A prospective double-blind, randomized clinical trial of levocarnitine to treat autism spectrum disorders.

BACKGROUND: L-carnitine was proposed as a potential treatment for patients diagnosed with an autism spectrum disorder to improve mitochondrial dysfunction, but no prior randomized controlled trials have been conducted. MATERIAL/METHODS: Thirty subjects diagnosed with an ASD were randomly assigned to receive a standardized regimen (50 mg L-carnitine/kg bodyweight/day) of liquid L-carnitine (n=19) or placebo (n=11) for 3-months. Measures included changes in professionally completed Childhood Autism Rating Scale (CARS), hand muscle testing, and modified clinical global impression (CGI) forms; parent completed Autism Treatment Evaluation Checklist (ATEC), treatment adherence measurement (TAM), frequency and intensity of side effect rating (FISER)/global rating of side effect burden (GRSEB)/patient report of incidence of side effects (PRISE) forms; and lab testing. RESULTS: Significant improvements were observed in CARS (-2.03, 95% CI=-3.7 to -0.31), CGI (-0.69, 95% CI=-1.1 to -0.06), and ATEC scores. Significant correlations between changes in serum free-carnitine levels and positive clinical changes were observed for hand muscle strength (R2=0.23, P=0.046), cognitive scores (R2=0.27, P=0.019), and CARS scores (R2=0.20, P=0.047). Study subjects were protocol-compliant (average adherence was >85%) and generally well-tolerated the L-carnitine therapy given. CONCLUSIONS: L-carnitine therapy (50 mg/kilogram-bodyweight/day) administered for 3-months significantly improved several clinical measurements of ASD severity, but subsequent studies are recommended.

Social contexts influence ethical considerations of research.

This article argues that we could improve the design of research protocols by developing an awareness of and a responsiveness to the social contexts of all the actors in the research enterprise, including subjects, investigators, sponsors, and members of the community in which the research will be conducted. "Social context" refers to the settings in which the actors are situated, including, but not limited to, their social, economic, political, cultural, and technological features. The utility of thinking about social contexts is introduced and exemplified by the presentation of a hypothetical case in which one central issue is limitation of the probability of injury to subjects by selection of individuals who are not expected to live long enough for the known risks of the study to become manifest as harms. Benefits of such considerations may include enhanced subject satisfaction and cooperation, community acceptance, and improved data quality, among other desirable consequences.

Expanding the Contours of Forensic Consulting.

Forensic psychiatry as a subspecialty discipline is presently experiencing a broad and essentially constructive conversation concerning its foundations and their implications for teaching and practice. The essay by Griffith and Greenidge proposes developing the art of consultation to include bringing out the contextual realities often invisible at first to the quarreling parties. Often enough they can thus be spared embarrassment as they come to recognize that their shared values matter more than any differences. This outcome may prove especially broadly true in the religious arena.

Cancer survival in five continents: a worldwide population-based study (CONCORD).

BACKGROUND: Cancer survival varies widely between countries. The CONCORD study provides survival estimates for 1.9 million adults (aged 15-99 years) diagnosed with a first, primary, invasive cancer of the breast (women), colon, rectum, or prostate during 1990-94 and followed up to 1999, by use of individual tumour records from 101 population-based cancer registries in 31 countries on five continents. This is, to our knowledge, the first worldwide analysis of cancer survival, with standard quality-control procedures and identical analytic methods for all datasets. METHODS: To compensate for wide international differences in general population (background) mortality by age, sex, country, region, calendar period, and (in the USA) ethnic origin, we estimated relative survival, the ratio of survival noted in the patients with cancer, and the survival that would have been expected had they been subject only to the background mortality rates. 2800 life tables were constructed. Survival estimates were also adjusted for differences in the age structure of populations of patients with cancer. FINDINGS: Global variation in cancer survival was very wide. 5-year relative survival for breast, colorectal, and prostate cancer was generally higher in North America, Australia, Japan, and northern, western, and southern Europe, and lower in Algeria, Brazil, and eastern Europe. CONCORD has provided the first opportunity to estimate cancer survival in 11 states in USA covered by the National Program of Cancer Registries (NPCR), and the study covers 42% of the US population, four-fold more than previously available. Cancer survival in black men and women was systematically and substantially lower than in white men and women in all 16 states and six metropolitan areas included. Relative survival for all ethnicities combined was 2-4% lower in states covered by NPCR than in areas covered by the Surveillance Epidemiology and End Results (SEER) Program. Age-standardised relative survival by use of the appropriate race-specific and state-specific life tables was up to 2% lower for breast cancer and up to 5% lower for prostate cancer than with the census-derived national life tables used by the SEER Program. These differences in population coverage and analytical method have both contributed to the survival deficit noted between Europe and the USA, from which only SEER data have been available until now. INTERPRETATION: Until now, direct comparisons of cancer survival between high-income and low-income countries have not generally been available. The information provided here might therefore be a useful stimulus for change. The findings should eventually facilitate joint assessment of international trends in incidence, survival, and mortality as indicators of cancer control.

Commentary: further points for dialogue on the death penalty, the church, and our profession.

The invitation to dialogue on the subject of the death penalty is both important for our time and challenging in what it calls forth from us. It forces us to recognize both the fundamental privacy of individual intention and the potential breadth of its reach. It can deepen our sense of responsibility for what happens to others on our account, even in the apparent absence of intention. The astonishing power of the spoken word should be harnessed by cooperative dialogue to focus its consequences more sharply on the demands of justice. We need dialogue to attend faithfully to our deepest obligations and longings.

Instilling hope into forensic treatment: the antidote to despair and desperation.

The importance of hope in the treatment of physical ills is well documented. Less is known about its role in the treatment of mental illness. Hope, the expectation of achieving a goal, figures prominently among the curative influences that help forensic patients recover. The cognitive processes that fuel violence and bring patients into our care often result in the loss of hope. Successful treatment requires the restoration and fueling of hope as patients progress through the phases of recovery. We review the extant literature on hope as it relates to clinical concerns, including the genesis of violence, mood, adjustment to physical illness, spirituality, forensic assessment and treatment, staff morale, and patient-centered care.

Truth as Humility Nourishing Compassion Through Wisdom.

Among the strengths of forensic psychiatry as a profession is its ability to support lively discussion of critical questions, such as how to characterize its own essence and whether it belongs to the practice of medicine. The American Academy of Psychiatry and the Law is fortunate that Michael Norko has taken the occasion of his presidential address to describe in depth the results of the advanced stage of his probing on a truly spiritual level the fundamental place of compassion in the practice of forensic psychiatry. In so doing, he casts inevitable light on the seamless connections binding forensic psychiatry and medicine, particularly the importance for both of practicing compassion in our search for truth.

Clinicians' Need for an Ecological Approach to Violence Reduction.

We now know that harmful social policies, such as those that deny health care to some people, can generate structural violence and be far more harmful than any type of direct violence. A health professional who engages in public health promotion must thus consider the adverse effects of structural violence generated by bad policies. On this view, the dictum, "first, do no harm," can be interpreted as a mandate to protect patients from injustice. Health care professionals' responsibilities extend to motivating policies that prevent avoidable deaths and disabilities. As we exist within an ecology, we must each recognize our responsibility to care for one another and for the larger human community.

Commentary: It's about the fundamentals.

Recent actions by the American Psychiatric Association, the American Medical Association, and the American Psychological Association document a growing consensus that health professionals should not become directly involved in hostile interrogations. Challenging questions remain regarding the permissibility of indirect involvement, such as training directed toward promoting the humanity of interrogation procedures and the reliability of their results. A fundamental challenge comes from those who hold that a physician may relinquish the caring role and proceed to disregard medical ethics altogether. Some experts have even gone so far as to allege that all existing rules of medical ethics are baseless statements and thus cannot bind anyone. Forensic psychiatrists' continuing contributions to this debate are critical.

Commentary: refusing to give up on forensic research.

Increasing regulation may soon cost forensic patients the opportunity to benefit from participating in research. A wise preventive strategy is the institutional use of quality assurance and related processes for regulating its internal research. Candilis and colleagues provide abundant useful information for this purpose. Additional models to consider include a centralized Institutional Review Board, study coordinators, and services researchers. Research needs to be done on the regulation of forensic research.

Commentary: is the plot thickening for partisan forensic expert witnesses?

Knowledge of the past has a powerful way of clarifying the challenges of the present. Dr. Weiss enables the reader to exploit this phenomenon as it applies to the important perennial struggle of the expert witness for objectivity.

Transporting Forensic Psychiatric Patients.

Patients in a forensic psychiatric facility often require escorted transport to medical facilities for investigations or treatments of physical health ailments. Transporting these patients presents significant safety and custody challenges because of the nature of patients housed in forensic psychiatric facilities. A significant proportion of these patients may be transfers from the Department of Corrections (DOC) under legal mandates for psychiatric evaluation and treatment better provided in a hospital setting, and most of them will return to the DOC. Although departments of correction have protocols for escorting these potentially dangerous individuals, it is unclear whether receiving psychiatric hospitals have established procedures for maintaining the safety of others and custody of these individuals during transportation outside the hospital facility. The literature is sparse on precautions to be observed when transporting dangerous forensic psychiatric patients, including those with high escape risk. In this article, we describe one forensic inpatient facility's procedure for determining the appropriate level needed to transport these individuals outside of the forensic facility. We also describe the risk assessment procedure for determining level of transport. These are quality improvement measures resulting from a critical review of an incident of escape from the forensic facility several years ago.

The integral role of pastoral counseling by African-American clergy in community mental health.

OBJECTIVE: Little is currently known about the pastoral counseling work of pastors of African-American churches. The authors interviewed the pastors of nearly all African-American churches in a metropolitan area about their pastoral counseling work and related aspects of their ministry. METHODS: Of 121 African-American pastors identified, 99 completed a semistructured interview describing their backgrounds, attitudes, concerns, and work. The interview included detailed queries about how they understood and carried out any pastoral counseling work. RESULTS: The respondents averaged more than six hours of counseling work weekly and often addressed serious problems similar to those seen by secular mental health professionals, with whom they reported readily exchanging referrals. Many of the respondents reported having and maintaining specialized education for their counseling work, which they described as including both spiritual and psychological dimensions. Most of the pastors reported that they observe and address severe mental illness and substance abuse in their congregations and that they also counsel individuals outside their own denominations. CONCLUSIONS: African-American urban ministers functioning as pastoral counselors constitute an engaging and useful group with experiences and skills that can be tapped by interested secular professionals. Their work represents a significant mental health resource for persons who lack sufficient access to needed care.

Clergy counselors and confidentiality: a case for scrutiny.

As religious organizations contribute increasingly to community mental health, counseling by clergy acquires greater significance. As a result, clergy confront from time to time ethics challenges resulting from the need to balance a commitment to clients and an obligation to follow the requirements of religious doctrine. The recent New York case of Lightman v. Flaum highlights an example of this dilemma. A woman who asked two rabbis (Flaum and Weinberger) for help in her marriage complained that they had violated the confidentiality she expected of them. The rabbis requested summary judgment based on religious grounds, and the trial court rejected their request. The state's highest court concurred with an appeal court's reversal of the trial court. We discuss the arguments raised in this case about the extent to which clergy may owe a duty of confidentiality to those who consult them for psychological help, and we also consider the religion-based arguments that would fashion an exception to confidentiality in this unique context.

Ethics in forensic psychiatry publishing.

Several organizations have developed guidelines to help authors and editors of medical journals negotiate ethics dilemmas in publishing, but very little is known about how these guidelines translate to the context of forensic psychiatry. In this article, we explore the important topic of ethics in forensic psychiatry publishing. First, we review the historical development of ethics principles in medical and psychiatric publishing. We then analyze eight ethics dilemmas that have arisen in the publication of The Journal of the American Academy of Psychiatry and the Law (The Journal) from 2000 to 2009, including disputes about authorship, conflict of interest, redundant publication, bias in peer reviewers, confidentiality in case reports, and others. We identify ethics principles that were relevant to the dilemmas and discuss how they were resolved by the editors of The Journal. We conclude by using the principles identified in the practical resolution of ethics dilemmas to derive a conceptual foundation for ethics in forensic psychiatry publishing.

Validating tumor linkage using the NAACCR site pairs table.

The objective of this study is to illustrate use of the Site Pairs Table developed by the North American Association of Central Cancer Registries (NAACCR) Record Linkage Work Group to validate tumor linkage in a central registry database and to identify potential cases with inaccurate tumor linkage. Central registries often receive reports for patients with multiple tumors, and they receive multiple reports from different sources for the same tumor. Tumor site pairs (pairs of unique tumors for patients with multiple tumors) ought not refer to the same tumor as represented in the Site Pairs Table. Likewise, abstract pairs (pairs of abstracts relating to the same tumor) ought to be identified during the tumor linkage process as belonging to the same tumor. Three central cancer registries represented on the work group contributed data to the study. The data included cases diagnosed 1992-2003 and represented 143,288 patients with multiple tumors and 280,227 tumors with multiple abstracts. Totals of 181,118 tumor site pairs and 391,670 abstract site pairs were generated from the data and compared to the Site Pairs Table. Of the abstract site pairs 381,389 (97.4%) were found in the Site Pairs Table. One registry reviewed its portion of the 2.6% not found in the table and determined 12% of the cases were incorrectly linked and should change from one tumor to two tumors. Of the tumor site pairs, 144,793 (80%) were not found in the Site Pairs Table. Further evaluation of the remaining 20% by paired site and laterality, histology and timing showed 19.3% were considered unique tumors and 0.7% were identified as potential cases with inaccurate tumor linkage. Two registries reviewed their portion of these cases. One registry changed two tumors to one tumor on 44% of the cases they reviewed. The other registry changed two tumors to one tumor on 53% of the cases they reviewed. Analyzing site pairs within the registry database using the Site Pairs Table assists in identifying inaccurate tumor linkages as was shown in this study.

Racial/ethnic diversity in children's oncology clinical trials: ten years later.

BACKGROUND: During the past 50 years, clinical trials have led to dramatic improvement in pediatric cancer survival. Prior studies have shown that racial/ethnic and age groups have not been enrolled proportionally. Whites, Hispanics, and adolescents are under-represented and black children are over-represented. This study identifies the current racial/ethnic/age/sex representation in pediatric (ages birth to 19 years) cancer treatment trials. METHODS: The authors compared the observed proportions (O) of US children enrolled in Children's Oncology Group (COG) clinical trials from 2000 through 2003 with expected proportions (E), based on Surveillance, Epidemiology, and End Results (SEER) data. The enrollees were subgrouped by race/ethnicity, age, sex, and cancer type (solid or lymphohematopoietic). Chi-square tests and 95% confidence intervals were used for O versus E comparisons. RESULTS: Although representation was fairly proportional for each racial/ethnic group, significantly under-represented solid tumor subgroups were whites (males particularly), adolescents ages 10 to 19 years, and Hispanics aged <10 years. For lymphohematopoietic cancers, significantly under-represented subgroups were blacks, Hispanics, adolescents ages 10 to 19 years, blacks aged <10 years, Hispanics aged <5 years, white and black males, and black and Hispanic females. The most significantly under-represented groups were adolescents ages 15 to 19 years for both solid (9.1% O vs 34.3% E) and lymphohematopoietic (11.0% O vs 30.2% E) cancers and Hispanic females with lymphohematopoietic cancers (11.9% O vs 20.5% E). COG enrolled 26.8% of expected cancer cases. CONCLUSIONS: Although racial/ethnic groups are proportionally represented in COG trials, some specific subgroups including the youngest black and Hispanic children, Hispanic females, and particularly white adolescents ages 15 to 19 years may be under-represented and may benefit from targeted attention.