Breathing Out Completely Before Inhalation: The Most Problematic Step in Application Technique in Patients With Non-Mild Chronic Obstructive Pulmonary Disease.

Background: Patient adherence to an inhaled medication application technique (A-ApplT) represents a major health-care issue in patients with chronic obstructive pulmonary disease (COPD). However, there is a lack of studies evaluating this issue thoroughly. The aim of our study was to introduce a universal easy-to-use method of assessing the A-ApplT to chronic medication in moderate to very severe COPD individuals. Methods: The Czech Multicenter Research Database of COPD (COPD CMRD), a large observational prospective study, was used as a source of clinical data. A-ApplT was evaluated using our Five Steps Assessment. This measure is based on dichotomous evaluation of each of five predefined consecutive application technique steps and can be used in all settings for all currently available inhalation systems in COPD subjects. Results: A total of 546 participants (75.0% men; mean age 66.7 years; mean forced expiratory volume in 1s 44.7%) were available for analysis. This represents 69.6% of all patients recruited in the COPD CMRD. Less than one third of patients presented their application technique without any erroneous steps. The most problematic steps were breathing out completely in one breath immediately before inhalation (step No. 3), and the actual inhalation maneuver (step No. 4). The total number of errors was similar for dry powder inhalers and pressurized metered-dose inhalers. Conclusion: Our novel instrument, Five Steps Assessment, is comfortable for use in routine clinical practice to explore A-ApplT. The A-ApplT in real-life patients with non-mild COPD was inadequate and patients should be repeatedly trained by properly (re-)educated medical staff.

How General Practitioners and Their Patients Adhere to Osteoporosis Management: A Follow-Up Survey among Czech General Practitioners.

Introduction: General practitioners (GPs) are key participants in osteoporosis (OP) management. The aim was to evaluate their adherence to lege artis management of the disease, potential barriers, and to discuss differences observed in comparison with the baseline survey carried out in 2007; the focus was on secondary prevention. Methods: On behalf of two professional associations, 2-round postal survey among randomly selected GPs (>1/4 of all Czech GPs) was performed in 2014. The questionnaire covered areas concerning GP's role in the fight against OP, knowledge about OP, management of OP-related fractures, barriers to the management of OP, system- and patient-related in particular, and availability and use of information sources. Results: The overall questionnaire return rate was 37% (551 respondents); mean age of the respondents was 53 year (37% men). The GP's role in the treatment of OP was rated as essential in 28 and 37% of men and women, respectively (P = 0.012). The guideline for diagnosis and treatment of OP for GPs was considered accessible by 92% of respondents. As much as 60% of the respondents were adherent to the guideline, i.e., used it repeatedly. The knowledge of several risk factors was very good, however, recommended daily intake of calcium was stated correctly by only 41% of respondents, and daily intake of vitamin D by only 40%. Three quarters reported active steps after a fracture: referral to a specialist, life-style recommendations, prescription of calcium/vitamin D supplements. Half of the respondents focus on fall prevention. System-related barriers, such as lack of possibility to prescribe selected drugs (61%) and financial limits set by health insurance company (44%) were most frequently reported. Patient-related barriers were also common, patient's non-adherence (reported by 29%) and patient's reluctance to go to a specialist (18%). Conclusion: GPs adhered to OP management more than in 2007. Knowledge of risk factors and involvement in post-fracture care was relatively high. Compared to baseline survey, patient-related barriers, patient non-adherence in particular, were more common. Prescribing conditions are still an important issue. Among GPs, education should be focused on calcium and vitamin D intake, doses, sources, and supplements.

Patterns of Non-adherence to Supplementation with Calcium and Vitamin D in Persistent Postmenopausal Women Are Similar at Start and 1 Year Later: A Qualitative Longitudinal Study.

Background: Osteoporosis is a chronic disease and adherence can fluctuate over time. Therefore, longer observation is necessary to investigate the stability of patients' adherence. The study aim was to compare the overall adherence (OA) to supplementation with the fixed combination of calcium and vitamin D (Ca/D) in postmenopausal women at baseline and after 1 year, and to evaluate the fluctuation of the OA in individual months. Furthermore, we studied whether adherence is influenced by signing of informed consent and routine medical check-up. Methods: This was a longitudinal, observational study. The data were obtained from the Osteocenter of University Hospital in Hradec Kralove, Czech Republic. Adherence was measured using electronic bottles type Medication Events Monitoring System (MEMS). The study was carried out in two 3-month periods; the baseline in 2013 (signing of informed consent while medical check-up) and the follow-up (medical check-up) in 2014. The adherence and adherence-related outcomes were studied in patients who had initiated osteoporosis treatment and were persistent. Results: 21 (49%) out of 43 patients who avoided drug dispenser and were persistent both at baseline and at follow-up, completed the study and were included. Median age was 76. Evaluating the whole 3-month periods, the OA did not differ significantly at baseline and at follow-up, the OA was 71 and 68%, respectively. However, the adherence in month 1 at baseline was significantly higher than the adherence in month 2 at baseline (p < 0.001) and also than the adherence in month 1 at follow-up (p = 0.010). Analysing the study period without month 1, a stable adherence was observed in 48% of patients. About 33% of doses were omitted at baseline and 34% at follow-up. As many as 71% of the patients took drug holidays at baseline, and 76% at follow-up. Conclusion: The OA was insufficient, around 70% both at baseline and at follow-up. One half of the patients showed a stable adherence. The patterns of non-adherence were very similar at follow-up. Signing of the informed consent seems to act as bias more than regular medical check-up.

Adherence to denosumab in the treatment of osteoporosis and its utilization in the Czech Republic.

OBJECTIVES: The objective was to analyze adherence and current trends in utilization and prescription practice patterns of the anti-RANKL monoclonal antibody denosumab in the treatment of postmenopausal osteoporosis (OP). METHODS: The prescription-based database of the General Health Insurance Company of the Czech Republic that covers approximately 60% of the Czech population (6 million) was used as the data source. Medication possession ratio (MPR) and persistence were calculated for all patients (both OP medication-naïve and medication-experienced) with postmenopausal OP from the start of their therapy with denosumab 60 mg per ml subcutaneous injection within a period between September 2011, i.e. first denosumab availability, and May 2014. Clinical data such as fractures, co-morbidities and co-medication were not analyzed. RESULTS: A total of 7904 women treated with denosumab were analyzed; 93.8% of patients were identified as compliant (MPR ≥0.8) while 6.2% were non-compliant (MPR < 0.8). Persistence (base case, i.e. refill gap ≤30 days) was 59.1% after 12 months and 34.8% after 24 months. By 2013, i.e. within 2 years, denosumab became the second most utilized and most costly drug after oral bisphosphonates. CONCLUSIONS: Despite relatively high MPR and persistence rate observed in denosumab treatment, adherence enhancing strategies, focused on persistence in particular, are still needed. The uptake of denosumab has been rapid, its utilization keeps rising swiftly, and denosumab already represents a significant part of the osteoporosis therapy budget.

The impact of changes in national prescribing conditions for statins on their public expenditure and utilization in the Czech Republic 1997-2013.

OBJECTIVES: In the Czech Republic (CZ) extensive price regulation and prescribing conditions are common instruments often employed with new drugs. Since the introduction of statins onto the market in 1990s the originally strict conditions gradually relaxed while the prescription rates and public costs were rising. The aim was to analyze long-term utilization trends of statins, changes in their reimbursement prices and prescribing conditions, and the evolution of the market. METHODS: From January 1997 to December 2013 statin use was measured in terms of defined daily doses per 1000 insured per day (DDD/TID). The prescription-based database of the General Health Insurance Company of the Czech Republic in 1997 covering 7825,216 inhabitants, i.e. 76% of CZ population, was used as the administrative data source. Also the overall expenditure, unit prices, and reimbursement criteria were analyzed. RESULTS: Between 1997 and 2013 the utilization of statins rose from 2 to 96 DDD/TID while the expenditure rose 5.5-fold. The rise of prescription for each molecule was always observed after the liberation of the prescribing criteria. In the study period reimbursement prices of simvastatin and atorvastatin gradually decreased to just 5% of their initial values. CONCLUSIONS: The rising consumption of statins in CZ clearly corresponds in time with the liberation of prescribing conditions allowing for prescription by general practitioners and with the introduction of generics accompanied by a swift and repeated reimbursement price cuts.

Fat- and fiber-related diet behavior among type 2 diabetes patients from distinct regions.

PURPOSE: Diet and eating habits are of key importance in patients with type 2 diabetes mellitus (T2DM). The purpose of this comparative study was to analyze fat- and fiber-related behavior (FFB) in patients with T2DM from distinct cultural areas. PATIENTS AND METHODS: Observational study was carried out in the Czech Republic (CR) (n=200), the US (n=207), and Yemen (n=200). Patients completed the Fat- and Fiber-related Diet Behavior Questionnaire (FFBQ). RESULTS: Differences in all aspects of FFB among countries were found (P<0.05). The best fat-related behavior reported was from patients from the CR. Patients from the US showed the worst fat-related behavior in total. On the other hand, patients from the US reported the best fiber-related behavior. Patients from Yemen reached the worst scores in all fat-related domains. Patients from all studied countries reported the best results in the "modify meat" and "avoid fat as flavoring" and the worst in the "substitute high fiber" subscales. CONCLUSION: Professionals involved in the diet education of T2DM patients should be aware of the specificity of diet in their country when advising patients keeping general recommendations. We suggest them to be as specific as possible and concentrate on fiber-related behavior.

Drug holidays: the most frequent type of noncompliance with calcium plus vitamin D supplementation in persistent patients with osteoporosis.

PURPOSE: All current recommendations include calcium and vitamin D (Ca-D) as an integrated part of osteoporosis treatment. The purpose of this pilot study was to analyze compliance with a fixed combination of Ca-D in women persistent with the treatment. PATIENTS AND METHODS: An observational study was carried out in three osteocenters in the Czech Republic. Women with osteoporosis ≥55 years of age concurrently treated with oral ibandronate were eligible. Compliance was evaluated in a period of 3 months by Medication Event Monitoring System (MEMS), tablet count, and self-report. Nonpersistence was defined as a MEMS-based gap in the use of Ca-D to be 30 days or more. RESULTS: A total of 73 patients were monitored, of which 49 patients were analyzed (target population). Based on MEMS, mean overall compliance was 71%; good compliance (≥80%) was observed in 59% of the patients. As many as 71% of the patients took drug holidays (≥3 consecutive days without intake); overall compliance of these patients was 59% and was slightly lower on Fridays and weekends. Patients without drug holidays were fully compliant (did not omit individual doses). Compliance differed according to daily time at which the patients mostly used the Ca-D. Afternoon/evening takers showed a mean overall compliance of 82% while morning/night takers only 51% (P=0.049). Based on MEMS, tablet count, and self-report, compliance ≥75% was observed in 59%, 100%, and 87% of the patients, respectively. Outcomes obtained by the three methods were not associated with each other. Undesirable concurrent ingestion of Ca-D and ibandronate was present only twice. CONCLUSION: Despite almost perfect self-reported and tablet count-based compliance, MEMS-based compliance was relatively poor. Consecutive supplementation-free days were common; more than two-thirds of the patients took at least one drug holiday. This pilot study showed drug holiday to be the most important type of noncompliance with Ca-D in those who are persistent with the treatment.

Consumption of osteoanabolic drugs and strontium ranelate in the treatment of osteoporosis in the Czech Republic in 2005-2011.

Anti-osteoporosis drugs with osteoanabolic (teriparatide, intact parathormone) and dual (strontium ranelate) mechanism of action are currently available for the treatment of postmenopausal, glucocorticoid induced or male osteoporosis in the Czech Republic (CZ). These expensive drugs are subjects of special prescribing limitations (2nd line treatments). The objective was to analyze trends in consumption of osteoanabolic and dual drugs in the treatment of osteoporosis since their introduction onto the market in CZ (2005-2011). The prescription-based database of the General Health insurance Company of the Czech Republic that covers approximately 60% of the Czech population was used as the data source. An insured person with a recorded prescription for teriparatide (TRPD), intact parathormone (iPTH) or strontium ranelate (SR) in the period of interest was defined as a patient; 271 (224), 77 (75) and 5930 (5545) patients (women) treated with TRPD, iPTH and SR in 2011, respectively, were identified. The median age of patients on TRPD and SR ranged from 71 to 74 years in 2006-2011. The number of patients treated with TRPD between 2009 and 2011 has been stable, while in iPTH the number increased 2.8 times in the same time period. The number of patients treated with SR has been steadily rising since its introduction in 2005. SR was prescribed most often by physicians specialized in internal medicine (42%) and rheumatology (25%). Male patients accounted for 6% of the SR consumers in 2011. The consumption of dual and osteoanabolic drugs has been rapidly increasing. Consumption rates in men (both absolute and relative) have been increasing but still remain relatively low.

Healthy adherer effect - the pitfall in the interpretation of the effect of medication adherence on health outcomes.

RATIONALE, AIMS AND OBJECTIVES: Different designs of studies monitoring adherence may cause bias and subsequent unavailability to compare results. Healthy adherer effect (HAE) is a type of bias reflecting patient behaviour. It cannot be easily monitored in study population and can favourably affect health outcomes that may be incorrectly attributed to drug therapy. The aim of this paper was to assess the HAE impact on health outcomes of studies concerning medication adherence. METHODS: Systematic review of literature from PubMed, EMBASE and Cochrane Register of Controlled Trials identified all randomized controlled or observational studies dealing with HAE. Included studies were analysed with respect to relationships between HAE, adherence to therapy and health outcomes. RESULTS: Seven studies were identified - two randomized controlled and five cohort studies. Significant occurrence of HAE in relation to mortality was not observed while one study indicated the presence of HAE in relation to surrogate (bone mineral density). Cohort studies were mainly based on drug class effect, but HAE was not revealed. Factors associated with patient behaviour (e.g. smoking, regular preventive screening) were also not clearly associated with the occurrence of HAE, but their inclusion in design of cohort studies can help to detect health seeking behaviour. CONCLUSION: Only a few studies concerning HAE were found, but they did not obtain any consistent conclusions. HAE impact was supposed particularly on treatment outcomes that may be easier affected by patient behaviour. However, researchers and clinicians should be still aware of HAE, interpret results carefully and verified them in further studies.

An analysis of fat-related and fiber-related behavior in men and women with type 2 diabetes mellitus: key findings for clinical practice.

BACKGROUND: Despite the efforts of health care providers, adherence of patients with type 2 diabetes to the recommended diet is poor. The aim of this study was to describe the eating habits with emphasis on fat and fiber-related behavior (FFB) as well as the relationship between FFB behavior and parameters of diabetes control in men and women with type 2 diabetes mellitus. METHODS: The subjects in this observational cross-sectional study were 200 patients (54.5% male, mean age 66.2 ± 10.1 years, mean Diabetes Control and Complications Trial [DDCT] glycosylated hemoglobin [HbA1c] 7.6% ± 1.7%) recruited from diabetes outpatient clinics in the Czech Republic. The subjects filled out the Fat- and Fiber-related Diet Behavior Questionnaire. The most recent patient data on diabetes control and drug therapy were derived from patient medical records. RESULTS: Patients tend to modify the dishes they are used to, rather than remove them completely from their diet and replace them by other types of foods. It is easier to perform healthier fat-related behaviors than fiber-related ones. Women scored significantly better than men on the fat-related diet habits summary scale (P = 0.002), as well as on "modify meat" (P = 0.001) and "substitute specially manufactured low-fat foods" (P = 0.045) subscales. A better score on the fat-related diet habits summary scale was significantly associated with higher HbA1c (ρ = -0.248; P = 0.027) and higher waist circumference (ρ = -0.254; P = 0.024) in women. CONCLUSION: Type 2 diabetes patients are likely to vary in their FFB behavior, and their dietary habits depend on gender. Health care professionals should pay attention to these facts when providing specific education. Emphasis should be placed on how to increase the fiber intake in diabetic patients.

Adherence in adults with type 1 diabetes mellitus correlates with treatment satisfaction but not with adverse events.

PURPOSE: Diabetes self-care and self-monitoring adherence has a positive effect on the metabolic control of the disease. The aim of this study was to analyze the adherence to self-care recommendations and to identify its correlates in adults with type 1 diabetes mellitus. PATIENTS AND METHODS: One hundred and eleven patients with type 1 diabetes were enrolled in an observational cross-sectional study conducted at the Diabetes Center of the University Hospital in Hradec Králové, Czech Republic. Diabetes self-care adherence was measured by the Self Care Inventory-Revised, and treatment satisfaction by the Diabetes Treatment Satisfaction Questionnaire-status version. Additional data were collected from self-administered questionnaires and medical records. The Mann-Whitney test, Spearman correlations, and multiple linear regressions were used in the statistical analysis. RESULTS: The mean age of patients was 42.4 years; 59.5% of them were females and 53.2% of all patients used an insulin pump. The mean glycosylated hemoglobin (HbA1c) was 66.2 ± 15.3 mmol/mol and the mean insulin dosage was 0.6 ± 0.3 IU insulin/kg/day. The number of hypoglycemic episodes (including severe) that patients had in the last month before taking the survey was 3.6 ± 3.2. Self-care adherence was associated with treatment satisfaction (0.495; P = 0.004) along with frequency of self-monitoring of before meal blood glucose (0.267; P = 0.003). It was not associated with the incidence of hypoglycemic events or any other insulin therapy-related problems or with socio-demographic or clinical characteristics. CONCLUSION: Treatment satisfaction is one of the key factors that need to be targeted to maximize benefits to patients. Self-care adherence in adults with type 1 diabetes did not correlate with socio-demographic and clinical characteristics, nor with adverse events.

Osteoporosis risk assessment and management in primary care: focus on quantity and quality.

INTRODUCTION AND HYPOTHESIS: Early identification of high-risk patients by general practitioners (GPs) plays the key role in the management of osteoporosis (OP). METHODS: We conducted a postal questionnaire survey among 1500 Czech GPs to examine their behaviour related to OP. RESULTS: The overall questionnaire return rate was 38%. The respondents (mean age 52 years; 61.5% women) did not differ from non-respondents. OP knowledge correlated negatively with age (P<0.001). The most common reason for both suspicion of OP and referral for suspected OP is the patient's complaints. When the initial skeletal examination for suspected OP is conducted on the GP's initiative, it is most often X-ray (76%) followed by osteodensitometry (61%). The respondents address five patients (median) per month about this issue. The number of referrals to a specialist for suspected OP during the last quarter was 5 (median). The most commonly reported barriers to OP management were financial limits set by the health insurance agency (71%) and lack of authorization to prescribe selected drugs (71%). CONCLUSIONS: The GPs should pay greater attention to risk factors and be more active in the detection of at-risk patients. It is necessary to motivate the GPs and to overcome the barriers to effective clinical practice.

Self-reported compliance with osteoporosis medication-qualitative aspects and correlates.

OBJECTIVES: The analysis aims to assess (1) compliance with anti-osteoporosis pharmacotherapy and (2) the prevalence of calcium and vitamin D co-medication among Czech women in common clinical practice. METHODS: A cross-sectional multicentre questionnaire survey was performed in consecutive secondary care female patients aged > or =40 years. Three main dimensions of compliance were studied: drug compliance (based on missed doses over the last month), co-medication with calcium/vitamin D and compliance with dosing instructions for safe and effective use of bisphosphonates (BIS). RESULTS: The therapy in 200 osteoporosis patients was alendronate (44.5%), risedronate (24.5%), raloxifene (18%) and calcitonin (13%). The three dimensions of compliance were not associated with each other. None of the compliance-related outcomes correlated with the osteoporosis knowledge score obtained in the Osteoporosis Questionnaire (OPQ) of Pande et al. The most frequently reported reason for non-compliance was "drug not handy". Similar mean compliance rates were achieved with once daily and once weekly BIS. The rates of current calcium and vitamin D co-medication were 73% and 62%, respectively. Calcium co-medication was associated with obtaining information on medications against osteoporosis from other sources besides health care professionals (P = 0.038). Compliance with dosing instructions correlated negatively with age (P = 0.001). CONCLUSION: Compliance with osteoporosis medication in Czech women is suboptimal, in particular the prevalence of co-medication with calcium/vitamin D should be higher. It is needed to implement strategies focused on the patient's beliefs about the disease and perceptions of outcome rather than those promoting the knowledge alone.

Knowledge of osteoporosis correlated with hormone therapy use and health status.

OBJECTIVES: The study objectives were: (a) to evaluate knowledge about osteoporosis and to identify its correlates among women > or =40 years of age attending outpatient centers; (b) to compare the level of knowledge between women already receiving treatment for osteoporosis and first-time attendees. METHODS: A cross-sectional survey was conducted with women recruited from nine outpatient centres in the Czech Republic. The women were divided into two subgroups: patients who have already been diagnosed with osteoporosis (osteopenia) and who are receiving treatment for the disease (OS group); first-time attendees who have been referred for the assessment of osteoporosis (comparison group). The patient's knowledge of osteoporosis was assessed using the Osteoporosis Questionnaire (OPQ) developed by Pande et al. [Pande KC, Takats D, Kanis JA, Edwards V, Slade P, McCloskey EV. Development of a questionnaire (OPQ) to assess patient's knowledge about osteoporosis. Maturitas 2000;37:75-81]. RESULTS: A total of 474 women (median age 63 years) were studied (306 in the OS group, 168 in the comparison group). Knowledge scores based on OPQ (median) were 7 and 6 points in the OS and comparison groups, respectively. When adjusted for age, the statistics showed better knowledge patients in the OS group (P=0.019). In both the OS and comparison groups, knowledge was found to be correlated positively with education (P<0.001) and experience of hormone replacement therapy (HRT) (P<0.001) and negatively with age (P<0.001). Knowledge was higher among women with better health status in the OS group. CONCLUSION: Knowledge about osteoporosis among Czech women aged > or =40 years and attending outpatient centers is relatively poor. To improve it, special attention should be paid to elderly women, those who have not used HRT, poorly educated women and those treated with several drugs.