[Introduction to qualitative evidence synthesis - Variants and application]. / Einführung in die qualitative Evidenzsynthese ­ Varianten und Anwendung.

Qualitative evidence syntheses (QES) are still uncommon in German rehabilitation research, although robust syntheses of qualitative evidence may lead to more strongly scientifically based decisions in health care. This article introduces the topic of qualitative evidence synthesis by describing three different synthesis methods - thematic synthesis, meta-ethnography, and grounded theory synthesis - and illustrating them with examples from rehabilitation research. This is followed by guidance on selecting the appropriate QES-method and reflections on the challenges of QES that are associated with the literature search and quality assessment of the studies to be included in the synthesis. Likewise considerations on quality criteria and their application are taken into account. GRADE-CERQual provides guidance for assessing confidence of findings from QES. Finally the value of QES for rehabilitation research is discussed.

[Implementation of a novel form of care for the early detection and prevention of emotional and behavioral problems in children in the pediatric setting: Qualitative interviews with pediatricians, practice staff and parents]. / Implementierung einer neuen Versorgungsform zur Früherkennung und Prävention emotionaler und Verhaltensauffälligkeiten bei Kindern im kinderärztlichen Setting: Qualitative Interviews mit Kinderärzt*innen, Praxispersonal und Sorgeberechtigten.

AIM OF THE STUDY: Evaluation of the implementation of a standardized screening using the Strengths and Difficulties Questionnaire (SDQ) as part of the routine pediatric health check-ups in the Dresden area (Germany) in order to detect emotional and behavioral problems (EBPs) in children early and allocate them to indicated preventive programs and/or to further counselling and treatment services. METHODS: 1.) Semi-structured interviews were performed with participating pediatricians (n=4), practice staff (n=4) and custodians of screened children (n=17) and subjected to content analysis regarding feasibility, advantages and disadvantages of the screening and the targeted allocation, as well as barriers and facilitators of using the screening and the preventive programs and further services. 2.) A self-developed questionnaire survey (descriptive analysis: means and frequencies) was conducted among pediatricians (n=34/99) to inquire about the implementation of the SDQ screening regarding feasibility, advantages, disadvantages and necessary conditions for a potential adoption of the screening to standard health services. RESULTS: In the interviews, the pediatricians and practice staff reported that the SDQ screening embedded in routine pediatric health check-ups was simple and could be carried out in a few minutes. The screening helped to identify and address possible EBPs in children and to recommend a targeted service. Apart from the expenditure of time, no disadvantages were mentioned. As expected, parent-related (e.g. fears, attitudes and trust in the pediatrician), child-related (does not want to reveal any information about him- or herself , attitude and motivation), service provider-related (presentation of services), organizational (necessary signatures, financing, waiting time) and service-related (duration, costs, venue, designation) factors influenced the families' use of the screening and further services. Interviewed custodians whose child participated in an indicated preventive program within the project (n=11) would recommend the SDQ screening and preventive program to other families. In the questionnaire survey 28/31 pediatricians "completely" or "rather" agreed on a 5-point Likert scale that the SDQ screening and targeted allocation should be included in standard pediatric care. DISCUSSION: The use of the SDQ, which is one of the most widely used and, despite its brevity, most valid screening instruments for the early detection of EBPs, in routine pediatric health check-ups and the targeted allocation of further health services represent a feasible approach to the early identification and clarification of EBPs in children as well as their allocation to indicated preventive services. CONCLUSION: An adoption of the novel form of care (SDQ screening and targeted allocation to indicated preventive programs and further services) to standard pediatric care unfolds its benefits if preventive and care services for EBPs in children are made available nationwide.

Prioritization and resource allocation in the context of the COVID-19 pandemic. Recommendations for colorectal and pancreatic cancer in Germany.

In the context of the COVID-19 pandemic, there has been a scarcity of resources with various effects on the care of cancer patients. This paper provides an English summary of a German guideline on prioritization and resource allocation for colorectal and pancreatic cancer in the context of the pandemic. Based on a selective literature review as well as empirical and ethical analyses, the research team of the CancerCOVID Consortium drafted recommendations for prioritizing diagnostic and treatment measures for both entities. The final version of the guideline received consent from the executive boards of nine societies of the Association of Scientific Medical Societies in Germany (AWMF), 20 further professional organizations and 22 other experts from various disciplines as well as patient representatives. The guiding principle for the prioritization of decisions is the minimization of harm. Prioritization decisions to fulfill this overall goal should be guided by 1. the urgency relevant to avoid or reduce harm; 2. the likelihood of success of the diagnostic or therapeutic measure advised; and 3. the availability of alternative treatment options. In the event of a relevant risk of harm as a result of prioritization, these decisions should be made by means of a team approach. Gender, age, disability, ethnicity, origin and other social characteristics, such as social or insurance status, as well as the vehemence of a patient's treatment request and SARS-CoV-2 vaccination status should not be used as prioritization criteria. The guideline provides concrete recommendations for 1. diagnostic procedures, 2. surgical procedures for cancer, and 3. systemic treatment and radiotherapy in patients with colorectal or pancreatic cancer within the context of the German healthcare system.

Evaluation of the telemedical health care network "SAFE BIRTH" for pregnant women at risk, premature and sick newborns and their families: study protocol of a cluster-randomized controlled stepped-wedge trial.

BACKGROUND: The Perinatal Center of the University Hospital Carl Gustav Carus Dresden has initiated the telemedical healthcare network "SAFE BIRTH" to coordinate and improve specialized care in non-metropolitan regions for pregnant women and newborns. The network incorporates five intervention bundles (IB): (1) Multi-professional, inter-disciplinary prenatal care plan; (2) Neonatal resuscitation; (3) Neonatal antibiotic stewardship; (4) Inter-facility transfer of premature and sick newborns; (5) Psycho-social support for parents. We evaluate if the network improves care close to home for pregnant women, premature and sick newborns. METHODS: To evaluate the complex healthcare intervention "SAFE BIRTH" we will conduct a cluster-randomized controlled stepped-wedge trial in five prenatal medical outpatient offices and eight non-metropolitan hospitals in Saxony, Germany. The offices and hospitals will be randomly allocated to five respectively eight sequential steps over a 30-month period to implement the telemedical IB. We define one specific primary process outcome for each IB (for instance IB#1: "Proportion of patients with inclusion criterion IB#1 who have a prenatal care plan and psychosocial counseling within one week"). We estimated a separate multilevel logistic regression model for each primary process outcome using the intervention status as a regressor (control or intervention group). Across all IB, a total of 1,541 and 1,417 pregnant women or newborns need to be included in the intervention and control group, respectively, for a power above 80% for small to medium intervention effects for all five hypothesis tests. Additionally, we will assess job satisfaction and sense of safety of health professionals caring for newborns (questionnaire survey) and we will assess families' satisfaction, resilience, quality of life and depressive, anxiety and stress symptoms (questionnaire surveys). We will also evaluate the cost-effectiveness of "SAFE BIRTH" (statutory health insurance routine data, process data) and barriers to its implementation (semi-structured interviews). We use multilevel regression models adjusting for relevant confounders (e.g. socioeconomic status, age, place of residence), as well as descriptive analyses and qualitative content analyses. DISCUSSION: If the telemedical healthcare network "SAFE BIRTH" proves to be effective and cost-efficient, strategies for its translation into routine care should be developed. TRIAL REGISTRATION: German clinical trials register. DRKS-ID: DRKS00031482.

Evaluation of a flexible and integrative psychiatric care model in a department of child and adolescent psychiatry in Tübingen, Germany: study protocol (EVA_TIBAS).

BACKGROUND: Model projects for flexible and integrated treatment (FIT) in Germany aim at advancing the quality of care for people with mental disorders. A new FIT model project was established in 2017 at the Department of child and adolescent psychiatry (KJP) of the University Hospital Tübingen (Universitätsklinikum Tübingen, UKT). The study design of EVA_TIBAS presented here describes the evaluation of the FIT model project at the KJP of the UKT. This evaluation aims at quantifying the anticipated FIT model project changes, which are to improve patients' cross-sectoral care at the same maximum cost as standard care. METHODS: EVA_TIBAS is a controlled cohort study using a mix of quantitative and qualitative methods. The FIT evaluation consists of three modules. In Module A, anonymized claims data of a statutory health insurance fund will be used to compare outcomes (duration of inpatient and day care psychiatric treatment, inpatient and day care psychiatric length of stay, outpatient psychiatric treatment in hospital, inpatient hospital readmission, emergency admission rate, direct medical costs) of patients treated in the model hospital with patients treated in structurally comparable control hospitals (estimated sample size = ca. 600 patients). In Module B, patient-reported outcomes (health related quality of life, symptom burden, return to psychosocial relationships (e.g. school, friends, hobbies), treatment satisfaction, societal costs) will be assessed quantitatively using validated questionnaires for the model and two control hospitals (estimated sample size = ca. 300 patients). A subsequent health economic evaluation will be based on cost-effectiveness analyses from both the insurance fund's and the societal perspective. In Module C, about 30 semi-structured interviews will examine the quality of offer, effects and benefits of the service offered by the social service of the AOK Baden-Württemberg (for stabilizing the overall situation of care in the family) in the model hospital. A focus group discussion will address the quality of cooperation between employees of the university hospital and the social services. DISCUSSION: The results of this evaluation will be used to inform policy makers whether this FIT model project or aspects of it should be implemented into standard care. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov PRS (ID: NCT04727359 , date: 27 January 2021).

Rapid Review on the Associations of Social and Geographical Isolation and Intimate Partner Violence: Implications for the Ongoing COVID-19 Pandemic.

While the COVID-19 pandemic forced millions of people to stay home and minimize their social contacts, newspaper reports worldwide raised concerns as they reported an increasing rate of intimate partner violence (IPV). One link of the measures enforced to control the pandemic to IPV might be a possible side effect of those measures, namely social and geographical isolation. As there was no scientific data investigating the association of IPV and social and geographical isolation in the context of epidemics or pandemics at the time of conducting this rapid review, we aimed at investigating a broader range of contexts of social as well as geographical isolation and its association with IPV to draw conclusions regarding the COVID-19 pandemic. We searched Embase, PubMed, PsycINFO, and Web of Science (core collection). A research strategy was developed and observational studies were included if they considered men and/or women, estimates of social and geographical isolation, and IPV as a primary outcome. Of the 526 identified studies, 11 were included in this review. The included studies involved 15,695 women and were conducted in the USA, Sweden, Ethiopia, Egypt, Spain, and Turkey. Indicators of social isolation such as lack of social, emotional, or informational support or the frequency and quality of social contacts were narratively assessed. Geographical isolation was primarily assessed by physical distance to the next town or support service. Both social and geographic isolation were found to be associated with an increased risk of IPV. Recommendations made by the individual studies include the following: (a) improving access to social networks outside the victims' own group, (b) improving their economic circumstances, (c) asserting the responsibility for those in contact with the victims, and (d) increasing the focus on access to preventive services and programs need to be taken into account. Therefore, considering the particular infrastructure and legislation of the countries affected by the pandemic, policies need to ensure constant access to shelters and other help services and increase awareness for IPV in the society. In addition, future studies are warranted to assess prevalence rates and risk factors of IPV during the COVID-19 pandemic.

Implementing longitudinal integrated curricula: Systematic review of barriers and facilitators.

PURPOSE: The increase of longitudinal integrated curricula in medical schools worldwide represents the shift towards an outcome-oriented education. This novel model allows comprehensive student-patient interactions over time and integrates the educational content across disciplines. According to quantitative research, students, patients, doctors and communities benefit from this educational model in terms of participant satisfaction, learning outcomes and clinician recruitment. However, quantitative research does not provide detailed information on programme implementation processes. Therefore, this review aims to summarise facilitators and barriers of programme implementation reported in qualitative and mixed methods studies. METHOD: The authors reviewed the literature about facilitators and barriers for the implementation of longitudinal integrated curricula in undergraduate medical education programmes. The systematic search was conducted in MEDLINE, Embase and PsycINFO on 2 December 2019. The authors used the CASP checklist for qualitative research for the critical appraisal and summarised the results across studies using thematic content analysis. RESULTS: The authors screened 1682 reports. Twenty studies examining 17 different curricula met the inclusion criteria. Most curricula were implemented in the United States (n = 6/17), Australia (n = 5/17) or Canada (n = 4/17). Programme implementation is facilitated and hampered by its educational components (eg continuity of supervision, safe learning environments), organisational structures (eg community involvement) and participating students' and staff' motivation and personality. The critical appraisal revealed that several studies lacked transparent documentation and adequate reflection on the researcher-participant relationship (n = 20/20), data collection instruments (n = 12/20) and recruitment strategy (n = 4/20). CONCLUSIONS: The authors derived practical recommendations for the implementation of undergraduate, patient-centred, integrated medical curricula. Programme managers need to define and communicate common objectives with all participants. They should clarify the implementation of the objectives in all processes in a transparent and structured manner. Considering reporting guidelines, future studies in this field should document more transparently the methods used to gain qualitative insights and the researchers' personal involvement.