Representativeness of the patients admitted to psychiatric inpatient units for hypothetical participation in practical clinical trial CATIE

2011 ◽  
Vol 26 (S2) ◽  
pp. 1369-1369
Author(s):  
M.C. Díaz ◽  
N. Morales ◽  
K. Nieto ◽  
E. Iniesta ◽  
M.A. Martin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
External Validity ◽  
Psychiatric Inpatient ◽  
Internal Validity ◽  
Clinical Population ◽  
Psychiatric Ward ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Psychiatric Inpatient Unit ◽  
Inpatient Units

IntroductionPharmacological treatment of patients with schizophrenia and other psychoses get scientific backing of its main clinical trials. Methodological guarantees these test tend to strengthen the internal validity of the results at the expense of external validity and the ability to generalize the results to the clinical population. For this reason, and to minimize the shortcomings of external validity while maintaining internal validity, has been promoted in recent years to carry out large clinical trials based on clinical practice. This type of test expands the criteria for inclusion, limiting the exclusion criteria to incorporate as many patients as possible. The first and most significant of these trials was the CATIE trial (Lieberman et al, 2005).ObjectivesDiscuss eligibility patients admitted during the year 2009 in a psychiatric inpatient unit with a diagnosis of schizophrenia for participation in CATIE.MethodsA total of 145 patients (27.6% females, mean age 39.6+/−12.8 years), consecutively admitted to an inpatient psychiatric ward with a clinical diagnosis of schizophrenia or other psychoses were assessed to test if they would fulfill criteria for participation in CATIE.Results60 (41.4%) patients did not fulfill CATIE inclusion criteria. Mental retardation (n = 22, p < 0.001), absence of consent (n = 15, p < 0.001) and refusal to take oral medication (n = 12, p < 0.001) were the main factors responsible for not meeting criteria. Meeting the criteria was not significantly related to gender or specific diagnosis.ConclusionsThe 41.38% of patients did not meet criteria for participation in the CATIE study.

Eligibility of the patients admitted to psychiatric inpatient units for participation in catie clinical trial

2011 ◽  
Vol 26 (S2) ◽  
pp. 1368-1368
Author(s):  
M.C. Diaz ◽  
N. Morales ◽  
J. Ruiz ◽  
K. Nieto ◽  
E. Iniesta ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Psychiatric Inpatient ◽  
Internal Validity ◽  
Inpatient Unit ◽  
Clinical Population ◽  
Psychiatric Ward ◽  
Inclusion Criteria ◽  
Psychiatric Inpatient Unit ◽  
Inpatient Units ◽  
Real Patients

IntroductionClinical trials (CT) are the main scientific support of the recommendations of pharmacological treatment of patients with schizophrenia. However, CT tend to strengthen the internal validity at the expense of external validity and the ability to generalize the results to the clinical population. For this reason, in recent years have developed large practical clinical trials that expand the inclusion criteria to incorporate as many real patients as possible. The first and most significant of these trials was the CATIE study (Lieberman et al, 2005).ObjectivesTo analyze eligibility for participation in CATIE of patients admitted during 2009 in a psychiatric inpatient unit with a diagnosis of schizophrenia.MethodsA total of 145 patients (27.6% females, mean age 39.6+/−12.8 years), consecutively admitted to an inpatient psychiatric ward with a clinical diagnosis of schizophrenia were assessed to test if they would fulfill criteria for participation in CATIE.Results60 (41.4%) patients did not fulfill CATIE inclusion criteria. Mental retardation (n = 22, p < 0.001), absence of informed consent (n = 15, p < 0.001) and refusal to take oral medication (n = 12, p < 0.001) were the main factors responsible for not meeting inclusion criteria.Meeting the criteria was not significantly related to gender or specific diagnosis.Conclusions41.4% of patients admitted to a psychiatric inpatient unit with a diagnosis of schizophrenia did not meet criteria for participation in the CATIE study.

scholarly journals Critical Appraisal on the Selection Criteria for Evidence-based Healthcare

2021 ◽  
Author(s):  
Paulo Cesar Morales Mayer ◽  
Caroline Amélia Gonçalves ◽  
Franz Porzsolt
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials ◽  
Selection Criteria ◽  
Human Subjects ◽  
Evidence Based ◽  
Inclusion Criteria ◽  
Pragmatic Trials ◽  
Exclusion Criteria ◽  
Policy Makers ◽  
Evidence Based Healthcare

Abstract Background: Evidence-Based healthcare deals basically with published clinical trials to guide the decision making on what treatment to use for any specific conditions.Aims: The present paper assessed the inclusion and exclusion criteria used in clinical trials of cervical cancer aiming at establishing a clear distinction between each criterion.Methods: We performed a bibliographical search in pubmed with the terms cervical cancer and treatment or therapy filtered for clinical trials with human subjects for the last ten years. A total of 30 papers were used extracting and classifying the inclusion and exclusion category according to the characteristic they described. Results: We found no clear parameter to establish which criteria could exclusively serve as inclusion or exclusion across the papers, about 56% of the categories identified were found either listed as inclusion or exclusion criteria or even as both in some cases.Conclusions: The key issue of selection criteria is not in its form but in its function, the first point to consider is if the trial is experimental (focused on efficacy and proof of principle) or observational (pragmatic trials, focused on effectiveness and real world conditions). We suggest, inclusion criteria should be broad, focused on the investigated condition; exclusion criteria should apply only to the subset of this “included” population, and do not take part in observational studies. These conclusions do not serve only for researchers but should affect practitioners and policy makers to correctly compare the results of investigated treatment.

Repurposing Ruxolitinib in Combating COVID-19: a mini review

2021 ◽  
Vol 02 ◽  
Author(s):  
Inshia Begum ◽  
Fathima Murthuza ◽  
Juwairiya Syed Iqbaluddin ◽  
Hafsah Fatima Arsal
Keyword(s):  
Clinical Trials ◽  
Severity Of Illness ◽  
Current Evidence ◽  
Public Healthcare ◽  
Inclusion Criteria ◽  
Research Papers ◽  
Exclusion Criteria ◽  
Mixed Treatment ◽  
Marked Selectivity ◽  
Insight Into

Background: The pandemic caused by Coronavirus Disease 2019 (COVID-19), also known as Severe Acute Respiratory Syndrome-Related Coronavirus (SARS-CoV-2), is believed to be one of the greatest threats to global health in the 21st century. Recent collective evidence has warranted Ruxolitinib as a potential agent in recovery. Ruxolitinib is a potent and selective inhibitor of Jack kinase (JAK) 1 and 2 with modest to marked selectivity against tyrosine kinase two and JAK3. Objective: The review aims to outline the current evidence regarding the repurposed treatment for COVID- 19 and give insight into the clinical trials. There has been considerable interest in introducing existing therapeutic agents against COVID-19 to reduce the severity of illness and ease the burden on public healthcare systems. Method: A literature search was conducted using keywords like ‘Ruxolitinib trial’ and ‘COVID-19 Ruxolitinib’ on PubMed, Google Scholar, Science Direct, and Cochrane databases to select research papers and articles on the topic published from January to October 2020. Inclusion criteria were restricted to articles on Ruxolitinib and COVID. In contrast, the exclusion criteria stipulated that any study done on COVID-19 involving a mixed treatment regimen with Ruxolitinib and other drug/s or any studies not pertinent to the purpose of the study would be omitted. Conclusion: Based on the successful outcomes of various researches conducted and clinical trials performed, the use of Ruxolitinib has shown significant improvement and faster clinical recovery among COVID-19 patients of varying severity of infection, advanced age, and multiple comorbidities. This review provides an overview of various such studies with their promising outcomes.

A Focus on Evaluating Major Study Limitations in Order to Apply Clinical Trials to Patient Care: Implications for the Healthcare Team

2020 ◽  
pp. 001857872093175
Author(s):  
Mary J. Ferrill ◽  
Alireza FakhriRavari ◽  
Lisa Hong ◽  
Jody Jacobson Wedret
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Patient Care ◽  
External Validity ◽  
Healthcare Providers ◽  
Internal Validity ◽  
Healthcare Team ◽  
Evidence Based ◽  
Major Study ◽  
Clinically Significant

Background: With more than a million new biomedical articles published annually, healthcare providers must stay up to date in order to provide optimal evidence-based patient care. The concise ROOTs (relevance, observe validity, obtain clinically significant results, and translate results to clinical practice) format is a valuable tool to assist with literature evaluation. Purpose: To illustrate how major study limitations found in clinical trials might inhibit the ability to adopt the findings of such studies to patient care. Methods: Examples from published clinical trials that contain major study flaws were used to illustrate, if taken at face value, would lead to erroneous assumptions, and if adopted, could potentiallly harm patients. Conclusion: When evaluating the literature, it is crucial to identify limitations in the published literature that might reduce the internal validity, affect the results, or limit the external validity of clinical trials, hence affecting the usability of literature for patient care. This article provides examples of clinical trials that contain major study limitations with potentially erroneous assumptions. These illustrations are meant to show how important it is to delve deeper into an article before conclusions are drawn.

Identification of the causes that influence recruitment in oncology clinical trials (OCT)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17562-e17562
Author(s):  
L. E. Fein ◽  
A. Romera ◽  
C. M. Micheri ◽  
M. I. Diaz ◽  
R. A. Sala
Keyword(s):  
Clinical Trials ◽  
Data Analysis ◽  
Informed Consent ◽  
Distant Metastases ◽  
Patient Recruitment ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Measurable Disease ◽  
Oncology Clinical Trials ◽  
Clinical Records

e17562 Background: Prediction of patient recruitment in OCT is one of the most important variables to guarantee timely closure of the trial. Earlier data analysis and conclusions define further research or discontinuation of the development of a given drug. Methods: Retrospective analysis of the recruitment and clinical records of all the patients of the COR that were contacted to participate in an OCT from 2006 to 2008 to identify the causes according to which patients did not participate. Results: Total of candidates 346, 175 women (50.6%). Average age 60 years (range 36 to 89). 42 patients (12%) rejected to participate in an OCT. 80 patients (23%) were screening failures (SF). 59 patients (17%) for not fulfilling an inclusion criteria (IC). Non appropriate stage or absence of measurable disease at screening (35%), abnormal labs (14%) and state of receptors or biomarkers (9%). Total of clinically unpredictable IC SF was 57.5%. 21 patients (6%) were SF due to an exclusion criteria (EC). Presence of distant metastases (12,5%), abnormal labs (2.5%) and abnormal EKG (2.5%). Total of clinically unpredictable EC SF was 19%. Conclusions: 35% of candidate patients did not participate. The most frequent cause was SF (23%). 76.5% of these SF were impossible to determine when informed consent was signed. 12% of patients rejected to participate for different reasons. Our results did not identify a predominant modifiable reason to improve recruitment. For future feasibility analyses our estimation of 35% dropout will be considered standard. [Table: see text] No significant financial relationships to disclose.

Frequent users of an acute psychiatric inpatient unit: A 5-year retospective study

2011 ◽  
Vol 26 (S2) ◽  
pp. 518-518
Author(s):  
G. Cardoso ◽  
J. Graça ◽  
C. Klut ◽  
S. Xavier ◽  
A. Neto ◽  
...  
Keyword(s):  
Psychiatric Diagnosis ◽  
Psychiatric Inpatient ◽  
Inpatient Unit ◽  
Small Subset ◽  
Frequent User ◽  
Frequent Users ◽  
Psychiatric Inpatient Unit ◽  
Group Frequency ◽  
Inpatient Units ◽  
Depressive Patients

IntroductionA small subset of patients with above average admissions to psychiatric inpatient units is recognized in clinical practice. These frequent users tend to be younger and to have a diagnosis of schizophrenia or affective disorder. Social conditions and the severity of the illness seem to be associated with this increased number of admissions.Aims/ObjectivesTo study demographic and clinical characteristics of frequent and non-frequent users of a psychiatric inpatient unit.MethodsRetrospective data of all the patients admitted to a psychiatric inpatient unit from January 2004 to December 2008 were reviewed. Frequent-users were defined as patients with 3 or more admissions over that period of time, and non-frequent users as those with less than 3 admissions. The two groups were compared in terms of age, gender, ethnicity, psychiatric diagnosis and compulsory admissionsResultsIn a total of 2018 admissions and 1348 patients, the frequent-user group represented 10.2% (n = 137) of the patients and 28.9%(n = 584) of the admissions. Frequent-users were significantly younger (39.5 vs. 44.5 years, p = .001), more frequently black (22.6 vs. 19.4%, p < .001) and compulsorily admitted (27.7 vs. 14%, p < .001) than non-frequent users. Patients with bipolar disorder (p = .001), schizophrenia (p = .003) belonged significantly more to frequent-users group, while unipolar depressive patients (p = .016) and other diagnosis (p = .011) was more significantly represented in the non-frequent users group. Frequency of admission did not differ with gender.ConclusionsThe results concerning age and psychiatric diagnosis are consistent with previous studies. Compulsory admissions and black ethnicity were significantly higher among frequent- users.

Healthy lifestyles programme in an acute psychiatric inpatient unit

2017 ◽  
Vol 41 (S1) ◽  
pp. S379-S380
Author(s):  
I. Ganhao ◽  
M. Trigo ◽  
A. Paixao ◽  
J. Cardoso
Keyword(s):  
Weight Control ◽  
Psychiatric Inpatient ◽  
Mental Healthcare ◽  
Healthcare Services ◽  
Inpatient Unit ◽  
Healthy Lifestyles ◽  
Caffeine Consumption ◽  
Complex Needs ◽  
Psychiatric Inpatient Unit ◽  
Inpatient Units

IntroductionMental health issues and illnesses are associated with poor self-care and unhealthy lifestyles that contribute to morbidity, mortality and overall decrease in quality of life when compared to the general population. Healthy lifestyle promotion is infrequently considered a priority in mental healthcare services, especially in acute psychiatric inpatient units.ObjectivesTo present a healthy lifestyles promotion programme implemented in an acute psychiatric inpatient unit.AimsTo reflect on how to design an adequate programme for patients with complex needs.MethodsIn a general psychiatric inpatient unit, a team of two psychologists and one psychiatrist, ventured to introduce weekly activities that included drawing, colouring, painting, crafts and games, that provided a context for patients and the team to sit down together or to gradually “drift” together and make possible conversations focusing on tobacco smoking, caffeine consumption, weight control, physical activity and health promoting activities.ResultsInstead of individual or group psychoeducation talk interventions, play and art strategies, in closer proximity with the patients, made it far easier to engage difficult patients and made psychoeducation possible and fun.ConclusionsPatients with severe mental illness are frequently reluctant to engage in activities targeting healthy lifestyles, especially in acute psychiatric inpatient units, when insight and motivation for change may be low due to illness and consequences of illness. Play and art therapy interventions led by a team of mental healthcare professionals who participate directly with the patients, may be an innovative, more effective and enjoyable strategy.Disclosure of interestThe authors have not supplied their declaration of competing interest.

The challenges of facilitating a mindfulness programme in a psychiatric inpatient unit

2015 ◽  
Vol 33 (4) ◽  
pp. 265-267
Author(s):  
D. Lavin
Keyword(s):  
Mental Health ◽  
Psychiatric Inpatient ◽  
Acute Stage ◽  
Inpatient Unit ◽  
Mental Health Setting ◽  
Exclusion Criteria ◽  
Training Requirements ◽  
Inpatient Mental Health ◽  
Psychiatric Inpatient Unit ◽  
Mental Health Difficulties

Facilitating mindfulness programmes within an inpatient mental health setting is discussed. The difficulty in effectively engaging patients at this acute stage in their illness is focussed upon. Other challenges discussed are identifying appropriate inclusion and exclusion criteria; identifying the optimal programme format for this setting; promoting mindfulness within the environment of the inpatient unit and the training requirements for programme facilitators. The article concludes that due attention should be given to these challenges in order to maintain the integrity of mindfulness as an effective intervention for mental health difficulties.

scholarly journals Maximum Temperature and Solar Radiation as Predictors of Bipolar Patient Admission in an Emergency Psychiatric Ward

2019 ◽  
Vol 16 (7) ◽  
pp. 1140 ◽  
Author(s):  
Andrea Aguglia ◽  
Gianluca Serafini ◽  
Andrea Escelsior ◽  
Giovanna Canepa ◽  
Mario Amore ◽  
...  
Keyword(s):  
Solar Radiation ◽  
Psychiatric Inpatient ◽  
Bipolar Patient ◽  
Primary Diagnosis ◽  
Meteorological Variables ◽  
Maximum Temperature ◽  
Psychiatric Ward ◽  
Psychiatric Inpatient Unit ◽  
Bipolar Patients ◽  
The Impact

Environmental variables can regulate behavior in healthy subjects. Recently, some authors investigated the role of meteorological variables in bipolar patients with an impact on both the onset and course of bipolar disorder (BD). The aim of this study was to investigate the impact of meteorological variables and other indexes in bipolar hospitalized patients. We examined all patients admitted to the Psychiatric Inpatient Unit of San Luigi Gonzaga Hospital, Orbassano (Turin, Italy) from September 2013 to August 2015, collecting several socio-demographic and clinical characteristics. Seven hundred and thirty patients were included. Compared to the day of admission of control individuals, patients with BD were admitted on a day that presented higher minimum, medium, and maximum temperature, higher maximum humidity, higher solar radiation, and higher hours of sunshine. After logistic regression analysis, admissions to the emergency psychiatric ward due to a primary diagnosis of BD were associated with maximum temperature and solar radiation. The current study provides a novel perspective on the question surrounding seasonal mood patterns in patients with BD. A greater awareness of all possible precipitating factors is needed to inform self-management and psycho-educational programs as well as to improve resilience regarding affective recurrences in the clinical practice.

Quality of life measurements in major depression

1996 ◽  
Vol 11 (3) ◽  
pp. 123-126 ◽  
Author(s):  
P Bech
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Major Depression ◽  
External Validity ◽  
Randomized Clinical Trials ◽  
Internal Validity ◽  
Efficacy And Safety ◽  
Quality Of Life Measurements

SummaryIn randomized clinical trials in patients with major depression quality of life is considered as an important dimension of treatment outcome in relation to clinical efficacy and safety. The internal validity, reliability, as well as external validity of quality of life scales have been analysed. It is concluded that such scales have their most appropriate applicability in medicine and long-term trials with antidepressants.

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