Challenges in Recruiting University Students for Web-Based Indicated Prevention of Depression and Anxiety: Results From a Randomized Controlled Trial (ICare Prevent).

BACKGROUND: Depression and anxiety are common mental health conditions in college and university student populations. Offering transdiagnostic, web-based prevention programs such as ICare Prevent to those with subclinical complaints has the potential to reduce some barriers to receiving help (eg, availability of services, privacy considerations, and students' desire for autonomy). However, uptake of these interventions is often low, and accounts of recruitment challenges are needed to complement available effectiveness research in student populations. OBJECTIVE: The aims of this study were to describe recruitment challenges together with effective recruitment strategies for ICare Prevent and provide basic information on the intervention's effectiveness. METHODS: A 3-arm randomized controlled trial was conducted in a student sample with subclinical symptoms of depression and anxiety on the effectiveness of an individually guided (human support and feedback on exercises provided after each session, tailored to each participant) and automatically guided (computer-generated messages provided after each session, geared toward motivation) version of ICare Prevent, a web-based intervention with transdiagnostic components for the indicated prevention of depression and anxiety. The intervention was compared with care as usual. Descriptive statistics were used to outline recruitment challenges and effective web-based and offline strategies as well as students' use of the intervention. A basic analysis of intervention effects was conducted using a Bayesian linear mixed model, with Bayes factors reported as the effect size. RESULTS: Direct recruitment through students' email addresses via the central student administration was the most effective strategy. Data from 35 participants were analyzed (individually guided: n=14, 40%; automatically guided: n=8, 23%; care as usual: n=13, 37%). Use of the intervention was low, with an average of 3 out of 7 sessions (SD 2.9) completed. The analyses did not suggest any intervention effects other than anecdotal evidence (all Bayes factors10≤2.7). CONCLUSIONS: This report adds to the existing literature on recruitment challenges specific to the student population. Testing the feasibility of recruitment measures and the greater involvement of the target population in their design, as well as shifting from direct to indirect prevention, can potentially help future studies in the field. In addition, this report demonstrates an alternative basic analytical strategy for underpowered randomized controlled trials. TRIAL REGISTRATION: International Clinical Trials Registry Platform NTR6562; https://tinyurl.com/4rbexzrk. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-018-2477-y.

Symptom clusters among cancer survivors: what can machine learning techniques tell us?

PURPOSE: Knowledge regarding symptom clusters may inform targeted interventions. The current study investigated symptom clusters among cancer survivors, using machine learning techniques on a large data set. METHODS: Data consisted of self-reports of cancer survivors who used a fully automated online application 'Oncokompas' that supports them in their self-management. This is done by 1) monitoring their symptoms through patient reported outcome measures (PROMs); and 2) providing a personalized overview of supportive care options tailored to their scores, aiming to reduce symptom burden and improve health-related quality of life. In the present study, data on 26 generic symptoms (physical and psychosocial) were used. Results of the PROM of each symptom are presented to the user as a no well-being risk, moderate well-being risk, or high well-being risk score. Data of 1032 cancer survivors were analysed using Hierarchical Density-Based Spatial Clustering of Applications with Noise (HDBSCAN) on high risk scores and moderate-to-high risk scores separately. RESULTS: When analyzing the high risk scores, seven clusters were extracted: one main cluster which contained most frequently occurring physical and psychosocial symptoms, and six subclusters with different combinations of these symptoms. When analyzing moderate-to-high risk scores, three clusters were extracted: two main clusters were identified, which separated physical symptoms (and their consequences) and psycho-social symptoms, and one subcluster with only body weight issues. CONCLUSION: There appears to be an inherent difference on the co-occurrence of symptoms dependent on symptom severity. Among survivors with high risk scores, the data showed a clustering of more connections between physical and psycho-social symptoms in separate subclusters. Among survivors with moderate-to-high risk scores, we observed less connections in the clustering between physical and psycho-social symptoms.

Cross-cultural adaptation and validation of the Dutch language version of the Pictorial Fear of Activity Scale - Cervical.

BACKGROUND: The Pictorial Fear of Activity Scale-Cervical (PFActS-C) is a reliable and valid instrument to assess fear of movement in people with whiplash associated disorders. It is not available in Dutch and has not been evaluated in other neck pain populations. This study aimed to systematically translate the PFActS-C into Dutch and evaluate the psychometric properties of this Dutch Language Version (DLV) in people with non-specific neck pain. METHODS: The PFActS-C was translated according to international guidelines. Internal consistency, test-retest reliability, floor and ceiling effects, face validity and construct validity (convergent and discriminant validity by hypotheses testing and structural validity by confirmatory and exploratory factor-analyses) of the PFActS-C-DLV were tested in 125 people with non-specific neck pain. RESULTS: The PFActS-C-DLV showed good to excellent internal consistency (Cronbach's alpha: 0.98) and stability over time (ICC: 0.90 [95%CI: 0.82-0.93). Four out of five a priori formulated hypotheses regarding related (convergent validity) and unrelated (discriminant validity) constructs were confirmed. However, the confirmatory factor analysis could not confirm the expected 1-factor solution. Furthermore, the exploratory factor analyses revealed that also a higher factor solution would not lead to a good fit of the model. CONCLUSIONS: The PFActS-C-DLV is a reliable region-specific instrument for people with non-specific neck pain. The construct validity was supported, based on hypotheses testing. However, factor analyses could not confirm a 1-factor solution, so the underlying construct of the PFActS-C-DLV remains unclear. Given the PFActS-C's photographic format, we believe these findings also have relevance for the original English version.

Cost and Effectiveness of Blended Versus Standard Cognitive Behavioral Therapy for Outpatients With Depression in Routine Specialized Mental Health Care: Pilot Randomized Controlled Trial.

BACKGROUND: Cognitive behavioral therapy (CBT) is an effective treatment, but access is often restricted due to costs and limited availability of trained therapists. Blending online and face-to-face CBT for depression might improve cost-effectiveness and treatment availability. OBJECTIVE: This pilot study aimed to examine the costs and effectiveness of blended CBT compared with standard CBT for depressed patients in specialized mental health care to guide further research and development of blended CBT. METHODS: Patients were randomly allocated to blended CBT (n=53) or standard CBT (n=49). Blended CBT consisted of 10 weekly face-to-face sessions and 9 Web-based sessions. Standard CBT consisted of 15 to 20 weekly face-to-face sessions. At baseline and 10, 20, and 30 weeks after start of treatment, self-assessed depression severity, quality-adjusted life-years (QALYs), and costs were measured. Clinicians, blinded to treatment allocation, assessed psychopathology at all time points. Data were analyzed using linear mixed models. Uncertainty intervals around cost and effect estimates were estimated with 5000 Monte Carlo simulations. RESULTS: Blended CBT treatment duration was mean 19.0 (SD 12.6) weeks versus mean 33.2 (SD 23.0) weeks in standard CBT (P<.001). No significant differences were found between groups for depressive episodes (risk difference [RD] 0.06, 95% CI -0.05 to 0.19), response to treatment (RD 0.03, 95% CI -0.10 to 0.15), and QALYs (mean difference 0.01, 95% CI -0.03 to 0.04). Mean societal costs for blended CBT were €1183 higher than standard CBT. This difference was not significant (95% CI -399 to 2765). Blended CBT had a probability of being cost-effective compared with standard CBT of 0.02 per extra QALY and 0.37 for an additional treatment response, at a ceiling ratio of €25,000. For health care providers, mean costs for blended CBT were €176 lower than standard CBT. This difference was not significant (95% CI -659 to 343). At €0 per additional unit of effect, the probability of blended CBT being cost-effective compared with standard CBT was 0.75. The probability increased to 0.88 at a ceiling ratio of €5000 for an added treatment response, and to 0.85 at €10,000 per QALY gained. For avoiding new depressive episodes, blended CBT was deemed not cost-effective compared with standard CBT because the increase in costs was associated with negative effects. CONCLUSIONS: This pilot study shows that blended CBT might be a promising way to engage depressed patients in specialized mental health care. Compared with standard CBT, blended CBT was not considered cost-effective from a societal perspective but had an acceptable probability of being cost-effective from the health care provider perspective. Results should be carefully interpreted due to the small sample size. Further research in larger replication studies focused on optimizing the clinical effects of blended CBT and its budget impact is warranted. TRIAL REGISTRATION: Netherlands Trial Register NTR4650; https://www.trialregister.nl/trial/4408. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-014-0290-z.

Translation of the eHealth Impact Questionnaire for a Population of Dutch Electronic Health Users: Validation Study.

BACKGROUND: The eHealth Impact Questionnaire (eHIQ) provides a standardized method to measure attitudes of electronic health (eHealth) users toward eHealth. It has previously been validated in a population of eHealth users in the United Kingdom and consists of 2 parts and 5 subscales. Part 1 measures attitudes toward eHealth in general and consists of the subscales attitudes towards online health information (5 items) and attitudes towards sharing health experiences online (6 items). Part 2 measures the attitude toward a particular eHealth application and consists of the subscales confidence and identification (9 items), information and presentation (8 items), and understand and motivation (9 items). OBJECTIVE: This study aimed to translate and validate the eHIQ in a Dutch population of eHealth users. METHODS: The eHIQ was translated and validated in accordance with the COnsensus-based Standards for the selection of health status Measurement INstruments criteria. The validation comprised 3 study samples, with a total of 1287 participants. Structural validity was assessed using confirmatory factor analyses and exploratory factor analyses (EFAs; all 3 samples). Internal consistency was assessed using hierarchical omega (all 3 samples). Test-retest reliability was assessed after 2 weeks, using 2-way intraclass correlation coefficients (sample 1). Measurement error was assessed by calculating the smallest detectable change (sample 1). Convergent and divergent validity were assessed using correlations with the remaining measures (all 3 samples). A graded response model was fit, and item information curves were plotted to describe the information provided by items across item trait levels (all 3 samples). RESULTS: The original factor structure showed a bad fit in all 3 study samples. EFAs showed a good fit for a modified factor structure in the first study sample. This factor structure was subsequently tested in samples 2 and 3 and showed acceptable to good fits. Internal consistency, test-retest reliability, convergent validity, and divergent validity were acceptable to good for both the original as the modified factor structure, except for test-retest reliability of one of the original subscales and the 2 derivative subscales in the modified factor structure. The graded response model showed that some items underperformed in both the original and modified factor structure. CONCLUSIONS: The Dutch version of the eHIQ (eHIQ-NL) shows a different factor structure compared with the original English version. Part 1 of the eHIQ-NL consists of 3 subscales: attitudes towards online health information (5 items), comfort with sharing health experiences online (3 items), and usefulness of sharing health experiences online (3 items). Part 2 of the eHIQ-NL consists of 3 subscales: motivation and confidence to act (10 items), information and presentation (13 items), and identification (3 items).

The International Index of Erectile Function (IIEF)-A Systematic Review of Measurement Properties.

INTRODUCTION: The International Index of Erectile Function (IIEF) is a patient-reported outcome measure to evaluate erectile dysfunction and other sexual problems in men. AIM: To perform a systematic review of the measurement properties of the 15-item patient-reported outcome measure (IIEF-15) and the shortened 5-item version (IIEF-5). METHODS: A systematic search of scientific literature up to April 2018 was performed. Data were extracted and analyzed according to COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines for structural validity, internal consistency, reliability, measurement error, hypothesis testing for construct validity, and responsiveness. Evidence of measurement properties was categorized into sufficient, insufficient, inconsistent, or indeterminate, and quality of evidence as very high, high, moderate, or low. RESULTS: 40 studies were included. The evidence for criterion validity (of the Erectile Function subscale), and responsiveness of the IIEF-15 was sufficient (high quality), but inconsistent (moderate quality) for structural validity, internal consistency, construct validity, and test-retest reliability. Evidence for structural validity, test-retest reliability, construct validity, and criterion validity of the IIEF-5 was sufficient (moderate quality) but indeterminate for internal consistency, measurement error, and responsiveness. CLINICAL IMPLICATIONS: Lack of evidence for and evidence not supporting some of the measurement properties of the IIEF-15 and IIEF-5 shows the importance of further research on the validity of these questionnaires in clinical research and clinical practice. STRENGTHS & LIMITATIONS: A strength of the current review is the use of predefined guidelines (COSMIN). A limitation of this review is the use of a precise rather than a sensitive search filter regarding measurement properties to identify studies to be included. CONCLUSION: The IIEF requires more research on structural validity (IIEF-15), internal consistency (IIEF-15 and IIEF-5), construct validity (IIEF-15), measurement error (IIEF-15 and IIEF-5), and responsiveness (IIEF-5). The most pressing matter for future research is determining the unidimensionality of the IIEF-5 and the exact factor structure of the IIEF-15. Neijenhuijs KI, Holtmaat K, Aaronson NK, et al. The International Index of Erectile Function (IIEF)-A Systematic Review of Measurement Properties. J Sex Med 2019;16:1078-1091.

The Female Sexual Function Index (FSFI)-A Systematic Review of Measurement Properties.

INTRODUCTION: The Female Sexual Function Index (FSFI) is a patient-reported outcome measure measuring female sexual dysfunction. The FSFI-19 was developed with 6 theoretical subscales in 2000. In 2010, a shortened version became available (FSFI-6). AIM: To investigate the measurement properties of the FSFI-19 and FSFI-6. METHODS: A systematic search was performed of Embase, Medline, and Web of Science for studies that investigated measurement properties of the FSFI-19 or FSFI-6 up to April 2018. Data were extracted and analyzed according to COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. Evidence was categorized into sufficient, insufficient, inconsistent, or indeterminate, and quality of evidence as very high, high, moderate, or low. MAIN OUTCOME MEASURES: The Main Outcome Measure is the evidence of a measurement property, and the quality of evidence based on the COSMIN guidelines. RESULTS: 83 studies were included. Concerning the FSFI-19, the evidence for internal consistency was sufficient and of moderate quality. The evidence for reliability was sufficient but of low quality. The evidence for criterion validity was sufficient and of high quality. The evidence for structural validity was inconsistent of low quality. The evidence for construct validity was inconsistent of moderate quality. Concerning the FSFI-6, the evidence for criterion validity was sufficient of moderate quality. The evidence for internal consistency was rated as indeterminate. The evidence for reliability was inconsistent of low quality. The evidence for construct validity was inconsistent of very low quality. No information was available on structural validity of the FSFI-6, and measurement error, responsiveness, and cross-cultural validity of both FSFI-6 and FSFI-19. CLINICAL IMPLICATIONS: Conflicting and lack of evidence for some of the measurement properties of the FSFI-19 and FSFI-6 indicates the importance of further research on the validity of these patient-reported outcome measures. We advise researchers who use the FSFI-19 to perform confirmatory factor analyses and report the factor structure found in their sample. Regardless of these concerns, the FSFI-19 and FSFI-6 have strong criterion validity. Pragmatically, they are good screening tools for the current definition of female sexual dysfunction. STRENGTH & LIMITATION: A strong point of the review is the use of predefined guidelines. A limitation is the use of a precise rather than a sensitive search filter. CONCLUSIONS: The FSFI requires more research on structural validity (FSFI-19 and FSFI-6), reliability (FSFI-6), construct validity (FSFI-19), measurement error (FSFI-19 and FSFI-6), and responsiveness (FSFI-19 and FSFI-6). Further corroboration of measurement invariance (both across cultures and across subpopulations) in the factor structure of the FSFI-19 is necessary, as well as tests for the unidimensionality of the FSFI-6. Neijenhuijs KI, Hooghiemstra N, Holtmaat K, et al. The Female Sexual Function Index (FSFI)-A Systematic Review of Measurement Properties. J Sex Med 2019;16:640-660.

Measuring health-related quality of life in colorectal cancer patients: systematic review of measurement properties of the EORTC QLQ-CR29.

INTRODUCTION: The EORTC QLQ-CR29 is a patient-reported outcome measure to evaluate health-related quality of life among colorectal cancer patients in research and clinical practice. The aim of this systematic review was to investigate whether the initial positive results regarding the measurement properties of the QLQ-CR29 are confirmed in subsequent studies. METHODS: A systematic search of Embase, Medline, PsycINFO, and Web of Science was conducted to identify studies investigating the measurement properties of the QLQ-CR29 published up to January 2019. For the 11 included studies, data were extracted, methodological quality was assessed, results were synthesized, and evidence was graded according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology on the measurement properties: structural validity, internal consistency, reliability, measurement error, construct validity (hypothesis testing, including known-group comparison, convergent and divergent validity), cross-cultural validity, and responsiveness. RESULTS: Internal consistency was rated as "sufficient," with low evidence. Reliability was rated as "insufficient," with moderate evidence. Construct validity (hypothesis testing; known-group comparison, convergent and divergent validity) was rated as "inconsistent," with moderate evidence. Structural validity, measurement error, and responsiveness were rated as "indeterminate" and could therefore not be graded. CONCLUSION: This review indicates that current evidence supporting the measurement properties of the QLQ-CR29 is limited. Additionally, better quality research is needed, taking into account the COSMIN methodology.

A systematic review of the measurement properties of the European Organisation for Research and Treatment of Cancer In-patient Satisfaction with Care Questionnaire, the EORTC IN-PATSAT32.

PURPOSE: The EORTC IN-PATSAT32 is a patient-reported outcome measure (PROM) to assess cancer patients' satisfaction with in-patient health care. The aim of this study was to investigate whether the initial good measurement properties of the IN-PATSAT32 are confirmed in new studies. METHODS: Within the scope of a larger systematic review study (Prospero ID 42017057237), a systematic search was performed of Embase, Medline, PsycINFO, and Web of Science for studies that investigated measurement properties of the IN-PATSAT32 up to July 2017. Study quality was assessed, data were extracted, and synthesized according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. RESULTS: Nine studies were included in this review. The evidence on reliability and construct validity were rated as sufficient and of the quality of the evidence as moderate. The evidence on structural validity was rated as insufficient and of low quality. The evidence on internal consistency was indeterminate. Measurement error, responsiveness, criterion validity, and cross-cultural validity were not reported in the included studies. Measurement error could be calculated for two studies and was judged indeterminate. CONCLUSION: In summary, the IN-PATSAT32 performs as expected with respect to reliability and construct validity. No firm conclusions can be made yet whether the IN-PATSAT32 also performs as well with respect to structural validity and internal consistency. Further research on these measurement properties of the PROM is therefore needed as well as on measurement error, responsiveness, criterion validity, and cross-cultural validity. For future studies, it is recommended to take the COSMIN methodology into account.

A systematic review of the measurement properties of the Body Image Scale (BIS) in cancer patients.

INTRODUCTION: Body image is acknowledged as an important aspect of health-related quality of life in cancer patients. The Body Image Scale (BIS) is a patient-reported outcome measure (PROM) to evaluate body image in cancer patients. The aim of this study was to systematically review measurement properties of the BIS among cancer patients. METHODS: A search in Embase, MEDLINE, PsycINFO, and Web of Science was performed to identify studies that investigated measurement properties of the BIS (Prospero ID 42017057237). Study quality was assessed (excellent, good, fair, poor), and data were extracted and analyzed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology on structural validity, internal consistency, reliability, measurement error, hypothesis testing for construct validity, and responsiveness. Evidence was categorized into sufficient, insufficient, inconsistent, or indeterminate. RESULTS: Nine studies were included. Evidence was sufficient for structural validity (one factor solution), internal consistency (α = 0.86-0.96), and reliability (r > 0.70); indeterminate for measurement error (information on minimal important change lacked) and responsiveness (increasing body image disturbance in only one study); and inconsistent for hypothesis testing (conflicting results). Quality of the evidence was moderate to low. No studies reported on cross-cultural validity. CONCLUSION: The BIS is a PROM with good structural validity, internal consistency, and test-retest reliability, but good quality studies on the other measurement properties are needed to optimize evidence. It is recommended to include a wider variety of cancer diagnoses and treatment modalities in these future studies.

Response to Comment on "Estimating the reproducibility of psychological science".

Gilbert et al. conclude that evidence from the Open Science Collaboration's Reproducibility Project: Psychology indicates high reproducibility, given the study methodology. Their very optimistic assessment is limited by statistical misconceptions and by causal inferences from selectively interpreted, correlational data. Using the Reproducibility Project: Psychology data, both optimistic and pessimistic conclusions about reproducibility are possible, and neither are yet warranted.

A Young Scientists' Perspective on DBS: A Plea for an International DBS Organization.

Our think tank tasked by the Dutch Health Council, consisting of Radboud University Nijmegen Honours Academy students with various backgrounds, investigated the implications of Deep Brain Stimulation (DBS) for psychiatric patients. During this investigation, a number of methodological, ethical and societal difficulties were identified. We consider these difficulties to be a reflection of a still fragmented field of research that can be overcome with improved organization and communication. To this effect, we suggest that it would be useful to found a centralized DBS organization. Such an organization makes it possible to 1) set up and maintain a repository, 2) facilitate DBS studies with a larger sample size, 3) improve communication amongst researchers, clinicians and ethical committees, and 4) improve communication between DBS experts and the public at large.