The development of the DISCO-RC for measuring children's discomfort during research procedures

Background: There is a need for data on children's self-reported discomfort in clinical research, helping ethics committees to make their evaluation of discomfort described in study protocols evidence-based. Since there is no appropriate instrument to measure children's discomfort during medical research procedures, we aimed to develop a generic, short and child-friendly instrument: the DISCO-RC questionnaire (DISCOmfort in Research with Children). Methods: This article describes the six steps of the development of the DISCO-RC. First, we updated a literature search on children's self-reported discomfort in clinical research to get insight in what words are used to measure discomfort (step 1). Subsequently, we interviewed 46 children (6-18years) participating in research to get insight into important forms of discomfort for children (step 2), and asked them about their preferred response option for measuring discomfort (step 3). Next, we consulted nine paediatric research professionals from various backgrounds for input on the content and feasibility of the DISCO-RC (step 4). Based on the previous steps, we developed a draft version of the DISCO-RC, which we discussed with the professionals. The DISCO-RC was then pretested in 25 children to ensure face-validity from the child's perspective and feasibility (step 5). Finally, validity, reliability and internal consistency were tested (step 6). Results: The search-update revealed several words used for measuring discomfort in research (e.g. 'worries', 'unpleasantness'). The interviews gave insight into important forms of discomfort for children in research (e.g. 'pain', 'boredom'). Children preferred a 5-point Likert scale as response option for the DISCO-RC. The experts recommended a short, digital instrument involving different forms of discomfort, and measuring discomfort of individual research procedures. Pretesting of the DISCO-RC resulted in a few layout changes, and feedback from the children confirmed the feasibility of the DISCO-RC. Convergent validity and test-retest reliability were acceptable. Internal consistency based on item-rest correlations and Cronbach's alpha were low, as expected. Conclusions: The DISCO-RC is a generic, practical and psychometrically sound instrument for measuring children's discomfort during research procedures. It contributes to make the evaluation of discomfort in paediatric research evidence-based. Therefore, we recommend including the DISCO-RC as standard component of paediatric research studies

The influence of maternal vulnerability and parenting stress on chronic pain in adolescents in a general population sample: The TRAILS study

Investigating possible psychosocial predictors of unexplained chronic pain in adolescents is crucial in understanding its development and prevention. A general population sample of adolescents (n=2230) from the TRAILS cohort study was investigated longitudinally to assess the influence of maternal vulnerability, in terms of anxiety, depression and stress, and parenting stress at age 10-12years, on the presence of chronic pain at age 12-15years. Of these adolescents, 269 (12.9%) reported experiencing chronic pain, of which 77% reported severe chronic pain and 22% reported multiple chronic pain. Maternal anxiety, maternal stress and higher levels of parenting stress were related to chronic pain at a later age. Subgroup analyses showed similar results for adolescents with severe chronic pain. Mediation analyses indicated that parenting stress mediates the effect between maternal anxiety, or stress, and chronic pain. The findings suggest that interventions to diminish maternal feelings of anxiety and stress, while in turn adjusting maternal behaviour, may prevent the development of chronic pain in adolescenc

Bungaku to shashin : Bodoreru no sozoryoku to inyu no senryaku

Objectives The objective of this study is to obtain population norms and to assess test-retest reliability of EQ-5D-5L and WHOQOL-BREF for the Indonesian population. Methods A representative sample of 1056 people aged 17–75 years was recruited from the Indonesian general population. We used a multistage stratified quota sampling method with respect to residence, gender, age, education level, religion and ethnicity. Respondents completed EQ-5D-5L and WHOQOL-BREF with help from an interviewer. Norms data for both instruments were reported. For the test-retest evaluations, a sub-sample of 206 respondents completed both instruments twice. Results The total sample and test-retest sub-sample were representative of the Indonesian general population. The EQ-5D-5L shows almost perfect agreement between the two tests (Gwet’s AC: 0.85–0.99 and percentage agreement: 90–99%) regarding the five dimensions. However, the agreement of EQ-VAS and index scores can be considered as poor (ICC: 0.45 and 0.37 respectively). For the WHOQOL-BREF, ICCs of the four domains were between 0.70 and 0.79, which indicates moderate to good agreement. For EQ-5D-5L, it was shown that female and older respondents had lower EQ-index scores, whilst rural, younger and higher-educated respondents had higher EQ-VAS scores. For WHOQOL-BREF: male, younger, higher-educated, high-income respondents had the highest scores in most of the domains, overall quality of life, and health satisfaction. Conclusions This study provides representative estimates of self-reported health status and quality of life for the general Indonesian population as assessed by the EQ-5D-5L and WHOQOL-BREF instruments. The descriptive system of the EQ-5D-5L and the WHOQOL-BREF have high test-retest reliability while the EQ-VAS and the index score of EQ-5D-5L show poor agreement between the two tests. Our results can be useful to researchers and clinicians who can compare their findings with respect to these concepts with those of the Indonesian general population

Psychoeducation for breast cancer: A systematic review and meta-analysis

Background: Psychoeducation has emerged as an intervention for women with breast cancer (BC). This meta-analysis evaluated the effectiveness of psychoeducation on adherence to diagnostic procedures and medical treatment, anxiety, depression, quality of life (QoL), and BC knowledge among patients with BC symptoms or diagnosis and BC survivors. Methods: A systematic literature search (in PubMed, Embase, PsycINFO and Cochrane) for randomised controlled trials (RCTs) comparing the effects of psychoeducation to control among patients with BC symptoms or diagnosis and BC survivors. Effects were expressed as relative risks (RRs) and standardized mean differences (SMDs) with their 95% confidence intervals. Results: Twenty-seven RCTs (7742 participants; 3880 psychoeducation and 3862 controls) were included. Compared with controls, psychoeducation had no significant effect on adherence to diagnostic procedures and medical treatment (RR 1.553; 95% CI 0.733 to 3.290, p = .16), but it significantly decreased anxiety (SMD -0.710, 95% CI -1.395 to −0.027, p = .04) and improved QoL with (SMD 0.509; 95% CI 0.096 to 0.923, p < .01). No effects were found for psychoeducation on depression (SMD -0.243, 95% CI -0.580 to 0.091, p = .14), or BC knowledge (SMD 0.718, 95% CI -0.800 to 2.236, p = .23). Conclusion: We demonstrated that psychoeducation did not improve adherence to diagnostic procedures and treatment, depression and BC knowledge but was valuable for reducing anxiety and improving QoL. Future studies may explore the effectiveness of psychoeducation in promoting adherence across various types of cancer

Test-Retest Reliability of EQ-5D-5L Valuation Techniques:The Composite Time Trade-Off and Discrete Choice Experiments

Objectives: To explore the test-retest reliability of the composite time trade-off (C-TTO) and discrete choice experiment (DCE) used in the Indonesian five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) valuation study. Methods: A representative sample aged 17 years and older was recruited from the Indonesian general population by stratified quota sampling with respect to residence, sex, and age. Trained interviewers conducted computer-assisted face-to-face interviews using the EuroQol valuation technology. Each respondent valued 10 health states using C-TTO and 7 pairs of health states in a DCE exercise. The retest interview was conducted after 2 weeks by the same interviewer. The Wilcoxon matched-pairs signed-rank test, intraclass correlation coefficient, and multilevel regression were applied in comparing the C-TTO test and retest data. For DCE, the analysis of proportions was used. Results: A total of 226 respondents with characteristics similar to the Indonesian population completed the retest interview. For C-TTO, 82 (95.3%) of 86 health states had no significant mean value differences between test and retest. The mean value of the second test was statistically significantly higher than that of the first test by 0.042. For DCE, 72.5% of responses were identical. DCE retest showed a different pattern concerning the relative importance of the dimensions, whereas the C-TTO remained the same. Conclusions: C-TTO is stable over time, whereas in DCE the relative values of the dimensions shift. The results support the use of the C-TTO, in particular the Indonesian EQ-5D-5L value set, and suggest a critical examination of the reliability of DCE results over time

A self-help intervention for reducing time to diagnosis in Indonesian women with breast cancer symptoms

Objective: We investigated the effectiveness of a self-help intervention named PERANTARA, which aims to improve adherence to diagnostic procedures among women with breast cancer (BC) symptoms to reduce the time to a definitive diagnosis. Methods: With a cluster randomized crossover design across four hospitals, PERANTARA and treatment as usual (TAU) or TAU only was provided at successive periods in a randomly determined order. The main outcome was the time between the first medical consultation and the definitive diagnosis. Secondary outcomes were BC knowledge, measured by the Breast Cancer Knowledge Test (BCKT); symptoms of anxiety and depression, measured by the Hospital Anxiety and Depression Scale (HADS); quality of life, measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF); and health status, measured by the EQ-5D-5L. A linear mixed model analysis was conducted to analyse the outcomes. Results: We recruited 132 women with BC symptoms from four hospitals; 67 participants were in the intervention group, and 65 participants were in the control group. PERANTARA reduced the time to definitive diagnosis by 13.3 days (M [SD]: 25.90 [23.20] in the intervention group vs 39.29 [35.10] in the control group; mean difference = −13.26, 95% CI = −24.51 to −2.00, P =.02). No significant difference was found between the groups in BC knowledge, symptoms of anxiety, depression, quality of life, or health status. Conclusions: PERANTARA reduced the time to definitive diagnosis among Indonesian women with BC symptoms. Psychoeducation may be an important addition to regular BC care to prevent undue delays in diagnostic procedures