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.

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.

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.

[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.

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.

Environmental and behavioural modifications for improving food and fluid intake in people with dementia.

BACKGROUND: Weight loss, malnutrition and dehydration are common problems for people with dementia. Environmental modifications such as, change of routine, context or ambience at mealtimes, or behavioural modifications, such as education or training of people with dementia or caregivers, may be considered to try to improve food and fluid intake and nutritional status of people with dementia. OBJECTIVES: Primary: To assess the effects of environmental or behavioural modifications on food and fluid intake and nutritional status in people with dementia. Secondary: To assess the effects of environmental or behavioural modifications in connection with nutrition on mealtime behaviour, cognitive and functional outcomes and quality of life, in specific settings (i.e. home care, residential care and nursing home care) for different stages of dementia. To assess the adverse consequences or effects of the included interventions. SEARCH METHODS: We searched the Specialized Register of Cochrane Dementia and Cognitive Improvement (ALOIS), MEDLINE, Eembase, PsycINFO, CINAHL, ClinicalTrials.gov and the World Health Organization (WHO) portal/ICTRP on 17 January 2018. We scanned reference lists of other reviews and of included articles. SELECTION CRITERIA: We included randomised controlled trials (RCTs) investigating interventions designed to modify the mealtime environment of people with dementia, to modify the mealtime behaviour of people with dementia or their caregivers, or both, with the intention of improving food and fluid intake. We included people with any common dementia subtype. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, extracted data and assessed the risk of bias of included trials. We assessed the quality of evidence for each outcome using the GRADE approach. MAIN RESULTS: We included nine studies, investigating 1502 people. Three studies explicitly investigated participants with Alzheimer's disease; six did not specify the type of dementia. Five studies provided clear measures to identify the severity of dementia at baseline, and overall very mild to severe stages were covered. The interventions and outcome measures were diverse. The overall quality of evidence was mainly low to very low.One study implemented environmental as well as behavioural modifications by providing additional food items between meals and personal encouragement to consume them. The control group received no intervention. Differences between groups were very small and the quality of the evidence from this study was very low, so we are very uncertain of any effect of this intervention.The remaining eight studies implemented behavioural modifications.Three studies provided nutritional education and nutrition promotion programmes. Control groups did not receive these programmes. After 12 months, the intervention group showed slightly higher protein intake per day (mean difference (MD) 0.11 g/kg, 95% confidence interval (CI) -0.01 to 0.23; n = 78, 1 study; low-quality evidence), but there was no clear evidence of a difference in nutritional status assessed with body mass index (BMI) (MD -0.26 kg/m² favouring control, 95% CI -0.70 to 0.19; n = 734, 2 studies; moderate-quality evidence), body weight (MD -1.60 kg favouring control, 95% CI -3.47 to 0.27; n = 656, 1 study; moderate-quality evidence), or score on Mini Nutritional Assessment (MNA) (MD -0.10 favouring control, 95% CI -0.67 to 0.47; n = 656, 1 study; low-quality evidence). After six months, the intervention group in one study had slightly lower BMI (MD -1.79 kg/m² favouring control, 95% CI -1.28 to -2.30; n = 52, 1 study; moderate-quality evidence) and body weight (MD -8.11 kg favouring control, 95% CI -2.06 to -12.56; n = 52, 1 study; moderate-quality evidence). This type of intervention may have a small positive effect on food intake, but little or no effect, or a negative effect, on nutritional status.Two studies compared self-feeding skills training programmes. In one study, the control group received no training and in the other study the control group received a different self-feeding skills training programme. For both comparisons the quality of the evidence was very low and we are very uncertain whether these interventions have any effect.One study investigated general training of nurses to impart knowledge on how to feed people with dementia and improve attitudes towards people with dementia. Again, the quality of the evidence was very low so that we cannot be certain of any effect.Two studies investigated vocal or tactile positive feedback provided by caregivers while feeding participants. After three weeks, the intervention group showed an increase in calories consumed per meal (MD 200 kcal, 95% CI 119.81 to 280.19; n = 42, 1 study; low-quality evidence) and protein consumed per meal (MD 15g, 95% CI 7.74 to 22.26; n = 42, 1 study; low-quality evidence). This intervention may increase the intake of food and liquids slightly; nutritional status was not assessed. AUTHORS' CONCLUSIONS: Due to the quantity and quality of the evidence currently available, we cannot identify any specific environmental or behavioural modifications for improving food and fluid intake in people with dementia.

Omega-3 fatty acids for the treatment of dementia.

BACKGROUND: Omega-3 polyunsaturated fatty acids (omega-3 PUFAs) from fish and plant sources are commonly considered as a promising non-medical alternative to improve brain functions and slow down the progression of dementia. This assumption is mostly based on findings of preclinical studies and epidemiological research. Resulting explanatory models aim at the role omega-3 PUFAs play in the development and integrity of the brain's neurons, their protective antioxidative effect on cell membranes and potential neurochemical mechanisms directly related to Alzheimer-specific pathology. Epidemiological research also found evidence of malnutrition in people with dementia. Considering this and the fact that omega-3 PUFA cannot be synthesised by humans, omega-3 PUFAs might be a promising treatment option for dementia. OBJECTIVES: To assess the efficacy and safety of omega-3 polyunsaturated fatty acid (PUFA) supplementation for the treatment of people with dementia. SEARCH METHODS: We searched the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group (ALOIS), MEDLINE, EMBASE, PsycINFO, CINAHL, ClinicalTrials.gov and the World Health Organization (WHO) portal/ICTRP on 10 December 2015. We contacted manufacturers of omega-3 supplements and scanned reference lists of landmark papers and included articles. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in which omega-3 PUFA in the form of supplements or enriched diets were administered to people with Alzheimer's disease (AD), vascular dementia (VaD), dementia with Lewy bodies (DLB), Parkinson's disease dementia (PDD) or frontotemporal dementia (FTD). DATA COLLECTION AND ANALYSIS: The primary outcome measures of interest were changes in global and specific cognitive functions, functional performance, dementia severity and adverse effects. Two review authors independently selected studies, extracted data and assessed the quality of trials according to the Cochrane Handbook for Systematic Reviews of Interventions. We rated the quality of the evidence using the GRADE approach. We received unpublished data from the trial authors and collected adverse effects information from the published articles. We conducted meta-analyses for available outcome measures at six months. MAIN RESULTS: We included three comparable randomised, placebo-controlled trials investigating omega-3 PUFA supplements in 632 participants with mild to moderate AD over six, 12 and 18 months. We found no studies investigating other types of dementia. All trials were of high methodological quality. The overall quality of evidence for most of the outcomes was high.There was no evidence of a benefit from omega-3 PUFAs on cognitive function when measured at six months with the Alzheimer's Disease Assessment Scale - Cognitive subscale (standardised mean difference (SMD) -0.02, 95% confidence interval (CI) -0.19 to 0.15; 566 participants; 3 studies; high quality evidence) or Mini-Mental State Examination (mean difference (MD) 0.18, 95% CI -1.05 to 1.41; 202 participants; 2 studies; high quality evidence) or on activities of daily living (SMD -0.02, 95% CI -0.19 to 0.16; 544 participants; 2 studies; high quality evidence). There was also no effect at six months of treatment on severity of dementia measured with the Clinical Dementia Rating - Sum of Boxes (MD -0.00, 95% CI -0.58 to 0.57; 542 participants; 2 studies; high quality evidence) or on quality of life measured with the Quality of Life Alzheimer's Disease scale (MD -0.10, 95% CI -1.28 to 1.08; 322 participants; 1 study; high quality evidence). There was no difference at six months on mental health measured with the Montgomery-Åsberg Depression Rating Scale (MD -0.10, 95% CI -0.74 to 0.54; 178 participants: 1 study; high quality of evidence) or the Neuropsychiatric Inventory (SMD 0.10, 95% CI -0.07 to 0.27; 543 participants; 2 studies; high quality of evidence). One very small study showed a benefit for omega-3 PUFAs in instrumental activities of daily living after 12 months of treatment (MD -3.50, 95% CI -4.30 to -2.70; 22 participants; moderate quality evidence). The included studies did not measure specific cognitive function. The studies did not report adverse events well. Two studies stated that all adverse events were mild and that they did not differ in overall frequency between omega-3 PUFA and placebo groups. Data from one study showed no difference between groups in frequency of any adverse event (risk ratio (RR) 1.02, 95% CI 0.95 to 1.10; 402 participants; 1 study; moderate quality evidence) or any serious adverse event (RR 1.05, 95% CI 0.78 to 1.41; 402 participants; 1 study; high quality evidence) at 18 months of treatment. AUTHORS' CONCLUSIONS: We found no convincing evidence for the efficacy of omega-3 PUFA supplements in the treatment of mild to moderate AD. This result was consistent for all outcomes relevant for people with dementia. Adverse effects of omega-3 PUFAs seemed to be low, but based on the evidence synthesised in this review, we cannot make a final statement on tolerability. The effects on other populations remain unclear.

Nutritional interventions for preventing and treating pressure ulcers.

BACKGROUND: Pressure ulcers affect approximately 10% of people in hospitals and older people are at highest risk. A correlation between inadequate nutritional intake and the development of pressure ulcers has been suggested by several studies, but the results have been inconsistent. OBJECTIVES: To evaluate the effects of enteral and parenteral nutrition on the prevention and treatment of pressure ulcers. SEARCH METHODS: In March 2014, for this first update, we searched The Cochrane Wounds Group Specialised Trials Register, the Cochrane Central register of Controlled Trials (The Cochrane Library), the Database of Abstracts of Reviews of Effects (DARE) (The Cochrane Library), the Health Technology Assessment Database (HTA) (The Cochrane Library), the Cochrane Methodology Register (The Cochrane Library), NHS Economic Evaluation Database (The Cochrane Library), Ovid Medline, Ovid Embase and EBSCO CINAHL. No date, language or publication status limits were applied. SELECTION CRITERIA: Randomised controlled trials (RCTs) evaluating the effects of enteral or parenteral nutrition on the prevention and treatment of pressure ulcers, which measured the incidence of new ulcers, ulcer healing or changes in pressure ulcer severity. There were no restrictions on types of patient, setting, date, publication status or language. DATA COLLECTION AND ANALYSIS: Two review authors independently screened for inclusion, and disagreement was resolved by discussion. Two review authors independently extracted data and assessed quality using the Cochrane Collaboration tool for assessing risk of bias. MAIN RESULTS: We included 23 RCTs, many were small (between 9 and 4023 participants, median 88) and at high risk of bias.Eleven trials compared a combination of nutritional supplements, consisting of a minimum of energy and protein in different dosages, for the prevention of pressure ulcers. A meta-analysis of eight trials (6062 participants) that compared the effects of mixed nutritional supplements with standard hospital diet found no clear evidence of an effect of supplementation on pressure ulcer development (pooled RR 0.86; 95% CI 0.73 to 1.00; P value 0.05; I(2) = 13%, random effects). This outcome is at unclear or high risk of bias.Fourteen trials evaluated the effects of nutritional supplements on the healing of existing pressure ulcers: seven trials examined mixed nutritional supplements, three the effects of proteins, two trials examined zinc, and two studies examined ascorbic acid. The included trials were heterogeneous with regard to participants, interventions, comparisons and outcomes and meta-analysis was not appropriate. There was no clear evidence of an improvement in pressure ulcer healing from the nutritional supplements evaluated in any of these individual studies. AUTHORS' CONCLUSIONS: There is currently no clear evidence of a benefit associated with nutritional interventions for either the prevention or treatment of pressure ulcers. Further trials of high methodological quality are necessary.

Efficacy and experiences of telephone counselling for informal carers of people with dementia.

BACKGROUND: Informal carers of people with dementia can suffer from depressive symptoms, emotional distress and other physiological, social and financial consequences. OBJECTIVES: This review focuses on three main objectives:To:1) produce a quantitative review of the efficacy of telephone counselling for informal carers of people with dementia;2) synthesize qualitative studies to explore carers' experiences of receiving telephone counselling and counsellors' experiences of conducting telephone counselling; and3) integrate 1) and 2) to identify aspects of the intervention that are valued and work well, and those interventional components that should be improved or redesigned. SEARCH METHODS: The Cochrane Dementia and Cognitive Improvement Group's Specialized Register, The Cochrane Library, MEDLINE, MEDLINE in Process, EMBASE, CINAHL, PSYNDEX, PsycINFO, Web of Science, DIMDI databases, Springer database, Science direct and trial registers were searched on 3 May 2011 and updated on 25 February 2013. A Forward Citation search was conducted for included studies in Web of Science and Google Scholar. We used the Related Articles service of PubMed for included studies, contacted experts and hand-searched abstracts of five congresses. SELECTION CRITERIA: Randomised controlled trials (RCTs) or cross-over trials that compared telephone counselling for informal carers of people with dementia against no treatment, usual care or friendly calls for chatting were included evaluation of efficacy. Qualitative studies with qualitative methods of data collection and analysis were also included to address experiences with telephone counselling. DATA COLLECTION AND ANALYSIS: Two authors independently screened articles for inclusion criteria, extracted data and assessed the quantitative trials with the Cochrane 'Risk of bias' tool and the qualitative studies with the Critical Appraisal Skills Program (CASP) tool. The authors conducted meta-analyses, but reported some results in narrative form due to clinical heterogeneity. The authors synthesised the qualitative data and integrated quantitative RCT data with the qualitative data. MAIN RESULTS: Nine RCTs and two qualitative studies were included. Six studies investigated telephone counselling without additional intervention, one study combined telephone counselling with video sessions, and two studies combined it with video sessions and a workbook. All quantitative studies had a high risk of bias in terms of blinding of participants and outcome assessment. Most studies provided no information about random sequence generation and allocation concealment. The quality of the qualitative studies ('thin descriptions') was assessed as moderate. Meta-analyses indicated a reduction of depressive symptoms for telephone counselling without additional intervention (three trials, 163 participants: standardised mean different (SMD) 0.32, 95% confidence interval (CI) 0.01 to 0.63, P value 0.04; moderate quality evidence). The estimated effects on other outcomes (burden, distress, anxiety, quality of life, self-efficacy, satisfaction and social support) were uncertain and differences could not be excluded (burden: four trials, 165 participants: SMD 0.45, 95% CI -0.01 to 0.90, P value 0.05; moderate quality evidence; support: two trials, 67 participants: SMD 0.25, 95% CI -0.24 to 0.73, P value 0.32; low quality evidence). None of the quantitative studies included reported adverse effects or harm due to telephone counselling. Three analytical themes (barriers and facilitators for successful implementation of telephone counselling, counsellor's emotional attitude and content of telephone counselling) and 16 descriptive themes that present the carers' needs for telephone counselling were identified in the thematic synthesis. Integration of quantitative and qualitative data shows potential for improvement. For example, no RCT reported that the counsellor provided 24-hour availability or that there was debriefing of the counsellor. Also, the qualitative studies covered a limited range of ways of performing telephone counselling. AUTHORS' CONCLUSIONS: There is evidence that telephone counselling can reduce depressive symptoms for carers of people with dementia and that telephone counselling meets important needs of the carer. This result needs to be confirmed in future studies that evaluate efficacy through robust RCTs and the experience aspect through qualitative studies with rich data.

[Conflict of interest with industry--a survey of nurses in the field of wound care in Germany, Australia and Switzerland]. / Interessenkonflikte mit der Industrie--eine Befragung von Pflegenden im Bereich der Wundversorgung in Deutschland, Österreich und der Schweiz.

BACKGROUND: Nurses in the field of wound care are increasingly being courted by the wound industry. OBJECTIVES: A survey regarding nurses' perceptions and participation in pharmaceutical marketing was conducted. METHODS: Based on existing instruments, a standardized questionnaire (39 items, 5-point Likert scale) was developed. It was sent electronically and by mail to all nursing members of the Austrian Society for Vascular Care (ÖGvP), the German Wound Healing Society (DGfW e. V.) and the Swiss Association for Wound Care (SAfW). RESULTS: 178 nurses participated in the survey (75 % women; aged 27 - 70 years [median 45], 0 - 40 years [median 9] practice in the area of the wound care). Only about one fourth of the respondents (23,0 %) did not participate in pharmaceutical marketing last year. Generally small gifts were more frequently received than expensive gifts. Most of the nurses valued inexpensive gifts, educational gifts and gifts with patient benefit as appropriate. The majority of respondents consider themselves as less influenceable in decision making, compared to physicians. CONCLUSIONS: The behavior and attitude of nurses are ambivalent. The occurrence of conflict of interest is partly justified by perceived patient benefit. Lack of knowledge about the topic and social desirability could be the cause of an uncritical attitude. For a more critical approach education and ethical standards are necessary.

[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.

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.

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.

[From bedside to evidence - and back to bedside. 5 years evidence-based guidelines in South Tyrol: methods and experiences]. / Vom Bett zur Evidenz - und wieder zurück. 5 Jahre evidenzbasierte Leitlinien in Südtirol: Vorgehen und Erfahrungen.

In South Tyrol we developed guidelines with two different methodological approaches: one relates to the autonomous development of a nursing guideline for oral care using GRADE, and the other relates to the adaptation process of the NICE guideline on the prevention of venous thromboembolism. Both methods do have advantages and disadvantages: by autonomously developing guidelines the guideline panel identifies more with the product but time and effort is much higher than adapting and amending existing (high quality) guidelines. On the other hand there are only few high quality nursing guidelines. Additionally, the experiences in South Tyrol show that nursing guidelines seem to be not really suitable for a 1:1 application into practice because nearly half of the nurses have not changed their practice - although they knew the content of the guideline. Therefore, in order to promote the implementation process multimodal strategies on different organisational levels were adopted. Amongst these was the involvement of management through the negotiations of objectives, training and active participation of staff in the development of user-friendly application tools.

[Timing of dressing removal in the healing of surgical wounds by primary intention: a meta-analysis]. / Zeitpunkt der entfernung des wundverbands bei primär heilenden chirurgischen wunden: eine meta-analyse.

An appropriate postoperative wound management helps to prevent surgical site infections. However, ideal timing of dressing removal is an unresolved issue in current practice. The objective of this systematic review therefore was to provide a comprehensive synthesis of existing evidence concerning the efficacy of different periods of postoperative dressing removal in surgical wounds which are healing by primary intention. We searched MEDLINE, EMBASE, CINAHL, The Cochrane Library (all in August 2011), and hand-searched additional sources. All randomised controlled trials that were comparing different periods of leaving dressings in place, including not dressing the surgical site at all, and covering wounds until suture removal were included. We conducted our systematic review and meta-analysis in accordance with the recommendations of the Cochrane Collaboration. Eight trials with a total of 2097 participants were included in our meta-analysis. All studies were at high or unclear risk of bias. This meta-analysis did not show a higher rate of wound infections or other wound complications associated with an early dressing removal in wounds that are healing by primary intention: risk difference (RD) -0.01; 95%-confidence interval (CI) -0.03, 0.01. However, conclusions are limited due to bad study quality of included studies. Finally more sound research is needed.

[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.

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.

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.

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.

Types of indwelling urinary catheters for long-term bladder drainage in adults.

BACKGROUND: Prolonged urinary catheterization is common amongst people in long-term care settings and this carries a high risk of developing a catheter-related urinary tract infection and associated complications. A variety of different kinds of urethral catheters are available. Some have been developed specifically to lower the risk of catheter-associated infection, for example antiseptic or antibiotic impregnated catheters. Ease of use, comfort and handling for the caregivers and patients, and cost-effectiveness are also important factors influencing choice. OBJECTIVES: The primary objective was to determine which type of indwelling urinary catheter is best to use for long-term bladder drainage in adults. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register (last searched 31 March 2011), which includes searches of CENTRAL, MEDLINE and handsearching of journals and conference proceedings, and the reference lists of relevant articles. SELECTION CRITERIA: All randomised trials comparing types of indwelling urinary catheters for long-term catheterization in adults. Long-term catheterization was defined as more than 30 days. DATA COLLECTION AND ANALYSIS: Data extraction has been undertaken by two review authors working independently and simultaneously. Any disagreement has been resolved by a third review author. The included trial data were handled according to the methods of the Cochrane Handbook for Systematic Reviews of Interventions. MAIN RESULTS: Three trials were included, involving 102 adults in various settings. Two trials had a parallel group design and one was a randomised cross-over trial.Only two of the six targeted comparisons were assessed by these trials: antiseptic impregnated catheters versus standard catheters (one trial) and one type of standard catheter versus another standard catheter (two trials).The single small cross-over trial was inadequate to assess the value of silver alloy (antiseptic) impregnated catheters. In the two trials comparing different types of standard catheters, estimates of differences were all imprecise because the trials also had small sample sizes; confidence intervals (CI) were too wide to rule out clinically important differences. One trial did suggest, however, that the use of a hydrogel coated latex catheter rather than a silicone catheter may be better tolerated (risk ratio (RR) for need for early removal 0.41, 95% CI 0.22 to 0.77). AUTHORS' CONCLUSIONS: The updated search could not reveal any additional evidence. Very few trials have compared different types of catheter for long-term bladder drainage. All trials were small and showed methodological weaknesses. Therefore, the evidence was not sufficient as a reliable basis for practical conclusions. Further, better quality trials are needed to address the current lack of evidence in this clinically important area.