JAMA patient page. Randomized controlled trials

JAMA The Journal of the American Medical Association (Impact Factor: 35.29). 03/2010; 303(12):1216. DOI: 10.1001/jama.303.12.1216
Source: PubMed
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    ABSTRACT: Analytic studies make it possible to study and verify causal hypotheses and clinical studies, specifically contribute the greatest level of evidence in the verification of these hypothesis. A randomized clinical trial (RCT) is a planned experiment in which two or more preventive, curative or rehabilitating interventions, assigned in an individualized and random way to a group of patients to study the effect of these interventions in man, are compared. To do so, a series of methodological aspects must be taken into account, such as the choice of the subject sample based on adequate screening criteria, random allotment of the subjects to the different intervention groups, choice of the control group, masking or blinding of some or all the subjects participating in the study and description of losses and drop-outs for correct analysis of the data. The characteristics of the type of study, conducted in humans, imply the need for the fulfillment of some ethical and legal requirements that protect the participants, reason why it is essential to obtain an informed consent and favorable report from the Ethics Committee for its conduction.
    SEMERGEN - Medicina de Familia 06/2007; 33(6):296-304. DOI:10.1016/S1138-3593(07)73899-6

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    ABSTRACT: Audiologic rehabilitation aims to improve communication for people with hearing impairment. Education is widely regarded as an integral part of rehabilitation, but the effect of the delivery method of an educational program on the experience of hearing problems has rarely been investigated in controlled trials. The purpose of this study was to examine the short-term effects of complementing an educational program for hearing aid users with telephone consultations, delivered through weekly discussions with the subjects about information obtained from a book on hearing and hearing aids. This study used a randomized, controlled design. In total, 69 hearing aid users were randomly assigned to an intervention group (n = 33) or a control group (n = 36). The intervention group had access to a book and received weekly topic-based reading instructions related to the different chapters of the book. Five telephone calls were made to the members of the intervention group. During the calls, an audiologist discussed new information with the participant as needed. The control participants also read the book, but they did not discuss the contents of the book with a professional. The Hearing Handicap Inventory for the Elderly (HHIE), the Hospital Anxiety and Depression Scale (HADS), and the International Outcome Inventory for Hearing Aids (IOI-HA) were used to measure the outcomes of this study. Participants in the intervention group had a reduction in self-reported hearing handicap, while there were no significant changes in the control group. In the intervention group, 45% of the participants showed an improvement of ≥36% on the HHIE, while only 17% of the control group showed an improvement of ≥36%. There were also improvements on the HADS total and the depression subscale for the intervention group. No changes occurred on the IOI-HA. Reading about hearing and hearing aids can reduce the hearing handicap and reported anxiety in hearing aid users. In this study, discussing the content of the book that was provided with a professional during weekly telephone consultations and having weekly home assignments further improved emotional well-being, as demonstrated by the HHIE (emotional scale) and HADS (depression scale), but these activities had no effect on hearing aid outcomes as measured by the IOI-HA.
    Journal of the American Academy of Audiology 11/2011; 22(10):654-62. DOI:10.3766/jaaa.22.10.4 · 1.58 Impact Factor