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OBJECTIVE: Guidelines recommend deprescribing benzodiazepine receptor agonists (BZRA) in older adults, yet implementation in clinical practice remains limited. Adapting effective, evidence-based interventions to a new context is a resource-saving strategy. In Canada, the D-PRESCRIBE intervention comprised a patient educational brochure and a pharmaceutical opinion inviting physicians to revise BZRA prescribing and consider safer alternatives. Due to its effectiveness on BZRA deprescribing among Canadian older adults, we aimed to adapt the D-PRESCRIBE intervention to the Belgian community setting. DESIGN: Recommendations from the ADAPT guidance, that provides a systematic approach for adapting interventions to new contexts, were followed. We conducted a mixed-methods study that comprised (1) group discussions and cognitive interviews to assess the acceptability and need for adaptation of the intervention's components and (2) a survey on the adapted pharmaceutical opinion. A research committee involving stakeholders' representatives decided on the adaptations, respecting the core functions of both tools. Changes in intervention components were reported following the Model for Adaptation Design and Impact framework. SETTING: Belgian French-speaking community setting. PARTICIPANTS: Six older adults (≥65 years), six general practitioners (GPs) and seven pharmacists participated in the group discussions or interviews. 46 GPs and 91 pharmacists responded to the survey. RESULTS: Participants welcomed the brochure positively. Still, some changes in the vocabulary, wording, photos and icons were made for several purposes including making the patient feel concerned about the brochure and softening the use of fear. The pharmaceutical opinion aroused mixed perceptions. Its name, layout and content were adapted to enhance its acceptability and fit with our healthcare system, practices and national guidelines. The survey highlighted several enablers and barriers to its use from the perspectives of GP and pharmacist. CONCLUSIONS: The Canadian D-PRESCRIBE intervention was adapted to the Belgian setting following a thorough and transparent process. Its feasibility will be tested in a future pilot study (NCT:05929417).
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Desprescrições , Humanos , Idoso , Bélgica , Masculino , Feminino , Canadá , Benzodiazepinas/uso terapêutico , Educação de Pacientes como Assunto/métodos , Idoso de 80 Anos ou mais , Padrões de Prática MédicaRESUMO
OBJECTIVE: We aimed to develop a context-specific intervention toward benzodiazepine deprescribing in nursing homes (NHs), with insights from behavior-change theories and involvement of stakeholders. DESIGN: Selection of behavior change techniques (BCTs), through online survey and group discussion, followed by operationalization of these BCTs into intervention components. SETTING AND PARTICIPANTS: The intervention was developed for Belgian NHs, involving various stakeholders: health care professionals (HCPs), NH administrators, and policy makers. METHODS: Using the Theory and Techniques Tool, we preselected the BCTs linked to one of the 9 Theoretical Domain Framework domains identified as being the main barriers for benzodiazepine deprescribing in Belgian NHs. These were then presented to stakeholders. Based on the APEASE (Acceptability, Practicability, Effectiveness, Affordability, Side-effects, and Ethics) criteria, participants ranked BCTs through an online survey, and then performed final selection during a group discussion. Selected BCTs were operationalized into intervention components, with specific contents and methods of delivery validated by stakeholders. RESULTS: Thirty-seven potential BCTs were identified. Eighteen stakeholders participated in the survey, and 7 in the group discussion. This led to the final inclusion of 9 BCTs: instruction on how to perform the behavior, information about health consequences, pros and cons, problem solving, goal setting (behavior), social comparison, restructuring physical environment, restructuring social environment, and graded tasks. These BCTs were operationalized into a 6-component intervention: process and goal setting, HCP education, physical environment adaptations, audit and feedback, NH residents' and relatives' increased awareness, and multidisciplinary work. CONCLUSION AND IMPLICATIONS: Use of a theory-based approach toward intervention development has the potential to improve the probability of its feasibility and effectiveness in tackling barriers to benzodiazepine deprescribing. By doing so, we have developed a multifaceted approach with actions taken at the patient, HCP, and NH levels. Our novel 6-component intervention will be evaluated in a pilot cluster-randomized controlled trial to assess its feasibility.
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Benzodiazepinas , Desprescrições , Casas de Saúde , Humanos , Benzodiazepinas/administração & dosagem , Bélgica , Idoso , Masculino , Feminino , Terapia Comportamental/métodos , Inquéritos e Questionários , Idoso de 80 Anos ou maisRESUMO
INTRODUCTION: In older adults with type 2 diabetes (T2D), overtreatment with hypoglycaemic drugs (HDs: sulfonylureas, glinides and/or insulins) is frequent and associated with increased 1-year mortality. Deintensification of HD is thus a key issue, for which evidence is though limited. The primary objective of this study will be to estimate the effect of deintensifying HD on clinical outcomes (hospital admission or death) within 3 months in older adults (≥75 years) with T2D. METHODS: We will emulate with real-world data a target trial, within The Health Improvement Network cohort, a large-scale database of data collected from electronic medical records of 2000 general practitioners in France. From 1 January 2010 to 28 February 2019, we will include eligible patients ≥75 years who will have T2D, a stable dose of HDs, glycated haemoglobin A1c (HbA1c) value <75 mmol/mol (9.0%) and no deintensification in the past year. The target trial will be sequentially emulated (ie, eligibility assessed) every month in the database. Patients will be classified at baseline of each sequential trial in the intervention arm (deintensification of HDs: decrease of ≥50% in the total dose of HDs, including complete cessation) or control arm (no deintensification of HDs). The pooled dataset for all sequential emulated trials will be analysed. The primary outcome will be time to first occurrence of hospital admission or death, within 3 months. Secondary outcomes will be hospitalisation, death, appropriateness of glycaemic control and occurrence of HbA1c >75 mmol/mol within 1 year. Participants will be followed from baseline to 12 months after randomisation, administrative censoring, or death, whichever occurs first. A pooled logistic regression will be used to estimate the treatment effect on the incidence of the outcomes. DISSEMINATION AND ETHICS: No ethical approval is needed for using retrospectively this fully anonymised database. The results will be disseminated during conferences and through publications in scientific journals.
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Diabetes Mellitus Tipo 2 , Idoso , Humanos , Diabetes Mellitus Tipo 2/tratamento farmacológico , França/epidemiologia , Hemoglobinas Glicadas , Hipoglicemiantes/uso terapêutico , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: The revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire explores older adults' views on deprescribing in general. Those views may differ, however, when the target is a specific drug such as benzodiazepine receptor agonists (BZRA). OBJECTIVE: This study aimed to adapt the 22-item French rPATD questionnaire to create a BZRA-specific instrument and to assess the psychometric properties of this new tool. METHODS: The adaptation of the questionnaire comprised 3 steps: 1) item transformation during group discussions with 8 healthcare providers and 8 BZRA users (aged ≥65 years), 2) pre-test of the questionnaire with 12 other older adults to ensure items understanding, 3) evaluation of the psychometric properties of the new questionnaire with 221 older BZRA users recruited in Belgium, France, and Switzerland. Construct validity was assessed using exploratory factor analysis (EFA), internal consistency with Cronbach's alpha, and test-retest reliability with intraclass correlation coefficient (ICC). RESULTS: After the pre-test, the questionnaire had 24 items (19 adapted from the French rPATD, 3 removed, and 5 added). The EFA, however, found that several items performed poorly. Eleven items were consequently removed, based on statistical performance and clinical relevance. Three factors were extracted from the EFA performed on the 11 retained items and were named "Concerns about stopping BZRA", "BZRA inappropriateness", and "Dependence on BZRA". The questionnaire also includes two global questions about willingness to reduce BZRA dosage and willingness to discontinue BZRA. All factors showed acceptable internal consistency (0.68 ≤ Cronbach's alpha ≤0.74). Two factors showed acceptable test-retest reliability. The "Concerns about stopping BZRA" factor was found to vary over time (ICC [95%CI]: 0.35[-0.02; 0.64]). CONCLUSIONS: We developed and validated a 13-item questionnaire to evaluate the attitudes of older people towards BZRA deprescribing. Despite some limitations, this questionnaire appears to be a useful tool for facilitating shared decision-making on BZRA deprescribing.
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Desprescrições , Receptores de GABA-A , Humanos , Idoso , Reprodutibilidade dos Testes , Atitude , Inquéritos e Questionários , PsicometriaRESUMO
BACKGROUND: Benzodiazepine receptor agonists (BZRAs) are commonly prescribed in older adults despite an unfavorable risk-benefit ratio. Hospitalizations may provide a unique opportunity to initiate BZRA cessation, yet little is known about cessation during and after hospitalization. We aimed to measure the prevalence of BZRA use before hospitalization and the rate of cessation 6 months later, and to identify factors associated with these outcomes. METHODS: We conducted a secondary analysis of a cluster randomized controlled trial (OPtimising thERapy to prevent Avoidable hospital admissions in the Multimorbid elderly [OPERAM]), comparing usual care and in-hospital pharmacotherapy optimization in adults aged 70 years or over with multimorbidity and polypharmacy in four European countries. BZRA cessation was defined as taking one or more BZRA before hospitalization and not taking any BZRA at the 6-month follow-up. Multivariable logistic regression was performed to identify factors associated with BZRA use before hospitalization and with cessation at 6 months. RESULTS: Among 1601 participants with complete 6-month follow-up data, 378 (23.6%) were BZRA users before hospitalization. Female sex (odds ratio [OR] 1.52 [95% confidence interval 1.18-1.96]), a higher reported level of depression/anxiety (OR up to 2.45 [1.54-3.89]), a higher number of daily drugs (OR 1.08 [1.05-1.12]), use of an antidepressant (OR 1.74 [1.31-2.31]) or an antiepileptic (OR 1.46 [1.02-2.07]), and trial site were associated with BZRA use. Diabetes mellitus (OR 0.60 [0.44-0.80]) was associated with a lower probability of BZRA use. BZRA cessation occurred in 86 BZRA users (22.8%). Antidepressant use (OR 1.74 [1.06-2.86]) and a history of falling in the previous 12 months (OR 1.75 [1.10-2.78]) were associated with higher BZRA cessation, and chronic obstructive pulmonary disease (COPD) (OR 0.45 [0.20-0.91]) with lower BZRA cessation. CONCLUSION: BZRA prevalence was high among included multimorbid older adults, and BZRA cessation occurred in almost a quarter of them within 6 months after hospitalization. Targeted BZRA deprescribing programs could further enhance cessation. Specific attention is needed for females, central nervous system-acting co-medication, and COPD co-morbidity. REGISTRATION: ClinicalTrials.gov identifier: NCT02986425. December 8, 2016.
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Doença Pulmonar Obstrutiva Crônica , Receptores de GABA-A , Idoso , Humanos , Feminino , Polimedicação , Multimorbidade , Medição de Risco , HospitalizaçãoRESUMO
Introduction: Older and multimorbid adults with type 2 diabetes (T2D) are at high risk of cardiovascular disease (CVD) and chronic kidney disease (CKD). Estimating risk and preventing CVD is a challenge in this population notably because it is underrepresented in clinical trials. Our study aims to (1) assess if T2D and haemoglobin A1c (HbA1c) are associated with the risk of CVD events and mortality in older adults, (2) develop a risk score for CVD events and mortality for older adults with T2D, (3) evaluate the comparative efficacy and safety of novel antidiabetics. Methods and analysis: For Aim 1, we will analyse individual participant data on individuals aged ≥65 years from five cohort studies: the Optimising Therapy to Prevent Avoidable Hospital Admissions in Multimorbid Older People study; the Cohorte Lausannoise study; the Health, Aging and Body Composition study; the Health and Retirement Study; and the Survey of Health, Ageing and Retirement in Europe. We will fit flexible parametric survival models (FPSM) to assess the association of T2D and HbA1c with CVD events and mortality. For Aim 2, we will use data on individuals aged ≥65 years with T2D from the same cohorts to develop risk prediction models for CVD events and mortality using FPSM. We will assess model performance, perform internal-external cross validation, and derive a point-based risk score. For Aim 3, we will systematically search randomized controlled trials of novel antidiabetics. Network meta-analysis will be used to determine comparative efficacy in terms of CVD, CKD, and retinopathy outcomes, and safety of these drugs. Confidence in results will be judged using the CINeMA tool. Ethics and dissemination: Aims 1 and 2 were approved by the local ethics committee (Kantonale Ethikkommission Bern); no approval is required for Aim 3. Results will be published in peer-reviewed journals and presented in scientific conferences.
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BACKGROUND AND OBJECTIVES: Antiplatelet therapy, when prescribed in combination with anticoagulant therapy to older patients with atrial fibrillation and no recent cardiovascular event, is inappropriate and a reversible risk factor of major bleeding. We aimed to assess the trend over time of the prevalence of inappropriate combined antiplatelet and anticoagulant therapy and to determine its associated factors during the direct oral anticoagulant era. METHODS: This was a study of consecutive older patients (age ≥ 75 years) with atrial fibrillation, receiving anticoagulant therapy upon admission, and undergoing a comprehensive geriatric assessment during their first admission in a Belgian teaching hospital between 2009 and 2018. Antiplatelet therapy was considered inappropriate in the absence of a recent cardiovascular event. We studied the prevalence of inappropriate combined antiplatelet and anticoagulant therapy by 2-year periods and assessed its associated factors since the year 2013. RESULTS: Inappropriate combined antiplatelet and anticoagulant therapy was identified in 21% of the 654 patients (median age 84 years, 51% women), with a prevalence decreasing (p ≤ 0.01) from 25% (2009-10) to 14.8% (2017-18). Among the 469 patients recruited during the direct oral anticoagulant era, inappropriate combined antiplatelet and anticoagulant therapy (19%) was associated in a multivariable analysis with a history of stroke/transient ischemic attack (odds ratio 2.13, p = 0.007), anticoagulation with low-molecular-weight heparin (odds ratio 3.44, p = 0.015), and a history of vascular disease (odds ratio 5.68, p < 0.001). CONCLUSIONS: While inappropriate combined antiplatelet and anticoagulant therapy has declined over the last decade, there is still room for improvement. Antiplatelet deprescribing should be considered in all patients with inappropriate combined antiplatelet and anticoagulant therapy, including those with vascular disease and no recent cardiovascular event.
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Fibrilação Atrial , Ataque Isquêmico Transitório , Acidente Vascular Cerebral , Humanos , Feminino , Idoso , Idoso de 80 Anos ou mais , Masculino , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Inibidores da Agregação Plaquetária/efeitos adversos , Anticoagulantes/efeitos adversos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/complicações , Fatores de RiscoRESUMO
Objectives: We identified factors associated with healthcare costs and health-related quality of life (HRQoL) of multimorbid older adults with polypharmacy. Methods: Using data from the OPERAM (OPtimising thERapy to prevent Avoidable hospital admissions in the Multimorbid older people) trial, we described the magnitude and composition of healthcare costs, and time trends of HRQoL, during 1-year after an acute-care hospitalization. We performed a cluster analysis to identify groups with different cost and HRQoL trends. Using multilevel models, we also identified factors associated with costs and HRQoL. Results: Two months after hospitalization monthly mean costs peaked (CHF 7'124) and HRQoL was highest (0.67). They both decreased thereafter. Age, falls, and comorbidities were associated with higher 1-year costs. Being female and housebound were negatively associated with HRQoL, while moderate alcohol consumption had a positive association. Being independent in daily activities was associated with lower costs and higher HRQoL. Conclusion: Although only some identified potential influences on costs and HRQoL are modifiable, our observations support the importance of prevention before health deterioration in older people with multimorbid illness and associated polypharmacy.
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BACKGROUND: Diabetes overtreatment is a frequent and severe issue in multimorbid older patients with type 2 diabetes (T2D). OBJECTIVE: This study aimed at assessing the association between diabetes overtreatment and 1-year functional decline, hospitalisation and mortality in older inpatients with multimorbidity and polypharmacy. METHODS: Ancillary study of the European multicentre OPERAM project on multimorbid patients aged ≥70 years with T2D and glucose-lowering treatment (GLT). Diabetes overtreatment was defined according to the 2019 Endocrine Society guideline using HbA1c target range individualised according to the patient's overall health status and the use of GLT with a high risk of hypoglycaemia. Multivariable regressions were used to assess the association between diabetes overtreatment and the three outcomes. RESULTS: Among the 490 patients with T2D on GLT (median age: 78 years; 38% female), 168 (34.3%) had diabetes overtreatment. In patients with diabetes overtreatment as compared with those not overtreated, there was no difference in functional decline (29.3% vs 38.0%, P = 0.088) nor hospitalisation rates (107.3 vs 125.8/100 p-y, P = 0.115) but there was a higher mortality rate (32.8 vs 21.4/100 p-y, P = 0.033). In multivariable analyses, diabetes overtreatment was not associated with functional decline nor hospitalisation (hazard ratio, HR [95%CI]: 0.80 [0.63; 1.02]) but was associated with a higher mortality rate (HR [95%CI]: 1.64 [1.06; 2.52]). CONCLUSIONS: Diabetes overtreatment was associated with a higher mortality rate but not with hospitalisation or functional decline. Interventional studies should be undertaken to test the effect of de-intensifying GLT on clinical outcomes in overtreated patients.
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Diabetes Mellitus Tipo 2 , Hipoglicemia , Humanos , Feminino , Idoso , Masculino , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Multimorbidade , PolimedicaçãoRESUMO
BACKGROUND: A palliative care approach (PCA), including advanced care planning (ACP), should be considered for patients with limited life expectancy. The Belgian Palliative Care Indicators Tool (Be-PICT) has been released to help identify patients who may benefit from such approach. This study aimed at measuring 1-year mortality and describe the quality of life in older inpatients, according to baseline Be-PICT results. METHODS: Prospective multicentre cohort study in older patients (≥ 75 years) admitted at geriatrics and cardiology wards of four Belgian hospitals. The palliative profile was defined as a positive Be-PICT.1, defined by the presence of its three criteria, i.e. a negative physician's answer to the surprise question 'would you be surprised if this patient dies in the 6-12 next months?', ≥ 1 poor health indicator and ≥ 1 life-limiting condition. RESULTS: Of the 379 patients (50% aged ≥85 years; 51% female), 52 (14%) presented a palliative profile and 83 (23%) died within 1 year. Be-PICT.1 showed the following characteristics to predict 1-year mortality: sensitivity 0.54, specificity 0.83, positive and negative predictive values 0.48 and 0.86, positive and negative likelihood ratios 3.22 and 0.55. The patients with a palliative profile were at higher mortality risk (hazard ratio 4.79 p < 0.001) and 1-year mortality rate (45%). Not using the SQ allowed to improve sensitivity to include a larger number of patients who may benefit from ACP and PCA. CONCLUSIONS: Be-PICT.1 is a simple case-finding tool to identify older inpatients being at high mortality risk and candidates for ACP and PCA.
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Pacientes Internados , Cuidados Paliativos , Humanos , Feminino , Idoso , Masculino , Cuidados Paliativos/métodos , Estudos Prospectivos , Estudos de Coortes , Qualidade de Vida , Bélgica/epidemiologia , PrognósticoRESUMO
BACKGROUND: Diabetes overtreatment is a frequent and major issue in older people with type 2 diabetes but its definition is often inconsistent and may be misleading. This critical review has aimed at examining the definitions of diabetes overtreatment in older people used in research studies. METHODS: Studies addressing diabetes overtreatment in people aged 65 or older were identified by searching the PubMed database according to an extensive search equation. RESULTS: Twenty-two research studies providing a definition of diabetes overtreatment in people aged were found. Overall, 12 different definitions of diabetes overtreatment were used. All studies defined overtreatment according to a HbA1c threshold (varying from <42 mmol/mol [<6.0%] to <64 mmol/mol [<8%]). Amongst them, 2 definitions had no consideration about glucose-lowering (GL) treatment, 6 required the prescribing of ≥1 GL agent(s), and 4 the prescribing of ≥1 GL agent(s) inducing the high risk of hypoglycaemia (i.e., sulfonylurea(s) or insulin(s)). Only 4 definitions (four studies) were individualised, using varying HbA1c thresholds according to patients' age or health status. CONCLUSIONS: Definitions of diabetes overtreatment are heterogeneous across research studies, which is confusing. A standardised definition, based on the individual risk of hypoglycaemia and/or its complications must be promoted in order to bring clarity and greater insight into this field, as well as to improve the quality of management of diabetes in older patients.
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Diabetes Mellitus Tipo 2 , Hipoglicemia , Humanos , Idoso , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Hipoglicemiantes/uso terapêutico , Insulina , Hipoglicemia/induzido quimicamente , Hipoglicemia/epidemiologia , Hipoglicemia/complicações , Glucose , Sobretratamento , GlicemiaRESUMO
Importance: The most appropriate therapy for older adults with multimorbidity may depend on life expectancy (ie, mortality risk), and several scores have been developed to predict 1-year mortality risk. However, often, these mortality risk scores have not been externally validated in large sample sizes, and a head-to-head comparison in a prospective contemporary cohort is lacking. Objective: To prospectively compare the performance of 6 scores in predicting the 1-year mortality risk in hospitalized older adults with multimorbidity. Design, Setting, and Participants: This prognostic study analyzed data of participants in the OPERAM (Optimising Therapy to Prevent Avoidable Hospital Admissions in Multimorbid Older People) trial, which was conducted between December 1, 2016, and October 31, 2018, in surgical and nonsurgical departments of 4 university-based hospitals in Louvain, Belgium; Utrecht, the Netherlands; Cork, Republic of Ireland; and Bern, Switzerland. Eligible participants in the OPERAM trial had multimorbidity (≥3 coexisting chronic diseases), were aged 70 years or older, had polypharmacy (≥5 long-term medications), and were admitted to a participating ward. Data were analyzed from April 1 to September 30, 2020. Main Outcomes and Measures: The outcome of interest was any-cause death occurring in the first year of inclusion in the OPERAM trial. Overall performance, discrimination, and calibration of the following 6 scores were assessed: Burden of Illness Score for Elderly Persons, CARING (Cancer, Admissions ≥2, Residence in a nursing home, Intensive care unit admit with multiorgan failure, ≥2 Noncancer hospice guidelines) Criteria, Charlson Comorbidity Index, Gagné Index, Levine Index, and Walter Index. These scores were assessed using the following measures: Brier score (0 indicates perfect overall performance and 0.25 indicates a noninformative model); C-statistic and 95% CI; Hosmer-Lemeshow goodness-of-fit test and calibration plots; and sensitivity, specificity, and positive and negative predictive values. Results: The 1879 patients in the study had a median (IQR) age of 79 (74-84) years and 835 were women (44.4%). The median (IQR) number of chronic diseases was 11 (8-16). Within 1 year, 375 participants (20.0%) died. Brier scores ranged from 0.16 (Gagné Index) to 0.24 (Burden of Illness Score for Elderly Persons). C-statistic values ranged from 0.62 (95% CI, 0.59-0.65) for Charlson Comorbidity Index to 0.69 (95% CI, 0.66-0.72) for the Walter Index. Calibration was good for the Gagné Index and moderate for other mortality risk scores. Conclusions and Relevance: Results of this prognostic study suggest that all 6 of the 1-year mortality risk scores examined had moderate prognostic performance, discriminatory power, and calibration in a large cohort of hospitalized older adults with multimorbidity. Overall, none of these mortality risk scores outperformed the others, and thus none could be recommended for use in daily clinical practice.
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Hospitalização , Multimorbidade , Idoso , Doença Crônica , Feminino , Humanos , Masculino , Estudos Prospectivos , Fatores de RiscoRESUMO
BACKGROUND: Inappropriate polypharmacy has been linked with adverse outcomes in older, multimorbid adults. OPERAM is a European cluster-randomized trial aimed at testing the effect of a structured pharmacotherapy optimization intervention on preventable drug-related hospital admissions in multimorbid adults with polypharmacy aged 70 years or older. Clinical results of the trial showed a pattern of reduced drug-related hospital admissions, but without statistical significance. In this study we assessed the cost-effectiveness of the pharmacotherapy optimisation intervention. METHODS: We performed a pre-planned within-trial cost-effectiveness analysis (CEA) of the OPERAM intervention, from a healthcare system perspective. All data were collected within the trial apart from unit costs. QALYs were computed by applying the crosswalk German valuation algorithm to EQ-5D-5L-based quality of life data. Considering the clustered structure of the data and between-country heterogeneity, we applied Generalized Structural Equation Models (GSEMs) on a multiple imputed sample to estimate costs and QALYs. We also performed analyses by country and subgroup analyses by patient and morbidity characteristics. RESULTS: Trial-wide, the intervention was numerically dominant, with a potential cost-saving of CHF 3'588 (95% confidence interval (CI): -7'716; 540) and gain of 0.025 QALYs (CI: -0.002; 0.052) per patient. Robustness analyses confirmed the validity of the GSEM model. Subgroup analyses suggested stronger effects in people at higher risk. CONCLUSION: We observed a pattern towards dominance, potentially resulting from an accumulation of multiple small positive intervention effects. Our methodological approaches may inform other CEAs of multi-country, cluster-randomized trials facing presence of missing values and heterogeneity between centres/countries.
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Revisão de Medicamentos , Qualidade de Vida , Idoso , Análise Custo-Benefício , Humanos , Multimorbidade , PolimedicaçãoRESUMO
AIMS: The diagnosis of heart failure (HF) is an important problem in primary care. We previously demonstrated a 74% increase in registered HF diagnoses in primary care electronic health records (EHRs) following an extended audit procedure. What remains unclear is the accuracy of registered HF pre-audit and which EHR variables are most important in the extended audit strategy. This study aims to describe the diagnostic HF classification sequence at different stages, assess general practitioner (GP) HF misclassification, and test the predictive performance of an optimized audit. METHODS AND RESULTS: This is a secondary analysis of the OSCAR-HF study, a prospective observational trial including 51 participating GPs. OSCAR used an extended audit based on typical HF risk factors, signs, symptoms, and medications in GPs' EHR. This resulted in a list of possible HF patients, which participating GPs had to classify as HF or non-HF. We compared registered HF diagnoses before and after GPs' assessment. For our analysis of audit performance, we used GPs' assessment of HF as primary outcome and audit queries as dichotomous predictor variables for a gradient boosted machine (GBM) decision tree algorithm and logistic regression model. Of the 18 011 patients eligible for the audit intervention, 4678 (26.0%) were identified as possible HF patients and submitted for GPs' assessment in the audit stage. There were 310 patients with registered HF before GP assessment, of whom 146 (47.1%) were judged not to have HF by their GP (over-registration). There were 538 patients with registered HF after GP assessment, of whom 374 (69.5%) did not have registered HF before GP assessment (under-registration). The GBM and logistic regression model had a comparable predictive performance (area under the curve of 0.70 [95% confidence interval 0.65-0.77] and 0.69 [95% confidence interval 0.64-0.75], respectively). This was not significantly impacted by reducing the set of predictor variables to the 10 most important variables identified in the GBM model (free-text and coded cardiomyopathy, ischaemic heart disease and atrial fibrillation, digoxin, mineralocorticoid receptor antagonists, and combinations of renin-angiotensin system inhibitors and beta-blockers with diuretics). This optimized query set was enough to identify 86% (n = 461/538) of GPs' self-assessed HF population with a 33% reduction (n = 1537/4678) in screening caseload. CONCLUSIONS: Diagnostic coding of HF in primary care health records is inaccurate with a high degree of under-registration and over-registration. An optimized query set enabled identification of more than 80% of GPs' self-assessed HF population.
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Clínicos Gerais , Insuficiência Cardíaca , Registros Eletrônicos de Saúde , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/epidemiologia , Humanos , Aprendizado de Máquina , Atenção Primária à SaúdeRESUMO
OBJECTIVES: We estimated the effect of pneumococcal vaccination (PV) on acute lower respiratory tract infections (LRTIs) in various age and risk groups using different methods within a causal inference methodological framework. STUDY DESIGN AND SETTING: We used data from a general practitioners' morbidity registry for the year 2019. Both traditional statistical methods (regression-based and propensity score methods) and machine learning techniques were deployed. Multiple imputation was used to account for missing data. Relative risks (RRs) with 95% confidence intervals were estimated. Sensitivity analyses were performed to account for the severity of LRTIs and differences in vaccination registration. RESULTS: All methods showed a standardized mean difference below 0.1 for each covariate. No method was found to be superior to another. PV (combination of conjugate and polysaccharide vaccine) had an overall protective effect for severe LRTIs. PV was protective in different age and risk groups, especially in people aged 50-84 years with an intermediate risk group. CONCLUSION: Using several techniques, PV was found to prevent severe LRTIs and confirmed the recommendations of the Belgian Superior Health Council.
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Infecções Pneumocócicas , Infecções Respiratórias , Adulto , Humanos , Infecções Pneumocócicas/prevenção & controle , Vacinas Pneumocócicas/uso terapêutico , Pontuação de Propensão , Sistema de Registros , Fatores de Risco , VacinaçãoRESUMO
PURPOSE: In geriatric patients with type 2 diabetes (T2D), appropriate glycaemic control is crucial to avoid overtreatment and hypoglycaemia. This study compared glycaemic control appropriateness across three major clinical practice guidelines (CPGs). METHODS: Retrospective study of geriatric older inpatients with T2D and glucose-lowering treatment before admission. Patients were classified as appropriately treated, overtreated or undertreated using CPGs from Diabetes Canada 2018 (DC18), the Endocrine Society 2019 (ES19) and the American Diabetes Association 2021 (ADA21). RESULTS: Of the 318 geriatric patients (median age 84 years, 54% women, 66% in poor health), 46%, 25% and 82% were appropriately treated, while 38%, 57% and 0% were overtreated, based on DC18, ES19 and ADA21, respectively. CONCLUSION: Large discrepancy of glycaemic control appropriateness was detected across these CPGs and concerned mainly overtreatment. This finding relates to the absence in ADA21 of a lower HbA1c value, which may be an obstacle to the prevention of hypoglycaemia.
Assuntos
Diabetes Mellitus Tipo 2 , Hipoglicemia , Idoso , Idoso de 80 Anos ou mais , Glicemia , Diabetes Mellitus Tipo 2/induzido quimicamente , Diabetes Mellitus Tipo 2/tratamento farmacológico , Feminino , Controle Glicêmico , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemia/tratamento farmacológico , Hipoglicemia/prevenção & controle , Hipoglicemiantes/uso terapêutico , Masculino , Estudos RetrospectivosRESUMO
BACKGROUND: identifying drug-related hospital admissions (DRAs) in older people is difficult. A standardised chart review procedure has recently been developed. It includes an adjudication team (physician and pharmacist) screening using 26 triggers and then performing causality assessment to determine whether an adverse drug event (ADE) occurred (secondary to an adverse drug reaction, overuse, misuse or underuse) and whether the ADE contributed to hospital admission (DRA). OBJECTIVE: to assess the performance of those triggers in detecting DRA. DESIGN: retrospective study using data from the OPERAM (OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people) trial. SETTINGS: four European medical centres. SUBJECTS: multimorbid (≥ 3 chronic medical conditions) older (≥ 70 years) inpatients with polypharmacy (≥ 5 chronic medications) were enrolled in the OPERAM trial (N = 2,008) and followed for 12 months. We included patients with ≥1 adjudicated hospitalisation during the follow-up. METHODS: the positive predictive value (PPV; number of DRAs identified by trigger/number of triggers) was calculated for each trigger and for the tool as a whole. RESULTS: of 1,235 hospitalisations adjudicated for 832 patients, 716 (58%) had at least one trigger; an ADE was identified in 673 (54%) and 518 (42%) were adjudicated as DRAs. The overall PPV of the trigger tool for detecting DRAs was 0.66 [0.62-0.69]. CONCLUSIONS: this tool performs well for identifying DRAs in older people. Based on our results, a revised version of the tool was proposed but will require external validation before it can be incorporated into research and clinical practice.