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.

Abstract TP10: Selection Criteria, Is The Clue To Successful Thrombectomy?

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Pedro Cardona ◽  
Helena Quesada ◽  
Luis Cano ◽  
Lucia Aja ◽  
De Miquel MA. ◽  
...  
Keyword(s):  
Acute Stroke ◽  
Functional Outcome ◽  
Selection Criteria ◽  
Intravenous Thrombolysis ◽  
Correct Selection ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Stroke Treatment

In our comprehensive stroke center we analyze correct selection criteria to use self-expandable retrievable intracranial stents for acute stroke treatment. The criteria for intervention were the onset of neurological symptoms, a National Institute of Health Stroke Scale Score (NIHSS) ≥9 at presentation, large vessel occlusion stroke demonstrated by angio-CT, and failure of intravenous thrombolysis or exclusion criteria to administrate it. METHODS: We performed an retrospective analysis of 512 consecutive patients with acute ischemic stroke candidates for thrombectomy, from April of 2010 to June of 2012, that met inclusion criteria for intervention. Experienced vascular neurologists selected 171 patients to undergoing endovascular therapy using retrievable stents (Solitaire,Trevo). Successful recanalization results were assessed by follow-up angiography immediately after the procedure (TIMI 2-3/TICI 2b-3 score), and good functional outcome was considered when ≤2 mRankin score (mRS) was achieved at 90 days. RESULTS: A total of 171 patients were treated, 87% with anterior circulation stroke. The mean age was 67.5 years (range 32-87); 58% men. The median NIHSS at presentation was 17 (range 6-26). Recanalization (TICI 2b-3) was achieved in 73% of patients. Symptomatic hemorrhage occurred in 8%. Ninety-day mortality was 19, 5% and good 90-day functional outcome (mRS ≤2) was achieved by 45%. Unsuccessful recanalization (TICI 0-2a) was a significant predictor of poor outcome (mRS≤2: 9%). When we analyzed these patients according to inclusion criteria of IMS trial, 101 patients who met strict criteria achieved good neurological outcome more frequently (51% versus 34%) and significant lower mortality rates (17% vs 28%) compared with the group of 70 patients with IMS exclusion criteria. CONCLUSIONS: Efficacy in recanalization, safety of thrombectomy and its consequent good clinical outcome is sufficiently established. It is important an experienced vascular neurologist to select possible candidates (proportion of evaluated/treated patients 3:1). Inclusion criteria for acute stroke trials do not always represent real population of stroke patients as well as their clinical results.

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.

scholarly journals Bobble Head Doll Syndrome: what have we described in the scientific literature?

2021 ◽  
Author(s):  
Felipe dos Santos Souza ◽  
Alvaro Moreira Rivelli
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Selection Criteria ◽  
Scientific Literature ◽  
Case Reports ◽  
Dorsomedial Nucleus ◽  
Specific Knowledge ◽  
Exclusion Criteria ◽  
The Third ◽  
Repetitive Movements

Introduction: The bobble head syndrome (BHDS) is described in the literature as a complex and rare syndrome with repetitive movements of the anteroposterior head. Furthermore, it is known that this movement disorder is due to the effect of pressure from the third dilated ventricle, which distorts the red dorsomedial nucleus and the dentatorubrotalamic pathways. Objective: to evaluate the number of studies on the syndrome and, added to the findings, describe the manifestations about the Bobble Head Doll Syndrome, elucidating the main neurological exams, treatments used and reported prognoses, in order to make it a potential diagnosis in children who present a compatible clinic. Methodology: a systematic review based on databases (SCIELO <LILACS and PUBMED), using the PRISMA method with the following descriptor: Bobble Head Doll Syndrome. The selection criteria included: studies made available in full, case reports, reviews and clinical trials. Exclusion criteria: articles not available in full, duplicates and works that only touched on the theme. Results: it was found in the scientific literature, PUBMED: 52 studies and SCIELO: 0. SCIELO: 2. Conclusions: the articles selected based on the established criteria showed a significant scientific scarcity around the Bobble Head Doll Syndrome. The dissemination of new studies and documentation of case reports is essential in understanding both the general syndrome and the specific knowledge of the procedures in which neurologists must take it. In this sense, the epidemiology is approximately between 2 and less than 5 years of age in children.

scholarly journals DIFFERENCE IN BLOOD FUNCTION TOXICITY BETWEEN STADIUM IIB-IIIB SQUAMOUS CELL CERVICAL CANCER PATIENTS WITH PACLITAXEL CISPLATIN AND PACLITAXEL CARBOPLATIN CHEMOTHERAPY AT SANGLAH HOSPITAL, DENPASAR.

2018 ◽  
Vol 11 (1) ◽  
pp. 224
Author(s):  
Indrayathi Pa ◽  
Noviyani R ◽  
Niruri R ◽  
Budiana Ing ◽  
Tunas K
Keyword(s):  
Cervical Cancer ◽  
Observational Research ◽  
Hematologic Toxicity ◽  
Inclusion Criteria ◽  
Cancer Treatments ◽  
Exclusion Criteria ◽  
Consecutive Sampling ◽  
Normality Test ◽  
Before And After ◽  
The Difference

 Objective: Paclitaxel cisplatin and paclitaxel carboplatin were chemotherapy regimens used for cervical cancer treatments at Sanglah Hospital, Denpasar. They came with hematologic toxicity side effects. This could be monitored from hemoglobin, thrombocyte, and leukocyte parameter. Data that compared the toxicity of these two regimens were still limited at Sanglah Hospital, Denpasar. Therefore, it was necessary to conduct a research about the difference in blood function toxicity between patients who underwent paclitaxel cisplatin chemotherapy and those who underwent paclitaxel carboplatin chemotherapy based on those three parameters.Methods: This was a prospective observational research with consecutive sampling, inclusion, and exclusion criteria. It was carried out from January to August 2016 at Sanglah Hospital, Denpasar. Patients were categorized into two groups based on their chemotherapy regimens. Next, blood samples from both groups were tested for its hemoglobin, thrombocyte, and leukocyte level before and after chemotherapy. The data underwent normality test using either Shapiro–Wilk or Mann–Whitney test with SPSS.Results: There were 17 patients who fulfilled the inclusion criteria. The result showed a decrease in hemoglobin, thrombocyte, as well as leukocyte values in patients who underwent paclitaxel cisplatin and paclitaxel carboplatin chemotherapy.Conclusion: The decrease of both hemoglobin and leukocyte level was not meaningful in both groups (p>0.05). Meanwhile, the decrease of thrombocyte level was meaningful in both groups (*p<0.05) in which patients who belong to paclitaxel carboplatin chemotherapy group showed a higher decrease of thrombocyte values.

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.

The Protection of the Person is Central in CIOMS International Ethical Guidelines

2014 ◽  
Vol 3 (4) ◽  
pp. 270-272
Author(s):  
Michel Vallotton ◽  
Sian Fluss ◽  
Gian Sjolin Forsberg
Keyword(s):  
Clinical Trials ◽  
Selection Criteria ◽  
Meta Analysis ◽  
Epidemiological Studies ◽  
Nongovernmental Organization ◽  
Evidence Based ◽  
Ethical Guidelines ◽  
The Subject ◽  
Based Medicine ◽  
And Storage

In this brief article the authors report on the objectives of this nongovernmental organization and, most particularly, on the protection of the person in its International Ethical Guidelines for the fields of clinical trials and epidemiological studies. They emphasize the terminology used to describe the subjects or the populations involved in these studies. They discuss the possibility and nature of harm to persons involved in such studies, and justify the requirement for informed consent also for the persons involved in epidemiological studies. Finally, they consider the roles of such trials and studies as the basis for evidence-based medicine, including cases when their results are pooled in meta-analysis. This methodology is the subject of examination by a CIOMS Working Group of  problems concerning identification and selection criteria, analysis and interpretation of results (including unpublished results), and storage of data.

The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives

2003 ◽  
Vol 31 (3) ◽  
pp. 398-418 ◽  
Author(s):  
Trudo Lemmens ◽  
Paul B. Miller
Keyword(s):  
Clinical Trials ◽  
Human Subjects ◽  
Legal Issues ◽  
Exclusion Criteria ◽  
Research Results ◽  
The Past ◽  
Ethical And Legal Issues ◽  
Commercial Research

Over the past 5 years, a series of articles in leading American newspapers has revealed the extent to which the conduct of clinical trials may be affected by inducements offered by corporate research sponsors and accepted by some unscrupulous physicians. The cases described were disturbing. They involved physicians engaged in excessive “enrollment activities” in exchange for money. Some of these physicians perpetrated fraud, falsifying their recruitment records in order to increase their profits. Others ignored exclusion criteria designed to ensure the safety of subjects and the validity of research results, referring their patients to research investigating treatments for conditions from which they did not suffer. One of the articles reports that physicians focusing exclusively on commercial research regularly divulge annual incomes upwards of $1,000,000 with profits in excess of $300,000. Two physicians accumulated well over $10,000,000 through clinical trials activities in less than a decade.

scholarly journals P126: Development of inclusion and exclusion criteria for ECPR in a regional hospital

CJEM ◽  
2018 ◽  
Vol 20 (S1) ◽  
pp. S101-S101
Author(s):  
D. Rollo ◽  
P. Atkinson ◽  
J. Fraser ◽  
J. Mekwan ◽  
J. P. French ◽  
...  
Keyword(s):  
Selection Criteria ◽  
Selection Process ◽  
Selection Criterion ◽  
Flow Time ◽  
Regional Hospital ◽  
Current Evidence ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Patient Selection Criterion ◽  
Selection Of

Introduction: Extracorporeal cardiopulmonary resuscitation (ECPR), a method of cardiopulmonary bypass, is increasingly being used to supplement traditional CPR to improve outcomes for cardiac arrest (CA). CA and particularly out of hospital CA (OHCA) have poor outcomes. Prior to development of a 3 phase ECPR program in a Canadian regional hospital, we wished to identify and optimize a practical selection process (inclusion and exclusion criteria) for patients who may benefit from ECPR. Methods: Using a locally modified Delphi technique, we followed a literature review to construct a proposed set of evidence based criteria with a questionnaire, where inclusion and exclusion criteria were scored by a selected group of 13 experts. Following 3 rounds, and additional review by an international expert in the field of ECPR, consensus was achieved for patient selection criterion. Results: First round responses achieved 87.5% agreement for selection of exclusion criteria. Inclusion criteria had agreement 62.5%. Responses to the second round for selection of inclusion criteria were unanimous at 100% with the exception of age parameters (<65 years vs. <70 years). The third and final set of criteria achieved 100% consensus though subsequent expert review refined a single exclusion criteria (asystole). Agreed inclusion criteria were: witnessed CA, age <70, refractory arrest, no flow time <10min, total downtime <60min, and a cardiac or select non-cardiac etiology (PE, drug OD, poisoning, hypothermia). Exclusion criteria were : unwitnessed arrest, asystole, certain etiologies (uncontrolled bleeding, irreversible brain damage, trauma), and comorbidities (severe disability limiting ADLs, standing DNR, palliation). Simplified criteria for EMS transport included witnessed OHCA, age, and no flow time. Conclusion: Selection criteria of candidates for ECPR are important components for any program. Expert consensus review of current evidence is an effective method for development of ECPR selection criteria.

Pre-enrolment screening reporting in randomized controlled trials from five pharmacology journals

2016 ◽  
Vol 3 (2) ◽  
pp. 72
Author(s):  
Sachin M. Satpute ◽  
Manthan N. Mehta ◽  
Kiran Deshmukh ◽  
Kumardeep B. Paul
Keyword(s):  
Clinical Pharmacology ◽  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Evidence Based ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Randomized Controlled ◽  
Protocol Development ◽  
Indian Journal ◽  
Based Medicine

<p class="abstract"><strong><span lang="EN-US">Background:</span></strong>Randomized controlled trials (RCTs) when appropriately conducted and reported represent the gold standard in evidence based medicine. Various guidelines including <span lang="EN-US">the consolidated standards of reporting trials (</span>CONSORT 2010) recommend the reporting of the number of participants screened for potential recruitment. The aim of this study was to assess the reporting of pre-enrolment screening figure in randomized controlled trials from five pharmacology journals.</p><p class="abstract"><strong><span lang="EN-US">Methods:</span></strong>RCTs from the five pharmacology journals with descending order of impact factor i.e. The journal of clinical pharmacology (JCP), British journal of clinical pharmacology (BJCP), European journal of clinical pharmacology (EJCP), Journal of pharmacology and pharmacotherapeutics (JPP) and Indian journal of pharmacology (IJP) published between January 2013 to December 2014 were reviewed using standardized criteria.</p><p class="abstract"><strong><span lang="EN-US">Results:</span></strong>37 out of 174 (21.27%) did not report the number of participants screened prior to recruitment. From the 137 RCTs that reported this screening figure, 95,494 (46.30%, range: 41-60.60%) of the screened participants (2, 06,243) were subsequently enrolled. About 52.49% of those screened and not enrolled, did not meet inclusion criteria or met exclusion criteria and about 11.89% declined to participate in an RCT.  </p><p class="abstract"><strong><span lang="EN-US">Conclusions:</span></strong><span lang="EN-US"> Thus, there was about 80% reporting of pre-enrolment screening figure in RCTs from five pharmacology journals which need further improvement. The practice of documenting pre-enrolment screening figure and associated exclusion reasons will help to plan appropriate recruitment strategies during protocol development.</span></p>

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