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This study analyzes the life stories of eight young people living with vertically transmitted HIV in order to understand their perceptions marked by secrecy and silence regarding their experiences with the virus. Conducted at a specialized outpatient clinic in Rio de Janeiro, the study adopted circle dance, a Complementary and Integrative Health Practice, as a care tool. Using a qualitative approach and Life History as a data collection method, the focus was to understand the youth’s experiences related to the disease and the crucial aspects of their lives. Three girls and five boys participated in the study, all aware of their diagnosis. The principal emerging themes included family dynamics, school environment connection, challenges in treatment adherence, age at the time of diagnosis disclosure, and time elapsed since then. Analyzing these young people’s narratives allowed us to explore individual and social aspects of their experiences, revealing their similarities and differences. The circle dance workshops provided a playful space for expressing emotions and feelings through body movements, expanding young people’s perspectives on the future. [ABSTRACT FROM AUTHOR]

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This article discusses the topic of clinical trial transparency and disclosure from the perspective of medical writing. It highlights the changes and developments in regulations and policies governing the public disclosure of clinical trial data and documents, including the implementation of the EU Clinical Trials Regulation and the impact of the COVID-19 pandemic. The article emphasizes the importance of staying up to date with these changes and provides resources for updates and insights. It also covers various aspects of clinical trial transparency and disclosure, such as the protection of personal data, transitioning trials to new regulations, plain language summaries of trial results, and the challenges of regional differences in transparency requirements. The article concludes by mentioning upcoming articles that will further explore different aspects of clinical trial transparency and disclosure. [Extracted from the article]

The article focuses on the relaunch of EMA (European Medicines Agency) Clinical Data Publication Policy 0070, effective from September 2023. It provides key details such as scope, early preparation recommendations for sponsors, the new Q&A document, and the use of a structured Anonymisation Report template. It also highlights the continuation of COVID-19 and public health emergency clinical data publication.

The article discusses the journey towards clinical research transparency. It highlights the importance of publicly sharing research results and the creation of registries like ClinicalTrials.gov and the EU Clinical Trials Information System. The article also mentions the launch of the EMA clinical data site and the Health Canada Public Release of Clinical Information initiative. Medical writers are recognized as champions of data transparency and public disclosure in healthcare. The article concludes by mentioning that transparency and disclosure are still developing in other fields of research. [Extracted from the article]

As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which contain sensitive and confidential information about company intellectual property including, but not limited to, its manufacturing methods, drug composition, names of suppliers, and future development plans. Many manufacturers are examining their processes to minimise references to this confidential data during the document authoring process and how they track and identify confidential information throughout the study lifecycle. This has created a catalyst for medical writing, transparency, legal, and regulatory teams to collaborate and enhance their processes to minimise disruption to the trial approval process while embracing the opportunities to share more with the public. [ABSTRACT FROM AUTHOR]

The article discusses the development of clinical trial registries in China, including the launch of the ChinaDrugTrials.org.cn platform in 2013. It outlines key events in the establishment of the National Clinical Trial Registry and the regulations requiring trial registration. It also mentions concerns about the consistent posting of trial results and suggests the need for data exchange between registries to improve transparency.

People with HIV (PWH) and community members have advocated for the development of a home-based viral load test device that could make analytical treatment interruptions (ATIs) less burdensome. We assessed community acceptability of a novel home-based viral load test device. In 2021, we conducted 15 interviews and 3 virtual focus groups with PWH involved in HIV cure research. We used conventional thematic analysis to analyze the data. PWH viewed the home-based viral load test device as a critical adjunct in ongoing HIV cure trials with ATIs. The ability to test for viral load at home on demand would alleviate anxiety around being off ART. Participants drew parallels with glucometers used for diabetes. A preference was expressed for the home-based test to clearly indicate whether one was detectable or undetectable for HIV to mitigate risk of HIV transmission to partners. Perceived advantages of the device included convenience, sense of control, and no puncturing of veins. Perceived concerns were possible physical marks, user errors and navigating the logistics of mailing samples to a laboratory and receiving test results. Participants expressed mixed effects on stigma, such as helping normalize HIV, but increased potential for inadvertent disclosure of HIV status or ATI participation. Increasing pluri-potency of the device beyond viral load testing (e.g., CD4+ count test) would increase its utility. Participants suggested pairing the device with telemedicine and mobile health technologies. If proven effective, the home-based viral load test device will become a critical adjunct in HIV cure research and HIV care. [ABSTRACT FROM AUTHOR]

The article discusses the importance of clinical trial transparency and disclosure in the medical writing field. It highlights the challenges of navigating new regulations and expectations while protecting personal data and commercially confidential information. The article emphasizes the need for medical writers to find a balance between openness and protection. It also mentions the push for plain language summaries and the potential use of AI to improve accessibility and engagement. The article acknowledges the complexity of transparency in a global context and emphasizes the importance of accurate and meaningful information. The author encourages continuous learning and staying informed about best practices in order to uphold the highest standards of transparency while protecting privacy and integrity. [Extracted from the article]

Victims of Childhood Sexual Abuse (CSA) may be met with skeptical responses when they disclose their experience. The fear of such a response means that most victims delay telling anyone about the abuse. The aim of this study was to explore how contextual factors of abuse such as victim gender and age, perpetrator gender, and victim-perpetrator relationship affect a response to CSA. Further, we explored what personality traits may predict a skeptical response. An online questionnaire with 357 undergraduate students asked participants to read a vignette describing CSA, and to indicate the extent to which they believed the vignette, whether they blamed the victim or perpetrator, and what punishment they would recommend for the perpetrator. Results indicated that older victims were less likely to be believed and more likely to be blamed than younger victims. Further, we found more blame was placed on a perpetrator of intrafamilial abuse compared with extrafamilial abuse, but only if the perpetrator was male. Female perpetrators were punished less harshly than male perpetrators, but female intrafamilal perpetrators received harsher punishment than female extrafamilial perpetrators. No such effect was found for male perpetrators. Openness to Experience was associated with a more supportive response to CSA, as was Agreeableness. Implications and future directions are discussed. [ABSTRACT FROM AUTHOR]

The article present an overview of the current clinical trial disclosure landscape in Asia, specifically in four countries, China, Japan, South Korea, and Taiwan. It discusses the mandatory national clinical trial registries in these countries, their requirements for trial registration before subject enrollment, and the posting of trial results. It highlights the differences in results posting timelines and the format of posted results in these countries.

In this article, I summarise how, as a medical writer with over 20 years of experience in regulatory writing, all with a contract research organisation, I transitioned into the world of disclosure and how I now have my feet firmly in both camps: regulatory medical writing and clinical trial disclosure. I describe how disclosure captured my attention and the subsequent actions I have taken. [ABSTRACT FROM AUTHOR]

Increased transparency is one of the provisions of the Clinical Trial and Medical Device Regulations. This article discusses the impact of transparency and disclosure on medical devices. Many modern-day medical devices are software-driven. These, as well as the patients implanted with or wearing these devices, have become part of the so-called Internet of Things, and are therefore vulnerable to cyber attacks. Disclosure of information, data, and documents pertaining to medical devices will increase this vulnerability. In the rapidly changing regulatory landscape, the role of medical writers in anonymisation of patient data takes on a whole new magnitude. It is not only about protecting patient privacy, it is about ensuring patient safety. [ABSTRACT FROM AUTHOR]

We welcome Ms Woolrich's response to our guest editorial entitled "Surviving clinical errors in practice" as representing the perspective of the insurance industry in this complex issue faced regularly by veterinarians. Ms Woolrich recommends that insurance companies should be primarily involved in decisions on how to communicate clinical errors to clients to minimise the risk of litigation. We particularly welcome the argument made by Ms Woolrich that insurance companies can play a supporting role for veterinarians in navigating the difficulties of disclosing errors made in clinical practice to minimise litigation. [Extracted from the article]

Background: Mobile health (mHealth) provides a new opportunity for disease prediction and patient health self-management. However, privacy problems in mHealth have drawn significant attention to patients' online health information disclosure and to the possibility that privacy concerns may hinder mHealth development. Objective: Privacy calculus theory (PCT) has been widely used to understand personal information disclosure behaviors with the basic assumption of a rational and linear decision-making process. However, cognitive behavior processes are complex and mutual. In an attempt to gain a fuller understanding of information disclosure behavior, we further optimize a PCT-based information disclosure model by identifying the mutual relationship between costs (privacy concerns) and benefits. Social support, which has been proven to be a distinct and significant disclosure benefit of mHealth, was chosen as the representative benefit of information disclosure. Methods: We examine a structural equation model that incorporates privacy concerns, health information disclosure intention in mHealth, and social support from mHealth, all at the individual level. Results: A validated questionnaire was completed by 253 randomly selected participants. The result indicated that perceived health information sensitivity positively enhances patients' privacy concern (beta path coefficient 0.505, P <.001), and higher privacy concern levels will decrease their health information disclosure intention (beta path coefficient –0.338, P <.001). Various individual characteristics influence perceived health information sensitivity in different ways. One dimension of social support, informational support, negatively moderates the effect of the relationship between perceived health information sensitivity and privacy concerns (beta path coefficient –0.171, P =.092) and the effect of the relationship between privacy concerns and health information disclosure intention (beta path coefficient –0.105, P =.092). However, another dimension, emotional support, has no direct moderation effect on the relationship between privacy concerns and health information disclosure intention. Conclusions: The results indicate that social support can be regarded as a disutility reducer. That is, on the one hand, it reduces patients' privacy concerns; on the other hand, it also reduces the negative impact of privacy concerns on information disclosure intention. Moreover, the moderation effect of social support is partially supported. Informational support, one dimension of social support, is significant (beta path coefficient –0.171, P =.092), while the other dimension, emotional support, is not significant (beta path coefficient –0.137, P =.146), in mHealth. Furthermore, the results are different among patients with different individual characteristics. This study also provides specific theoretical and practical implications to enhance the development of mHealth. JMIR Mhealth Uhealth 2021;9(2):e19594 doi:10.2196/19594 [ABSTRACT FROM AUTHOR]

An introduction is presented in which the editors discuss the theme of the issue, providing articles related to public disclosure of clinical data.