The influence of allocation concealment and intention to treat analysis on treatment effects of physical therapy interventions in low back pain clinical trials: a meta-epidemiological study

• Grant number: 16/10317-0
• Support Opportunities: Scholarships in Brazil - Post-Doctoral
• Start date: November 01, 2016
• End date: July 31, 2018
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Leonardo Oliveira Pena Costa
• Grantee: Matheus Oliveira de Almeida
• Host Institution: Pró-Reitoria de Pós-Graduação, Pesquisa e Extensão. Universidade Cidade de São Paulo (UNICID). São Paulo , SP, Brazil
• Associated scholarship(s): 17/06548-9 - THE INFLUENCE OF ALLOCATION CONCEALMENT AND INTENTION TO TREAT ANALYSIS ON TREATMENT EFFECTS OF PHYSICAL THERAPY INTERVENTIONS IN LOW BACK PAIN RANDOMIZED CONTROLLED TRIALS: A META-EPIDEMIOLOGICAL STUDY, BE.EP.PD

Abstract

The presence of methodological bias, such as inadequate allocation concealment and lack of intention to treat analysis, may influence the findings from randomized controlled trials, overestimating the treatment effects. Meta-epidemiologic studies have been done in medicine areas. However, in physical therapy, there is a paucity of this kind of study, with no studies in low back pain area. The present study is justified, given the importance and utility that meta-epidemiological studies will bring to the physical therapy scientific and clinical community. The objective of this study is to establish the influence of allocation concealment and the use of intention to treat analysis on the treatment effect of the interventions in low back pain clinical trials. A search on the main databases will be performed. We will include a random sample of meta-analyses composed by randomized controlled trials that compared physical therapy interventions in individuals with low back pain with placebo or no intervention, and have pain intensity as the main outcome. The evaluation of the allocation concealment and the use of intention to treat analysis will be assessed following the Cochrane Handbook recommendations. Information about bibliographic data, study characteristics, participants' characteristics and study results will be extracted. A random effect model of meta-analyses will be used to pool the effect sizes. A meta-regression will be realized to assess the association between study characteristics (allocation concealment and intention to treat analysis) and effect size. (AU)

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

DE ALMEIDA, MATHEUS OLIVEIRA; SARAGIOTTO, BRUNO TIROTTI; MAHER, CHRIS; COSTA, LEONARDO OLIVEIRA PENA. Allocation Concealment and Intention-To-Treat Analysis Do Not Influence the Treatment Effects of Physical Therapy Interventions in Low Back Pain Trials: a Meta-epidemiologic Study. ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION, v. 100, n. 7, p. 1359-1366, JUL 2019. (16/10317-0)

ALMEIDA, MATHEUS OLIVEIRA; SARAGIOTTO, BRUNO T.; MAHER, CHRIS G.; PENA COSTA, LEONARDO OLIVEIRA. Influence of allocation concealment and intention-to-treat analysis on treatment effects of physical therapy interventions in low back pain randomised controlled trials: a protocol of a meta-epidemiological study. BMJ OPEN, v. 7, n. 9, SEP 2017. (16/10317-0)

CADETE SCOLA, LUIZ FELICIO; MOSELEY, ANNE M.; THABANE, LEHANA; ALMEIDA, MATHEUS; MENEZES COSTA, LUCIOLA DA CUNHA. A methodological survey on reporting of pilot and feasibility trials for physiotherapy interventions: a study protocol. BMJ OPEN, v. 9, n. 5, MAY 2019. (16/10317-0)