Martin Härter

Assessing the Quality of Decision Support Technologies Using the International Patient Decision Aid Standards instrument (IPDASi)

Objectives To describe the development, validation and inter-rater reliability of an instrument to measure the quality of patient decision support technologies (decision aids). Design Scale development study, involving construct, item and scale development, validation and reliability testing. Setting There has been increasing use of decision support technologies – adjuncts to the discussions clinicians have with patients about difficult decisions. A global interest in developing these interventions exists among both for-profit and not-for-profit organisations. It is therefore essential to have internationally accepted standards to assess the quality of their development, process, content, potential bias and method of field testing and evaluation. Methods Scale development study, involving construct, item and scale development, validation and reliability testing. Participants Twenty-five researcher-members of the International Patient Decision Aid Standards Collaboration worked together to develop the instrument (IPDASi). In the fourth Stage (reliability study), eight raters assessed thirty randomly selected decision support technologies. Results IPDASi measures quality in 10 dimensions, using 47 items, and provides an overall quality score (scaled from 0 to 100) for each intervention. Overall IPDASi scores ranged from 33 to 82 across the decision support technologies sampled (n = 30), enabling discrimination. The inter-rater intraclass correlation for the overall quality score was 0.80. Correlations of dimension scores with the overall score were all positive (0.31 to 0.68). Cronbachs alpha values for the 8 raters ranged from 0.72 to 0.93. Cronbachs alphas based on the dimension means ranged from 0.50 to 0.81, indicating that the dimensions, although well correlated, measure different aspects of decision support technology quality. A short version (19 items) was also developed that had very similar mean scores to IPDASi and high correlation between short score and overall score 0.87 (CI 0.79 to 0.92). Conclusions This work demonstrates that IPDASi has the ability to assess the quality of decision support technologies. The existing IPDASi provides an assessment of the quality of a DSTs components and will be used as a tool to provide formative advice to DSTs developers and summative assessments for those who want to compare their tools against an existing benchmark.

Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials.

Objectives To assess the benefits and harms of reboxetine versus placebo or selective serotonin reuptake inhibitors (SSRIs) in the acute treatment of depression, and to measure the impact of potential publication bias in trials of reboxetine. Design Systematic review and meta-analysis including unpublished data. Data sources Bibliographic databases (Medline, Embase, PsycINFO, BIOSIS, and Cochrane Library), clinical trial registries, trial results databases, and regulatory authority websites up until February 2009, as well as unpublished data from the manufacturer of reboxetine (Pfizer, Berlin). Eligibility criteria Double blind, randomised, controlled trials of acute treatment (six weeks or more) with reboxetine versus placebo or SSRIs in adults with major depression. Outcome measures Remission and response rates (benefit outcomes), as well as rates of patients with at least one adverse event and withdrawals owing to adverse events (harm outcomes). Data extraction and data synthesis The procedures for data extraction and assessment of risk of bias were always conducted by one person and checked by another. If feasible, data were pooled by meta-analyses (random effects model). Publication bias was measured by comparing results of published and unpublished trials. Results We analysed 13 acute treatment trials that were placebo controlled, SSRI controlled, or both, which included 4098 patients. Data on 74% (3033/4098) of these patients were unpublished. In the reboxetine versus placebo comparison, no significant differences in remission rates were shown (odds ratio 1.17, 95% confidence interval 0.91 to 1.51; P=0.216). Substantial heterogeneity (I2=67.3%) was shown in the meta-analysis of the eight trials that investigated response rates for reboxetine versus placebo. A sensitivity analysis that excluded a small inpatient trial showed no significant difference in response rates between patients receiving reboxetine and those receiving placebo (OR 1.24, 95% CI 0.98 to 1.56; P=0.071; I2=42.1%). Reboxetine was inferior to SSRIs (fluoxetine, paroxetine, and citalopram) for remission rates (OR 0.80, 95% CI 0.67 to 0.96; P=0.015) and response rates (OR 0.80, 95% CI 0.67 to 0.95; P=0.01). Reboxetine was inferior to placebo for both harm outcomes (P<0.001 for both), and to fluoxetine for withdrawals owing to adverse events (OR 1.79, 95% CI 1.06 to 3.05; P=0.031). Published data overestimated the benefit of reboxetine versus placebo by up to 115% and reboxetine versus SSRIs by up to 23%, and also underestimated harm. Conclusions Reboxetine is, overall, an ineffective and potentially harmful antidepressant. Published evidence is affected by publication bias, underlining the urgent need for mandatory publication of trial data.

Measurement of shared decision making - a review of instruments

The last years have seen a clear move towards shared decision making (SDM) and increased patient involvement in many countries. However, as the field of SDM research is still relatively young, new instruments for the measurement of (shared) decision making (process, outcome and surrounding elements) are constantly being developed. Thus, the aims of this structured review were to give an update on current developments regarding the measurement in the field of SDM, as well as to give a short overview of published and unpublished instruments. We conducted an electronic literature search in PubMed and the Web of Science database, performed hand searches of relevant journals and contacted key authors in the field. We found eight scales that have been subjected to further psychometric testing, eleven new and psychometrically tested instruments and nine developments that are still in the publishing process. The results show that there is a trend towards measuring SDM processes from a dyadic approach (assessing both the patients and the clinicians perspective). More and more scales have been developed and tested in languages other than English, which indicates the growing research efforts in various countries. While reliability of most scales is good, they differ in their extent of validation. Further psychometric testing is needed, as well as the development of a theoretical measurement framework in order to improve consistency of measured constructs across research groups.

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.

Psychiatric disorders and associated factors in cancer: results of an interview study with patients in inpatient, rehabilitation and outpatient treatment.

An association between mental disorders, especially affective and anxiety disorders, and cancer has been reported in many studies. The present study investigated current (4-weeks-, 12-months-, and lifetime-prevalence rates of comorbid mental disorders in cancer patients. Through a cross-sectional design, 517 patients (75% female patients) from two acute inpatient care clinics, two rehabilitation clinics and nine specialised practices for oncology were examined with standardised scales for psychological burden and quality of life. Somatic parameters were assessed through standardised medical records. In the second-stage-examination, a sample of 200 patients was interviewed with standardised clinical interview (CIDI) in order to obtain DSM-IV diagnoses of mental disorders. Differences in the type of mental disorders were examined for gender, treatment setting, severity of cancer and physical impairment. Prevalence rates of mental disorders were 23.5% for the 4-weeks, 40% for the 12-months, and 56.5% for the lifetime periods. The current and 12-months rates of affective and anxiety disorders were approximately 25-33% higher than prevalence rates found in recent epidemiological studies of the general population. These higher rates were, however, mainly due to the preponderance of female patients with a higher risk for mental disorders compared with males. The most prevalent current disorders were affective (9.5%), and anxiety disorders (13%). Female gender was associated with an approximately 2-fold risk of mental disorders during the patients lifespan. Current diagnosis of affective disorders in women was highly related to the cancer. Physical impairment was also associated with the frequency of current psychiatric disorders, especially affective and anxiety disorders. The frequency of mental disorders in cancer patients does not differ from results of recent international epidemiological studies of the normal population. The slightly higher rates of anxiety disorders are mainly due to phobias (simple, social and agoraphobia) without urgent need for treatment. A relatively large portion of patients, however, fulfil the criteria of minor depressive disorder which deserves clinical attention.

High agreement of self-report and physician-diagnosed somatic conditions yields limited bias in examining mental-physical comorbidity.

OBJECTIVE To quantify the misclassification bias of self-reported somatic diseases and its impact on the estimation of comorbidity with mental disorders. STUDY DESIGN AND SETTING Data were drawn from the German National Health Interview and Examination Survey (N=7,124), which assessed both self-reported and physician-diagnosed somatic diseases. Eight chronic diseases were examined: coronary heart disease, heart failure, asthma, chronic bronchitis, diabetes, cancer, arthrosis, and arthritis. Mental disorders were assessed by means of the Munich-Composite International Interview. RESULTS The agreement of case ascertainment by patient self-report and physician diagnosis was high (kappa: 0.74-0.92), except for arthritis (0.53). False-positive and false-negative disease statuses were partly associated with age, sex, socioeconomic status, somatic comorbidities, marital status, and mood and anxiety disorders. In most conditions, the odds ratios (ORs) of comorbid mental disorders based on self-reported diseases were slightly overestimated with regard to mood disorders (relative OR: 0.91-1.38), whereas there proved to be no such trend regarding anxiety disorders (0.82-1.05). Substance disorders were partly biased without showing an interpretable trend across diseases (0.49-2.58). CONCLUSIONS Evaluation of mental-physical comorbidity based on self-reported and physician-diagnosed physical conditions yielded similar results, with modestly inflated ORs for mood disorders for several self-reported physical conditions.

Risk factors for chronic depression — A systematic review

BACKGROUND One of five patients with an acute depressive episode develops chronic depression. Risk factors for a current depressive episode to become chronic are insufficiently known. This review was conducted to examine which factors represent a risk factor for the development of chronic depression for patients diagnosed with a depressive episode. METHOD Medline, Psycinfo, ISI Web of Science, CINHAL and BIOSIS Previews were searched up until September 2007, complemented by handsearching in the December 1987 to December 2007 issues of Journal of Affective Disorders and investigating reference lists of included articles and existing reviews. On the basis of a formal checklist, two investigators independently decided which studies to include or exclude. RESULTS 25 relevant primary studies with a total of 5192 participants were included in the systematic review. Overall the methodological quality of the included studies was found to be sufficient. Data synthesis was performed via vote counting. The following risk factors were identified: younger age at onset, longer duration of depressive episode, and family history of mood disorders. Psychological comorbidity i.e. anxiety disorders, personality disorders and substance abuse, low level of social integration, negative social interaction and lower severity of depressive symptoms repeatedly appeared concurrently with chronic depression. LIMITATIONS Most included studies were cross-sectional thus drawing causal conclusions with regard to risk factors proved to be difficult. CONCLUSION Risk factors for a current depressive episode to become chronic were identified. To date only few significant longitudinal studies on this topic are available.

Policy and practice developments in the implementation of shared decision-making: an international perspective

Martin Harter, Dipl. Psych., MD PhDChair Department of Medical Psychology,Center for Psychosocial Medicine, UniversityMedical Center Hamburg-Eppendorf,Martinistrase 52, D-20246 Hamburg,Tel.: +49 (0) 40 / 7410-52978,Fax: +49 (0) 40/7410-58170E-Mail: m.haerter@uke.uni-hamburg.deTrudy van der Weijden, PhD, MDProfessor Implementation of Clinical PracticeGuidelines, School Caphri, Department ofGeneral Practice, Peter Debyeplein 1, 6229 HAMaastricht, P.O. Box 616, 6200 MD Maastricht,the Netherlands, Tel.: +31 43 3882877,Fax: +31 43 3619344E-Mail:trudy.vanderweijden@maastrichtuniversity.nlGlyn Elwyn, BA MB BCh MSc FRCGP PhDDirector of Research, Department of PrimaryCare and Public Health, Clinical EpidemiologyIRG, Cardiff University, Neuadd Meironnydd,Heath Park: Cardiff: CF14 4YS,Tel.: +44 29 20 68 71 95E-Mail: elwyng@cardiff.ac.uk

Quality of life in medically ill persons with comorbid mental disorders: a systematic review and meta-analysis.

Background: This systematic review aims to investigate the association between comorbid mental disorders and quality of life (QoL) in patients with chronic medical diseases. Methods: Studies investigating adults with diabetes mellitus, coronary artery disease, asthma, chronic back pain and colorectal cancer were included. Two reviewers independently extracted data and assessed methodological criteria. Effect sizes for QoL scores were analyzed in random-effects meta-analyses. Subgroup and sensitivity analyses were conducted. Results: The database search identified 7,291 references and 65 primary studies were included. Medically ill persons with comorbid mental disorders showed a significantly decreased overall (d = –1.10; 95% CI = –1.34 to –0.86), physical (d = –0.64; 95% CI = –0.74 to –0.53) and psychosocial (d = –1.18; 95% CI = –1.42 to –0.95) QoL compared to persons without mental disorders. Subgroup analyses did not reveal significant differences between the examined medical diseases or mental disorders. Conclusion: The review provides evidence of a substantially reduced psychosocial and physical QoL in medically ill patients with comorbid mental disorders. This patient-reported outcome highlights the importance of recognizing and treating comorbid mental disorders in the medically ill.

Development and psychometric properties of the Shared Decision Making Questionnaire – physician version (SDM-Q-Doc)

OBJECTIVE To develop and psychometrically test a brief instrument for assessing the physicians perspective of the shared decision-making process in clinical encounters. METHODS We adapted the 9-item Shared Decision Making Questionnaire (SDM-Q-9) for patients to generate a new version for physicians (SDM-Q-Doc). The physician version was tested in clinical encounters between 29 physicians and 324 patients in German outpatient care contexts. Analyses of the extent to which the instrument was accepted, the reliability of the instrument, and the factorial structure of the scale were performed. RESULTS Physicians showed a high level of acceptance toward the SDM-Q-Doc. Item discrimination parameters were above .4 for all but one item. An analysis of internal consistency yielded a Cronbachs α of .88. Factor analysis confirmed a one-dimensional structure. CONCLUSION The results of this study suggest that the SDM-Q-Doc is a well-accepted and reliable instrument for assessing the physicians perspective during SDM processes in clinical encounters. To our knowledge, the SDM-Q-Doc is the first psychometrically tested scale available for assessing the physicians perspective. PRACTICE IMPLICATIONS The SDM-Q-Doc can be used in studies that analyze the effectiveness of the implementation of SDM and as a quality indicator in quality assurance programs and health service assessments.