Methodological and Statistical Practices of Using Symptom Networks to Evaluate Mental Health Interventions: A Review and Reflections.

The network approach to psychopathology, which assesses associations between individual symptoms, has recently been applied to evaluate treatments for mental disorders. While various options for conducting network analyses in intervention research exist, an overview and an evaluation of the various approaches are currently missing. Therefore, we conducted a review on network analyses in intervention research. Studies were included if they constructed a symptom network, analyzed data that were collected before, during or after treatment of a mental disorder, and yielded information about the treatment effect. The 56 included studies were reviewed regarding their methodological and analytic strategies. About half of the studies based on data from randomized trials conducted a network intervention analysis, while the other half compared networks between treatment groups. The majority of studies estimated cross-sectional networks, even when repeated measures were available. All but five studies investigated networks on the group level. This review highlights that current methodological practices limit the information that can be gained through network analyses in intervention research. We discuss the strength and limitations of certain methodological and analytic strategies and propose that further work is needed to use the full potential of the network approach in intervention research.

Effects of a shared decision-making implementation programme on patient-centred communication in oncology-Secondary analysis of a randomised controlled trial.

BACKGROUND: There is a need for better implementation of patient-centred (PC) communication and shared decision-making (SDM) in routine cancer care. OBJECTIVE: The aim of this study was to assess whether a programme to implement SDM in oncology had effects on PC communication in clinical encounters. DESIGN: This study constitutes a secondary analysis of data derived from an implementation trial applying a stepped wedge design that, among other strategies, incorporated training and coaching to enhance the PC communication skills of physicians. SETTING AND PARTICIPANTS: We analysed audio recordings of clinical encounters collected in three departments of a comprehensive cancer centre in Germany before and after rolling out the implementation programme. MAIN VARIABLES STUDIED: We assessed the PC communication skills of physicians. MAIN OUTCOME MEASURES: Each recording was rated by two researchers using the German version of the Four Habits Coding Scheme (4HCS), an observer-based measure of PC communication. Interrater reliability of the outcome measure was acceptable but moderate. Demographic data of patients participating in audio recordings were analysed. METHODS: Data were analysed using descriptive statistics and linear mixed-effects models. RESULTS: In total, 146 encounters, 74 before and 72 after implementation, were evaluated. The mean age of patients was 57.1 years (SD = 13.8), 70.3% were female, the largest portion of patients had medium formal education (32.4%) and were (self-) employed (37.8%). No statistically significant effect of the implementation programme on the physicians' PC communication skills was found. DISCUSSION: The results indicate that the investigated programme to implement SDM in oncology, including training and coaching, had no effects on PC communication in clinical encounters. These results are in contrast to other studies that report the effects of specific training or coaching on PC communication. Reasons for the lack of effect include the short duration of our training compared to other studies, limited reliability and moderate interrater reliability of the 4HCS scale, limited reach of the intervention programme as well as the inclusion of physicians regardless of their exposure to the interventions. CONCLUSION: Further research is needed to develop implementation strategies that improve physicians' PC communication skills. PATIENT CONTRIBUTION: Data on patients and clinical encounters with patients and physicians were analysed. There was no other patient or public involvement.

Trajectories of depressive and anxiety symptoms and associated risk factors during the COVID-19 pandemic in Germany: A longitudinal cohort study.

BACKGROUND: Most COVID-19-related mental health research focused on average levels of mental health parameters in the general population. However, considering heterogeneous groups and their long-term responses could deepen our understanding of mental health during community crises. This four-wave study aimed to (1) identify subgroups with different trajectories of depressive and anxiety symptoms in the German general population, and (2) investigate associated risk factors. METHODS: We analyzed self-report data from N = 1257 German adults participating in a European cohort study, assessed in summer 2020 (T1), and at 6 (T2), 12 (T3), and 30 months (T4). Depressive and anxiety symptoms were measured using the PHQ-4. Sociodemographic, health-related, and pandemic-related variables were assessed at baseline. We applied growth mixture modeling to identify subgroups of symptom trajectories and conducted multinomial logistic regression to examine factors associated with class membership. RESULTS: We identified six symptom trajectories: Low-stable (n = 971, 77.2 %), Continuous deterioration (n = 30, 2.4 %), Transient deterioration (n = 75, 6.0 %), Continuous improvement (n = 97, 7.7 %), Transient improvement (n = 38, 3.0 %) and Chronicity (n = 46, 3.7 %). Age, education, work status, mental health diagnoses, self-reported health, and pandemic-related news consumption were significantly associated with subgroup membership. LIMITATIONS: The generalizability of the study is constrained by an unrepresentative sampling method, a notable dropout rate, and limited consideration of risk factors. CONCLUSION: Most people experienced low symptoms or improvement during the pandemic, while others experienced chronic or transient symptoms. Specific risk factors were associated with these trajectories, revealing nuanced mental health dynamics.

Symptom-specific improvement across therapies and their putative mediators: A mediation network intervention analysis.

OBJECTIVE: We evaluated differential treatment effects on specific symptoms and their mediators for Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and Supportive Psychotherapy (SP) in persistently depressed patients. METHOD: We conducted a Bayesian mediation network intervention analysis with data from a randomized controlled trial comparing CBASP and SP. Three networks were calculated to investigate (1) differential treatment effects on specific symptoms, (2) differential treatment effects on the potential mediators interpersonal problems and social functioning, and (3) associations between change in symptoms and change in the potential mediators. RESULTS: First, we found no evidence that CBASP more strongly improves most depressive symptoms specifically, except minimal evidence of symptom-specific effects on sleeping problems and self-esteem. Second, no and minimal evidence for differential treatment effects on interpersonal problems and social functioning was shown, respectively. Third, interpersonal problems and social functioning were strongly related to depressive symptoms. CONCLUSION: While CBASP showed superior treatment effects for overall symptom severity, this treatment might not be superior in improving specific symptoms and the potential mediators interpersonal problems and social functioning. Still, interpersonal problems and social functioning seem to play an important role for depression symptoms. Future research needs to further investigate potential working mechanisms of CBASP.Trial registration: ClinicalTrials.gov identifier: NCT00970437.

Implementation of Hospital Mortality Reviews: A Systematic Review.

OBJECTIVE: The objective of this study was to give an overview of the published literature on the implementation of mortality reviews in hospital settings. METHODS: We searched MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, and Web of Science databases up to August 2022 for studies describing implementation or results of implementation of hospital mortality reviews published in English or German. Quality appraisal was conducted using the Mixed Methods Appraisal Tool. Two independent reviewers screened the title/abstract and the full text of potentially relevant records and extracted data using a standardized form. We synthesized and integrated quantitative and qualitative findings narratively following a convergent segregated mixed methods review approach. RESULTS: From the 884 studies screened, 18 publications met all inclusion criteria and were included in the review. Observed mortality rates reported in 10 publications ranged from 0.4% to 7.8%. In 10 publications, mortality reviews were implemented as a multistep process. In 7 publications, structured mortality review meetings were implemented. Key aspects of success in developing and implementing mortality reviews in hospitals were involvement of multiple stakeholders, providing enough resources for included staff, and constant monitoring and adaption of the processes. CONCLUSIONS: Although awareness of hospital mortality reviews has increased over the last decades, published research in this area is still rare. Our results may inform hospitals considering development and implementation of mortality reviews by providing key aspects and lessons learned from existing implementation experiences.

Evaluation of a patient-centered communication skills training for nurses (KOMPAT): study protocol of a randomized controlled trial.

BACKGROUND: To ensure high quality of nurses' communication as part of patient-centered care, training of communication skills is essential. Previous studies indicate that communication skills trainings can improve communication skills of nurses and have a positive effect on emotional and psychological burden. However, most show methodological limitations, are not specifically developed for nurses or were developed for oncological setting only. METHODS: This study aims to evaluate the effectiveness of a needs-based communication skills training for nursing professionals and to derive indications for future implementation. A two-armed randomized controlled trial including components from both effectiveness and implementation research will be applied. Additionally, a comprehensive process evaluation will be carried out to derive indications for future implementation. Nurses (n=180) of a university medical center in Germany will be randomized to intervention or waitlist-control group. The intervention was developed based on the wishes and needs of nurses, previously assessed via interviews and focus groups. Outcomes to measure effectiveness were selected based on Kirkpatrick's four levels of training evaluation and will be assessed at baseline, post-training and at 4-weeks follow-up. Primary outcome will be nurses' self-reported self-efficacy regarding communication skills. Secondary outcomes include nurses' communication skills assessed via standardized patient assessment, knowledge about patient-centered communication, mental and work-related burden, and participants' satisfaction with training. DISCUSSION: To our knowledge, this is the first study systematically evaluating the effectiveness of a patient-centered communication skills training for nursing professionals in Germany. Results will yield insight whether a needs-based intervention can improve nurses' self-efficacy regarding communication skills and other secondary outcomes. TRIAL REGISTRATION: Clinical trial registration number: NCT05700929, trial register: ClinicalTrials.gov (date of registration: 16 November 2022).

Optimizing treatment expectations and decision making through informed consent for psychotherapy: A randomized controlled trial.

OBJECTIVE: The objective of this research was to determine the efficacy and safety of an optimized informed consent (OIC) consultation for psychotherapy. METHOD: We performed a randomized controlled superiority online trial involving 2 weeks of treatment and 3 months of follow-up. One hundred twenty-two adults with mental disorders confirmed by structured interview currently neither in out- nor inpatient psychotherapy (mean age: 32, gender identity: 51.6% female, 1.6% diverse), were randomized. Participants received an information brochure about psychotherapy for self-study (treatment as usual [TAU]; n = 61) or TAU plus a one-session OIC utilizing expectation management, contextualization, framing, and shared decision making (n = 61). The primary outcome was treatment expectations at 2-week follow-up. RESULTS: At 2-week follow-up, participants receiving OIC showed more positive treatment expectations compared to those receiving TAU only (mean difference: 0.70, 95% CI [0.36, 1.04]) with a medium effect size (d = 0.73). Likewise, OIC positively influenced motivation (d = 0.74) and adherence intention (d = 0.46). OIC entailed large effects on reduction of decisional conflict (d = 0.91) and increase of knowledge (d = 0.93). Participants receiving OIC showed higher capacity to consent to treatment (d = 0.63) and higher satisfaction with received information (d = 1.34) compared to TAU. No statistically significant group differences resulted for expected adverse effects of psychotherapy. Results were maintained at 3-month follow-up. Data sets for n = 10 cases (8.2%) were missing (postassessment n = 4, 2-week n = 6, 3-month follow-up n = 8). CONCLUSIONS: Explaining to patients how psychotherapy works via a short consultation was effective in strengthening treatment expectations and decision making in a nonharmful way. Further trials clarifying whether this effectively translates to better treatment outcomes are required. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Longitudinal Clusters of Long-Term Trajectories in Patients with Early-Onset Chronic Depression: 2 Years of Naturalistic Follow-Up after Extensive Psychological Treatment.

INTRODUCTION: In clinical trials, mostly group-level treatment effects of repeated cross-sectional measures are analyzed. However, substantial heterogeneity regarding individual symptom profiles and the variability of treatment effects are often neglected, especially over the long-term course. To provide effective personalized treatments, investigations of these characteristics are urgently needed. METHODS: Depression severity ratings over 104 weeks of follow-up after year-long treatment with the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) or Supportive Psychotherapy (SP) were analyzed. Longitudinal cluster analysis and multinomial logistic regression analysis were conducted to investigate intraindividual trajectories from one of the largest psychotherapy trials in early-onset chronic depression. RESULTS: Two-year post-study-treatment trajectories of N = 188 patients with early-onset chronic depression were grouped into four prototypical clusters. Overall, 16.0% of patients remitted (cluster 1) and most of them did not receive any treatment during the 2-year follow-up. However, 84.0% of patients continued to experience subthreshold (37.2% cluster 2) or major depressive symptoms (46.8% clusters 3-4) and spent on average more than half of the follow-up in pharmacological and psychological treatment. Hierarchical regression analysis indicated that previous study treatment with CBASP or SP did not significantly predict cluster allocation, while baseline variables accounted for a large proportion of explained variance (R2 N = 0.64). CONCLUSION: While some patients experienced stable remission over 2 years of follow-up, the majority of patients experienced subthreshold or major depressive symptoms regardless of former study treatment with CBASP or SP. This calls for a long-term perspective implementing staging and innovative treatment approaches such as the sequential model or modular psychotherapy.

Effectiveness and feasibility of an interprofessional training program to improve patient safety-A cluster-randomized controlled pilot study.

Introduction: Interprofessional healthcare teams are important actors in improving patient safety. To train these teams, an interprofessional training program (IPTP) with two interventions (eLearning and blended learning) was developed to cover key areas of patient safety using innovative adult learning methods. The aims of this study were to pilot test IPTP regarding its effectiveness and feasibility. The trial was registered with DRKS-ID: DRKS00012818. Methods: The design of our study included both a pilot investigation of the effectiveness of the two interventions (eLearning and blended learning) and testing their feasibility (effectiveness-implementation hybrid design). For testing the effectiveness, a multi-center cluster-randomized controlled study with a three-arm design [intervention group 1 (IG1): eLearning vs. intervention group 2 (IG2)]: blended learning (eLearning plus interprofessional in-person training) vs. waiting control group (WCG) and three data collection periods (pre-intervention, 12 weeks post-intervention, and 24 weeks follow-up) was conducted in 39 hospital wards. Linear mixed models were used for the data analysis. The feasibility of IPTP was examined in 10 hospital wards (IG1) and in nine hospital wards (IG2) using questionnaires (formative evaluation) and problem-focused interviews with 10% of the participants in the two intervention groups. The collected data were analyzed in a descriptive exploratory manner. Results: Pilot testing of the effectiveness of the two interventions (eLearning and blended learning) showed no consistent differences between groups or a clear pattern in the different outcomes (safety-related behaviors in the fields of teamwork, error management, patient involvement, and subjectively perceived patient safety). Feasibility checks of the interventions showed that participants used eLearning for knowledge activation and self-reflection. However, there were many barriers to participating in eLearning, for example, lack of time or access to computers at the ward. With regard to in-person training, participants stated that the training content sensitized them to patient-safety-related issues in their everyday work, and that awareness of patient safety increased. Discussion: Although the interventions were judged to be feasible, no consistent effects were observed. A possible explanation is that the duration of training and the recurrence rate may have been insufficient. Another conceivable explanation would be that participants became more sensitive to patient safety-critical situations due to their knowledge acquired through the IPTP; therefore, their assessment post-intervention was more critical than before. In addition, the participants reported high pre-measurement outcomes. Future studies should examine the evidence of the intervention within a confirmatory study after adapting it based on the results obtained.

Factorial, Construct, and Predictive Validity of the Motivation for Treatment Scale in Alcohol-Use Disorder Withdrawal Treatment.

INTRODUCTION: The aim of the present study was to examine for the first time the factorial, construct, and predictive validity of the motivation for treatment (MfT) scale in a cohort of patients undergoing inpatient-qualified alcohol withdrawal treatment with the goal of referring patients to further treatment. The MfT scale has previously been evaluated in different settings of substance abuse treatment, revealing factorial ambiguity. To the best of our knowledge, the present study is the first study that conducted comprehensive factor analyses versus separate analyses of the factors conducted in prior studies in order to clarify the aforementioned factorial ambiguity. METHODS: A total of 249 patients (mean age 45.2 years (SD = 10.3); 34.4% females) with alcohol dependence were assessed. Data were obtained from four inpatient clinics specialized in qualified alcohol withdrawal treatment in Germany. First, confirmatory factor analyses were carried out to examine the fit of the four models discussed in the literature. Second, an exploratory factor analysis was conducted. Correlations of the new factors with other motivational constructs and referral to a subsequent treatment were investigated as measures of construct and predictive validity. RESULTS: None of the four models showed an acceptable fit to the data in confirmatory analyses. The exploratory analysis suggested to eliminate seven items because of inappropriate factor loadings and resulted in a shortened MfT scale, which consists of three factors based on 17 items. For the latent variables "problem recognition," "desire for help," and "treatment readiness," satisfactory composite reliability was found with 0.82, 0.80, and 0.78, respectively. Evidence for predictive validity was found in the correlation between "treatment readiness" and referral to a subsequent treatment. DISCUSSION/CONCLUSION: The new shortened MfT scale exhibited remarkable parsimony, which is desirable in settings such as withdrawal treatment, where patients frequently are cognitively or physically impaired. Despite its briefness, construct and predictive validity were better than in the original version of the MfT scale. The factorial validity of the suggested scale needs to be corroborated in further research.

Correction: Application of the skills network approach to measure physician competence in shared decision making based on self-assessment.

[This corrects the article DOI: 10.1371/journal.pone.0282283.].

Implications of the Network Theory for the Treatment of Mental Disorders: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Conceptualizing mental disorders as latent entities has been challenged by the network theory of mental disorders, which states that psychological problems are constituted by a network of mutually interacting symptoms. While the implications of the network approach for planning and evaluating treatments have been intensively discussed, empirical support for the claims of the network theory regarding treatment effects is lacking. Objective: To assess the extent to which specific hypotheses derived from the network theory regarding the (interindividual) changeability of symptom dynamics in response to treatment align with empirical data. Design, Setting, and Participants: This secondary analysis entails data from a multisite randomized clinical trial, in which 254 patients with chronic depression reported on their depressive symptoms at every treatment session. Data collection was conducted between March 5, 2010, and October 14, 2013, and this analysis was conducted between November 1, 2021, and May 31, 2022. Intervention: Thirty-two sessions of either disorder-specific or nonspecific psychotherapy for chronic depression. Main Outcomes and Measures: Longitudinal associations of depressive symptoms with each other and change of these associations through treatment estimated by a time-varying longitudinal network model. Results: In a sample of 254 participants (166 [65.4%] women; mean [SD] age, 44.9 [11.9] years), symptom interactions changed through treatment, and this change varied across treatments and individuals. The mean absolute (ie, valence-ignorant) strength of symptom interactions (logarithmic odds ratio scale) increased from 0.40 (95% CI, 0.36-0.44) to 0.60 (95% CI, 0.52-0.70) during nonspecific psychotherapy and to 0.56 (95% CI, 0.48-0.64) during disorder-specific psychotherapy. In contrast, the mean raw (ie, valence-sensitive) strength of symptom interactions decreased from 0.32 (95% CI, 0.28-0.36) to 0.26 (95% CI, 0.20-0.32) and to 0.09 (95% CI, 0.02-0.16), respectively. Changing symptom severity could be explained to a large extent by symptom interactions. Conclusions and Relevance: These findings suggest that specific treatment-related hypotheses of the network theory align well with empirical data. Conceptualizing mental disorders as symptom networks and treatments as measures that aim to change these networks is expected to give further insights into the working mechanisms of mental health treatments, leading to the improvement of current and the development of new treatments. Trial Registration: ClinicalTrials.gov Identifier: NCT00970437.

A Statistical Definition of Epidemic Waves.

The timely identification of expected surges of cases during infectious disease epidemics is essential for allocating resources and preparing interventions. Failing to detect critical phases in time may lead to delayed implementation of interventions and have serious consequences. This study describes a simple way to evaluate whether an epidemic wave is likely to be present based solely on daily new case count data. The proposed measure compares two models that assume exponential or linear dynamics, respectively. The most important assumption of this approach is that epidemic waves are characterized rather by exponential than linear growth in the daily number of new cases. Technically, the coefficient of determination of two regression analyses is used to approximate a Bayes factor, which quantifies the support for the exponential over the linear model and can be used for epidemic wave detection. The trajectory of the coronavirus epidemic in three countries is analyzed and discussed for illustration. The proposed measure detects epidemic waves at an early stage, which are otherwise visible only by inspecting the development of case count data retrospectively. Major limitations include missing evidence on generalizability and performance compared to other methods. Nevertheless, the outlined approach may inform public health decision-making and serve as a starting point for scientific discussions on epidemic waves.

Predictors of Discharge Destination After Stroke.

BACKGROUND: Determining the discharge destination after acute stroke care is important to prevent long-term disabilities and improve cost efficiency. OBJECTIVE: The aim of this study was to investigate where stroke patients are discharged to after acute treatment and to identify personal, social, stroke-related, and clinical predictors of discharge destination. METHODS: The present study included a secondary exploratory analysis of a prospective observational study. Patients with acute ischemic stroke, transient ischemic attack, or intracerebral hemorrhage were recruited consecutively over a 15-month period. A hierarchical multinomial logistic regression was performed to identify predictors of the primary outcome of discharge destination. RESULTS: We included 1026 stroke patients (48.7% female) with a mean age of 73.3 years (standard deviation 12.9 years) in the analysis. Overall, 55% of the patients were discharged home, 33% to a rehabilitation center, 3% to a residential facility, and 8% to another acute care hospital. Predictors that statistically significantly influenced the odds of the discharge destination were age, living situation pre-stroke, living location pre-stroke, stroke type, stroke severity, treatment type, and length of stay. Higher stroke severity was associated with discharge to all four inpatient facilities. CONCLUSIONS: In line with previous research, predictors such as stroke severity and living situation pre-stroke significantly influenced the odds of the discharge destination. In contrast, pre-existing conditions and functional impairment pre-stroke had no significant impact on the primary outcome. This discrepancy could be due to a rather functional study sample before stroke and the use of clinical and patient-reported outcome measures.

Application of the skills network approach to measure physician competence in shared decision making based on self-assessment.

Several approaches to and definitions of 'shared decision making' (SDM) exist, which makes measurement challenging. Recently, a skills network approach was proposed, which conceptualizes SDM competence as an organized network of interacting SDM skills. With this approach, it was possible to accurately predict observer-rated SDM competence of physicians from the patients' assessments of the physician's SDM skills. The aim of this study was to assess whether using the skills network approach allows to predict observer-rated SDM competence of physicians from their self-reported SDM skills. We conducted a secondary data analysis of an observational study, in which outpatient care physicians rated their use of SDM skills with the physician version of the 9-item Shared Decision Making Questionnaire (SDM-Q-Doc) during consultations with chronically ill adult patients. Based on the estimated association of each skill with all other skills, an SDM skills network for each physician was constructed. Network parameters were used to predict observer-rated SDM competence, which was determined from audio-recorded consultations using three widely used measures (OPTION-12, OPTION-5, Four Habits Coding Scheme). In our study, 28 physicians rated consultations with 308 patients. The skill 'deliberating the decision' was central in the population skills network averaged across physicians. The correlation between parameters of the skills networks and observer-rated competence ranged from 0.65 to 0.82 across analyses. The use and connectedness of the skill 'eliciting treatment preference of the patient' showed the strongest unique association with observer-rated competence. Thus, we found evidence that processing SDM skill ratings from the physicians' perspective according to the skills network approach offers new theoretically and empirically grounded opportunities for the assessment of SDM competence. A feasible and robust measurement of SDM competence is essential for research on SDM and can be applied for evaluating SDM competence during medical education, for training evaluation, and for quality management purposes. [A plain language summary of the study is available at https://osf.io/3wy4v.].

Effectiveness of a coordinated ambulatory care program for patients with mental disorders or multiple sclerosis: results of a prospective non-randomized controlled trial in South Germany.

Background: The Psychiatry, Neurology, Psychosomatics and Psychotherapy (PNP) program of the German statutory health insurance AOK BW promotes coordinated and evidence-based specialist care with the aim of providing individualized, guideline-based outpatient care, strengthening the collaboration between health care providers, as well as reducing care costs. The purpose of this study was to evaluate its effectiveness regarding patient-reported outcomes compared to the less specialized general practitioner program (GP) and usual care (UC). Materials and methods: AOK insured patients, who were on sick leave due to a mental disorder (affective disorder, anxiety disorder, adjustment disorder, somatoform disorder, alcohol abuse disorder, schizophrenia) or multiple sclerosis were included in the prospective non-randomized controlled study. All patients either participated in the PNP program (intervention group, IG-PNP), the general practitioner program (control group, CG-GP) or usual care (control group, CG-UC). Entropy balancing was used to adjust for baseline imbalance between groups. Primary outcome was health-related quality of life, assessed by the Short-form health survey (SF-36) 12 months after diagnosis. Secondary outcomes included symptom severity, functional health, and treatment satisfaction. Results: Of the 14,483 insured patients who were contacted, 1,104 patients participated at baseline and 725 at follow-up. The adjusted mean differences of SF-36 sum score did not significantly differ between groups: -1.89 (95%-CI = -4.60; 0.81, p = 0.170) between IG-PNP and CG-GP, and -1.42 (95%-CI = -4.05; 1.22, p = 0.293) between PNP and CG-UC. The adjusted mean differences of secondary outcomes did not differ between groups, except for a slightly higher increase of functional health in CG-UC. Conclusion: We found no evidence that the PNP program is superior to the GP program or to usual care in terms of patient-reported outcomes or treatment satisfaction. The results are limited by the low response rate. Accordingly, future studies should strive for more representative samples. To improve the program, an integration of further collaborative care elements and guideline recommendations might be useful. Clinical trial registration: DRKS (German Clinical Trials Register https://drks.de/search/en); identifier (DRKS00013114).

Higher comorbidity burden is associated with lower self-reported quality of life after stroke.

Introduction: This study assesses the association of comorbidity burden and polypharmacy with self-reported quality of life after stroke. Patients and methods: We performed a post-hoc analysis of a prospective, single-center, observational study of outcome evaluation by patient-reported outcome measures in stroke clinical practice. Consecutive patients with acute ischemic stroke (AIS) were enrolled and self-reported health-related quality of life (HrQoL) was assessed 90 days after acute stroke using the Patient-reported Outcomes Measurement Information System 10-Question Short-Form (PROMIS-10). Comorbidities at baseline were assessed by the Charlson Comorbidity Index (CCI). Polypharmacy was defined as medication intake of ≥5 at baseline. We used linear regression analysis to study the association of CCI, polypharmacy and other clinical covariates with HrQoL after stroke. Results: Of 781 patients (median age 76 years, 48.4% female) enrolled, 30.2% had a CCI Score ≥2, and 31.5% presented with polypharmacy. At follow up, 71 (9.1%) had died. In 409 (52.4%) reached for outcome evaluation, Global Physical Health T-Score was 43.8 ± 10 and Global Mental Health T-Score was 43.5 ± 8.76, indicating lower HrQoL than the average population. A CCI Score ≥2, higher NIHSS Score, female sex, dependency on others for dressing, toileting and mobility before index stroke, atrial fibrillation and hypertension were independent predictors of worse physical and mental health outcomes, while polypharmacy was not. Conclusion: In patients with AIS, high comorbidity burden and polypharmacy are frequent. Comorbidity burden at admission is independently associated with worse self-reported physical and mental health three months after stroke.

Psychomotor development in two-year-old Ivorian and Ghanaian children - Psychometric properties of the Kilifi Developmental Inventory.

The assessment of psychomotor development in young children from low- and middle-income countries is impeded due to the lack of tools specifically designed for these resource-constrained contexts. This cross-sectional study aimed at analysing the measurement properties of the Kilifi Developmental Inventory (KDI) in two-year-old children. We administered the KDI to 289 children from Côte d'Ivoire and 230 children from Ghana. The postulated internal structure with two first-order latent variables (locomotor performance and eye-hand coordination) that loaded on a second-order latent variable (psychomotor functioning) was supported. The reliability of most factors and scales was sufficient. Interrater reliability of most items was acceptable. Correlations were weak between the scale scores and age and gender, respectively. The findings are limited by the restricted age range of the sample. Overall, the KDI showed promising measurement properties for the assessment of psychomotor performance in children from sub-Saharan countries.

Development and content validity of the Experienced Patient-Centeredness Questionnaire (EPAT)-A best practice example for generating patient-reported measures from qualitative data.

INTRODUCTION: To effectively foster patient-centeredness (PC), it is crucial to measure its implementation. So far, there is no German measure to assess PC comprehensively. The aim of this study is to develop and select items for the Experienced Patient-Centeredness (EPAT) Questionnaire, a patient-reported experience measure (PREM). The EPAT intends to assess PC from the perspective of adult patients treated for different chronic diseases in inpatient and outpatient settings in Germany. Furthermore, we aim at providing a best-practice example for developing PREMs from qualitative data. METHODS: The development process comprised a three-phase mixed-method design: (1) preparation, (2) item generation and (3) item selection and testing of content validity. We generated items using qualitative content analysis based on information from focus groups, key informant interviews and literature search. We selected items using relevance rating and cognitive interviews. Participants were patients from four chronic disease groups (cancer, cardiovascular disease, mental disorder, musculoskeletal disorder) and healthcare experts (e.g., clinicians, researchers, patient representatives). RESULTS: We conducted six focus groups with a total of 40 patients, key informant interviews with 10 experts and identified 48 PREMs from international literature. After team discussion, we reached a preliminary pool of 152 items. We conducted a relevance rating with 32 experts and 34 cognitive interviews with 21 patients. We selected 125 items assessing 16 dimensions of PC and showed high relevance and comprehensibility. CONCLUSIONS: The EPAT questionnaire is currently undergoing psychometric testing. The transparent step-by-step report provides a best practice example that other researchers may consider for developing PREMs. Integrating literature and experts with a strong focus on patient feedback ensured good content validity. The EPAT questionnaire will be helpful in assessing PC in routine clinical practice in inpatient and outpatient settings for research and quality improvement. PATIENT OR PUBLIC CONTRIBUTION: Patients were not involved as active members of the research team. While developing the funding proposal, we informally reached out to several patient organizations who all gave us positive feedback on the study aims, thereby confirming their relevance. Those patient organizations endorsed the funding proposal with formal letters of support and supported recruitment by disseminating advertisements for study participation.