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1.  Enhancing recovery rates: Lessons from year one of IAPT☆ 
Behaviour Research and Therapy  2013;51(9):597-606.
Background
The English Improving Access to Psychological Therapies (IAPT) initiative aims to make evidence-based psychological therapies for depression and anxiety disorder more widely available in the National Health Service (NHS). 32 IAPT services based on a stepped care model were established in the first year of the programme. We report on the reliable recovery rates achieved by patients treated in the services and identify predictors of recovery at patient level, service level, and as a function of compliance with National Institute of Health and Care Excellence (NICE) Treatment Guidelines.
Method
Data from 19,395 patients who were clinical cases at intake, attended at least two sessions, had at least two outcomes scores and had completed their treatment during the period were analysed. Outcome was assessed with the patient health questionnaire depression scale (PHQ-9) and the anxiety scale (GAD-7).
Results
Data completeness was high for a routine cohort study. Over 91% of treated patients had paired (pre-post) outcome scores. Overall, 40.3% of patients were reliably recovered at post-treatment, 63.7% showed reliable improvement and 6.6% showed reliable deterioration. Most patients received treatments that were recommended by NICE. When a treatment not recommended by NICE was provided, recovery rates were reduced. Service characteristics that predicted higher reliable recovery rates were: high average number of therapy sessions; higher step-up rates among individuals who started with low intensity treatment; larger services; and a larger proportion of experienced staff.
Conclusions
Compliance with the IAPT clinical model is associated with enhanced rates of reliable recovery.
Highlights
•We studied clinical outcomes in 19,395 patients who completed treatment in year one of the IAPT programme.•Overall 40.3% of patients showed reliable recovery, 63.7% showed reliable improvement and 6.6% showed reliable deterioration.•Considerable between service variability in outcomes was observed.•Several service and patient level predictors of outcome were identified.•Compliance with NICE treatment guidelines was associated with improved outcomes.
doi:10.1016/j.brat.2013.06.004
PMCID: PMC3776229  PMID: 23872702
Depression; Anxiety disorders; IAPT; Psychological therapies; NICE; CBT; Dissemination; Outcome monitoring
2.  NICE guidance: a comparative study of the introduction of the single technology appraisal process and comparison with guidance from Scottish Medicines Consortium 
BMJ Open  2012;2(1):e000671.
Objectives
To compare the timelines and recommendations of the Scottish Medicines Consortium (SMC) and National Institute of Health and Clinical Excellence (NICE), in particular since the single technology assessment (STA) process was introduced in 2005.
Design
Comparative study of drug appraisals published by NICE and SMC.
Setting
NICE and SMC.
Participants
All drugs appraised by SMC and NICE, from establishment of each organisation until August 2010, were included. Data were gathered from published reports on the NICE website, SMC annual reports and European Medicines Agency website.
Primary and secondary outcome measures
Primary outcome was time from marketing authorisation until publication of first guidance. The final outcome for each drug was documented. Drug appraisals by NICE (before and after the introduction of the STA process) and SMC were compared.
Results
NICE and SMC appraised 140 drugs, 415 were appraised by SMC alone and 102 by NICE alone. NICE recommended, with or without restriction, 90% of drugs and SMC 80%. SMC published guidance more quickly than NICE (median 7.4 compared with 21.4 months). Overall, the STA process reduced the average time to publication compared with multiple technology assessments (median 16.1 compared with 22.8 months). However, for cancer medications, the STA process took longer than multiple technology assessment (25.2 compared with 20.0 months).
Conclusions
Proportions of drugs recommended for NHS use by SMC and NICE are similar. SMC publishes guidance more quickly than NICE. The STA process has improved the time to publication but not for cancer drugs. The lengthier time for NICE guidance is partly due to measures to provide transparency and the widespread consultation during the NICE process.
Article summary
Article focus
Has the STA process resulted in speedier guidance for NICE?
What are the differences in recommendation and timelines between SMC and NICE?
Key messages
The STA system has resulted in speedier guidance for some drugs but not for cancer drugs.
SMC publishes speedier guidance than NICE.
SMC and NICE recommend a similar proportion of drugs.
Strength and limitations of this study
Although some differences by SMC and NICE are shown, it is not possible in this study to say which is correct.
Accuracy of outcome data taken from NICE website and SMC annual reports is unclear.
doi:10.1136/bmjopen-2011-000671
PMCID: PMC3269048  PMID: 22290398
3.  An evaluation of the impact of NICE guidance on GP prescribing. 
BACKGROUND: One of the aims of the National Institute for Clinical Excellence (NICE) is to promote faster access to the best treatments. However, there is no published research on the impact that NICE guidance has had on prescribing decisions. AIMS: To explore the attitudes of general practitioners (GPs) to NICE guidance and to investigate any changes in prescribing patterns. DESIGN: Descriptive cross-sectional study. SETTING: North Devon Primary Care Trust. METHOD: Five technology appraisals most likely to impact on GP prescribing were investigated. Prescribing analysis and cost (PACT) data were analysed for changes in prescribing patterns before and after the publication of each technology appraisal. A postal questionnaire, developed from semi-structured interviews, was sent to all GPs within a single primary care trust (PCT) to explore factors that were encouraging or discouraging adherence to NICE guidance. RESULTS: PACT data showed that there was an increase in the prescribing of the drugs studied immediately after NICE guidance, with the exception of zanamivir (Relenza [GlaxoSmithKline]); only one zanamivir inhaler was prescribed during the study period. Although there was an increase in the prescribing of maintenance doses of proton pump inhibitors, there was also an increase in treatment doses. Eighty-one (82.7%) questionnaires were completed and returned. In general, there was a balance between the factors that encouraged and those that discouraged adherence. The main exception was zanamivir, where factors that discouraged adherence greatly exceeded factors that encouraged adherence. CONCLUSIONS: This study showed that NICE guidance in isolation had little impact on GP prescribing. Where the guidance coincided with information from other sources, or personal experience, there was some evidence that technology appraisals triggered an increase in prescribing, but that this was not always sustained. The recommendations of NICE concerning zanamivir were universally rejected and there was evidence that this had undermined confidence in NICE recommendations in general.
PMCID: PMC1314802  PMID: 14965388
4.  Reconstructing Tuberculosis Services after Major Conflict: Experiences and Lessons Learned in East Timor 
PLoS Medicine  2006;3(10):e383.
Background
Tuberculosis (TB) is a major public health problem in developing countries. Following the disruption to health services in East Timor due to violent political conflict in 1999, the National Tuberculosis Control Program was established, with a local non-government organisation as the lead agency. Within a few months, the TB program was operational in all districts.
Methods and Findings
Using the East Timor TB program as a case study, we have examined the enabling factors for the implementation of this type of communicable disease control program in a post-conflict setting. Stakeholder analysis was undertaken, and semi-structured interviews were conducted in 2003 with 24 key local and international stakeholders. Coordination, cooperation, and collaboration were identified as major contributors to the success of the TB program. The existing local structure and experience of the local non-government organisation, the commitment among local personnel and international advisors to establishing an effective program, and the willingness of international advisers and local counterparts to be flexible in their approach were also important factors. This success was achieved despite major impediments, including mass population displacement, lack of infrastructure, and the competing interests of organisations working in the health sector.
Conclusions
Five years after the conflict, the TB program continues to operate in all districts with high notification rates, although the lack of a feeling of ownership by government health workers remains a challenge. Lessons learned in East Timor may be applicable to other post-conflict settings where TB is highly prevalent, and may have relevance to other disease control programs.
A qualitative study of re-introduction of tuberculosis services in East Timor in 1999, after a period of civil conflict, concluded coordination, cooperation, and collaboration contributed to the success achieved.
Editors' Summary
Background.
Tuberculosis is an infectious disease and one of the world's most serious health problems. It causes between 2 million and 3 million deaths every year, most of them in developing countries. The success of national control programs has varied considerably between countries. In times of war or other emergencies, control efforts are considerably hampered. East Timor is a former Portuguese colony in Southeast Asia annexed by Indonesia in 1975. It is a small country of about 1 million people situated some 500 miles northwest of Australia. In 1999, following a referendum on independence from Indonesia, violent civil conflict led to the destruction of much of East Timor's health-care system. As tuberculosis was known to be one of the country's biggest health problems, efforts to improve treatment were launched during the transition to independence in 2002. Several organizations, led by a local non-government organization (NGO), Caritas East Timor, collaborated in the new program. Many difficulties had to be overcome, including the forced movement of people away from their homes during the fighting, the departure of many health-care workers from the country, and the destruction of health-care facilities. Nevertheless, in its first three years the program diagnosed and commenced treatment on 10,722 patients. The rate of treatment success reached 81% in 2003, which—in international terms—is regarded as very high.
Why Was This Study Done?
The researchers wanted to find out from the people involved with the program how well they thought it was performing, what its strengths were, and what remained to be achieved. The lessons learned could be of use in other countries, particularly those recovering from civil conflict and other emergencies.
What Did the Researchers Do and Find?
In 2003, the researchers reviewed all available documents that had been written about the tuberculosis program. They also carried out interviews with 24 senior people involved with the program. Some of them were East Timorese, and some were from international organizations. The questions asked in the interviews were semi-structured. In other words, the researchers wanted to make sure that certain topics were covered but also wanted the people they questioned to have freedom in the way they gave their answers; they were not restricted to answering only “yes” or “no.” This kind of approach, where there is no gathering of precise figures that can be mathematically analyzed, is known as qualitative research.
The national tuberculosis program was considered to be working well in 2003. The researchers concluded that good coordination, cooperation, and collaboration were the most important factors contributing to the successes that had been achieved. The existing local structure and experience of the local NGO, the commitment among local personnel and international advisors to establishing an effective program, and the willingness of international advisers and local counterparts to be flexible in their approach were also important factors. The feeling among some government health workers that they lacked “ownership” of the program was one problem that still needed to be overcome.
What Do These Findings Mean?
Even after a major conflict, it was possible to launch an effective tuberculosis program in East Timor. Other countries in similar situations might be able to achieve success by applying the same approach. Unfortunately, renewed conflict broke out in East Timor in 2006. It will again be necessary to restore services, putting to use the lessons already learned.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030383.
Basic information about tuberculosis can be found on the Web site of the US National Institute of Allergy and Infectious Diseases
The Web site of the World Health Organization's Stop TB department describes the recommended strategies for tuberculosis control
TB Alert, a UK-based charity that promotes tuberculosis awareness worldwide, has information on tuberculosis in several European, African, and Asian languages
A country profile of East Timor is available on the BBC Web site
doi:10.1371/journal.pmed.0030383
PMCID: PMC1550733  PMID: 16933956
5.  Impact of the QOF and the NICE guideline in the diagnosis andmanagement of depression: a qualitative study 
The British Journal of General Practice  2011;61(586):e279-e289.
Background
The National Institute for Health and clinical Excellence (NICE) depression guideline (2004) and the updated Quality and Outcomes Framework (QOF) ( 2006) in general practice have introduced the concepts of screening severity assessment, for example using the Patient Health Questionnaire 9 (PHQ-9), and ‘stepped care’ for depression.
Aim
To explore primary care practitioner perspectives on the clinical utility of the NICE guideline and the impact of the QOF on diagnosis and management of depression in routine practice.
Design and setting
Qualitative study using focus groups from four multidisciplinary practice teams with diverse populations in south Yorkshire.
Method
Four focus groups were conducted, using a topic guide and audiotaping. There were 38 participants: GPs, nurses, doctors in training, mental health workers, and a manager. Data analysis was iterative and thematic.
Results
The NICE guideline, with its embedded principles of holism and evidence-based practice, was viewed positively but its impact was compromised by resource and practitioner barriers to implementation. The perceived imposition of the screening questions and severity assessments (PHQ-9) with no responsive training had required practitioners to work hard to minimise negative impacts on their work, for example: constantly adapting consultations to tick boxes; avoiding triggering open displays of distress without the time to offer appropriate care; positively managing how their patients were labelled. Further confusion was experienced around the evolving content of psychological interventions for depression.
Conclusion
Organisational barriers to the implementation of the NICE guideline and the limited scope of the QOF highlight the need for policy makers to work more effectively with the complex realities of general practice in order to systematically improve the quality and delivery of ‘managed’ care for depression.
doi:10.3399/bjgp11X572472
PMCID: PMC3080233  PMID: 21619752
depression; primary health care; qualitative
6.  Implications of ICD-9/10 CM Transition for Public Health Surveillance: Challenges, Opportunities, and Lessons Learned from Multiple Sectors of Public Health 
Objective
To provide a forum for local, state, federal, and international public health/health care sectors to share promising practices and lessons learned in transitioning their organizations in the use of ICD-9 to ICD-10 codes for their respective surveillance activities.
Introduction
This roundtable will provide forum for a diverse set of representatives from the local, state, federal and international public health care sectors to share tools, resources, experiences, and promising practices regarding the potential impact of the transition on their surveillance activities. This forum will promote the sharing of lessons learned, foster collaborations, and facilitate the reuse of existing resources without having to “reinvent the wheel”. It is hope that this roundtable will lay the ground-work for a more formal, collaborative, and sustainable venue within ISDS to aid in preparing the public health surveillance community for the coming ICD-9/10 CM transition.
Methods
The moderators will engage the participants in the discussion through dialogue in how their programs are currently using ICD-9 CM codes for surveillance and how the transition will impact their respective programs.
PMCID: PMC3692847
ICD-9; ICD-10; Transition
7.  How pragmatic is it? Lessons learned using PRECIS and RE-AIM for determining pragmatic characteristics of research 
Background
The need for high-quality evidence that is applicable in real-world, routine settings continues to increase. Pragmatic trials are designed to evaluate the effectiveness of interventions in real-world settings, whereas explanatory trials aim to test whether an intervention works under optimal situations. There is a continuum between explanatory and pragmatic trials. Most trials have aspects of both, making it challenging to label and categorize a trial and to evaluate its potential for translation into practice.
Methods
We summarize our experience applying the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) combined with external validity items based on the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to three studies to provide a more robust and comprehensive assessment of trial characteristics related to translation of research. We summarize lessons learned using domains from the combined frameworks for use in study planning, evaluating specific studies, and reviewing the literature and make recommendations for future use.
Results
A variety of coders can be trained to use the PRECIS and RE-AIM domains. These domains can also be used for diverse purposes, content areas, and study types, but are not without challenges. Both PRECIS and RE-AIM domains required modification in two of the three studies to evaluate and rate domains specific to study type. Lessons learned involved: dedicating enough time for training activities related to the domains; use of reviewers with a range of familiarity with specific study protocols; how to best adapt ratings that reflect complex study designs; and differences of opinion regarding the value of creating a composite score for these criteria.
Conclusions
Combining both frameworks can specifically help identify where and how a study is and is not pragmatic. Using both PRECIS and RE-AIM allows for standard reporting of key study characteristics related to pragmatism and translation. Such measures should be used more consistently to help plan more pragmatic studies, evaluate progress, increase transparency of reporting, and integrate literature to facilitate translation of research into practice and policy.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0096-x) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-014-0096-x
PMCID: PMC4243945  PMID: 25163664
Pragmatic trials; External validity; Research translation; PRECIS; RE-AIM
8.  Yoga Lessons for Consciousness Research: A Paralimbic Network Balancing Brain Resource Allocation 
Consciousness has been proposed to play a key role in shaping flexible learning and as such is thought to confer an evolutionary advantage. Attention and awareness are the perhaps most important underlying processes, yet their precise relationship is presently unclear. Both of these processes must, however, serve the evolutionary imperatives of survival and procreation. They are thus intimately bound by reward and emotion to help to prioritize efficient brain resource allocation in order to predict and optimize behavior. Here we show how this process is served by a paralimbic network consisting primarily of regions located on the midline of the human brain. Using many different techniques, experiments have demonstrated that this network is effective and specific for self-awareness and contributes to the sense of unity of consciousness by acting as a common neural path for a wide variety of conscious experiences. Interestingly, hemodynamic activity in the network decreases with focusing on external stimuli, which has led to the idea of a default mode network. This network is one of many networks that wax and vane as resources are allocated to accommodate the different cyclical needs of the organism primarily related to the fundamental pleasures afforded by evolution: food, sex, and conspecifics. Here we hypothesize, however, that the paralimbic network serves a crucial role in balancing and regulating brain resource allocation, and discuss how it can be thought of as a link between current theories of so-called “default mode,” “resting state networks,” and “global workspace.” We show how major developmental disorders of self-awareness and self-control can arise from problems in the paralimbic network as demonstrated here by the example of Asperger syndrome. We conclude that attention, awareness, and emotion are integrated by a paralimbic network that helps to efficiently allocate brain resources to optimize behavior and help survival.
doi:10.3389/fpsyg.2011.00366
PMCID: PMC3241341  PMID: 22203808
consciousness; attention; reward; pleasure; cingulate cortex; orbitofrontal cortex; precuneus; paralimbic network
9.  Clinical Research After Catastrophic Disasters: Lessons Learned From Hurricane Katrina 
When catastrophic disasters such as Hurricane Katrina strike, psychologists and other mental health professionals often wonder how to use resources and fill needed roles. We argue that conducting clinical research in response to disasters is 1 important way that these professionals can contribute. However, we recognize that designing and implementing a clinical research study can be a daunting task, particularly in the context of the personal and system-wide chaos that follows most disasters. Thus, we offer a detailed description of our own experiences with conducting clinical research as part of our response to Hurricane Katrina. We describe our study design, recruitment and data collection efforts, and summarize and synthesize the lessons we have learned from this endeavor. Our hope is that others who may wish to conduct disaster-related research will learn from our mistakes and successes.
doi:10.1037/0735-7028.39.1.107
PMCID: PMC2631178  PMID: 19177173
clinical research; disasters; Hurricane Katrina; roles
10.  The practice of ‘doing’ evaluation: lessons learned from nine complex intervention trials in action 
Background
There is increasing recognition among trialists of the challenges in understanding how particular ‘real-life’ contexts influence the delivery and receipt of complex health interventions. Evaluations of interventions to change health worker and/or patient behaviours in health service settings exemplify these challenges. When interpreting evaluation data, deviation from intended intervention implementation is accounted for through process evaluations of fidelity, reach, and intensity. However, no such systematic approach has been proposed to account for the way evaluation activities may deviate in practice from assumptions made when data are interpreted.
Methods
A collective case study was conducted to explore experiences of undertaking evaluation activities in the real-life contexts of nine complex intervention trials seeking to improve appropriate diagnosis and treatment of malaria in varied health service settings. Multiple sources of data were used, including in-depth interviews with investigators, participant-observation of studies, and rounds of discussion and reflection.
Results and discussion
From our experiences of the realities of conducting these evaluations, we identified six key ‘lessons learned’ about ways to become aware of and manage aspects of the fabric of trials involving the interface of researchers, fieldworkers, participants and data collection tools that may affect the intended production of data and interpretation of findings. These lessons included: foster a shared understanding across the study team of how individual practices contribute to the study goals; promote and facilitate within-team communications for ongoing reflection on the progress of the evaluation; establish processes for ongoing collaboration and dialogue between sub-study teams; the importance of a field research coordinator bridging everyday project management with scientific oversight; collect and review reflective field notes on the progress of the evaluation to aid interpretation of outcomes; and these approaches should help the identification of and reflection on possible overlaps between the evaluation and intervention.
Conclusion
The lessons we have drawn point to the principle of reflexivity that, we argue, needs to become part of standard practice in the conduct of evaluations of complex interventions to promote more meaningful interpretations of the effects of an intervention and to better inform future implementation and decision-making.
doi:10.1186/1748-5908-9-75
PMCID: PMC4079170  PMID: 24935096
Complex interventions; Evaluation; Behavioural interventions; Health service; Low-income setting; Reflection; Trials
11.  50 years a biomedical engineer remembering a long and fascinating journey 
Looking back at one point of life appears as a nice exercise to round out and summarize. However, the objective should not be simply to tell a story; it must transmit a message to the young. To start with, two concepts are useful: Respect for others begins when you learn to laugh at yourself and, taken from an old saying, I did not want to be poor ... but money wouldn't make me rich. After elementary and high schools, during times of turmoil, I describe my engineering school years at the University of Buenos Aires and a working experience in an international telecommunications company. Significant events taught me a concept, rooted in another motto: Isn't this house nice? It is my house, and I love it very much. In 1960, I began my activities in the USA. A couple of bad decisions resulted in significant events for me teaching me an important truth: "Beware of golden promises; time is the most precious asset". Finally, in 1972, settled down in Tucumán until retirement in 2001, a long period of productive activity came about, not without difficulties and also stained by a dark political interval. Crises seem to characterize our generations in Argentina. Non-the-less, there were some real accomplishments: an undergraduate program in BME and a National BME Society (SABI) plus an archive of specialized published material. After spending time following retirement in Peru and Italy, my current activity came as unexpected dessert at the University of Buenos Aires, with a small research group, so offering the opportunity of transmitting what I still have available.
doi:10.1186/1475-925X-11-1
PMCID: PMC3286407  PMID: 22208504
12.  Student Perspectives on Curricular Change: Lessons from an Undergraduate Lower-Division Biology Core 
Inquiry-based laboratories are acknowledged as the preferred method of instruction for development of research skills. Much has been written about changes in student performance associated with inquiry, but less is known about how students view the inquiry-based format or whether they perceive a benefit from this type of instruction. The Student Assessment of Learning Gains (SALG) survey was used to evaluate and compare student reactions to the new, inquiry-based laboratories of a lower-division undergraduate curriculum, from implementation to the present (an interval of 3 yr). Initial student response to the format and value of the inquiry labs improved over time. The quality of the graduate teaching assistants and the clarity of the laboratory manual were important variables influencing student perception. A student's perception of his/her retention of lab-related skills was strongly associated with perceptions of gains in those skills. Student responses reflect their most current laboratory experience and not a cumulative effect of participation in the core series of courses. Student success in the inquiry format was not associated with gender or status as a transfer student. The majority of students believe that their experiences in the lower-division inquiry labs have prepared them for upper-division course work.
doi:10.1187/cbe.05-06-0084
PMCID: PMC1635130  PMID: 17012192
13.  Rapid HIV testing program implementation: lessons from the emergency department 
Background
The US Centers for Disease Control and Prevention (CDC) guidelines and the World Health Organization (WHO) both recommend HIV testing in health-care settings. However, neither organization provides prescriptive details regarding how these recommendations should be adapted into clinical practice in an emergency department.
Methods
We have implemented an HIV-testing program in the ED of a major academic medical center within the scope of the Universal Screening for HIV Infection in the Emergency Room (USHER) Trial—a randomized clinical trial evaluating the feasibility and cost-effectiveness of HIV screening in this setting.
Results and conclusion
Drawing on our collective experiences in establishing programs domestically and internationally, we offer a practical framework of lessons learned so that others poised to embark on such HIV testing programs may benefit from our experiences.
doi:10.1007/s12245-009-0123-x
PMCID: PMC2760703  PMID: 20157472
HIV; Testing; Screening; Emergency department
14.  Priority setting in health care: Lessons from the experiences of eight countries 
All health care systems face problems of justice and efficiency related to setting priorities for allocating a limited pool of resources to a population. Because many of the central issues are the same in all systems, the United States and other countries can learn from the successes and failures of countries that have explicitly addressed the question of health care priorities.
We review explicit priority setting efforts in Norway, Sweden, Israel, the Netherlands, Denmark, New Zealand, the United Kingdom and the state of Oregon in the US. The approaches used can be divided into those centered on outlining principles versus those that define practices. In order to establish the main lessons from their experiences we consider (1) the process each country used, (2) criteria to judge the success of these efforts, (3) which approaches seem to have met these criteria, and (4) using their successes and failures as a guide, how to proceed in setting priorities. We demonstrate that there is little evidence that establishment of a values framework for priority setting has had any effect on health policy, nor is there evidence that priority setting exercises have led to the envisaged ideal of an open and participatory public involvement in decision making.
doi:10.1186/1475-9276-7-4
PMCID: PMC2248188  PMID: 18208617
15.  Needle Exchange and the HIV Epidemic in Vancouver: Lessons Learned from 15 years of research 
During the mid-1990s, Vancouver experienced a well characterized HIV outbreak among injection drug users (IDU) and many questioned how this could occur in the presence of a high volume needle exchange program (NEP). Specific concerns were fuelled by early research demonstrating that frequent needle exchange program attendees were more likely to be HIV positive than those who attended the NEP less frequently. Since then, some have misinterpreted this finding as evidence that NEPs are ineffective or potentially harmful. In light of continuing questions about the Vancouver HIV epidemic, we review 15 years of peer-reviewed research on Vancouver’s NEP to describe what has been learned through this work. Our review demonstrates that: 1) NEP attendance is not causally associated with HIV infection, 2) frequent attendees of Vancouver’s NEP have higher risk profiles which explain their increased risk of HIV seroconversion, and 3) a number of policy concerns, as well as the high prevalence of cocaine injecting contributed to the failure of the NEP to prevent the outbreak. Additionally, we highlight several improvements to Vancouver’s NEP that contributed to declines in syringe sharing and HIV incidence. Vancouver’s experience provides a number of important lessons regarding NEP. Keys to success include refocusing the NEP away from an emphasis on public order objectives by separating distribution and collection functions, removing syringe distribution limits and decentralizing and diversifying NEP services. Additionally, our review highlights the importance of context when implementing NEPs, as well as ongoing evaluation to identify factors that constrain or improve access to sterile syringes.
doi:10.1016/j.drugpo.2012.03.006
PMCID: PMC3392518  PMID: 22579215
needle exchange programs; injection drug use; HIV/AIDS; policing; Vancouver
16.  Community-Based Participatory Research: Lessons Learned from the Centers for Children’s Environmental Health and Disease Prevention Research 
Environmental Health Perspectives  2005;113(10):1463-1471.
Over the past several decades there has been growing evidence of the increase in incidence rates, morbidity, and mortality for a number of health problems experienced by children. The causation and aggravation of these problems are complex and multifactorial. The burden of these health problems and environmental exposures is borne disproportionately by children from low-income communities and communities of color. Researchers and funding institutions have called for increased attention to the complex issues that affect the health of children living in marginalized communities—and communities more broadly—and have suggested greater community involvement in processes that shape research and intervention approaches, for example, through community-based participatory research (CBPR) partnerships among academic, health services, public health, and community-based organizations. Centers for Children’s Environmental Health and Disease Prevention Research (Children’s Centers) funded by the National Institute of Environmental Health Sciences and U.S. Environmental Protection Agency were required to include a CBPR project. The purpose of this article is to provide a definition and set of CBPR principles, to describe the rationale for and major benefits of using this approach, to draw on the experiences of six of the Children’s Centers in using CBPR, and to provide lessons learned and recommendations for how to successfully establish and maintain CBPR partnerships aimed at enhancing our understanding and addressing the multiple determinants of children’s health.
doi:10.1289/ehp.7675
PMCID: PMC1281296  PMID: 16203263
children’s health; collaborative research; community-based participatory research; partnership
17.  Telling Children They Have HIV: Lessons Learned from Findings of a Qualitative Study in Sub-Saharan Africa 
AIDS Patient Care and STDs  2010;24(4):247-256.
Abstract
HIV-infected children in developing countries are living longer lives as they gain access to antiretroviral treatment programs. As they grow older, their parents/guardians are faced with the difficult decision of if, when, and how to inform their child of his/her HIV status. Both negative and positive social, psychological, and behavioral impacts of disclosure to children have been reported, including improved adherence to medication regimens. Understanding the disclosure process from the perspective of HIV positive children, therefore, is critical to developing these interventions. Through children's experiences we can learn about what works well, what needs to be strengthened, and what is missing in current disclosure practices. We conducted in-depth interviews with eight caregiver–child dyads in Kinshasa, Democratic Republic of the Congo. The children were in a comprehensive HIV pediatric care and treatment program and had already been told their HIV diagnosis. For the analysis we placed particular emphasis on children's reports of communication with their caregivers and health care providers about their illness. Patterns emerged of limited communication between children and their caregivers as well as their providers, before, during, and after disclosure. From the perspective of children in this study, disclosure was largely a discrete event rather than a process. Sociocultural contexts surrounding HIV/AIDS, as well as health status, variations in parent–child communication and the relationships between health providers and children under their care, should inform psychosocial interventions delivered alongside treatment programs.
doi:10.1089/apc.2009.0217
PMCID: PMC2864057  PMID: 20397899
18.  Reflective Practice and Competencies in Global Health Training: Lesson for Serving Diverse Patient Populations 
Background
Resident interest in global health care training is growing and has been shown to have a positive effect on participants' clinical skills and cultural competency. In addition, it is associated with career choices in primary care, public health, and in the service of underserved populations. The purpose of this study was to explore, through reflective practice, how participation in a formal global health training program influences pediatric residents' perspectives when caring for diverse patient populations.
Methods
Thirteen pediatric and combined-program residents enrolled in a year-long Global Health Scholars Program at Cincinnati Children's Hospital Medical Center during the 2007–2008 academic year. Educational interventions included a written curriculum, a lecture series, one-on-one mentoring sessions, an experience abroad, and reflective journaling assignments. The American Society for Tropical Medicine and Hygiene global health competencies were used as an a priori coding framework to qualitatively analyze the reflective journal entries of the residents.
Results
Four themes emerged from the coded journal passages from all 13 residents: (1) the burden of global disease, as a heightened awareness of the diseases that affect humans worldwide; (2) immigrant/underserved health, reflected in a desire to apply lessons learned abroad at home to provide more culturally effective care to immigrant patients in the United States; (3) parenting, or observed parental, longing to assure that their children receive health care; and (4) humanitarianism, expressed as the desire to volunteer in future humanitarian health efforts in the United States and abroad.
Conclusions
Our findings suggest that participating in a global health training program helped residents begin to acquire competence in the American Society for Tropical Medicine and Hygiene competency domains. Such training also may strengthen residents' acquisition of professional skills, including the Accreditation Council for Graduate Medical Education competencies.
doi:10.4300/JGME-D-10-00081.1
PMCID: PMC2951788  PMID: 21976097
19.  Bringing Bike Share to a Low-Income Community: Lessons Learned Through Community Engagement, Minneapolis, Minnesota, 2011 
Background
High prevalence of physical inactivity contributes to adverse health outcomes. Active transportation (cycling or walking) is associated with better health outcomes, and bike-sharing programs can help communities increase use of active transportation.
Community Context
The Minneapolis Health Department funded the Nice Ride Minnesota bike share system to expand to the Near North community in Minneapolis, Minnesota. Near North is a diverse, low-income area of the city where residents experience health disparities, including disparities in physical activity levels.
Methods
The installation of new bike share kiosks in Near North resulted in an environmental change to support physical activity. Community engagement was conducted pre-intervention only and consisted of focus groups, community meetings, and interviews. Postintervention data on bike share trips and subscribers were collected to assess intervention effectiveness.
Outcome
Focus group participants offered insights on facilitators and barriers to bike share and suggested system improvements. Community engagement efforts showed that Near North residents were positive about Nice Ride and wanted to use the system; however, the numbers of trips and subscriptions in Near North were low.
Interpretation
Results show that the first season of the expansion was moderately successful in improving outreach efforts and adapting bike share to meet the needs of low-income populations. However, environmental change without adequate, ongoing community engagement may not be sufficient to result in behavior change.
doi:10.5888/pcd10.120274
PMCID: PMC3748276  PMID: 23948339
20.  Quality assessment of diagnostic before-after studies: development of methodology in the context of a systematic review 
Background
Quality assessment tools for primary studies of test accuracy are relatively well developed, although only one is validated (QUADAS), but very little work has been done to develop tools to quality-assess studies evaluating the impact of diagnostic testing on management of patients (diagnostic or therapeutic yield). The recent draft NICE Guide to the Methods of Technology Appraisal (2007) suggests QUADAS "as a useful starting point for appraising studies that evaluate the sensitivity and specificity of a test" but does not mention how to quality assess diagnostic or therapeutic yield studies, in particular diagnostic before-after studies. In the context of undertaking a rapid systematic review of structural neuroimaging in psychosis for NICE, we describe the modifications that we made to QUADAS, our experience of this in practice and in relation to published theory on diagnostic or therapeutic yield studies.
Methods
The QUADAS tool was assessed for use in the review by two systematic reviewers with in-depth knowledge of the clinical area being reviewed and the types of studies being found in the searches that could answer the clinical question. Modifications were made following discussion as considered appropriate.
Results
Two QUADAS questions were removed altogether and. four additional questions were developed to capture additional quality issues not addressed by QUADAS. However, the developed checklist only partially helped to discern implications of the study designs on the results given.
Conclusion
The division between topic-specific and more generic quality items of relevance to diagnostic before-after studies is important. With more time, further work could have been done to create a better quality assessment tool, for example by incorporating some of the issues mentioned in previous work in this area. This paper is a discussion around quality assessment and is intended to offer insights into the types of issues that should be assessed. A quality assessment tool for diagnostic before-after studies that incorporates items from QUADAS and published theory needs to be further developed and validated.
doi:10.1186/1471-2288-9-3
PMCID: PMC2630991  PMID: 19152699
21.  Comparison of screening strategies to improve the diagnosis of latent tuberculosis infection in the HIV-positive population: a cohort study 
BMJ Open  2012;2(2):e000762.
Background
HIV is the most important risk factor for progression of latent tuberculosis infection (LTBI) to active tuberculosis (TB). Detection and treatment of LTBI is necessary to reduce the increasing burden of TB in the UK, but a unified LTBI screening approach has not been adopted.
Objective
To compare the effectiveness of a TB risk-focused approach to LTBI screening in the HIV-positive population against current UK National Institute for Health and Clinical Excellence (NICE) guidance.
Design
Prospective cohort study.
Setting
Two urban HIV treatment centres in London, UK.
Participants
114 HIV-infected individuals with defined TB risk factors were enrolled prospectively as part of ongoing studies into HIV and TB co-infection.
Outcome measures
The yield and case detection rate of LTBI cases within the research study were compared with those generated by the NICE criteria.
Results
17/114 (14.9%, 95% CI 8.3 to 21.5) had evidence of LTBI. Limiting screening to those meeting NICE criteria for the general population (n=43) would have detected just over half of these, 9/43 (20.9%, 95% CI 8.3 to 33.5) and those meeting criteria for HIV co-infection (n=74) would only have captured 8/74(10.8%, 95% CI 3.6 to 18.1) cases. The case detection rates from the study and NICE approaches were not significantly different. LTBI was associated with the presence of multiple TB risk factors (p=0.002).
Conclusion
Adoption of a TB risk-focused screening algorithm that does not use CD4 count stratification could prevent more cases of TB reactivation, without changing the case detection rate. These findings should be used to inform a large-scale study to create unified guidelines.
Article summary
Article focus
HIV is the single most important risk factor for the progression of LTBI to active TB.
Despite this, the UK approach to screening for LTBI in HIV co-infected individuals is not unified as the evidence base is insufficient.
We hypothesised that LTBI screening in HIV co-infected individuals required an approach focused on TB risk factors that was broader than recommended by NICE.
Key messages
Screening strategies for LTBI in HIV co-infected patients that focus on limited TB risk factors (recent entrance from a TB endemic area or history of TB contact) or limit screening to those with a CD4 count of ≤500 cells/μl would detect approximately half the total cases in this cohort.
A TB risk-focused approach could aid in the prevention of more cases of active TB and HIV co-infection.
Strengths and limitations of this study
This study addresses the utility of NICE guidance for LTBI screening in the HIV co-infected population.
Numbers were relatively small, therefore a large study is needed to better inform UK guidance on LTBI screening in the HIV co-infected population.
doi:10.1136/bmjopen-2011-000762
PMCID: PMC3293130  PMID: 22382123
22.  Metal-on-Metal Hip Resurfacing Arthroplasty 
Background
Metal-on-metal (MOM) hip resurfacing arthroplasty (HRA) is in clinical use as an appropriate alternative to total hip arthroplasty in young patients. In this technique, a metal cap is placed on the femoral head to cover the damaged surface of the bone and a metal cup is placed in the acetabulum.
Objectives
The primary objective of this analysis was to compare the revision rates of MOM HRA using different implants with the benchmark set by the National Institute of Clinical Excellence (NICE). The secondary objective of this analysis was to review the literature regarding adverse biological effects associated with implant material.
Review Methods
A literature search was performed on February 13, 2012, to identify studies published from January 1, 2009, to February 13, 2012.
Results
The revision rates for MOM HRA using 6 different implants were reviewed. The revision rates for MOM HRA with 3 implants met the NICE criteria, i.e., a revision rate of 10% or less at 10 years. Two implants had short-term follow-ups and MOM HRA with one of the implants failed to meet the NICE criteria.
Adverse tissue reactions resulting in failure of the implants have been reported by several studies. With a better understanding of the factors that influence the wear rate of the implants, adverse tissue reactions and subsequent implant failure can be minimized. Many authors have suggested that patient selection and surgical technique affect the wear rate and the risk of tissue reactions.
The biological effects of high metal ion levels in the blood and urine of patients with MOM HRA implants are not known. Studies have shown an increase in chromosomal aberrations in patients with MOM articulations, but the clinical implications and long-term consequences of this increase are still unknown. Epidemiological studies have shown that patients with MOM HRA implants did not have an overall increase in mortality or risk of cancer. There is insufficient clinical data to confirm the teratogenicity of MOM implants in humans.
Conclusions
Metal-on-metal HRA can be beneficial for appropriately selected patients, provided the surgeon has the surgical skills required for performing this procedure.
Plain Language Summary
There are many young patients with hip diseases who need to have hip replacement surgery. Although a traditional hip replacement is an acceptable procedure for these patients, some surgeons prefer using a newer technique in young patients called hip resurfacing. In this technique, instead of removing the head of the femoral bone, a metal cap is placed on the femoral head to cover the damaged surface of the bone and a metal cup is placed in the hip socket, similar to the cups used in traditional hip replacement.
The analysis of the revision rates (i.e., how soon and in how many patients the surgery needs to be redone) and safety of resurfacing implants showed that generally these implants can last 10 years or more for the majority of young people. Good outcomes can be expected when skilled surgeons perform the surgery in properly selected patients.
However, since these implants are made of metal (cobalt and chromium alloy), there is concern about excess metal debris production due to friction between the 2 metal components leading to high levels of metal ions in the blood and urine of patients. The production of metal debris may result in inflammation in the joint or development of a benign soft tissue mass leading to implant failure. However, it has been shown that this risk can be reduced by proper positioning of the implant and the careful selection of patients for this procedure.
Little is known about the long-term biological effects of high levels of metal ions in the blood and urine of patients who have received metal implants. There is concern about potential increases in the risk of cancer and the risk of fetal abnormalities, but these effects have not been established yet. However, since cobalt and chromium can pass the placental barrier, implants that are not metal-on-metal are recommended for women at childbearing ages if they need a hip replacement.
PMCID: PMC3440005  PMID: 23074429
23.  Practitioners' views on managing childhood obesity in primary care: a qualitative study 
Background
In 2006 the Department of Health and the National Institute for Health and Clinical Excellence (NICE) published guidance on the management of childhood obesity, for use by primary care practitioners. Little is known, however, about practitioners' views and experiences of managing childhood obesity in primary care.
Aim
To explore practitioners' views of primary care as a setting in which to treat childhood obesity.
Design of study
Qualitative interview study.
Setting
Primary care and other community settings based in Bristol, England.
Method
Interviews explored practitioners' views and experiences of managing childhood obesity and their knowledge of the recent guidance provided by the Department of Health and NICE. Interviews were audiotaped and transcribed verbatim. Analysis was thematic and comparisons made both within and across the interviews.
Results
Thirty practitioners were interviewed: 12 GPs, 10 practice nurses, four school nurses, and four health visitors. Participants varied in their views about whether primary care is an appropriate treatment setting for childhood obesity. However, all described factors that limited the extent to which they could intervene effectively: a lack of expertise, resources, and contact with primary school children; the causes of childhood obesity; and the need to work with parents. It was also apparent that very few participants had knowledge of the recent guidance.
Conclusion
Practitioners do not currently view primary care as an effective treatment setting for childhood obesity and it is unlikely that the guidance from the Department of Health and NICE will have a meaningful impact on their management of this condition.
doi:10.3399/bjgp09X472269
PMCID: PMC2765837  PMID: 19712545
child health; obesity; primary health care; qualitative research
24.  Cognitive state monitoring and the design of adaptive instruction in digital environments: lessons learned from cognitive workload assessment using a passive brain-computer interface approach 
According to Cognitive Load Theory (CLT), one of the crucial factors for successful learning is the type and amount of working-memory load (WML) learners experience while studying instructional materials. Optimal learning conditions are characterized by providing challenges for learners without inducing cognitive over- or underload. Thus, presenting instruction in a way that WML is constantly held within an optimal range with regard to learners' working-memory capacity might be a good method to provide these optimal conditions. The current paper elaborates how digital learning environments, which achieve this goal can be developed by combining approaches from Cognitive Psychology, Neuroscience, and Computer Science. One of the biggest obstacles that needs to be overcome is the lack of an unobtrusive method of continuously assessing learners' WML in real-time. We propose to solve this problem by applying passive Brain-Computer Interface (BCI) approaches to realistic learning scenarios in digital environments. In this paper we discuss the methodological and theoretical prospects and pitfalls of this approach based on results from the literature and from our own research. We present a strategy on how several inherent challenges of applying BCIs to WML and learning can be met by refining the psychological constructs behind WML, by exploring their neural signatures, by using these insights for sophisticated task designs, and by optimizing algorithms for analyzing electroencephalography (EEG) data. Based on this strategy we applied machine-learning algorithms for cross-task classifications of different levels of WML to tasks that involve studying realistic instructional materials. We obtained very promising results that yield several recommendations for future work.
doi:10.3389/fnins.2014.00385
PMCID: PMC4260500  PMID: 25538544
passive brain-computer interface; EEG; cross-task classification; working-memory load; adaptive learning environments; cognitive load theory
25.  Defining and classifying medical error: lessons for patient safety reporting systems 
Background: It is important for healthcare providers to report safety related events, but little attention has been paid to how the definition and classification of events affects a hospital's ability to learn from its experience.
Objectives: To examine how the definition and classification of safety related events influences key organizational routines for gathering information, allocating incentives, and analyzing event reporting data.
Methods: In semi-structured interviews, professional staff and administrators in a tertiary care teaching hospital and its pharmacy were asked to describe the existing programs designed to monitor medication safety, including the reporting systems. With a focus primarily on the pharmacy staff, interviews were audio recorded, transcribed, and analyzed using qualitative research methods.
Results: Eighty six interviews were conducted, including 36 in the hospital pharmacy. Examples are presented which show that: (1) the definition of an event could lead to under-reporting; (2) the classification of a medication error into alternative categories can influence the perceived incentives and disincentives for incident reporting; (3) event classification can enhance or impede organizational routines for data analysis and learning; and (4) routines that promote organizational learning within the pharmacy can reduce the flow of medication error data to the hospital.
Discussion: These findings from one hospital raise important practical and research questions about how reporting systems are influenced by the definition and classification of safety related events. By understanding more clearly how hospitals define and classify their experience, we may improve our capacity to learn and ultimately improve patient safety.
doi:10.1136/qshc.2002.003376
PMCID: PMC1758057  PMID: 14757794

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