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.

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.

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.

Psychometric evaluation of the German version of the Patient Activation Measure (PAM13).

BACKGROUND: The Patient Activation Measure (PAM) consists of 13 items and assesses patient (or consumer) self-reported knowledge, skills, and confidence for self-management of one's health or chronic condition. The aim of this study was to translate the original American version of the PAM13 into German and to test the psychometric properties of the German version in an elderly, multimorbid population with various chronic conditions. METHODS: Translation was performed by a standardized forward-backward translation process. The PAM13 was sent to 9.075 participants enrolled in a randomized controlled study. 4.306 participants responded to the questionnaire. Descriptive and reliability analyses were carried out. To examine scale properties, Andrich's Rasch Rating Scale Model was fitted. RESULTS: The internal consistency is good (α = 0.88) and the item-rest-correlations were found as strong to moderate. The unidimensionality of the construct was confirmed, with a variance explanation of 40.9% and good model-fits for the Rasch model. However, the lowest response options were very rarely used across all items (below 5%) and ranking order of items according to their difficulty was substantially different from that of the American version. Differential item functioning (DIF) was found in subgroups (sex, age, health status), but differences were small. CONCLUSION: The German version of the PAM13 showed acceptable reliability and the model-fit statistics confirmed the Rasch model. The different ranking order of the items and the unfair distribution of the response options suggest further research on validation and revision of the construct.

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.

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.

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.

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.

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.

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.

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.

How do health services researchers understand the concept of patient-centeredness? Results from an expert survey.

BACKGROUND: The concept of patient-centeredness has gained in importance over recent decades, including its growing importance on a health policy level. However, many different definitions and frameworks exist. This renders both research and implementation into clinical practice difficult. This study aimed at assessing how German researchers conceptualize patient-centeredness, how they translate the German equivalent into English, and what they consider the most important references on the topic. METHODS: All researchers within a German research priority program on patient-centeredness were invited to participate in an online survey with open questions. The data regarding the definitions of patient-centeredness were analyzed using the method of conventional content analysis. Descriptive statistics were used to analyze the responses on translations and references. RESULTS: Thirty-eight (28%) of 136 invited researchers participated in the study. The definitions given by the participants could be classified into ten categories: patient as a unique person, involvement in decision-making, patient information, essential characteristics of the physician, biopsychosocial perspective, patient empowerment, individualized services, patient-reported outcomes, involvement in health policy and coordination and teamwork. The results for the translation of the German word "Patientenorientierung" into English indicate that uncertainty regarding the appropriate English terminology exists. All participants provided a different reference on patient-centeredness that was important to them. CONCLUSION: The results show a certain degree of "shared meaning" regarding the concept of patient-centeredness. However, they also indicate a considerable amount of "surplus meaning", which can be seen as an indicator for the fuzziness of a theoretical concept. All in all, this study has shown that the conceptual ambiguity found in the literature on patient-centeredness is partly reflected in the conceptualizations of German researchers working in that field. This calls for more conceptual work, eg, developing an integrative model on patient-centeredness grounded in the international literature.

Assessment of trust in physician: a systematic review of measures.

Over the last decades, trust in physician has gained in importance. Studies have shown that trust in physician is associated with positive health behaviors in patients. However, the validity of empirical findings fundamentally depends on the quality of the measures in use. Our aim was to provide an overview of trust in physician measures and to evaluate the methodological quality of the psychometric studies and the quality of psychometric properties of identified measures. We conducted an electronic search in three databases (Medline, EMBASE and PsycInfo). The secondary search strategy included reference and citation tracking of included full texts and consultation of experts in the field. Retrieved records were screened independently by two reviewers. Full texts that reported on testing of psychometric properties of trust in physician measures were included in the review. Study characteristics and psychometric properties were extracted. We evaluated the quality of design, methods and reporting of studies with the COnsensus based Standards for the selection of health status Measurement INstruments (COSMIN) checklist. The quality of psychometric properties was assessed with Terwee's 2007 quality criteria. After screening 3284 records and assessing 169 full texts for eligibility, fourteen studies on seven trust in physician measures were included. Most of the studies were conducted in the USA and used English measures. All but one measure were generic. Sample sizes range from 25 to 1199 participants, recruited in very heterogeneous settings. Quality assessments revealed several flaws in the methodological quality of studies. COSMIN scores were mainly fair or poor. The overall quality of measures' psychometric properties was intermediate. Several trust in physician measures have been developed over the last years, but further psychometric evaluation of these measures is strongly recommended. The methodological quality of psychometric property studies could be improved by adhering to quality criteria like the COSMIN checklist.

Development and testing of culturally sensitive patient information material for Turkish, Polish, Russian and Italian migrants with depression or chronic low back pain (KULTINFO): study protocol for a double-blind randomized controlled trial.

BACKGROUND: Many of the approximately 15 million people with a migration background living in Germany (19% of the population) are inadequately reached by existing healthcare provision. In the literature, the necessity for cultural adaptation of information material for patients with a migration background is often cited as a measure for improving healthcare.In this study, culturally sensitive information material will be developed and evaluated for patients with a migration background and depression or chronic low back pain. In this respect, it will be examined whether culturally sensitive information material is judged as more useful by the patients than standard translated patient information without cultural adaptation. METHODS/DESIGN: The implementation and evaluation of culturally sensitive patient information material will occur in the framework of a double-blind randomized controlled parallel-group study in four study centres in Germany. Primary care patients with a Turkish, Polish, Russian or Italian migration background with a diagnosis of depressive disorder or chronic low back pain will be included and randomly allocated to the intervention group or the control group. In the intervention group, culturally sensitive patient information will be handed to the patient at the end of the physician consultation, while in the control group, standard translated patient information material will be provided. The patients will be surveyed by means of questionnaires following the consultation as well as after 8 weeks and 6 months. In addition to the primary outcome (subjective usefulness), several patient- and physician-rated secondary outcomes will be considered. DISCUSSION: The study will provide an empirical answer to the question of whether persons with a migration background perceive culturally sensitive patient information material as more useful than translated information material without cultural adaptation. TRIAL REGISTRATION: Deutsches Register Klinischer Studien (DRKS-ID) DRKS00004241 and Universal Trial Number (UTN) U1111-1135-8043.

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.

Evaluation of dimensions and measurement scales in patient-centeredness.

BACKGROUND: Patient-centeredness has gained importance over the last two decades. However, there is an absence of theoretical clarity regarding the term patient-centeredness. This results in inconsistent measurement of patient-centeredness, which leads to difficulties in comparing research results. To overcome these difficulties, the aims of this study are (1) to identify the dimensions of patient-centeredness and include them in an integrative model, (2) to select and assess the most relevant dimensions of the model, (3) to identify and assess measurement instruments and find evidence for the selected dimensions, and (4) to assess the relevance and applicability of the conceptualization and measurement of patient-centeredness in clinical practice and health services research. METHODS: This project is divided into four phases. First, a systematic review will be conducted to identify the constructs and dimensions of patient-centeredness. Second, experts (eg, researchers, clinicians, and patient representatives) will assess and prioritize the identified relevant dimensions using a Delphi survey. Third, the selected dimensions will be assessed regarding their operationalization, and the results will be summarized in a systematic review. Evidence of the measures will be assessed in a scoping review. Fourth, an expert workshop will be held. Experts will assess the results of the previous phases regarding the relevance and applicability of the conceptualization and measurement of patient-centeredness. DISCUSSION: This study will provide an integrative model of patient-centeredness based on the current literature. This model can be used to improve upon the comparability of research results. Through a detailed insight into the existence and evidence of measurement dimensions of patient-centeredness, existing gaps in this field will be shown. Finally, the expert assessment will show the relevance and feasibility of the concept and measures in clinical practice and health services research. Therefore, this study will contribute important knowledge to enhance future research on patient-centeredness and establish a foundation for its implementation.