Better Safe Than Sorry. A Scoping Review of Monitoring for Negative Effects in Preregistrations of Psychological Interventions.

Although negative effects of psychological interventions are suspected to be common, they are rarely investigated. Experts and international guidelines agree that monitoring for negative effects in clinical studies is needed to make psychological interventions safer and to empower patients before they give their consent to participate. Therefore, monitoring should already be considered during planning and preregistration of a study. The aim of this scoping review was to find out how frequently studies on psychological interventions monitor their negative effects according to preregistrations and to investigate reasons why monitoring is not carried out. Preregistrations of psychological interventions on ClinicalTrials.gov were scrutinized for information on monitoring of negative effects and other study characteristics. In a survey, researchers of studies where no monitoring was reported were asked for reasons for not doing so. Overall, 2231 preregistrations of psychological interventions were found; of these, only 3.4% included explicit information on monitoring for negative effects. In the survey, more researchers reported having conducted monitoring, although the type of monitoring was often inadequate. The type of monitoring varied widely, and specific monitoring measurements were rarely used repeatedly. Monitoring for negative effects was more prevalent in studies investigating treatments versus low-threshold interventions, in studies conducted in Europe versus other continents and in more recent studies. Researchers reported lack of knowledge as the most frequent reason for not monitoring negative effects. Our results imply a lack of monitoring and inconsistent information on negative effects in preregistrations, with inconsistent use of the term monitoring and measurements, and a lack of knowledge among researchers. Improved knowledge and a standardized approach, starting with an adequate preregistration, would be helpful to routinely examine negative effects in psychological interventions to make them safer and better.

Pediatric chronic pain grading-a revised classification of the severity of pediatric chronic pain.

ABSTRACT: In this study, we describe the development and validation of a revised Pediatric Chronic Pain Grading (P-CPG) for children aged 8 to 17 years that adds emotional impairment to previously used measures of pain intensity and functional impairment. Such a measure enables the assessment of chronic pain severity in different epidemiological and clinical populations, the stratification of treatment according to pain severity, and the monitoring of treatment outcome. The P-CPG was developed using a representative sample of school children with chronic pain (n = 454; Mage = 12.95, SD = 2.22). Construct validity and sensitivity to change were examined within a sample of N = 2448 children and adolescents (Mage = 12.71, SD = 2.47) comprising 3 subsamples (school n = 1562, primary care n = 129, and tertiary care n = 757) affected by chronic pain to varying extents. Results showed that P-CPG grades differed significantly among the 3 subsamples, with school children being least affected by chronic pain and tertiary care patients being most affected. As P-CPG grade increased, so did pain intensity, functional impairment, pain-related school absence, and emotional impairment. Convergent validity was demonstrated by significant positive correlations between the P-CPG and global ratings of pain severity as well as objective claims data; the latter reflects greater health care costs with increasing P-CPG scores. Sensitivity to change was supported by a significant reduction in baseline P-CPG grades 3 and 6 months after intensive interdisciplinary pain treatment in tertiary care sample. In conclusion, the P-CPG is an appropriate measure of pain severity in children and adolescents with chronic pain in clinical as well as epidemiological settings.

Clinically significant differences in self-reported pain scores in children with headaches.

OBJECTIVES: Changes in pain scores that represent clinically significant differences in children with headaches are necessary for study design and interpretation of findings reported in studies. We aimed to determine changes in pain scores associated with a minimum clinically significant difference (MCSD), ideal clinically significant difference (ICSD), and patient-perceived adequate analgesia (PPAA) in this population. METHODS: We performed a secondary analysis of two prospective studies of children with headaches presenting to an emergency department. Two serial assessments were performed in children aged 6-17 and 4-17 years who self-reported their pain intensity using the Verbal Numerical Rating Scale (VNRS) and Faces Pain Scale-Revised (FPS-R), respectively. Children qualitatively described any endorsed change in pain score; those who received an analgesic were asked if they wanted additional analgesics to decrease their pain intensity. We used receiver operating characteristic curve-based methodology to identify changes in pain scores associated with "a little less" (MCSD) and "much less" (ICSD) pain and patients declining additional analgesics because they experienced adequate analgesia after treatment (PPAA). RESULTS: We analyzed 105 children: 63.8% were female and the median (IQR) age was 13 (10-15) years. Ninety-eight children were analyzed for the VNRS and 101 were analyzed for the FPS-R. For the VNRS, raw change and percent reductions in pain scores associated with MCSD, ICSD, and PPAA were 2/10 and 25%, 4/10 and 56%, and 3/10 and 50%, respectively, and for the FPS-R, 2/10 and 25%, 4/10 and 67%, and 4/10 and 60%, respectively. The area under the curve (AUC) associated with a MCSD for both scales ranged from 94% to 98%; the AUC associated with an ICSD or PPAA for both scales ranged from 76% to 83%. CONCLUSIONS: We identified changes in pain score associated with patient-centered outcomes in children with headaches suitable for designing trials and assigning clinical significance to changes in pain scores reported in studies.

Acceptance of Medical Artificial Intelligence in Skin Cancer Screening: Choice-Based Conjoint Survey.

BACKGROUND: There is great interest in using artificial intelligence (AI) to screen for skin cancer. This is fueled by a rising incidence of skin cancer and an increasing scarcity of trained dermatologists. AI systems capable of identifying melanoma could save lives, enable immediate access to screenings, and reduce unnecessary care and health care costs. While such AI-based systems are useful from a public health perspective, past research has shown that individual patients are very hesitant about being examined by an AI system. OBJECTIVE: The aim of this study was two-fold: (1) to determine the relative importance of the provider (in-person physician, physician via teledermatology, AI, personalized AI), costs of screening (free, 10€, 25€, 40€; 1€=US $1.09), and waiting time (immediate, 1 day, 1 week, 4 weeks) as attributes contributing to patients' choices of a particular mode of skin cancer screening; and (2) to investigate whether sociodemographic characteristics, especially age, were systematically related to participants' individual choices. METHODS: A choice-based conjoint analysis was used to examine the acceptance of medical AI for a skin cancer screening from the patient's perspective. Participants responded to 12 choice sets, each containing three screening variants, where each variant was described through the attributes of provider, costs, and waiting time. Furthermore, the impacts of sociodemographic characteristics (age, gender, income, job status, and educational background) on the choices were assessed. RESULTS: Among the 383 clicks on the survey link, a total of 126 (32.9%) respondents completed the online survey. The conjoint analysis showed that the three attributes had more or less equal importance in contributing to the participants' choices, with provider being the most important attribute. Inspecting the individual part-worths of conjoint attributes showed that treatment by a physician was the most preferred modality, followed by electronic consultation with a physician and personalized AI; the lowest scores were found for the three AI levels. Concerning the relationship between sociodemographic characteristics and relative importance, only age showed a significant positive association to the importance of the attribute provider (r=0.21, P=.02), in which younger participants put less importance on the provider than older participants. All other correlations were not significant. CONCLUSIONS: This study adds to the growing body of research using choice-based experiments to investigate the acceptance of AI in health contexts. Future studies are needed to explore the reasons why AI is accepted or rejected and whether sociodemographic characteristics are associated with this decision.

An observational study on the adherence to study registrations in German interventional and observational studies from various fields.

Background: The registration of studies, especially in the case of clinical trials, is required by the declaration of Helsinki and the policies of various scientific journals. However, numerous analyses have found considerable discrepancies between published articles and accompanying trial registrations. The aim of this study is to assess such discrepancies for a sample of studies with recruiting locations in Germany. Additionally, the association between the adherence to registrations and possible involvement of Coordinating Centers for Clinical Studies (KKS) as well as Universities of Excellence was tested. Methods: For a sample of 376 interventional or observational study registrations, we found 115 published articles. Subsequently, we searched for discrepancies in the study design, the key inclusion criteria, the interventions, the blinding, and a primary and a secondary outcome. Results: We found discrepancies in 26% of all studies, most frequently in the secondary outcomes, where 16.5% of the secondary outcomes per study that were registered in most detail had discrepancies. When running regression models for adherence discrepancies, the only variable that had a statistically significant association with better adherence was registration on ClinicalTrials.gov. The association of potential involvement of a KKS with adherence ratings was positive, too, but statistically insignificant. Conclusions: In summary, the amount of discrepancies between registrations and published articles remains elevated.

Confidence intervals and sample size planning for optimal cutpoints.

Various methods are available to determine optimal cutpoints for diagnostic measures. Unfortunately, many authors fail to report the precision at which these optimal cutpoints are being estimated and use sample sizes that are not suitable to achieve an adequate precision. The aim of the present study is to evaluate methods to estimate the variance of cutpoint estimations based on published descriptive statistics ('post-hoc') and to discuss sample size planning for estimating cutpoints. We performed a simulation study using widely-used methods to optimize the Youden index (empirical, normal, and transformed normal method) and three methods to determine confidence intervals (the delta method, the parametric bootstrap, and the nonparametric bootstrap). We found that both the delta method and the parametric bootstrap are suitable for post-hoc calculation of confidence intervals, depending on the sample size, the distribution of marker values, and the correctness of model assumptions. On average, the parametric bootstrap in combination with normal-theory-based cutpoint estimation has the best coverage. The delta method performs very well for normally distributed data, except in small samples, and is computationally more efficient. Obviously, not every combination of distributions, cutpoint optimization methods, and optimized metrics can be simulated and a lot of the literature is concerned specifically with cutpoints and confidence intervals for the Youden index. This complicates sample size planning for studies that estimate optimal cutpoints. As a practical tool, we introduce a web-application that allows for running simulations of width and coverage of confidence intervals using the percentile bootstrap with various distributions and cutpoint optimization methods.

A dual-factor model perspective on depressed inpatients: examining the dynamics of mental health and therapy outcomes.

Background: The dual-factor model of mental health posits that mental health and mental illness constitute two distinct axes; accordingly the model identifies four mental health groups: (1) complete mental health, (2) troubled, (3) vulnerable, (4) symptomatic but content. Yet, only a few studies investigated effectiveness of therapy on both dimensions of mental health simultaneously. Against this background, the present study aimed to determine proportions and changes of group assignments in depressed inpatients undergoing therapy. Method: N = 1,044 depressed inpatients (age in years: M = 53.36, SD = 9.81, range: 17-83) completed a pre- and a post-treatment survey including questionnaires on depression, anxiety, and positive mental health. A total of n = 328 persons completed the survey also at 6-month and 12-month follow-up assessments. Results: In the classification that included depression symptoms and positive mental health, 49% of the participants were classified as troubled and 13.2% were classified as completely mentally healthy at the pre-treatment assessment. At the post-treatment, 9.5% were classified as troubled and 55.7% were classified as completely mentally healthy. In the classification that included anxiety symptoms and positive mental health, 21.9% of the participants were classified as troubled and 14.2% were classified as completely mentally healthy at the pre-treatment assessment. At the post-treatment, 3.7% were classified as troubled and 56.1% were classified as completely mentally healthy. About 10 to 20% of patients showed an improvement in depression/anxiety and positive mental health, whereas another 10 to 20% showed a reduction in depression/anxiety, but only a minor increase in positive mental health between pre- and post-treatment. Conclusion: Findings are in line with past research inspired by the dual-factor model in showing that enhancing positive mental health and alleviating psychopathology do not always co-occur in treatment. It is therefore important to implement measures of both psychopathology and positive mental health in therapy outcome studies, and to promote interventions targeting both psychopathology and positive mental health.

A randomized controlled trial on long-term effectiveness of a psychosocial aftercare program following paediatric chronic pain treatment: Who benefits the most?

BACKGROUND: For paediatric chronic pain patients, intensive interdisciplinary pain treatment (IIPT) is a well-established treatment. The treatment's short-term effectiveness can be improved by an additive psychosocial aftercare (PAC). However, neither the program's long-term effectiveness nor the patients in particular need have been investigated yet. METHODS: This study aimed at determining the long-term effects of PAC and detecting predictors of treatment outcome within a multicentre randomized controlled trial measured at five time points up to 12 months after discharge. At inpatient admission to IIPT, patients (N = 419, 14.3 years of age, 72.3% female) were randomly assigned to intervention or control group. After IIPT discharge, the intervention group received PAC, whereas the control group received treatment as usual (TAU). Patient-reported outcomes included pain and emotional characteristics. Clinicians assessed potential psychosocial risk factors and their prognosis of treatment outcome. Statistical analyses included mixed-models and univariable logistic regressions. RESULTS: Data at the 12-month follow-up (n = 288) showed a significant benefit of PAC compared with TAU; the majority (59.0%) of patients in the PAC-group reported no chronic pain compared to 29.2% of TAU-patients (p < 0.001). Patients with a single parent specifically benefited from PAC compared to TAU. Clinicians were able to make a reliable prognosis of treatment outcome, but did not successfully predict which patients would benefit the most from PAC. CONCLUSIONS: Study results suggest that PAC is highly effective irrespective of patient characteristics, but particularly for patients with single parents. Its broad implementation could help to improve the long-term outcomes of youth with severely disabling chronic pain. SIGNIFICANCE: A psychosocial aftercare following paediatric IIPT leads to significantly better pain and emotional outcomes compared to treatment as usual up to 12 months after discharge, especially for patients with single parents.

Registration quality and availability of publications for clinical trials in Germany and the influence of structural factors.

INTRODUCTION: Analyses of clinical trial registries (CTRs) offer insights into methodological problems of published research studies, e.g., non-publication and outcome-switching. Here, we use CTRs as a tool to evaluate clinical studies conducted in Germany and test how their registration quality is associated with time and structural factors: Coordinating Centers for Clinical Trials (KKS) and Universities of Excellence. METHODS: We searched ClinicalTrials.gov, the DRKS, and the ICTRP for clinical trials recruiting participants in Germany. As a measure for the methodological quality, we assessed the proportion of trials that were pre-registered. In addition, the registration quality and availability of publications relating to the trials were manually assessed for a sample (n = 639). Also, the influence of the structural factors was tested using regression models. RESULTS: We identified 35,912 trials that were conducted in Germany. 59% of trials were pre-registered. Surprisingly, Universities of Excellence had lower pre-registration rates. The influence of KKS was unclear and also difficult to test. Interventional trials were more likely to be pre-registered. Registration quality improved over time and was higher in interventional trials. As of early 2021, 49% of trials that started until the end of 2015 have published scientific articles. 187 of 502 studies on ClinicalTrials.gov for which we found published articles did not reference any in the registry entry. DISCUSSION: The structural predictors did not show consistent relationships with the various outcome variables. However, the finding that the study type and time were related to better registration quality suggests that regulatory regimes may have an impact. Limitations of this non-pre-registered study were that no modifications to registry entries were tracked and the coarse measure of KKS involvement.

Clinical Interpretation of Self-Reported Pain Scores in Children with Acute Pain.

OBJECTIVE: To identify self-reported pain scores that best represent categories of no pain, mild, moderate, and severe pain in children, and a pain score that accurately represents a child's perceived need for medication, that is, a minimum pain score at which a child would want an analgesic. STUDY DESIGN: Prospective cross-sectional cohort study of children aged 6-17 years presenting to a pediatric emergency department with painful and nonpainful conditions. Pain was measured using the 10-point Verbal Numerical Rating Scale. Receiver operating characteristic -based methodology was used to determine pain scores that best differentiated no pain from mild pain, mild pain from moderate pain, and moderate pain from severe pain. Descriptive statistics were used to determine the perceived need for medication. RESULTS: We analyzed data from 548 children (51.3% female, 61.9% with a painful condition). The scores that best represent categories of pain intensity are as follows: 0-1 for no pain; 2-5 for mild pain; 6-7 for moderate pain; and 8-10 for severe pain. The area under the curve for the cut points differentiating each category ranged from 0.76 to 0.88. The median pain score representing the perceived need for medication was 6 (IQR, 4-7; range, 0-10). CONCLUSIONS: We identified population-level self-reported pain scores in children associated with categories of pain intensity that differ from scores conventionally used. Implementing our findings may provide a more accurate representation of the clinical meaning of pain scores and reduce selection bias in research. Our findings do not support the use of pain scores in isolation for clinical decision making or the use of a pain score threshold to represent a child's perceived need for medication.

Effectiveness of a Psychosocial Aftercare Program for Youth Aged 8 to 17 Years With Severe Chronic Pain: A Randomized Clinical Trial.

Importance: Severe chronic pediatric pain causes individual suffering and significantly affects social functioning and psychological well-being. For children with high pain severity, intensive interdisciplinary pain treatment (IIPT) is a well-established treatment. However, across specialized centers, it is not sufficient for all patients. Objective: To evaluate the effectiveness of a psychosocial aftercare (PAC) program for pediatric patients with severe chronic pain followed up for 6 months after discharge from IIPT. Design, Setting, and Participants: This multicenter randomized clinical trial with 4 assessment points (pre-IIPT, immediately post-IIPT, 3 months, and 6 months) was conducted at 3 pediatric specialized tertiary care pain centers in Germany between September 11, 2018, and March 31, 2020. Included patients were aged 8 to 17 with a severe chronic pain condition who had been admitted for IIPT. Data were analyzed from June 8 to September 4, 2020. Interventions: Patients and their families were randomly assigned to 1 of 2 study groups at inpatient IIPT admission. Both groups received standardized 3- to 4-week IIPT. After IIPT discharge, the intervention group received PAC and the control group received usual care. PAC involved ongoing contact with a social worker for as long as the family requested the support, up to a maximum of 6 months. Main Outcomes and Measures: The primary outcome measure was pain at 6 months, measured using the Chronic Pain Grading (CPG), an instrument based on an algorithm indicating severity of the chronic pain disorder. Secondary outcomes included other pain-related and emotional parameters. Results: A total of 419 patients were randomized (mean [SD] age, 14.3 [2.1] years; 303 [72.3%] girls; 116 [27.7%] boys), with 218 assigned to usual care and 201 assigned to PAC. At baseline in both groups, the median (IQR) CPG was 3 (2-4). Superiority of PAC compared with usual care was demonstrated at 6 months (median [IQR] CPG: usual care, 2 [2-3]; PAC, 1 [1-2]; r = 0.30; 95% CI, 0.17-0.41). Additionally, PAC significantly improved emotional parameters (eg, significant time × group interaction: b = -8.84; P < .001). Conclusions and relevance: This randomized clinical trial found that PAC improved pain-related and emotional parameters during the intervention 6 months after discharge from IIPT. Future research is needed to investigate the intervention's long-term effects. Trial Registration: German Clinical Trials Register ID: DRKS00015230.

Not sad enough for a depression trial? A systematic review of depression measures and cut points in clinical trial registrations.

INTRODUCTION: Patient reported outcomes are central to the evaluation of behavioral, drug, or somatic interventions focusing depression. Continuous measures are mostly interpreted with cut points that serve as inclusion criteria and define remission. The present review provides an overview of measures (BDI; BDI-II; CESD; HADS; HAMD-17; MADRS; PHQ-9; QIDS) and cut points in clinical trials on depression and tests for systematic differences concerning varying types of interventions. METHODS: We analyzed 2632 trials registered via clinicaltrials.gov registered between 2000/01/01 - 2019/12/31 that used one or more pre-specified measures of depression of which 1600 reported cut points for either inclusion of participants or the definition of clinical remission. RESULTS: The included studies more often used clinician-administered scales than self-report questionnaires as criterion for the inclusion of study participants and for the definition of clinical remission. Clinician administered scales are dominating in drug trials, while self-report questionnaires are primarily used in behavioral trials. This trend accelerated during the last 20 years. Compared to studies on behavioral therapies, studies with drug or other interventions used higher cut points to include patients. Comparisons between the interventions revealed highly significant differences in the used cut points of MADRS, HAMD-17 and PHQ-9. CONCLUSIONS: Choice of measure and cut points is an important aspect of trial design and should be homogenized in order to make trials of different types of interventions more readily comparable. Similarly, systematic differences between treatment types in how patients are included and how remission is defined also hamper the comparisons between different treatment modalities.

Psychometric Properties of a Self-Report Version of the Sexual Interest and Desire Inventory-Female (SIDI-F-SR).

BACKGROUND: The Sexual Interest and Desire Inventory-Female (SIDI-F) is a clinician-administered scale that allows for a comprehensive assessment of symptoms related to Hypoactive Sexual Desire Dysfunction (HSDD). As self-report questionnaires may facilitate less socially desirable responding and as time and resources are scarce in many clinical and research settings, a self-report version was developed (Sexual Interest and Desire Inventory- Female Self-Report; SIDI-F-SR). AIM: To assess the psychometric properties of the SIDI-F-SR and to investigate the agreement between the SIDI-F and SIDI-F-SR. METHODS: A total of 170 women (Mage = 37, SD = 11, range = 20-69) with HSDD answered the SIDI-F, administered by a clinical psychologist via telephone, first, followed by the SIDI-F-SR, delivered as an Internet-based questionnaire. A subset of 19 women answered the SIDI-F-SR twice over a period of 14 weeks. OUTCOMES: Convergent validity of the SIDI-F-SR was assessed via correlations with the desire subscale of the Female Sexual Function Index and the Female Sexual Distress Scale Revised. Internal consistency and test-retest reliability as well as intraclass correlation and predictors of absolute agreement between SIDI-F and SIDI-F-SR were examined. RESULTS: Test-retest-reliability was good (r = 0.74). Convergent validity was low but comparable between SIDI-F and SIDI-F-SR. Internal consistency of the SIDI-F-SR was acceptable (α = 0.76) and comparable to the SIDI-F (α = 0.74). When corrections for the restriction of range were applied, internal consistency of the SIDI-F-SR increased to 0.91. There was high agreement between SIDI-F and SIDI-F-SR (ICC = 0.86). On average, women scored about one point higher (indicated more desire) in the self-report vs the clinician-administered scale. CLINICAL IMPLICATIONS: The SIDI-F-SR can be used in settings where time and resources are limited. Whether the clinical cutoff point for the SIDI-F is adequate for the SIDI-F-SR has yet to be determined. STRENGTHS AND LIMITATIONS: Large sample of diverse women with HSDD. Lack of control groups (ie, healthy controls, women with other sexual dysfunctions). CONCLUSION: The SIDI-F-SR showed promising psychometric properties in a sample of women with HSDD. Velten J, Hirschfeld G, Meyers M, et al. Psychometric Properties of a Self-Report Version of the Sexual Interest and Desire Inventory-Female (SIDI-F-SR). J Sex Med 2021;18:990-995.

Adolescents' Explanatory Models for Headaches and Associations with Behavioral and Emotional Outcomes.

More than one-third of adolescents experience recurrent headaches. Usually, these headaches are of primary origin and modulated by different biological and psychosocial factors. While parents are often consulted in scientific research and medical care about the nature of their child's headache, it is unclear to what extent parents and their children agree upon the factors that cause them. Adolescents' own attributions of headaches have rarely been investigated, and it is unclear how those attributions affect behavioral and emotional outcomes. In the present study, adolescents with chronic headaches (N = 248) and their parents (N = 120) rated the influence of various biological and psychosocial factors on the adolescents' headaches. Associations between these factors and several behavioral and emotional outcomes were examined. The most frequently reported factor by both samples was stress; however, concordance between parents and adolescents was generally low. The factor "other disease" was significantly associated with medication consumption and school absence. This study is one of the first to provide insights into adolescents' own attributions of headaches. Furthermore, the significant associations of the factor with behavioral outcomes reveal the importance of understanding personal explanatory models of headache. Future studies should examine associations between subjective headache causes and the individual's experience of the disorder to improve headache interventions.

Factors associated with physician consultation and medication use in children and adolescents with chronic pain: A scoping review and original data.

BACKGROUND: Although paediatric chronic pain is common, it is not yet clear which individuals with chronic pain are likely to seek health care for their pain. The aims of this study were to summarize the current evidence of the characteristics of children and adolescents with chronic pain who consult a physician or use medication for their pain. Additionally, we aimed to expand knowledge by further investigating key and promising, factors in a large community sample of adolescents. METHODS: First, using scoping review methodology, studies on health care utilisation in paediatric chronic pain were identified by the systematic literature search. Out of 1,158 articles, 12 were included for data extraction. Second, in a population-based cross-sectional survey, data of N = 2,280 adolescents (10-18 years) and their parents (N = 1,464), were analysed. Univariable logistic and multivariable LASSO regression models were calculated for adolescents with chronic pain (n = 749) to identify predictors of physician visits or analgesics intake due to pain, controlling for acute illness and injury. RESULTS: The scoping review identified higher pain intensity, frequency, severity and pain-related disability as significant individual factors associated with physician consultation. Female sex and higher pain intensity were associated with medication consumption. Multivariable analyses with cross-sectional data revealed only pain-related school absence to be associated with physician consultation; analgesic medication use was associated with school absence and higher pain intensity. CONCLUSION: Original data from this study support prior findings. School absence and pain intensity, plausible surrogates for pain severity, are the most relevant factors in health care utilisation due to chronic pain. SIGNIFICANCE: A scoping summary of existing research on predictors for physician consultation and medication use in children and adolescents with chronic pain is provided. Furthermore, the role of potential predictors for health care utilisation-sociodemographic, pain, school, psychological and parent-related characteristics-is analysed in a population-based cross-sectional survey. Controlling for illness and injuries, and using a strict chronic pain definition, the cross-sectional survey allows conclusions on healthcare utilisation specific to chronic pain in adolescents.

Screening for health-related quality of life in children and adolescents: Optimal cut points for the KIDSCREEN-10 for epidemiological studies.

INTRODUCTION: Generic measures of health-related quality of life are important in pediatrics. Here, we try to establish optimal cut points for the self-report and parental-report versions of the KIDSCREEN-10. METHOD: We re-analyzed data from the German Health Interview and Examination Survey for Children and Adolescents (KiGGS) study. In total, data from 2566 children, 2136 younger adolescents, and 2740 older adolescents were used. The KIDSCREEN-10 was contrasted to three different anchors: the strength and difficulties questionnaire, self-rated general health, and chronic diseases. A kernel-based method and bootstrapping were used to determine the optimal cut points and their variability. RESULTS: We found large differences in HRQoL between children with vs. without mental health problems but there is only medium-to-small differences in HRQoL between children with vs. without chronic diseases and children with self-rated good vs. poor physical health. Acceptable levels of classification accuracy were found in relation to mental health problems for all versions (AUCs between 0.77 and 0.79), but only for the parental-report version in relation to general health and for no version in relation to chronic diseases. Cut points identified as optimal differed systematically between parental-report versions (cut point = 41.13) and self-report for younger (cut point = 42.52) and older adolescents (cut point = 40.29). CONCLUSION: The results aid the interpretation of KIDSCREEN-10 in epidemiological studies. Specifically, we suggest a cut point of 41 should be used to interpret the parental-report version of the KIDSCREEN and 40 and 42, respectively, for young and older adolescents.

Long-Term Effectiveness of Cognitive Behavioral Therapy in Routine Outpatient Care: A 5- to 20-Year Follow-Up Study.

OBJECTIVE: Long-term follow-ups several years after receiving cognitive behavioral therapy (CBT) are scarce and most of the existing literature describes follow-up data of randomized-controlled trials. Thus, very little is known about the long-term effects of CBT in routine care. METHODS: We investigated psychological functioning in a sample of 263 former outpatients who had received CBT for a variety of mental disorders such as depression, anxiety-, eating- or somatoform disorders 8.06 (SD 5.08) years after treatment termination. All participants completed a diagnostic interview as well as the Brief-Symptom Inventory (BSI) and the Beck Depression Inventory (BDI). Effect sizes and response rates according to Jacobson and Truax [J Consult Clin Psychol 1991;59:12-9] were calculated from pre- to posttreatment and from pretreatment to follow-up assessment. RESULTS: Pre- to posttreatment effect sizes ranged between 0.75 (BDI) and 0.63 (BSI) and pretreatment to follow-up effect sizes were 0.92 (BDI) and 0.75 (BSI). Of all patients, 29% (BDI) and 17% (BSI) experienced clinically significant change at posttreatment and 42% (BDI) and 24% (BSI) at follow-up. CONCLUSION: The results point to the long-term effectiveness of CBT under routine conditions for a wide array of problems, especially when compared to the long-term effects of medical treatment. It is noteworthy that the results at follow-up were even better than at posttreatment, indicating further improvement. However, about a quarter of the patients did not respond sufficiently to therapy, neither concerning short-term nor long-term effects.

Affect and worry during a checking episode: A comparison of individuals with symptoms of obsessive-compulsive disorder, anorexia nervosa, bulimia nervosa, body dysmorphic disorder, illness anxiety disorder, and panic disorder.

Checking behavior (CB) occurs in a variety of disorders such as obsessive-compulsive (OCD), body dysmorphic (BDD), illness anxiety (IA), and panic disorder (PD), as well as anorexia (AN) and bulimia nervosa (BN). Etiological models of these disorders - with the exception of those for PD - postulate that CB mainly occurs in situations characterized by negative affect and serves to regulate it. We aimed to test these assumptions: N = 386 individuals with a self-reported diagnosis of one of the disorders rated their affect at baseline, directly before a remembered CB episode, during, immediately afterwards, and 15 and 60 minutes afterwards, and rated their endorsement of different functions of CB. The results show that transdiagnostically negative affect is significantly higher before CB compared to baseline, and is significantly reduced from before CB to all post-CB assessments. Reduction of negative affect and Attainment of certainty were the sole functions predicting the affective course during CB, and most prominently reported transdiagnostically. Assumptions of the etiological models were confirmed, suggesting that exposure and ritual prevention should be examined across disorders. As attainment of certainty seems to be predictive for the course of CB, this might be targeted in cognitive interventions.

Changes in Pain Score Associated With Clinically Meaningful Outcomes in Children With Acute Pain.

BACKGROUND: Identifying changes in pain score associated with clinically meaningful outcomes is necessary when using self-report measures to assess pain in children. We aimed to determine the changes in pain score associated with a minimum clinically significant difference (MCSD), ideal clinically significant difference (ICSD), and patient-perceived adequate analgesia (PPAA) and to evaluate for differences based on initial pain intensity and patient characteristics. METHODS: This was a cross-sectional study of children 6 to 17 and 4 to 17 years old who were assessed using the Verbal Numerical Rating Scale (VNRS) and Faces Pain Scale-Revised (FPS-R), respectively. Children qualitatively described any endorsed change in pain score; those who received an analgesic were asked if they wanted additional analgesics to decrease their pain intensity. We used a receiver operating characteristic curve-based methodology to identify changes in pain score associated with "a little less" and "much less" pain (MCSD and ICSD, respectively) and patients declining additional analgesics because of adequate analgesia (PPAA). RESULTS: We enrolled 431 children with painful conditions. For the VNRS, raw change and percent reductions in pain scores associated with MCSD, ICSD, and PPAA were 2/10 and 20%, 3/10 and 44%, and 2/10 and 29%, respectively, and for the FPS-R, 2/10 and 33%, 4/10 and 60%, and 4/10 and 40%, respectively. Raw change in pain scores increased with increasing initial pain intensity, but percent reductions remained stable. There were no significant differences based on patient characteristics such as age, sex, and race/ethnicity. CONCLUSION: Our findings provide patient-centered outcomes in children that are suitable for designing trials and are generalizable across patient characteristics.