Publications

BACKGROUND

Transplantation of cells derived through the manipulation of pluripotent stem cells may involve great uncertainty and the possibility of serious risks.

PURPOSE

To develop guidelines for the ethical conduct of clinical trials using such stem cells.

METHODS

Review of literature on clinical trials ethics and clinical applications of stem cells; critical deliberation on potential guidelines.

RESULTS

Such transplantation should be allowed in clinical practice only after clinical trials demonstrate efficacy and safety. These clinical trials should follow ethical principles that guide all clinical research. Additional requirements to strengthen trial design, coordinate scientific and ethics review, verify that participants understand key features of the trial, and ensure publication of findings are also warranted because of the highly innovative nature of the intervention, limited experience in humans, and the high hopes of patients who have no alternative effective treatments.

LIMITATIONS

These recommendations will need to be modified in light of actual experience with stem cell clinical trials.

CONCLUSIONS

These recommendations will help guarantee that the efficacy and safety of innovative stem cell interventions will be rigorously established, while also protecting study participants.

OBJECTIVE

Tympanostomy tube insertion is the most common procedure that requires general anesthesia for children in the United States. We report on the clinical characteristics of a cohort of New York City children who received tympanostomy tubes in 2002.

METHODS

This retrospective cohort study included all 1046 children who received tubes in 2002 in any of 5 New York City area hospitals. We analyzed clinical data for all 682 (65%) children for whom we were able to abstract data for the preceding year from all of 3 sources: hospital, pediatrician, and otolaryngologist medical charts.

RESULTS

Mean age was 3.8 years, 57% were male, and 74% had private insurance. More than 25% of children had received tubes previously. The stated reason for surgery was otitis media with effusion for 60.4% of children, recurrent acute otitis media for 20.7%, and eustachian tube dysfunction for 10.6%. Children with recurrent acute otitis media averaged 3.1 +/- 0.2 episodes (median: 3.0) in the previous year; those with otitis media with effusion averaged effusions that were 29 +/- 1.7 days long (median: 16 days) at surgery. Twenty-five percent of children had bilateral effusions of >42 days' duration at surgery. Despite a clinical practice guideline for otitis media with effusion that recommends withholding tympanostomy tubes for otherwise healthy children until a bilateral effusion is at least 3 to 4 months old, 50% of children had surgery without having had 3 months of effusion cumulatively during the year before surgery.

CONCLUSIONS

The clinical characteristics of children who received tympanostomy tubes varied widely. Many children with otitis media with effusion had shorter durations of effusions than are generally recommended before surgery. The extent of variation in treating this familiar condition with limited treatment options suggests both the importance and the difficulty of managing common practice in accordance with clinical practice guidelines.

A neglected topic in aging depression research is the potential role of the parent-adult child relationship. In this study we examined whether adult children's reports of having relied upon parents for instrumental and expressive support are associated with parents' depressive symptoms. The sample included 304 parents (aged 50-72 years), matched to a randomly selected adult offspring, from the University of Southern California Longitudinal Study of Generations. We measured parents' depressive symptoms by using the Center for Epidemiologic Studies Depression Scale at baseline and 3 and 6 years later. The final longitudinal analysis showed that, when we adjusted for relevant variables including age, gender, income, self-rated health, and child's depressive symptoms, the adult child's reliance on instrumental support was associated with fewer parental depressive symptoms (p =.036). Expressive support did not show the same pattern. Thus, adult children's reliance on instrumental support might contribute to their parents' mental health.

BACKGROUND

The efficacy of a nurse case-managed intervention was evaluated in subsamples of participants with one of the following characteristics: female gender, African American ethnicity, recruited from a homeless shelter, a history of military service, lifetime injection drug use, daily alcohol and drug use, poor physical health, and a history of poor mental health.

OBJECTIVE

To determine whether a validated nurse case-managed intervention with incentives and tracking would improve adherence to latent tuberculosis infection treatment in subsamples of homeless persons with characteristics previously identified in the literature as predictive of nonadherence.

METHODS

A prospective 2-group site-randomized design was conducted with 520 homeless adults residing in 12 homeless shelters and residential recovery sites in the Skid Row region of Los Angeles from 1998 to 2003.

RESULTS

Daily drug users, participants with a history of injection drug use, daily alcohol users, and persons who were not of African American race or ethnicity had particularly poor completion rates, even in the nurse case-managed intervention program (48%, 55%, 54%, and 50%, respectively). However, the intervention achieved a 91% completion rate for homeless shelter residents and significantly improved latent tuberculosis infection treatment adherence in 9 of 12 subgroups tested (odds ratios = 2.51-10.41), including daily alcohol and drug users, when potential confounders were controlled using logistic regression analysis.

DISCUSSION

Nurse case management with incentives appears to be a good foundation for increasing adherence to 6-month isoniazid treatment in a variety of homeless subgroups and, in particular, for sheltered homeless populations. However, additional social-structural and environmental strategies are needed to address those at greatest risk of nonadherence.

These practice parameters are an update of the previously published recommendations regarding the use of autotitrating positive airway pressure (APAP) devices for titrating pressures and treating adult patients with obstructive sleep apnea syndrome. Continuous positive airway pressure (CPAP) at an effective setting verified by attended polysomnography is a standard treatment for obstructive sleep apnea (OSA). APAP devices change the treatment pressure based on feedback from various patient measures such as airflow, pressure fluctuations, or measures of airway resistance. These devices may aid in the pressure titration process, address possible changes in pressure requirements throughout a given night and from night to night, aid in treatment of OSA when attended CPAP titration has not or cannot be accomplished, or improve patient comfort. A task force of the Standards of Practice Committee of the American Academy of Sleep Medicine has reviewed the literature published since the 2002 practice parameter on the use of APAP. Current recommendations follow: (1) APAP devices are not recommended to diagnose OSA; (2) patients with congestive heart failure, patients with significant lung disease such as chronic obstructive pulmonary disease; patients expected to have nocturnal arterial oxyhemoglobin desaturation due to conditions other than OSA (e.g., obesity hypoventilation syndrome); patients who do not snore (either naturally or as a result of palate surgery); and patients who have central sleep apnea syndromes are not currently candidates for APAP titration or treatment; (3) APAP devices are not currently recommended for split-night titration; (4) certain APAP devices may be used during attended titration with polysomnography to identify a single pressure for use with standard CPAP for treatment of moderate to severe OSA; (5) certain APAP devices may be initiated and used in the self-adjusting mode for unattended treatment of patients with moderate to severe OSA without significant comorbidities (CHF, COPD, central sleep apnea syndromes, or hypoventilation syndromes); (6) certain APAP devices may be used in an unattended way to determine a fixed CPAP treatment pressure for patients with moderate to severe OSA without significant comorbidities (CHF, COPD, central sleep apnea syndromes, or hypoventilation syndromes); (7) patients being treated with fixed CPAP on the basis of APAP titration or being treated with APAP must have close clinical follow-up to determine treatment effectiveness and safety; and (8) a reevaluation and, if necessary, a standard attended CPAP titration should be performed if symptoms do not resolve or the APAP treatment otherwise appears to lack efficacy.