Lessons learned from eight teams: The value of pilot and feasibility studies in self-management science.

Designing and conducting effective intervention research is an important domain of nursing science. Nurse scientists have long recognized people with chronic conditions need effective self-management strategies across the lifespan, so they have led the way in establishing theoretical and practical grounds for the science of self-management. Guidance from pilot and feasibility research for self-management interventions is scarce. Documented exemplars of successes and failures in pilot and feasibility study designs are scant in the literature. The purpose of this paper is to illustrate methodological approaches using pilot and feasibility examples. To maximize collective lessons learned in self-management science study design, features of our pilot and feasibility research strategies that yielded both desirable and undesirable outcomes are described, analyzed, and paired with alternative solutions. A National Institute of Nursing Research P30 grant center, awarded grants to 8 pilot investigators to pilot self-management interventions. A wide variety of chronic conditions were addressed, including heart failure, chronic kidney disease, multiple sclerosis, diabetes, and HIV. The investigators provided their experiences of study implementation. Common themes across the studies were identified. There were four lessons learned from these studies: 1) maximize resources and develop enough evidence for subsequent studies; 2) embed patient-centered feasibility within implementation testing with new patient populations; 3) develop a flexible participant recruitment plan to allow for adjustments when unexpected barriers arise; and 4) define study-specific data collection procedures to demonstrate feasibility. Researchers conducting preliminary small-scale self-management intervention research must balance resources to develop and implement interventions to meet pilot and feasibility objectives.

An initial investigation of the reliability and validity of the Compensatory Cognitive Strategies Scale.

Although many cognitive performance tests and self-reported cognitive concerns scales have been used to evaluate cognitive functioning, fewer measures assess the use of compensatory cognitive strategies for daily activities among those experiencing mild levels of cognitive impairment. The Compensatory Cognitive Strategies Scale was developed to measure frequency of self-reported cognitive strategies to decrease distractions, organise and sequence activities, and to utilise newly available computer aids to assist memory among those with multiple sclerosis (MS). Cronbach's alpha, a measure of internal consistency reliability, was .89 and .90 in two different samples. Concurrent validity was supported by the total score's moderate correlation with the MMQ-Strategy Scale (rs = .67) and by a statistically significant increase in total scores for those who had participated in an intervention designed to improve their cognitive abilities. Correlations were stronger with another strategy measure than with measures of other constructs such as health-promoting behaviours, thus supporting the scales convergent versus divergent validity. These initial findings suggest that the Compensatory Cognitive Strategies Scale may be useful to both researchers and clinicians working to build compensatory strategies for day-to-day functioning among those with mild cognitive impairment.

Care homes get creative - and residents have a ball.

Care home residents are acting out The Great Gatsby. Well, they're acting out the making of the movie: there are actors, a director, camera operator and some of the staff are extras.

Ecological and metabolomic responses of plants to deer exclosure in a suburban forest.

Trees and shrubs in suburban forests can be subject to chronic herbivory from abundant white-tailed deer, influencing survival, growth, secondary metabolites, and ecological success in the community. We investigated how deer affect the size, cover, and metabolomes of four species in the understory of a suburban forest in central New Jersey, USA: the woody shrubs Euonymus alatus and Lindera benzoin, the tree Nyssa sylvatica, and the semi-woody shrub Rosa multiflora. For each species, we compared plants in 38 16 m2 plots with or without deer exclosure, measuring proportion cover and mean height after 6.5 years of fencing. We scored each species in all plots for deer browsing over 8 years and assessed selection by deer among the species. We did untargeted metabolomics by sampling leaves from three plants of each species in an equal number of fenced and unfenced plots, conducting chloroform-methanol extractions followed by LC-MS/MS, and conducting statistical analysis on MetaboAnalyst. The proportion of a species browsed ranged from 0.24 to 0.35. Nyssa sylvatica appeared most selected by and susceptible to deer; in unfenced plots, both its cover and mean height were significantly lower. Only cover or height was lower for E. alatus and L. benzoin in unfenced plots, while R. multiflora height was greater. The metabolomic analysis identified 2333 metabolites, which clustered by species but not fencing treatment. However, targeted analysis of the top metabolites grouped by fencing for all samples and for each species alone and was especially clear in N. sylvatica, which also grouped by fencing using all metabolites. The most significant metabolites that were upregulated in fenced plants include some involved in defense-related metabolic pathways, e.g., monoterpenoid biosynthesis. In overbrowsed suburban forests, variation of deer impact on species' ecological success, potentially mediated by metabolome-wide chemical responses to deer, may contribute to changes in community structure.

Woody plant secondary chemicals increase in response to abundant deer and arrival of invasive plants in suburban forests.

Plants in suburban forests of eastern North America face the dual stressors of high white-tailed deer density and invasion by nonindigenous plants. Chronic deer herbivory combined with strong competition from invasive plants could alter a plant's stress- and defense-related secondary chemistry, especially for long-lived juvenile trees in the understory, but this has not been studied. We measured foliar total antioxidants, phenolics, and flavonoids in juveniles of two native trees, Fraxinus pennsylvanica (green ash) and Fagus grandifolia (American beech), growing in six forests in the suburban landscape of central New Jersey, USA. The trees grew in experimental plots subjected for 2.5 years to factorial treatments of deer access/exclosure × addition/no addition of the nonindigenous invasive grass Microstegium vimineum (Japanese stiltgrass). As other hypothesized drivers of plant secondary chemistry, we also measured nonstiltgrass herb layer cover, light levels, and water availability. Univariate mixed model analysis of the deer and stiltgrass effects and multivariate structural equation modeling (SEM) of all variables showed that both greater stiltgrass cover and greater deer pressure induced antioxidants, phenolics, and flavonoids, with some variation between species. Deer were generally the stronger factor, and stiltgrass effects were most apparent at high stiltgrass density. SEM also revealed that soil dryness directly increased the chemicals; deer had additional positive, but indirect, effects via influence on the soil; in beech photosynthetically active radiation (PAR) positively affected flavonoids; and herb layer cover had no effect. Juvenile trees' chemical defense/stress responses to deer and invasive plants can be protective, but also could have a physiological cost, with negative consequences for recruitment to the canopy. Ecological implications for species and their communities will depend on costs and benefits of stress/defense chemistry in the specific environmental context, particularly with respect to invasive plant competitiveness, extent of invasion, local deer density, and deer browse preferences.

Clinical Decision-Making: Restless Legs Syndrome and Dementia in Older Adults.

Restless legs syndrome (RLS), one of the more prevalent sleep disturbances among older adults, impacts quality of life. Patients with dementia are at high risk for developing RLS and may be unable to describe their symptoms. Often underdiagnosed, RLS can contribute to discomfort, pain, nighttime agitation, disturbed sleep, and falls. Clinical assessment is crucial and should include a thorough evaluation with input from the patient and family, deprescribing medication if possible, and consideration of common sleep-disturbing factors. Evidence-based treatment in this population is limited; overall focus should center on relieving discomfort while identifying and treating bothersome sleep symptoms.

Experiences of African American Women with Multiple Sclerosis.

BACKGROUND: Despite growing understanding that African American patients may have a more aggressive course of multiple sclerosis (MS) and experience disparities in diagnosis and treatment, fewer studies have examined how African Americans experience MS and its effect on their lives. This study explored the experiences of African American women with MS to inform future research and practice. METHODS: Face-to-face semistructured interviews were conducted with 19 African American women. Inductive content analysis was used to identify major categories and subcategories. RESULTS: The analyses yielded three major categories: no one could believe I had MS, it is tough living with MS, and you have to keep going. Many women reported that the MS diagnosis was a surprise to them and their doctors because of the common belief that MS is a "Caucasian disease." For this reason, many women felt their diagnosis had been delayed while their physicians initially focused on other diseases considered more typical in African American individuals. Living with losses related to social and family activities, independence, and employment was especially challenging for them. Faith in God, coming to grips with the diagnosis, and health promotion behaviors were key strategies for dealing with their MS. Women also spoke of pushing forward, working through MS challenges, and taking care of themselves, thus preserving their identity as strong Black women, a culturally important construct in the African American community. CONCLUSIONS: Future research should explore the interactions of culture with coping strategies and the development of useful and valued resources and supports for African American people with MS.

Nighttime Agitation in Persons with Dementia as a Manifestation of Restless Legs Syndrome.

OBJECTIVES: Nighttime agitation or "sundowning" is challenging for clinicians and caregivers to manage in older adults in the dementia stage of Alzheimer's disease (AD-D). Our research previously revealed that nighttime agitation might be a manifestation of restless legs syndrome (RLS). The current study aims to describe the characteristics of older adults with AD-D, nighttime agitation, and RLS, and to evaluate sleep disturbance and iron status in relation to nighttime agitation severity. DESIGN: An observational study with baseline descriptive and correlational data from a clinical trial. SETTING AND PARTICIPANTS: Long-term care (n = 69) and independent living (n = 7); age 82.91 ± 9.46 years, with AD-D, nighttime agitation, and RLS. MEASUREMENTS: Trained observers counted nighttime agitation behaviors. Independent variables were age; cognition measured by the Mini-Mental State Examination; minutes slept from actigraphy; transferrin saturation percentage (TS%) and transferrin from fasting blood samples; and illness severity using the Cumulative Illness Rating Scale for Geriatrics. Bivariate and multivariable linear regression models were generated. RESULTS: In the multivariable model, sleep minutes (P = .002) and TS% (P = .003) were negatively associated with frequency of nighttime agitation behaviors, and they explained 20% of the variance. Seventy-nine percent received 1 or more medications that worsen RLS symptoms, such as antihistamines and serotonin reuptake inhibitors. CONCLUSIONS AND IMPLICATIONS: We encourage clinicians to consider nighttime agitation as a manifestation of RLS. Treatment of iron deficiency indicated by low TS% and deprescribing medications that exacerbate RLS may decrease nighttime agitation, improve sleep, and enhance quality of life in older adults with AD-D.

A randomized controlled trial of a wellness intervention for women with fibromyalgia syndrome.

OBJECTIVE: To examine the effects of a wellness intervention, Lifestyle Counts, for women with fibromyalgia syndrome on the level of self-efficacy for health-promoting behaviours, health-promoting activity and perceived quality of life. DESIGN: A randomized controlled single-blinded trial with treatment and attention-control groups. SETTING: Community in the southwestern United States. SUBJECTS: Convenience sample of 187 women (98 treatment, 89 attention control) with fibromyalgia syndrome (mean age = 53.08 years, SD 9.86). INTERVENTION: The two-phase Lifestyle Counts intervention programme included lifestyle change classes for eight weeks, with goal-setting and telephone follow-up for three months. Participants in the attention-control group were offered an equivalent amount of contact in classes on general disease-related information and health education topics and unstructured follow-up phone calls. Participants were followed for a total of eight months after baseline. OUTCOME MEASURES: Self-report instruments measuring self-efficacy for health behaviours, health-promotion behaviours and health-related quality of life (SF-36 and the Fibromyalgia Impact Questionnaire) were completed at baseline, two months (after the classes), five months (after telephone follow-up) and at eight months. RESULTS: Both groups improved significantly (P<0.05) over time on the measures of self-efficacy, health behaviours, fibromyalgia impact and quality of life. There were significant group x time interactions for scores on the Health Promoting Lifestyle II subscales of physical activity and stress management. CONCLUSIONS: The Lifestyle Counts wellness intervention holds promise for improving health-promoting behaviours and quality of life of women with fibromyalgia syndrome.

Nighttime Agitation and Restless Legs Syndrome in Persons With Alzheimer's Disease: Study Protocol for a Double-Blind, Placebo-Controlled, Randomized Trial (NightRest).

Nighttime agitation is a prevalent symptom in persons with Alzheimer's disease (AD). Effective treatments are absent due to our limited knowledge of its etiology. We hypothesized that restless legs syndrome (RLS), a common neurological sensorimotor disorder of uncomfortable leg sensations that appear at night and interfere with sleep, might be a cause for nighttime agitation in persons with AD. RLS is infrequently identified in persons with AD because traditional diagnosis is dependent on patients answering complex questions about their symptoms. With a validated observational tool for RLS diagnosis, the Behavioral Indicators Test-Restless Legs, we aim to diagnose RLS and determine the effect of gabapentin enacarbil (GEn) compared to placebo on nighttime agitation, sleep, antipsychotic medications, and the mechanism for these effects. We hypothesize that frequency of RLS behaviors will mediate the relationship between GEn and nighttime agitation. This study is an 8-week, double-blind, placebo-controlled, randomized pilot clinical trial, followed by an 8-week open-label trial, that is being conducted in long-term care settings and private homes. The results of this study may shift, personalize, and improve standards of care for treatment of nighttime agitation; reduce aggression and other nighttime agitation behaviors; and improve sleep. TARGETS: Persons with AD with nighttime agitation potentially caused by RLS. INTERVENTION DESCRIPTION: Diagnose RLS and determine the effect of GEn. MECHANISMS OF ACTION: The frequency of RLS behaviors will mediate the relationship between GEn and nighttime agitation. OUTCOMES: Determine the effect of GEn on nighttime agitation, sleep, and antipsychotic medications. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03082755 (Date of registration March 6, 2017). [Research in Gerontological Nursing, 13(6), 280-288.].

Development of an Interprofessional Educational Electronic Health Record.

This paper identifies issues relating to academic health record systems and outlines a project currently underway to develop an open source educational clinical information system to better support interprofessional health education.

When no one has time: measuring the impact of computerization on health care workers.

Technological change is a constant in today's workplace, especially the modern health care workplace. The introduction of electronic health records changes workloads, job demands, interactions with other health care professionals, and work roles-all elements that have previously been noted to increase work stress and impact health. Despite the significant changes that accompany computerization, it is seldom studied as a source of stress. Also, the health effects of computerization within health care have not been extensively studied. This article summarizes the potential environmental impact of computerization on workers, with special reference to health care workers, and suggests ways occupational health nurses can monitor the health consequences of new technology and intervene in case of adverse health impact. In many health care organizations, high work pressure and staff shortages make it impractical, and perhaps impossible, to use standard in-depth research methods to investigate this issue. Therefore, several less obtrusive methods that can be triangulated are suggested as an alternative.

Computer-assisted cognitive rehabilitation in persons with multiple sclerosis: Results of a multi-site randomized controlled trial with six month follow-up.

BACKGROUND: The effects of multiple sclerosis (MS) on cognition have gained increasing recognition as one of the major disabling symptoms of the disease. Despite the prevalence of these symptoms and their impact on quality of life, limited attention has been given to strategies that might help manage the cognitive changes commonly experienced by persons with MS. OBJECTIVE: The primary purpose of this study was to determine the effectiveness of a novel computer-assisted cognitive rehabilitation intervention MAPSS-MS (Memory, Attention, Problem Solving Skills in MS) in a multi-site trial with persons with MS. METHODS: Persons with MS (N = 183) with cognitive concerns were randomly assigned to either the 8-week MAPSS-MS intervention or usual care plus freely available computer games. Participants completed self-report and performance measures of cognitive functioning, compensatory strategies and depression at baseline, immediately after the MAPSS-MS intervention, and three and six months post-intervention. Changes in study outcomes were analyzed using intention to treat methodology, ANOVA with repeated measures, and ANCOVA. RESULTS: Both groups improved significantly on all outcome measures. The intervention group outperformed the comparison group on all measures, and there were statistically significant differences on selected measures. CONCLUSION: Findings suggest that MAPSS-MS is a feasible intervention that could be broadly implemented in community settings. It has been shown to be modestly successful in improving cognitive functioning.

Effects of white-tailed deer and invasive plants on the herb layer of suburban forests.

Lack of hunting and predators and proximity to human communities make suburban forests prone to high deer abundance and non-native plant invasions. I investigated these likely drivers of community structure in the herb layers of six suburban forests in one region of New Jersey, USA. In 223 plots I assessed the herb layer response to 2.5 years with or without deer fencing and the early stage of invasion from seed additions of Microstegium vimineum, an invasive, annual grass. Non-native plants and herbaceous native plants were affected very little by fencing or M. vimineum invasion. In contrast, across all forests the combination of deer access and M. vimineum addition had a strongly negative effect on woody native percent cover. Forests differed in overall fencing effects on woody natives; their cover was greater in fenced plots in just three forests, suggesting greater deer pressure in those forests during the experiment. The early invasion by M. vimineum was greatest in two of these same forests, but was not influenced by fencing. Multi-group structural equation modelling compared two groups of forests that differed in vegetation abundance and other characteristics. It paralleled the results above and also showed no negative influence of non-native cover on native cover, even in the forests where non-native cover was greater. It identified a positive effect of light level on herb layer plants in the forests with less vegetation, and also revealed a positive effect of soil water potential (SWP) on non-native plants in the forests with more vegetation, which had higher SWP. These suburban forests within a common region varied widely in native and non-native herb layer abundance, the early success of M. vimineum invasion and the herb layer's response to early invasion and protection from deer.

The Benefits and Risks of CrossFit: A Systematic Review.

With the increase in popularity of the CrossFit exercise program, occupational health nurses may be asked questions about the appropriateness of CrossFit training for workers. This systematic literature review was conducted to analyze the current research on CrossFit, and assess the benefits and risks of this exercise strategy. Thirteen studies ( N = 2,326 participants) examined the use of CrossFit training among adults; CrossFit is comparable to other exercise programs with similar injury rates and health outcomes. Occupational health nurses should assess previous injuries prior to recommending this form of exercise. Ideal candidates for CrossFit are adults who seek high-intensity exercise with a wide variety of exercise components.

Physical activity and cognitive function in adults with multiple sclerosis: an integrative review.

PURPOSE: To identify and synthesize the research evidence concerning (1) the relationship between physical activity and cognitive performance in persons with multiple sclerosis (MS) and (2) to review the reported effects of physical activity interventions on neurocognitive performance conducted in this population. METHODS: Relevant peer-reviewed journal articles were identified by searching PubMed, PsychINFO, and SPORTDiscus through May 2016. Full-text articles meeting the inclusion criteria were evaluated for quality using tools developed by the National Institutes of Health. Studies deemed to be of poor quality were excluded from the review. RESULTS: Nineteen studies meeting the inclusion/exclusion criteria were analyzed. Nine studies reported significant relationships between higher levels of physical activity or cardiorespiratory fitness and measures of cognitive function. Data extracted from 10 physical activity intervention studies reported mixed results on the effectiveness of physical activity to improve selected domains of cognitive function in persons with MS. CONCLUSION: Although correlational studies provide evidence to support a linkage between physical activity and cognitive function in persons with MS, this linkage is confounded by factors that may have influenced the studies' results. Evidence derived from intervention studies that could support a positive effect of physical activity on cognition in persons with MS is equivocal. Implications for Rehabilitation Physical activity has numerous benefits for persons with multiple sclerosis (MS) including improvements in balance, ambulation, depression, fatigue, and quality of life. Structured physical activity programs may contribute to cognitive function stability or improvement in persons with MS.

Evaluation of Intervention Fidelity in a Multisite Clinical Trial in Persons With Multiple Sclerosis.

BACKGROUND: Careful consideration of intervention fidelity is critical to establishing the validity and reliability of research findings, yet such reports are often lacking in the research literature. It is imperative that intervention fidelity be methodically evaluated and reported to promote the translation of effective interventions into sound evidence-based practice. PURPOSE: The purpose of this article is to explore strategies used to promote intervention fidelity, incorporating examples from a multisite clinical trial, that illustrate the National Institutes of Health Behavior Change Consortium's 5 domains for recommended treatment practices: (1) study design, (2) facilitator training, (3) intervention delivery, (4) intervention receipt, and (5) intervention enactment. A multisite randomized clinical trial testing the efficacy of a computer-assisted cognitive rehabilitation intervention for adults with multiple sclerosis is used to illustrate strategies promoting intervention fidelity. METHODS: Data derived from audiotapes of intervention classes, audits of computer exercises completed by participants, participant class attendance, and goal attainment scaling suggested relatively high fidelity to the intervention protocol. CONCLUSION: This study illustrates how to report intervention fidelity in the literature guided by best practice strategies, which may serve to promote fidelity monitoring and reporting in future studies.

Integrating Acupuncture Within a Wellness Intervention for Women With Multiple Sclerosis.

PURPOSE: This pilot study explored change over time in symptom management, health promotion, and quality of life following exposure to a holistic intervention combining group acupuncture with group sessions about health promotion for women with multiple sclerosis. DESIGN: This was a pre/post nonexperimental design. METHOD: Fourteen women (average age 54 years) attended eight classes designed to help participants build the skills necessary to improve their health and consequently their overall quality of life. Acupuncture was provided in a group setting either immediately before or after each class. FINDINGS: Self-reported fatigue, stress, pain, depression, anxiety, and sleep interference decreased significantly, and overall health-promoting behaviors, self-efficacy for health promotion, social functioning, and quality of life increased significantly. In addition, focus groups held with the participants indicated that they responded positively to the combination of acupuncture with an efficacy-building health promotion intervention. CONCLUSIONS: The results of this pilot study add to the growing literature demonstrating that holistic health promotion interventions may have positive benefits for people with multiple sclerosis. Delivering acupuncture to a small group of individuals attending wellness classes appears to be feasible and was generally well received by the study participants.

Use of a violence risk assessment tool in an acute care hospital: effectiveness in identifying violent patients.

This study examined the use and effectiveness of the Alert assessment form. The form is part of the Alert system, used by one large acute care hospital to identify patients with a propensity for violence. All reported incidents of patient violence from August 1, 2003, through December 31, 2004, were included in patient charts. One hundred seventeen violent patient charts were reviewed and compared with 161 non-violent patient charts, randomly chosen from the same time period. Overall use of the Alert assessment form for violent and non-violent patients was 75.7% and 35.4%, respectively. The assessment form was found to have moderate sensitivity (71%) and high specificity (94%). It is reasonably effective in identifying potentially violent or aggressive patients when it is used according to protocol. Efforts to improve the tool are warranted, as is evaluation of its benefit in settings with low prevalence of violence. Also, greater effort must be taken to prevent violence once an aggressive patient has been identified.