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Background As populations are aging, a growing number of home care clients are frail and use multiple, complex medications. Combined with the lack of coordination of care this may pose uncontrolled polypharmacy and potential patient safety risks. The aim of this study was to assess the impact of a care coordination intervention on medication risks identified in drug regimens of older home care clients over a one-year period. Methods Two-arm, parallel, cluster randomized controlled trial with baseline and follow-up assessment at 12 months. The study was conducted in Primary Care in Lohja, Finland: all 5 home care units, the public healthcare center, and a private community pharmacy. Participants: All consented home care clients aged > 65 years, using at least one prescription medicine who were assessed at baseline and at 12 months. Intervention: Practical nurses were trained to make the preliminary medication risk assessment during home visits and report findings to the coordinating pharmacist. The coordinating pharmacist prepared the cases for the triage meeting with the physician and home care nurse to decide on further actions. Each patient’s physician made the final decisions on medication changes needed. Outcomes were measured as changes in medication risks: use of potentially inappropriate medications and psychotropics; anticholinergic and serotonergic load; drug-drug interactions. Results Participants (n = 129) characteristics: mean age 82.8 years, female 69.8%, mean number of prescription medicines in use 13.1. The intervention did not show an impact on the medication risks between the original intervention group and the control group in the intention to treat analysis, but the per protocol analysis indicated tendency for effectiveness, particularly in optimizing central nervous system medication use. Half (50.0%) of the participants with a potential need for medication changes, agreed on in the triage meeting, had none of the medication changes actually implemented. Conclusion The care coordination intervention used in this study indicated tendency for effectiveness when implemented as planned. Even though the outcome of the intervention was not optimal, the value of this paper is in discussing the real world experiences and challenges of implementing new practices in home care. Trial registration ClinicalTrials.gov (NCT02545257). Registered September 9 2015.

Background and Aims Presence of sleep‐disordered breathing (SDB) and especially obstructive sleep apnea (OSA) is a known risk factor for ischemic stroke. Additionally, SDB effects negatively on recovery after stroke. Up to one fourth of strokes are present on awakening. The link between OSA and wake‐up stroke (WUS) has been suggested. We aim to determine the association between OSA and WUS in a Finnish stroke unit cohort. Material and Methods An observational prospective longitudinal study consisted of 95 TIA (transient ischemic attack) and mild to moderate stroke patients referred to a Stroke Unit in Finland. Respiratory polygraphy was performed within 72 h of hospital admission. Patients were classified into WUS and non‐WUS, and functional outcome measures (mRS, rehabilitation, hospitalization time) were collected. Functional outcomes and prevalence of OSA were compared between non‐WUS and WUS. Results OSA (AHI > 15/h) was more frequent among WUS than non‐WUS (71% and 36%, respectively, p = 0.009). Functional outcome measured with mRS was worse in patients with WUS than non‐WUS on registration day and at hospital discharge (p = 0.001). Need for rehabilitation in WUS was 43% of cases compared to 23% of non‐WUS (p = 0.067). Hospitalization time was longer (5–15days) in 55% of WUS and 41% of non‐WUS patients (p = 0.261). Conclusion Moderate‐to‐severe OSA is related to WUS compared to non‐WUS. In addition, WUS have worse short‐term outcomes measured in mRS. Further studies are needed to determine if OSA is causally linked to WUS., The aim of this observational longitudinal study is to determine the relationship between WUS and OSA .We conclude that the proportion of moderate to severe OSA is higher stroke and TIA patients with WUS compared to patients with non‐WUS. WUS have worse short‐term outcomes measured in mRS. Further studies are needed to determine if OSA is causally linked to WUS.

Ercan Celikkayalar,1 Marja Airaksinen,1 Sirkka-Liisa Kivelä,1,2 Jenni Nieminen,1 Jenni Kleme,1 Juha Puustinen1,3,4 1Clinical Pharmacy Group, Division of Pharmacology and Pharmacotherapy, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland; 2Unit of Family Medicine, Department of Clinical Medicine, Faculty of Medicine, University of Turku, Turku, Finland; 3Social Security Center of Pori, Pori, Finland; 4Unit of Neurology, Satasairaala Central Hospital, Pori, FinlandCorrespondence: Ercan Celikkayalar Email eacelikkayalar@gmail.comPurpose: The use of benzodiazepines and related drugs (BZD) is common among older adults although there is growing evidence of their harmful effects. This study investigated how well older people are aware of the potential risks related to the BZD they are taking and whether the risk awareness has changed in the years between 2004 and 2015.Patients and Methods: The data were collected by interviewing BZD using home-dwelling patients aged ≥ 65 years with normal cognitive function (MMSE ≥ 20) who were admitted to the hospital within a 1 month study period in the years 2004 and 2015. Patients were asked whether they were aware of the ten main potential risks related to BZD use. A risk awareness score (range 0– 10) was assessed for each patient, each known potential risk yielding one point.Results: The study included 37 patients in 2004 and 31 patients in 2015. In 2004, 6/37 patients (16%), while 16/31 patients (52%) in 2015 had risk awareness scores between 6 and 10. Awareness of dependence (p=0.047), interaction with alcohol (p=0.001), dizziness (p=0.002) and developing tolerance (p=0.002) had improved, while awareness of the other potential risks remained unchanged, muscle weakness being the least known (3/37 in 2004 and 4/31 in 2015 were aware of it as a potential risk). Regular BZD use had declined (p=0.043) but pro re nata (PRN; when required) BZD use had increased (p=0.003) between the years 2004 and 2015.Conclusion: Older BZD users’ awareness of some potential risks related to BZD use (dependence, interaction with alcohol, dizziness and developing tolerance) had improved between 2004 and 2015, while awareness of other potential risks remained unchanged.Keywords: benzodiazepines, risk awareness, potentially inappropriate medications, insomnia, aged, interview

Objectives Presence of sleep-disordered breathing (SDB) affects negatively recovery from stroke. The aim of this study is to evaluate the relationships between sleep-disordered breathing (SDB) and outcome measures in Finnish stroke unit cohort: mRS, need of rehabilitation and hospitalization time. Material and Methods An observational longitudinal study consisted of 95 patients referred to the Stroke Unit of Satakunta Hospital District over a period of November 2013 to March 2016. Patients were tested for SDB within 72 hr from the hospital admission because of ischemic stroke or TIA. The patients underwent polysomnography with NOX T3 wireless recorder. Results There are 37% (n = 35) non-OSA patients, 20% (n = 19) of patients have mild obstructive sleep apnea (OSA) and 39% (n = 37) have moderate/severe OSA and 4% (n = 4) have CSA. Patients with OSA have higher proportion of disability scores of mRS 3-5 (38%) compared to non-OSA (11%) and mild OSA (5%) patients on registration day (mRS0), and the same trend is seen at hospital discharge 35% versus 9% and 5%. (p = .009). Proportion of patients with OSA who needed rehabilitation is 65% (n = 19) versus non-OSA patients 17.5% (n = 4) and mild OSA patients 17.5% (n = 4;p = .039). We observed longer duration of hospitalization (5-15 days) in 29% of OSA patients compared to mild OSA patients 47% and OSA patients 54%. (p = .045). Conclusion Ischemic stroke patients with OSA have higher disability, higher need of rehabilitation, and longer hospitalization length. Prescreening tools for recognizing these stroke patients in acute phase could be valuable. That could result in earlier initiation of treatment and might prevent worse recovery from stroke.

Background Lyme neuroborreliosis (LNB) is often treated with intravenous ceftriaxone even if doxycycline is suggested to be noninferior to ceftriaxone. We evaluated the efficacy of oral doxycycline in comparison to ceftriaxone in the treatment of LNB. Methods Patients with neurological symptoms suggestive of LNB without other obvious reasons were recruited. The inclusion criteria were (1) production of Borrelia burgdorferi–specific antibodies in cerebrospinal fluid (CSF) or serum; (2) B. burgdorferi DNA in the CSF; or (3) an erythema migrans during the past 3 months. Participants were randomized in a 1:1 ratio to receive either oral doxycycline 100 mg twice daily for 4 weeks, or intravenous ceftriaxone 2 g daily for 3 weeks. The participants described their subjective condition with a visual analogue scale (VAS) from 0 to 10 (0 = normal; 10 = worst) before the treatment, and 4 and 12 months after the treatment. The primary outcome was the change in the VAS score at 12 months. Results Between 14 September 2012 and 28 December 2017, 210 adults with suspected LNB were assigned to receive doxycycline (n = 104) or ceftriaxone (n = 106). The per-protocol analysis comprised 82 patients with doxycycline and 84 patients with ceftriaxone. The mean change in the VAS score was −3.9 in the doxycycline group and −3.8 in the ceftriaxone group (mean difference, 0.17 [95% confidence interval, −.59 to .92], which is within the prespecified equivalence margins of −1 to 1 units). Participants in both groups improved equally. Conclusions Oral doxycycline is equally effective as intravenous ceftriaxone in the treatment of LNB. Clinical Trials Registration NCT01635530 and EudraCT 2012-000313-37.

The magnitude of safety risks related to medications of the older adults has been evidenced by numerous studies, but less is known of how to manage and prevent these risks in different health care settings. The aim of this study was to coordinate resources for prospective medication risk management of home care clients ≥ 65 years in primary care and to develop a study design for demonstrating effectiveness of the procedure. Health care units involved in the study are from primary care in Lohja, Southern Finland: home care (191 consented clients), the public healthcare center, and a private community pharmacy. System based risk management theory and action research method was applied to construct the collaborative procedure utilizing each profession’s existing resources in medication risk management of older home care clients. An inventory of clinical measures in usual clinical practice and systematic review of rigorous study designs was utilized in effectiveness study design. The new coordinated medication management model (CoMM) has the following 5 stages: 1) practical nurses are trained to identify clinically significant drug-related problems (DRPs) during home visits and report those to the clinical pharmacist. Clinical pharmacist prepares the cases for 2) an interprofessional triage meeting (50–70 cases/meeting of 2 h) where decisions are made on further action, e.g., more detailed medication reviews, 3) community pharmacists conduct necessary medication reviews and each patients’ physician makes final decisions on medication changes needed. The final stages concern 4) implementation and 5) follow-up of medication changes. Randomized controlled trial (RCT) was developed to demonstrate the effectiveness of the procedure. The developed procedure is feasible for screening and reviewing medications of a high number of older home care clients to identify clients with severe DRPs and provide interventions to solve them utilizing existing primary care resources. The study is registered in the Clinical Trials.gov ( NCT02545257 ). Registration date September 9 2015.

Background: Home care (HC) clients are increasingly older, have many chronic diseases, and use multiple medicines and thus are at high risk for drug-related problems (DRPs). Objective: Establish the sensitivity of practical nurse (PN) administered DRP risk assessment tool (DRP-RAT) compared with geriatrician’s assessment of the medical record. Identify the clinically most significant DRPs needing action. Methods: Twenty-six PNs working in HC of Härkätie Health Center in Lieto, Finland, 46 HC clients (≥65 years), and a geriatrician participated in this pilot study. The geriatrician reviewed HC clients’ medications using 3 different methods. The reviews were based on the following: (1) the PN’s risk screening (ie, PN-completed DRP-RAT) and medication list, (2) health center’s medical records, and (3) methods 1 and 2 together. The main outcome was the number of “at-risk patients” (ie, the patient is at risk of clinically significant DRPs) by using each review method. Secondary outcomes were clinically most significant DRP-risk predicting factors identified by the geriatrician. Results: The geriatrician reviewed 45 clients’ medications using all 3 methods. Based on PN-completed DRP-RAT and medication list, 93% (42/45) of the clients were classified as “at-risk patients.” Two other review methods resulted in 45/45 (100%) “at-risk patients.” Symptoms suggestive of adverse drug reactions were the most significant risk predicting factors. Small sample size limits the generalizability of the results. Conclusions: The PN-completed DRP-RAT was able to provide clinically important timely patient information for clinical decision making. DRP-RAT could make it possible to more effectively involve PNs in medication risk management among older HC clients.

Background: Clinical characterization of motion in patients with Parkinson disease (PD) is challenging: symptom progression, suitability of medication, and level of independence in the home environment can vary across time and patients. Appointments at the neurological outpatient clinic provide a limited understanding of the overall situation. In order to follow up these variations, longer-term measurements performed outside of the clinic setting could help optimize and personalize therapies. Several wearable sensors have been used to estimate the severity of symptoms in PD; however, longitudinal recordings, even for a short duration of a few days, are rare. Home recordings have the potential benefit of providing a more thorough and objective follow-up of the disease while providing more information about the possible need to change medications or consider invasive treatments. Objective: The primary objective of this study is to collect a dataset for developing methods to detect PD-related symptoms that are visible in walking patterns at home. The movement data are collected continuously and remotely at home during the normal lives of patients with PD as well as controls. The secondary objective is to use the dataset to study whether the registered medication intakes can be identified from the collected movement data by looking for and analyzing short-term changes in walking patterns. Methods: This paper described the protocol for an observational case-control study that measures activity using three different devices: (1) a smartphone with a built-in accelerometer, gyroscope, and phone orientation sensor, (2) a Movesense smart sensor to measure movement data from the wrist, and (3) a Forciot smart insole to measure the forces applied on the feet. The measurements are first collected during the appointment at the clinic conducted by a trained clinical physiotherapist. Subsequently, the subjects wear the smartphone at home for 3 consecutive days. Wrist and insole sensors are not used in the home recordings. Results: Data collection began in March 2018. Subject recruitment and data collection will continue in spring 2019. The intended sample size was 150 subjects. In 2018, we collected a sample of 103 subjects, 66 of whom were diagnosed with PD. Conclusions: This study aims to produce an extensive movement-sensor dataset recorded from patients with PD in various phases of the disease as well as from a group of control subjects for effective and impactful comparison studies. The study also aims to develop data analysis methods to monitor PD symptoms and the effects of medication intake during normal life and outside of the clinic setting. Further applications of these methods may include using them as tools for health care professionals to monitor PD remotely and applying them to other movement disorders. Trial Registration: ClinicalTrials.gov NCT03366558; https://clinicaltrials.gov/ct2/show/NCT03366558 International Registered Report Identifier (IRRID): DERR1-10.2196/12808

Long-term use of benzodiazepines or benzodiazepine receptor agonists is widespread, although guidelines recommend short-term use. Only few controlled studies have characterized the effect of discontinuation of their chronic use on sleep and quality of life. We studied perceived sleep and quality of life in 92 older (age 55-91 years) outpatients with primary insomnia before and after withdrawal from long-term use of zopiclone, zolpidem or temazepam (BZDA). BZDA was withdrawn during 1 month, during which the participants received psychosocial support and blindly melatonin or placebo. A questionnaire was used to study perceived sleep and quality of life before withdrawal, and 1 month and 6 months later. 89 participants completed the 6-month follow-up. As melatonin did not improve withdrawal, all participants were pooled and then separated based solely on the withdrawal results at 6 months (34 Withdrawers. 55 Nonwithdrawers) for this secondary analysis. At 6 months, the Withdrawers had significantly (P

Background: Studies on persistence of benzodiazepine agonist (BZDA) withdrawal in older outpatients are few, and few studies on long-term persistence over years have yet been published. To describe the persistence of temazepam, zolpidem, and zopiclone (BZDA) withdrawal among older outpatients at 3 years from the beginning of withdrawal, as well as any changes in use of other medications. Methods: 92 outpatients (>= 55 years) with primary insomnia, long-term BZDA use as hypnotics (mean duration of BZDA use 9.9 +/- 6.2 years), and willingness to withdraw from BZDAs each received either melatonin or a placebo nightly for one month. During this period, BZDAs were meant to be gradually withdrawn. Sleep hygiene counselling and psychosocial support were provided. Three years later, use of BZDAs and other medications was determined by interview and confirmed from medical records. Results: Of the original 92 outpatients, 83 (90%) participated in the 3-year survey (mean follow-up 3.3 +/- 0.2 years). The number of BZDA-free participants decreased from 34 (37%) at 6 months to 26 (28%; intention-to-treat) at 3 years, that of irregular BZDA users decreased from 44 (48%) at 6 months to 27 (29%) at 3 years, while that of regular users increased from 11 (12%) at 6 months to 30 (33%) at 3 years (P = 0.001). Those who were regular BZDA users at 3 years had at baseline (before withdrawal) higher BMI (P = 0.001) than did other participants. At 3 years, the total number of medications remained unchanged for non-users (P = 0.432), but increased for the irregular (P = 0.011) and regular users (P = 0.026) compared to baseline. At 3 years, compared to baseline, use of antidepressants, dopamine agonists, melatonin, and NSAIDs/paracetamol was significantly more common in the whole cohort, but their use did not differ between the BZDA-user subgroups. Randomization to melatonin or placebo during BZDA withdrawal was unrelated to BZDA-withdrawal result. Conclusions: At 3 years after withdrawal, the number of BZDA-free participants had decreased, but still one-third of the subjects remained BZDA-free, and one-third had reduced their use. Successful BZDA withdrawal did not lead to any increase in total number of medications; use of symptomatic medications in the whole cohort, however, did increase.

Objectives Sleep‐Disordered Breathing (SDB) is frequent in stroke patients. Polysomnography (PSG) and cardiorespiratory polygraphy are used to confirm SDB, but the need for PSG exceeds the available resources for systematic testing. Therefore, a simple and robust pre‐screening instrument is necessary to identify the patients with an urgent need for a targeted PSG. The aim of this systematic review was to identify and evaluate the available methods to pre‐screen stroke patients possibly suffering from SDB. Materials and Methods Eleven studies out of 3,561 studies met the inclusion criteria. The selected studies assessed the efficiency of seven instruments based on the data acquired clinically or by inquiries (Berlin Questionnaire, Epworth Sleepiness Scale, SOS, Modified Sleep Apnea Scale of the Sleep Disorders Questionnaire, STOP‐BANG, Four‐variable Screening Tool and Multivariate Apnea Index) and three physiological measures (capnography, nocturia, nocturnal oximetry). The instruments were used to predict SDB in patients after acute or subacute stroke. Either PSG or cardiorespiratory polygraphy was used as a standard to measure SDB. Results No independent studies using the same questionnaires, methods or criteria were published reducing generalizability. Overall, the questionnaires were quite sensitive in finding SDB but not highly specific in identifying the non‐affected. The physiological measures (capnography) indicated promising results in predicting SDB, but capnography is not an ideal pre‐screening instrument as it requires a specialist to interpret the results. Conclusions The results of pre‐screening of SDB in acute and subacute stroke patients are promising but inconsistent. The current pre‐screening methods cannot readily be referred to clinicians in neurologic departments. Thus, it is necessary to conduct more research on developing novel pre‐screening methods for detecting SDB after stroke.

summary Background: Recent epidemiologic studies have shown that the use of psychotropics is associated with many symptoms and may result in dependence and tolerance among elderly individuals. The aim of this study was to describe the symptoms related to withdrawal or dose reduction of long-term benzodiazepine (BZD) or BZD-related drugs (RDs) use and to compare them with nonuse of these drugs in community-dwelling individuals aged 65 and older. Methods: The study was a post hoc analysis embedded in a 12-month randomized, controlled fallprevention trial that included withdrawal of BZDs and RDs. The participants (n ¼ 248) in the intervention group were divided into the following four groups according to their use of BZDs/RDs at baseline and follow-up: (1) withdrawal (WG), (2) reduction (RG), (3) unchanged (UG), and (4) nonusers (NUG). Differences in symptom changes were compared between and within these four groups. Results: Using BZD/RD was associated with numerous symptoms at baseline and during the intervention. At follow-up, those symptoms reduced significantly among all participants. However, there were no significant differences between the groups in the changes of symptoms during the follow-up. Selfperceived health improved in only NUG (p < 0.001), but not in the other groups (WG, RG, and UG). Conclusion: Withdrawal or reduction of BZD/RD produced positive effects on physical, psychological, or cognitive symptoms among all participants, but no differences between the groups were detected. We recommend that clinical goals should be carefully assessed against the risks of long-term BZD/RD use, and that withdrawal interventions should be initiated for community-dwelling users aged 65 and older, especially those long-term users who may already be experiencing adverse drug effects.

Aim We compared the efficacy of melatonin and placebo as adjuvants in the withdrawal of patients from long term temazepam, zopiclone or zolpidem (here ‘BZD’) use. Methods A double-blind, placebo-controlled, randomized trial was conducted in a primary health care outpatient clinic. Ninety-two men or women (≥55 years) with primary insomnia and chronic BZD use received controlled release melatonin 2 mg (CRM) (n = 46) or placebo (n = 46) during the 1 month withdrawal from BZDs. Psychosocial support was provided. Follow-up continued for up to 6 months. Successful BZD withdrawal by the end of 1 month was confirmed by BZD plasma determinations, while reduction in BZD use and abstinence continuing for 6 months were noted. Results There were two drop-outs on CRM and one on placebo. After a 1 month withdrawal, 31 participants (67%; 95% CI 54, 81) on CRM and 39 (85%; 74, 95) on placebo had withdrawn completely (intention-to-treat analysis between groups, P = 0.051; per protocol P = 0.043). Reduction in BZD use was similar or even more rare in the CRM than in the placebo group (P = 0.052 per protocol). After 6 months, 14 participants in the CRM group and 20 in the placebo group remained non-users of BZD (NS between groups). BZD doses were higher in the CRM than in the placebo group at the end of the 6 month follow-up (P = 0.025). Withdrawal symptoms did not differ between the groups. Conclusions Gradual dose reduction of BZDs combined with CRM or placebo, and psychosocial support produced high short term and moderate long term BZD abstinence. CRM showed no withdrawal benefit compared with placebo.

Background in men, the concomitant use of two or more benzodiazepines or two or more antipsychotics is associated with an increased risk of fracture(s). Potential associations between the concomitant use of drugs with central nervous system effects and fracture risk have not been studied. Objective the purpose was to describe the gender-specific risk of fractures in a population aged 65 years or over associated with the use of an opioid, antiepileptic or anticholinergic drug individually; or, their concomitant use with each other; or the concomitant use of one of these with a psychotropic drug. Methods this study was part of a prospective, population-based study performed in Lieto, Finland. Information about fractures in 1,177 subjects (482 men and 695 women) was confirmed with radiology reports. Results at 3 years of follow-up, the concomitant use of an opioid with an antipsychotic was associated with an increased risk of fractures in men. During the 6-year follow-up, the concomitant use of an opioid with a benzodiazepine was also related to the risk of fractures for males. No significant associations were found for females. Conclusion the concomitant use of an opioid with an antipsychotic, or with a benzodiazepine may increase the risk of fractures in men aged 65 years and older.

Background/Aims: Psychotropics and antiepileptics (AE) are medications commonly used among the aged with cognitive decline or dementia, although they may precipitate further cognitive decline. Our aim was to analyze the relationships between the use of (i) psychotropics (i.e. benzodiazepines or related drugs, BZD, antipsychotics, AP, or antidepressants, AD), opioids (Op), anticholinergics (ACh) or AEs or the concomitant use of two of these drugs, and (ii) the risk of precipitous cognitive decline in an older (≧65 years) cognitively disabled population. Methods: A longitudinal population-based study of general aged community-dwelling patients was executed in two phases (1990–1991 and 1998–1999) in Lieto, Finland. Fifty-two individuals cognitively disabled (MMSE score 0–23) at the 1990–1991 baseline form this study’s sample. Cognitive abilities were assessed in each phase with the Mini-Mental State Examination (MMSE) and medication utilization data were collected in both phases. The mean follow-up time was 7.6 years. Multivariate models were used to analyze the change in MMSE total score between medication users and non-users. Results: BZD or any psychotropic use was associated with greater cognitive decline in elders aged ≧75 years compared to non-users (change in MMSE sum score: –8.6 ± 7.0 vs. –3.3 ± 5.6 and –5.9 ± 7.0 vs. –2.7 ± 6.4, respectively). A greater decline was also associated specifically with the concomitant use of BZD and AP (–16 vs. –1.4 ± 7.8); as were BZD and any drug with CNS effects (–9.6 ± 9.9 vs. –1.3 ± 7.2) compared to non-users. The concomitant use of BZD and AD (–10.7 ± 4.7 vs. –3.2 ± 5.6) or ACh (–15.0 ± 8.5 vs. –3.3 ± 5.6) or any drug with CNS effects (–13.3 ± 6.5 vs. –3.3 ± 5.6) was associated with cognitive decline in patients ≧75 years compared to non-users of any drug with CNS effects. Conclusion: The use of a BZD or any psychotropic medication may be an independent risk factor for cognitive decline in the cognitively disabled aged, and patients co-prescribed psychotropic medications had greater cognitive decline. Studies with larger sample sizes and studies on possible pathophysiologic mechanisms are needed.