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.

Translation and psychometric evaluation of the German version of the IcanSDM measure - a cross-sectional study among healthcare professionals.

BACKGROUND: Shared decision-making (SDM) between patients and healthcare professionals (HCPs) is a key component of patient-centred care. To implement SDM in clinical practice and to evaluate its effects, it is helpful to know about HCPs' perception of SDM barriers. The measure IcanSDM was developed in Canada and assesses the perception of SDM barriers. To our knowledge, no equivalent measure exists in German. Therefore, the aim of this study was to translate and adapt the IcanSDM measure to be used by a German speaking population and evaluate its psychometric properties. METHODS: This is a cross-sectional psychometric study based on a secondary analysis of baseline data from a SDM implementation study. The original 8-item IcanSDM was translated into German using a team translation protocol. We assessed comprehensibility via cognitive interviews with n = 11 HCPs. Based on results of cognitive interviews, the translated IcanSDM version was revised. Two hundred forty-two HCPs filled out the measure. Psychometric analysis included acceptance (completion rate), item characteristics (response distribution, skewness, item difficulties, corrected item-total correlations, inter-item correlations), factorial structure (confirmatory factor analysis (CFA), model fit), and internal consistency (Cronbach's α). RESULTS: We translated and adapted the German IcanSDM successfully except for item 8, which had to be revised after the cognitive interviews. Completion rate was 98%. Skewness of the items ranged between -.797 and 1.25, item difficulties ranged between 21.63 and 70.85, corrected item-total-correlations ranged between .200 and .475, inter-item correlations ranged between .005 and .412. Different models based on CFA results did not provide a valid factorial structure. Cronbach's α ranged between .563 and .651 for different factor models. CONCLUSION: We provide the first German measure for assessing perception of SDM barriers by HCPs. The German IcanSDM is a brief measure with good acceptance. However, we found unsatisfying psychometric properties, which were comparable to results of the original scale. In a next step, the IcanSDM should be further developed and modified and predictive validity should be evaluated.

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.

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.

Translation and psychometric evaluation of the German version of the Organisational Readiness for Implementing Change measure (ORIC): a cross-sectional study.

OBJECTIVES: To translate the Organisational Readiness for Implementing Change measure into German and assess its psychometric properties. DESIGN: Cross-sectional psychometric study based on secondary analysis of baseline data from a shared decision-making implementation study. SETTING: Three departments within one academic cancer centre in Hamburg, Germany. PARTICIPANTS: For comprehensibility assessment of the translated ORIC version, we conducted cognitive interviews with healthcare professionals (HCPs, n=11). Afterwards, HCPs (n=230) filled out the measure. PRIMARY AND SECONDARY OUTCOME MEASURES: The original English version of the ORIC was translated into German using a team translation protocol. Based on comprehensibility assessment via cognitive interviews with HCPs, the translated version was revised. We analysed acceptance (completion rate), factorial structure (exploratory factor analysis (EFA), confirmatory factor analysis (CFA), model fit), item characteristics (item difficulties, corrected item-total correlations, inter-item correlations) and internal consistency (Cronbach's α). RESULTS: Translation and cognitive testing of the German ORIC was successful except for item 10, which showed low comprehensibility as part of content validity in cognitive interviews. Completion rate was >97%. EFA and CFA provided a one-factorial structure. Item difficulties ranged between 55.98 and 65.32, corrected item-total-correlation ranged between 0.665 and 0.774, inter-item correlations ranged between 0.434 and 0.723 and Cronbach's α was 0.93. CONCLUSIONS: The German ORIC is a reliable measure with high completion rates and satisfying psychometric properties. A one-factorial structure of the German ORIC was confirmed. Item 10 showed limited comprehensibility and therefore reduces content validity of the measure. The German ORIC can be used to analyse organisational readiness for change as a precursor for implementation success of various interventions.

Assessing the relevance and implementation of patient-centredness from the patients' perspective in Germany: results of a Delphi study.

OBJECTIVE: Patient-centredness (PC) has particularly grown in relevance in health services research as well as in politics and there has been much research on its conceptualisation. However, conceptual work neglected the patients' perspective. Thus, it remains unclear which dimensions of PC matter most to patients. This study aims to assess relevance and current degree of implementation of PC from the perspective of chronically ill patients in Germany. METHODS: We conducted a Delphi study. Patients were recruited throughout Germany using community-based strategies (eg, newspapers and support groups). In round 1, patients rated relevance and implementation of 15 dimensions of PC anonymously. In round 2, patients received results of round 1 and were asked to re-rate their own results. Participants had to have at least one of the following chronic diseases: cancer, cardiovascular disease, mental disorder or musculoskeletal disorder. Furthermore, patients had to be at least 18 years old and had to give informed consent prior to participation. RESULTS: 226 patients participated in round 1, and 214 patients in round 2. In both rounds, all 15 dimensions were rated highly relevant, but currently insufficiently implemented. Most relevant dimensions included 'patient safety', 'access to care' and 'patient information'. Due to small sizes of subsamples between chronic disease groups, differences could not be computed. For the other subgroups (eg, single disease vs multi-morbidity), there were no major differences. CONCLUSION: This is one of the first studies assessing PC from patients' perspective in Germany. We showed that patients consider every dimension of PC relevant, but currently not well implemented. Our results can be used to foster PC healthcare delivery and to develop patient-reported experience measures to assess PC of healthcare 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.

Assessment of patient centredness through patient-reported experience measures (ASPIRED): protocol of a mixed-methods study.

INTRODUCTION: The impact of patient centredness (PC) in healthcare has grown over the years. However, conceptualisations of PC are heterogeneous. Existing patient-reported measures of PC have shown inconsistencies and shortcomings. This impedes the comparison of results across studies. To foster PC, it is important to know which dimensions matter most to patients and to be able to measure its current extent from the patients' perspective. This study aims (1) to assess relevance of dimensions of PC from the patients' perspective, (2) to develop and psychometrically test a core set of patient-reported experience measures (PREMs) assessing PC and (3) to investigate the feasibility of implementation of this core set in routine healthcare. METHODS AND ANALYSIS: A mixed-methods approach will be used. In phase 1, 200 patients will assess the relevance of the dimensions of PC in a Delphi study using a plain language description. In phase 2, the core set of PREMs will be developed through literature reviews, focus groups, key informant interviews and content validity ratings. The core set will be tested psychometrically in a cross-sectional study with 2000 inpatient and outpatients with different chronic conditions (ie, cancer, cardiovascular diseases, mental disorders and musculoskeletal disorders). In phase 3, the feasibility of implementation of the core set will be assessed through semistructured interviews with healthcare practitioners after piloting in routine care. Furthermore, an expert workshop will be held on how to foster implementation. 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 Ethics Committee of the Medical Association Hamburg, Germany (study ID: PV5724). The study results will be disseminated in scientific journals and through collaboration partners and plain language press releases.

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.

Use of the 9-item Shared Decision Making Questionnaire (SDM-Q-9 and SDM-Q-Doc) in intervention studies-A systematic review.

BACKGROUND: The Shared Decision Making Questionnaire (SDM-Q-9 and SDM-Q-Doc) is a 9-item measure of the decisional process in medical encounters from both patients' and physicians' perspectives. It has good acceptance, feasibility, and reliability. This systematic review aimed to 1) evaluate the use of the SDM-Q-9 and SDM-Q-Doc in intervention studies on shared decision making (SDM) in clinical settings, 2) describe how the SDM-Q-9 and SDM-Q-Doc performed regarding sensitivity to change, and 3) assess the methodological quality of studies and study protocols that use the measure. METHODS: We conducted a systematic review of studies published between 2010 and October 2015 that evaluated interventions to facilitate SDM. The search strategy comprised three databases (EMBASE, PsycINFO, and Medline), reference tracking, citation tracking, and personal knowledge. Two independent reviewers screened titles and abstracts as well as full texts of potentially relevant records. We extracted the data using a pilot tested sheet, and we assessed the methodological quality of included studies using the Quality Assessment Tools from the U.S. National Institute of Health (NIH). RESULTS: Five completed studies and six study protocols fulfilled the inclusion criteria. The measure was used in a variety of health care settings, mainly in Europe, to evaluate several types of interventions. The reported mean sum scores ranged from 42 to 75 on a scale from 0 to 100. In four studies no significant change was detected in the mean-differences between main groups. In the fifth study the difference was small. Quality assessment revealed a high risk of bias in four of the five completed studies, while the study protocols received moderate quality ratings. CONCLUSIONS: We found a wide range of areas in which the SDM-Q-9 and SDM-Q-Doc were applied. In the future this review may help researchers decide whether the measure fits their purposes. Furthermore, the review revealed risk of bias in previous trials that used the measure, and may help future trials decrease this risk. More research on the measure's sensitivity to change is strongly suggested.

Effectiveness of telephone-based aftercare case management for adult patients with unipolar depression compared to usual care: A randomized controlled trial.

BACKGROUND: Patients with depression often have limited access to outpatient psychotherapy following inpatient treatment. The objective of the study was to evaluate the long-term effectiveness of a telephone-based aftercare case management (ACM) intervention for patients with depression. METHODS: We performed a prospective randomized controlled trial in four psychotherapeutic inpatient care units with N = 199 patients with major depression or dysthymia (F32.x, F33.x, F34.1, according to the ICD-10). The ACM consisted of six phone contacts at two-week intervals performed by trained and certified psychotherapists. The control group received usual care (UC). The primary outcome was depressive symptom severity (BDI-II) at 9-month follow-up, and secondary outcomes were health-related quality of life (SF-8, EQ-5D), self-efficacy (SWE), and the proportion of patients initiating outpatient psychotherapy. Mixed model analyses were conducted to compare improvements between treatment groups. RESULTS: Regarding the primary outcome of symptom severity, the groups did not significantly differ after 3 months (p = .132; ES = -0.23) or at the 9-month follow-up (p = .284; ES = -0.20). No significant differences in health-related quality of life or self-efficacy were found between groups. Patients receiving ACM were more likely to be in outpatient psychotherapy after 3 months (OR: 3.00[1.12-8.07]; p = .029) and 9 months (OR: 4.78 [1.55-14.74]; p = .006) than those receiving UC. CONCLUSIONS: Although telephone-based ACM did not significantly improve symptom severity, it seems to be a valuable approach for overcoming treatment barriers to the clinical pathways of patients with depression regarding their access to outpatient psychotherapy.

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.

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.