Use of pragmatic randomized trials in multiple sclerosis: A systematic overview.

BACKGROUND: Pragmatic trials are increasingly recognized for providing real-world evidence on treatment choices. OBJECTIVE: The objective of this study is to investigate the use and characteristics of pragmatic trials in multiple sclerosis (MS). METHODS: Systematic literature search and analysis of pragmatic trials on any intervention published up to 2022. The assessment of pragmatism with PRECIS-2 (PRagmatic Explanatory Continuum Indicator Summary-2) is performed. RESULTS: We identified 48 pragmatic trials published 1967-2022 that included a median of 82 participants (interquartile range (IQR) = 42-160) to assess typically supportive care interventions (n = 41; 85%). Only seven trials assessed drugs (15%). Only three trials (6%) included >500 participants. Trials were mostly from the United Kingdom (n = 18; 38%), Italy (n = 6; 13%), the United States and Denmark (each n = 5; 10%). Primary outcomes were diverse, for example, quality-of-life, physical functioning, or disease activity. Only 1 trial (2%) used routinely collected data for outcome ascertainment. No trial was very pragmatic in all design aspects, but 14 trials (29%) were widely pragmatic (i.e. PRECIS-2 score ⩾ 4/5 in all domains). CONCLUSION: Only few and mostly small pragmatic trials exist in MS which rarely assess drugs. Despite the widely available routine data infrastructures, very few trials utilize them. There is an urgent need to leverage the potential of this pioneering study design to provide useful randomized real-world evidence.

The spinal cord injury-induced immune deficiency syndrome: results of the SCIentinel study.

Infections are prevalent after spinal cord injury (SCI), constitute the main cause of death and are a rehabilitation confounder associated with impaired recovery. We hypothesize that SCI causes an acquired lesion-dependent (neurogenic) immune suppression as an underlying mechanism to facilitate infections. The international prospective multicentre cohort study (SCIentinel; protocol registration DRKS00000122; n = 111 patients) was designed to distinguish neurogenic from general trauma-related effects on the immune system. Therefore, SCI patient groups differing by neurological level, i.e. high SCI [thoracic (Th)4 or higher]; low SCI (Th5 or lower) and severity (complete SCI; incomplete SCI), were compared with a reference group of vertebral fracture (VF) patients without SCI. The primary outcome was quantitative monocytic Human Leukocyte Antigen-DR expression (mHLA-DR, synonym MHC II), a validated marker for immune suppression in critically ill patients associated with infection susceptibility. mHLA-DR was assessed from Day 1 to 10 weeks after injury by applying standardized flow cytometry procedures. Secondary outcomes were leucocyte subpopulation counts, serum immunoglobulin levels and clinically defined infections. Linear mixed models with multiple imputation were applied to evaluate group differences of logarithmic-transformed parameters. Mean quantitative mHLA-DR [ln (antibodies/cell)] levels at the primary end point 84 h after injury indicated an immune suppressive state below the normative values of 9.62 in all groups, which further differed in its dimension by neurological level: high SCI [8.95 (98.3% confidence interval, CI: 8.63; 9.26), n = 41], low SCI [9.05 (98.3% CI: 8.73; 9.36), n = 29], and VF without SCI [9.25 (98.3% CI: 8.97; 9.53), n = 41, P = 0.003]. Post hoc analysis accounting for SCI severity revealed the strongest mHLA-DR decrease [8.79 (95% CI: 8.50; 9.08)] in the complete, high SCI group, further demonstrating delayed mHLA-DR recovery [9.08 (95% CI: 8.82; 9.38)] and showing a difference from the VF controls of -0.43 (95% CI: -0.66; -0.20) at 14 days. Complete, high SCI patients also revealed constantly lower serum immunoglobulin G [-0.27 (95% CI: -0.45; -0.10)] and immunoglobulin A [-0.25 (95% CI: -0.49; -0.01)] levels [ln (g/l × 1000)] up to 10 weeks after injury. Low mHLA-DR levels in the range of borderline immunoparalysis (below 9.21) were positively associated with the occurrence and earlier onset of infections, which is consistent with results from studies on stroke or major surgery. Spinal cord injured patients can acquire a secondary, neurogenic immune deficiency syndrome characterized by reduced mHLA-DR expression and relative hypogammaglobulinaemia (combined cellular and humoral immune deficiency). mHLA-DR expression provides a basis to stratify infection-risk in patients with SCI.

Comparing different scoping and mapping review methodologies: A practical example using the nursing mobile workstation.

AIMS: To provide (1) an overview of core characteristics of scoping and mapping review methodologies and (2) to illustrate the differences and similarities of these methodologies using literature on nursing mobile workstations. DESIGN: Systematic review. METHODS: Systematic searches were conducted to identify (1) scoping and mapping review methodologies used in the field of nursing and (2) literature on nursing mobile workstations. For each systematic search, two reviewers independently screened all titles, abstracts, and full texts. We conducted narrative syntheses for both review questions. Publications on scoping and mapping review methodologies in the field of nursing were searched in MEDLINE (PubMed), Web of Science, Scopus, and CINAHL (September 2022). Publications on nursing mobile workstations were searched in MEDLINE (PubMed), CINAHL, and Web of Science (April 2022). RESULTS: We identified six scoping and mapping review methodologies (aim 1): bibliometric analysis, evidence mapping, focused mapping review and synthesis, and scoping review. The methodologies aim to provide a graphical, tabular, or narrative overview without a formal critical assessment of the literature. We provide an overview of key variables that reflect the different focus of these methodologies. We also included 26 publications on nursing mobile workstations (aim 2). Nineteen different terms were used to describe the workstations. An overall definition of the nursing mobile workstation was not found. CONCLUSION: Scoping and mapping methodologies are regularly applied in nursing research. Although there is overlap between the different methodologies, we found some unique characteristics. Despite the regular use of nursing mobile workstations, little is known about their impact in care processes and important features. Future studies on nursing mobile workstations could explore the impact of the workstations in the care process and the current functions of the workstations. A universal definition of the workstations is warranted. CLINICAL RELEVANCE: Most publications address aspects of practicability of nursing mobile workstations, but we found no universal definition. Little knowledge is available on the impact of the workstations in clinical practice.

The evidence base of US Food and Drug Administration approvals of novel cancer therapies from 2000 to 2020.

Concerns have been raised that regulatory programs to accelerate approval of cancer drugs in cancer may increase uncertainty about benefits and harms for survival and quality of life (QoL). We analyzed all pivotal clinical trials and all non-pivotal randomized controlled trials (RCTs) for all cancer drugs approved for the first time by the FDA between 2000 and 2020. We report regulatory and trial characteristics. Effects on overall survival (OS), progression-free survival and tumor response were summarized in meta-analyses. Effects on QoL were qualitatively summarized. Between 2000 and 2020, the FDA approved 145 novel cancer drugs for 156 indications based on 190 clinical trials. Half of indications (49%) were approved without RCT evidence; 82% had a single clinical trial only. OS was primary endpoint in 14% of trials and QoL data were available from 25%. The median OS benefit was 2.55 months (IQR, 1.33-4.28) with a mean hazard ratio for OS of 0.75 (95%CI, 0.72-0.79, I2  = 42). Improvement for QoL was reported for 7 (4%) of 156 indications. Over time, priority review was used increasingly and the mean number of trials per indication decreased from 1.45 to 1.12. More trials reported results on QoL (19% in 2000-2005; 41% in 2016-2020). For 21 years, novel cancer drugs have typically been approved based on one single, often uncontrolled, clinical trial, measuring surrogate endpoints. This leaves cancer patients without solid evidence that novel drugs improve their survival or QoL and there is no indication towards improvement.

Challenges and care strategies associated with the admission to nursing homes in Germany: a scoping review.

BACKGROUND: The admission to a nursing home is a critical life-event for affected persons as well as their families. Admission related processes are lacking adequate participation of older people and their families. To improve transitions to nursing homes, context- and country-specific knowledge about the current practice is needed. Hence, our aim was to summarize available evidence on challenges and care strategies associated with the admission to nursing homes in Germany. METHODS: We conducted a scoping review and searched eight major international and German-specific electronic databases for journal articles and grey literature published in German or English language since 1995. Further inclusion criteria were focus on challenges or care strategies in the context of nursing home admissions of older persons and comprehensive and replicable information on methods and results. Posters, only-abstract publications and articles dealing with mixed populations including younger adults were excluded. Challenges and care strategies were identified and analysed by structured content analysis using the TRANSCIT model. RESULTS: Twelve studies of 1,384 records were finally included. Among those, seven were qualitative studies, three quantitative observational studies and two mixed methods studies. As major challenges neglected participation of older people, psychosocial burden among family caregivers, inadequate professional cooperation and a lack of shared decision-making and evidence-based practice were identified. Identified care strategies included strengthening shared decision-making and evidence-based practice, improvement in professional cooperation, introduction of specialized transitional care staff and enabling participation for older people. CONCLUSION: Although the process of nursing home admission is considered challenging and tends to neglect the needs of older people, little research is available for the German health care system. The perspective of the older people seems to be underrepresented, as most of the studies focused on caregivers and health professionals. Reported care strategies addressed important challenges, however, these were not developed and evaluated in a comprehensive and systematic way. Future research is needed to examine perspectives of all the involved groups to gain a comprehensive picture of the needs and challenges. Interventions based on existing care strategies should be systematically developed and evaluated to provide the basis of adequate support for older persons and their informal caregivers.

Interventions for preventing and reducing the use of physical restraints of older people in general hospital settings.

BACKGROUND: Physical restraints, such as bedrails, belts in chairs or beds, and fixed tables, are commonly used for older people in general hospital settings. Reasons given for using physical restraints are to prevent falls and fall-related injuries, to control challenging behavior (such as agitation or wandering), and to ensure the delivery of medical treatments. Clear evidence of their effectiveness is lacking, and potential harms are recognised, including injuries associated with the use of physical restraints and a negative impact on people's well-being. There are widespread recommendations that their use should be reduced or eliminated. OBJECTIVES: To assess the best evidence for the effects and safety of interventions aimed at preventing and reducing the use of physical restraint of older people in general hospital settings. To describe the content, components and processes of these interventions. SEARCH METHODS: We searched the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE (Ovid SP), Embase (Ovid SP), PsycINFO (Ovid SP), CINAHL (EBSCOhost), Web of Science Core Collection (Clarivate), LILACS (BIREME), ClinicalTrials.gov and the World Health Organization's meta-register the International Clinical Trials Registry Portal on 20 April 2022. SELECTION CRITERIA: We included randomised controlled trials and controlled clinical trials that investigated the effects of interventions that aimed to prevent or reduce the use of physical restraints in general hospital settings. Eligible settings were acute care and rehabilitation wards. We excluded emergency departments, intensive care and psychiatric units, as well as the use of restrictive measures for penal reasons (e.g. prisoners in general medical wards). We included studies with a mean age of study participants of at least 65 years. Control groups received usual care or active control interventions that were ineligible for inclusion as experimental interventions. DATA COLLECTION AND ANALYSIS: Two review authors independently selected the articles for inclusion, extracted data, and assessed the risk of bias of all included studies. Data were unsuitable for meta-analysis, and we reported results narratively. We used GRADE methods to describe our certainty in the results. MAIN RESULTS: We included four studies: two randomised controlled trials (one individually-randomised, parallel-group trial and one clustered, stepped-wedge trial) and two controlled clinical trials (both with a clustered design). One study was conducted in general medical wards in Canada and three studies were conducted in rehabilitation hospitals in Hong Kong. A total of 1709 participants were included in three studies; in the fourth study the number of participants was not reported. The mean age ranged from 67 years to 84 years. The duration of follow-up covered the period of patients' hospitalisation in one study (21 days average length of stay) and ranged from 4 to 11 months in the other studies. The definition of physical restraints differed slightly, and one study did not include bedrails. Three studies investigated organisational interventions aimed at implementing a least-restraint policy to reduce physical restraints. The theoretical approach of the interventions and the content of the educational components was comparable across studies. The fourth study investigated the use of pressure sensors for participants with an increased falls risk, which gave an alarm if the participant left the bed or chair. Control groups in all studies received usual care. Three studies were at high risk of selection bias and risk of detection bias was unclear in all studies. Because of very low-certainty evidence, we are uncertain about the effect of organisational interventions aimed at implementing a least-restraint policy on our primary efficacy outcome: the use of physical restraints in general hospital settings. One study found an increase in the number of participants with at least one physical restraint in the intervention and control groups, one study found a small reduction in both groups, and in the third study (the stepped-wedge study), the number of participants with at least one physical restraint decreased in all clusters after implementation of the intervention but no detailed information was reported. For the use of bed or chair pressure sensor alarms for people with an increased fall risk, we found moderate-certainty evidence of little to no effect of the intervention on the number of participants with at least one physical restraint compared with usual care. None of the studies systematically assessed adverse events related to use of physical restraint use, e.g. direct injuries, or reported such events. We are uncertain about the effect of organisational interventions aimed at implementing a least-restraint policy on the number of participants with at least one fall (very low-certainty evidence), and there was no evidence that organisational interventions or the use of bed or chair pressure sensor alarms for people with an increased fall risk reduce the number of falls (low-certainty evidence from one study each). None of the studies reported fall-related injuries. We found low-certainty evidence that organisational interventions may result in little to no difference in functioning (including mobility), and moderate-certainty evidence that the use of bed or chair pressure sensor alarms has little to no effect on mobility. We are uncertain about the effect of organisational interventions on the use of psychotropic medication; one study found no difference in the prescription of psychotropic medication. We are uncertain about the effect of organisational interventions on nurses' attitudes and knowledge about the use of physical restraints (very low-certainty evidence). AUTHORS' CONCLUSIONS: We are uncertain whether organisational interventions aimed at implementing a least-restraint policy can reduce physical restraints in general hospital settings. The use of pressure sensor alarms in beds or chairs for people with an increased fall risk has probably little to no effect on the use of physical restraints. Because of the small number of studies and the study limitations, the results should be interpreted with caution. Further research on effective strategies to implement a least-restraint policy and to overcome barriers to physical restraint reduction in general hospital settings is needed.

Staff-to-resident abuse in nursing homes: a scoping review.

BACKGROUND: Elder abuse in long-term care is an important public health concern with social, health-related, and economic implications. Staff-to-resident abuse is of particular interest since institutions should protect residents' rights and prevent harm. To provide an up-to date comprehensive overview of staff-to-resident abuse in nursing homes, we performed a scoping review considering types of abuse, their prevalence and associated factors, descriptions, experiences, and preventive interventions. METHODS: We performed a scoping review following the framework provided by Arksey and O'Malley. We searched MEDLINE (via PubMed), CINAHL, PsycINFO via Ovid, and Cochrane Library. Additionally, we performed free web searching using Google Scholar and checked relevant reviews. Two reviewers independently selected studies. We narratively synthesised the results. RESULTS: Out of 3876 references retrieved by our search, we included 46 studies in 47 reports. The prevalence rates of abuse varied widely, ranging from 0 to 93% depending on the type of abuse. Associated factors of abuse at the staff, resident, and nursing home level were evaluated inconsistently. Abuse was perceived ambiguous: even though it was considered unacceptable, it was underreported. We found only four studies addressing preventive interventions. Of these, four made recommendations for intervention development. Only one study with an experimental design examined a multi-component intervention including education and mutual support. CONCLUSIONS: The review yielded heterogenous evidence not allowing a concrete conclusion on prevalence and associated factors. However, the results show the significance of the problem and indicate that there are associate factors of abuse that can be influenced by appropriate interventions. These are amongst other staff education, organisational culture, and conditions. Further research should investigate the composition and content of preventive interventions and their potential to reduce abusive behaviours.

Facilitators and barriers to implement nurse-led interventions in long-term dementia care: a qualitative interview study with Swiss nursing experts and managers.

BACKGROUND: To support the implementation of nurse-led interventions in long-term dementia care, in-depth knowledge of specific supporting factors and barriers is required. Conditions and structures of caring for people with dementia differ widely, depending on the country and the care context. Our study aimed to describe the experiences and opinions of nursing experts and managers with regard to facilitators and barriers to the implementation of nurse-led interventions in long-term dementia care. METHODS: We conducted a qualitative descriptive study using individual interviews based on qualitative vignettes as a useful stimulus to generate narrations allowing to study peoples' perceptions and beliefs. The study took place in nursing homes in the German-speaking part of Switzerland and in the Principality of Liechtenstein using purposive sampling. We intended to conduct the interviews face-to-face in a quiet room according to the participant's choice. However, due to the lockdown of nursing homes during the COVID-19 pandemic in spring 2020, we performed interviews face-to-face and by video. We analysed data thematically following Braun and Clarke to achieve a detailed, nuanced description. To verify our interpretation and to ensure congruence with participants' perspectives, we conducted member checks. The Standards for Reporting Qualitative Research (SRQR) served to structure our manuscript. RESULTS: Six dyads of nursing home managers and nursing experts from six nursing homes took part in our study (n = 12). Our thematic analysis yielded seven themes reflecting facilitators and barriers to implementing nurse-led interventions in long-term dementia care: «A common attitude and cohesion within the organization¼, «Commitment on several levels¼, «A needs-oriented implementation¼, «The effect and the public perception of the intervention¼, «A structured and guided implementation process¼, «Supporting knowledge and competencies¼, as well as «Resources for implementing the intervention¼. CONCLUSIONS: To support the implementation of nurse-led interventions in long-term dementia care, active commitment-building seems essential. It is necessary that the value of the intervention is perceptible.Commitment-building is the precondition to reach the persons involved, such as nursing home managers, nursing staff, residents and relatives. Furthermore, nurses should precisely inform about the intervention. It is necessary that the value of the intervention is perceptible. In addition, nurses should adjust the interventions to the situational needs of people with dementia, thus. Therefore, it is important to support dementia-specific competencies in long-term care. Findings indicate that the barrier is determined by the intervention and its implementation - and not by the behaviour of the person with dementia.

Agreement in Risk of Bias Assessment Between RobotReviewer and Human Reviewers: An Evaluation Study on Randomised Controlled Trials in Nursing-Related Cochrane Reviews.

PURPOSE: RobotReviewer is a machine learning system for semi-automated assistance in risk of bias assessment. The tools's performance in randomized controlled trials (RCTs) in the field of nursing remains unknown. We aimed therefore to evaluate the agreement in risk of bias assessment between RobotReviewer and human reviewers. DESIGN: Evaluation study using a retrospective diagnostic design. METHODS: We used RobotReviewer as the index test and human reviewers' risk of bias assessment reported in Cochrane reviews as the reference test. A convenience sample of electronically available English-language full texts of RCTs included in Cochrane reviews with nurs* in the title were eligible for inclusion. In this context, we assessed random sequence generation, allocation concealment, and blinding (personnel or participants and assessors) corresponding to Cochrane risk of bias version 2011. Two independent research teams performed and double-checked data extraction and analysis. We calculated sensitivity, specificity, receiver operating characteristic (ROC) curve, the area under the ROC curve, predictive values, observed percentage of agreement, and Cohen's kappa (including confidence intervals, if applicable). FINDINGS: The selection process yielded 190 RCTs published between 1958 and 2016 in 23 Cochrane reviews published between 2000 and 2018. Missing assessments of risk of bias domains in Cochrane reviews or RobotReviewer yielded varying sample sizes per risk of bias domain. Sensitivity ranged from 0.44 to 0.88 and specificity from 0.48 to 0.95. Positive predictive value was highest for allocation concealment (0.79) and lowest for blinding assessors (0.25). Cohen's kappa was moderate for randomization (0.52), allocation concealment (0.60), and for blinding of personnel/patients (0.43). Blinding of outcome assessors had only slight agreement (0.04). CONCLUSIONS: This is the first evaluation of risk of bias assessment by RobotReviewer in RCTs included in nursing-related Cochrane reviews. It yielded a moderate degree of agreement with human reviewers for randomization and allocation concealment, and an adequate sensitivity for detecting low risk of selection bias. CLINICAL RELEVANCE: Based on our results, using the RobotReviewer for risk of bias assessment in RCTs can be supportive in some risk of bias domains. However, human reviewers should supervise the semi-automated assessment process.

Overlaps of multiple database retrieval and citation tracking in dementia care research: a methodological study.

OBJECTIVE: We aimed to determine overlaps and optimal combination of multiple database retrieval and citation tracking for evidence synthesis, based on a previously conducted scoping review on facilitators and barriers to implementing nurse-led interventions in dementia care. METHODS: In our 2019 scoping review, we performed a comprehensive literature search in eight databases (CENTRAL, CINAHL, Embase, Emcare, MEDLINE, Ovid Nursing Database, PsycINFO, and Web of Science Core Collection) and used citation tracking. We retrospectively analyzed the coverage and overlap of 10,527 retrieved studies published between 2015 and 2019. To analyze database overlap, we used cross tables and multiple correspondence analysis (MCA). RESULTS: Of the retrieved studies, 6,944 were duplicates and 3,583 were unique references. Using our search strategies, considerable overlaps can be found in some databases, such as between MEDLINE and Web of Science Core Collection or between CINAHL, Emcare, and PsycINFO. Searching MEDLINE, CINAHL, and Web of Science Core Collection and using citation tracking were necessary to retrieve all included studies of our scoping review. CONCLUSIONS: Our results can contribute to enhancing future search practice related to database selection in dementia care research. However, due to limited generalizability, researchers and librarians should carefully choose databases based on the research question. More research on optimal database retrieval in dementia care research is required for the development of methodological standards.

Persons with dementia as internet users: what are their needs? A qualitative study.

AIMS AND OBJECTIVES: The aim of this study was to identify the needs and expectations of persons with dementia regarding dementia-related information on the internet concerning content, presentation, navigation, language and design. BACKGROUND: Research on internet-related needs of persons with dementia is lacking. However, the importance of the internet as a source of health information is increasing. To improve health literacy and to ensure participation in therapy decisions, target group-specific health information is necessary, especially for persons with chronic conditions like dementia. DESIGN: We conducted a qualitative interview study between April 2019 and April 2020 in the German-speaking part of Switzerland. To report the study, we used the COREQ checklist. METHODS: We analysed the interview data using content analysis according to Mayring. RESULTS: Four interviews with five persons with dementia took place. We identified two main themes: (1) 'use of media and changing needs' and (2) 'information about dementia on the internet'. The first theme is related to changing user habits due to progressing dementia. The second theme is focussed on requirements concerning design and content. Critical reception and assessment of internet-based information are also addressed. CONCLUSIONS: Information should be adapted to the course of disease. Opportunities and positive aspects should also be mentioned. The presentation should be well-structured. Health professionals might support persons with dementia in searching and interpreting internet-based information. RELEVANCE TO CLINICAL PRACTICE: Website operators should consider specific needs of persons with dementia regarding design and content. Involving persons with dementia in the development of website content and design could be an opportunity for better meeting their needs.

What feedback do reviewers give when reviewing qualitative manuscripts? A focused mapping review and synthesis.

BACKGROUND: Peer review is at the heart of the scientific process. With the advent of digitisation, journals started to offer electronic articles or publishing online only. A new philosophy regarding the peer review process found its way into academia: the open peer review. Open peer review as practiced by BioMed Central (BMC) is a type of peer review where the names of authors and reviewers are disclosed and reviewer comments are published alongside the article. A number of articles have been published to assess peer reviews using quantitative research. However, no studies exist that used qualitative methods to analyse the content of reviewers' comments. METHODS: A focused mapping review and synthesis (FMRS) was undertaken of manuscripts reporting qualitative research submitted to BMC open access journals from 1 January - 31 March 2018. Free-text reviewer comments were extracted from peer review reports using a 77-item classification system organised according to three key dimensions that represented common themes and sub-themes. A two stage analysis process was employed. First, frequency counts were undertaken that allowed revealing patterns across themes/sub-themes. Second, thematic analysis was conducted on selected themes of the narrative portion of reviewer reports. RESULTS: A total of 107 manuscripts submitted to nine open-access journals were included in the FMRS. The frequency analysis revealed that among the 30 most frequently employed themes "writing criteria" (dimension II) is the top ranking theme, followed by comments in relation to the "methods" (dimension I). Besides that, some results suggest an underlying quantitative mindset of reviewers. Results are compared and contrasted in relation to established reporting guidelines for qualitative research to inform reviewers and authors of frequent feedback offered to enhance the quality of manuscripts. CONCLUSIONS: This FMRS has highlighted some important issues that hold lessons for authors, reviewers and editors. We suggest modifying the current reporting guidelines by including a further item called "Degree of data transformation" to prompt authors and reviewers to make a judgment about the appropriateness of the degree of data transformation in relation to the chosen analysis method. Besides, we suggest that completion of a reporting checklist on submission becomes a requirement.

What hinders and facilitates the implementation of nurse-led interventions in dementia care? A scoping review.

BACKGROUND: The implementation of evidence-based interventions for people with dementia is complex and challenging. However, successful implementation might be a key element to ensure evidence-based practice and high quality of care. There is a need to improve implementation processes in dementia care by better understanding the arising challenges. Thus, the aim of this study was to identify recent knowledge concerning barriers and facilitators to implementing nurse-led interventions in dementia care. METHODS: We performed a scoping review using the methodological framework of Arksey and O'Malley. Studies explicitly reporting on the implementation process and factors influencing the implementation of a nurse-led intervention in dementia care in all settings were included. We searched eight databases from January 2015 until January 2019. Two authors independently selected the studies. For data analysis, we used an inductive approach to build domains and categories. RESULTS: We included 26 studies in the review and identified barriers as well as facilitators in five domains: policy (e.g. financing issues, health insurance), organisation (e.g. organisational culture and vision, resources, management support), intervention/implementation (e.g. complexity of the intervention, perceived value of the intervention), staff (e.g. knowledge, experience and skills, attitude towards the intervention), and person with dementia/family (e.g. nature and stage of dementia, response of persons with dementia and their families). CONCLUSIONS: Besides general influencing factors for implementing nursing interventions, we identified dementia-specific factors reaching beyond already known barriers and facilitators. A pre-existing person-centred culture of care as well as consistent team cultures and attitudes have a facilitating effect on implementation processes. Furthermore, there is a need for interventions that are highly flexible and sensitive to patients' condition, needs and behaviour.

Implementation of a complex intervention to improve participation in older people with joint contractures living in nursing homes: a process evaluation of a cluster-randomised pilot trial.

BACKGROUND: Joint contractures in frail older people are associated with serious restrictions in participation. We developed the Participation Enabling CAre in Nursing (PECAN) intervention, a complex intervention to enable nurses to promote participation in nursing home residents with joint contractures. The aim of this study was to examine the feasibility of the implementation strategy and to identify enablers and barriers for a successful implementation. METHODS: The implementation of PECAN was investigated in a 6-month pilot cluster-randomised controlled trial (c-RCT). As a key component of the implementation strategy, nominated nurses were trained as facilitators in a one-day workshop and supported by peer-mentoring (visit, telephone counselling). A mixed-methods approach was conducted in conjunction with the pilot trial and guided by a framework for process evaluations of c-RCTs. Data were collected using standardised questionnaires (nursing staff), documentation forms, problem-centred qualitative interviews (facilitators, therapists, social workers, relatives, peer-mentors), and a group discussion (facilitators). A set of predefined criteria on the nursing home level was examined. Quantitative data were analysed using descriptive statistics. Qualitative data were analysed using directed content analysis. RESULTS: Seven nursing homes (n = 4 intervention groups, n = 3 control groups) in two regions of Germany took part in the study. Facilitators responded well to the qualification measures (workshop participation: 14/14; workshop rating: "good"; peer-mentor visit participation: 10/14). The usage of peer-mentoring via telephone varied (one to seven contacts per nursing home). Our implementation strategy was not successful in connection with supplying the intervention to all the nurses. The clear commitment of the entire nursing home and the respect for the expertise of different healthcare professionals were emphasised as enablers, whereas a lack of impact on organisational conditions and routines and a lack of time and staff competence were mentioned as barriers. CONCLUSION: The PECAN intervention was delivered as planned to the facilitators but was unable to produce comprehensive changes in the nursing homes and subsequently for the residents. Strategies to systematically include the management and the nursing team from the beginning are needed to support the facilitators during implementation in the main trial. TRIAL REGISTRATION: German clinical trials register, DRKS00010037 . Registered 12 February 2016.

Educational interventions to improve literature searching skills in the health sciences: a scoping review.

OBJECTIVE: The authors reviewed educational interventions for improving literature searching skills in the health sciences. METHODS: We performed a scoping review of experimental and quasi-experimental studies published in English and German, irrespective of publication year. Targeted outcomes were objectively measurable literature searching skills (e.g., quality of search strategy, study retrieval, precision). The search methods consisted of searching databases (CINAHL, Embase, MEDLINE, PsycINFO, Web of Science), tracking citations, free web searching, and contacting experts. Two reviewers performed screening and data extraction. To evaluate the completeness of reporting, the Template for Intervention Description and Replication (TIDieR) was applied. RESULTS: We included 6 controlled trials and 8 pre-post trials from the 8,484 references that we screened. Study participants were students in various health professions and physicians. The educational formats of the interventions varied. Outcomes clustered into 2 categories: (1) developing search strategies (e.g., identifying search concepts, selecting databases, applying Boolean operators) and (2) database searching skills (e.g., searching PubMed, MEDLINE, or CINAHL). In addition to baseline and post-intervention measurement, 5 studies reported follow-up. Almost all studies adequately described their intervention procedures and delivery but did not provide access to the educational material. The expertise of the intervention facilitators was described in only 3 studies. CONCLUSIONS: The results showed a wide range of study populations, interventions, and outcomes. Studies often lacked information about educational material and facilitators' expertise. Further research should focus on intervention effectiveness using controlled study designs and long-term follow-up. To ensure transparency, replication, and comparability, studies should rigorously describe their intervention.

Interventions to reduce physical restraints in general hospital settings: A scoping review of components and characteristics.

AIMS AND OBJECTIVES: To describe the characteristics of interventions for reducing physical restraints in general hospital settings. BACKGROUND: Physical restraints, such as bedrails and belts in beds and chairs, are commonly used in general hospital settings. However, there is no clear evidence on their effectiveness but some evidence on potential risks for harm. DESIGN: Scoping review. METHODS: We conducted a systematic database search (MEDLINE via PubMed, CINAHL, Cochrane Library; March 2020) and snowballing techniques. We included both interventional studies and quality improvement projects conducted in general hospital settings and published in English or German language. Two reviewers independently performed the study selection and data extraction. The Scoping Reviews (PRISMA-ScR) Checklist was used. RESULTS: We included 31 articles (published between 1989 and 2018), 15 quality improvement projects and 16 intervention studies. Only five studies used a controlled design. Most studies and quality improvement projects investigated multicomponent interventions including education (predominantly for nursing staff) and additional components (e.g. case conferences). Three studies examined simple educational programmes without additional components. CONCLUSIONS: A large number of multicomponent interventions for preventing and reducing physical restraints in general hospital settings have been developed. The interventions differed widely regarding the components, contents and settings. Well-designed evaluation studies investigating the effects of such interventions are lacking. RELEVANCE TO CLINICAL PRACTICE: Multicomponent educational interventions might be one approach to change clinical practice, but only insufficient information is available about potential effects of these approaches.

Prioritäten der Pflegeforschung für das Themenfeld "Dementia Care" im deutschsprachigen Raum - Eine Delphi-Studie.

Priorities of nursing research in dementia care in German-speaking countries - A Delphi study Abstract. Background and objective: To meet the central needs of people with dementia, their relatives and their caregivers in complex living conditions and care situations, a substantive examination of research priorities is required. The aim of this work was the identification and prioritisation of nursing research topics concerning dementia care in German-speaking countries. METHODS: To identify existing research agendas in dementia care, we conducted a systematic literature research. As part of a Delphi process, systematically identified dementia care experts from German-speaking countries supplemented research priorities extracted from existing research agendas and assessed their importance. Subsequently, they prioritized topics of particular importance for nursing research. RESULTS: Fifteen experts supplemented 61 topics previously identified in existing research agendas. They assessed 107 topics in terms of their importance and prioritized 79 topics. CONCLUSIONS: The research priorities developed are a potential framework for nursing science, health policy and research funding in order to structure research activities. To ensure currency, priorities should be regularly updated and re-opened for discussion.

[Publications German-speaking countries in high impact journals: development and validation of a search filter]. / Publikationen aus dem deutschsprachigen Raum in Zeitschriften mit hohem Impact Factor: Entwicklung und Validierung eines Suchfilters.

Publications German-speaking countries in high impact journals: development and validation of a search filter Abstract. BACKGROUND: The number of publications in journals with a high impact factor is an indication of a discipline's participation in international discourse. A search filter allows reliable and reproducible searches for specific publications. AIM: Development and validation of a geographic search filter for publications by nursing scientists affiliated to German-speaking countries in nursing journals with a high impact factor. METHODS: The search filter was objectively developed following several steps: (i) creation of a development and a validation set, each consisting of relevant and non-relevant publications, (ii) generation of the search filter by means of text analysis of the development set, (iii) internal validation based on the development set and (iv) external validation using the validation set. The validity was examined regarding several accuracy parameters, e. g. sensitivity, specificity, positive predictive value (PPV) and number needed to read (NNR). RESULTS: The search filter correctly identified 22 of 30 relevant and 16 of 21 non-relevant publications in the development set: sensitivity 80 % (95 % CI 66 - 94), specificity 76 % (95 % CI 58 - 94), PPV 83 % (95 % CI 69 - 97). External validation yielded similar or better results: sensitivity 81 % (95 % CI 67 - 96), specificity 88 % (95 % CI 71 - 100), PPV 88 % (95 % CI 75 - 100). The NNR was 1.2 and 1.1, respectively. CONCLUSIONS: The search filter has the potential to identify the intended publications.

Needs of people with dementia and their informal caregivers concerning assistive technologies.

Background and objective: Assistive technologies might be a suitable option for supporting people with dementia and their informal caregivers. To avoid "one-fits-all"-solutions and to design useful technologies, it is essential to consider the end-users' needs. The objective of this review was to examine the needs of people with dementia and their informal caregivers with regard to assistive technologies. Methods: We conducted a scoping review based on a comprehensive literature search in databases, handsearching, and free web searching. Additionally, we performed citation tracking of included studies. We included all types of study designs. Two researchers independently selected the studies. The results were thematically categorised by two researchers. Results: The search yielded 7160 references. 18 of 24 included studies were qualitative. The studies had been conducted in 13 different countries, mostly in Europe. The sample size ranged between two and 270 participants. Most of the studies involved people with dementia as well as informal caregivers. The analysis resulted in eleven themes. The themes could be assigned to three domains: "needed technologies", "characteristics of needed technologies", and "information about technologies". Conclusions: The results might guide future usage, development and research addressing end users' needs with regard to assistive technologies.