CRISTOPH – A cluster-randomised intervention study to optimise the treatment of patients with hypertension in General Practice

<p>Abstract</p> <p>Background</p> <p>Recent guidelines for the management of hypertension focus on treating patients according to their global cardiovascular risk (CVR), rather than strictly keeping blood pressure, or other risk factors, below set limit values. The objective of this study is to compare the effect of a simple versus a complex educational intervention implementing this new concept among General Practitioners (GPs).</p> <p>Methods/design</p> <p>A prospective longitudinal cluster-randomised intervention trial with 94 German GPs consecutively enroling 40 patients each with known hypertension. All GPs then received a written manual specifically developed to transfer the global concept of CVR into daily General Practice. After cluster-randomisation, half of the GPs additionally received a clinical outreach visit, with a trained peer discussing with them the concept of global CVR referring to example study patients from the respective GP. Main outcome measure is the improvement of calculated CVR six months after intervention in the subgroup of patients with high CVR (but no history of cardiovascular disease), defined as 10-year-mortality ≥ 5% employing the European SCORE formula. Secondary outcome measures include the intervention's effect on single risk factors, and on prescription rates of drugs targeting CVR. All outcome measures are separately studied in the three subgroups of patients with 1. high CVR (defined as above), 2. low CVR (SCORE < 5%), and 3. a history of cardiovascular disease. The influence of age, sex, social status, and the perceived quality of the respective doctor-patient-relation on the effects will be examined.</p> <p>Discussion</p> <p>To our knowledge, no other published intervention study has yet evaluated the impact of educating GPs with the goal to treat patients with hypertension according to their global cardiovascular risk.</p> <p>Trial registration</p> <p>ISRCTN44478543</p

Cooperative leadership as a condition for patient-reported rehabilitation success

Meyer T, Kleineke V, Stamer M. Cooperative leadership as a condition for patient-reported rehabilitation success. Frontiers in Rehabilitation Sciences. 2023;4: 1114666.Introduction: Rehabilitation is a complex intervention that takes place in a complex setting. The MeeR project (characteristics of successful rehabilitation facilities) aims to identify complex conditions of successful rehabilitation outcomes.; Methods: A project with a sequential mixed-methods study design with a quantitative prestudy and a qualitative main study was applied. In the quantitative study, quality assurance data of the German Pension Insurance was used to (1) develop and compute a multifacet z-standardized outcome index based on patient-reported outcome data, (2) rank k=273 orthopedic rehabilitation facilities comprising n=112,895 patients and k=86 cardiac rehabilitation institutions comprising n=30,299 patients based on their outcome index score by means of a league table, and (3) adjust the ranking by basic patient characteristics (age, gender, diagnosis, weeks out of work prior to rehabilitation, application for pension). In the qualitative main study, k=6 rehabilitation facilities (orthopedic and cardiac rehabilitation centers) were recruited based on the results of the quantitative analysis: three facilities that ranked top 10% and three facilities that ranked lowest 10% of the adjusted league table. All six rehabilitation facilities were visited each for 1 week by two researchers. We conducted participant observations, expert interviews with medical and administrative leaders, group discussions with rehab team members, and group discussions with patients. Subsequently, a systematic comparison of the results of the upper and lower 10% facilities was conducted to identify those characteristics that distinguished those institutions from one another.; Results: One of the three clusters of characteristics that distinguished the above and below 10% facilities related to teamwork or interdisciplinary cooperation: among others, the extent of interdisciplinary cooperation was higher in the rehabilitation facilities with a higher degree of success, the leading medical doctors were less dominant in these institutions, and there was also a more comprehensive representation of the team within team meetings, i.e., the quality and amount of interdisciplinary cooperation were higher in these institutions compared to rehabilitation facilities with a lower level of success.; Discussion: This project provided qualitative evidence for the role of interdisciplinary cooperation and collaborative leadership and its different facets for patient-related successful rehabilitation in orthopedic and cardiac rehabilitation. It provides valuable insights into the fabric and structure of a rehabilitation institution and a variety of target points for team development and group-leading interventions. © 2023 Meyer, Kleineke and Stamer

Noncompliance: a never-ending story: understanding the perspective of patients with rheumatoid arthritis

In der sozialwissenschaftlichen Forschung ist seit etwa 25 Jahren Konsens, dass der Begriff der Compliance in der medizinischen Therapieforschung wenig erhellend, wenn nicht gar kontraproduktiv ist. Dennoch wird in der medizinischen Welt nach wie vor problematisiert und skandalisiert, wenn Patient/innen ärztliche Verordnungen kritisch sehen oder diese tatsächlich nicht befolgen. Anknüpfend an diese Thematik sind Interviews mit Patientinnen und Patienten durchgeführt worden, die seit wenigstens acht bis zehn Jahren an rheumatoider Arthritis leiden, einer chronischen Erkrankung, die häufig zu Behinderungen und dem Verlust des Sozialstatus führt. Die Samplebildung erfolgte in Kooperation mit dem Deutschen Rheuma-Forschungszentrum (DRFZ) an der Charité in Berlin. Bei der Erhebungsmethode handelt es sich um teilstrukturierte Interviews mit einem narrativen Erzähleinstieg. Ausgewertet worden sind die Interviews sowohl inhaltsanalytisch als auch mittels einer Nutzung von Elementen der Grounded-Theory-Methodologie. Unsere qualitative Studie hat gezeigt, dass Patientinnen und Patienten große Anstrengungen unternehmen, ihre Krankheit zu bewältigen und dass es darauf ankäme, sie hierbei professionell zu unterstützen, statt ihre individuellen Entscheidungen für oder gegen therapeutische Empfehlungen zu kritisieren.For roughly the last 25 years there has been consensus in social science research that the term "compliance" in medical therapy research lacks clarity and may even be counter-productive. However, the medical world continues to be disconcerted and scandalized when patients take a critical attitude to doctors' instructions or indeed fail to comply with them. In order to explore this area, interviews were conducted with patients who have suffered for at least eight to ten years from rheumatoid arthritis, a chronic disease that often leads to disability and a decline in social status. The sample was created in cooperation with the German Rheumatism Research Center (DRFZ) at the Charité Berlin Hospital. The survey methodology comprised partially structured interviews with an initial narrative exploration. The interviews were analyzed both in terms of their content as well as with the use of elements of the framework concept of "grounded theory methodology." Our qualitative study has shown that patients take great efforts to manage their disease and that the important thing here is to provide professional support rather than to criticize patients' individual beliefs, preferences and decisions for or against therapeutic recommendations

Non-Compliance: Eine endlose Geschichte. Die Perspektive von Patientinnen und Patienten mit rheumatoider Arthritis verstehen

Durante aproximadamente los últimos 25 años ha habido consenso en la investigación en ciencia social en torno a que el término "cumplimiento" en la terapia médica carece de claridad y puede incluso ser contraproducente. Sin embargo, el mundo médico sigue estando desconcertado y se escandaliza cuando los pacientes toman una actitud crítica a las instrucciones de los doctores o de verdad fallan en cumplirlas. Para explorar este área, se hicieron entrevistas a pacientes que han sufrido durante al menos ocho a diez años de la artritis reumatoide, una enfermedad crónica que a menudo conduce a la inhabilidad y a una disminución en el status social. La muestra fue creada con la cooperación del Centro Alemán de Investigación del Reumatismo en el Hospital de Caridad de Berlín. La metodología de estudio comprendió entrevistas parcialmente estructuradas con una exploración narrativa inicial. Ambas entrevistas fueron analizadas en términos de su contenido así como con el empleo de los elementos del marco de "metodología de teoría fundamentada". Nuestro estudio cualitativo ha mostrado que los pacientes hacen grandes esfuerzos para manejar su enfermedad y que lo más importante aquí es proporcionar el apoyo profesional en lugar de criticar las creencias individuales de los pacientes, preferencias y decisiones para o en contra de las recomendaciones terapéuticas.URN: http://nbn-resolving.de/urn:nbn:de:0114-fqs130370For roughly the last 25 years there has been consensus in social science research that the term "compliance" in medical therapy research lacks clarity and may even be counter-productive. However, the medical world continues to be disconcerted and scandalized when patients take a critical attitude to doctors' instructions or indeed fail to comply with them. In order to explore this area, interviews were conducted with patients who have suffered for at least eight to ten years from rheumatoid arthritis, a chronic disease that often leads to disability and a decline in social status. The sample was created in cooperation with the German Rheumatism Research Center (DRFZ) at the Charité Berlin Hospital. The survey methodology comprised partially structured interviews with an initial narrative exploration. The interviews were analyzed both in terms of their content as well as with the use of elements of the framework concept of "grounded theory methodology." Our qualitative study has shown that patients take great efforts to manage their disease and that the important thing here is to provide professional support rather than to criticize patients' individual beliefs, preferences and decisions for or against therapeutic recommendations.URN: http://nbn-resolving.de/urn:nbn:de:0114-fqs130370In der sozialwissenschaftlichen Forschung ist seit etwa 25 Jahren Konsens, dass der Begriff der Compliance in der medizinischen Therapieforschung wenig erhellend, wenn nicht gar kontraproduktiv ist. Dennoch wird in der medizinischen Welt nach wie vor problematisiert und skandalisiert, wenn Patient/innen ärztliche Verordnungen kritisch sehen oder diese tatsächlich nicht befolgen. Anknüpfend an diese Thematik sind Interviews mit Patientinnen und Patienten durchgeführt worden, die seit wenigstens acht bis zehn Jahren an rheumatoider Arthritis leiden, einer chronischen Erkrankung, die häufig zu Behinderungen und dem Verlust des Sozialstatus führt. Die Samplebildung erfolgte in Kooperation mit dem Deutschen Rheuma-Forschungszentrum (DRFZ) an der Charité in Berlin. Bei der Erhebungsmethode handelt es sich um teilstrukturierte Interviews mit einem narrativen Erzähleinstieg. Ausgewertet worden sind die Interviews sowohl inhaltsanalytisch als auch mittels einer Nutzung von Elementen der Grounded-Theory-Methodologie. Unsere qualitative Studie hat gezeigt, dass Patientinnen und Patienten große Anstrengungen unternehmen, ihre Krankheit zu bewältigen und dass es darauf ankäme, sie hierbei professionell zu unterstützen, statt ihre individuellen Entscheidungen für oder gegen therapeutische Empfehlungen zu kritisieren.URN: http://nbn-resolving.de/urn:nbn:de:0114-fqs13037

Cooperative leadership as a condition for patient-reported rehabilitation success

IntroductionRehabilitation is a complex intervention that takes place in a complex setting. The MeeR project (characteristics of successful rehabilitation facilities) aims to identify complex conditions of successful rehabilitation outcomes.MethodsA project with a sequential mixed-methods study design with a quantitative prestudy and a qualitative main study was applied. In the quantitative study, quality assurance data of the German Pension Insurance was used to (1) develop and compute a multifacet z-standardized outcome index based on patient-reported outcome data, (2) rank k = 273 orthopedic rehabilitation facilities comprising n = 112,895 patients and k = 86 cardiac rehabilitation institutions comprising n = 30,299 patients based on their outcome index score by means of a league table, and (3) adjust the ranking by basic patient characteristics (age, gender, diagnosis, weeks out of work prior to rehabilitation, application for pension). In the qualitative main study, k = 6 rehabilitation facilities (orthopedic and cardiac rehabilitation centers) were recruited based on the results of the quantitative analysis: three facilities that ranked top 10% and three facilities that ranked lowest 10% of the adjusted league table. All six rehabilitation facilities were visited each for 1 week by two researchers. We conducted participant observations, expert interviews with medical and administrative leaders, group discussions with rehab team members, and group discussions with patients. Subsequently, a systematic comparison of the results of the upper and lower 10% facilities was conducted to identify those characteristics that distinguished those institutions from one another.ResultsOne of the three clusters of characteristics that distinguished the above and below 10% facilities related to teamwork or interdisciplinary cooperation: among others, the extent of interdisciplinary cooperation was higher in the rehabilitation facilities with a higher degree of success, the leading medical doctors were less dominant in these institutions, and there was also a more comprehensive representation of the team within team meetings, i.e., the quality and amount of interdisciplinary cooperation were higher in these institutions compared to rehabilitation facilities with a lower level of success.DiscussionThis project provided qualitative evidence for the role of interdisciplinary cooperation and collaborative leadership and its different facets for patient-related successful rehabilitation in orthopedic and cardiac rehabilitation. It provides valuable insights into the fabric and structure of a rehabilitation institution and a variety of target points for team development and group-leading interventions

[Prophylaxis and therapy of postdural puncture headache--a critical evaluation of treatment options]

Since the first description of spinal and epidural anaesthesia, postdural puncture headache (PDPH) is a well known complication. Its prophylaxis and treatment has been studied and discussed for more than 100 years, but the evidence is still limited. Due to relatively low prevalence of PDPH, prospective RCTs are often missing, and the frequently self-limiting character of PDPH impedes an adequate interpretation of results from studies without a control group. Taking side effects and complications into account, a prophylactic treatment of PDPH cannot be recommended. In case of PDPH, non-opioid analgesics are the first choice treatment. The epidural blood patch remains the mainstay of severe PDPH therapy. Noninvasive therapies like theophylline, sumatriptan and ACTH can be an alternative. However, an evidence-based recommendation is lacking. The development of standard operating procedures for accidental dural punctures and PDPH is recommended

The Long Way Toward Cooperation

To better understand why cooperation between health care professionals is still often problematic, we carried out 25 semistructured face-to-face expert interviews with physicians and nurses in different rural and urban areas in northern Germany. Using Mayring’s qualitative content analysis method to analyze the data collected, we found that doctors and nurses interpreted interprofessional conflicts differently. Nursing seems to be caught in a paradoxical situation: An increasing emphasis is placed on achieving interprofessional cooperation but the core areas of nursing practice are subject to increasing rationalization in the current climate of health care marketization. The subsequent and systematic devaluation of nursing work makes it difficult for physicians to acknowledge nurses’ expertise. We suggest that to ameliorate interprofessional cooperation, nursing must insist on its own logic of action thereby promoting its professionalization; interprofessional cooperation cannot take place until nursing work is valued by all members of the health care system

Pharmacogenetics in palliative care

Response to analgesics, anticancer pharmacotherapy and pharmacotherapy of other cancer related symptoms vary broadly between individuals. Age, disease, comorbidities, concomitant medication, organ function and patients' compliance may partly explain the differences. However, the focus of ongoing research has shifted towards genomic variants of phase I and II drug metabolizing enzymes with one important goal being an individual dose adjustment according to a patient's genotype. Polymorphisms of the cytochrome P 450 2D6 influence the metabolism of many drugs including the analgesics codeine, tramadol, hydrocodone and oxycodone, as well as the metabolism of tricyclic antidepressants and the anticancer drug tamoxifen. Other candidate genes such as (opioid)-receptors, transporters and other molecules important for pharmacotherapy in pain management are discussed. Although pharmacogenetics as a diagnostic tool has the potential to improve patient therapy, study results are often equivocal and limited by small sample sizes and often by their retrospective design. Well designed studies are needed to demonstrate superiority of pharmoacogenetics to conventional dosing regimes

CYP2D6- and CYP3A-dependent enantioselective plasma concentrations of ondansetron in postanesthesia care

An influence of polymorphic cytochromes P450 (CYP) 2D6 genetic variants on antiemetic efficacy of ondansetron has been suggested. However, the role of CYP3A in ondansetron metabolism and efficacy has been unclear. In this study, we evaluated the hypothesis that genotype-dependent CYP2D6 and CYP3A activity selectively influences plasma concentrations of ondansetron enantiomers. Additionally, the effects of doubling the ondansetron dose on genotype-dependent plasma concentrations were investigated