Statement For Physicians Research Articles

Barriers and facilitators to first-line (1L) treatment intensification (TI) in metastatic castration-sensitive prostate cancer (mCSPC): The IMPLEMENT study.

224 Background: Despite evidence of benefits and guideline recommendations for first-line treatment intensification (ie, androgen-deprivation therapy with chemotherapy, novel hormonal therapies, or both) in mCSPC, it is underutilized. We examined barriers and facilitators that US urologists and oncologists face with treatment intensification for mCSPC and identified behavior change techniques to address these through an implementation science approach. Methods: We conducted 36 double-blind, semi-structured, virtual interviews with practicing US urologists and oncologists who manage mCSPC using an interview guide based on the theoretical domains framework. Saturation was met when no new themes emerged. Physician statements were coded into 11 domains and themes to identify barriers and facilitators. To confirm codebook reliability, 10% of transcripts were double coded independently (k=0.77). Key domains and the associated barriers and facilitators were analyzed for frequency, perceived potential to impact behavior, and presence of disagreement. Top domains were cross-referenced with a taxonomy of validated behavior change techniques. Results: 36 interviewed physicians (20 low intensifiers[≤50% of patients get treatment intensification]; 16 high intensifiers [>50% of patients get treatment intensification]), 14 (39%) were from academic centers. Five impactful domains and the associated barriers and facilitators were identified along with behavior change techniques to overcome them (Table). Conclusions: Underutilization of treatment intensification in US is multifactorial. Poor knowledge, habit, anticipated regret, costs, and reserving treatment intensification for later use were prominent barriers. These can be addressed through behavior change techniques to improve mCSPC care. [Table: see text]

Abstract 17420: Enhanced Identification of Cardiac Wall Motion Abnormalities: An Externally Validated Deep Neural Network Approach Outperforms Expert and Quantitative Analysis of Electrocardiograms

Background: Cardiac wall motion abnormalities (WMA) independently predict mortality and other adverse events beyond ejection fraction. Clinical screening relies on detection of ECG Q waves yet has poor predictive accuracy. Hypothesis: We hypothesized that ECG features beyond the Q wave could be identified by deep learning to improve WMA detection over standard ECG measurements. Methods: We collected ECGs and echocardiogram pairs (Panel A) in 35,210 unique patients who underwent both studies within 60 days at Stanford University. WMAs were determined by natural language processing (NLP) of clinical reports (Panel B). Five second ECG signals were extracted digitally and used to develop and test a DNN. For development, 80% of the pairs were used and 20% (N = 7042) were reserved for internal validation. We then tested the model performance on 2,338 echo/ECG pairs from Emory University. For comparison, qualitative physician statements from the ECG interpretation suggesting myocardial injury, ischemia, or infarct were labeled using NLP, and a logistic regression model was developed to include quantitative Q-wave measurements. Results: In the internal validation cohort (62.9±16.9 years, 47% female, 58% white), DNN of the ECG detected echocardiographic WMA with a c-statistic of 0.781 (CI: 0.764-0.798) which was superior to quantitative ECG Q wave measurement (0.632, CI: 0.605-0.661) or qualitative interpretation (0.595) (Panel C). Performance was not improved by incorporating demographic data. In the external cohort (61.9±16.0 years, 48% female, 48% white), the DNN AUC was 0.723 (CI:0.689-0.758). Conclusion: Deep learning improves detection of cardiac WMAs from the electrocardiogram in an externally validated model compared with standard ECG analysis. Application of this model may provide improved screening for regional myocardial injury. Further work will determine which features beyond the Q wave provide improved performance.

Improving Compliance with Dyslipidemia Screening Guidelines in a Single-center U.S. Outpatient Pediatric Cardiology Clinic.

Introduction:The development of atherosclerotic cardiovascular disease begins in childhood. The American Academy of Pediatrics (AAP) endorsed guidelines recommending universal hyperlipidemia screening of children ages 9–11 and again at 17–21 years. An AAP Periodic Survey of Fellows demonstrated less than half of pediatricians report adherence to these guidelines. This quality improvement initiative’s objective was to improve compliance with AAP hyperlipidemia guidelines in an outpatient pediatric cardiology clinic at a single academic center to 80% over a 2-month time frame.Methods:We report the results of an IRB-approved chart review at a single-center outpatient pediatric cardiology practice. We defined pediatric cardiologists’ compliance as documented prior lipid screening, ordering a lipid panel, or documented recommendation for follow-up screening. Two plan-do-study-act (PDSA) cycles were undertaken. The first intervention included an informational session to provide pediatric cardiologists with AAP recommendations. The second intervention involved weekly email reminders and a statement for physicians in the electronic medical record.Results:We collected data from 600 individual charts of patients seen over 35 clinic days. We received charts before the first PDSA intervention. Baseline compliance with outpatient hyperlipidemia screening was 0%. After the first PDSA cycle, the average screening rate improved to 49%. After the second PDSA cycle, the average screening rate improved to 89%, and there was a centerline shift in the data, indicating improvement.Conclusion:We improved the pediatric cardiologists’ compliance with the AAP-recommended hyperlipidemia screening guidelines from 0% to 89% through 2 intervention cycles. Further efforts may be required to sustain this change.

Childhood Cancer Patients in a Family-Oriented Rehabilitation Program: Goals and Change in Physical Functioning

Childhood cancer often leads to physical and psychosocial burdens that can persist beyond the end of treatment. Family-oriented rehabilitation programs (FOR) focus on long-term consequences and support families in returning to daily life. The objectives of this study were to describe rehabilitation goals and goal attainment, to analyze the relationship between physical functioning and physical well-being and to examine predictors of changes in physical functioning during the FOR. In a prospective observational study, statements of physicians regarding rehabilitation goals, goal achievement and physical functioning of 175 children (<18 years of age at the time of diagnosis of leukemia or central nervous system tumor) at the beginning and the end of a FOR were analyzed. The physical well-being of the patients was assessed from a parent and child perspective. Correlation coefficients were calculated to analyze the relation between physical functioning and physical well-being. Predictors of changes in physical functioning were examined with a multiple regression analysis. The most frequently mentioned rehabilitation goals were the increase of physical functioning and the integration into the peer group. Overall, the goal achievement ranged from 82 to 100%. Physical functioning improved significantly during the FOR. A significant positive correlation between the physician's assessment of physical functioning and the parental assessment of physical well-being could be found at the beginning of the FOR. According to the regression model, female gender of the child and a longer time since diagnosis were associated with a lower change in physical functioning. Furthermore, a higher degree of physical consequential damages was associated with a larger change. The 4-week multimodal rehabilitation program of the FOR addressed various physical and psychosocial burdens and was accompanied by a significant improvement of the physical functioning of childhood cancer patients. The change in physical functioning was associated with different sociodemographic and medical factors (eg, sex). The consideration of these factors could help with optimizing the program.

Заболеваемость школьников и эффективность диспансерного наблюдения на различных этапах обучения

The publication presents results of investigation of health of 437 school students at diff erent stages of school education (before entering school, after the 1st grade, at the moment of transition to subject-oriented learning and upon completion of school education) and depending on the school starting age. Dynamic detectability analysis of school students with consideration for the school starting age within a period of 10 years has shown an increase in the ratio of school students with diseases of the upper respiratory tract, skeletomuscular system and vision organs. Substantial growth of the listed pathologies was predominant at the 2nd and the 4th stages of observation and predominantly in school students who started their education at the age of 6 and 8. The data obtained have enhanced the importance of formation of healthy lifestyle habits and skills in the students and their parents within the framework of the National Priority Projects of Russia. Aim of study. To evaluate the state of health in school students who started their education at different ages within a 10-years observation period based on dynamic analysis of depleted and general incidence, detection rate of the relevant pathology (ARVI) and health index. Material and methods. Within the framework of the study, dynamic evaluation of the state of health in 437 school students at diff erent stages of school education (before entering school, aft er the 1st grade, at the moment of transition to subject-oriented learning and upon completion of school education) based on medical history and medical documents, data obtained from clinical examination, statements of physicians in niche specialities based on medical checkup data. Th e results obtained are presented for groups of school students with consideration for the school starting age.Results. Results of the study with analysis of school students’ health state indices attest to a decrease in functional reserves and a more adverse trend in incidence indices (depleted, general and the number of diseases per one student in a year) during school education among children who started their education at the age of 6 and 8. Conclusion. The presented analysis of schools students’ state of health at diff erent stages of school education depending on the school starting age has made it possible to present generalised data on the incidence in school students over a 10-years period of dynamic observation, outline adverse trends in the state of health in children who started their school education at the age of 6 and 8 years and to note the necessity of a more careful attention to children at a lower chronological age in comparison to a more functionally prepared peers, while that increases the probability of maladaptation under the circumstances of school workload with consequent deterioration of the child’s health and high incidence during the whole period of studying.

‘I’m praying for a miracle’: characteristics of spiritual statements in paediatric intensive care unit care conferences

ContextSupporting spiritual needs is a well-established aspect of palliative care, but no data exist regarding how physicians engage with patients and families around spirituality during care conferences in paediatric intensive...

Turn analysis and patient-centredness in paediatric otolaryngology surgical consultations.

Physician and patient/parent communication is of utmost importance in consultations to improve the shared decision-making (SDM) processes. This study investigated SDM-related outcomes through turn analysis and an assessment of patient-centred dialogue. Multi-centre prospective cohort study analysing audio- and video-recorded patient/parent-physician interactions. Two tertiary paediatric hospitals in Halifax, Nova Scotia and Salt Lake City, Utah. Paediatric otolaryngologists, patients and parents during consultation for adenotonsillectomy. Medical dialogue measures (turn analysis, patient-centredness scores via the Roter Interaction Analysis System) and SDM questionnaires (SDM-Q-9). Turn density was significantly higher for physicians than patients/parents (P<.001), as were total statements (P<.001), and total time talking (P<.001). The opening statement was completed by the physician in 91.5% of interactions and was significantly longer than family opening statements (P=.003). The mean number of informed consent elements addressed per interaction was 4.5 out of 6. The mean patient-centredness score was 0.2 (range 0-0.56). Significant negative correlations between patient-centredness score and physician turn density (r=-.390, P=.002), physician mean turn time (r=-.406, P=.001), total physician statements (r=-.426, P=.001) and total physician speaking time (r=-.313, P=.016) were noted. There were no correlations in SDM questionnaire scores with turn analysis variables, informed consent elements or patient-centredness scores. Surgeons dominated the consultation in terms of talking, mostly in a unidirectional manner. Neither patient-centredness nor turn analysis correlated with perceptions of SDM from the parents' perspective.

Views of psycho-oncologists, physicians, and nurses on cancer care-A qualitative study.

BackgroundAs worldwide cancer prevalence continues to increase, the challenges facing cancer care are also increasing. Various topics related to deficiencies in cancer care have been discussed repeatedly in the literature. The most frequently stated topics are the unmet psychosocial support needs of cancer patients, difficulties in multidisciplinary teamwork, difficulties in communication between physicians and patients, and issues in palliative care settings. However, there is little research regarding the views of health care providers on these topics. With the aim of gaining abundant information regarding the care of German cancer patients, this study explores the stances of psycho-oncologists, physicians, and nurses regarding the quality of cancer care.Materials and methodsSemi-structured interviews were conducted at the University Medical Center Hamburg-Eppendorf (UKE) and in different oncological outpatient offices in Hamburg; twenty-five interviews in total were conducted with health care providers. Interviews were semi-structured to gain a broad range of information on cancer care. The data were analyzed using thematic analysis by Braun and Clarke with an inductive, constant comparison approach to identify themes and categorized codes.ResultsThe following five principle themes were identified in the interviews: “psycho-oncological care”, “cooperation of health care providers”, “palliative care”, “health care provider-patient contact”, and “coordination and organization of care”. Participants seemed satisfied with the overall quality of cancer care in Germany. Nevertheless, the results showed deficiencies regarding communication among different health care providers and between health care providers and patients. Important findings in conjunction with these communication problems were a lack of psycho-oncological support, shortages in the oncology work force, language and cultural barriers, and deficient education in the communication of providers.ConclusionsThe statements of psycho-oncologists, physicians, and nurses on cancer care provide a suitable basis to conduct further focused research on the studied deficiencies in cancer care. In particular, communication in psycho-oncological care, communication within multidisciplinary teams, and health care provider-patient communication should be further explored with the aim of developing new ideas for improvements and thereby enhancing the quality of cancer care.

The Vanishing Art of Medical Underwriting.

The Vanishing Art of Medical Underwriting.

Discussing Benefits and Risks of Tracheostomy: What Physicians Actually Say.

When contemplating tracheostomy placement in a pediatric patient, a family-physician conference is often the setting for the disclosure of risks and benefits of the procedure. Our objective was to compare benefits and risks of tracheostomy presented during family-physician conferences to an expert panel's recommendations for what should be presented. We conducted a retrospective review of 19 transcripts of audio-recorded family-physician conferences regarding tracheostomy placement in children. A multicenter, multidisciplinary expert panel of clinicians was surveyed to generate a list of recommended benefits and risks for comparison. Primary analysis of statements by clinicians was qualitative. Single-center PICU of a tertiary medical center. Family members who participated in family-physician conferences regarding tracheostomy placement for a critically ill child from April 2012 to August 2014. We identified 300 physician statements describing benefits and risks of tracheostomy. Physicians were more likely to discuss benefits than risks (72% vs 28%). Three broad categories of benefits were identified: 1) tracheostomy would limit the impact of being in the PICU (46%); 2) perceived obstacles of tracheostomy can be overcome (34%); and 3) tracheostomy optimizes respiratory health (20%). Risks fell into two categories: tracheostomy involves a big commitment (71%), and it has complications (29%). The expert panel's recommendations were similar to risks and benefits discussed during family conferences; however, they suggested physicians present an equal balance of discussion of risks and benefits. When discussing tracheostomy placement, physicians emphasized benefits that are shared by physicians and families while minimizing the risks. The expert panel recommended a balanced approach by equally weighing risks and benefits. To facilitate educated decision making, physicians should present a more extensive range of risks and benefits to families making this critical decision.

Speaking a Different Language: A Qualitative Analysis Comparing Language of Palliative Care and Pediatric Intensive Care Unit Physicians.

Family conferences in the pediatric intensive care unit (ICU) often include palliative care (PC) providers. We do not know how ICU communication differs when the PC team is present. To compare language used by PC team and ICU physicians during family conferences. A retrospective cohort review of ICU family conferences with and without the PC team. Forty-four bed pediatric ICU in a tertiary medical center. Nine ICU physicians and 4 PC providers who participated in 18 audio-recorded family conferences. Of the 9 transcripts without the PC team, we identified 526 ICU physician statements, generating 10 thematic categories. The most common themes were giving medical information and discussing medical options. Themes unique to ICU physicians included statements of hopelessness, insensitivity, and "health-care provider challenges." Among the 9 transcripts with the PC team, there were 280 statements, generating 10 thematic categories. Most commonly, the PC team offered statements of support, giving medical information, and quality of life. Both teams promoted family engagement by soliciting questions; however, the PC team was more likely to use open-ended questions, offer support, and discuss quality of life. Pediatric ICU physicians spend more time giving medical information, whereas the PC team more commonly offers emotional support. The addition of the PC team to ICU family conferences may provide a balanced approach to communication.

Exploring the premise of lost altruism: content analysis of two codes of ethics

As an ideal, altruism has long enjoyed privileged status in medicine and medical education. As a practice, altruism is perceived to be in decline in the current generation. A number of educational efforts are underway to reclaim this "lost value" of medicine. In this paper we explore constructions of altruism over a defined period of time through a content analysis of the Canadian and Australian Medical Associations (CMA and AMA respectively) Codes of Ethics. We analyzed all editions of both Codes (1868-2004), using a content analysis approach, including thematic analysis. We coded as altruistic or non-altruistic, respectively, statements in which the interest of the patient is placed ahead of the physician's and statements in which the interest of the physician is given primacy. We examined the pattern of appearance and disappearance of these statements over time. We identified 13 altruistic and 2 non-altruistic statements across all editions. There is a gradual and uneven loss of altruistic content over time. The CMA Codes of 1938, 1970 and 2004 and the AMA code of 1992 represent significant change points. The most recent versions of both Codes contain only 1 altruistic statement and both non-altruistic statements. We conclude that altruism appears to be a fluid and changing concept over time. Loss of altruism is not merely a current generational issue but extends through the past century and is likely due to political and social forces. These results call into question current educational attempts to reclaim altruism, and point to the social evolution of the ideal.

"Don't Try to Cover the Sky with Your Hands": Parents' Experiences with Prognosis Communication About Their Children with Advanced Cancer.

Physicians worry that disclosure of prognostic information can be distressing and deprive families of hope. Retrospective studies have shown that prognostic disclosure does not abrogate hope, but prospective data are lacking. The study objective was to prospectively evaluate responses to prognosis communication among parents of children with advanced cancer. For this qualitative study we audiotaped conversations between clinicians and parents of children with newly relapsed or refractory cancer, and then interviewed parents about experiences with prognosis communication. Parents were asked to reflect on physician statements about prognosis. Subjects were 32 pairs of parents and clinicians of children with relapsed or refractory cancer treated at Dana-Farber/Boston Children's Center for Cancer and Blood Disorders, Boston, Massachusetts. Prognosis was discussed in 28/32 conversations (88%). Although most parents (N = 22, 69%) found prognostic information upsetting, most also valued honest communication about prognosis (N = 22, 69%.) Parents noted that frank disclosure fostered hope by relieving uncertainty and allowing them to make the best possible decisions for their children. Excessive optimism or a lack of information, in contrast, was sometimes experienced as a threat to hope and the parent-clinician relationship. A minority of parents were upset by clinician communication about prognosis (N = 4, 12%), but most did not consider the clinician responsible for their distress. Rather, parents attributed distress to the difficult situation. Many parents consider prognosis communication to be both difficult and necessary. While upsetting, prognostic information engenders hope by helping parents feel prepared to do their best for their children in the difficult days to come.

What is a medical decision? A taxonomy based on physician statements in hospital encounters: a qualitative study

ObjectiveThe medical literature lacks a comprehensive taxonomy of decisions made by physicians in medical encounters. Such a taxonomy might be useful in understanding the physician-centred, patient-centred and shared decision-making in...

Elective cardioversion: is it a truly nurse-led service?

British Journal of Cardiac NursingVol. 10, No. 10 CommentElective cardioversion: is it a truly nurse-led service?Sally Baker, Emily TrevorSally BakerSearch for more papers by this author, Emily TrevorSearch for more papers by this authorSally Baker; Emily TrevorPublished Online:6 Oct 2015https://doi.org/10.12968/bjca.2015.10.10.484AboutSectionsView articleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail View article References Boodhoo L, Bordoli G, Mitchell AR, Lloyd G, Sulke N, Patel N (2004) The safety and effectiveness of a nurse led cardioversion service under sedation. Heart 90(12): 1443–6 Crossref, Google ScholarHarrison SJ, Mayet J (2002) Physician administered sedation for DC cardioversion. Heart 88(2): 117–8 Crossref, Google ScholarLewis R (2001) Nurse-led Primary Care: Learning from PMS pilots. King's Fund. http://tinyurl.com/nd766yh (accessed 20 September 2015) Google ScholarRaipancholia R, Sentinella L, Lynch M (2001) Role of conscious sedation for external cardioversion. Heart 86(5): 571–2 Crossref, Google ScholarShea JB, Maisel WH (2002) Cardiology patient pages. Cardioversion. Circulation 106(22): e176–8 Crossref, Google ScholarWorcestershire Acute Hospitals NHS Trust (2014) Cardiac patients discharged in a heartbeat. http://tinyurl.com/oom926z (accessed 20 September 2015) Google ScholarYurchak PM, Williams PV, Achord AC (1993) Clinical competence in elective direct current (DC) cardioversion. A statement for physicians from the ACP/ACC/AHA Task Force on Clinical Privileges in Cardiology. J Am Coll Cardiol 22(1): 336–9 Crossref, Google Scholar FiguresReferencesRelatedDetailsCited byThe impact of a nurse‐led elective direct current cardioversion in atrial fibrillation on patient outcomes: A systematic review5 May 2019 | Journal of Clinical Nursing, Vol. 10 2 October 2015Volume 10Issue 10ISSN (online): 2052-2207 Metrics History Published online 6 October 2015 Published in print 2 October 2015 Information© MA Healthcare LimitedPDF download

Custodian for elderly with memory impairment in Sweden – a study of 260 physicians’ statements to the court

BackgroundIn the modern world with new family structures, international migration and increased life expectancy, there is a growing need for legal ways of assisting elderly with impaired mental capacity to decide about their life and assets. There are few studies about the physician’s role when a court appoints proxies for vulnerable elderly. Many doctors do not know how to assess mental capacity, and most lawyers and judges know little about medicine.MethodsApplications for a custodian sent to the Stockholm Chief Guardian’ Office in Sweden were used. Physician’s statements to the court for elderly with memory impairment were selected and 260 statements were scrutinized with regard to formal quality, the narrative content and the physician who wrote it.ResultsThe quality of the statements varied from one sentence to excellent. Most statements were written by senior family practitioners or geriatricians. Seventeen % of the statements were handwritten and had more formal shortcomings than machine/computer written statements.The majority of patients needed massive help with daily life and economy. Median age was 84 years of age. MMSE score was given in 20% of the cases and varied from 6–27.A diagnosis of dementia was established in 57%. At the time of application, at least 48% were in a hospital or nursing home and at least 27% were in their private home. Only 5% were living with a spouse or a child. In 53% of the cases, the doctor knew the patient, but in 40% of the cases, the identity of the patient was not confirmed. The physician found that 54% were unable to understand the idea of getting a custodian, but out of those very vulnerable elderly, 20% had signed consent and 57% were considered able to be heard in court.ConclusionsThere is a large variation in the quality of physicians’ statements to the court concerning the mental capacity of elderly patients with cognitive impairment. Many statements have serious short-comings, and the system is not safe. There is a strong need for guide-lines, and additional training for all professionals involved.

PC-FACS

PC-FACS

Indicadores de absenteísmo e diagnósticos associados às licenças médicas de trabalhadores da área de serviços de uma indústria de petróleo

OBJETIVOS: Determinar indicadores do absenteísmo por licença médica (LM) em trabalhadores da área de serviços de uma indústria de petróleo, identificando as patologias associadas. MÉTODOS: Este estudo descreve resultados de estudo coorte retrospectivo com 782 trabalhadores de uma empresa de petróleo no período de 1º de janeiro de 2007 a 31 de dezembro de 2009. RESULTADOS: 542 trabalhadores tiveram eventos de faltas ao trabalho que geraram licença médica. Registrou-se 3,3 episódios de LM por trabalhador e 69,3% dos trabalhadores tiveram pelo menos um episódio de LM. Os episódios de LM duraram em média 6,6 dias, com desvio padrão de 9,8 dias. A maior proporção de episódios de absenteísmo por LM deveu-se às doenças do sistema osteomuscular e tecido conjuntivo. Dezesseis dentre os 782 trabalhadores apresentaram 17 episódios de LM associadas ao trabalho (acidente típico, de trajeto e doença ocupacional). CONCLUSÕES: O estudo ratificou a importância do afastamento por doenças do sistema osteomuscular e o impacto das doenças ocupacionais no absenteísmo por licença médica, detectando índices semelhantes ao da literatura, numa população pouco explorada do ponto de vista epidemiológico.

Specialist Physicians’ Sensitivity to Patient Affect and Satisfaction

Studies indicate that physicians do not respond adequately to patients' emotional issues. Physician sensitivity to patient affect has not been much explored. To describe specialist physicians' sensitivity to patient affect and satisfaction. Cross-sectional study of physicians' and patients' postvisit questionnaire statements about patient affective states and satisfaction. A representative sample of 71 physicians covering nonpsychiatric clinical specialties in a general teaching hospital were observed during 497 encounters with patients (outpatient, inpatient on rounds, emergency room, maximum 8 encounters per physician). Standardized correlations between physician and patient statements. Physician statements about patient negative affect were moderately correlated with patient self-report of negative affect [r=0.379 (0.301; 0.452)]. Physician statements about patient positive affect and patient satisfaction were weakly correlated with patient self-report of positive affect [r=0.238 (0.153; 0.319)] and satisfaction [r=0.219 (0.134; 0.301)]. Internists [r=0.300 (0.161; 0.428)] were significantly less sensitive to negative affect than surgeons [r=0.500 (0.360; 0.618), P=0.038] and neurologists [r=0.621 (0.432; 0.758), P=0.007]. Physicians previously known by the patient were significantly more sensitive to negative affect than those who were not known [r=0.509 (0.391; 0.611) vs. 0.293 (0.189; 0.390), P=0.006]. We could not find differences in affective sensitivity between male and female physicians. Specialist physicians have moderate ability to identify patient negative affect and poor ability to identify patient positive affect and patient satisfaction.

Wirksamkeit und Verträglichkeit eines pflanzlichen Arzneimittels mit Weißdornbeeren und D-Campher bei hypotonen und orthostatischen Kreislaufregulationsstörungen

Korodin Herz-Kreislauf-Tropfen, a herbal drug containing D-camphor (CAS 76-22-2; 2.5 %) and a liquid extract of fresh hawthorn berries (97.3%), has been used since many years for the treatment of orthostatic hypotension. The combination as well as its constituents were tested in clinical trials against placebo with healthy volunteers and patients using tilt-tests. The objective of this study was to investigate efficacy and safety of the drug under the conditions of medical practice in comparison to other drugs admitted for this indication. The study was performed as an epidemiological retrospective cohort study in 46 medical practices in Germany. In the practices the files were reviewed for patients who were treated between 1st January 2000 and 31st December 2002 for orthostatic hypotension. Included in the study were all patients who were treated either with the test drug or a control drug containing etilefrine, oxilofrine, midodrine, norfenefrine or dihydroergotamine and who met the inclusion criteria. The data of the files were coded, transferred to case report forms and augmented by the physician's statements about symptoms and success. Effect criteria were the improvement of symptoms and change of blood pressure during treatment. The correctness of the data was controlled using anonymous copies of the files. A total of 490 patients (399 in the test-group and 91 in the control group) between 11 and 102 years were included in the study. To correct heterogeneities in baseline conditions, treatment results were adjusted by regression and stratification to equal baseline conditions using the propensity score. The adjusted odds ratio for improvement was 5.6, the adjusted mean increase of the systolic blood pressure the 2-fold compared to the control group. The difference was highly significant and did not depend on age or initial blood pressure. In the test group two adverse events were observed which had no relation to the medication; in the control group one reversible event with a probable relation to the medication was observed. The test drug was proven as effective and safe in the treatment of orthostatic hypotension in medical practice for all age groups and independent of the initial blood pressures.