Evidence-based Alternatives Research Articles

Promoting Inclusion Through Evidence-Based Alternatives to Restraint and Seclusion

The use of restraint and seclusion in schools has been identified repeatedly as an approach that is overused, misused, and potentially dangerous. In this article, we emphasize the importance of an approach to supporting students with significant problem behavior that focuses on prevention, evidence-based intervention procedures, heightened levels of monitoring, and documented professional development. While the need for the use of restraint in emergency conditions will remain, the overall rate at which restraint and seclusion are used needs to be reduced and the quality of support for students with significant problem behavior needs to improve. An example of one district that is adopting a comprehensive alternative approach is provided.

Nutrition, Pharmacological and Training Strategies Adopted by Six Bodybuilders: Case Report and Critical Review.

The purpose of this study was to report and analyze the practices adopted by bodybuilders in light of scientific evidence and to propose evidence-based alternatives. Six (four male and two female) bodybuilders and their coaches were directly interviewed. According to the reports, the quantity of anabolic steroids used by the men was 500–750 mg/week during the bulking phase and 720–1160 mg during the cutting phase. The values for women were 400 and 740 mg, respectively. The participants also used ephedrine and hydrochlorothiazide during the cutting phase. Resistance training was designed to train each muscle once per week and all participants performed aerobic exercise in the fasted state in order to reduce body fat. During the bulking phase, bodybuilders ingested ~2.5 g of protein/kg of body weight. During the cutting phase, protein ingestion increased to ~3 g/kg and carbohydrate ingestion decreased by 10–20%. During all phases, fat ingestion corresponded to ~15% of the calories ingested. The supplements used were whey protein, chromium picolinate, omega 3 fatty acids, branched chain amino acids, poly-vitamins, glutamine and caffeine. The men also used creatine in the bulking phase. In general, the participants gained large amounts of fat-free mass during the bulking phase; however, much of that fat-free mass was lost during the cutting phase along with fat mass. Based on our analysis, we recommend an evidence-based approach by people involved in bodybuilding, with the adoption of a more balanced and less artificial diet. One important alert should be given for the combined use of anabolic steroids and stimulants, since both are independently associated with serious cardiovascular events. A special focus should be given to revisiting resistance training and avoiding fasted cardio in order to decrease the reliance on drugs and thus preserve bodybuilders’ health and integrity.

Optimizing the Use of State Prescription Drug Monitoring Programs for Public Safety

State prescription drug monitoring programs (PMPs), which collect and distribute data on prescription controlled substances dispensed in a state, are tools to curb prescription drug abuse. The programs help identify prescription misuse and abuse, detect diversion of controlled substances, and facilitate access to medication for treatment. Health care professionals, such as the advanced practice registered nurse, may incorporate PMP data into the clinical setting as a tool for educated decision making and monitoring. State officials seek to transform PMPs into more effective health care information delivery tools by implementing five key operational practices: real-time dispenser reporting to PMPs, interstate sharing of PMP data, expanded access to PMP data by health care professionals, integration of PMP data into electronic health systems, and distribution of proactive alerts to health care professionals. As policy makers strive to optimize PMP use, they must also ensure stable, long-term funding for the programs, support the use of evidence-based treatment alternatives, and provide adequate addiction treatment resources. This article describes the history of PMPs, efforts to improve PMP use for clinical decision making, and necessary future steps to optimize the role of PMPs in state prescription drug abuse prevention strategies.

'Is it the crime of the century?': factors for psychiatrists and service users that influence the long-term prescription of hypnosedatives.

Given the longstanding controversy about hypnosedative use, we aimed to investigate the attitudes of prescribing psychiatrists and service users towards long-term use of hypnosedative medication, and their perceptions of barriers to evidence-based nonmedication alternatives. Qualitative data from focus groups in Aotearoa/NZ were analysed thematically. A novel research design involved a service user researcher contributing throughout the research design and process. Service users and psychiatrists met to discuss each other's views, initially separately, and subsequently together. Analysis of the data identified four key themes: the challenge, for both parties, of sleep disturbance among service users with mental health problems; the conceptual and ethical conflicts for service users and psychiatrists in managing this challenge; the significant barriers to service users accessing evidence-based nonmedication alternatives; and the initial sense of disempowerment, shared by both service users and psychiatrists, which was transformed during the research process. Our results raise questions about the relevance of the existing guidelines for this group of service users, highlight the resource and time pressures that discourage participants from embarking on withdrawal regimes and education programmes on alternatives, highlight the lack of knowledge about alternatives and reflect the complex interaction between sleep and mental health problems, which poses a significant dilemma for service users and psychiatrists.

APA Assembly: Your Voice Within APA

Back to table of contents Previous article Next article From the SpeakerFull AccessAPA Assembly: Your Voice Within APAJenny BoyerM.D.Jenny BoyerSearch for more papers by this authorM.D.Published Online:30 Apr 2015https://doi.org/10.1176/appi.pn.2015.5a20AbstractWhat is the APA Assembly? What can we do for each other?APA’s governance has sometimes been perceived, by members and nonmembers alike, as not reaching out and helping our individual members. APA’s district branches and state associations (DBs/SAs) provide local leadership on local issues and representation on national issues. The DBs/SAs send elected representatives to serve on the APA Assembly, which meets twice a year—in November in Washington, D.C., and in May at the annual meeting. APA members may attend those meetings to observe and have their voices heard through their Assembly representatives regarding their interests and opinions.The Assembly members develop, review, submit, and pass action papers advising the Assembly speaker, president, Board of Trustees, and chief executive officer and his support staff to address specific topics and speak for psychiatrists in the United States and Canada. Position papers are developed on specific issues. For example, the issue of maintenance of certification (MOC) has been discussed within the APA Assembly since 2008. Many psychiatrists have felt a sense of loss with regard to MOC and maintenance of licensure (MOL) with the imposition of requirements that do not have clear validity, that is, that are not clearly evidence based. The American Board of Psychiatry and Neurology (ABPN), acting on behalf of the American Board of Medical Specialties (ABMS), has been responsible for the development and enactment of MOC criteria. For the past seven years, the Assembly and its members have struggled with MOC-related issues through multiple action papers and, more recently, more direct contact with the ABPN and ABMS. The Assembly and APA leadership represent the voice of APA members dissatisfied with MOC. In February the speaker of the Assembly and other leaders of APA voiced members’ concerns to the ABPN regarding Part 4 of MOC, which is “Improvement in Medical Practice.” Part 4 includes the following:Engage in ongoing assessment and improvement activities to improve patient outcomes.Demonstrate use of evidence-based and best practices in comparison with peer performance and national benchmarks.Immediately thereafter, the Assembly Executive Committee (AEC) overwhelmingly endorsed a motion to recommend the elimination of Part 4. I introduced this motion at the March meeting of the Board of Trustees, which unanimously approved it and also created a task force to study evidence-based alternatives to Part 4. The motion affirmed the need for continuing maintenance of certification (Psychiatric News, April 17). In a letter to the ABPN signed by Chief Executive Officer and Medical Director Saul Levin, M.D., M.P.A., and APA President Paul Summergrad, M.D., APA urged the ABPN to advocate to the ABMS for the elimination of Part 4, a position that has also been promulgated by other specialty board members. With this action, the Board of Trustees acted in a strong and affirmative manner, representing the will of the Assembly and the APA membership. In addition, Assembly members have taken the initiative in their home states to ensure that MOL is not linked to MOC. At present, there is a dynamic discussion between the ABMS, ABPN, and APA with other medical specialty boards for changes in the MOC program.Members may not realize their voices can be heard through their Assembly representatives, but using this avenue is vitally important to APA’s ability to live out its mission of ensuring that our patients have access to high-quality care and supporting members’ educational and professional needs. The Assembly is your voice to the national APA. If you do not know your Assembly representatives, contact your local DB/SA and introduce yourself so that you may communicate your concerns to them and through them to the APA Assembly. APA will welcome your voice. After APA’s 2015 annual meeting in Toronto, Assembly representatives will be requesting their DB/SA executive secretaries to contact their respective members to encourage them to voice their opinions about issues of concern. This is what we can do for each other, for our profession, and for our patients. ■Jenny Boyer, M.D., is speaker of the APA Assembly. ISSUES NewArchived

12-month outcomes of community engagement versus technical assistance to implement depression collaborative care: a partnered, cluster, randomized, comparative effectiveness trial.

Depression collaborative care implementation using community engagement and planning (CEP) across programs improves 6-month client outcomes in minority communities, compared with technical assistance to individual programs (resources for services [RS]). However, 12-month outcomes are unknown. To compare effects of CEP and RS on mental health-related quality of life (MHRQL) and use of services among depressed clients at 12 months. Matched health and community programs (n= 93) in 2 communities randomly assigned to receive CEP or RS. (ClinicalTrials.gov: NCT01699789). Self-reported MHRQL and services use at baseline, 6 months, and 12 months. Los Angeles, California. 1018 adults with depressive symptoms (8-item Patient Health Questionnaire score ≥10), 88% of whom were an ethnic minority. CEP and RS to implement depression collaborative care. The primary outcome was poor MHRQL (12-item mental health composite score ≤40) at baseline, 6 months, and 12 months; the secondary outcome was use of services at 12 months. At 6 months, the finding that CEP outperformed RS to reduce poor MHRQL was significant but sensitive to underlying statistical assumptions. At 12 months, some analyses suggested that CEP was advantageous to MHRQL, whereas others did not confirm a significant difference favoring CEP. The finding that CEP reduced behavioral health hospitalizations at 6 months was less evident at 12 months and was sensitive to underlying statistical assumptions. Other services use did not significantly differ between interventions at 12 months. Data are self-reported, and findings are sensitive to modeling assumptions. In contrast to 6-month results, no consistent effects of CEP on reducing the likelihood of poor MHRQL and behavioral health hospitalizations were found at 12 months. Still, given the needs of underresourced communities, the favorable profile of CEP, and the lack of evidence-based alternatives, CEP remains a viable strategy for policymakers and communities to consider. National Institute of Mental Health, Robert Wood Johnson Foundation, California Community Foundation, National Library of Medicine, and National Institutes of Health/National Center for Advancing Translational Science for the UCLA Clinical and Translational Science Institute.

State Higher Education Performance Funding for Community Colleges: Diverse Effects and Policy Implications

Background/Context Community colleges are central to the United States’ college completion goals. A popular strategy pushed by a number of influential policy organizations and foundations is a policy of tying state funding to community college completions, otherwise known simply as performance funding. This is happening despite little to no evidence that such a strategy actually increases institutional performance. Purpose This study asks: To what extent does the introduction of performance funding programs impact two-year degree completion among participating states? Population/Participants We created a unique panel data set for the period 1990 through 2010, using states as our primary unit of analysis. The data set contains 1,050 total observations, drawing from a range of postsecondary data sources. Research Design We used a quasi-experimental regression technique called difference-indifferences regression technique. We also included in our model multiple control variables and year and state fixed effects. Findings/Results We find that the program had no effect on average and mixed results for the individual states where performance funding was associated with lower completions in six states, greater completions in four states, and inconclusive patterns in nine states. Conclusions We conclude that performance funding is no “silver bullet” for improving community college completions; rather, in some cases, it may interfere with national completion goals. We recommend that state policy makers seek out evidence-based alternatives for improving community college completions.

Community-Based Recovery and Youth Justice

Four well-known delinquency intervention and prevention programs remain both publicly and politically popular regardless of a large body of evidence-based research revealing their ineffectiveness in promoting a lasting desistance from youth violence and crime. Scared straight programs, Drug Abuse Resistance Education (D.A.R.E.), youth boot camps, and secure large-scale, custodial juvenile correctional facilities overemphasize offender “risk management and maintenance” as opposed to individual, group-based, and/or collective well-being. This article will identify the values that these current and dominant community-centered youth justice initiatives reflect, and it will explain how these values further (or forestall) offender desistance. Viable, evidence-based alternatives consistent with the value orientation of therapeutic and restorative programming will also be evaluated. The article concludes by examining the efficacy of this alternative normative agenda to foster successful desistance from juvenile delinquency and crime.

Efficacy and cost-effectiveness of minimal guided and unguided internet-based mobile supported stress-management in employees with occupational stress: a three-armed randomised controlled trial.

BackgroundInternet- and mobile based stress-management interventions (iSMI) may be an effective means to address the negative consequences of occupational stress. However, available results from randomised controlled trials are conflicting. Moreover, it is yet not clear whether guided or unguided self-help iSMI provide better value for money. Internet-based mental health interventions without guidance are often much less effective than interventions including at least some guidance from a professional. However, direct comparisons in randomised controlled trials are scarce and, to the best of our knowledge, the comparative (cost)-effectiveness of guided vs. unguided iSMI has not yet been studied. Hence, this study investigates the acceptability and (cost-) effectiveness of minimal guided and unguided iSMI in employees with heightened levels of perceived stress.MethodsA three-armed randomised controlled trial (RCT) will be conducted to compare a minimal guided and unguided iSMI with a waiting list control condition (WLC). Both active conditions are based on the same iSMI, i.e. GET.ON Stress, and differ only with regard to the guidance format. Employees with heightened levels of perceived stress (PSS ≥ 22) will be randomised to one of three conditions. Primary outcome will be comparative changes in perceived stress (PSS). Secondary outcomes include changes in self-reported depression, work-engagement, presenteeism and absenteeism. Moreover, a cost-effectiveness analysis will be conducted from a societal perspective, including both direct medical costs and costs related to productivity losses. In addition, a cost-benefit analysis will be conducted from the employer’s perspective. Incremental net-benefit regression analyses will address the question if there are any baseline factors (i.e. subgroups of employees) associated with particularly favorable cost-effectiveness when the experimental intervention is offered. Assessments take place at baseline, 7 weeks post-treatment and 6 months after randomisation.DiscussionOnline-based (guided) self-help interventions could be an acceptable, effective and economically sustainable approach to offer evidence-based intervention alternatives to reduce the negative consequences associated with work-related stress. This study evaluates the (cost-) effectiveness of two versions of an iSMI, minimal guided and unguided iSMI. Thus, the present study will further enhance the evidence-base for iSMI and provide valuable information about the optimal balance between outcome and economic costs.Trial registrationGerman Clinical Trial Registration (DRKS): DRKS00005687.

The Cost of Incarceration in Texas: Estimating the Benefits of Reducing the Prison Population

In the wake of the recent economic crisis state policymakers have begun to consider redirecting expenditures on corrections as a way to trim state budgets. Recent attention has focused on reducing prison populations as a solution. However, this is a politically charged issue that has to balance the needs of the government and criminal justice system in the milieu of resource scarcity, with the needs of the offenders, and the safety of the community. This paper assesses how reducing inmates’ time served in prison, eliminating the use of prison for parole or probation technical violators, and decriminalizing ‘victimless’ crimes could impact the financial costs of incarceration in the state of Texas. Implications for policy and evidence-based alternatives to incarceration are discussed.

Cold-water immersion and iced-slush ingestion are effective at cooling firefighters following a simulated search and rescue task in a hot environment.

Firefighters are exposed to hot environments, which results in elevated core temperatures. Rapidly reducing core temperatures will likely increase safety as firefighters are redeployed to subsequent operational tasks. This study investigated the effectiveness of cold-water immersion (CWI) and iced-slush ingestion (SLUSH) to cool firefighters post-incident. Seventy-four Australian firefighters (mean ± SD age: 38.9 ± 9.0 years) undertook a simulated search and rescue task in a heat chamber (105 ± 5 °C). Testing involved two 20-min work cycles separated by a 10-min rest period. Ambient temperature during recovery periods was 19.3 ± 2.7 °C. Participants were randomly assigned one of three 15-min cooling protocols: (i) CWI, 15 °C to umbilicus; (ii) SLUSH, 7 g·kg(-1) body weight; or (iii) seated rest (CONT). Core temperature and strength were measured pre- and postsimulation and directly after cooling. Mean temperatures for all groups reached 38.9 ± 0.9 °C at the conclusion of the second work task. Both CWI and SLUSH delivered cooling rates in excess of CONT (0.093 and 0.092 compared with 0.058 °C·min(-1)) and reduced temperatures to baseline measurements within the 15-min cooling period. Grip strength was not negatively impacted by either SLUSH or CONT. CWI and SLUSH provide evidence-based alternatives to passive recovery and forearm immersion protocols currently adopted by many fire services. To maximise the likelihood of adoption, we recommend SLUSH ingestion as a practical and effective cooling strategy for post-incident cooling of firefighters in temperate regions.

Acupuncture in the Treatment of Cancer-Related Psychological Symptoms

Acupuncture is being adopted by cancer patients for a wide range of cancer-related symptoms including highly prevalent psychological symptoms like depression, anxiety, insomnia, and impairment in quality of life. Pharmacological treatment of prevalent symptoms like anxiety, depression, and sleep disturbance can contribute to the high chemical burden already carried by cancer patients, creating additional side effects. As a result, patients and providers alike are interested in evidence-based nonpharmacologic alternatives like acupuncture for these symptoms. This article reviews the current literature (January 2000 through April 2013) for acupuncture in cancer-related psychological symptoms with attention to both efficacy and acupuncture-specific methodology. All published studies that met our review criteria demonstrate a positive signal for acupuncture for the treatment of depression, anxiety, sleep disturbance, and for improving quality of life with most results showing statistical significance. However, there are only a handful of acupuncture studies that were specifically designed to evaluate depression, sleep disturbance, and quality of life as primary outcomes, and no studies were found that looked at anxiety as a primary outcome in this population. Published studies in cancer patients and survivors show that acupuncture treatment is not only safe but also more acceptable with fewer side effects than standard of care pharmacological treatments like antidepressants. Finally, there is wide variability in both the implementation and reporting of acupuncture methods in the literature, with only 2 of 12 studies reporting full details of acupuncture methods as outlined in the revised Standards for Reporting Interventions in Clinical Trials of Acupuncture guidelines, published in 2010 and providing an essential framework for the reporting of acupuncture methodology. This lack of methodological detail affects outcomes, generalizability, and validity of research involving acupuncture. Reasons for ongoing challenges in the development of high-quality acupuncture trials are discussed. In conclusion, results are encouraging for the development of randomized trials to directly evaluate the therapeutic impact of acupuncture in cancer-related psychological symptoms, including depression, anxiety, sleep disturbance, and quality of life, but attention to acupuncture methodological specific challenges in the development of high-quality research is necessary.

Teaching Evidence-based Management: Insights from an Empirical Study of an EBM Decision Process

In response to criticisms that management education is hampered by insufficient empirical examples of how evidence-based management plays out inside organizations, we present an illustrative case study of an EBM decision process. Our empirical investigation focuses on a hospital emergency department in Australia and the decision process a physician manager followed to solve an operations management problem. Analysis of interview and archival data shows a six-stage process of evidence-based decision making: (1) problem recognition and assigning a mandate; (2) assembling literature and internal evidence; (3) cross-pollinating evidence and reformulating the problem; (4) engaging stakeholders and generating evidence-based alternatives; (5) commitment to an evidence-based solution and implementation; and (6) evaluation of outcomes. Our findings offer insight into EBM teaching and research by opening up the characteristics of the decision process, the decision context and the decision maker that shape how EBM plays out in practice.

Toward Rational Pharmacotherapy for Posttraumatic Stress Disorder: Reprise

Toward Rational Pharmacotherapy for Posttraumatic Stress Disorder: Reprise

Atypical antipsychotics for older adults: are they safe and effective as we once thought?

The initial enthusiasm for atypical antipsychotics as being safe and effective for treating older adults with psychotic disorders has diminished. Despite multiple short-term double-blind trials, these drugs have not been approved by the FDA for the most common form of psychosis in this population – i.e., psychosis associated with dementia. On the contrary, these drugs have received FDA warnings for adverse cerebrovascular events and mortality in these patients. Our pragmatic clinical trial failed to show evidence of either safety or effectiveness of the four most commonly prescribed atypical antipsychotics in middle-aged and older patients with different psychotic disorders – schizophrenia as well as psychosis associated with mood disorders, dementia or PTSD. A reconsideration of the common use of these medications, especially off-label use, in older patients is warranted. Unfortunately, there are no evidence-based alternatives to these agents in the target population. Wider employment of psychosocial interventions, cautious and limited use of medications, shared decision making, and greater research on developing better treatments are the order of the day.

The Evaluation of the Effectiveness of Relaxation Training and Sleep Hygiene Education for Insomnia of Depressed Patients

Background: Insomnia is a frequent complaint of patients with major depressive disorder. The lifetime prevalence rate of major depressive disorder is 17% (Sadock & Sadock, 2007). Studies have found that a significantly higher percentage of women than men aged 20–55 years report difficulty maintaining sleep (Soares, 2005). Purpose: This scholarly project involved the implementation and evaluation of a relaxation training and sleep hygiene education intervention for female patients who experience major depressive disorder and insomnia. Theoretical Model: Middle-range theory of unpleasant symptoms (Lenz, Pugh, Milligan, Gift, & Suppe, 1997). Sample: A convenience sample of 10 female participants was recruited from an outpatient psychiatric private practice. Methods: Participants attended 4 consecutive, weekly outpatient sessions lasting approximately 1 hr. The initial session consisted of conducting a psychiatric evaluation and administration of the Pittsburgh Sleep Quality Index to measure rating of sleep quantity and quality. Principles of sleep hygiene and relaxation exercises were introduced during the initial session. Subsequent sessions focused on reinforcement of the principles of sleep hygiene and relaxation training. Results: Sleep hygiene education and relaxation training were effective in treating insomnia of depressed patients. Implications for Nursing: Implementation of sleep hygiene education and relaxation training provides nurses with evidence-based treatment alternatives or complements to pharmacotherapy in depressed patients.

Pharmacotherapy in Pedatric PTSD: A Developmentally-Focused Review of the Evidence

After the experience of a traumatic event, children and adolescents are especially vulnerable to developing debilitating symptoms of Posttraumatic Stress Disorder (PTSD). Criteria for diagnosing this disorder in the pediatric population have proven insufficiently sensitive for children, especially those who are very young. Age-related PTSD symptom expression suggests PTSD assessment and treatment requires developmental consideration. Preschool age children, school age children, adolescents, and adults also possess potentially distinct differences from one another in pharmacokinetics, psychosocial influences, and neurobiology. Pharmacotherapy is often indicated for use in the treatment of pediatric PTSD. Extrapolation of evidence in adult literature for safety, tolerability, and efficacy is nonlinear and should not substitute for dedicated drug trials in pediatric PTSD. This paper reviews all identified randomized controlled trials (RCTs), uncontrolled and open label trials, and case reports/series regarding pharmacotherapy in this population. Emphasis is placed on methodologic rigor and developmental consideration. These trials are discussed in sufficient detail to inform readers of their relative strengths and weaknesses, and of the generalizability of the studies’ conclusions. This review summarizes reports by drug class and developmental cohorts (preschool age, school age, and adolescents). The review will help clinicians a) decide when medications are needed, b) understand current evidence-based alternatives and c) utilize a developmental approach in the selection of medication.

Alternatives to Detention for African American Adolescents with Substance Use and Co-occurring Disorders

Juvenile justice services, disproportionate minority contact, and alternatives to detention for African American adolescents with substance use and co-occurring disorders continue to be areas of concern for juvenile justice, substance abuse, and mental health administrators. Additionally, salient is the question regarding the purpose of the juvenile justice system. Whether its focus is “punishment or rehabilitation” affects outlook, services, approaches, and outcomes. This article examines disproportionate minority contact and alternatives to detention for African American adolescents with substance use and co-occurring disorders along with evidence-based and community-based alternatives to detention.

L5.3 Building an Information Platform for New Drug Discovery

Acceleration in the continuum of discovery, translation and delivery of personalized cancer care requires an integrated network information system to utilize the overwhelming amount of information being generated in basic, translational and clinical research. The stakeholders themselves: researchers, clinicians, administrators and patients must be part of developing and delivering a rapid learning, knowledge-based health system that creates value for the stakeholder, and provides evidence-based alternatives. For example, by having access to a large prospective database of patients, clinicians would be able to find patients most suitable for clinical trials based on their clinical and molecular characteristics which would result in shortening the time to reach adequate patient accrual, and patients would be most suitably matched to the “right” trial. In 2003, the Moffitt Cancer Center in Tampa, Florida launched an initiative in personalized cancer care that has now expanded to 18 health institutions in 10 states, called Total Cancer CareTM (TCC). Critical to the pursuit of personalized medicine is the development of a large regional cancer biorepository in parallel with the development of a relational data warehouse and an information system containing patient's clinical and molecular data. The Total Cancer CareTM Protocol, now with >89K consented patients, >32K tumors and >16K genetic profiles, provides the mechanism to accomplish these goals. A Health and Research Informatics platform facilitates the rapid identification of patient subjects eligible for specific trials. Several pre-clinical projects to define biomarker prevalence, concordance between gene expression and protein expression, and to validate biomarkers, are underway using the TCC database. Specific cohorts of subjects with various cancers identified at Moffitt and within the TCC consortium have been found to be clinically and molecularly eligible for trials involving a variety of biomarkers and targeted agents. Enrollment on these early phase studies that use CLIA defined biomarkers is well underway. This approach has the potential to dramatically decrease trial accrual times, require fewer subjects per trial, and result in increased response rates by specifically targeting molecular alterations in patient tumors.

Ethical challenges in the management of multiple pregnancies: the professional responsibility model of perinatal ethics

Abstract Ethics is an essential component for the responsible clinical management of multiple gestation and decision-making about such pregnancies with pregnant women. The ethical concept of the fetus as a patient is presented as the basis for identifying a professionally responsible approach to selective termination, twin-to-twin transfusion syndrome, and to discordant beneficence-based obligations that exist when one or more fetuses are adversely affected by a fetal anomaly or complication of pregnancy. The roles for directive counseling, i.e., making evidence-based recommendations, and for non-directive counseling, i.e., offering evidence-based alternatives but making no recommendations, are described. The professional responsibility model of perinatal ethics creates a practical framework to guide the clinical judgment of perinatologists and the informed process about the clinical management of multiple pregnancies.