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Comparative CT with stress manoeuvres for diagnosing distal isolated tibiofibular syndesmotic injury in acute ankle sprain: a protocol for an accuracy- test prospective study

Por: Rodrigues · J. C. · Santos · A. L. G. · Prado · M. P. · Alloza · J. F. M. · Masagao · R. A. · Rosemberg · L. A. · Barros · D. d. C. S. · Castro · A. d. A. e. · Demange · M. K. · Lenza · M. · Ferretti · M.
Introduction

Although several imaging options are available for diagnosing syndesmotic injury, a fundamental question that guides treatment remains unanswered. Syndesmotic instability is still challenging to diagnose correctly, and syndesmotic disruption and true syndesmotic instability should be differentiated. Currently, imaging tests quickly diagnose severe syndesmotic instability but have difficulty in diagnosing mild and moderate cases. This study aims to investigate which strategy among an existing CT index test and two new add-on CT index tests with stress manoeuvres more accurately diagnoses syndesmotic instability. The secondary objective is to investigate the participants’ disability outcomes by applying the Foot and Ankle Ability Measure questionnaire.

Methods and analyses

This study of a diagnostic accuracy test will consecutively select individuals older than 18 years with a clinical diagnosis of a suspected acute syndesmotic injury. Three strategies of the CT index test (one in the neutral position and two with stress) will examine the accuracy using MRI as the reference standard. The external rotation and dorsiflexion of the ankle will guide the stress manoeuvres. A comparison of measurements between the injured syndesmosis and the uninjured contralateral side of the same individual will investigate the syndesmotic instability, by evaluating the rotational and translational relationships between the fibula and tibia. Sensitivity, specificity, area under the receiver operating characteristic curve and likelihood analyses will compare the diagnostic accuracies of the strategies.

Ethics and dissemination

The Internal Review Board and the Einstein Ethics Committee approved this study (registered number 62100016.5.0000.0071). All participants will receive an oral description of the study’s aim, and the choice to participate will be free and voluntary. Participants will be enrolled after they sign the written informed consent form, including the terms of confidentiality. The results will be presented at national and international conferences and published in peer-reviewed journals and social media.

Trial registration number

ClinicalTrials.gov Registry (NCT04095598; preresults).

Do patients with chronic low-back pain experience a loss of health-related quality of life? A protocol for a systematic review and meta-analysis

Por: Coluccia · A. · Pozza · A. · Gusinu · R. · Gualtieri · G. · Muzii · V. F. · Ferretti · F.
Introduction

Health-related quality of life in chronic low back pain (LBP) is an important issue since various individual factors such as perceived loss of autonomy, inability to continue daily life and anxiety can contribute to maintenance or deterioration of this condition. Health-related quality of life is also important because it can predict the probability of recovery or recrudescence over time. In the literature, there is no systematic review on this topic. The present paper describes a protocol of the first systematic review and meta-analysis aimed at summarising the data on health-related quality of life in patients with chronic LBP compared with healthy controls. Gender, age and comorbidity of psychiatric disorders (mood or anxiety disorders) will be explored as moderators. Studies will be included if they used a case–control design comparing adults with chronic LBP to healthy controls on health-related quality of life through validated interviews/questionnaires.

Methods and analysis

According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses, a systematic review and meta-analysis will be conducted from 10th to 17th January 2020. Independent reviewers will search published/unpublished studies through electronic databases (Scopus, PubMed, EMBASE and the Cochrane Library) and additional sources, will extract the data and assess the methodological quality through the Newcastle-Ottawa Scale. Random-effect meta-analysis will be carried out by calculating effect sizes as Cohen’s d indices. Publication bias will be assessed and moderators of the effect sizes will be investigated through weighted least squares meta-regression.

The knowledge whether health-related quality of life is better or worse as a function of some individual characteristics may suggest personalised care pathways according to a precision medicine approach.

Ethics and dissemination

The current review does not require ethics approval. The results will be disseminated through publications in peer-reviewed journals.

PROSPERO registration number

CRD42019131749

The 'Hikikomori syndrome: worldwide prevalence and co-occurring major psychiatric disorders: a systematic review and meta-analysis protocol

Por: Pozza · A. · Coluccia · A. · Kato · T. · Gaetani · M. · Ferretti · F.
Introduction

The ‘Hikikomori’ syndrome (HS) consists of prolonged and severe social withdrawal. It has been studied first in Japan and recently has increasingly drawn the attention of researchers and clinicians all over the world. It is unclear whether it exists in other cultural contexts than Asia. The existing systematic reviews did not provide a quantitative synthesis on its prevalence. In addition, a summary of the co-occurring rates of psychiatric disorders is lacking. To provide a more comprehensive understanding of the clinical picture, it seems important to investigate which psychiatric disorders listed in the classification systems are most frequently associated with this psychological condition affecting young people. This paper describes a systematic review and meta-analysis protocol summarising worldwide prevalence of the HS in general population and clinical samples with psychiatric disorders. The review will also assess the co-occurrence between HS and each psychiatric disorder defined by any version of the Diagnostic and Statistical Manual of Mental Disorders (DSM) or International Classification of Diseases (ICD) in any clinical samples with psychiatric disorders.

Methods and analysis

A systematic review will be conducted according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Studies will be included if they use youth aged 12–35 years, recruited from general population or population with psychiatric disorders, if they use international criteria to diagnose HS. No restriction about design or language will be applied. The search will be conducted during the first week of November 2019 by two independent reviewers through the databases Scopus, PubMed, PsycINFO, Web of Science, by examining study references, by looking for conference proceedings/dissertations/theses, by contacting study corresponding authors. Random-effect meta-analysis will be performed by computing effect sizes as logit event rates. Study quality will be assessed through the Newcastle-Ottawa Scale.

Ethics and dissemination

The current review does not require ethics approval. The results will be disseminated through conference presentations and publications in peer-reviewed journals.

PROSPERO registration number

CRD 42018098747.

Detection of pulmonary nodules: a clinical study protocol to compare ultra-low dose chest CT and standard low-dose CT using ASIR-V

Por: Ludwig · M. · Chipon · E. · Cohen · J. · Reymond · E. · Medici · M. · Cole · A. · Moreau Gaudry · A. · Ferretti · G.
Introduction

Lung cancer screening in individuals at risk has been recommended by various scientific institutions. One of the main concerns for CT screening is repeated radiation exposure, with the risk of inducing malignancies in healthy individuals. Therefore, lowering the radiation dose is one of the main objectives for radiologists. The aim of this study is to demonstrate that an ultra-low dose (ULD) chest CT protocol, using recently introduced hybrid iterative reconstruction (ASiR-V, GE medical Healthcare, Milwaukee, Wisconsin, USA), is as performant as a standard ‘low dose’ (LD) CT to detect non-calcified lung nodules ≥4 mm.

Methods and analysis

The total number of patients to include is 150. Those are referred for non-enhanced chest CT for detection or follow-up of lung nodule and will undergo an additional unenhanced ULD CT acquisition, the dose of which is on average 10 times lower than the conventional LD acquisition. Total dose of the entire exam (LD+ULD) is lower than the French diagnostic reference level for a chest CT (6.65 millisievert). ULD CT images will be reconstructed with 50% and 100% ASiR-V and LD CT with 50%. The three sets of images will be read in random order by two pair of radiologists, in a blind test, where patient identification and study outcomes are concealed. Detection rate (sensitivity) is the primary outcome. Secondary outcomes will include concordance of nodule characteristics; interobserver reproducibility; influence of subjects’ characteristics, nodule location and nodule size; and concordance of emphysema, coronary calcifications evaluated by visual scoring and bronchial alterations between LD and ULD CT. In case of discordance, a third radiologist will arbitrate.

Ethics and dissemination

The study was approved by the relevant ethical committee. Each study participant will sign an informed consent form.

Trial registration number

NCT03305978; Pre-results.

Perceived physical health in obsessive-compulsive disorder: a protocol for a systematic review and meta-analysis

Por: Pozza · A. · Ferretti · F. · Coluccia · A.
Introduction

Obsessive-compulsive disorder (OCD) is a mental health condition associated with severe impairment in a variety of quality of life domains, an increased physical health burden, and a higher risk of general medical conditions and mortality compared with the general population. While there is a large amount of literature on psychological quality of life, a systematic review of perceived physical health in OCD is lacking. A quantitative summary might suggest that policy makers also focus the evaluation on perceived physical health and develop new strategies also aimed at this outcome. The current paper presents a protocol for the first systematic review and meta-analysis aimed at summarising perceived physical health in OCD by specifically examining perceived physical health status, bodily pain and role limitations due to physical problems in patients with OCD compared with controls. The review will also investigate potential demographic and clinical moderators of perceived physical health status (age, gender, OCD severity, publication date, methodological quality).

Methods and analysis

A systematic review and meta-analysis will be conducted according to PRISMA guidelines. Studies will be included if using a clinical group with a current primary diagnosis of OCD established by international standardised criteria, if measuring perceived physical health status, and if using screened or community participants as controls. No publication date or language restriction will be applied. An online systematic search of electronic databases (Scopus, PubMed, PsycINFO, EMBASE, Cochrane Library), and examination of conference proceedings and theses/dissertations will be conducted by independent reviewers. Risk of bias will be assessed through the Newcastle-Ottawa Scale.

Ethics and dissemination

The current review does not require ethics approval. The results will be disseminated through publications in peer-reviewed journals.

PROSPERO registration number

2018 CRD42018106194.

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