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Purpose: This study compared a tablet PC questionnaire with a paper method for reliability and patient preferences in the acquisition of patient-reported outcomes (PROs) for patients treated with radiotherapy. By comparing the two modes of PRO administration, we aimed to evaluate the adequacy of using tablet PC questionnaires in future clinical use.Methods: Patients were randomized in a crossover study design using two different methods for PRO entry. A group of 89 patients answered a paper questionnaire followed by the tablet PC version, whereas 89 patients in another group completed the tablet PC questionnaire followed by the paper version. Surveys were performed four times per patient throughout the course of the radiotherapy. The Korean versions of the M.D. Anderson Symptom Inventory (MDASI-K) and the Brief Fatigue Inventory (BFI-K) were used. The primary endpoint of our current study was an assessment of patient preference for the survey method. The proportions of patients preferring each mode of questionnaire were evaluated.Results: The proportion of patients who preferred the tablet PC version, paper form, or who had no preference was 52.2, 22.1, and 25.7 %, respectively. More than half of the patients preferred the tablet PC to the paper version in all four surveys. Age, gender, educational status, prior experience of using a tablet PC, and the order of paper to tablet PC administration did not impact patient preferences. Inter-class correlation coefficients (ICCs) between the modes were 0.92 for MDASI-K and 0.94 for BFI-K and ranged from 0.91 to 0.96 on both instruments during the four surveys.Conclusions: A tablet PC-based PRO is an acceptable and reliable method compared with paper-based data collection for Korean patients receiving radiotherapy. [ABSTRACT FROM AUTHOR]

Objectives: To compare data based on computerized and paper versions of health status questionnaires (HSQs) for sampling patient-reported outcomes (PROs) in patients with fibromyalgia (FM). In addition, to examine associations between patient characteristics (age, education, computer experience) and differences between versions. Finally, to evaluate the acceptability of computer-based questionnaires among patients with FM.Method: The study population comprised female patients diagnosed with FM. All patients completed six HSQs: the Fibromyalgia Impact Questionnaire (FIQ), the Major Depression Inventory (MDI), the 36-item Short Form Health Survey (SF-36), the painDETECT questionnaire (PDQ), the Coping Strategies Questionnaire (CSQ), and the Generalized Anxiety Disorder Self-Assessment Questionnaire (GAD-10), both on paper and using a touch screen. One HSQ was tested at a time in a repeated randomized cross-over design. The two versions were completed with a 5-min interval and between each HSQ the participants had a 5-min break. Means, mean differences with 95% confidence intervals (CIs), medians, median differences, and intraclass correlation coefficients (ICCs) were calculated for all HSQs, including relevant subscales. Associations between patient characteristics and differences between versions were explored using Spearman's correlation coefficients.Results: Twenty women, mean age 48.4 years, participated in the study. Except for one item, ICCs between touch-screen and paper versions of the HSQs examined indicated acceptable agreement (ICC = 0.71-0.99). Overall, mean and median differences revealed no differences between versions. No significant associations were observed for patient characteristics. None of the participants preferred paper questionnaires over computerized versions.Conclusions: The computerized HSQs using a touch screen gave comparable results to answers given on paper and were generally preferred by the participants. [ABSTRACT FROM AUTHOR]

Background: Accurate quantification of pain in a clinical setting is vital. The use of an electronic pain scale enables data to be collected, analyzed, and utilized much faster compared with traditional paper-based scales. The advancement of smart technology in pediatric and adult pain evaluation may offer opportunities to introduce easy-to-use and reliable pain assessment methods within different clinical settings. If promptly introduced within different pediatric and adult pain clinic services, validated and easily accessible mobile health pain apps may lead to early pain detection, promoting improvement in patient's quality of life and leading to potentially less time off from school or work.Objective: This cross-sectional observational study aimed to investigate the interchangeability of an electronic visual analog scale (eVAS) app with a traditional paper visual analog scale (pVAS) among Australian children, adolescents, and adults for pain evaluation.Methods: Healthy participants (age range 10-75 years) were recruited from a sporting club and a secondary school in Melbourne (Australia). The data collection process involved application of pressure (8.5 kg/cm2) from a Wagner Force Dial FDK 20 to the midpoint of the thumb. The pressure was applied twice with a 5-minute interval. At each pressure application, participants were asked to randomly record their pain perception using the "eVAS" accessible via the "Interactive Clinics" app and the traditional pVAS. Statistical analysis was conducted to determine intermethod and intramethod reliabilities.Results: Overall, 109 healthy participants were recruited. Adults (mean age 42.43 years, SD 14.50 years) had excellent reliability, with an intraclass correlation coefficient (ICC) of 0.94 (95% CI 0.91-0.96). Children and adolescents (mean age 13.91 years, SD 2.89 years) had moderate-to-good intermethod and intramethod reliabilities, with an ICC of 0.80 (95% CI 0.70-0.87) and average ICC of 0.80 (95% CI 0.69-0.87), respectively.Conclusions: The eVAS app appears to be interchangeable compared with the traditional pVAS among children, adolescents, and adults. This pain evaluation method may offer new opportunities to introduce user-friendly and validated pain assessment apps for patients, clinicians, and allied health professionals. [ABSTRACT FROM AUTHOR]

Integration of e-Health technologies for purposes of both assessment and intervention has recently become an interest area in pediatric psychology. The purpose of this study is to present psychometric characteristics of a technology-based (i.e., tablet administration) approach for measuring quality of life (QOL) in children. Eighty children (8-12 years) completed the Quality of Life Systemic Inventory for Children (QLSI-C) twice over a 2-week delay, in a crossover design that used paper and tablet-based modes of administration. Equivalence of scores across methods was examined using intraclass correlation coefficients (ICC), augmented by paired t test and Pearson's correlations. Test-retest reliability was assessed using paired t test and Pearson's correlations while internal consistency was assessed using Cronbach's coefficient. Results showed a good concordance across methods of administration (ICCs = .72 to .91; r = .56 to .83). Paired t test showed no significant differences between the tablet and paper version of the QLSI-C. Internal consistency reliability yielded acceptable Cronbach's alphas for all QLSI-C scores, with all α > .70. Test-retest reliability for the tablet-administered QLSI-C was good (r = .66 to .90). Paired t test showed no significant difference between Time 1 and 2 for the QLSI-C scores, except for the state score. Findings established the reliability of the tablet-administered QLSI-C scores. This technology approach to assessment is more attractive for children, decreases time for administration, and enhances the ease of scoring. These advantages might encourage both clinicians and researchers to consider using e-Health developments in assessment in pediatric psychology. (PsycINFO Database Record [ABSTRACT FROM AUTHOR]

Purpose: To validate electronic versions of the Mini Pediatric and Pediatric Asthma Caregiver's Quality of Life Questionnaires (MiniPAQLQ and PACQLQ, respectively), determine completion times and correlate QOL of children and caregivers.Methods: A total of 63 children and 64 caregivers completed the paper and electronic MiniPAQLQ or PACQLQ. Agreement between versions of each questionnaire was summarized by intraclass correlation coefficients (ICC). The correlation between MiniPAQLQ and PACQLQ scores from child-caregiver pairs was assessed using Pearson's correlation coefficient.Results: There was no significant difference (mean difference = 0.1, 95% CI -0.1, 0.2) in MiniPAQLQ Overall Scores between paper (5.9 ± 1.0, mean ± SD) and electronic (5.8 ± 1.0) versions, or any of the domains. ICCs ranged from 0.89 (Overall) to 0.86 (Emotional Function). Overall PACQLQ scores for both versions were comparable (5.9 ± 0.9 and 5.8 ± 1.0; mean difference = 0.0; 95% CI -0.1, 0.2). ICCs ranged from 0.81 (Activity Limitation) to 0.88 (Emotional Function). The electronic PACQLQ took 26 s longer (95% CI 11, 41; p < 0.001). Few participants (3-11%) preferred the paper format. MiniPAQLQ and PACQLQ scores were significantly correlated (all p < 0.05) for Overall (r paper = 0.33, r electronic = 0.27) and Emotional Function domains (r paper = 0.34, r electronic = 0.29).Conclusions: These electronic QOL questionnaires are valid, and asthma-related QOL of children and caregivers is related. [ABSTRACT FROM AUTHOR]

Objective: To explore feasibility of using child/young person patient-reported outcome measures (PROMs) routinely in practice, using vision-specific instruments and paediatric ophthalmology as the exemplar.Methods: Participants comprised patients aged 8-17 years, with visual impairment or low vision (visual acuity of the logarithm of the minimum angle of resolution (logMAR) worse than 0.3 in the better eye), attending the Department of Ophthalmology at Great Ormond Street Hospital, London, UK. All participants completed age-appropriate PROMs before attending their outpatient appointment. Half were randomly assigned to completion at home, with the choice of paper-and-pencil or electronic format. The other half were invited to complete PROMs during their hospital appointment, and randomly assigned to completion format. All participants completed a face-to-face survey exploring their attitudes and preferences. Analysis comprised survival analysis, and direct comparisons of proportions, with complementary qualitative data analysis.Results: 93 patients participated. 48 (98%) completing PROMs at home chose the paper-and-pencil format. Completion at home took longer than at hospital (median=20, vs 14 min, p<0.001). Visual acuity was associated with completion time (p=0.007) and missing data (p=0.03). Overall, 52 (60%) reported a preference for completion at home but there was no clear preference for format (37 (43%) preferred either format).Conclusion: PROM completion at home ahead of hospital appointments may be preferable for collecting complete, high-quality datasets. Despite equipoise on preference for format, the majority of those completing at home chose the traditional paper-and-pencil format, despite impaired sight. These findings should inform implementation of child/young person PROMs into routine practice. [ABSTRACT FROM AUTHOR]

Background: Interest in collecting Patient Reported Outcomes using electronic methods such as mobile phones has increased in recent years. However there is debate about the level of measurement equivalence between the traditional paper and newer electronic modes. Information about the acceptability of the electronic versions to respondents is also required. The aim of this study is to compare the equivalence of delivering a widely used generic measure of health status (EQ-5D-5L) across two administration modes (paper and mobile phone).Methods: Respondents from a research cohort of people in South Yorkshire were identified, and randomly allocated to one of two administration modes (paper vs. mobile phone) based on stratifications for age and gender (and across a range of self-reported health conditions). A parallel group design was used where each respondent only completed EQ-5D-5L using one of the modes. In total, 70 respondents completed the measure in the mobile phone arm, and 66 completed the standard paper version. Follow up usability questions were also included to assess the acceptability of the mobile version of EQ-5D-5L. Measurement equivalence was compared at the dimension, utility score and visual analogue scale level using chi square analysis and ANOVA, and by comparing mean differences to an estimated minimally important difference value.Results: Response rates were higher in the mobile arm. The mean EQ-5D-5L utility and VAS scores, and the frequency of respondents endorsing individual EQ-5D-5L dimension response levels did not significantly differ across the administration modes. The majority of the mobile arm agreed that the mobile version of EQ-5D-5L was easy to complete, and that the phone was easy to use, and that they would complete mobile health measures again.Conclusions: Completing health status measures such as EQ-5D using mobile phones produces equivalent results to more traditional methods, but with added benefits (for example lessening the burden of data entry). Respondents are positive towards completing questionnaires using these methods. The results provide evidence that electronic measures are valid for use to collect data in a range of settings including clinical trials, routine care, and in health diary settings. [ABSTRACT FROM AUTHOR]

Purpose: In a randomised controlled trial, patients were offered financial incentives to improve their adherence to anti-psychotic maintenance medication. Compared to a control group without the incentives, they had an improved adherence and also better subjective quality of life (SQOL) after 1 year. This paper explores the question as to whether this improvement in SQOL was associated with the amount of money received or with the improved adherence itself.Method: A secondary analysis was performed using data of the experimental group in the trial. Adherence was assessed as the percentage of all prescribed long-acting anti-psychotic injections that were taken by the patient. In regression models, we tested whether changes in medication adherence and/or the amount of incentives received over the 12-month period was associated with SQOL, as rated on the DIALOG scale.Results: Adherence changed from 68.49 % at baseline to 88.23 % (mean difference in adherence = 19.59 %, SD = 17.52 %). The total amount of incentives received within the 1-year study period varied between £75 and £735, depending on the treatment cycle and the number of long-acting injections taken. Improvement in adherence was found to be a significant predictor of better subjective quality of life (β = 0.014, 95 % CI 0.003-0.025, p = 0.014), whilst the amount of incentives received was not (β = 0.0002, 95 % CI -0.002 to 0.002, p = 0.818).Conclusion: Improved medication adherence is associated with a more favourable SQOL. This underlines the clinical relevance of improved adherence in response to financial incentives in this patient group. [ABSTRACT FROM AUTHOR]

Background: Electronic formats of patient-reported outcome (PRO) measures are now routinely used in clinical research studies. When changing from a validated paper and pen to electronic administration it is necessary to establish their equivalence. This study reports on the value of Rasch analysis in this process.Methods: Three groups of US pulmonary hypertension (PH) patients participated. The first completed an electronic version of the CAMPHOR Activity Limitation scale (e-sample) and this was compared with two pen and paper administrated samples (pp1 and pp2). The three databases were combined and analysed for fit to the Rasch model. Equivalence was evaluated by differential item functioning (DIF) analyses.Results: The three datasets were matched randomly in terms of sample size (n = 147). Mean age (years) and percentage of male respondents were as follows: e-sample (51.7, 16.0 %); pp1 (50.0, 14.0 %); pp2 (55.5, 40.4 %). The combined dataset achieved fit to the Rasch model. Two items showed evidence of borderline DIF. Further analyses showed the inclusion of these items had little impact on Rasch estimates indicating the DIF identified was unimportant.Conclusions: Differences between the performance of the electronic and pen and paper administrations of the CAMPHOR Activity Limitation scale were minor. The results were successful in showing how the Rasch model can be used to determine the equivalence of alternative formats of PRO measures. [ABSTRACT FROM AUTHOR]

Background: Impaired physical function due to chemotherapy-induced peripheral neuropathy (CIPN) symptoms may lead to diminished quality of life. However, even with the knowledge of the effects of CIPN on physical function, clinicians infrequently assess and manage CIPN. Interventions that prioritize the early identification of CIPN to provide prompt treatment may reduce the impact of CIPN on physical function. The purpose of this paper is to compare self-reported physical function in individuals receiving neurotoxic chemotherapy between Electronic Symptom Assessment-Cancer (ESRA-C) intervention group (e.g., opportunity for symptom screening, self-care recommendations, communication coaching, and symptom tracking) and control group participants (i.e., electronic assessment alone). Secondary outcomes include pain intensity, sensory/motor CIPN, depression, fatigue, and insomnia.Methods: The data used in this paper are a subset of a randomized controlled trial that examined the impact of the ESRA-C intervention on symptom distress in individuals receiving cancer treatment. Since the interest in this analysis is on the effects of neurotoxic chemotherapy on physical function, subjects were included if they received platinum and/or taxane-based chemotherapy and completed the baseline and end-of-treatment measures. Participants completed standardized questionnaires of physical function, CIPN, fatigue, depression, pain intensity, and insomnia prior to treatment, 3-6 weeks after treatment initiation, and after the completion of treatment. Changes in mean scores are compared between groups using linear mixed models adjusting for age.Results: Intervention group participants reported significantly less reduction in physical functioning (baseline: 87.4/100; end-of-treatment: 84.5/100) relative to the control (baseline: 90.2/100; end-of-treatment: 81.8/100) (p = 0.011). For secondary measures, significantly less depression (p = 0.005) was observed in the intervention group as compared to the control, but otherwise, there were no between-group differences. Among participants who received high cumulative doses of neurotoxic chemotherapy, the intervention group reported significantly less severe sensory (p = 0.007) and motor CIPN (p = 0.039) relative to the control.Conclusion: Use of the ESRA-C intervention led to less reduction in physical function in comparison to the control in individuals receiving neurotoxic chemotherapy. Further research is needed to confirm our findings and to identify how electronic symptom assessment technology may mediate physical function preservation.Trial Registration: ClinicalTrials.Gov NCT00852852 . Registered 27 February 2009. [ABSTRACT FROM AUTHOR]

Background: The ICECAP measures potentially offer a broader assessment of quality of life and well-being, in comparison to measures routinely used in economic evaluation, such as the EQ-5D-3 L. This broader assessment may allow measurement of the full effects of an intervention or treatment. Previous research has indicated that the ICECAP-O (for older people) and EQ-5D-3 L measure provide complementary information. This paper aims to determine similar information for the ICECAP-A (for the entire adult population) in terms of whether the measure is a substitute or complement to the EQ-5D-3 L.Methods: Data from the BEEP trial - a multi-centre, pragmatic, randomised controlled trial - were used. Spearman rank correlations and exploratory factor analytic methods were used to assess whether ICECAP-A and EQ-5D-3 L are measuring the same, or different, constructs.Results: A correlation of 0.49 (p < 0.01) was found between the ICECAP-A tariff score and the EQ-5D-3 L index. Using the pooled items of the EQ-5D-3 L and the ICECAP-A a two factor solution was optimal, with the majority of EQ-5D-3 L items loading onto one factor and the majority of ICECAP-A items onto another.Conclusion: The results presented in this paper indicate that ICECAP-A and EQ-5D-3 L are measuring two different constructs and provide largely different, complementary information. Results showed a similarity to results presented by Davis et al. using the ICECAP-O.Trial Registration: ISRCTN 93634563. [ABSTRACT FROM AUTHOR]

Rationale: Several new drugs for idiopathic pulmonary fibrosis (IPF) are in development. Tools are needed to assess whether these drugs benefit patients on outcomes that matter most to them. Health-related quality of life (HRQL) is one such outcome. It is influenced by many factors, but symptoms and their impacts are two strong drivers.Objectives: To develop a questionnaire to assess symptoms, disease impacts, and HRQL specifically for patients with IPF.Methods: Working with the U.S. Food and Drug Administration through the Drug Development Tool Qualification process, focus groups, concept elicitation, and cognitive debriefing interviews were conducted to inform the development of a 44-item pilot questionnaire. The pilot paper-and-pen questionnaire was migrated to an equivalent electronic version and field-tested in a 14-day study. Response data were subjected to psychometric testing, including exploratory factor analysis, item calibration using item response theory models, test-retest reliability, and validity testing.Measurements and Main Results: A total of 125 patients with IPF (62.4% men) completed the longitudinal study. The mean ± SD age of the cohort was 69 ± 7.60 years, and the mean FVC% predicted was 71 ± 20.0. After factor and item analyses, 35 items were retained, and these comprise the two modules (symptoms and impacts) of the Living with IPF (L-IPF) questionnaire. The L-IPF yields five scales demonstrating good psychometric properties, including correlation with concurrently collected FVC% predicted and the ability to discriminate between patients with differing levels of IPF severity.Conclusions: The L-IPF is a new questionnaire that assesses symptoms, disease impacts, and HRQL in patients with IPF. [ABSTRACT FROM AUTHOR]

Aim: To: (1) investigate the relationship between upper-limb impairment and health-related quality of life (HRQoL) for children with cerebral palsy and (2) develop a mapping algorithm from the Cerebral Palsy Quality of Life Questionnaire for Children (CPQoL-Child) onto the Child Health Utility 9D (CHU9D) measure.Method: The associations between physical and upper-limb classifications and HRQoL of 76 children (40 females, 36 males) aged 6 to 15 years (mean age 9 years 7 months [SD 3y]) were assessed. Five statistical techniques were developed and tested, which predicted the CHU9D scores from the CPQoL-Child total/domain scores, age, and sex.Results: Most participants had mild impairments. The Manual Ability Classification System (MACS) level was significantly negatively correlated with CHU9D and CPQoL-Child (r=-0.388 and r=-0.464 respectively). There was a negative correlation between the Neurological Hand Deformity Classification (NHDC) and CPQoL-Child (r=-0.476, p<0.05). The generalized linear model with participation, pain domain, and age had the highest predictive accuracy.Interpretation: The weak negative correlations between classification levels and HRQoL measures may be explained by the restricted range of impairment levels of the participants. The MACS and NHDC explained the impact of upper-limb impairment on HRQoL better than the other classifications. The generalized linear model with participation, pain, and age is the suggested mapping algorithm. The suggested mapping algorithm will facilitate the use of CPQoL-Child for economic evaluation and can be used to conduct cost-utility analyses.What This Paper Adds: The Manual Ability Classification System and Neurological Hand Deformity Classification were the best predictors of health-related quality of life measures. Age and Cerebral Palsy Quality of Life Questionnaire for Children participation and pain domain scores can predict Child Health Utility 9D scores. [ABSTRACT FROM AUTHOR]

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Purpose: The aim of this paper is to describe a model of palliative rehabilitation for newly diagnosed advanced cancer patients and present data on how it was utilised during a randomised controlled trial (RCT).Methods: We designed a highly flexible, multidisciplinary model of palliative rehabilitation consisting of a "basic offer" and tailored elements. The model was evaluated in the setting on an RCT investigating the effect of systematic referral to a palliative rehabilitation clinic concurrently with standard oncology treatment or standard treatment alone. The basic offer of palliative rehabilitation was two consultations and a 12-week possibility of contacting a palliative rehabilitation team, if needed. In addition, patients and family caregivers could be offered participation in a 12-week patient/caregiver school combined with individually tailored physical exercise in groups, individual consultations, or both. Contacts with the palliative rehabilitation team and participant evaluation were registered prospectively.Results: Between December 2014 and December 2017, 132 adults with newly diagnosed advanced cancer were seen in the palliative rehabilitation outpatient clinic. Twenty percent of the participants received the basic offer only (n = 26), 45% additionally participated in the group program (n = 59), and 35% received supplementary individual consultations without participating in the group program (n = 47). The intervention was primarily led by nurses, and the main themes of the individual consultations were coping, pain, and nutrition. When asked if they would recommend the intervention to others in the same situation, 93% of the respondents agreed, 7% partly agreed, and no one disagreed.Conclusion: The new model of palliative rehabilitation presented here had a flexibility to meet the needs of the participants and led to a very high degree of patient satisfaction. It could serve as an inspiration to other cancer centres wanting to integrate palliative care into standard oncology services. [ABSTRACT FROM AUTHOR]

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

In this paper we report on the process of translating five mental health outcome measures into Spanish and adapting them to Latino culture. The instruments considered are the World Health Organization-Disability Assessment Scale, the Burden Assessment Scale, the Family Burden Scale, Lehman's Quality of Life Interview and the Continuity of Care in Mental Health Services Interview. A systematic process of translation and adaptation of the instruments was followed with the goal of achieving cultural equivalence between the English and Spanish versions of the instruments in five dimensions: semantic, content, technical, construct, and criterion equivalence. In this paper we present data about the semantic, content, and technical equivalence. Various steps were taken to achieve equivalence in these dimensions, including the use of a bilingual committee, a multi-national bilingual committee, back-translation, and focus groups with mental health patients and their relatives. [ABSTRACT FROM AUTHOR]

Background: The National Institute for Health and Care Excellence (NICE) recommends evidence-based parenting programmes as a first-line intervention for conduct disorders (CD) in children aged 5-11 years. As these are not effective in 25-33% of cases, NICE has requested research into second-line interventions. Child and Adolescent Psychotherapists (CAPTs) address highly complex problems where first-line treatments have failed and there have been small-scale studies of Psychoanalytic Child Psychotherapy (PCP) for CD. A feasibility trial is needed to determine whether a confirmatory trial of manualised PCP (mPCP) versus Treatment as Usual (TaU) for CD is practicable or needs refinement. The aim of this paper is to publish the abridged protocol of this feasibility trial.Methods and Design: TIGA-CUB (Trial on improving Inter-Generational Attachment for Children Undergoing Behaviour problems) is a two-arm, pragmatic, parallel-group, multicentre, individually randomised (1:1) controlled feasibility trial (target n = 60) with blinded outcome assessment (at 4 and 8 months), which aims to develop an optimum practicable protocol for a confirmatory, pragmatic, randomised controlled trial (RCT) (primary outcome: child's behaviour; secondary outcomes: parental reflective functioning and mental health, child and parent quality of life), comparing mPCP and TaU as second-line treatments for children aged 5-11 years with treatment-resistant CD and inter-generational attachment difficulties, and for their primary carers. Child-primary carer dyads will be recruited following a referral to, or re-referral within, National Health Service (NHS) Child and Adolescent Mental Health Services (CAMHS) after an unsuccessful first-line parenting intervention. PCP will be delivered by qualified CAPTs working in routine NHS clinical practice, using a trial-specific PCP manual (a brief version of established PCP clinical practice). Outcomes are: (1) feasibility of recruitment methods, (2) uptake and follow-up rates, (3) therapeutic delivery, treatment retention and attendance, intervention adherence rates, (4) follow-up data collection, and (5) statistical, health economics, process evaluation, and qualitative outcomes.Discussion: TIGA-CUB will provide important information on the feasibility and potential challenges of undertaking a confirmatory RCT to evaluate the effectiveness and cost-effectiveness of mPCP.Trial Registration: Current Controlled Trials, ID: ISRCTN86725795 . Registered on 31 May 2016. [ABSTRACT FROM AUTHOR]

Background: The Adult Social Care Outcomes Toolkit (ASCOT-SCT4) is a multi-attribute utility index designed for the evaluation of long-term social care services. The measure comprises eight attributes that capture aspects of social care-related quality of life. The instrument has previously been validated with a sample of older adults who used home care services in England. This paper aims to demonstrate the instrument's test-retest reliability and provide evidence for its validity in a diverse sample of adults who use publicly-funded, community-based social care in England.Methods: A survey of 770 social care service users was conducted in England. A subsample of 100 services users participated in a follow-up interview between 7 and 21 days after baseline. Spearman rank correlation coefficients between the ASCOT-SCT4 index score and the EQ-5D-3 L, the ICECAP-A or ICECAP-O and overall quality of life were used to assess convergent validity. Data on variables hypothesised to be related to the ASCOT-SCT4 index score, as well as rating of individual attributes, were also collected. Hypothesised relationships were tested using one-way ANOVA or Fisher's exact test. Test-retest reliability was assessed using the intra-class correlation coefficient for the ASCOT-SCT4 index score at baseline and follow-up.Results: There were moderate to strong correlations between the ASCOT-SCT4 index and EQ-5D-3 L, the ICECAP-A or ICECAP-O, and overall quality of life (all correlations ≥ 0.3). The construct validity was further supported by statistically significant hypothesised relationships between the ASCOT-SCT4 index and individual characteristics in univariate and multivariate analysis. There was also further evidence for the construct validity for the revised Food and drink and Dignity items. The test-retest reliability was considered to be good (ICC = 0.783; 95% CI: 0.678-0.857).Conclusions: The ASCOT-SCT4 index has good test-retest reliability for adults with physical or sensory disabilities who use social care services. The index score and the attributes appear to be valid for adults receiving social care for support reasons connected to underlying mental health problems, and physical or sensory disabilities. Further reliability testing with a wider sample of social care users is warranted, as is further exploration of the relationship between the ASCOT-SCT4, ICECAP-A/O and EQ-5D-3 L indices. [ABSTRACT FROM AUTHOR]

Background: Pregnant women with depression and/or anxiety prior to pregnancy are at higher risk of preterm birth, breastfeeding problems, postpartum depression, and disruption of the mother-infant attachment. It is well documented that exercise improves psychological well-being in nonpregnant subjects with symptoms of depression. However, in only a few small studies have researchers examined the effect of exercise on symptoms of depression among pregnant women. We hypothesize that physiotherapist-supervised group exercise for pregnant women at risk of antenatal depression increases their psychological well-being. This paper describes the study protocol of a randomized controlled trial (RCT) on a supervised group exercise intervention for pregnant women with a current or previous history of depression and/or anxiety.Methods/design: The RCT is being carried out at the Department of Obstetrics, Rigshospitalet, Copenhagen University Hospital, in the period 2016-2019. The inclusion criteria are pregnant women ≥18 years of age with depression and/or anxiety requiring treatment by a psychiatrist or a psychologist within the last 10 years and/or intake of antidepressants in the 3 months prior to conception and/or during pregnancy. The women must have appropriate Danish language skills, be pregnant with a single fetus, give written informed consent, and be at 17-22 gestational weeks when the intervention begins. The primary outcome is psychological well-being (the five-item World Health Organization Well-being Index). Secondary outcomes are symptoms of depression (Edinburgh Postnatal Depression Scale), functional ability (General Health Questionnaire), clinical symptoms of anxiety (State-Trait Anxiety Inventory), sleep quality and sleep disturbances (Pittsburgh Sleep Quality Index), and pregnancy and delivery outcomes. The intervention is supervised group exercise twice weekly for 12 weeks. The control group will receive standard antenatal care. On the basis of sample size calculation, a total of 300 women will be randomly assigned to either the intervention or the control group in a ratio of 1:1.Discussion: The trial is expected to contribute to the body of knowledge used in planning antenatal care for pregnant women at risk of depression.Trial Registration: ClinicalTrials.gov, NCT02833519 . Registered on 19 May 2016. [ABSTRACT FROM AUTHOR]

Background: This paper describes the cross-cultural adaptation of the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) into Malay version (Malay PIDAQ), an oral health-related quality of life (OHRQoL) instrument specific for orthodontics for Malaysian adolescents between 12 and 17 years old.Methods: The PIDAQ was cross-culturally adapted into Malay version by forward- and backward-translation processes, followed by psychometric validations. After initial investigation of the conceptual suitability of the measure for the Malaysian population, the PIDAQ was translated into Malay, pilot tested and back translated into English. Psychometric properties were examined across two age groups (319 subjects aged 12-14 and 217 subjects aged 15-17 years old) for factor structure, internal consistency, reproducibility, discriminant and construct validity, criterion validity, and assessment of floor and ceiling effects.Results: Fit indices by confirmatory factor analysis showed good fit statistics (comparative fit index = 0.936, root-mean-square error of approximation = 0.064) and invariance across age groups. Internal consistency and reproducibility tests were satisfactory (Cronbach's α = 0.71-0.91; intra-class correlations = 0.72-0.89). Significant differences in Malay PIDAQ mean scores were observed between subjects with severe malocclusion and those with slight malocclusion based on a self-rated and an investigator-rated malocclusion index, for all subscales and all age groups (p < 0.05). Construct validity of the Malay PIDAQ subscales with those who rated themselves with excellent to poor dental appearance and those who felt they needed or did not need braces, showed significant associations for all age groups (p < 0.05). Criterion validity also showed significant association between the Malay PIDAQ scores with those with and without impact on daily activities attributed to malocclusion. There were no ceiling effects detected but floor effects were detected for the Aesthetic Concern subscale.Conclusion: The study has provided initial evidence for the validity and reliability of the Malay PIDAQ to assess the impact of malocclusion on the OHRQoL of 12-17 year old Malaysian adolescents. [ABSTRACT FROM AUTHOR]

Background: Employment status and working conditions are strong determinants of male health, and are therefore an important focus in the Australian Longitudinal Study on Male Health (Ten to Men). In this paper, we describe key work variables included in Ten to Men, and present analyses relating psychosocial job quality to mental health and subjective wellbeing at baseline.Methods: A national sample of males aged 10 to 55 years residing in private dwellings was drawn using a stratified multi-stage cluster random sample design. Data were collected between October 2013 and July 2014 for a cohort of 15,988 males, representing a response fraction of 35 %. This analysis was restricted to 18-55 year old working age participants (n = 13,456). Work-related measures included employment status, and, for those who were employed, a number of working conditions including an ordinal scale of psychosocial job quality (presence of low job control, high demand and complexity, high job insecurity, and low fairness of pay), and working time-related stressors such as long working hours and night shift work. Associations between psychosocial job quality and two outcome measures, mental ill-health and subjective wellbeing, were assessed using multiple linear regression.Results: The majority of participants aged 18-55 years were employed at baseline (85.6 %), with 8.4 % unemployed and looking for work, and 6.1 % not in the labour force. Among employed participants, there was a high prevalence of long working hours (49.9 % reported working more than 40 h/week) and night shift work (23.4 %). Psychosocial job quality (exposure to 0/1/2/3+ job stressors) prevalence was 36 %/ 37 %/ 20 %/ and 7 % of the working respondents. There was a dose-response relationship between psychosocial job quality and each of the two outcome measures of mental health and subjective wellbeing after adjusting for potential confounders, with higher magnitude associations between psychosocial job quality and subjective wellbeing.Conclusions: These results extend the study of psychosocial job quality to demonstrate associations with a global measure of subjective wellbeing. Ten to Men represents a valuable new resource for the longitudinal and life course study of work and health in the Australian male population. [ABSTRACT FROM AUTHOR]

Previous research has highlighted the positive impact of greater health-related quality of life (Hr-QoL) and subjective well-being (SWB) on chronic diseases' severity and progression. There is a paucity of studies investigating the long-term trajectories of these variables among hypertensive patients. The present study aims to investigate the relationships between psychological variables (Type A and D personality, locus of control—LoC, self-esteem, and trait anxiety) with SWB and Hr-QoL in patients with hypertension and comorbid metabolic syndrome. A total of 185 volunteer patients (130 males, 70.3%; mean age 54 ± 10.93) were enrolled. Patients filled out measures of Hr-QoL and SWB, LoC, and self-esteem at three time points—Type A and D behaviors and anxiety measures only at baseline. Analyses were run through two-level hierarchical mixed models with repeated measures (Level 1) nested within participants (Level 2), controlling for sociodemographic and clinical confounders. Neither Hr-QoL nor SWB changed over time. Patients with greater self-esteem and internal LoC (and lower external LoC) increased their SWB and Hr-QoL up to 1-year follow-up. A greater Type A behavior and trait anxiety at baseline predicted a longitudinal increase in most of the dependent variables. Results suggest that it could be useful to tailor interventions targeting specific variables to increase Hr-QoL and SWB among hypertensive patients. [ABSTRACT FROM AUTHOR]

Background and Objectives: Nutrition literacy is a concept that improves individuals' diet quality, and quality of life and contributes to enhancing their general health by using and interpreting nutrition-related information correctly. This study purposed to determine the nutritional literacy and quality of life levels of university students and relate them with anthropometric measurements. Materials and Methods: This is a cross-sectional study and was conducted with 374 university students over the age of 18 at a state university. Nutrition literacy was assessed by using the Evaluation Instrument of Nutrition Literacy on Adults (EINLA), and quality of life was evaluated with the World Health Organization's Quality of Life Questionnaire (Turkish_WHOQOL-BREF). Waist, middle-upper arm, neck circumference, body weight, and height were measured in accordance with appropriate techniques by researchers. Independent t and One-Way ANOVA tests were used to determine differences between two and more than two mean values. Pearson correlation analysis was used to detect relationships between scores of total EINLA, its sections, total Turkish_WHOQOL-BREF and its dimensions, and other variables. Results: The mean EINLA and WHOQOL-BREF scores of the participants were 25.3±4.7 (borderline) and 54.3±15.1, respectively. While the EINLA score varied according to gender, faculty (health sciences vs others), and degree (1 to 4), the WHOQOL-BREF score varied according to gender and living place (home vs dormitory). EINLA and WHOQOL-BREF scores of BMI (underweight to obese), waist circumference, and neck circumference (normal vs at risk) groups were not different. It was found positive significant relationships between the second section of EINLA (reading comprehension and interpretation) and psychological health, the third section of EINLA (food groups), and social relationships (p<0.05). Conclusion: Nutrition literacy, anthropometric measurements, and quality of life of university students are affected by a multifactorial situation. [ABSTRACT FROM AUTHOR]

Purpose: This paper aims to estimate the comorbidity of mental disorders and chronic physical conditions and to describe the impact of these conditions on health-related quality of life (HRQoL) in a sample of older primary care (PC) attendees by gender.Methods: Cross-sectional survey, conducted in 77 PC centres in Catalonia (Spain) on 1192 patients over 65 years old. Using face-to-face interviews, we assessed HRQoL (SF-12), mental disorders (SCID and MINI structured clinical interviews), chronic physical conditions (checklist), and disability (Sheehan disability scale). We used multivariate quantile regressions to model which factors were associated with the physical component summary-short form 12 and mental component summary-short form 12.Result: The most frequent comorbidity in both men and women was mood disorder with chronic pain and arthrosis. Mental disorders mainly affected 'mental' QoL, while physical disorders affected 'physical' QoL. Mental disorders had a greater impact on HRQoL than chronic physical conditions, with mood and adjustment disorders being the most disabling conditions. There were some gender differences in the impact of mental and chronic physical conditions on HRQoL. Anxiety disorders and pain had an impact on HRQoL but only in women. Respiratory diseases had an effect on the MCS in women, but only affected the PCS in men.Conclusions: Mood and adjustment disorders had the greatest impact on HRQoL. The impact profile of mental and chronic physical conditions differs between genders. Our results reinforce the need for screening for mental disorders (mainly depression) in older patients in PC. [ABSTRACT FROM AUTHOR]

Objective: This paper evaluates the effectiveness of motivational enhancement therapy plus cognitive behavioural therapy on depressive symptoms, glycosylated haemoglobin, fasting glucose, body mass index (BMI), and health-related quality of life in type II diabetes patients.Methods: A controlled trial was conducted to compare patients who received the behavioural intervention with untreated controls on measures of health outcomes. A total of 31 intervention group participants and 30 controls were selected from patients that met the inclusion criteria from a hospital-based endocrinology outpatient department. The outcome measures including depressive symptoms, glycosylated haemoglobin, fasting glucose, BMI, and both physical and mental quality of life were collected before (T1), after (T2), and after 90 days (T3) following the intervention.Results: The experimental group showed a significant reduction in glycosylated haemoglobin, fasting glucose, and depressive symptoms and a significant increase in physical quality of life and mental quality of life at T2 and T3, while patients in the control group with usual care showed no changes over time.Conclusion: The behavioural intervention facilitated a significant improvement in psychological adjustment and glycemic control, thus strengthening diabetes control skills and leading to healthy outcomes. It is feasible that nurses and psychiatrists can deliver the behavioural intervention for diabetes patients to decrease their depressive symptoms. Sharing discussion and problem-solving experiences is particularly helpful method for self-control, and these will be beneficially influential on further research. [ABSTRACT FROM AUTHOR]

Purpose: The macular degeneration quality of life (MacDQoL) instrument is a validated condition-specific measure of quality of life in patients with macular degeneration. This paper presents the first mapping algorithm to predict EQ-5D from responses to the MacDQoL instrument.Methods: Responses to the MacDQoL and EQ-5D-3L instruments from 482 patients were collected from the IVAN multicentre trial of two alternative drug treatments for neovascular age-related macular degeneration. Regression specifications were estimated using OLS, censored least absolute deviation, Tobit and two-part models. Their predictive performance was assessed using mean squared error. An internal validation sample based on a random selection of 25 % of patients was used to assess the performance of the model estimated on the remaining 75 % of patients.Results: A two-part model had the best predictive performance on the full sample. The covariates of this model include responses and weighted impact scores for all 23 condition-specific domains of the MacDQoL, and responses to a general MacDQoL quality of life question. The selected models were successful at predicting means and standard deviations of target populations, but prediction is weaker at the upper and lower extremes of the EQ-5D-3L distribution.Conclusion: The mapping algorithms provide a means of predicting EQ-5D-3L index scores from MacDQoL scores, and could facilitate cost-effectiveness analyses when the latter but not the former are available to researchers. Further validation of the performance of the algorithms using external data would provide a means of establishing the robustness of the algorithms. [ABSTRACT FROM AUTHOR]

Objective: The clinical symptoms of schizophrenia are associated with serious social, quality of life and functioning alterations. Typically, data on health utilities are not available in clinical studies in schizophrenia. This makes the economic evaluation of schizophrenia treatments challenging. The purpose of this article was to provide a mapping function to predict unobserved utility values in patients with schizophrenia from the available clinical and socio-demographic information.Methods: The analysis was performed using data from EuroSC, a 2-year, multi-centre, cohort study conducted in France (N = 288), Germany (N = 618), and the UK (N = 302), totalling 1208 patients. Utility was calculated based on the EQ-5D questionnaire. The relationships between the utility values and the patients' socio-demographic and clinical characteristics (Positive and Negative Syndrome Scale--PANSS, Calgary Depression Scale for Schizophrenia--CDSS, Global Assessment of Functioning--GAF, extra-pyramidal symptoms measured by Barnes Akathisia Scale-BAS, age, sex, country, antipsychotic type) were modelled using a random and a fixed individual effects panel linear model.Results: The analysis demonstrated the prediction ability of the used parameters for estimating utility measures in patients with schizophrenia. Although there are small variations between countries, the same variables appear to be the key predictors. From a clinical perspective, age, gender, psychopathology, and depression were the most important predictors associated with the EQ-5D.Conclusion: This paper proposed a reliable, robust and easy-to-apply mapping method to estimate EQ-5D utilities based on demographic and clinical measures in schizophrenia. [ABSTRACT FROM AUTHOR]

Purpose: The Strengths and Difficulties Questionnaire (SDQ) is a behavioural screening tool for children. The SDQ is increasingly used as the primary outcome measure in population health interventions involving children, but it is not preference based; therefore, its role in allocative economic evaluation is limited. The Child Health Utility 9D (CHU9D) is a generic preference-based health-related quality of-life measure. This study investigates the applicability of the SDQ outcome measure for use in economic evaluations and examines its relationship with the CHU9D by testing previously published mapping algorithms. The aim of the paper is to explore the feasibility of using the SDQ within economic evaluations of school-based population health interventions.Methods: Data were available from children participating in a cluster randomised controlled trial of the school-based roots of empathy programme in Northern Ireland. Utility was calculated using the original and alternative CHU9D tariffs along with two SDQ mapping algorithms. t tests were performed for pairwise differences in utility values from the preference-based tariffs and mapping algorithms.Results: Mean (standard deviation) SDQ total difficulties and prosocial scores were 12 (3.2) and 8.3 (2.1). Utility values obtained from the original tariff, alternative tariff, and mapping algorithms using five and three SDQ subscales were 0.84 (0.11), 0.80 (0.13), 0.84 (0.05), and 0.83 (0.04), respectively. Each method for calculating utility produced statistically significantly different values except the original tariff and five SDQ subscale algorithm.Conclusion: Initial evidence suggests the SDQ and CHU9D are related in some of their measurement properties. The mapping algorithm using five SDQ subscales was found to be optimal in predicting mean child health utility. Future research valuing changes in the SDQ scores would contribute to this research. [ABSTRACT FROM AUTHOR]

Background: Neighborhood characteristics are important determinants of individual health and well-being. For example, characteristics such as noise and pollution affect health directly, while other characteristics affect health and well-being by either providing resources (e.g. social capital in the neighborhood), which individuals can use to cope with health problems, or limiting the use thereof (e.g. crime). This also suggests that there might be age differentials in the impact of these characteristics, since individuals at different stages of life might need different resources. However, there is a lack of empirical evidence on age differentials in associations between well-being, health, and neighborhood characteristics.Objective: This paper studies associations between a wide range of neighborhood characteristics with the health and well-being of residents of the greater Berlin area. In particular, we focus on differences in the effects between younger (aged 20-35) and older (aged 60+) residents.Methods: We used data from the Berlin Aging Study II (312 younger and 993 older residents of the Berlin metropolitan area in Germany). We used survey data on health and well-being, combined these with subjective perceptions of the neighborhood, and geo-referenced indicators on the neighborhood, e.g. amenities (public transport, physicians, and hospitals).Results: The results show that access to public transportation is associated with better outcomes on all measures of health and well-being, and social support is associated with higher life satisfaction and better mental health. There are considerable differences between both age groups: while the associations between access to public transport and health and well-being are similar for both age groups, neighborhood social capital shows stronger associations for older residents. However, the difference is not always statistically significant.Conclusion: Having access to services is associated with better health and well-being regardless of age. Local policy makers should focus on lowering barriers to mobility in order to improve the health and well-being of the population. Since the social capital of a neighborhood is associated with better health and well-being among older residents, investments that increase social capital (e.g. community centers) might be warranted in neighborhoods with higher shares of older residents. [ABSTRACT FROM AUTHOR]

Background: Quality of life (QoL) is an important measure and outcome within chronic disease management and treatment, including substance use disorders (SUD). The aim of this paper was to investigate correlates of poorer QoL of individuals entering SUD treatment in Norway, in order to identify subgroups that may most benefit from different interventions.Methods: Twenty-one treatment facilities invited all incoming patients to participate. Five hundred forty-nine patients who enrolled between December 2012 and April 2015 are analyzed. QoL, substance use, mental and physical comorbidities, and exercise behaviors were measured. Multinomial regression analysis was used to determine variables significantly associated with poorer QoL.Results: The majority of both genders (75 %) reported "poor" or "very poor" QoL at intake. Depression showed a strong association with poor QoL (relative risk ratio [RRR] 3.3, 95 % confidence interval [CI] 1.0-10.3) and very poor QoL (RRR 3.8, 1.2-11.8) among women. Physical inactivity among men was associated with very poor QoL (RRR 2.0, 1.1-3.7), as was reporting eating most meals alone (RRR 2.6, 1.4-4.8). Evaluating one's weight as too low was also associated with poor QoL (RRR 2.0, 1.0-3.9) and very poor QoL (RRR 2.0, 1.1-3.7) among men. Consuming methadone/buprenorphine was a protective factor for men reporting poor QoL (RRR 0.5, 0.3-0.9) and very poor QoL (RRR 0.4, 0.2-0.9), as well as for women reporting very poor QoL (RRR 0.2, 0.0-0.6).Conclusions: Factors associated with poorer QoL among other healthy and clinical populations, such as impaired social and physical well-being and psychological distress, were also seen associated in this sample. Treatment should be targeted towards patients with these particular vulnerabilities in addition to focusing on substance-related factors, and interventions proven to improve the QoL of other populations with these vulnerabilities should be explored in a SUD context. [ABSTRACT FROM AUTHOR]

Purpose: This study evaluated the efficacy of a self-guided Web-based cognitive behaviour therapy (CBT) intervention compared to an attention control in improving cancer-related distress, health-related quality of life (HRQOL), and maladaptive coping, among people recently diagnosed with cancer.Methods: Sixty individuals with cancer diagnosed in the previous 6 months and receiving treatment with curative intent were randomised to receive either the 6-week intervention Cancer Coping Online (CCO: n = 30) or the 6-week Web-based attention control (n = 30). Outcome measures, including cancer distress (the Posttraumatic Stress Scale - Self-Report), general distress (Depression Anxiety Stress Scale), quality of life (EORTC QLQ-C30), and coping (mini-MAC), were administered at baseline, immediately post-intervention, and at 3 and 6 months post-intervention.Results: Significant main effects for time were found for cancer distress, global QOL, physical function, role function, social function, and anxious preoccupation. Post hoc between-group comparisons showed CCO participants had statistically significantly higher physical functioning compared to controls at 3 months of follow-up (d = -0.52, p = 0.02). Furthermore, compared to controls, post hoc comparisons found moderate between-group effect sizes favouring CCO post-intervention for cancer distress (d = 0.43) and anxious preoccupation (d = 0.38), and at 6 months of follow-up for global QOL (d = -0.43).Conclusions: These results provide preliminary support for the potential efficacy of a self-guided Web-based CBT programme in improving aspects of HRQOL, cancer-related distress, and anxious preoccupation after cancer diagnosis. This paper provides justification for, and will help inform the development of, subsequent larger multi-site studies. [ABSTRACT FROM AUTHOR]

Background: Masticatory functioning alters with age. However, mastication has been found to be related to, for example, cognitive functioning, food intake, and some aspects of activities of daily living. Since cognitive functioning and activities of daily living show a decline in older adults with dementia, improving masticatory functioning may be of relevance to them. A possible way to improve mastication may be showing videos of people who are chewing. Observing chewing movements may activate the mirror neuron system, which becomes also activated during the execution of that same movement. The primary hypothesis is that the observation of chewing has a beneficial effect on masticatory functioning, or, more specifically, masticatory ability of older adults with dementia. Secondary, the intervention is hypothesized to have beneficial effects on food intake, cognition, activities of daily living, depression, and quality of life.Methods/design: An adjusted parallel randomized controlled trial is being performed in dining rooms of residential care settings. Older adults with dementia, for whom also additional eligibility criteria apply, are randomly assigned to the experimental (videos of chewing people) or control condition (videos of nature and buildings), by drawing folded pieces of paper. Participants who are able to watch each other's videos are assigned to the same study condition. The intervention takes place during lunchtime, from Monday to Friday, for 3 months. During four moments of measurement, masticatory ability, food intake, cognitive functioning, activities of daily living, depression, and quality of life are assessed. Tests administrators blind to the group allocation administer the tests to participants.Discussion: The goal of this study is to examine the effects of video observation of chewing on masticatory ability and several secondary outcome measures. In this study, the observation of chewing is added to the execution of the same action (i.e., during eating). Beneficial effects on masticatory ability, and consequently on the other outcome measures are hypothesized. The intervention may be easily integrated into daily care, and might add to the lives of the increasing number of older adults with dementia by beneficially influencing multiple daily life functions.Trial Registration: NTR5124. Registration date: 30 March 2015. [ABSTRACT FROM AUTHOR]

Background: Minimally adequate treatment (MAT) is intended to represent treatment minimally sufficient for common mental health problems. For children, MAT has been defined over a twelve-month period as either eight or more mental health visits, or four to seven visits plus relevant medication. MAT is used to identify those missing out on adequate care, but it is unknown whether MAT improves children's outcomes.Methods: This paper examines whether MAT is associated with improved outcomes for children. It uses survey data from the nationally representative Longitudinal Study of Australian children on 596 children with mental health problems based on the Strengths and Difficulties Questionnaire at ages 8-15 years, linked to health service administrative data from 2012 to 2016. Statistical analysis examines the association of MAT with later quality of life (Pediatric Quality of Life Inventory), using a lagged dependent variable model to account for time-varying unobserved confounding.Results: Compared to children with lower levels of treatment, those who received MAT between baseline and follow up had no statistically significant improvement in either quality of life or mental health symptoms.Limitations: The observational data provide insight into real-world practice but require statistical methods to account for selection into treatment.Conclusions: While clinical trials show mental health treatments can be efficacious, this study shows no evidence that children receiving MAT in routine practice have better outcomes. These findings demonstrate the need for better understanding of the nature and impact of children's mental health care as it is delivered and received in routine practice. [ABSTRACT FROM AUTHOR]

Background: The Connor-Davidson Resilience Scale (CD-RISC) is inarguably one of the best-known instruments in the field of resilience assessment. However, the criteria for the psychometric quality of the instrument were based only on classical test theory.Method: The aim of this paper has focused on the calibration of the CD-RISC with a nonclinical sample of 444 adults using the Rasch-Andrich Rating Scale Model, in order to clarify its structure and analyze its psychometric properties at the level of item.Results: Two items showed misfit to the model and were eliminated. The remaining 22 items form basically a unidimensional scale. The CD-RISC has good psychometric properties. The fit of both the items and the persons to the Rasch model was good, and the response categories were functioning properly. Two of the items showed differential item functioning.Conclusions: The CD-RISC has an obvious ceiling effect, which suggests to include more difficult items in future versions of the scale. [ABSTRACT FROM AUTHOR]

Background: Nursing home patients have complex mental and physical health problems, disabilities and social needs, combined with widespread prescription of psychotropic drugs. Preservation of their quality of life is an important goal. This can only be achieved within nursing homes that offer competent clinical conditions of treatment and care. COmmunication, Systematic assessment and treatment of pain, Medication review, Occupational therapy, Safety (COSMOS) is an effectiveness-implementation hybrid trial that combines and implements organization of activities evidence-based interventions to improve staff competence and thereby the patients' quality of life, mental health and safety. The aim of this paper is to describe the development, content and implementation process of the COSMOS trial.Methods/design: COSMOS includes a 2-month pilot study with 128 participants distributed among nine Norwegian nursing homes, and a 4-month multicenter, cluster randomized effectiveness-implementation clinical hybrid trial with follow-up at month 9, including 571 patients from 67 nursing home units (one unit defined as one cluster). Clusters are randomized to COSMOS intervention or current best practice (control group). The intervention group will receive a 2-day education program including written guidelines, repeated theoretical and practical training (credited education of caregivers, physicians and nursing home managers), case discussions and role play. The 1-day midway evaluation, information and interviews of nursing staff and a telephone hotline all support the implementation process. Outcome measures include quality of life in late-stage dementia, neuropsychiatric symptoms, activities of daily living, pain, depression, sleep, medication, cost-utility analysis, hospital admission and mortality.Discussion: Despite complex medical and psychosocial challenges, nursing home patients are often treated by staff possessing low level skills, lacking education and in facilities with a high staff turnover. Implementation of a research-based multicomponent intervention may improve staff's knowledge and competence and consequently the quality of life of nursing home patients in general and people with dementia in particular.Trial Registration: ClinicalTrials.gov NCT02238652. [ABSTRACT FROM AUTHOR]

Background: Early and integrated specialized palliative care is often recommended but has still only been investigated in relatively few randomized clinical trials.Objective: To investigate the effect of early specialized palliative care plus standard care versus standard care on the explorative outcomes in the Danish Palliative Care Trial (DanPaCT).Methods: We conducted a randomized multicentre, parallel-group clinical trial. Consecutive patients with metastatic cancer were included if they had symptoms or problems that exceeded a predefined threshold according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Outcomes were estimated as the differences between the intervention and the control groups in the change from baseline to the weighted mean of the 3- and 8-week follow-ups measured as areas under the curve.Results: In total, 145 patients were randomized to early specialized palliative care plus standard care versus 152 to standard care only. Early specialized palliative care had no significant effect on any of the symptoms or problems. Of the 21 items addressing satisfaction, specialized palliative care improved the item 'overall satisfaction with the help received from the health care system' with 9 points (95% confidence interval 3.8 to 14.2, p = 0.0006) and three other items (all p < 0.05).Conclusion: In line with the analyses of the primary and secondary outcomes in DanPaCT, we did not find that specialized palliative care, as provided in DanPaCT, affected symptoms and problems. However, patients in the intervention group seemed more satisfied with the health care received than those in the standard care group.Trial Registration: NCT01348048. [ABSTRACT FROM AUTHOR]

Health-related quality of life (HRQOL) assessment in children and adolescents with chronic health conditions is increasingly considered as a relevant topic. The aim of the EU-funded DISABKIDS project is to develop, test, and implement European instruments for the assessment of HRQOL of children and adolescents with disabilities and their families. The current paper describes the development and pilot testing of a chronic generic HRQOL measure. Using literature searches, expert consulting and focus groups with children/adolescents and their families, items of the instruments were developed and translated into the respective languages. A pilot test with 360 children and adolescents was conducted. Children and adolescents (8-12, 13-16 years) with different chronic health conditions (asthma, epilepsy, diabetes, arthritis, atopic dermatitis, cerebral palsy, and cystic fibrosis) as well as their families were included. Data were analysed according to predefined psychometric and content criteria. Psychometric analyses resulted in a 56-item chronic generic HRQOL questionnaire with six domains ('Medication', 'Physical', 'Emotion', 'Independence', 'Social Inclusion', 'Social Exclusion') with acceptable internal consistency. [ABSTRACT FROM AUTHOR]

Background: We implemented a comprehensive intervention program targeting general practice staff, that proved successful in optimizing practice organization and clinical decision-making. In this paper, health-related quality of life (HRQL) is investigated as a clinical outcome.Objective: To evaluate the effect of the implementation of an intervention program on the HRQL in patients at high cardiovascular risk.Research Design: Randomized controlled trial. Intervention practices (n = 62) received a comprehensive intervention program (by means of outreach visitors) lasting 21 months. HRQL of patients at high cardiovascular risk was assessed by the MOS 36-Item Short-Form Health Survey (SF-36), at baseline and after intervention. Three patient categories were distinguished: diabetes mellitus, cardiovascular disease and hypertension.Results: HRQL deteriorated in all respondents, but more pronounced in the control group. In diabetes patients the differences between intervention and control group were significant for the Vitality and Mental Health scales, with mean difference in change of 3.93 (95% CI: 1.08-6.78) and 3.71 (95% CI: 0.73-6.68), respectively. Patients with cardiovascular disease had significantly different changes on three scales: physical functioning (3.57, 95% CI: 0.71-6.43), vitality (3.01, 95% CI: 0.72-5.30) and social functioning (3.96, 95% CI: 0.50-7.42). In patients with hypertension, there were no differences between the intervention and control group.Conclusion: Our comprehensive intervention program resulted in changes in HRQL on several domains, particularly in patients with diabetes and cardiovascular disease. [ABSTRACT FROM AUTHOR]

Extensive qualitative evidence, but limited quantitative evidence, indicates that mutual aid organizations such as Men's Sheds have positive impacts on wellbeing, health-related quality of life, and loneliness. A recently developed theoretical model proposes that Men's Sheds may have these impacts via mediating factors such as broadening social networks, increasing behavioural activation and physical activity, reducing alcohol use, and providing meaning in life. The aim of this study was to quantitatively test a model whereby psychological safety (feeling safe, accepted, and valued) is associated with Men's Shed engagement (frequency of attendance, duration of membership, diversity of activities), which is associated with the hypothesized mediators, which, in turn, are associated with wellbeing, health-related quality of life, and loneliness. Men's Shed members (N  = 333, M age = 70.90 years, SD = 10.34, 98% male) completed a survey assessing the factors in the model. The hypothesized path model provided an excellent fit to the data. Findings indicated that higher psychological safety was associated with higher engagement, which, in turn, was associated with larger social networks and more meaning in life, which were associated with higher wellbeing and lower loneliness. Higher behavioural activation and less alcohol use were also associated with higher wellbeing. Higher Men's Shed engagement was not associated with higher behavioural activation and physical activity, or less alcohol use, but behavioural activation and alcohol use were directly associated with health-related quality of life. Implications for optimizing health outcomes within Men's Sheds are discussed. [ABSTRACT FROM AUTHOR]

Objective: Distress screening programs aim to ensure appropriate psychooncological support for cancer patients, but many eligible patients do not use these services. To improve distress management, we need to better understand patients' supportive care needs. In this paper, we report the first key finding from a longitudinal study that focused on patients' intentions to use psychooncological support and its association with distress and uptake of the psychooncology service.Methods: We conducted a prospective, observational study in an Oncology Outpatient Clinic and assessed distress, intention to use psychooncological support, and uptake of the psychooncology service by using the Distress Thermometer, a semistructured interview, and hospital records. We analyzed data with a mixed-methods approach.Results: Of 333 patients (mean age 61 years; 55% male; 54% Distress Thermometer ≥ 5), 25% intended to use the psychooncology service (yes), 33% were ambivalent (maybe), and 42% reported no intention (no). Overall, 23% had attended the psychooncology service 4 months later. Ambivalent patients reported higher distress than patients with no intention (odds ratio = 1.18, 95% confidence interval [1.06-1.32]) but showed significantly lower uptake behavior than patients with an intention (odds ratio = 14.04, 95% confidence interval [6.74-29.24]). Qualitative analyses revealed that ambivalent patients (maybe) emphasized fears and uncertainties, while patients with clear intentions (yes/no) emphasized knowledge, attitudes, and coping concepts.Conclusions: We identified a vulnerable group of ambivalent patients with high distress levels and low uptake behavior. To optimize distress screening programs, we suggest addressing and discussing patients' supportive care needs in routine clinical practice. [ABSTRACT FROM AUTHOR]

This paper investigates the relationship between individual psychosocial wellbeing and place characteristics in Mexico, using multi-level models and nationally representative survey data. We explore psychosocial wellbeing in terms of self-reported depression symptoms, feelings of sadness and experience of stress; analyse place characteristics at the level of municipality and at the level of locality; and investigate individual-level heterogeneities in the relationship by gender, age, wealth and employment status. Our results suggest the existence of a significant relationship between individual psychosocial wellbeing and place characteristics, and provide evidence of heterogeneity in how place characteristics affect the psychosocial wellbeing of different groups. [ABSTRACT FROM AUTHOR]

Background: We present the detailed protocol set up to investigate how agonistic sport affects the self-perceived psychological and emotional well-being of disabled young people.Methods: The study will be carried out on a number of subjects as large as 800-1200, using well-established indices that give a quantitative measure of such well-being, namely SF-12 and PGWBI. The related questionnaires will be administered to the participants to a forthcoming international event, the European Para-Youth Games, 9-15 October 2017, Liguria, Italy, as well as to a reference population of a similar number of subjects, made up of young disabled people that do not practice agonistic sport.Discussion: We expect that the outcomes of the study may strongly impact not only the socio-sanitary field but also society in general, as disabled people can be considered an extreme situation in the issue of balancing individual needs and environment to pursue psychological well-being.Trial Registration: ISRCTN14389453 (29 June 2017). [ABSTRACT FROM AUTHOR]

Background/Objective: As the health services were reorganized during the COVID-19 restricting access to family caregivers, we explored the experience of women in the perinatal period, attending a specialist perinatal mental health service. Methods: Patients (n = 38) in the outpatient list for review were assessed over phone based on a predesigned, semi-structured questionnaire, comprising both quantitative (demographic, clinical variables) and qualitative open-ended questions regarding their experience of services during COVID-19. Results: The responses provided insight into how the pandemic affected the experience of pregnancy of mentally ill women and the impact of changes in perinatal mental health services. The main concerns centered around reduced support from close family members during the perinatal period due to the lockdown, anxiety regarding COVID transmission, absence of a supporting persons in antenatal clinics, difficulty accessing support from midwives, and health visitors as well as the use of virtual clinics for mental health consultations. Conclusions: The results suggested possible methods of improving perinatal mental health support during challenging times, which included ensuring in-person consultations, access to family even remotely, increasing accessibility through alternative means; providing and close monitoring of additional psychosocial support when needed. [ABSTRACT FROM AUTHOR]

Introduction and Aims: The Australian Treatment Outcomes Profile (ATOP) is a brief instrument that assesses a range of substance use, health and well-being measures over the past 28 days. Previously, it has been validated in general adult Australian alcohol and other drug (AOD) treatment populations. However, the increasing number of older-aged clients attending AOD treatment warrants the instrument to be validated for this population. The aim of this study was to validate the ATOP for use in older AOD populations, by comparing it with validated 'gold standard' measures used in older populations.Design and Methods: A convenience sample of 99 participants aged ≥50 attending specialist AOD services in Sydney, Australia were administered the ATOP by a researcher, along with alcohol use (AUDIT) and health questionnaires [Physical Health Questionnaire-15, 12-item short-form Health Survey (SF-12) and Geriatric Depression Scale].Results: The ATOP items had strong agreement with the comparison instruments. The highest correlation was between the 28 days alcohol use and the AUDIT. ATOP psychological health scores highly correlated with the SF-12 mental health subscale and the Geriatric Depression Scale, and ATOP physical health scores significantly correlated with the SF-12 physical health subscale and the Physical Health Questionnaire-15. The ATOP Quality of Life score significantly correlated with all health measures. Discussion and Conclusions The ATOP has good concurrent validity with other validated substance use and health measures in an older population. Comparison with general older populations demonstrated the poorer health of this group of older AOD clients in particular.[Lintzeris N, Monds L A, Rivas G, Leung S, Withall A, Draper B. The Australian Treatment Outcomes Profile instrument as a clinical tool for older alcohol and other drug clients: A validation study. Drug Alcohol Rev 2016;35:673-677]. [ABSTRACT FROM AUTHOR]

During the outbreak of the COVID-19 pandemic, Norwegian health authorities introduced social distancing measures in nursing homes. The aim was to protect vulnerable residents from contracting the potentially deadly infection. Drawing on individual interviews with nursing home managers and physicians, and focus groups with nursing staff, we explore and describe consequences the social distancing measures had on nursing home residents’ health and wellbeing. The analysis indicates that most residents became socially deprived, while some became calmer during the nursing home lockdown. Nursing home staff, physicians and managers witnessed that residents’ health and functional capacity declined when services to maintain health, such as physiotherapy, were put on hold. In conclusion, we argue that although Norwegian health authorities managed to keep the infection rates low in nursing homes, this came at a high price for the residents however, as the social distancing measures also negatively impacted their health and wellbeing. [ABSTRACT FROM AUTHOR]

Objectives: Our study discusses health related quality of life (HRQOL) as measured by 36-item Short Form (SF-36) for rural-to-urban migrants in China, and assesses the validity and reliability of the SF-36 for this group.Methods: In 2012,765 rural-to-urban migrant respondents chosen by probability and the non-probability sampling methods have completed the survey in Wuhan, Mid-China. The reliability of SF-36 is analyzed by Cronbach's alpha (α) coefficient, split-half coefficient, theta (θ) and omega (Ω) coefficient, the validity is calculated by confirmatory factor analysis (CFA) and known-group methods.Result: Split-half reliability coefficient is 0.717. Cronbach's alpha coefficient is 0.776. Theta and omega coefficient are 0.862 and 0.903 respectively. CFA statistical analysis results are shown as follows: GFI = 0.926, Chi-Square/Df = 2.059, RMSEA = 0.037, CFI = 0.939. Physical and mental component summary (PCS/MCS) scores are tabulated by known-group variables and show a statistical significance.Conclusion: In general, SF-36 is a reliable and valid instrument for measuring HRQOL of rural-to-urban migrants in China. Furthermore, Chinese migrants have lived and worked in a hard environment, their salaries are much lower than that of the counterparts, HRQOL of this group is also a little lower and deserves much attention from society. [ABSTRACT FROM AUTHOR]

This paper is the first to apply prospect theory to societal health-related decision making. In particular, we allow for utility curvature, equity weighting, sign-dependence, and loss aversion in choices concerning quality of life of other people. We find substantial inequity aversion, both for gains and losses, which can be attributed to both diminishing marginal utility and differential weighting of better-off and worse-off. There are also clear framing effects, which violate expected utility. Moreover, we observe loss aversion, indicating that subjects give more weight to one group's loss than another group's gain of the same absolute magnitude. We also elicited some information on the effect of the age of the studied group. The amount of inequity aversion is to some extent influenced by the age of the considered patients. In particular, more inequity aversion is observed for gains of older people than gains of younger people. [ABSTRACT FROM AUTHOR]