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.

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.

A Self-Help Guided Psychoeducational Intervention for Indonesian Women with Breast Cancer Symptoms: Development and Pilot Feasibility Study

Background: Delay in the diagnosis of breast cancer (BC) may lead to an advanced stage of the disease and a poor prognosis. A psychoeducational intervention can be crucial in helping women with BC symptoms complete the examination procedures and reduce diagnosis delay of BC. Objective: To develop a psychoeducational intervention to reduce the delay of BC diagnosis among Indonesian women with BC symptoms. Methods: The development of the intervention included an inventory of crucial elements in developing psychoeducation through literature review as well as consultation with BC patients and healthcare providers. Additionally, we developed PERANTARA as the first pilot version of the self-help guided psychoeducational intervention. PERANTARA is an abbreviation for "Pengantar Perawatan Kesehatan Payadura", which means an introduction to breast health treatment. The pilot feasibility study combined an expert review and a pilot testing in hospital settings. A semi-structured interview and the client satisfaction inventory were utilized to measure feasibility and acceptability of the intervention for Indonesian women with BC symptoms. Results: PERANTARA contained an oncologist's explanation about BC and the BC survivors' testimony to reduce the time to diagnosis. The pilot study results showed that most patients were satisfied with and trusted on PERANTARA. Conclusion: PERANTARA was feasible and acceptable for Indonesian patients with BC symptoms. The development framework suggested in this study can be applied to develop psychoeducational packages for other patients group, in particular, those interventional packages aimed at reducing diagnosis and treatment delays and nonadherence.

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.

Quality of life and health status of Indonesian women with breast cancer symptoms before the definitive diagnosis: A comparison with Indonesian women in general.

OBJECTIVES: Breast cancer (BC) is prevalent in low and middle-income countries (LMICs) where the majority of cases are diagnosed in late stages. The aims of this study were: (1) to assess quality of life (QOL) and health status of Indonesian women with BC symptoms before definitive diagnosis; (2) to compare QOL and health status between women with BC symptoms before definitive diagnosis and Indonesian women in general; (3) to evaluate the association between demographic variables (age, residence, social economic status and education level) and QOL within the Indonesian women with BC symptoms before definitive diagnosis. METHODS: We used WHOQOL-BREF to measure QOL and EQ-5D-5L for health status. Multivariate analysis of covariance (MANCOVA) was used to compare QOL and health status between women with BC symptoms and women from the general Indonesian population in order to control for confounders. Regression analyses were used for testing the association between the demographic variables, QOL, and health status. RESULTS: In comparison with the data from the women from the general population (n = 471), the women with BC symptoms (n = 132) reported lower QOL, especially in physical and psychological domains. They also reported more problems in all dimensions of health status. Higher education and monthly income were positively associated with QOL and health status among the women with BC symptoms. CONCLUSION: Before receiving a definitive diagnosis, women who visit hospitals with symptoms of BC, report a lower QOL and health status than women in general. Our results suggest that healthcare providers should provide targeted strategies for women with BC symptoms to improve their QOL.

Living in uncertainty due to floods and pollution: the health status and quality of life of people living on an unhealthy riverbank.

BACKGROUND: People living on the banks of polluted rivers with yearly flooding lived in impoverished and physically unhealthy circumstances. However, they were reluctant to move or be relocated to other locations where better living conditions were available. This study aimed to investigate the health status, quality of life (QoL), happiness, and life satisfaction of the people who were living on the banks of one of the main rivers in Jakarta, Indonesia, the Ciliwung. METHODS: Respondents were 17 years and older and recruited from the Bukit Duri community (n = 204). Three comparison samples comprised: i) a socio-demographically matched control group, not living on the river bank (n = 204); ii) inhabitants of Jakarta (n = 305), and iii) the Indonesian general population (n = 1041). Health status and QoL were measured utilizing EQ-5D-5L, WHOQOL-BREF, the Happiness Scale, and the Life Satisfaction Index. A visual analogue scale question concerning respondents' financial situations was added. MANOVA and multivariate regression analysis were used to analyze the differences between the Ciliwung respondents and the three comparison groups. RESULTS: The Ciliwung respondents reported lower physical QoL on WHOQOL-BREF and less personal happiness than the matched controls but rated their health (EQ-5D-5L) and life satisfaction better than the matched controls. Similar results were obtained by comparison with the Jakarta inhabitants and the general population. Bukit Duri inhabitants also perceived themselves as being in a better financial situation than the three comparison groups even though their incomes were lower. CONCLUSIONS: The recent relocation to a better environment with better housing might improve the former Ciliwung inhabitants' quality of life and happiness, but not necessarily their perceived health, satisfaction with life, and financial situations.

Quality of life of the Indonesian general population: Test-retest reliability and population norms of the EQ-5D-5L and WHOQOL-BREF.

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.

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 (6-18 years) 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 child's perspective on discomfort during medical research procedures: a descriptive study.

OBJECTIVE: The evaluation of discomfort in paediatric research is scarcely evidence-based. In this study, we make a start in describing children's self-reported discomfort during common medical research procedures and compare this with discomfort during dental check-ups which can be considered as a reference level of a 'minimal discomfort' medical procedure. We exploratory study whether there are associations between age, anxiety-proneness, gender, medical condition, previous experiences and discomfort. We also describe children's suggestions for reducing discomfort. DESIGN: Cross-sectional descriptive study. SETTING: Paediatric research at three academic hospitals. PATIENTS: 357 children with and without illnesses (8-18 years, mean=10.6 years) were enrolled: 307 from paediatric research studies and 50 from dental care. MAIN OUTCOME MEASURES: We measured various generic forms of discomfort (nervousness, annoyance, pain, fright, boredom, tiredness) due to six common research procedures: buccal swabs, MRI scans, pulmonary function tests, skin prick tests, ultrasound imaging and venepunctures. RESULTS: Most children reported limited discomfort during the research procedures (means: 1-2.6 on a scale from 1 to 5). Compared with dental check-ups, buccal swab tests, skin prick tests and ultrasound imaging were less discomforting, while MRI scans, venepunctures and pulmonary function tests caused a similar degree of discomfort. 60.3% of the children suggested providing distraction by showing movies to reduce discomfort. The exploratory analyses suggested a positive association between anxiety-proneness and discomfort. CONCLUSIONS: The findings of this study support the acceptability of participation of children in the studied research procedures, which stimulates evidence-based research practice. Furthermore, the present study can be considered as a first step in providing benchmarks for discomfort of procedures in paediatric research.

The Indonesian EQ-5D-5L Value Set.

BACKGROUND: The EQ-5D is one of the most used generic health-related quality-of-life (HRQOL) instruments worldwide. To make the EQ-5D suitable for use in economic evaluations, a societal-based value set is needed. Indonesia does not have such a value set. OBJECTIVE: The aim of this study was to derive an EQ-5D-5L value set from the Indonesian general population. METHODS: A representative sample aged 17 years and over was recruited from the Indonesian general population. A multi-stage stratified quota method with respect to residence, gender, age, level of education, religion and ethnicity was utilized. Two elicitation techniques, the composite time trade-off (C-TTO) and discrete choice experiments (DCE) were applied. Interviews were undertaken by trained interviewers using computer-assisted face-to-face interviews with the EuroQol Valuation Technology (EQ-VT) platform. To estimate the value set, a hybrid regression model combining C-TTO and DCE data was used. RESULTS: A total of 1054 respondents who completed the interview formed the sample for the analysis. Their characteristics were similar to those of the Indonesian population. Most self-reported health problems were observed in the pain/discomfort dimension (39.66%) and least in the self-care dimension (1.89%). In the value set, the maximum value was 1.000 for full health (health state '11111') followed by the health state '11112' with value 0.921. The minimum value was -0.865 for the worst state ('55555'). Preference values were most affected by mobility and least by pain/discomfort. CONCLUSIONS: We now have a representative EQ-5D-5L value set for Indonesia. We expect our results will promote and facilitate health economic evaluations and HRQOL research in Indonesia.

A protocol for a cluster-randomized controlled trial of a self-help psycho-education programme to reduce diagnosis delay in women with breast cancer symptoms in Indonesia.

BACKGROUND: Breast cancer (BC) is the most frequent cancer occurring in women across the world. Its mortality rate in low-middle income countries (LMICs) is higher than in high-income countries (HICs), and in Indonesia BC is the leading cause of cancer deaths among women. Delay in breast cancer diagnosis negatively impacts cancer prognosis. Only about 30% of patients who come to the hospital to check on their breast abnormalities, continue thorough examination to biopsy to get a diagnosis based on the results of anatomical pathology. Many Indonesian women with breast cancer were already in an advanced stage when starting treatment. Therefore, delay in diagnosis is a serious problem that needs to be addressed. The present study will investigate whether our newly developed self-help psycho-educational programme, "PERANTARA", for women with breast cancer symptoms is effective to reduce patient diagnosis delay in Indonesia. METHODS: A cluster-randomized controlled trial will be conducted in 106 patients in four hospitals in Bandung, West Java, Indonesia. Data will be collected at baseline (pre-assessment), 7 days after the intervention (post-assessment), and at 3 months (follow-up assessments). The primary outcome is delay in diagnosis and treatment. Secondary outcomes are breast cancer knowledge, anxiety and depression, and quality of life. Exploratively, adherence with treatment will be measured too. Data will be analysed by hierarchical linear modelling (HLM) to assess differential change over time. DISCUSSION: If proven effective, PERANTARA will be evaluated and implemented in a diversity of settings for local cares (such as in POSYANDU, PUSKESMAS) that provide health education/psycho-education for women with breast symptoms. TRIAL REGISTRATION: ISRCTN12570738 . Date: November 19th, 2016.

Employing quality control and feedback to the EQ-5D-5L valuation protocol to improve the quality of data collection.

OBJECTIVES: In valuing health states using generic questionnaires such as EQ-5D, there are unrevealed issues with the quality of the data collection. The aims were to describe the problems encountered during valuation and to evaluate a quality control report and subsequent retraining of interviewers in improving this valuation. METHODS: Data from the first 266 respondents in an EQ-5D-5L valuation study were used. Interviewers were trained and answered questions regarding problems during these initial interviews. Thematic analysis was used, and individual feedback was provided. After completion of 98 interviews, a first quantitative quality control (QC) report was generated, followed by a 1-day retraining program. Subsequently individual feedback was also given on the basis of follow-up QCs. The Wilcoxon signed-rank test was used to assess improvements based on 7 indicators of quality as identified in the first QC and the QC conducted after a further 168 interviews. RESULTS: Interviewers encountered problems in recruiting respondents. Solutions provided were: optimization of the time of interview, the use of broader networks and the use of different scripts to explain the project's goals to respondents. For problems in interviewing process, solutions applied were: developing the technical and personal skills of the interviewers and stimulating the respondents' thought processes. There were also technical problems related to hardware, software and internet connections. There was an improvement in all 7 indicators of quality after the second QC. CONCLUSION: Training before and during a study, and individual feedback on the basis of a quantitative QC, can increase the validity of values obtained from generic questionnaires.

Are positive experiences of children in non-therapeutic research justifiable research benefits?

BACKGROUND: Conducting non-therapeutic research is ethically challenging because participation conveys risks and burden and no health benefit. In this paper, we report the positive experiences of a diverse group of healthy and ill children (6-18 years) who participated in non-therapeutic research studies and discuss whether these positive experiences can justifiably be viewed as benefits. METHODS: We used semistructured interviews from an earlier study about children's experiences in clinical research and did a secondary analysis on the positive experiences of the children in the non-therapeutic studies (N=30). Interviews were analysed using 'thematic' analysis. RESULTS: The interviewed children most frequently mentioned as positive experiences of non-therapeutic research participation helping others and the gratification that comes with it, possible health benefits in the future, having fun and new/increased knowledge about the human body, hospitals and doing research. Less frequently mentioned were getting a present, not having to go to school and getting extra attention from healthcare staff. CONCLUSIONS: Our study shows that children participating in non-therapeutic research have various positive experiences while taking part. We argue that some of these justifiably could be taken into the risk-benefit analysis in certain situations or maybe even as a standard part of this analysis. This may help to increase the number of (crucial) non-therapeutic studies with children.

Are Cardiac Autonomic Nervous System Activity and Perceived Stress Related to Functional Somatic Symptoms in Adolescents? The TRAILS Study.

OBJECTIVE: Stressors have been related to medically insufficiently explained or functional somatic symptoms (FSS). However, the underlying mechanism of this association is largely unclear. In the current study, we examined whether FSS are associated with different perceived stress and cardiac autonomic nervous system (ANS) levels during a standardized stressful situation, and whether these associations are symptom-specific. METHODS: We examined 715 adolescents (16.1 years, 51.3% girls) from the Dutch cohort study Tracking Adolescents' Individual Lives Sample during the Groningen Social Stress Test (GSST). FSS were assessed by the Youth Self-Report, and clustered into a cluster of overtiredness, dizziness and musculoskeletal pain and a cluster of headache and gastrointestinal symptoms. Perceived stress levels (i.e. unpleasantness and arousal) were assessed by the Self-Assessment Manikin, and cardiac ANS activity by assessing heart rate variability (HRV-HF) and pre-ejection period (PEP). Perceived stress and cardiac ANS levels before, during, and after the GSST were studied as well as cardiac ANS reactivity. Linear regression analyses were used to examine the associations. RESULTS: Perceived arousal levels during (beta = 0.09, p = 0.04) and after (beta = 0.07, p = 0.047) the GSST, and perceived unpleasantness levels before (beta = 0.07, p = 0.048) and during (beta = 0.12, p = 0.001) the GSST were related to FSS during the past couple of months. The association between perceived stress and FSS was stronger for the FSS cluster of overtiredness, dizziness and musculoskeletal pain than for the cluster of headache and gastrointestinal symptoms. Neither ANS activity levels before, during, and after the GSST, nor maximal HF-HRV and PEP reactivity were related to FSS. CONCLUSIONS: This study suggests that perceived stress levels during social stress are related to FSS, whereas cardiac ANS activity and reactivity are not related to FSS.

Hearing the voices of children: self-reported information on children's experiences during research procedures: a study protocol.

INTRODUCTION: In paediatric research, there is a tension between what you can ask from a child and what is needed for the development of evidence-based treatments. To find an optimal balance in conducting clinical research and protecting the child, it is necessary to have empirical data on children's experiences. Until now, there are scarce empirical data on the experiences from the perspective of the child. In this manuscript, we describe the protocol of a two-phase study measuring children's self-reported experiences during research procedures. METHODS AND ANALYSIS: In the first phase of our study, we aim to interview approximately 40 children (6-18 years) about their self-reported experiences during research procedures. In the second phase, we will develop a questionnaire to measure children's experiences during research procedures in a quantitative way. We will use the interview outcomes for the development of this questionnaire. Next, we will measure the experiences of children during seven research procedures with this questionnaire. A one-month follow-up is conducted to investigate the emotional impact of the research procedures on the children. Children will be recruited from different research studies in three academic children's hospitals in the Netherlands. ETHICS AND DISSEMINATION: The ethics committee of the VU University medical center evaluated both studies and indicated that there was no risk/discomfort associated, stating that both phases are exempt from getting approval under the Dutch Law. Dissemination of results will occur by conference presentations and peer-reviewed publications. The findings of our project can help Institutional Review Boards and paediatric researchers when evaluating the discomforts of research procedures described in study protocols or when designing a study. Information on experiences of children involved in previous studies may also help children and parents in future research with their decision-making about participation in clinical research, or parts thereof.

Children's self reported discomforts as participants in clinical research.

INTRODUCTION: There is little empirical evidence on children's subjective experiences of discomfort during clinical research procedures. Therefore, Institutional Review Boards have limited empirical information to guide their decision-making on discomforts for children in clinical research. To get more insight into what children's discomforts are during clinical research procedures, we interviewed a group of children on this topic and also asked for suggestions to reduce possible discomforts. MATERIALS AND METHODS: Forty-six children (aged 6-18) participating in clinical research studies (including needle-related procedures, food provocation tests, MRI scans, pulmonary function tests, questionnaires) were interviewed about their experiences during the research procedures. Thematic analysis was used to analyze the interviews. RESULTS: The discomforts of the interviewed children could be divided into two main groups: physical and mental discomforts. The majority experienced physical discomforts during the research procedures: pain, shortness of breath, nausea, itchiness, and feeling hungry, which were often caused by needle procedures, some pulmonary procedures, and food provocation tests. Mental discomforts included anxiousness because of anticipated pain and not knowing what to expect from a research procedure, boredom and tiredness during lengthy research procedures and waiting, and embarrassment during Tanner staging. Children's suggestions to reduce the discomforts of the research procedures were providing distraction (e.g. watching a movie or listening to music), providing age-appropriate information and shortening the duration of lengthy procedures. DISCUSSION: Our study shows that children can experience various discomforts during research procedures, and it provides information about how these discomforts can be reduced according to them. Further research is needed with larger samples to study the number of children that experience these mentioned discomforts during research procedures in a quantitative way.

Concurrent and longitudinal bidirectional relationships between toddlers' chronic pain and mental health: the generation R study.

OBJECTIVE: The aim was to investigate the concurrent and longitudinal associations of chronic pain with behavioral and emotional problems in toddlers, as it is not known which comes first in life. METHODS: The study was embedded in the Generation R Study, a prospective population-based cohort study. Parents of 3,751 toddlers completed questionnaires of their child's health and development. Behavioral and emotional problems were measured at 1.5 and 3 years, chronic pain was measured at 2 and 3 years. RESULTS: There were concurrent associations between chronic pain and internalizing problems, e.g. anxiety/depression symptoms. However, chronic pain did not precede the development of new behavioral and emotional problems. Also, behavioral and emotional problems did not precede new-onset chronic pain, except for somatic symptoms, which increased the likelihood of chronic pain. CONCLUSIONS: Chronic pain was associated with concurrent internalizing problems. Somatic complaints were not only concurrently related to pain but also predicted new-onset pain.

Symptom-specific associations between low cortisol responses and functional somatic symptoms: the TRAILS study.

BACKGROUND: Functional somatic symptoms (FSS), like chronic pain and overtiredness, are often assumed to be stress-related. Altered levels of the stress hormone cortisol could explain the association between stress and somatic complaints. We hypothesized that low cortisol levels after awakening and low cortisol levels during stress are differentially associated with specific FSS. METHODS: This study is performed in a subsample of TRAILS (Tracking Adolescents' Individual Lives Survey) consisting of 715 adolescents (mean age: 16.1 years, SD=0.6, 51.3% girls). Adolescents' cortisol levels after awakening and during a social stress task were assessed. The area under the curve with respect to the ground (AUCg) and the area under the curve above the baseline (AUCab) were calculated for these cortisol levels. FSS were measured using the Youth Self-Report and pain questions. Based upon a factor analysis, FSS were divided into two clusters, one consisting of headache and gastrointestinal symptoms and the other consisting of overtiredness, dizziness and musculoskeletal pain. RESULTS: Regression analyses revealed that the cluster of headache and gastrointestinal symptoms was associated with a low AUCg of cortisol levels during stress (ß=-.09, p=.03) and the cluster of overtiredness, dizziness and musculoskeletal pain with a low AUCg of cortisol levels after awakening (ß=-.15, p=.008). All these analyses were adjusted for the potential confounders smoking, physical activity level, depression, corticosteroid use, oral contraceptive use, gender, body mass index and, if applicable, awakening time. CONCLUSION: Two clusters of FSS are differentially associated with the stress hormone cortisol.

Pubertal status predicts back pain, overtiredness, and dizziness in American and Dutch adolescents.

OBJECTIVE: Functional somatic symptoms, symptoms for which no organic pathologic basis can be found, are more prevalent in girls than in boys, and this difference tends to increase during adolescence. This might be explained, at least in part, by pubertal development. We hypothesized that pubertal maturation predicts the development of most functional somatic symptoms and that this especially is true for girls. METHOD: We used 2 longitudinal population-based studies to examine our hypotheses: the Longitudinal Study of Pain in Adolescents in Seattle (n = 1996 [49.7% girls]) and the Dutch Tracking Adolescents' Individual Lives Survey (n = 2230 [51.0% girls]). Two assessment waves of each study were used. American adolescents were younger than Dutch adolescents at the first (11.6 vs 13.6) and second (14.5 vs 16.2) assessment waves, but they were in about the same pubertal development stage. Functional somatic symptoms were measured by pain questions, the Symptom Checklist-90, and the Youth Self-report. The Pubertal Development Scale was used to assess pubertal development on a continuous scale in both cohorts. RESULTS: Ordinal logistic regression analyses revealed that American and Dutch adolescents at a later pubertal status at baseline were more likely (odds ratios ranged from 1.24 to 1.61) to report back pain, overtiredness, and dizziness but not stomach pain and headache 2 to 3 years later. Although these relationships were not equally strong for boys and girls, no significant gender differences were found. CONCLUSIONS: Pubertal status predicted the frequency of some, but not all, functional somatic symptoms at follow-up.

The influence of attachment and temperament on venipuncture distress in 14-month-old infants: the Generation R Study.

OBJECTIVE: This study examined the effects of attachment and temperament on infant distress during venipuncture. METHOD: The study was embedded in the Generation R Study, a prospective population-based study. Two different research procedures (i.e., blood sampling and the Ainsworth Strange Situation Procedure) yielded measures of venipuncture distress and attachment security and disorganization in 246 infants aged 14 months. Four temperament traits (distress to limitations, fear, recovery from distress, and sadness) were assessed using the maternally reported Infant Behavior Questionnaire-Revised, at the age of 6 months. RESULTS: There were no differences between mean levels of distress during venipuncture in infants classified as having insecure attachment, but there was a trend for disorganized attachment. The temperament traits were not related to distress. However, children with a disorganized attachment and higher temperamental fear had more venipuncture distress. CONCLUSION: When different risk factors are present simultaneously, infant distress is heightened.