Reducing antibiotic use for uncomplicated urinary tract infection in general practice by treatment with uva-ursi (REGATTA) - a double-blind, randomized, controlled comparative effectiveness trial.

BACKGROUND: Uncomplicated urinary tract infections (UTI) are common in general practice and usually treated with antibiotics. This contributes to increasing resistance rates of uropathogenic bacteria. A previous trial showed a reduction of antibiotic use in women with UTI by initial symptomatic treatment with ibuprofen. However, this treatment strategy is not suitable for all women equally. Arctostaphylos uva-ursi (UU, bearberry extract arbutin) is a potential alternative treatment. This study aims at investigating whether an initial treatment with UU in women with UTI can reduce antibiotic use without significantly increasing the symptom burden or rate of complications. METHODS: This is a double-blind, randomized, and controlled comparative effectiveness trial. Women between 18 and 75 years with suspected UTI and at least two of the symptoms dysuria, urgency, frequency or lower abdominal pain will be assessed for eligibility in general practice and enrolled into the trial. Participants will receive either a defined daily dose of 3 × 2 arbutin 105 mg for 5 days (intervention) or fosfomycin 3 g once (control). Antibiotic therapy will be provided in the intervention group only if needed, i.e. for women with worsening or persistent symptoms. Two co-primary outcomes are the number of all antibiotic courses regardless of the medical indication from day 0-28, and the symptom burden, defined as a weighted sum of the daily total symptom scores from day 0-7. The trial result is considered positive if superiority of initial treatment with UU is demonstrated with reference to the co-primary outcome number of antibiotic courses and non-inferiority of initial treatment with UU with reference to the co-primary outcome symptom burden. DISCUSSION: The trial's aim is to investigate whether initial treatment with UU is a safe and effective alternative treatment strategy in women with UTI. In that case, the results might change the existing treatment strategy in general practice by promoting delayed prescription of antibiotics and a reduction of antibiotic use in primary care. TRIAL REGISTRATION: EudraCT: 2016-000477-21 . Clinical trials.gov: NCT03151603 (registered: 10 May 2017).

High prevalence of prescription of psychotropic drugs for older patients in a general hospital.

BACKGROUND: Many elderly patients receive psychotropic drugs. Treatment with psychotropic agents is associated with serious side effects including an increased risk of falls and fractures. Several psychotropic drugs are considered potentially inappropriate for treatment of the elderly. METHODS: A retrospective chart review was conducted covering all patients aged ≥ 65 years who were admitted to Evangelisches Krankenhaus Göttingen-Weende between 01/01/2013 and 03/31/2013. Psychotropic drugs reviewed for included benzodiazepines, Z-drugs, antidepressants and neuroleptics, but not drugs for sedation during artificial ventilation or pre-medication before surgery. Potentially inappropriate drugs were identified according to the PRISCUS list. To assess which factors were associated with the administration of psychotropic drugs, univariate and multivariable logistic regression analyses were performed. RESULTS: The charts of 2130 patients (1231 women) were analyzed. 53.9% of all patients received at least one psychotropic medication (29.5% benzodiazepines, 12.6% Z-drugs, 22.2% antidepressants, 11.9% neuroleptics). The mean number of psychotropic drugs prescribed per patient with at least one prescription was 1.6. Patients treated in the geriatric department most often received antidepressants (45.0%), neuroleptics (20.6%) and Z-drugs (27.5%). Benzodiazepines and Z-drugs were prescribed mostly as medication on demand (77.7% of benzodiazepines, 73.9% of Z-drugs). Surgical patients most frequently received benzodiazepines (37.1%). Nearly one-third of all patients ≥ 65 years was treated with at least one potentially inappropriate psychotropic medication. The mean number of potentially inappropriate psychotropic medications per patient with at least one psychotropic prescription was 0.69. The percentage of patients with potentially inappropriate psychotropic medication was highest in the surgical departments (74.1%). Female gender (adjusted OR 1.36; 95% CI 1.14 to 1.63), stay in the Department of Geriatrics (2.69; 2.01 to 3.60) or the interdisciplinary intensive care unit (1.87; 1.33 to 2.64) and age ≥ 85 years (1.33; 1.10 to 1.60) were associated with psychotropic drug treatment. CONCLUSIONS: A high percentage of patients aged ≥ 65 years received psychotropic drugs. The chance that a potentially inappropriate psychotropic drug would be administered was highest in the surgical departments. Antidepressants, neuroleptics and Z-drugs were used surprisingly often in geriatric medicine. Educational strategies could reduce the use of psychotropic drugs and the prescription of potentially inappropriate medications.

Effectiveness of the 23-Valent Pneumococcal Polysaccharide Vaccine (PPV23) against Pneumococcal Disease in the Elderly: Systematic Review and Meta-Analysis.

BACKGROUND: Routine vaccination of elderly people against pneumococcal diseases is recommended in many countries. National guidelines differ, recommending either the 23-valent polysaccharide vaccine (PPV23), the 13-valent conjugate vaccine (PCV13) or both. Considering the ongoing debate on the effectiveness of PPV23, we performed a systematic literature review and meta-analysis of the vaccine efficacy/effectiveness (VE) of PPV23 against invasive pneumococcal disease (IPD) and pneumococcal pneumonia in adults aged ≥60 years living in industrialized countries. METHODS: We searched for pertinent clinical trials and observational studies in databases MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews. We assessed the risk of bias of individual studies using the Cochrane Risk of Bias tool for randomized controlled trials and the Newcastle-Ottawa Scale for observational studies. We rated the overall quality of the evidence by GRADE criteria. We performed meta-analyses of studies grouped by outcome and study design using random-effects models. We applied a sensitivity analysis excluding studies with high risk of bias. RESULTS: We identified 17 eligible studies. Pooled VE against IPD (by any serotype) was 73% (95%CI: 10-92%) in four clinical trials, 45% (95%CI: 15-65%) in three cohort studies, and 59% (95%CI: 35-74%) in three case-control studies. After excluding studies with high risk of bias, pooled VE against pneumococcal pneumonia (by any serotype) was 64% (95%CI: 35-80%) in two clinical trials and 48% (95%CI: 25-63%) in two cohort studies. Higher VE estimates in trials (follow-up ~2.5 years) than in observational studies (follow-up ~5 years) may indicate waning protection. Unlike previous meta-analyses, we excluded two trials with high risk of bias regarding the outcome pneumococcal pneumonia, because diagnosis was based on serologic methods with insufficient specificity. CONCLUSIONS: Our meta-analysis revealed significant VE of PPV23 against both IPD and pneumococcal pneumonia by any serotype in the elderly, comparable to the efficacy of PCV13 against vaccine-serotype disease in a recent clinical trial in elderly people. Due to its broader serotype coverage and the decrease of PCV13 serotypes among adults resulting from routine infant immunization with PCV13, PPV23 continues to play an important role for protecting adults against IPD and pneumococcal pneumonia.

Reaching the Elderly: Understanding of health and preventive experiences for a tailored approach - Results of a qualitative study.

BACKGROUND: Often preventive measures are not accessed by the people who were intended to be reached. Programs for older adults may target men and women, older adults, advanced old age groups and/or chronically ill patients with specific indications. The defined target groups rarely participate in the conception of programs or in the design of information materials, although this would increase accessibility and participation. In the German "Reaching the Elderly" study (2008-2011), an approach to motivating older adults to participate in a preventive home visit (PHV) program was modified with the participatory involvement of the target groups. The study examines how older men and women would prefer to be addressed for health and prevention programs. METHODS: Four focus groups (N = 42 participants) and 12 personal interviews were conducted (women and men in 2 age groups: 65-75 years and ≥ 76 years). Participants from two districts of a major German city were selected from a stratified random sample (N = 200) based on routine data from a local health insurance fund. The study focused on the participants' knowledge about health and disease prevention and how they preferred to be approached and addressed. Videos of the focus groups were recorded and analysed using mind mapping techniques. Interviews were digitally recorded, transcribed verbatim and subjected to qualitative content analysis. RESULTS: A gender-specific approach profile was observed. Men were more likely to favor competitive and exercise-oriented activities, and they associated healthy aging with mobility and physical activity. Women, on the other hand, displayed a broader understanding of healthy aging, which included physical activity as only one aspect as well as a healthy diet, relaxation/wellness, memory training and independent living; they preferred holistic and socially oriented services that were not performance-oriented. The "older seniors" (76+) were ambivalent towards certain wordings referring to aging. CONCLUSIONS: Our results suggest that gender-specific needs must be considered in order to motivate older adults to participate in preventive services. Age-specific characteristics seem to be less relevant. It is more important to pay attention to factors that vary according to the individual state of health and life situation of the potential participants.

Interprofessional collaboration in nursing homes (interprof): a grounded theory study of general practitioner experiences and strategies to perform nursing home visits.

BACKGROUND: Interprofessionalism, considered as collaboration between medical professionals, has gained prominence over recent decades and evidence for its impact has grown. The steadily increasing number of residents in nursing homes will challenge medical care and the interaction across professions, especially nurses and general practitioners (GPs). The nursing home visit, a key element of medical care, has been underrepresented in research. This study explores GP perspectives on interprofessional collaboration with a focus on their visits to nursing homes in order to understand their experiences and expectations. This research represents an aspect of the interprof study, which explores medical care needs as well as the perceived collaboration and communication by nursing home residents, their families, GPs and nurses. This paper focusses on GPs' views, investigating in particular their visits to nursing homes in order to understand their experiences. METHODS: Open guideline-interviews covering interprofessional collaboration and the visit process were conducted with 30 GPs in three study centers and analyzed with grounded theory methodology. GPs were recruited via postal request and existing networks of the research partners. RESULTS: Four different types of nursing home visits were found: visits on demand, periodical visits, nursing home rounds and ad-hoc-decision based visits. We identified the core category "productive performance" of home visits in nursing homes which stands for the balance of GPs´ individual efforts and rewards. GPs used different strategies to perform a productive home visit: preparing strategies, on-site strategies and investing strategies. CONCLUSION: We compiled a theory of GPs home visits in nursing homes in Germany. The findings will be useful for research, and scientific and management purposes to generate a deeper understanding of GP perspectives and thereby improve interprofessional collaboration to ensure a high quality of care.

Understanding and reducing the prescription of hypnotics and sedatives at the interface of hospital care and general practice: a protocol for a mixed-methods study.

INTRODUCTION: Hypnotics and sedatives, especially benzodiazepines and Z-drugs, are frequently prescribed for longer periods than recommended-in spite of potential risks for patients. Any intervention to improve this situation has to take into account the interplay between different actors, interests and needs. The ultimate goal of this study is to develop-together with the professionals involved-ideas for reducing the use of hypnotics and sedatives and then to implement and evaluate adequate interventions in the hospital and at the primary and secondary care interface. METHODS AND ANALYSIS: The study will take place in a regional hospital in northern Germany and in some general practices in this region. We will collect data from doctors, nurses, patients and a major social health insurer to define the problem from multiple perspectives. These data will be explored and discussed with relevant stakeholders to develop interventions. The interventions will be implemented and, in a final step, evaluated. Both quantitative and qualitative data, including surveys, interviews, chart reviews and secondary analysis of social health insurance data, will be collected to obtain a full understanding of the frequency and the reasons for using hypnotics and sedatives. ETHICS AND DISSEMINATION: Approval has been granted from the ethics review committee of the University Medical Center Göttingen, Germany. Results will be disseminated to researchers, clinicians and policy makers in peer-reviewed journal articles and conference publications. One or more dissemination events will be held locally during continuous professional development events for local professionals, including (but not confined to) the study participants.

Does an increase in visits to general practice indicate a malignancy?

BACKGROUND: An increase in a patient's visits to doctors usually raises concerns and may be a 'red flag' for a patient's deterioration of health. The aim of this study was to analyze whether an increase of patient-physician contacts is a first sign of a malignancy in a patient's near future. METHODS: This is a retrospective case-control study. From 153 German general practices' electronic patient records (EPR), cases with at least one new malignancy diagnosis and no-malignancy controls were matched for gender and age. We calculated (1) the number of contacts in the first quarter up to the sixth quarter before a malignancy diagnosis was made and (2) the inter-contact interval (ICI), i.e. the time lag between two consecutive patient-physician contacts measured in days. Differences between cases and controls were investigated in several analyses of variance, with group and time as main factors. RESULTS: A total of 3,310 cases and 3,310 controls could be included. The number of contacts for cases in the six quarters before a malignancy diagnosis increased from 4.8 contacts (SD 4.3) to 5.5 contacts (SD 4.8). The number of contacts for controls increased only marginally from 4.3 contacts (SD 3.6) to 4.5 (SD 4.2). The factor 'group' (cases vs. controls) was highly significant in the analyses of variance, also 'time' and the interaction 'group * time'. The effect size, however, was very small (R(2) being less than 0.02), which is the equivalent for about one additional contact per quarter in cases directly before a newly made malignancy diagnosis. CONCLUSION: An increase in contact frequency is a call for GPs to become more attentive towards these patients. It may raise the suspicion of an impending serious disease but the increase is not so dramatic and unique that it can be interpreted a reliable sign of a malignant diagnosis.

Applying for, reviewing and funding public health research in Germany and beyond.

Public health research is complex, involves various disciplines, epistemological perspectives and methods, and is rarely conducted in a controlled setting. Often, the added value of a research project lies in its inter- or trans-disciplinary interaction, reflecting the complexity of the research questions at hand. This creates specific challenges when writing and reviewing public health research grant applications. Therefore, the German Research Foundation (DFG), the largest independent research funding organization in Germany, organized a round table to discuss the process of writing, reviewing and funding public health research. The aim was to analyse the challenges of writing, reviewing and granting scientific public health projects and to improve the situation by offering guidance to applicants, reviewers and funding organizations. The DFG round table discussion brought together national and international public health researchers and representatives of funding organizations. Based on their presentations and discussions, a core group of the participants (the authors) wrote a first draft on the challenges of writing and reviewing public health research proposals and on possible solutions. Comments were discussed in the group of authors until consensus was reached. Public health research demands an epistemological openness and the integration of a broad range of specific skills and expertise. Applicants need to explicitly refer to theories as well as to methodological and ethical standards and elaborate on why certain combinations of theories and methods are required. Simultaneously, they must acknowledge and meet the practical and ethical challenges of conducting research in complex real life settings. Reviewers need to make the rationale for their judgments transparent, refer to the corresponding standards and be explicit about any limitations in their expertise towards the review boards. Grant review boards, funding organizations and research ethics committees need to be aware of the specific conditions of public health research, provide adequate guidance to applicants and reviewers, and ensure that processes and the expertise involved adequately reflect the topic under review.

Predicting antibiotic prescription after symptomatic treatment for urinary tract infection: development of a model using data from an RCT in general practice.

BACKGROUND: Uncomplicated urinary tract infection (UTI) is often treated with antibiotics, resulting in increasing resistance levels. A randomised controlled trial showed that two-thirds of females with UTI treated symptomatically recovered without subsequent antibiotic treatment. AIM: To investigate whether there are differences between females with a UTI who were subsequently prescribed antibiotics and those who recovered with symptomatic treatment only, and to develop a model to predict those who can safely and effectively be treated symptomatically. DESIGN AND SETTING: This is a subgroup analysis of females assigned to ibuprofen in a UTI trial in general practices. METHOD: Multiple logistic regression analysis was used to select variables for a prediction model, The discriminative value of the model was estimated by the area under the receiver operator curve (AUC) and the effects of different thresholds were calculated within the model predicting antibiotic prescription and need for follow-up visits. RESULTS: Of the 235 females in the ibuprofen group, 79 were subsequently prescribed antibiotics within 28 days of follow-up. The final model included five predictors: urgency/frequency, impaired daily activities, and positive dipstick test results for erythrocytes, leucocytes, and nitrite. The AUC was 0.73 (95% CI = 0.67 to 0.80). A reasonable threshold for antibiotic initiation would result in 58% of females presenting with UTI being treated with antibiotics. Of the remaining females, only 6% would return to the practice because of symptomatic treatment failure. CONCLUSION: The present model revealed moderately good accuracy and could be the basis for a decision aid for GPs and females to find the treatment option that fits best.

Recurrent urinary tract infections and complications after symptomatic versus antibiotic treatment: follow-up of a randomised controlled trial.

BACKGROUND: Uncomplicated urinary tract infections (UTI) are common in general practice, and are usually treated with antibiotics. Recurrent UTI often pose a serious problem for affected women. Little is known about recurrent UTI and complications when uncomplicated UTI are treated without antibiotics. With ICUTI (Immediate vs. conditional antibiotic use in uncomplicated UTI, funded by BMBF No. 01KG1105) we assessed whether initial symptomatic treatment with ibuprofen could be a treatment alternative for uncomplicated UTI. The presented analysis aims to assess the influence of initial (non-)antibiotic treatment on recurrent UTI rates and pyelonephritis after day 28 up to 6 months after trial participation. METHODS: This study is a retrospective long-term follow-up analysis of ICUTI patients, surveyed telephonically six months after inclusion in the trial. Recurrent UTI, pyelonephritis or hospitalizations were documented. Statistical evaluation was performed by descriptive and multivariate analyses with SPSS 21. RESULTS: For the six months follow-up survey, 386 trial participants could be contacted (494 had been included in ICUTI initially, 446 had completed the trial). From day 28 until 6 months after inclusion in ICUTI, 84 recurrent UTI were reported by 80 patients. Univariate and multivariate analyses showed no effect of initial treatment group or antibiotic treatment on number of patients with recurrent UTI. Yet, both analyses showed that patients with a history of previous UTI had significantly more often recurrent UTI. Pyelonephritis occurred in two patients of the antibiotic group and in one patient in the non-antibiotic group. CONCLUSION: This follow-up analysis of a trial comparing antibiotic vs. symptomatic treatment for uncomplicated UTI showed that non-antibiotic treatment has no negative impact on recurrent UTI rates or pyelonephritis after day 28 and up to six months after initial treatment. Thus, a four week follow-up in UTI trials seems adequate.

A geriatric assessment in general practice: prevalence, location, impact and doctor-patient perceptions of pain.

BACKGROUND: To investigate what a geriatric assessment in general practice adds towards previous findings of prevalence, location, impact and the dyadic doctor-patient perception of pain in this age group. METHODS: Cross-sectional study. Consecutive patients aged 70 and over underwent a comprehensive geriatric assessment in general practice that included a basic pain assessment (severity, sites and impact). Patients with pain and their doctors then independently rated its importance. Pain was correlated with further findings from the assessment, such as overall health, physical impairments, everyday function, falls, mood, health related lifestyle, social circumstances, using bivariate and multivariate statistics. Patient-doctor agreement on the importance of pain was calculated using kappa statistics. RESULTS: 219 out of 297 patients (73.7 %) reported pain at any location. Pain was generally located at multiple sites. It was most often present at the knee (33.9%), the lumbar spine (33.5%) as well as the hip (13.8%) and correlated with specific impairments such as restrictions of daily living (knee) or sleep problems (spine). Patients with pain and their physicians poorly agreed on the importance of the pain problem. CONCLUSIONS: A basic pain assessment can identify older patients with pain in general practice. It has resulted in a high prevalence exceeding that determined by encounters in consultations. It has been shown that a geriatric assessment provides an opportunity to address pain in a way that is adapted to older patients' needs - addressing all sites, its specific impact on life, and the patients' perceived importance of pain. Since there is little doctor-patient agreement, this seems a valuable strategy to optimize concrete treatment decisions and patient centered care. TRIAL REGISTRATION: This study is registered in the German Clinical Trial Register ( DRKS00000792 ).

Quality of life in patients after resection of pT3 lateral tongue carcinoma: Microvascular reconstruction versus primary closure.

BACKGROUND: Controversy exists regarding the functional advantages of free flap reconstruction after partial glossectomy as compared to primary closure. METHODS: Forty patients were included in this retrospective analysis after resection of pT3 lateral tongue carcinomas. Twenty patients received a free forearm flap and 20 patients had a primary closure. All patients had adjuvant chemoradiation, were free of disease at least 1 year after therapy, and completed the German versions of the European Organization for Research and Treatment of Cancer (EORTC) questionnaires Quality of Life Questionnaire-Core 30-questions (QLQ-C30) and Quality of Life Questionnaire-Core 30 Head and Neck 35-questions (QLQ-H&N35). RESULTS: Mean time between surgery and quality of life (QOL) assessment was 16.2 ± 3.4 months. The average resection was 41.60% (reconstruction) of the oral tongue, and 39.1% (primary closure). After reconstruction, patients had significantly (p > .05) fewer problems with the swallowing, speech, and social eating subdomains of the EORTC QLQ-H&N35. All other items showed no significant differences. CONCLUSION: Our preliminary results suggest that free flaps might be useful when treating pT3 tongue cancer.

Ibuprofen versus fosfomycin for uncomplicated urinary tract infection in women: randomised controlled trial.

STUDY QUESTION: Can treatment of the symptoms of uncomplicated urinary tract infection (UTI) with ibuprofen reduce the rate of antibiotic prescriptions without a significant increase in symptoms, recurrences, or complications? METHODS: Women aged 18-65 with typical symptoms of UTI and without risk factors or complications were recruited in 42 German general practices and randomly assigned to treatment with a single dose of fosfomycin 3 g (n=246; 243 analysed) or ibuprofen 3 × 400 mg (n=248; 241 analysed) for three days (and the respective placebo dummies in both groups). In both groups additional antibiotic treatment was subsequently prescribed as necessary for persistent, worsening, or recurrent symptoms. The primary endpoints were the number of all courses of antibiotic treatment on days 0-28 (for UTI or other conditions) and burden of symptoms on days 0-7. The symptom score included dysuria, frequency/urgency, and low abdominal pain. STUDY ANSWER AND LIMITATIONS: The 248 women in the ibuprofen group received significantly fewer course of antibiotics, had a significantly higher total burden of symptoms, and more had pyelonephritis. Four serious adverse events occurred that lead to hospital referrals; one of these was potentially related to the trial drug. Results have to be interpreted carefully as they might apply to women with mild to moderate symptoms rather than to all those with an uncomplicated UTI. WHAT THIS PAPER ADDS: Two thirds of women with uncomplicated UTI treated symptomatically with ibuprofen recovered without any antibiotics. Initial symptomatic treatment is a possible approach to be discussed with women willing to avoid immediate antibiotics and to accept a somewhat higher burden of symptoms. FUNDING, COMPETING INTERESTS, DATA SHARING: German Federal Ministry of Education and Research (BMBF) No 01KG1105. Patient level data are available from the corresponding author. Patient consent was not obtained but the data are anonymised and risk of identification is low.Trial registration No ClinicalTrialGov Identifier NCT01488955.

Manual Therapy by General Medical Practitioners for Nonspecific Low Back Pain in Primary Care: The ManRück Study Protocol of a Clinical Trial.

BACKGROUND: Nonspecific low back pain (LBP) is a common reason for accessing primary care. Manual therapy (MT) may be an effective treatment, but data from clinical studies including relevant subgroups and clinical settings are sparse. The objective of this article is to describe the protocol of a study that will measure whether an MT protocol provided by general medical practitioners will lead to a faster pain reduction in patients with nonspecific LBP than does standard medical care. METHODS/DESIGN: The study is an experimental pre-/postintervention design. The intervention consists of add-on MT treatment by general medical practitioners who have received MT training but are otherwise inexperienced in mobilization techniques. Participating general medical practitioners (n = 10) will consecutively recruit and treat patients before and after their training, serving as their own internal controls. The primary end point is a combined outcome assessing change in pain score over days 0 to 3 and time until pain is reduced by 2 points on an 11-point numeric pain scale and painkiller use is stopped. Secondary outcomes are patients' functional capacities assessed using a questionnaire, amount of sick leave taken, patient satisfaction, and referrals for further treatment. TRIAL REGISTRATION: German clinical trials register: DRKS-ID DRKS00003240.

Why do - or don't - patients with urinary tract infection participate in a clinical trial? A qualitative study in German family medicine.

BACKGROUND: Insufficient patient recruitment can impair the conduct of clinical trials substantially, not least because a significant number of eligible patients decline trial participation. Though barriers and motivational factors have been worked out for patients with cancer or chronic diseases, little is known about primary care patients' perceptions towards trial participation when visiting their family practitioner (FP) with acute uncomplicated conditions. This study aims to assess primary care patients' motivation and barriers to participate in trials, and to identify factors that optimize patient recruitment in future trials. METHODS: This study was embedded in a drug trial comparing two treatment strategies for women with uncomplicated urinary tract infection in primary care. Semi-structured telephone interviews both with trial participants and decliners were conducted. The interview guideline focused on patients' personal motivational or hampering factors. Further topics were study theme, FPs' role, randomization, trial procedures, and potential motivational factors or barriers presumed to be relevant for other patients. Transcripts were analyzed by summarizing content analysis. RESULTS: 20 interviews with trial participants and 5 interviews with trial decliners were conducted. RESULTS show various reasons for trial participation from three categories: personal aspects, trial related aspects and patient-physician-relationship. A relevant trial topic and perceived personal benefit promotes participation as well as the wish to support research in general. Additionally, a maximum of safety concerning symptom relief reassures patients significantly. Trust in the FP plays also an important role in the decision process. Trial decliners show strong individual treatment preferences, which, together with individual reasons, lead to trial refusals. CONCLUSIONS: To optimize recruitment conditions for further clinical trials on acute and common conditions in family medicine, the following key issues should be considered: emphasizing patients' personal benefit, featuring patient relevant trial topics, providing a maximum of safety, keeping effort by trial procedures comfortable.

Older patients' perceived burdens of their health problems: a cross-sectional analysis in 74 German general practices.

BACKGROUND: Older patients often experience the burden of multiple health problems. Physicians need to consider them to arrive at a holistic treatment plan. Yet, it has not been systematically investigated as to which personal burdens ensue from certain health conditions. OBJECTIVE: The objective of this study is to examine older patients' perceived burden of their health problems. PATIENTS AND METHODS: The study presents a cross-sectional analysis in 74 German general practices; 836 patients, 72 years and older (mean 79±4.4), rated the burden of each health problem disclosed by a comprehensive geriatric assessment. Patients rated each burden using three components: importance, emotional impact, and impact on daily activities. Cluster analyses were performed to define patterns in the rating of these components of burden. In a multilevel logistic regression analysis, independent factors that predict high and low burden were explored. RESULTS: Patients had a median of eleven health problems and rated the burden of altogether 8,900 health problems. Four clusters provided a good clustering structure. Two clusters describe a high burden, and a further two, a low burden. Patients attributed a high burden to social and psychological health problems (especially being a caregiver: odds ratio [OR] 10.4, 95% confidence interval [CI] 4.4-24.4), to specific symptoms (eg, claudication: OR 2.3, 95% CI 1.3-4.0; pain: OR 2.3, 95% CI 1.6-3.1), and physical disabilities. Patients rated a comparatively low burden for most of their medical findings, for cognitive impairment, and lifestyle issues (eg, hypertension: OR 0.2, 95% CI 0.2-0.3). CONCLUSION: The patients experienced a relatively greater burden for physical disabilities, mood, or social issues than for diseases themselves. Physicians should interpret these burdens in the individual context and consider them in their treatment planning.

"It's MAGIC"--development of a manageable geriatric assessment for general practice use.

BACKGROUND: Geriatric assessments are established tools in institutional care since they enable standardized detection of relevant age-related disorders. Geriatric assessments could also be helpful in general practice. However, they are infrequently used in this setting, mainly due to their lengthy administration. The aim of the study was the development of a "manageable geriatric assessment--MAGIC", specially tailored to the requirements of daily primary care. METHODS: MAGIC was developed based on the comprehensive Standardized Assessment for Elderly People in Primary Care (STEP), using four different methodological approaches: We relied on A) the results of the PRISCUS study by assessing the prevalence of health problems uncovered by STEP, the importance of the respective problems rated by patients and general practitioners, as well as the treatment procedures initiated subsequently to the assessment. Moreover, we included findings of B) a literature analysis C) a review of the STEP assessment by experienced general practitioners and D) focus groups with general practitioners. RESULTS: The newly created MAGIC assessment consists of 9 items and covers typical geriatric health problems and syndromes: function, falls, incontinence, cognitive impairment, impaired ears and eyes, vaccine coverage, emotional instability and isolation. CONCLUSIONS: MAGIC promises to be a helpful screening instrument in primary care consultations involving elderly multimorbid patients. Applicable within a minimum of time it still covers health problems highly relevant with regard to a potential loss of autonomy. Feasibility will be tested in the context of a large, still ongoing randomized controlled trial on "reduction of potentially inadequate medication in elderly patients" (RIME study; DRKS-ID: DRKS00003610) in general practice.

Interprofessional collaboration and communication in nursing homes: a qualitative exploration of problems in medical care for nursing home residents ­ study protocol.

AIM: This study explores the current state of collaboration and communication between nurses and general practitioners in nursing homes, as well as needs and expectations of nursing home residents and their families. Finally, we aim to develop a new model of collaboration and communication. BACKGROUND: Rising numbers of residents in nursing homes present a challenge for general practice and nursing in most Western countries. In Germany, general practitioners visit their patients in nursing homes, where nurses work in shifts. This leads to a big variety of contacts with regard to persons involved and ways of communication. DESIGN: Qualitative multicentre study. METHODS: Study part 1 explores needs and problems in interprofessional collaboration in interviews with nursing home residents and their relatives, general practitioners and nurses. Simultaneously, general practitioners' visits in nursing homes are observed directly. In study part 2, general practitioners and nurses will discuss findings from study part 1 in focus groups, aiming to develop strategies for the improvement of shortcomings in a participatory way. Based on the results, experts will contribute to the emerging model of collaboration and communication in a multi-professional workshop. Finally, this model will be tested in a small feasibility study. The German Federal Ministry of Education and Research approved funding in March 2011. DISCUSSION: The study is expected to uncover deficits and opportunities in interprofessional collaboration in nursing homes. It provides deeper understanding of the concepts of all involved person groups and adds important clues for the interaction between professionals and older people in this setting.