Recruitment and enrollment of participants in an online diabetes self-management intervention in a virtual environment.

Effective recruitment of research participants is essential for successful randomized controlled trials and remains one of the most challenging and labor-intensive aspects of conducting research. The purpose of this manuscript is to describe recruitment methods for this two-group, internet-based intervention trial and enrollment status in relation to recruitment methods, accounting for accrual rates and recruitment costs and to discuss our recruitment results and limitations informed by the Clinical Trials Transformation Initiative (CTTI) team's evidence and expert-based recommendations for recruitment. The primary study was a two-group randomized controlled trial designed to evaluate the efficacy of a virtual environment, Diabetes LIVE©, compared to a traditional website format to provide diabetes self-management education and support to adults with type 2 diabetes. Our recruitment experience was labor-intensive, multimodal, and required multiple iterations throughout the study to meet recruitment goals. To allow for more efficient and realistic budgets aligned with funding, researchers should engage stakeholders in recruitment planning and monitor and report personnel time and cost by recruitment methods. To allow for more efficient and effective recruitment into meaningful clinical trials and of interest to participants, researchers should use a participative approach during all study phases, including question development.

Management Team Perceptions of Risks and Strategies for Preventing Falls Among Short-Stay Patients in Nursing Homes.

We sought to understand strategies reported by members of the nursing home management team used to prevent falls in short-stay nursing home patients. Using Donabedian's model of structure, process, and outcomes, we interviewed 16 managers from 4 nursing homes in central North Carolina. Nursing home managers identified specific barriers to fall prevention among short-stay patients including rapid changes in functional and cognitive status, staff unfamiliarity with short-stay patient needs and patterns, and policies impacting care. Few interventions for reducing falls among short-stay patients were used at the structure level (eg, specialized units, workload ratio, and staffing consistency); however, many process-level interventions were used (eg, patient education on problem solving, self-care/mobility, and safety). We described several barriers to fall prevention among short-stay patients in nursing homes. From these descriptions, we propose three interventions that might reduce falls for short-stay patients and could be tested in future research: (1) clustering short-stay patients within a physical location to permit higher staff-patient ratios and enhanced surveillance, (2) population-based prevention interventions to supplement existing individually tailored prevention strategies (eg, toileting schedules, medication review for all), and (3) transitional care interventions that transmit key information from hospitals to nursing homes.

Resident Vignettes for Assessing Care Quality in Nursing Homes.

OBJECTIVES: Validated process measures that correlate with patient outcomes are needed for research and quality improvement. DESIGN: Cross-sectional analysis within a cluster-randomized fall prevention study. SETTING: Nursing homes in North Carolina (n = 16). PARTICIPANTS: Nursing home staff (n = 541) and residents with 1 or more falls in 6 months (n = 597). MEASUREMENTS: Fall-prevention process measures in 4 categories derived from Assessing Care of Vulnerable Elders quality indicators were measured in 2 ways: (1) chart abstraction; and (2) staff responses to clinical vignettes of hypothetical residents at risk for falls. Recurrent fall rates (falls/resident/year) were measured. The proportion of the total variation in falls rates explained by the scores for each method (chart abstraction or vignette) was calculated using multilevel adjusted models. RESULTS: Chart and vignette measures of comorbidity management were moderately correlated (Pearson correlation coefficient 0.43), whereas other process measure categories had low or negative correlation between the 2 methods (psychoactive medication reduction 0.13, environmental modification -0.42, and exercise/rehabilitation -0.08). Measures of environmental modification and comorbidity management explained a moderate amount of the total variation in recurrent fall fates, vignettes (7%-10% variation explained) were superior to chart abstraction (2%-6% variation explained). Vignette responses from unlicensed staff (nurse aides and rehabilitation aides) explained more variance than registered nurses, licensed practical nurses, or other licensed staff in these categories. Process measures for psychoactive medication reduction and exercise/rehabilitation did not explain any of the variation in fall outcomes. Overall, vignette process measures explained 3.9% and chart abstraction measures explained 0% of the variation in fall outcomes. CONCLUSIONS: Clinical vignettes completed by nursing home staff had greater association with resident recurrent fall rates than traditional chart abstraction process measures.

Effect of Promoting High-Quality Staff Interactions on Fall Prevention in Nursing Homes: A Cluster-Randomized Trial.

Importance: New approaches are needed to enhance implementation of complex interventions for geriatric syndromes such as falls. Objective: To test whether a complexity science-based staff training intervention (CONNECT) promoting high-quality staff interactions improves the impact of an evidence-based falls quality improvement program (FALLS). Design, Setting, and Participants: Cluster-randomized trial in 24 nursing homes receiving either CONNECT followed by FALLS (intervention), or FALLS alone (control). Nursing home staff in all positions were asked to complete surveys at baseline, 3, 6, and 9 months. Medical records of residents with at least 1 fall in the 6-month pre- and postintervention windows (n = 1794) were abstracted for fall risk reduction measures, falls, and injurious falls. Interventions: CONNECT taught staff to improve their connections with coworkers, increase information flow, and use cognitive diversity in problem solving. Intervention components included 2 classroom sessions, relationship mapping, and self-monitoring. FALLS provided instruction in the Agency for Healthcare Research and Quality's Falls Management Program. Main Outcomes and Measures: Primary outcomes were (1) mean number of fall risk reduction activities documented within 30 days of falls and (2) median fall rates among residents with at least 1 fall during the study period. In addition, validated scales measured staff communication quality, frequency, timeliness, and safety climate. Results: Surveys were completed by 1545 staff members, representing 734 (37%) and 811 (44%) of eligible staff in intervention and control facilities, respectively; 511 (33%) respondents were hands-on care workers. Neither the CONNECT nor the FALLS-only facilities improved the mean count of fall risk reduction activities following FALLS (3.3 [1.6] vs 3.2 [1.5] of 10); furthermore, adjusted median recurrent fall rates did not differ between the groups (4.06 [interquartile range {IQR}, 2.03-8.11] vs 4.06 [IQR, 2.04-8.11] falls/resident/y). A modest improvement in staff communication measures was observed overall (mean, 0.03 [SE, 0.01] points on a 5-point scale; P = .03) and for communication timeliness (mean, 0.8 [SE, 0.03] points on a 5-point scale; P = .02). There was wide variation across facilities in intervention penetration. Conclusions and Relevance: An intervention targeting gaps in staff communication and coordination did not improve the impact of a falls quality improvement program. New approaches to implementing evidence-based care for complex conditions in the nursing home are urgently needed. Trial Registration: clinicaltrials.gov Identifier: NCT00636675.

A novel program for ABSN students to generate interest in geriatrics and geriatric nursing research.

The current shortage of nurse researchers in geriatrics adversely affects the capacity of nurses to conduct research to advance the evidence-based care of older adults. In an effort to generate interest in geriatrics and geriatric nursing research, the Duke University School of Nursing designed a summer internship for four students enrolled in the accelerated baccalaureate nursing (ABSN) program. This paper describes the experience of these ABSN students and the staff and faculty who worked with them. The program design, staff and faculty experiences, benefits and challenges, as well as recommendations for future programs are discussed. The purpose of this article is to highlight the benefits and challenges of offering research experiences to nursing students in an ABSN program to stimulate interest in geriatrics and geriatric nursing research.

Study of Individualization and Bias in Nursing Home Fall Prevention Practices.

OBJECTIVES: Little is known about how nursing home staff use resident characteristics to individualize care delivery or whether care is affected by implicit bias. DESIGN: Randomized factorial clinical vignette survey. SETTING: Sixteen nursing homes in North Carolina. PARTICIPANTS: Nursing, rehabilitation, and social services staff (n = 433). MEASUREMENTS: Vignettes describing hypothetical residents were generated from a matrix of clinical and demographic characteristics. Resident age, race and gender were suggested by a photo. Participants completed up to four randomly assigned vignettes (n = 1615), rating the likelihood that 12 fall prevention activities would be used for the resident. Fixed and random effects mixed model analysis examined the impact of vignette resident characteristics and staff characteristics on four intervention categories. RESULTS: Staff reported a higher likelihood of fall prevention activities in all four categories for residents with a prior fall (0.2-0.5 points higher, 10 point scale, P < 0.05), but other risk factors did not affect scores. There was little evidence of individualization; only dementia increased the reported likelihood of environmental modification (0.3, P < 0.001, 95% CI 0.2-0.5). Individualization did not vary with staff licensure category or clinical experience. Registered nurses consistently reported higher likelihoods of all fall prevention activities than did licensed practical nurses, unlicensed staff and other professional staff (1.0-2.7 points, P < 0.001 to 0.005). There was a small degree of implicit racial bias; staff indicated that environmental modification would be less likely to occur in otherwise identical vignettes including a photo of a black rather than a white resident (-0.2 points, 95% CI -0.3 to -0.1). CONCLUSION: Nursing home staff report a standardized approach to fall prevention without individualization. We found a small impact from implicit racial bias that should be further explored.

Sustaining complex interventions in long-term care: a qualitative study of direct care staff and managers.

BACKGROUND: Little is known about the sustainability of behavioral change interventions in long-term care (LTC). Following a cluster randomized trial of an intervention to improve staff communication (CONNECT), we conducted focus groups of direct care staff and managers to elicit their perceptions of factors that enhance or reduce sustainability in the LTC setting. The overall aim was to generate hypotheses about how to sustain complex interventions in LTC. METHODS: In eight facilities, we conducted 15 focus groups with 83 staff who had participated in at least one intervention session. Where possible, separate groups were conducted with direct care staff and managers. An interview guide probed for staff perceptions of intervention salience and sustainability. Framework analysis of coded transcripts was used to distill insights about sustainability related to intervention features, organizational context, and external supports. RESULTS: Staff described important factors for intervention sustainability that are particularly challenging in LTC. Because of the tremendous diversity in staff roles and education level, interventions should balance complexity and simplicity, use a variety of delivery methods and venues (e.g., group and individual sessions, role-play/storytelling), and be inclusive of many work positions. Intervention customizability and flexibility was particularly prized in this unpredictable and resource-strapped environment. Contextual features noted to be important include addressing the frequent lack of trust between direct care staff and managers and ensuring that direct care staff directly observe manager participation and support for the program. External supports suggested to be useful for sustainability include formalization of changes into facility routines, using "train the trainer" approaches and refresher sessions. High staff turnover is common in LTC, and providing materials for new staff orientation was reported to be important for sustainability. CONCLUSIONS: When designing or implementing complex behavior change interventions in LTC, consideration of these particularly salient intervention features, contextual factors, and external supports identified by staff may enhance sustainability. TRIAL REGISTRATION: ClinicalTrial.gov, NCT00636675.

A study of the immune properties of human umbilical cord lining epithelial cells.

BACKGROUND AIMS: Our previous study has demonstrated the stem cell-like properties of human umbilical cord lining epithelial cells (CLECs) and their capability for epidermal reconstitution in organotypic skin culture; however, the immunogenicity of these cells has not been clearly defined. We assessed several aspects of the immune properties of CLECs in vitro. METHODS: We examined CLECs for their immunoregulatory function in a mixed lymphocyte culture experiment. We characterized the expression patterns of the major histocompatibility complex (MHC), co-stimulatory molecules and the pro-/anti-inflammatory cytokines and growth factors in CLECs by means of reverse transcription-polymerase chain reaction, Western blotting, flow cytometry and FlowCytomix multiple analyte detection assays. RESULTS: CLECs were found not to induce but to suppress the proliferation response of the peripheral blood mononuclear cells in a mixed lymphocyte culture assay. They did not express the MHC class II antigen HLA-DR but the non-classic MHC class I antigens HLA-G and HLA-E and lacked the expression of the co-stimulatory molecules CD40, CD80 and CD86. In addition, they produced less interleukin-1ß and transforming growth factor-ß1 but more interleukin-4 and hepatocyte growth factor than did adult keratinocytes, a pattern in favor of wound healing with less inflammation response. CONCLUSIONS: Our data suggest that CLECs have an immunosuppressive function in addition to their low immunogenicity. This could be at least partially explained by their expression of HLA-G and HLA-E molecules associated with immune tolerance and absence of HLA-DR and co-stimulatory molecules. The demonstration that CLECs produce a favorable pattern of cytokines and growth factors for wound healing provides further support for their potential clinical application in allogeneic cell therapy.

Chiropractic management of pubic symphysis shear dysfunction in a patient with overactive bladder.

OBJECTIVE: The purpose of this case report is to describe chiropractic management of a patient with overactive bladder (OAB) and to describe an hypothetical anatomical basis for a somato-vesical reflex and possible clinical link between pelvic and symphysis pubis dysfunction to OAB. CLINICAL FEATURES: A 24-year-old nulliparous female with idiopathic OAB, with a primary complaint of nocturia presented for chiropractic care. Her sleep was limited to 2 consecutive hours due to bladder urgency. Pubic symphysis shear dysfunction was observed on physical examination. INTERVENTION AND OUTCOMES: The primary treatment modality used was chiropractic side-posture drop-table manipulation designed to reduce pubic shear dysfunction. After 8 treatments in 1 month, the pubic shear gradually reduced while nocturia diminished and consecutive sleep hours increased from 2 to 7. At 1-year follow-up, the nocturia remained resolved. CONCLUSION: The patient reported in this case responded favorably to chiropractic care, which resulted in reduced nocturia and increased sleep continuity.

A study of the combination of triamcinolone and 5-fluorouracil in modulating keloid fibroblasts in vitro.

BACKGROUND: Preliminary clinical trials suggest a superior effect when steroids and 5-fluorouracil are injected together for the intralesional therapy of keloids. In addition, it has been proposed that low-dose 5-fluorouracil may have advantages over conventional high dosages. We explored the molecular basis for the potential synergy involved in the combined treatment with triamcinolone and 5-fluorouracil. METHODS: The effects of triamcinolone alone or in combination with low-dose 5-fluorouracil on cell proliferation, cell-cycle progression, apoptosis and regulation of p53, p21, type I collagen (Col-1), vascular endothelial growth factor (VEGF), transforming growth factor-beta1 (TGF-beta1) and matrix metalloproteinase-2 (MMP-2) production in primary cultured keloid fibroblasts were examined by MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide), flow cytometric and Western blotting assays. RESULTS: Triamcinolone suppressed cell proliferation and induced G1 cell-cycle arrest but not apoptosis. By contrast, 5-fluorouracil induced G2 cell-cycle arrest and apoptosis that may be associated with p53 activation and p21 up-regulation. The modulation of Col-1, VEGF, TGF-beta1 and MMP-2 expression by triamcinolone and 5-fluorouracil alone or their combination varied between individual cell lines; the trend is to promote a reduction in Col-1 and TGF-beta1 but up-regulation of MMP-2 expression. 5-Fluorouracil played a predominant role in the combined treatment leading to more significant cell proliferation inhibition, apoptosis, Col-1 suppression and MMP-2 induction (p < 0.05). CONCLUSIONS: Our data provide the molecular-based evidence for the observed clinical benefits of adding 5-fluorouracil to a steroid injection for improved scar regression and reduced recurrence of keloids. We expect fewer undesirable side effects in the combined treatment when the lower therapeutic dose of the individual drugs is to be used.

Multidisciplinary vascular malformations clinic in Hong Kong.

OBJECTIVE: To review clinical characteristics, imaging modalities, and treatment outcomes of patients referred to a multidisciplinary clinic for management of vascular malformations. DESIGN: Retrospective case series. SETTING: Multidisciplinary vascular malformation out-patient referral clinic in a teaching hospital in Hong Kong. PATIENTS: The 141 attendees of the clinic from August 2005 to November 2011. MAIN OUTCOME MEASURES: Management and treatments offered, and responses to treatment. RESULTS: Of the 141 patients, 46% were diagnosed to have low-flow vascular malformations, 16% were diagnosed to have high-flow vascular malformations, and 15% were diagnosed to have a haemangioma. Prior to attending the clinic, approximately one third (32%) of the patients had a clinical diagnosis that was consistent with the final diagnosis. Overall, the radiological and clinical diagnoses were consistent in 43% of the patients. Magnetic resonance imaging and ultrasonography were the most commonly used imaging modalities. Of the 73 patients who received active treatment, 70% had a good response, 12% had minimal improvement, 8% had no change, and 7% had a recurrence or a major complication; in 3% of the patients the outcome was unknown. CONCLUSION: From this retrospective case series, it is evident that confusion still exists over vascular malformations and haemangiomas. Multidisciplinary clinics have a role in providing an accurate diagnosis and facilitating appropriate management and treatment plans. Magnetic resonance imaging and ultrasonography had demonstrable utility in determining the extent of the lesions and flow type.

Advanced skin, scar and wound care centre for children: A new era of care.

Advanced wound care centres are now a well established response to the growing epidemic of chronic wounds in the adult population. Is the concept transferable to children? Whilst there is not the same prevalence of chronic wounds in children there are conditions affecting the integumentary system that do have a profound effect on the quality of life of both children and their families. We have identified conditions involving the skin, scars and wounds which contribute to a critical number of potential patients that can justify the setting up of an advanced skin, scar and wound care centre for children. The management of conditions such as giant naevi, extensive scarring and epidermolysis bullosa challenge medical professionals and lead to new and novel treatments to be developed. The variation between and within such conditions calls for a customizing of individual patient care that involves a close relationship between research scientists and clinicians. This is translational medicine of its best and we predict that this is the future of wound care particularly and specifically in children.

An update review of stem cell applications in burns and wound care.

The ultimate goal of the treatment of cutaneous burns and wounds is to restore the damaged skin both structurally and functionally to its original state. Recent research advances have shown the great potential of stem cells in improving the rate and quality of wound healing and regenerating the skin and its appendages. Stem cell-based therapeutic strategies offer new prospects in the medical technology for burns and wounds care. This review seeks to give an updated overview of the applications of stem cell therapy in burns and wound management since our previous review of the "stem cell strategies in burns care".

Aggressive surgical palliation for advanced girdle tumours.

BACKGROUND: The surgical management of advanced, incurable, malignant disease presents particular ethical and technical challenges. The clear goal is palliation and the surgical futility must be avoided. This case series presents some particular challenges in end-of-life surgery. MATERIALS AND METHODS: Fifteen patients referred with advanced malignant disease involving a limb girdle were reviewed. RESULTS: In one case, a patient pleaded for surgery after initially requesting a delay to seek treatment from a Chinese Traditional Herbalist. The increase in tumour bulk led to problems with surgery and the patient died in a hospital a few weeks later. This case illustrates 'futility' not recognized and encountered. The remaining 14 patients exhibited positive palliation with improved quality of dying and appreciation expressed by patients, relatives and staff. CONCLUSION: In selected cases, with a skilled and experienced surgical team, patients with advanced malignant disease can still benefit from aggressive surgical palliation. The margin of error is small between palliation being attempted and futility being achieved. This considerably adds to the challenge of end-of-life surgery.

Analgesic effects of preoperative gabapentin after tongue reconstruction with the anterolateral thigh flap.

OBJECTIVE: To investigate gabapentin's role in head and neck cancer surgery following the demonstration of the effectiveness of gabapentin in reducing postoperative pain. DESIGN: Non-randomised open-label trial. SETTING: Prince of Wales Hospital, Hong Kong. MAIN OUTCOME MEASURES: Pain scores, analgesic usage, and the frequency of adverse effects. PATIENTS: In patients undergoing anterolateral thigh flap reconstruction after resection of tongue carcinoma, those who had an oral dose of gabapentin before surgery were compared to those who did not. RESULTS: Postoperative pain was reduced in the gabapentin group (1.2) compared to the control group (1.7) [P=0.05]. In the gabapentin group, mean morphine (patient-controlled analgesia) use (3.5 mg), sedation scores (1.0), and antiemetic usage (0 mg metoclopramide) were all significantly reduced in comparison to the controls with respective figures of 11.4 mg, 1.6, and 12.2 mg. CONCLUSION: Single preoperative doses of gabapentin led to significant reductions in postoperative pain and nausea with reduced analgesic and antiemetic usage, without additional side-effects or increases in operative complications.