Intentional and actional components of engaged participation in public health research studies: qualitative synthesis of a recruitment and retention process into the theory-informed INTACT-RS framework.

BACKGROUND: Ensuring motivated and successful study participation is a key challenge in the design and conduct of health research studies. Previously, recruitment barriers and facilitators have been identified mainly from experience, and rarely based on theoretical approaches. We developed a framework of intentional and actional components of engaged participation in public health research studies (INTACT-RS), informed by psychological behavioral models. We aimed a) to identify precise indicators for each framework component and b) to better understand which components and decision processes are essential for study participants. METHODS: Within a multicenter research network, we applied various approaches to recruit parents of newborns, pediatricians, and midwives. All recruitment processes were documented from the perspective of both participants and researchers. We used different qualitative and quantitative data material, which we applied in a multistage process according to the basic principles of qualitative content analysis. RESULTS: INTACT-RS encompasses pre-intentional, intentional and actional phases with a total of n = 15 components covering all aspects of an individual's involvement with a research study. During intention formation, an understanding of efforts and benefits, why participation is valuable beyond contributing to research, and how others perceive the study, were particularly important to (potential) participants. Subsequently (intentional phase), participants consider how and when participation is compatible with their own resources, ability and availability, and hence seek for close communication with, and flexibility and support from the research team. During and after (initial) participation (actional phase), participants' assessment of whether expectations and interests have been met impact crucial further steps, especially the willingness to continue and to recommend participation to others. A strong topic-wise and or supportive participation interest as well as active, continuous exchange with the researchers appeared to be central determinants of study completion and data validity. CONCLUSIONS: A theoretical framework is now available to plan and conduct recruitment of different target groups, which accounts for essential motivational and volitional decision-making processes. Based on empirically specified constructs, possible barriers can be addressed even before the initial recruitment process. Therefore, recommendations for scientific practice have been formulated.

Midwives' empathy and shared decision making from women's perspective - sensitivity of an assessment to compare quality of care in prenatal and obstetric care.

BACKGROUND: For quality-oriented evaluation of prenatal and obstetric care, it is important to systematically consider the perspective of the women receiving care in order to comprehensively assess and optimize quality in a woman-centered manner. Empathy and Shared Decision Making (SDM) are essential components of woman-centered midwifery care. The aim of the study was to analyze measurement invariance of the items of the Consultation and Relational Empathy (CARE) and Shared Decision Making-Questionnaire (SDM-Q-9) scales depending on the prenatal versus obstetric care setting. METHODS: One hundred fifty women retrospectively assessed aspects of woman-centered midwifery care in both prenatal and obstetric care setting. The birth of the child was a maximum of 12 months ago. A structural equation modelling approach was adopted to separate true effects from response shift (RS) effects depending on care setting. The latter were analyzed in terms of recalibration (changing women's internal measurement standards), Reprioritization (changing associations of items and construct) as well as Reconceptualization (redefining the target construct). RESULTS: A response shift model was identified for both assessments (pregnancy/birth: CFI = .96/.96; SRMR = .046/.051). At birth, both scales indicated lower quality of care compared with prenatal care (SDM-Q-9-M/CARE-8-M:|d| = 0.190/0.392). Although no reconceptualization is required for the items of both scales, RS effects are evident for individual items. Due to recalibration and reprioritization effects, the true differences in the items are partly underestimated (SDM-Q-9-M/CARE-8-M: 3/2 items) or overestimated (4/2 items). CONCLUSION: The structure of the constructs SDM and Empathy, indicating woman-centered midwifery care, are moderated by the care settings. To validly assess midwives' empathy and shared decision making from women's perspective, setting-dependent response shift effects have to be considered. The proven item-specific response effects contribute to a better understanding of construct characteristics in woman-centered care by midwives during pregnancy and childbirth.

Analyzing the effects of barriers to and facilitators of medication adherence among patients with cardiometabolic diseases: a structural equation modeling approach.

BACKGROUND: Based on the theoretical model of medication adherence (WHO, 2003), the aims of the study were (1) to develop and test a theory-based multidimensional model for the predictive power of barriers to and facilitators of medication adherence and (2) to identify the mediating effects of barriers to medication adherence on drug-related patient outcomes (barrier "MedAd- ": forget; facilitator "MedAd + ": regular intake). METHODS: Within a cross-sectional study entitled "Increasing medication adherence to improve patient safety in cardiological rehabilitation (PaSiMed)", the model was evaluated in structural analytical terms based on data collected online of N = 225 patients with cardiometabolic diseases. The revised "Freiburg questionnaire on medication adherence (FF-MedAd-R)" was used to measure the latent constructs (e.g., facilitator: communication; barrier: reservations)." RESULTS: The structural equation model proved to exhibit an appropriate data fit (RMSEA: .05; CFI: .92). For all first-order facilitators of medication adherence, a high proportion of variance (62-94%) could be explained by the second-order factor "Physician-patient relationship (PPR)". All paths from "PPR" to the constructs depicting barriers to medication adherence showed significant negative effects. Facilitators ("MedAd + ") and barriers ("MedAd-") accounted for 20% and 12% of the variance, respectively, in global items of medication adherence. Whereas "Carelessness" showed a full mediation for "MedAd-", ''Reservations'' showed a partial mediation for "MedAd + ". CONCLUSIONS: "PPR" is an important predictor of patient medication adherence. The results underline the importance of a trustful physician-patient relationship in reducing barriers and enhancing medication adherence.

Burden of informal caregivers of people without natural speech: a mixed-methods intervention study.

BACKGROUND: People with disabilities and without natural speech often rely on care provided by informal caregivers. The caregiving situation of these informal caregivers has been poorly researched. The objectives of the study are 1) to identify stressors, resources, and coping strategies among informal caregivers of people without natural speech and 2) to examine whether a complex intervention in augmentative and alternative communication (AAC) that is not primarily tailored to the needs of informal caregivers can reduce care-related burden. METHODS: The main components of the AAC intervention were (1) initial counselling session, (2) 4 AAC training sessions, (3) 20 AAC therapy sessions and (4) accompanying case management. The control group received only the initial counselling session. Within a quasi-experimental intervention study, survey data on self-perceived burden (Burden Scale for Family Caregivers, BSFC-s) from n = 154 informal caregivers of people without natural speech were collected at three time points between June 2018 and April 2021 from a postal survey. Qualitative interviews with n = 16 informal caregivers were conducted. RESULTS: Caregivers reported various stressors such as limited communication with the cared-for person and concerns about the living situation in adulthood. Diverse resources and effective coping strategies, which the caregivers refer to when dealing with stressors, could also be identified. Burden was significantly reduced in the intervention group compared to the control group. According to the results of the qualitative study, AAC use led to better communication skills and a reduction in behavioural problems and thus a decreased burden. CONCLUSIONS: The AAC intervention seems to have a positive impact on self-perceived burden. Linkages between intervention components and burden reduction as well as stressors and coping strategies could be identified and provide an evidence-based foundation for developing future holistic interventions for families with individuals without natural speech. TRIAL REGISTRATION: German Clinical Trials Register (DRKS); ID: DRKS00013628 (registered on 05/02/2018).

Measuring social capital of healthcare organizations reported by employees for creating positive workplaces - validation of the SOCAPO-E instrument.

BACKGROUND: In highly segmented and complex healthcare organizations social capital is assumed to be of high relevance for the coordination of tasks in healthcare. So far, comprehensively validated instruments on social capital in healthcare organizations are lacking. The aim of this work is to validate an instrument measuring social capital in healthcare organizations. METHODS: This validation study is based on a cross-sectional survey of 1050 hospital employees from 49 German hospitals which specialize in breast cancer care. Social capital was assessed by a six-item scale. Reliability analyses and confirmatory factor analyses were conducted to determine the content validity of items within the theory-driven one-dimensional scale structure. The scale's associations with measures of the social aspects of the work environment (identification, social support, open communication climate) were estimated to test convergent validity. Criterion-related validity was evaluated by conducting structural equation modelling to examine the predictive validity of the scale with measures of work engagement, well-being and burnout. RESULTS: A one-dimensional structure of the instrument could be identified (CFI = .99; RMSEA = .06). Convergent validity was shown by hypothesis-consistent correlations with social support offered by supervisors and colleagues, a climate of open communication, and employee commitment to the organization. Criterion-related validity of the social capital scale was proved by its prediction of employee work engagement (R2 = .10-.13 for the three subscales), well-being (R2 = .13), and burnout (R2 = .06-.11 for the three subscales). CONCLUSIONS: The confirmed associations between social capital and work engagement, burnout as well as well-being stress the importance of social capital as a vital resource for employee health and performance in healthcare organizations. In healthcare organizations this short instrument can be used as an efficient instrument to measure the organizations' social capital.

[Analyzing the Informational Content of Observational and Rating Data]. / Analyse des Informationsgehalts von Merkmalseinschätzungen und Beurteilungsdaten.

In rehabilitation, decisions are often based on ratings or judgements made by rehabilitation patients, therapists or peer-reviewers. But, depending on aspects of the assessment setting, ratings of an issue (e. g., quality of communication, quality of health care) may vary systematically or due to stochastic error components. Rating scores may be affected by the properties of the rater, raters' perspective (e. g., self- vs. external ratings), rating situation or measurement point in time, respectively. Hence, rating scores should be considered as composite scores comprising several systematic information aspects. Generalizability theory provides an analytical framework allowing to decompose underlying information facets and to determine their influence on the obtained rating data. First, a differentiated model can be identified ensuring a more valid data interpretation (generalizability aspect). Second, well-founded recommendations enhancing reliability and validity of the assessment may be derived (decision aspect). In this article we demonstrate how to apply generalizability theory to enhance the clarity of the informational content of ratings and to foster rating quality in typical rehabilitation settings.

[Evidence-Based Approaches in Rehabilitation - Research Designs and Conceptual Foundations for Analyzing the Efficacy and Effectiveness of Rehabilitation Treatments]. / Evidenzbasierung in der Rehabilitation ­ Studiendesigns und konzeptuelle Grundlagen der empirischen Analyse der Wirksamkeit von Rehabilitationsmaßnahmen.

Rehabilitation is evidenced based if treatments are applied that proved to enhance rehabilitation outcomes - generally patients' health or participation- effectively in a causal manner. Randomized control trials (RCTs) allow determining the efficacy of treatments unambiguously. If alternative research designs (e. g. case-control studies, cohort studies, observational studies) are adopted, the association of the treatment and the improvement of the health status or participation may be biased by confounding variables (limitations of internal validity). Several variants of the basic RCT designs have been developed (e. g. cluster-randomized trials, factorial designs, pragmatic trials) to adapt RCTs to the demands of practical applications. Additionally, deciding and acting evidence-based requires rehabilitation treatments and recommendations which have been developed on a solid theoretical basis and which are applied in practical rehabilitation care appropriately. Especially, because treatments have to be chosen and provided according to rehabilitation patients' individual needs. Furthermore, in every day care the application of treatments has to be matched to the specific conditions of the respective rehabilitation institution. Thus, a comprehensive understanding of evidence requires not only efficacy studies adopting RCTs. Additionally, knowledge about treatment efficacy has to be complemented by studies investigating conceptual and theoretical foundations of effective treatments (intervention design) as well as studies to apply treatments in practical rehabilitation care (implementation research) appropriately.

[Validation of the Short-Form-Health-Survey-12 (SF-12 Version 2.0) assessing health-related quality of life in a normative German sample]. / Validierung der Messung gesundheitsbezogener Lebensqualität mittels des Short-Form-Health-Survey-12 (SF-12 Version 2.0) in einer deutschen Normstichprobe.

Validation of the Short-Form-Health-Survey-12 (SF-12 Version 2.0) assessing health-related quality of life in a normative German sample Objectives: Convergent and divergent validation of the Short-Form-Health-Survey-12 assessing HRQoL by analyzing its associations with depressiveness (PHQ-9), social support (OSS-3) and satisfaction with life (SWLS). Methods: A normative German sample (N = 2.524) was analyzed using correlation, regression as well as confirmatory factor analysis and structural equation modelling for ordinal data. Results: The SF-12-scale Mental Health is associated most strongly with the validation criteria (PHQ: r[scales/constructs] = -.73/-.88, OSS-3: r = .35/.55, SWLS: r = .47/.62). Mental Health (ß = .36) and Social Support (OSS-3; ß = .25) allow to explain a significant amount of variance of the SWLS (R2 = .28). On construct level Emotional Role Functioning (ß = .28) proved to be significant additionally. Conclusions: The SF-12 scales are associated with the validation criteria as expected. The SF- 12 proved to be suitable for modelling core components of HRQoL within a biopsychosocial framework aiming at predicting satisfaction with life.

[DNVF-Memorandum III - Methods for Health Services Research, Part 4 - Concept and Methods for Organizational Health Services Research. Chapter 3 - Methodological Approaches for the Evaluation and Implementation of Complex Interventions in Healthcare Organizations]. / DNVF-Memorandum III ­ Methoden für die Versorgungsforschung, Teil 4 ­ Konzept und Methoden der organisationsbezogenen Versorgungsforschung. Kapitel 3 ­ Methodische Ansätze zur Evaluation und Implementierung komplexer Interventionen in Versorgungsorganisationen.

Organizational health services research is still a relatively young field of research in Germany which is of increasing interest. The German Network Health Services Research e.V. (DNVF e.V.) published in 2009 - supported by expert associations and individual members of the DNVF - a guide on "Methods for organizational health services research" of the Memorandum III, part 1 [1]. Originating from this publication and facilitated by the increasing relevance of the field, a necessity to refine the conceptual and methodological basis became evident. The update and extension of the publication from 2009 consists of three chapters: (1) Definition and concept of organizational health services research, (2) Methodological approaches in organizational health services research: indicators, data sources, data collection and data analysis, (3) Methodological approaches for the design, evaluation and implementation of complex interventions in health care organizations. The aim of the third chapter is to present methods for intervention design, evaluation of effectiveness and efficacy as well as implementation research with particular regard to the organizational context of interventions to improve health care.

[DNVF-Memorandum III - Methods for Health Services Research, Part 4 - Concept and Methods for Organizational Health Services Research: Short Version]. / DNVF-Memorandum III ­ Methoden für die Versorgungsforschung, Teil 4 ­ Konzept und Methoden der organisationsbezogenen Versorgungsforschung: Kurzfassung.

Organizational health services research in Germany is of increasing relevance. Based on the guide on methods for organizational health services research of the Memorandum III, part 1 from the year 2009, the fundamentals and standards have now been refined. The memorandum captures the theoretical framework, basic methodological approaches and methods in health services research for the design, evaluation and implementation of complex interventions in healthcare organizations.

[Multilevel Analysis as a Tool to Analyze Research Questions in Rehabilitation Science]. / Die Mehrebenenanalyse als Verfahren zur Analyse rehabilitationswissenschaftlicher Forschungsfragen.

Studies in rehabilitation science often investigate data representing different hierarchical data levels. Hierarchical sample structures prevail if single cases (e. g. rehabilitation patients) are grouped or are members of grouped entities or clusters (e. g. teams, groups, institutions), respectively. Analyzing data of rehabilitation patients treated in different institutions it has to be regarded that belonging to a specific institution (level 2; cluster-level) may be associated with individuals' (level 1) characteristics systematically. If rehabilitation patients take part in different training groups, specific characteristics of the training groups (level 2) may affect treatment effects of individuals (level 1) significantly. Multilevel analysis or hierarchical linear models allow for simultaneously modelling such multilevel data structures in an integrative and comprehensive manner. In this article it will be shown which specific aspects concerning hierarchical sampling procedures, data organization, specification of research hypotheses, statistical data analysis as well as interpretation of study results have be regarded to model potential clustering effects appropriately.

[Bayes' Theorem and Base Rate Error: On the Predictive Value of Risk Factors and Screening Tests]. / Bayes'sches Theorem und der Basisratenfehler: Zum Vorhersagewert von Risikofaktoren und Screeningverfahren.

Regularly, risk assessments or decisions are based on dichotomous characteristics or measures. For instance, critical high values in screening tests may indicate an enhanced risk of having a disease. The prevalence of a risk factor (e. g. high blood pressure, depression) may indicate the need of a medical treatment or the occurrence of a negative consequence (e. g. early retirement). In such situations risk assessments are typically based on conditional event rates or conditional event probabilities: What is the risk of having a disease under the condition of having a symptom, risk factor or a critical screening indication? The valid interpretation of conditional event rates poses a considerable challenge for practitioners as well as for rehabilitation patients. Typically, for rare events the risk of having a disease is considerably overestimated if a critical predictor prevails. The Bayes' theorem describes the decision related informations structure appropriately. It is shown, which informations have to be taken into account to ensure valid risk assessments. Using absolute frequencies instead of relative frequencies or proportions may prevent erroneous conclusions. Graphical displays of absolute frequencies by area diagrams or decision trees are recommended to ensure a better comprehensibility of risk information.

[Confounding and Biasing Variables in Observational and Intervention Studies in Rehabilitation]. / Konfundierungen und Störfaktoren in rehabilitationswissenschaftlichen Beobachtungs- und Interventionsstudien.

To prove and determine effects of rehabilitation treatments, appropriate study designs have to be applied which allow inferring that differences in the outcome variables (e .g. health state) are causally determined by rehabilitation treatments. In observational studies confounding variables may affect or distort the association between treatment and outcome variables. Preference for a treatment, motivation for treatment or level of impairment before rehabilitation are typical confounders in rehabilitational intervention studies. These potential confounders are especially important if patients chose treatment voluntarily or the treatment has been suggested because of specific impairment characteristics (external program effects). Appropriately controlled intervention studies (especially randomized control trials, RCTs) allow controlling for such biasing effects. But also for appropriate controlled intervention studies, biasing effects may arise due to the implementation of the study design (e. g. selection of participants, applying assessment instruments, communication of participants of different study groups; design effects, treatment contaminations) and may deteriorate the unambiguous interpretability of empirical results. It is shown which confounding and distortional effects have to be regarded that may affect the interpretability of associations. Recommendations for planning, conducting and analyzing empirical studies are given to avoid such biasing effects in the best possible way.

[Basic Statistical Measures for Dichotomous Data Formats: Risk, Odds, Logits, Relative Risk, Odds Ratio]. / Grundlegende Maßzahlen zur Analyse 2-stufiger Merkmalsausprägungen: Risiko, Odds, Logits, Relatives Risiko, Odds Ratio.

In rehabilitation science dichotomous data formats are frequently used to indicate or analyze patient characteristics. Although underlying information may be more fine graded, dichotomous or dichotomized data formats like 'yes vs. no', 'salient vs. not salient' or 'capable to work vs. not capable to work' are often adequate information formats for communication or decision making purposes. Definitions and properties of risk, odds and logits - typically applied in rehabilitation research - are outlined as frequency measures of occurrence. The association of two variables can be characterized by relative risk, risk reduction, logit reduction, odds ratio and ln(odds ratio). As odds ratio is independent from base rates it reflects association strength unambiguously. Hence, important correlational measures are defined as functions of odds ratio. It will be illustrated that statistical aspects as well as aspects regarding comprehensibility of the represented information are decisive to select appropriate measures and present data information appropriately.

Trajectories of mental health in children and adolescents during the COVID-19 pandemic: findings from the longitudinal COPSY study.

BACKGROUND: Mental health and health-related quality of life (HRQoL) in children and adolescents deteriorated during the COVID-19 pandemic. The aim of this population-based longitudinal study was to explore whether distinct mental health trajectories in youths can be identified over the course of the pandemic. METHODS: Mental health problems (MHP), psychosomatic symptoms and HRQoL were assessed at five time points between May 2020 and October 2022 in 744 children and adolescents aged 7 to 20 years using established instruments. We used generalized mixture modeling to identify distinct mental health trajectories and fixed-effects regressions to analyse covariates of the identified profiles of change. RESULTS: We found five distinct linear latent trajectory classes each for externalising MHP and psychosomatic symptoms and four trajectory classes for internalising MHP. For HRQoL, a single-class solution that indicates a common development process proved to be optimal. The largest groups remained almost stable at a low internalising and externalising symptom level (64 to 74%) and consistently showed moderate psychosomatic symptoms (79%), while 2 to 18% showed improvements across the pandemic. About 10% of the youths had consistently high internalising problems, while externalising problems deteriorated in 18% of youths. Class membership was significantly associated with initial HRQoL, parental and child burden, personal resources, family climate and social support. CONCLUSIONS: The mental health of most children and adolescents remained resilient throughout the pandemic. However, a sizeable number of youths had consistently poor or deteriorating mental health. Those children and adolescents need special attention in schools and mental health care.

Assessment of interprofessional obstetric and midwifery care from the midwives' perspective using the Interprofessional Collaboration Scale (ICS).

Introduction: Interprofessional collaboration of physicians and midwives is essential for appropriate and safe care of pregnant and parturient women as well as their newborns. The complexity of woman-centered care settings requires the continuous exchange of information and the coordinated implementation of multi-and interprofessional care concepts. To analyze the midwives' perspective on the multi-and interprofessional care process during pregnancy, birth and postpartum period, we aimed to adapt and psychometrically evaluate the Interprofessional Collaboration Scale (ICS). Methods: The ICS (13 items) was answered by 299 midwives for (i) prenatal and postpartum care as well as (ii) perinatal care. Three items on equitable communication (EC) identified in qualitative interviews with N = 6 midwives were added as further aspects of quality in collaborative midwifery care. Confirmatory factor analysis was used to test competing theoretically hypothesized factorial model structures, including both care settings simultaneously, i.e., birth and prenatal/postpartum. Results: A two-dimensional structure assuming the 13 original ICS items and the 3 items on EC as psychometric distinct item groups accounts for the data best. After deleting 5 ICS items with insufficient indicator reliability, a very good-fitting model structure was obtained for both prenatal/postpartum as well as perinatal care: χ2df = 192 = 226.35, p = 0.045, CFI = 0.991, RMSEA = 0.025 (90%CI: [0.004; 0.037]). Both the reduced ICS-R and the EC scale (standardized response mean = 0.579/1.401) indicate significantly higher interprofessional collaboration in the birth setting. Responsibility in consulting, attitudes toward obstetric care and frequency of collaboration with other professional groups proved to be associated with the ICS-R and EC scale as expected. Discussion: For the adapted ICS-R and the EC scale a good construct validity could be confirmed. Thus, the scales can be recommended as a promising assessment for recording the collaboration of midwives with physicians working in obstetric care from the perspective of midwives. The instrument provides a validated assessment basis in midwifery and obstetric care to identify potentially divergent perspectives within interprofessional care teams in woman's centered care.

Why context matters when changing the diet: A narrative review of placebo, nocebo, and psychosocial context effects and implications for outcome research and nutrition counselling.

Placebo (PE) and nocebo effects (NE) have been subjects of systematic research in medicine and psychotherapy for many decades to distinguish between the (specific) pharmacological effect of medication and the (unspecific) effect of the context. Despite this significant research, the awareness, operationalisation, and reflection of the multiplicity of PE, NE, and psychosocial context effects (PSCE) is currently limited when researching outcomes of diet changes in studies without randomisation and placebo control. This neglection is critical as it could systematically influence outcomes by moderating and mediating them and thus reducing the validity and evidence base of these studies. Therefore, we performed a (non-systematic) narrative review (NR) on the following objectives: (1) present a concise overview about the relevance of PE, NE, and PSCE in medicine and nutrition research; (2) review the current state of research on reflecting context effects when studying diet changes; (3) provide useful theoretical foundations via consideration and integration of micro- and macro context effects; (4) operationalise as hypotheses the potential PE, NE, and PSCE which are specific for researching diet changes; and (5) derive their impact for future research as well as for nutrition counselling. The electronic search in this NR for objective (2) identified N = 5 publications and for objective (4) we found N = 61 articles retrieved in the first round of search, additional references were identified by a manual and snowball search among the cited references resulting finally in N = 37. This NR offers a synoptical basis to foster awareness and operationalisation of a variety of PE, NE, and PSCE. Interdisciplinary research teams should monitor these factors using, e.g., qualitative, mixed-method studies, process evaluation, item bank approaches, moderator and mediator analysis that might reveal substantially new insights, and outcomes of relevance to science and nutrition counselling. Nevertheless, the present NR has several limitations, especially as it is non-systematic, because it is a very heterogeneous field of research, in which the topic we are investigating is usually regarded as marginal and subordinate. Therefore, future research should conduct systematic reviews and particularly theory-based primary studies (experimental research) on hypotheses of PE, NE, and PSCE in outcome research in diet changes.

Validation of a patient-reported measure of social support provided by nurses in breast cancer care (SuPP-N): based on a cross-sectional patient survey in 83 German hospitals.

OBJECTIVES: To validate the patient-reported measure of Social Support Perceived by Patients Scale-Nurses (SuPP-N). DESIGN/SETTING: A secondary data analysis based on a cross-sectional breast cancer patient survey in 83 German hospitals. Patients were asked to give written informed consent before they were discharged. If they agreed to participate, the questionnaire was sent via mail to their home address after discharge. PARTICIPANTS: Of 5583 eligible patients, 4841 consented to participate in the study and 4217 returned completed questionnaires (response rate: 75.5 %). For the data analysis n=3954 respondents were included. On average, participants were 60 years old and mostly in cancer stages I and II. PRIMARY AND SECONDARY OUTCOME MEASURES: Perceived social support was assessed with a three-item patient-reported scale (SuPP-N). Convergent validity and criterion-related validity were tested using the following constructs: trust in nurses, trust in the treatment team (Wake Forest Physician Trust Scale, adapted), quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire), processes organisation, availability of nurses. RESULTS: The structural equation model (SEM) assuming a one-dimensional structure of the instrument showed acceptable goodness of fit (root mean square error of approximation=0.04, Comparative Fit Index=0.96 and Tucker-Lewis Index=0.96; factor loadings ≥0.83). Hypothesis-consistent correlations with trust in nurses (beta=0.615; p<0.01) and trust in the treatment team (beta=0.264; p<0.01) proved convergent validity. Criterion-related validity was proved by its association with patients' quality of life (beta=-0.138; p<0.01), processes organisation (beta=-0.107; p<0.01) and the availability of nurses (beta=0.654; p<0.01). CONCLUSION: The results of the SEM identify potential important factors to foster social support by nurses in cancer care. In patient surveys, the SuPP-N can be used efficiently to measure patient-reported social support provided by nurses. The use of the scale can contribute to gain a better understanding of the relevance of social support provided by nurses for patients and to detect possible deficits and derive measures with the aim of improving the patient-nurse interaction.