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Importance of accurate and accessible recording of healthcare contacts in mental health [Comment]

Jack, Ruth H; Coupland, Carol A C; Joseph, Rebecca M; Hollis, Chris; Morriss, Richard; Knaggs, Roger David; Cipriani, Andrea; Cortese, Samuele; Hippisley-Cox, Julia
PMID: 37697323
ISSN: 1741-7015
CID: 5593932

Remote Recruitment Strategy and Structured E-Parenting Support (STEPS) App: Feasibility and Usability Study

Kostyrka-Allchorne, Katarzyna; Chu, Petrina; Ballard, Claire; Lean, Nancy; French, Blandine; Hedstrom, Ellen; Byford, Sarah; Cortese, Samuele; Daley, David; Downs, Johnny; Glazebrook, Cristine; Goldsmith, Kimberley; Hall, Charlotte L; Kovshoff, Hanna; Kreppner, Jana; Sayal, Kapil; Shearer, James; Simonoff, Emily; Thompson, Margaret; Sonuga-Barke, Edmund J S
BACKGROUND:The Structured E-Parenting Support (STEPS) app provides support for parents of children with elevated hyperactivity, impulsivity, inattention, and conduct problems who are awaiting clinical assessment. STEPS will be evaluated in a randomized controlled trial (RCT) within the Online Parent Training for the Initial Management of ADHD Referrals (OPTIMA) research program in the United Kingdom. Phase 1 of the OPTIMA tested the feasibility of participants' recruitment and the app's usability. OBJECTIVE:This study aimed to adapt a digital routine clinical monitoring system, myHealthE, for research purposes to facilitate waitlist recruitment; test using remote methods to screen and identify participants quickly and systematically; pilot the acceptability of the recruitment and assessment protocol; and explore the usability of STEPS. METHODS:myHealthE was adapted to screen patients' data. Parents' and clinicians' feedback on myHealthE was collected, and information governance reviews were conducted in clinical services planning to host the RCT. Potential participants for the observational feasibility study were identified from new referrals using myHealthE and non-myHealthE methods. Descriptive statistics were used to summarize the demographic and outcome variables. We estimated whether the recruitment rate would meet the planned RCT sample size requirement (n=352). In addition to the feasibility study participants, another group of parents was recruited to assess the STEPS usability. They completed the adapted System Usability Scale and responded to open-ended questions about the app, which were coded using the Enlight quality construct template. RESULTS:Overall, 124 potential participants were identified as eligible: 121 (97.6%) via myHealthE and 3 (2.4%) via non-myHealthE methods. In total, 107 parents were contacted, and 48 (44.9%) consented and were asked if, hypothetically, they would be willing to participate in the OPTIMA RCT. Of the 28 feasibility study participants who provided demographic data, 21 (75%) identified as White. Their children had an average age of 8.4 (SD 1.7) years and 65% (31/48) were male. During the primary recruitment period (June to July 2021) when 45 participants had consented, 38 (84%) participants agreed hypothetically to take part in the RCT (rate of 19/mo, 95% CI 13.5-26.1), meeting the stop-go criterion of 18 participants per month to proceed with the RCT. All parents were satisfied or very satisfied with the study procedures. Parents (n=12) recruited to assess STEPS' usability described it as easy to navigate and use and as having an attractive combination of colors and visual design. They described the content as useful, pitched at the right level, and sensitively presented. Suggested improvements included adding captions to videos or making the recorded reflections editable. CONCLUSIONS:Remote recruitment and study procedures for testing a parenting intervention app are feasible and acceptable for parents. The parents felt that STEPS was a useful and easy-to-use digital parenting support tool. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)/UNASSIGNED:RR2-10.1186/s40814-021-00959-0.
PMCID:10520770
PMID: 37695667
ISSN: 2561-6722
CID: 5593722

Sleep parameters and problems in adolescents with and without ADHD: A systematic review and meta-analysis

Marten, Finja; Keuppens, Lena; Baeyens, Dieter; Boyer, Bianca E; Danckaerts, Marina; Cortese, Samuele; Van der Oord, Saskia
BACKGROUND/UNASSIGNED:Adolescence is characterized by an increase in the rate of sleep problems, which might be even more pronounced in adolescents with ADHD. This systematic review with meta-analysis aimed to compare sleep in adolescents with and without ADHD, including sleep parameters, both subjectively and objectively measured, sleep problems and sleep hygiene. METHODS/UNASSIGNED:Medline, CINAHL, PsycINFO, EMBASE, ERIC, Web of Science, and PubMed databases were searched for studies with case-control designs (published between 1980 and 2022) directly comparing sleep in adolescents (12-25 years) with ADHD to typically developing controls. Standardized mean differences were calculated and a random-effects model was implemented using RevMan. RESULTS/UNASSIGNED: = 3) in any parameter. Differences in sleep hygiene could not be examined due to a limited number of studies. CONCLUSIONS/UNASSIGNED:Adolescents with ADHD report significantly worsened subjectively sleep parameters and more sleep problems compared to controls. These findings are still preliminary as a limited number of studies was identified. Nevertheless, it is advised to routinely include sleep assessment in the ADHD diagnostic process. More research is needed with a focus on objective measurement and sleep hygiene in ADHD.
PMCID:10501691
PMID: 37720581
ISSN: 2692-9384
CID: 5735222

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? [Comment]

Purgato, Marianna; Cortese, Samuele
Adverse Events (AEs) are defined as any unfavorable and unintended sign or symptom, that may occur during or after receipt of any intervention. The principle of non-maleficence requires careful consideration to ensure that existing or new psychological interventions are not harmful before they can be considered beneficial. In this context, the safety of psychological interventions, including the possible occurrence of AEs, is increasingly important for patients, families, and clinicians. The evaluation of AEs is crucial to obtain a complete understanding of the risk/benefit balance of psychological interventions. There is a need for researchers and clinicians to assess and report AEs comprehensively and in a coordinated manner. It is necessary to have more accurate data on the recording of AEs in protocols to enhance transparency and consistency, as well as to improve practice. Finally, and to facilitate this process, there is a need for standards for data collection.
PMID: 37532230
ISSN: 1475-357x
CID: 5594532

An umbrella review of candidate predictors of response, remission, recovery, and relapse across mental disorders

Solmi, Marco; Cortese, Samuele; Vita, Giovanni; De Prisco, Michele; Radua, Joaquim; Dragioti, Elena; Köhler-Forsberg, Ole; Madsen, Nanna M; Rohde, Christopher; Eudave, Luis; Aymerich, Claudia; Pedruzo, Borja; Rodriguez, Victoria; Rosson, Stella; Sabé, Michel; Hojlund, Mikkel; Catalan, Ana; de Luca, Beatrice; Fornaro, Michele; Ostuzzi, Giovanni; Barbui, Corrado; Salazar-de-Pablo, Gonzalo; Fusar-Poli, Paolo; Correll, Christoph U
We aimed to identify diagnosis-specific/transdiagnostic/transoutcome multivariable candidate predictors (MCPs) of key outcomes in mental disorders. We conducted an umbrella review (protocol  link ), searching MEDLINE/Embase (19/07/2022), including systematic reviews of studies reporting on MCPs of response, remission, recovery, or relapse, in DSM/ICD-defined mental disorders. From published predictors, we filtered MCPs, validating MCP criteria. AMSTAR2/PROBAST measured quality/risk of bias of systematic reviews/individual studies. We included 117 systematic reviews, 403 studies, 299,888 individuals with mental disorders, testing 796 prediction models. Only 4.3%/1.2% of the systematic reviews/individual studies were at low risk of bias. The most frequently targeted outcome was remission (36.9%), the least frequent was recovery (2.5%). Studies mainly focused on depressive (39.4%), substance-use (17.9%), and schizophrenia-spectrum (11.9%) disorders. We identified numerous MCPs within disorders for response, remission and relapse, but none for recovery. Transdiagnostic MCPs of remission included lower disease-specific symptoms (disorders = 5), female sex/higher education (disorders = 3), and quality of life/functioning (disorders = 2). Transdiagnostic MCPs of relapse included higher disease-specific symptoms (disorders = 5), higher depressive symptoms (disorders = 3), and younger age/higher anxiety symptoms/global illness severity/ number of previous episodes/negative life events (disorders = 2). Finally, positive trans-outcome MCPs for depression included less negative life events/depressive symptoms (response, remission, less relapse), female sex (response, remission) and better functioning (response, less relapse); for schizophrenia, less positive symptoms/higher depressive symptoms (remission, less relapse); for substance use disorder, marital status/higher education (remission, less relapse). Male sex, younger age, more clinical symptoms and comorbid mental/physical symptoms/disorders were poor prognostic factors, while positive factors included social contacts and employment, absent negative life events, higher education, early access/intervention, lower disease-specific and comorbid mental and physical symptoms/conditions, across mental disorders. Current data limitations include high risk of bias of studies and extraction of single predictors from multivariable models. Identified MCPs can inform future development, validation or refinement of prediction models of key outcomes in mental disorders.
PMID: 37957292
ISSN: 1476-5578
CID: 5611042

Balancing risks and benefits of cannabis use: umbrella review of meta-analyses of randomised controlled trials and observational studies

Solmi, Marco; De Toffol, Marco; Kim, Jong Yeob; Choi, Min Je; Stubbs, Brendon; Thompson, Trevor; Firth, Joseph; Miola, Alessandro; Croatto, Giovanni; Baggio, Francesca; Michelon, Silvia; Ballan, Luca; Gerdle, Björn; Monaco, Francesco; Simonato, Pierluigi; Scocco, Paolo; Ricca, Valdo; Castellini, Giovanni; Fornaro, Michele; Murru, Andrea; Vieta, Eduard; Fusar-Poli, Paolo; Barbui, Corrado; Ioannidis, John P A; Carvalho, Andrè F; Radua, Joaquim; Correll, Christoph U; Cortese, Samuele; Murray, Robin M; Castle, David; Shin, Jae Il; Dragioti, Elena
OBJECTIVE:To systematically assess credibility and certainty of associations between cannabis, cannabinoids, and cannabis based medicines and human health, from observational studies and randomised controlled trials (RCTs). DESIGN:Umbrella review. DATA SOURCES:PubMed, PsychInfo, Embase, up to 9 February 2022. ELIGIBILITY CRITERIA FOR SELECTING STUDIES:Systematic reviews with meta-analyses of observational studies and RCTs that have reported on the efficacy and safety of cannabis, cannabinoids, or cannabis based medicines were included. Credibility was graded according to convincing, highly suggestive, suggestive, weak, or not significant (observational evidence), and by GRADE (Grading of Recommendations, Assessment, Development and Evaluations) (RCTs). Quality was assessed with AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews 2). Sensitivity analyses were conducted. RESULTS:101 meta-analyses were included (observational=50, RCTs=51) (AMSTAR 2 high 33, moderate 31, low 32, or critically low 5). From RCTs supported by high to moderate certainty, cannabis based medicines increased adverse events related to the central nervous system (equivalent odds ratio 2.84 (95% confidence interval 2.16 to 3.73)), psychological effects (3.07 (1.79 to 5.26)), and vision (3.00 (1.79 to 5.03)) in people with mixed conditions (GRADE=high), improved nausea/vomit, pain, spasticity, but increased psychiatric, gastrointestinal adverse events, and somnolence among others (GRADE=moderate). Cannabidiol improved 50% reduction of seizures (0.59 (0.38 to 0.92)) and seizure events (0.59 (0.36 to 0.96)) (GRADE=high), but increased pneumonia, gastrointestinal adverse events, and somnolence (GRADE=moderate). For chronic pain, cannabis based medicines or cannabinoids reduced pain by 30% (0.59 (0.37 to 0.93), GRADE=high), across different conditions (n=7), but increased psychological distress. For epilepsy, cannabidiol increased risk of diarrhoea (2.25 (1.33 to 3.81)), had no effect on sleep disruption (GRADE=high), reduced seizures across different populations and measures (n=7), improved global impression (n=2), quality of life, and increased risk of somnolence (GRADE=moderate). In the general population, cannabis worsened positive psychotic symptoms (5.21 (3.36 to 8.01)) and total psychiatric symptoms (7.49 (5.31 to 10.42)) (GRADE=high), negative psychotic symptoms, and cognition (n=11) (GRADE=moderate). In healthy people, cannabinoids improved pain threshold (0.74 (0.59 to 0.91)), unpleasantness (0.60 (0.41 to 0.88)) (GRADE=high). For inflammatory bowel disease, cannabinoids improved quality of life (0.34 (0.22 to 0.53) (GRADE=high). For multiple sclerosis, cannabinoids improved spasticity, pain, but increased risk of dizziness, dry mouth, nausea, somnolence (GRADE=moderate). For cancer, cannabinoids improved sleep disruption, but had gastrointestinal adverse events (n=2) (GRADE=moderate). Cannabis based medicines, cannabis, and cannabinoids resulted in poor tolerability across various conditions (GRADE=moderate). Evidence was convincing from observational studies (main and sensitivity analyses) in pregnant women, small for gestational age (1.61 (1.41 to 1.83)), low birth weight (1.43 (1.27 to 1.62)); in drivers, car crash (1.27 (1.21 to 1.34)); and in the general population, psychosis (1.71 (1.47 to 2.00)). Harmful effects were noted for additional neonatal outcomes, outcomes related to car crash, outcomes in the general population including psychotic symptoms, suicide attempt, depression, and mania, and impaired cognition in healthy cannabis users (all suggestive to highly suggestive). CONCLUSIONS:Convincing or converging evidence supports avoidance of cannabis during adolescence and early adulthood, in people prone to or with mental health disorders, in pregnancy and before and while driving. Cannabidiol is effective in people with epilepsy. Cannabis based medicines are effective in people with multiple sclerosis, chronic pain, inflammatory bowel disease, and in palliative medicine but not without adverse events. STUDY REGISTRATION:PROSPERO CRD42018093045. FUNDING:None.
PMID: 37648266
ISSN: 1756-1833
CID: 5606992

Psychosocial interventions for the prevention of self-harm repetition: protocol for a systematic review and network meta-analysis

Orri, Massimiliano; Gifuni, Anthony J; Ougrin, Dennis; Boruff, Jill; Cipriani, Andrea; Furukawa, Toshiaki A; Schaffer, Dalia; Del Giovane, Cinzia; Inja, Ayla; Turecki, Gustavo; Geoffroy, Marie-Claude; Cortese, Samuele
INTRODUCTION:Suicide is an important public health problem. Providing evidence-based psychosocial interventions to individuals presenting with self-harm is recognised as an important suicide prevention strategy. Therefore, it is crucial to understand which intervention is most effective in preventing self-harm repetition. We will evaluate the comparative efficacy of psychosocial interventions for the prevention of self-harm in adults. METHODS AND ANALYSIS:We will perform a systematic review and network meta-analysis (NMA) of randomised controlled trials (RCTs) testing psychosocial interventions for the prevention of self-harm repetition. We will include RCTs in adults (mean age: 18 years or more) who presented with self-harm in the 6 months preceding enrolment in the trial. Interventions will be categorised according to their similarities and underpinning theoretical approaches (eg, cognitive behavioural therapy, case management). A health sciences librarian will update and adapt the search strategy from the most recent Cochrane pairwise systematic review on this topic. The searches will be performed in MEDLINE (Ovid), Embase (Ovid), PsycInfo (Ovid), CINAHL (EBSCO), Cochrane Central (Wiley), Cochrane Protocols (Wiley), LILACS and PSYNDEX from 1 July 2020 (Cochrane review last search date) to 1 September 2023. The primary efficacy outcome will be self-harm repetition. Secondary outcomes will include suicide mortality, suicidal ideation and depressive symptoms. Retention in treatment (ie, drop-outs rates) will be analysed as the main acceptability outcome. Two reviewers will independently assess the study eligibility and risk of bias (using RoB-2). An NMA will be performed to synthesise all direct and indirect comparisons. Ranked forest plots and Vitruvian plots will be used to represent graphically the results of the NMA. Credibility of network estimates will be evaluated using Confidence in NMA (CINeMA). ETHICS AND DISSEMINATION:As this is the protocol for an aggregate-data level NMA, ethical approval will not be required. Results will be disseminated at national/international conferences and in peer-review journals. TRIAL REGISTRATION NUMBER:CRD42021273057.
PMCID:10450075
PMID: 37620269
ISSN: 2044-6055
CID: 5598882

Subjective and objective sleep alterations in medication-naïve children and adolescents with autism spectrum disorder: a systematic review and meta-analysis

Kim, Heeyeon; Kim, Jae Han; Kim, Junghwan; Kim, Jong Yeob; Cortese, Samuele; Smith, Lee; Koyanagi, Ai; Radua, Joaquim; Fusar-Poli, Paolo; Carvalho, Andre F; Salazar de Pablo, Gonzalo; Shin, Jae Il; Cheon, Keun-Ah; Solmi, Marco
AIMS/OBJECTIVE:This study aimed to summarize the evidence on sleep alterations in medication-naïve children and adolescents with autism spectrum disorder (ASD). METHODS:-curve analysis were done. A priori planned meta-regression and subgroup analysis were also performed to identify potential moderators. RESULTS:0.48; 95% CI 0.29 to 0.66). Potential publication bias was detected for sleep latency, sleep period time and total sleep time measured by polysomnography. Some sleep alterations were moderated by age, sex and concurrent intellectual disability. The median NOS score was 8 (interquartile range 7.25-8.75). CONCLUSION/CONCLUSIONS:We found that medication-naïve children and adolescents with ASD presented significantly more subjective and objective sleep alterations compared to TD and identified possible moderators of these differences. Future research requires an analysis of how these sleep alterations are linked to core symptom severity and comorbid behavioural problems, which would provide an integrated therapeutic intervention for ASD. However, our results should be interpreted in light of the potential publication bias.
PMID: 37469173
ISSN: 2045-7979
CID: 5535902

National trends in prevalence of sadness, counseling for sadness, and sleep time among Koreans amid pandemic, 2009-2021: A nationwide representative study of over 2.8 million individuals [Letter]

Choi, Jungwoo; Kim, Minji; Lee, Seung Won; Rhee, Sang Youl; Yang, Hwi; Kim, Hyeon Jin; Kwon, Rosie; Koyanagi, Ai; Smith, Lee; Kim, Min Seo; Fond, Guillaume; Boyer, Laurent; López Sánchez, Guillermo F; Elena, Dragioti; Cortese, Samuele; Shin, Jae Il; Lee, Hayeon; Lee, Jinseok; Rahmati, Masoud; Cho, Wonyoung; Yon, Dong Keon
PMID: 37480782
ISSN: 1876-2026
CID: 5536272

From cancer prevention to death: the case for transdiagnostic services for physical health in people with mental disorders

Solmi, Marco; Cortese, Samuele; Wooten, Jared C; Anderson, Kelly K
PMID: 37353252
ISSN: 2215-0374
CID: 5533702