Correlation between the number of patient-reported adverse events, adverse drug events, and quality of life in older patients: an observational study.

BACKGROUND: Previous studies on medication therapy management services, e.g. medication reconciliation and medication review, do not show consistent improvements in patient's health-related quality of life. However, these services can reduce adverse drug events. AIM: To evaluate the correlation between health-related quality of life and adverse events/adverse drug events reported by patients. METHOD: Older patients (≥ 65 years) with polypharmacy (≥ 5 medicines) admitted to orthopaedic or surgical wards were included. Patients were contacted post-discharge to evaluate patient-reported adverse events, health-related quality of life using the EuroQol questionnaire and self-perceived health status on a 5-point Likert scale. The outcomes were the correlation between health-related quality of life and the number of adverse events/adverse drug events, and potential predictors for these events. Spearman correlation and Poisson regression were used for data analysis. RESULTS: 102 patients were included. The correlation between health-related quality of life and adverse events was weak but significant (Spearman correlation coefficient: - 0.328, p = 0.001). No correlation was found for adverse drug events (- 0.064, p = 0.521). Self-perceived health status was a predictor for adverse events, not for adverse drug events. Health-related quality of life was neither a predictor for adverse events, nor for adverse drug events. CONCLUSION: The correlation between the number of patient-reported adverse events, adverse drug events and health-related quality of life measured by the EuroQol was weak. There is a need for a questionnaire that includes the impact of medication use and is sensitive to outcomes that are affected by medication therapy management services.

[A man with an abnormality of the upper arm on an X-ray of the chest]. / Een man met een afwijkende bovenarm op de X-thorax.

A 82-year-old man was referred to our hospital because of a history of falling. Routine radiography of the chest accidentally showed an abnormality of the left upper arm. The x-ray showed calcifications - rings and arcs - also known as popcorn calcifications. This is a typical radiological sign which may indicate a tumour of the condroid matrix.

Acetaminophen for self-reported sleep problems in an elderly population (ASLEEP): study protocol of a randomized placebo-controlled double-blind trial.

BACKGROUND: The prevalence of sleep disorders increases with age. Sleep disorders may have serious health implications and may be related to serious underlying diseases. Many older people use hypnotics, like benzodiazepines, although these medications have serious side effects and often lead to habituation. Acetaminophen is one of the most frequently used off-label drugs for sleep disorders, although little is known about its effects. Our objective is to investigate whether acetaminophen is effective in treating self-reported sleep disorders in older people. METHODS/DESIGN: Participants, aged 65 years or older (n=150), who have sleep disorders will be randomized for treatment with either acetaminophen 1000 mg or placebo, once daily at bedtime in a double-blind design. Eligible patients should be able to give informed consent, should not be cognitively impaired (Minimal Mental State Examination (MMSE) score≥20), should not have pain, and should not use acetaminophen on a regular basis because of pain complaints. The study will take three weeks to complete. During these three weeks, the participants register their sleep behavior in a sleep diary. The participants will use the study medication during the second and third week. The primary endpoint will be the self-reported sleep disorders at the end of week three, as measured by means of the Insomnia Severity Index (ISI). To validate these subjective sleep parameters against objectively measured indices of the sleep-wake pattern, we will measure the periods of wakefulness and sleep in a subgroup of participants, using an actigraph worn on the wrist during the entire study period. DISCUSSION: The proposed study will contribute to our knowledge about the treatment of sleep disorders in an older population. There is a need for treatments for sleep disorders without serious adverse effects. Acetaminophen might be a simple and inexpensive alternative for the regimes that are currently used with older people. TRIAL REGISTRATION: The Netherlands National Trial Register NTR2747.

The value of a comprehensive geriatric assessment for patient care in acutely hospitalized older patients with cancer.

INTRODUCTION: A comprehensive geriatric assessment systematically collects information on geriatric conditions and is propagated in oncology as a useful tool when assessing older cancer patients. OBJECTIVES: The objectives were: (a) to study the prevalence of geriatric conditions in cancer patients aged ≥ 65 years, acutely admitted to a general medicine ward; (b) to determine functional decline and mortality within 12 months after admission; and (c) to assess which geriatric conditions and cancer-related variables are associated with 12-month mortality. METHODS: This was an observational cohort study of 292 cancer patients aged ≥ 65 years, acutely admitted to the general medicine and oncology wards of two university hospitals and one secondary teaching hospital. Baseline assessments included patient characteristics, reason for admission, comorbidity, and geriatric conditions. Follow-up at 3 and 12 months was aimed at functional decline (loss of one or more activities of daily living [ADL]) and mortality. RESULTS: The median patient age was 74.9 years, and 95% lived independently; 126 patients (43%) had metastatic disease. A high prevalence of geriatric conditions was found for instrumental ADL impairment (78%), depressive symptoms (65%), pain (65%), impaired mobility (48%), malnutrition (46%), and ADL impairment (38%). Functional decline was observed in 8% and 33% of patients at 3 and 12 months, respectively. Mortality rates were 38% at 3 months and 64% at 12 months. Mortality was associated with cancer-related factors only. CONCLUSION: In these acutely hospitalized older cancer patients, mortality was only associated with cancer-related factors. The prevalence of geriatric conditions in this population was high. Future research is needed to elucidate if addressing these conditions can improve quality of life.

Contraindications for anticoagulation in older patients with atrial fibrillation; a narrative review.

BACKGROUND: Oral anticoagulation (OAC) is the most effective treatment to prevent strokes in patients with atrial fibrillation (AF). Many older patients are not prescribed OAC. OBJECTIVE: To explore which co-morbid conditions in older patients with AF have been associated with under-treatment with OAC, or were used as exclusion criteria for trials, or have been associated with increased risk of bleeding. METHODS: A Pubmed search was conducted with the terms elderly, atrial fibrillation, stroke risk, bleeding risk, intracranial haemorrhage, cognition, fall risk, renal dysfunction, alcohol abuse, malignancy, polypharmacy, NSAID, under-treatment, under-use and under-prescription. RESULTS: Higher age is associated with under-treatment. Patients with a higher risk of stroke show higher rates of bleeding complications. The associations of bleeding rates with possible contraindications are inconsistent. DISCUSSION: Published bleeding rates reflect selection bias, describing mainly relatively healthy older patients. The use of stratification schemes for stroke risk and for bleeding risk will have to be implemented. CONCLUSION: The decision to prescribe OAC in older patients with AF remains a challenging task since bleeding risk is difficult to estimate reliably. Stratification schemes may be helpful.

Reasons for undertreatment with oral anticoagulants in frail geriatric outpatients with atrial fibrillation: a prospective, descriptive study.

OBJECTIVES: The main aims of the study were to explore whether oral anticoagulation (OAC) for atrial fibrillation (AF) in geriatric outpatients is prescribed in accordance with international (American College of Cardiology/American Heart Association/European Society of Cardiology [ACC/AHA/ESC]) and Dutch national guidelines for the general practitioner (GP) and to identify whether age and selected co-morbid conditions are associated with undertreatment. As a secondary objective, we wanted to establish how many patients discontinue OAC because of major bleeding. METHODS: In 2004, at the first visit of all patients to the geriatric day clinic of the Slotervaart Hospital in Amsterdam, the Netherlands, demographic data, Mini-Mental State Examination score, medical history, Charlson Comorbidity Index score, and data on medication use and changes were documented. The presence of AF was established by assessment of medical history information obtained by the GP, the history taken from patients and their caregivers, and the results of clinical evaluation, including ECG findings. Associations between the use of OAC, demographic data and co-morbid conditions registered in the Dutch NHG (Nederlands Huisartsen Genootschap [Dutch College of General Practitioners]) standard for GPs as risk factors for stroke or contraindications to the use of OAC were analysed. The reasons for discontinuing OAC were assessed after 4 years by requesting the information from the anticoagulation services or the GP. RESULTS: At the time of the initial visit, 17.5% of the 807 outpatients had chronic AF (n = 135) or were known to have paroxysmal AF (n = 6). The mean age of the 141 patients in this cohort was 84.3 years (SD 6.2 years). Co-morbid conditions increasing the risk of stroke were present in 129 patients (91.5%). Contraindications to the use of OAC were observed in 118 patients (83.7%). Of the 116 patients with AF in their history before their visit, 57.8% were being treated with OAC at the time of their visit. After comprehensive geriatric assessment, 73 (51.8%) of the 141 patients with chronic or paroxysmal AF were continued on OAC. Of the 141 patients with chronic or paroxysmal AF, 110 (78.0%) had both extra stroke risk factors and contraindications to the use of OAC. Only increasing age was significantly and independently associated with not being prescribed anticoagulants (p < 0.001). At the 4-year follow-up, OAC had been discontinued in 5.5% of patients because of major bleeding; three patients (4.1%) taking OAC had died as a result of major bleeding, and one other patient had discontinued treatment because of a major, non-lethal bleeding episode. CONCLUSION: Applying the NHG standard for appropriate prescription, and disregarding age as a risk factor or contraindication, in this population, 14 of 141 patients (9.9%) were inappropriately prescribed OAC, salicylates or no prophylaxis. Since only patient age was associated with not prescribing OAC in this study, higher age still seems to be considered the most important contraindication to anticoagulation therapy. Implementation of better models for stratifying bleeding risk in the frail elderly is needed. After 4 years, the cumulative rate of bleeding causing discontinuation of anticoagulation therapy in this usual-care study of frail older patients was not alarmingly higher than in other usual-care studies.

Treatment of hypertension in an elderly outpatient population in the Netherlands.

BACKGROUND: The treatment of older patients with hypertension has been controversial-in addition to uncertainty regarding appropriate blood pressure (BP) targets in the very old, there are concerns that excessive BP lowering could result in adverse events such as falls, stroke, and cognitive problems. The Hypertension in the Very Elderly Trial (HYVET), however, found that lowering BP in patients aged > or =80 years was associated with decreased morbidity and mortality. OBJECTIVE: This study compared the findings of HYVET with data from a population of elderly outpatients with hypertension in a clinical practice setting. METHODS: This was a retrospective study of prospectively collected data from patients aged > or =80 years with a history of hypertension who visited a geriatric diagnostic day clinic in the Netherlands in 2004. The data were analyzed to determine how many patients were being prescribed antihypertensive medication, how many would have been eligible for HYVET, how many achieved adequate BP control, and whether reaching BP goals was associated with the number and type of antihypertensive medications received or with eligibility for HYVET. RESULTS: During 2004, 518 patients aged > or =80 years visited the geriatric diagnostic day clinic, of whom 147 met the criteria for inclusion in this study. One hundred forty-one patients (95.9%) were receiving antihypertensive medication, although only 52 (35.4%) would have been eligible for HYVET. Dementia, which was an exclusion criterion in HYVET, was the major reason for ineligibility (70 [47.6%]). Greater proportions of patients in this study had comorbidities compared with the HYVET population (stroke: 22.4% vs 6.7%, respectively; myocardial infarction: 7.5% vs 3.1%; heart failure: 11.6% vs 2.9%; diabetes mellitus: 21.1% vs 6.8%). At the time of the clinic visit, 50.3% of patients had adequate BP control, as defined in HYVET (systolic BP <150 mm Hg and diastolic BP <80 mm Hg). Levels of BP control were similar in patients who would and would not have been ineligible for HYVET. Only the mean (SD) number of antihypertensive medications received was significantly associated with the achievement of BP control compared with failure to achieve adequate BP control (2.2 [1.0] vs 1.8 [1.1], respectively; P < 0.05). CONCLUSIONS: Based on the findings of this study, the benefits of treating elderly patients with hypertension in clinical practice may be lower than those reported by HYVET. The study results support the current recommendation that all patients with hypertension should be treated with >1 antihypertensive medication if adequate control is not achieved at low doses of a single medication.

Discrepancies in reported drug use in geriatric outpatients: relevance to adverse events and drug-drug interactions.

BACKGROUND: Increased age is associated with polypharmacy. Polypharmacy is a risk factor for severe adverse drug reactions (ADRs) and is associated with an increased risk of mortality. OBJECTIVES: The main goal of the current study was to describe the frequency and relevancy of discrepancies in drug use in Dutch geriatric outpatients as reported by the patients and their caregivers, documented by the referring general practitioner (GP), and registered by the public pharmacy. The frequency of medication discrepancy adverse patient events (MDAPEs) was also recorded. In addition, possible contributing factors-such as increasing age, cognitive status and depressive symptoms, the number of medications used, the number of physicians visited by the patient, and the presence of a caregiver to supervise medication use-were studied. METHODS: This was a prospective descriptive study conducted at the geriatric outpatient clinic of a teaching hospital. Between January 1 and May 1, 2005, consecutive patients were included if they were aged >65 years, reported use of > or =1 medication, and if they could understand the goals and consequences of participating in the study. The medications described by geriatric patients and their caregivers were compared with the drugs listed by their GP. The pharmacies of the referred patients were asked to send a description of the drugs distributed in the 6 months preceding the patient's visit to the geriatric outpatient clinic. The classification of ADRs and undertreatment as clinically relevant was done by study investigators who were blinded for the presence of discrepancy. RESULTS: A total of 120 outpatients were included. The mean (SD) age of the study patients was 82.3 (6.8) years; 71.7% were women. Of the 120 patients, 113 patients (94.2%) reported taking >1 drug and 88 (73.3%) were prescribed > or =4 drugs. At least 1 discrepancy between the medication lists of the patients, GP, or pharmacy was present in 104 of the 120 patients (86.7%). In 90 patients (75.0%), there was > or =1 discrepancy between the medication reported by the patient and the GP. Patients with > or =1 discrepancy reported taking a higher mean number of drugs and had more prescribing physicians in addition to their GP. Twenty-nine patients (24.2%) experienced an MDAPE involving the use of drugs the GP had not correctly described in the letter of referral. The pharmacy was unaware of the use of medication involved in an MDAPE in 2 patients. CONCLUSIONS: Geriatricians should assume that the medication lists supplied by GPs are incomplete or incorrect, and be aware that in approximately 25% of patients, symptoms may be caused by medication use inaccurately described in the referral. Reports by the community pharmacy may supply valuable additional information. Because there are also discrepancies between patients and pharmacies, medication use from a database-with data from prescribing physicians and pharmacy systems-will still have to be confirmed by the patient.