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Recenti Progressi in Medicina Nov 2019
Topics: Academies and Institutes; Codes of Ethics; Conflict of Interest; Drug Approval; Drug Labeling; Europe; Financial Support; Humans; Observational Studies as Topic; Pharmacoepidemiology; Pharmacovigilance; Registries; Research; Research Personnel
PubMed: 31808435
DOI: 10.1701/3265.32351 -
Recenti Progressi in Medicina Nov 2019
Topics: Control Groups; Data Interpretation, Statistical; Databases, Factual; Equivalence Trials as Topic; Evidence-Based Medicine; Humans; Observational Studies as Topic; Pharmaceutical Preparations; Pragmatic Clinical Trials as Topic; Randomized Controlled Trials as Topic; Reproducibility of Results; Technology Assessment, Biomedical; Technology Transfer; Time Factors; Treatment Outcome
PubMed: 31808432
DOI: 10.1701/3265.32327 -
BMJ Open May 2023It is estimated that of those who die in high-income countries, 69%-82% would benefit from palliative care with a high prevalence of advanced chronic conditions and...
Identification of palliative care needs and prognostic factors of survival in tailoring appropriate interventions in advanced oncological, renal and pulmonary diseases: a prospective observational protocol.
INTRODUCTION
It is estimated that of those who die in high-income countries, 69%-82% would benefit from palliative care with a high prevalence of advanced chronic conditions and limited life prognosis. A positive response to these challenges would consist of integrating the palliative approach into all healthcare settings, for patients with all types of advanced medical conditions, although poor clinician awareness and the difficulty of applying criteria to identify patients in need still pose significant barriers. The aim of this project is to investigate whether the combined use of the NECPAL CCOMS-ICO and Palliative Prognostic (PaP) Score tools offers valuable screening methods to identify patients suffering from advanced chronic disease with limited life prognosis and likely to need palliative care, such as cancer, chronic renal or chronic respiratory failure.
METHODS AND ANALYSIS
This multicentre prospective observational study includes three patient populations: 100 patients with cancer, 50 patients with chronic renal failure and 50 patients with chronic pulmonary failure. All patients will be treated and monitored according to local clinical practice, with no additional procedures/patient visits compared with routine clinical practice. The following data will be collected for each patient: demographic variables, NECPAL CCOMS-ICO questionnaire, PaP Score evaluation, Palliative Performance Scale, Edmonton Symptom Assessment System, Eastern Cooperative Oncology Group Performance Status and data concerning the underlying disease, in order to verify the correlation of the two tools (PaP and NECPAL CCOMS-ICO) with patient status and statistical analysis.
ETHICS AND DISSEMINATION
The study was approved by local ethics committees and written informed consent was obtained from the patient. Findings will be disseminated through typical academic routes including poster/paper presentations at national and international conferences and academic institutes, and through publication in peer-reviewed journals.
Topics: Humans; Palliative Care; Prognosis; Health Services Needs and Demand; Chronic Disease; Neoplasms; Lung Diseases; Observational Studies as Topic; Multicenter Studies as Topic
PubMed: 37253494
DOI: 10.1136/bmjopen-2022-065971 -
Canadian Journal of Psychiatry. Revue... Oct 2021Suicide rates are higher in rural compared to urban areas. Although this pattern appears to be driven by higher rates among men, there is limited evidence about the... (Review)
Review
Rural-Urban Differences in Suicide Mortality: An Observational Study in Newfoundland and Labrador, Canada: Différences de la Mortalité Par Suicide en Milieu Rural-Urbain: Une Étude Observationnelle à Terre-Neuve et Labrador, Canada.
BACKGROUND
Suicide rates are higher in rural compared to urban areas. Although this pattern appears to be driven by higher rates among men, there is limited evidence about the characteristics of rural people who die by suicide in Canada. The objective of this study was to examine the demographics, manner of death, and social and clinical antecedents of people who died by suicide in rural areas compared to urban areas.
METHODS
We conducted an observational study of all suicide deaths that occurred among Newfoundland and Labrador residents between 1997 and 2016 using a linked data set derived from a comprehensive review of provincial medical examiner records. We used tests and χ to assess associations between rural/urban status and variables related to demographics, circumstances, and manner of death, as well as social and medical history. Logistic regression was utilized to assess the independent contribution of any variable found to be significant in univariate analysis.
RESULTS
Rural people who died by suicide accounted for 54.8% of all deaths over a 20-year period. Overall, 81.6% of people who died were male. Compared to urban, rural people who died by suicide were younger, more likely to use firearms or hanging, and had a higher mean blood alcohol content at the time of death (27.69 vs. 22.95 mmol/L). Rural people were also less likely to have had a known history of a prior suicide attempt, psychiatric disorder, alcohol or substance abuse, or chronic pain.
DISCUSSION
The demographic and clinical differences between rural and urban people who died by suicide underscore the need for suicide prevention approaches that account for place-based differences. A key challenge for suicide prevention in rural communities is to ensure that interventions are developed and implemented in a manner that fits local contexts.
Topics: Canada; Firearms; Humans; Male; Newfoundland and Labrador; Observational Studies as Topic; Rural Population; Substance-Related Disorders; Urban Population
PubMed: 33576277
DOI: 10.1177/0706743721990315 -
Heart, Lung & Circulation Oct 2023
Topics: Humans; Defibrillators, Implantable; Device Removal; New Zealand; Pacemaker, Artificial; Retrospective Studies; Treatment Outcome; Observational Studies as Topic
PubMed: 37940214
DOI: 10.1016/j.hlc.2023.10.001 -
The American Journal of Managed Care May 2022Patient assistance programs (eg, co-pay assistance) may reduce patients' out-of-pocket costs for prescription medicines, providing financial assistance to access... (Review)
Review
OBJECTIVES
Patient assistance programs (eg, co-pay assistance) may reduce patients' out-of-pocket costs for prescription medicines, providing financial assistance to access medicines for reduced or no cost. A literature review to identify peer-reviewed articles on studies evaluating the impact of co-pay assistance on clinical, patient, and economic outcomes was conducted.
STUDY DESIGN
A literature review was conducted by searching Embase and MEDLINE.
METHODS
The population of interest was patients who had received co-pay assistance; the intervention was co-pay assistance; comparator was no co-pay assistance; and outcomes were treatment adherence, compliance, discontinuation, interruption, barriers to adherence, and specific therapeutic outcomes. Articles from the United States published between January 2015 and June 2021 were included.
RESULTS
A total of 1249 initial articles were identified, of which 19 published articles representing 12 studies were included. Most studies were retrospective claims analyses (n = 10); there was also 1 randomized controlled trial and 1 prospective and observational study. One article assessed the association between co-pay assistance and patient-reported outcomes, 7 explored the relationship between co-pay assistance and clinical outcomes, and 6 assessed the impact of policy/program changes on co-pay assistance. Co-pay assistance was associated with improved treatment persistence/adherence across various diseases, with limited indirect evidence of this translating into clinical outcomes improvements. Lack of long-term outcomes and uncertainty around program sustainment from co-pay assistance programs are limitations.
CONCLUSIONS
Limited evidence suggests a potential link between co-pay assistance and clinical outcomes; future research addressing study design challenges in measuring the effects of co-pay assistance is needed.
Topics: Humans; Insurance Claim Review; Observational Studies as Topic; Prospective Studies; Retrospective Studies; United States
PubMed: 35546593
DOI: 10.37765/ajmc.2022.89151 -
Journal of Alzheimer's Disease : JAD 2022Longitudinal observational cohort studies are being conducted worldwide to understand cognition, biomarkers, and the health of the aging population better. Cross-cohort... (Review)
Review
Longitudinal observational cohort studies are being conducted worldwide to understand cognition, biomarkers, and the health of the aging population better. Cross-cohort comparisons and networks of registries in Alzheimer's disease (AD) foster scientific exchange, generate insights, and contribute to the evolving clinical science in AD. A scientific working group was convened with invited investigators from established cohort studies in AD, in order to form a research collaboration network as a resource to address important research questions. The Connecting Cohorts to Diminish Alzheimer's Disease (CONCORD-AD) collaboration network was created to bring together global resources and expertise, to generate insights and improve understanding of the natural history of AD, to inform design of clinical trials in all disease stages, and to plan for optimal patient access to disease-modifying therapies once they become available. The network brings together expertise and data insights from 7 cohorts across Australia, Europe, and North America. Notably, the network includes populations recruited through memory clinics as well as population-based cohorts, representing observations from individuals across the AD spectrum. This report aims to introduce the CONCORD-AD network, providing an overview of the cohorts involved, reporting the common assessments used, and describing the key characteristics of the cohort populations. Cohort study designs and baseline population characteristics are compared, and available cognitive, functional, and neuropsychiatric symptom data, as well as the frequency of biomarker assessments, are summarized. Finally, the challenges and opportunities of cross-cohort studies in AD are discussed.
Topics: Aged; Alzheimer Disease; Biomarkers; Cognition; Cohort Studies; Computer Communication Networks; Humans; International Cooperation; Observational Studies as Topic
PubMed: 34776434
DOI: 10.3233/JAD-210525 -
Archives of Physical Medicine and... Apr 2023To systematically review perceptions from adults, children, and caregivers in scientific and open sources to determine how well lower extremity orthotic devices (LEODs)... (Review)
Review
OBJECTIVE
To systematically review perceptions from adults, children, and caregivers in scientific and open sources to determine how well lower extremity orthotic devices (LEODs) meet users' functional, expressive, aesthetic, and accessibility (FEA2) needs.
DATA SOURCES
Scientific source searches were conducted in the National Library of Medicine (PubMed/MEDLINE) and Web of Science; open source searches were conducted in Google Search Engine in April 2020.
STUDY SELECTION
Inclusion criteria were reporting of users' perceptions about a LEOD, experimental or observational study design, including qualitative studies, and full text in English. Studies were excluded if the device only provided compression or perception data could not be extracted. One hundred seventy three scientific sources of 3440 screened were included (total of 1108 perceptions); 36 open sources of 150 screened were included (total of 508 perceptions).
DATA EXTRACTION
Users' perceptions were independently coded by 2 trained, reliable coders.
DATA SYNTHESIS
Across both source types, there were more perceptions about functional needs, and perceptions were more likely to be positive related to functional than expressive, aesthetic, or accessibility needs. Perceptions about expression, aesthetics, and accessibility were more frequently reported and more negative in open vs scientific sources. Users' perceptions varied depending on users' diagnosis and device type.
CONCLUSIONS
There is significant room for improvement in how LEODs meet users' FEA2 needs, even in the area of function, which is often the primary focus when designing rehabilitation devices. Satisfaction with LEODs may be improved by addressing users' unmet needs. Individuals often choose not to use prescribed LEODs even when LEODs improve their function. This systematic review identifies needs for LEODs that are most important to users and highlights how well existing LEODs address those needs. Attention to these needs in the design, prescription, and implementation of LEODs may increase device utilization.
Topics: Adult; Child; Humans; Qualitative Research; Lower Extremity; Orthotic Devices; Observational Studies as Topic
PubMed: 36395874
DOI: 10.1016/j.apmr.2022.10.010 -
Journal of Hepatology Jun 2024Hepatocellular carcinoma (HCC) is the fourth leading cause of cancer death worldwide and its prognosis is highly heterogeneous, being related not only to tumour burden... (Review)
Review
Hepatocellular carcinoma (HCC) is the fourth leading cause of cancer death worldwide and its prognosis is highly heterogeneous, being related not only to tumour burden but also to the severity of underlying chronic liver disease. Moreover, advances in systemic therapies for HCC have increased the complexity of patient management. Randomised-controlled trials represent the gold standard for evidence generation across all areas of medicine and especially in the oncology field, as they allow for unbiased estimates of treatment effect without confounders. Observational studies have many problems that could reduce their internal and external validity. However, large prospective (well-conducted) observational real-world studies can detect rare adverse events or monitor the occurrence of long-term adverse events. How best to harness real world data, which refers to data generated from the routine care of patients, and real-world 'evidence', which is the evidence generated from real-world data, represents an open challenge. In this review article, we aim to provide an overview of the benefits and limitations of different study designs, particularly focusing on randomised-controlled trials and observational studies, to address important and not fully resolved questions in HCC research.
Topics: Humans; Liver Neoplasms; Carcinoma, Hepatocellular; Research Design; Observational Studies as Topic; Randomized Controlled Trials as Topic
PubMed: 38307346
DOI: 10.1016/j.jhep.2024.01.018 -
BMJ Open Jun 2021Stroke is the leading neurological cause of adult long-term disability in Europe. Even though functional consequences directly related to neurological impairment are...
INTRODUCTION
Stroke is the leading neurological cause of adult long-term disability in Europe. Even though functional consequences directly related to neurological impairment are well studied, post-stroke trajectories of functional health according to the International Classification of Functioning, Disability and Health are poorly understood. Particularly, no study investigated the relationship between post-stroke trajectories of activities of daily living (ADL) and self-rated health (SRH). However, such knowledge is of major importance to identify patients at risk of unfavourable courses. This prospective observational study aims to investigate trajectories of ADL and SRH, and their modifying factors in the course of the first year after stroke.
METHODS AND ANALYSIS
The study will consecutively enrol 300 patients admitted to a tertiary care hospital with acute ischaemic stroke or transient ischaemic attack (TIA; Age, Blood Pressure, Clinical Features, Duration of symptoms, Diabetes score ≥3). Patient inclusion is planned from May 2021 to September 2022. All participants will complete an interview assessing ADL, SRH, mental health, views on ageing and resilience-related concepts. Participants will be interviewed face-to-face 1-5 days post-stroke/TIA in the hospital; and will be followed up after 6 weeks, 3 months, 6 months and 12 months via telephone. The 12-month follow-up will also include a neurological assessment. Primary endpoints are ADL operationalised by modified Rankin Scale scores and SRH. Secondary outcomes are further measures of ADL, functional health, physical activity, falls and fatigue. Views on ageing, social support, resilience-related concepts, affect, frailty, illness perceptions and loneliness will be examined as modifying factors. Analyses will investigate the bidirectional relationship between SRH and ADL using bivariate latent change score models.
ETHICS AND DISSEMINATION
The study has been approved by the institutional review board of the University Medicine Greifswald (Ref. BB 237/20). The results will be disseminated through scientific publications, conferences and media. Moreover, study results and potential implications will be discussed with patient representatives.
TRIAL REGISTRATION NUMBER
NCT04704635.
Topics: Activities of Daily Living; Adult; Brain Ischemia; Europe; Humans; Ischemic Attack, Transient; Observational Studies as Topic; Stroke
PubMed: 34187831
DOI: 10.1136/bmjopen-2021-049944