There are many types of pain assessments available to researchers conducting clinical trials, ranging from simple, single-item Visual Analog Scale (VAS) questions through extensive, multidimensional inventories. The primary question addressed in this survey of top-tier medical journals was: Which pain assessments are most commonly used in trials? Articles addressing chronic musculoskeletal pain in clinical trials were identified in seven major medical journals for the year 2003. A total of 50 studies (total original research articles reviewed: 1,476) met selection criteria, and from these we identified 28 types of pain assessments. Selected studies were classified according to the dimensions of pain assessed, the type of scale and descriptors/anchors used, and the reporting period specified. The most frequently used assessments were the single-item VAS scale and the Numeric Rating Scale (NRS); multidimensional inventories were used infrequently. There was considerable variability in the instructions patients received about the period to consider when evaluating their pain, and many studies provided only cursory information about their assessments in the methods. Overall, it appears that clinical trials utilize simple measures of pain and that there is no widely accepted standard for clinical pain assessment that would facilitate comparison of outcomes across trials.Perspective-This review highlights the heterogeneity of pain outcome measures used and the abundance of single-item measures in clinical trials. While there are many pain outcome measures available to clinical researchers, more consistency in the field should be encouraged so that results between studies can be compared.
KeywordsPain; Self-report; Patient Reported Outcomes; Clinical Trials Pain is a leading public health problem in the United States affecting over 50 million Americans at an annual cost exceeding $100 billion dollars. 46 This translates into 70 million healthcare visits a year, making pain the leading cause for health care utilization. Fifteen percent of adults in the United States have had chronic low back pain at some point in their lives, resulting in 250 million lost days of work, and conferment of disability to over 10 million Americans. 20 Corresponding author: Leighann Litcher- Kelly, Putnam Hall, South Campus, Stony Brook, NY 11974-8790, Phone: 631-632-3094, Fax: 631-632-3165, E-mail: Leighann.Litcher@sunysb.edu. Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Current reviewWith the large number of options available to clinical researchers, our interest was...
Conclusions: Our study provided physiological information about the normal swallowing process related to the normal pressure of VP, TB, lower pharynx and UES. This data showed no statistical difference in pharyngeal swallow pressure parameters according to the viscosity of the bolus material. Finally HRM procedure is safe for future evaluation of swallowing dynamics.Objective: To determine whether six weeks of training using balance games on the Wii Fit Plus disc would improve balance in sedentary community dwelling individuals and whether this form of training would be acceptable to the population. Design: Single group pre-test post-test. Setting: A videogaming laboratory at the University of the West Indies, Jamaica. Participants: Sedentary persons, 60 years and older, residing at their homes in the parishes of Kingston and St. Andrew Jamaica. Interventions: Wii balance exercises 30 minutes twice per week for 6 weeks using obstacle course, penguin slide, soccer heading, river bubble, snow board games, tilt table, skateboard and yoga tree pose. Main Outcome Measure(s): Balance was assessed using a modified Star Excursion Balance Test (SEBT), the Multidirectional Reach Test (MDRT), the Berg Balance Scale (BBS) and the Clinical Test for Sensory Interaction in Balance (CTSIB). Acceptability of the training was assessed based on brief interview with the participants. The change in scores was analyzed using the paired t-test. Results: A total of 33 persons were recruited with 28 completing the study. There was significant improvement in SEBT scores for both the right and left lower extremities (p<0.01), MDRT scores (p<0.001) and BBS scores (p<0.01). There was no significant change in CTSIB scores. All persons who completed the study indicated that they had fun during the sessions and they would recommend this form of training to other persons. Conclusions: Balance training using Nintendo Wii games is an effective and acceptable form of exercise for community dwelling elderly persons.
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