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OBJECTIVE To investigate the characteristics of the design and report of termed (so-called) pragmatic randomized clinical trials in the field of manual therapy. Specifics OBJECTIVES To assess the pragmatic attitude of pragmatic MT RCTs. To assess the reporting quality of pragmatic MT RCTs. To assess the quality of pragmatic MT RCTs METHODS In this descriptive study, the pragmatic attitude of 100 RCT about manual therapy interventions will be assessed. 1. Eligibility criteria RCTs published assessing a manual technique or a combination of manual techniques will be included. The terms “effectiveness”(of an intervention), “pragmatic” (methodological design) or “ naturalistic” (methodological design) should be included in the title or the abstract. Exclusion criteria: Experimental interventions delivered through the use of tools, devices (electrotherapy, kinesiotaping, dry needling, acupuncture) or drugs without MT involvement Experimental interventions involving active exercises without MT involvement. Experimental interventions with a combination of therapies without a MT intervention involved. Articles not written in English. Protocols or poster/conference presentations. Articles were the full-text can not be found With the articles included that fulfil the inclusion and exclusion criteria a sample of 100 articles will be complete as follows: RCTs termed pragmatic (PRCTs) in its design will be all included until 100 articles. If PRCT’s sample will not be enough to achieve 100 articles, the articles termed “effectiveness” in the title or abstract will be include and randomized until obtaining the definitive sample of 100 articles (differentiating those articles where the control intervention is a placebo/sham and those that is and active intervention or usual care). 2. Search Strategy We will conduct a search in MEDLINE and the Cochrane Central Register of Controlled Trials. The search strategy will combine controlled vocabulary with search terms related to the field of manual therapy and the design of interest. From the articles provided by the search, we will randomly order them using the Microsoft Excel random generator to obtain the sample required. 3. Sample size calculation Sample size will be a convenience sample of 100 articles. 4. Data extraction We will design a data extraction form (table 1) that will include 4 parts: 1) Information about: a) bibliometric identification elements b) specific characteristics of the study (see table 1) 2) PRECIS-2 tool: This tool was created to analyze if the study design was in accordance with the initial objective and to help in the design of its applicability. Consist of 9 domains: eligibility, recruitment, setting, organization, flexibility delivery, flexibility adherence, follow up, primary outcome and primary analysis. Every domain scores from 1 to 5 on a Likert scale, being 1 a value very explanatory and 5 very pragmatic. 3 score means as explanatory as pragmatic. This score is drawn in a graphic called “precis wheel” that shows graphically how explanatory or pragmatic is a study. A wide wheel means more pragmatic and a narrow wheel more explanatory. 3) CONSORT reporting guideline, with extension for pragmatic trials and non-pharmacological interventions. 4) RISK OF BIAS Cochrane tool: Cochrane risk-of-bias tool for randomized trials (RoB) is the recommended tool to assess the risk of bias in randomized trials included in Cochrane Reviews. A pilot of the form will be performed with 8 RCTs and a Kappa value will be obtained. 5. Review group The review group will consist of 5 reviewers. The articles will be reviewed by pairs made up of the principal investigator of the study and one other member of the review group. Disagreements will be discussed and resolved by the pairs. 6. Data analysis A descriptive analysis of the categorical variables will be performed and presented as percentages. A quantitative and graphic description (precis wheel) of the pragmatic attitude of the articles will be performed. A qualitative analysis of the information about the pragmatic attitude described by the authors will be assessed.
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