Chiodo Gt

Impact of intensified dental care on outcomes in human immunodeficiency virus infection

This study evaluated the health effects of routine and intensified dental care and disease prevention in persons with human immunodeficiency virus (HIV). We recruited 376 HIV-infected persons ages 19 to 61 with CD4 counts between 100 and 750 into a year-long two-arm randomized controlled trial. Control group subjects (n = 185) received professional dental protective treatment and checkups at baseline, 6 months, and 1 year, plus dental care. Enhanced care patients (n = 191) received bimonthly protective treatment and twice-daily chlorhexidine mouthrinses to treat gingivitis. Active decay, gingivitis, oral pain, impact of oral health on functioning, and global functional status improved in both groups. The mean depth of periodontal pockets decreased 0.18 mm (control group) versus 0.27 mm (enhanced group) (p < 0.04), as did an erythema index (-1.22 versus -1.78, p < 0.01). No effects on acquired immune deficiency syndrome (AIDS)-related complications, symptoms, or mortality were observed. We concluded that access to dental screening, prophylaxis, and repair will significantly improve oral health, functioning, and quality of life in persons with AIDS.

Oral cancer detection. The importance of routine screening for prolongation of survival

The incidence of oral cancer has increased in the past ten years. Early diagnosis and treatment are essential to long-term survival; however, patients at highest risk visit the dentist infrequently. The reddish, velvety or erythroplakial lesion at the base of the tongue or floor of the mouth is highly suspicious in any patient and requires further evaluation. High-risk patients with less suspicious appearing lesions must be reevaluated on close recall. Prognosis improves vastly when the lesion is detected and treated early. One study demonstrated a 64% five-year survival rate for patients with oral cancer that was diagnosed before regional lymph node involvement versus a 15% five-year survival for patients whose lesions were diagnosed after regional lymph node involvement. By including an oral cancer examination in routine physical examination of patients, the physician and public health nurse can increase the likelihood of early detection of oral cancer.

A qualitative study of institutional review board members’ experience reviewing research proposals using emergency exception from informed consent

Background: Emergency exception to informed consent regulation was introduced to provide a venue to perform research on subjects in emergency situations before obtaining informed consent. For a study to proceed, institutional review boards (IRBs) need to determine if the regulations have been met. Aim: To determine IRB members’ experience reviewing research protocols using emergency exception to informed consent. Methods: This qualitative research used semistructured telephone interviews of 10 selected IRB members from around the US in the fall of 2003. IRB members were chosen as little is known about their views of exception to consent, and part of their mandate is the protection of human subjects in research. Interview questions focused on the length of review process, ethical and legal considerations, training provided to IRB members on the regulations, and experience using community consultation and notification. Content analysis was performed on the transcripts of interviews. To ensure validity, data analysis was performed by individuals with varying backgrounds: three emergency physicians, an IRB member and a layperson. Results: Respondents noted that: (1) emergency exception to informed consent studies require lengthy review; (2) community consultation and notification regulations are vague and hard to implement; (3) current regulations, if applied correctly, protect human subjects; (4) legal counsel is an important aspect of reviewing exception to informed-consent protocols; and (5) IRB members have had little or no formal training in these regulations, but are able to access materials needed to review such protocols. Conclusions: This preliminary study suggests that IRB members find emergency exception to informed consent studies take longer to review than other protocols, and that community consultation and community notification are the most difficult aspect of the regulations with which to comply but that they adequately protect human subjects.