Successes and Opportunities during the Pandemic: Reflections and Revelations from a Vaccine Development Perspective.

The Centre of Regulatory Excellence (CoRE) launched an annual lecture series in 2021 in Singapore to honor the memory of the late Professor Sir Alasdair Breckenridge, CoRE's founding Chair, and foster dialogue on global biomedical and regulatory perspectives, challenges, and advances. The 2022 Sir Alasdair Breckenridge Lecture "Success and Opportunities in the Pandemic" was delivered by Dr Penny M Heaton, former CEO of the Bill & Melinda Gates Foundation Research Institute and current Global Therapeutics Lead for Vaccines at Johnson & Johnson. Dr Heaton highlighted key lessons on the importance of trust, collaboration, and transparency in the context of health care and vaccine production.

Education on Depression in Mental Health Apps: Systematic Assessment of Characteristics and Adherence to Evidence-Based Guidelines.

BACKGROUND: Suboptimal understanding of depression and mental health disorders by the general population is an important contributor to the wide treatment gap in depression. Mental health literacy encompasses knowledge and beliefs about mental disorders and supports their recognition, management, and prevention. Besides knowledge improvement, psychoeducational interventions reduce symptoms of depression, enhance help-seeking behavior, and decrease stigma. Mental health apps often offer educational content, but the trustworthiness of the included information is unclear. OBJECTIVE: The aim of this study is to systematically evaluate adherence to clinical guidelines on depression of the information offered by mental health apps available in major commercial app stores. METHODS: A systematic assessment of the educational content regarding depression in the apps available in the Apple App Store and Google Play was conducted in July 2020. A systematic search for apps published or updated since January 2019 was performed using 42matters. Apps meeting the inclusion criteria were downloaded and assessed using two smartphones: an iPhone 7 (iOS version 14.0.1) and a Sony XPERIA XZs (Android version 8.0.0). The 156-question assessment checklist comprised general characteristics of apps, appraisal of 38 educational topics and their adherence to evidence-based clinical guidelines, as well as technical aspects and quality assurance. The results were tabulated and reported as a narrative review, using descriptive statistics. RESULTS: The app search retrieved 2218 apps, of which 58 were included in the analysis (Android apps: n=29, 50%; iOS apps: n=29, 50%). Of the 58 included apps, 37 (64%) apps offered educational content within a more comprehensive depression or mental health management app. Moreover, 21% (12/58) of apps provided non-evidence-based information. Furthermore, 88% (51/58) of apps included up to 20 of the educational topics, the common ones being listing the symptoms of depression (52/58, 90%) and available treatments (48/58, 83%), particularly psychotherapy. Depression-associated stigma was mentioned by 38% (22/58) of the apps, whereas suicide risk was mentioned by 71% (41/58), generally as an item in a list of symptoms. Of the 58 included apps, 44 (76%) highlighted the importance of help seeking, 29 (50%) emphasized the importance of involving the user's support network. In addition, 52% (30/58) of apps referenced their content, and 17% (10/58) included advertisements. CONCLUSIONS: Information in mental health and depression apps is often brief and incomplete, with 1 in 5 apps providing non-evidence-based information. Given the unmet needs and stigma associated with the disease, it is imperative that apps seize the opportunity to offer quality, evidence-based education or point the users to relevant resources. A multistakeholder consensus on a more stringent development and publication process for mental health apps is essential.

Early detection of eating disorders: a scoping review.

PURPOSE: Early detection of eating disorders (EDs) could improve their prognosis, decrease morbidity and mortality, and prevent the risk of evolution towards a chronic form and somatic, psychiatric and psychosocial complications. The objective of this review was to examine the current scientific data concerning the early detection of EDs, which is one of the facets of secondary prevention. METHOD: A scoping literature review was carried out following the PRISMA-ScR criteria, including all articles on ED detection published up to 2021 on PUBMED and PSYCINFO. RESULTS: 43 articles were included. Anorexia nervosa and bulimia nervosa were the most widely studied disorders. The articles focused on professionals from the medical field (GPs, psychiatrists, gynaecologists, gastroenterologists and residents), from the paramedical field, from education and sport, and from the general population. The assessments conducted with the professionals receiving interventions aiming to improve detection demonstrated their efficacy. Interventions for ED detection in the general population and at school seemed less efficacious. CONCLUSION: The results highlighted some lines of action to be implemented. They pointed towards improving initial and continuing education for professional carers; e-learning could be an interesting solution for continuing education. Improving training with specific instructors, school personnel and sports professionals is also one of the solutions for a better detection of EDs. Specific recommendations could be published for fitness centre professionals to help them to deal with clients suspected of having an ED. Among secondary school students and in the general population, a better dissemination of mental health literacy and the development of mental health first aid programs could help improve early detection. LEVEL OF EVIDENCE: Level I: Evidence obtained from systematic reviews.

Self-guided Cognitive Behavioral Therapy Apps for Depression: Systematic Assessment of Features, Functionality, and Congruence With Evidence.

BACKGROUND: Mental health disorders affect 1 in 10 people globally, of whom approximately 300 million are affected by depression. At least half of the people affected by depression remain untreated. Although cognitive behavioral therapy (CBT) is an effective treatment, access to mental health specialists, habitually challenging, has worsened because of the COVID-19 pandemic. Internet-based CBT is an effective and feasible strategy to increase access to treatment for people with depression. Mental health apps may further assist in facilitating self-management for people affected by depression; however, accessing the correct app may be cumbersome given the large number and wide variety of apps offered by public app marketplaces. OBJECTIVE: This study aims to systematically assess the features, functionality, data security, and congruence with evidence of self-guided CBT-based apps targeting users affected by depression that are available in major app stores. METHODS: We conducted a systematic assessment of self-guided CBT-based apps available in Google Play and the Apple App Store. Apps launched or updated since August 2018 were identified through a systematic search in the 42matters database using CBT-related terms. Apps meeting the inclusion criteria were downloaded and assessed using a Samsung Galaxy J7 Pro (Android 9) and iPhone 7 (iOS 13.3.1). Apps were appraised using a 182-question checklist developed by the research team, assessing their general characteristics, technical aspects and quality assurance, and CBT-related features, including 6 evidence-based CBT techniques (ie, psychoeducation, behavioral activation, cognitive restructuring, problem solving, relaxation, and exposure for comorbid anxiety) as informed by a CBT manual, CBT competence framework, and a literature review of internet-based CBT clinical trial protocols. The results were reported as a narrative review using descriptive statistics. RESULTS: The initial search yielded 3006 apps, of which 98 met the inclusion criteria and were systematically assessed. There were 20 well-being apps; 65 mental health apps, targeting two or more common mental health disorders, including depression; and 13 depression apps. A total of 28 apps offered at least four evidence-based CBT techniques, particularly depression apps. Cognitive restructuring was the most common technique, offered by 79% (77/98) of the apps. Only one-third of the apps offered suicide risk management resources, whereas 17% (17/98) of the apps offered COVID-19-related information. Although most apps included a privacy policy, only a third of the apps presented it before account creation. In total, 82% (74/90) of privacy policies stated sharing data with third-party service providers. Half of the app development teams included academic institutions or health care providers. CONCLUSIONS: Only a few self-guided CBT-based apps offer comprehensive CBT programs or suicide risk management resources. Sharing of users' data is widespread, highlighting shortcomings in health app market governance. To fulfill their potential, self-guided CBT-based apps should follow evidence-based clinical guidelines, be patient centered, and enhance users' data security.

Accuracy of diagnostic judgments using ICD-11 vs. ICD-10 diagnostic guidelines for obsessive-compulsive and related disorders.

BACKGROUND: We report results of an internet-based field study evaluating the diagnostic guidelines for the newly introduced ICD-11 grouping of obsessive-compulsive and related disorders (OCRD). We examined accuracy of clinicians' diagnostic judgments applying draft ICD-11 as compared to the ICD-10 diagnostic guidelines to standardized case vignettes. METHODS: 1,717 mental health professionals who are members of the World Health Organization's Global Clinical Practice Network completed the study in Chinese, English, French, Japanese, Russian or Spanish. Participants were randomly assigned to apply ICD-11 or ICD-10 guidelines to one of nine pairs of case vignettes. RESULTS: Participants using ICD-11 outperformed those using ICD-10 in correctly identifying newly introduced OCRD, although results were mixed for differentiating OCRD from disorders in other groupings largely due to clinicians having difficulty differentiating challenging presentations of OCD. Clinicians had difficulty applying a three-level insight qualifier, although the 'poor to absent' level assisted with differentiating OCRD from psychotic disorders. Brief training on the rationale for an OCRD grouping did not improve diagnostic accuracy suggesting sufficient detail of the proposed guidelines. LIMITATIONS: Standardized case vignettes were manipulated to include specific characteristics; the degree of accuracy of clinicians' diagnostic judgments about these vignettes may not generalize to application in routine clinical practice. CONCLUSIONS: Overall, use of the ICD-11 guidelines resulted in more accurate diagnosis of case vignettes compared to the ICD-10 guidelines, particularly in differentiating OCRD presentations from one another. Specific areas in which the ICD-11 guidelines did not perform as intended provided the basis for further revisions to the guidelines.

How service users and carers understand, perceive, rephrase, and communicate about "depressive episode" and "schizophrenia" diagnoses: an international participatory research.

BACKGROUND: For ICD-11, the WHO emphasized the clinical utility of communication and the need to involve service users and carers in the revision process. AIMS: The objective was to assess whether medical vocabulary was accessible, which kinds of feelings it activated, whether and how users and carers would like to rephrase terms, and whether they used diagnosis to talk about mental health experiences. METHOD: An innovative protocol focused on two diagnoses (depressive episode and schizophrenia) was implemented in 15 different countries. The same issues were discussed with users and carers: understanding, feelings, rephrasing, and communication. RESULTS: Most participants reported understanding the diagnoses, but associated them with negative feelings. While the negativity of "depressive episode" mostly came from the concept itself, that of "schizophrenia" was largely based on its social impact and stigmatization associated with "mental illness". When rephrasing "depressive episode", a majority kept the root "depress*", and suppressed the temporal dimension or renamed it. Almost no one suggested a reformulation based on "schizophrenia". Finally, when communicating, no one used the phrase "depressive episode". Some participants used words based on "depress", but no one mentioned "episode". Very few used "schizophrenia". CONCLUSION: Data revealed a gap between concepts and emotional and cognitive experiences. Both professional and experiential language and knowledge have to be considered as complementary. Consequently, the ICD should be co-constructed by professionals, service users, and carers. It should take the emotional component of language, and the diversity of linguistic and cultural contexts, into account.

The classification of feeding and eating disorders in the ICD-11: results of a field study comparing proposed ICD-11 guidelines with existing ICD-10 guidelines.

BACKGROUND: The World Health Organization (WHO) International Classification of Diseases and Related Health Problems (ICD) is used globally by 194 WHO member nations. It is used for assigning clinical diagnoses, providing the framework for reporting public health data, and to inform the organization and reimbursement of health services. Guided by overarching principles of increasing clinical utility and global applicability, the 11th revision of the ICD proposes major changes that incorporate empirical advances since the previous revision in 1992. To test recommended changes in the Mental, Behavioral, and Neurodevelopmental Disorders chapter, multiple vignette-based case-controlled field studies have been conducted which examine clinicians' ability to accurately and consistently use the new guidelines and assess their overall clinical utility. This manuscript reports on the results from the study of the proposed ICD-11 guidelines for feeding and eating disorders (FEDs). METHOD: Participants were 2288 mental health professionals registered with WHO's Global Clinical Practice Network. The study was conducted in Chinese, English, French, Japanese, and Spanish. Clinicians were randomly assigned to apply either the ICD-11 or ICD-10 diagnostic guidelines for FEDs to a pair of case vignettes designed to test specific clinical questions. Clinicians selected the diagnosis they thought was correct for each vignette, evaluated the presence of each essential feature of the selected diagnosis, and the clinical utility of the diagnostic guidelines. RESULTS: The proposed ICD-11 diagnostic guidelines significantly improved accuracy for all FEDs tested relative to ICD-10 and attained higher clinical utility ratings; similar results were obtained across all five languages. The inclusion of binge eating disorder and avoidant-restrictive food intake disorder reduced the use of residual diagnoses. Areas needing further refinement were identified. CONCLUSIONS: The proposed ICD-11 diagnostic guidelines consistently outperformed ICD-10 in distinguishing cases of eating disorders and showed global applicability and appropriate clinical utility. These results suggest that the proposed ICD-11 guidelines for FEDs will help increase accuracy of public health data, improve clinical diagnosis, and enhance health service organization and provision. This is the first time in the revision of the ICD that data from large-scale, empirical research examining proposed guidelines is completed in time to inform the final diagnostic guidelines.

Why and how to support depsychiatrisation of adult transidentity in ICD-11: A French study.

BACKGROUND: For the 11th version of the International Classification of Diseases, the WHO recommended to rename transgender transidentity as "gender incongruence", to remove it from the chapter of mental and behavioral disorders, and to put it in a new category titled "Conditions related to sexual health". This should contribute to reduce stigmatisation while maintaining access to medical care. One argument in favor of depsychiatrisation is to demonstrate that essential features of gender identity disorders, namely psychological distress and functional impairment, are not necessarily reported by every transgender person, and may result from social rejection and violence rather than dysphoria itself. Initially confirmed in Mexico, these hypotheses were tested in a specific French medical context, where access to care does not require any prior mental health evaluation or diagnosis. METHOD: In 2017, 72 transgender persons completed retrospective interviews which focused on the period when they became aware that they might be transgender and perhaps would need to do something about it. RESULTS: Results showed that psychological distress and functional impairment were not reported by every participant, that they may result from rejection and violence, and especially from rejection and violence coming from coworkers and schoolmates. Additional data showed that the use of health services for body transformation did not depend on distress and dysfunction. Finally, participants preferred ICD 11 to employ "transgender" or "transidentity" rather than "gender incongruence". CONCLUSION: Results support depsychiatrisation. They are discussed in terms of medical, ethical, legal, and social, added values and implications of depsychiatrisation.

Anxiety and Fear-Related Disorders in the ICD-11: Results from a Global Case-controlled Field Study.

BACKGROUND: This article reports the results of one of a series of global field studies implemented by the World Health Organization (WHO) to evaluate the accuracy, clinical utility, and global applicability of the new diagnostic guidelines for Mental, Behavioural and Neurological Disorders included in the next version of WHO's International Classification of Diseases (ICD-11). AIMS OF THE STUDY: The purpose of this study was to compare the diagnostic accuracy and clinical utility ratings of global clinicians implementing the ICD-11 diagnostic guidelines for Anxiety and Fear-Related Disorders, relative to those applying ICD-10 guidelines. The study also aimed to identify elements of the guidelines that required further refinement or clarification. METHODS: 1840 global mental health professionals registered with WHO's Global Clinical Practice Network completed the study in one of six study languages. Participants were randomly assigned to apply either the ICD-11 or ICD-10 guidelines to diagnose standardized case vignettes, and to rate the clinical utility of their assigned guidelines. RESULTS: ICD-11's diagnostic accuracy and clinical utility were equivalent or superior to that of ICD-10. Global clinicians were significantly more accurate in diagnosing Generalized Anxiety Disorder, Specific Phobia and adult cases of Separation Anxiety Disorder when using ICD-11 and provided high clinical utility ratings for these disorders. Clinicians also found the ICD-11 guidelines easy to use, clear, and a good fit to patients they see in their clinical practice. However, clinicians had difficulty with distinguishing the boundary between disorder and normality for subthreshold cases of anxiety, and also with applying the new ICD-11 guidelines on panic attacks. CONCLUSIONS: The new diagnostic guidelines for Anxiety Disorders in ICD-11 can be applied in an acceptably consistent manner by global clinicians and perform as well or better than the previous guidelines for ICD-10. Study findings also helped identify aspects of the ICD-11 guidelines that required refinement prior to their publication and areas that should be emphasized in training programs.

Do mental health professionals use diagnostic classifications the way we think they do? A global survey.

We report on a global survey of diagnosing mental health professionals, primarily psychiatrists, conducted as a part of the development of the ICD-11 mental and behavioural disorders classification. The survey assessed these professionals' use of various components of the ICD-10 and the DSM, their attitudes concerning the utility of these systems, and usage of "residual" (i.e., "other" or "unspecified") categories. In previous surveys, most mental health professionals reported they often use a formal classification system in everyday clinical work, but very little is known about precisely how they are using those systems. For example, it has been suggested that most clinicians employ only the diagnostic labels or codes from the ICD-10 in order to meet administrative requirements. The present survey was conducted with clinicians who were members of the Global Clinical Practice Network (GCPN), established by the World Health Organization as a tool for global participation in ICD-11 field studies. A total of 1,764 GCPN members from 92 countries completed the survey, with 1,335 answering the questions with reference to the ICD-10 and 429 to the DSM (DSM-IV, DSM-IV-TR or DSM-5). The most frequent reported use of the classification systems was for administrative or billing purposes, with 68.1% reporting often or routinely using them for that purpose. A bit more than half (57.4%) of respondents reported often or routinely going through diagnostic guidelines or criteria systematically to determine whether they apply to individual patients. Although ICD-10 users were more likely than DSM-5 users to utilize the classification for administrative purposes, other differences were either slight or not significant. Both classifications were rated to be most useful for assigning a diagnosis, communicating with other health care professionals and teaching, and least useful for treatment selection and determining prognosis. ICD-10 was rated more useful than DSM-5 for administrative purposes. A majority of clinicians reported using "residual" categories at least sometimes, with around 12% of ICD-10 users and 19% of DSM users employing them often or routinely, most commonly for clinical presentations that do not conform to a specific diagnostic category or when there is insufficient information to make a more specific diagnosis. These results provide the most comprehensive available information about the use of diagnostic classifications of mental disorders in ordinary clinical practice.

Homelessness and stakeholders' involvement in the Grand Duchy of Luxembourg: a qualitative study.

BACKGROUND: In 2013, between 150 and 200 people per night in the Grand Duchy of Luxembourg are estimated roofless. Abilities to respond to emergencies in the GDL are perceptibly decreased due to longer stays in emergency shelters. This study aimed to analyse the needs of long-term homeless (LTH) individuals and to put forward professional recommendations to improve support and care for homeless individuals. METHODS: A local, cross-sectional, qualitative study carried out between February and September 2013 in the GDL. Semi-structured interviews and focus groups were conducted with homeless people living in Caritas housing facilities permanently over a period of 2 years or temporarily over a period of 3 years, as well as Caritas professionals and Luxembourgish psychiatrists. They mainly focused on the homeless person's life pathways, needs and expectations, and difficulties encountered. RESULTS: Twenty-two homeless persons, 13 professionals from Caritas and three Luxembourgish psychiatrists participated. Homeless persons' needs and expectations consist of the following: (i) seeking freedom and peacefulness, (ii) having their own space, being independent and (iii) living like everyone else. Professionals mainly complained about difficulties for supporting LTH persons and the lack of collaboration with Luxembourg stakeholders from social and psychiatric departments. CONCLUSION: This study has found that the current approach is not appropriate for the management of LTHness in the country. This study recommends changes within the Caritas facilities and outside, on the basis of three concepts: (i) a decent home as an essential need, (ii) respect of freedom of choice and (iii) a housing-first model.