Dissatisfaction with opioid maintenance treatment partly explains reported side effects of medications.

BACKGROUND: Drop-out is a core problem in opioid maintenance treatment (OMT), but patients' reactions to and acceptance of the various OMT medications are insufficiently investigated. In Norway, there has been vocal patient resistance to the newest medication, buprenorphine-naloxone (BNX), and complaints have focused on the side effect profile. There has been no comparison of patient satisfaction and side effects of the three most common OMT medications. AIM: To compare patient satisfaction with OMT and side effects of BNX, buprenorphine monopreparate (BUP), and methadone (MET) as reported by patients. METHODS: Data were drawn from a national peer-to-peer survey developed by a patient advocacy group. The survey engaged more than 1000 OMT patients, corresponding to one seventh of OMT patients in Norway. The associations between side effects, treatment satisfaction, and patient characteristics were tested in multinomial logistic regressions. RESULTS: High patient satisfaction with OMT overall was reported despite lower satisfaction with medication itself and widely prevalent side effects. Among each medication group, dissatisfaction with medications or OMT in general along with poor health status increased the relative risk ratio of reporting the heaviest side effect burden. MET users reported the highest side effect burden and BNX users the lightest, but BNX users were more dissatisfied with their medication. CONCLUSIONS: Side effects are a concern for nearly all OMT patients, and they do not appear to accumulate with age or length of treatment. BNX users' dissatisfaction with their medication is of particular concern, and expectations and preferences of medication may be influencing their dissatisfaction.

[Expectation about maintenance therapy among the GINECO French ovarian cancer cohort from the European NOGGO/ENGOT-ov22 Expression IV survey]. / Attentes des patientes suivies pour un cancer de l'ovaire concernant les traitements d'entretien : résultats de la cohorte française GINECO de l'enquête européenne NOGGO/ENGOT-ov22 (Expression IV).

BACKGROUND: Expression IV survey evaluated the patients' expectations to a maintenance therapy. METHODS: From January 2015 to March 2016, 401 French patients, in first line or recurrent disease, answered a 24-items anonymous questionnaire. The results were specifically analyzed according to the demographic characteristics and treatment lines. RESULTS: Among the patients, 62% had already been informed about maintenance therapy. Thirty-seven percent of patients received a maintenance treatment: 111 patients during first line and 39 patients in relapse. Expectations of patients were: 1) the chance of cure (73%), 2) the tumor shrinkage (36%), 3) quality of life improvement (35%) and 4) tumor growth reduction (27%). Among the responders, 42% were willing to take the treatment for 6-24 months, 20% for 24-60 months and 38% until tumor progression. 64% of patients expected more than a 6 months progression-free survival. Patients older than 70 years were less informed than their younger counterparts (48% vs 66%) and had lesser hope for cure with maintenance treatment (60% vs 77%). Patients in relapse had more expectation than patients in remission (tumor shrinkage: 47% vs 22%, slowing of tumor growth: 37% vs 15%, improving the progression-free survival of more than 6 months: 71% vs 53%, respectively). Among patients, 48% in relapse consented to take a treatment until progression vs 24% of patients in remission. CONCLUSION: This sub-analysis in French patients demonstrate a gap between the efficacy of maintenance therapy and the patients' expectations in ovarian cancer, particularly in relapsing disease justifying better information and explanations.

Living with life-prolonging chemotherapy-control and meaning-making in the tension between life and death.

Chemotherapy, radiotherapy, hormone therapy and immune therapy have made many cancers chronic, potential curable diseases rather than inevitably fatal, but the treatments are often both mentally and physically stressful even if the side effects varies. The right use of palliative chemotherapy is a complex issue and there are many aspects to take into consideration. The aim of the study was to gain insight into the illness narratives of cancer patients, from the day they suspected that something was wrong up to the present day where they are living with incurable cancer, undergoing life-prolonging chemotherapy. Thirteen narrators were included. They were all cancer patients on chemotherapy with the intention of prolonging life (informed by their oncologist) in an outpatient's clinic in Norway. Narrative analyse of their illness stories was applied. The main findings showed that the narrators considered their lives worth living in spite of the treatment. They seemed to take control and build a new life on "what was left after the storm," and described how they found meaning living in the tension between life and death.

Adherence to Rectal Mesalamine in Patients with Ulcerative Colitis.

BACKGROUND: Rectal mesalamine is an effective induction and maintenance therapy for ulcerative colitis. Little is known about the adherence rates to rectal mesalamine or barriers to its use. The aim was to quantify the prevalence of nonadherence to rectal mesalamine and to identify patient-reported barriers to adherence. METHODS: A cohort of patients with ulcerative colitis was prospectively enrolled in this observational study and followed for 12 months. Adherence was assessed by tracking pharmacy refills (medication possession ratio). Individual interviews were undertaken in a subset of subjects. Transcripts from the focus groups and interviews were analyzed to identify themes and links between these themes using qualitative data software (MaxQDA). RESULTS: Seventy patients prescribed rectal mesalamine were prospectively enrolled in the study. At enrollment, 39 of 70 subjects (55%) self-reported "occasional nonadherence" to rectal mesalamine. Over the 12-month follow-up period, only 20 subjects (26%) completed 3 or more refills. Males, or subjects prescribed a once-a-day suppository, were significantly more likely to refill than females (odds ratio = 3.3, 95% confidence interval, 1.1-10.9) or those prescribed suppositories more than once a day (odds ratio = 1.3, 95% confidence interval, 1.1-1.7). By medication possession ratio criteria, 71% of all subjects were nonadherent with their prescribed regimen (medication possession ratio <0.6). Nonadherers were significantly older than adherent subjects: mean age 48 years in nonadherers, versus 37 in adherers, P = 0.04. Patients who were nonadherent to rectal mesalamine frequently cited the mode of administration (65%) and busy lifestyle (40%) as reasons for nonadherence. CONCLUSIONS: Intentional nonadherence is common in patients who have been prescribed rectal mesalamine. Gender, age, frequency of dosing, and lifestyle factors may impact adherence.

[Maintenance chemotherapy: futility or utility?]. / Chimiothérapie de maintenance: futile ou utile?

In incurable diseases, maintenance therapy aims to prolong the response achieved through induction. The goal is to delay disease progression, thus prolonging survival. Two maintenance modalities are used. The first, called continuation maintenance, consists of continuing the same agent used in the initial treatment. The second, called switch-maintenance, introduces an early second line drug immediately after induction. Proving the superiority of a maintenance strategy implies a better outcome with the maintenance compared to the same therapeutic agent used upon disease progression. This benefit may be observed in terms of overall survival and/or quality of life.

Attitudes to mesalamine questionnaire: a novel tool to predict mesalamine nonadherence in patients with IBD.

OBJECTIVES: Poor adherence to mesalamine is common and driven by a combination of lifestyle and behavioral factors, as well as health beliefs. We sought to develop a valid tool to identify barriers to patient adherence and predict those at risk for future nonadherence. METHODS: A 10-item survey was developed from patient-reported barriers to adherence. The survey was administered to 106 patients with ulcerative colitis who were prescribed mesalamine, and correlated with prospectively collected 12-month pharmacy refills (medication possession ratio (MPR)), urine levels of salicylates, and self-reported adherence (Morisky Medication Adherence Scale (MMAS)-8). RESULTS: From the initial 10-item survey, 8 items correlated highly with the MMAS-8 score at enrollment. Computer-generated randomization produced a derivation cohort of 60 subjects and a validation cohort of 46 subjects to assess the survey items in their ability to predict future adherence. Two items from the patient survey correlated with objective measures of long-term adherence: their belief in the importance of maintenance mesalamine even when in remission and their concerns about side effects. The additive score based on these two items correlated with 12-month MPR in both the derivation and validation cohorts (P<0.05). Scores on these two items were associated with a higher risk of being nonadherent over the subsequent 12 months (relative risk (RR) =2.2, 95% confidence interval=1.5-3.5, P=0.04). The area under the curve for the performance of this 2-item tool was greater than that of the 10-item MMAS-8 score for predicting MPR scores over 12 months (area under the curve 0.7 vs. 0.5). CONCLUSIONS: Patients' beliefs about the need for maintenance mesalamine and their concerns about side effects influence their adherence to mesalamine over time. These concerns could easily be raised in practice to identify patients at risk of nonadherence (Clinical Trial number NCT01349504).

Association between depression and maintenance medication adherence among Medicare beneficiaries with chronic obstructive pulmonary disease.

OBJECTIVE: Depression is a significant comorbidity in patients with chronic obstructive pulmonary disease (COPD). Although comorbid depression is associated with low use and poor adherence to medications treating other chronic conditions, evidence of the relationship between depression and COPD management is limited. This study estimated the association between depression and COPD maintenance medication (MM) adherence among patients with COPD. METHODS: This cross-sectional study used a 5% random sample of 2006-2007 Chronic Condition Warehouse data. Medicare beneficiaries enrolled in Parts A, B, and D plans with diagnosed COPD who survived through 2006 were included (n = 74,863). COPD MM adherence was measured as medication discontinuation and proportion of days covered (PDC). Depression was identified through the International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes. Multivariable models with modified generalized estimating equations were used to estimate adjusted association between depression diagnosis and medication adherence, controlling for sociodemographics, comorbidities, and disease severity. RESULTS: Among the sample, about one third (33.6%) had diagnosed depression. More than half (61.8%) of beneficiaries with COPD filled at least one COPD MM prescription. Depressed beneficiaries had a higher likelihood of using COPD MM than non-depressed beneficiaries (adjusted prevalence ratios [PR] = 1.02; 95% confidence intervals [CI] = 1.01, 1.03). Among COPD MM users, depressed beneficiaries were more likely to discontinue medications (PR = 1.09; 95% CI = 1.04, 1.14) and less likely to exhibit PDC ≥ 0.80 (PR = 0.89; 95% CI = 0.86, 0.92) than non-depressed beneficiaries. CONCLUSIONS: Depression is prevalent in Medicare beneficiaries with COPD and independently associated with lower COPD MM adherence. Interventions to improve medication adherence for COPD patients may consider management of comorbidities such as depression.

Effectiveness of financial incentives to improve adherence to maintenance treatment with antipsychotics: cluster randomised controlled trial.

OBJECTIVE: To test whether offering financial incentives to patients with psychotic disorders is effective in improving adherence to maintenance treatment with antipsychotics. DESIGN: Cluster randomised controlled trial. SETTING: Community mental health teams in secondary psychiatric care in the United Kingdom. PARTICIPANTS: Patients with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder, who were prescribed long acting antipsychotic (depot) injections but had received 75% or less of the prescribed injections. We randomly allocated 73 teams with a total of 141 patients. Primary outcome data were available for 35 intervention teams with 75 patients (96% of randomised) and for 31 control teams with 56 patients (89% of randomised). INTERVENTIONS: Participants in the intervention group were offered £15 (€17; $22) for each depot injection over a 12 month period. Participants in the control condition received treatment as usual. MAIN OUTCOME MEASURE: The primary outcome was the percentage of prescribed depot injections given during the 12 month intervention period. RESULTS: 73 teams with 141 consenting patients were randomised, and outcomes were assessed for 131 patients (93%). Average baseline adherence was 69% in the intervention group and 67% in the control group. During the 12 month trial period adherence was 85% in the intervention group and 71% in the control group. The adjusted effect estimate was 11.5% (95% confidence interval 3.9% to 19.0%, P=0.003). A secondary outcome was an adherence of ≥ 95%, which was achieved in 28% of the intervention group and 5% of the control group (adjusted odds ratio 8.21, 95% confidence interval 2.00 to 33.67, P=0.003). Although differences in clinician rated clinical improvement between the groups failed to reach statistical significance, patients in the intervention group had more favourable subjective quality of life ratings (ß=0.71, 95% confidence interval 0.26 to 1.15, P=0.002). The number of admissions to hospital and adverse events were low in both groups and did not show substantial differences. CONCLUSION: Offering modest financial incentives to patients with psychotic disorders is an effective method for improving adherence to maintenance treatment with antipsychotics. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77769281.

Sertindole in the long-term treatment of schizophrenia.

This study assessed the safety and tolerability of sertindole in the long-term treatment of schizophrenia. An open-label, noncomparative, flexible-dose study was carried out in 11 European countries. Upon completion of an 8-week, haloperidol-referenced randomized clinical trial with sertindole, patients were offered sertindole maintenance treatment up to 18 months. In total, 294 patients were enrolled, of whom 237 (81%) had received sertindole and 57 (19%) had received haloperidol in the lead-in trial. The modal dose during the maintenance period was 16 mg/day. Patients showed therapeutic improvement indicated by significant decreases in the Positive And Negative Syndrome Scale and Clinical Global Impression 'severity-of-illness' scores. An adverse event was the primary reason for withdrawal in 13% of patients. The most common adverse events were fatigue and weight gain, both with incidences of 14%. The incidence of extrapyramidal symptoms was 18%, and 11% of the patients required anticholinergic medication. No statistically significant changes were observed in laboratory values or vital signs, but the mean serum prolactin levels decreased. The mean change in weight from baseline to the last assessment was 2.7 kg. The largest weight increase was observed in patients who were underweight at baseline. Long-term treatment with sertindole was safe and well tolerated, and patients showed clinical improvement beyond acute treatment.

[Patients' beliefs about long-term glucocorticoid therapy and their association to treatment adherence]. / Le ressenti des patients vis-à-vis d'une corticothérapie orale prolongée influence l'adhérence déclarée à ce traitement.

BACKGROUND: In patients treated with systemic glucocorticoids (GCs), it is unknown if beliefs about the treatment are associated with level of reported adherence. PATIENTS AND METHODS: Cross-sectional study conducted in two departments of internal medicine during a six-month period. All patients receiving long-term GCs therapy were asked to fill in a questionnaire regarding their beliefs about (specific scale of the Beliefs about Medicines Questionnaire) and their adherence to (four-item Morisky-Green scale) GCs. Logistic regression analysis was used to assess association between beliefs about GCs and adherence to treatment. RESULTS: One hundred and eighty one questionnaires were analysed (women: 79%, median age [IQR]: 47 [33-61] years, median duration of treatment: 18 [7-72] months, median daily dosage of prednisone equivalent: 10 [6-20] mg). Among these 181 patients, 83 (46%) reported a "concern" score equal to or higher than the "necessity" score. Nineteen percent of patients reported a low adherence level. In multivariate analysis, these patients were significantly younger (OR: 0.96 [0.93-0.98] per increasing year of age, P=0.002) and reported more frequently a "concern" score higher than a "necessity" score (OR: 3.08 [1.27-7.46], P=0.01) as compared to patients reporting a high adherence level. CONCLUSION: Informing patients about the "necessity" of GCs and taking into account their "concerns" about adverse events or their fear of becoming dependent on the medication may improve their adherence to treatment.