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Neuropsychiatrie : Klinik, Diagnostik,... Dec 2023Systematic reviews indicated that home treatment is an effective and cost-saving alternative to conventional acute psychiatric treatment options. Treatment success has...
Study protocol of an observational study in acute psychiatric home treatment: How does home treatment work? Identification of common factors and predictors of treatment success.
BACKGROUND
Systematic reviews indicated that home treatment is an effective and cost-saving alternative to conventional acute psychiatric treatment options. Treatment success has often been defined as a reduction of hospital admissions. In the current study, symptoms and well-being are assessed regularly during treatment as an indicator for treatment success. Patients' characteristics such as diagnosis, age, substance use, and motivation for treatment were discussed as predictors for treatment success. A second focal point of the study lies in the examination of the therapeutic relationship in terms of the outcome, which has not yet been systematically investigated in home treatment.
METHODS
This is an observational study with a prospective naturalistic design. Measurements are carried out at baseline, during and at the end of treatment as well as at the 3‑month follow-up. Patients' characteristics as potential predictors for treatment success will be assessed at baseline. In addition, the perceived relationship between the patients and the team will be measured daily and weekly throughout the treatment. Treatment success is by the changes in symptoms and general well-being assessed weekly. We aim to include 82 participants assigned to home treatment. Variance analyses with repeated measurements will be conducted to evaluate treatment success.
CONCLUSION
By examining potential patient- and relationship-related predictors of treatment success, insights into relevant determining variables of treatment success in this setting are expected. The results might help to better identify who benefits the most from home treatment.
Topics: Humans; Prospective Studies; Treatment Outcome; Hospitalization; Substance-Related Disorders; Motivation; Observational Studies as Topic
PubMed: 36941465
DOI: 10.1007/s40211-023-00457-0 -
Pharmacoepidemiology and Drug Safety Feb 2018Lack of control for time-varying exposures can lead to substantial bias in estimates of treatment effects. The aim of this study is to provide an overview and guidance... (Review)
Review
PURPOSE
Lack of control for time-varying exposures can lead to substantial bias in estimates of treatment effects. The aim of this study is to provide an overview and guidance on some of the available methodologies used to address problems related to time-varying exposure and confounding in pharmacoepidemiology and other observational studies. The methods are explored from a conceptual rather than an analytical perspective.
METHODS
The methods described in this study have been identified exploring the literature concerning to the time-varying exposure concept and basing the search on four fundamental pharmacoepidemiological problems, construction of treatment episodes, time-varying confounders, cumulative exposure and latency, and treatment switching.
RESULTS
A correct treatment episodes construction is fundamental to avoid bias in treatment effect estimates. Several methods exist to address time-varying covariates, but the complexity of the most advanced approaches-eg, marginal structural models or structural nested failure time models-and the lack of user-friendly statistical packages have prevented broader adoption of these methods. Consequently, simpler methods are most commonly used, including, for example, methods without any adjustment strategy and models with time-varying covariates. The magnitude of exposure needs to be considered and properly modelled.
CONCLUSIONS
Further research on the application and implementation of the most complex methods is needed. Because different methods can lead to substantial differences in the treatment effect estimates, the application of several methods and comparison of the results is recommended. Treatment episodes estimation and exposure quantification are key parts in the estimation of treatment effects or associations of interest.
Topics: Bias; Data Interpretation, Statistical; Drug-Related Side Effects and Adverse Reactions; Humans; Observational Studies as Topic; Pharmacoepidemiology; Practice Guidelines as Topic; Study Guides as Topic; Time Factors; Treatment Outcome
PubMed: 29285840
DOI: 10.1002/pds.4372 -
BMJ Open Oct 2023The relationship of acute right heart dysfunction (RHD) with long-term cardiopulmonary dysfunction and its' associated morbidity has not been clearly elucidated. We...
INTRODUCTION
The relationship of acute right heart dysfunction (RHD) with long-term cardiopulmonary dysfunction and its' associated morbidity has not been clearly elucidated. We propose a prospective, observational study to assess the natural history of acute RHD using a combination of imaging, functional and qualitative assessment methods, including the recently described combination of simultaneous maximal effort cardiopulmonary exercise testing and stress echocardiography.
METHODS AND ANALYSIS
We propose a single-centre study of patients ≥18 years admitted to either the intensive care or respiratory close observation units with RHD on transthoracic echocardiography (TTE). Participants will undergo a repeat TTE ~72 hours after the initial study, with a final TTE performed prior to discharge in patients who have a prolonged (>1 week) stay. Inpatient clinical, biochemical and therapeutic indices will be collected contemporaneously. At ~6 months postdischarge, participants will undergo evaluation with validated symptom assessment tools (Dyspnoea-12 and PAH-SYMPACT Questionnaires) and a combined maximal effort cardiopulmonary exercise test and stress echocardiogram. This study is an observational, hypothesis-generating study with a recruitment target of 100 patients established based on typical admission rates of the relevant hospital departments. Measures of central tendency and dispersion will be used to describe the cohort. Inferential statistics will be used to compare the two a priori defined groups of those whose RHD had resolved prior to hospital discharge and those whose dysfunction persisted at time of discharge.
ETHICS AND DISSEMINATION
This study has received ethics approval from the local ethics committee (Nepean and Blue Mountains Local Health District approval, project 2021/ETH12111). Written informed consent will be sought from all patients prior to recruitment. The results will be submitted for publication in a relevant peer-reviewed journal and presented at an appropriate national/international conference.
STUDY REGISTRATION
Australian New Zealand Clinical Trials Registry, ANZCTR12623000309684.
Topics: Humans; Prospective Studies; Aftercare; Patient Discharge; Australia; Echocardiography; Observational Studies as Topic
PubMed: 37848309
DOI: 10.1136/bmjopen-2023-074571 -
Research and Reporting Considerations for Observational Studies Using Electronic Health Record Data.Annals of Internal Medicine Jun 2020Electronic health records (EHRs) are an increasingly important source of real-world health care data for observational research. Analyses of data collected for purposes... (Review)
Review
Electronic health records (EHRs) are an increasingly important source of real-world health care data for observational research. Analyses of data collected for purposes other than research require careful consideration of data quality as well as the general research and reporting principles relevant to observational studies. The core principles for observational research in general also apply to observational research using EHR data, and these are well addressed in prior literature and guidelines. This article provides additional recommendations for EHR-based research. Considerations unique to EHR-based studies include assessment of the accuracy of computer-executable cohort definitions that can incorporate unstructured data from clinical notes and management of data challenges, such as irregular sampling, missingness, and variation across time and place. Principled application of existing research and reporting guidelines alongside these additional considerations will improve the quality of EHR-based observational studies.
Topics: Data Collection; Electronic Health Records; Humans; Observational Studies as Topic; Primary Health Care
PubMed: 32479175
DOI: 10.7326/M19-0873 -
Andrology Jan 2018Semen quality and male fertility are declining worldwide. As it was observed that physiologic and pathologic processes of spermatogenesis can be influenced by diet, the... (Review)
Review
Semen quality and male fertility are declining worldwide. As it was observed that physiologic and pathologic processes of spermatogenesis can be influenced by diet, the relation between dietary habits and semen parameters has been the focus of much interest. To review the human observational studies on this issue, we performed a systematic literature search, up to November 2016 (MEDLINE and EMBASE). We included all observational full-text papers reporting the relation between dietary habits and semen parameters. Article selection was carried out in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Twenty-three observational studies were included. Overall, 8477 healthy men and 1204 men presenting at Fertility Clinics were included in the selected studies. Even if some inconsistencies are present, possibly due to the different effect of nutrients in fertile and infertile men, results support the hypothesis that diets including fruit and vegetables, for their contents in vitamins, and fish or low-fat dairy products as the main source of proteins, are associated with better semen quality. Recommendations may be confidently provided because of the many beneficial effects of a healthy diet, although further studies are needed to clarify the currently inconsistent findings and to shed light on the underlying mechanisms.
Topics: Diet; Humans; Male; Observational Studies as Topic; Semen Analysis
PubMed: 29266782
DOI: 10.1111/andr.12452 -
BMJ Open Jun 2021The involvement of the vestibular system in the motor and higher (cognitive) performances of typically developing or vestibular-impaired children is currently unknown or...
INTRODUCTION
The involvement of the vestibular system in the motor and higher (cognitive) performances of typically developing or vestibular-impaired children is currently unknown or has only scarcely been explored. Interestingly, arguments for an interaction between vestibular, motor and cognitive functions in children can also be supported by research on children known for their difficulties in motor and/or cognitive processing (eg, children with neurodevelopmental disorders (NDD)), as they often present with vestibular-like characteristics. Therefore, in order to elucidate this interaction, and to increase the understanding of the pathophysiology and symptomatology of vestibular disorders and NDD in children, the Balanced Growth project was developed. It includes the following objectives: (1) to understand the association between motor skills, cognitive performances and the vestibular function in typically developing school-aged children, with special focus on the added value of the vestibular system in higher cognitive skills and motor competence; (2) to investigate whether a vestibular dysfunction (with/without an additional auditory disease) has an impact on motor skills, cognitive performances and motor-cognitive interactions in children and (3) to assess if an underlying vestibular dysfunction can be identified in school-aged children with NDD, with documentation of the occurrence and characteristics of vestibular dysfunctions in this group of children using an extensive vestibular test battery.
METHODS AND ANALYSIS
In order to achieve the objectives of the observational cross-sectional Balanced Growth study, a single-task and dual-task test protocol was created, which will be performed in three groups of school-aged children (6-12 years old): (1) a typically developing group (n=140), (2) (audio) vestibular-impaired children (n=30) and (3) children with an NDD diagnosis (n=55) (ie, autism spectrum disorder, attention deficit/hyperactivity disorder and/or developmental coordination disorder). The test protocol consists of several custom-made tests and already existing validated test batteries and includes a vestibular assessment, an extensive motor assessment, eight neurocognitive tests, a cognitive-motor interaction assessment and includes also additional screenings to control for potential confounding factors (eg, hearing status, intelligence, physical activity, etc).
ETHICS AND DISSEMINATION
The current study was approved by the ethics committee of Ghent University Hospital on 4 June 2019 with registration number B670201940165 and is registered at Clinical Trials (clinicaltrials.gov) with identifier NCT04685746. All research findings will be disseminated in peer-reviewed journals and presented at vestibular as well as multidisciplinary international conferences and meetings.
TRIAL REGISTRATION NUMBER
NCT04685746.
Topics: Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Child; Cognition; Cross-Sectional Studies; Humans; Observational Studies as Topic; Vestibular Diseases
PubMed: 34117049
DOI: 10.1136/bmjopen-2021-049165 -
Journal of Crohn's & Colitis Nov 2023Participatory research, also referred to as patient and public involvement, is an approach that involves collaborating with patients affected by the focus of the... (Review)
Review
Participatory research, also referred to as patient and public involvement, is an approach that involves collaborating with patients affected by the focus of the research, on the design, development and delivery of research to improve outcomes. There are two broad justifications for this: first, that it enhances the quality and relevance of research, and second, that it satisfies the ethical argument for patient inclusion in decisions about them. This synergistic and collaborative effort, which bridges the divide between researchers and participants with the lived condition, is now a mainstream activity and widely accepted as best practice. Although there has been a substantial increase in the literature over the past two decades, little has been published on how participatory research has been used in inflammatory bowel disease [IBD] research and little guidance as to how researchers should go about this. With an increasing incidence and prevalence worldwide, combined with declining study enrolment in an era of perennial unmet need, there are a multitude of benefits of participatory research to IBD patients and investigators, including research output that is informed and relevant to the real world. A key example of participatory research in IBD is the I-CARE study, a large-scale, pan-European observational study assessing the safety of advanced therapies, which had significant patient involvement throughout the study. In this review, we provide a comprehensive overview of the benefits and challenges of participatory research and discuss opportunities of building strategic alliances between IBD patients, healthcare providers and academics to strengthen research outcomes.
Topics: Humans; Inflammatory Bowel Diseases; Patient Participation; Observational Studies as Topic
PubMed: 37220886
DOI: 10.1093/ecco-jcc/jjad090 -
F1000Research 2020The post-anesthesia care unit (PACU) is a clinical area designated for patients recovering from invasive procedures. There are typically several geographically...
The post-anesthesia care unit (PACU) is a clinical area designated for patients recovering from invasive procedures. There are typically several geographically dispersed PACUs within hospitals. Patients in the PACU can be unstable and at risk for complications. However, clinician coverage and patient monitoring in PACUs is not well regulated and might be sub-optimal. We hypothesize that a telemedicine center for the PACU can improve key PACU functions. The objective of this study is to demonstrate the potential utility and acceptability of a telemedicine center to complement the key functions of the PACU. These include participation in hand-off activities to and from the PACU, detection of physiological derangements, identification of symptoms requiring treatment, recognition of situations requiring emergency medical intervention, and determination of patient readiness for PACU discharge. This will be a single center prospective before-and-after proof-of-concept study. Adults (18 years and older) undergoing elective surgery and recovering in two selected PACU bays will be enrolled. During the initial three-month observation phase, clinicians in the telemedicine center will not communicate with clinicians in the PACU, unless there is a specific patient safety concern. During the subsequent three-month interaction phase, clinicians in the telemedicine center will provide structured decision support to PACU clinicians. The primary outcome will be time to PACU discharge readiness determination in the two study phases. The attitudes of key stakeholders towards the telemedicine center will be assessed. Other outcomes will include detection of physiological derangements, complications, adverse symptoms requiring treatments, and emergencies requiring medical intervention. This trial is registered on clinicaltrials.gov, NCT04020887 (16 July 2019).
Topics: Adult; Anesthesia; Humans; Monitoring, Physiologic; Observational Studies as Topic; Patient Discharge; Prospective Studies; Telemedicine
PubMed: 33214879
DOI: 10.12688/f1000research.26794.1 -
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 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