Materials and Methods
Predetermined entry criteria allowed inclusion of only those children who: (1) had no family history of asthma; (2) had no personal or family history of atopic disease; (3) had been receiving treatment for asthma for at least 2 years; (4) had parents who did not smoke; (5) had at least three emergency visits or hospital admissions per year in the preceding 1 year; (6) required a combination of short- and long-acting bronchodilators, leuko-triene antagonists, and inhaled or oral corticosteroids for the management of asthma; (7) did not have a history of respiratory syncytial virus bronchiolitis; and (8) could swallow a tablet or capsule. All the patients were derived from a geographically distinct region where all children with asthma, who are deemed to require care by a specialist, are referred to the only one specialist, and all the patients with GI problems are referred to the only pediatric gastroenterologist in that region.
All consecutive children with asthma fulfilling these entry criteria and referred to the gastroenterologist for ruling out GER disease underwent extended esophageal pH monitoring (20 to 24 h) using a dual-channel (10 cm apart) pH probe with the distal channel placed and confirmed radiologically at approximately 3 cm proximal to the gastroesophageal junction. All asthma medications were continued uninterrupted. No advice regarding diet or positioning was given. Care was taken to ensure that no antacids were consumed during or up to 3 days before the study. Those children who had an abnormal pH study finding (pH < 4 in the distal esophagus for > 5% of the time) underwent aggressive anti-GER treatment with lifestyle changes, a prokinetic, and a proton-pump inhibitor. At the initial visit, extensive counseling was provided about the different components of anti-GER treatment as well as the role of anti-GER surgery.
These children then underwent regular follow-up at intervals of 4 weeks for asthma management based on symptoms in the preceding 4 weeks. Medications were added or deleted based on this assessment. Patients were also seen for acute exacerbation, and medications were adjusted accordingly. Every 4 weeks, the dose of the prokinetic was adjusted based on current weight. The children with a normal pH probe study finding were given the option of no anti-GER treatment or an empiric therapeutic trial of anti-GER treatment as outlined above. The latter was based on the premise that results of an esophageal pH monitoring are not 100% sensitive for diagnosing GER disease. Treatments were instituted after obtaining informed consent.
The prokinetics used were either cisapride, 1 mg/kg/d divided in three doses, or metoclopramide, 0.15 mg/kg per dose tid administered before meals. The proton-pump inhibitor used was lansoprazole, 30 mg/d, as a single dose early in the morning. The inhaled corticosteroids used were either budesonide, 200 to 400 pg bid, or fluticasone, 110 to 220 pg bid.
The tests for internal consistency in the ranking conducted by the patients showed very good results with a low number of inconsistent replies. Concerning external validity, the initial questionnaire in the present study showed that patients reported breathlessness and cough as the most troublesome symptoms compared with chest tightness and sleep disturbance. This result is in accordance with the findings of Osman.
In total, 85% of patients expressed preferences for an alternative treatment to their current regimen. The presented preference structure indicates variations in patient preferences that might need to be addressed in clinical practice. Some patients may benefit from treatments recommended in guidelines that allow increased flexibility in application. Furthermore, the conjoint analysis in this study underestimates the value of treatments with relatively higher effectiveness, ie, the addition of a long-acting bronchodilator for regular use to ICS, or the use of a rapid- and long-acting drug as needed (formot-erol) instead of a rapid- and short-acting bronchodi-lator (eg, terbutaline)13 since, in the conjoint analysis, the effectiveness was considered to be constant with all alternative treatments.
The estimates of the willingness to pay for a preferred treatment were in most cases similar to, or higher than, the actual cost of the treatments. A relevant research approach to investigate this further could be to apply conjoint analysis in conjunction with a clinical and economic study that measures clinical benefits and cost-effectiveness.
The findings of this study based on the aggregated results from almost 300 patients can be summarized as follows. Patients focused primarily on the effectiveness of a treatment, ranking SFDs as the most important attribute of treatment. In terms of available therapies, treatment with a combination inhaler was preferred overall, while reliever therapy that was both rapid and long acting was preferred over short-acting drugs. The most preferred treatment was a combination inhaler for maintenance and as-needed use. Interestingly, 85% of patients preferred an alternative treatment over their current treatment, and they were prepared to pay extra for their preferred treatment.
Background: Gastroesophageal reflux (GER) plays a role in inducing or exacerbating asthma. Methods: We evaluated asthma outcome before and after anti-GER treatment in older children (age range, 5 to 10.5 years) who had persistent moderate asthma and were being treated with short- and long-acting bronchodilators, inhaled corticosteroids, and leukotriene antagonists. Forty-six such consecutive children underwent extended esophageal pH monitoring. Of the 27 patients (59%) who had evidence of GER disease, 18 patients underwent medical treatment (lifestyle changes, proton pump inhibitors, and prokinetics) and 9 patients opted for surgical treatment (Nissen fundoplication) of GER.
Interestingly, many physicians who responded to our questionnaires appear to use the hospital admission blanket consent form to cover invasive medical procedures performed during the hospital stay. We suspect that permission to give transfusions in the perioperative period is part of some surgical consent forms and may account for the rate (36%) of separate consent obtained for transfusions reported by surgical intensivists. Insofar as a patient’s condition varies and is an important determinant of the risk of each procedure, blanket consent (to general treatments) at hospital admission may not adequately inform the patient about risks. We invited those using such a strategy to send us their blanket consent form, but no respondent sent a form. We suspect that the general (nonsurgical) hospital admission consent-to-treat form for most institutions is similar to ours. That form does not list specific procedures, risks, benefits, and alternatives that might be undertaken during hospitalization/critical illness. Such general blanket consent may not satisfy the criteria of informed consent as outlined in the Belmont report.
This study has at least three important limitations. First, the method of national sampling is unlikely to represent a broad crosssection of clinical practices. The study did not examine the practices of hospitals without teaching programs. Second, the response rates of the two national questionnaires, fair (27%) for critical care directors and poor (5%) for medicine directors, could contribute to significant reporting bias. Nonetheless, data from the state of Connecticut (where almost all ICUs were surveyed) included many institutions that were not university-affiliated, and consent practices were not dissimilar to the national sample. Finally, response patterns suggest that some (as many as nine) internists may have interpreted the questionnaire to ask how many unique consent forms they use (rather than for which procedures they go through the process of obtaining consent). Aside from these nine respondents, the patterns of other respondents suggest that they understood the intent of the question, but the frequencies listed in the internist’s questionnaire may underestimate (by roughly 15%) the true frequencies at which internists obtain consent for various procedures. These shortcomings notwithstanding, this study demonstrates a relative lack of consensus regarding whether the obtaining of separate informed consent is required for many common medical procedures.
The plaintiff won the case on the grounds that “a reasonable person” would have expected to know of such complications before the procedure in order to make an informed decision about whether to undergo the laminectomy.
Few court cases have examined the legal consequences of not obtaining informed consent for a procedure that goes awry. Some cases are settled with plaintiffs before they make it to court. Other suits are not brought because the recovery of monetary damages on cases that hinge purely on informed consent is insufficient to warrant filing suit. However, we could find no specific precedent test cases regarding the list of procedures in our study. Even though major complications and death are rare complications of these medical procedures, such results are possible, especially in critically ill patients. If patients are not informed and a major complication of a procedure ensues, the violation of regulatory standards (vide supra) and the invocation of the reasonable person standard could, theoretically, leave practitioners open to punitive judgements.
Interestingly, many physicians who responded to our questionnaires appear to use the hospital admission blanket consent form to cover invasive medical procedures performed during the hospital stay. We suspect that permission to give transfusions in the perioperative period is part of some surgical consent forms and may account for the rate (36%) of separate consent obtained for transfusions reported by surgical intensivists. Insofar as a patient’s condition varies and is an important determinant of the risk of each procedure, blanket consent (to general treatments) at hospital admission may not adequately inform the patient about risks. We invited those using such a strategy to send us their blanket consent form, but no respondent sent a form. We suspect that the general (nonsurgical) hospital admission consent-to-treat form for most institutions is similar to ours. That form does not list specific procedures, risks, benefits, and alternatives that might be undertaken during hospitalization/critical illness. Such general blanket consent (used to cover invasive procedures) may not satisfy the criteria of informed consent as outlined in the Belmont report.