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BMJ Open Jun 2023In ageing societies, the number of older adults with complex chronic conditions (CCCs) is rapidly increasing. Care for older persons with CCCs is challenging, due to...
Optimising the care for older persons with complex chronic conditions in home care and nursing homes: design and protocol of I-CARE4OLD, an observational study using real-world data.
INTRODUCTION
In ageing societies, the number of older adults with complex chronic conditions (CCCs) is rapidly increasing. Care for older persons with CCCs is challenging, due to interactions between multiple conditions and their treatments. In home care and nursing homes, where most older persons with CCCs receive care, professionals often lack appropriate decision support suitable and sufficient to address the medical and functional complexity of persons with CCCs. This EU-funded project aims to develop decision support systems using high-quality, internationally standardised, routine care data to support better prognostication of health trajectories and treatment impact among older persons with CCCs.
METHODS AND ANALYSIS
Real-world data from older persons aged ≥60 years in home care and nursing homes, based on routinely performed comprehensive geriatric assessments using interRAI systems collected in the past 20 years, will be linked with administrative repositories on mortality and care use. These include potentially up to 51 million care recipients from eight countries: Italy, the Netherlands, Finland, Belgium, Canada, USA, Hong Kong and New Zealand. Prognostic algorithms will be developed and validated to better predict various health outcomes. In addition, the modifying impact of pharmacological and non-pharmacological interventions will be examined. A variety of analytical methods will be used, including techniques from the field of artificial intelligence such as machine learning. Based on the results, decision support tools will be developed and pilot tested among health professionals working in home care and nursing homes.
ETHICS AND DISSEMINATION
The study was approved by authorised medical ethical committees in each of the participating countries, and will comply with both local and EU legislation. Study findings will be shared with relevant stakeholders, including publications in peer-reviewed journals and presentations at national and international meetings.
Topics: Humans; Aged; Aged, 80 and over; Artificial Intelligence; Aging; Algorithms; Chronic Disease; Home Care Services; Observational Studies as Topic
PubMed: 37385750
DOI: 10.1136/bmjopen-2023-072399 -
American Journal of Respiratory and... Jul 2019Over the past decade, several large registries of patients with idiopathic pulmonary fibrosis (IPF) have been established. These registries are collecting a wealth of... (Review)
Review
Over the past decade, several large registries of patients with idiopathic pulmonary fibrosis (IPF) have been established. These registries are collecting a wealth of longitudinal data on thousands of patients with this rare disease. The data collected in these registries will be complementary to data collected in clinical trials because the patient populations studied in registries have a broader spectrum of disease severity and comorbidities and can be followed for a longer period of time. Maintaining the quality and completeness of registry databases presents administrative and resourcing challenges, but it is important to ensuring the robustness of the analyses. Data from patient registries have already helped improve understanding of the clinical characteristics of patients with IPF, the impact that the disease has on their quality of life and survival, and current practices in diagnosis and management. In the future, analyses of biospecimens linked to detailed patient profiles will provide the opportunity to identify biomarkers linked to disease progression, facilitating the development of precision medicine approaches for prognosis and therapy in patients with IPF.
Topics: Biological Specimen Banks; Comorbidity; Disease Progression; Humans; Idiopathic Pulmonary Fibrosis; Observational Studies as Topic; Registries; Severity of Illness Index
PubMed: 31034241
DOI: 10.1164/rccm.201902-0431CI -
Osteoarthritis and Cartilage Nov 2022
Topics: Causality; Observational Studies as Topic
PubMed: 36063988
DOI: 10.1016/j.joca.2022.08.010 -
European Journal of Hospital Pharmacy :... Nov 2021Paediatric inpatients are a high-risk population for drug-related problems, yet there is a lack of data concerning drug-related problems and pharmaceutical interventions... (Observational Study)
Observational Study
OBJECTIVES
Paediatric inpatients are a high-risk population for drug-related problems, yet there is a lack of data concerning drug-related problems and pharmaceutical interventions in paediatric hospitals in France. The objective of this study was to describe drug-related problems, pharmaceutical interventions and the acceptance rate of physicians based on the characteristics of both medication order and pharmaceutical interventions.
METHODS
A 12-month, monocentric, observational and prospective study was conducted from 1 June 2016 to 31 May 2017 in a French university paediatric hospital. Prescription analysis was performed at the central pharmacy. The data were collected by querying the drug prescription database of the e-prescription software. Data on drugs, prescribers, drug-related problems and interventions were recorded. The primary outcome was the measurement of the number of drug-related problems in paediatric hospitalised patients (medical and surgical wards). Secondary outcomes were classification of drug-related problems and pharmaceutical interventions. Physician acceptance of pharmaceutical interventions was additionally assessed.
RESULTS
The main types of drug-related problems were supratherapeutic dosage (33.8%), improper administration (22.9%) and subtherapeutic dosage (16.8%). A total of 1742 pharmaceutical interventions were recorded. The rate of pharmaceutical interventions was 2.48 per 100 drug prescriptions. Acceptance rate of physicians was 51.7%. Some 530 different drugs were involved. The drugs most frequently involved in pharmaceutical interventions were drugs for the nervous system (31.3%) and anti-infectives (20.2%). Pharmaceutical interventions related to dose adjustment accounted for half of the interventions ahead of drug choice interventions (35.4%).
CONCLUSIONS
This study illustrates the frequency of drug-related problems in paediatric inpatients and the ability of pharmacists to identify them in their daily work. However, it also highlights the difficulty in obtaining physician acceptance (or even clear refusal) of pharmaceutical interventions with a review of the prescription at the central pharmacy.
Topics: Child; Hospitals, Pediatric; Humans; Medication Errors; Observational Studies as Topic; Pharmacists; Pharmacy Service, Hospital; Prospective Studies
PubMed: 33115799
DOI: 10.1136/ejhpharm-2020-002319 -
BMC Medicine Mar 2023While epidemiological studies have found correlations between light at night (LAN) and health effects, none has so far investigated the impacts of LAN on population...
BACKGROUND
While epidemiological studies have found correlations between light at night (LAN) and health effects, none has so far investigated the impacts of LAN on population mortality yet. We aimed to estimate the relative risk for mortality from exposure to LAN in Mainland China.
METHODS
This time-stratified case-crossover nationwide study used NPP-VIIRS to obtain daily LAN data of Mainland China between 2015 and 2019. The daily mortality data were obtained from the Disease Surveillance Point System in China. Conditional Poisson regression models were applied to examine the relative risk (RR) for mortality along daily LAN in each county, then meta-analysis was performed to combine the county-specific estimates at the national or regional level.
RESULTS
A total of 579 counties with an average daily LAN of 4.39 (range: 1.02-35.46) were included in the main analysis. The overall RRs per 100 nW/cm/sr increases in daily LAN were 1.08 (95%CI: 1.05-1.11) for all-cause mortality and 1.08 (95%CI: 1.05-1.11) for natural-cause mortality. A positive association between LAN and all natural cause-specific mortality was observed, of which the strongest effect was observed on mortality caused by neuron system disease (RR = 1.32, 95%CI: 1.14-1.52). The results were robust in both younger and old, as well as in males and females. The more pronounced effect of LAN was observed in median LAN-level regions. Combined with an exposure-response curve, our study suggests a non-linear association between LAN and mortality in China.
CONCLUSIONS
Our study shows LAN is associated with mortality in China, particularly for neuron system disease-related mortality. These findings have important implications for public health policy establishment to minimize the health consequences of light pollution.
Topics: Female; Humans; Male; Cause of Death; China; Environmental Exposure; Observational Studies as Topic
PubMed: 36927443
DOI: 10.1186/s12916-023-02822-w -
BMJ Open Sep 2023Very preterm infants are at risk of abnormal microbiome colonisation in the first weeks to months of life. Several important associated factors have been identified...
INTRODUCTION
Very preterm infants are at risk of abnormal microbiome colonisation in the first weeks to months of life. Several important associated factors have been identified including gestational age, mode of delivery, antibiotic exposure and feeding. Preterm infants are at risk of a number of pathologies for which the microbiome may play a central role, including necrotising enterocolitis and sepsis. The objective of this study is to determine detailed microbiome changes that occur around implementation of different management practices including empiric antibiotic use, advancement of feeds and administration of probiotics during admission to the neonatal intensive care unit.
METHODS AND ANALYSIS
A single-site, longitudinal observational study of infants born less than 32 weeks gestation, including collection of maternal samples around delivery and breastmilk and infant samples from admission through discharge from the neonatal unit.
ETHICS AND DISSEMINATION
The protocol was approved by the Clinical Research Ethics Committee of the Cork Teaching Hospitals.The findings from this study will be disseminated in peer-reviewed journals, during scientific conferences, and directly to the study participants. Sequencing data will be deposited in public databases.
TRIAL REGISTRATION NUMBER
NCT05803577.
Topics: Humans; Infant, Newborn; Anti-Bacterial Agents; Gestational Age; Infant, Premature; Infant, Very Low Birth Weight; Microbiota; Observational Studies as Topic
PubMed: 37748849
DOI: 10.1136/bmjopen-2023-075060 -
International Journal of Clinical... Jun 2016Observational studies have been recognised to be essential for investigating the safety profile of medications. Numerous observational studies have been conducted on the... (Review)
Review
Observational studies have been recognised to be essential for investigating the safety profile of medications. Numerous observational studies have been conducted on the platform of large population databases, which provide adequate sample size and follow-up length to detect infrequent and/or delayed clinical outcomes. Cohort and case-control are well-accepted traditional methodologies for hypothesis testing, while within-individual study designs are developing and evolving, addressing previous known methodological limitations to reduce confounding and bias. Respective examples of observational studies of different study designs using medical databases are shown. Methodology characteristics, study assumptions, strengths and weaknesses of each method are discussed in this review.
Topics: Databases, Pharmaceutical; Humans; Observational Studies as Topic; Pharmacoepidemiology; Research Design
PubMed: 27003827
DOI: 10.1007/s11096-016-0285-6 -
Contraception Aug 2022Systematically review the existing evidence about couples-based interventions and postpartum contraceptive uptake and generate recommendations for future research. (Review)
Review
OBJECTIVE
Systematically review the existing evidence about couples-based interventions and postpartum contraceptive uptake and generate recommendations for future research.
DATA SOURCES
PubMed, Web of Science, PsycINFO, Embase, and CINAHL through June 7, 2021.
STUDY SELECTION AND DATA EXTRACTION
Studies with a couples-based intervention assessing postpartum contraceptive uptake. Two independent reviewers screened studies, extracted data, and assessed risk of bias with RoB-2 (Cochrane Risk of Bias 2) for randomized and ROBINS-I (Risk of Bias in Non-Randomized Studies - Interventions) for observational studies. Data were synthesized in tables, figures, and a narrative review.
RESULTS
A total of 925 papers were identified, 66 underwent full text review, and 17 articles, which included 18 studies - 16 randomized, 2 observational - were included. The lack of intervention and outcome homogeneity precluded meta-analysis and isolating the effect of partner involvement. Four studies were partner-required, where partner involvement was a required component of the intervention, and 14 were partner-optional. Unadjusted risk differences ranged from 0.01 to 0.51 in favor of couples-based interventions increasing postpartum contraceptive uptake versus standard of care. Bias assessment of the 16 randomized studies classified 8, 3, and 5 studies as at a high, some concern, and low risk of bias. Common sources of bias included intervention non-adherence and missing outcome data. One observational study was at a high and the other at a low risk of bias.
CONCLUSIONS
Future studies that assess couples-based interventions must clearly define and measure how partners are involved in the intervention and assess how intervention adherence impacts postpartum contraceptive uptake.
Topics: Contraceptive Agents; Contraceptive Devices; Female; Humans; Observational Studies as Topic; Postpartum Period; Text Messaging
PubMed: 35577147
DOI: 10.1016/j.contraception.2022.05.001 -
JAMA Network Open Sep 2023Observational (nonexperimental) studies that aim to emulate a randomized trial (ie, the target trial) are increasingly informing medical and policy decision-making, but...
IMPORTANCE
Observational (nonexperimental) studies that aim to emulate a randomized trial (ie, the target trial) are increasingly informing medical and policy decision-making, but it is unclear how these studies are reported in the literature. Consistent reporting is essential for quality appraisal, evidence synthesis, and translation of evidence to policy and practice.
OBJECTIVE
To assess the reporting of observational studies that explicitly aimed to emulate a target trial.
EVIDENCE REVIEW
We searched Medline, Embase, PsycINFO, and Web of Science for observational studies published between March 2012 and October 2022 that explicitly aimed to emulate a target trial of a health or medical intervention. Two reviewers double-screened and -extracted data on study characteristics, key predefined components of the target trial protocol and its emulation (eligibility criteria, treatment strategies, treatment assignment, outcome[s], follow-up, causal contrast[s], and analysis plan), and other items related to the target trial emulation.
FINDINGS
A total of 200 studies that explicitly aimed to emulate a target trial were included. These studies included 26 subfields of medicine, and 168 (84%) were published from January 2020 to October 2022. The aim to emulate a target trial was explicit in 70 study titles (35%). Forty-three studies (22%) reported use of a published reporting guideline (eg, Strengthening the Reporting of Observational Studies in Epidemiology). Eighty-five studies (43%) did not describe all key items of how the target trial was emulated and 113 (57%) did not describe the protocol of the target trial and its emulation.
CONCLUSION AND RELEVANCE
In this systematic review of 200 studies that explicitly aimed to emulate a target trial, reporting of how the target trial was emulated was inconsistent. A reporting guideline for studies explicitly aiming to emulate a target trial may improve the reporting of the target trial protocols and other aspects of these emulation attempts.
Topics: Randomized Controlled Trials as Topic; Observational Studies as Topic
PubMed: 37755828
DOI: 10.1001/jamanetworkopen.2023.36023 -
International Journal of Clinical... Aug 2021Background People living in nursing homes are highly vulnerable and frail. Polypharmacy and inappropriate prescription (IP) are also common problems. Objectives The... (Review)
Review
Background People living in nursing homes are highly vulnerable and frail. Polypharmacy and inappropriate prescription (IP) are also common problems. Objectives The objectives of the study are (i) to study the baseline situation and calculate the frailty index (FI) of the residents, (ii) to assess the results of routine clinical practice to do a pharmacotherapy review (patient-centred prescription (PCP) model) (Molist Brunet et al., Eur Geriatr Med. 2015;6:565-9) and (iii) to study the relationship between IP and frailty, functional dependence, advanced dementia and end-of-life situation. Setting Two nursing homes in the same geographical area in Catalonia (Spain). Method This was a prospective, descriptive and observational study of elderly nursing home residents. Each patient's treatment was analysed by applying the PCP model, which centres therapeutic decisions on the patient's global assessment and individual therapeutic goal. Main outcome measure Prevalence of polypharmacy and IP. Results 103 patients were included. They were characterized by high multimorbidity and frailty. Up to 59.2% were totally dependent. At least one IP was identified in 92.2% of residents. Prior to the pharmacological review, the mean number of chronic medications prescribed per resident was 6.63 (SD 2.93) and after this review it was 4.97 (SD 2.88). Polypharmacy decreased from 72.55% to 52.94% and excessive polypharmacy fell from 18.62% to 5.88%.The highest prevalence of IP was detected in people with a higher FI, in those identified as end-of-life, and also in more highly dependent residents (p < 0.05). Conclusions People who live in nursing homes have an advanced frailty. Establishing individualized therapeutic objectives with the application of the PCP model enabled to detect 92.2% of IP. People who are frailer, are functionally more dependent and those who are end-of-life are prescribed with inappropriate medication more frequently.
Topics: Aged; Goals; Humans; Nursing Homes; Observational Studies as Topic; Polypharmacy; Prescriptions; Prospective Studies
PubMed: 33247821
DOI: 10.1007/s11096-020-01206-x