Background The ability to perform vape tricks (ie, blowing large vapor clouds or shapes like rings) using e-cigarettes appeals to youth. Vape tricks are promoted on social media, but the promotion of vape tricks on social media is not well understood. Objective The aim of this study was to examine how vape tricks were promoted on YouTube to youth. Methods Videos on vape tricks that could be accessed by underage youth were identified. The videos were coded for number of views, likes, dislikes, and content (ie, description of vape tricks, e-cigarette devices used for this purpose, video sponsors [private or industry], brand marketing, and contextual characteristics [eg, model characteristics, music, and profanity]). Results An analysis of 59 sample videos on vape tricks identified 25 distinct vape tricks. These videos had more likes than dislikes (11 to 1 ratio) and a 32,017 median view count. 48% (28/59) of the videos were posted by industry accounts (27% [16/59] provaping organizations, 15% [9/59] online shops, and 3% [2/59] vape shops) and 53% by private accounts (55% [17/31] private users, 26% [8/31] vape enthusiasts, and 19% [6/31] YouTube influencers); 53% (31/59) of the videos promoted a brand of e-cigarette devices, e-liquids, or online/vape shops, and 99% of the devices used for vape tricks were advanced generation devices. The models in the videos were 80.2% (160/198) male, 51.5% white (102/198), and 61.6% (122/198) aged 18 to 24 years; 85% (50/59) of the videos had electronic dance music and hip hop, and 32% (19/59) had profanity. Conclusions Vape trick videos on YouTube, about half of which were industry sponsored, were accessible to youth. Restrictions of e-cigarette marketing on social media, such as YouTube, are needed.
Background At the onset of the COVID-19 pandemic, there was limited understanding of symptom experience and disease progression. We developed and validated a fit-for-purpose disease-specific instrument to assess symptoms in patients with COVID-19 to inform endpoints in an interventional trial for non-hospitalized patients. Methods The initial drafting of the 23-item Symptoms Evolution of COVID-19 (SE-C19) Instrument was developed based on the Centers for Disease Control and Prevention symptom list and available published literature specific to patients with COVID-19 as of Spring 2020. The measurement principles outlined in the Food and Drug Administration (FDA) Patient-Reported Outcomes (PRO) guidance and the FDA's series of four methodological Patient-Focused Drug Development guidance documents were also considered. Following initial development, semi-structured qualitative interviews were conducted with a purposive sample of 30 non-hospitalized COVID-19 patients. Interviews involved two stages: (1) concept elicitation, to obtain information about the symptoms experienced as a result of COVID-19 in the patients’ own words, and (2) cognitive debriefing, for patients to describe their understanding of the SE-C19 instructions, specific symptoms, response options, and recall period to ensure the content of the SE-C19 is relevant and comprehensive. Five clinicians treating COVID-19 outpatients were also interviewed to obtain their insights on symptoms experienced by patients and provide input on the SE-C19. Results Patients reported no issues regarding the relevance or appropriateness of the SE-C19 instructions, including the 24-h recall period. The comprehensiveness of the SE-C19 was confirmed against the conceptualization of the patient experience of symptoms developed in the qualitative research. Minor conceptual gaps were revealed to capture nuances in the experience of nasal and gustatory symptoms and systemic manifestations of sickness. Almost all items were endorsed by patients as being appropriate, well understood, and easy to respond to. The clinicians largely approved all items, response options, and recall period. Conclusions The qualitative research provided supportive evidence of the content validity of the SE-C19 to assess the symptoms of outpatients with COVID-19, and its use in clinical trials to evaluate the benefit of treatment. Minor changes may be considered to improve conceptual clarity and ease of responding.
ObjectivesThere is little in-depth qualitative evidence of how symptoms manifest themselves in outpatients with COVID-19 and how these in turn impact outpatients’ daily lives. The objective of the study was therefore to explore the experience of outpatients with COVID-19 qualitatively, concerning the symptomatic experience and its subsequent impact on daily life.SettingQualitative research study comprising virtual in-depth, open-ended interviews with outpatients and clinicians.ParticipantsThirty US adult patients with COVID-19 were interviewed within 21 days of diagnosis. Patients were 60% female and 87% white, who had to self-report one of the following: fever, cough, shortness of breath/difficulty breathing, change/loss of taste/smell, vomiting/diarrhoea or body/muscle aches. Five independent clinicians were also interviewed about their experience treating outpatients.Primary and secondary outcome measuresTranscripts were analysed thematically to organise symptoms and impacts of daily life into higher-order overarching categories, and subsequently propose a conceptual model. The adequacy of the sample size was assessed by conceptual saturation analysis.ResultsPatient-reported concepts were organised into six symptom themes (upper respiratory, lower respiratory, systemic, gastrointestinal, smell and taste, and other) and seven impact themes (activities of daily living, broad daily activities, leisure/social activities, and physical, emotional, professional and quarantine-specific impacts). Symptom type, severity, duration and time of onset varied by patient. Clinicians endorsed all patient-reported symptoms.ConclusionsThe manifestation of symptoms in outpatients is heterogeneous and affects all aspects of daily life. Outpatients offered new detailed insights into their symptomatic experiences, including heterogeneous experiences of smell and taste, and the impacts that symptoms had on their daily lives. Findings of this research may be used to supplement existing knowledge of the outpatient experience of mild-to-moderate COVID-19, to further inform treatment guidelines and to provide an evidence base for evaluating potential treatment benefits.
Purpose: Various clinical outcome assessments (COAs) are used in clinical research to assess and monitor treatment efficacy in pediatric attention-deficit/hyperactivity disorder (ADHD) trials. It is unclear whether the concepts assessed are those that are important to patients and their caregivers. The concepts measured by commonly used COAs in this population have not been explicitly compared. Methods: We conducted reviews of the qualitative literature to extract information on pediatric ADHD-related concepts reported by pediatric patients, parents, and teachers. Using these concepts, we developed a conceptual framework of pediatric ADHD using both the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria and the additional symptoms and behavioral impacts identified in the literature. We searched for COAs that have been used in pediatric ADHD research and mapped their items based on their conceptual underpinning. Results: Of the 27 COAs found in the empirical literature, 4 COAs assessed only DSM symptoms. The most comprehensive coverage of our conceptual framework was seen in the Swanson, Nolan, and Pelham Rating Scale-DSM-IV (SNAP-IV). Eighteen COAs were used in at least 1 clinical trial: ADHD-Rating Scale-IV (ADHD-RS-IV) was used most often (n=77), followed by SNAP-IV (n=50), Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP; n=31), Weiss Functional Impairment Rating Scale (WFIRS; n=24), and Vanderbilt ADHD Diagnostic Rating Scale (VADRS; n=15). Conclusion: We identified symptoms and behavioral impacts from qualitative studies in pediatric ADHD that are not included in DSM-based criteria. Most COAs used in pediatric ADHD clinical trials measure only those symptoms listed in the DSM. While these COAs can measure symptom severity, they may not assess the full range of symptoms and impacts important to patients and their caregivers. Future research is needed to measure all concepts important to patients and caregivers within ADHD clinical trials.
Introduction Small cell lung cancer (SCLC) is a subtype of lung cancer, the second most common cancer diagnosis worldwide. Currently, there is little published qualitative research that provides insight into the disease-related symptoms and impacts that are relevant to patients living with SCLC as directly reported by patients themselves. Methods This qualitative, cross-sectional, noninterventional, descriptive study included concept elicitation interviews with participants diagnosed with SCLC and the development of a conceptual model of clinical treatment benefit. Results Concept elicitation interview data from 26 participants with SCLC were used to develop a conceptual model of clinical treatment benefit that organized 28 patient-reported concepts into two domains: disease-related symptoms (organ-specific and systemic) and impacts. Organ-specific symptoms included cough, chest pain, and difficulty breathing. Systemic symptoms included pain, fatigue, appetite loss, and dizziness. Impacts included physical functioning, role functioning, reduced movement, impact on sleep, and weight loss. Conclusion As evidenced by this study, people with SCLC experience considerable and significant symptoms and impacts, including physical and role functioning challenges, that affect their quality of life. This conceptual model will inform the design of a patient-reported outcome (PRO) questionnaire for a future SCLC clinical trial, helping to establish the content validity of the items and questionnaires used in the trial and ensuring that the questionnaires and items selected are appropriately targeted to the population. This conceptual model could also be used to inform future SCLC clinical trials. Supplementary Information The online version contains supplementary material available at 10.1007/s40487-023-00223-w.
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