Sabrina Müller

Nonadherence in Outpatient Thrombosis Prophylaxis with Low Molecular Weight Heparins after Major Orthopaedic Surgery

BackgroundAccording to some current guidelines, extended thromboprophylaxis after hip and knee arthroplasties is recommended. Outpatient prophylaxis with low molecular weight heparins (LMWH) is an important part of this prophylaxis, although the rates of adherence to these regimens is not known.Questions/purposesWe determined (1) the degree of nonadherence (NA) of patients with LMWH outpatient prophylaxis, and (2) whether specific independent factors explain NA.MethodsNA was determined by syringe count and by indirect and direct questions to patients. We defined six different NA indicators. To identify factors explaining LMWH NA, we used three different logistic regression models.ResultsNA rates ranged between 13% and 21% depending on the indicator used for measurement. Patients who were nonadherent missed between 38% and 53% of their outpatient LMWH injections. If patients attended an outpatient rehabilitation program, the probability for their NA increased substantially. Moreover, the NA probability increased with each additional day between acute hospitalization and start of rehabilitation (linking days). NA was lower for patients who feared thrombosis or who believed antithrombotic drugs to be the most important measure in thromboprophylaxis.Level of EvidenceLevel II, prognostic study. See the Guidelines for Authors for a complete description of levels of evidence.

Toward identifying the causes and combinations of causes increasing the risks of nonadherence to medical regimens: combined results of two German self-report surveys.

OBJECTIVES This study aimed to identify the causes of the nonadherence (NA) of German patients to their prescribed medication. In the course of the investigation, the NA risk profiles resulting from the combination of the various causes were identified. METHODS Two cross-sectional surveys with a total of 1517 patients (comprising 1177 patients contacted by telephone and forming survey 1 and a different set of 340 patients interviewed in-depth and face-to-face forming survey 2) were conducted. Self-reported NA was measured by the generic Morisky Medication Adherence Scale (MMAS). Survey 1 used a four-item MMAS and Survey 2 an eight-item MMAS. RESULTS Approximately 35% to 40% of the patients can be described as nonadherent. In survey 1, a few causes explain the NA (chronic disease, younger age, and fewer medications required to be taken). The more detailed survey 2 shows that the existence of intentional NA has considerably more influence than any other causal factors. Positive medication beliefs, a positive mood, and a good patient-doctor relationship reduce the NA risk. Furthermore, patients who are easily able to recognize the correct medication, as evidenced by ability to correctly identify the packaging, have a reduced NA probability. Concerning additive risk, patients who are chronically ill but display no other causes of risk have an NA probability of 10.4%. By contrast, in patients displaying all the identified causes of risk, the rate increases to 93.9%. CONCLUSIONS About one-third of patients can be classified as nonadherent. Intentional/medication-based NA causal factors explain the NA considerably better than do socioeconomics. The existence of more than one cause of risk considerably increases the NA risk of a patient.

Nonadherence in outpatient thromboprophylaxis after major orthopedic surgery: a systematic review

The necessity for extended medication-based thromboprophylaxis after hip/knee-replacement surgery (major orthopedic surgery) has been acknowledged in international guidelines. In this article, we review and critically appraise the literature regarding patients’ nonadherence (NA) in outpatient thromboprophylaxis after major orthopedic surgery. We conducted a systematic literature review. All studies published since 1990 and that were found to report research about NA in outpatient thrombosis prophylaxis after major orthopedic surgery were included. Only six relevant contributions could be identified. All these studies dealt with parenteral low-molecular-weight heparins or fondaparinux prophylaxis. The extent of NA (defined as existing when a patient fails to take the prescribed medication on at least 1 day) ranged from 13 to 37%. In one large German survey, patients who were nonadherent missed between 38 and 43% of their outpatient low-molecular-weight heparin injections. Subjective factors can play a role in increasing NA; such factors include a lack of knowledge of or having no fear concerning thrombosis in general and a lack of specific knowledge regarding measures to prevent it, as well as a negative evaluation of injections as the form of therapy application. Waiting times between acute in-hospital treatment and admission to rehabilitation clinics, as well as abstention from stationary rehabilitation programs, form objective adherence barriers. Therefore, NA is a phenomenon influenced by subjective patient-related factors as well as objective, care-provision structural factors. Current trends in patient care (e.g., shorter hospital stays and lengthened ambulant care) are likely to increase both the number of nonadherent patients and the extent of NA, if the current state of knowledge proves an accurate predictor of the future. At present, it appears that between one and two of every five patients are not adherent when parenteral prophylaxis is used. Whether or not new oral anticoagulation alternatives will be capable of improving the situation remains open for future research.

Validation of the Adherence Barriers Questionnaire – an instrument for identifying potential risk factors associated with medication-related non-adherence

BackgroundMedication non-adherence is a major challenge in the real-life treatment of chronically ill patients. To meet this challenge, adherence interventions with a tailored approach towards patient-specific adherence barriers that are identified with a reliable and practicable questionnaire are needed. The aim of this investigation was to develop and validate such a questionnaire, the “Adherence Barriers Questionnaire (ABQ)”.MethodsThe German ABQ was developed and tested in 432 patients with atrial fibrillation in a multicentre observational cohort study. Evaluation of the questionnaire included an assessment of internal consistency as well as factor analysis. Criterion-related external validity was assessed by comparing the ABQ score with (1) the degree of self-reported adherence and (2) the time in therapeutic range which describes the anticoagulation quality achieved by patients treated with oral anticoagulation.ResultsThe final 14-item ABQ scale demonstrated high internal consistency (Cronbach’s alpha = 0.820). Factor analysis identified a three-factor solution, representing intentional adherence barriers with 5 items (31.9% of the variance), medication-/health care system-related adherence barriers with 5 items (13.3% of the variance) and unintentional adherence barriers with 4 items (7.7% of the variance).The ABQ correlated significantly with self-reported non-adherence (Spearman’s rho = 0.438, p < 0.001) as well as time in therapeutic range (Spearman’s rho = − 0.161, p < 0.010). Patients with above-average ABQ scores (increased number and/or strength of existing adherence barriers) were significantly (p < 0.005, Pearson Chi-Square) more likely to have a poor anticoagulation quality (TTR < 60%) than patients with a lower ABQ score (44.6% versus 27.3%).ConclusionsThe ABQ is a practicable, reliable and valid instrument for identifying patient-specific barriers to medication-related adherence. Future research is required to examine the ability of the ABQ to identify patient perception/behaviour changes over time which may be important for the measurement of success of adherence interventions.

Does Package Design Matter for Patients

Introduction: The objective of this study was to discover whether over-the-counter (OTC) package designs differ in their ability to transfer drug-safety-related information to pharmacy customers. The research was intended to answer two questions: (i) how well and quickly do customers comprehend, and what are the main characteristics of customers who have difficulty understanding relevant medical information on a package; and (ii) do alternative package designs provide for significantly different levels of comprehension?Methods: We performed cross-sectional face-to-face interviews with 452 pharmacy customers in 17 German pharmacies. In each of three sequential experiments (one OTC brand per experiment), each participant was shown two packages of the same brand and was asked three drug-related questions per package. The different abilities of the three package designs to transfer information correctly and rapidly were compared by descriptive statistics; the significance of differences was tested by Wilcoxon tests.Results: Older people, those with physical problems, people not in a receptive mood, and those with a poor doctor-patient relationship or a lack of trust in medicines in general, answered the questions with a significantly higher number of errors and/or required significantly more time to do so, than the remainder of the sample. When compared with two other package designs, one of the tested designs with special design characteristics proved superior.Conclusions: The design of a medication package can measurably influence the quality and speed of information transfer to pharmacy customers. Because drug safety and adherence are associated with drug knowledge, the design of packaging should be given more attention.

Quality of Life, Glycemic Control, Safety and Tolerability Associated with Liraglutide or Insulin Initiation in Patients with Type 2 Diabetes in Germany: Results from the Prospective, Non-interventional LIBERTY Study

PURPOSE To assess quality of life, glycemic control, and safety/tolerability associated with liraglutide versus insulin initiation in patients with type 2 diabetes in Germany. METHODS Liraglutide/insulin-naïve adults with type 2 diabetes and inadequate glycemic control despite using oral antidiabetic medication were assigned to liraglutide (≤1.8 mg daily; n=878) or any insulin (n=382) according to the treating physicians decision and followed for 52 weeks. The primary objective was to evaluate Audit of Diabetes-Dependent Quality of Life (ADDQoL) scores. RESULTS At baseline, the liraglutide group was younger and had shorter type 2 diabetes duration, lower glycated hemoglobin (HbA1c), higher body mass index, and a lower prevalence of certain diabetes-related complications than the insulin group (all p<0.05). ADDQoL average weighted impact scores improved numerically in both groups from baseline to 52 weeks (mean difference [95% confidence interval], liraglutide vs. insulin: 0.159 [-0.023;0.340]; not significant). Changes in general wellbeing and five ADDQoL domains significantly favored liraglutide (remaining 14 domains, not significant). HbA1c reductions were greater with insulin than liraglutide (-2.0% vs. -1.2%; p<0.01); however, mean HbA1c after 52 weeks was 7.2% in both groups. Compared with insulin, liraglutide significantly decreased body mass index (-1.54 kg/m2 vs. +0.27 kg/m2; p<0.001), systolic blood pressure (-5.03 mmHg vs. -1.03 mmHg; p<0.01) and non-severe hypoglycemia (0.85% vs. 4.55% at 52 weeks; p<0.01). Adverse drug reactions were reported for<3% of patients in both groups. CONCLUSIONS Liraglutide improved certain ADDQoL components and reduced body mass index, systolic blood pressure, and non-severe hypoglycemia versus insulin. Both treatments improved glycemic control.

Non-persistence and non-adherence to MTX therapy in patients with rheumatoid arthritis: a retrospective cohort study based on German RA patients

Objective This study aimed to assess the level of nonpersistence (NP) and nonadherence (NA) to methotrexate (MTX) therapy in German patients with rheumatoid arthritis (RA). Materials and methods Based on German claims data, RA patients who received a MTX therapy (subgroup: treatment-naive patients) were analyzed. NP was defined as treatment gap >12 weeks. Regarding NA, it is the overall medication possession ratio (MPR) during an observational period of 12 or 24 months after therapy, and the MPR is calculated only for the periods of therapy continuation; NA was defined as MPR <80%. Results A total of 7,146 RA patients who received at least one MTX prescription (subgroup: 1,211 treatment-naive patients) could be observed (mean age: 64.4 years, 73.6% female). Percentage of NP patients among MTX-naive patients after 6, 12 and 18 months was 16.7%, 34.0% and 36.7%, respectively. After MTX therapy discontinuation, 39.9% had restarted their MTX therapy, 13.8% had received another non-MTX synthetic disease-modifying antirheumatic drug (sDMARD), 8.1% had biological DMARD (bDMARD) and 49.2% had not received any DMARD prescription at all. Overall, 12- and 24-month MPRs for MTX therapy were 83.0% and 76.5% with a percentage of NA patients of 25.8% and 33.8%, respectively. During periods of general treatment continuation, the percentage of patients with an MPR <80% was 6.5%. Conclusion NP to MTX treatment seems to be common in one-fourth of German patients with RA. An additional number of patients, at least 6.5%, are also affected by NA. A considerable percentage of RA patients who discontinued MTX therapy do not receive any follow-up DMARD therapy.