Tag Archives: controlled trial

Children With Asthma: Session 3

Children With Asthma: Session 3I. Review of asthma status and understanding of asthma
a. Discuss progress and problems
b. Play “Asthma Jeopardy” to review and reinforce the mastery of basic asthma facts by the parent(s) and child
II. Review progress in eliminating the child’s exposure to tobacco smoke
a. If participants were not at previous sessions, explain what cotinine is and what it means
b. Show “Secondhand Smoke Revised” video, and discuss the ideas with the family
c. Review the cotinine test results collected before the last session, and provide a copy of the result to parents to take home
d. Explain the relationship between the last cotinine results and the 4-day ETS exposure prior to the test, and compare it to previous cotinine results and exposures
e. Complete a new 4-day ETS exposure recall

Children With Asthma: Session 2

I. Review of progress
a. Discuss progress and problems
II. Use of metered-dose inhaler
a. Review written instructions on inhaler use
b. Demonstrate use of (placebo) inhaler with the child and have the parent use the “inhaler usage skills checklist” during the demonstration
c. Discuss inhaler-use techniques, and answer any questions
III. Review of asthma pathophysiology with the child (if possible) and the adult(s)
a. Review the “Picture of My Body and What Happens With Asthma” handout
b. If the patient is an older child, have the child practice explaining asthma to a friend
c. Demonstrate with a straw how difficult it is to breathe when the child gets asthma
d. Review “My Early Warning Signs” and “My Asthma Triggers” handout

Children With Asthma: ETS reduction intervention

Children With Asthma: ETS reduction interventionAn intervention of this nature might have greater acceptance in a clinical (ie, nonresearch) setting, where meetings with the nurse could be approached as a normal component of the care of children with asthma. A research setting poses special challenges due to the burdens of data collection and to the detail and formality of the consent procedures. The extent of advance disclosure in ETS reduction intervention studies has varied. Notwithstanding the differences in the criteria of investigators and IRBs for informed consent that are implicit in these variations, full disclosure most likely decreases the willingness to participate on the part of some caregivers. Published reports of ETS reduction interventions should carefully describe the recruitment and disclosure procedures and should document participation rates in order to define the limitations of generalization of the results. www.mycanadianpharmacy.com

Appendix: Outline of the Behaviorally Based Counseling and Cotinine-Feedback Intervention
Session 1

Children With Asthma: Study Participation and Generalization of the Results

Wilson et al reported that maternal smokers were less likely than nonsmokers to enroll in an asthma education research study and, if enrolled and randomized to the intervention, were less likely to attend education sessions than were nonsmokers. We observed here that children whose families did not comply with the follow-up assessments had greater baseline ETS exposure than those who were retained but were no more likely to have a maternal caregiver who smoked (children with cotinine data at follow-up, 47%; children without cotinine data at follow-up, 50%). We could not determine whether children whose parents declined to participate in the study at all may have had still greater exposure than did participants, because we lacked the necessary data on nonparticipants. The results of any intervention study that recruits nonvolunteers (ie, individuals who were not identified by virtue of their seeking assistance with ETS reduction or smoking cessation) necessarily generalize only to those willing to participate. It is likely that those who are contemplating or willing to contemplate making changes in smoking practices are more likely to participate in such a study than those who are at a precontemplation stage, hence the results of the experiment may generalize only to the former population. canadian neighborhood pharmacy

Children With Asthma: Smoking by Other Family Members and Friends

Children With Asthma: Smoking by Other Family Members and FriendsThe limitations of infrequent urine cotinine tests as a measure of typical exposure may seem to imply that providing feedback on cotinine levels as part of the intervention is questionable. However, the problems that arise in its use as an outcome measure are primarily due to temporal sampling problems, rather than to any insensitivity or unreliability of the assay in the range of cotinine levels in which we are interested (notwithstanding the complexities of the assays and of nicotine metabolism and excretion). In the present intervention, the results of cotinine measurements were always communicated to the caregiver in conjunction with a review of the parent’s report of the child’s exposure history during the period leading up to that report, which was given on the day the urine sample was taken. In this way, high or low values could be interpreted and discussed, and the parent could be reinforced for a reduction or queried further if there was an apparent discrepancy between the assay value and the reported exposure. In some cases, such queries prompted the recall of previously unreported exposure (eg, that a sister’s boyfriend, a chain smoker, had moved into the home), which then uncovered the need for a new strategy to eliminate exposure. When used in this manner, the cotinine level results had face validity to the parents and nurse educator and were well-accepted. Other family members also appeared to be more readily convinced of the reality and importance of the exposure by the laboratory results than by the caregiver’s assertions. canadian health care mall

Children With Asthma: ETS exposure and disease

The present results pose a different issue. We have noted the possibility that the intervention improved health-care utilization through some mechanism other than ETS exposure reduction. However, the latter interpretation cannot be ruled out, especially given the relatively large effect size and the relatively small sample. The dose-response relationship between reductions in ETS exposure and improvements in asthma outcomes is unknown at present. Modest reductions in ETS exposure actually may have important benefits in children with hyperreactive airways, and decreases sustained during the winter months may be especially important since that is the time when children and smokers tend to be indoors, ventilation is poorer, and viral respiratory tract infections are most prevalent. Further, prenatal exposure and the duration of prior exposure may modify the dose-response relationship. If these considerations are important, the failure of most ETS reduction studies to measure asthma outcomes as well as exposure, coupled with a relatively high variance in the measure of exposure and the rather low statistical power in some instances, may result in an underestimation of the value of such interventions.

Children With Asthma: Methodologic Issues

Children With Asthma: Methodologic IssuesResolving the questions on which this study fails to be statistically clear (ie, on the questions of the mechanism) will require further controlled trials in which objective data are concurrently gathered on family asthma-management behaviors (eg, medication adherence and other environmental control practices), as well as on ETS exposure and asthma outcomes (eg, symptoms, lung function, activity limitations, and health-care utilization). We suggest that it also would be important to measure the stage of change of the caregiver with regard to smoking cessation and the prohibition of smoking in the home at the outset and at the conclusion of the study. With permission, stage data might also be gathered from those caregivers who decline to participate. This information could help to identify the segment of the ETS-exposed population that is reached by such an intervention and could reveal whether certain types of caregivers are more responsive to the intervention than others and whether the intervention is able to move participants from a precontemplation stage to contemplation and action.

Children With Asthma: ETS exposure

We did not demonstrate a statistically clear mechanism that would account for the effects of the intervention on asthma outcomes by its effect on measures of exposure. Compared to the main outcome (health-care utilization), which was measured on all subjects, the exposure variables were measured only on about two thirds of the subjects at follow-up. Furthermore, the less-than-perfect association among the measures of exposure indicates that there is considerable variation associated with these measures. When an intervening variable on the causal pathway between treatment and outcome is measured with error, the test of the mechanistic hypothesis loses precision and can give a false-negative result. These considerations cause us to be cautious in the interpretation of the apparently negative results with respect to the hypothesis that the effects of the intervention on health-care utilization are entirely or in part due to a reduction in ETS exposure. Larger studies, with more complete follow-up and even greater attention to reduction of error in the measurement of ETS exposure, are necessary to adequately evaluate the hypothesis that some or all of the clinical effect of our intervention is due to measurable effects on exposure. canadian neighborhood pharmacy

Children With Asthma: CCR

Children With Asthma: CCRWe made the ad hoc observation that the benefits of the intervention were even more pronounced (ORa, 0.16; p = 0.01) when the comparison was restricted to the subset (approximately 59%) of the children in the intervention group and the control group whose families cooperated with all the active data collection requirements of the study during the follow-up. Within the intervention group, those who participated in the active follow-up also proved more likely to attend intervention sessions, supporting the conclusion that the observed reduction in healthcare utilization was in some manner directly related to exposure to the intervention. For the subgroup with follow-up cotinine data, no baseline difference in cotinine levels or the number of smokers in the home was observed between children in the intervention and control groups.

Children With Asthma: Discussion

We found that an educational intervention that emphasized reduction in ETS exposure and that used a variety of motivational, instructional, and other aides to promote behavior change was associated with significantly lower odds of having more than one acute medical visit for asthma (OR, 0.32; p = 0.03 [after controlling for baseline visits]) and also with a nonsignificant trend toward lower odds of hospitalization (OR, 0.34; p = 0.14). Using statistical bootstrap procedures, we confirmed that these logistic regression results were not a statistical artifact of the inherent tendency for the level of health-care utilization to be correlated from 1 year to the next.
This result is both statistically and clinically significant, especially for a population of very low-income, ETS-exposed, minority children with a history of acute exacerbations. One fourth of the children had been hospitalized for asthma in the preceding year. The population also was composed entirely of nonvolunteer families, that is, families who were not in the process of seeking assistance with exposure reduction, smoking cessation, or asthma control when they were recruited.

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