyses revealed that after controlling for COVID-19 impact, the social norms intervention group maintained higher adherence over time compared to the control group. Small to moderate effect sizes were noted for seizure severity and HRQOL between groups. ConclusionThis pilot intervention appeared feasible and acceptable. Increases in adherence in the treatment versus control group were modest, but a future larger more adequately powered study is needed to detect effects. Notably, it appeared the COVID pandemic influenced adherence behaviors during our trial.

Longitudinal associations between age 20 problematic substance use and opioid use disorder incidence at age 30 – findings from an urban cohort

This study used data from a longitudinal prevention study in an urban cohort to examine associations between nicotine dependence, alcohol, and cannabis use disorder and disorder criteria at age 20, with opioid use disorder (OUD) incidence or criteria onset by age 30. The study sample included 1408 participants (57.5% female, 72.5% African American) drawn from two cohorts of participants in a mid-Atlantic region of the U.S. as part of a series of randomized controlled trials of elementary school-based universal prevention interventions. Lifetime cannabis use disorder (CUD), alcohol use disorder (AUD; both DSM-IV), and current nicotine dependence (Fagerstrom Test for Nicotine Dependence, FTND) assessed at age 20 were used to predict (1) DSM-IV lifetime OUD at age 30, and (2) OUD criteria between ages 20 and 30 in multivariable logistic regression models. Covariates for all analyses included sociodemographics (sex, race, and free/reduced-priced lunch status), community disadvantage, and intervention status. Nicotine dependence (FTND≥3) at age 20 predicted age 30 DSM-IV lifetime OUD (aOR = 2.37; 95% CI 1.02,5.54). The number of CUD criteria (aOR = 1.30; 95% CI 1.09,1.57) and nicotine dependence severity scores (aOR = 1.22; 95% CI = 1.05,1.41) at age 20 predicted any OUD criteria between the ages of 20 and 30. Findings are consistent with previous research on opioid use behavior in young adulthood and suggest that nicotine dependence and CUD criteria among urban young people predict onset of OUD and OUD criteria in young adulthood.

Treatment for mild hypertension in pregnancy with different strategies: A systematic review and meta-analysis.

To synthesize the evidence from randomized controlled trials (RCTs) of antihypertensive treatment for mild pregnancy hypertension. We searched various databases from inception to June 2022, using keywords including hypertension; pregnancy; therapy; treatment; pregnancy outcomes; maternal outcomes; and perinatal outcomes. Only RCTs of antihypertensive treatment for mild hypertension in pregnancy comparing placebo/no therapy were included. We used Review Manager version 5.3 for statistical analyses. In all, eight studies were eligible, with a total of 4211 participants. Compared with control, the active treatment significantly prevented preeclampsia (OR 0.55; 95%CI, 0.39-0.78), placental abruption (OR 0.39; 95%CI, 0.17-0.91), severe hypertension (OR 0.35; 95%CI, 0.17-0.71), end-organ dysfunction (OR 0.34; 95%CI, 0.19-0.62) and preterm birth (OR 0.69; 95%CI, 0.59-0.82), with no increased risk of small for gestational age (SGA) (OR 1.25; 95%CI, 0.78-2.00), or admission to the NICU (OR 0.83; 95%CI, 0.54-1.28). Subgroup analyses demonstrated that the tight control group did not show an advantage over the less-tight control group in improving pregnancy outcomes. In pregnant women with mild pregnancy-induced hypertension or chronic hypertension, antihypertensive treatment still provided precise benefits of improving pregnancy outcomes without increased risk in fetal outcomes.

Leisure-Related Social Work Interventions for Patients with Cognitive Impairment: A Systematic Review and Meta-Analysis.

The social work profession has been exploring nonpharmacological interventions for patients with cognitive impairment, but there are few evidence-based research outputs. Systematically evaluating the effectiveness of social work interventions for people with cognitive impairment can shed light on the matter to further improve similar interventions. Randomized controlled trials of nonpharmacological interventions for patients with cognitive impairment were selected from key literature databases in both English and Chinese from 2010 to 2021. A systematic review and meta-analysis with Revman 5.4 were performed. Seven trials were included, involving 851 patients with cognitive impairment. The meta-analysis showed that, in terms of overall cognitive function, the Montreal Cognitive Assessment score (MD = 1.64, 95% CI [0.97, 2.30], p < 0.001) of the intervention group was superior to the control group, but there was no significant difference in the Mini-Mental State Examination score between the two groups (MD = 0.33, 95% CI [-0.16, 0.82], p = 0.18). Compared with the control group, nonpharmacological intervention can effectively improve the neuropsychiatric condition of patients (SMD = -0.42, 95% CI [-0.64, -0.20], p = 0.0002). In summary, the current evidence shows that nonpharmacological social work interventions had a positive effect on the cognitive function and neuropsychiatric status of patients with cognitive impairment. Suggestions for future nonpharmacological intervention practice are discussed.