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111 result(s) for "Thomas, Lois H."
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What can management theories offer evidence-based practice? A comparative analysis of measurement tools for organisational context
Background Given the current emphasis on networks as vehicles for innovation and change in health service delivery, the ability to conceptualise and measure organisational enablers for the social construction of knowledge merits attention. This study aimed to develop a composite tool to measure the organisational context for evidence-based practice (EBP) in healthcare. Methods A structured search of the major healthcare and management databases for measurement tools from four domains: research utilisation (RU), research activity (RA), knowledge management (KM), and organisational learning (OL). Included studies were reports of the development or use of measurement tools that included organisational factors. Tools were appraised for face and content validity, plus development and testing methods. Measurement tool items were extracted, merged across the four domains, and categorised within a constructed framework describing the absorptive and receptive capacities of organisations. Results Thirty measurement tools were identified and appraised. Eighteen tools from the four domains were selected for item extraction and analysis. The constructed framework consists of seven categories relating to three core organisational attributes of vision, leadership, and a learning culture, and four stages of knowledge need, acquisition of new knowledge, knowledge sharing, and knowledge use. Measurement tools from RA or RU domains had more items relating to the categories of leadership, and acquisition of new knowledge; while tools from KM or learning organisation domains had more items relating to vision, learning culture, knowledge need, and knowledge sharing. There was equal emphasis on knowledge use in the different domains. Conclusion If the translation of evidence into knowledge is viewed as socially mediated, tools to measure the organisational context of EBP in healthcare could be enhanced by consideration of related concepts from the organisational and management sciences. Comparison of measurement tools across domains suggests that there is scope within EBP for supplementing the current emphasis on human and technical resources to support information uptake and use by individuals. Consideration of measurement tools from the fields of KM and OL shows more content related to social mechanisms to facilitate knowledge recognition, translation, and transfer between individuals and groups.
Study protocol: ICONS: Identifying continence options after stroke: A randomised trial
Background Urinary incontinence following acute stroke is common, affecting between 40%-60% of people in hospital after a stroke. Despite the availability of clinical guidelines for urinary incontinence and urinary incontinence after stroke, national audit data suggest incontinence is often poorly managed. Conservative interventions (e.g. bladder training, pelvic floor muscle training and prompted voiding) have been shown to have some effect with participants in Cochrane systematic reviews, but have not had their effectiveness demonstrated with stroke patients. Methods/Design A cluster randomised controlled pilot trial designed to assess the feasibility of a full-scale cluster randomised trial and to provide preliminary evidence of the effectiveness and cost-effectiveness of a systematic voiding programme for the management of continence after stroke. Stroke services will be randomised to receive the systematic voiding programme, the systematic voiding programme plus supported implementation, or usual care. The trial aims to recruit at least 780 participants in 12 stroke services (4 per arm). The primary outcome is presence/absence of incontinence at six weeks post-stroke. Secondary outcomes include frequency and severity of incontinence, quality of life and cost-utility. Outcomes will be measured at six weeks, three months and (for participants recruited in the first three months) twelve months after stroke. Process data will include rates of recruitment and retention and fidelity of intervention delivery. An integrated qualitative evaluation will be conducted in order to describe implementation and assist in explaining the potential mediators and modifiers of the process. Trial Registration ISRCTN: ISRCTN08609907
Assessing fidelity to treatment delivery in the ICONS (Identifying Continence OptioNs after Stroke) cluster randomised feasibility trial
Background The implementation of strategies to monitor and enhance treatment fidelity is of paramount importance in trials of complex interventions. A recent framework published by the National Institutes of Health Behavior Change Consortium recommends addressing five areas of treatment fidelity, one of which is delivery of treatment. This study aimed to explore fidelity to treatment delivery of the ICONS intervention (a systematic voiding programme [SVP]). This included exploring the feasibility of a method to assess fidelity to treatment delivery and collecting preliminary evidence of the level of fidelity to SVP delivery in order to inform strategies for improving fidelity in a future trial. Methods Delivery of treatment was recorded by nurses through completion of daily clinical logs, which included: a voiding interval, proposed voiding times and actual voiding times. The a priori method for assessment of fidelity – comparing actual voiding times with proposed voiding times – was trialled on a small amount of data. Due to errors in documentation of the voiding intervals and proposed voiding times it was not possible to assess fidelity directly as planned. A new method was devised, which included identification of ‘key quality indicators’. Results This new approach to assessing fidelity used key quality indicators based upon presence of the data needed to make the comparison between proposed and actual voiding times. The proportion of clinical logs with correct documentation of voiding intervals and proposed voiding times was less than 40 %. For clinical logs with correct documentation, an actual voiding time within 30 min of the proposed voiding time was identified on approximately 55 % of occasions. Conclusions Lessons learnt from this study have implications for the future ICONS definitive trial and for other trials of complex interventions. Implementation of a complex intervention may often deviate from what is intended. While careful consideration should be given to the best method of fidelity assessment, an iterative approach allowing flexibility to adapt pre-planned methods is recommended within feasibility trials. As fidelity to treatment delivery in the ICONS feasibility trial appeared to be relatively low, more attention to implementation strategies will be required in the definitive trial. Trial registration Identifier: ISRCTN08609907 ; date registered: 07/07/2010.
Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial
Background Urinary incontinence (UI) affects half of patients hospitalised after stroke and is often poorly managed. Cochrane systematic reviews have shown some positive impact of conservative interventions (such as bladder training) in reducing UI, but their effectiveness has not been demonstrated with stroke patients. Methods We conducted a cluster randomised controlled feasibility trial of a systematic voiding programme (SVP) for the management of UI after stroke. Stroke services were randomised to receive SVP (n = 4), SVP plus supported implementation (SVP+, n = 4), or usual care (UC, n = 4). Feasibility outcomes were participant recruitment and retention. The main effectiveness outcome was presence or absence of UI at six and 12 weeks post-stroke. Additional effectiveness outcomes included were the effect of the intervention on different types of UI, continence status at discharge, UI severity, functional ability, quality of life, and death. Results It was possible to recruit patients (413; 164 SVP, 125 SVP+, and 124 UC) and participant retention was acceptable (85% and 88% at six and 12 weeks, respectively). There was no suggestion of a beneficial effect on the main outcome at six (SVP versus UC: odds ratio (OR) 0.94, 95% CI: 0.46 to 1.94; SVP+ versus UC: OR: 0.62, 95% CI: 0.28 to 1.37) or 12 weeks (SVP versus UC: OR: 1.02, 95% CI: 0.54 to 1.93; SVP+ versus UC: OR: 1.06, 95% CI: 0.54 to 2.09). No secondary outcomes showed a strong suggestion of clinically meaningful improvement in SVP and/or SVP+ arms relative to UC at six or 12 weeks. However, at 12 weeks both intervention arms had higher estimated odds of continence than UC for patients with urge incontinence. Conclusions The trial has met feasibility outcomes of participant recruitment and retention. It was not powered to demonstrate effectiveness, but there is some evidence of a potential reduction in the odds of specific types of incontinence. A full trial should now be considered. Trial registration ISRCTN Registry, ISRCTN08609907 , date of registration: 7 July 2010.
Food safety and food quality
The quality and safety of the food we eat attracts a great deal of publicity and is high on the list of public concerns. This highly emotive 15th volume of Issues in Environmental Science and Technology brings together a group of experts to present up-to-date and balanced overviews on a wide range of topics including GM crops; hazardous microorganisms such as E. coli; the BSE/CJD problem; and cancer-causing chemicals, both natural and synthetic.
Development of a scale to assess nurses' knowledge of stroke: a pilot study
Objective: To develop and test an evidence-based scale to assess nurses' knowledge of stroke. Design: Question development by a multidisciplinary group of experts in stroke. Two self-completion questionnaire surveys. Setting: Two stroke units, one general medical and two elderly care wards in three hospitals in the North-East of England. Subjects: Fifty-eight qualified nurses. Interventions: Scale to assess nurses' knowledge of stroke. Results: The overall response rate was 60%. Nurses on stroke units knew more about stroke than those in medical/elderly care wards. The scale was capable of discriminating between stroke units and medical /elderly care wards: mean difference was 4.18 (95% confidence intervals 1.68–6.69; p <0.001). Cronbach's α was 0.7 indicating adequate internal consistency. Item non-response did not exceed 10% for any question. Conclusions: We have developed a knowledge of stroke scale capable of discriminating between nurses based in stroke units and medical/elderly care wards, with low item non-response and adequate internal consistency. The scale is suitable for use as a component of studies evaluating the nursing of stroke patients.
Newcastle satisfaction with nursing scales: an instrument for quality assessments of nursing care
OBJECTIVES--To test the validity and reliability of scales for measuring patients' experiences of and satisfaction with nursing care; to test the ability of the scales to detect differences between hospitals and wards; and to investigate whether place of completion, hospital, or home influences response. DESIGN--Sample survey. SETTING--20 wards in five hospitals in the north east of England. PATIENTS--2078 patients in general medical and surgical wards. MAIN MEASURES-- Experiences of and satisfaction with nursing care. RESULTS--75% of patients approached to complete the questionnaires did so. Construct validity and internal consistency were both satisfactory. Both the experience and satisfaction scales were found to detect differences between randomly selected wards and hospitals. A sample of patients (102) were sent a further questionnaire to complete at home. 73% returned this; no significant differences were found in either experience or satisfaction scores between questionnaires given in hospital or at home. CONCLUSION--Scales to measure patients' experiences of and satisfaction with nursing in acute care have been developed and found to be valid, reliable, and able to detect differences between hospitals and wards. Questionnaires can be given before patients leave hospital or at home without affecting scores, but those given at home have a lower response rate.
Optimization of an Image-Guided Laser-Induced Choroidal Neovascularization Model in Mice
The mouse model of laser-induced choroidal neovascularization (CNV) has been used in studies of the exudative form of age-related macular degeneration using both the conventional slit lamp and a new image-guided laser system. A standardized protocol is needed for consistent results using this model, which has been lacking. We optimized details of laser-induced CNV using the image-guided laser photocoagulation system. Four lesions with similar size were consistently applied per eye at approximately double the disc diameter away from the optic nerve, using different laser power levels, and mice of various ages and genders. After 7 days, the mice were sacrificed and retinal pigment epithelium/choroid/sclera was flat-mounted, stained with Isolectin B4, and imaged. Quantification of the area of the laser-induced lesions was performed using an established and constant threshold. Exclusion criteria are described that were necessary for reliable data analysis of the laser-induced CNV lesions. The CNV lesion area was proportional to the laser power levels. Mice at 12-16 weeks of age developed more severe CNV than those at 6-8 weeks of age, and the gender difference was only significant in mice at 12-16 weeks of age, but not in those at 6-8 weeks of age. Dietary intake of omega-3 long-chain polyunsaturated fatty acid reduced laser-induced CNV in mice. Taken together, laser-induced CNV lesions can be easily and consistently applied using the image-guided laser platform. Mice at 6-8 weeks of age are ideal for the laser-induced CNV model.
Bevacizumab for advanced cervical cancer: final overall survival and adverse event analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240)
On Aug 14, 2014, the US Food and Drug Administration approved the antiangiogenesis drug bevacizumab for women with advanced cervical cancer on the basis of improved overall survival (OS) after the second interim analysis (in 2012) of 271 deaths in the Gynecologic Oncology Group (GOG) 240 trial. In this study, we report the prespecified final analysis of the primary objectives, OS and adverse events. In this randomised, controlled, open-label, phase 3 trial, we recruited patients with metastatic, persistent, or recurrent cervical carcinoma from 81 centres in the USA, Canada, and Spain. Inclusion criteria included a GOG performance status score of 0 or 1; adequate renal, hepatic, and bone marrow function; adequately anticoagulated thromboembolism; a urine protein to creatinine ratio of less than 1; and measurable disease. Patients who had received chemotherapy for recurrence and those with non-healing wounds or active bleeding conditions were ineligible. We randomly allocated patients 1:1:1:1 (blocking used; block size of four) to intravenous chemotherapy of either cisplatin (50 mg/m2 on day 1 or 2) plus paclitaxel (135 mg/m2 or 175 mg/m2 on day 1) or topotecan (0·75 mg/m2 on days 1–3) plus paclitaxel (175 mg/m2 on day 1) with or without intravenous bevacizumab (15 mg/kg on day 1) in 21 day cycles until disease progression, unacceptable toxic effects, voluntary withdrawal by the patient, or complete response. We stratified randomisation by GOG performance status (0 vs 1), previous radiosensitising platinum-based chemotherapy, and disease status (recurrent or persistent vs metastatic). We gave treatment open label. Primary outcomes were OS (analysed in the intention-to-treat population) and adverse events (analysed in all patients who received treatment and submitted adverse event information), assessed at the second interim and final analysis by the masked Data and Safety Monitoring Board. The cutoff for final analysis was 450 patients with 346 deaths. This trial is registered with ClinicalTrials.gov, number NCT00803062. Between April 6, 2009, and Jan 3, 2012, we enrolled 452 patients (225 [50%] in the two chemotherapy-alone groups and 227 [50%] in the two chemotherapy plus bevacizumab groups). By March 7, 2014, 348 deaths had occurred, meeting the prespecified cutoff for final analysis. The chemotherapy plus bevacizumab groups continued to show significant improvement in OS compared with the chemotherapy-alone groups: 16·8 months in the chemotherapy plus bevacizumab groups versus 13·3 months in the chemotherapy-alone groups (hazard ratio 0·77 [95% CI 0·62–0·95]; p=0·007). Final OS among patients not receiving previous pelvic radiotherapy was 24·5 months versus 16·8 months (0·64 [0·37–1·10]; p=0·11). Postprogression OS was not significantly different between the chemotherapy plus bevacizumab groups (8·4 months) and chemotherapy-alone groups (7·1 months; 0·83 [0·66–1·05]; p=0·06). Fistula (any grade) occurred in 32 (15%) of 220 patients in the chemotherapy plus bevacizumab groups (all previously irradiated) versus three (1%) of 220 in the chemotherapy-alone groups (all previously irradiated). Grade 3 fistula developed in 13 (6%) versus one (<1%). No fistulas resulted in surgical emergencies, sepsis, or death. The benefit conferred by incorporation of bevacizumab is sustained with extended follow-up as evidenced by the overall survival curves remaining separated. After progression while receiving bevacizumab, we did not observe a negative rebound effect (ie, shorter survival after bevacizumab is stopped than after chemotherapy alone is stopped). These findings represent proof-of-concept of the efficacy and tolerability of antiangiogenesis therapy in advanced cervical cancer. National Cancer Institute.
Bevacizumab for advanced cervical cancer: patient-reported outcomes of a randomised, phase 3 trial (NRG Oncology–Gynecologic Oncology Group protocol 240)
GOG 240 was a practice-changing randomised phase 3 trial that concluded that chemotherapy plus bevacizumab for advanced cervical cancer significantly improves overall and progression-free survival, and the proportion of patients achieving an overall objective response, compared with chemotherapy alone. In this study, we aimed to analyse patient-reported outcomes in GOG 240. Eligible adult participants (aged ≥18 years) had primary stage IVB or recurrent or persistent carcinoma of the cervix with measurable disease and GOG performance status of 0–1. Participants were randomly assigned by web-based permuted block randomisation (block size 4) in a 1:1:1:1 ratio to the four treatment groups: cisplatin (50 mg/m2 intravenously on day 1 or 2 of the treatment cycle) and paclitaxel (135 mg/m2 intravenously over 24 h or 175 mg/m2 intravenously over 3 h on day 1), with or without bevacizumab (15 mg/kg intravenously on day 1 or 2), or paclitaxel (175 mg/m2 over 3 h on day 1) and topotecan (0·75 mg/m2 for 30 min on days 1–3) with or without bevacizumab (15 mg/kg intravenously on day 1). Treatment assignment was concealed at randomisation (everyone was masked to treatment assignment, achieved by the use of a computer encrypted numbering system at the National Cancer Institute) and became open-label when each patient was registered to the trial. Treatment cycles were repeated every 21 days until disease progression or unacceptable toxicity, whichever occurred first. The coprimary endpoints of the trial were overall survival and safety; the primary quality-of-life endpoint was the score on the Functional Assessment of Cancer Therapy-Cervix Trial Outcome Index (FACT-Cx TOI). For our analysis of patient-reported outcomes, participants were assessed before treatment cycles 1, 2, and 5, and at 6 and 9 months after the start of cycle 1, with the FACT-Cx TOI, items from the FACT-GOG-Neurotoxicity subscale, and a worst pain item from the Brief Pain Inventory. All patients who completed baseline quality-of-life assessments and at least one further follow-up assessment were evaluable for quality-of-life outcomes. This study is registered with ClinicalTrials.gov, number NCT00803062. Between April 6, 2009, and Jan 3, 2012, a total of 452 patients were enrolled in the trial, of whom 390 completed baseline quality-of-life assessment and at least one further assessment and were therefore evaluable for quality-of-life outcomes. In these patients, patient-reported outcome completion declined from 426 (94%) of 452 (at baseline) to 193 (63%) of 307 (9 months post-cycle 1), but completion rates did not differ significantly between treatment regimens (p=0·78). The baseline FACT-Cx TOI scores did not differ significantly between patients who received bevacizumab versus those who did not (p=0·27). Compared with patients who received chemotherapy alone, patients who received chemotherapy plus bevacizumab reported FACT-Cx TOI scores that were an average of 1·2 points lower (98·75% CI −4·1 to 1·7; p=0·30). Improvements in overall survival and progression-free survival attributed to the incorporation of bevacizumab into the treatment of advanced cervical cancer were not accompanied by any significant deterioration in health-related quality of life. Patients responding to anti-angiogenesis therapy who maintain an acceptable quality of life could be suitable at progression for treatment with other novel therapies that might confer additional benefit. National Institutes of Health.