Pub Date : 2024-10-23DOI: 10.1016/S2589-7500(24)00221-8
The Lancet Digital Health
{"title":"Lifting the veil on health datasets","authors":"The Lancet Digital Health","doi":"10.1016/S2589-7500(24)00221-8","DOIUrl":"10.1016/S2589-7500(24)00221-8","url":null,"abstract":"","PeriodicalId":48534,"journal":{"name":"Lancet Digital Health","volume":"6 11","pages":"Page e772"},"PeriodicalIF":23.8,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142510626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-23DOI: 10.1016/S2589-7500(24)00154-7
Jun Ma PhD , Yao Zhang PhD , Song Gu MSc , Cheng Ge MSc , Shihao Mae BSc , Adamo Young MSc , Cheng Zhu PhD , Prof Xin Yang PhD , Prof Kangkang Meng PhD , Ziyan Huang BSc , Fan Zhang MSc , Yuanke Pan MSc , Shoujin Huang BSc , Jiacheng Wang PhD , Mingze Sun PhD , Prof Rongguo Zhang PhD , Dengqiang Jia PhD , Jae Won Choi MD , Natália Alves MSc , Bram de Wilde PhD , Prof Bo Wang PhD
Deep learning has shown great potential to automate abdominal organ segmentation and quantification. However, most existing algorithms rely on expert annotations and do not have comprehensive evaluations in real-world multinational settings. To address these limitations, we organised the FLARE 2022 challenge to benchmark fast, low-resource, and accurate abdominal organ segmentation algorithms. We first constructed an intercontinental abdomen CT dataset from more than 50 clinical research groups. We then independently validated that deep learning algorithms achieved a median dice similarity coefficient (DSC) of 90·0% (IQR 87·4–91·3%) by use of 50 labelled images and 2000 unlabelled images, which can substantially reduce manual annotation costs. The best-performing algorithms successfully generalised to holdout external validation sets, achieving a median DSC of 89·4% (85·2–91·3%), 90·0% (84·3–93·0%), and 88·5% (80·9–91·9%) on North American, European, and Asian cohorts, respectively. These algorithms show the potential to use unlabelled data to boost performance and alleviate annotation shortages for modern artificial intelligence models.
{"title":"Unleashing the strengths of unlabelled data in deep learning-assisted pan-cancer abdominal organ quantification: the FLARE22 challenge","authors":"Jun Ma PhD , Yao Zhang PhD , Song Gu MSc , Cheng Ge MSc , Shihao Mae BSc , Adamo Young MSc , Cheng Zhu PhD , Prof Xin Yang PhD , Prof Kangkang Meng PhD , Ziyan Huang BSc , Fan Zhang MSc , Yuanke Pan MSc , Shoujin Huang BSc , Jiacheng Wang PhD , Mingze Sun PhD , Prof Rongguo Zhang PhD , Dengqiang Jia PhD , Jae Won Choi MD , Natália Alves MSc , Bram de Wilde PhD , Prof Bo Wang PhD","doi":"10.1016/S2589-7500(24)00154-7","DOIUrl":"10.1016/S2589-7500(24)00154-7","url":null,"abstract":"<div><div>Deep learning has shown great potential to automate abdominal organ segmentation and quantification. However, most existing algorithms rely on expert annotations and do not have comprehensive evaluations in real-world multinational settings. To address these limitations, we organised the FLARE 2022 challenge to benchmark fast, low-resource, and accurate abdominal organ segmentation algorithms. We first constructed an intercontinental abdomen CT dataset from more than 50 clinical research groups. We then independently validated that deep learning algorithms achieved a median dice similarity coefficient (DSC) of 90·0% (IQR 87·4–91·3%) by use of 50 labelled images and 2000 unlabelled images, which can substantially reduce manual annotation costs. The best-performing algorithms successfully generalised to holdout external validation sets, achieving a median DSC of 89·4% (85·2–91·3%), 90·0% (84·3–93·0%), and 88·5% (80·9–91·9%) on North American, European, and Asian cohorts, respectively. These algorithms show the potential to use unlabelled data to boost performance and alleviate annotation shortages for modern artificial intelligence models.</div></div>","PeriodicalId":48534,"journal":{"name":"Lancet Digital Health","volume":"6 11","pages":"Pages e815-e826"},"PeriodicalIF":23.8,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142510629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-16DOI: 10.1016/S2589-7500(24)00192-4
Timo O Nieder, Janis Renner, Susanne Sehner, Amra Pepić, Antonia Zapf, Martin Lambert, Peer Briken, Arne Dekker
<p><strong>Background: </strong>Transgender and gender diverse (TGD) people in remote areas face challenges accessing health-care services, including mental health care and gender-affirming medical treatment, which can be associated with psychological distress. In this study, we aimed to evaluate the effectiveness of a 4-month TGD-informed e-health intervention to improve psychological distress among TGD people from remote areas in northern Germany.</p><p><strong>Methods: </strong>In a randomised controlled trial done at a single centre in Germany, adults (aged ≥18 years) who met criteria for gender incongruence or gender dysphoria and who lived at least 50 km outside of Hamburg in one of the northern German federal states were recruited and randomly assigned (1:1) to i<sup>2</sup>TransHealth intervention or a wait list control group. Randomisation was performed with the use of a computer-based code. Due to the nature of the intervention, study participants and clinical staff were aware of treatment allocation, but researchers responsible for data analysis were masked to allocation groups. Study participants in the intervention group (service users) started the i<sup>2</sup>TransHealth intervention immediately after completing the baseline survey after enrolment. Participants assigned to the control group waited 4 months before they were able to access i<sup>2</sup>TransHealth services or regular care. The primary outcome was difference in the Brief Symptom Inventory (BSI)-18 summary score between baseline and 4 months, assessed using a linear model analysis. The primary outcome was assessed in the intention-to-treat (ITT) population, which included all randomly assigned participants. The trial was registered with ClinicalTrials.gov, NCT04290286.</p><p><strong>Findings: </strong>Between May 12, 2020, and May 2, 2022, 177 TGD people were assessed for eligibility, of whom 174 were included in the ITT population (n=90 in the intervention group, n=84 in the control group). Six participants did not provide data for the primary outcome at 4 months, and thus 168 people were included in the analysis population (88 participants in the intervention group and 80 participants in the control group). At 4 months, in the intervention group, the adjusted mean change in BSI-18 from baseline was -0·65 (95% CI -2·25 to 0·96; p=0·43) compared with 2·34 (0·65 to 4·02; p=0·0069) in the control group. Linear model analysis identified a significant difference at 4 months between the groups with regard to change in BSI-18 summary scores from baseline (between-group difference -2·98 [95% CI -5·31 to -0·65]; p=0·012). Adverse events were rare: there were two suicide attempts and one participant was admitted to hospital in the intervention group, and in the control group, there was one case of self-harm and one case of self-harm followed by hospital admission.</p><p><strong>Interpretation: </strong>The intervention was clinically significant in averting worsening psychologi
{"title":"Effect of the i<sup>2</sup>TransHealth e-health intervention on psychological distress among transgender and gender diverse adults from remote areas in Germany: a randomised controlled trial.","authors":"Timo O Nieder, Janis Renner, Susanne Sehner, Amra Pepić, Antonia Zapf, Martin Lambert, Peer Briken, Arne Dekker","doi":"10.1016/S2589-7500(24)00192-4","DOIUrl":"https://doi.org/10.1016/S2589-7500(24)00192-4","url":null,"abstract":"<p><strong>Background: </strong>Transgender and gender diverse (TGD) people in remote areas face challenges accessing health-care services, including mental health care and gender-affirming medical treatment, which can be associated with psychological distress. In this study, we aimed to evaluate the effectiveness of a 4-month TGD-informed e-health intervention to improve psychological distress among TGD people from remote areas in northern Germany.</p><p><strong>Methods: </strong>In a randomised controlled trial done at a single centre in Germany, adults (aged ≥18 years) who met criteria for gender incongruence or gender dysphoria and who lived at least 50 km outside of Hamburg in one of the northern German federal states were recruited and randomly assigned (1:1) to i<sup>2</sup>TransHealth intervention or a wait list control group. Randomisation was performed with the use of a computer-based code. Due to the nature of the intervention, study participants and clinical staff were aware of treatment allocation, but researchers responsible for data analysis were masked to allocation groups. Study participants in the intervention group (service users) started the i<sup>2</sup>TransHealth intervention immediately after completing the baseline survey after enrolment. Participants assigned to the control group waited 4 months before they were able to access i<sup>2</sup>TransHealth services or regular care. The primary outcome was difference in the Brief Symptom Inventory (BSI)-18 summary score between baseline and 4 months, assessed using a linear model analysis. The primary outcome was assessed in the intention-to-treat (ITT) population, which included all randomly assigned participants. The trial was registered with ClinicalTrials.gov, NCT04290286.</p><p><strong>Findings: </strong>Between May 12, 2020, and May 2, 2022, 177 TGD people were assessed for eligibility, of whom 174 were included in the ITT population (n=90 in the intervention group, n=84 in the control group). Six participants did not provide data for the primary outcome at 4 months, and thus 168 people were included in the analysis population (88 participants in the intervention group and 80 participants in the control group). At 4 months, in the intervention group, the adjusted mean change in BSI-18 from baseline was -0·65 (95% CI -2·25 to 0·96; p=0·43) compared with 2·34 (0·65 to 4·02; p=0·0069) in the control group. Linear model analysis identified a significant difference at 4 months between the groups with regard to change in BSI-18 summary scores from baseline (between-group difference -2·98 [95% CI -5·31 to -0·65]; p=0·012). Adverse events were rare: there were two suicide attempts and one participant was admitted to hospital in the intervention group, and in the control group, there was one case of self-harm and one case of self-harm followed by hospital admission.</p><p><strong>Interpretation: </strong>The intervention was clinically significant in averting worsening psychologi","PeriodicalId":48534,"journal":{"name":"Lancet Digital Health","volume":" ","pages":""},"PeriodicalIF":23.8,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142478075","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-09DOI: 10.1016/S2589-7500(24)00220-6
{"title":"Correction to Lancet Digit Health 2024; published online Sept 17. https://doi.org/10.1016/S2589-7500(24)00143-2","authors":"","doi":"10.1016/S2589-7500(24)00220-6","DOIUrl":"10.1016/S2589-7500(24)00220-6","url":null,"abstract":"","PeriodicalId":48534,"journal":{"name":"Lancet Digital Health","volume":"6 11","pages":"Page e777"},"PeriodicalIF":23.8,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142394367","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-07DOI: 10.1016/S2589-7500(24)00197-3
Clara E Tandar , John C Lin , Fatima Cody Stanford
{"title":"Combating medical misinformation and rebuilding trust in the USA","authors":"Clara E Tandar , John C Lin , Fatima Cody Stanford","doi":"10.1016/S2589-7500(24)00197-3","DOIUrl":"10.1016/S2589-7500(24)00197-3","url":null,"abstract":"","PeriodicalId":48534,"journal":{"name":"Lancet Digital Health","volume":"6 11","pages":"Pages e773-e774"},"PeriodicalIF":23.8,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142394366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-04DOI: 10.1016/S2589-7500(24)00149-3
Edward R Watkins, Fiona C Warren, Alexandra Newbold, Claire Hulme, Timothy Cranston, Benjamin Aas, Holly Bear, Cristina Botella, Felix Burkhardt, Thomas Ehring, Mina Fazel, Johnny R J Fontaine, Mads Frost, Azucena Garcia-Palacios, Ellen Greimel, Christiane Hößle, Arpine Hovasapian, Veerle E I Huyghe, Kostas Karpouzis, Johanna Löchner, Guadalupe Molinari, Reinhard Pekrun, Belinda Platt, Tabea Rosenkranz, Klaus R Scherer, Katja Schlegel, Bjorn W Schuller, Gerd Schulte-Korne, Carlos Suso-Ribera, Varinka Voigt, Maria Voß, Rod S Taylor
<p><strong>Background: </strong>Based on evidence that mental health is more than an absence of mental disorders, there have been calls to find ways to promote flourishing at a population level, especially in young people, which requires effective and scalable interventions. Despite their potential for scalability, few mental wellbeing apps have been rigorously tested in high-powered trials, derived from models of healthy emotional functioning, or tailored to individual profiles. We aimed to test a personalised emotional competence self-help app versus a cognitive behavioural therapy (CBT) self-help app versus a self-monitoring app to promote mental wellbeing in healthy young people.</p><p><strong>Methods: </strong>This international, multicentre, parallel, open-label, randomised controlled trial within a cohort multiple randomised trial (including a parallel trial of depression prevention) was done at four university trial sites in four countries (the UK, Germany, Spain, and Belgium). Participants were recruited from schools and universities and via social media from the four respective countries. Eligible participants were aged 16-22 years with well adjusted emotional competence profiles and no current or past diagnosis of major depression. Participants were randomised (1:1:1) to usual practice plus either the emotional competence app, the CBT app or the self-monitoring app, by an independent computerised system, minimised by country, age, and self-reported gender, and followed up for 12 months post-randomisation. The primary outcome was mental wellbeing (indexed by the Warwick-Edinburgh Mental Well Being Scale [WEMWBS]) at 3-month follow-up, analysed in participants who completed the 3-month follow-up assessment. Outcome assessors were masked to group allocation. The study is registered with ClinicalTrials.gov, NCT04148508, and is closed.</p><p><strong>Findings: </strong>Between Oct 15, 2020, and Aug 3, 2021, 2532 participants were enrolled, and 847 were randomly assigned to the emotional competence app, 841 to the CBT app, and 844 to the self-monitoring app. Mean age was 19·2 years (SD 1·8). Of 2532 participants self-reporting gender, 1896 (74·9%) were female, 613 (24·2%) were male, 16 (0·6%) were neither, and seven (0·3%) were both. 425 participants in the emotional competence app group, 443 in the CT app group, and 447 in the self-monitoring app group completed the follow-up assessment at 3 months. There was no difference in mental wellbeing between the groups at 3 months (global p=0·47). The emotional competence app did not differ from the CBT app (mean difference in WEMWBS -0·21 [95% CI -1·08 to 0·66]) or the self-monitoring app (0·32 [-0·54 to 1·19]) and the CBT app did not differ from the self-monitoring app (0·53 [-0·33 to 1·39]). 14 of 1315 participants were admitted to or treated in hospital (or both) for mental health-related reasons, which were considered unrelated to the interventions (five participants in the emotional competence
{"title":"Emotional competence self-help mobile phone app versus cognitive behavioural self-help app versus self-monitoring app to promote mental wellbeing in healthy young adults (ECoWeB PROMOTE): an international, multicentre, parallel, open-label, randomised controlled trial.","authors":"Edward R Watkins, Fiona C Warren, Alexandra Newbold, Claire Hulme, Timothy Cranston, Benjamin Aas, Holly Bear, Cristina Botella, Felix Burkhardt, Thomas Ehring, Mina Fazel, Johnny R J Fontaine, Mads Frost, Azucena Garcia-Palacios, Ellen Greimel, Christiane Hößle, Arpine Hovasapian, Veerle E I Huyghe, Kostas Karpouzis, Johanna Löchner, Guadalupe Molinari, Reinhard Pekrun, Belinda Platt, Tabea Rosenkranz, Klaus R Scherer, Katja Schlegel, Bjorn W Schuller, Gerd Schulte-Korne, Carlos Suso-Ribera, Varinka Voigt, Maria Voß, Rod S Taylor","doi":"10.1016/S2589-7500(24)00149-3","DOIUrl":"10.1016/S2589-7500(24)00149-3","url":null,"abstract":"<p><strong>Background: </strong>Based on evidence that mental health is more than an absence of mental disorders, there have been calls to find ways to promote flourishing at a population level, especially in young people, which requires effective and scalable interventions. Despite their potential for scalability, few mental wellbeing apps have been rigorously tested in high-powered trials, derived from models of healthy emotional functioning, or tailored to individual profiles. We aimed to test a personalised emotional competence self-help app versus a cognitive behavioural therapy (CBT) self-help app versus a self-monitoring app to promote mental wellbeing in healthy young people.</p><p><strong>Methods: </strong>This international, multicentre, parallel, open-label, randomised controlled trial within a cohort multiple randomised trial (including a parallel trial of depression prevention) was done at four university trial sites in four countries (the UK, Germany, Spain, and Belgium). Participants were recruited from schools and universities and via social media from the four respective countries. Eligible participants were aged 16-22 years with well adjusted emotional competence profiles and no current or past diagnosis of major depression. Participants were randomised (1:1:1) to usual practice plus either the emotional competence app, the CBT app or the self-monitoring app, by an independent computerised system, minimised by country, age, and self-reported gender, and followed up for 12 months post-randomisation. The primary outcome was mental wellbeing (indexed by the Warwick-Edinburgh Mental Well Being Scale [WEMWBS]) at 3-month follow-up, analysed in participants who completed the 3-month follow-up assessment. Outcome assessors were masked to group allocation. The study is registered with ClinicalTrials.gov, NCT04148508, and is closed.</p><p><strong>Findings: </strong>Between Oct 15, 2020, and Aug 3, 2021, 2532 participants were enrolled, and 847 were randomly assigned to the emotional competence app, 841 to the CBT app, and 844 to the self-monitoring app. Mean age was 19·2 years (SD 1·8). Of 2532 participants self-reporting gender, 1896 (74·9%) were female, 613 (24·2%) were male, 16 (0·6%) were neither, and seven (0·3%) were both. 425 participants in the emotional competence app group, 443 in the CT app group, and 447 in the self-monitoring app group completed the follow-up assessment at 3 months. There was no difference in mental wellbeing between the groups at 3 months (global p=0·47). The emotional competence app did not differ from the CBT app (mean difference in WEMWBS -0·21 [95% CI -1·08 to 0·66]) or the self-monitoring app (0·32 [-0·54 to 1·19]) and the CBT app did not differ from the self-monitoring app (0·53 [-0·33 to 1·39]). 14 of 1315 participants were admitted to or treated in hospital (or both) for mental health-related reasons, which were considered unrelated to the interventions (five participants in the emotional competence","PeriodicalId":48534,"journal":{"name":"Lancet Digital Health","volume":" ","pages":""},"PeriodicalIF":23.8,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142378382","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-04DOI: 10.1016/S2589-7500(24)00148-1
Edward R Watkins, Fiona C Warren, Alexandra Newbold, Claire Hulme, Timothy Cranston, Benjamin Aas, Holly Bear, Cristina Botella, Felix Burkhardt, Thomas Ehring, Mina Fazel, Johnny R J Fontaine, Mads Frost, Azucena Garcia-Palacios, Ellen Greimel, Christiane Hößle, Arpine Hovasapian, Veerle E I Huyghe, Kostas Karpouzis, Johanna Löchner, Guadalupe Molinari, Reinhard Pekrun, Belinda Platt, Tabea Rosenkranz, Klaus R Scherer, Katja Schlegel, Bjorn W Schuller, Gerd Schulte-Korne, Carlos Suso-Ribera, Varinka Voigt, Maria Voß, Rod S Taylor
<p><strong>Background: </strong>Effective, scalable interventions are needed to prevent poor mental health in young people. Although mental health apps can provide scalable prevention, few have been rigorously tested in high-powered trials built on models of healthy emotional functioning or tailored to individual profiles. We aimed to test a personalised emotional competence app versus a cognitive behavioural therapy (CBT) self-help app versus a self-monitoring app to prevent an increase in depression symptoms in young people.</p><p><strong>Methods: </strong>This multicentre, parallel, open-label, randomised controlled trial, within a cohort multiple randomised trial (including a parallel trial of wellbeing promotion) was done at four university trial sites in the UK, Germany, Spain, and Belgium. Participants were recruited from schools, universities, and social media from the four respective countries. Eligible participants were aged 16-22 years with increased vulnerability indexed by baseline emotional competence profile, without current or past diagnosis of major depression. Participants were randomly assigned (1:1:1) to usual practice plus either the personalised emotional competence self-help app, the generic CBT self-help app, or the self-monitoring app by an independent computerised system, minimised by country, age, and self-reported gender, and followed up for 12 months post-randomisation. Outcome assessors were masked to group allocation. The primary outcome was depression symptoms (according to Patient Health Questionnaire-9 [PHQ-9]) at 3-month follow-up, analysed in participants who completed the 3-month follow-up assessment. The study is registered with ClinicalTrials.gov, NCT04148508, and is closed.</p><p><strong>Findings: </strong>Between Oct 15, 2020, and Aug 3, 2021, 1262 participants were enrolled, including 417 to the emotional competence app, 423 to the CBT app, and 422 to the self-monitoring app. Mean age was 18·8 years (SD 2·0). Of 1262 participants self-reporting gender, 984 (78·0%) were female, 253 (20·0%) were male, 15 (1·2%) were neither, and ten (0·8%) were both. 178 participants in the emotional competence app group, 191 in the CBT app group, and 199 in the self-monitoring app group completed the follow-up assessment at 3 months. At 3 months, depression symptoms were lower with the CBT app than the self-monitoring app (mean difference in PHQ-9 -1·18 [95% CI -2·01 to -0·34]; p=0·006), but depression symptoms did not differ between the emotional competence app and the CBT app (0·63 [-0·22 to 1·49]; p=0·15) or the self-monitoring app and emotional competence app (-0·54 [-1·39 to 0·31]; p=0·21). 31 of the 541 participants who completed any of the follow-up assessments received treatment in hospital or were admitted to hospital for mental health-related reasons considered unrelated to interventions (eight in the emotional competence app group, 15 in the CBT app group, and eight in the self-monitoring app group). No deaths o
{"title":"Emotional competence self-help app versus cognitive behavioural self-help app versus self-monitoring app to prevent depression in young adults with elevated risk (ECoWeB PREVENT): an international, multicentre, parallel, open-label, randomised controlled trial.","authors":"Edward R Watkins, Fiona C Warren, Alexandra Newbold, Claire Hulme, Timothy Cranston, Benjamin Aas, Holly Bear, Cristina Botella, Felix Burkhardt, Thomas Ehring, Mina Fazel, Johnny R J Fontaine, Mads Frost, Azucena Garcia-Palacios, Ellen Greimel, Christiane Hößle, Arpine Hovasapian, Veerle E I Huyghe, Kostas Karpouzis, Johanna Löchner, Guadalupe Molinari, Reinhard Pekrun, Belinda Platt, Tabea Rosenkranz, Klaus R Scherer, Katja Schlegel, Bjorn W Schuller, Gerd Schulte-Korne, Carlos Suso-Ribera, Varinka Voigt, Maria Voß, Rod S Taylor","doi":"10.1016/S2589-7500(24)00148-1","DOIUrl":"10.1016/S2589-7500(24)00148-1","url":null,"abstract":"<p><strong>Background: </strong>Effective, scalable interventions are needed to prevent poor mental health in young people. Although mental health apps can provide scalable prevention, few have been rigorously tested in high-powered trials built on models of healthy emotional functioning or tailored to individual profiles. We aimed to test a personalised emotional competence app versus a cognitive behavioural therapy (CBT) self-help app versus a self-monitoring app to prevent an increase in depression symptoms in young people.</p><p><strong>Methods: </strong>This multicentre, parallel, open-label, randomised controlled trial, within a cohort multiple randomised trial (including a parallel trial of wellbeing promotion) was done at four university trial sites in the UK, Germany, Spain, and Belgium. Participants were recruited from schools, universities, and social media from the four respective countries. Eligible participants were aged 16-22 years with increased vulnerability indexed by baseline emotional competence profile, without current or past diagnosis of major depression. Participants were randomly assigned (1:1:1) to usual practice plus either the personalised emotional competence self-help app, the generic CBT self-help app, or the self-monitoring app by an independent computerised system, minimised by country, age, and self-reported gender, and followed up for 12 months post-randomisation. Outcome assessors were masked to group allocation. The primary outcome was depression symptoms (according to Patient Health Questionnaire-9 [PHQ-9]) at 3-month follow-up, analysed in participants who completed the 3-month follow-up assessment. The study is registered with ClinicalTrials.gov, NCT04148508, and is closed.</p><p><strong>Findings: </strong>Between Oct 15, 2020, and Aug 3, 2021, 1262 participants were enrolled, including 417 to the emotional competence app, 423 to the CBT app, and 422 to the self-monitoring app. Mean age was 18·8 years (SD 2·0). Of 1262 participants self-reporting gender, 984 (78·0%) were female, 253 (20·0%) were male, 15 (1·2%) were neither, and ten (0·8%) were both. 178 participants in the emotional competence app group, 191 in the CBT app group, and 199 in the self-monitoring app group completed the follow-up assessment at 3 months. At 3 months, depression symptoms were lower with the CBT app than the self-monitoring app (mean difference in PHQ-9 -1·18 [95% CI -2·01 to -0·34]; p=0·006), but depression symptoms did not differ between the emotional competence app and the CBT app (0·63 [-0·22 to 1·49]; p=0·15) or the self-monitoring app and emotional competence app (-0·54 [-1·39 to 0·31]; p=0·21). 31 of the 541 participants who completed any of the follow-up assessments received treatment in hospital or were admitted to hospital for mental health-related reasons considered unrelated to interventions (eight in the emotional competence app group, 15 in the CBT app group, and eight in the self-monitoring app group). No deaths o","PeriodicalId":48534,"journal":{"name":"Lancet Digital Health","volume":" ","pages":""},"PeriodicalIF":23.8,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142378381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/S2589-7500(24)00170-5
Sarah Jiang , Perisa Ashar , Md Mobashir Hasan Shandhi , Jessilyn Dunn
The PhysioNet open access database (PND) is one of the world's largest and most comprehensive repositories of biosignal data and is widely used by researchers to develop, train, and validate algorithms. To contextualise the results of such algorithms, understanding the underlying demographic distribution of the data is crucial—specifically, the race, ethnicity, sex or gender, and age of study participants. We sought to understand the underlying reporting patterns and characteristics of the demographic data of the datasets available on PND. Of the 181 unique datasets present in the PND as of July 6, 2023, 175 involved human participants, with less than 7% of studies reporting on all four of the key demographic variables. Furthermore, we found a higher rate of reporting sex or gender and age than race and ethnicity. In the studies that did include participant sex or gender, the samples were mostly male. Additionally, we found that most studies were done in North America, particularly in the USA. These imbalances and poor reporting of representation raise concerns regarding potential embedded biases in the algorithms that rely on these datasets. They also underscore the need for universal and comprehensive reporting practices to ensure equitable development and deployment of artificial intelligence and machine learning tools in medicine.
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