[Effects of nursing visits on primary nursing : An evaluation study in an intensive care unit]. / Auswirkungen der Pflegevisite auf die Prozessverantwortliche Pflege : Eine Evaluationsstudie auf der Intensivstation.

BACKGROUND: After a pilot phase in 2017, nursing visits (PV) were implemented in an intensive care unit (ICU) at a university hospital. So far, published findings on the impact of PV on the primary nursing organisation system (process-responsible nursing [PP]) could not be identified. AIM: Primary aim was to investigate the effects of PV on PP from the nurses perspective. Secondary aims included comparison with the results of the pilot phase (t0) to determine further effects, general conditions of the PP and the overall evaluation. METHODS: A quantitative evaluation study using a standardised questionnaire was used. RESULTS: The survey was conducted in September to October 2023 (t1) with a response rate of 74.6% (n = 47). On a scale of 1-6 (strongly agree; strongly disagree), 100.0% of the process-responsible nurses (PP; n = 8) and 77.0% of the nurses without process responsibility (P; n = 30) rated the PV at levels 1-3 (p = 0.328) as contributing to the evaluation of care planning for patients with process responsibility. PV provided support for the implementation of PP (PP: 100.0%, n = 8; P: 79.5%, n = 31; p = 0.318) and had a statistically significant effect (r = 0.97, p = 0.035) on improving the quality of care and care planning for patients with procedural responsibility. The nurses indicated with levels 1-3 that the patients were more consciously brought into the focus of nursing care through the PV (t1: 74.4%, n = 35; t0: 86.4%, n = 38; p = 0.953). The PV should take place weekly and was rated with a median of 2 (IQR t1: 1-3; t0:1-2). CONCLUSION: PV support the implementation of PP and patient-centred care in the ICU.

Randomized feasibility trial for evaluating the impact of primary nursing on delirium duration during intensive care unit stay.

OBJECTIVE: We tested the feasibility of a randomized controlled trial for comparing primary nursing with standard care. RESEARCH METHODOLOGY: Elective cardiac surgical patients were eligible for inclusion. Patients with an intensive care unit stay of ≥ 3 days were followed up until intensive care unit discharge. Recruitment period was one year. SETTING: Two intensive care units at a university hospital specialized in cardiovascular and diabetic diseases. MAIN OUTCOME MEASURES: Primary outcomes were recruitment and delivery rate. Primary clinical outcome was duration of delirium, as assessed by the Confusion Assessment Method for Intensive Care Units. Secondary outcomes included the incidence of delirium, anxiety (10-point Numeric Rating Scale), and the satisfaction of patient relatives (validated questionnaire). RESULTS: Of 369 patients screened, 269 could be allocated to primary nursing (n = 134) or standard care (n = 135), of whom 46 patients and 48 patients, respectively, underwent an intensive care unit stay ≥ 3 days. Thus, recruitment and delivery rates were 73 and 26 %, respectively. During primary nursing and standard care, 18 and 24 patients developed a delirium, with a median duration of 32 (IQR: 14-96) and 24 (IQR: 8-44) hours (P = 0.10). The risk difference of delirium for primary nursing versus standard care was 11 % and the relative risk was 0.65 (95 % CI: 0.28-1.46; P = 0.29). The extent of anxiety was similar between groups (P = 0.13). Satisfaction could be assessed in 73.5 % of relatives, without substantial differences between groups. CONCLUSION: Data demonstrate that a trial for comparing primary nursing with standard care is generally feasible. However, the incidence of delirium may be a better primary outcome parameter than delirium duration, both in terms of long-term patient outcome and robustness of data quality. IMPLICATIONS FOR CLINICAL PRACTICE: A randomized clinical trial regarding nursing organization during intensive care unit stay requires detailed planning of patient recruitment, data evaluation, and power calculation.

Cross-sectional evaluation of pharmaceutical care competences in nurse education: how well do curricula prepare students of different educational levels?

BACKGROUND: Nurses play an important role in interprofessional pharmaceutical care. Curricula related to pharmaceutical care, however, vary a lot. Mapping the presence of pharmaceutical care related domains and competences in nurse educational programs can lead to a better understanding of the extent to which curricula fit expectations of the labour market. The aim of this study was to describe 1) the presence of pharmaceutical care oriented content in nursing curricula at different educational levels and 2) nursing students' perceived readiness to provide nurse pharmaceutical care in practice. METHODS: A quantitative cross-sectional survey design was used. Nursing schools in 14 European countries offering educational programs for levels 4-7 students were approached between January and April 2021. Through an online survey final year students had to indicate to what extent pharmaceutical care topics were present in their curriculum. RESULTS: A total of 1807 students participated, of whom 8% had level 4-5, 80% level 6, 12% level 7. Up to 84% of the students indicated that pharmaceutical care content was insufficiently addressed in their curriculum. On average 14% [range 0-30] felt sufficiently prepared to achieve the required pharmaceutical care competences in practice. In level 5 curricula more pharmaceutical care domains were absent compared with other levels. CONCLUSIONS: Although several pharmaceutical care related courses are present in current curricula of level 4-7 nurses, its embedding should be extended. Too many students perceive an insufficient preparation to achieve pharmaceutical care competences required in practice. Existing gaps in pharmaceutical care should be addressed to offer more thoroughly prepared nurses to the labour market.

Nutritional interventions for preventing and treating pressure ulcers.

BACKGROUND: Pressure ulcers are localized injuries to the skin or the underlying tissue, or both, and are common in older and immobile people, people with diabetes, vascular disease, or malnutrition, as well as those who require intensive or palliative care. People with pressure ulcers often suffer from severe pain and exhibit social avoidance behaviours. The prevention and treatment of pressure ulcers involves strategies to optimize hydration, circulation, and nutrition. Adequate nutrient intake can reduce the risk factor of malnutrition and promote wound healing in existing pressure ulcers. However, it is unclear which nutrients help prevent and treat pressure ulcers. This is an update of an earlier Cochrane Review. OBJECTIVES: To evaluate the benefits and harms of nutritional interventions (special diets, supplements) for preventing and treating pressure ulcers in people with or without existing pressure ulcers compared to standard diet or other nutritional interventions. SEARCH METHODS: We used extensive Cochrane search methods. The latest search was in May 2022. SELECTION CRITERIA: We included randomized controlled trials (RCTs) in people with or without existing pressure ulcers, that compared nutritional interventions aimed at preventing or treating pressure ulcers with standard diet or other types of nutritional interventions. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcome for prevention studies was the proportion of participants who developed new (incident) pressure ulcers. For treatment studies, our primary outcomes were time to complete pressure ulcer healing, number of people with healed pressure ulcers, size and depth of pressure ulcers, and rate of pressure ulcer healing. Secondary outcomes were side effects, costs, health-related quality of life and acceptability. We used GRADE to assess certainty of evidence for each outcome. MAIN RESULTS: We included 33 RCTs with 7920 participants. Data for meta-analysis were available from 6993 participants. Pressure ulcer prevention Eleven studies (with 12 arms) compared six types of nutritional interventions for the prevention of pressure ulcers. Compared to standard diet, energy, protein and micronutrient supplements may result in little to no difference in the proportion of participants developing a pressure ulcer (energy, protein and micronutrient supplements 248 per 1000, standard diet 269 per 1000; RR 0.92, 95% CI 0.71 to 1.19; 3 studies, 1634 participants; low-certainty evidence). Compared to standard diet, protein supplements may result in little to no difference in pressure ulcer incidence (protein 21 per 1000, standard diet 28 per 1000; RR 0.75, 95% CI 0.49 to 1.14; 4 studies, 4264 participants; low-certainty evidence). The evidence is very uncertain about the gastrointestinal side effects of these supplements (protein 109 per 1000, standard diet 155 per 1000; RR 0.70, 95% CI 0.06 to 7.96; 2 studies, 140 participants, very low-certainty evidence). The evidence is very uncertain about the effects of protein, arginine, zinc and antioxidants; L-carnitine, L-leucine, calcium, magnesium and vitamin D; EPA, GLA and antioxidants; disease-specific supplements on pressure ulcer incidence when compared to standard diet (1 study each; very low-certainty evidence for all comparisons). Pressure ulcer treatment Twenty-four studies (with 27 arms) compared 10 types of nutritional interventions or supplements for treatment of pressure ulcers. Compared to standard diet, energy, protein and micronutrient supplements may slightly increase the number of healed pressure ulcers (energy, protein and micronutrients 366 per 1000, standard diet 253 per 1000; RR 1.45, 95% CI 1.14 to 1.85; 3 studies, 577 participants, low-certainty evidence). The evidence is very uncertain about the effect of these supplements on gastrointestinal side effects. Compared to standard diet, the evidence is very uncertain about the effect of protein, arginine, zinc and antioxidant supplements on pressure ulcer healing (pressure ulcer area: mean difference (MD) 2 cm² smaller, 95% CI 4.54 smaller to 0.53 larger; 2 studies, 71 participants, very low-certainty evidence). The evidence on side effects of these supplements is very uncertain. Compared to standard diet, supplements with arginine and micronutrients may not increase the number of healed pressure ulcers, but the evidence suggests a slight reduction in pressure ulcer area (MD 15.8% lower, 95% CI 25.11 lower to 6.48 lower; 2 studies, 231 participants, low-certainty evidence). The evidence is very uncertain about changes in pressure ulcer scores, acceptability, and side effects of these supplements. Compared to placebo, collagen supplements probably improve the mean change in pressure ulcer area (MD 1.81 cm² smaller, 95% CI 3.36 smaller to 0.26 smaller; 1 study, 74 participants, moderate-certainty evidence). The evidence is very uncertain about the effect of these supplements on side effects. The evidence is very uncertain about the effects of vitamin C, different doses of arginine; EPA, GLA (special dietary fatty acids) and antioxidants; protein; a specialized amino acid mixture; ornithine alpha-ketoglutarate and zinc supplements on pressure ulcer healing (1 or 2 studies each; very low-certainty evidence). AUTHORS' CONCLUSIONS: The benefits of nutritional interventions with various compositions for pressure ulcer prevention and treatment are uncertain. There may be little or no difference compared to standard nutrition or placebo. Nutritional supplements may not increase gastrointestinal side effects, but the evidence is very uncertain. Larger studies with similar nutrient compositions would reduce these uncertainties. No study investigated the effects of special diets (e.g. protein-enriched diet, vegetarian diet) on pressure ulcer incidence and healing.

Drivers of disease severity and burden of hidradenitis suppurativa: a cross-sectional analysis on 553 German patients.

BACKGROUND: Hidradenitis suppurativa (HS) is an inflammatory disease of the inverse skin regions with an age peak at around 40 years and an estimated prevalence of 1%. Nodules and abscesses can develop into fistules and scarring, which cause severe pain. HS is a progressive, life-defining disease that leads to physical limitations, inability to work, and social isolation. There is still little data on the drivers of disease severity and burden. METHOD: The cross-sectional study is based on the baseline data of 553 participants of the health care research project "EsmAiL," which was carried out as a multicenter randomized controlled trial. It included adult HS-patients presenting with at least three inflammatory lesions and at least a moderate impact on quality of life. RESULTS: Disease activity increases with age. Men are more severely affected than women but feel less burdened. Obesity negatively influences disease activity and disease burden. Affected individuals have a higher level of education than the age adjusted population, but the unemployment rate is significantly higher. Disease activity significantly reduces quality of life and promotes depression and anxiety. CONCLUSIONS: HS is a severe and debilitating dermatosis. As a result of the well-established factors involved, HS requires a multi-causal approach to management, in addition to medical and surgical treatment. This must take into account all available therapeutic options, as well as patient education to reduce risk factors and pain, and psychological support. HS requires interdisciplinary and multi-professional care. To prevent disease progression, a structured treatment plan is needed.

A center-based, ambulatory care concept for hidradenitis suppurativa improves patient outcomes and is also cost-effectiveness.

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease affecting approximately 1% of the population. The patient journey through the German health care system leads to high disease burden and substantial treatment costs. The EsmAiL study showed that an innovative, interprofessional, multimodal care-concept reduces disease activity and burden of HS compared to standard care. This paper examines the costs of treating HS in Germany and compares them with those of the innovative care concept implemented in EsmAiL. METHODS: EsmAiL was a two-arm, multicenter, prospective randomized controlled trial including 553 adults with HS. The study was registered in the German Clinical Trials Registry (DRKS00022135). The control group (CG) remained in standard care, whereas the intervention group (IG) was referred to specialized so-called 'acne-inversa-centres (AiZ)' where patients were treated with a structured, interdisciplinary approach. The present paper analyses the treatment costs for a subpopulation based on health insurance cost data from the two largest German health insurers. Quality-Adjusted Life Years (QALY) was assessed based on Dermatology Life Quality Index (DLQI). RESULTS: Total annual treatment costs per patient were €3,966.07 in standard care (n = 89) and €3,974.37 in the innovative care (n = 93). The costs per additional QALY amounted to €12,698.72 in the IG. Given the conventional and established threshold of €22,600 to €33,900 per QALY, the innovative treatment in AiZ proved to be cost-effective. CONCLUSION: Treatment costs of HS are substantial and increase with disease severity. The new form of care is cost-effective and is expected to decrease costs in the long run.

A structured, multimodal form of care reduces costs in the treatment of Hidradenitis suppurativa compared to standard care.

[Development and implementation of primary nursing in the intensive care unit: evaluation in mixed-methods design.] / Entwicklung und Implementierung von Prozessverantwortlicher Pflege auf der Intensivstation.

Development and implementation of primary nursing in the intensive care unit: evaluation in mixed-methods design. Abstract:Background: In a university hospital, the development and implementation of Primary Nursing (Prozessverantwortliche Pflege, PP) in a pilot intensive care unit was initiated. To develop the roles of nurses with and without process responsibility a working group PP was founded while taking into account the skill-grade mix. Aim: The working group aimed to develop the roles of process-responsible nurses (PP) and nurses (P), as well as to plan and implement the implementation process. Methods: Development and piloting steps were taken based on the recommendations of the Medical Research Council. At three measurement points, the instrument for recording nursing systems (IzEP©) was used quantitatively and a focus group interview, as well as a ward process analysis, were used qualitatively in t0 (as-is analysis before development and piloting), t1 (6 months after implementation) and t2 (12 months after implementation). Results: PP mainly take over the care process's design and control. The IzEP© analysis showed that room care was practiced in t0 with 50.0%. The values increased towards PP from 74.0% in t1 to 83.5% in t2. Qualitatively obtained data supported these results and showed further optimization potential for practice. Conclusions: The results prove the successful implementation of PP in practice. For the development and implementation of new nursing roles, the involvement of the affected nurses is mandatory.

Technology-Based Counselling for People with Dementia and Their Informal Carers: A Systematic Review and Meta-Analysis.

BACKGROUND: Information technology can enhance timely and individual support for people with Alzheimer's disease and other dementias and their informal carers. OBJECTIVE: To review the effectiveness of technology-based counselling interventions for people with dementia and informal carers. METHODS: Randomized controlled trials of remote dementia counselling interventions were included. We searched CINAHL, Cochrane Library, MEDLINE, PsycINFO, and the Web of Science Core Collection (April 2021) in combination with citation tracking and free web searching (October to November 2021). We provide meta-analyses for caregiver depression, burden, and self-efficacy/mastery and structured reporting for other outcomes. The Grading of Recommendations Assessment, Development and Evaluation approach and the Risk of Bias 2 tool were applied. RESULTS: We included five randomized controlled trials involving 880 participants. Interventions were provided for carers (four studies) or dyads (one study). Carers were predominantly women and were the spouses or children of people with dementia. Counselling was delivered via telephone or videoconference with two to 23 sessions over 1 to 12 months. Control groups received educational and resource materials only, standard (helpline) services, non-directive support, or home visits. Meta-analysis for our primary outcome, depressive symptoms in carers, revealed no statistically significant effect (SMD -0.15; 95% CI -0.40 to 0.10). There were also no significant effects on burden and self-efficacy/mastery. We rated the certainty of evidence as low to very low and all outcomes at an overall high risk of bias. CONCLUSION: The effectiveness of technology-based counselling interventions for people with dementia and informal carers remains uncertain. Theory-based approaches are needed for the development and evaluation of these interventions.

A centre-based ambulatory care concept for hidradenitis suppurativa improves disease activity, disease burden and patient satisfaction: results from the randomized controlled EsmAiL trial.

BACKGROUND: Hidradenitis suppurativa (HS) is an inflammatory disease of the inverse skin regions that occurs in young women, in particular, and affects approximately 1% of the population. Outpatient care is often inadequate and usually cannot prevent progression. OBJECTIVES: To evaluate in the EsmAiL ('Evaluation eines strukturierten und leitlinienbasierten multmodalen Versorgungskonzepts für Menschen mit Akne inversa') trial whether an innovative care concept can decrease disease activity and burden, and improve patient satisfaction. METHODS: EsmAiL was conducted as a two-arm, multicentre, prospective, randomized controlled trial that included 553 adults with HS. Inclusion criteria were a minimum of three inflammatory lesions and at least a moderate impact of the disease on quality of life. The control group (CG) remained under standard care, while patients in the intervention group (IG) were treated according to a trial-specific, multimodal concept. The primary endpoint was the absolute change in International Hidradenitis Suppurativa Severity Score System (IHS4). RESULTS: In total, 274 patients were randomized to the IG and 279 to the CG. Altogether, 377 attended the final assessment after 12 months of intervention. Participants in the IG (n = 203) achieved a mean improvement in IHS4 of 9.3 points, while the average decrease in IHS4 in patients in the CG (n = 174) was 5.7 points (P = 0.003). Patients treated under the new care concept also reported a statistically significantly higher decrease in pain, Dermatology Life Quality Index and Hospital Anxiety and Depression Scale scores compared with those in the CG (P < 0.001). Patient satisfaction was also statistically significantly higher in the IG compared with the CG (P < 0.001). CONCLUSIONS: The establishment of standardized treatment algorithms in so-called 'acne inversa centres' in the ambulatory setting has a substantial, positive impact on the course of HS and significantly improves patient satisfaction.

Patient-related effects of primary nursing : Protocol of a pilot randomized controlled trial.

BACKGROUND: Since January 2022, a primary nursing system called process-responsible nursing (PP) has substituted the standard room care system in an intensive care unit (ICU) at our institution. The process of the development and implementation of PP is already being evaluated in a separate study as an actual analysis prior to implementation, as well as after 6 and 12 months. AIM: This pilot randomized controlled trial (RCT) aims to test the feasibility of an RCT. For this purpose, the duration of delirium, among other things, will be compared in the project ICU with the results of standard care in another ICU at the university hospital. As secondary aims, the incidence of delirium, anxiety, the satisfaction of relatives, and the effects of PP on nurses will be assessed. METHODS: It is planned to recruit about 400-500 patients over a period of one year. They will be allocated to PP or standard care. Delirium will be assessed using the Confusion Assessment Method for Intensive Care Units by specifically trained nurses three times a day. Anxiety in patients, the satisfaction of relatives, and the effects of PP on nurses will be evaluated using the numeric rating scale, a standardized questionnaire, and a focus group interview, respectively. EXPECTED RESULTS: The primary hypothesis is that compared to usual care PP reduces the duration of delirium by at least 8 h. Additional hypotheses are that PP reduces anxiety in patients and increases the satisfaction of relatives.

[The role of nurses in pharmaceutical care in Germany: A qualitative analysis]. / Die Rolle der Pflegenden in der pharmazeutischen Versorgung in Deutschland ­ Eine qualitative Analyse.

BACKGROUND: In 13 European countries, laws have been passed that allow nurses to prescribe medicines, but mostly within a limited framework and with a doctor involved. Germany is not among these countries. Only the prescription of medical aids has already been included into the development of extended nursing competencies. We investigated the views of the health care professions involved (doctors, pharmacists and nurses) regarding the role of nurses in pharmaceutical care. METHOD: We conducted 22 semi-structured interviews with 23 members of the three professional groups involved in the European research project DeMoPhaC. These data collected in Germany were analysed using qualitative content analysis. Five main categories were developed. RESULTS: Pharmaceutical care by nurses can be described within the following main categories: 1. Knowledge and competences, 2. Patient care, 3. Communication, 4. Multi-professional team and 5. System. The communication between the professional groups involved and with patients and caregivers is of particular importance. Interaction in the multi-professional team is just as crucial. Pharmaceutical care takes place within the health system which sets the framework and often boundaries as well. The current and ideally conceived roles of nurses are seen differently in the respondents' respective contexts. Between the professional groups there is both agreement and dissent on the topics addressed. However, the development of nursing roles requires collaborative and transparent processes in teams and organisations. Particularly in the hospital setting, the participants saw a great need for change in order to achieve cooperation at eye level. DISCUSSION: The results show that nurses play their role in the complex field of pharmaceutical care under very heterogeneous circumstances. The empowerment of nurses, which was called for by some participants, cannot be achieved from within the professional group alone. Cooperation from all the players involved is needed. The development of nursing roles in the medication process with simultaneous expansion of qualifications and competences can contribute to making the nursing role more attractive. Clear role models promote the transparency of processes for all involved. If all players know what they can expect of nurses, tasks can be redistributed in the multiprofessional team. CONCLUSION: The above-mentioned diversity of perspectives can be a resource for development and individual solutions. However, it can also be interpreted negatively as a sign of uncertainty and less standardised ways of working. In view of the data evaluated here, the prescription of medicines by non-medical professionals remains a distant goal for developments in the German health care system. First of all, structures and processes are required that permanently guarantee safe pharmaceutical care with equal participation of all relevant stakeholders.

Nurse students' competences in interprofessional pharmaceutical care in Europe: Cross-sectional evaluation.

BACKGROUND: Safe pharmaceutical care requires competent nurses with specific knowledge, skills and attitudes. It is unclear whether nursing students are adequately prepared to perform pharmaceutical care in practice. Mapping their pharmaceutical care competences can lead to a better understanding of the extent to which curricula fit expectations of the labour market. OBJECTIVES: To assess pharmaceutical care competences of final-year nursing students of different educational levels. DESIGN: A cross-sectional survey design. SETTINGS: In 14 European countries, nursing schools who offer curricula for level 4 to 7 students were approached. PARTICIPANTS: Through convenience sampling 1741 final-year student nurses of level 4 to 7 were included. Sampling strategies were country-specific. METHODS: A web-platform was developed with an assessment of the level in which students mastered pharmaceutical care competences. Knowledge questions, case studies (basic/advanced level), self-reported practical skills and attitudes were evaluated. RESULTS: Mean scores for knowledge questions differed significantly (p < 0.001) between level 5 (56/100), level 6 (68/100) and level 7 students (72/100). For basic cases level 5 students reached lower scores (64/100) compared with level 6 (71/100) and level 7 (72/100) students (p = 0.002 and p = 0.005). For more advanced cases no difference between levels was observed (overall mean 61/100). Most students (63-90 %) considered themselves skilled to perform pharmaceutical care and had positive attitudes towards their participation in pharmaceutical care (65-97 %). CONCLUSIONS: Relatively low knowledge scores were calculated for final-year student nurses. In some domains, lower levels of students might be insufficiently prepared to take up responsibilities in pharmaceutical care. Our assessment can be used as a tool for educators to evaluate how prepared nursing students are for pharmaceutical care. Its further implementation for students of different educational levels will allow benchmarking between the levels, both within and between countries.

Technology-based counselling in dementia (TeCoDem): study protocol of a mixed-methods systematic review with qualitative comparative analysis and meta-analysis.

INTRODUCTION: Information technology can enhance timely and individual support for people with dementia and informal carers. There is some evidence that people with dementia and informal carers would benefit from technology-based counselling. However, it remains unclear which features of those interventions relate to beneficial outcomes and which aspects are necessary for a successful implementation. Therefore, the primary objectives are: (1) to identify conditions of successful implementation of technology-based counselling interventions in dementia and (2) to investigate the effectiveness of those interventions. METHODS AND ANALYSIS: We will conduct a mixed-methods systematic review. The first primary objective requires evidence from various study designs addressing aspects on effective and non-effective implementation of technology-based counselling. This could be telephone-based, web-based or mobile-based interventions for people with dementia and informal carers. For the second primary objective, randomised controlled trials (RCTs) dealing with any outcomes will be included. Year of publication and language will not be restricted. We will search CINAHL, Cochrane Library, MEDLINE, PsycINFO and Web of Science up to April 2021. Additionally, we will perform web searching and citation tracking. To achieve the first primary objective, a Qualitative Comparative Analysis (QCA) will be conducted. The QCA enables us to identify necessary or sufficient components for a successful implementation. To reach the second primary objective, a meta-analysis will be performed with respect to potential clinical and statistical heterogeneity of RCTs. The revised Risk of Bias tool 2.0 will be used to check the risk of bias in RCTs. For all other study designs, the Mixed Method Appraisal Tool will be used. ETHICS AND DISSEMINATION: Ethics approval is not required for this review. We will disseminate our findings through scientific and non-scientific journal articles and conference presentations as well as formats directed to the public and decision-makers in healthcare. PROSPERO REGISTRATION NUMBER: CRD42021245473.

The NUPHAC-EU Framework for Nurses' Role in Interprofessional Pharmaceutical Care: Cross-Sectional Evaluation in Europe.

Clear role descriptions promote the quality of interprofessional collaboration. Currently, it is unclear to what extent healthcare professionals consider pharmaceutical care (PC) activities to be nurses' responsibility in order to obtain best care quality. This study aimed to create and evaluate a framework describing potential nursing tasks in PC and to investigate nurses' level of responsibility. A framework of PC tasks and contextual factors was developed based on literature review and previous DeMoPhaC project results. Tasks and context were cross-sectionally evaluated using an online survey in 14 European countries. A total of 923 nurses, 240 physicians and 199 pharmacists responded. The majority would consider nurses responsible for tasks within: medication self-management (86-97%), patient education (85-96%), medication safety (83-95%), monitoring adherence (82-97%), care coordination (82-95%), and drug monitoring (78-96%). The most prevalent level of responsibility was 'with shared responsibility'. Prescription management tasks were considered to be nurses' responsibility by 48-81% of the professionals. All contextual factors were indicated as being relevant for nurses' role in PC by at least 74% of the participants. No task nor contextual factor was removed from the framework after evaluation. This framework can be used to enable healthcare professionals to openly discuss allocation of specific (shared) responsibilities and tasks.

Developing a competence framework for nurses in pharmaceutical care: A Delphi study.

BACKGROUND: Nurses play an important role in pharmaceutical care. They are involved in: detecting clinical change; communicating/discussing pharmacotherapy with patients, their advocates, and other healthcare professionals; proposing and implementing medication-related interventions; and ensuring follow-up of patients and medication regimens. To date, a framework of nurses' competences on knowledge, skills, and attitudes as to interprofessional pharmaceutical care tasks is missing. OBJECTIVES: To reach agreement with experts about nurses' competences for tasks in interprofessional pharmaceutical care. METHODS: A two-phase study starting with a scoping review followed by five Delphi rounds was performed. Competences extracted from the literature were assessed by an expert panel on relevance by using the RAND/UCLA method. The experts (n = 22) involved were healthcare professionals, nurse researchers, and educators from 14 European countries with a specific interest in nurses' roles in interprofessional pharmaceutical care. Descriptive statistics supported the data analysis. RESULTS: The expert panel reached consensus on the relevance of 60 competences for 22 nursing tasks. Forty-one competences were related to 15 generic nursing tasks and 33 competences were related to seven specific nursing tasks. CONCLUSIONS: This study resulted in a competence framework for competency-based nurse education. Future research should focus on imbedding these competences in nurse education. A structured instrument should be developed to assess students' readiness to achieve competence in interprofessional pharmaceutical care in clinical practice.

[GRADE guidelines 20: Assessing the certainty of evidence in the importance of outcomes or values and preferences - inconsistency, imprecision, and other domains]. / GRADE Leitlinien: 20. Untersuchung der Vertrauenswürdigkeit in die Evidenz zur Beurteilung der Wichtigkeit von Endpunkten oder Werten und Präferenzen ­ Inkonsistenz, unzureichende Präzision und andere Domänen.

OBJECTIVE: To provide Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) guidance for assessing inconsistency, imprecision, and other domains for the certainty of evidence about the relative importance of outcomes. STUDY DESIGN AND SETTING: We applied the GRADE domains to rate the certainty of evidence in the importance of outcomes to several systematic reviews, iteratively reviewed draft guidance, and consulted GRADE members and other stakeholders for feedback. RESULTS: We describe the rationale for considering the remaining GRADE domains when rating the certainty in a body of evidence for the relative importance of outcomes. As meta-analyses are not common in this context, inconsistency and imprecision assessments are challenging. Furthermore, confusion exists about inconsistency, imprecision, and true variability in the relative importance of outcomes. To clarify this issue, we suggest that the true variability is neither equivalent to inconsistency nor imprecision. Specifically, inconsistency arises from population, intervention, comparison and outcome and methodological elements that should be explored and, if possible, explained. The width of the confidence interval and sample size inform judgments about imprecision. We also provide suggestions on how to detect publication bias and discuss the domains to rate up the certainty. CONCLUSION: We provide guidance and examples for rating inconsistency, imprecision, and other domains for a body of evidence describing the relative importance of outcomes.

[GRADE Guidelines: 19. Assessing the certainty of evidence in the importance of outcomes or values and preferences: Risk of bias and indirectness]. / GRADE-Leitlinien: 19. Bewertung der Vertrauenswürdigkeit der Evidenz für die Bedeutung von Endpunkten oder Werten und Präferenzen ­ Risiko für Bias und Indirektheit.

OBJECTIVES: The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group defines patient values and preferences as the relative importance patients place on the main health outcomes. We provide GRADE guidance for assessing the risk of bias and indirectness domains for certainty of evidence about the relative importance of outcomes. STUDY DESIGN AND SETTING: We applied the GRADE domains to rate the certainty of evidence in the importance of outcomes to several systematic reviews, iteratively reviewed draft guidance and consulted GRADE members and other stakeholders for feedback. RESULTS: This is the first of two articles. A body of evidence addressing the importance of outcomes starts at "high certainty"; concerns with risk of bias, indirectness, inconsistency, imprecision, and publication bias lead to downgrading to moderate, low, or very low certainty. We propose the following subdomains of risk of bias: selection of the study population, missing data, the type of measurement instrument, and confounding; we have developed items for each subdomain. The population, intervention, comparison, and outcome elements associated with the evidence determine the degree of indirectness. CONCLUSION: This article provides guidance and examples for rating the risk of bias and indirectness for a body of evidence summarizing the importance of outcomes.

Souvenaid for Alzheimer's disease.

BACKGROUND: Souvenaid is a dietary supplement with a patented composition (Fortasyn Connect™)which is intended to be used by people with Alzheimer's disease (AD). It has been designed to support the formation and function of synapses in the brain, which are thought to be strongly correlated with cognitive function. If effective, it might improve symptoms of Alzheimer's disease and also prevent the progression from prodromal Alzheimer's disease to dementia. We sought in this review to examine the evidence for this proposition. OBJECTIVES: To assess the effects of Souvenaid on incidence of dementia, cognition, functional performance, and safety in people with Alzheimer's disease. SEARCH METHODS: We searched ALOIS, i.e. the specialised register of the Cochrane Dementia and Cognitive Improvement Group, MEDLINE (Ovid SP), Embase (Ovid SP), PsycINFO (Ovid SP), Web of Science (ISI Web of Science), Cinahl (EBSCOhost), Lilacs (BIREME), and clinical trials registries up to 24 June 2020. We also reviewed citations of reference lists of landmark papers, reviews, and included studies for additional studies and assessed their suitability for inclusion in the review. SELECTION CRITERIA: We included randomised, placebo-controlled trials which evaluated Souvenaid in people diagnosed with mild cognitive impairment (MCI) due to AD (also termed prodromal AD) or with dementia due to AD, and with a treatment duration of at least 16 weeks. DATA COLLECTION AND ANALYSIS: Our primary outcome measures were incidence of dementia, global and specific cognitive function, functional performance, combined cognitive-functional outcomes and adverse events. We selected studies, extracted data, assessed the quality of trials and intended to conduct meta-analyses according to the Cochrane Handbook for Systematic Reviews of Interventions. We rated the quality of the evidence using the GRADE approach. We present all outcomes grouped by stage of AD. MAIN RESULTS: We included three randomised, placebo-controlled trials investigating Souvenaid in 1097 community-dwelling participants with Alzheimer's disease. One study each included participants with prodromal AD, mild AD dementia and mild-to-moderate AD dementia. We rated the risks of bias of all trials as low. One study (in prodromal AD) was funded by European grants. The other two studies were funded by the manufacturer of Souvenaid. One trial investigated the incidence of dementia in people with prodromal AD at baseline, and found little to no difference between the Souvenaid group and the placebo group after 24 months (RR 1.09, 95% CI 0.82 to 1.43; 1 trial, 311 participants; moderate quality of evidence). In prodromal AD, and in mild and mild-to-moderate Alzheimer's disease dementia, Souvenaid probably results in little or no difference in global or specific cognitive functions (moderate quality of evidence). Everyday function, or the ability to perform activities of daily living, were measured in mild and mild-to-moderate AD dementia. Neither study found evidence of a difference between the groups after 24 weeks of treatment (moderate quality of evidence). Two studies investigated combined cognitive-functional outcomes with the Clinical Dementia Rating Sum of Boxes and observed conflicting results. Souvenaid probably results in slight improvement, which is below estimates of meaningful change, in participants with prodromal Alzheimer's disease after 24 months (moderate quality of evidence), but probably has little to no effect in mild-to-moderate Alzheimer's disease dementia after 24 weeks (moderate quality of evidence). Adverse effects observed were low in all trials, and the available data were insufficient to determine any connection with Souvenaid. AUTHORS' CONCLUSIONS: Two years of treatment with Souvenaid probably does not reduce the risk of progression to dementia in people with prodromal AD. There is no convincing evidence that Souvenaid affects other outcomes important to people with AD in the prodromal stage or mild-to-moderate stages of dementia. Conflicting evidence on combined cognitive-functional outcomes in prodromal AD and mild AD dementia warrants further investigation. Adverse effects of Souvenaid seem to be uncommon, but the evidence synthesised in this review does not permit us to make a definitive statement on the long-term tolerability of Souvenaid. The effects of Souvenaid in more severe AD dementia or in people with AD at risk of nutritional deficiencies remain unclear.

GRADE-Leitlinien zu Gerechtigkeit 4. Berücksichtigung der Gerechtigkeit im Gesundheitswesen bei der Entwicklung von GRADE-Leitlinien: von der Evidenz zur Empfehlung.

OBJECTIVES: The aim of this paper is to provide detailed guidance on how to incorporate health equity within the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) evidence to decision process. STUDY DESIGN AND SETTING: We developed this guidance based on the GRADE evidence to decision frame-work, iteratively reviewing and modifying draft documents, in person discussion of project group members and input from other GRADE members. This is a German translation of the original paper published in English. RESULTS: Considering the impact on health equity may be required, both in general guidelines and guide-lines that focus on disadvantaged populations. We suggest two approaches to incorporate equity considerations: (1) assessing the potential impact of interventions on equity and (2) incorporating equity considerations when judging or weighing each of the evidence to decision criteria. We provide guidance and include illustrative examples. CONCLUSION: Guideline panels should consider the impact of recommendations on health equity with attention to remote and underserviced settings and disadvantaged populations. Guideline panels may wish to incorporate equity judgments across the evidence to decision framework. This is the fourth and final paper in a series about considering equity in the GRADE guideline development process. This series is coming from the GRADE equity subgroup.