Clinical effectiveness of patient-targeted feedback following depression screening in general practice (GET.FEEDBACK.GP): an investigator-initiated, prospective, multicentre, three-arm, observer-blinded, randomised controlled trial in Germany.

BACKGROUND: Screening for depression in primary care alone is not sufficient to improve clinical outcomes. However, targeted feedback of the screening results to patients might result in beneficial effects. The GET.FEEDBACK.GP trial investigated whether targeted feedback of the depression screening result to patients, in addition to feedback to general practitioners (GPs), leads to greater reductions in depression severity than GP feedback alone or no feedback. METHODS: The GET.FEEDBACK.GP trial was an investigator-initiated, multicentre, three-arm, observer-blinded, randomised controlled trial. Depression screening was conducted electronically using the Patient Health Questionnaire-9 (PHQ-9) in 64 GP practices across five regions in Germany while patients were waiting to see their GP. Currently undiagnosed patients (aged ≥18 years) who screened positive for depression (PHQ-9 score ≥10), were proficient in the German language, and had a personal consultation with a GP were randomly assigned (1:1:1) into a group that received no feedback on their depression screening result, a group in which only the GP received feedback, or a group in which both GP and patient received feedback. Randomisation was stratified by treating GP and PHQ-9 depression severity. Trial staff were masked to patient enrolment and study group allocation and GPs were masked to the feedback recieved by the patient. Written feedback, including the screening result and information on depression, was provided to the relevant groups before the consultation. The primary outcome was PHQ-9-measured depression severity at 6 months after randomisation. An intention-to-treat analysis was conducted for patients who had at least one follow-up visit. This study is registered at ClinicalTrials.gov (NCT03988985) and is complete. FINDINGS: Between July 17, 2019, and Jan 31, 2022, 25 279 patients were approached for eligibility screening, 17 150 were excluded, and 8129 patients completed screening, of whom 1030 (12·7%) screened positive for depression. 344 patients were randomly assigned to receive no feedback, 344 were assigned to receive GP-targeted feedback, and 339 were assigned to receive GP-targeted plus patient-targeted feedback. 252 (73%) patients in the no feedback group, 252 (73%) in the GP-targeted feedback group, and 256 (76%) in the GP-targeted and patient-targeted feedback group were included in the analysis of the primary outcome at 6 months, which reflected a follow-up rate of 74%. Gender was reported as female by 637 (62·1%) of 1025 participants, male by 384 (37·5%), and diverse by four (0·4%). 169 (16%) of 1026 patients with available migration data had a migration background. Mean age was 39·5 years (SD 15·2). PHQ-9 scores improved for each group between baseline and 6 months by -4·15 (95% CI -4·99 to -3·30) in the no feedback group, -4·19 (-5·04 to -3·33) in the GP feedback group, and -4·91 (-5·76 to -4·07) in the GP plus patient feedback group, with no significant difference between the three groups (global p=0·13). The difference in PHQ-9 scores when comparing the GP plus patient feedback group with the no feedback group was -0·77 (-1·60 to 0·07, d=-0·16) and when comparing with the GP-only feedback group was -0·73 (-1·56 to 0·11, d=-0·15). No increase in suicidality was observed as an adverse event in either group. INTERPRETATION: Providing targeted feedback to patients and GPs after depression screening does not significantly reduce depression severity compared with GP feedback alone or no feedback. Further research is required to investigate the potential specific effectiveness of depression screening with systematic feedback for selected subgroups. FUNDING: German Innovation Fund. TRANSLATION: For the German translation of the abstract see Supplementary Materials section.

Measuring patient activation: the utility of the Patient Activation Measure administered in an interview setting.

BACKGROUND: Patient activation is an emerging field in healthcare research concerning knowledge, skills, and confidence of patients in managing their health. This is particularly important for patients with chronic diseases, who often require more complex care management and self-care skills. However, due to temporary or longer-lasting visual impairments, certain patient groups cannot answer a questionnaire independently. The main objective is to investigate the psychometric properties of the German Patient Activation Measure® (PAM) survey in an everyday clinical setting where it has to be read aloud. METHODS: Outpatients with macular edema participated in this questionnaire-based cross-sectional study. The study assessed patient activation by the PAM® survey, self-rated health, self-efficacy, quality of life, and general mood. Interviewers read questionnaires aloud to patients. Psychometric properties of the PAM® survey were investigated by item response theory (IRT), Cronbach's α and trait-trait correlations. RESULTS: The analysis included N = 554 patients. Median age was 69 (IQR 62.0-76.0) years and mean overall activation score 74.1 (SD 13.7). All items showed ceiling effects. Empirical reliability from the IRT model and Cronbach's α were 0.75. The PAM® survey showed a Spearman correlation of 0.54 with self-efficacy, 0.51 with quality of life and 0.34 with general mood. CONCLUSION: The read-aloud PAM® survey has been shown to provide to adequate measurement precision and convergent validity to be used as a screening tool in an everyday clinical setting. Objective assessment in an interview setting with the PAM® survey is possible. PAM® items are good in distinguishing lower to middle activated patients, but not patients with high activation. Further, issues with structural validity need more investigation.

Patient information, communication and competence empowerment in oncology: Results and learnings from the PIKKO study.

PURPOSE: Many concepts for accompanying and supporting cancer patients exist and have been studied over time. One of them was PIKKO (a German acronym for "Patient information, communication and competence empowerment in oncology"), which combined a patient navigator, socio-legal and psychological counseling (with psychooncologists), courses dealing with various supportive aspects, and a knowledge database with validated and easy-to-understand disease-related information. The aim was to increase the patients' health-related quality of life (HRQoL), self-efficacy as well as health literacy and to reduce psychological complaints such as depression and anxiety. METHODS: To this purpose, an intervention group was given full access to the modules in addition to treatment as usual, while a control group received only treatment as usual. Over twelve months, each group was surveyed up to five times. Measurements were taken using the SF12, PHQ-9, GAD, GSE, and HLS-EU-Q47. RESULTS: No significant differences were found in scores on the mentioned metrics. However, each module was used many times and rated positively by the patients. Further analyses showed a tendency higher score in health literacy with higher intensity of use of the database and higher score in mental HRQoL with higher intensity of use of counseling. CONCLUSION: The study was affected by several limitations. A lack of randomization, difficulties in recruiting the control group, a heterogeneous sample, and the COVID-19 lockdown influenced the results. Nevertheless, the results show that the PIKKO support was appreciated by the patients and the lack of measurable effects was rather due to the mentioned limitations than to the PIKKO intervention. TRIAL REGISTRATION: This study was retrospectively registered in the German Clinical Trial Register under DRKS00016703 (21.02.2019, retrospectively registered). https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00016703.

Attachment and patient activation as predictors of the interest and use of telemedical health applications -results of an observational study in primary health care.

BACKGROUND: Telemedicine applications are becoming more accepted and offer great potential to support physicians and patients. However, there is an increasing need for research, especially in personal predictors that determine the interest and use of telemedicine and e-health applications. This study aims to identify if attachment and patient activation are potential predictors of the interest in and the use of e-health applications in primary care patients. METHODS: We used data from the cross-sectional observational Weimar TelMed study on 192 patients treated by general practitioners from a practice of family medicine in Thuringia, the middle of Germany. The adult attachment was measured using the ECR-RD12 and patient activation with the PAM-13D. Multiple regression analysis by the General Linear Model was used to evaluate the association between attachment, patient activation, and interest in and use of e-health applications. RESULTS: Patient activation was associated with a higher interest in e-health care. The attachment dimension avoidance was a potential predictor of interest in e-health and e-health-care use. CONCLUSION: Adult attachment is an essential predictor of different ways of healthcare use. While avoidant patients evade contact with general practitioners, self-determined access via e-health seems to improve the health care of these patients. A personalized view might be a basis for the evaluation of individual approaches in Primary Care.

Factor Structure and Convergent Validity of the Short Version of the Bielefeld Partnership Expectations Questionnaire in Patients With Anxiety Disorder and Healthy Controls.

The short version of the Bielefeld Partnership Expectations Questionnaire (BPEQ-12) assesses the partner-related attachment dimensions fear of rejection, readiness for self-disclosure, and conscious need for care. The presented study investigated the factor structure in two samples and evaluated the convergent validity of scales. The sample included N = 175 patients with panic disorder and/or agoraphobia and N = 143 healthy controls. Besides, the BPEQ, the Experiences in Close Relationships Questionnaire (ECR), and the Brief Symptom Inventory (BSI) were assessed as well, and the Adult Attachment Prototype Rating (AAPR) was conducted. A confirmatory factor analysis of the three factor model (using a WLSMV estimator) revealed an acceptable model fit for the entire sample, patients and controls in terms of low RMSEA and SRMR (< 0.08) and high CFI and TLI (> 0.95). We found metric, scalar, and strict measurement invariance for the presence of anxiety disorder (ΔCFI ≤ -0.01 and ΔRMSEA ≥ 0.01). However, only for fear of rejection and readiness for self-disclosure the reliability was acceptable (Cronbach's α > 0.7), and convergent validity in terms of large correlations (r > 0.7) with the ECR scales was found in both samples. The scale conscious need for care had a questionable reliability (Cronbach's α > 0.6) and correlated only slightly with ECR-R scales. We conclude that fear of rejection and readiness for self-disclosure of the BPEQ-12 are reliable and valid scales for measuring partner-related attachment in healthy and clinical samples.

[Attachment predicts changes in the level of personality functioning after psychotherapeutic inpatient treatment]. / Bindung als Prädiktor von Strukturveränderungen im Verlauf von stationärer Psychotherapie.

Objectives: The relationship between patients' attachment strategies and the effectiveness of psychotherapy is empirically well established. However, studies on outcome measures other than symptomatic change are mostly lacking. The present study investigates if attachment anxiety and avoidance predict changes in personality functioning at the end of inpatient psychotherapy. Method: In two independent samples (the first sample consisting of N = 967 diagnostically heterogeneous patients, Fachklinikum Tiefenbrunn, and the second sample comprising N = 344 patients with personality impairments, Rehaklinik Bad Grönenbach), personality functioning was assessed by means of the short version of the OPD structure questionnaire OPD-SQS (OPD-Strukturfragebogen 12-Item-Screeningversion, OPD-SFK) at admission and discharge in a naturalistic study design. Data on the Brief Symptom Inventory (BSI) and the Inventory of Interpersonal Problems (IIP-32) were evaluated as additional outcome measures in the first sample. Patients' attachment strategies were assessed at admission using the German short version of the Experiences in Close Relationships (ECR-RD 12). Results: Attachment avoidance at baseline was inversely associated with improvements in personality functioning, psychopathology, and interpersonal problems. In the sample of patients diagnosed with personality disorders (sample 2), we found a negative association between attachment anxiety and improvements in the ability to make contact with others. Conclusions: Considering the limitations, our results underline the relevance of attachment for the treatment outcome of inpatient psychotherapy. The assessment of patient's attachment strategy as part of standardized diagnostics can be helpful in clinical practice regarding prognosis, therapy planning as well as the adjustment of the therapeutic relationship while treating patients suffering from impairments in personality functioning.

Patient characteristics as predictors of sleep disturbances in multimorbid primary care patients - A secondary analysis.

OBJECTIVE: The aim of the study was to identify patient characteristics (adult attachment, health status, number and severity of chronic conditions, social support) predictive sleep disturbances after 12 months. METHODS: In a secondary analysis of a prospective longitudinal study dealing with adult attachment and self-management, attachment- and health-related characteristics, socio-demographic data at baseline and symptoms of insomnia at the follow up (12 month later) was recorded by 219 patients between the ages of 50 and 85 years with multimorbidity in primary care. Adult attachment was measured by the ECR-RD12. The overall health status was measured using a visual analogue scale (VAS) and a standardized list of chronic conditions. The number and severity of chronic diseases (CIRS-G) was assessed by general practitioners (GPs). Sleep disturbances was measured by the ISI 12 month later. RESULTS: Approximately 19% of the respondents were found to have clinically relevant symptoms of insomnia, and a further 34% to be subclinical insomnia. Attachment-related anxiety, a poorer perceived social support, the number of chronic conditions and a better general health status could predict higher levels of sleep disturbance after 12 month. CONCLUSION: Sleep disorders can play a major role in patients with multimorbidity. Attachment anxiety and lack of social support may also be possible risk factors for the development of sleep disturbances.

[The Influence of Attachment Characteristics and Disease-Specific Predictors on Health-Related Quality of Life in Elderly Patients with Multimorbidity]. / Der Einfluss von Bindungsmerkmalen und erkrankungsspezifischen Prädiktoren auf die gesundheitsbezogene Lebensqualität von älteren Patienten und Patientinnen mit Multimorbidität.

OBJECTIVE: Our aim was to further investigate factors influencing multimorbid primary care patients in relation to mental and physical quality of life. METHODS: 219 elderly patients over 50 years with multiple chronic conditions were assessed for quality of life, attachment, depression, and health status at baseline and follow-up after 12 months. Multivariate analyses were performed to identify potential predictors. RESULTS: Depression, age, and avoidance had a negative influence, and health a positive influence, on physical quality of life. Mental quality of life was negatively influenced by attachment-related anxiety and depression. Relevant predictors that predicted quality of life in one year were health status, depression, and attachment-related anxiety. CONCLUSION: To maintain quality of life, mental health and attachment needs of multimorbid patients should be considered.

[Sexual Dysfunctions as a Part of Sexual Health in Primary Care]. / Sexuelle Funktionsstörungen als Teilbereich der sexuellen Gesundheit in der Primärmedizin.

Sexual dysfunctions have a high prevalence in all age groups. Nevertheless, the topics of sexual health and sexual disorders were not often thematized in primary care. This article provides an overview of the importance of sexual dysfunction as part of sexual health, particularly in the low-intensive medical care.

Evaluation of a short version of the Experiences in Close Relationships-Revised questionnaire (ECR-RD8): results from a representative German sample.

BACKGROUND: Attachment insecurity is a prominent risk factor for the development and course of psychiatric and psychosomatic disorders. The Experiences in Close Relationships - Revised (ECR-R) questionnaire is a widely used self-report to assess attachment related anxiety and avoidance. However, its length has the potential to restrict its use in large, multi-instrument studies. The aim of this study was to develop and evaluate a brief version of the ECR-R, and provide norm values for the German population. METHODS: A screening version of the original ECR-R was developed through principal components analysis of datasets from several previous studies. In a representative sample of 2428 randomly selected individuals from the German population, we compared fit indices of different models by means of confirmatory factor analyses (CFA). We investigated the convergent validity of the screening version in an independent convenience sample of 557 participants. Correlations between the short and the full scale were investigated in a re-analysis of the original German ECR-R evaluation sample. RESULTS: CFA indicated a satisfactory model fit for an eight-item version (ECR-RD8). The ECR-RD8 demonstrated adequate reliability. The subscales correlated as expected with another self-report measure of attachment in an independent sample. Individuals with higher levels of attachment anxiety, but especially higher levels of attachment avoidance were significantly more likely to not be in a relationship, across all age groups. Correlations between the short and the full scale were high. CONCLUSIONS: The ECR-RD8 appears to be a reliable, valid, and economic questionnaire for assessing attachment insecurity. In addition, the reported population-based norm values will help to contextualize future research findings.

Illness perception and health care use in individuals with irritable bowel syndrome: results from an online survey.

BACKGROUND: Individual illness perception is known to influence a range of outcome variables. However, little is known regarding illness perception in irritable bowel syndrome (IBS) and its relation to the use of the health care system. This study hypothesised a relationship between illness perception and inappropriate health care use (under-, over- and misuse). METHODS: An internet-based, cross-sectional study in participants affected by IBS symptoms was carried out (April - October 2019) using open questions as well as validated standardized instruments, e.g. the illness perception questionnaire revised (IPQ-R) and its subscales. Sub-group comparisons were done non-parametrically and effect sizes were reported. Potential predictors of (1) conventional health care utilisation and (2) utilisation of treatment approaches with lacking or weak evidence regarding effectiveness in IBS were examined with logistic regression analyses and reported as odds ratio (OR) and 95% confidence interval. RESULTS: Data from 513 individuals were available. More than one-third (35.7%) of participants were classified as high utilisers (> 5 doctor visits during the last year). Several indicators of inappropriate health care use were detected, such as a low proportion of state-of-the-art gynaecological evaluation of symptoms (35.0% of women) and a high proportion of individuals taking ineffective and not recommended non-steroidal antirheumatic drugs for IBS (29.4%). A majority (57.7%) used treatment approaches with lacking or weak evidence regarding the effectiveness in IBS (e.g. homeopathy). Being a high utiliser as defined above was predicted by the perceived daily life consequences of IBS (IPQ-R subscale "consequences", OR = 1.189 [1.100-1.284], p ≤ 0.001) and age (OR = 0.980 [0.962-0.998], p = 0.027). The use of treatment approaches with lacking or weak evidence was forecasted by the perceived daily life consequences (OR = 1.155 [1.091-1.223], p ≤ 0.001) and gender (reference category male: OR = 0.537 [0.327-0.881], p = 0.014), however effect sizes were small. CONCLUSIONS: Daily life consequences, perceived cure and personal control as aspects of individual disease perception seem to be related to individuals' health care use. These aspects should be a standard part of the medical interview and actively explored. To face inappropriate health care use patients and professionals need to be trained. Interdisciplinary collaborative care may contribute to enhanced quality of medical supply in IBS.

[Evaluation of the Sexual Sensation Seeking Scale: Results of a Representative German Population Survey]. / Evaluation der Sexual Sensation Seeking Scale: Ergebnisse einer repräsentativen deutschen Bevölkerungsumfrage.

Previous studies on Sexual Sensation Seeking (SSS) and the Sexual Sensation Seeking Scale (SSSS) were mainly carried out on random samples selected according to age and gender. In this study, the German version of the SSSS was evaluated on a representative survey of men and women, which covers the age range of the adult German population. The quality criteria and the factor structure of the German version of the Sexual Sensation Seeking Scale were examined on a representative sample of N=2420 (54% women, 36% men) aged between 18-93 years (M=50.44, SD=16.97). The internal consistency of the scale was good (α =0.91). Correlations with external criteria (Need Inventory of Sensation Seeking: r=0.56; Sexual Compulsivity Scale: r=0.68; p <0.001 for both comparisons) indicatde convergent validity. Age and gender-specific effects in the expected direction supported the construct validity: The values of the SSSS decreased with age. Men reported higher sexual sensation seeking across all age groups. The one-dimensional structure of the scale could not be clearly confirmed by factor analysis (CFA). The SSSS proved to be a reliable method for measuring sexual sensation seeking in the German population. In the future, sexual sensation seeking should be classified not only as risk behavior, but also be included in research as a resource-oriented positive predictor of sexual health.

[Psychometric evaluation of the Experiences in Close Relationships Revised German 12-item version (ECR-RD 12) in a sample of psychotherapeutic inpatients]. / Evaluation der deutschsprachigen Kurzform des Experiences in Close Relationships Questionnaire (ECR-RD 12) im stationären Psychotherapiesetting.

Psychometric evaluation of the Experiences in Close Relationships Revised German 12-item version (ECR-RD 12) in a sample of psychotherapeutic inpatients Objectives: The ECR-R assesses the self-description of adult attachment strategies in romantic relationships. The present study evaluates the psychometric properties of the German 12-item short version ECR-RD 12 in a large sample of patients in psychotherapeutic inpatient treatment. Method: Inpatients in psychotherapeutic treatment (N = 2231) were assessed using the ECR-RD 12 and other clinical questionnaires. Its psychometric properties and factor structure of were evaluated. Results: The psychometric properties of the short form measure were in line with the German full length version (ECR-RD). In contrast to theoretical assumptions, factor analysis suggested a three factor solution in the present sample. Discussion: The ECR-RD 12 can be recommended as a screening measure for assessing attachment styles in inpatient psychotherapeutic settings. Further studies are required to investigate the factor structure of the measure in clinical samples.

[Attachment Characteristics and Speciality Choice among Medical Students]. / Bindungsmerkmale und Facharztpräferenz bei Medizinstudierenden.

OBJECTIVES: Based upon a study by Ciechanowski et al. [27], a parallel survey was performed at the medical school of the University of Jena with the goal to determine a relationship between specialty choice and attachment characteristics among medical students. METHOD: A sample of 411 medical students from different phases of the medical training (73,2% females, mean age: 22.7 yrs.) were asked about their current specialty choice and invited to describe themselves in three different attachment questionnaires. These were the Relationship Style Questionnaire (RSQ), the Bielefeld Partnership Expectation Questionnaire and the Relationship-specific Attachment Scales for adults in the versions related to the mother and the partner. In comparing subgroups, we first used Ciechanowski et al.'s [27] differentiation of specialty contrasting primary and non-primary care specialties. In addition, a categorization of Buddeberg-Fischer et al. [29] differentiating a total of 7 subgroups was used (general medicine, internal medicine, surgery, anesthesiology/emergency medicine, pediatrics, psychiatry/neurology and obstetrics/gynecology). RESULTS: Comparing the groups according to Ciechanowski et al.'s categorization, differences occurred that were not replicating the original study: Students of the first subgroup (primary care) appeared to be more insecurely attached (according to the RSQ) and showed higher scores in subscales indicating dependency and preoccupation (e. g. fear of separation, dependently related to mother and partner). Similar as in Ciechanowski's study, the second group (non-primary care) revealed more individuals categorized as avoidant (or self-reliant). To differentiate the picture, the 7 categories according to Buddeberg-Fischer et al. [27] were compared. This comparison indicated that future pediatricians were classified as more insecure and ambivalent, whereas anesthesiologists more commonly were avoidant and dismissing. This picture was confirmed using comparisons of the questionnaire subscales. Since gender differences occurred both, related to specialty choice as well as attachment, gender was considered as a covariate in the analyses. CONLUSIONS: In contrast to the study of Ciechanowski et al. [27], future pediatricians as part of the primary care group were characterized by a tendency to be dependent and preoccupied in all attachment measures, whereas the result of a tendency to be more avoidant and self-reliant among anesthesiologists and students choosing emergency medicine was more in line with the US-American study. Future research dealing with the motivation to choose specific fields of action in medicine should consider other psychological characteristics as well as biographical aspects.

Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial.

INTRODUCTION: Approximately one out of six patients in primary care suffers from depression, which often remains undetected. Evidence regarding the efficacy of depression screening in primary care, however, is inconsistent. A previous single-centre randomised controlled trial (RCT) in cardiac patients, the DEPSCREEN-INFO trial, provided the first evidence that written feedback to patients following a positive depression screening reduces depression severity and leads to more comprehensive patient engagement in mental healthcare. To amplify these effects, the feedback should be tailored according to patients' needs and preferences. The GET.FEEDBACK.GP RCT will test the efficacy of this patient-targeted feedback intervention in primary care. METHODS AND ANALYSIS: The multicentre three-arm GET.FEEDBACK.GP RCT aims to recruit a total of 1074 primary care patients from North, East and South Germany. Patients will be screened for depression using the Patient Health Questionnaire-9 (PHQ-9). In the case of a positive depression screening result (PHQ-9 score ≥10), the participant will be randomised into one of three groups to either receive (a) patient-targeted and general practitioner (GP)-targeted feedback regarding the depression screening results, (b) only GP-targeted feedback or (c) no feedback. Patients will be followed over a period of 12 months. The primary outcome is depression severity (PHQ-9) 6 months after screening. Secondary outcomes include patient engagement in mental healthcare, professional depression care and cost-effectiveness. According to a statistical analysis plan, the primary endpoint of all randomised patients will be analysed regarding the intention-to-treat principle. ETHICS AND DISSEMINATION: The Ethics Committee of the Hamburg Medical Association approved the study. A clinical trial company will ensure data safety, monitoring and supervision. The multicentre GET.FEEDBACK.GP RCT is the first trial in primary care that tests the efficacy of a patient-targeted feedback intervention as an adjunct to depression screening. Its results have the potential to influence future depression guidelines and will be disseminated in scientific as well as patient-friendly language. TRIAL REGISTRATION NUMBER: NCT03988985.

Patient information, communication and competence empowerment in oncology (PIKKO) - evaluation of a supportive care intervention for overall oncological patients. Study protocol of a non-randomized controlled trial.

BACKGROUND: Cancer patients have to undergo a difficult medical therapy and are also confronted with various psychological, social and economic problems. Support is available from many providers, but patients often gain no access to it. Accordingly, there is a need for a single point of contact that can provide advice, information and assistance. In the state of Saarland, Germany, a supportive new consulting and information path (PIKKO) for all types of cancer is currently evaluated by the German Cancer Society, the Cancer Society of the Saarland, three statutory health insurances and the Jena University Hospital. PIKKO is designed to improve quality of life, self-efficacy, health literacy and patient satisfaction and to reduce psychological distress, related health care costs and the days of inability to work. This methodical work presents the process and analysis planning of this evaluation. METHODS: The study population includes all cancer types, both new and existing diseases. PIKKO (with patient navigator, oncological knowledge database, specialized oncological counseling) is evaluated within a controlled, non-randomized, comparative, multicenter, longitudinal design. In addition to patient surveys, data from statutory health insurances and utilization data from the web database are collected, and interviews with patient navigators and doctors are carried out. Patients are assigned to a control (usual care) or an intervention group (u. c. + PIKKO). Primary outcome is the health related quality of life (SF-12) six months after baseline. Secondary outcomes are self-efficacy (GSE), psychological distress such as depression (PHQ-9) or anxiety (GAD-7), health literacy (HLS-EU-Q47) and patient satisfaction in health care (Qualiskope-A). Furthermore, the time course of direct costs of medical care (e.g. work disability days) and usage data of the intervention modules are analyzed. Among other statistical procedures, we use t-tests, univariate tests and growth curve models. DISCUSSION: If PIKKO proves to be effective, recommendations can be made to health organizations, which should lead to the concept being rolled out throughout Germany and included into oncological guidelines. We expect PIKKO to be a useful addition to usual cancer care, helping to improve the quality of life of cancer patients and reduce healthcare costs. TRIAL REGISTRATION: This study was retrospectively registered in the German Clinical Trial Register under DRKS00016703 (21.02.2019, the reason for the delay was the prioritization of the study management in the first year to establish the new approach into practice). https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00016703.

Assessing empowerment as multidimensional outcome of a patient education program for adolescents with chronic conditions: A latent difference score model.

OBJECTIVES: The current study aims to examine the construct of empowerment in the context of a transition education program. Patient education programs strive to empower adolescents with chronic conditions to take responsibility for their own health care to manage their transition from pediatric to adult medicine. Our study aimed to identify the core components of patient empowerment and examined whether its components are responsive to a patient education program. METHODS: Data was collected in two longitudinal studies involving N = 723 adolescents with chronic conditions. We used Latent Difference Score models (LDSm) of: 1) self-efficacy (GSE), 2) transition competence (TCS), and 3) patient activation (PAM) to quantify the latent variable of patient empowerment (PE). Additionally, the LDSm were extended to analyze the effects of group affiliation (intervention vs. control) and participants' age on empowerment. RESULTS: PE was identifiable by the three components. The intervention group developed significantly higher scores of PE compared to the control group. Age (13-21 years) did not moderate the relation between group affiliation and PE. CONCLUSIONS: We quantified PE successfully using a psychometric modeling of change. Patient empowerment is measureable and utilizable in the specific context of transition of adolescents with chronic conditions.

Association of adult attachment and suicidal ideation in primary care patients with multiple chronic conditions.

BACKGROUND: Suicidal ideation is a common health concern in primary care. Attachment theory indicates that subjects with higher anxiety and/or avoidance may be more susceptible to suicidal ideation. Therefore, the aim of our study was to examine the association of attachment anxiety, avoidance, and suicidal ideation in middle-aged to elderly, chronically ill primary care patients. METHODS: The APRICARE Study comprised 207 patients aged 50-85 years with a minimum of three chronic diseases. Adult attachment, depressive symptoms and suicidal ideation were measured via the self-report questionnaires Experiences in Close Relationships-Revised (ECR-RD12) and Patient Health Questionnaire - 9 (PHQ-9). Univariable and adjusted associations of suicidal ideation with ECR-RD12-attachment anxiety, ECR-RD12-attachment avoidance, and ECR-RD12-insecure adult attachment were examined via logistic regression analyses. RESULTS: Suicidal ideation was present in 13% of all patients. ECR-RD12-anxiety was significantly associated with suicidal ideation (OR = 1.88, CI 1.44-2.44), while ECR-RD12-avoidance was not associated. In patients with suicidal ideation, 85% were insecurely attached compared to 63% in those without suicidal ideation - thus the OR for suicidal ideation in insecurely attached patients was 3.33 (CI = 1.10-10.04) with securely attached patients as reference. Further variables associated with suicidal ideation were depressive symptomatology, living alone (especially in men) and obesity (especially in women). LIMITATIONS: The study was cross-sectional in design, and suicidal ideation was assessed using a single item self-report measure. CONCLUSION: General practitioners should be aware of attachment styles in order to have a better chance to identify patients at risk for suicide.