Internet-based randomized trials successful and economical tool in low risk interventions .
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):158 BMC Musculoskelet Disord. 2008 Jan 11;9:4.140 participants, >18 years of age, with spondyloarthropathy (SpA) were randomized to receive either a probiotic drink or a placebo over a 12 week period. The probiotic drinks were not any superior in improving well-being or bowel symptoms. Internet-based randomized controlled trial was a suitable economical method with a potential applicability in examining the complementary and alternative medicine interventions at low cost.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Sí = 1
Incierto = 0,5
No relevante = 0
No = 0
La evaluación de los criterios de información evalúa la transparencia con la que los autores informan de las características metodológicas y del ensayo dentro de la publicación. La evaluación se divide en cinco categorías que se presentan a continuación.
4/4
Randomization
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
El Índice de Fragilidad es una herramienta que ayuda en la interpretación de hallazgos significativos, proporcionando una medida de fuerza para un resultado. El Índice de Fragilidad representa el número de eventos consecutivos que es necesario añadir a un resultado dicotómico para que el hallazgo deje de ser significativo. Un número pequeño representa un hallazgo más débil y un número grande un hallazgo más fuerte.
¿Por qué se necesitaba ahora este estudio?
Complementary and alternative medicines (CAMs) are used in chronic and acute health conditions for maintaining wellness. However, the use of CAMs is limited, since there have not been many clinical trials performed on CAMs. This study evaluated the effectiveness of probiotics in the symptom control of spondyloarthropathy.
¿Cuál era la pregunta principal de la investigación?
Is the probiotic use superior to placebo in terms of well-being, bowel symptoms, and arthritis severity (disease activity and function) after 12 weeks of treatment?
- 65% (96/147) completed the entire 3 month long trial.
- CAM Outcome: No clinically significant differences were observed in the global well-being, bowel symptoms, or severity of arthritis between the two groups.
- Adherence to medication was comparable in both the groups, placebo=3938/5796 (67.9%) and intervention group= 3748/5544 (67.6%).
- No difference in the adverse event rates between the groups were recorded
¿Qué es lo que más debo recordar?
Internet-based tools were useful and economical for conducting a successful randomized controlled trials in low risk interventions. The probiotic did not improve well-being, disease activity, or function compared to placebo.
¿Cómo afectará esto al cuidado de mis pacientes?
The internet-based RCT is a feasible method to examine the CAM intervention. it is also is a cost-effective approach for assessing low-risk interventions.
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