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INCREASE OF ADHERENCE TO TREATMENT IN THE PATIENTS WITH COPD: HOW MUCH THE BURDEN OF EXACERBATIONS CAN BE REDUCED?
Mostovoy Y., Sidorov A., Slepchenko N.
National Pirogov Memorial Medical University, Vinnytsya
Vinnytsya, Ukraine
ABSTRACT
Chronic obstructive pulmonary disease (COPD) exacerbation is one of the key problems which appear during the management of the patients with COPD. Insufficient adherence to basis therapy taking can increase the quantity of exacerbations.
The aim of the study was to detect how much the quantity and total duration of the COPD exacerbation can be reduced. It is also how parameters that characterize exacerbations burden can be decreased.
Materials and methods. The 156 patients with severe and very severe COPD (C and D groups according to GOLD) were enrolled into program for treatment adherence optimization. The study consisted of 5 visits during the year. During each visit short structured discussion regarding necessity to adhere to basis therapy regimen was conducted with the patients as well as training / re-training on inhaler use. The data regarding exacerbations before the beginning of the patient participation in this study were taken from their routine medical records. During the patients participation in the study the exacerbations were registered during unplanned visits to site or to other doctors.
Results and their discussion. During 1 year when the patients participate in the study the adherence level increased from 44.41 ± 1.07% to 75.21 ± 0.78%. Total quantity of exacerbations decreased from 2.07 ± 0.08 to 0.87 ± 0.07 during the year. The quantity of severe exacerbations decreased from 1.10 ± 0.09 to 0.48 ± 0.07. Total duration of exacerbations diminished from 20.06 ± 0.80 to 8.60 ± 0.61 days, i.e. on 57.1%. The total quantity of hospitalizations decreased on 61.9% and the hospitalizations duration diminished on 72.5%.
Conclusions. In total almost all the parameters that characterize exacerbations burden decreased on more than 50%. It means that COPD exacerbations burden diminished significantly.
Keywords: COPD, exacerbations, exacerbations burden, adherence to treatment.
Among the issues associated with management of the patients suffered from chronic obstructive pulmonary disease (COPD) special attention is paid to COPD exacerbations. The COPD exacerbations is a main reason of the disease progression, seek for medical help and hospitalisations, quality of life decrease and mortality increase due to COPD.
The occurrence of the even one exacerbation which required hospitalization increases mortality risk twice. Experience of 3 and more COPD exacerbations increases mortality risk 4 times in comparison with patients without exacerbations [2].
As it was demonstrated in The Study Towards a Revolution in COPD Health (TORCH) in the patients with COPD that have proper adherence to treatment the
number of exacerbations is 44% less [5,13]. In PHARMACOP study the consultation regarding necessity to maintain appropriate regimen of basis therapy led to decrease of the number of severe COPD exacerbations by 55% and of hospitalizations frequency by 72% [12].
Taking this data into consideration the idea of adherence to COPD treatment optimization looks very promising. However, the influence of the growing adherence to basis therapy on the parameters that characterize exacerbations burden quantitatively was described in scientific literature insufficiently.
The aim of the study is to establish the influence of optimized adherence to basis therapy due to COPD on the parameters that characterize exacerbations burden in case of this disease.
Materials and methods. The 156 patients with severe and very severe COPD (C and D groups according to GOLD 2017) were enrolled into the program for adherence optimization. The total quantity of the patients included 83 (53.2%) men and 73 (46.8%) women. The average age of the patients was 64.0 ± 0.7 years. The average COPD duration was 11.7 ± 0.4 years.
This study was conducted in the out-patient medical institution Medical Centre "Pulse" (Vinnytsya, Ukraine) from January 2017 to January 2019. The patients that were included into study asked for medical consultation due to COPD in the institution at least once before the start of their participation.
The fluticasone/salmeterol combination was used as basis therapy medication during the study. It was taken by the patients before their participation in the study irregularly. The inhaler was discus. In order to reach correctness during the comparison of the clinical and functional parameters before the study and after the start of participation in it the basis therapy remains the same. In other case the difference between the mentioned parameters could be explained with basis therapy medication change and not only with adherence to treatment improve.
The initial level of adherence to treatment due to COPD was assessed. The adherence to treatment was calculated as portion of the days when the patient took prescribed medication in percent from total quantity of the days when the prescribed medication should be taken. The doses number that were taken in fact were detected by dose counter of the inhaler.
During the study patients visited Centre for five times. These visits were V1 (initial visit) and V2, V3, V4 and V5 that were conducted 1 month, 3 months, 6 months and 12 months after the patients started their participation in the study.
During the first visit each patient was instructed to take basis therapy regularly and the initial training to use inhaler correctly was conducted.
In the period between the scheduled visits to site phone calls were made each month with reminders to perform doctor's prescriptions. The regimen of the treatment was discussed during each next visit. The patients also demonstrated their ability to use inhaler correctly. If mistakes in inhaler use technique were revealed the re-training was conducted to the patient.
During the initial visit the parameters that characterize COPD exacerbations burden during the year before study were assessed in accordance to routine medical records. The mentioned records included in-patient and out-patient documents. The data regarding exacerbations that occurred during the study were registered according to unscheduled visits for medical assistance to our institution or according to medical documents about treatment of the COPD exacerbations in other medical institutions.
The follow parameters that characterize exacerbations burden were registered during each of 2 years:
1) total quantity of COPD exacerbations during a
year;
2) total quantity of severe COPD exacerbations during a year;
3) total duration of COPD exacerbations during a
year;
4) total duration of severe COPD exacerbations during a year;
5) total quantity of hospitalizations due to COPD exacerbations during a year;
6) total duration of hospitalizations due to COPD exacerbations during a year;
7) total quantity of disability days due to COPD exacerbations;
8) total quantity of the days when the patient could not perform their usual physical and social activity which was not connected with job during a year;
9) total quantity of visits to family doctor;
10) total quantity of visits to pulmonologist;
11) quantity of asking for emergency assistance (call for ambulance) during the year due to COPD exacerbations;
12) total quantity of the patients that have COPD exacerbations during a year;
13) total quantity of the patients that have severe COPD exacerbations during a year.
The usual physical activity was considered activity that is habitual to the patient by the load severity and duration.
According to Ministry of Public Health of Ukraine Order # 555 dated 27-JUN-2013 and to international guideline GOLD (Global Initiative for Chronic Obstructive Lung Disease) 2017 COPD exacerbation is persistent increase of symptoms intensity in comparison with usual stable condition when variance of symptoms is more severe than day-to-day variance and it is especially acute at the very beginning. The event requires additional treatment by short-acting bronchodi-lators only or short-acting bronchodilators in combination with antibiotics and/or systemic glucocorticoids [1,6].
Severe COPD exacerbation is exacerbation when the patient needs hospitalization or admission for emergency care [6].
There were no significant changes of the point of view on COPD exacerbation in the new version of the international guideline [7].
Each of visits included:
1) initial level of adherence to treatment determination;
2) compressed structured discussion with patient about necessity to adhere to regimen of COPD basis therapy;
3) initial training/ re-training with step-by-step demonstration of the inhaler correct use which contains basis therapy medication;
4) self-demonstration of inhaler use by the patient for few times;
5) pro-active discussion of events that could be qualified as exacerbations or as severe exacerbations and seek for medical help in other doctors.
The average values (M), average errors of average values (m) and quantity of investigations (n) were calculated for the received data.
The reliability assessment of intergroup difference (P) was made with use of T-test for dependent samples. The statistical software SPSS 21.0 was used.
Results and their discussion. The results of step-by-step growing of adherence to treatment value are summarized on Fig. 1
The initial level of adherence which was 44.41 ± 1.07% raised to 75.21 ± 0.78%, i.e. by 30.8%. Although final level of adherence to treatment did not exceed 80%, the parameters that characterize exacerbations burden diminished significantly.
The data regarding COPD exacerbations and parameters that were calculated for their quantitative characteristic are summarized in table 1.
70,92 71 22 T 75,21
53,36 ^-±n 85 A ----— W____
44 41 T +0 85 • ▼ +0,84 J^ +0,78
- - T +1,07 ^ W^
pvl - pv2, v3, v4, v5 < 0,001 pv2 - pv3, v4, v5 < 0,001 pv3 - pv5 < 0,001 pv4 - pv5 < 0,001
I
V1
V2
V3
V4
V5
Fig. 1. Dynamics of adherence to COPD treatment during the study.
Footnotes.
1. V1 - initial visit, V2 - 1 month after, V3 - 3 months after, V4 - 6 months after and V5 - 12 months after beginning of the patients' participation in the study.
2. The reliability assessment of intergroup adherence to treatment differences (P) was made using T-test for dependent samples.
During the patients' participation in the study the total quantity of exacerbations decreased from 2.07 ± 0.08 to 0.87 ± 0.07, i.e. by 58.0%. During the same period of the time quantity of severe COPD exacerbations decreased from 20.06 ± 0.80 to 8.60 ± 0.61 days. i.e. by
57.1%. Decrease of total duration of severe exacerbations was even more pronounced, it reached 69.6%.
On the background of the growing adherence the quantity of hospitalizations due to exacerbations decreased as well as their duration. Total quantity of hospitalizations decreased from 1.26 ± 0.10 to 0.48 ± 0.07, i.e. by 61.9%. Total durations of hospital stay of the patients diminished by 72.5%.
The significant decrease of disability days due to COPD exacerbations was observed. Before the beginning of the patients' participation in the study the quantity of disability days was 23.60 ± 0.80 per year. During the patients' participation in the study this parameter diminished by 55.4% and it was 10.52 ± 0.73 days.
Table 1
Dynamics of parameters that characterize COPD exacerbations burden in the patients during their participation _in the study.___
Parameters Stages of the study Р
V1 V5
Total quantity of COPD exacerbations during a year 2.07±0.08 0.87±0.07 <0.001
Quantity of COPD exacerbations during a year 1.10±0.09 0.48±0.07 <0.001
Total duration of COPD exacerbations during a year, days 20.06±0.80 8.60±0.61 <0.001
Total duration of severe COPD exacerbations during a year, days 12.15±0.85 3.69±0.52 <0.001
Total quantity of hospitalizations due to COPD exacerbations during a year 1.26±0.10 0.48±0.07 <0.001
Total duration of hospitalizations due to COPD exacerbations during a year, days 12.02±0.84 3.31±0.48 <0.001
Total quantity of days of unability due to COPD exacerbations during a year 23.60±0.88 10.52±0.73 <0.001
Total quantity of the days when the patient could not perform their usual physical and social activity which was not connected with job during a year 16.51±0.93 5.38±0.58 <0.001
Total quantity of visits to family doctor 5.25±0.19 1.69±0.13 <0.001
Total quantity of visits to pulmonologist 2.47±0.09 0.91±0.07 <0.001
Quantity of asking for emergency assistance (call for ambulance) during the year due to COPD exacerbations 2.76±0.23 1.19±0.17 <0.001
Total quantity of the patients that have COPD exacerbations during a year 140 (89.7%) 93 (59.6%) <0.001
Total quantity of the patients that have severe COPD exacerbations during a year. 97 (62.2%) 42 (26.9%) <0.001
Footnotes.
1. V1 - initial visit and V5 - 12 months after beginning of the patients' participation in the study.
2. The reliability assessment of intergroup values differences (P) was made using T-test for dependent samples.
During the year before study the total quantity of days when the patient could not have usual physical and social activity that was not associated with job was 16.51 ± 0.93. During the study this parameter decreased by 67.4% and it was 5.38 ± 0.58 days.
The significant decrease of the quantity of the visits to family doctors and to pulmonologist was found out. The quantity of visits to family doctors diminished from 5.25 ± 0.19 to 1.69 ± 0.13, i.e. by 67.8%. The quantity of visits to pulmonologist decreased from 2.47 ± 0.09 to 0.91 ± 0.07, i.e. by 63.2%.
The quantity of asking for emergency assistance (call for ambulance) diminished from 2.76 ± 0.23 to 1.19 ± 0.17, i.e. by 56.9%.
The quantity of the patients that had at least 1 COPD exacerbation during the year before study was 140. This value was 89.7% from the total quantity of 156 patients that were enrolled into study. During the study COPD exacerbations occurred in 93 patients (59.6%). Thus, the quantity of the patients with at least 1 COPD exacerbation decreased by 33.6% during the participation in the study.
During the patients' participation in the study the most of parameters that characterize COPD exacerbations burden decreased by more than 50%. It testifies that COPD exacerbations burden can be significantly reduced on the background of the actions that can increase adherence to basis therapy due to COPD.
Conclusions.
1. During the year adherence to basis therapy increased by 30.8%.
2. The total quantity of COPD exacerbations decreased by 58.0% during the year.
3. The quantity of severe COPD exacerbations diminished by 56.4% during the year.
4. The quantity of hospitalizations due to COPD exacerbations decreased by 61.9%.
5. Total duration of hospitalizations due to COPD diminished by 72.5%.
6. The most of parameters that characterize COPD exacerbations burden decreased by more than 50% that testifies its significant reduce.
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