Magda Vytrisalova

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.

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.

Adherence to oral bisphosphonates: 30 more minutes in dosing instructions matter

Abstract Objectives Low adherence to treatment with bisphosphonates significantly impedes its effectiveness. The objectives were: (1) to compare adherence to oral weekly and monthly bisphosphonates with emphasis on dosing instructions; and (2) to study associations between adherence and beliefs about the bisphosphonate treatment among women ≥ 55 years. Methods A multicenter survey was performed in secondary-care patients with osteoporosis. Osteoporosis Specific Morisky Medication Adherence Scale (OS-MMAS), questions on compliance with five dosing instructions and Beliefs about Medicines Questionnaire (BMQ) Specific were used. Results As many as 363 questionnaires (response rate 95%) were analyzed. Respondents (mean age 69 years) were treated with weekly bisphosphonates (37%) or monthly ibandronate (63%). Based on OS-MMAS, 67% of respondents showed high adherence with no differences between the subgroups. Only 44% of respondents were compliant with all dosing instructions. Compliance with dosing instructions concerning time interval (fasting and staying upright) was 71% in weekly and 52% in monthly subgroups, respectively (p < 0.001). Compliance with dosing instructions correlated positively with education (p = 0.009). The mean BMQ necessity score of 18.4 was greater than the mean BMQ concerns score of 13.3. OS-MMAS score correlated with necessity (p = 0.010). Persistence derived from OS-MMAS correlated with both necessity (p = 0.014) and concerns (p = 0.041). Conclusion Despite relatively high adherence to the treatment, most patients do not follow dosing instructions. Reduced bioavailability, particularly of monthly ibandronate, can be expected in clinical practice. Adherence-related outcomes are associated with beliefs about the oral treatment with bisphosphonates.

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

Abstract 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.

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 patients complaints. When the initial skeletal examination for suspected OP is conducted on the GPs 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.

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.

Adherence to osteoporosis guideline: survey among Czech general practitioners

Rationale and objectivesGeneral practitioners (GPs) play an important role in management of patients at risk of osteoporosis (OP). The objectives were to assess (1) knowledge about OP and use of OP clinical guideline in comparison with other information sources and (2) association between the use of individual information sources and knowledge and self-reported quality of care among GPs.MethodsSurvey among random sample of Czech GPs was performed to find out their attitudes and role in OP management. The return rate of the postal questionnaire was 38% (525 respondents). Quality of care was assessed using three indicators: suspicion on OP, referral to the specialist and initial check-up.ResultsRespondents (median age 52 years, 59% women) had a very good knowledge of several risk factors, while others, namely low body mass index, history of hip fracture in mother and smoking were perceived as risk factors by only 40%, 45% and 55% of respondents, respectively. 10% of GPs stated the correct answer regarding daily calcium intake recommended for postmenopausal women. The OP guideline was considered accessible by 83% of respondents and used repeatedly by 54%. Use of the guideline correlated positively with knowledge score (P < 0.001), while use of each individual other source of information did not. Use of the guideline correlated with all three indicators of quality of care. Use of each other information source correlated only with a maximum of two indicators.ConclusionWe identified areas of insufficient knowledge that should be targeted in educational activities for GPs. It is recommended to further motivate GPs to use their clinical guidelines regularly.

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.

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 GPs 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 GPs 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, patients non-adherence (reported by 29%) and patients 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.

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.