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Abstract Background Patients with advanced cancer who no longer have standard treatment options available may decide to participate in early phase clinical trials (i.e. experimental treatments with uncertain outcomes). Shared decision-making (SDM) models help to understand considerations that influence patients’ decision. Discussion of patient values is essential to SDM, but such communication is often limited in this context and may require new interventions. The OnVaCT intervention, consisting of a preparatory online value clarification tool (OnVaCT) for patients and communication training for oncologists, was previously developed to support SDM. This study aimed to qualitatively explore associations between patient values that are discussed between patients and oncologists during consultations about potential participation in early phase clinical trials before and after implementation of the OnVaCT intervention. Methods This study is part of a prospective multicentre nonrandomized controlled clinical trial and had a between-subjects design: pre-intervention patients received usual care, while post-intervention patients additionally received the OnVaCT. Oncologists participated in the communication training between study phases. Patients’ initial consultation on potential early phase clinical trial participation was recorded and transcribed verbatim. Applying a directed approach, two independent coders analysed the transcripts using an initial codebook based on previous studies. Steps of continuous evaluation and revision were repeated until data saturation was reached. Results Data saturation was reached after 32 patient-oncologist consultations (i.e. 17 pre-intervention and 15 post-intervention). The analysis revealed the values: hope, perseverance, quality or quantity of life, risk tolerance, trust in the healthcare system/professionals, autonomy, social adherence, altruism, corporeality, acceptance of one’s fate, and humanity. Patients in the pre-intervention phase tended to express values briefly and spontaneously. Oncologists acknowledged the importance of patients’ values, but generally only gave ‘contrasting’ examples of why some accept and others refuse to participate in trials. In the post-intervention phase, many oncologists referred to the OnVaCT and/or asked follow-up questions, while patients used longer phrases that combined multiple values, sometimes clearly indicating their weighing. Conclusions While all values were recognized in both study phases, our results have highlighted the different communication patterns around patient values in SDM for potential early phase clinical trial participation before and after implementation of the OnVaCT intervention. This study therefore provides a first (qualitative) indication that the OnVaCT intervention may support patients and oncologists in discussing their values. Trial registration Netherlands Trial Registry: NL7335, registered on July 17, 2018.

Background: Sleep problems are common in adults with ADHD and may be bidirectionally associated with ADHD severity and other psychiatric symptoms. We investigated the prevalence of positive screenings for various sleep disorders, and their association with psychiatric comorbidities in a large sample of adults with ADHD from a specialized outpatient clinic. Methods: We included data of 3,691 adult patients diagnosed with ADHD, who had filled out a screener for sleep disorders (Holland Sleep Disorders Questionnaire (HSDQ)) as part of routine diagnostic assessment. The HSDQ screens for the sleep disorders insomnia, parasomnia, hypersomnia, circadian rhythm sleep disorders (CRSD), restless legs syndrome (RLS)/periodic limb movement disorder (PLMD), and sleep-related breathing disorders (SBD). As delayed sleep phase syndrome (DSPS) is very frequent in ADHD, we additionally screened for DSPS. Psychiatric comorbidities were diagnosed through clinical assessment and the Mini International Neuropsychiatric Interview (M.I.N.I.) Plus, which assesses 26 psychiatric disorders following the classification of the DSM-5. All data were retrieved from the electronic patient files. Results: Mean age was 35.4 and 49.4% of the patients were female. About 60% of the adults with ADHD screened positive for any sleep disorder. Highest prevalences were found for symptoms of DSPS (36%), insomnia (30%), and RLS/ PLMD (29%). Sleep problems in adults with ADHD were associated with comorbid depression, anxiety, substance use disorder, personality disorder, and post-traumatic stress disorder. Conclusion: Adults with ADHD often report sleep problems, which are associated with specific psychiatric comorbidities. Systematic screening for sleep disorders in adult patients with ADHD can contribute to a better understanding of their complaints and may aid improved and integrated treatment for the sleep and psychiatric problems.

Introduction Many low-income and middle-income countries (LMIC) suffer from a double burden of infectious diseases (ID) and non-communicable diseases (NCD). Previous research suggests that a high rate of gender inequality is associated with a higher ID and NCD burden in LMIC, but it is unknown whether gender inequality is also associated with a double burden of disease. In this ecological study, we explored the association between gender inequality and the double burden of disease in LMIC.Methods For 108 LMIC, we retrieved the Gender Inequality Index (GII, scale 0–1) and calculated the double burden of disease, based on disability-adjusted life-years for a selection of relevant ID and NCD, using WHO data. We performed logistic regression analysis to study the association between gender inequality and the double burden of disease for the total population, and stratified for men and women. We adjusted for income, political stability, type of labour, urbanisation, government health expenditure, health infrastructure and unemployment. Additionally, we conducted linear regression models for the ID and NCD separately.Results The GII ranged from 0.13 to 0.83. A total of 37 LMIC had a double burden of disease. Overall, the adjusted OR for double burden of disease was 1.05 per 0.01 increase of GII (95% CI 0.99 to 1.10, p=0.10). For women, there was a borderline significant positive association between gender inequality and double burden of disease (OR 1.05, 95% CI 1.00 to 1.11, p=0.06), while there was no association in men (OR 0.99, 95% CI 0.95 to 1.04, p=0.75).Conclusion We found patterns directing towards a positive association between gender inequality and double burden of disease, overall and in women. This finding suggests the need for more attention for structural factors underlying gender inequality to potentially reduce the double burden of disease.