scholarly journals Issues in Outcomes Research: An Overview of Randomization Techniques for Clinical Trials

2008 ◽  
Vol 43 (2) ◽  
pp. 215-221 ◽  
Author(s):  
Minsoo Kang ◽  
Brian G. Ragan ◽  
Jae-Hyeon Park
Keyword(s):  
Clinical Trials ◽  
Athletic Training ◽  
A Priori ◽  
Evidence Based ◽  
Random Assignment ◽  
Treatment Groups ◽  
The Past ◽  
Adaptive Techniques

Abstract Objective: To review and describe randomization techniques used in clinical trials, including simple, block, stratified, and covariate adaptive techniques. Background: Clinical trials are required to establish treatment efficacy of many athletic training procedures. In the past, we have relied on evidence of questionable scientific merit to aid the determination of treatment choices. Interest in evidence-based practice is growing rapidly within the athletic training profession, placing greater emphasis on the importance of well-conducted clinical trials. One critical component of clinical trials that strengthens results is random assignment of participants to control and treatment groups. Although randomization appears to be a simple concept, issues of balancing sample sizes and controlling the influence of covariates a priori are important. Various techniques have been developed to account for these issues, including block, stratified randomization, and covariate adaptive techniques. Advantages: Athletic training researchers and scholarly clinicians can use the information presented in this article to better conduct and interpret the results of clinical trials. Implementing these techniques will increase the power and validity of findings of athletic medicine clinical trials, which will ultimately improve the quality of care provided.

(Uncontrolled) Donation after Cardiac Determination of Death: A Note of Caution

2008 ◽  
Vol 36 (4) ◽  
pp. 760-765 ◽  
Author(s):  
Christopher James Doig ◽  
David A. Zygun
Keyword(s):  
Organ Failure ◽  
Organ Transplant ◽  
Standard Of Care ◽  
Determination Of Death ◽  
The Past ◽  
The World ◽  
Tissue Recovery ◽  
End Stage

“I think there’s a big strong belief in [...] the community … and maybe it’s in the world at large that somehow the doctors are more concerned about harvesting the organs than what’s best for the patient.”1 In the past 45 years, organ and tissue recovery and transplantation have moved from the occasional and experimental to a standard of care for end-stage organ failure; receiving an organ transplant is for many the only opportunity for increased quantity and/or quality of life. The increasing prevalence of diseases such as viral hepatitis, diabetes, and hypertension has significantly increased the incidence of end-organ failure. Additionally, surgical advances have permitted less stringent qualification criteria, so that people of advanced age or patients who may be in a physiologically fragile state are now eligible to be organ recipients. These changes have created a significant demand for organs.

scholarly journals Surveillance AFter Extremity Tumor surgerY (SAFETY): A Protocol for an International Randomized Controlled Trial

2018 ◽  
Author(s):  
Patricia Schneider ◽  
Michelle Ghert
Keyword(s):  
Ct Scan ◽  
Chest Radiograph ◽  
Controlled Trial ◽  
Disease Recurrence ◽  
Evidence Based ◽  
Treatment Groups ◽  
Randomized Controlled ◽  
Extremity Sarcoma ◽  
Chest Ct Scan

Title: Surveillance AFter Extremity Tumor surgerY International Randomized Controlled TrialShort Title: SAFETYMethodology: Multi-center, 2 x 2 factorial superiority randomized controlled trial (RCT).Coordinating Center: This study will be centrally coordinated by the Methods Center at the Center for Evidence-Based Orthopaedics (CEO) at McMaster University in Hamilton, Ontario Canada. Clinical Sites: We are expecting ten clinical sites to be involved in the pilot phase. Further sites will be recruited for the definitive phase.Primary Objectives: The overall objective is to determine the effect of surveillance strategy on patient survival after surgery for a soft-tissue sarcoma of the extremity by comparing the effectiveness of: A) a surveillance frequency of every three months vs. every six months; and B) CT scans vs. chest radiographs.Secondary Objectives: We will explore: A) the effects of the post-operative surveillance strategies on patient-important outcomes (patient anxiety, overall satisfaction and quality of life), oncologic outcomes (local recurrence- and metastasis-free survival) and treatment-related complications (chemotherapy- and thoracotomy-related complications); and B) the net costs of post-operative surveillance strategies and of metastasis treatment and treatment-related complications. Treatment Groups: This study will compare two surveillance frequencies (every three months vs. every six months) and two imaging modalities (CT scan vs. chest radiograph) for a total of four treatment groups: 1)Surveillance visit and chest CT scan every three months for two years;2)Surveillance visit and chest CT scan every six months for two years; 3)Surveillance visit and chest radiograph every three months for two years; or4)Surveillance visit and chest radiograph every six months for two years. Study Outcome: The primary outcome is overall survival at five years post-randomization. Follow-Up: Upon completion of the two-year intervention phase, study participants will be followed every six months for another three years. Sample Size: Pilot - 200 participants | Definitive - 830 participantsEstimated Study Duration: Pilot - September 2019 – January 2023 | Definitive - TBDSignificance: Following treatment for a primary extremity sarcoma, patients remain at risk for the development of local and systemic disease recurrence. Metastasis (distant recurrence) to the lung is the most frequent single location of disease recurrence in sarcoma patients, occurring in almost half of all patients. Therefore, careful post-operative surveillance is an integral element of patient care. However, the detection of metastases does not necessarily affect long-term survival and may negatively impact quality of life. Surveillance strategies have not been well researched and have been identified as the top research priority in the extremity sarcoma field. The SAFETY trial will provide the necessary evidence to develop evidence-based surveillance guidelines, and is poised to have a significant impact on the post-operative care and outcomes of extremity soft-tissue sarcoma patients.

scholarly journals An Evidence-Based Determination of Issues Affecting Quality of Life and Patient-Reported Outcomes in Lung Cancer: Results of a Survey of 660 Patients

2014 ◽  
Vol 9 (9) ◽  
pp. 1243-1248 ◽  
Author(s):  
Richard J. Gralla ◽  
Patricia J. Hollen ◽  
Pavlos Msaouel ◽  
Beverly Vincent Davis ◽  
Judith Petersen
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Patient Reported Outcomes ◽  
Evidence Based ◽  
Patient Reported

Fatigue and HIV

2017 ◽  
Author(s):  
William Breitbart ◽  
Anna L. Dickerman
Keyword(s):  
Quality Of Life ◽  
Treatment Adherence ◽  
Symptom Management ◽  
Treatment Strategies ◽  
Hiv And Aids ◽  
Evidence Based ◽  
Important Condition ◽  
Evidence Based Treatment ◽  
The Past

Fatigue is commonly reported by persons with HIV and AIDS and is associated with impaired physical function, reduced quality of life, and suboptimal treatment adherence. Patients regard fatigue as an important condition to be addressed because it is disabling and distressing. In the past, fatigue was overlooked and undertreated by physicians, but clinicians caring for persons with HIV and AIDS have been giving more attention to symptom management and patients’ quality of life. Increased attention to symptom management in HIV and AIDS warrants familiarity with major issues in evaluation and treatment of fatigue. This chapter reviews the definition and assessment of fatigue, prevalence of fatigue in HIV/AIDS and its impact on patients, medical and psychological causes of fatigue, and evidence-based treatment strategies.

scholarly journals Adherence to the 2008 IHS guidelines for controlled trials of drugs for the preventive treatment of chronic migraine in adults

Cephalalgia ◽  
2019 ◽  
Vol 39 (8) ◽  
pp. 1058-1066 ◽  
Author(s):  
Marie Deen ◽  
Daniele Martinelli ◽  
Judith Pijpers ◽  
Hans-Christoph Diener ◽  
Stephen Silberstein ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Chronic Migraine ◽  
International Headache Society ◽  
A Priori ◽  
Preventive Treatment ◽  
Controlled Clinical Trials ◽  
Trial Quality ◽  
Definition Of ◽  
Double Blinded

Introduction Since the definition of chronic migraine as a new disease entity in 2004, numerous clinical trials have examined the efficacy of preventive treatments in chronic migraine. Our aim was to assess the adherence of these trials to the Guidelines of the International Headache Society published in 2008. Methods We searched PubMed for controlled clinical trials investigating preventive treatment for chronic migraine in adults designed after the release of the Guidelines and published until December 2017. Trial quality was evaluated with a 13-item scoring system enlisting essential recommendations adapted from the Guidelines. Results Out of 3352 retrieved records, we included 16 papers in the analysis dealing with pharmacological treatment of chronic migraine. The median score was 6.5 (range 2–13). All trials were randomized, the large majority (81.25%) were placebo-controlled and double-blinded (87.5%). Adherence was lowest on i) a priori definition of outcomes (31.25%), ii) primary endpoint definition (37.5%%) and iii) trial registration (37.5%). Discussion Most clinical trials adhered to the recommendations of the IHS, whereas adherence to migraine-specific recommendations was lower. Greater awareness and adherence to the guidelines are essential to improve the quality of clinical trials, validity of publications and the generalizability of the results.

scholarly journals Ethics of placebo use in randomised studies: primer for physiotherapists

2006 ◽  
Vol 62 (4) ◽  
Author(s):  
N. T. Amusat
Keyword(s):  
Clinical Trials ◽  
Health Professionals ◽  
Randomized Trials ◽  
The Body ◽  
Basic Knowledge ◽  
Evidence Based ◽  
Active Comparator ◽  
Ethical Concerns ◽  
Effectiveness Studies

Evidence based practice is driving the need to establish effectiveness of interventions employed by health professionals. The need to show effectiveness for interventions employed by physiotherapists has not been greater. This has led to an increase in the body of evidence available on physiotherapeutic methods. The quality of the evidence, however, has made it difficult to draw definitive conclusions on the effect of some of these interventions. There is therefore a call for improved methodologies in physiotherapy effectiveness studies. These needs may prompt even greater use of randomized trials with or without a placebo arm, which are regarded as the best way to show effectiveness. The use of placebo rather than an active  comparator has advantages in showing absolute effectiveness of interventions. However, there may be ethical concerns posed by its use in clinical trials. The balance is therefore required between good ethics and sound science. The goal of this article is to provide physiotherapists with a basic knowledge of the ethics of placebo use in randomized studies. This should prepare researchers to better balance ethical needs with scientific imperatives when designing effectiveness studies.

scholarly journals DATABASE DEVELOPMENT OF THE MANAGEMENT INNOVATIVE ACTIVITY IN THE INDUSTRIAL ENTERPRISE

2018 ◽  
Vol 2018 (1) ◽  
pp. 21-27
Author(s):  
Алексей Курлов ◽  
Aleksey Kurlov ◽  
Андрей Гулевитский ◽  
Andrey Gulevitsky
Keyword(s):  
System Analysis ◽  
Innovation Management ◽  
A Priori ◽  
Industrial Enterprise ◽  
Information Support ◽  
Industrial Enterprises ◽  
Preparatory Stage ◽  
Implementation Of Innovations

This article focuses on the decision of problems of increase of efficiency of introduction of innovation in industrial enterprise. The publication includes a description of the author's approach to innovation in the industrial enterprise, implemented in the form of a database. The main functions of the database are divided into two main stages – preparatory and informative. The functions of the preparatory stage include the collection of information about the industrial enterprise, the rationale for the choice of innovation, determination of the composition and administration of training (retraining), justification of the technical appearance of innovation. At the supporting stage, the database allows information support in the development and implementation of innovations in terms of timing, volume and costs, to carry out a priori and a posteriori evaluation of the quality of innovation on the basis of situational norms, as well as support for decision-making on innovation management in the industrial enterprise. The database is based on the theory of system analysis, the basic principles of the theory of innovation, methods of situational modeling, graph theory and probability theory. The results of the developed database can be used by modern industrial enterprises in the implementation of innovations.

scholarly journals It’s time to eliminate the mismatch between pediatric training and practice

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Frank Oberklaid
Keyword(s):  
Clinical Practice ◽  
Training Programs ◽  
Evidence Based ◽  
Community Settings ◽  
Service Delivery Models ◽  
The Past ◽  
Repeated Calls ◽  
Delivery Models ◽  
Pediatric Morbidity

AbstractThe quality of pediatric clinical practice is dependent on the training received during residency. It is assumed that the content of the training will adequately prepare pediatricians for the sorts of problems and issues they will be asked to manage in community settings. While over the past several decades there have been major changes in pediatric morbidity, there is evidence that training and service delivery models have not evolved; there is a significant mismatch between training and evidence-based clinical practice. A recent paper published in this journal (1) drew attention to the inadequacy of pediatricians’ training in child development. The reality of major gaps in the content and experiences of pediatric training in Israel are widely held, and there have been repeated calls for an increased focus on community child health and developmental and behavioural pediatrics. While it appears that finally there are some small initial steps to this end, it is strongly recommended that there be a long overdue, radical rethink of pediatric training programs.

scholarly journals Learning from Patient and Site Perspectives to Develop Better Mobile Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative

2019 ◽  
Author(s):  
Cindy Geoghegan ◽  
Virginia Nido ◽  
Angie Botto-Ven Bemden ◽  
Zachary Hallinan ◽  
Les Jordan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Mobile Technologies ◽  
Evidence Based

In order to harness the potential of mobile technologies to enhance the quality of clinical research, it is critical to first understand how to engage patients and research sites when planning and conducting mobile clinical trials. The Clinical Trials Transformation Initiative has developed the first comprehensive, evidence-based set of recommendations for incorporating patient and site perspectives in mobile clinical trials, which can aid in engaging stakeholders, addressing site challenges, and maximizing value for participants.

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