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1.  Placement matching of alcohol-dependent patients based on a standardized intake assessment: rationale and design of a randomized controlled trial 
BMC Psychiatry  2014;14(1):286.
Despite considerable research on substance-abuse placement matching, evidence is still inconclusive. The aims of this exploratory trial are to evaluate (a) the effects of following matching guidelines on health-care costs and heavy drinking, and (b) factors affecting the implementation of matching guidelines in the treatment of alcohol-dependent patients.
A total of 286 alcohol-dependent patients entering one of four participating detoxification units and having no arrangements for further treatment will be recruited. During the first week of treatment, all patients will be administered Measurements in the Addictions for Triage and Evaluation (MATE), European Quality of Life-Five Dimensions health status questionnaire (EQ-5D), and the Client Socio-Demographic and Service Receipt Inventory—European Version (CSSRI-EU). Patients who are randomly allocated to the intervention group will receive feedback regarding their assessment results, including clear recommendations for subsequent treatment. Patients of the control group will receive treatment as usual and, if requested, global feedback regarding their assessment results, but no recommendations for subsequent treatment. At discharge, treatment outcome and referral decisions will be recorded. Six months after discharge, patients will be administered MATE-Outcome, EQ-5D, and CSSRI-EU during a telephone interview.
This trial will provide evidence on the effects and costs of using placement-matching guidelines based on a standardized assessment with structured feedback in the treatment of alcohol-dependent patients. A process evaluation will be conducted to facilitate better understanding of the relationship between the use of guidelines, outcomes, and potential mediating variables.
Trial registration
German Clinical Trials Register DRKS00005035. Registered 03 June 2013.
PMCID: PMC4198792  PMID: 25312546
Placement-matching guidelines; MATE; Level of care; Alcohol dependence; Health-services research
2.  Balancing the presentation of information and options in patient decision aids: an updated review 
Standards for patient decision aids require that information and options be presented in a balanced manner; this requirement is based on the argument that balanced presentation is essential to foster informed decision making. If information is presented in an incomplete/non-neutral manner, it can stimulate cognitive biases that can unduly affect individuals’ knowledge, perceptions of risks and benefits, and, ultimately, preferences. However, there is little clarity about what constitutes balance, and how it can be determined and enhanced. We conducted a literature review to examine the theoretical and empirical evidence related to balancing the presentation of information and options.
A literature search related to patient decision aids and balance was conducted on Medline, using MeSH terms and PubMed; this search supplemented the 2011 Cochrane Collaboration’s review of patient decision aids trials. Only English language articles relevant to patient decision making and addressing the balance of information and options were included. All members of the team independently screened clusters of articles; uncertainties were resolved by seeking review by another member. The team then worked in sub-groups to extract and synthesise data on theory, definitions, and evidence reported in these studies.
A total of 40 articles met the inclusion criteria. Of these, six explained the rationale for balancing the presentation of information and options. Twelve defined “balance”; the definition of “balance” that emerged is as follows: “The complete and unbiased presentation of the relevant options and the information about those options—in content and in format—in a way that enables individuals to process this information without bias”. Ten of the 40 articles reported assessing the balance of the relevant decision aid. All 10 did so exclusively from the users’ or patients’ perspective, using a five-point Likert-type scale. Presenting information in a side-by-side display form was associated with more respondents (ranging from 70% to 96%) judging the information as “balanced”.
There is a need for comparative studies investigating different ways to improve and measure balance in the presentation of information and options in patient decision aids.
PMCID: PMC4044010  PMID: 24625214
3.  Basing information on comprehensive, critically appraised, and up-to-date syntheses of the scientific evidence: a quality dimension of the International Patient Decision Aid Standards 
Patients and clinicians expect patient decision aids to be based on the best available research evidence. Since 2005, this expectation has translated into a quality dimension of the International Patient Decision Aid Standards.
We reviewed the 2005 standards and the available literature on the evidence base of decision aids as well as searched for parallel activities in which evidence is brought to bear to inform clinical decisions. In conducting this work, we noted emerging and research issues that require attention and may inform this quality dimension in the future.
This dimension requires patient decision aids to be based on research evidence about the relevant options and the nature and likelihood of their effect on outcomes that matter to patients. The synthesis of evidence should be comprehensive and up-to-date, and the evidence itself subject to critical appraisal. Ethical (informed patient choice), quality-of-care (patient-centered care), and scientific (evidence-based medicine) arguments justify this requirement. Empirical evidence suggests that over two thirds of available decision aids are based on high-quality evidence syntheses. Emerging issues identified include the duties of developers regarding the conduct of systematic reviews, the impact of comparative effectiveness research, their link with guidelines based on the same evidence, and how to present the developers’ confidence in the estimates to the end-users. Systematic application of the GRADE system, common in contemporary practice guideline development, could enhance satisfaction of this dimension.
While theoretical and practical issues remained to be addressed, high-quality patient decision aids should adhere to this dimension requiring they be based on comprehensive and up-to-date summaries of critically appraised evidence.
PMCID: PMC4044946  PMID: 24625191
4.  Shared decision-making in antihypertensive therapy: a cluster randomised controlled trial 
BMC Family Practice  2013;14:135.
Hypertension is one of the key factors causing cardiovascular diseases. A substantial proportion of treated hypertensive patients do not reach recommended target blood pressure values. Shared decision making (SDM) is to enhance the active role of patients. As until now there exists little information on the effects of SDM training in antihypertensive therapy, we tested the effect of an SDM training programme for general practitioners (GPs). Our hypotheses are that this SDM training (1) enhances the participation of patients and (2) leads to an enhanced decrease in blood pressure (BP) values, compared to patients receiving usual care without prior SDM training for GPs.
The study was conducted as a cluster randomised controlled trial (cRCT) with GP practices in Southwest Germany. Each GP practice included patients with treated but uncontrolled hypertension and/or with relevant comorbidity. After baseline assessment (T0) GP practices were randomly allocated into an intervention and a control arm. GPs of the intervention group took part in the SDM training. GPs of the control group treated their patients as usual. The intervention was blinded to the patients. Primary endpoints on patient level were (1) change of patients’ perceived participation (SDM-Q-9) and (2) change of systolic BP (24h-mean). Secondary endpoints were changes of (1) diastolic BP (24h-mean), (2) patients’ knowledge about hypertension, (3) adherence (MARS-D), and (4) cardiovascular risk score (CVR).
In total 1357 patients from 36 general practices were screened for blood pressure control by ambulatory blood pressure monitoring (ABPM). Thereof 1120 patients remained in the study because of uncontrolled (but treated) hypertension and/or a relevant comorbidity. At T0 the intervention group involved 17 GP practices with 552 patients and the control group 19 GP practices with 568 patients. The effectiveness analysis could not demonstrate a significant or relevant effect of the SDM training on any of the endpoints.
The study hypothesis that the SDM training enhanced patients’ perceived participation and lowered their BP could not be confirmed. Further research is needed to examine the impact of patient participation on the treatment of hypertension in primary care.
Trial registration
German Clinical Trials Register (DRKS): DRKS00000125
PMCID: PMC3847233  PMID: 24024587
Hypertension; Shared decision-making; Ambulatory blood pressure monitoring; Educational training; Primary care; Family medicine; Cluster randomised controlled trial
5.  Implementation of shared decision making by physician training to optimise hypertension treatment. Study protocol of a cluster-RCT 
Hypertension is one of the key factors causing cardiovascular diseases which make up the most frequent cause of death in industrialised nations. However about 60% of hypertensive patients in Germany treated with antihypertensives do not reach the recommended target blood pressure. The involvement of patients in medical decision making fulfils not only an ethical imperative but, furthermore, has the potential of higher treatment success. One concept to enhance the active role of patients is shared decision making. Until now there exists little information on the effects of shared decision making trainings for general practitioners on patient participation and on lowering blood pressure in hypertensive patients.
In a cluster-randomised controlled trial 1800 patients receiving antihypertensives will be screened with 24 h ambulatory blood pressure monitoring in their general practitioners’ practices. Only patients who have not reached their blood pressure target (approximately 1200) will remain in the study (T1 – T3). General practitioners of the intervention group will take part in a shared decision making-training after baseline assessment (T0). General practitioners of the control group will treat their patients as usual. Primary endpoints are change of systolic blood pressure and change of patients’ perceived participation. Secondary endpoints are changes of diastolic blood pressure, knowledge, medical adherence and cardiovascular risk. Data analysis will be performed with mixed effects models.
The hypothesis underlying this study is that shared decision making, realised by a shared decision making training for general practitioners, activates patients, facilitates patients’ empowerment and contributes to a better hypertension control. This study is the first one that tests this hypothesis with a (cluster-) randomised trial and a large sample size.
Trial registration
WHO International Clinical Trials:
PMCID: PMC3467178  PMID: 22966894
Arterial hypertension; Cardiovascular diseases; Cardiovascular risk; Shared decision making; Educational training; Blood pressure control; Ambulatory blood pressure monitoring; Adherence; Primary care; Family medicine

Results 1-5 (5)