Addressing the challenges of transforming laboratory advances into Alzheimer's Disease treatments

This essay addresses the challenges of clinical trials to develop treatments for Alzheimer’s Disease (AD). The issues covered are enrolling subjects, defining clinically meaningful endpoints, and making the claim that a drug slows the progression of the disease. The perspective to address these challenges is that dementia research should embrace a biopsychosocial model for drug development. In this model, the patient and caregiver are seen as interrelated subjects of both treatment and research and outcome measures reflect biomarkers of the disease, the functional morbidity of AD and the distress of caregiving.     

Effectiveness of psychotherapy with children and adolescents.

This article reviews the outcome evidence of psychotherapy for children and adolescents. The questions that guide treatment research, conclusions about alternative treatments, and the impact on different types of problems are reviewed. Alternative treatments for children and adolescents have produced change across a diverse range of emotional and behavioral problems. Progress and advances in treatment research are illustrated by highlighting alternative treatments and factors that contribute to outcome in the treatment of conduct problem children. Although important advances can be readily identified in outcome research, the pace of progress has been thwarted by challenges of the subject matter (e.g., developmental issues, comorbidity, and the diverse parent, family, and other contextual factors in which child dysfunction is embedded) and deficiencies in current research (e.g., ambiguity in the characteristics of the samples, weak statistical power, departure of treatment conditions in research from those that characterize clinical work). Notwithstanding the recency of empirical attention to the topic, progress is evident in developing effective treatments for a wide range of problems.     

The Stage Model for Psychotherapy Manual Development: A Valuable Tool for Promoting Evidence- Based Practice

This article provides a commentary on the stage model for psychotherapy manual development proposed by Carroll and Nuro (this issue). We endorse the emphasis on the evolution of treatment manuals, dependent on their stage of development, research base, and intended audience. At the same time, we discuss some of the conceptual and practical challenges to the smooth and steady transition of treatment manuals from efficacy trials into clinical practice. These issues include incentives for researchers to conduct effectiveness trials, lack of funding for such research, skepticism in some quarters of the field about the utility of treatment manuals, issues of dissemination, and the general lack of feedback from the clinical community to the developers of treatment manuals about ways to make them flexible enough for use in clinical practice. We end with an encouragement of the template of a stage model for manual development.     

What we know and what we need to learn about the treatment of dissociative disorders

In this editorial, I briefly review research design issues and the current treatment research for dissociative disorders (DD), discuss the limitations and challenges of conducting treatment studies for patients with DD, and conclude by describing what I see as the first wave and second wave in the field of dissociation. Insurers and federally funded programs are increasingly requiring that treatment be empirically supported in order for treatment to be reimbursed. For example, psychoanalysis will no longer be reimbursed in The Netherlands because of what is perceived as a lack of empirical support. Other countries have also established standards about the treatments that have sufficient empirical support to merit government payment. I believe it is only a matter of time before it is common for patients with DD to be required to seek out empirically supported treatment if they want treatment to be reimbursed. We need to financially support treatment studies in order to develop a more solid empirical basis for the treatment of DD.     

A critical review of psychological treatments of posttraumatic stress disorder in refugees

Despite much research evidence that refugees suffer from elevated rates of posttraumatic stress disorder (PTSD), relatively few studies have examined the effectiveness of psychological treatments for PTSD in refugees. The field of refugee mental health intervention is dominated by two contrasting approaches, namely trauma-focused therapy and multimodal interventions. This article firstly defines these two approaches, then provides a critical review of 19 research studies that have been undertaken to investigate the efficacy of these treatments. Preliminary research evidence suggests that trauma-focused approaches may have some efficacy in treating PTSD in refugees, but limitations in the methodologies of studies caution against drawing definitive inferences. It is clear that research assessing the treatment of PTSD in refugees is lagging behind that available for other traumatized populations. The review examines important considerations in the treatment of refugees. A theoretical framework is offered that outlines contextual issues, maintaining factors, change mechanisms and the distinctive challenges to traditional trauma-focused treatments posed by the needs of refugees with PTSD.     

Assessment tools in obesity - psychological measures, diet, activity, and body composition

The global increase in the prevalence of obesity has led to an increased need for measurement tools for research, management and treatment of the obese person. The physical size limitations imposed by obesity, variations in body composition from that of normal weight, and a complex psychopathology all pose tremendous challenges to the assessment of an obese person. There is little published research regarding what tools can be used with confidence. This review is designed to provide researchers and clinicians with a guide to the current and emerging measurement tools specifically associated with obesity research and practice. Section 1 addresses psychological measures of well being. Sections 2, 3, and 4 focus on the assessment of food intake, activity, and body composition. All sections address basic challenges involved in the study and management of obesity, and highlight methodological issues associated with the use of common assessment tools. The best available methods for use in the obese both in research and clinical practice are recommended.     

Commentary: Studying Usual Care in Child and Adolescent Therapy: It's Anything but Routine

Efforts to enhance the quality of mental health care provided to children and youth require an understanding of the nature and impact of existing clinical services. The Practice and Research: Advancing Collaboration (PRAC) study described by Garland, Hurlburt, and Hawley (2006) is currently documenting the diverse treatment practices used in community settings. The study reflects the use of a hybrid design that integrates methods commonly used in treatment outcome and services research paradigms. This article discusses some of the key issues, directions, and challenges associated with efforts designed to enhance the quality of usual care illustrated in their article. Suggestions are made to encourage integrative investigations in the context of practice-based research networks devoted to promoting effective child and adolescent treatment.     

Stepped care treatment for eating disorders

A stepped care approach would link different patient needs to therapeutic modalities that range from simple advice to intensive inpatient care. Brief methods, including self-help and psychoeducation, may be effective for a subset of patients with bulimia nervosa and binge eating disorder. Identifying this subset remains a challenge. It is unclear how patients who fail to respond to evidence-based, first-line treatments should be treated. Given the absence of data on effective treatment of anorexia nervosa (AN), discussion of a stepped care approach is speculative. Because AN typically demands expert and sustained treatment, the lower levels of stepped care models are inapplicable for these patients. A stepped care approach poses methodological challenges for clinical research and raises important clinical issues, such as when to switch from 1 level of treatment to another.     

Ethical and practical challenges of sharing data from genome-wide association studies: the eMERGE Consortium experience

In 2007, the National Human Genome Research Institute (NHGRI) established the Electronic MEdical Records and GEnomics (eMERGE) Consortium (www.gwas.net) to develop, disseminate, and apply approaches to research that combine DNA biorepositories with electronic medical record (EMR) systems for large-scale, high-throughput genetic research. One of the major ethical and administrative challenges for the eMERGE Consortium has been complying with existing data-sharing policies. This paper discusses the challenges of sharing genomic data linked to health information in the electronic medical record (EMR) and explores the issues as they relate to sharing both within a large consortium and in compliance with the National Institutes of Health (NIH) data-sharing policy. We use the eMERGE Consortium experience to explore data-sharing challenges from the perspective of multiple stakeholders (i.e., research participants, investigators, and research institutions), provide recommendations for researchers and institutions, and call for clearer guidance from the NIH regarding ethical implementation of its data-sharing policy.     

Training graduate-level pediatric psychology researchers at Case Western Reserve University: meeting the challenges of the new millennium

OBJECTIVE: To describe the challenges in training graduate-level pediatric psychology researchers for successful careers and to discuss solutions. METHODS: We reviewed experiences in training graduate students at Case Western Reserve University to identify key challenges in research training and potential strategies to meet them. RESULTS: We identified the following key challenges: stimulating graduate students' career interest in pediatric psychology research; teaching students about the pragmatic challenges of conducting research in pediatric settings, specialized research design, and data analytic issues; helping students to develop essential research skills; developing opportunities for student research-related collaborations; helping students develop professional identities as researchers; and developing and supporting their research careers beyond graduate school. CONCLUSIONS: Useful strategies for meeting these challenges include involving an interdisciplinary faculty in research training; developing specialized training methods that focus on critical research skills such as writing and data analysis; peer support; and involvement with multiple mentors who are successful researchers. Pediatric psychologists should also develop opportunities for the next generation of researchers by facilitating research job options and leadership opportunities.     

Type 1 reaction in leprosy: a model for a better understanding of tissue immunity under an immunopathological condition

Type 1 reaction (T1R) or reversal reaction is the leading cause of physical disabilities and deformities in leprosy. Leprosy patients, even after being considered cured and released from treatment, may suffer from reactional episodes for long periods of time. Early diagnosis is a great challenge for effectively treating and managing T1R. There is an urgent need to identify the most significant biomarkers to prevent recurrent T1R and to differentiate late T1R from relapse. T1R continues to be treated with corticosteroids and complications due to iatrogenic treatment remain frequent. This review aims to provide a framework from which to approach the great challenges that still persist in T1R management and debate key issues in order to reduce the distance between basic research and the clinic.     

Safety in the academic medical center: transforming challenges into ingredients for improvement.

Patient safety has emerged as an important challenge to the leadership of academic medical centers (i.e., teaching hospitals with significant research activity). This article describes the evidence regarding patient safety at academic medical centers (AMCs) and the special circumstances of AMCs that create challenges and opportunities for making improvements. While the research on the relative safety of patients in AMCs compared to other types of hospitals is sparse, it seems clear that AMCs in general do not stand out as models of patient safety. AMCs are unique as health care providers because of the multiple consequences of their three missions: patient care, research, and teaching. Aspects of these missions can serve to both enhance an AMC's ability to address safety issues and at the same time create unique and challenging barriers. For example, the research enterprise may distract managers' focus on safety issues but at the same time provide a wealth of highly trained talent for investigating and reducing safety problems. By addressing these challenges, AMCs have the opportunity, even the obligation, to be both the source of new knowledge on health care safety as well as the transmitter of new skills in safe patient care for the health care providers of the future.     

Practical implementation issues and challenges for biobanks in the return of individual research results

Whether or not to give research results back to individuals whose specimens are used for biomedical research is a subject of considerable controversy. Much of the debate has been focused around the ethical and legal concerns with some consideration of broader social issues such as whether or not people will be affected by such information for employment or health care. Much less attention has been paid to biobanks that collect the specimens used to generate the research findings and the issues and operational requirements for implementing return of individual research results. In this article, we give the biobanks’ perspective and highlight that given the diversity among the types of biobanks, it may be difficult to design and implement a blanket policy in this complex area. We discuss the variability in the types of biobanks and some important issues that should be considered in determining whether or not research results should be provided to individuals whose specimens are used in biomedical research. We also discuss challenges that should be considered in implementing any approaches to the return of research results.Genet Med 2012:14(4):478–483     

Ethical Challenges in Community-Based Research: Introduction to the Series

We describe the inspiration for this series of articles and articulate several themes that run throughout the four articles that follow. Particular ethical challenges in community-based mental health research are identified, as is the tension between existing ethical codes and policies and the requirements of more collaborative, community-based research. We edited this special series with an eye toward promoting greater discussion of ethical issues in this realm and the eventual development and promotion of guidelines for ethical decision-making in community-based research.     

Clinical trials in children with Down syndrome: issues from a cognitive research perspective

Clinical and translational research play a key role in the transition of basic research discoveries to effective therapies. In Down syndrome (DS), these research approaches are not well utilized or developed to test new therapies to improve cognitive and/or adaptive function in this population. This article reviews the history of clinical trial research in children with DS from a cognitive research perspective and discusses important issues relevant to the conduct of well designed clinical trials for this population. Specific issues addressed include: funding, study design, study medication, subject recruitment and retention, safety, and efficacy challenges. The Duke Down Syndrome Research Team's program of clinical research of cholinesterase inhibitors for individuals with DS serves as the model application for the identified research principles. It is hoped that this article will raise awareness of the unmet need for clinical research in the cognitive and adaptive function of individuals with DS, especially children with DS.     

Neurocognitive outcomes in survivors of childhood cancer

OBJECTIVE:s To review issues associated with neurocognitive outcome in survivors of pediatric cancer. Recommendations are made for future research directions. METHODS: A large body of literature pertaining to neurocognitive outcome in cancer survivors was reviewed. Brain development and methodological issues that provide challenges to conducting meaningful research in cancer outcomes also are discussed. RESULTS: Neurotoxic agents used in some cancer therapies produce permanent neurocognitive sequelae, especially in very young children. CONCLUSIONS: The state of neurocognitive research for pediatric cancer survivors needs to move beyond empirical studies of neurocognitive sequelae to research that will identify individual patients at risk for neurocognitive morbidity.     

Conceptual and ethical issues in therapy for the psychological problems of gay men, lesbians, and bisexuals

Reviewed here are a number of conceptual and ethical issues surrounding the study and treatment of gay men, lesbians, and bisexuals (GLB), with particular emphasis on the frequently overlooked political and ethical dimensions of what therapists choose to treat, indeed, on the goals patients themselves want to work towards. Several issues are discussed, including the relevance and irrelevance of sexual orientation and the role of therapist biases in assessment and treatment planning, the need for better understanding of how the problems of GLB patients are construed and the associated dangers of stereotyping, the challenges of coming out and the ways therapists can help patients make the decision and how to implement it, the extra effort required to be a GLB person in terms of the formation of an unconventional social and sexual identity, the trust issues that can arise when one partner in a committed relationship requests protected sex, the challenges and rewards of parents "coming out" as family members of a gay son or daughter, the social invisibility of lesbians and the deleterious effects this can have on them, social support issues for GLB youth, and the need for professionals to take a broad, institutional community psychology perspective to their study and treatment of GLB individuals.     

Educational and psychosocial programmes for adolescents with diabetes: approaches, outcomes and cost-effectiveness

Diabetes incurs heavy personal and health system costs. Self-management is required if complications are to be avoided. Adolescents face particular challenges as they learn to take responsibility for their diabetes. A systematic review of educational and psychosocial programmes for adolescents with diabetes was undertaken. This aimed to: identify and categorise the types of programmes that have been evaluated; assess the cost-effectiveness of interventions; identify areas where further research is required. Sixty-two papers were identified and subjected to a narrative review. Generic programmes focus on knowledge/skills, psychosocial issues, and behaviour/self-management. They result in modest improvements across a range of outcomes but improvements are often not sustained, suggesting a need for continuous support, possibly integrated into normal care. In-hospital education at diagnosis confers few advantages over home treatment. The greatest returns may be obtained by targeting poorly controlled individuals. Few studies addressed resourcing issues and robust cost-effectiveness appraisals are required to identify interventions that generate the greatest returns on expenditure.     

Experiences with community engagement and informed consent in a genetic cohort study of severe childhood diseases in Kenya

Background  

The potential contribution of community engagement to addressing ethical challenges for international biomedical research is well described, but there is relatively little documented experience of community engagement to inform its development in practice. This paper draws on experiences around community engagement and informed consent during a genetic cohort study in Kenya to contribute to understanding the strengths and challenges of community engagement in supporting ethical research practice, focusing on issues of communication, the role of field workers in 'doing ethics' on the ground and the challenges of community consultation.