Assessment of relevance and actual implementation of person-centeredness in healthcare and social support services for women with unintended pregnancy in Germany (CarePreg): results of expert workshops.

INTRODUCTION: Person-centeredness is a key principle in the German healthcare system. However, access to high-quality care for women with unintended pregnancy is limited due to social stigma and legal restrictions. There is little research on the adoption of person-centeredness in care for women with unintended pregnancy. The aim of this study was to analyze relevance and actual implementation of dimensions of person-centeredness in psycho-social and medical abortion care from the view of abortion care providers. METHODS: Counselors and gynecologist working in psycho-social or medical abortion care participated in one of two digital workshops. Discussions were semi-structured based on the 16 dimensions of an integrative model of person-centeredness, audio-recorded and transcribed verbatim. During qualitative content analysis, deductive categories based on the integrative model of person-centeredness were applied and inductive categories were developed. Additionally, participants rated relevance and actual implementation of the dimensions in an online survey. RESULTS: The 18 workshop participants most intensively discussed the dimensions "access to care", "person-centered characteristics of healthcare providers" and "personally tailored information". Four additional categories on a macro level ("stigmatization of women with unintended pregnancy", "stigmatization of healthcare providers", "political and legal aspects" and "corona pandemic") were identified. Most dimensions were rated as highly relevant but implementation status was described as rather low. CONCLUSIONS: In Germany, high quality person-centered care for women with unintended pregnancy is insufficiently implemented through limited access to information, a lack of abortion care providers, and stigmatization. There is a need for changes in health care structures to enable nationwide person-centered care for women with unintended pregnancy. Those changes include a more easy access to evidence-based information and person-centered abortion care, more education on abortion care for healthcare providers, integration of topics of abortion care in medical schools and promotion of de-stigmatizing actions to enable abortions as part of the general healthcare.

Major influencing factors on routine implementation of shared decision-making in cancer care: qualitative process evaluation of a stepped-wedge cluster randomized trial.

BACKGROUND: Shared decision-making (SDM) is highly relevant in oncology but rarely implemented in routine care. In a stepped-wedge cluster randomized implementation trial, the outcome evaluation of a theoretically and empirically based multi-component SDM implementation program did not show a statistically significant effect on patient-reported SDM uptake. Within this SDM implementation trial, a thorough a priori planned process evaluation was conducted. Thus, the aim of this study was to investigate factors influencing SDM implementation in the context of a multi-component SDM implementation program. METHODS: We conducted qualitative process evaluation of a stepped-wedge SDM implementation trial. Qualitative data included interviews with nurses and physicians of participating departments, field notes by the study team, and meeting minutes. Data were analyzed via deductive and inductive qualitative content analysis on basis of the Consolidated Framework for Implementation Research (CFIR). RESULTS: Transcripts of 107 interviews with 126 nurses and physicians, 304 pages of field note documentation, and 125 pages of meeting minutes were analyzed. Major factors influencing SDM implementation were found for all domains of the CFIR: a) four regarding characteristics of the individuals involved (e.g., perceived personal relevance, individual motivation to change), b) eleven regarding the inner setting (e.g., leadership engagement, networks and communication, available resources, compatibility with clinical practice), c) two regarding the outer setting (e.g., culture of health care delivery), d) eight regarding characteristics of the intervention (e.g., relative advantage, adaptability), and e) three regarding the implementation process (e.g., integration into existing structures). Furthermore, we found strong interrelations between several of the influencing factors within and between domains. CONCLUSIONS: This comprehensive process evaluation complements the outcome evaluation of the SDM implementation trial and adds to its interpretation. The identified influencing factors can be used for planning, conducting, and evaluating SDM implementation in the future. TRIAL REGISTRATION: clinicaltrials.gov, NCT03393351, registered 8 January 2018, https://clinicaltrials.gov/ct2/show/NCT03393351.

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.

Assessment of person-centeredness in healthcare and social support services for women with unintended pregnancy (CarePreg): protocol for a mixed-method study.

INTRODUCTION: For women with unintended pregnancy, access to high-quality care has been found limited due to social stigma and legal restrictions, especially when seeking abortion. To foster person-centeredness (PC), recognising the experiences and needs of women is the first premise. This study aims to (1) identify relevant dimensions of PC (2) evaluate PC in healthcare and social support services, (3) develop recommendations for further actions in healthcare and social support services for women with unintended pregnancy. METHODS AND ANALYSIS: We will use a mixed-methods approach. Phase 1: expert workshops with 10-15 healthcare professionals and counsellors and semistructured interviews with 15-20 women with unintended pregnancy will be conducted to assess the relevance of PC dimensions. Phase 2: quantitative assessment of PC dimensions within healthcare and support services will be conducted. We aim to include 600 women with an unintended pregnancy (1) until 24 weeks of pregnancy or (2) who sought abortion within the past 8 weeks, over three measurement points within 12 months. To deepen the results, semistructured interviews will be conducted. Phase 3: a workshop with 10-15 experts and an online survey with 100-150 experts will be used to indicate recommendations. Participants will be gained through relevant care facilities. An ethical advisory board and an advisory board of affected women will be involved throughout the study. ETHICS AND DISSEMINATION: The study will be carried out in accordance to the latest version of the Helsinki Declaration of the World Medical Association and principles of good scientific practice. The study was approved by the Local Psychological Ethics Committee of the University Medical Center Hamburg-Eppendorf, Germany (LPEK-0260). Written informed consent will be sought prior to study participation. The study results will be disseminated in scientific journals, through collaboration partners and plain language press releases.

Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial.

BACKGROUND: Shared decision-making (SDM) is preferred by many patients in cancer care. However, despite scientific evidence and promotion by health policy makers, SDM implementation in routine health care lags behind. This study aimed to evaluate an empirically and theoretically grounded implementation program for SDM in cancer care. METHODS: In a stepped wedge design, three departments of a comprehensive cancer center sequentially received the implementation program in a randomized order. It included six components: training for health care professionals (HCPs), individual coaching for physicians, patient activation intervention, patient information material/decision aids, revision of quality management documents, and reflection on multidisciplinary team meetings (MDTMs). Outcome evaluation comprised four measurement waves. The primary endpoint was patient-reported SDM uptake using the 9-item Shared Decision Making Questionnaire. Several secondary implementation outcomes were assessed. A mixed-methods process evaluation was conducted to evaluate reach and fidelity. Data were analyzed using mixed linear models, qualitative content analysis, and descriptive statistics. RESULTS: A total of 2,128 patient questionnaires, 559 questionnaires from 408 HCPs, 132 audio recordings of clinical encounters, and 842 case discussions from 66 MDTMs were evaluated. There was no statistically significant improvement in the primary endpoint SDM uptake. Patients in the intervention condition were more likely to experience shared or patient-lead decision-making than in the control condition (d=0.24). HCPs in the intervention condition reported more knowledge about SDM than in the control condition (d = 0.50). In MDTMs the quality of psycho-social information was lower in the intervention than in the control condition (d = - 0.48). Further secondary outcomes did not differ statistically significantly between conditions. All components were implemented in all departments, but reach was limited (e.g., training of 44% of eligible HCPs) and several adaptations occurred (e.g., reduced dose of coaching). CONCLUSIONS: The process evaluation provides possible explanations for the lack of statistically significant effects in the primary and most of the secondary outcomes. Low reach and adaptations, particularly in dose, may explain the results. Other or more intensive approaches are needed for successful department-wide implementation of SDM in routine cancer care. Further research is needed to understand factors influencing implementation of SDM in cancer care. TRIAL REGISTRATION: clinicaltrials.gov, NCT03393351 , registered 8 January 2018.

What do patients expect? Assessing patient-centredness from the patients' perspective: an interview study.

OBJECTIVE: Although there has been much conceptual work on patient-centredness (PC), patients' perspectives on PC were neglected. In a previous study, participating patients rated the relevance of 16 dimensions of an integrative model of PC as high to very high. However, it remained unclear which specific behaviours described in the dimensions were considered most relevant. Thus, the aim of the current study was to further explore which of the specific behaviours described in the model are especially relevant for the high ratings in the previous study. METHODS AND DESIGN: We conducted semistructured interviews with 20 patients with chronic diseases (16 females, 4 males, mean age: 52 years). Patients answered questions regarding their experiences in the German healthcare system and how optimal healthcare would look like from their perspective. Furthermore, patients were asked to reflect on the most important aspects which they had mentioned in the interview before. Data were analysed via content analysis. RESULTS: Participants addressed many different aspects of PC, but mostly focused on three major themes: (1) time appropriate access to care, (2) competence, empathy and being taken seriously by HCPs, (3) HCPs' individual consideration of each patient's situation (eg, wishes and needs). Minor themes were: (1) taking a holistic perspective of the patient, (2) patient-centred communication, (3) integration of multidisciplinary treatment elements, (4) transparency regarding waiting time and (5) reduction of unequal access to care. CONCLUSION: This study enriches the construct of PC by depicting essential aspects of PC from the patients' perspective. The results allow prioritising strategies to implement patient-centred care. Thus, this study helps to pursue the ultimate goal of fostering patient-centred healthcare delivery in Germany.

Engagement With a Web-Based Intervention to Reduce Harmful Drinking: Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Engagement with digital behavior change interventions (DBCIs) is considered a prerequisite for intervention efficacy. However, in many trials on DBCIs, participants use the intervention either only little or not at all. OBJECTIVE: To analyze engagement with a web-based intervention to reduce harmful drinking, we explored (1) whether engagement with a web-based alcohol intervention is related to drinking outcomes, (2) which user characteristics are associated with measures of engagement, and (3) whether reported outcomes are associated with data captured by voluntary intervention questionnaires. METHODS: We analyzed data of the intervention arm of a randomized controlled trial on a DBCI to reduce risky alcohol consumption. Data were collected at baseline (T0), after 90 days (T1), and at the end of the 180-day usage period (T2). Engagement with the intervention was measured via system usage data as well as self-reported usage. Drinking behavior was measured as average daily alcohol consumption as well as the number of binge drinking days. User characteristics included demographics, baseline drinking behavior, readiness to change, alcohol-related outcome expectancies, and alcohol abstinence self-efficacy. Following a bivariate approach, we performed two-tailed Welch's t tests and Wilcoxon signed rank/Mann-Whitney U tests or calculated correlation coefficients. RESULTS: The data of 306 users were analyzed. Time spent engaging with the intervention as measured by system usage did not match self-reported usage. Higher self-reported usage was associated with higher reductions in average daily alcohol consumption (T1: ρ=0.39, P<.001; T2: ρ=0.29, P=.015) and in binge drinking days (T1: ρ=0.62, P<.001; T2: ρ=0.3, P=.006). Higher usage was reported from users who were single (T1: P<.001; T2: P<.001), users without children (T1: P<.001; T2: P<.001), users who did not start or finish secondary education (T1: P<.001; T2: P<.001), users without academic education (T1: P<.001; T2: P<.001), and those who worked (T1: P=.001; T2: P=.004). Relationships between self-reported usage and clinical or psychological baseline characteristics were complex. For system usage, the findings were mixed. Reductions in drinking captured by intervention questionnaires were associated with reported outcomes. CONCLUSIONS: Though self-reported usage could be consistently linked to better outcomes and multiple user characteristics, our findings add to the overall inconclusive evidence that can be found throughout the literature. Our findings indicate potential benefits of self-reports as measures of engagement and intervention questionnaires as a basis for tailoring of intervention content. Future studies should adopt a theory-driven approach to engagement research utilizing psychometrically sound self-report questionnaires and include short ecological momentary assessments within the DBCIs. TRIAL REGISTRATION: German Clinical Trials Register DRKS00006104; https://tinyurl.com/y22oc5jo.

The Effectiveness of an Internet Intervention Aimed at Reducing Alcohol Consumption in Adults.

BACKGROUND: In 2012, approximately 3.38 million people in Germany had an alcoholrelated disorder. Internet interventions can help lower alcohol consumption, albeit with mostly small effect sizes. It is still unclear whether the effectiveness of programs aimed at lowering alcohol consumption can be improved by individually adjusting program content for each participant. We studied the effectiveness of Vorvida, a new cognitive-behavioral internet intervention with individual adjustment of content. METHODS: A randomized controlled trial was conducted on 608 adults with problematic alcohol consumption. The primary outcome was self-reported alcohol con - sumption in the past 30 days (as determined by the Quantity-Frequency-Index, QFI) and in the past 7 days (using the Timeline Follow-Back method, TFB). The secondary outcomes were drinking behavior (binge drinking/drunkenness) and satisfaction with Vorvida. Data were collected at three time points: at baseline (t0) and three and six months later (t1, t2). Trial registration: DRKS00006104. RESULTS: The intention-to-treat (ITT) analysis revealed significant differences between groups at time t1 with respect to alcohol consumption (QFI: d = 0.28; TFB: d = 0.42), binge drinking (d = 0.87), and drunkenness (d = 0.39). Satisfaction with the intervention was high (27.4 [standard deviation, SD: 5.3] out of 32 points). All effects persisted, or were stronger, at time t2. Alcohol consumption, as measured by the QFI, declined over the interval from t0 to t2 in both groups: from 63.69 g/day (SD: 61.4) to 32.67 g/day (SD: 39.78) in the intervention group, and from 61.64 g/day (SD: 58.84) to 43.75 g/day (SD: 43.68) in the control group. CONCLUSION: Vorvida was found to be effective in persons with risky, problematic alcohol consumption. Further studies should determine which elements of the program contribute most to effectiveness in routine clinical practice, and what long-term effects can be achieved.

Assessment of patient information needs: A systematic review of measures.

BACKGROUND: Providing patient information is a central aspect of patient-centered care. Fulfilling personal information needs has positive effects on several health-related outcomes. Measurement instruments help to identify individual information needs in an effective way. The present study gives an overview of existing information needs measures and further evaluates the quality of their psychometric properties and their psychometric studies. METHODS: We conducted a systematic search on psychometric studies of measures that assess information needs in PubMed and Embase. Furthermore, we carried out a secondary search with reference and citation tracking of the included articles. Title, abstracts and full texts were screened by two independent reviewers for eligibility. We extracted data on content of the measures, validation samples and psychometric properties. In addition we rated the methodological quality with the COSMIN checklist and the quality of psychometric properties with the criteria of Terwee and colleagues. RESULTS: 24 studies on 21 measures were included. Most instruments assessed information needs of patients with cancer or cardiac diseases. The majority of the instruments were in English language and from western countries. Most studies included information on internal consistency and content validity. The ratings showed mixed results with clear deficiencies in the methodological quality of most studies. DISCUSSION: This is the first systematic review that summarized the existing evidence on measures on patient information needs using two instruments for a systematic quality assessment. The results show a need for more psychometric studies on existing measures. In addition, reporting on psychometric studies needs to be improved to be able to evaluate the reliability of the psychometric properties. Furthermore, we were not able to identify any measures on information needs for some frequent chronic diseases. Other methods to elicit information needs (e.g. open-ended interviews, question prompt sheets) could be considered as alternatives if sound measures are missing.

Psychosocial Distress of Patients with Psoriasis: Protocol for an Assessment of Care Needs and the Development of a Supportive Intervention.

BACKGROUND: Psoriasis is a chronic inflammatory disease that is often associated with a number of somatic and mental comorbidity. Patients with psoriasis show an increased risk of depression and (social) anxiety. OBJECTIVE: The aims of this study are 1) to explore the psychosocial distress of patients with psoriasis and to assess their care needs; and 2) to develop a supportive intervention based on the prior results. METHODS: A multi-stage design with four phases combining quantitative and qualitative methodology will be used and conducted in two centers. 1) A scoping review and focus groups will be used to design a questionnaire to assess the psychosocial distress and care needs of the patients. 2) The questionnaire developed in phase 1 will be used in a cross-sectional survey to assess the extent of psychosocial distress and supportive care needs in 400 patients with psoriasis. 3) A systematic review and meta-analysis will be conducted to identify psychosocial and psychoeducational interventions for patients with psoriasis and to describe their effectiveness. 4) Based on the results of the phases 2 and 3 a manualized supportive intervention will be developed and the feasibility and acceptance of the intervention will be assessed. RESULTS: Currently, phase 1 of the project has been completed and the recruitment for phase 2 has been started. The systematic review and meta-analysis of phase 3 are conducted simultaneously to phase 2 and results are expected soon. Phase 4 has not been started yet. CONCLUSIONS: The expected results of this study will show the extent of psychosocial distress of patients with psoriasis in Germany and supplement previous research with findings about the supportive care needs of this patient group. Moreover, the developed intervention will help to address the psychosocial support needs of patients with psoriasis. Research shows that psychosocial support is strongly needed.

[On the Way to Culture-Sensitive Patient Information Materials: Results of a Focus Group Study]. / Auf dem Weg zu kultursensitiven Patienteninformationsmaterialien: Ergebnisse einer Fokusgruppenuntersuchung.

AIM: This study was part of a double-blind randomised controlled trial aimed to evaluate the effects of culture-sensitive patient information materials (PIM) compared with standard translated material. The study aimed to obtain the data for the development of culture sensitive PIM about unipolar depression for the 4 largest migrant groups in Germany (Turkish, Polish, Russian and Italian migration background). METHOD: A qualitative study using 4 manual-based focus groups (FG), one for each migrant group, with 29 participants (9 with a Turkish (TüG), 8 with a Polish (PoG), 5 with a Russian (RuG) and 7 with an Italian (ItG) migration background) was conducted. The discussions were recorded, transcribed and analyzed using qualitative content analysis. RESULTS: 7 categories were identified. For the (1.) development of a good culture-sensitive PIM an easy language, a clear structure, an assessable extent of information and the avoidance of stereotypes were highlighted cross-culturally in all four FG. RuG and PoG had the largest (2.) lack of information about the German health care system. Concerning the (3.) illness perception RuG named problems with recognizing and understanding depression. PoG, RuG and TüG thematized (4.) feared consequences of the illness and of professional helpseeking. ItG, PoG, RuG had fears concerning (5.) psychotropic drugs as a result from insufficient knowledge about medication. For (6.) doctor-patient relationship cultural specifics were identified in RuG and TüG and for (7.) migration or culture specific reasons for depression in RuG, ItG and TüG. CONCLUSION: Although the identified categories were relevant for all or for the majority of migrant groups, for most categories specific cultural aspects were discovered. These findings show the importance of a culture sensitive adaptation of PIM.

German translation, cultural adaptation, and validation of the Health Literacy Questionnaire (HLQ).

The Health Literacy Questionnaire (HLQ), developed in Australia in 2012 using a 'validity-driven' approach, has been rapidly adopted and is being applied in many countries and languages. It is a multidimensional measure comprising nine distinct domains that may be used for surveys, needs assessment, evaluation and outcomes assessment as well as for informing service improvement and the development of interventions. The aim of this paper is to describe the German translation of the HLQ and to present the results of the validation of the culturally adapted version. The HLQ comprises 44 items, which were translated and culturally adapted to the German context. This study uses data collected from a sample of 1,058 persons with chronic conditions. Statistical analyses include descriptive and confirmatory factor analyses. In one-factor congeneric models, all scales demonstrated good fit after few model adjustments. In a single, highly restrictive nine-factor model (no cross-loadings, no correlated errors) replication of the original English-language version was achieved with fit indices and psychometric properties similar to the original HLQ. Reliability for all scales was excellent, with a Cronbach's Alpha of at least 0.77. High to very high correlations between some HLQ factors were observed, suggesting that higher order factors may be present. Our rigorous development and validation protocol, as well as strict adaptation processes, have generated a remarkable reproduction of the HLQ in German. The results of this validation provide evidence that the HLQ is robust and can be recommended for use in German-speaking populations. TRIAL REGISTRATION: German Clinical Trial Registration (DRKS): DRKS00000584. Registered 23 March 2011.

Standardization of the Beck Hopelessness Scale in the general population.

BACKGROUND: The Beck Hopelessness Scale (BHS) is a self-report instrument for the quantification of hopelessness in nonpsychiatric, as well as psychiatric patients. Hopelessness is a key psychological variable in suicide prediction. Until now the psychometric properties of the instrument have not been studied in a representative sample of the general population. AIMS: The objectives of the study were to generate normative data and to further investigate the construct validity and factorial structure of the BHS. METHODS: A nationally representative face-to-face household survey was conducted in Colombia in 2012 (N = 1500). RESULTS: Cronbach's alpha coefficient for the BHS was 0.81. Confirmatory factor analysis supported a three-factor model, achieving good fit indices (total sample: RMSEA = 0.043, CFI = 0.936, TLI = 0.921). Normative data for the BHS were generated for both genders and different age levels. Intercorrelations with hopelessness were highest for depression (r = 0.57), followed by anxiety (r = 0.52). CONCLUSIONS: The normative data provide a framework for the interpretation and comparisons of the BHS with other populations. Evidence supports reliability and validity of the three-factor BHS as a measure of hopelessness in the general population.

Effects of culture-sensitive adaptation of patient information material on usefulness in migrants: a multicentre, blinded randomised controlled trial.

OBJECTIVES: To evaluate the usefulness of culture-sensitive patient information material compared with standard translated material. DESIGN: Multicentre, double-blind randomised controlled trial. SETTING: 37 primary care practices. PARTICIPANTS: 435 adult primary care patients with a migration background with unipolar depressive disorder or non-specific chronic low back pain were randomised. Patients who were unable to read in the language of their respective migration background were excluded. Sufficient data were obtained from 203 women and 106 men. The largest group was of Russian origin (202 patients), followed by those of Turkish (52), Polish (30) and Italian (25) origin. INTERVENTIONS: Intervention group: provision of culture-sensitive adapted material. CONTROL GROUP: provision of standard translated material. MAIN OUTCOME MEASURES: Primary outcome: patient-rated usefulness (USE) assessed immediately after patients received the material. SECONDARY OUTCOMES: patient-rated usefulness after 8 weeks and 6 months, symptoms of depression (PHQ-9), back pain (Back Pain Core Set) and quality of life (WHO-5) assessed at all time points. RESULTS: Usefulness was found to be significantly higher (t=1.708, one-sided p=0.04) in the intervention group (USE-score=65.08, SE=1.43), compared with the control group (61.43, SE=1.63), immediately after patients received the material, in the intention-to-treat analysis, with a mean difference of 3.65 (one-sided 95% lower confidence limit=0.13). No significant differences were found for usefulness at follow-up (p=0.16, p=0.71). No significant effect was found for symptom severity in depression (p=0.95, p=0.66, p=0.58), back pain (p=0.40, p=0.45, p=0.32) or quality of life (p=0.76, p=0.86, p=0.21), either immediately after receiving the material, or at follow-up (8 weeks; 6 months). Patients with a lower level of dominant society immersion benefited substantially and significantly more from the intervention than patients with a high level of immersion (p=0.005). CONCLUSION: Cultural adaptation of patient information material provides benefits over high quality translations. Clinicians are encouraged to use culture-sensitive material in their consultations, particularly with low-acculturated patients. TRIAL REGISTRATION NUMBER: German Register for Clinical Trials: DRKS00004241, Universal Trial Number: U1111-1135-8043, Results.

Assessing Communication Skills of Medical Students in Objective Structured Clinical Examinations (OSCE)--A Systematic Review of Rating Scales.

BACKGROUND: Teaching and assessment of communication skills have become essential in medical education. The Objective Structured Clinical Examination (OSCE) has been found as an appropriate means to assess communication skills within medical education. Studies have demonstrated the importance of a valid assessment of medical students' communication skills. Yet, the validity of the performance scores depends fundamentally on the quality of the rating scales used in an OSCE. Thus, this systematic review aimed at providing an overview of existing rating scales, describing their underlying definition of communication skills, determining the methodological quality of psychometric studies and the quality of psychometric properties of the identified rating scales. METHODS: We conducted a systematic review to identify psychometrically tested rating scales, which have been applied in OSCE settings to assess communication skills of medical students. Our search strategy comprised three databases (EMBASE, PsycINFO, and PubMed), reference tracking and consultation of experts. We included studies that reported psychometric properties of communication skills assessment rating scales used in OSCEs by examiners only. The methodological quality of included studies was assessed using the COnsensus based Standards for the selection of health status Measurement INstruments (COSMIN) checklist. The quality of psychometric properties was evaluated using the quality criteria of Terwee and colleagues. RESULTS: Data of twelve studies reporting on eight rating scales on communication skills assessment in OSCEs were included. Five of eight rating scales were explicitly developed based on a specific definition of communication skills. The methodological quality of studies was mainly poor. The psychometric quality of the eight rating scales was mainly intermediate. DISCUSSION: Our results reveal that future psychometric evaluation studies focusing on improving the methodological quality are needed in order to yield psychometrically sound results of the OSCEs assessing communication skills. This is especially important given that most OSCE rating scales are used for summative assessment, and thus have an impact on medical students' academic success.

Vorvida: study protocol of a randomized controlled trial testing the effectiveness of Internet-based self-help program for the reduction of alcohol consumption for adults.

BACKGROUND: Problem drinking is an important global health concern, causing premature mortality and morbidity. Only few problem drinkers seek professional care, unfortunately, because of multiple barriers such as insufficient change motivation, fear of stigmatization or limited access to care. The aim of this study will be to examine the effectiveness of a novel Internet intervention termed Vorvida, which was developed based on established cognitive-behavioral therapy techniques with the aim of reducing problematic alcohol consumption. METHODS/DESIGN: A two-arm randomized control trial (RCT) will be conducted to determine whether using Vorvida results in greater reductions in self-reported problem drinking, compared with a care-as-usual/waitlist (CAU/WL) control group. There will be a baseline assessment (t0) and follow-up assessments after three (t1) and six months (t2). Inclusion criteria will be: minimum age of 18, an average consumption of alcohol >24/12 g (men/women) per day and an AUDIT-C score ≥ 3, as well as informed consent. Participants will be randomly assigned to the intervention or control condition at a ratio of 1:1. Recruitment, informed consent, randomization and assessment will be Internet-based. Primary outcome will be change in self-reported alcohol consumption between t0 and t1. Secondary outcomes will be self-reported drinking behavior, expectancies of effects of alcohol use, abstinence and relapse tendencies, self-efficacy and motivation to change. DISCUSSION: This study is expected to establish the extent to which a novel Internet intervention could contribute to reducing problem drinking among adults with mild to severe alcohol use disorders who may or may not seek or access a traditional treatments. Potentially, this program could be an effective and efficient tool to help reduce problem drinking on a population level because a great number of users can be reached simultaneously without adding burden to treating clinicians. TRIAL REGISTRATION: German Clinical Trial Registration (DRKS): DRKS00006104. Registered 14 April 2014.

Which Dimensions of Patient-Centeredness Matter? - Results of a Web-Based Expert Delphi Survey.

BACKGROUND: Present models and definitions of patient-centeredness revealed a lack of conceptual clarity. Based on a prior systematic literature review, we developed an integrative model with 15 dimensions of patient-centeredness. The aims of this study were to 1) validate, and 2) prioritize these dimensions. METHOD: A two-round web-based Delphi study was conducted. 297 international experts were invited to participate. In round one they were asked to 1) give an individual rating on a nine-point-scale on relevance and clarity of the dimensions, 2) add missing dimensions, and 3) prioritize the dimensions. In round two, experts received feedback about the results of round one and were asked to reflect and re-rate their own results. The cut-off for the validation of a dimension was a median < 7 on one of the criteria. RESULTS: 105 experts participated in round one and 71 in round two. In round one, one new dimension was suggested and included for discussion in round two. In round two, this dimension did not reach sufficient ratings to be included in the model. Eleven dimensions reached a median ≥ 7 on both criteria (relevance and clarity). Four dimensions had a median < 7 on one or both criteria. The five dimensions rated as most important were: patient as a unique person, patient involvement in care, patient information, clinician-patient communication and patient empowerment. DISCUSSION: 11 out of the 15 dimensions have been validated through experts' ratings. Further research on the four dimensions that received insufficient ratings is recommended. The priority order of the dimensions can help researchers and clinicians to focus on the most important dimensions of patient-centeredness. Overall, the model provides a useful framework that can be used in the development of measures, interventions, and medical education curricula, as well as the adoption of a new perspective in health policy.

Usefulness scale for patient information material (USE) - development and psychometric properties.

BACKGROUND: One economical way to inform patients about their illness and medical procedures is to provide written health information material. So far, a generic and psychometrically sound scale to evaluate cognitive, emotional, and behavioral aspects of the subjectively experienced usefulness of patient information material from the patient's perspective is lacking. The aim of our study was to develop and psychometrically test such a scale. METHODS: The Usefulness Scale for Patient Information Material (USE) was developed using a multistep approach. Ultimately, three items for each subscale (cognitive, emotional, and behavioral) were selected under consideration of face validity, discrimination, difficulty, and item content. The final version of the USE was subjected to reliability analysis. Structural validity was tested using confirmatory factor analysis, and convergent and divergent validity were tested using correlation analysis. The criterion validity of the USE was tested in an experimental design. To this aim, patients were randomly allocated to one of two groups. One group received a full version of an information brochure on depression or chronic low back pain depending on the respective primary diagnosis. Patients in the second group received a reduced version with a lower design quality, smaller font size and less information. Patients were recruited in six hospitals in Germany. After reading the brochure, they were asked to fill in a questionnaire. RESULTS: Analyzable data were obtained from 120 questionnaires. The confirmatory factor analysis supported the structural validity of the scale. Reliability analysis of the total scale and its subscales showed Cronbach's α values between .84 and .94. Convergent and divergent validity were supported. Criterion validity was confirmed in the experimental condition. Significant differences between the groups receiving full and reduced information were found for the total score (p<.001) and its three subscales (cognitive p<.001, emotional p=.001, and behavioral p<.001), supporting criterion validity. CONCLUSIONS: We developed a generic scale to measure the subjective usefulness of written patient information material from a patient perspective. Our construct is defined in line with current theoretical models for the evaluation of written patient information material. The USE was shown to be a short, reliable and valid psychometric scale.

Measurement of physician-patient communication--a systematic review.

BACKGROUND: Effective communication with health care providers has been found as relevant for physical and psychological health outcomes as well as the patients' adherence. However, the validity of the findings depends on the quality of the applied measures. This study aimed to provide an overview of measures of physician-patient communication and to evaluate the methodological quality of psychometric studies and the quality of psychometric properties of the identified measures. METHODS: A systematic review was performed to identify psychometrically tested instruments which measure physician-patient communication. The search strategy included three databases (EMBASE, PsycINFO, PubMed), reference and citation tracking and personal knowledge. Studies that report the psychometric properties of physician-patient communication measures were included. Two independent raters assessed the methodological quality of the selected studies with the COSMIN (COnsensus based Standards for the selection of health status Measurement INtruments) checklist. The quality of psychometric properties was evaluated with the quality criteria of Terwee and colleagues. RESULTS: Data of 25 studies on 20 measures of physician-patient communication were extracted, mainly from primary care samples in Europe and the USA. Included studies reported a median of 3 out of the nine COSMIN criteria. Scores for internal consistency and content validity were mainly fair or poor. Reliability and structural validity were rated mainly of fair quality. Hypothesis testing scored mostly poor. The quality of psychometric properties of measures evaluated with Terwee et al.'s criteria was rated mainly intermediate or positive. DISCUSSION: This systematic review identified a number of measures of physician-patient communication. However, further psychometric evaluation of the measures is strongly recommended. The application of quality criteria like the COSMIN checklist could improve the methodological quality of psychometric property studies as well as the comparability of the studies' results.

An integrative model of patient-centeredness - a systematic review and concept analysis.

BACKGROUND: Existing models of patient-centeredness reveal a lack of conceptual clarity. This results in a heterogeneous use of the term, unclear measurement dimensions, inconsistent results regarding the effectiveness of patient-centered interventions, and finally in difficulties in implementing patient-centered care. The aim of this systematic review was to identify the different dimensions of patient-centeredness described in the literature and to propose an integrative model of patient-centeredness based on these results. METHODS: Protocol driven search in five databases, combined with a comprehensive secondary search strategy. All articles that include a definition of patient-centeredness were eligible for inclusion in the review and subject to subsequent content analysis. Two researchers independently first screened titles and abstracts, then assessed full texts for eligibility. In each article the given definition of patient-centeredness was coded independently by two researchers. We discussed codes within the research team and condensed them into an integrative model of patient-centeredness. RESULTS: 4707 records were identified through primary and secondary search, of which 706 were retained after screening of titles and abstracts. 417 articles (59%) contained a definition of patient-centeredness and were coded. 15 dimensions of patient-centeredness were identified: essential characteristics of clinician, clinician-patient relationship, clinician-patient communication, patient as unique person, biopsychosocial perspective, patient information, patient involvement in care, involvement of family and friends, patient empowerment, physical support, emotional support, integration of medical and non-medical care, teamwork and teambuilding, access to care, coordination and continuity of care. In the resulting integrative model the dimensions were mapped onto different levels of care. CONCLUSIONS: The proposed integrative model of patient-centeredness allows different stakeholders to speak the same language. It provides a foundation for creating better measures and interventions. It can also be used to inform the development of clinical guidance documents and health policy directives, and through this support the shift towards patient-centered health care.