Extending the PROMIS item bank "ability to participate in social roles and activities": a psychometric evaluation using IRT.

OBJECTIVE: Our objective was to explore whether the extension of the PROMIS item bank Ability to Participate in Social Roles and Activities (APSRA) with new items would result in more effective targeting (i.e., selecting items that are appropriate for each individual's trait level), and more reliable measurements across all latent trait levels. METHODS: A sample of 1,022 Dutch adults completed all 35 items of the original item bank plus 17 new items (in Dutch). The new items presented in this publication have been translated provisionally from Dutch into English for presentation purposes. We evaluated the basic IRT assumptions unidimensionality, local independence, and monotonicity. Furthermore, we examined the item parameters, and assessed differential item functioning (DIF) for sex, education, region, age, and ethnicity. In addition, we compared the test information functions, item parameters, and θ scores, for the original and extended item bank in order to assess whether the measurement range had improved. RESULTS: We found that the extended item bank was compatible with the basic IRT assumptions and showed good reliability. Moreover, the extended item bank improved the measurement in the lower trait range, which is important for reliably assessing functioning in clinical populations (i.e., persons reporting lower levels of participation). CONCLUSION: We extended the PROMIS-APSRA item bank and improved its psychometric quality. Our study contributes to PROMIS measurement innovation, which allows for the addition of new items to existing item banks, without changing the interpretation of the scores and while maintaining the comparability of the scores with other PROMIS instruments.

Goal-Directed Treatment of Patients With Anxiety and Mood Disorders in a Regular Curative Mental Health Care Setting.

This study examined whether goal-directed treatment leads to improved treatment outcomes for patients with a primary mood or anxiety disorder and whether beneficial outcomes are achieved sooner compared to treatment as usual. In a quasi-experimental controlled study with a nested design, 17 therapists received training in goal-directed treatment and treated 105 patients with anxiety or mood disorders using principles of goal-directed treatment. Treatment results on a generic self-report instrument were compared with two control groups: a historical control group consisting of 16 of the 17 participating therapists, who provided treatment as usual to 97 patients before having received training in goal-directed treatment, and a parallel control group consisting of various therapists, who provided treatment as usual to 105 patients. Symptom reduction on a self-report measure was compared using multilevel analysis. A survival analysis was performed to assess whether a satisfactory end state had been reached sooner after goal-directed treatment. The results of this study show that goal-directed treatment only led to a significantly better overall treatment outcome compared to the parallel treatment as usual group. Furthermore, goal-directed treatment was significantly shorter than both treatment as usual groups. In conclusion, this research suggest that goal-directed treatment led to a similar or better treatment outcome in a shorter amount of time.

Effectiveness of web-based guided self-help cognitive behavioral therapy-enhanced for binge-eating disorder: An implementation study.

INTRODUCTION: Web-based guided self-help cognitive behavioral therapy-enhanced (CBT-E) is a 12-weeks, 12-sessions, digitalized version of part II of the self-help book Overcoming Binge Eating. This intervention is effective when offered under controlled circumstances in a randomized-controlled-trial. It is unknown how patients with binge-eating disorder (BED) respond to this intervention when offered in real-world clinical-settings. The aim of this study is to examine post-intervention effectiveness of guided self-help CBT-E for BED in real-world settings. METHOD: The present study used a cohort-design examining the effectiveness of web-based guided self-help CBT-E according to an intention-to-treat (ITT) analysis. BED patients (n = 278) were assessed pre- and post-intervention. The primary outcome was reduction in binge-eating episodes. Other outcomes were full-recovery (EDE-Q score <2.77 and abstinence from binge-eating episodes), impaired psychosocial functioning, defined as secondary impairment, and general psychopathology post-intervention. RESULTS: The number of binge-eating episodes reduced by an average of 16 binge-eating episodes per 4 weeks pre-intervention to five binge-eating episodes during the last 4 weeks of treatment. Abstinence from binge eating was reported by 30%, and 28% reported full recovery. Effect sizes (Cohen's d) were large (d ≥ 1.0) for all outcome measures. There were no differences in outcomes between the ITT and the completers sample. DISCUSSION: Guided self-help CBT-E is associated with significant improvements. The effects of guided self-help CBT-E offered in a real-world-setting are comparable to self-help CBT-E offered in a randomized-controlled-trial. However, it should be noted that comparisons with randomized-controlled-trials requires caution. Longer-term follow-up data are necessary to measure persistence of treatment benefits. PUBLIC SIGNIFICANCE: Offering CBT-E as a web-based guided self-help intervention has several benefits for patients with BED. Guided self-help CBT-E is associated with significant improvements on the short term when offered in real-world clinical settings.

Economic evaluation of web-based guided self-help cognitive behavioral therapy-enhanced for binge-eating disorder compared to a waiting list: A randomized controlled trial.

INTRODUCTION: The aim is to perform an economic evaluation alongside a randomized controlled trial comparing guided self-help cognitive behavioral therapy-enhanced (CBT-E) for binge-eating disorder (BED) to a waiting list control condition. METHODS: BED patients (N = 212) were randomly assigned to guided self-help CBT-E or the 3-month waiting list. Measurements took place at baseline and the end-of-treatment. The cost-effectiveness analysis was performed using the number of binge-eating episodes during the last 28 days as an outcome indicator according to the eating disorder examination. A cost-utility analysis was performed using the EuroQol-5D. RESULTS: The difference in societal costs over the 3 months of the intervention between both conditions was €679 (confidence interval [CI] 50-1330). The incremental costs associated with one incremental binge eating episode prevented in the guided self-help condition was approximately €18 (CI 1-41). From a societal perspective there was a 96% likelihood that guided self-help CBT-E led to a greater number of binge-eating episodes prevented, but at higher costs. Each additional quality-adjusted life year (QALY) gained was associated with incremental costs of €34,000 (CI 2494-154,530). With a 95% likelihood guided self-help CBT-E led to greater QALY gain at higher costs compared to waiting for treatment. Based on the National Institute for Health and Clinical Excellence willingness-to-pay threshold of €35,000 per QALY, guided self-help CBT-E can be considered cost-effective with a likelihood of 95% from a societal perspective. DISCUSSION: Guided self-help CBT-E is likely a cost-effective treatment for BED in the short-term (3-month course of treatment). Comparison to treatment-as-usual is recommended for future research, as it enables an economic evaluation with a longer time horizon. PUBLIC SIGNIFICANCE: Offering treatment remotely has several benefits for patients suffering from binge-eating disorders. Guided self-help CBT-E is an efficacious and likely cost-effective treatment, reducing binge eating and improving quality-of-life, albeit at higher societal costs.

Psychopathology and health-related quality of life as patient-reported treatment outcomes: evaluation of concordance between the Brief Symptom Inventory (BSI) and the Short Form-36 (SF-36) in psychiatric outpatients.

PURPOSE: Treatment outcome for common psychiatric disorders, such as mood and anxiety disorders, is usually assessed by self-report measures regarding psychopathology [e.g., via Brief Symptom Inventory (BSI)]. However, health-related quality of life [as measured by the 36-item Short-Form Health Survey (SF-36)] may be a useful supplementary outcome domain for routine outcome monitoring (ROM). To date, the assessment of both outcomes has become fairly commonplace with severe mental illness, but this is not yet the case for common psychiatric disorders. The present study examined among outpatients with common psychiatric disorders whether aggregate assessments of change across treatment regarding psychopathology and health-related quality of life yield similar results and effect sizes. METHODS: We compared treatment outcome on the BSI and the SF-36 in a sample of 13,423 outpatients. The concordance of both instruments was assessed at various time points during treatment. RESULTS: Scores on both instruments were associated, but not so strongly to suggest they measure the same underlying construct. The SF-36 scales presented a varied picture of treatment outcome: understandably, patients changed more on the mental component scales than on physical component scales. Outcome according to the BSI was quite similar to outcome according to scales of the SF-36 that showed the largest change. CONCLUSIONS: Although (mental health) scores on both instruments are associated, adding the SF-36 in addition to the BSI in treatment evaluation research produces valuable information as the SF-36 measures a broader concept and contains physical/functional component scales, resulting in a more complete clinical picture of individual patients.

Prognostic Value of Pathological Personality Traits for Treatment Outcome in Anxiety and Depressive Disorders: The Leiden Routine Outcome Monitoring Study.

ABSTRACT: Previous studies have failed to take baseline severity into account when assessing the effects of pathological personality traits (PPT) on treatment outcome. This study assessed the prognostic value of PPT (Dimensional Assessment of Personality Pathology-Short Form) on treatment outcome (Brief Symptom Inventory [BSI-posttreatment]) among patients with depressive and/or anxiety disorders ( N = 5689). Baseline symptom level (BSI-pretreatment) was taken into account as a mediator or moderator variable. Results showed significant effects of PPT on outcome, of which Emotional Dysregulation demonstrated the largest association ( ß = 0.43, p < 0.001). When including baseline BSI score as a mediator variable, a direct effect ( ß = 0.11, p < 0.001) remained approximately one-third of the total effect. The effects of Emotional Dysregulation (interaction effect ß = 0.061, p < 0.001) and Inhibition (interaction effect ß = 0.062, p < 0.001), but not Compulsivity or Dissocial Behavior, were moderated by the baseline symptom level. PPT predicts higher symptom levels, both before and after treatment, but yields relatively small direct effects on symptom decline when the effect of pretreatment severity is taken into account.

A survey of depression and anxiety disorders in urban and rural Suriname.

BACKGROUND: Suriname is a Low-middle income country consisting of diverse population groups. Epidemiological studies concerning mental disorders like depression and anxiety had not been conducted until 2015. The treatment gap for mental disorders in Low and middle-income countries (LMICs) may reach 76-80% as treatment is not always readily available. In this study, we estimate and compare the prevalence of potential cases of depression and anxiety, as well as the size of the treatment gap in a rural (Nickerie) and urban (Paramaribo) region of Suriname, a lower middle-income country. METHODS: Subjects were selected by a specific sampling method of the national census bureau. The Center for Epidemiological Studies-Depression (CES-D) was used to assess depression. Generalized anxiety disorder was assessed with the Generalized Anxiety Disorder 7 (GAD-7) and The Agoraphobic Cognitions Questionnaire (ACQ), the Body Sensations Questionnaire (BSQ) were used to assess Panic disorder. The treatment gap was calculated by estimating the percentage of subjects with depression or anxiety that did not seek out professional help. RESULTS: About 18% of the respondents from Nickerie and 16% from Paramaribo were at risk of depression and the established cut-off values of the instruments used indicate that about 3-4% in both regions may suffer from Generalized Anxiety Disorder. Women in both samples were most at risk of high anxiety about body sensations and maladaptive thoughts about panic. The treatment gap varies between 78 and 100% for the two disorders. CONCLUSIONS: A high depression rate has been found in both areas, especially among young females. In addition, a high treatment gap is noted which insinuates that more therapeutic strategies are required to tackle depression and anxiety in Suriname.

Impact of COVID-19 social distancing measures on routine mental health care provision and treatment outcome for common mental disorders in the Netherlands.

OBJECTIVE: The uptake of digital interventions in mental health care (MHC) has been slow, as many therapists and patients believe that in-person contact is essential for establishing a good working relationship and good outcomes in treatment. The public health policies regarding social distancing during the coronavirus disease-2019 (COVID-19) pandemic forced an abrupt transformation of MHC provisions for outpatients: Since mid-March 2020, nearly all in-person contact was replaced with videoconferencing. The COVID-19 crisis offered a unique opportunity to investigate whether MHC with videoconferencing yields inferior results as compared to in-person interventions. METHOD: In a large urban MHC facility in the Netherlands, measurement-based care is routine practice. Outcome data are regularly collected to support shared decision making and monitor patient progress. For this study, pretest and post-test data were used to compare outcomes for three cohorts: treatments performed prior to, partially during and entirely during the COVID-19 lockdown. Outcomes were compared in two large data sets: Basic MHC (N = 1392) and Specialized MHC (N = 1040). RESULTS: Therapeutic outcomes appeared robust for COVID-19 conditions across the three cohorts: No differences in outcomes were found between treatments that were conducted during lockdown compared to in-person treatments prior to COVID-19, or treatments which started in-person, but needed to be continued by means of videoconferencing. DISCUSSION: Videoconferencing care during the COVID-19 pandemic had similar outcomes compared to traditional in-person care. These real-world results corroborate findings of previous randomized controlled studies and meta-analyses in which videoconferencing and in-person care has been directly compared in terms of clinical effectiveness.

Common measures or common metrics? A plea to harmonize measurement results.

OBJECTIVE: There is a great variety of measurement instruments to assess similar constructs in clinical research and practice. This complicates the interpretation of test results and hampers the implementation of measurement-based care. METHOD: For reporting and discussing test results with patients, we suggest converting test results into universally applicable common metrics. Two well-established metrics are reviewed: T scores and percentile ranks. Their calculation is explained, their merits and drawbacks are discussed, and recommendations for the most convenient reference group are provided. RESULTS: We propose to express test results as T scores with the general population as reference group. To elucidate test results to patients, T scores may be supplemented with percentile ranks, based on data from a clinical sample. The practical benefits are demonstrated using the published data of four frequently used instruments for measuring depression: the CES-D, PHQ-9, BDI-II and the PROMIS depression measure. DISCUSSION: Recent initiatives have proposed to mandate a limited set of outcome measures to harmonize clinical measurement. However, the selected instruments are not without flaws and, potentially, this directive may hamper future instrument development. We recommend using common metrics as an alternative approach to harmonize test results in clinical practice, as this will facilitate the integration of measures in day-to-day practice.

Eating disorder examination questionnaire (EDE-Q): validity and norms for Saudi nationals.

PURPOSE: The aim of this study was to develop an Arabic version of the EDE-Q and to assess its psychometric properties and utility as a screener in the Saudi population. An additional aim was to establish EDE-Q norms for Saudis. METHOD: EDE-Q data were collected in a convenience sample of the Saudi community (N = 2690), of which a subset was also subjected to the EDE interview (N = 98). Various models for the factor structure were evaluated on their fit by CFA. With ROC analysis, the AUC was calculated to test how well the EDE-Q discriminated between Saudis at high and low risk for eating disorders. RESULTS: The original four factor model of the EDE-Q was not supported. Best fit was found for a three factor model, including the weight/shape concern scale, dietary restraint scale and eating concern scale. The ROC analysis showed that the EDE-Q could accurately discriminate between individuals at high and low risk for an eating disorder according to the EDE interview. Optimal cut off of 2.93 on the global score yielded a sensitivity of 82% and specificity of 80%. EDE-Q scores were fairly associated with BMI. DISCUSSION: Psychometric characteristics of the Saudi version of the EDE-Q were satisfactory and results support the discriminant and convergent validity. Severity level of eating disorder pathology can be determined by the EDE-Q global score. Global scores were high compared to what is found in Western community samples, leading to high prevalence estimates for Saudis at high risk for eating disorders. LEVEL OF EVIDENCE: Not applicable, empirical psychometric study.

Support for the higher-order factor structure of the WHODAS 2.0 self-report version in a Dutch outpatient psychiatric setting.

PURPOSE: Previous studies of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) interview version suggested a second-order model, with a general disability factor and six factors on a lower level. The goal of this study is to investigate if we can find support for a similar higher-order factor structure of the 36-item self-report version of the WHODAS 2.0 in a Dutch psychiatric outpatient sample. We aim to give special attention to the differences between the non-working group sample and the working group sample. Additionally, we intend to provide preliminary norms for clinical interpretation of the WHODAS 2.0 scores in psychiatric settings. METHODS: Patients seeking specialized ambulatory treatment, primarily for depressive or anxiety symptoms, completed the WHODAS 2.0 as part of the initial interview. The total sample consisted of 770 patients with a mean age of 37.5 years (SD = 13.3) of whom 280 were males and 490 were females. Several factorial compositions (i.e., one unidimensional model and two second-order models) were modeled using confirmatory factor analysis (CFA). Descriptive statistics, model-fit statistics, reliability of the (sub)scales, and preliminary norms for interpreting test scores are reported. RESULTS: For the non-working group, the second-order model with a general disability factor and six factors on a lower level, provided an adequate fit. Whereas, for the working group, the second-order model with a general disability factor and seven factors on a lower level seemed more appropriate. The WHODAS 2.0 36-item self-report form showed adequate levels of reliability. Percentile ranks and normalized T-scores are provided to aid clinical evaluations. CONCLUSION: Our results lend support for a factorial structure of the WHODAS 2.0 36-item self-report version that is comparable to the interview version. While we conjecture that a seven-factor solution might give a better reflection of item content and item variance, further research is needed to assess the clinical relevance of such a model. At this point, we recommend using the second-order structure with six factors that matches past findings of the interview form.

Online cognitive behavioral therapy enhanced for binge eating disorder: study protocol for a randomized controlled trial.

BACKGROUND: Binge eating disorder is characterized by recurrent episodes of binge eating accompanied by a sense of lack of control. Of the different treatments available, Cognitive Behavioral Therapy-Enhanced and guided self-help treatment are recommended. As online treatment offers several additional advantages, we have developed a CBT-Enhanced online guided self-help intervention. The aim of this study is to determine whether this intervention reduces eating disorder pathology and increases the amount of binge free days in adults classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder, compared to an untreated waiting list condition. The experimental condition is hypothesized to be superior to the waiting list condition. METHODS: The efficacy of an online guided self-help intervention for binge eating disorder will be assessed by conducting a randomized controlled trial. The trial will target adult individuals classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder with a body mass index between 19.5 and 40, referred to an eating disorder treatment center. Dual arm allotment will be performed in a 1:1 ratio stratified for BMI above or below 30. Randomization will be blinded to the online intervention (n = 90), or to the control waiting list condition (n = 90). Assessors will be blinded and assessments will be administered at baseline, week 5, at end-of-treatment, and at 12 and 24 weeks follow-up. Primary outcome will be eating disorder pathology, operationalized as number of days on which binge eating occurred between the two conditions during the period of the intervention. Secondary outcome measures will be differences in other eating disorder pathology, clinical impairment and in quality of life, while therapeutic alliance, demographic characteristics and followed treatment module will serve as effect moderators. Several types of costs will be assessed. DISCUSSION: This paper presents an online guided self-help Cognitive Behavioral Therapy- Enhanced study protocol for individuals classified with binge eating disorder or other specified feeding or eating disorder. Efficacy will be examined through a Randomized Controlled Trial. TRIAL REGISTRATION: The study protocol is registered with the Netherlands Trial Registry NTR (NTR 7994) since 6 September 2019.

Comparative responsiveness of generic versus disorder-specific instruments for depression: An assessment in three longitudinal datasets.

BACKGROUND: Routine outcome monitoring (ROM) may enhance individual treatment and is also advocated as a means to compare the outcome of different treatment programs or providers. There is debate on the optimal instruments to be used for these separate tasks. METHODS: Three sets with longitudinal data from ROM were analyzed with correlational analysis and repeated measures ANOVAs, allowing for a head-to-head comparison of measures regarding their sensitivity to detect change. The responsiveness of three disorder-specific instruments, the Beck Depression Inventory, the Inventory of Depressive Symptoms, and the Mood and Anxiety Symptoms Questionnaire, was compared to three generic instruments, the Symptom Checklist (SCL-90), the Outcome Questionnaire (OQ-45), and the Brief Symptom Inventory, respectively. RESULTS: In two of the three datasets, disorder-specific measures were more responsive compared to the total score on generic instruments. Subscale scores for depression embedded within generic instruments are second best and almost match disorder-specific scales in responsiveness. No evidence of a desynchronous response on outcome measures was found. LIMITATIONS: The present study compares measures head-to-had, and responsiveness is not assessed against an external criterion, such as clinical recovery. DISCUSSION: Disorder-specific measures yield the most precise assessment for individual treatment and are recommended for clinical use. Generic measures may allow for comparisons across diagnostic groups and their embedded subscales approach the responsiveness of disorder-specific measures.

Shared decision-making in mental health care using routine outcome monitoring: results of a cluster randomised-controlled trial.

PURPOSE: To investigate the effects of Shared Decision-Making (SDM) using Routine Outcome Monitoring (ROM) primary on patients' perception of Decisional Conflict (DC), which measures patients' engagement in and satisfaction with clinical decisions, and secondary on working alliance and treatment outcomes. METHOD: Multi-centre two-arm matched-paired cluster randomised-controlled trial in Dutch specialist mental health care. SDM using ROM (SDMR) was compared with Decision-Making As Usual (DMAU). Outcomes were measured at baseline (T0) and 6 months (T1). Multilevel regression and intention-to-treat analyses were used. Post hoc analyses were performed on influence of subgroups and application of SDMR on DC. RESULTS: Seven teams were randomised to each arm. T0 was completed by 186 patients (51% intervention; 49% control) and T1 by 158 patients (51% intervention, 49% control). DC, working alliance, and treatment outcomes reported by patients did not differ significantly between two arms. Post hoc analyses revealed that SDMR led to less DC among depressed patients (p = 0.047, d =- 0.69). If SDMR was applied well, patients reported less DC (SDM: p = 0.000, d = - 0.45; ROM: p = 0.021, d = - 0.32), which was associated with better treatment outcomes. CONCLUSION: Except for patients with mood disorders, we found no difference between the arms for patient-reported DC. This might be explained by the less than optimal uptake of this generic intervention, which did not support patients directly. Regarding the positive influence of a higher level of applying SDM and ROM on less DC and better treatment outcomes, the results are encouraging for further investments in patient-oriented development and implementation of SDMR.

The Assessment and Impact of Careless Responding in Routine Outcome Monitoring within Mental Health Care.

Careless responding by mental health patients on self-report assessments is rarely investigated in routine care despite the potential for serious consequences such as faulty clinical decisions. We investigated validity indices most appropriate for detecting careless responding in routine outcome monitoring (ROM) in mental health-care. First, we reviewed indices proposed in previous research for their suitability in ROM. Next, we evaluated six selected indices using data of the Brief Symptom Inventory and the Mood and Anxiety Symptom Questionnaire from 3,483 outpatients. Simulations showed that for typical ROM scales the Lmax index, Mahalanobis distance, and inter-item standard deviation may be too strongly confounded with the latent trait value to compare careless responding across patients with different symptom severity. Application of two different classification methods to the validity indices did not converge in similar prevalence estimates of careless responding. Finally, results suggest that careless responding does not have a substantial biasing effect on scale-score statistics. We recommend the lzp person-fit index to screen for random careless responding in large ROM data sets. However, additional research should further investigate methods for detecting repetitive responding in typical ROM data and assess whether there are specific circumstances in which simpler validity statistics or direct screening methods perform similarly as the lzp index.

Bias through selective inclusion and attrition: Representativeness when comparing provider performance with routine outcome monitoring data.

BACKGROUND: Observational research based on routine outcome monitoring is prone to missing data, and outcomes can be biased due to selective inclusion at baseline or selective attrition at posttest. As patients with complete data may not be representative of all patients of a provider, missing data may bias results, especially when missingness is not random but systematic. METHODS: The present study establishes clinical and demographic patient variables relevant for representativeness of the outcome information. It applies strategies to estimate sample selection bias (weighting by inclusion propensity) and selective attrition bias (multiple imputation based on multilevel regression analysis) and estimates the extent of their impact on an index of provider performance. The association between estimated bias and response rate is also investigated. RESULTS: Provider-based analyses showed that in current practice, the effect of selective inclusion was minimal, but attrition had a more substantial effect, biasing results in both directions: overstating and understating performance. For 22% of the providers, attrition bias was estimated to be in excess of 0.05 ES. Bias was associated with overall response rate (r = .50). When selective inclusion and attrition bring providers' response below 50%, it is more likely that selection bias increased beyond a critical level, and conclusions on the comparative performance of such providers may be misleading. CONCLUSIONS: Estimates of provider performance were biased by selection, especially by missing data at posttest. Results on the extent and direction of bias and minimal requirements for response rates to arrive at unbiased performance indicators are discussed.

Treatment results for severe psychiatric illness: which method is best suited to denote the outcome of mental health care?

BACKGROUND: The present study investigates the suitability of various treatment outcome indicators to evaluate performance of mental health institutions that provide care to patients with severe mental illness. Several categorical approaches are compared to a reference indicator (continuous outcome) using pretest-posttest data of the Health of Nation Outcome Scales (HoNOS). METHODS: Data from 10 institutions and 3189 patients were used, comprising outcomes of the first year of treatment by teams providing long-term care. RESULTS: Findings revealed differences between continuous indicators (standardized pre-post difference score ES and ΔT) and categorical indicators (SEM, JTRCI, JTCS, JTRCI&CS, JTrevised) on their ranking of institutions, as well as substantial differences among categorical indicators; the outcome according to the traditional JT approach was most concordant with the continuous outcome indicators. CONCLUSIONS: For research comparing group averages, a continuous outcome indicator such as ES or ΔT is preferred, as this best preserves information from the original variable. Categorical outcomes can be used to illustrate what is accomplished in clinical terms. For categorical outcome, the classical Jacobson-Truax approach is preferred over the more complex method of Parabiaghi et al. with eight outcome categories. The latter may be valuable in clinical practice as it allows for a more detailed characterization of individual patients.

Decisional conflict in mental health care: a cross-sectional study.

PURPOSE: Decisional conflict refers to the degree to which patients are engaged in and feel comfortable about important clinical decisions. Until now, the concept has received little attention in mental health care. We investigate the level of decisional conflict in mental health care and whether this is influenced by socio-demographics, treatment setting, diagnoses, and locus of control. METHODS: Cross-sectional study among 186 patients in Dutch specialist mental health care using the Decisional Conflict Scale, which measures five dimensions of decisional conflict: information, support, clarification of values, certainty, and decisional quality. Descriptive statistics and forward stepwise linear regression analyses were used. RESULTS: Patients report relatively high levels of decisional conflict, especially those with more external locus of control. Having a personality disorder and higher education also increases decisional conflict on the dimensions support and clarification of values, respectively. Less decisional conflict was experienced by patients with psychotic disorders on the dimension certainty and by women on the information domain. CONCLUSIONS: Decisional conflict is common among patients in specialist mental health care and is very useful for assessing the quality of clinical decision making. Measuring decisional conflict and knowledge about influencing factors can be used to improve patients' participation in clinical decision making, adherence to treatment and clinical outcomes.

Standardization of health outcomes assessment for depression and anxiety: recommendations from the ICHOM Depression and Anxiety Working Group.

PURPOSE: National initiatives, such as the UK Improving Access to Psychological Therapies program (IAPT), demonstrate the feasibility of conducting empirical mental health assessments on a large scale, and similar initiatives exist in other countries. However, there is a lack of international consensus on which outcome domains are most salient to monitor treatment progress and how they should be measured. The aim of this project was to propose (1) an essential set of outcome domains relevant across countries and cultures, (2) a set of easily accessible patient-reported instruments, and (3) a psychometric approach to make scores from different instruments comparable. METHODS: Twenty-four experts, including ten health outcomes researchers, ten clinical experts from all continents, two patient advocates, and two ICHOM coordinators worked for seven months in a consensus building exercise to develop recommendations based on existing evidence using a structured consensus-driven modified Delphi technique. RESULTS: The group proposes to combine an assessment of potential outcome predictors at baseline (47 items: demographics, functional, clinical status, etc.), with repeated assessments of disease-specific symptoms during the treatment process (19 items: symptoms, side effects, etc.), and a comprehensive annual assessment of broader treatment outcomes (45 items: remission, absenteeism, etc.). Further, it is suggested reporting disease-specific symptoms for depression and anxiety on a standardized metric to increase comparability with other legacy instruments. All recommended instruments are provided online ( www.ichom.org ). CONCLUSION: An international standard of health outcomes assessment has the potential to improve clinical decision making, enhance health care for the benefit of patients, and facilitate scientific knowledge.

A digital intake approach in specialized mental health care: study protocol of a cluster randomised controlled trial.

BACKGROUND: Enhancing patient participation is becoming increasingly important in mental health care as patients use to have a dependent, inactive role and nonadherence to treatment is a regular problem. Research shows promising results of initiatives stimulating patient participation in partnership with their clinicians. However, few initiatives targeting both patients' and clinicians' behaviour have been evaluated in randomised trials (RCT). Therefore, in GGz Breburg, a specialized mental health institution, a digital intake approach was developed aimed at exploring treatment needs, expectations and preferences of patients intended to prepare patients for the intake consultations. Subsequently, patients and clinicians discuss this information during intake consultations and make shared decisions about options in treatment. The aim of this trial is to test the efficacy of this new digital intake approach facilitated by Routine Outcome Monitoring (ROM), peer support and training of clinicians as compared to the intake as usual. The primary outcome is decisional conflict about choices in treatment. Secondary outcomes focus on patient participation, shared decision making, working alliance, adherence to treatment and clinical outcomes. METHODS: This article presents the study protocol of a cluster-randomised controlled trial in four outpatient departments for adults with depression, anxiety and personality disorders, working in two different regions. Randomisation is done between two similar intake-teams within each department. In the four intervention teams the new intake approach is implemented. The four control teams apply the intake as usual and will implement the new approach after the completion of the study. In total 176 patients are projected to participate in the study. Data collection will be at baseline, and at two weeks and two months after the intake. DISCUSSION: This study will potentially demonstrate the efficacy of the new digital intake approach in mental health care in terms of the primary outcome the degree of decisional conflict about choices in treatment. The findings of this study may contribute to the roll out of such eHealth initiatives fostering patient involvement in decision making about their treatment. TRIAL REGISTRATION: Trial registration: Dutch Trial Register NTR5677 . Registered 17th January 2016.