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Purpose: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core Questionnaire (QLQ-C30) is a widely used generic self-report measure of health-related quality of life (HRQOL) for cancer patients. However, no validated voice script for interviewer-led telephone administration was previously available. The aim of this study was to develop a voice script for interviewer administration via telephone. Methods: Following guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Mixed Modes Good Research Practices Task Force, a randomised cross-over equivalence study, including cognitive debriefing, was conducted to assess equivalence between paper and telephone administration modes. Assuming an expected intraclass correlation coefficient (ICC) of 0.70 and a minimally acceptable level of 0.50, a sample size of 63 was required. Results: Cognitive interviews with five cancer patients found the voice script to be clear and understandable. Due to a protocol deviation in the first wave of testing, only 26 patients were available for analyses. A second wave of recruitment was conducted, adding 37 patients (n = 63; mean age 55.48; 65.1% female). Total ICCs for mode comparison ranged from 0.72 (nausea and vomiting, 95% CI 0.48–0.86) to 0.90 (global health status/QoL, 95% CI 0.80–0.95; pain, 95% CI 0.79–0.95; constipation, 95% CI 0.80–0.95). For paper first administration, all ICCs were above 0.70, except nausea and vomiting (ICC 0.55; 95% CI 0.24–0.76) and financial difficulties (ICC 0.60; 95% CI 0.31–0.79). For phone first administration, all ICCs were above 0.70. Conclusions: The equivalence testing results support the voice script's validity for administration of the QLQ-C30 via telephone. [ABSTRACT FROM AUTHOR]

Purpose Pain and stress-related ill-health are major causes of long-term disability and sick leave. This study evaluated the effects of a brief psychosocial program, which previously has been tested for an at-risk population of employees. Methods The Effective Communication within the Organization (ECO) program, where supervisors and employees were trained in communication and problem solving, was compared to an active control consisting of psychoeducative lectures (PE) about pain and stress in a cluster randomized controlled trial. First-line supervisors were randomized to ECO or PE, and a total of 191 mainly female employees with self-reported pain and/or stress-related ill-health were included. The hybrid format programs consisted of 2–3 group sessions. Sick leave data was collected from social insurance registers, before and 6-months after the program. Secondary outcomes (work ability, work limitations, pain-disability risk, exhaustion symptoms, perceived stress, perceived health, quality of life, perceived communication and support from supervisors) were assessed at baseline, post intervention, and at 6-months follow-up. Results No effects were observed on primary or secondary outcome variables. Pain symptoms were common (89%), however a lower proportion (30%) were identified as at risk for long-term pain disability, which might explain the lack of evident effects. The Covid-19 pandemic affected participation rates and delivery of intervention. Conclusion In this study, preventive effects of the ECO program were not supported. Altogether, the findings point at the importance of selecting participants for prevention based on screening of psychosocial risk. Further research on workplace communication and support, and impact on employee health is warranted. [ABSTRACT FROM AUTHOR]

Purpose: To determine the dose-response of vitamin D3 supplementation on serum 25-hydroxyvitamin D [25(OH)D] among Chinese adults. Methods: In this 5-arm, randomized, double-blinded controlled trial, 76 healthy participants were assigned to orally administrate 0, 400, 800, 1200 or 2000 IU/d of vitamin D3 for 16 weeks. Serum 25(OH)D, parathyroid hormone, calcium, biomarkers of liver and renal function were measured at multiple time points. Results: The mean (SD) serum 25(OH)D at baseline was 31.6 (8.7) nmol/L, and the dose-response relationship was curvilinear with a plateau around 6 weeks for all doses. At week 16, 25(OH)D was increased by 6.0 (6.5), 21.7 (15.8), 26.3 (12.6), 32.0 (12.8) and 36.3 (26.0) nmol/L for 0, 400, 800, 1200 and 2000 IU/d (all P ≤ 0.002), corresponding to approximately 19, 53, 67, 77 and 80 % of reversion of vitamin D deficiency, respectively. Daily intake of 800 IU vitamin D3 reached a targeted 25(OH)D ≥ 30 nmol/L in at least 97.5 % of Chinese, but not a targeted 25(OH)D ≥ 50 nmol/L even with 2000 IU/d. Change of 25(OH)D was inversely associated with change of PTH concentration ( r = −0.39, P < 0.001) after controlling for age and sex. No between-group differences were observed in terms of the change in serum calcium, alanine transaminase, aspartate aminotransferase, gamma-glutamyltransferase and creatinine ( P ≥ 0.22). Conclusions: Supplementation with 400, 800, 1200 or 2000 IU/d vitamin D could improve the vitamin D deficiency with various degrees. Whether 2000 IU/d vitamin D3 would generate a better result without side effect requires more studies with larger samples in future. [ABSTRACT FROM AUTHOR]

Early intervention for autism spectrum disorder (ASD) tends to focus on enhancing social-communication skills. We report the acceptability, feasibility and impact on child functioning of a new 8 weeks parent-group intervention to manage restricted and repetitive behaviours (RRB) in young children with ASD aged 3-7 years. Forty-five families took part in the pilot RCT. A range of primary and secondary outcome measures were collected on four occasions (baseline, 10, 18 and 24 weeks) to capture both independent ratings and parent-reported changes in RRB. This pilot established that parents were willing to be recruited and randomised, and the format and content of the intervention was feasible. Fidelity of delivery was high, and attendance was 90 %. A fully powered trial is now planned. [ABSTRACT FROM AUTHOR]

Background: Multidimensional tinnitus models describe dysfunctional cognitions as a complicating factor in the process of tinnitus habituation. However, this concept has rarely been investigated in previous research. Purpose: The present study investigated the effects of two cognitive-behavioral treatments on dysfunctional tinnitus-related cognitions in patients with chronic tinnitus. Furthermore, dysfunctional cognitions were examined as possible predictors of the therapeutic effect on tinnitus distress. Method: A total of 128 patients with chronic tinnitus were randomly assigned to either an Internet-delivered guided self-help treatment (Internet-based cognitive-behavioral therapy, ICBT), a conventional face-to-face group therapy (cognitive-behavioral group therapy, GCBT), or an active control group in the form of a web-based discussion forum (DF). To assess tinnitus-related dysfunctional thoughts, the Tinnitus Cognitions Scale (T-Cog) was used at pre- and post-assessment, as well as at the 6- and 12-month follow-up. Results: Multivariate ANOVAs with post hoc tests revealed significant and comparable reductions of dysfunctional tinnitus-related cognitions for both treatments (GCBT and ICBT), which remained stable over a 6- and 12-month period. Negative correlations were found between the catastrophic subscale of the T-Cog and therapy outcome for ICBT, but not for GCBT. This means a higher degree of catastrophic thinking at baseline was associated with lower benefit from ICBT directly after the treatment. Hierarchical regression analysis confirmed catastrophizing as a predictor of poorer therapy outcome regarding emotional tinnitus distress in ICBT. No associations were detected in the follow-up assessments. Conclusion: Both forms of CBT are successful in reducing dysfunctional tinnitus-related cognitions. Catastrophizing significantly predicted a less favorable outcome regarding emotional tinnitus distress in ICBT. Clinical implications of these results are described. Dysfunctional cognitions could be targeted more intensively in therapy and in future research on tinnitus. [ABSTRACT FROM AUTHOR]

In a report of the effectiveness of MEHRIT, a social-interaction-based intervention for autism, Casenhiser et al. (Autism 17(2):220-241, ) failed to find a significant advantage for language development in the treatment group using standardized language assessments. We present the results from a re-analysis of their results to illustrate the importance of measuring communicative language acts (formally called 'speech acts'). Reanalysis confirmed that children in the MEHRIT group outperformed the community treatment group on measures of MLUm, number of utterances produced, and various speech act categories. The study underscores the importance of functional language measures in guiding and evaluating treatment for children with autism, and suggests that MEHRIT is effective in improving children's use of language during parent-child interactions. [ABSTRACT FROM AUTHOR]

Acceptance-based psychological interventions can potentially minimize the burden of chronic pain. This randomized controlled trial evaluated an internet-delivered, guided self-help intervention based on Acceptance and Commitment Therapy (ACT). A total of 238 chronic pain sufferers from the general population were randomly allocated to either ACT (n = 82), an internet-based control condition Expressive Writing (n = 79) or a waiting list condition (n = 77). Participants completed measures at baseline, posttreatment (3 months) and at a 3-month follow-up. At follow-up, ACT participants had improved in pain interference in daily life (primary outcome) compared to participants in Expressive Writing (Cohen's d = .47), but not compared to waiting list participants ( p value = .11). Those who adhered to the ACT-intervention (48 %) did improve significantly compared to waiting list participants (d = .49). ACT-participants also showed superior improvement on depression, pain intensity, psychological inflexibility and pain catastrophizing (d: .28-.60). Significant clinical improvement was present. Especially, 28 % of ACT-participants showed general clinically relevant improvement in pain interference, as well as in pain intensity and depression (vs. Expressive Writing and waiting list 5 %). Given these findings, internet-based ACT programs may be a promising treatment modality for chronic pain. [ABSTRACT FROM AUTHOR]

This study examined whether the Program for the Education and Enrichment of Relational Skills (PEERS: Social skills for teenagers with developmental and autism spectrum disorders: The PEERS treatment manual, Routledge, New York, ) affected neural function, via EEG asymmetry, in a randomized controlled trial of adolescents with Autism spectrum disorders (ASD) and a group of typically developing adolescents. Adolescents with ASD in PEERS shifted from right-hemisphere gamma-band EEG asymmetry before PEERS to left-hemisphere EEG asymmetry after PEERS, versus a waitlist ASD group. Left-hemisphere EEG asymmetry was associated with more social contacts and knowledge, and fewer symptoms of autism. Adolescents with ASD in PEERS no longer differed from typically developing adolescents in left-dominant EEG asymmetry at post-test. These findings are discussed via the Modifier Model of Autism (Mundy et al. in Res Pract Persons Severe Disabl 32(2):124, ), with emphasis on remediating isolation/withdrawal in ASD. [ABSTRACT FROM AUTHOR]

The purpose of this pilot study was to evaluate the efficacy of the interview skills curriculum (ISC), a manualized 12-week group-delivered intervention for young adults with autism spectrum disorder (ASD). This intervention aims to increase social-pragmatic skills essential to a successful job interview. Twenty-eight adults (18-36 years) were randomly assigned to one of two groups: ISC or waitlist control. Results revealed that the experimental group showed larger gains in social-pragmatic skills observed during a mock job interview than the control group. Treatment effects on distal outcomes, including social adaptive behaviors and depressive symptoms were not significant, although the respective effect sizes were medium/large. Results indicate that a brief, low-intensity treatment can improve the job-interview performance of young adults with ASD. [ABSTRACT FROM AUTHOR]