Adaptation to Occupational Exposure to Moderate Endotoxin Concentrations: A Study in Sewage Treatment Plants in Germany.

Acute or chronic inhalation of endotoxin may lead to changes of lung function and inflammatory markers in the airways. Adaptation to workplace exposure may be possible. In this study, we investigated the possible difference in inflammatory markers assessed in nasal lavage fluid (NALF) in chronical exposure compared to voluntary subjects exposed acutely to endotoxin. We sought to define the variability of inflammatory markers in NALF and the dose-related changes after moderate exposure in naïve subjects. Endotoxin exposure (4-1039 EU/m3) resulted from routine work during one shift in sewage treatment plants. Subjects were matched to pairs (8 workers escorted by 10 students). Inflammatory markers were investigated before, directly after, and 16 h after the shift end. Additional NALF samples were collected in students without any specific exposure after 3 days. In NALF, total cell count, and interleukin (IL)-8 and IL-1ß concentrations were significantly higher in workers than in students at all times pointing to workplace-related long-lasting exposure resulting in adaptation. However, concentration of inflammatory markers without specific exposure in students showed a great variability, covering the whole range of values recorded in the workers. The findings of this study make us to recommend a repeated assessment of inflammatory markers in healthy volunteers before the investigation of exposure-related changes and a sample size adequate for statistical analysis.

Associations of fatigue to work-related stress, mental and physical health in an employed community sample.

BACKGROUND: While work-related fatigue has become an issue of concern among European employees, the relationship between fatigue, depression and work-related stressors is far from clear. The purposes of this study were (1) to determine the associations of fatigue with work-related stressors, severe medical disease, health behavior and depression in the working population and (2) to determine the unique impact of work-related stressors on fatigue. METHODS: We used cross-sectional data of N = 7,930 working participants enrolled in the Gutenberg Health Study (GHS) from 2007 to 2012 filled out the Personal Burnout Scale (PBS) of the Copenhagen Psychosocial Questionnaire (COPSOQ), the PHQ-9, and a list of work-related stressors. RESULTS: A total of 27.5% reported increased fatigue, esp. women, younger persons with a lower social status and income, smokers, severely medically ill, previously and currently depressed participants. Fatigue was consistently associated with severe medical disease, health behavior and depression, which need to be taken into account as potential confounders when analyzing its relationship to work-related strains. Depression was consistently associated with work-related stressors. However, after statistically partialling out depression, fatigue was still significantly associated with work-related stress. CONCLUSIONS: Fatigue as an indicator of allostatic load is consistently associated with work-related stressors such as work overload after controlling for depression. The brief Personal Burn-out Scale is suitable for assessing work-related fatigue in the general population.

Influence of quality of recovery on patient satisfaction with anaesthesia and surgery: a prospective observational cohort study.

Patient satisfaction and quality of recovery are important measures of quality. Whether, and to what extent, patient satisfaction is influenced by quality of recovery, however, is not clear. The aim of this study was to evaluate the additional influence of quality of recovery on total patient satisfaction with anaesthesia and surgery. In this prospective cohort study, we used a validated quality of recovery questionnaire and a multi-item patient satisfaction questionnaire. Patients completed the quality of recovery questionnaire pre-operatively and 24 h postoperatively. One to two weeks after discharge, a third quality of recovery questionnaire was sent out, together with the patient satisfaction questionnaire. If no response was received after 2 weeks, a reminder containing the quality of recovery and the satisfaction questionnaire were mailed. Seven hundred and thirty-four patients were consecutively assessed for eligibility. Five hundred and seventy-nine patients completed at least one questionnaire (recruitment rate 79%). Four hundred and sixty-seven patients (81%) completed all four questionnaires. The total satisfaction score was high, with a mean (SD) of 94.6 (10.7) on a 0-100 scale. Correlation analysis between quality of recovery and total patient satisfaction showed correlations of 0.2-0.3. Testing different aspects of quality of recovery in models already containing the significant factors of patient satisfaction did not improve the model fit markedly. We conclude that quality of recovery has only a marginal additional effect on total patient satisfaction with anaesthesia and surgery.

Current and cumulative night shift work and subclinical atherosclerosis: results of the Gutenberg Health Study.

PURPOSE: The study examines the association between exposure to current and cumulative night shift work and subclinical parameters of atherosclerosis. METHODS: Participants of a population-based cohort study (the Gutenberg Health Study, N = 15,010) aged 35-64 years were examined at baseline (2007-2012). Investigations included measurements of arterial stiffness, vascular function [reactive hyperaemia (RH) index], and intima media thickness (IMT). Also, a complete job history (including up to 15 periods), occupational exposures, a variety of lifestyle, and dispositional variables were enquired. RESULTS: Night shift work was performed by 1071 out of 8065 currently employed individuals. The strongest association after adjustment for age, sex, job complexity level, being a manager, overtime work, and noise appeared for more than 660 night shifts within the last 10 years and a significantly increased arterial stiffness of 0.33 m/s. This reflects a 4 % flow velocity increase for individuals with more than 660 night shifts compared to non-night workers. Regarding the entire professional life, night shift workers showed a significantly decreased vascular function by -0.054 RH index points by using the same adjustment. IMT values did not differ statistically from non-night workers. Lifestyle and dispositional factors showed an influence on all used subclinical atherosclerosis parameters. CONCLUSIONS: The cross-sectional results demonstrate an association between night work and detrimental changes in the atherosclerotic process. The association is more pronounced with more years in night shift and is partly explained by lifestyle and dispositional factors. Longitudinal analyses are necessary to confirm the results.

Patient satisfaction with anaesthesia - Part 1: satisfaction as part of outcome - and what satisfies patients.

Patients' involvement in all decision processes is becoming increasingly important in modern healthcare. Patient satisfaction is a sensitive measure of a well-functioning health service system. The objective of this review is to discuss patient satisfaction as part of outcome quality, to define the somewhat abstract term 'satisfaction', and to discuss the role of surrogate markers within the field of satisfaction with anaesthesia care. We critically discuss what is relevant to satisfy patients with anaesthesia care, and we provide guidance on improving satisfaction.

Patient satisfaction with anaesthesia - Part 2: construction and quality assessment of questionnaires.

The construction of a new, valid and reliable questionnaire to measure patient satisfaction is a complex and time-consuming task. It must follow a rigorous, step-by-step approach, and should as a minimum include elements of content validity, criterion validity, construct validity and reliability. The objective of this review is to present a protocol for the construction of a psychometric questionnaire, supplemented by practical aspects for researchers and clinicians.

Implementation of shared decision making in anaesthesia and its influence on patient satisfaction.

There is a lack of data about the implementation of shared decision making in anaesthesia. To assess patients' preference to be involved in medical decision making and its influence on patient satisfaction, we studied 197 matched pairs (patients and anaesthetists) using two previously validated questionnaires. Before surgery, patients had to decide between general vs regional anaesthesia and, where appropriate, between conventional postoperative pain therapy vs catheter techniques. One hundred and eighty-six patients (94%) wished to be involved in shared decision making. One hundred and twenty-two patients (62%) experienced the exact amount of shared decision making that they wanted; 44 (22%) were slightly more involved and 20 (10%) slightly less involved in shared decision making than they desired. Preferences regarding involvement in shared decision making were similar between patients and anaesthetists with mean (SD) points of 54.1 (16.2) vs 56.4 (27.6) (p=0.244), respectively on a 0-100 scale; however, patients were found to have a stronger preference for a totally balanced shared decision-making process (65% vs 32%). Overall patient satisfaction was high: 88% were very satisfied and 12% satisfied with a mean (SD) value of 96.1 (10.6) on a 0-100 scale. Shared decision making is important for providing high levels of patient satisfaction.

Heat-related mortality in Freiburg and Rostock in 2003 and 2005 - methodology and results.

In Freiburg and Rostock, heatwaves were compared to control periods for the years 2003/2005. In Freiburg, a long heatwave in 2003 cost 21 lives (equal to a significant excess mortality of 33 %). No or no significant excess mortalities were found for shorter heatwaves in Freiburg and for Rostock. The detection of heat-related mortality depends on the size of the cities (population) and the heatwave characteristics.

[Burnout in anesthesiology and intensive care : is there a problem in Germany?]. / Burn-out in der Anästhesie und Intensivmedizin : Gibt es ein Problem in Deutschland?

BACKGROUND: With the demands faced by anesthetists and intensive care physicians apparently increasing continuously in Germany, the increased risk of burnout in comparison with the general working population is discussed. This debate has previously been merely speculative because of the lack of studies comparing the burn-out risk of the German working population with anesthetists. Accordingly it was not certain whether anesthetists really are at greater risk of developing burnout as has often been suggested. Moreover, age, gender, function, workplace environment, e.g. working at a hospital compared to a general practitioner (GP) surgery, may influence the risk of burnout. Therefore, this study examined whether the risk for anesthetists in Germany suffering from burnout really is greater than in other occupations. In addition, factors influencing the burnout risks of anesthetists were analyzed. METHOD: A total of 3,541 questionnaires completed by German aaesthetists for a study on work satisfaction by the CBI (Copenhagen Burnout Inventory, part of the Copenhagen Psychosocial Questionnaire, COPSOQ) were analyzed. Apart from calculating the number of participants with a high risk of developing burnout syndrome, the data were used to calculate a generalized burnout score for all participants. The score was compared with data from both a random sample representing a wide variety of occupations from among the general population in Germany (n = 4,709) and a random sample of German hospital doctors (n = 616). In addition, subgroups were formed by gender, function (senior consultant, senior physician, specialist, junior doctor) and type and place of work (university hospital, public hospital, private clinic, GP surgery, freelance work) and the proportion of each group with a high risk of burnout syndrome was calculated. In addition, general burnout scores were compared statistically for differences among the various groups. RESULTS: The proportion of study participants with a high risk of burnout was 40.1%. Differences were found to exist between genders (male 37.2% versus female 46%), qualifications (senior consultant 28.9%, senior physician 38%, specialist 41.5%, junior doctor 46.7%) and working in a hospital (41.3%) compared to a GP surgery (33.2%). The random sample of hospital doctors (n = 616) showed a burnout score of 49 ± 19 (mean ± standard deviation), compared to 44 ± 19 for a random sample of the German population (n = 4,709) and 42 ± 19 for anesthetists (p < 0.01). Of the subgroups formed, the highest score (49.1 ± 19) was recorded for female junior doctors working in anesthesia. The type of hospital did not influence the burnout score (university hospital 43.8 ± 19.8 versus public hospital 42.9 ± 19.1 versus private hospital 42.4 ± 18.7, p > 0.05). Working in a hospital was found to result in higher burnout scores than in a GP surgery or freelance work (43 ± 19.2 versus 38.1 ± 20.5; t(3531) = 5.0, p < 0.001) CONCLUSIONS: Despite 40.1% of anesthetists being at high risk of burnout, generally speaking the risk of burnout among anesthetists was not higher than in other occupational groups in Germany. However, burnout risks for specific groups, such as female junior doctors in anesthesia, were higher and the possibility of providing social support in the workplace should be considered.

[Evaluation of interventions intended to reduce psychosocial work stress. Proposal for a classification scheme]. / Evaluation von Maßnahmen zur Verringerung psychosozialer Arbeitsbelastungen. Vorschlag eines Kategorisierungs- und Punkteschemas.

Evidence for the effectiveness of measures aiming to reduce psychosocial work stress is sporadic. This is contradictory to the requirement identified by the German Social Security Code (SGB VII) that interventions constitute the most important method of maintaining and improving employees' health. Reasons for this can be seen in the complexity of the subject and methodological issues concerning scientific standards. In addition, agreed quality standards are nonexistent for the evaluation of intervention measures. For this reason, a synopsis of existing audit and evaluation schemes was performed, thus, resulting in refined and adapted quality standards for intervention measures aiming to reduce psychosocial work stress. The quality criteria presented in this paper comprise aims, effectiveness, and facilitators, each being composed of several indicators. The criteria are designed as quality indicators which translate the outcome of an evaluation into quality figures. The process is transparent and offers a rational basis for communication, planning, and decision-making in health promotion.

Validity and responsiveness of the Osnabrück Hand Eczema Severity Index (OHSI): a methodological study.

BACKGROUND: The Osnabrück Hand Eczema Severity Index (OHSI) is a scoring system for the assessment of the severity of hand eczema (HE). OBJECTIVE: To assess the clinimetric value of the OHSI and to validate the longitudinal responsiveness of the OHSI using the Manuscore as a gold standard. METHODS: OHSI and Manuscore scores were compared before and after 3 weeks' inpatient treatment of 62 patients with occupational HE. Correlation coefficients and 95% limits of agreement were calculated and the ability of OHSI to identify severe HE was analysed. The responsiveness of the OHSI in monitoring skin changes over time was evaluated by calculating effect sizes. RESULTS: High correlation was found between the OHSI and Manuscore at both scoring occasions (around r(s) = 0.77). Differences between both measurements were within the 95% limits of agreement for 94% of patients, with a tendency for the OHSI to underestimate the severity at very low and at very high values compared with the Manuscore. Responsiveness to change was good. Both instruments showed significant improvement between the scoring occasions. Using the OHSI values, the proportion of classification to the correct tertile of score change was 69%. Effect size from untreated to treated was 0.6 for the Manuscore and 1.1 for the OHSI, with higher effect sizes in individuals with severe HE. CONCLUSIONS: Even though the OHSI allows less differentiation than the Manuscore, it shows adequate validity and responsiveness to change. Thus the OHSI is suitable for both monitoring the severity of HE and the effects of treatment.

Patient education program to enhance decision autonomy in multiple sclerosis relapse management: a randomized-controlled trial.

BACKGROUND: Contrary to strong recommendations for high-dose intravenous corticosteroid treatment for relapses in multiple sclerosis (MS), uncertainty remains about most aspects of relapse management. Oral corticosteroids administered by physicians or patients themselves or no corticosteroids also appear justifiable. OBJECTIVE: To evaluate an education program that aims to involve patients with MS in decisions on relapse management. METHODS: In three German MS centers, 150 patients with relapsing MS were randomly assigned to a single, 4-h group session or a standard information leaflet. The primary outcome measure was the proportion of relapses with oral or no corticosteroid therapy as an indicator of patient autonomy in treatment decision making. Other outcomes included perceived decision autonomy, quality of life, and disability status. RESULTS: In the intervention group (IG), 108/139 (78%) relapses were treated with oral or no corticosteroids compared with 101/179 (56%) in the control group; P < 0.0001. Patients' perceived autonomy of treatment decision making was significantly higher in the IG; P < 0.0001. Quality of life, disability status, and adverse events of corticosteroid therapies were comparable. CONCLUSION: The patient education program led to more autonomous decision making in patients with relapsing MS. Relevant changes in relapse management were observed.

Informed shared decision making about immunotherapy for patients with multiple sclerosis (ISDIMS): a randomized controlled trial.

BACKGROUND AND PURPOSE: To evaluate the effects of an evidence-based patient decision aid (DA) on multiple sclerosis (MS) immunotherapy. METHODS: Two hundred and ninety-seven MS patients who were considering or reconsidering immunotherapy participated in a randomized community-based controlled trial in Germany. An intervention group (IG) received the DA and a control group (CG) received standard information. Primary outcome measure was the match between the patient's preferred and actual roles during consultation with the physician. Secondary end-point was treatment choice. The course of the decision-making process and patients; evaluation of the decision were also evaluated. Data were collected at baseline, after receiving the information, after consultation with the physician and 6 months after baseline. RESULTS: The percentage of preference matches did not differ between groups (IG 49%, CG 51%, P = 0.71). There were no differences in immunotherapy choices between groups. IG patients temporarily became more critical of immunotherapy and rated the information as significantly more helpful. CONCLUSIONS: Although the intervention led to intensified processing of the information it affected neither the roles adopted in physician-patient encounters nor the immunotherapy choices made. Providing patients with balanced information may not be sufficient to alter the decision-making process.

Communication during ward rounds in internal medicine. An analysis of patient-nurse-physician interactions using RIAS.

OBJECTIVE: Describe the content and of mode of patient-physician-nurse interactions during ward-rounds in Internal Medicine. METHODS: In 267/448 patients, 13 nurses, and 8 physicians from two wards in General Internal Medicine 448 interactions on ward rounds were tape recorded by observers. After exclusion of interactions with more than three participants (N=150), a random sample of 90 interactions was drawn. Data were analysed with a modified RIAS version that allowed for the registration of a third contributor and for the assessment of the direction of a communicative action (e.g.: nurse-->patient, etc.). Furthermore, time spent per individual patient was registered with a stop-watch. RESULTS: A total of 12,078 utterances (144 per ward round) were recorded. Due to problems with the comprehensibility of some interactions the final data set contains 71 ward round interactions with 10,713 utterances (151 per ward round interaction). The average time allotted to an individual patient during ward-rounds was 7.5 min (range: 3-16 min). The exchange of medical information is the main topic in physicians (39%) and nurses (25%), second common topic in patients (28%), in whom communicative actions like agreement or checking are more common (30% patients/25% physicians/22% nurses). Physicians and patients use a substantial number of communicative actions (1397/5531 physicians; 1119/3733 patients). Patients receive about 20 bits of medical or therapeutic information per contact during ward-rounds. CONCLUSIONS: If ward rounds serve as the central marketplace of information nurses' knowledge is under-represented. Further research should try to determine whether the quality of patient care is related to a well balanced exchange of information, to which nurses, physicians, and patients contribute their specific knowledge. PRACTICE IMPLICATIONS: Given the fact that in-patients in Interna Medicine usually present complex problems, the exchange of factual information, expectations, and concepts is of paramount importance. We hope that this paper is going to direct the attention of the scientific community to the characteristics of ward-rounds because they will remain the central marketplace of communication in hospital.

[Need for and use of a university clinic mental health liaison service]. / Psychosomatischer Liaisondienst am Universitätsklinikum. Bedarf und Inanspruchnahme.

BACKGROUND: Little is known about the complex decision-making process involving recognition of psychosocial stress, its diagnosis, and psychotherapeutic intervention within the framework of a psychosomatic consulting and liaison service. PATIENTS AND METHODS: Psychosocial stress was recorded using a psychometric questionnaire for 392 patients on admission to hospital, the estimated need of psychotherapeutic treatment, and the application of a psychosomatic liaison service. RESULTS: Of the examined patients, 44% presented with at least one mental disorder requiring treatment according to ICD-10 criteria. According to the expert opinions, a need for psychotherapeutic treatment was present in 41%, while 54% were themselves motivated for at least one of the psychotherapeutic treatments offered. Psychotherapy was actually received by 35% of the patients. While mental disorders and emotional distress were significant predictors of the need for treatment as rated by experts, they played no genuine role in determining indication or whether a patient accepts the use of psychotherapy CONCLUSION: Psychotherapeutic interventions in the liaison service are not always effective or related to the indication.

A description of the standardized measurement procedures and recommended threshold limit values for biological hazards in Germany.

On the basis of EU directives 89/391/EEC (to encourage improvements in the safety and health of workers at work) and 2000/54/EC (on the protection of workers from risks related to exposure to biological agents at work), biological hazards at work have to be assessed and preventive measures have to be introduced in all member states of the EU. In Germany, national legislation (Biological Agents Ordinance - BioStoffV and Technical Rules on Biological Agents, TRBA) and recommendations of workers' compensation boards define standardized methods for the assessment of airborne mold, bacteria, and endotoxins. This article describes policies and practices in Germany for measurement of airborne bioaerosols and for interpretation of measurements relative to the standards. As an example, methods and results of measurements in agriculture are shown. The standardized measurement procedures proved suitable for use in livestock buildings. The results of the exploratory measurements in different livestock buildings confirmed the often high concentrations of airborne biological hazards in agriculture that are reported in the literature.

[Regulatory aspects of clinical trials with emphasis on biologicals]. / Regulatorische Aspekte klinischer Prüfungen unter besonderer Berücksichtigung biologischer Arzneimittel.

Clinical trials play a central role in clinical development for achieving marketing authorization for a drug. Carefully planned and carried out clinical trials allow for valid conclusions on the efficacy and/or safety of a drug. In order to do so, various requirements have to be fulfilled: clinical studies are to be planned and conducted in accordance with Good Clinical Practice, scientifically sound methods have to be applied, the patients' safety has to be ensured, trial objectives and results have to be clinically relevant, quality and transparency of all steps from planning to reporting a clinical study have to be ensured. For biologicals, special attention has to be paid to specific aspects, such as their mode of action or possible impact on the environment. Various guidelines reflecting regulatory aspects are available to support drug development. In addition, specific questions on drug development might be discussed directly between study sponsors and regulatory agencies. Due to the changes imposed by the 12th law amending the German Drug Law (Arzneimittelgesetz), the relevant German authorities will be more involved in the planning and conduct of clinical trials.

Effect of a diphtheria booster vaccination in adults with a documented history of an incomplete primary series vaccination.

BACKGROUND: An incomplete series of diphtheria vaccination is frequently found in the vaccination documents of adult patients. This paper investigates the effect of a booster vaccination in adults with an incomplete series of primary vaccination. MATERIALS AND METHODS: The effect of one diphtheria booster vaccination in adults with a documented history of only two childhood vaccinations has been investigated in 21 adults. Before the vaccination and 4 to 8 weeks thereafter, blood samples were taken and analyzed with an in vitro neutralization assay. RESULTS: None of the participants had prevaccinal full protective diphtheria antitoxin levels (AT) > or = 0.1 IU/ml and four (19%) had limited serological protection (AT 0.01 to 0.1 IU/ml). After the vaccination, 14 individuals (67%) had protective LeveLs and six (29%) had limited protective levels. The risk for post-booster non-protection (AT < 0.1 IU/ml) was 7.7 times higher in comparison with a group of 170 adults with a history of at least one booster vaccination. CONCLUSION: A specific immunologic memory exists in adults with a history of only two previous diphtheria vaccinations. However, our results also indicate the need for a second booster vaccination in this group if long-term protection is to be achieved.