Standardising outcome reporting for clinical trials of interventions for heavy menstrual bleeding: Development of a core outcome set

OBJECTIVE: To develop a core outcome set for heavy menstrual bleeding (HMB). DESIGN: Core outcome set (COS) development methodology described by the COMET initiative. SETTING: University hospital gynaecology department, online international survey and web-based international consensus meetings. POPULATION OR SAMPLE: Phase 1: Systematic review of previously reported outcomes to identify potential core outcomes. Phase 2: Qualitative studies with patients to identify outcomes most important to them. Phase 3: Online two-round Delphi survey to achieve consensus about which outcomes are most important. Phase 4: A consensus meeting to finalise the COS. METHODS: Phase 1: Systematic review of previously reported outcomes to identify potential core outcomes. Phase 2: Qualitative studies with patients to identify outcomes most important to them. Phase 3: Online two-round Delphi survey to achieve consensus about which outcomes are most important. Phase 4: A consensus meeting to finalise the COS. MAIN OUTCOME MEASURES: Outcome importance was assessed in the Delphi survey on a 9-point scale. RESULTS: From the ‘long list’ of 114, 10 outcomes were included in the final COS: subjective blood loss; flooding; menstrual cycle metrics; severity of dysmenorrhoea; number of days with dysmenorrhoea; quality of life; adverse events; patient satisfaction; number of patients going on to have further treatment for HMB and haemoglobin level. CONCLUSIONS: The final COS includes variables that are feasible for use in clinical trials in all resource settings and apply to all known underlying causes of the symptom of HMB. These outcomes should be reported in all future trials of interventions, their systematic reviews, and clinical guidelines to underpin policy

Association between chronic stress and body composition in European adolescents

Introduction: The present study investigated the association between the experience of stress and body composition among European adolescents. Methods: Results are based on observations in the HELENA study. Participants were 1141 adolescents (43.0% male, 12.5-17.5 years) from six European centres (Ghent, Zaragoza, Athens, Stockholm, Vienna, Pecs). Respondents completed the Adolescent Stress Questionnaire, containing 10 subscales that represent different dimensions of stress: home life (HL), school performance (SP), school attendance (SA), romantic relationships (RR), peer pressure (PP), teacher interaction (TI), future uncertainty (FU), school-leisure conflict (SLC), financial pressure (FP) and emerging adult responsibility (EAR). The population was divided in tertiles according to the total score (TS) and subscales. Height, weight, skinfold thicknesses (biceps, triceps, subscapular, suprailiac, thigh, calf) and circumferences (arm, biceps, waist, hip, thigh) were measured. Body mass index (BMI), sum of skinfolds (SS) and body fat percentage (BF%) were calculated. Results: Adolescents in the highest tertile of TS and most subscales showed, compared to those in the lowest tertile, significantly higher means for BMI, sum of skinfolds, all or some individual skinfolds and circumferences (except biceps circumference), and for BF%. Most significant differences in means between the extreme tertiles were shown for HL, SP, PP, FU, SLC and FP, while none were observed for EAR. Similar results were obtained when adjusting for age and gender. Conclusion: European adolescents experiencing higher levels of stress had higher BMI, skinfold thicknesses, circumferences and BF%, indicative for a more adipose body compositio

Lessons learned from conducting a study of emotions and positive personality change in Syrian origin young adults who have recently resettled in the Netherlands

Post-traumatic growth is a compelling idea, yet extant research has often employed retrospective reports of change, rather than examining change over time. Research on samples of people that are traditionally seen as hard-to-reach are rare within personality psychology. In Karakter, we assessed a sample of Syrian origin young adults who recently resettled in the Netherlands (initial N = 168) four times over a 13-month period to examine experiences of adversity, emotions, and positive personality change. Here, we provide a detailed narrative of the research process, beginning with a description of how we incorporated open science practices in Karakter. We then turn to a discussion of the changes, challenges, and opportunities we encountered in the research. In doing so, we discuss conceptual and methodological considerations when examining personality change. We close with suggestions for researchers who are interested in conducting similar studies with populations that are underrecruited in the futur