Improvements in vision-related quality of life in blind patients implanted with the Argus II Epiretinal Prosthesis

Background: The purpose of this analysis is to report the change in quality of life (QoL) after treatment with the Argus II Epiretinal Prosthesis in patients with end-stage retinitis pigmentosa. Methods: The Vision and Quality of Life Index (VisQoL) was used to assess changes in QoL dimensions and overall utility score in a prospective 30-patient single-arm clinical study. VisQoL is a multi-attribute instrument consisting of six dimensions (injury, life, roles, assistance, activity and friendship) that may be affected by visual impairment. Within each dimension, patients were divided into two groups based on how much their QoL was affected by their blindness at baseline (moderate/severe or minimal). Outcomes were compared within each dimension sub-group between baseline and the combined follow-up periods using the Friedman test. In addition, data from the six dimensions were combined into a single utility score, with baseline data compared to the combined follow-up periods. Results: Overall, 80 per cent of the patients reported difficulty in one or more dimensions preimplant. Composite VisQoL utility scores at follow-up showed no statistically significant change from baseline; however, in three of the six VisQoL dimensions (injury, life and roles), patients with baseline deficits showed significant and lasting improvement after implantation with Argus II. In two of the three remaining dimensions (assistance and activity), data trended toward an improvement. In the final VisQoL dimension (friendship), none of the patients reported baseline deficits, suggesting that patients had largely adjusted to this attribute. Conclusion: Patients whose vision negatively affected them with respect to three VisQoL dimensions (that is, getting injured, coping with the demands of their life and fulfilling their life roles) reported significant improvement in QoL after implantation of the Argus II retinal prosthesis. Furthermore, the benefit did not deteriorate at any point during the 36-month follow-up, suggesting a long-term, durable improvement

Economic costs of minor depression: a population-based study

Objective: Although the clinical relevance of minor depression has been demonstrated in many studies, the economic costs are not well explored. In this study, we examine the economic costs of minor depression. Method: In a large-scale, population-based study in the Netherlands (n ¼ 5504) the costs of minor depression were compared with the costs of major depression and dysthymia. Excess costs, i.e. the costs of a disorder over and above the costs attributable to other illnesses, were estimated with help of regression analysis. The direct medical costs, the direct non-medical costs and the indirect non-medical costs were calculated. The year 2003 was used as the reference year. Results: The annual per capita excess costs of minor depression were US$2141 (95$ 1023, while the costs of major depression were US$ 3313 (95% CI ¼ 1234–5390) higher than the base rate. The costs of minor depression per 1 million inhabitants were 160 million dollars per year, which is somewhat less than the costs of major depression (192 million dollars per year). Conclusion: The economic costs associated with minor depression are considerable and approach those of major depression

Comparing the immune response to a novel intranasal nanoparticle PLGA vaccine and a commercial BPI3V vaccine in dairy calves

peer-reviewedBackground There is a need to improve vaccination against respiratory pathogens in calves by stimulation of local immunity at the site of pathogen entry at an early stage in life. Ideally such a vaccine preparation would not be inhibited by the maternally derived antibodies. Additionally, localized immune response at the site of infection is also crucial to control infection at the site of entry of virus. The present study investigated the response to an intranasal bovine parainfluenza 3 virus (BPI3V) antigen preparation encapsulated in PLGA (poly dl-lactic-co-glycolide) nanoparticles in the presence of pre-existing anti-BPI3V antibodies in young calves and comparing it to a commercially available BPI3V respiratory vaccine. Results There was a significant (P < 0.05) increase in BPI3V-specific IgA in the nasal mucus of the BPI3V nanoparticle vaccine group alone. Following administration of the nanoparticle vaccine an early immune response was induced that continued to grow until the end of study and was not observed in the other treatment groups. Virus specific serum IgG response to both the nanoparticle vaccine and commercial live attenuated vaccine showed a significant (P < 0.05) rise over the period of study. However, the cell mediated immune response observed didn’t show any significant rise in any of the treatment groups. Conclusion Calves administered the intranasal nanoparticle vaccine induced significantly greater mucosal IgA responses, compared to the other treatment groups. This suggests an enhanced, sustained mucosal-based immunological response to the BPI3V nanoparticle vaccine in the face of pre-existing antibodies to BPI3V, which are encouraging and potentially useful characteristics of a candidate vaccine. However, ability of nanoparticle vaccine in eliciting cell mediated immune response needs further investigation. More sustained local mucosal immunity induced by nanoparticle vaccine has obvious potential if it translates into enhanced protective immunity in the face of virus outbreak

Forced migrants involved in setting the agenda and designing research to reduce impacts of complex emergencies: combining Swarm with patient and public involvement

Background: Many events with wide-ranging negative health impacts are notable for complexity: lack of predictability, non-linear feedback mechanisms and unexpected consequences. A multi-disciplinary research team was tasked with reducing the public health impacts from complex events, but without a pre-specified topic area or research design. This report describes using patient and public involvement within an adaptable but structured development process to set research objectives and aspects of implementation. Methods: An agile adaptive development approach, sometimes described as swarm, was used to identify possible research areas. Swarm is meant to quickly identify strengths and weaknesses of any candidate project, to accelerate early failure before resources are invested. When aspects of the European migration crisis were identified as a potential priority topic area, two representatives of forced migrant communities were recruited to explore possible research ideas. These representatives helped set the specific research objectives and advised on aspects of implementation, still within the swarm framework for project development. Results: Over ten months, many research ideas were considered by the collaborative working group in a series of six group meetings, supplemented by email contact in between. Up to four possible research ideas were scrutinised at any one meeting, with a focus on identifying practical or desirable aspects of each proposed project. Interest settled on a study to solicit original data about successful strategies that forced migrants use to adapt to life in the UK, with an emphasis on successfully promoting resilience and minimizing emotional distress. “Success in resettlement” was identified to be a more novel theme than “barriers to adaption” research. A success approach encourages participation when individuals may find discussion of mental illness stigmatising. The patient representatives helped with design of patient-facing and interview training materials, interviewer training (mock interviews), and aspects of the recruitment. Conclusion: Using patient and public involvement (PPI) within an early failure development approach that itself arises from theory on complex adaptive systems, we successfully implemented a dynamic development process to determine research topic and study design. The PPI representatives were closely involved in setting research objectives and aspects of implementation

Rasch model analysis of the Depression, Anxiety and Stress Scales (DASS)

<p>Abstract</p> <p>Background</p> <p>There is a growing awareness of the need for easily administered, psychometrically sound screening tools to identify individuals with elevated levels of psychological distress. Although support has been found for the psychometric properties of the Depression, Anxiety and Stress Scales (DASS) using classical test theory approaches it has not been subjected to Rasch analysis. The aim of this study was to use Rasch analysis to assess the psychometric properties of the DASS-21 scales, using two different administration modes.</p> <p>Methods</p> <p>The DASS-21 was administered to 420 participants with half the sample responding to a web-based version and the other half completing a traditional pencil-and-paper version. Conformity of DASS-21 scales to a Rasch partial credit model was assessed using the RUMM2020 software.</p> <p>Results</p> <p>To achieve adequate model fit it was necessary to remove one item from each of the DASS-21 subscales. The reduced scales showed adequate internal consistency reliability, unidimensionality and freedom from differential item functioning for sex, age and mode of administration. Analysis of all DASS-21 items combined did not support its use as a measure of general psychological distress. A scale combining the anxiety and stress items showed satisfactory fit to the Rasch model after removal of three items.</p> <p>Conclusion</p> <p>The results provide support for the measurement properties, internal consistency reliability, and unidimensionality of three slightly modified DASS-21 scales, across two different administration methods. The further use of Rasch analysis on the DASS-21 in larger and broader samples is recommended to confirm the findings of the current study.</p

Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science

Abstract Background Many interventions found to be effective in health services research studies fail to translate into meaningful patient care outcomes across multiple contexts. Health services researchers recognize the need to evaluate not only summative outcomes but also formative outcomes to assess the extent to which implementation is effective in a specific setting, prolongs sustainability, and promotes dissemination into other settings. Many implementation theories have been published to help promote effective implementation. However, they overlap considerably in the constructs included in individual theories, and a comparison of theories reveals that each is missing important constructs included in other theories. In addition, terminology and definitions are not consistent across theories. We describe the Consolidated Framework For Implementation Research (CFIR) that offers an overarching typology to promote implementation theory development and verification about what works where and why across multiple contexts. Methods We used a snowball sampling approach to identify published theories that were evaluated to identify constructs based on strength of conceptual or empirical support for influence on implementation, consistency in definitions, alignment with our own findings, and potential for measurement. We combined constructs across published theories that had different labels but were redundant or overlapping in definition, and we parsed apart constructs that conflated underlying concepts. Results The CFIR is composed of five major domains: intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation. Eight constructs were identified related to the intervention (e.g., evidence strength and quality), four constructs were identified related to outer setting (e.g., patient needs and resources), 12 constructs were identified related to inner setting (e.g., culture, leadership engagement), five constructs were identified related to individual characteristics, and eight constructs were identified related to process (e.g., plan, evaluate, and reflect). We present explicit definitions for each construct. Conclusion The CFIR provides a pragmatic structure for approaching complex, interacting, multi-level, and transient states of constructs in the real world by embracing, consolidating, and unifying key constructs from published implementation theories. It can be used to guide formative evaluations and build the implementation knowledge base across multiple studies and settings.http://deepblue.lib.umich.edu/bitstream/2027.42/78272/1/1748-5908-4-50.xmlhttp://deepblue.lib.umich.edu/bitstream/2027.42/78272/2/1748-5908-4-50-S1.PDFhttp://deepblue.lib.umich.edu/bitstream/2027.42/78272/3/1748-5908-4-50-S3.PDFhttp://deepblue.lib.umich.edu/bitstream/2027.42/78272/4/1748-5908-4-50-S4.PDFhttp://deepblue.lib.umich.edu/bitstream/2027.42/78272/5/1748-5908-4-50.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/78272/6/1748-5908-4-50-S2.PDFPeer Reviewe

Cost-effectiveness of problem-solving treatment in comparison with usual care for primary care patients with menthal health problems: a randomized trial

BACKGROUND: Mental health problems are common and are associated with increased disability and health care costs. Problem-Solving Treatment (PST) delivered to these patients by nurses in primary care might be efficient. The aim of this study was to evaluate the cost-effectiveness of PST by mental health nurses compared with usual care (UC) by the general practitioner for primary care patients with mental health problems. METHODS: An economic evaluation from a societal perspective was performed alongside a randomized clinical trial. Patients with a positive General Health Questionnaire score (score ≥ 4) and who visited their general practitioner at least three times during the past 6 months were eligible. Outcome measures were improvement on the Hospital Anxiety and Depression Scale and QALYs based on the EQ-5D. Resource use was measured using a validated questionnaire. Missing cost and effect data were imputed using multiple imputation techniques. Bootstrapping was used to analyze costs and cost-effectiveness of PST compared with UC. RESULTS: There were no statistically significant differences in clinical outcomes at 9 months. Mean total costs were €4795 in the PST group and €6857 in the UC group. Costs were not statistically significantly different between the two groups (95% CI -4698;359). The cost-effectiveness analysis showed that PST was cost-effective in comparison with UC. Sensitivity analyses confirmed these findings. CONCLUSIONS: PST delivered by nurses seems cost-effective in comparison with UC. However, these results should be interpreted with caution, since the difference in total costs was mainly caused by 3 outliers with extremely high indirect costs in the UC group. TRIAL REGISTRATION: Nederlands Trial Register ISRCTN5102101

An Integrative Approach to Understanding Counterproductive Work Behavior: The Roles of Stressors, Negative Emotions, and Moral Disengagement

Several scholars have highlighted the importance of examining moral disengagement (MD) in understanding aggression and deviant conduct across different contexts. The present study investigates the role of MD as a specific social-cognitive construct that, in the organizational context, may intervene in the process leading from stressors to counterproductive work behavior (CWB). Assuming the theoretical framework of the stressor-emotion model of CWB, we hypothesized that MD mediates, at least partially, the relation between negative emotions in reaction to perceived stressors and CWB by promoting or justifying aggressive responses to frustrating situations or events. In a sample of 1,147 Italian workers, we tested a structural equations model. The results support our hypothesis: the more workers experienced negative emotions in response to stressors, the more they morally disengaged and, in turn, enacted CW

A primary care, multi-disciplinary disease management program for opioid-treated patients with chronic non-cancer pain and a high burden of psychiatric comorbidity

BACKGROUND: Chronic non-cancer pain is a common problem that is often accompanied by psychiatric comorbidity and disability. The effectiveness of a multi-disciplinary pain management program was tested in a 3 month before and after trial. METHODS: Providers in an academic general medicine clinic referred patients with chronic non-cancer pain for participation in a program that combined the skills of internists, clinical pharmacists, and a psychiatrist. Patients were either receiving opioids or being considered for opioid therapy. The intervention consisted of structured clinical assessments, monthly follow-up, pain contracts, medication titration, and psychiatric consultation. Pain, mood, and function were assessed at baseline and 3 months using the Brief Pain Inventory (BPI), the Center for Epidemiological Studies-Depression Scale scale (CESD) and the Pain Disability Index (PDI). Patients were monitored for substance misuse. RESULTS: Eighty-five patients were enrolled. Mean age was 51 years, 60% were male, 78% were Caucasian, and 93% were receiving opioids. Baseline average pain was 6.5 on an 11 point scale. The average CESD score was 24.0, and the mean PDI score was 47.0. Sixty-three patients (73%) completed 3 month follow-up. Fifteen withdrew from the program after identification of substance misuse. Among those completing 3 month follow-up, the average pain score improved to 5.5 (p = 0.003). The mean PDI score improved to 39.3 (p < 0.001). Mean CESD score was reduced to 18.0 (p < 0.001), and the proportion of depressed patients fell from 79% to 54% (p = 0.003). Substance misuse was identified in 27 patients (32%). CONCLUSIONS: A primary care disease management program improved pain, depression, and disability scores over three months in a cohort of opioid-treated patients with chronic non-cancer pain. Substance misuse and depression were common, and many patients who had substance misuse identified left the program when they were no longer prescribed opioids. Effective care of patients with chronic pain should include rigorous assessment and treatment of these comorbid disorders and intensive efforts to insure follow up

Health care reform and job satisfaction of primary health care physicians in Lithuania

BACKGROUND: The aim of this research paper is to study job satisfaction of physicians and general practitioners at primary health care institutions during the health care reform in Lithuania. METHODS: Self-administrated anonymous questionnaires were distributed to all physicians and general practitioners (N = 243, response rate – 78.6%), working at Kaunas primary health care level establishments, in October – December 2003. RESULTS: 15 men (7.9%) and 176 women (92.1%) participated in the research, among which 133 (69.6%) were GPs and 58 (30.4%) physicians. Respondents claimed to have chosen to become doctors, as other professions were of no interest to them. Total job satisfaction of the respondents was 4.74 point (on a 7 point scale). Besides 75.5% of the respondents said they would not recommend their children to choose a PHC level doctor's profession. The survey also showed that the respondents were most satisfied with the level of autonomy they get at work – 5.28, relationship with colleagues – 5.06, and management quality – 5.04, while compensation (2.09), social status (3.36), and workload (3.93) turned to be causing the highest dissatisfaction among the respondents. The strongest correlation (Spearmen's ratio) was observed between total job satisfaction and such factors as the level of autonomy – 0.566, workload – 0.452, and GP's social status – 0.458. CONCLUSION: Total job satisfaction of doctors working at primary health care establishments in Lithuania is relatively low, and compensation, social status, and workload are among the key factors that condition PHC doctors' dissatisfaction with their job