Tyrosine kinase inhibitor treatment discontinuation in chronic myeloid leukemia: patient views.

Patients with chronic myeloid leukemia (CML) in deep molecular remission may discontinue tyrosine kinase inhibitor (TKI) treatment without relapse. The present study aims to gain insight into the views of CML patients on TKI treatment discontinuation and identify factors that are associated with their willingness to discontinue treatment. A cross-sectional study, among adult Dutch CML patients was conducted to assess willingness and their views on benefits of and concerns about discontinuation. A total of 185 patients participated of whom 76% were willing to discontinue TKI-treatment. Patients considered the absence of side effects the most important benefit whereas fear of disease recurrence was their most prominent concern. Adequate monitoring was the most important prerequisite for TKI-treatment discontinuation. However, ambiguity with respect to perquisites indicate that patients on long-term TKI treatment should be adequately informed both on the possibility to discontinue treatment and on its benefits, risks, and measures that address risks.

Response and Adherence to Nilotinib in Daily practice (RAND study): an in-depth observational study of chronic myeloid leukemia patients treated with nilotinib.

INTRODUCTION: This comprehensive observational study aimed to gain insight into adherence to nilotinib and the effect of (non)adherence on exposure (Cmin) and treatment outcomes. METHODS: Chronic myeloid leukemia (CML) patients using nilotinib were followed for 12 months. Adherence was measured by Medication Event Monitoring System (MEMS), pill count, and Medication Adherence Report Scale (MARS-5). Nilotinib Cmin and patient-reported outcomes (i.e., quality of life, side effects, beliefs, satisfaction) were measured at baseline, 3, 6, and 12 months. RESULTS: Sixty-eight patients (57.5 ± 15.0 years, 49% female) participated. Median adherence to nilotinib (MEMS and pill count) was ≥ 99% and adherence < 90% was rare. Self-reported nonadherence (MARS-5) increased in the first year of treatment to a third of patients. In line with the strong beliefs in the necessity of taking nilotinib, forgetting to take a dose was more prevalent than intentionally adjusting/skipping doses. Nilotinib Cmin were generally above the therapeutic target in 95% of patients. Patients reported a variety of side effects, of which fatigue was most frequent. The mean Cmin was higher in patients who reported severe itching and fatigue. The overall 1-year MMR rate ranged from 47 to 71%. CONCLUSION: Substantial nonadherence (< 90%) to nilotinib was rare and nilotinib Cmin were generally above the therapeutic target. Lack of response in our group of patients was not related to nonadherence or inadequate Cmin. Nevertheless, a considerable number of patients experienced difficulties in adhering to the twice daily fasted dosing regimen, emphasizing the importance of continuous support of medication adherence in CML. CLINICAL TRIAL REGISTRATION: NTR3992 (Netherlands Trial Register, www.trialregister.nl ).

Food-effect study of nilotinib in chronic myeloid leukaemia (NiFo study): Enabling dose reduction and relief of treatment burden.

OBJECTIVES: Taking advantage of its food-dependent bioavailability, the present study investigated the effect of a reduced dose taken with real-life meals on the pharmacokinetics (PK) of nilotinib in chronic myeloid leukaemia (CML) patients. METHODS: Nilotinib was taken fasted (300 mg BID, days 1-4) or with real-life meals (200 mg BID, days 5-11). Rich sampling (days 1, 3, 8, 11) allowed for non-compartmental PK analysis. Nilotinib exposure (AUC0-12 h  -Cmin -Cmax ) and its intra- and interpatient variability were compared between the two regimens. Adverse events were recorded by means of a patient diary and ECG monitoring. RESULTS: Fifteen patients aged 40-74 years participated. Nilotinib PK following 200 mg BID taken with a meal strongly resembled that of 300 mg BID taken fasted (Cmin percentile (P)10-P90: 665-1404 ng/mL and 557-1743 ng/mL, respectively). Meals delayed nilotinib absorption. Intra- and interpatient variability were not increased by intake with meals. Nilotinib with food was well tolerated. CONCLUSION: With support of therapeutic drug monitoring, the use of a reduced 200 mg nilotinib dose with real-life meals seems feasible and safe. Future (confirmatory) studies should further explore the usefulness of nilotinib dosing together with food, including the relationship with treatment efficacy as well as long-term effects on quality of life. CLINICAL TRIAL REGISTRATION: NTR5000 (Netherlands Trial Register, www.trialregister.nl).

Implementation fidelity of an intervention programme to enhance adherence to antihypertensive medication in Dutch community pharmacies.

Background Insight into the delivery of interventions is necessary to gain a better understanding of what caused an intervention to succeed or fail. The Cardiovascular medication non-Adherence Tailored Intervention (CATI) study failed to show effectiveness of a patient-tailored, pharmacist-led intervention programme on self-reported adherence to antihypertensive medication. Objective To evaluate the implementation fidelity of the CATI intervention programme. Setting Twenty Dutch community pharmacies. Method The process of a randomised controlled trial was evaluated. Both quantitative and qualitative data were collected and analysed according to Carrolls' Conceptual Framework for Implementation Fidelity. Implementation fidelity is defined as the degree to which the intervention was implemented as intended. Main outcome measure Four key intervention components of the intervention programme (i.e., first consultation: barrier identification, information and advice, written summary, and follow-up consultation). Results For most participants the key intervention components were implemented as intended. The training of pharmacists, intensive monitoring during the study and structured and easy-to-use intervention materials facilitated the implementation of the intervention. The method to select participants for the intervention programme was considered insufficient and pharmacists questioned the eligibility of some participants because of a low degree of intake non-adherence. Conclusion Implementation fidelity was moderate to high for all key intervention components. Therefore, the absence of effectiveness of the CATI intervention programme on self-reported medication adherence cannot be explained by poor implementation of the intervention. However, the limited genuine eligibility of some participants resulted in a limited potential for improvement in medication adherence.

Factors Associated With Nonadherence to Cardiovascular Medications: A Cross-sectional Study.

BACKGROUND: Cardiovascular medications have well-established benefits in the primary and secondary prevention of cardiovascular diseases. Unfortunately, adherence to these medicines is often suboptimal. To develop interventions intended to enhance adherence to cardiovascular medications, more insight is needed into the complex character of medication nonadherence. OBJECTIVE: The aim of the present study was to identify which factors are associated with nonadherence to cardiovascular medications in a sample of patients from Dutch community pharmacies. METHODS: In this cross-sectional study, patients using cardiovascular medications from 23 community pharmacies were included. Patient demographics, medication and disease characteristics, knowledge, quality of life, attitude toward medicines, and satisfaction with information were assessed. Both an adherent sample (n = 146) and a sample of patients nonadherent to prescribed medications (n = 109) during the last 6 months as assessed with pharmacy refill data (proportion of days covered <80%) were selected. Associations with refill nonadherence were assessed using univariate and multivariate logistic regression analyses. RESULTS: In total, 255 patients participated (53.3% men, 71.6 ± 10.9 years). Factors associated with cardiovascular medication nonadherence in multivariate analyses included experiencing difficulties with medication use due to forgetting, having insufficient knowledge on what to do when a dose is forgotten, and having an ambivalent attitude toward medicines (beliefs of high necessity and high concerns). CONCLUSIONS: Intervention strategies to enhance cardiovascular medication nonadherence should be targeted mainly to the unintentional dimension of nonadherence and include information and tools to prevent forgetting. Conversely, the influence of factors that underlie intentional nonadherence, particularly patients' beliefs about medicines, should also be addressed.

The Cost-Effectiveness of an Intervention Program to Enhance Adherence to Antihypertensive Medication in Comparison With Usual Care in Community Pharmacies.

Introduction: Hypertension is considered an important public health issue. Inadequate disease management and non-adherence to antihypertensive medication may result in suboptimal clinical outcomes thereby imposing a financial burden on society. This study evaluates the cost-effectiveness of a patient-tailored, pharmacist-led intervention program aimed to enhance adherence to antihypertensive medication in comparison with usual care. Materials and Methods: An economic evaluation was conducted alongside a pragmatic randomized controlled trial with 9-months follow-up among 170 patients using antihypertensive medication. Effect outcomes included self-reported adherence (MARS-5), beliefs about medicines (BMQ Concern and Necessity scales) and quality-adjusted life-years (QALYs). Costs were measured from a societal perspective. Missing cost and effect data were imputed using multiple imputation. Bootstrapping was used to estimate uncertainty around the cost-differences and the incremental cost-effectiveness ratios. Cost-effectiveness planes and acceptability curves were estimated. Results: There were no significant differences in costs or effects between the intervention program and usual care. The probability of cost-effectiveness of the intervention in comparison with usual care was 0.27 at a willingness-to-pay value of 0 €/unit of effect gained. At a willingness-to-pay value of 20,000 €/unit of effect gained, the probability of cost-effectiveness was 0.70, 0.27, 0.64, 0.87, and 0.36 for the continuous MARS-5 score, dichotomized MARS-5 score, BMQ Concern scale, BMQ Necessity scale and QALYs, respectively. Discussion: In patients with hypertension, the patient-tailored, pharmacist-led intervention program to enhance medication adherence was not considered cost-effective as compared to usual care with regard to self-reported medication adherence, beliefs about medicines and QALYs.

Feasibility of and patients' perspective on nilotinib dried blood spot self-sampling.

PURPOSE: To obtain insight into the feasibility of, and the patients' perspective on, dried blood spot (DBS) self-sampling by patients with chronic myeloid leukemia (CML) using nilotinib. METHODS: Sixty-eight patients with CML using nilotinib participated in this multicenter observational study. Patients were asked to perform blood sampling by means of the DBS method at home just before drug intake (trough level) and to complete a questionnaire including demographics and five questions on their experience with DBS self-sampling. RESULTS: Sixty-one patients (57.5 ± 15.0 years, 49% female) provided 178 DBS samples of which 137 (77%) proved useful in clinical practice. Twenty percent of the samples were rejected because the spot size was too small for analysis. A further 3% were taken at the wrong time. Unsuitable DBS samples were provided by 23 patients. Their educational level was significantly lower than that of patients whose samples were all suitable (p = 0.041). Patients considered DBS self-sampling easy and not painful, and three quarters of the patients performed DBS sampling without additional assistance. Patients' belief in the reliability of DBS self-sampling was moderate to high. It was preferred over venous sampling by 37% of the patients, whereas 39% had no preference. CONCLUSION: DBS self-sampling by CML patients is feasible in clinical practice provided that patients, particularly those with a lower educational level, are adequately instructed about sample collection with emphasis on timing and volume of sample collection.

Effectiveness of a Patient-Tailored, Pharmacist-Led Intervention Program to Enhance Adherence to Antihypertensive Medication: The CATI Study.

Introduction: Non-adherence to medication is a complex health care problem. In spite of substantial efforts, up till now little progress has been made to effectively tackle the problem with adherence-enhancing interventions. The aim of this study was to investigate the effectiveness of a patient-tailored, pharmacist-led and theory-driven intervention program aimed to enhance self-reported adherence to antihypertensive medication. Materials and Methods: A parallel-group randomized controlled trial in 20 community pharmacies with nine months follow-up was conducted. Patients (45-75 years) using antihypertensive medication and considered non-adherent based on both pharmacy dispensing data and a self-report questionnaire were eligible to participate. The intervention program consisted of two consultations with the pharmacist to identify participants' barriers to adhere to medication and to counsel participants in overcoming these barriers. The primary outcome was self-reported medication adherence. Secondary outcomes were beliefs about medicines, illness perceptions, quality of life and blood pressure. Mixed-model and generalized estimating equation (GEE) analyses were used to assess overall effects of the intervention program and effects per time point. Results: 170 patients were included. No significant differences between intervention and control groups were found in self-reported adherence, quality of life, illness perceptions, beliefs about medicines (concern scale), and blood pressure. After nine months, intervention participants had significantly stronger beliefs about the necessity of using their medicines as compared to control participants (mean difference 1.25 [95% CI: 0.27 to 2.24], p = 0.012). Discussion: We do not recommend to implement the intervention program in the current form for this study population. Future studies should focus on how to select eligible patient groups with appropriate measures in order to effectively target adherence-enhancing interventions. Trial Register: NTR5017 http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5017.

Needs for information and reasons for (non)adherence in chronic myeloid leukaemia: Be aware of social activities disturbing daily routines.

OBJECTIVES: To obtain insight into patients' reasons for medication (non)adherence in chronic myeloid leukaemia (CML) and needs and wishes regarding information and communication. METHODS: A mixed-method study on the basis of a questionnaire and semi-structured interviews. The CML patient advocacy group asked patients to participate. RESULTS: Sixty-one patients (54 ± 12 years, 43% male) using imatinib, dasatinib or nilotinib participated. Fifteen patients (25%) reported to miss an intake at least once a month. Most were not worried about missing an intake and did not discuss missed intakes with their healthcare provider (HCP). Social activities disturbing daily routines and the wish to avoid side effects resulted in nonadherence. Patients wanted extensive and understandable information provided timely on all aspects of CML treatment, in particular on side effects, and a more supportive HCP attitude. CONCLUSIONS: Nonadherence to CML medication does not cause concern in all patients and is not discussed pro-actively. HCP have a clear role in supporting medication adherence in CML and must be aware that social activities disturbing daily routines contribute to nonadherence. HCP should discuss (non)adherence in a direct manner, motivate patients to play an active role in managing their medication and timely provide extensive and understandable information on all aspects of CML.

The impact of cardiovascular medication use on patients' daily lives: a cross-sectional study.

Background The management of multiple long-term medicines of patients with chronic diseases creates a burden for patients. However, limited research is performed on its impact on patients' daily lives. Objective The aim of this study was to explore the impact of cardiovascular medication on different daily life aspects and to examine differences of these aspects between adherent and non-adherent patients. Setting Two community pharmacies in the Netherlands. Method In this cross-sectional study patients (≥ 45 years) using cardiovascular medication participated. Two equally group sized samples of patients non-adherent as assessed with pharmacy refill data, and patients adherent were selected. Main outcome measure Data were collected by means of the Living with Medicines Questionnaire measuring the impact of medicines use on patients' daily lives. Results In total, 196 patients participated, including 96 non-adherent patients. Substantial proportions of patients experienced medication-related burden on different daily life aspects. This burden was mainly related to the acceptance of long-term medicine use, medication-related concerns or dissatisfaction, the interference of medicines with social and daily lives, and the interaction and communication with health care providers. No statistically significant results were found when comparing the impact on patients' daily lives between adherent and nonadherent patients. Conclusion Health care providers should acknowledge the impact of multiple long-term medicines on patient's daily lives and should make an effort to diminish patients' medication-related burden by improving patient-provider relationships and by providing adequate treatment information incorporating patients' individual circumstances. This may facilitate the integration of long-term medicine use in patients' daily lives.

Patient satisfaction with information on oral anticancer agent use.

Adequate information on oral anticancer agent (OACA) use is an essential element of optimal cancer care. The present study aimed to get insight into the experiences of patients with information on OACA treatment and their characteristics regarding information dissatisfaction. Patients of four Dutch university hospitals using OACA participated in this observational study and completed the Satisfaction with Information about Medicines Scale (SIMS), EORTC Quality of Life Questionnaire-C30, Brief Illness Perception Questionnaire, and Beliefs about Medicines Questionnaire-Specific. Logistic regression analyses were used to determine factors associated with dissatisfaction with information. Patients (n = 208) using capecitabine (35%), lenalidomide (15%), imatinib (14%), temozolomide (12%), sunitinib (11%), thalidomide (5%), dasatinib (4%), erlotinib (2%), and nilotinib (2%) participated. Information on the following SIMS-items was inadequate: how OACA elicit their effect, how long it takes before treatment works, how to conclude that treatment is effective, the risk of side effects and its management, interference with sex life, drowsiness, interference with other medication and alcohol and what to do in case of a missed dose. Younger age, hematological malignancy, dyspnoea, positive perception of consequences of the cancer, low perception of treatment control, and indifferent attitude towards OACA were associated with dissatisfaction with information. In conclusion, a considerable number of patients would have appreciated receiving more information on specific issues relating to the consequences of OACA treatment such as the effects and side effects of OACA and the interference of treatment with various aspects of their daily life. Oncologists, hematologists, lung-oncologists and pharmacists may reconsider the provision of information on OACA treatment.

Dried blood spot sampling of nilotinib in patients with chronic myeloid leukaemia: a comparison with venous blood sampling.

OBJECTIVES: To compare nilotinib concentrations obtained by venous blood sampling and dried blood spot (DBS) in patients with chronic myeloid leukaemia (CML). It was investigated how to predict nilotinib plasma levels on the basis of DBS. METHODS: Forty duplicate DBS and venous blood samples were collected from 20 patients. Capillary blood was obtained by finger prick and spotted on DMPK-C Whatman sampling paper, simultaneously with venous blood sampling. Plasma concentrations were predicted from DBS concentrations using three methods: (1) individual and (2) mean haematocrit correction and (3) the bias between plasma and DBS concentrations. Results were compared using Deming regression and Bland-Altman analysis. KEY FINDINGS: Nilotinib plasma concentrations ranged from 376 to 2663 µg/l. DBS concentrations ranged from 144 to 1518 µg/l. The slope was 0.56 (95% CI, 0.51 to 0.61) with an intercept of -41.68 µg/l (95% CI, -93.78 to 10.42). Mean differences between calculated and measured plasma concentrations were -14.3% (method 1), -14.0% (method 2) and -0.6% (method 3); differences were within 20% of the mean in 73%, 85% and 80% of the samples, respectively. The slopes were respectively 0.96 (95% CI, 0.86 to 1.06), 0.95 (95% CI, 0.86 to 1.03) and 1.00 (95% CI, 0.91 to 1.09). CONCLUSIONS: Plasma concentrations of nilotinib could be predicted on the basis of DBS. DBS sampling to assess nilotinib concentrations in CML patients seems a suitable alternative for venous sampling.

Supporting adherence to oral anticancer agents: clinical practice and clues to improve care provided by physicians, nurse practitioners, nurses and pharmacists.

BACKGROUND: Healthcare provider (HCP) activities and attitudes towards patients strongly influence medication adherence. The aim of this study was to assess current clinical practices to support patients in adhering to treatment with oral anticancer agents (OACA) and to explore clues to improve the management of medication adherence. METHODS: A cross-sectional, observational study among HCPs in (haemato-)oncology settings in Belgium and the Netherlands was conducted in 2014 using a composite questionnaire. A total of 47 care activities were listed and categorised into eight domains. HCPs were also asked about their perceptions of adherence management on the items: insight into adherence, patients' communication, capability to influence, knowledge of consequences and insight into causes. Validated questionnaires were used to assess beliefs about medication (BMQ) and shared decision making (SDM-Q-doc). RESULTS: In total, 208 HCPs (29% male) participated; 107 from 51 Dutch and 101 from 26 Belgian hospitals. Though a wide range of activities were reported, certain domains concerning medication adherence management received less attention. Activities related to patient knowledge and adverse event management were reported most frequently, whereas activities aimed at patient's self-efficacy and medication adherence during ongoing use were frequently missed. The care provided differed between professions and by country. Belgian physicians reported more activities than Dutch physicians, whereas Dutch nurses and pharmacists reported more activities than Belgian colleagues. The perceptions of medication adherence management were related to the level of care provided by HCPs. SDM and BMQ outcomes were not related to the care provided. CONCLUSIONS: Enhancing the awareness and perceptions of medication adherence management of HCPs is likely to have a positive effect on care quality. Care can be improved by addressing medication adherence more directly e.g., by questioning patients about (expected) barriers and discussing strategies to overcome them, by asking for missed doses and offering (electronic) reminders to support long-term medication adherence. A multidisciplinary approach is recommended in which the role of the pharmacist could be expanded.

The (cost-)effectiveness of a patient-tailored intervention programme to enhance adherence to antihypertensive medication in community pharmacies: study protocol of a randomised controlled trial.

BACKGROUND: Medication non-adherence is a complex health care problem. Due to non-adherence, substantial numbers of cardiovascular patients benefit from their medication to only a limited extent. In order to improve adherence, a variety of pharmacist-led interventions have been developed. However, even the most effective interventions achieved only a modest positive effect. To be effective, interventions should be targeted at underlying barriers to adherence, developed in a systematic manner and tailored to specific features of a target group and setting. The current paper describes the design of the Cardiovascular medication non-Adherence Tailored Intervention (CATI) study aimed to evaluate the (cost-)effectiveness of a patient-tailored intervention programme in patients using antihypertensive medication. METHODS: The CATI study is a randomised controlled trial that will be performed in 13 community pharmacies. Patients aged 45-75 years using antihypertensive medication and considered non-adherent according to pharmacy dispensing data, as well according to a self-report questionnaire, are eligible to participate. Patients in the intervention condition will receive a patient-tailored, pharmacist-led intervention programme. This programme consists of a structured interview at the pharmacy to identify patients' barriers to adherence and to counsel patients in order to overcome these barriers. The primary outcome is self-reported medication adherence measured with the MARS-5 questionnaire. Secondary outcome measures are blood pressure, illness perceptions, quality of life and societal costs. A cost-effectiveness analysis and process evaluation will also be performed. DISCUSSION: This study will provide insight into the (cost-)effectiveness of a patient-tailored, pharmacist-led intervention programme in non-adherent patients using antihypertensive medication. This intervention programme allows community pharmacists to support their patients in overcoming barriers to adherence and improving medication adherence in a structured and patient-tailored manner. An effective intervention will not only enhance medication adherence, but may also improve health outcomes and decrease health care utilisation and costs. TRIAL REGISTRATION: Netherlands Trial Register (identifier: NTR5017), registered on 2 February 2015.

Adherence and Patients' Experiences with the Use of Capecitabine in Daily Practice.

Introduction: Capecitabine is a widely prescribed oral anticancer agent. We studied medication adherence and explored its use in daily practice from a patients' perspective. Patients and Methods: Patients (n = 92) starting capecitabine were followed up to five 3-week cycles. Adherence was assessed using a pill count, pharmacy data and dosing information from the patients' medical file. Self-reported adherence was measured using the Medication Adherence Report Scale (MARS). At baseline and during week 2 of cycles 1, 3, and 5, patients filled out questionnaires about quality of life, symptoms, attitude toward medicines and disease and use in daily practice. Simultaneously, blood samples were taken to determine the area under the curve (AUC) of 5'-deoxy-5-fluorouridine (5'-DFUR), 5-fluorouracil (5-FU), and α-fluoro-ß-alanine (FBAL) by a population pharmacokinetic model. Associations between AUCs and patient-reported symptoms were tested for cycles 3 and 5. Results: Most patients (84/92; 91%) had an adherence rate of ≥95 and ≤ 105%. The percentage of patients reporting any non-adherence behavior measured with MARS increased from 16% at cycle 1 to 29% at cycle 5. Symptoms were reported frequently and the dosing regimen was adjusted by the physician at least once in 62% of patients. In multivariate analysis the probability of an adjustment increased with the number of co-medication (OR 1.19, 95% CI: 1.03-1.39) and a stronger emotional response to the disease (OR 1.32, 95% CI: 1.10-1.59). The AUC of 5'-DFUR was associated with weight loss (OR 1.10, 95% CI: 1.01-1.19), AUC of FBAL with hand-foot syndrome (OR 0.90, 95% CI: 0.83-0.99), rhinorrhea (OR 1.21, 95% CI: 1.03-1.42 weight loss (OR 1.09, 95% CI: 1.00-1.20) and depression (OR 0.90, 95% CI: 0.82-0.99). Side effects were reported by one third of patients as the reason to discontinue treatment. Conclusion: Adherence to capecitabine was generally high. Nevertheless, adherence measured with MARS decreased over time Adherence management to support implementation of correct capecitabine use is specifically relevant in longer term treatment. In addition, it appears that adverse event management is important to support persistence. With the extending armamentarium of oral targeted anticancer agents and prolonged treatment duration, we expect the issue of medication adherence of increasing importance in oncology.

Guideline Adherence Regarding the Use of Expensive Drugs in Daily Practice: The Examples of Trastuzumab in Breast Cancer and Bortezomib in Multiple Myeloma.

BACKGROUND: The present study was designed to obtain insights into guideline adherence regarding the use of expensive drugs in The Netherlands in daily practice and into the patients' perspective on the decision-making process. MATERIAL AND METHODS: A retrospective review of medical charts regarding the use of trastuzumab in early and metastatic breast cancer (EBC/MBC) and bortezomib in multiple myeloma (MM) was conducted. Prescription according to clinical practice guidelines was assessed. The review was supplemented with patient interviews. RESULTS: Of 702 adjuvant-treated EBC patients, 97% had a documented human epidermal growth factor receptor 2 (HER2) testing (23% HER2 positive). 92% (147/160) of the HER2-positive EBC patients were treated with trastuzumab. Of 594 MBC patients, 81% had a documented HER2 testing (19% HER2 positive). 82% (75/91) of the HER2-positive MBC patients were treated with trastuzumab. Of 68 MM patients, 50% were treated with bortezomib. Reasons not to treat were consistent with the guidelines. Patients were generally satisfied with the decision-making process; improvements in patient education were suggested (e.g., repeating the information given, adding information on side effects). CONCLUSIONS: Guidelines were generally well followed with respect to trastuzumab and bortezomib, indicating that funding did not influence the treatment decisions of physicians. In view of the growing numbers of both cancer patients and expensive new anticancer drugs, and increasing budget constraints, it is unclear whether the present-day policies will guarantee a similar level of guideline adherence. Patient involvement in decision-making could be increased by improving the patient education on treatment.

Adherence to oral anticancer agents: Healthcare providers' perceptions, beliefs and shared decision making in Belgium and the Netherlands.

BACKGROUND: Little is known about healthcare providers' (HCPs) perceptions of adherence management of oral anticancer agents (OACA). The study aims to explore HCPs perceptions of OACA and adherence. METHODS: A cross-sectional, multi-center observational study among HCPs in hemato-oncology settings in Belgium and the Netherlands was conducted. Physicians, nurse practitioners, nurses and pharmacists were asked to complete questionnaires on their perception of patient adherence and its management (PAMQ) and their beliefs about OACA (BMQ-Specific). Physicians were also asked to complete a questionnaire on their perception of shared decision making (SDM-Q-Doc). RESULTS: The sample consisted of 254 HCPs. Variations were found between HCPs on the PAMQ: 56%, 50%, 28% and 23% of, respectively, physicians, nurse practitioners, nurses and pharmacists reported to know the level of adherence of their patients and 59%, 53%, 43% and 10% of, respectively, physicians, nurse practitioners, nurses and pharmacists think that patients discuss adherence with them. 70%, 82%, 63% and 62% of, respectively, physicians, nurse practitioners, nurses and pharmacists reported to have knowledge of causes of non-adherence, while 78%, 87%, 76% and 80% of them reported to have knowledge of consequences of non-adherence. 81%, 92%, 83% and 67% of, respectively, physicians, nurse practitioners, nurses and pharmacists felt able to influence adherence. Lower concerns beliefs were associated with a higher total score on the PAMQ [ß (SE)=-0.85 (0.24); CI -1.33--0.38]. Physicians scored a mean of 75 on the SDM-scale. CONCLUSIONS: A considerable part of the HCPs states they do not know the adherence of their patients, nor do they think patients discuss adherence with them. However, they feel to have knowledge of adherence and perceive to be able to influence adherence of their patients.

Assistive technology and self-rated health in comparison with age peers: a longitudinal study in 55-64-year-olds.

PURPOSE: To determine changes in self-rated health in comparison with age peers (SRH-AP) among 55-64-year-olds, as affected by (1) initiating, (2) ceasing, and (3) prolonging the use of assistive technology (AT). METHODS: Data included two national cohorts of 55-64-year-olds from the Longitudinal Aging Study Amsterdam (total N = 1968), with baseline cycles in 1992-93 and 2002-03 and 3-year follow-ups. The effect of AT use on SRH-AP was studied in analyses of variance for repeated measurements, adjusting for age and self-reported disability. RESULTS: Respondents using AT reported poorer SRH-AP than respondents not using AT. Over time disability increased for respondents prolonging and initiating AT use and decreased for respondents ceasing AT use. No major changes were seen in SRH-AP over time, except for a small improvement for respondents prolonging AT use. CONCLUSIONS: AT use had a negative influence on SRH-AP, but this influence subsided over time for prolonged AT use. Despite longitudinal changes in disability, there was a marked stability of SRH-AP over time which may be attributed to AT use. Implications for Rehabilitation Both the proportion of 55-64-year-olds using AT and the proportion reporting disability was significantly higher in the recent cohort as compared to the early cohort. 55-64-Year-olds not using AT rated their health compared with age peers (SRH-AP) better than those using AT. 55-64-Year-olds who prolonged the use of AT reported the poorest ratings of SRH-AP, but also showed the clearest improvement in SRH-AP, suggesting that the initial negative influence of AT use on SRH-AP may subside over time.

Adherence, exposure and patients' experiences with the use of erlotinib in non-small cell lung cancer.

PURPOSE: Erlotinib is an orally administered tyrosine kinase inhibitor used for treatment of non-small cell lung cancer. Understanding actual use of medication is essential for optimizing treatment conditions. METHODS: In this multicentre prospective observational study, patients starting erlotinib treatment were followed for 4 months. Adherence was assessed using a medication event monitoring system (MEMS). Area under the curve (AUC) was determined after 1, 2 and 4 months. Before start and at monthly intervals, patients filled out questionnaires about attitude towards medication and disease, quality of life, symptoms and use in daily practice. RESULTS: Sixty-two patients (median age 63.5 years, 53 % male) were included of whom 15 were still on treatment after 4 months. MEMS data of 55 patients revealed a mean adherence of 96.8 ± 4.0 %. Over one-third of patients had an adherence rate <95 %. At 1 month, 21 % of patients did not always correctly take erlotinib without food. Associated risk factors were older age, suboptimal adherence, ocular symptoms and stomatitis (all p < 0.05). After 1 month of treatment, fatigue (91 %) and rash (86 %) were the most common symptoms reported. AUCss of erlotinib was higher in patients with rash and patients with moderate-severe anorexia (both p < 0.05). CONCLUSION: Though adherence to erlotinib treatment is generally high, non-adherence might be an issue in a considerable number of patients. To support optimal erlotinib intake, clinicians need to take adequate measures to ameliorate symptoms and to address adherence and correct intake without food. Especially older patients and those who experience stomatitis may need extra attention.