Effectiveness of a screening tool to assess prevention and rehabilitation needs of 45 to 59 years old in primary care - study protocol of a pragmatic randomized controlled trial (PReHa45).

BACKGROUND: For years it has been stated that the need for prevention and rehabilitation is not always identified early enough. Although many individuals have regular contact with a general practitioner (GP), this access path for applying for a prevention or rehabilitation service has not been fully exploited. The important role of GPs in supporting the intention to apply is highlighted in the research. This study aims to evaluate the effectiveness of the "check-up 45 + " to support GPs both in identifying the need for prevention and rehabilitation services and in submitting applications. METHODS: The study is designed as a two-arm, pragmatic 1:1 randomised controlled study (RCT), which will be conducted in about 20 general practices in the German states of Berlin and Brandenburg. Patients (n = 1,654) aged from 45 to 59 years will be recruited by medical assistants. In addition to usual care, both study groups will receive a questionnaire covering socio-economic and occupational variables to be filled out immediately in the waiting room. The intervention group passes through the "check-up 45 + ". This includes the completion of the "screening 45 + " that aims to assess the need for prevention and rehabilitation services. Medical assistants will immediately evaluate this 2-page screening tool. If a need is identified and confirmed by the GP, information and application documents will be handed over. Moreover, the application process for rehabilitation services is simplified. Primary outcome is the proportion of applications for prevention or rehabilitation services financed by the German Pension Insurance. Administrative data will be provided for this purpose. Secondary outcomes include the proportion of approved applications and completed services. In addition, the proportion of persons with a need for prevention or rehabilitation according to the "check-up 45 + " will be examined. Semi-structured interviews will be conducted and content-analysed to determine the practicability and acceptance of the "check-up 45 + " by the relevant stakeholders. DISCUSSION: Prevention and rehabilitation need is insufficiently identified and addressed so far. This study will determine the effectiveness of the "check-up 45 + " in primary care. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00028303, 03.03.2022).

Indwelling pleural catheters for non-malignant pleural effusions: report on a single centre's 10 years of experience.

BACKGROUND: Recurrent pleural effusion is a common cause of dyspnoea, cough and chest pain during the course of infectious pleurisy and non-malignant diseases like congestive heart failure (CHF) or liver cirrhosis with hepatic hydrothorax (HH). With regard to the chronic character of the underlying diseases, indwelling pleural catheters (IPC) are increasingly used, not only assuring immediate symptom relief but also potentially leading to pleurodesis without sclerosing agents. PATIENTS AND METHODS: In this single-centre retrospective observational study, patient characteristics, procedural variables and outcome in patients with IPC in non-malignant pleural effusion (NMPE) were evaluated and prognostic factors for pleurodesis were identified. RESULTS: From 2006 to 2017, 54 patients received 62 IPC, of whom 48.4% with CHF and 43.5% with HH. The median length of insertion was 1.5 months (IQR 0.6-2.9 months), the median survival time after insertion 3.2 months (IQR 1.1-16.0). An adequate symptom relief was achieved in 93.2% with no need for subsequent interventions. In patients surviving ≥30 days after IPC insertion, pleurodesis was observed in 45.9%, being associated to age (<55 years, p=0.02), the primary diagnosis (p=0.03) and interventions for the underlying disease (p<0.001). Complications occurred in 24.2% of all procedures (n=15), the majority concerning mechanical obstructions (n=10) and infections (n=4). Patients with HH had an excess risk for complications (37.3%). CONCLUSION: Efficacy in symptom relief and a generally manageable safety profile recommend IPC as a first-line treatment option in NMPE, where disease-specific treatments are exhausted. Caution is warranted in patients with HH due to an excess risk for complications.

Occupation as a Proxy for Job Exposures? Routine Data Analysis Using the Example of Rehabilitation.

AIM OF THE STUDY: Job exposures are associated with health-related outcomes including sick leave and reduction in earning capacity. Rehabilitation of persons in working age aims primarily to secure or restore work capacity. Information concerning job exposures is, however, not directly available in routine data of healthcare payers. Since exposures relate to specific occupations and the current occupation is part of routine data, job exposures may be determined indirectly via job-exposure matrices (JEM). The aim of the study is to describe the possibilities and challenges of the representation of job exposures by the occupation according to routine data using the example of rehabilitation. METHODS: The Scientific Use File 'SUFRSDLV15B' of the German Pension Insurance was analysed. We used data from n=1 242 171 persons in work with at least one completed medical rehabilitation between 2008 and 2015 (dataset 1). The occupation is coded according to KldB 88 or KldB 2010 (German Classification of Occupations). In addition, data from a nationwide survey with 2530 rehabilitation patients was available (dataset 2). Job exposures are operationalized by the Job Exposure Index via JEM. The relationship to the return-to-work prognosis at the end of rehabilitation (dataset 1) and to patient reported outcome measures (dataset 2) is described. RESULTS: Information concerning the occupation is available for about 91% of rehabilitation measures of employed patients for the year prior to rehabilitation. At high levels of job exposures, the proportion of persons with a predicted working capacity in the last job of fewer than 3 h per day increased by a factor of 4 compared to low-level job exposures (23.5 vs. 6.1%). On the other hand, there is a low association only to reduced working capacity in the general labour market (2.9 vs. 2.4%). High-level job exposures are associated with self-reported, work-related impairments. CONCLUSION: The Job Exposure Index may offer a valid approach to depict occupation-related exposures. The index can be used in the analysis of routine data of the pension insurance and other social security funds, as well as in the linkage of individual assessment data with routine data containing the occupation, without any additional data collection effort. Due to its construction based on job classifications, it will not replace the assessment of individual burdens.

Indwelling pleural catheters for malignancy-associated pleural effusion: report on a single centre's ten years of experience.

INTRODUCTION: Recurrent pleural effusion is a common cause of dyspnoea, cough and chest pain during the course of malignant diseases. Chemical pleurodesis had been the only definitive treatment option until two decades ago. Indwelling pleural catheters (IPC) emerged as an alternative, not only assuring immediate symptom relief but also potentially leading to pleurodesis in the absence of sclerosing agents. METHODS: In this single-centre retrospective observational study patient characteristics, procedural variables and outcome in a large population of patients with IPC in malignancy were evaluated and prognostic factors for pleurodesis were identified. RESULTS: From 2006 to 2016, 395 patients received 448 IPC, of whom 121 (30.6%) had ovarian, 91 (23.0%) lung and 45 (11.4%) breast cancer. The median length of IPC remaining in place was 1.2 months (IQR, 0.5-2.6), the median survival time after insertion 2.0 months (IQR, 0.6-6.4). An adequate symptom relief was achieved in 94.9% of all patients, with no need for subsequent interventions until last visit or death. In patients surviving ≥30 days after IPC insertion, pleurodesis was observed in 44.5% and was more common in patients < 60 years (HR, 1.72; 95% CI, 1.05-2.78; p = 0.03). The use of an additional talc slurry via the IPC was highly predictive for pleurodesis (HR 6.68; 95% CI, 1.44-31.08; p = 0.02). Complications occurred in 13.4% of all procedures (n = 60), 41.8% concerning infections (local infections at the tunnel/exit site (n = 14) and empyema (n = 11)), and 98.3% being low or mild grade (n = 59). Complication rates were higher in men than women (18.6 vs. 12.4%, p = 0.023). CONCLUSION: High efficacy in symptom relief and a favourable safety profile confirm IPC as suitable first line option in most malignant pleural effusions. The study presents the largest dataset on IPC in gynaecologic cancer to date. Gender-specific differences in complication rates warrant further study.

Guidelines and recommendations for ensuring Good Epidemiological Practice (GEP): a guideline developed by the German Society for Epidemiology.

OBJECTIVE: To revise the German guidelines and recommendations for ensuring Good Epidemiological Practice (GEP) that were developed in 1999 by the German Society for Epidemiology (DGEpi), evaluated and revised in 2004, supplemented in 2008, and updated in 2014. METHODS: The executive board of the DGEpi tasked the third revision of the GEP. The revision was arrived as a result of a consensus-building process by a working group of the DGEpi in collaboration with other working groups of the DGEpi and with the German Association for Medical Informatics, Biometry and Epidemiology, the German Society of Social Medicine and Prevention (DGSMP), the German Region of the International Biometric Society (IBS-DR), the German Technology, Methods and Infrastructure for Networked Medical Research (TMF), and the German Network for Health Services Research (DNVF). The GEP also refers to related German Good Practice documents (e.g. Health Reporting, Cartographical Practice in the Healthcare System, Secondary Data Analysis). RESULTS: The working group modified the 11 guidelines (after revision: 1 ethics, 2 research question, 3 study protocol and manual of operations, 4 data protection, 5 sample banks, 6 quality assurance, 7 data storage and documentation, 8 analysis of epidemiological data, 9 contractual framework, 10 interpretation and scientific publication, 11 communication and public health) and modified and supplemented the related recommendations. All participating scientific professional associations adopted the revised GEP. CONCLUSIONS: The revised GEP are addressed to everyone involved in the planning, preparation, execution, analysis, and evaluation of epidemiological research, as well as research institutes and funding bodies.

[Rehabilitation of Patients with Peripheral Arterial Disease in the Context of Guideline Recommendations]. / Rehabilitation von Menschen mit einer peripheren arteriellen Verschlusskrankheit im Kontext aktueller Leitlinien. Eine Analyse auf Basis von Routinedaten.

BACKGROUND: The study examines the rehabilitation of patients with peripheral arterial disease (PAD) in the context of current guidelines. METHODOLOGY: All medical rehabilitations completed in 2014 with the initial diagnosis of PAD (ICD-10-GM: I70.2) were analyzed. Sociodemographic and socio-medical characteristics as well as the therapies received were evaluated and compared to current guideline recommendations. RESULTS: 1289 patients with PAD (mean age 56.1 years, 78.3% men) where included in the study. Social-medical parameters outline a fairly multimorbid cohort with poor prognosis for long-term occupational outcome and survival. Evidence-based therapies based on guideline recommendations (including supervised walking 58%, vascular training 63% and PAD-specific education lessons 64%) were performed to a lesser extent than expected. CONCLUSION: The results suggest an overall high standard of rehabilitation of patients with PAD. However, the poor socio-medical prognosis and the partial lack of compliance with guideline recommendations indicate the need for action. The development of specific recommendations for rehabilitation of PAD-patients could therefore be useful.

[Importance of Job Demands for Rehabilitation Patients - Application of an Index According to Occupations]. / Bedeutung von Arbeitsbelastungen bei Rehabilitanden ­ Anwendung eines Index für Berufstätigkeiten.

OBJECTIVE: To investigate the importance of job demands for rehabilitation patients. METHODS: A secondary data analysis of 2,089 rehabilitation patients of the Federal German Pension Insurance was conducted. The job exposure index of Kroll was used based on occupations. RESULTS: The prevalence of high job demands was 11.2%. The index correlated significantly with reha-relevant impairments. Furthermore, there was a significant association between high job demands and an unfavorable return-to-work prognosis at discharge from rehabilitation, also independently of the presence of self-reported severe restrictions of work ability. CONCLUSION: The job exposure index reflects occupation-specific job demands of rehabilitation patients. The construction of the index based on the relevant occupation classifications enables its broad application in analyses using routinely collected health data.

Prevalence of comorbid depressive symptoms in rehabilitation: A cross-indication, nationwide observational study.

OBJECTIVE: Patients in rehabilitation with comorbid depressive disorders display increased morbidity, mortality and inability to work. The aim of this study is to determine the prevalence of comorbid depressive symptoms in rehabilitation. METHODS: A total of 6,000 patients were contacted by post at the same time as receiving approval for their medical rehabilitation from German Federal Pension Insurance. Depressive symptoms were assessed using the Patient Health Questionnaire (PHQ-2). Results were compared with prevalences in the general population by analysing the German Health Interview and Examination Survey for Adults (DEGS). RESULTS: A total of 2,152 out of 5,891 patients participated in the study (response rate: 36.5%). The prevalence of self-reported depressive symptoms was 33.1% (women 34.1%, men 31.3%). In contrast, 7.8% of the German general population reported depressive symptoms (women 9.4%, men 6.2%). The highest prevalences were found in neurological (36.4%) and orthopaedic (35.6%) rehabilitation, the lowest in cancer rehabilitation (23.0%). Depressive symptoms were significantly associated with higher comorbidity and impairment due to pain, with lower social support and self-efficacy and with specific work-related problems. CONCLUSION: A short routine screening yielded a positive test result for depressive symptoms in a third of rehabilitation patients, thus approximately four times higher than in the general population. This is valuable information in order to better adjust treatment to patient needs.

The Efficacy of Goal Setting in Cardiac Rehabilitation-a Gender-Specific Randomized Controlled Trial.

BACKGROUND: Patients with coronary heart disease undergo cardiac rehabilitation in order to reduce their cardiovascular risk factors. Often, however, the benefit of rehabilitation is lost over time. It is unclear whether this happens in the same way to men and women. We studied whether the setting of gender-specific behavior goals with an agreement between the doctor and the patient at the end of rehabilitation can prolong its positive effects. METHODS: This study was performed with a mixed-method design. It consisted of qualitative interviews and group discussions with patients, doctors and other treating personnel, and researchers, as well as a quantitative, randomized, controlled intervention trial in which data were acquired at four time points (the beginning and end of rehabilitation and then 6 and 12 months later). 545 patients, 262 of them women (48.1%), were included. The patients were assigned to a goal checking group (n = 132), a goal setting group (n = 143), and a control group (n = 270). The primary endpoints were health-related behavior (exercise, diet, tobacco consumption), subjective state of health, and medication adherence. The secondary endpoints included physiological protection and risk factors such as blood pressure, cholesterol (HDL, LDL, and total), blood sugar, HbA1c, and body-mass index. RESULTS: The intervention had no demonstrable effect on the primary or secondary endpoints. The percentage of smokers declined to a similar extent in all groups from the beginning of rehabilitation to 12 months after its end (overall figures: 12.4% to 8.6%, p <0.05). The patients' exercise behavior, diet, and subjective state of health also improved over the entire course of the study. Women had a healthier diet than men. Subgroup analyses indicated a possible effect of the intervention on exercise behavior in women who were employed and in men who were not (p<0.01). CONCLUSION: The efficacy of goal setting was not demonstrated. Therefore, no indication for its routine provision can be derived from the study results.

Annual Papanicolaou screening for 5 years among human papillomavirus-negative women.

BACKGROUND: Primary human papilloma virus (HPV) screening is more effective than cytology in reducing the risk of cervical cancer, but screening intervals should be extended in HPV-negative women. However, some Markov models predicted that long intervals are associated with an excess risk of cervical cancer. The aim of this analysis was to estimate the real-life risks and benefits of annual Papanicolaou (Pap) screening in HPV-negative women with normal cytology. METHODS: Women with negative Hybrid Capture 2 (HC2) results and normal cytology at the time of inclusion in the Hannover HPV screening trial underwent annual Pap smears for 5 years. A subgroup was randomly selected for retesting with cytology, HC2, and colposcopy 60-68 months after recruitment. RESULTS: Of 4236 women included, 3406 had at least one Pap smear, but only 1185 attended all five annual screening visits. The proportion of women with at least one abnormal smear was 14.4% in 60 months. The probability of abnormal smears increased continuously over time. No case of ≥ CIN2+ was observed during 5 years. Of 605 women selected for subgroup analysis, 292 agreed to be retested (48.3%). The rate of high-risk HPV at 60-68 months was 3.0% (9/296). CONCLUSIONS: The long-term risk of high-grade neoplasia after an initial negative HC2 test and normal cytology result was low, while the rate of false-positive abnormal Pap smears was significant and increased constantly over time. Pap smear screening of HPV-negative women more frequently than every 5 years could be potentially harmful and seems to be of little clinical value.