In defense of adolescents: They really do use braces for the hours prescribed, if good help is provided. Results from a prospective everyday clinic cohort using thermobrace - PubMed (original) (raw)

In defense of adolescents: They really do use braces for the hours prescribed, if good help is provided. Results from a prospective everyday clinic cohort using thermobrace

Sabrina Donzelli et al. Scoliosis. 2012.

Abstract

Background: The effectiveness of bracing relies on the quality of the brace, compliance of the patient, and some disease factors. Patients and parents tend to overestimate adherence, so an objective assessment of compliance has been developed through the use of heat sensors. In 2010 we started the everyday clinical use of a temperature sensor, and the aim of this study is to present our initial results.

Population: A prospective cohort of 68 scoliosis patients that finished at least 4 months of brace treatment on March 31, 2011: 48 at their first evaluation (79% females, age 14.2±2.4) and 20 already in treatment.

Treatment: Bracing (SPoRT concept); physiotherapic specific exercises (SEAS School); team approach according to the SOSORT Bracing Management Guidelines.Methods. A heat sensor, "Thermobrace" (TB), has been validated and applied to the brace. The real (measured by TB) and referred (reported by the patient) compliances were calculated.Statistics. The distribution was not normal, hence median and 95% interval confidence (IC95) and non-parametric tests had to be used.

Results: Average TB use: 5.5±1.5 months. Brace prescription was 23 hours/day (h/d) (IC95 18-23), with a referred compliance of 100% (IC95 70.7-100%) and a real one of 91.7% (IC95 56.6-101.7%), corresponding to 20 h/d (IC95 11-23). The more the brace was prescribed, the more compliant the patient was (94.8% in 23 h/d vs. 73.2% in 18 h/d, P < 0.05). Sixty percent of the patients had at least 90% compliance, and 45% remained within 1 hour of what had been prescribed. Non-wearing days were 0 (IC95 0-12.95), and involved 29% of patients.

Conclusion: This is the first study using a TB in a setting of respect for the SOSORT criteria for bracing, and it states that it is possible to achieve a very good compliance, even with a full time prescription, and better than what was previously reported (80% maximum). We hypothesize that the treating team (SOSORT criteria) plays a major role in our results. This study suggests that compliance is neither due to the type of treatment only nor to the patient alone. According to our experience, TB offers valuable insights and do not undermine the relationship with the patients.

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Figures

Figure 1

Figure 1

The heat-sensor device used in this study: “Thermobrace”. The heat-sensor device used in this study, “iButton™ DS1922L-F5#” (

http://www.maxim-ic.com/datasheet/index.mvp/id/4088/t/al

) (Maxim Integrated Products, Inc.; 120 San Gabriel Drive Sunnyvale, CA 94086), which we called “Thermobrace” for this specific use.

Figure 2

Figure 2

Placement of the Thermobrace in a Sforzesco brace. Example of placement of the Thermobrace in a Sforzesco brace worn by a patient included in the study.

Figure 3

Figure 3

Example of patient compliance data. Screenshots of the specially developed software for everyday use (freely usable in Internet:

http://www.scoliosismanager.org/thermobrace

) with an example of patient compliance data. a: Reliability data, time of use, compliance (in red) and comparison with last prescription; graph of average use per month; graph of average use per hour of the day. b: on the left: graph of average use per day of the week; graph of number of days per daily hours of use; exceptions (i.e., day of use very different from the others). On the right: graph of daily transitions (i.e. brace on/off cycles) and raw data.

Figure 4

Figure 4

Clime temperature and comparison among environmental temperature in the north and in the south of Italy. The upper graph shows that the hottest period of the year was during the month of August, in the lower part the graph shows that the trendo of temeprature in Milan and in Messina were very similar.

Figure 5

Figure 5

The real compliance was high, even if frequently overestimated by patients and their parents.

Figure 6

Figure 6

Hours of difference from what was prescribed and what was referred by patients. Graph reporting the hours of difference from what was prescribed and what was referred by patients. In green the best range (0–1 hours difference), in yellow an almost acceptable (2–3 hours difference), in red the not acceptable (4 or more hours of difference). Nearly 45% of patients remained in the range of 1 hour from what was prescribed and 55% based on what they referred.

Figure 7

Figure 7

Patients with more than two checks through Thermobrace. Patients with more than two checks through Thermobrace (two clinical evaluations almost every 6 months): If some differences can be seen, there were no statistically significant differences during the months in the general population. Single patients tend to maintain the same compliance rate, with a few exceptions.

Figure 8

Figure 8

Histogram of the compliance percentages. This graph illustrate the compliance of each patient. Since we find a not normal distribution and data were positively skewed, in statistical terms the median represents more correctly than the average our results.

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