Effectiveness of trauma-focused art therapy (TFAT) for psychological trauma: study protocol of a multiple-baseline single-case experimental design.

INTRODUCTION: Treatments such as eye movement desensitisation and reprocessing and (narrative) exposure therapies are commonly used in psychological trauma. In everyday practice, art therapy is also often used, although rigorous research on its efficacy is lacking. Patients seem to benefit from the indirect, non-verbal experiential approach of art therapy. This protocol paper describes a study to examine the effectiveness of a 10-week individual trauma-focused art therapy (TFAT) intervention. METHODS AND ANALYSIS: A mixed-methods multiple-baseline single-case experimental design will be conducted with 25-30 participants with psychological trauma. Participants will be randomly assigned to a baseline period lasting 3-5 weeks, followed by the TFAT intervention (10 weeks) and follow-up (3 weeks). Quantitative measures will be completed weekly: the Beck Depression Inventory-II, the Mental Health Continuum Short Form, the Resilience Scale, the Rosenberg Self-Esteem Scale and the Self-expression and Emotion Regulation in Art Therapy Scale. The Post-Traumatic Stress Disorder Checklist-5 will be completed at week 1 and week 10. Qualitative instruments comprise a semistructured interview with each individual patient and therapist, and a short evaluation for the referrer. Artwork will be used to illustrate the narrative findings. Quantitative outcomes will be analysed with linear mixed models using the MultiSCED web application. Qualitative analyses will be performed using thematic analysis with ATLAS.ti. ETHICS AND DISSEMINATION: This study has been approved by the ethics committee of the HAN University of Applied Sciences (ECO 394.0922). All participants will sign an informed consent form and data will be treated confidentially. Findings will be published open access in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05593302.

Factors associated with health status and exacerbations in COPD maintenance therapy with dry powder inhalers.

The study aimed to determine the associations of Peak Inspiratory Flow (PIF), inhalation technique and adherence with health status and exacerbations in participants with COPD using DPI maintenance therapy. This cross-sectional multi-country observational real-world study included COPD participants aged ≥40 years using a DPI for maintenance therapy. PIF was measured three times with the In-Check DIAL G16: (1) typical PIF at resistance of participant's inhaler, (2) maximal PIF at resistance of participant's inhaler, (3) maximal PIF at low resistance. Suboptimal PIF (sPIF) was defined as PIF lower than required for the device. Participants completed questionnaires on health status (Clinical COPD Questionnaire (CCQ)), adherence (Test of Adherence to Inhalers (TAI)) and exacerbations. Inhalation technique was assessed by standardised evaluation of video recordings. Complete data were available from 1434 participants (50.1% female, mean age 69.2 years). GOLD stage was available for 801 participants: GOLD stage I (23.6%), II (54.9%), III (17.4%) and IV (4.1%)). Of all participants, 29% had a sPIF, and 16% were shown able to generate an optimal PIF but failed to do so. sPIF was significantly associated with worse health status (0.226 (95% CI 0.107-0.346), worse units on CCQ; p = 0.001). The errors 'teeth and lips sealed around mouthpiece', 'breathe in', and 'breathe out calmly after inhalation' were related to health status. Adherence was not associated with health status. After correcting for multiple testing, no significant association was found with moderate or severe exacerbations in the last 12 months. To conclude, sPIF is associated with poorer health status. This study demonstrates the importance of PIF assessment in DPI inhalation therapy. Healthcare professionals should consider selecting appropriate inhalers in cases of sPIF.

Determinants and consequences of polypharmacy in patients with a depressive disorder in later life.

OBJECTIVES: Polypharmacy and late-life depression often congregate in the geriatric population. The primary objective is to identify determinants of polypharmacy in patients with depression, and second to examine polypharmacy in relation to various clinical phenotypes of depression and its course. METHODS: A longitudinal observational study using data of the Netherlands Study of Depression in Older persons (NESDO) including 375 patients with depression ≥ 60 years and 132 non-depressed comparisons. Linear and logistic regression were used to analyze both polypharmacy (dichotomous: ≥5 medications) and number of prescribed drugs (continuous) in relation to depression, various clinical phenotypes, and depression course. RESULTS: Polypharmacy was more prevalent among patients with depression (46.9%) versus non-depressed comparisons (19.7%). A lower level of education, lower cognitive functioning, and more chronic diseases were independently associated with polypharmacy. Adjusted for these determinants, polypharmacy was associated with a higher level of motivational problems, anxiety, pain, and an earlier age of onset. A higher number of drugs was associated with a worse course of late-life depression (OR = 1.24 [95% CI: 1.03-1.49], p = 0.022). CONCLUSION: Older patients with depression have a huge risk of polypharmacy, in particular among those with an early onset depression. As an independent risk factor for chronic depression, polypharmacy needs to be identified and managed appropriately. Findings suggest that depression moderates polypharmacy through shared risk factors, including motivational problems, anxiety, and pain. The complex interaction with somatic health burden requires physicians to prescribe medications with care.

Perceptions on Home-Administration of Biologics in the Context of Severe Asthma: An International Qualitative Study.

BACKGROUND: Biologics are an effective therapy for severe asthma. Home administration of biologics by patients is likely to facilitate their accessibility. Yet little is known about patients' and health care providers' (HCPs) perceptions regarding home administration of biologics. OBJECTIVE: The aim of this study is to create more insight into the perceptions and experiences of patients and HCPs regarding home administration of biologics in the context of the treatment of severe asthma. METHODS: A qualitative international study was performed in the Netherlands, United States, Australia, and United Kingdom. In each country, 2 focus groups were held with potential/recent and long-term users of biologics at home. Prior to the focus groups, patients were prompted with themes on online forums. For triangulation purposes, interviews were held with HCPs to discuss salient findings from forums and focus groups. Data were analyzed with qualitative content analysis. RESULTS: In total, 75 patients participated in the forums, of which 40 participated in the focus groups. Furthermore, 12 HCPs were interviewed. The following overarching themes were identified: living with severe asthma; practical aspects of using biologics; the role of HCPs regarding biologics; social support from family, friends, and others; effectiveness of biologics and other treatments; side effects of biologics. CONCLUSIONS: This study showed that, for those using biologics for severe asthma, the benefits of home administration of biologics usually outweigh inconvenience and side effects. Guided practice, accessible support contact, and monitoring including social support should be central in the transition from hospital to home administration of asthma biologics.

Anticholinergic and Sedative Medications and Dynamic Gait Parameters in Older Patients.

BACKGROUND: Anticholinergic and sedative medications are associated with poorer physical function in older age. Gait and physical function have traditionally been assessed with the time needed to execute objective function tests. Accelerometer-based gait parameters provide a precise capturing of gait dynamics and patterns and as such have added value. OBJECTIVES: This study examined the associations between cumulative exposure to anticholinergic and sedative medications and gait dimensions as assessed with accelerometer-based dynamic gait parameters. METHODS: Data were collected from outpatients of a diagnostic geriatric day clinic who underwent a comprehensive geriatric assessment (CGA). Cumulative exposure to anticholinergic and sedative medications was quantified with the Drug Burden Index (DBI), a linear additive pharmacological dose-response model. From a total of 22 dynamic gait parameters, the gait dimensions 'Regularity', 'Complexity', 'Stability', 'Pace', and 'Postural Control' were derived using factor analysis (and standardized total scores for these dimensions were calculated accordingly). Data were analyzed with multivariable linear regression analysis, in which adjustment was made for the covariates age, gender, body mass index (BMI), Mini Mental State Examination (MMSE) score, Charlson Comorbidity Index (CCI) including dementia, and number of medications not included in the DBI. RESULTS: A total of 184 patients participated, whose mean age was 79.8 years (± SD 5.8), of whom 110 (60%) were women and of whom 88 (48%) had polypharmacy (i.e., received treatment with ≥5 medications). Of the 893 medications that were prescribed in total, 157 medications (17.6%) had anticholinergic and/or sedative properties. Of the patients, 100 (54%) had no exposure (DBI = 0), 42 (23%) had moderate exposure (0 > DBI ≤ 1), while another 42 (23%) had high exposure (DBI >1) to anticholinergic and sedative medications. Findings showed that high cumulative exposure to anticholinergic and sedative medications was related with poorer function on the Regularity and Pace dimensions. Furthermore, moderate and high exposure were associated with poorer function on the Complexity dimension. CONCLUSIONS: These findings show that in older patients with comorbidities, cumulative anticholinergic and sedative exposure is associated with poorer function on multiple gait dimensions.

Online Consultations Between General Practitioners and Psychiatrists in the Netherlands: A Qualitative Study.

Objective: To examine the nature and scope of questions about psychiatric patient cases submitted by general practitioners (GPs) to an established online consultation platform and to determine if they could have been answered by consulting existing clinical guidelines. Methods: All anonymized psychiatric cases submitted by GPs to the online electronic Prisma platform between September 2018 and November 2019 were examined in a mixed-methods study. Descriptive statistics and qualitative thematic analysis were used, followed by axial coding to arrive at overarching themes to characterize cases. Results: Of the 136 included cases, 44.1% concerned female patients and about half concerned patients aged 31-60 years. Common psychiatric disorders were depression, attention deficit hyperactivity disorder, sleeping problems, sexual disorders, and eating disorders. The first response was usually given within 2 h (interquartile range, 0-14.3 h), with 86% answered within 24 h and 95% within 48 h. Qualitative analysis revealed four themes, namely "type of question," "cases in relation to current clinical guidelines," "case complexity" and "the doctor being pressured." Type of question comprised diagnostic, therapeutic, and referral questions. Notably, for 44.1% of questions no current clinical guidelines was present and 46.3% of cases were deemed complex in nature. GPs were willing to share their experiences of coping with being pressured by patients. Conclusion: The findings of this study support the potential for an online electronic consultation platform to facilitate feasible and useful interprofessional consultation between GPs and psychiatrists for a broad range mental illnesses and questions of varying complexity.

The Cognitive Online Self-Test Amsterdam (COST-A): Establishing norm scores in a community-dwelling population.

BACKGROUND: Heightened public awareness about Alzheimer's disease and dementia increases the need for at-home cognitive self-testing. We offered Cognitive Online Self-Test Amsterdam (COST-A) to independent groups of cognitively normal adults and investigated the robustness of a norm-score formula and cutoff. METHODS: Three thousand eighty-eight participants (mean age ± standard deviation = 61 ± 12 years, 70% female) completed COST-A and evaluated it. Demographically adjusted norm scores were the difference between expected COST-A scores, based on age, gender, and education, and actual scores. We applied the resulting norm-score formula to two independent cohorts. RESULTS: Participants evaluated COST-A to be of adequate difficulty and duration. Our norm-score formula was shown to be robust: ≈8% of participants in two cognitively normal cohorts had abnormal scores. A cutoff of -1.5 standard deviations proved optimal for distinguishing normal from impaired cognition. CONCLUSION: With robust norm scores, COST-A is a promising new tool for research and clinical practice, providing low cost and minimally invasive remote assessment of cognitive functioning.

Impact of PIF, Inhalation Technique and Medication Adherence on Health Status and Exacerbations in COPD: Protocol of a Real-World Observational Study (PIFotal COPD Study).

INTRODUCTION: Dry powder inhalers (DPIs), a commonly prescribed inhaler type for respiratory diseases, require patients to generate sufficient peak inspiratory flow (PIF) to ensure optimal drug delivery to the airways. Effectiveness of therapy also requires a good inhalation technique and adequate medication adherence. For patients with chronic obstructive pulmonary disease (COPD), recent studies conducted in tertiary care suggest that DPI users with suboptimal PIF have poorer COPD-related health status and increased exacerbation risk versus those with optimal PIF. The PIFotal study will investigate the impact of PIF, inhalation technique and medication adherence on patient-reported outcomes in patients with COPD in primary care using a DPI for their maintenance therapy. METHODS AND ANALYSIS: This cross-sectional observational study will assess 1200 patients (aged ≥ 40 years, diagnosed with COPD and using a DPI for COPD maintenance therapy for ≥ 3 months) from the Netherlands, Spain, Portugal, Poland, Greece and Australia. Assessments will consist of (1) PIF measurements (usual patient inhalation manoeuvre, maximal PIF against resistance of own inhaler, and maximal PIF against low resistance); (2) Clinical COPD Questionnaire (CCQ), COPD Assessment Test and Test of Adherence to Inhalers scores; and (3) video recordings of patient inhalation technique. Dependent variables include health status (CCQ score), number of self-reported exacerbations in previous 12 months, and healthcare resource utilisation in previous 6 months. Independent variables include PIF values, inhalation technique errors, medication adherence, and demographic and clinical characteristics. In the primary analysis, the mean difference in CCQ score between patients (1) with optimal/suboptimal PIF, (2) exhibiting/not exhibiting inhalation technique errors, and (3) adhering/not adhering to medication will be examined in a multivariable linear mixed model. ETHICS: The study protocol was approved by ethics committees/institutional review boards of all participating sites prior to enrolment; written informed consent was obtained from all study participants. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT04532853.

Association between sedentary time and cognitive function: A focus on different domains of sedentary behavior.

Studies which examined the association between sedentary behavior (SB) and cognitive function have presented equivocal findings. Mentally active/inactive sedentary domains may relate differently to cognitive function. We examined associations between SB and cognitive function, specifically focusing on different domains. Participants were recruited from the Nijmegen Exercise Study 2018 in the Netherlands. SB (h/day) was measured with the Sedentary Behavior Questionnaire. Cognitive function was assessed with a validated computer self-test (COST-A), and a z-score calculated for global cognitive function. Multivariate linear regression assessed associations between tertiles of sedentary time and cognitive function. Cognition tests were available from 2821 participants, complete data from 2237 participants (43% female), with a median age of 61 [IQR 52-67] and a mean sedentary time of 8.3 ± 3.2 h/day. In fully adjusted models, cognitive function was significantly better in participants with the highest total sedentary time (0.07 [95% CI 0.02-0.12], P = 0.01), work-related sedentary time (0.13 [95% CI 0.07-0.19], P < 0.001), and non-occupational computer time (0.07 [95% CI 0.02-0.12], P = 0.01), compared to the least sedentary. Leisure sedentary time and time spent sedentary in the domains TV, reading or creative time showed no association with cognitive function in final models (all P > 0.05). We found a strong, independent positive association between total SB and cognitive function in a heterogenous population. This relation was not consistent across different domains, with especially work- and computer-related SB being positively associated with cognitive function. This highlights the importance of assessing the various sedentary domains in understanding the relation between sedentary time and cognitive function.

Developing a clinical prediction rule for repeated consultations with functional somatic symptoms in primary care: a cohort study.

OBJECTIVES: Patients who present in primary care with chronic functional somatic symptoms (FSS) have reduced quality of life and increased health care costs. Recognising these early is a challenge. The aim is to develop and internally validate a clinical prediction rule for repeated consultations with FSS. DESIGN AND SETTING: Records from the longitudinal population-based ('Lifelines') cohort study were linked to electronic health records from general practitioners (GPs). PARTICIPANTS: We included patients consulting a GP with FSS within 1 year after baseline assessment in the Lifelines cohort. OUTCOME MEASURES: The outcome is repeated consultations with FSS, defined as ≥3 extra consultations for FSS within 1 year after the first consultation. Multivariable logistic regression, with bootstrapping for internal validation, was used to develop a risk prediction model from 14 literature-based predictors. Model discrimination, calibration and diagnostic accuracy were assessed. RESULTS: 18 810 participants were identified by database linkage, of whom 2650 consulted a GP with FSS and 297 (11%) had ≥3 extra consultations. In the final multivariable model, older age, female sex, lack of healthy activity, presence of generalised anxiety disorder and higher number of GP consultations in the last year predicted repeated consultations. Discrimination after internal validation was 0.64 with a calibration slope of 0.95. The positive predictive value of patients with high scores on the model was 0.37 (0.29-0.47). CONCLUSIONS: Several theoretically suggested predisposing and precipitating predictors, including neuroticism and stressful life events, surprisingly failed to contribute to our final model. Moreover, this model mostly included general predictors of increased risk of repeated consultations among patients with FSS. The model discrimination and positive predictive values were insufficient and preclude clinical implementation.

Drug Burden Index and Cognitive and Physical Function in Aged Care Residents: A Longitudinal Study.

OBJECTIVES: Anticholinergic/antimuscarinic and sedative medications (eg, benzodiazepines) have been found to be associated with poorer cognitive and physical function and mobility impairment in older age. However, previous studies were mostly conducted among community-dwelling older individuals and had often a cross-sectional design. Accordingly, our aim was to examine longitudinal associations between cumulative exposure to anticholinergic and sedative medications and cognitive and physical function among residents from aged care homes. DESIGN: Longitudinal study. SETTING AND PARTICIPANTS: A total of 4624 residents of Dutch aged care homes of whom data were collected between June 2005 and April 2014. METHODS: Outcome measures were collected with the Long-Term Care Facilities assessment from the international Residential Assessment Instrument (interRAI-LTCF) and included the Cognitive Performance Scale, the Activities of Daily Living (ADL) Hierarchy scale, a timed 4-meter walk test, distance walked, hours of physical activity, and days being outside. Cumulative exposure to anticholinergic and sedative medications was calculated with the Drug Burden Index (DBI), a linear additive pharmacological dose-response model. Associations were examined with linear mixed models to take the potential dependence of observations into account (ie, data were collected at repeated assessment occasions of residents who were clustered in aged care homes). Analyses were adjusted for sex, age, dementia, comorbidity (neurological, psychiatric, cardiovascular, oncological, and pulmonary), fractures, depressive symptoms, and medications excluded from the DBI. RESULTS: We observed significant longitudinal associations between a higher DBI and poorer ADLs, fewer hours of physical activity, and fewer days being outside. We found no significant longitudinal association between a higher DBI and poorer cognitive function. CONCLUSIONS AND IMPLICATIONS: Over time, cumulative exposure to anticholinergic and sedative medications is associated with poorer physical but not cognitive function in aged care residents. Careful monitoring of aged care residents with high cumulative anticholinergic and sedative medication exposure is needed.

Factors associated with workarounds in barcode-assisted medication administration in hospitals.

AIMS AND OBJECTIVES: To identify that workarounds (defined as "informal temporary practices for handling exceptions to normal procedures or workflow") by nurses using information technology potentially compromise medication safety. Therefore, we aimed to identify potential risk factors associated with workarounds performed by nurses in Barcode-assisted Medication Administration in hospitals. BACKGROUND: Medication errors occur during the prescribing, distribution and administration of medication. Errors could harm patients and be a tragedy for both nurses and medical doctors involved. Interventions to prevent errors have been developed, including those based on information technology. To cope with shortcomings in information technology-based interventions as Barcode-assisted Medication Administration, nurses perform workarounds. Identification of workarounds in information technology is essential to implement better-designed software and processes which fit the nurse workflow. DESIGN: We used the data from our previous prospective observational study, performed in four general hospitals in the Netherlands using Barcode techniques, to administer medication to inpatients. METHODS: Data were collected from 2014-2016. The disguised observation was used to gather information on potential risk factors and workarounds. The outcome was a medication administration with one or more workarounds. Logistic mixed models were used to determine the association between potential risk factors and workarounds. The STROBE checklist was used for reporting our data. RESULTS: We included 5,793 medication administrations among 1,230 patients given by 272 nurses. In 3,633 (62.7%) of the administrations, one or more workarounds were observed. In the multivariate analysis, factors significantly associated with workarounds were the medication round at 02 p.m.-06 p.m. (adjusted odds ratio [OR]: 1.60, 95% CI: 1.05-2.45) and 06 p.m.-10 p.m. (adjusted OR: 3.60, 95% CI: 2.11-6.14) versus the morning shift 06 a.m.-10 a.m., the workdays Monday (adjusted OR: 2.59, 95% CI: 1.51-4.44), Wednesday (adjusted OR: 1.92, 95% CI: 1.2-3.07) and Saturday (adjusted OR: 2.24, 95% CI: 1.31-3.84) versus Sunday, the route of medication, nonoral (adjusted OR: 1.28, 95% CI: 1.05-1.57) versus the oral route of drug administration, the Anatomic Therapeutic Chemical classification-coded medication "other" (consisting of the irregularly used Anatomic Therapeutic Chemical classes [D, G, H, L, P, V, Y, Z]) (adjusted OR: 1.49, 95% CI: 1.05-2.11) versus Anatomic Therapeutic Chemical class A (alimentary tract and metabolism), and the patient-nurse ratio ≥6-1 (adjusted OR: 5.61, 95% CI: 2.9-10.83) versus ≤5-1. CONCLUSIONS: We identified several potential risk factors associated with workarounds performed by nurses that could be used to target future improvement efforts in Barcode-assisted Medication Administration. RELEVANCE TO CLINICAL PRACTICE: Nurses administering medication in hospitals using Barcode-assisted Medication Administration frequently perform workarounds, which may compromise medication safety. In particular, nurse workload and the patient-nurse ratio could be the focus for improvement measures as these are the most clearly modifiable factors identified in this study.

Long-Term Exposure to Anticholinergic and Sedative Medications and Cognitive and Physical Function in Later Life.

BACKGROUND: Anticholinergic and sedative medications are frequently prescribed to older individuals. These medications are associated with short-term cognitive and physical impairment, but less is known about long-term associations. We therefore examined whether over 20 years cumulative exposure to these medications was related to poorer cognitive and physical functioning. METHODS: Older adult participants of the Longitudinal Aging Study Amsterdam (LASA) were followed from 1992 to 2012. On seven measurement occasions, cumulative exposure to anticholinergic and sedative medications was quantified with the drug burden index (DBI), a linear additive pharmacological dose-response model. Cognitive functioning was assessed with the Mini-Mental State Examination (MMSE), Alphabet Coding Task (ACT, three trials), Auditory Verbal Learning Test (AVLT, learning and retention condition), and Raven Colored Progressive Matrices (RCPM, two trials). Physical functioning was assessed with the Walking Test (WT), Cardigan Test (CT), Chair Stands Test (CST), Balance Test (BT), and self-reported Functional Independence (FI). Data were analyzed with linear mixed models adjusted for age, education, sex, living with a partner, BMI, depressive symptoms, comorbidities (cardiovascular disease, diabetes, cancer, COPD, osteoarthritis, CNS diseases), and prescribed medications. RESULTS: Longitudinal associations were found of the DBI with poorer cognitive functioning (less items correct on the three ACT trials, AVLT learning condition, and the two RCPM trials) and with poorer physical functioning (longer completion time on the CT, CST, and lower self-reported FI). CONCLUSIONS: This longitudinal analysis of data collected over 20 years, showed that higher long-term cumulative exposure to anticholinergic and sedative medications was associated with poorer cognitive and physical functioning.

Barriers and Facilitators of Conducting Medication Reviews in Nursing Home Residents: A Qualitative Study.

Objectives: Inappropriate medication prescribing is a recognized clinical problem in nursing home residents of whom many have polypharmacy. However, results about the effectiveness of medication reviews targeted at improving prescribing and deprescribing have been equivocal. We therefore examined barriers and facilitators of conducting medication reviews. Method: We purposively sampled medication reviews to capture salient barriers and facilitators of conducting medication reviews both in nursing home care units for dementia and disabling conditions. We held semi-structured interviews about consecutive steps of medication reviews. Interviews were transcribed verbatim and analyzed with the "method of constant comparison." Results: Six nursing home residents/relatives of nursing home residents, 8 elder care physicians, 5 pharmacists, and 10 nurses took part in the semi-structured interviews. We observed four overarching themes of barriers and facilitators: "realizing fidelity of the patient perspective (theme 1)," "level of comprehensiveness of medication reviews (theme 2)," "inclinations of healthcare providers (theme 3)," and "inter-professional collaboration and alliances (theme 4)." Theme 1 "realizing fidelity of the patient perspective" referred to the observation that assessing the patient perspective was a delicate balance between the value and the impediments of a proper assessment of the patient perspective. Theme 2 "level of comprehensiveness of medication reviews" reflected the struggle of practitioners to find an optimum between medication reviews being both comprehensive and feasible. Theme 3 "inclinations of healthcare providers" concerned setting intervention targets that were complementary to the practices of physicians and keeping the pharmacist blind to the patient perspective as a countermeasure to physicians' inclinations. Finally, theme 4 "inter-professional collaboration and alliances" highlighted mutual support and inter-professional collaboration to strengthen healthcare practitioners' contributions. Discussion: These themes of barriers and facilitators emphasize the need to improve meta-communication during the medication review process. This pertains to the need for healthcare providers to appraise the fidelity of the patient perspective in a dialogue with residents/relatives. Furthermore, discourse between healthcare practitioners is needed beforehand about the level of comprehensiveness intervention targets, and inter-professional collaboration.

Feasibility, acceptability and potential effectiveness of an information technology-based, pharmacist-led intervention to prevent an increase in anticholinergic and sedative load among older community-dwelling individuals.

BACKGROUND: Anticholinergic/sedative medications are frequently used by older people, despite their negative impacts on cognitive and physical function. We explore the feasibility, acceptability and potential effectiveness of an innovative information technology (IT)-based intervention to prevent an increase in anticholinergic/sedative load in older people. METHODS: This was a prospective study in 51 Dutch community pharmacies. Pharmacists used an IT-based tool to identify patients aged ⩾65 years, with existing high anticholinergic/sedative loads (drug burden index ⩾2) and a newly initiated anticholinergic/sedative medication. We determined the following. Feasibility: number of eligible patients identified. Acceptability: pharmacists' satisfaction with the intervention, pharmacists' time investment and patients' willingness to reduce medication use. Potential effectiveness: number of recommendations, rate of agreement of general practitioners (GPs) with proposed recommendations and factors associated with agreement. To evaluate the latter, pharmacists conducted medication reviews and proposed recommendations to GPs for 5-10 patients selected by the IT-based tool. RESULTS: We included 305 patients from 47 pharmacies. Feasibility: a mean of 17.0 (standard deviation, 8.8) patients were identified per pharmacy. Acceptability: 43 pharmacists (91.5%) were satisfied with the intervention. The median time investment per patient was 33 min (range 6.5-210). Of 35 patients, 30 (85.7%) were willing to reduce medication use. Potential effectiveness: pharmacists proposed 351 recommendations for 212 patients (69.5%). GPs agreed with recommendations for 108 patients (35.4%). Agreement to stop a medication was reached in 19.8% of recommendations for newly initiated medications (37 of 187) and for 15.2% of recommendations for existing medications (25 of 164). Agreement was more likely for recommendations on codeine [odds ratio (OR) 3.30; 95% confidence interval (CI) 1.14-9.57] or medications initiated by a specialist (OR 2.85; 95% CI 1.19-6.84) and less likely for pharmacies with lower level of collaboration with GPs (OR 0.15; 95% CI 0.02-0.97). CONCLUSION: This innovative IT-based intervention was feasible, acceptable and potentially effective. In one-third of patients an increase in anticholinergic/sedative load was prevented within reasonable time investment.

Distinct Profiles on Subjective and Objective Adherence Measures in Patients Prescribed Antidepressants.

OBJECTIVE: A recurrent observation is that associations between self-reported and objective medication adherence measures are often weak to moderate. Our aim was therefore to identify patients with different profiles on self-reported and objective adherence measures. STUDY DESIGN AND SETTING: This was an observational study of 221 community pharmacy patients who were dispensed antidepressants. Adherence profiles were estimated with Latent Profile Analysis (LPA) using data on self-reported adherence (Medication Adherence Rating Scale) complemented with data on medication beliefs (perceived necessity and concerns measured with the Beliefs about Medicines Questionnaire) and data from objective adherence measures (electronic monitoring of medication taking and the Medication Possession Ratio calculated from pharmacy dispensing data). RESULTS: 'Goodness-of-fit' statistics indicated the presence of three classes: "concordantly high adherent" (83%, high adherence on all measures), "concordantly suboptimal adherent" (11%, low adherence on all measures), and "discordant" (6%, high self-reported adherence but lower adherence on objective measures). CONCLUSION: Most patients had concordant outcomes on self-reported and objective measures of adherence. A small discordant class had high self-reported but low objective adherence. LPA will enable sensitivity analyses in future studies, for example excluding patients from the discordant class.

Anticholinergic and sedative medication use in older community-dwelling people: A national population study in the Netherlands.

PURPOSE: To identify the proportion of older adults with a high anticholinergic/sedative load and to identify patient subgroups based on type of central nervous system (CNS)-active medication used. METHODS: A cross-sectional study of a nationwide sample of patients with anticholinergic/sedative medications dispensed by 1779 community pharmacies in the Netherlands (90% of all community pharmacies) in November 2016 was conducted. Patients aged older than 65 years with a high anticholinergic/sedative load defined as having a drug burden index (DBI) greater than 1 were included. Proportion of patients with a high anticholinergic/sedative load was calculated by dividing the number of individuals in our study population by the 2.4 million older patients using medications dispensed from study pharmacies. Patient subgroups based on type of CNS-active medications used were identified with latent class analysis. RESULTS: Overall, 8.7% (209 472 individuals) of older adults using medications had a DBI greater than 1. Latent class analysis identified four patient subgroups (classes) based on the following types of CNS-active medications used: "combined psycholeptic/psychoanaleptic medication" (class 1, 57.9%), "analgesics" (class 2, 17.9%), "antiepileptic medication" (class 3, 17.8%), and "anti-Parkinson medication" (class 4, 6.3%). CONCLUSIONS: A large proportion of older adults in the Netherlands had a high anticholinergic/sedative load. Four distinct subgroups using specific CNS-active medication were identified. Interventions aiming at reducing the overall anticholinergic/sedative load should be tailored to these subgroups.

Non-adherence to antidepressants among older patients with depression: a longitudinal cohort study in primary care.

Background: Depression is common among older adults and is typically treated with antidepressants. Objective: To determine the non-adherence rates to antidepressants among older adults in primary care, based on non-initiation, suboptimal implementation or non-persistence. Methods: We selected all patients aged ≥60 years and diagnosed with depression in 2012, from the Netherlands Institute for Health Services Research (NIVEL) Primary Care Database. Non-initiation was defined as no dispensing within 14 days of the first prescription; suboptimal implementation, as fewer than 80% of the days covered by dispensed dosages; and non-persistence, as discontinuation within 294 days after first dispense. First, we determined the antidepressant non-initiation, suboptimal implementation and non-persistence rates. Second, we examined whether comorbidity and chronic drug use were associated with non-adherence by mixed-effects logistic regression (non-initiation or suboptimal implementation as dependent variables) and a clustered Cox regression (time to non-persistence). Results: Non-initiation, suboptimal implementation and non-persistence rates were 13.5%, 15.2% and 37.1%, respectively. As the number of chronically used drugs increased, the odds of suboptimal implementation (odds ratio, 0.89; 95% confidence interval, 0.83-0.95) and of non-persistence (hazard ratio, 0.87; 95% confidence interval, 0.82-0.92) reduced. Conclusions: Non-adherence to antidepressants is high among older patients with depression in primary care settings. Adherence is better when patients are accustomed to taking larger numbers of prescribed drugs, but this only provides partial explanation of the variance. GPs should be aware of the high rates of non-adherence. Emphasizing the importance of adhering to the optimal length of antidepressant therapy might be prudent first steps to improving adherence.

Non-adherence to cardiovascular drugs in older patients with depression: A population-based cohort study.

BACKGROUND: Depression is common among patients with cardiovascular disease and has been associated with both drug non-adherence and increased mortality. Non-adherence can occur because of non-initiation, suboptimal implementation, or non-persistence. We aimed to determine if depression increased the risk of any of these components of non-adherence among older patients prescribed cardiovascular drugs in primary care. METHODS: A longitudinal analysis of routine primary care data from the Nivel Primary Care Database was performed using data for 2011-2013. A total of 1512 patients aged ≥60 years diagnosed with depression in 2012 were compared with age- and sex-matched groups with either other psychological diagnoses (N = 1457) or mentally healthy controls (N = 1508), resulting in the inclusion of 4477 patients. Non-adherence was classified as non-initiation, suboptimal implementation, or non-persistence. Regression analyses were performed to determine the association between mental health status and non-initiation, suboptimal implementation, and non-persistence. RESULTS: Mixed-effects logistic regression analyses showed increased odds for suboptimal implementation of beta-blockers among depressed patients (2.18; 95% CI 1.29-3.69). For non-persistence, a clustered Cox regression analysis demonstrated that, compared with controls, there was an increased hazard ratio for depressed patients to discontinue beta-blockers (2.31; 95% CI 1.58-3.37) and calcium antagonists (1.74; 95% CI 1.23-2.46). CONCLUSIONS: It is likely that older patients in primary care diagnosed with depression are at increased risk of non-persistence with cardiovascular drug therapy. Because non-adherence is associated with increased cardiovascular mortality, it is important that physicians ensure that older depressed patients persevere with therapy.

Reducing the anticholinergic and sedative load in older patients on polypharmacy by pharmacist-led medication review: a randomised controlled trial.

OBJECTIVE: To evaluate if a pharmacist-led medication review is effective at reducing the anticholinergic/sedative load, as measured by the Drug Burden Index (DBI). DESIGN: Randomised controlled single blind trial. SETTING: 15 community pharmacies in the Northern Netherlands. PARTICIPANTS: 157 community-dwelling patients aged ≥65 years who used ≥5 medicines for ≥3 months, including at least one psycholeptic/psychoanaleptic medication and who had a DBI≥1. INTERVENTION: A medication review by the community pharmacist in collaboration with the patient's general practitioner and patient. PRIMARY AND SECONDARY OUTCOMES MEASURES: The primary outcome was the proportion of patients whose DBI decreased by at least 0.5. Secondary outcomes were the presence of anticholinergic/sedative side effects, falls, cognitive function, activities of daily living, quality of life, hospital admission and mortality. Data were collected at baseline and 3 months follow-up. RESULTS: Mean participant age was 75.7 (SD, 6.9) years in the intervention arm and 76.6 (SD, 6.7) years in the control arm, the majority were female (respectively 69.3% and 72.0%). Logistic regression analysis showed no difference in the proportion of patients with a≥0.5 decrease in DBI between intervention arm (17.3%) and control arm (15.9%), (OR 1.04, CI 0.47 to 2.64, p=0.927). Intervention patients scored higher on the Digit Symbol Substitution Test, measure of cognitive function (OR 2.02, CI 1.11 to 3.67, p=0.021) and reported fewer sedative side effects (OR 0.61, CI 0.40 to 0.94, p=0.024) at follow-up. No significant difference was found for other secondary outcomes. CONCLUSIONS: Pharmacist-led medication review as currently performed in the Netherlands was not effective in reducing the anticholinergic/sedative load, measured with the DBI, within the time frame of 3 months. Preventive strategies, signalling a rising load and taking action before chronic use of anticholinergic/sedative medication is established may be more successful. TRIAL REGISTRATION NUMBER: NCT02317666.