[Patients are Satisfied with the Physician-Patient Communication: A Pilot Study Applying the "Individual Clinician Feedback" Questionnaire]. / Patienten zeigen sich zufrieden mit der Arzt-Patienten-Kommunikation ­ eine Pilotstudie mit dem "Individual Clinician Feedback"- Fragebogen.

AIM OF THE STUDY: Patient-centeredness as an essential aspect of quality of patient care is becoming increasingly important. The aim of the pilot study is to gain insight into the physician-patient communication from the patient's perspective. A German questionnaire in a maximum care hospital was tested. METHODS: The German "Individual Clinician Feedback" questionnaire (ICF) was tested in a pilot study in the special consultation in a voluntary cohort of surgeons. In the survey period from June to August 2015, the questionnaire was given to the patient. The physicians received their assessment results as a compressed score. They were rated on a scale of 1-10 on which 10 is "very good". RESULTS: 12 physicians were recruited from five departments. There was a high response rate of 46% (n=219). The patients evaluated the communication as very good (on average over all items and physicians 8.5 to 9.5 points). 89% of the patients had the feeling that the doctor took adequate time for them, while 50% of the patients had a consultation time of 11-20 min. 12% of the patients had still open questions after treatment that they did not ask. 19% and 21% of patients reported that the physician has not asked them if they had any questions, or that they just forgot about it at the end of treatment. CONCLUSION: The results of the pilot study are associated with a good response rate and patients were mostly very satisfied with the physician-patient communication. However, a selection bias among participating physicians is likely.

Specific barriers to the conduct of randomised clinical trials on medical devices.

BACKGROUND: Medical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal regulation for demonstration of benefits and exclusion of harms to patients. The medical device industry argues that the classical evidence hierarchy cannot be applied for medical devices, as randomised clinical trials are impossible to perform. This article aims to identify the barriers for randomised clinical trials on medical devices. METHODS: Systematic literature searches without meta-analysis and internal European Clinical Research Infrastructure Network (ECRIN) communications taking place during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project. RESULTS: In addition to the barriers that exist for all trials, we identified three major barriers for randomised clinical trials on medical devices, namely: (1) randomisation, including timing of assessment, acceptability, blinding, choice of the comparator group and considerations on the learning curve; (2) difficulties in determining appropriate outcomes; and (3) the lack of scientific advice, regulations and transparency. CONCLUSIONS: The present review offers potential solutions to break down the barriers identified, and argues for applying the randomised clinical trial design when assessing the benefits and harms of medical devices.

DEFINING THE RELEVANT OUTCOME MEASURES IN MEDICAL DEVICE ASSESSMENTS: AN ANALYSIS OF THE DEFINITION PROCESS IN HEALTH TECHNOLOGY ASSESSMENT.

BACKGROUND: Defining relevant outcome measures for clinical trials on medical devices (MD) is complex, as there is a large variety of potentially relevant outcomes. The chosen outcomes vary widely across clinical trials making the assessment in evidence syntheses very challenging. The objective is to provide an overview on the current common procedures of health technology assessment (HTA) institutions in defining outcome measures in MD trials. METHODS: In 2012-14, the Web pages of 126 institutions involved in HTA were searched for methodological manuals written in English or German that describe methods for the predefinition process of outcome measures. Additionally, the institutions were contacted by email. Relevant information was extracted. All process steps were performed independently by two reviewers. RESULTS: Twenty-four manuals and ten responses from the email request were included in the analysis. Overall, 88.5 percent of the institutions describe the type of outcomes that should be considered in detail and 84.6 percent agree that the main focus should be on patient relevant outcomes. Specifically related to MD, information could be obtained in 26 percent of the included manuals and email responses. Eleven percent of the institutions report a particular consideration of MD related outcomes. CONCLUSIONS: This detailed analysis on common procedures of HTA institutions in the context of defining relevant outcome measures for the assessment of MD shows that standardized procedures for MD from the perspective of HTA institutions are not widespread. This leads to the question if a homogenous approach should be implemented in the field of HTA on MD.

HEALTH TECHNOLOGY ASSESSMENT OF PUBLIC HEALTH INTERVENTIONS: A SYNTHESIS OF METHODOLOGICAL GUIDANCE.

OBJECTIVES: The evaluation of public health interventions poses some challenges. As a consequence, health technology assessment (HTA) methods for public health interventions (PHI) have to be adapted. This study aimed to summarize the available guidance on methods for HTA of PHI. METHODS: We systematically searched for methodological guidance on HTA of PHIs. Our focus was on research synthesis methods to evaluate effectiveness. Relevant information was synthesized narratively in a standardized way. RESULTS: Only four guidance documents were identified specifically for HTAs of PHI. The approaches used for HTAs of PHIs are broader and more flexible than those for medical interventions. For this reason, there is a tendency to identify the intervention components and context factors that influence the effectiveness and transferability of an intervention rather than to assess its effectiveness in general. The details in the guidance vary without justification. Unjustified heterogeneity between the different guidance approaches is most pronounced for quality assessment, assessment of applicability, and methods to integrate qualitative and quantitative evidence. Descriptions for the assessment of integrity, heterogeneity, sustainability, context factors, and applicability are often vague. CONCLUSIONS: The heterogeneity in approaches indicates that there is currently no consensus on methods to deal with the challenges of the PHI evaluations. A possible explanation for this may be that the methods are not sufficiently developed, and advantages and disadvantages of a certain method in relation to the research question (e.g., broad/focused) have not yet been sufficiently evaluated.

Studies analysing the need for health-related information in Germany - a systematic review.

BACKGROUND: Exploring health-related information needs is necessary to better tailor information. However, there is a lack of systematic knowledge on how and in which groups information needs has been assessed, and which information needs have been identified. We aimed to assess the methodology of studies used to assess information needs, as well as the topics and extent of health-related information needs and associated factors in Germany. METHODS: A systematic search was performed in Medline, Embase, Psycinfo, and all databases of the Cochrane Library. All studies investigating health-related information needs in patients, relatives, and the general population in Germany that were published between 2000 and 2012 in German or English were included. Descriptive content analysis was based on predefined categories. RESULTS: We identified 19 studies. Most studies addressed cancer or rheumatic disease. Methods used were highly heterogeneous. Apart from common topics such as treatment, diagnosis, prevention and health promotion, etiology and prognosis, high interest ratings were also found in more specific topics such as complementary and alternative medicine or nutrition. Information needs were notable in all surveyed patient groups, relatives, and samples of the general population. Younger age, shorter duration of illness, poorer health status and higher anxiety and depression scores appeared to be associated with higher information needs. CONCLUSION: Knowledge about information needs is still scarce. Assuming the importance of comprehensive information to enable people to participate in health-related decisions, further systematic research is required.

Up-to-dateness of reviews is often neglected in overviews: a systematic review.

BACKGROUND AND OBJECTIVE: As systematic reviews may run out of date, it might be necessary to update them. Out-of-date reviews may jeopardize the comparability when used in the context of overviews (review of reviews). METHODS: Seven electronic databases were searched for overviews up to November 2012. We first aimed to analyze whether the authors of overviews additionally searched for primary studies or alternatively explained why they did not. Second, we sought to analyze the actual publication lag (publication date of the overview - publication date of the review) in overviews and to develop recommendations for authors of overviews. RESULTS: We included 147 overviews. The mean publication lag in overviews was more than 5 years. A median of 36% of the reviews were published more than 6 years ago. Only one in four reviews considered up-to-dateness. The methods for updating reviews were heterogeneous. We found no overview that systematically investigated whether an update was necessary. CONCLUSION: The issue of up-to-dateness when conducting overviews seems to be neglected by most authors of overviews. Authors should assess the quality of evidence, based on their included reviews first.

Short- and long-term subjective medical treatment outcome of trauma surgery patients: the importance of physician empathy.

PURPOSE: To investigate accident casualties' long-term subjective evaluation of treatment outcome 6 weeks and 12 months after discharge and its relation to the experienced surgeon's empathy during hospital treatment after trauma in consideration of patient-, injury-, and health-related factors. The long-term results are compared to the 6-week follow-up outcomes. PATIENTS AND METHODS: Two hundred and seventeen surgery patients were surveyed at 6 weeks, and 206 patients at 12 months after discharge from the trauma surgical general ward. The subjective evaluation of medical treatment outcome was measured 6 weeks and 12 months after discharge with the respective scale from the Cologne Patient Questionnaire. Physician Empathy was assessed with the Consultation and Relational Empathy Measure. The correlation between physician empathy and control variables with the subjective evaluation of medical treatment outcome 12 months after discharge was identified by means of logistic regression analysis under control of sociodemographic and injury-related factors. RESULTS: One hundred and thirty-six patients were included within the logistic regression analysis at the 12-month follow-up. Compared to the 6-week follow-up, the level of subjective evaluation of medical treatment outcome was slightly lower and the association with physician empathy was weaker. Compared to patients who rated the empathy of their surgeon lower than 31 points, patients with ratings of 41 points or higher had a 4.2-fold higher probability to be in the group with a better medical treatment outcome (3.5 and above) on the Cologne Patient Questionnaire scale 12 months after discharge from hospital (P=0.009, R (2)=33.5, 95% confidence interval: 1.440-12.629). CONCLUSION: Physician empathy is the strongest predictor for a higher level of trauma patients' subjective evaluation of treatment outcome 6 weeks and 12 months after discharge from the hospital. Interpersonal factors between surgeons and their patients are possible key levers for improving patient outcomes in an advanced health system. Communication trainings for surgeons might prepare them to react appropriately to their patients' needs and lead to satisfactory outcomes for both parties.

Improving the adherence of type 2 diabetes mellitus patients with pharmacy care: a systematic review of randomized controlled trials.

BACKGROUND: Oral medication for patients with type 2 diabetes mellitus plays an important role in diabetes care and is associated with a high level self-care behavior and self-management. However, poor adherence to diabetes treatment is common which causes severe health complications and increased mortality. Barriers to adherence may consist of complex treatment regimens often along with long-term multi-therapies, side effects due to the medication as well as insufficient, incomprehensible or confusing information or instructions provided by the health care provider. Multidisciplinary approaches can support adherence success and can enable a more effective management of diabetes care. One approach in diabetes care can be the involvement of a pharmacist. The aim was to analyze the effectiveness of adherence-enhancing pharmacist interventions for oral medication in type 2 diabetes mellitus. METHODS: A systematic review of randomized controlled trials. The study quality was assessed with the Cochrane risk of bias tool. RESULTS: Of 491 hits, six publications were included. Two studies mainly examining educational interventions showed a significant improvement in adherence. Moreover, the quality of the included studies was deficient. CONCLUSION: Although pharmacist interventions might potentially improve adherence to type 2 diabetes mellitus medication, high-quality studies are needed to assess effectiveness.

Adherence-enhancing interventions for active antiretroviral therapy in sub-Saharan Africa: a systematic review and meta-analysis.

UNLABELLED: Background In sub-Saharan Africa, an estimated 23% of HIV-infected patients are nonadherent. The objective was to evaluate the effectiveness of adherence-enhancing interventions for active antiretroviral therapy (ART) in HIV-infected patients in sub-Saharan Africa. METHODS: A systematic literature search was performed with the following inclusion criteria: adult HIV patients treated with ART, an intervention to enhance patient adherence, adherence rate as an outcome, a clinical or patient outcome, a randomised controlled trial and conducted in sub-Saharan Africa. Studies were selected by two reviewers independently. Data on patient characteristics, interventions, adherence definition and measures, and results were extracted. The risk of bias was evaluated by two reviewers independently. A meta-analysis was performed where appropriate. All discrepancies were discussed until consensus. RESULTS: Six trials fulfilled all inclusion criteria. One showed statistically significant results in favour of the intervention for adherence rate and clinical outcome. The other studies showed either no significant results for any outcome or heterogeneous results depending on the outcome type. Aside from the clinical outcomes in one study, all outcomes showed a tendency in favour of the intervention groups. In the meta-analysis short message service (SMS) interventions showed a statistically significant effect on adherence (risk difference=-0.10; 95% confidence interval (CI): -0.17 to -0.03) and modified directly observed therapy (DOT) showed a significant effect on mortality (relative risk=0.75; 95% CI: 0.44-1.26). CONCLUSION: The adherence-enhancing interventions (DOT, SMS interventions, counselling plus an alarm device) increased adherence only slightly, possibly because the high baseline adherence causes a ceiling effect.

Adherence influencing factors in patients taking oral anticancer agents: a systematic review.

BACKGROUND: The use of oral anticancer agents increased steadily in the last decades. Although oral anticancer agent adherence is important for a successful treatment, many patients are insufficiently adherent. PURPOSE: To evaluate adherence influencing factors in patients taking oral anticancer agents. METHODS: A systematic literature search was performed in Medline and Embase. Titles and abstracts and in case of relevance, full-texts were screened according to predefined inclusion criteria. The risk of bias was assessed. Both were carried out independently by two reviewers. Relevant data on study characteristics and results were extracted in standardized tables by one reviewer and checked by a second. A meta-analysis was not performed because of clinical and methodological heterogeneity between the studies to avoid misleading results. Data were synthesized in narrative way using a standardized procedure. RESULTS: Twenty-two relevant studies were identified. The study quality was moderate. Especially the risk of bias regarding the measurement of influencing factors and adherence was mostly unclear. Social support, intake of aromatase inhibitors, and lower out-of-pocket costs for OACA seem to have a positive effect on adherence. Depression and the number of different medications seem to have a negative effect on adherence. Low age and very high age seem to be associated with lower adherence. The remaining factors showed either mostly no influence or were heterogeneous regarding the effect direction and statistical significance. CONCLUSIONS: There are some factors that seem to have influence on adherence in patients taking OACA. However, due to the heterogeneity no general conclusions can be made also for these factors that can be applied to all indications, medications, settings, countries etc. The results should rather be considered as indications for factors that can have an influence on adherence to OACA.

Methods for systematic reviews of health economic evaluations: a systematic review, comparison, and synthesis of method literature.

INTRODUCTION: The quality of systematic reviews of health economic evaluations (SR-HE) is often limited because of methodological shortcomings. One reason for this poor quality is that there are no established standards for the preparation of SR-HE. The objective of this study is to compare existing methods and suggest best practices for the preparation of SR-HE. METHODS: To identify the relevant methodological literature on SR-HE, a systematic literature search was performed in Embase, Medline, the National Health System Economic Evaluation Database, the Health Technology Assessment Database, and the Cochrane methodology register, and webpages of international health technology assessment agencies were searched. The study selection was performed independently by 2 reviewers. Data were extracted by one reviewer and verified by a second reviewer. On the basis of the overlaps in the recommendations for the methods of SR-HE in the included papers, suggestions for best practices for the preparation of SR-HE were developed. RESULTS: Nineteen relevant publications were identified. The recommendations within them often differed. However, for most process steps there was some overlap between recommendations for the methods of preparation. The overlaps were taken as basis on which to develop suggestions for the following process steps of preparation: defining the research question, developing eligibility criteria, conducting a literature search, selecting studies, assessing the methodological study quality, assessing transferability, and synthesizing data. DISCUSSION: The differences in the proposed recommendations are not always explainable by the focus on certain evaluation types, target audiences, or integration in the decision process. Currently, there seem to be no standard methods for the preparation of SR-HE. The suggestions presented here can contribute to the harmonization of methods for the preparation of SR-HE.

Factors influencing adherence in Hepatitis-C infected patients: a systematic review.

BACKGROUND: Adherence is a crucial point for the successful treatment of a hepatitis-C virus infection. Studies have shown that especially adherence to ribavirin is important.The objective of this systematic review was to identify factors that influence adherence in hepatitis-C infected patients taking regimes that containing ribavirin. METHODS: A systematic literature search was performed in Medline and Embase in March 2014 without limits for publication date. Titles and abstracts and in case of relevance, full-texts were screened according to predefined inclusion criteria. The risk of bias was assessed. Both process steps were carried out independently by two reviewers. Relevant data on study characteristics and results were extracted in standardized tables by one reviewer and checked by a second. Data were synthesized in a narrative way using a standardized procedure. RESULTS: Nine relevant studies were identified. The number of analyzed patients ranged between 12 and 5706 patients. The study quality was moderate. Especially the risk of bias regarding the measurement of influencing factors was mostly unclear."Psychiatric disorders" (N = 5) and having to take "higher doses of ribavirin" (N = 3) showed a negative influence on adherence. In contrast, a "HIV co-infection" (N = 2) and the "hemoglobin level" (N = 2) were associated with a positive influence on adherence. Furthermore, there is the tendency that male patients are more adherent than female patients (N = 6). "Alcohol consumption" (N = 2), "education", "employment status", "ethnic group","hepatitis-C virus RNA" (N = 4), "genotype" (N = 5), "metavir activity" (N = 1) and "weight" (N = 3) showed mostly no effect on adherence. Although, some studies showed statistically significant results for "age", "drug use" , "genotype", "medication dose interferon", and "treatment experience" the effect is unclear because effect directions were partly conflicting.The other factors were heterogeneous regarding the effect direction and/or statistical significance. CONCLUSION: There are some factors that seem to show an influence on adherence. However, due to the heterogeneity (e.g. patient characteristics, regimes, settings, countries) no general conclusions can be made. The results should rather be considered as indications for factors that can have an influence on adherence in hepatitis-C infected patients taking regimes that containing ribavirin.

Systematic review finds overlapping reviews were not mentioned in every other overview.

OBJECTIVES: The objective of this study was to determine if the authors mention overlapping reviews in overviews (reviews of reviews). In addition, we aimed to calculate the actual overlap in published overviews using newly introduced, validated measures. STUDY DESIGN AND SETTINGS: We systematically searched for overviews from 2009 to 2011. Reviews included in the overviews were obtained. Tables (review×primary publication) were generated for each overview. The first occurrence of a primary publication is defined as the index publication. We calculated the "corrected covered area" (CCA) as a measure of overlap by dividing the frequency of repeated occurrences of the index publication in other reviews by the product of index publications and reviews, reduced by the number of index publications. Subgroup analyses were performed to investigate further differences in the overviews. RESULTS: Only 32 of 60 overviews mentioned overlaps. The median CCA was 4.0. Validation of the CCA and other overlap measures was in accordance with our predefined hypotheses. The degree of overlap tended to be higher in health technology assessment reports than in journal publications and was higher with increasing numbers of publications. CONCLUSIONS: Overlaps must be reported in well-conducted overviews, and this can comprehensively be accomplished using the CCA method.

Adherence enhancing interventions for oral anticancer agents: a systematic review.

BACKGROUND: The use of oral anticancer agents has increased in the last decades. Adherence is a crucial factor for the success of oral anticancer agent therapy. However, many patients are non-adherent. OBJECTIVE: The objective was to evaluate the effectiveness of adherence interventions in patients taking oral anticancer agents. METHODS: A systematic literature search was performed in Medline and Embase. Titles and abstracts and in case of potential relevance, full-texts were assessed for eligibility according to the predefined inclusion criteria. The study quality was evaluated. Both process steps were carried out independently by two reviewers. Relevant data on study design, patients, interventions and results were extracted in standardized tables by one reviewer and checked by a second reviewer. RESULTS: Six controlled studies were included. Only one study was randomized. The study quality was moderate to low. One study showed statistically significant results in favor of the adherence intervention, two studies showed a tendency in favor of the intervention, one study showed an inconsistent result depending on the adherence definition and one study showed almost identical adherence rates in both groups. One study showed a tendency in favor of the control group. CONCLUSIONS: Although most of the interventions are not very effective, it appears that certain adherence enhancing interventions could have a promising effect. One crucial point is the consideration of the baseline adherence when choosing patients to avoid ceiling effects. The evidence is limited due to lack of sufficient studies and partly inconsistent results. Further high quality studies are needed.

Methodological approaches in conducting overviews: current state in HTA agencies.

OBJECTIVES: Overviews search for reviews rather than for primary studies. They might have the potential to support decision making within a shorter time frame by reducing production time. We aimed to summarize available instructions for authors intending to conduct overviews as well as the currently applied methodology of overviews in international Health Technology Assessment (HTA) agencies. METHODS: We identified 127 HTA agencies and scanned their websites for methodological handbooks as well as published overviews as HTA reports. Additionally, we contacted HTA agencies by e-mail to retrieve possible unidentified handbooks or other related sources. RESULTS: In total, eight HTA agencies providing methodological support were found. Thirteen HTA agencies were found to have produced overviews since 2007, but only six of them published more than four overviews. Overviews were mostly employed in HTA products related to rapid assessment. Additional searches for primary studies published after the last review are often mentioned in order to update results. CONCLUSIONS: Although the interest in overviews is rising, little methodological guidance for the conduct of overviews is provided by HTA agencies. Overviews are of special interest in the context of rapid assessments to support policy-making within a short time frame. Therefore, empirical work on overviews needs to be extended. National strategies and experience should be disclosed and discussed.

[Overviews - status quo, potentials and perspectives]. / Overviews - Status Quo, Potentiale und Ausblick.

The increase in scientific literature has led reviewers to conduct overviews, hereby creating a new publication type. Overviews of reviews may have several advantages. For example, they can be conducted in a shorter time frame, they offer the opportunity of providing decision makers with a broader summary of the evidence, allowing comparison of multiple treatments, and they can be helpful in investigating discordant findings from multiple systematic reviews. However, there are some specific characteristics concerning methodology in conducting overviews. Questions that arise are how to deal with overlapping reviews, how the quality of the included reviews should be assessed, how discordant results should be dealt with, whether and how additional searches for current primary studies should be conducted. Overviews of reviews often lack methodological rigour. Methodological standards and reporting guidelines for overviews are needed to improve the quality of this new publication type.

Cost-effectiveness of adherence interventions for highly active antiretroviral therapy: a systematic review.

OBJECTIVES: The objective of this systematic review was to evaluate the cost-effectiveness of interventions aiming to increase the adherence to highly active antiretroviral therapy (HAART) in HIV-infected patients in developed countries (WHO stratum A). METHODS: A systematic search for comparative health economic studies was conducted in the following databases: EMBASE, MEDLINE, NHS Economic Evaluation Database, CINAHL, HEED, and EconLit. The identified publications were selected by two reviewers independently according to predefined inclusion and exclusion criteria. Furthermore, these were evaluated according to a standardized checklist and finally extracted, analyzed, and summarized. RESULTS: After reviewing the abstracts and full texts four relevant studies were identified. Different educational programs were compared as well as the Directly Observed Therapy (DOT). A critical aspect to be considered in particular was the poor transparency of the cost data. In three cost-utility analyses the costs per quality-adjusted life-year (QALY) in the baseline scenario were each under USD 15,000. The sensitivity analyses with a presumed maximum threshold of USD 50,000/QALY showed a predominantly cost-effective result. In one study that examined DOT the costs add up to over USD 150,000/QALY. CONCLUSIONS: It seems that adherence interventions for HAART in HIV-infected patients can be cost-effective. Nevertheless, the quality of the included studies is deficient and only a few of the possible adherence interventions are taken into consideration. A final assessment of the cost-effectiveness of adherence interventions in general is, therefore, not possible.

50% adherence of patients suffering chronic conditions--where is the evidence?

The World Health Organization states that in a widespread report that "in developed countries, adherence among patients suffering chronic diseases averages only 50%". We followed the quoted references to this statement. The data basis for this statement is one randomized controlled trial (RCT) on hypertensive steel workers in Canada published in 1975 and one study dealing with neurotic outpatients in Pennsylvania, USA published in 1965. Both studies are not suitable to assume such generalized adherence estimation and are not for different reasons transferable to today's patient care.