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Background antipsychotic drugs are regularly prescribed as first-line treatment for neuropsychiatric symptoms in persons with dementia although guidelines clearly prioritise non-pharmacological interventions. Objective we investigated a person-centred care approach, which has been successfully evaluated in nursing homes in the UK, and adapted it to German conditions. Design a 2-armed 12-month cluster-randomised controlled trial. Setting nursing homes in East, North and West Germany. Methods all prescribing physicians from both study arms received medication reviews for individual patients and were offered access to 2 h of continuing medical education. Nursing homes in the intervention group received educational interventions on person-centred care and a continuous supervision programme. Primary outcome: proportion of residents receiving at least one antipsychotic prescription after 12 months of follow-up. Secondary outcomes: quality of life, agitated behaviour, falls and fall-related medical attention, a health economics evaluation and a process evaluation. Results the study was conducted in 37 nursing homes with n = 1,153 residents (intervention group: n = 493; control group: n = 660). The proportion of residents with at least one antipsychotic medication changed after 12 months from 44.6% to 44.8% in the intervention group and from 39.8 to 33.3% in the control group. After 12 months, the difference in the prevalence was 11.4% between the intervention and control groups (95% confidence interval: 0.9–21.9; P = 0.033); odds ratio: 1.621 (95% confidence interval: 1.038–2.532). Conclusions the implementation of a proven person-centred care approach adapted to national conditions did not reduce antipsychotic prescriptions in German nursing homes. Trial registration ClinicalTrials.gov NCT02295462. [ABSTRACT FROM AUTHOR]

Background: The majority of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs are regularly prescribed as first-line treatment of neuropsychiatric symptoms in persons with dementia, although guidelines clearly prioritise non-pharmacological interventions. Frequently, antipsychotic drugs are prescribed for inappropriate reasons and for too long without regular reviewing. The use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. The aim of the study is to investigate whether a person-centred care approach, successfully evaluated in nursing homes in the United Kingdom, can be implemented in German nursing homes and, in comparison with a control group, can result in a clinically relevant reduction of the proportion of residents with antipsychotic prescriptions. Methods/design: The study is a cluster-randomised controlled trial comparing an intervention group (two-day initial training on person-centred care and ongoing training and support programme) with a control group. Both study groups will receive, as optimised usual care, a medication review by an experienced psychiatrist/geriatrician providing feedback to the prescribing physician. Overall, 36 nursing homes in East, North, and West Germany will be randomised. The primary outcome is the proportion of residents receiving at least one antipsychotic prescription (long-term medication) after 12 months of follow-up. Secondary outcomes are residents' quality of life, agitated behaviour, as well as safety parameters like falls and fall-related medical attention. A health economic evaluation and a process evaluation will be performed alongside the study. Discussion: To improve care, a reduction of the current high prescription rate of antipsychotics in nursing homes by the intervention programme is expected. Trial registration: ClinicalTrials.gov: NCT02295462 [ABSTRACT FROM AUTHOR]

Background Communication and information in order to reduce anxiety in the intensive care unit (ICU) has been described as area needing improvement. Therefore, the aim of this trial was to evaluate whether a structured information program that intensifies information given in standard care process reduces anxiety in ICU patients. Methods Multicenter, two-armed, non-blinded, parallel-group randomized controlled trial in hospitals in the cities of Marburg, Halle, and Stuttgart (Germany). The trial was performed in cardiac surgery, general surgery, and internal medicine ICUs. Two-hundred and eleven elective and non-elective ICU patients were enrolled in the study (intervention group, n = 104; control group, n = 107). The experimental intervention comprised a single episode of structured oral information that was given in addition to standard care and covered two main parts: (1) A more standardized part about predefined ICU specific aspects - mainly procedural, sensory and coping information, and (2) an individualized part about fears and questions of the patient. The control group received a non-specific episodic conversation of similar length additional to standard care. Both conversations took place at the beginning of the ICU stay and lasted 10-15 minutes. Study nurses administered both interventions. The primary outcome ICU-related anxiety (CINT-Score, 0-100 pts., higher scores indicate higher anxiety) was assessed after admission to a regular ward. Results The primary outcome could be measured in 82 intervention group participants and 90 control group participants resulting in mean values of 20.4 (SD 14.4) compared to 20.8 (SD 14.7) and a mean difference of -0.2 (CI 95% -4.5 to 4.1). Conclusions A structured information intervention additional to standard care during ICU stay had no demonstrated additional benefit compared to an unspecific communication of similar duration. Reduction of anxiety in ICU patients will probably require more continuous approaches to information giving and communication. [ABSTRACT FROM AUTHOR]

Berg A., Fleischer S., Kuss O., Unverzagt S. & Langer G. (2012) Timing of dressing removal in the healing of surgical wounds by primary intention: quantitative systematic review protocol. Journal of Advanced Nursing 68(2), 264-270. Abstract Aim. The purpose of this systematic review is to evaluate the efficacy of different lengths of time of postoperative dressing removal in the healing of surgical wounds by primary intention. Background. It is generally practiced and recommended in clinical guidelines to cover surgical incisions which are healing by primary intention postprocedure. However, the timing of dressing removal in relation to the prevention of surgical site infections has not yet been sufficiently examined. Methods. The systematic review and meta-analyses will be performed according to the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions. Randomized controlled trials will be included. Comparisons will be made between different durations of leaving dressings in place, including not dressing the surgical site at all, and covering wounds until suture removal. Primary outcome measure is the rate of surgical site infections. Funding of the review was confirmed in March 2010. Discussion. The results of the review can put the timing of dressing removal for wounds which are healing by primary intention into perspective. Because of the widespread use of surgical dressings, clinical practice could be changed in various settings. [ABSTRACT FROM AUTHOR]

Background: According to current evidence and psychological theorizing proper information giving seems to be a promising way to reduce patient anxiety. In the case of surgical patients, admission to the intensive care unit (ICU) is strongly associated with uncertainty, unpredictability and anxiety for the patient. Thus, ICU specific information could have a high clinical impact. This study investigates the potential benefits of a specifically designed ICU-related information program for patients who undergo elective cardiac, abdominal or thoracic surgery and are scheduled for ICU stay. Methods/Design: The trial is designed as a prospective randomized controlled trial including an intervention and a control group. The control group receives the standard preparation currently conducted by surgeons and anesthetists. The intervention group additionally receives a standardized information program with specific procedural, sensory and coping information about the ICU. A measurable clinical relevant difference regarding anxiety will be expected after discharge from ICU. Power calculation (α = 0.05; β = 0.20; Δ = 8.50 score points) resulted in a required sample size of N = 120 cardiac surgical patients (n = 60 vs. n = 60). Furthermore, N = 20 abdominal or thoracic surgical patients will be recruited (n = 10 vs. n = 10) to gain insight to a possible generalization to other patient groups. Additionally the moderating effect of specific patient attributes (need for cognition, high trait anxiety) will be investigated to identify certain patient groups which benefit most. Discussion: The proposed study promises to strengthen evidence on effects of a specific, concise information program that addresses the information needs of patients scheduled for ICU stay. [ABSTRACT FROM AUTHOR]

To develop and validate search filters for MEDLINE via PubMed according to two categories of the NLINKS-EBN matrix. The search results of the search filters were compared to a gold standard. The usage of nursing classification terms for the literature search in evidence-based nursing (EBN) is still limited because taxonomies are neither widely used in nursing literature nor applied for indexing by MEDLINE. The proposed filters achieved a sensitivity of 96% and a specificity of 94% for “secondary data” and a sensitivity of 87% and a specificity of 73% for “diagnostic tests.” The usage of database-specific search filters are a reliable and valid method to search for nursing classification terms in medical databases. [ABSTRACT FROM AUTHOR]

Background: Advance Care Planning interventions should be evaluated as broadly as possible to gain a holistic understanding of the Advance Care Planning process. However, validated early stage outcome instruments are lacking. Therefore, the Treatment-Preference-Measure-Advance Care Planning (Treat-Me-ACP) instrument was developed and validated as part of the cluster-randomized controlled trial STADPLAN (Study on Advance Care Planning in care-dependent community-dwelling older persons) to assess the effects of Advance Care Planning interventions on patients' medical treatment preferences. Methods: The design of Treat-Me-ACP is based on the Emanuel Medical Directive and the Life Support Preferences Questionnaires. Using a multi-stage team approach a preliminary version of the Treat-Me-ACP was developed and pre-tested. The pre-tested instrument consists of one global medical care goal-item, five hypothetical scenarios with five hypothetical treatments, and one how would you feel-item within each scenario. A total of five scenario preference scores and five treatment preference scores can be formed. This version was subsequently applied to a subsample of the STADPLAN project (n = 80) to assess patient's preferences at baseline (T0) and at 12-month follow-up (T2). The further validation steps were based on this subsample and included: (1) acceptance by using completion rate and frequencies of missing data, (2) internal consistency by using Cronbach's α to test whether it was possible to create preference scores by scenario and treatment, (3) concurrent validation examining the association between the global medical care goal-item and the preference scores and the association between the how would you feel-items and the scenario preference scores, and (4) responsiveness of the instrument to changes in preferences for life-sustaining treatments by comparing preference scores from T0 to T2 between study groups. Results: Acceptance of the instrument was high. Results of concurrent validation indicate that the five scenarios represent the global medical care goal well. The preference scores showed an average tendency for decreasing preferences for life-sustaining treatments across all scales for the intervention group during study follow-up. Conclusions: The Treat-Me-ACP can be used to evaluate the dynamics of patients' medical treatment preferences in Advance Care Planning. It has been validated for care-dependent community-dwelling older persons and can be used as an additional outcome measure in evaluating the effectiveness of ACP interventions. Trial registration: German Clinical Trials Register: DRKS00016886 on 04/06/2019. [ABSTRACT FROM AUTHOR]

Background: Process evaluation addresses the implementation, mechanisms of impact, and context of participants in complex interventions. The STADPLAN study assesses the effects of conversations on advance care planning (ACP) led by trained nurse facilitators. The complex intervention consists of several components that may lead to various changes in attitude and behavior regarding personal ACP activities. With the process evaluation, we aim to assess how changes were achieved in the STADPLAN intervention.Methods: The planned process evaluation study will be conducted alongside a cluster-randomized controlled trial on ACP in home care services (HCS). Trained nurse facilitators will deliver the ACP intervention consisting of an information brochure and two ACP conversations. A logic model depicts the assumed change processes of the intervention: the educational program enables nurses to conduct ACP conversations with patients and their caregivers. Patients gain knowledge and reflect upon and engage in their own ACP. Caregivers better understand patients' wishes and feel reassured in their role as surrogates. Designation of a surrogate and communication on ACP are facilitated. We will assess the effects of the educational program with questionnaires and a focus group including all participating nurses. We will measure ACP engagement, and prevalence of advance directives in patients, and ask for their experiences with the intervention. We will conduct semi-structured interviews with caregivers about their expectations and experiences regarding ACP in general and the intervention. We will address context factors, e.g., basic characteristics of the HCS (such as ownership, number of clients, staff and qualification). Analysis will be based upon the logic model, integrating qualitative and quantitative data.Discussion: The comprehensive process evaluation will provide essential information on the feasibility of implementation strategies and the clinical relevance of a nurse-led ACP intervention in home care recipients and its generalizability and transferability to other settings.Trial Registration: German Clinical Trials Register: DRKS00016886 . Registered retrospectively on June 4, 2019, first participant included on May 29, 2019. [ABSTRACT FROM AUTHOR]

Background: Most randomised controlled trials on advance care planning were conducted in people with advanced, life-limiting illnesses or in institutional settings. There are few studies on its effect in older people living in the community. Aim: To determine the effects of advance care planning in older community dwelling people. Design: The STADPLAN study was a cluster-randomised trial with 12 months follow-up. The complex intervention comprised a 2-days training for nurse facilitators that delivered a formal advance care planning counselling and a written information brochure. Patients in the control group received optimised usual care, that is, provision of a short information brochure. Setting/participants: Home care services in three regions of Germany were randomised using concealed allocation. Care dependent clients of participating home care services, aged 60 years or older, and rated to have a life-expectancy of at least 4 weeks were included. Primary outcome was active participation in care at 12 months, assessed by blinded investigators using the Patient Activation Measure (PAM-13). Results: Twenty-seven home care services and 380 patients took part. Three hundred seventy-three patients were included in the primary analysis (n = 206 in the intervention and n = 167 in the control group). There was no statistically significant difference between the intervention and control group with regard to the PAM-13 after 12 months (75.7 vs 78.4; p = 0.13). No differences in quality of life, anxiety and depression, advance care planning engagement, and in proportion of participants with advance directives were found between groups. Conclusions: The intervention showed no relevant effects on patient activation or quality of life in community dwelling older persons, possibly indicating the need for more tailored interventions. However, results are limited by a lack of statistical power. Trial registration: German Clinical Trials Register: DRKS00016886 [ABSTRACT FROM AUTHOR]

Background: The majority of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs are regularly prescribed as first-line treatment of neuropsychiatric symptoms in persons with dementia, although guidelines clearly prioritise non-pharmacological interventions. Frequently, antipsychotic drugs are prescribed for inappropriate reasons and for too long without regular reviewing. The use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. The aim of the study is to investigate whether a person-centred care approach, successfully evaluated in nursing homes in the United Kingdom, can be implemented in German nursing homes and, in comparison with a control group, can result in a clinically relevant reduction of the proportion of residents with antipsychotic prescriptions.Methods/design: The study is a cluster-randomised controlled trial comparing an intervention group (two-day initial training on person-centred care and ongoing training and support programme) with a control group. Both study groups will receive, as optimised usual care, a medication review by an experienced psychiatrist/geriatrician providing feedback to the prescribing physician. Overall, 36 nursing homes in East, North, and West Germany will be randomised. The primary outcome is the proportion of residents receiving at least one antipsychotic prescription (long-term medication) after 12 months of follow-up. Secondary outcomes are residents' quality of life, agitated behaviour, as well as safety parameters like falls and fall-related medical attention. A health economic evaluation and a process evaluation will be performed alongside the study.Discussion: To improve care, a reduction of the current high prescription rate of antipsychotics in nursing homes by the intervention programme is expected.Trial Registration: ClinicalTrials.gov: NCT02295462. [ABSTRACT FROM AUTHOR]

Background: In Western countries, it is common practice for a woman to be supported by a trusted person during childbirth, usually the other parent. Numerous studies have shown that this has a positive effect both on the woman's satisfaction with the birth process and on physical outcomes. However, there is little research on the birth experience of partners and their wellbeing. The aim of this review is to summarise the existing literature on partner experience, consider its quality and identify the underlying themes.Methods: Both a systematic literature search in three databases and a manual search were conducted, for qualitative, quantitative, and mixed-methods studies from Western countries examining the experiences of partners present at a birth.Results: A total of 35 studies were included. Only one study included same-sex partners (the other studies addressed fathers' experiences only) and only one validated questionnaire examining partners' birth experiences was identified. Four major themes were found to influence partners' birth experiences: (1) intense feelings, (2) role of support, (3) staff support, and (4) becoming a father.Conclusions: Partners may feel very vulnerable and stressed in this unfamiliar situation. They need emotional and informal support from staff, want to be actively involved, and play an important role for the birthing woman. To promote good attachment for parents, systematic exploration of the needs of partners is essential for a positive birth experience. Because of the diversity of family constellations, all partners should be included in further studies, especially same-sex partners. [ABSTRACT FROM AUTHOR]

Background: Person-centred care (PCC) has been suggested as the preferred model of dementia care in all settings. The EPCentCare study showed that an adapted PCC approach was difficult to implement and had no effect on prescription of antipsychotics in nursing home residents in Germany. This paper reports the qualitative process evaluation to identify facilitators and barriers of the implementation of PCC in German nursing homes from the perspective of participating practice development champions. Methods: Five individual and 14 group interviews were conducted with 66 participants (staff and managers) from 18 nursing homes. The analysis was based on inductive coding to identify factors influencing the PCC implementation process. Identified factors were systematised and structured by mapping them to the four constructs (coherence, cognitive participation, collective action, reflexive monitoring) of the Normalization Process Theory (NPT) as a framework that explains implementation processes. Results: Facilitating implementation factors included among others broadening of the care perspective (coherence), tolerance development within the care team regarding challenging behaviour (cognitive participation), testing new approaches to solutions as a multi-professional team (collective action), and perception of effects of PCC measures (reflexive monitoring). Among the facilitating factors reported in all the NPT constructs, thus affecting the entire implementation process, were the involvement of relatives, multi-professional teamwork and effective collaboration with physicians. Barriers implied uncertainties about the implementation and expectation of a higher workload (coherence), concerns about the feasibility of PCC implementation in terms of human resources (cognitive participation), lack of a person-centred attitude by colleagues or the institution (collective action), and doubts about the effects of PCC (reflexive monitoring). Barriers influencing the entire implementation process comprised insufficient time resources, lack of support, lack of involvement of the multi-professional team, and difficulties regarding communication with the attending physicians. Conclusions: The findings provide a comprehensive and detailed overview of facilitators and barriers structured along the implementation process. Thus, our findings may assist both researchers and clinicians to develop and reflect more efficiently on PCC implementation processes in nursing homes. Trial registration: ClinicalTrials.gov identifier: NCT02295462; November 20, 2014. [ABSTRACT FROM AUTHOR]

Purpose/Objectives: To describe the experience of female patients living with breast cancer-related lymphedema (BCRL) to gain a comprehensive understanding of this experience. The review is designed as a qualitative meta-synthesis.Data Sources: Electronic searches were conducted in MEDLINE®, CINAHL®, EMBASE, PsycINFO, and Social Sciences Citation Index. Articles were included where researchers used qualitative research methods and when a comprehensive description of methods and the study's findings were provided.Data Synthesis: From 2,185 references, 13 articles were included. A total of 94 author and participant aggregations were extracted, qualitatively assessed, and assigned to one of 14 categories. Four themes relating to the experience of living with BCRL were identified: experience of everyday life, energy sapping, personal empowerment, and contribution of others.Conclusions: Requirements of living with BCRL may only be influenced to a limited extent by the women themselves. They struggle with their situation, appearance, and the concomitant uncertainties. They feel strengthened where they succeed in developing a helpful view of their situation and where support structures are available to them.Implications for Nursing: Professionals can employ this meta-synthesis by contextualizing it as part of a process of critical reflection on their own endeavors to meet the requirements of women living with BCRL. [ABSTRACT FROM AUTHOR]

Background: The Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW) is a prevalent face-to-face interview method for measuring quality of life by integrating respondent-generated dimensions. To apply this method in clinical trials, a paper-administered alternative would be of interest. Therefore, our study aimed to analyze the agreement between the SEIQoL-DW and a paper questionnaire version (SEIQoL-PF/G).Methods: In a crossover design, both measures were completed in a random sequence. 104 patients at a heart surgery hospital in Germany were randomly assigned to receive either the SEIQoL-DW or the SEIQoL-PF/G as the first measurement in the sequence. Patients were approached on their earliest stable day after surgery. The average time between both measurements was 1 day (mean 1.3; SD 0.8). Agreement regarding the indices, ratings, and weightings of nominated life areas (cues) was explored using Bland-Altman plots with 95% limits of agreement (LoA). Agreement of the SEIQoL indices was defined as acceptable if the LoA did not exceed a threshold of 10 scale points. Data from n = 99 patients were included in the agreement analysis.Results: Both measures led to similarly nominated cues. The most frequently nominated cues were "physical health" and "family". In the Bland-Altman plot, the indices showed a mean of differences of 2 points (95% CI, - 1 to 6). The upper LoA showed a difference of 36 points (95% CI, 30 to 42), and the lower LoA showed a difference of - 31 points (95% CI, - 37 to - 26). Thus, the LoAs and confidence intervals exceeded the predefined threshold. The Bland-Altman plots for the cue levels and cue weights showed similar results. The SEIQoL-PF/G version showed a tendency for equal weighting of cues, while the weighting procedure of the SEIQoL-DW led to greater variability.Conclusions: For cardiac surgery patients, use of the current version of the SEIQoL-PF/G as a substitute for the SEIQoL-DW is not recommended. The current questionnaire weighting method seems to be unable to distinguish weighting for different cues. Therefore, the further design of a weighting method without interviewer support as a paper-administered measure of individual quality of life is desirable. [ABSTRACT FROM AUTHOR]

Background Indwelling urinary catheters go along with high risk of urinary tract infections. Clinical guidelines therefore recommend restrictive catheter use in hospitals. However, interventions to reduce indwelling urinary catheters in hospitals are challenging. Several systematic reviews identified promising approaches mostly as part of intervention bundles. It remains unclear how intervention components should actually be implemented. Therefore, we performed a comprehensive synthesis of existing evidence and aimed to identify and describe appropriate intervention components to reduce the use of indwelling urinary catheters in acute care hospitals, and to identify and describe implementation strategies associated with these intervention components. Methods We performed a scoping review with the following concepts of interest: interventions to reduce indwelling urinary catheters in hospitals, their theoretical foundation and drivers enabling implementation. The systematic search was conducted in five consecutive steps from July 2015 to February 2016 and covered the Cochrane Library, Med-line, Cinahl, and guideline databases. Primary research articles (published since 2008), systematic reviews, and clinical guidelines (updated at the latest in 2010) in German or English language were included (n = 70 publications). To systemize implementation strategies for intervention components we used implementation drivers related to organization and staff competency according to the Active Implementation Framework. Results Identified core intervention components were defined indications for indwelling urinary catheters, reminder systems, and stop orders. On the organizational level they are flanked by institutionalized guidelines addressing responsibilities and processes, integrating the program's components in electronic medical records, and performance assessment and feedback. On the staff competency level the interventions are accompanied by various training modalities as well as deployment of staff with special responsibilities and authorization. Consideration of multiprofessional stakeholders' view and circumstances by assessment of knowledge, barriers and needs was used to model an intervention and to support the implementation process. The intervention components can be justified in a satisfactory manner by a range of guideline recommendations and systematically assessed evidence of mainly observational trials. Conclusions The identified intervention components and implementation strategies are suitable to model a complex intervention to reduce catheters in hospitals. Many of the components involve multiprofessional aspects. In particular, collaboration of physicians and nurses seems to be mandatory. Limitations exist in the underlying evidence for some components due to used study designs in primary research. [ABSTRACT FROM AUTHOR]

Background: To assess the quality of life of people with dementia, measures are required for self-rating by the person with dementia, and for proxy rating by others. The Quality of Life in Alzheimer's Disease scale (QoL-AD) is available in two versions, QoL-AD-SR (self-rating) and QoL-AD-PR (proxy rating). The aim of our study was to analyse the inter-rater agreement between self- and proxy ratings, in terms of both the total score and the items, including an analysis specific to care setting, and to identify factors associated with this agreement.Methods: Cross-sectional QoL-AD data from the 7th Framework European RightTimePlaceCare study were analysed. A total of 1330 cases were included: n = 854 receiving home care and n = 476 receiving institutional long-term nursing care. The proxy raters were informal carers (home care) and best-informed professional carers (institutional long-term nursing care). Inter-rater agreement was investigated using Bland-Altman plots for the QoL-AD total score and by weighted kappa statistics for single items. Associations were investigated by regression analysis.Results: The overall QoL-AD assessment of those with dementia revealed a mean value of 33.2 points, and the proxy ratings revealed a mean value of 29.8 points. The Bland-Altman plots revealed a poor agreement between self- and proxy ratings for the overall sample and for both care settings. With one exception (item 'Marriage' weighted kappa 0.26), the weighted kappa values for the single QoL-AD items were below 0.20, indicating poor agreement. Home care setting, dementia-related behavioural and psychological symptoms, and the functional status of the person with dementia, along with the caregiver burden, were associated with the level of agreement. Only the home care setting was associated with an increase larger than the predefined acceptable difference between self- and proxy ratings.Conclusions: Proxy quality of life ratings from professional and informal carers appear to be lower than the self-ratings of those with dementia. QoL-AD-SR and QoL-AD-PR are therefore not interchangeable, as the inter-rater agreement differs distinctly. Thus, a proxy rating should be judged as a complementary perspective for a self-assessment of quality of life by those with dementia, rather than as a valid substitute. [ABSTRACT FROM AUTHOR]