Medication Criteria Research Articles

A - 101 Anticholinergic Drug Use in Older Adults with Dementia: a Systematic Review

Abstract Objective This systematic review examined the prevalence of anticholinergic medication use, a known risk factor for cognitive impairment, among older adults with dementia. Data Selection PubMed and Embase were searched in February 2023 and March 2024 for studies reporting on the prevalence of anticholinergic medication use in older adults (age 65+) with a pre-existing diagnosis of dementia. We appraised 560 peer-reviewed manuscripts to determine they met inclusion criteria. The systematic review was conducted, designed and reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Results Twenty-nine studies met the inclusion criteria. Anticholinergic medication use rates among adults aged 65 or older with dementia ranged from 4.4% to 63.4% across studies. The median prevalence was 23.1%. In addition to several versions of the Beers Criteria and STOPP Criteria, a range of potentially inappropriate medication criteria were used. Conclusions Anticholinergic medications were widely used among older adults with dementia. Compared to a prior systematic review published in 2019, the current results indicate an increase in the frequency of anticholinergic use among older adults with dementia. Given the presence of cognitive impairment in this population, healthcare providers should closely monitor anticholinergic burden in their older adult patients and consult with prescribers to consider risks and benefits associated with such medications. Future research examining the prevalence of anticholinergic use among a broader population of older adults (e.g., those with mild cognitive impairment) appears warranted.

Radiosurgical Thalamotomy for Essential Tremor: A Prospective Study with Blinded Assessment by a Movement Disorder Neurologist

To prospectively evaluate the effectiveness and safety of radiosurgical thalamotomy in patients with Essential Tremor (ET). Patients underwent stereotactic radiation VIM thalamotomy by a dedicated Cobalt 60 intracranial radiosurgery platform in a fixed headframe. 130 Gy was prescribed to the 100% isodose point with single 4mm collimator. Effectiveness was evaluated using validated tremor rating scale: upper limb CRST Part B ratings (CRST) in comparison to baseline. To be eligible minimal CRST score of 2 in writing or drawing was required. Writing and drawing score assessments were conducted by a single movement disorder neurologist in a blinded fashion. Mean writing and drawing scores were statistically compared with paired t-test. A total of 213 cases (203 patients) were enrolled in the study, 7 cases (and individual patients) withdrew prior to treatment. The total number of thalamotomies performed was 206. Ten patients had right and left thalamotomies on study. Eleven patients underwent a contralateral thalamotomy but their initial thalamotomy was not a case in this study. 30 patients withdrew or were lost to follow-up, 2 patients were withdrawn due to not meeting medication criteria after treatment, 12 patients were withdrawn not meeting CRST rating criteria. Two patients were lost to follow-up immediately following the procedure (one of whom was a patient who underwent right and left staged procedures - no follow-up was obtained after the second procedure). 177 cases completed 6-month follow-up; 169 cases completed 1 year follow-up; 113 cases completed 2-year follow-up. For 189 total evaluable cases pre-treatment, drawing score mean was 2.86 +/- 0.84, pre-treatment writing score mean was 2.96 +/- 0.86. WRITING At one year: 143 cases (writing side targeted) mean writing score 1.28 +/-1.11 P<.01. 77% of cases improved by 1 point or greater. At two years: 102 cases 1.48+/-1.11, P<.01. 78% of cases improved by 1 point or greater. DRAWING At one year: 169 cases mean drawing score 1.42 +/-0.97, P<.01. 71% of cases improved by 1 point or greater. At two years: 113 cases mean drawing score 1.49+/-0.98, P<.01. 71% of cases improved by 1 point or greater. Cumulative side effects at 6 months and 1 year were seen in 17 of 175 of patients. 12 mild, 3 moderate and 2 severe. Mild side effects included numbness of the fingers, lip or hand and mild dysarthria. Severe side effects were 1 thalamic hemorrhage resulting in contralateral weakness. 1 patient developed foot drop and slurring of speech. Cumulative 2-year side effects were 15 mild, 3 moderate and 3 severe (1 additional thalamic hemorrhage). Stereotactic radiosurgical thalamotomy provided a significant reduction in tremor at 1 and 2 years. The treatment is an effective noninvasive treatment option worthy of consideration in many patients. The treatment has a low but non-zero risk of significant SEs.

Promoting successful participation of people living with Alzheimer's disease and related dementias in pain-related neuroimaging research studies.

Recruitment and retention of participants for pain-related neuroimaging research is challenging and becomes increasingly so when research participants have a diagnosis of Alzheimer's disease and related dementias (ADRD). This article shares the authors' recommendations from several years of successful recruitment and completion of pain-related neuroimaging studies of people living with ADRD and includes supportive literature. While not an exhaustive list, this review covers several topics related to recruitment and retention of participants living with ADRD, including community engagement, capacity to consent, dementia diagnostic criteria, pain medication and other study exclusion criteria, participant and caregiver burden, communication concerns, and relationships with neuroimaging facilities. Threaded throughout the paper are important cultural considerations. Additionally, we discuss implications of the coronavirus (COVID-19) pandemic for recruitment. Once tailored to specific research study protocols, these proven strategies may assist researchers with successfully recruiting and retaining participants living with ADRD for pain-related neuroimaging research studies toward improving overall health outcomes.

Prevalence and predictors of Potentially Inappropriate Psychotropic Medication in older adults with psychiatric illness.

There is limited information available on the use of Potentially Inappropriate Psychotropic (PIP) medication in older adults having a psychiatric illness. To determine the prevalence of and predictors of prescribing PIP medications in older adults with psychiatric illness. A cross-sectional study was carried out at a tertiary care hospital on 456 patients of either sex, with a median age of 65 years attending the psychiatry outpatient department. Evaluation of PIP medication was done using Beers criteria 2019 and Screening tool of Older Persons Potentially Inappropriate Medication (STOPP) criteria 2015. Bivariate logistic regression was used to find out the predictors of PIP prescribing. Results of the study reflect that a staggering number of older adults, (more than 91% and 73%) out of a total of 456 patients were prescribed with at least one PIP medication identified by Beers criteria and STOPP criteria, respectively. Long-acting benzodiazepine (LABZD) like clonazepam was identified as one of the most commonly prescribed PIP medications by both sets of criteria. Further analysis revealed that older adults from rural background (Odds Ratio (OR) 2.60, 95% Confidence Interval (CI) 1.20-5.65; P=0.015), Tricyclic Antidepressant (TCA) (OR 0.30, 95% CI 0.12-0.75; P=0.010), LABZD (OR 33.72, 95% CI 11.27-100.85; P=<0.001), atypical antipsychotics (OR 22.35, 95% CI 5.31-93.99; P=<0.001) use were most common predictors for PIP medication prescribing. The study suggests that the Beer criteria detects more PIP medication than the STOPP criteria.

Research on Beers Criteria and STOPP/START Criteria based on the FDA FAERS database.

Inappropriate medication criteria for the elderly have played an important role in ensuring the safety of medications for the elderly. Too few drugs included in the criteria cannot guarantee the safety of medication for the elderly. Too many drugs included in the criteria will result in less selective medication for the elderly. This paper uses real-world data to evaluate the relationship between antihypertensive drugs and falls, so as to provide references for experts and scholars to revise the criteria of potentially inappropriate medications for the elderly and clinical safe medication. We use the US Food and Drug Administration Adverse Event Reporting System (FDA FAERS) to evaluate the association between specific antihypertensive drugs in six categories (alpha-1 receptor blockers (α-1 blockers), calcium channel blockers (CCBs), angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), beta-receptor blockers (β-blockers), and diuretics) and falls by data mining algorithms, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), Medicines and Healthcare Products Regulatory Agency (MHRA), and the empirical Bayes geometric mean (EBGM) and compared with the relevant drugs included in the Beers Criteria and STOPP/START Criteria. There are a total of 5,157,172 co-occurrences found in 973,447 reports aged 65years or older from 2016 to 2019 in the FDA FAERS database, and the number of co-occurrences of falls is 5917 for the six categories of 51 antihypertensive drugs. Four kinds of mining methods overlap detection of 12 kinds of positive signal drugs, none of which are not included in the Beers Criteria and 7 drugs are included in the STOPP/START Criteria; 1-3 kinds of mining methods overlap detection of positive signal drugs, a total of 12 kinds, and one drug is included in the Beers Criteria and 5 drugs are included in the STOPP/START Criteria; 22 drugs have fall adverse events, but no positive signal is detected, and 13 drugs are included in STOPP/START Criteria; and 5 drugs have no fall adverse events and 3 drugs are included in the STOPP/START Criteria. The FAERS database was used to confirm the potential connection between some antihypertensive drugs and fall adverse events through data mining algorithms. The Beers Criteria did not clearly indicate the antihypertensive drugs that caused falls, and the antihypertensive drugs included in the STOPP/START Criteria were too extensive and did not include β-blockers and diuretics. It is recommended that experts and scholars use real-world data (such as FAERS, EudraVigilance, WHO VigiBase, and so on) to further explore the relationship between specific antihypertensive drugs and falls in the elderly, so as to revise and improve the criteria for inappropriate medications for the elderly.

Cardiometabolic Conditions and All-Cause Dementia Among American Indian and Alaska Native People.

Diabetes, hypertension, and cardiovascular disease (CVD) are modifiable lifestyle-related cardiometabolic conditions associated with dementia. Yet, little is known regarding these associations among American Indian and Alaska Native (AI/AN) people. Thus, we examined the association of diabetes, hypertension, and CVD with all-cause dementia among AI/ANs aged 65 years and older. This was a cross-sectional analysis of the Indian Health Service Improving Health Care Delivery Data Project. Our study population was a 1:1 matched sample of 4 074 AI/ANs aged 65 years and older and Indian Health Service active users during fiscal year 2013. We employed International Classification of Diseases, Ninth Revision, Clinical Modification diagnostic codes for all-cause dementia, hypertension, and CVD. Diabetes was measured with a validated algorithm to identify adults with diabetes that uses diagnoses, laboratory test results, and medication criteria. Multivariable analyses revealed that diabetes and CVD were associated with increased odds of all-cause dementia and hypertension was not. Cardiovascular disease types associated with all-cause dementia differed with cerebrovascular disease having the strongest association. Analyses stratified by gender revealed that diabetes and CVD were associated with increased odds of all-cause dementia for women and only CVD was associated with all-cause dementia for men. Training and support of primary care clinicians, addressing cultural considerations, and ensuring inclusion of AI/ANs in research are steps that could help meet AI/AN people's needs. Our findings underscore to the importance of improved management and control of diabetes and CVD, which may lead to the prevention of dementia among older AI/ANs.

Osteoporosis Screening Is Often Indicated but Overlooked Prior to Rotator Cuff Repair

PurposeTo (1) report the percentage of patients undergoing rotator cuff repair (RCR) who were appropriately screened with dual-energy X-ray absorptiometry testing prior to surgery, if indicated, and (2) determine the percentage of patients properly prescribed osteoporosis medications within 6 months of surgery.MethodsConsecutive patients aged 50 years or older who underwent elective RCR at a single tertiary-care center over a 1-year period were reviewed. Fracture risk was estimated using the Fracture Risk Assessment Tool (FRAX) with and without bone mineral density. The U.S. National Osteoporosis Foundation (NOF) criteria for screening and treatment were applied. Patients with acute fractures or revision surgery were excluded.ResultsOf the 218 patients included, 129 were women (58.1%). The mean age was 61.5 ± 7.2 years. One hundred thirty-one RCRs (60.1%) occurred within 3 months of injury. A total of 69 patients (31.7%) met the NOF criteria for bone mineral density screening. Of these patients, 23 (33.3%) were appropriately screened with a dual-energy X-ray absorptiometry scan. Primary care providers initiated bone health assessment in 18 of the 23 appropriately screened patients, with orthopaedic providers initiating the workup in 3 patients (13.0%). Thirty-two patients (14.7%) met the NOF criteria for pharmacologic management of osteoporosis. Of these patients, 5 (15.6%) were treated. Patients meeting the medication criteria were older (69.1 ± 7.7 years vs 60.2 ± 6.3 years, P < .001), had a lower body mass index (28.8 ± 6.1 vs 31.5 ± 6.5, P = .028), and had chronic rotator cuff tears (P = .015).ConclusionsPatients aged 50 years or older undergoing RCR are often not appropriately screened for osteoporosis. Even when appropriately screened, only 15.6% of patients meeting the indications for pharmacologic intervention for bone health optimization were prescribed appropriate medications. Although bone health optimization may or may not affect surgical timing, patient encounters related to rotator cuff tears can be used as an opportunity for providers to initiate osteoporosis screening and treatment protocols.Level of EvidenceLevel IV, therapeutic case series.

What do family caregivers do when managing medications for their children with medical complexity?

Using a work domain analysis and complementary thematic analysis, this paper aims to describe medication management work, its constraints, and complexities from the perspectives of family caregivers of children with medical complexity—a medically fragile segment of the pediatric population often dependent on multiple and complex medication regimens for survival and optimal functioning. Analyses were informed by data generated through observations of 12 care coordination clinic visits within a pediatric complex care program, semi-structured interviews of 11 family caregivers, and reviews of program documents. Our results show that family caregivers: (1) formulate medication management goals, identify values and criteria to judge goals but these may not necessarily be acknowledged and explicitly supported by system resources and healthcare professionals (2) are engaged in a range of complex medication management tasks that are both physically and emotionally demanding without the support of well-designed tools and resources to enhance their work.

Neuroanatomical abnormalities in first-episode psychosis across independent samples: a multi-centre mega-analysis.

Neuroanatomical abnormalities in first-episode psychosis (FEP) tend to be subtle and widespread. The vast majority of previous studies have used small samples, and therefore may have been underpowered. In addition, most studies have examined participants at a single research site, and therefore the results may be specific to the local sample investigated. Consequently, the findings reported in the existing literature are highly heterogeneous. This study aimed to overcome these issues by testing for neuroanatomical abnormalities in individuals with FEP that are expressed consistently across several independent samples. Structural Magnetic Resonance Imaging data were acquired from a total of 572 FEP and 502 age and gender comparable healthy controls at five sites. Voxel-based morphometry was used to investigate differences in grey matter volume (GMV) between the two groups. Statistical inferences were made at p < 0.05 after family-wise error correction for multiple comparisons. FEP showed a widespread pattern of decreased GMV in fronto-temporal, insular and occipital regions bilaterally; these decreases were not dependent on anti-psychotic medication. The region with the most pronounced decrease - gyrus rectus - was negatively correlated with the severity of positive and negative symptoms. This study identified a consistent pattern of fronto-temporal, insular and occipital abnormalities in five independent FEP samples; furthermore, the extent of these alterations is dependent on the severity of symptoms and duration of illness. This provides evidence for reliable neuroanatomical alternations in FEP, expressed above and beyond site-related differences in anti-psychotic medication, scanning parameters and recruitment criteria.

Thinking on safety of "toxic" traditional Chinese medicine for external use

In recent years,the safety of " toxic" traditional Chinese medicine has received great attention. Similarly,the safety of " toxic" Chinese medicines for external use should not be ignored. In this paper,the adverse reactions of toxic Chinese medicine for external use were systematically studied; the causes for adverse reactions were analyzed; and the key problems on the external use of toxic Chinese medicine in modern clinical practice were put forward. For example,usage dosage(time,area),specific efficacy of external use,early warning index of toxicity,toxic dose,adverse effects,toxic symptoms and corresponding treatment measures all had no reference basis,lacking a systematic toxicity evaluation medication criteria for clinical external use of toxic Chinese medicine. Attention shall be paid to the toxicity of toxic Chinese medicine for external use,and the theory of toxicity evaluation should be established for the external use of " toxic" traditional Chinese medicine under specific conditions. The early warning mechanism for toxic and adverse effects were clarified,and relevant early warning sensitive indicators applicable to clinical use were established in this study to control its risk factors. The study on the mechanism of pharmacodynamics and toxicology of " toxic" traditional Chinese medicine for external use was strengthened to clarify the usage and specific effects of external use. On the basis of this,the study of synergism and reduction of toxicity was carried out to maximize the efficacy of external use of traditional Chinese medicine under specific conditions. A toxicity standard of " toxic" Chinese medicines for external use was put forward,which was of great significance to guide clinical safety,rationality,effectiveness as well as the research and development of new dosage forms for external use of traditional Chinese medicine.

Treating psoriatic arthritis to target: discordance between physicians and patients' assessment, non-adherence, and restricted access to drugs precluded therapy escalation in a real-world cohort.

The treat-to-target strategy (T2T) was associated with better outcomes in psoriatic arthritis (PsA) compared to standard care in clinical trials. This study aimed to analyze factors precluding treatment optimization in a T2T strategy conducted in a real-world cohort of PsA patients. A retrospective cross-sectional study nested in a cohort was conducted. Medical records of patients ≥ 18years old, fulfilling CASPAR criteria and with at least one visit in the PsA clinic, were reviewed. Demographic data, current medication, and minimal disease activity (MDA) criteria were recorded. Reasons for the non-escalation of therapy in patients who were not classified as MDA were reported as absolute and relative frequencies. In the 8-month period, 131 visits (corresponding to 74 patients) were conducted. The MDA criteria were available in 113 visits (86.3%) and patients were classified as MDA in 31.0% of the visits (N = 35/113). Although in 69.0% of the visits patients were not in MDA, (N = 78/113), therapy was adjusted in only 42.3% (N = 33/78). Reasons precluding treatment escalation in non-MDA subjects were physician's impression of remission (57.7%, N = 26), non-adherence to previous prescription (17.8%, N = 8), restricted access to drugs (17.8%, N = 8), adverse events (11.1%, N = 5), poor understanding of medication instructions (6.7%, N = 3), patient's refusal to escalate therapy (4.4%, N = 2), and recent change in therapy (2.2%, N = 1). Discordance between the physician's clinical evaluation and the MDA criteria, non-adherence to prescription, and poor access to drugs were the main factors precluding escalation of therapy in a T2T strategy in a real-world PsA cohort.

Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials

ObjectivesTo evaluate the long-term efficacy and safety of canakinumab in patients with active systemic juvenile idiopathic arthritis (JIA).MethodsPatients (2–19 years) entered two phase III studies and continued in the long-term...

Identifying heart failure using EMR-based algorithms

BackgroundHeart failure (HF) is a major clinical and public health problem, the management of which will benefit from large-scale pragmatic research that leverages electronic medical records (EMR). Requisite to using EMRs for HF research is the development of reliable algorithms to identify HF patients. We aimed to develop and validate computable phenotype algorithms to identify patients with HF using standardized data elements defined by the Patient Centered Outcomes Research Network (PCORnet) Common Data Model (CDM). MethodsWe built HF computable phenotypes utilizing the data domains of HF diagnosis codes, prescribed HF-related medications and N-terminal B-type natriuretic peptide (NT-proBNP). Algorithms were validated in a cohort (n = 76,254) drawn from Olmsted County, MN between 2010–2012 a sample of whose records were manually reviewed to confirm HF according to Framingham criteria. ResultsThe different algorithms we tested provided different tradeoffs between sensitivity and positive predictive value (PPV). The highest sensitivity (78.7%) algorithm utilized one HF diagnosis code and had the lowest PPV (68.5%). The addition of more algorithm components, such as additional HF diagnosis codes, HF medications or elevated NT-proBNP, improved the PPV while reducing sensitivity. When added to a diagnostic code, the addition of NT-proBNP (>450 pg/mL) had a similar impact compared to additional HF medication criteria, increasing PPV by ∼3–4% and decreasing sensitivity by ∼7–10%. ConclusionsAlgorithms derived from PCORnet CDM elements can be used to identify patients with HF without manual adjudication with reasonable sensitivity and PPV. Algorithm choice should be driven by the goal of the research.

Electronic assessment of cardiovascular potentially inappropriate medications in an administrative population database.

To explore the feasibility of the electronic assessment of potentially inappropriate medication (PIM) criteria in a large administrative database and to explore the validity of the cardiovascular subset of PIM criteria, by studying the association with relevant outcome. A cohort study using administrative data from Stockholm County, Sweden (VAL database). Eligible for inclusion were community-dwelling older people (≥65years), alive in Stockholm County on 31 December 2015. We applied PIM criteria pertaining to the cardiovascular medication group (first-level ATC Cgroup), and we assessed the association between PIM use and mortality and hospitalisation. Patients' (n=315120) mean age was 74.0years (range 65-114), and 54.7% were women. There were 111 cardiovascular PIM criteria in the repository, from which 44 were not registered or prescribed in our population. We excluded another 43 requiring information not available in the database, or duplicates, resulting in 24 applicable criteria. The prevalence of polypharmacy (≥ five medications) was 25.5% and the prevalence of at least one PIM use was 8.3%, including 2.8% underuse and 5.3% misuse. Patients with intake of ≥10 medications had 38% increased mortality risk compared to those with 0-4 medications. Unplanned hospitalisation and emergency department visits were positively associated with underuse (12% and 25%, respectively) and misuse (13% and 12%, respectively). It was feasible to select a subset of cardiovascular PIM criteria originating from different PIM lists and to apply this subset in an administrative database. Additionally, by applying this subset, we showed significant associations with clinical outcome.

A prospective randomized controlled study of Aurolab aqueous drainage implant versus Ahmed glaucoma valve in refractory glaucoma: A pilot study.

Purpose:To study the efficacy of the Aurolab aqueous drainage implant (AADI) compared to Ahmed glaucoma valve (AGV) in patients with refractory glaucoma.Methods:This was a prospective, randomized controlled trial. Thirty-eight adult patients (>18 years) scheduled for a glaucoma drainage device (GDD) were randomized into two groups to receive either AGV or AADI. Primary outcome measures: intraocular pressure (IOP) control and requirement of antiglaucoma medications; secondary outcome measures: final best correct visual acuity (log MAR), visual field (Visual field index [VFI], mean deviation [MD] and pattern standard deviation [PSD]), postoperative complications and additional interventions. Complete success was defined as IOP ≥5–≤18 mmHg without antiglaucoma medications/laser/additional glaucoma surgery or any vision threatening complications.Results:There were 19 age and sex-matched patients in each group. Both groups had comparable IOP before surgery (P = 0.61). The AGV group had significantly lower IOP compared to AADI group (7.05 ± 4.22 mmHg vs 17.90 ± 10.32 mmHg, P = <0.001) at 1 week. The mean postoperative IOP at 6 months was not significantly different in the two groups (13.3 ± 4.2 and 11.4 ± 6.8 mmHg respectively; P = 0.48). At 6 months, complete success rate according to antiglaucoma medication criteria was 78.94% in AADI and 47.36% in AGV groups. AGV group required 1.83 times more number of topical medications than AADI group. There was no significant difference in early (P = 0.75) and late (P = 0.71) postoperative complications in the AADI and AGV group. The complete success rate was higher in AADI group (68.42%) than AGV group (26.31%) (P = 0.034).Conclusion:In this study, AADI appears to have comparable efficacy versus AGV implant with higher complete success rate at 6 months follow-up.

Pharmacotherapy for Weight Management in the VHA.

Weight management medications (WMM) are underutilized as an adjunct to behavioral and lifestyle interventions. In fiscal years 2014-2015, a total of approximately 2500 veterans-a mere 2% of veterans receiving care from the Veterans Health Administration (VHA)-eligible for a WMM received a prescription for one. A State of the Art Conference on Weight Management workgroup, focused on pharmacotherapy, developed evidence-based recommendations and strategies to foster the appropriate use of WMM in the VHA. The workgroup identified patient, prescriber, and health system barriers to and facilitators for prescribing WMM. Barriers included patient and provider concerns about medication safety and efficacy, limited involvement of primary care, restrictive medication criteria for use (CFU), and skepticism among providers regarding the safety and efficacy of WMM and the perception of obesity as a disease. Potential facilitators for removing barriers included patient and provider education about WMM and the health benefits of weight loss, increased engagement of primary care providers in weight management, relaxation of the CFU, and creation of a system to help patients navigate through weight management treatment options. Several research questions were framed with regard to WMM in general, and specifically to the care of obese veterans. While some of the workgroup's conclusions reflect issues specific to the VHA, many are likely to be applicable to other health organizations.

Comparison of four criteria for potentially inappropriate medications in Brazilian community-dwelling older adults.

To compare four potentially inappropriate medication (PIM) criteria from different regions of the world in terms of their characteristics, concordance, sensitivity, specificity and predictive values in a community-dwelling sample. A cross-sectional, observational, epidemiological study was carried out by a door-to-door survey in a Brazilian city. The following PIM criteria were applied: Beers-2015, Screening Tool of Older People's Potentially Inappropriate Prescriptions (STOPP)-2015, The European Union (EU)(7)-PIM list and Taiwan criteria. The associations of criteria with the presence or absence of falls, hospitalizations and cognitive impairment were determined, and their sensitivity, specificity, positive predictive value, negative predictive value and concordance among the criteria were assessed. A total of 368 (92%) older adults were in continuous use of at least one drug. A high prevalence of PIM by Beers (50.0%), STOPP (46.2%), EU(7)-PIM (59.5%) and Taiwan 31.3%) criteria was found. There was a high concordance among the PIM criteria (66.3-81.8%), and a moderate-to-high intraclass correlation between criteria (0.607-0.851). In general, the Taiwan criterion had lower levels of sensitivity (25.7-34.0%) and higher levels of specificity (67.8-70.3%), The EU(7)-PIM criteria had higher levels of sensitivity (60-75.3%) and lower levels of specificity (41.1-46.9%), whereas the Beers and STOPP had a more balanced sensitivity/specificity ratio (sensitivity: STOPP 50.7-55.3% and Beers 53.0-56.9%; specificity: STOPP 56-56.6% and Beers 51.6-53.8%). The present study found moderate-to-high levels of concordance among the four PIM criteria assessed, pointing to a consensus in this field. However, each criterion showed particular characteristics: the EU(7)-PIM criterion had higher sensitivity, the Taiwan criterion higher specificity, and the Beers and STOPP a more balanced profile. These results highlight that each criterion has its own characteristics, and should be used according to health providers' objectives. Geriatr Gerontol Int 2017; 17: 1628-1635.

Screening Tool of Older Person's Prescriptions/Screening Tools to Alert Doctors to Right Treatment Medication Criteria Modified for U.S. Nursing Home Setting.

To develop a set of prescribing indicators measurable with available data from electronic nursing home (NH) databases by adapting the European-based 2014 Screening Tool of Older Person's Prescriptions (STOPP) and Screening Tools to Alert Doctors to Right Treatment (START) criteria of potentially inappropriate and underused medications for the U.S. A two-stage expert panel process. In the first stage, the investigator team reviewed 114 criteria for compatibility and measurability. In the second stage, an online modified e-Delphi (OMD) panel was convened to rate the validity of criteria, and two webinars were held to identify criteria with highest relevance to U.S. NHs. Seventeen experts with recognized reputations in NH care participated in the e-Delphi panel and 12 in the webinar. Compatibility and measurability were assessed by comparing criteria with U.S. terminology and setting standards and data elements in NH databases. Validity was rated using a 9-point Likert-type scale (1=not valid at all, 9=highly valid). Mean, median, interpercentile ranges, and agreement were determined for each criterion score. Relevance was determined by ranking the mean panel ratings on criteria that reached agreement; the webinar participants reviewed and approved half of the criteria with the highest mean values. Fifty-three STOPP/START criteria were deemed to be compatible with the U.S. NH setting and measurable using data from electronic NH databases. E-Delphi panelists rated 48 criteria as valid for U.S. NHs. Twenty-four criteria were deemed to be most relevant, consisting of 22 measures of potentially inappropriate medications and two measures of underused medications. This study created the first explicit criteria for assessing the quality of prescribing in U.S. NHs.

Participation of older people in preauthorization trials of recently approved medicines.

To investigate the inclusion of older people in clinical trials of recently authorized medicines, evaluating adherence to the 20-year-old International Conference of Harmonisation (ICH) guideline on geriatrics (E7). Observational. European public assessment reports, published clinical trials, World Health Organization International Clinical Trials Registry Platform. Individuals aged 65 and older and 75 and older. Number and proportion of randomized participants and all exclusion criteria of studies involving diseases characteristically associated with aging (venous thromboembolism, osteoporosis, atrial fibrillation) and diseases not unique to older adults (type 2 diabetes mellitus, depression, bipolar disorder, epilepsy). In 114 Phase II and III trials of 12 medicines, 43.1% of participants were aged 65 and older, and 16.1% were aged 75 and older. In trials involving diseases characteristically associated with ageing, 57% were aged 65 and older; 22% were aged 75 and older. In trials involving diseases not unique to old age, 9% were aged 65 and older, and 1% were aged 75 and older. Upper age limits were applied in 30.7% of the trials; the frequency did not differ between larger (sample size ≥ 500) and smaller trials (P = .36), although it was significantly lower in trials involving diseases characteristically associated with aging (18.0%) than in trials of diseases not unique to old age (45.3%; P = .002). Age-sensitive exclusion criteria, based on comorbidity (75.4%), concomitant medication (71.9%), and other criteria correlated with age (60.5%) were applied more frequently in larger trials (P < .02). Studies of diseases not uniquely associated with old age included an unacceptably low proportion of older people, contrary to the recommendations of the ICH E7 guideline. Although the proportion of older participants in trials of diseases characteristically associated with aging was appropriate for certain medicines, the use of age-sensitive exclusion criteria limits the representativeness of the trial population for daily practice.

Which outcome measures in SLE clinical trials best reflect medical judgment?

ObjectivesTo compare two measures of systemic lupus erythematosus (SLE) response: the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) and the Systemic Lupus Responder Index (SRI) against a...