Indonesia youth population norms for EQ-5D-Y-3 L, EQ-5D-Y-5 L and the PedsQL generic core scale: lower health related quality of life relates to high economic status and stress.

BACKGROUND: The availability of population norms from generic health-related quality of life (HRQoL) instruments can support the interpretation of health outcomes. This study aimed to provide Indonesian youth population norms for the generic HRQoL measures: EQ-5D-Y-3 L, EQ-5D-Y-5 L, and the PedsQL Generic Core Scales. In addition the opportunity arising from the generation of a large representative sample was taken to explore the relationships between HRQoL, health, and socio-economic factors. METHODS: A representative sample of 1103 Indonesian children (aged 8-16 years) completed EQ-5D-Y-3 L, EQ-5D-Y-5 L, the PedsQL Generic Core Scales, and questions related to demographic data and self-reported health status. A stratified quota sampling design was used to represent Indonesian children in terms of residence, age, gender, and geographical area. Family expenses per capita per month were retrieved from parents to determine a child's economic status. RESULTS: The total sample was representative of the Indonesian youth general population. The proportions of participants who reported problems were 43.35% (EQ-5D-Y-3 L), 44.10% (EQ-5D-Y-5 L), and 94.93% (PedsQL Generic), with 31.7% of children reporting health complaints. Older children (13-16 years) reported more problems than younger children (8-12 years). Children living in urban areas reported more problems than children living in rural areas. The lowest value health state reported was '12332' (valued at 0.54), and the minimum EQ VAS score was 60.00. Moderate correlations were found between EQ-5D-Y-3 L values to EQ VAS scores and to PedsQL Total Score. Hierarchical regression analysis showed that females, older age, and having health complaints contributed to a lower level of HRQoL as measured by EQ-5D-Y-3 L values, EQ VAS, and PedsQL Total Score. Remarkably, children with high economic status had lower EQ VAS and PedsQL Total Scores. Among symptoms, 'having stress' had the largest influence with respect to lower EQ-5D-Y-3L values, EQ VAS, and PedsQL Total Score. CONCLUSIONS: Population norms for children's HRQoL as measured by EQ-5D-Y-3 L, EQ-5D-Y-5 L, and the PedsQL Generic Scales are now available for Indonesia. Age, gender, economic status, and health complaints were related to children's HRQoL. These results provide a basis for health studies and health policy for the youth population of Indonesia.

Day hospital versus intensive outpatient mentalization-based treatment: 3-year follow-up of patients treated for borderline personality disorder in a multicentre randomized clinical trial.

BACKGROUND: Two types of mentalization-based treatment (MBT), day hospital MBT (MBT-DH) and intensive outpatient MBT (MBT-IOP), have been shown to be effective in treating patients with borderline personality disorder (BPD). This study evaluated trajectories of change in a multi-site trial of MBT-DH and MBT-IOP at 36 months after the start of treatment. METHODS: All 114 patients (MBT-DH n = 70, MBT-IOP n = 44) from the original multicentre trial were assessed at 24, 30 and 36 months after the start of treatment. The primary outcome was symptom severity measured with the Brief Symptom Inventory. Secondary outcome measures included borderline symptomatology, personality and interpersonal functioning, quality of life and self-harm. Data were analysed using multilevel modelling and the intention-to-treat principle. RESULTS: Patients in both MBT-DH and MBT-IOP maintained the substantial improvements made during the intensive treatment phase and showed further gains during follow-up. Across both conditions, 83% of patients improved in terms of symptom severity, and 97% improved on borderline symptomatology. No significant differences were found between MBT-DH and MBT-IOP at 36 months after the start of treatment. However, trajectories of change were different. Whereas patients in MBT-DH showed greater improvement during the intensive treatment phase, patients in MBT-IOP showed greater continuing improvement during follow-up. CONCLUSIONS: Patients in both conditions showed similar large improvements over the course of 36 months, despite large differences in treatment intensity. MBT-DH and MBT-IOP were associated with different trajectories of change. Cost-effectiveness considerations and predictors of differential treatment outcome may further inform optimal treatment selection.

EQ-5D-Y-3L and EQ-5D-Y-5L proxy report: psychometric performance and agreement with self-report.

BACKGROUND: Self-report is the standard for measuring people's health-related quality of life (HRQoL), including children. However, in certain circumstances children cannot report their own health. For this reason, children's HRQoL measures often provide both a self-report and a proxy-report form. It is not clear whether the measurement properties will be the same for these two forms. We investigated whether it would be beneficial to extend the classification system of the EQ-5D-Y proxy questionnaire from 3 to 5 response levels. The agreement between self-report and proxy-report was assessed for both EQ-5D-Y measures. METHODS: The study included 286 pediatric patients and their caregivers as proxies. At three consecutive measurements-baseline, test-retest and follow-up-the proxies assessed the child's HRQoL using the EQ-5D-Y-3L, EQ-5D-Y-5L, the PedsQL Generic, and matched disease-specific instruments. The proxy versions of EQ-5D-Y-3L and EQ-5D-Y-5L were compared in terms of feasibility, distribution properties, convergent validity, test-retest and responsiveness. Agreement between both EQ-5D-Y proxy versions to their respective self-report versions was assessed at baseline and follow-up. RESULTS: The proportion of missing responses was 1% for the EQ-5D-Y-3L and 1.4% for the EQ-5D-Y-5L. The frequency of health state with no problems in all dimensions (11111) was slightly lower for the EQ-5D-Y-5L (21.3% vs 16.7%). Regarding the convergent validity with the PedsQL and disease-specific measures, the proxy versions of EQ-5D-Y-3L and EQ-5D-Y-5L had similar magnitudes of associations between similar dimensions. The means of test-retest coefficients between the two versions of the EQ-5D-Y proxy were comparable (0.83 vs. 0.84). Regarding reported improved conditions, responsiveness of the EQ-5D-Y-5L proxy (26.6-54.1%) was higher than that of the EQ-5D-Y-3L proxy (20.7-46.4%). Except for acutely ill patients, agreement between the EQ-5D-Y-5L proxy and self-reports was at least moderate. CONCLUSIONS: Extending the number of levels of the proxy version of EQ-5D-Y can improve the classification accuracy and the ability to detect health changes over time. The level structure of EQ-5D-Y-5L was associated with a closer agreement between proxy and self-report. The study findings support extending the EQ-5D-Y descriptive system from 3 to 5 levels when administered by a proxy, which is often the case in the pediatric population.

Trauma and Outcomes of Mentalization-Based Therapy for Individuals With Borderline Personality Disorder.

OBJECTIVE: Recent meta-analyses suggest that many patients with borderline personality disorder have a history of complex trauma. Although trauma is central in mentalization-based approaches to the understanding of borderline personality disorder, surprisingly little is known about the effects of trauma on outcomes of mentalization-based treatment (MBT). This article investigates the prevalence and impact of childhood trauma among patients with borderline personality disorder participating in a randomized controlled trial (RCT) comparing day hospital MBT (MBT-DH) and intensive outpatient MBT (MBT-IOP). METHODS: All 114 patients from the original multicenter RCT in the Netherlands were included in this study. Childhood trauma was assessed at baseline (with the Childhood Trauma Questionnaire), and its impact on symptom severity, interpersonal functioning, and borderline pathology was investigated through multilevel modeling for 36 months after the start of treatment. RESULTS: Childhood trauma was common among patients with borderline personality disorder referred to MBT, with more than 85% meeting cutoff criteria for substantial childhood trauma. Childhood trauma had little impact on outcomes of either MBT-DH or MBT-IOP in terms of improved borderline personality disorder features or interpersonal functioning. However, patients with substantial childhood trauma seemed to improve more rapidly with MBT-DH, as compared with MBT-IOP, in terms of symptom severity. In addition, patients with a history of emotional neglect showed more rapid changes in symptoms of borderline personality disorder with MBT-DH compared with MBT-IOP. CONCLUSIONS: Findings are discussed in the context of a social communicative approach to borderline personality disorder, with a focus on the need to address trauma in MBT.

Improvements in PCOS characteristics and phenotype severity during a randomized controlled lifestyle intervention.

RESEARCH QUESTION: What is the effect of weight loss through different interventions (three-component lifestyle intervention with short message service [SMS+] versus three-component lifestyle intervention without SMS [SMS-] versus care as usual [CAU]) on polycystic ovary syndrome (PCOS) characteristics (ovulatory dysfunction, hyperandrogenism, polycystic ovarian morphology [PCOM]) and phenotype distribution? DESIGN: Analysis of secondary outcome measures of a randomized controlled trial. Women diagnosed with PCOS (n = 183), who wished to become pregnant, with a body mass index above 25 kg/m², were assigned to a 1-year three-component (cognitive behavioural therapy, diet, exercise) lifestyle intervention group, with or without SMS, or to CAU (advice to lose weight). RESULTS: The prevalence of biochemical hyperandrogenism was 30.9% less in the SMS- group compared with CAU after 1 year (P = 0.027). Within-group analyses revealed significant improvements in ovulatory dysfunction (SMS+: -39.8%, P = 0.001; SMS-: -30.5%, P = 0.001; CAU: -32.1%, P < 0.001), biochemical hyperandrogenism (SMS-: -27.8%, P = 0.007) and PCOM (SMS-: -14.0%, P = 0.034). Weight loss had a significantly favourable effect on the chance of having ovulatory dysfunction (estimate 0.157 SE 0.030, P < 0.001) and hyperandrogenism (estimate 0.097 SE 0.027, P < 0.001). CONCLUSIONS: All groups demonstrated improvements in PCOS characteristics, although these were more profound within the lifestyle intervention groups. Weight loss per se led to an amelioration of diagnostic characteristics and in the phenotype of PCOS. A three-component lifestyle intervention aimed at a 5-10% weight loss should be recommended for all women with PCOS before they become pregnant.

Comparing measurement properties of EQ-5D-Y-3L and EQ-5D-Y-5L in paediatric patients.

BACKGROUND: The adult versions EQ-5D-3L and EQ-5D-5L have been extensive compared. This is not the case for the EQ-5D youth versions. The study aim was to compare the measurement properties and responsiveness of EQ-5D-Y-3L and EQ-5D-Y-5L in paediatric patients. METHODS: A sample of patients 8-16 years old with different diseases and a wide range of disease severity was asked to complete EQ-5D-Y-3L, EQ-5D-Y-5L, PedsQL Generic Core Scale, and selected, appropriate disease-specific instruments, three times. EQ-5D-Y-3L and EQ-5D-Y-5L were compared in terms of: feasibility, (re-)distribution properties, discriminatory power, convergent validity, test-retest reliability, and responsiveness. RESULTS: 286 participating patients suffered from one of the following diseases: major beta-thalassemia, haemophilia, acute lymphoblastic leukaemia, acute illness. Missing responses were comparable between versions of the EQ-5D-Y, suggesting comparable feasibility. The number of patients in the best health state (level profile 11111) was equal in both EQ-5D-Y versions. The projection of EQ-5D-Y-3L scores onto EQ-5D-Y-5L for all dimensions showed that the two additional levels in EQ-5D-Y-5L slightly improved the accuracy of patients in reporting their problems, especially if severe. Convergent validity with PedsQL and disease-specific measures showed that the two EQ-5D-Y versions performed about equally. Test-retest reliability (EQ-5D-Y-3L 0.78 vs EQ-5D-Y-5L 0.84), and sensitivity for detecting health changes, were both better in EQ-5D-Y-5L. CONCLUSIONS: Extending the number of levels did not give clear superiority to EQ-5D-Y-5L over EQ-5D-Y-3L based on the criteria assessed in this study. However, increasing the number of levels benefitted EQ-5D-Y performance in the measurement of moderate to severe problems and especially in longitudinal study designs.

Evaluation of opening a type III/IV medical psychiatric unit.

OBJECTIVE: The aim of this study is to examine the impact of opening a medical psychiatric unit (MPU) on a variety of outcomes. METHODS: In this non-equivalent groups design, there were two groups: 'pre-MPU' and 'actual MPU'. Staff assessed whether patients in the pre-MPU group were eligible for admission to a planned MPU, resulting in virtual admissions and discharges. The actual MPU group consisted of patients admitted after opening of the MPU. RESULTS: The length of stay (LOS) in the hospital was one day longer for patients in the MPU group (8.68 vs. 9.89, p = .004), but the LOS on the MPU was comparable in both groups (5.63 vs. 6.06, p = .231). The LOS on the intensive care unit (ICU) was longer in the MPU group (0.10 vs. 0.40, p < .001), even as the time patients were physically restraint (0.28 vs. 0.83, p < .001). In the pre-MPU group, the odds were not significantly different for involuntary commitment (OR = 0.92; p = .866) and death within six months after discharge (OR = 1.84; p = .196). CONCLUSIONS: Both physical restraint and ICU admission have a link with patient complexity, it therefore seemed that opening of the MPU resulted in the treatment of more complex patients with a comparable LOS on the MPU.KEY POINTSThe LOS on the MPU was not significantly different between the groups before and after opening of the MPU.Opening of the MPU resulted in the admission of patients that were admitted more days to the ICU and to more days of physically restraint.It can be considered that opening of the MPU resulted in an increased ability to treat complex patients.

Six and eight weeks injection frequencies of bevacizumab are non-inferior to the current four weeks injection frequency for quality of life in neovascular age-related macular degeneration: a randomized controlled trial.

PURPOSE: Patients with neovascular age-related macular degeneration (nARMD) will not deteriorate on visual acuity and retinal thickness when treated with bevacizumab injection frequencies of 6 or 8 weeks compared to 4 weeks. This study aimed to investigate this non-inferiority in quality of life (QoL). We hypothesized that less frequent bevacizumab injections are not inferior regarding patients reported QoL. METHODS: Patients were randomized to bevacizumab every 4 (n = 64), 6 (n = 63), and 8 weeks (n = 64). Patients were at least 65 years old, have a best-corrected visual acuity of 20/200 to 20/20, no previous ARMD treatment and active leakage. Vision-related QoL questionnaire NEI VFQ-39 was used to assess QoL at baseline and after 1 year. General QoL questionnaire SF-36 was included for secondary analysis. Multilevel analyses were performed, correcting for age, gender and baseline. RESULTS: The 6 (3.68; 95% CI - 0.63 to 8.00) and 8 (2.15; 95% CI - 2.26 to 6.56) weeks bevacizumab regimens resulted in non-inferior QoL differences compared to 4 weeks on the NEI VFQ-39. Also on the SF-36 the differences were well within the non-inferiority limits. CONCLUSION: Non-inferiority of the 6 and 8 weeks frequencies was demonstrated compared to 4 weeks on vision-related and general QoL in patients with nARMD. These results are in line with previously published results of lower frequency injections regarding visual acuity and central retinal thickness. Lower injection frequency may reduce burden, side effects, and treatment costs. In consideration of these results, 8 weeks frequency injections of intravitreal bevacizumab could be considered in patients with nARMD.

United States Valuation of EQ-5D-5L Health States Using an International Protocol.

OBJECTIVE: To derive a US-based value set for the EQ-5D-5L questionnaire using an international, standardized protocol developed by the EuroQol Group. METHODS: Respondents from the US adult population were quota-sampled on the basis of age, sex, ethnicity, and race. Trained interviewers guided participants in completing composite time trade-off (cTTO) and discrete choice experiment (DCE) tasks using the EuroQol Valuation Technology software and routine quality control measures. Data were modeled using a Tobit model for cTTO data, a mixed logit model for DCE data, and a hybrid model that combined cTTO and DCE data. Model performance was compared on the basis of logical ordering of coefficients, statistical significance, parsimony, and theoretical considerations. RESULTS: Of 1134 respondents, 1062, 1099, and 1102 respondents provided useable cTTO, DCE, and cTTO or DCE responses, respectively, on the basis of quality control criteria and interviewer judgment. Respondent demographic characteristics and health status were similar to the 2015 US Census. The Tobit model was selected as the preferred model to generate the value set. Values ranged from -0.573 (55 555) to 1 (11 111), with 20% of all predicted health states scores less than 0 (ie, worse than dead). CONCLUSIONS: A societal value set for the EQ-5D-5L was developed that can be used for economic evaluations and decision making in US health systems. The internationally established, standardized protocol used to develop this US-based value set was recommended by the EuroQol Group and can facilitate cross-country comparisons.

Development of Therapist Adherence in Relation to Treatment Outcomes of Adolescents with Behavioral Problems.

Therapist adherence to the treatment manual is assumed to be crucial for adequate implementation and subsequent achievement of the intended, positive treatment outcomes. Although adherence has been mostly studied as a static factor, recent studies suggest that adherence might be dynamic and changes over time. We investigated how parent-perceived adherence to the multisystemic therapy (MST) model develops during treatment and how this development is related to treatment outcomes up to 18 months posttreatment, controlling for the effect of alliance. We used routinely collected data from 848 adolescents (66% male and 76% Western, M age = 15.25 years) and their caregivers participating in MST, a family- and community-based intervention for antisocial adolescents. Adherence and alliance were measured monthly through phone interviews with the caregivers using the Therapist Adherence Measure-Revised. Outcomes were assessed at the end of the treatment and at 18 months posttreatment using the scale Rule-Breaking Behavior of the Child Behavior Checklist and two MST Ultimate Outcomes (i.e., police contact and out-of-home placement). On average, adherence showed an increasing and then flattening slope. The initial level of adherence predicted treatment outcomes at the end of treatment but not at 18 months posttreatment. Change in adherence did not predict treatment outcomes after controlling for alliance. We advocate the need to consider the dynamic nature of adherence in research as well as clinical practice. Change in adherence during treatment, as well as its association with outcome, is likely to be dependent on the adherence measure being used.

Day hospital mentalization-based treatment v. specialist treatment as usual in patients with borderline personality disorder: randomized controlled trial.

BACKGROUND: Day hospital mentalization-based treatment (MBT-DH) is a promising treatment for borderline personality disorder (BPD) but its evidence base is still limited. This multi-site randomized trial compared the efficacy of MBT-DH delivered by a newly set-up service v. specialist treatment as usual (S-TAU) tailored to the individual needs of patients, and offered by a well-established treatment service. METHODS: Two mental healthcare institutes in The Netherlands participated in the study. Patients who met DSM-IV criteria for BPD and had a score of ⩾20 on the borderline personality disorder severity index (BPDSI) were randomly allocated to MBT-DH (N = 54) or S-TAU (N = 41). The primary outcome variable was the total score on the BPDSI. Secondary outcome variables included symptom severity, quality of life, and interpersonal functioning. Data were collected at baseline and every 6 months until 18-month follow-up, and were analyzed using multilevel analyses based on intention-to-treat principles. RESULTS: Both treatments were associated with significant improvements in all outcome variables. MBT-DH was not superior to S-TAU on any outcome variable. MBT-DH was associated with higher acceptability in BPD patients compared v. S-TAU, reflected in significantly higher early drop-out rates in S-TAU (34%) v. MBT-DH (9%). CONCLUSIONS: MBT-DH delivered by a newly set-up service is as effective as specialist TAU in The Netherlands in the treatment of BPD at 18-month follow-up. Further research is needed to investigate treatment outcomes in the longer term and the cost-effectiveness of these treatments.

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

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

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

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

Quality Control Process for EQ-5D-5L Valuation Studies.

BACKGROUND: The values of the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) are elicited using composite time trade-off and discrete choice experiments. Unfortunately, data quality issues and interviewer effects were observed in the first few EQ-5D-5L valuation studies. To prevent these issues from occurring in later studies, the EuroQol Group established a cyclic quality control (QC) process. OBJECTIVES: To describe this QC process and show its impact on data quality. METHODS: A newly developed QC tool provided information about protocol compliance, interviewer effects, and mean values by health state severity. In a cyclic process, this information is initially used to evaluate whether new interviewers meet minimal quality requirements and later to provide feedback about how their performance may be improved. To investigate the impact of this cyclic process, we compared the quality of the data in Dutch and Spanish valuation studies that did not have this QC process with that in the follow-up studies in the same countries that used the QC process. Data quality was measured using protocol violations, variability between interviewers, the proportion of inconsistent responders, and clustering of composite time trade-off values. RESULTS: In Spain, protocol violations were reduced from 87% in the valuation study to 5% in the follow-up study and in the Netherlands from 20% to 8%. In both countries, interviewers performed more homogeneously in the follow-up studies. The number of inconsistent respondents was reduced by 23.2% in Spain and 23.6% in the Netherlands. Values were less clustered in the follow-up studies. CONCLUSIONS: The implementation of a strict QC process in EQ-5D-5L valuation studies increases interviewer protocol compliance and promotes data quality.

Training for endoscopic surgical procedures should be performed in the dissection room: a randomized study.

BACKGROUND: Laparoscopic surgery is associated with a shallow learning curve. AnubiFiX embalming technique enables laparoscopic surgical training on supple embalmed and hence insufflatable human specimens in the dissection room. Aim of the present trial is to test whether dissection-based anatomy education is superior to classical frontal classroom education on the short and long term. METHODS: A total of 112 medical students were randomized in three groups. Group I attended classroom education, group II laparoscopic dissection-based education and group III received both. All groups completed an anatomy test on human specimens before, immediately after and 3 weeks after the anatomy training. RESULTS: Group II and III scored significantly better compared to group I immediately after the anatomy training (p I-II < 0.001, p I-III < 0.001). This difference was still significant after 3 weeks (p I-II < 0.001, p I-III < 0.001). No significant difference was found between group II and group III immediately after the course (p = 0.86), nor at the follow-up (p = 0.054). CONCLUSIONS: The AnubiFiX™ embalming technique enables laparoscopic anatomy education in human specimens, with superior outcomes on the short and long term, as compared to classical frontal classroom education.

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

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

Burden of Keloid Disease: A Cross-sectional Health-related Quality of Life Assessment.

Keloid scars may be painful, itch severely and be cosmetically disturbing. The burden of keloid disease, however, has not yet been determined. This study evaluated the association of keloid disease with health-related quality of life (HRQL) and identified indicators of burden using a cross-sectional survey study, with one disease-specific HRQL measure (Skindex-29) and 2 generic HRQL measures (SF-36 and EQ-5D-5L). A total of 106 keloid patients with no other skin diseases participated in the study. Having keloid disease was associated with a considerable impairment of emotional wellbeing, with most impairment on the emotional and mental HRQL. Pain and itch were the strongest indicators of HRQL impairment in keloid patients. Having painful or itchy keloids was related to low mental and emotional HRQL, implying that patients with keloids require access to effective treatment aimed at alleviating physical symptoms.

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

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