Is there an ethical obligation to disclose controversial risk? A question from the ACCORD Trial.

Researchers designing a clinical trial may be aware of disputed evidence of serious risks from previous studies. These researchers must decide whether and how to describe these risks in their model informed consent document. They have an ethical obligation to provide fully informed consent, but does this obligation include notice of controversial evidence? With ACCORD as an example, we describe a framework and criteria that make clear the conditions requiring inclusion of important controversial risks. The ACCORD model consent document did not include notice of prior trials with excess death. We develop and explain a new standard labeled risk in equipoise. We argue that our approach provides an optimal level of integrity to protect the informational needs of the reasonable volunteers who agree to participate in clinical trials. We suggest language to be used in a model consent document and the informed consent discussion when such controversial evidence exists.

Local legal infrastructure and population health.

OBJECTIVES: We explored the association between the legal infrastructure of local public health, as expressed in the exercise of local fiscal and legislative authority, and local population health outcomes. METHODS. Our unit of analysis was public health jurisdictions with at least 100,000 residents. The dependent variable was jurisdiction premature mortality rates obtained from the Mobilize Action Toward Community Health (MATCH) database. Our primary independent variables represented local public health's legal infrastructure: home rule status, board of health power, county government structure, and type of public health delivery system. Several control variables were included. We used a regression model to test the relationship between the varieties of local public health legal infrastructure identified and population health status. RESULTS: The analyses suggested that public health legal infrastructure, particularly reformed county government, had a significant effect on population health status as a mediator of social determinants of health. CONCLUSIONS: Because states shape the legal infrastructure of local public health through power-sharing arrangements, our findings suggested recommendations for state legislation that positions local public health systems for optimal impact. Much more research is needed to elucidate the complex relationships among law, social capital, and population health status.

Quality of life in patients postcolectomy for pediatric-onset ulcerative colitis.

BACKGROUND: Ulcerative colitis in children can have a negative effect on quality of life (QOL). METHODS: We included 16 of 31 patients who underwent colectomy for ulcerative colitis before 20 years of age between 1980 and 2005 at University of California in San Francisco Benioff Children's Hospital. A disease-specific QOL questionnaire (Inflammatory Bowel Disease Questionnaire-32), validated for adults, was used to determine QOL and an additional questionnaire addressing bowel function and reproductive health in long-term follow-up of these patients. RESULTS: Median age at the time of survey was 20.3 years (17.9-25.3), and time postcolectomy was 6.9 years (4.8-9.0). Mean total score was 159.7 ± 43.3 (58-210). Two patients (12.5%) had scores of ≥ 200, 12 (75.0%) had 101 to 199, and 2 (12.5%) had ≤ 100. Patients ages 18 years or younger at the time of survey showed higher QOL, particularly in emotional health (P=0.020), social function (P=0.014), and overall QOL (P=0.009). Social function scored highest of all of the systems (median 7; interquartile range 4-7). Patients with scores ≤ 100 had repeated episodes of pouchitis (16-30) compared with the other 14 patients (0-3). Children who were diagnosed ages 12 years or younger tended to have higher QOL (p=0.072). Years postcolectomy did not correlate to QOL. Eleven patients were sexually active. Two males had feelings of impotence and decreased libido, and 6 females experienced dyspareunia. Three women tried unsuccessfully to conceive after colectomy. One woman became pregnant 4 times, each leading to miscarriage. CONCLUSIONS: Younger age at time of colectomy, diagnosis, and survey show higher QOL. Highest satisfaction was found in ability to attend school, work, and social engagements. Pouchitis continued to be an issue for a small number of the patients, with 2 patients having recurring episodes that severely affected QOL. Patients reported decreased sexual activity and fertility at the time of survey due to colectomy, especially for females.

Describing local boards of health: insights from the 2008 National Association of Local Boards of Health Survey.

OBJECTIVES: We examined findings from the 2008 National Association of Local Boards of Health Survey to provide information about this understudied entity to the public health community. METHODS: The survey instrument consisted of 196 items covering five parts: (1) demographics; (2) composition and organizational structure; (3) roles, responsibilities, and authorities; (4) telecommunications infrastructure; and (5) concerns and needs. The survey was sent to chairs of local boards of health (LBHs) in 2008 (n = 3,276). After six months of follow-ups and reminders, and a month of data cleaning and screening, the final sample consisted of 870 respondents, for a return rate of 27%. RESULTS: LBHs tend to represent smaller communities and are primarily appointed. Governing and policy-making boards are more prevalent than advisory boards. Most boards do not have official websites or e-mail addresses of board members available to the public; however, most report the capability to receive training via webcasts. Boards express concerns and needs in a variety of areas, particularly public health law, strategic planning, and accreditation. CONCLUSIONS: Little is known about the more than 3,000 LBHs across the United States that are often charged with making and enforcing public health law. This article is a first step toward providing the public health community with information about LBHs based on survey data.

Postoperative outcome of colectomy for pediatric patients with ulcerative colitis.

BACKGROUND: Few studies have reported on the surgical outcomes of colectomy in pediatric patients with ulcerative colitis (UC). PATIENTS AND METHODS: We conducted a retrospective chart review of all pediatric patients diagnosed with UC who underwent colectomy at UCSF between 1980 and 2005 to identify early (within 30 days) and later complications of surgery. RESULTS: Complete medical records were available for 31 patients [12.4 +/- 3.3 (range 6-19) years] with UC who underwent colectomy at UCSF Children's Hospital. Total colectomy with ileal pouch anal anastomosis (IPAA) was performed in 21 of the 31 patients (12 without diverting ileostomy). Five of the 31 patients had an initial colectomy with IPAA and J-pouch performed later; 4 had an initial subtotal colectomy for urgent indications. Only one of 31 had IPAA with S-pouch. The median number of early postoperative complications was 1.0; 4 required additional surgery to treat complications. The most common early complications were small intestinal obstruction in 6 (19%) and wound infection in 4 (13%). Preoperative medications included corticosteroids in 25 (81%), 6-mercaptopurine/azathioprine in 10 (32%), and 5-aminosalicylates in 19 (61%). Medication exposure was not related to postoperative complications. Late complications included pouchitis in 12 (39%), anastomotic, anal, or rectal strictures in 5 (16%), and fistulas in 5 (16%); 1 (3%) was subsequently diagnosed as having Crohn disease. CONCLUSIONS: Postcolectomy morbidity is common among pediatric patients with UC. Preoperative medications were not associated with postoperative complications. Investigations to determine preoperative factors affecting surgical outcomes and long-term satisfaction following this surgery in a large pediatric cohort are needed.

State policy and health disparities: an examination of the impact of state offices of minority health.

For over two decades, a concerted effort has been underway to tackle health disparities. State Offices of Minority Health (OMH) have led efforts in data collection, training, and policy development. Yet, little evidence exists regarding the effectiveness of these efforts. I address this dearth of knowledge by examining the impact of state Offices of Minority Health on Black infant mortality rates. I perform a longitudinal regression analysis controlling for political, economic, and policy variables. I find that state OMHs are associated with a decrease in Black infant mortality rates. Furthermore, when Medicaid spending is low, the implementation of a state OMH decreases Black infant mortality over time. As Medicaid spending increases, however, the effect diminishes. State OMHs and Medicaid are important tools to decrease Black infant mortality rates. States that invest relatively little in health care for the poor should consider increasing investments in their Offices of Minority Health.