The Patient Activation Measure-13 (PAM-13) in an oncology patient population: psychometric properties and dimensionality evaluation.

BACKGROUND: Accurate assessment and enhancement of health-related skills among oncology patients are pivotal for optimizing cancer care. The Patient Activation Measure (PAM-13), a questionnaire designed to reflect an individual's knowledge, skills, and confidence in self-healthcare management, has been validated across diverse countries and settings. Concerns have been raised regarding the cross-situational applicability, as patients with specific diseases and cultural backgrounds interpret questionnaire items differently. This study aimed to examine the structural validity and psychometric properties of the PAM-13 in an oncological patient cohort. METHODS: Baseline data from a longitudinal non-randomized controlled study involving cancer out-patients (n = 1,125) from Comprehensive Cancer Centres in Southern Germany were analysed. The German version of the PAM-13 was employed. With classical test and item response theory methods data quality, reliability, convergent and structural validity, as well as psychometric properties were assessed. Exploratory (EFA) and confirmatory factor analyses (CFA) were employed to investigate the postulated unidimensionality of the underlying construct. With a partial credit model (PCM) we examined item fit, targeting, local independence and differential item functioning. RESULTS: Participants were predominantly female (73.0%) with a breast cancer diagnosis (41.3%). While items were generally well-accepted, ceiling effects were observed and a high mean PAM-13 score (69.7, SD = 14.2) was noted, potentially compromising responsiveness to interventions. Reliability was adequate (Cronbach's α = 0.81), person and item separation reliability were good to excellent (0.81 and 0.99, respectively). Explorations of the unidimensionality of the construct (EFA, CFA, PCM) yielded inconclusive results, hinting towards a two-factor solution. Item difficulty rankings deviated from the original. No differential item functioning was identified, and local independence was confirmed. CONCLUSIONS: While the PAM-13 serves as a valuable instrument for comprehending and promoting health-related skills in cancer patients, the identification of ceiling effects, disordered item-difficulty rankings, and inconclusive findings regarding unidimensionality contribute to the expanding body of evidence, emphasizing the dependency of PAM-13's validity and reliability on distinctive characteristics within the population under investigation. Future research should prioritize refining or adding PAM-13 items to better capture the specific health-related challenges within diverse populations, paving the way for more effective patient engagement strategies in oncology. TRIAL REGISTRATION NUMBER: DRKS00021779.

A Qualitative Analysis of Cancer Patients' Perceptions of an Interprofessional Counseling Service on Complementary and Integrative Healthcare.

Medical guidelines recommend actively addressing patients' information needs regarding complementary and integrative healthcare (CIH). Within the CCC-Integrativ study, an interprofessional counseling program on CIH was developed and implemented at four comprehensive cancer centers (CCCs) in Germany. As part of the process evaluation, this study examines cancer patients' experiences with interprofessional CIH counseling sessions conducted by a physician and a nurse. Forty problem-centered interviews were conducted using a semi-structured interview guide. All interviews were audio-recorded, transcribed verbatim, and analyzed using deductive-inductive content analysis based on Kuckartz and Rädiker's approach. Findings revealed that most participants had prior experience with CIH approaches and were burdened by physiological and psychological symptoms. Counseling sessions focused on cancer- and treatment-related symptoms and appropriate CIH recommendations (e.g., herbal poultice against anxieties and acupressure against nausea). Participants appreciated the mutual exchange and integration of perspectives from different healthcare professions within the interprofessional approach. They noted that the counseling team comprehensively addressed their healthcare and CIH information needs. Suggestions for improvement included the specificity of the CIH recommendations. As the participants only received counseling and no CIH treatments, information about reputable CIH providers was particularly important to many seeking advice. Patients with cancer receiving tailored CIH counseling from two healthcare professionals experienced benefits in CIH counseling for symptom management. The interprofessional teams offered a comprehensive perspective on patients' needs, proposing personalized recommendations for symptom control. These insights may foster collaboration between healthcare professionals interested in CIH counseling, enabling them to expand and consolidate their counseling services.

[Learning from Errors: Qualitative Analysis of Expert Reports on Malpractice in Family Medicine]. / Aus Fehlern lernen ­ qualitative Analyse von Gutachten zu hausärztlichen Behandlungsfehlern.

BACKGROUND: Expert committees of the German medical associations provide a free and out-of-court evaluation of putative cases of medical malpractice. They prepare reports that contain valuable information on process steps that precede the actual treatment error. The aim of the present study was to identify and systematically categorize individual process steps in the expert reports and thus to lay the foundations for the understanding of malpractice evaluation processes. METHODS: In this study, ten randomly selected and anonymized expert reports of the Expert Committee for Questions of Medical Liability of the District Medical Association of South Württemberg with identified GP treatment errors were evaluated, using the method of qualitative content analysis. In an iterative process, central elements of expert reports were classified into a deductively and inductively built category system. RESULTS: Six main categories with associated subcategories were identified: 1) structural aspects of the report, 2) doctor-patient communication, 3) medical course, 4) patient's experience, 5) action by the GP team, and 6) coordinative role in the health care system. The category system showed sufficient reliability with repeated use. CONCLUSION: This study offers an opportunity to learn from errors. The proposed system allows to structure the complexity of expert reports on GP malpractice and may thus serve as a tool in various contexts. In particular, it facilitates the preparation and comparative analysis of reports in a structured way. It could also be used in health care research as well as in education and training.

The role of qualification and quality management in the prescription of antipsychotics and potentially inappropriate medication (PIM) in nursing home residents in Germany: results of the HIOPP-3-iTBX study.

BACKGROUND: Nursing home residents (NHR) show high rates of polypharmacy. The HIOPP-3-iTBX study is the first cRCT on medication optimization in nursing homes (NH) in Germany. The intervention did not result in a reduction of PIM and/or antipsychotics. This analysis looks at structure quality in the HIOPP-3-iTBX study participants. AIMS: Evaluation of structure quality as part of a cluster-randomized controlled intervention study. METHODS: Structure quality in multiprofessional teams from n = 44 NH (n = 44 NH directors, n = 91 family doctors (FD), and n = 52 pharmacies with n = 62 pharmacists) was assessed using self-designed questionnaires at baseline. Main aspects of the questionnaires related to the qualification of participants, quality management, the medication process and size of the facilities. All completed questionnaires were included. number of PIM/antipsychotics was drawn from the baseline medication analysis in 692 NHR. Data were analyzed by descriptive statistics and mixed model logistic regression. RESULTS: The presence of a nurse with one of the additional qualifications pain nurse or Zertifiziertes Curriculum (Zercur) Geriatrie in the participating NH was associated with a lower risk for the prescription of PIM/antipsychotics. No association between any characteristic in the other participants at baseline was observed. CONCLUSIONS AND DISCUSSION: The results support the known role of nursing qualification in the quality and safety of care. Further studies need to look more closely at how use is made of the additional qualifications within the multiprofessional teams. Perspectively, the results can contribute to the development of quality standards in NH in Germany.

General practitioners' communication on complementary and integrative medicine for cancer patients: Findings from an analysis of consultations with standardised patients.

OBJECTIVE: Our aim was to explore whether general practitioners (GPs) communicate with cancer patients on complementary and integrative medicine (CIM) in a patient-centred and case-specific manner. METHODS: We designed two cases of standardised breast cancer patients and allocated 29 GPs to hold a consultation either with Case 1 or Case 2. Case 1 presented with fears of possible physical side effects of hormone treatment. Case 2 feared a loss in social functioning because of nausea and emesis as possible side effects of chemotherapy. Consultations were audiotaped and analysed using the Roter Interaction Analysis System (RIAS). We analysed whether recommended CIM treatments and GPs' focus on psychosocial or medical and therapy-related content differed according to whether they were counselling Case 1 or Case 2. RESULTS: In consultations with Case 1, GPs rather focused on medical and therapy-related content and most often recommended mistletoe, diets and sports. In contrast, GPs focused on psychosocial content and they most often recommended methods of self-care when counselling Case 2. CONCLUSION: The GPs in our sample reacted case-specifically to the patients' interest in CIM. Such responsive and patient-centred communication is a valuable resource but is often time-consuming. Adequate training and reimbursement should therefore be considered for GPs.

Protocol for the process evaluation of a counselling intervention designed to educate cancer patients on complementary and integrative health care and promote interprofessional collaboration in this area (the CCC-Integrativ study).

BACKGROUND: Conducting a process evaluation is essential to understand how health interventions work in different healthcare settings. Particularly in the case of complex interventions, it is important to find out whether the intervention could be carried out as planned and which factors had a beneficial or hindering effect on its implementation. The aim of this study is to present the detailed protocol of the process evaluation embedded in the controlled implementation study CCC-Integrativ aiming to implement an interprofessional counselling program for cancer patients on complementary and integrative health care (CIH). METHODS: This mixed methods study will draw upon the "Consolidated Framework for Implementation Research" (CFIR) combined with the concept of "intervention fidelity" to evaluate the quality of the interprofessional counselling sessions, to explore the perspective of the directly and indirectly involved healthcare staff, as well as to analyze the perceptions and experiences of the patients. The qualitative evaluation phase consists of analyzing audio-recorded counselling sessions, as well as individual and group interviews with the involved persons. The quantitative evaluation phase applies questionnaires which are distributed before (T0), at the beginning (T1), in the middle (T2) and at the end (T3) of the intervention delivery. DISCUSSION: This protocol provides an example of how a process evaluation can be conducted parallel to a main study investigating and implementing a complex intervention. The results of this mixed methods research will make it possible to identify strengths and weaknesses of the team-based intervention, and to target more specifically the key factors and structures required to implement healthcare structures to meet patients' unmet needs in the context of CIH. To our knowledge, this study is the first applying the CFIR framework in the context of interprofessional CIH counselling, and its results are expected to provide comprehensive and multidisciplinary management of cancer patients with complex supportive healthcare needs.

[Neutralizing monoclonal antibodies in COVID-19: a case series in general practice]. / Neutralisierende monoklonale Antikörper bei COVID-19: eine Fallserie aus der Hausarztpraxis.

BACKGROUND: Neutralizing monoclonal antibodies (mAB) against SARS-CoV-2 reduce the severity of COVID-19 in patients with risk factors. Early administration at the onset of infection is critical for their efficacy. At this early stage of the disease, family physicians are often the first help for patients and thus central to the further course of the disease. To date, however, mAB have only rarely been used in general practice. The purpose of this case series is to demonstrate that the administration of mAB is safely feasible in the primary care setting. CASE REPORT: We report seven cases at risk for severe COVID-19. Two of them were not vaccinated, five had drug induced immunosuppression, and one patient was at high risk because of trisomy-21. All patients were successfully treated with the mAB Sotrovimab in a GP's practice in January/ February 2022. Two patients were treated making a house call. Based on the cases, clinical information and a hands-on handling of this therapy are described. CONCLUSIONS: Neutralizing mAB can be administered safely and with manageable effort in primary care setting and can help prevent a severe course and hospitalization in patients with COVID-19 and risk factors.

Interprofessional evidence-based counselling programme for complementary and integrative healthcare in patients with cancer: study protocol for the controlled implementation study CCC-Integrativ.

INTRODUCTION: According to international literature, patients with cancer wish to have information on complementary and integrative healthcare (CIH). Medical guidelines recommend actively approaching patients with cancer discussing potential benefits and risks of individual CIH methods. While some CIH methods, for example, acupuncture and yoga, have been proven effective in high-quality studies, other CIH methods lack studies or bear the risk of interactions with chemotherapeutics, for example, herbal drugs. Therefore, an evidence-based interprofessional counselling programme on CIH will be implemented at four Comprehensive Cancer Centres in the federal state of Baden-Wuerttemberg, Germany. METHODS AND ANALYSIS: A complex intervention consisting of elements on patient, provider and system levels will be developed and evaluated within a multilayer evaluation design with confirmatory evaluation on patient level. Patients with a cancer diagnosis within the last 6 months will receive three individual counselling sessions on CIH within 3 months (=intervention on patient level). The counselling will be provided by an interprofessional team of medical and nursing staff. For this purpose, an intensive online training programme, a CIH knowledge database and an interprofessional team-building process were developed and implemented (=intervention on provider level). Moreover, training events on the basics of CIH are offered in the outpatient setting (=intervention on system level). Primary outcome of the evaluation at the patient level is patient activation measured (PAM) with the PAM-13 after 3 months. Secondary outcomes, for example, quality of life, self-efficacy and clinical parameters, will be assessed at baseline, after 3 months and at 6 months follow-up. The intervention group (n=1000) will be compared with a control group (n=500, treatment as usual, no CIH counselling. The outcomes and follow-up times in the control group are the same as in the intervention group. Moreover, the use of health services will be analysed in both groups using routine data. A qualitative-quantitative process evaluation as well as a health economic evaluation will identify relevant barriers and enabling factors for later roll-out. ETHICS AND DISSEMINATION: The study has been approved by the appropriate Institutional Ethical Committee of the University of Tuebingen, No. 658/2019BO1. The results of these studies will be disseminated to academic audiences and in the community. TRIAL REGISTRATION NUMBER: DRKS00021779; Pre-results.

Barriers to utilisation of cancer rehabilitation from the expert's view: A cross-sectional survey.

OBJECTIVE: The goal of this study was to investigate barriers to utilisation of cancer rehabilitation by querying a large sample of various professionals in health care with a comprehensive set of barriers. METHODS: We developed a questionnaire comprising 55 barriers to utilisation of cancer rehabilitation and administered it to four different types of medical, care and social work experts involved in the referral to cancer rehabilitation. An exploratory factor analysis was conducted and the extracted factors were ranked by mean values. Additionally, ANOVAs were calculated to test for group differences. RESULTS: Our sample (N = 606) consisted of 249 physicians, 194 social workers, 105 nurses and 55 psychologists in Germany. We identified seven barrier-dimensions: low appreciation of rehabilitation by professionals, insufficient coordination, insufficient application procedure, rehabilitation requirements not met, patients' unfulfilled demands, patients' social responsibilities and patients' coping style, with the latter being rated as the most obstructive thereof. Furthermore, we found statistically significant group differences for six of these factors with small- to medium-sized effects. CONCLUSION: Our results support previous publications implicating the patients' coping style as a barrier. We furthermore found evidence for barriers relating to processes and organisational issues, thereby expanding on the scope of patient-oriented publications. Suggestions for improving patients' health services accessibility are made.

Increasing Warmth in Oncological Patients: A Randomized Controlled Cross-Over Pilot Trial Examining the Efficacy of Mustard and Ginger Footbaths.

OBJECTIVE: To analyze the thermogenic effects of footbaths with medicinal powders in oncological patients (ON) and healthy controls (HC). INTERVENTION AND OUTCOMES: Thirty-six participants (23 ON, 13 HC; 24 females; 49.9 ± 13.3 years) received 3 footbaths in a random order with cross-over design: warm water only (WA), warm water plus mustard (MU, Sinapis nigra), and warm water plus ginger (GI, Zingiber officinale). Warmth perception of the feet (Herdecke Warmth Perception Questionnaire, HeWEF) at the follow-up (10 minutes after completion of footbaths, t2) was assessed as the primary outcome measure. Secondary outcome measures included overall warmth as well as self-reported warmth (HeWEF) and measured skin temperature (high resolution thermography) of the face, hands and feet at baseline (t0), post immersion (t1), and follow-up (t2). RESULTS: With respect to the warmth perception of the feet, GI and MU differed significantly from WA (P's < .05) with the highest effect sizes at t1 (WA vs GI, d = 0.92, WA vs MU, d = 0.73). At t2, perceived warmth tended to be higher with GI compared to WA (d = 0.46). No differences were detected between ON and HC for self-reported warmth. With respect to skin temperatures, face and feet skin temperatures of ON were colder (at t0 and t1, 0.42 ≥ d ≥ 0.68) and tended to have diametrical response patterns than HC (ON vs HC: colder vs warmer after MU). CONCLUSION: Among adult oncological patients and healthy controls, footbaths with mustard and ginger increased warmth perception of the feet longer than with warm water only. The potential impact of regularly administered thermogenic footbaths over extended periods merits further investigation for the recovery of cancer-related sense of cold.

Complementary medicine in Germany: a multi-centre cross-sectional survey on the usage by and the needs of patients hospitalized in university medical centers.

BACKGROUND: The results of recent surveys indicate that more than 50% of the German population has experience with complementary and alternative medicine (CAM) or uses CAM regularly. This study investigated the CAM usage and CAM-related needs of hospitalized patients at university medical centres in the state of Baden-Württemberg, Germany. METHODS: A multi-centre, paper-based, pseudonymous survey was carried out by the members of the Academic Centre for Complementary and Integrative Medicine. Patients of all ages, regardless of sex, diagnosis and treatment, who were hospitalized in the Department of Cardiology, Gastroenterology, Oncology, Gynaecology or Surgery at the university medical centres in Freiburg, Heidelberg, Tübingen and Ulm were eligible for inclusion. RESULTS: Of the 1275 eligible patients, 67% (n = 854) consented to participate in the survey. Forty-eight percent of the study participants stated that they were currently using CAM. The most frequently used therapies were exercise (63%), herbal medicine (54%) and dietary supplements (53%). Only 16% of the patients discussed CAM usage with their attending physician. Half of the patients (48%) were interested in CAM consultations. More than 80% of the patients desired reliable CAM information and stated that physicians should be better informed about CAM. CONCLUSIONS: The frequency of CAM usage and the need for CAM counselling among hospitalized patients at university medical centres in Baden-Württemberg are high. To better meet patients' needs, CAM research and physician education should be intensified. TRIAL REGISTRATION: German Clinical Trial register ( DRKS00015445 ).

[Creating evidence for naturopathic nursing interventions in oncology - a systematic approach]. / Generierung von Evidenz zu naturheilkundlichen Pflegeinterventionen in der Onkologie ­ ein systematisches Verfahren.

BACKGROUND: Nurses working in oncology use a wide range of naturopathic interventions in their daily practice to alleviate symptoms and improve the quality of life of oncological patients. However, there is no external evidence for many of these interventions. Due to a lack of scientific studies in the field, the aim of the project described here is to develop a standardized procedure to generate evidence on naturopathic interventions, on the basis of which recommendations may be derived for nursing practice. METHOD: The systematic procedure presented here was developed by the working group (WG) Integrative Nursing in Oncology over a period of four years in an iterative process. This process is based on the expert panel members' experience with the development of guidelines and/or quality instruments such as practice standards. RESULT: The systematic methodological approach presented here consists of three successive steps where internal and external evidence have been combined: a scoping review, a structured consensus process with oncology nurses to collect and evaluate naturopathic interventions, and finally a further supplementary literature review based on additional findings of the consensus conference. The procedure was successfully carried out for mucositis, insomnia, fatigue, hand-foot syndrome and chemotherapy-induced polyneuropathy. CONCLUSION: Through the step-by-step synthesis of internal evidence and the best available external evidence, the evidence base for naturopathic nursing interventions in oncology can be generated and practice recommendations derived. The procedure represents a successful theory-practice transfer through structured cooperation between (nursing) scientists and nursing practitioners. In terms of the AWMF classification, the practice recommendations developed in the process described fall somewhere in between an S1 guideline (informal consensus of an expert group) and an S2e guideline (evidence-based).

[Barriers in the Application Process for Oncological Rehabilitation: A Nationwide Expert Study]. / Barrieren der Antragstellung in der Onkologischen Rehabilitation: Eine bundesweite Expertenstudie.

PURPOSE: From the perspective of various expert groups involved in the care of oncological patients, barriers to the application process of oncological rehabilitation programs will be identified. The study was funded by the German Pension Insurance Association (DRV). METHODS: Based on an interview study (N=61), a questionnaire instrument with 55 items describing possible barriers in the application process was designed and implemented online. Participants with more than 33% missing values were excluded from the analyses. Mean value analyses were used to identify the most significant relevance. To identify overall dimensions an explorative factor analysis was conducted . RESULTS: A total of 606 experts from the oncological field were included in the analyses. Among them were 249 doctors, 194 social workers, 105 nurses / medical assistants, 55 psychologists / psycho-oncologists and three other professional groups. The queried experts were on average 51 years old (SD=10.4) and had been working in the oncological field for 17 years (SD=9.8). The barriers could be assigned to the following seven factor-analytically determined content sections: coping style, application procedure, rehabilitation requirements, coordination, social responsibilities, desires of patient and the priority of rehabilitation. According to the experts statements the main obstacles to an application were the patient's desire for normality, the rigid deadline for the application and the application procedure which is difficult for patients with a migration background to understand. It was also pointed out that it is difficult to place multimorbid patients in rehabilitation facilities. CONCLUSION: The following recommendations for action to facilitate access to rehabilitation can be derived from the expert study: optimization of the coordination between different expert groups, institutions and the cost units, flexibilisation of the deadline for follow-up, simplifying the application process, providing applications/information material in additional languages, orienting rehabilitation clinics towards specific patient groups.

[Barriers in the Application Process for Oncological Rehabilitation: Results of a Qualitative Expert Survey]. / Barrieren bei der Antragstellung zur onkologischen Rehabilitation: Ergebnisse einer qualitativen Expertenbefragung.

PURPOSE: In this study, which was funded by the German Federal Pension Fund (DRV), barriers in the application process for oncological rehabilitation services were examined from the perspective of various expert groups. METHODS: In an exploratory multicentre qualitative cross-sectional study 61 semi-structured interviews with experts working in oncological care were conducted: Physicians (n=26), social workers (n=22), psychologists/psycho-oncologists (n=6), nurses/medical assistants (n=5), administrative staff of the DRV (n=2). In guided interviews the participants were asked about their experiences with rehabilitation applications as well as their estimations and evaluations regarding possible reasons for non-utilisation. The evaluation of the interviews was computerized and based on the qualitative content analysis by Mayring. RESULTS: The respondents had an average age of 52.51 years (SD=10.06; min=25, max=71) and were working in the consultation or treatment of oncological patients for an average of 19.26 years (SD=10.15; min=1, max=42). In total, 854 statements were coded and assigned to the following three main categories: expert-related, system-related and patient-related barriers. In the first main category, scepticism about the benefits of rehabilitation services and an insufficiently met need for information on the part of experts became the focus of attention. In the main category of system-related barriers, aspects were mentioned that addressed the application procedure, the low availability of, for example, outpatient rehabilitation services and the absence of a functioning referral system. The main category of patient-related barriers included psychosocial factors such as subcategories on the topic of coping with the disease which include the patient's desire to come home, experience everyday life again and the fear of being confronted with the disease. CONCLUSION: The exploratory study revealed potential barriers in the application process for oncological rehabilitation services from an expert perspective. In particular, the findings form the basis for a multi-dimensional assessment instrument that can be used to analyze the barriers in a standardised way and to derive individual recommendations for action.

[DNVF Memorandum Health Services Research in Oncology]. / DNVF-Memorandum Versorgungsforschung in der Onkologie.

Health services research in oncology deals with all situations which cancer patients face. It looks at the different phases of care, i. e. prevention / early detection, prehabilitation, diagnostics, therapy, rehabilitation and palliative care as well as the various actors, including those affected, the carers and self-help. It deals with healthy people (e. g. in the context of prevention / early detection), patients and cancer survivors. Due to the nature of cancer and the existing care structures, there are a number of specific contents for health services research in oncology compared to general health services research while the methods remain essentially identical. This memorandum describes the subject, illustrates the care structures and identifies areas of health services research in oncology. This memorandum has been prepared by the Oncology Section of the German Network for Health Services Research and is the result of intensive discussions.

Defining Criteria for Guiding Cancer Patients to Find a Reputable Complementary Medicine Provider: Results of a Literature Review and a Consensus Procedure.

PURPOSE: Even in cases of positive evidence for complementary medicine (CM) therapies, it is still difficult for cancer patients to identify reputable providers. The aim of this study was to develop and evaluate a criteria list to provide guidance to cancer patients seeking a reputable CM provider. METHODS: The design combined a literature review, an expert consensus procedure (n=15) and an assessment from three stakeholder perspectives (patients (n=18), CM providers (n=26) and oncology physicians (n=20)). RESULTS: A total of 30 existing CM criteria were extracted from the literature, and 12 more were added by the experts. The main challenge was to define criteria that could easily be applied by the patients. A final comprehensive list of 8 criteria guiding cancer patients to find a reputable CM provider was developed. CONCLUSION: Health professionals and cancer information services might find the criteria list helpful when aiming to strengthen patients' awareness of quality-related factors associated with CM providers. The criteria developed might be helpful when standards are established for quality assurance in CM in oncology.

Ambulatory screening and decontamination to prevent Staphylococcus aureus complications in patients undergoing elective surgery (STAUfrei): study protocol for a controlled intervention study.

BACKGROUND: Surgical site infections (SSI) are the most common health care associated infections in German acute hospitals and can result in prolonged hospital stays, increased use of antibiotics and utilisation of care. Staphylococcus aureus bacteria (methicillin-resistant S Aureus (MRSA) and methicillin-susceptible S Aureus (MSSA)) are amongst the most prominent causes of SSI. While up to 90% of documented S Aureus colonization is already detectable prior to hospital admission, the majority of hygiene measures in Germany is focused on the hospital setting. It is hypothesized that early detection and decontamination of S Aureus colonization in primary care can prevent health care associated infections and reduce the number of S Aureus isolates in the hospital setting. METHODS: This study is a controlled interventional study (N = 13,260) with a pre-post comparison. The intersectoral intervention (over 2 years) will encompass the following elements: ambulatory detection and decontamination of MRSA and MSSA prior to elective surgery combined with a structured follow-up care. Patients from the control group will be screened in the hospital setting, in accordance with the standard operating procedure (SOP) in routine care. The primary endpoint is the reduction of MRSA and MSSA colonization upon hospital admission. Secondary endpoints are complication rate (SSI), length of stay, recolonization of patients (3 and 6 months after release), patient and provider satisfaction, patient compliance and cost development. DISCUSSION: In case of positive results, the chance of a widespread uptake and implementation in routine care are considered high. The active involvement of primary care providers in the implementation of screening and decontamination as well as follow-up care is a unique feature of this study. The positive resonance of primary care providers during the recruitment phase highlights the relevance of the topic to the participating actors. These efforts are coupled with patient education and specifically trained medical staff, promising a sustained impact. The STAUfrei care pathway can homogenize current practices in routine care and provide a template for further intersectoral cooperation. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00016615. Registered on April 1st, 2019.

KOKON: A Germany-Wide Collaborative Research Project to Identify Needs, Provide Information, Foster Communication and Support Decision-Making about Complementary and Alternative Medicine in Oncology.

BACKGROUND: The German Cancer Aid set up a priority research programme with the intention to generate high-quality information based on evidence and to make this information easily accessible for health-care professionals and advisors, researchers, patients, and the general public. SUMMARY: The Kompetenznetz Komplementärmedizin in der Onkologie (KOKON) received 2 funding periods within this programme. During the first funding period, KOKON assessed patients' and health-care professionals' informational needs, developed a consulting manual for physicians, developed an education programme for self-help groups, set up a knowledge database, and developed a pilot information website for patients. Funding period 2 continues with work that allows cancer patients and health-care professionals to make informed decisions about complementary and alternative medicine (CAM). For this aim, KOKON evaluates training programmes for physicians (oncology physicians, paediatric oncologists, and general practitioners) and for self-help groups. All training programmes integrate results from an analysis of the ethical, psychological, and medical challenges of CAM in the medical encounter, and the knowledge database is being extended with issues related to CAM for supportive and palliative care. Key Message: A Germany-wide collaborative research project to identify needs, provide information, foster communication, and support decision-making about CAM in oncology is being set up.

Holistic care program for elderly patients to integrate spiritual needs, social activity, and self-care into disease management in primary care (HoPES3): study protocol for a cluster-randomized trial.

BACKGROUND: Strategies to improve the care of elderly, multimorbid patients frequently focus on implementing evidence-based knowledge by structured assessments and standardization of care. In Germany, disease management programs (DMPs), for example, are run by general practitioners (GPs) for this purpose. While the importance of such measures is undeniable, there is a risk of ignoring other dimensions of care which are essential, especially for elderly patients: their spiritual needs and personal resources, loneliness and social integration, and self-care (i.e., the ability of patients to do something on their own except taking medications to increase their well-being). The aim of this study is to explore whether combining DMPs with interventions to address these dimensions is feasible and has any impact on relevant outcomes in elderly patients with polypharmacy. METHODS: An explorative, cluster-randomized controlled trial with general practices as the unit of randomization will be conducted and accompanied by a process evaluation. Patients aged 70 years or older with at least three chronic conditions receiving at least three medications participating in at least one DMP will be included. The control group will receive DMP as usual. In the intervention group, GPs will conduct a spiritual needs assessment during the routinely planned DMP appointments and explore whether the patient has a need for more social contact or self-care. To enable GPs to react to such needs, several aids will be provided by the study: a) training of GPs in spiritual needs assessment and training of medical assistants in patient counseling regarding self-care and social activity; b) access to a summary of regional social offers for seniors; and c) information leaflets on nonpharmacological interventions (e.g., home remedies) to be applied by patients themselves to reduce frequent symptoms in old age. The primary outcome is health-related self-efficacy (using the Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES-6G)). Secondary outcomes are general self-efficacy (using the General Self-Efficacy Scale (GSES)), physical and mental health (using the Short-Form Health Survey (SF-12)), patient activation (using the Patient Activation Measure (PAM)), medication adherence (using the Medication Adherence Report Scale (MARS)), beliefs in medicine (using the Beliefs About Medicines Questionnaire (BMQ)), satisfaction with GP care (using selected items of the European Project on Patient Evaluation of General Practice (EUROPEP)), social contacts (using the 6-item Lubben Social Network Scale (LSNS-6)), and loneliness (using the 11-item De-Jong-Gierveld Loneliness Scale (DJGS-11)). Interviews will be conducted to assess the mechanisms, feasibility, and acceptability of the interventions. DISCUSSION: If the interventions prove to be effective and feasible, large-scale implementation should be sought and evaluated by a confirmatory design. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00015696 . Registered on 22 January 2019.