Literature DB >> 24559783

Methodological considerations in the design and implementation of clinical trials.

Constance T Cirrincione, Ellen M Lavoie Smith, Herbert Pang.   

Abstract

OBJECTIVES: To review study design issues related to clinical trials led by oncology nurses, with special attention to those conducted within the cooperative group setting; to emphasize the importance of the statistician's role in the process of clinical trials. DATA SOURCES: Studies available at clinicaltrials.gov using experimental designs that have been published in peer-reviewed journals; cooperative group trials are highlighted.
CONCLUSION: The clinical trial is a primary means to test intervention efficacy. A properly designed and powered study with clear and measurable objectives is as important as the intervention itself. IMPLICATIONS FOR NURSING PRACTICE: Collaboration among the study team, including the statistician, is central in developing and conducting appropriately designed studies. For optimal results, collaboration is an ongoing process that should begin early on.
Copyright © 2014 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Clinical trials; Cooperative groups; Nurse scientist; Study designs

Mesh:

Year:  2013        PMID: 24559783      PMCID: PMC3980716          DOI: 10.1016/j.soncn.2013.12.011

Source DB:  PubMed          Journal:  Semin Oncol Nurs        ISSN: 0749-2081            Impact factor:   2.315


  12 in total

1.  Randomized controlled trial of tailored nursing interventions to improve cardiac rehabilitation enrollment.

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Journal:  Nurs Res       Date:  2012 Mar-Apr       Impact factor: 2.381

2.  Randomized, double-blinded, placebo-controlled crossover trial of treating erectile dysfunction with sildenafil after radiotherapy and short-term androgen deprivation therapy: results of RTOG 0215.

Authors:  Deborah Watkins Bruner; Jennifer L James; Charlene J Bryan; Thomas M Pisansky; Marvin Rotman; Thomas Corbett; Joycelyn Speight; Roger Byhardt; Howard Sandler; Søren Bentzen; Lisa Kachnic; Lawrence Berk
Journal:  J Sex Med       Date:  2011-01-14       Impact factor: 3.802

3.  Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial.

Authors:  Ellen M Lavoie Smith; Herbert Pang; Constance Cirrincione; Stewart Fleishman; Electra D Paskett; Tim Ahles; Linda R Bressler; Camilo E Fadul; Chetaye Knox; Nguyet Le-Lindqwister; Paul B Gilman; Charles L Shapiro
Journal:  JAMA       Date:  2013-04-03       Impact factor: 56.272

4.  Wisconsin Ginseng (Panax quinquefolius) to improve cancer-related fatigue: a randomized, double-blind trial, N07C2.

Authors:  Debra L Barton; Heshan Liu; Shaker R Dakhil; Breanna Linquist; Jeff A Sloan; Craig R Nichols; Travis W McGinn; Philip J Stella; Grant R Seeger; Amit Sood; Charles L Loprinzi
Journal:  J Natl Cancer Inst       Date:  2013-07-13       Impact factor: 13.506

5.  A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA.

Authors:  Debra L Barton; Edward J Wos; Rui Qin; Bassam I Mattar; Nathan Benjamin Green; Keith S Lanier; James Dewitt Bearden; John W Kugler; Kay L Hoff; Pavan S Reddy; Kendrith M Rowland; Mike Riepl; Bradley Christensen; Charles L Loprinzi
Journal:  Support Care Cancer       Date:  2010-05-25       Impact factor: 3.603

6.  The use of Valeriana officinalis (Valerian) in improving sleep in patients who are undergoing treatment for cancer: a phase III randomized, placebo-controlled, double-blind study (NCCTG Trial, N01C5).

Authors:  Debra L Barton; Pamela J Atherton; Brent A Bauer; Dennis F Moore; Bassam I Mattar; Beth I Lavasseur; Kendrith M Rowland; Robin T Zon; Nguyet A Lelindqwister; Gauri G Nagargoje; Timothy I Morgenthaler; Jeff A Sloan; Charles L Loprinzi
Journal:  J Support Oncol       Date:  2011 Jan-Feb

7.  Exercise manages fatigue during breast cancer treatment: a randomized controlled trial.

Authors:  Victoria Mock; Constantine Frangakis; Nancy E Davidson; Mary E Ropka; Mary Pickett; Barbara Poniatowski; Kerry J Stewart; Lane Cameron; Kristin Zawacki; Laura J Podewils; Gary Cohen; Ruth McCorkle
Journal:  Psychooncology       Date:  2005-06       Impact factor: 3.894

8.  Caregiving demands and well-being in parents of children treated with outpatient or inpatient methotrexate infusion: a report from the children's oncology group.

Authors:  Katherine P Kelly; Diane K Wells; Lu Chen; Elaine Reeves; Ellen Mass; Bruce Camitta; Pamela S Hinds
Journal:  J Pediatr Hematol Oncol       Date:  2014-08       Impact factor: 1.289

9.  Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial.

Authors:  Marie Bakitas; Kathleen Doyle Lyons; Mark T Hegel; Stefan Balan; Frances C Brokaw; Janette Seville; Jay G Hull; Zhongze Li; Tor D Tosteson; Ira R Byock; Tim A Ahles
Journal:  JAMA       Date:  2009-08-19       Impact factor: 56.272

10.  Challenges of recruitment of breast cancer survivors to a randomized clinical trial for osteoporosis prevention.

Authors:  Carol D Ott; Janice J Twiss; Nancy L Waltman; Gloria J Gross; Ada M Lindsey
Journal:  Cancer Nurs       Date:  2006 Jan-Feb       Impact factor: 2.592

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  1 in total

Review 1.  Factors influencing the statistical planning, design, conduct, analysis and reporting of trials in health care: A systematic review.

Authors:  Marina Zaki; Lydia O'Sullivan; Declan Devane; Ricardo Segurado; Eilish McAuliffe
Journal:  Contemp Clin Trials Commun       Date:  2022-01-29
  1 in total

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