Feasibility and long-term efficacy of a proactive health program in the treatment of chronic back pain: a randomized controlled trial.

BACKGROUND: To facilitate access to evidence-based care for back pain, a German private medical insurance offered a health program proactively to their members. Feasibility and long-term efficacy of this approach were evaluated. METHODS: Using Zelen's design, adult members of the health insurance with chronic back pain according to billing data were randomized to the intervention (IG) or the control group (CG). Participants allocated to the IG were invited to participate in the comprehensive health program comprising medical exercise therapy and life style coaching, and those allocated to the CG to a longitudinal back pain survey. Primary outcomes were back pain severity (Korff's Chronic Pain Grade Questionnaire) as well as health-related quality of life (SF-12) assessed by identical online questionnaires at baseline and 2-year follow-up in both study arms. In addition to analyses of covariance, a subgroup analysis explored the heterogeneity of treatment effects among different risks of back pain chronification (STarT Back Tool). RESULTS: Out of 3462 persons selected, randomized and thereafter contacted, 552 agreed to participate. At the 24-month follow-up, data on 189 of 258 (73.3%) of the IG were available, in the CG on 255 of 294 (86.7%). Significant, small beneficial effects were seen in primary outcomes: Compared to the CG, the IG reported less disability (1.6 vs 2.0; p = 0.025; d = 0.24) and scored better at the SF-12 physical health scale (43.3 vs 41.0; p < 0.007; d = 0.26). No effect was seen in back pain intensity and in the SF-12 mental health scale. Persons with medium or high risk of back pain chronification at baseline responded better to the health program in all primary outcomes than the subgroup with low risk at baseline. CONCLUSIONS: After 2 years, the proactive health program resulted in small positive long-term improvements. Using risk screening prior to inclusion in the health program might increase the percentage of participants deriving benefits from it. TRIAL REGISTRATION: The trial was registered at the German Clinical Trials Register under DRKS00015463 retrospectively (dated 4 Sept 2018).

[Employees with chronic diseases - additional results of randomized controlled trial among adult members of a German statutory health insurance with inflammatory bowel diseases]. / Chronisch krank und erwerbstätig - Weitere Ergebnisse einer randomisierten kontrollierten Interventionsstudie unter GKV-Versicherten mit chronisch entzündlichen Darmerkrankungen.

BACKGROUND: Chronic and prognostically doubtful diseases like inflammatory bowel diseases (IBD) often lead to reduced work ability. Whether self-management-interventions have positive effects on work related outcomes is so far unclear. METHODS: Data from a randomized controlled trial of adult members of a German statutory health insurance with medically confirmed IBD were reanalyzed. We focused on 337 gainfully employed study participants. They completed a screening questionnaire enquiring about 22 disease-related bio-psycho-social problems. The intervention group (IG) received individualized (problem-adapted) written recommendations; the control group remained under usual care. 12 months later a follow-up questionnaire was employed, data on sick leave were made available by the health insurance. RESULTS: The IG showed beneficial effects in all primary outcomes (EuroQol visual analog scale score, index for measuring participation restriction and number of self-reported disability days). At baseline one in four of the employed participants reported a negative subjective prognosis of their work capacity (assessed by means of a 3-item Likert scale, SPE scale). No positive intervention effects on work-related outcomes (subjective prognosis of gainful employment, episodes and days of sick leave) could be detected. CONCLUSIONS: In IBD patients work and earning capacity is often at risk and should be regularly assessed. Effective interventions to protect or restore gainful employment are needed. Medical-vocational rehabilitation could be a treatment option; its efficacy and benefit (in IBD) are still to be demonstrated.

[Put to Test: Medical Inpatient Rehabilitation of Inflammatory Bowel Diseases]. / Auf dem Prüfstand: stationäre medizinische Rehabilitation bei chronisch entzündlichen Darmerkrankungen.

BACKGROUND: Many CED-patients struggle with complex problem profiles and may be offered and profit from multidisciplinary multimodal rehabilitation. It is still unclear by whom and with what effects this option is used. METHODS: We compared the results of an observational cohort study of 199 CED-inpatients of a single rehab clinic with those of 310 gastroenterological outpatients using propensity score matching. RESULTS: Rehabilitands show more complex problem profiles than CED-outpatients. After 6 months of follow up direct and indirect change measures show generally small positive changes - however comparable in quality and size with that of matched outpatients. CONCLUSION: Complex rehab is mainly used by CED-patients with several bio-psycho-social problems. Our preliminary data do not suggest a marked additional benefit of inpatient rehab compared to specialised outpatient care. Stricter controlled trials are urgently needed.

[The Danish Debate on Priority Setting in Medicine--An Update]. / Die dänische Debatte über Priorisierung und Posteriorisierung in der Medizin - Was gibt es Neues?

In the last years, the Danish debate about priority setting in medicine has gained new strength. This paper shows the main focuses of the current discussion based on a research of Danish primary literature. For the first time since the 1990s the Danish Council of Ethics has been involved with priority setting in medicine in a project running from 2011 to 2013. The Council emphasises the importance of legitimate processes and calls for visible values and criteria. A focus of the debate is how to deal with new expensive drugs. Politicians, physicians, health economists and the Council of Ethics have called for a national institution for priority setting in medicine. They have mainly looked to the Norwegian National Council for Priority Setting in Health Care and the British National Institute for Health and Care Excellence for inspiration. The Danish Government considered establishing a national institute for priority setting, but the plans were not put into practice. In the year 2012 a new national project was launched to create clinical guidelines. Danish doctors welcome the guidelines as a good basis for priority setting. Just like in earlier Danish priority setting debates, a coordinating institution is lacking to bundle the discussion and keep it going. The debate seems to have come to an end once again. The fact that it was seriously considered to establish an institute for priority setting is a new development. It can be expected that the discussion will be resumed in the near future, possibly the idea of an institute for priority setting will be readopted. The general conditions for priority setting in health care have improved.

[Gaucher's disease and imiglucerase in 2009/2010: what leads to a suddenly enforced prioritisation?]. / M. Gaucher und Imiglucerase 2009/2010: Was leitet eine plötzlich erzwungene Priorisierung?

Gaucher's disease is, when left untreated, a progressive and in some subsets even life-threatening lysosomal storage disease. It is caused by a genetically linked deficit of acid beta-glucocerebrosidase. The enzyme can be replaced by Cerezyme(®)/imiglucerase produced by Genzyme Corp. The therapy has the potential to induce remis-sion and normalise the patient's life. In June 2009 Genzyme had to announce a viral contamination of its bioreactors which led to a sudden stop of the entire production of imiglucerase. Subsequently only 50-20% of the former supply could be provided worldwide. The situation was not normalised until the beginning of the year 2011. Due to this unexpected shortage the relevant actors had to clarify quickly and unprepared which patient groups to prioritise and whom to supply with what quantities of imiglucerase. The shortly enforced prioritisation and rationing provide an opportunity to describe and analyse the spontaneously choosen prioritisation criteria and reveal value preferences shared by clinicians, patients, patient representatives, and company representatives. To reconstruct the chain of events and reactions and the revealed criteria and value preferences partly standardised interviews with representatives of the relevant stakeholder groups were conducted. Very clearly, the actors spontaneously chose to follow a medical need and a social solidarity principle.

[Criteria for medical prioritisation: results from a regional survey and methodological reflections]. / Kriterien für die Priorisierung medizinischer Leistungen im Licht eines regionalen Surveys--Ergebnisse und methodologische Fragen.

AIMS: In Germany, in contrast to many foreign countries, scientists and medical professionals have been discussing prioritisation in medicine almost without consulting German citizens. We address the question of what questionnaire surveys can contribute to the understanding of citizens' attitudes towards prioritisation - with a focus on some difficulties and challenges of the method. METHOD: We conducted a postal survey with a random sample of 3 000 residents of the City of Lübeck (age ≥18). Respondents were asked to appraise different substantial and procedural criteria for prioritisation in medicine. In addition to descriptive statistical analyses, logistical regression models were performed to identify potential explanatory variables for the appraisal of prioritisation criteria. RESULTS: The response rate was 45.6% (N=1 363). Some prioritisation criteria are accepted by the majority: severity of disease, effectiveness of an intervention and a firm evidence base. Other criteria were appraised controversially: personal life-style, responsibility for family members and general prioritisation of children. A patient's responsibility in society and age as well as an intervention's cost-benefit ratio were generally rejected. The results of logistic regression analyses showed some significant but minor effects of demographic and health-related variables. The citizens in our study want decision-making procedures in health care to be transparent and equally applied to all patients. According to the survey respondents decisions about the catalogue of services of Germany's statutory health insurance should mainly be made by doctors. The statutory health insurance as well as patients and scientists also should take part in the decision-making procedure. DISCUSSION: Comparing our results to those of a national interview survey reveals some relevant differences: The respondents' assessment of some substantial criteria seems to vary according to the contextualisation and wording of the items. We found less difference - but still some inconsistent results - in the participants' appraisal of potential decision-makers in health care. To our surprise, the logistic regression models including standard demographic and health-related variables account for only a small proportion of the variance of all dependent variables. CONCLUSION: Our discussion emphasises some difficulties and challenges of questionnaire surveys on prioritisation criteria - reflecting on the state of the German debate on prioritisation. There has been hardly any public discussion on this issue prior to our survey in autumn 2009. It is thus unlikely that people have been able to state well-informed preferences. Instead they seem to have followed some kind of "social reflexes" depending on the context and wording of each item. Subsequent studies on preferences and priorities should (i) more closely assess the understanding of each item in advance and (ii) adapt the aims of their study and its methodology to the actual stage of the public discourse on the topic in question.

[Proactive screening for rehabilitation need in type 2 diabetics from an AOK Disease Management Programe: which patients will be identified?]. / Proaktives Screening nach Rehabilitationsbedarf bei Typ-2-Diabetikern im Disease-Management-Programm einer AOK: Welche Patienten können identifiziert werden?

BACKGROUND: Medical rehabilitation seems suitable for implementing multimodal interventions for the treatment of type 2 diabetes. Rehabilitation in Germany on principle requires that insurees file an application. Proactive screening for rehabilitation need has only been explored in pilot projects so far. It seems a promising attempt to assess rehab need by questionnaire especially in patients with type 2 diabetes. We do not know though how patients who have been screened positive for rehab need differ from other patients with type 2 diabetes as to their health and risk profiles. This could provide an indication of the validity of the proactive approach. METHODS: Members of an Allgemeine Ortskrankenkasse (AOK) Disease Management Program (DMP) for type 2 diabetes were screened for rehab need by questionnaire. 13 diabetes-specific problem areas were assessed. Problems were assigned to 10 specific treatments (problem-treatment-pairs). Rehab need was presumed if patients needed 3 or more treatments. Patients were then compared to regular rehab patients as well as patients with type 2 diabetes from primary care medical offices. RESULTS: From 5500 DMP-patients 829 returned the questionnaire (return rate: 15.5%). From these 94% met the criteria for rehab need; of these 55% needed 6 or more treatments (complex problems). Patients who screened positive for rehab suffered from more health problems and had worse risk profiles as compared to patients from medical offices, and disease burden was comparable or worse as compared to regular rehab patients. CONCLUSIONS: This indicates that proactive screening for rehab need in patients with type 2 diabetes leads to reasonable (valid) results. The very low return rate suggests that the sample may be considerably biased, though. Possibly, mainly patients with greater impairment to health responded to the screening.

[Feasibility and benefit of an active screening for rehab need and subsequent written advice to file an application for rehab treatment in AOK-insurants enrolled in the disease management program diabetes type 2 (PARTID-trial)]. / Praktikabilität und Nutzen eines aktiven Screenings auf Rehabedarf mit anschließender schriftlicher Beratung zur Rehaantragstellung bei AOK-Versicherten im Disease-Management-Programm Diabetes Typ 2 (PARTID-Studie).

BACKGROUND AND STUDY AIMS: Type 2 diabetes (DM II) is the world's most widespread metabolic disease. Numerous investigations have demonstrated that intensive, multimodal interventions can reduce the occurrence of DM-associated comobidities and mortality. Medical rehabilitation could offer such an alternative, albeit one with an obvious time limit. There is currently no active program in Germany designed to screen for pa-tients' need for rehab. Here, we investigated -whether screening for rehab need in DMII pa-tients accompanied by written advice to file an application for rehab treatment would generate a relevant number of rehab measures, whether -inpatient rehab results in improved mid-term prognoses, and which patients demonstrate a particular benefit from such a program. METHODS: We screened 5 500 employed individuals aged 18-54 years for their need for rehab via an extensive questionnaire based on the "Lübeck Algorithm". The patients were registered in the DMP (disease management program) Diabetes mellitus Type 2 in the AOK Rheinland/-Hamburg health insurance division, and payed into DRV (German statutory pension insurance -scheme) Rheinland retirement insurance. Pa-tients needing rehab who presented no exclusion criteria (i. e., for a rehab intervention far from their place of residence) were randomized to a control or intervention group at a ratio of 3:1. Patients in the intervention group received a letter from the AOK advising them to fill out an application for rehab. A very short, simple application form was included in the mailing. 12 months after randomization we conducted a query to determine the effects of rehab. Our primary endpoint was a cardiovascular risk score specifically devised for diabetics. Multi-level models were applied to measure changes in cardiovascular risk. RESULTS: 850 patients (rate of return=16%) returned completed screening forms to us. After having excluded those with faulty diagnoses and/or those who had refused to participate, 829 patients remained. 94% of them presented a need for rehab according to specific criteria (39% with a simple and 55% with complex problem profiles). 266 patients stated in the questionnaire that a rehab program was impossible for them for personal reasons. Of those patients who remained, we randomized 299 to the intervention cohort and 102 to the control group. Almost 70% of the intervention group completed an application for rehab, and our follow-up revealed that most of them participated in a rehab intervention. Return rate after one year was 82%. Analysis on the intention-to-treat (ITT) principle revealed no significant effect on cardiovascular risk (p=0.68); however, per-protocol analysis demonstrated a significant effect in the intervention cohort (p=0.025). Males, and patients with an uncomplicated problem profile profited from the intervention. DISCUSSION: We discovered that a proactive procedure leads to the identification of a highly relevant group of insured individuals, and that it is suited to generating a large number of medically -justified rehab applications. ITT analysis on the effi-cacy of inpatient rehabilitation for type 2 diabetes mellitus in terms of the cardiovascular 5-year risk, however, failed to display a significant statistical effect in this study population (insurees of generally lower socioeconomic status having no intention to apply for rehab treatment). Rehab treatment for type 2 diabetes does not seem to be universally effective. This of course does not apply to rehab in general, as patients usually participate in rehab of their own volition. More research is needed on this issue.

[Assessing complex health problems of patients with IBD--first step to patient activation]. / Komplexe psychosoziale Problemlagen bei Morbus Crohn und Colitis ulcerosa--fragebogengestütztes Assessment als erster Schritt zur Aktivierung von Patientinnen und Patienten.

BACKGROUND: Health care for inflammatory bowel diseases (IBD), to be comprehensive, takes a broad range of patients' somatic and psychosocial problems into account. Patients should be actively involved in health-care planning and organisation. METHODS: 431 adult patients with Crohn's disease (50 %) or ulcerative colitis participated in a postal questionnaire survey; 6 months apart it twice assessed the patients' individual problem profiles. The results of the assessment were back-reported to each patient combined with targeted (though standardised) recommendations for future care. This publication is the first of a series. It presents the basic study design, describes the prevalence of 16 psychosocial problem domains and analyses their association with socio-demographic and disease variables. RESULTS: Participants had a mean age of 46 years; 61 % were female; 57 % in remission (GIBDI ≤ 3). The most prevalent problems reported addressed sexual impairments (27 %), high stress (26 %) and depression (21 %). 27 % of the respondents did not report any psychosocial problem. One in five (21 %) described highly complex problem profiles (≥ 5 "active" problems) combined with a mean of 28 disability days within the past 3 months. Complex psychosocial profiles were associated with active disease, Crohn's disease and low educational level. CONCLUSIONS: IBD patients show a highly variable spectrum of psychosocial problems. Their number is closely associated with disease activity and a social status variable (school education). The gradient could complicate efforts to increase patient participation in care and to enhance self-management.

[The "Wunsch- und Wahlrecht" from §9 SGB IX in case of the application for the medical rehabilitation: findings of a regional survey among insurees of a federal pension fund and a compulsory health insurance fund]. / Das Wunsch- und Wahlrecht des §9 SGB IX bei der Beantragung einer medizinischen Rehabilitation: Ergebnisse eines regionalen Surveys unter Versicherten der Gesetzlichen Renten- und Krankenversicherung.

OBJECTIVES: The Social Code Book Nine (SGB IX), which was implemented in 2001, contains the "Wunsch- und Wahlrecht" for medical rehabilitation services in para. 9. This describes a right to participate and choose in the process of rehabilitation. The aim of the study was to collect representative data about the implementation of the para. 9 SGB IX during application for medical rehabilitation services from the applicants' point of view. METHODS: A total of 2 000 applicants for rehabilitation services (all somatic and psychosomatic indications) of a federal pension fund and a compulsory health insurance fund were invited to take part in a postal survey about the "Wunsch- und Wahlrecht". RESULTS: The response rate was 66%. Most respondents reported that their application for rehabilitation services was approved immediately. People who supported respondents during application and gave information about the "Wunsch- und Wahlrecht" differed according to the kind of rehabilitation services the respondent applied for. Half of the respondents reported to have known about their "Wunsch- und Wahlrecht". The percentage was considerably higher for patients applying for post-hospital rehabilitation. Approximately 2/3 of the respondents had wishes concerning the choice of rehabilitation clinic. Half of those respondents reported their wishes to the insurer. Most wishes concerned the choice of a specific clinic, a place/region or the clinic's distance from the applicant's home. Wishes reported to the insurer were often considered (89%). Most important selection criteria for rehabilitation clinics were aspects of accommodation, clinic facilities and location, followed by aspects of treatment and the respectful treatment of rehabilitation patients. Concerning the mode of information about rehabilitation clinics, applicants preferred brochures (vs. internet), comparative and impartial information about the clinic and subjective accounts of individual rehabilitation patients. CONCLUSIONS: This study is an evaluation of how the "Wunsch- und Wahlrecht" has been translated to reality of rehabilitation services provided by a federal pension fund and a compulsory health insurance fund. The findings show that many respondents know about their "Wunsch- und Wahlrecht" and make use of it to a certain degree. At the moment wishes still relate mainly to the place or region of rehabilitation. This shows the necessity of informing applicants about their "Wunsch- und Wahlrecht" on a regular basis. At the same time they must be enlightened about potentially important criteria for choosing a rehabilitation clinic.

[Liveonline aftercare in patients with abdominal obesity in cardio-diabetological rehabilitation: findings of a randomized controlled study]. / Liveonline-Nachbetreuung bei Patienten mit abdominaler Adipositas in der kardio-diabetologischen Rehabilitation: Ergebnisse einer randomisierten, kontrollierten Studie.

Obese patients were coached after inpatient medical rehabilitation with a 6 units comprehensive multimodal Liveonline aftercare program. In the randomized controlled study design, significant improvements in all outcome criteria were found both in treatment and control group. The improvements in the treatment group, however, were only partially superior to the control group, especially in the area of food habits. A statistically significant superiority of the treatment group concerning the primary targets waist circumference and body mass index could not be determined. The Liveonline aftercare was evaluated positively by the participants. Future research is discussed.

[Empirically derived recommendations for measuring patient-reported change in rehabilitation studies]. / Empirisch gestützte Empfehlungen für die patientenberichtete Veränderungsmessung in der medizinischen Rehabilitation.

Diverse methods are available for evaluation of (medical) interventions. In each case one has to decide on a specific method. Our aim was to analyze typical problems involved in the measurement of change. Different methods are delineated, and their specific pros and cons are set out. Subsequently, empirically derived recommendations are outlined on which method should be employed for which problem and under which circumstances. A characteristic of rehab treatment is that as a rule a multitude of problems are addressed, and accordingly, treatment goals are heterogenic. Straightforward recommendations for one or the other method cannot be given.

[Preference of patients with inflammatory bowel disease regarding information and shared decision-making: results from a cross-sectional survey in Germany]. / Zu welchen Themen wünschen Patientinnen und Patienten mit Morbus Crohn oder Colitis ulcerosa mehr Informationen und welche eigene Rolle bevorzugen sie bei medizinischen Behandlungsentscheidungen? Ergebnisse einer Betroffenenbefragung in Deutschland.

BACKGROUND: Evidence-based and consented pathways for patients with inflammatory bowel diseases (IBD, Crohn's disease, ulcerative colitis) call for tailored education programmes to foster shared decision-making and patient self-management. Their preferences should be taken into account. METHODS: In 2005 a cross-sectional postal questionnaire survey was conducted in different regions of Germany. Adult patients with ulcerative colitis (UC) or Crohn's disease (CD) were recruited from specialised gastroenterological practices, university outpatient clinics and the member registry of the relevant patient organisation DCCV. They returned a questionnaire including (inter)nationally established scales (e. g., HADS) as well as questions on their information needs, preferred information sources and their role in decision-making. RESULTS: Data of 1056 responders could be analysed (65 % female; CD: 58 %; DCCV member: 71 %). The mean age of the patients was 42 (SD 12,8) years. Almost all patients wanted more information on "treatment alternatives" (83 %), "causes of disease" (80 %) and "what can I (still) do by myself" (79 %). 27 % of the patients asked for more information on 15 or more of overall 19 topics. The high information need was significantly associated with HADS potential depressive disorder (score > 8) and HADS probable anxiety disorder (score > 10). Most IBD patients (70 %) obviously regard their physicians as the most desirable source of information, 67 % prefer an active involvement in clinical decision-making. CONCLUSIONS: The data demonstrate high information needs of IBD patients and may serve in the planning of future educational programmes.

[Priority setting: what is it all about, and how does it work?]. / Priorisierung: Was ist das und wie geht das?

This paper introduces the concept of priority setting in health care. Priority setting is understood as a notional approach to find out what to regard as more important or less important in health care. It primarily means to bring aspects into a ranking order. Priority setting is first and foremost theoretical work aimed at preparing decisions. It does not replace these decisions. Priority setting is not restricted to circumstances of scarce resources. It can be used, for example, for working more efficiently, for quality assurance, and also for rationing. Values or value decisions form the basis of priority setting. There should be a societal consensus regarding these values and the way priority setting is conducted. Priority settings can be done to very different objects, including objects from a macro-level, e. g. general goals of health care, from a meso-level, e. g. condition-treatment pairs, as well as from a micro-level, e. g. waiting lists. Swedish national prioritization guidelines serve as an example of how priority setting can be conducted. Here, condition-treatment pairs are developed on the basis of present health care occurrences. Then, priorities from 1 (highest priority) to 10 (lowest priority) are assigned on the basis of a priority setting model. The process includes all relevant stakeholders. Priorities are set on the basis of the severity of the problem, knowledge of the effect of an intervention and its cost-effectiveness, as well as the level of evidence of the knowledge contributing to the decision. In rehabilitation, priority setting is still an unfamiliar topic which only few scientific papers have taken up to date. Different aspects of priority setting that may be deemed important for rehabilitation are introduced.

[Use of trajectories for measuring change in medical rehabilitation: a contribution toward comparison of different methods of outcome measurement]. / Verwendung von Verlaufstypen zur Veränderungsmessung in der medizinischen Rehabilitation: Ein Beitrag zum Vergleich verschiedener Methoden der Ergebnismessung.

OBJECTIVE: The question of which methods should be used to assess the effects of medical rehabilitation has a long and controversial history. With regard to this background the project "Outcome measurement in medical rehabilitation" aimed at developing a better understanding of the process of change and its assessment. We also looked into possible causes for discrepancies between the results of direct and indirect measures of change. Aims of our study were: (1) to picture trajectories of change in a simple and descriptive way, (2) to compare the resulting solutions, (3) to highlight relations with direct measurement of change and/or global estimation of effects, (4) to compare the predictive value of different measurements of change. METHODS: We used available data from rehabilitation research which covered direct and indirect measurement of change as well as global measurement of effects and which therefore enabled us to compare different methods of outcome measurements. The well documented record includes data from n=466 patients with chronic back pain. Different trajectories (3 and 5 groups) were defined using their pre/post data. RESULTS: Depending on limits chosen for positive or negative courses and chosen outcome 20% to almost 40% of the patients showed improvements over the follow-up period. About the same percentages changed for the worse. However, two-thirds of the patients improved at least in one outcome. Compared with those, who did not experience improvements in any outcome, this group indicated better global rehabilitation effects. The different types of trajectories (3 and 5 groups) substantially contribute to the explained variance of catamnestic status at 12 months beyond other predictors as well as beyond initial status. The same applies to the prediction of disability days. CONCLUSION: The description of trajectories of change yields useful results. In contrast to complex statistical methods we were able to identify groups of patients that can easily be described.

[Pharmacotherapy in patients with ulcerative colitis]. / Medikamentöse Versorgung von Patienten mit Colitis ulcerosa.

BACKGROUND: Patients with ulcerative colitis experience various impairments. The pharmacological treatment of the disease comprises 5-aminosalicylic acid, corticosteroids as well as immunomodulatory and biological agents. Little self-reported data exist on the prescription of these drugs. METHODS: This cross-sectional study was conducted in 2005 as a postal survey in different regions of Germany [Kiel/Lübeck, Halle (Saale), Minden, Regensburg]. Patients with ulcerative colitis (UC) were recruited from specialised gastroenterological practices, university outpatient clinics, and the member registry of a prominent patient organisation (DCCV). Participants returned a questionnaire including established items and scales on physical and psychosocial well-being as well as the self-reported current medication. RESULTS: A total of 444 patients with ulcerative colitis returned the questionnaires. Most of the participants were female, had a high level of school education and were currently employed. Twenty-eight percent of the participants reported to receive corticosteroids and 71 % reported a current treatment with 5-aminosalicylic acid. Approximately one quarter of our study population reported a treatment with immunomodulatory agents. Analgesics were reported to be prescribed only in 15 % of the patients, primarily in patients with depressive symptoms. Patients recruited from specialised gastroenterological practices and university outpatient clinics were more likely to report the prescription of 5-aminosalicylic acid and immunomodulatory drugs than members of the patient organisation. Only 7 % of our patients received loperamide, however, probiotics (12 %) and complementary agents (36 %) seem to have an important role with regard to prevalence of intake. About 40 % of women but only 28 % of the men reported to use complementary agents. Persons with a duration of illness of less than 11 years (median split) were almost twice as likely to take corticosteroids than persons with a longer duration of ulcerative colitis. DISCUSSION: Our results suggest an estimation of prescription rates in ulcerative colitis. However, they raise new questions, for example, concerning a potential underuse of immunomodulatory agents in this patient population. With regard to the identified differences in prescription rates according to psychosocial characteristics further studies are needed to examine these relationships.

[The Danish debate on priority setting in medicine - characteristics and results]. / Priorisierung in der Medizin - Verlauf und Ergebnisse der dänischen Priorisierungsdebatte.

Priority setting in medicine helps to achieve a fair and transparent distribution of health-care resources. The German discussion about priority setting is still in its infancy and may benefit from other countries' experiences. This paper aims to analyse the Danish priority setting debate in order to stimulate the German discussion. The methods used are a literature analysis and a document analysis as well as expert interviews. The Danish debate about priority setting in medicine began in the 1970s, when a government committee was constituted to evaluate health-care priorities at the national level. In the 1980s a broader debate arose in politics, ethics, medicine and health economy. The discussions reached a climax in the 1990s, when many local activities - always involving the public - were initiated. Some Danish counties tried to implement priority setting in the daily routine of health care. The Council of Ethics was a major player in the debate of the 1990s and published a detailed statement on priority setting in 1996. With the new century the debate about priority setting seemed to have come to an end, but in 2006 the Technology Council and the Danish Regions resumed the discussion. In 2009 the Medical Association called for a broad debate in order to achieve equity among all patients. The long lasting Danish debate on priority setting has entailed only very little practical consequences on health care. The main problems seem to have been the missing effort to bundle the various local initiatives on a national level and the lack of powerful players to put results of the discussion into practice. Nevertheless, today the attitude towards priority setting is predominantly positive and even politicians talk freely about it.

[Relevance of the "Wunsch- und Wahlrecht" of § 9 social code book 9 in medical rehabilitation from the patients' perspective]. / Die Bedeutung des Wunsch- und Wahlrechts des § 9 SGB IX für die medizinische Rehabilitation aus Sicht der Rehabilitanden.

OBJECTIVES: Everyone applying for medical rehabilitation (and other benefits to support participation) has a "Wunsch- und Wahlrecht" (meaning the right to individual wishes and choice relative to assessments, services and institutions as well as to the various benefits) according to § 9 of Book 9 of the German Social Code (SGB 9) concerning every aspect of the implementation of these services. This study was aimed at exploring the wishes of rehabilitants, their attitudes towards and experiences with the various aspects of the "Wunsch- und Wahlrecht" as well as their criteria in choosing a rehabilitation centre. METHODS: A total of 10 open guided focus groups were conducted with 71 male and female participants from 5 different indications and aged between 26 and 80 years. Transcripts were analyzed by means of a summary content analysis. RESULTS: Persons applying for medical rehabilitation benefits did not as a rule get information about their "Wunsch- und Wahlrecht" during the application process. Applying for post-hospital rehabilitation often meant to be faced with an only allegedly existing choice ("pseudo Wunsch- und Wahlrecht"). The participants objected only rarely to this missing share in decision-making. Most of them did not care about their rights to choose a rehab centre if only the application for rehabilitation was allowed. Various arguments were brought forward against the "Wunsch- und Wahlrecht", especially insufficient information about and time for enforcement and implementation of the "Wunsch- und Wahlrecht". Despite an explicit stipulation in § 9 SGB 9, notices of approval rarely stated reasons for ignoring the wishes expressed by the applicants. Many participants had reflected only little about choosing a specific rehab centre when applying for rehabilitation. Accordingly, most of the participants had difficulties to mention possible selection criteria. DISCUSSION: On the whole, applicants have Only little knowledge about the "Wunsch- und Wahlrecht". This complicates its implementation considerably. The preconditions for making informed and valid choices between different clinics are not given under these circumstances. Most interviewees do not attach much value to the "Wunsch- und Wahlrecht". CONCLUSIONS: From a social law perspective, it should be demanded that rehab applicants have to get better information about their "Wunsch- und Wahlrecht" and that they must be empowered to decide on their choice based on objective and valid information. The active role in the rehabilitation process that should generally be demanded from rehabilitants, should also be encouraged and fostered in choosing a rehabilitation centre.

[Diagnosis and treatment of osteoporosis and rheumatoid arthritis in accordance with German guidelines. Results of a survey of patients, primary care physicians and rheumatologists]. / Diagnostik und Behandlung der Osteoporose bei rheumatoider Arthritis vor dem Hintergrund der Leitliniennutzung. Ergebnisse einer Befragung von Patienten, Hausärzten und Rheumatologen (ORA-Studie).

In a cross-sectional study the prevalence of osteoporosis and osteopenia in patients with rheumatoid arthritis (ORA study) was investigated. Additionally, patients, their family doctors and rheumatologists were surveyed on their awareness of osteoporosis in RA, prevention, diagnosis, treatment and use of guidelines.In the years 2005 and 2006 a total of 532 patients with RA (98 men, 434 women) aged 23-87 years were consecutively recruited from 9 German centers for rheumatology. Clinical examination included a detailed documentation of osteoporosis medication. Dual-energy X-ray absorptiometry (DXA) was used to measure bone mineral density (BMD) at the lumbar spine and neck of the femur. Questionnaires on osteoporosis were sent to 119 family doctors (87 men, 32 women) and 44 rheumatologists (30 men, 14 women).The survey showed that rheumatologists had a higher awareness of osteoporosis in RA and compared to family doctors they estimated a higher frequency and tested RA patients more often for osteoporosis. In line with osteoporosis guidelines rheumatologists and family doctors saw an indication for densitometry in RA patients on steroid therapy and/or low intensity trauma fractures. In contrast to the 2006 recommendations of osteoporosis guidelines 50% of family doctors and rheumatologists preferred bisphosphonate off-label-therapy for premeopausal women with RA and comorbid glucocorticoid-induced osteoporosis. On the other hand 50% of premenopausal RA patients with osteoporosis did not receive any osteoporosis medication.The survey revealed a high degree of guideline compliance in diagnosing osteoporosis in RA but deficits were observed in the administration of osteoporosis medication, especially in premenopausal women.

[Prophylaxis and treatment of osteoporosis in patients with rheumatoid arthritis (ORA study)]. / Medikamentöse Osteoporoseprophylaxe und -Therapie bei Patienten mit Rheumatoider Arthritis (ORA-Studie).

OBJECTIVE: The aim of this study was to examine bone mineral density (BMD), frequency of osteopenia and osteoporosis in a representative sample of patients with rheumatoid arthritis (RA) and to describe chemoprophylaxis and treatment of osteoporosis compared to evidence-based guidelines. PATIENTS AND METHODS: In 2005 and 2006, 532 patients with RA (98 men, 434 women) aged 23-87 years were recruited from 9 German rheumatology centers. Clinical examination included a detailed documentation of osteoporosis medication. Dual-energy X-ray absorptiometry (DXA) was used to measure BMD at the lumbar spine and femoral neck. Osteopenia and osteoporosis were defined according to the criteria of the World Health Organization. RESULTS: Of the RA patients 29% had normal BMD at the spine and femoral neck, 49% of the patients had osteopenia and 22% met the criteria for osteoporosis at any site. Of the patients 60% were receiving medication for prophylaxis or therapy of osteoporosis, 38% calcium/vitamin D alone, 20% as combinations mostly of calcium/vitamin D + bisphosphonate, 1% received bisphosphonate only and 1% hormone replacement therapy. Although the frequency of osteoporosis showed no significant differences between male and female patients, women with RA used osteoporosis medication more often than men (63% versus 49%, χ²-test, p <0.05). A total of 101 RA patients (83 menopausal women, 6 premenopausal women, 12 men) received corticosteroids in a daily dose of 7.5 mg or less for at least 3 months and had DXA T-scores below -2.0 at any site. In this patient group 41% of the menopausal women, 17% of the premenopausal women and 42% of the male patients were reported to receive medication with calcium/vitamin D + bisphosphonate. Calcium/vitamin D was used by 35% of the menopausal women, none of the premenopausal women and 50% of the male patients and 18% of the menopausal women, 67% of the premenopausal women and 8% of men received no prophylaxis or treatment for osteoporosis. CONCLUSION: According to the DVO (German Society for Osteoporosis) guidelines for osteoporosis (2009) menopausal women with corticosteroid therapy < 7.5 mg per day for at least 3 months and DXA T-scores below -2.0 should receive treatment with bisphosphonate and calcium/vitamin D. The data show that there were still deficits concerning prophylaxis and treatment of osteoporosis in RA.