Stenoses showing residual obstruction of the airway lumen of >50 percent after laser resection and mechanical dilatation or airways with collapsing walls caused by destruction of the cartilaginous support were kept patent with stents. In all patients we used silicone stents (Endoxane) (Fig 1) that were inserted according to the technique described by Dumon.
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Silicone Stents in the Management of Inoperable Tracheobronchial Stenoses – Methods (2)
Silicone Stents in the Management of Inoperable Tracheobronchial Stenoses – Methods (1)
Patients
Over a 2-year period, 91 patients (68 men, 23 women) with a median age of 65 years (range, 28 to 85 years) were referred to our units for investigation and treatment of inoperable central airway stenoses. Eighty-nine patients suffered from advanced malignant disease, and 2 had external compression of a main bronchus caused by benign disease (1 aortic aneurysm, 1 complex deformity of thoracic spine). All patients were first examined by fiberoptic bronchoscopy under local anesthesia to assess the need for endobronchial therapy unless they presented with life-threatening obstructions. In 58 patients (40 men, 18 women) with a median age of 65 years (range, 35 to 85 years) mainly intraluminal tumor growth necessitated laser resection only, whereas the 2 patients with benign disorders were treated with stent insertion only. The remaining 31 patients (25 men, 6 women) with a median age of 67 years (range, 28 to 79 years) all had malignancies and formed our study group. They presented with predominantly extrinsic compression of the central airways that was managed by laser therapy combined with insertion of silicone stents. The diagnoses of these patients are listed in Table 1.
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Silicone Stents in the Management of Inoperable Tracheobronchial Stenoses
Various treatment modalities have been developed for the management of inoperable malignant stenoses of the central airways. The Nd:YAG laser has become the most widely used method to relieve obstructions caused by intraluminal tumor growth. Airway narrowing caused by predominantly extrinsic compression or unstable bronchial walls due to destruction of the cartilaginous support is not amenable to laser therapy and must be treated with mechanical dilatation and/or stent placement to maintain airway patency. The different stent types currently available have been developed from metal and silicone models.
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Improving Inhaler Adherence in a Clinical Trial Through the Use of the Nebulizer Chronolog (15)
With the information derived from the NC, physicians can gain a better understanding of their patients’ inhaler use patterns and provide direct feedback on the appropriateness of inhaler use in an effort to improve adherence to the prescribed regimen. A limitation of the NC is that the currently available chronolog design is compatible with only a press-and-breathe MDI and not with breath-activated inhaler devices, such as a powder inhaler. Furthermore, patients with both asthma and COPD often use more than one type of MDI, thus complicating the ability to monitor each type of inhaler use in a clinical setting, unless additional NC devices dedicated to each type of MDI were used.
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Improving Inhaler Adherence in a Clinical Trial Through the Use of the Nebulizer Chronolog (14)
The absence of canister dumping in the feedback group may be due to the participants knowledge that the NC printout would expose this practice. In related research, Petranyi et al studied blood glucose level monitoring of diabetics using an electronic device which internally recorded the date and time of glucose monitoring, as well as the actual blood glucose level. Participants were asked to keep a diary of glucose monitoring, including the date, time, and glucose level. For the first two months, participants were unaware of the memory capability of the device. A majority of participants turned in deceptive diary reports which included blood glucose levels lower than those that were objectively monitored and nonexistent monitoring sessions. In contrast, after the initial blinded trial, when the same patients were made aware that the blood glucose monitor could record the exact date and time of glucose testing and actual glucose levels, subsequent concordance between diary entries of both glucose levels and the time of monitoring with those recorded by the monitoring device was almost perfect.
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Improving Inhaler Adherence in a Clinical Trial Through the Use of the Nebulizer Chronolog (13)
This study also demonstrates that the NC provides significantly more accurate information on adherence with prescribed usage than either self-reporting or canister weighing. If canister weighing had been the only objective measure of adherence used in this study, the differences between the two groups would not have been detected. In particular, inappropriate patterns of inhaler use (eg, excessive numbers of puffs per use) and canister dumping could be identified by electronic monitoring but not by canister weighing alone.
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Improving Inhaler Adherence in a Clinical Trial Through the Use of the Nebulizer Chronolog (12)
Moreover smokers in the feedback condition compared with those in the control condition had a significantly higher mean percentage of sets with two actuations (mean, 76.3 vs 52.5; p = 0.0004), a higher mean percentage of prescribed actuations (mean 84.5 vs 62.5; p = 0.0005) and a nonsignificant trend in mean chronolog sets per day (mean, 1.51 vs 1.33; p = 0.51). Thus, despite the difference in success in quitting smoking between the control and feedback groups, the feedback condition itself was associated with better adherence to prescribed patterns of MDI use independent of smoking status.
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Improving Inhaler Adherence in a Clinical Trial Through the Use of the Nebulizer Chronolog (11)
Discussion
In 1986, a task force of the American Academy of Allergy and Immunology recommended that measures to monitor and enhance adherence be included in the design of clinical trials. The present study demonstrates that providing information on the recording capabilities of the NC along with feedback of actual daily usage patterns can result in enhanced adherence to the prescribed MDI regimen compared with a control group. The feedback group used the MDI more often (more sets per day and in closer agreement to the prescribed three sets per day), used only the prescribed two actuations in more sets, had a greater percentage of actuations as prescribed, and had a greater percentage of adherent days; all of these intergroup differences in inhaler use were statistically significant. The feedback group also was more accurate in their self-reported MDI use and did not record a single canister dumping episode.
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Improving Inhaler Adherence in a Clinical Trial Through the Use of the Nebulizer Chronolog (10)
Accuracy of Self-Reporting
Accuracy of self-reporting was measured by comparing mean self-reported sets per day to mean NC sets per day for both the feedback and control groups. Self-reported adherence (fewer than one, one, two, or three sets per day) was compared with the corresponding mean NC adherence category (fewer than 0.5, 0.5 to 1.49, 1.5 to 2.49, and greater than 2.5 sets per day).
The self-reporting of 44 percent of the feedback participants matched their NC adherence category, compared with only 25 percent in the control group (p<0.007). Control group participants also were more likely to overestimate their actual usage by at least one NC adherence category (71 percent) compared with the feedback group (49 percent) (p<0.002).
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Improving Inhaler Adherence in a Clinical Trial Through the Use of the Nebulizer Chronolog (9)
The percentage of sets with one, two, three, and four or more actuations was calculated for each individual. Figure 1 shows the means of these percentages for both the feedback and control groups. The feedback group had a significantly greater mean percentage of sets with the prescribed two actuations (80.6 percent) than did the control group (60.3 percent [p<0.0001]). Each actuation by the feedback group was more likely to occur in accordance with the prescribed pattern of inhaler use. Assessment of the percentage of prescribed actuations (ie, actuations used as prescribed as a percentage of the total actuations) revealed that 88.8 percent of the feedback groups actuations were prescribed actuations compared with 68.8 percent for the control group (p<0.0001).
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