Efficacy, Safety and Activity of a Physician Based thoracic ultrasound

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Online Data Supplement
Diagnostic accuracy, safety and utilisation of respiratory physician
delivered thoracic ultrasound
Najib M Rahman1 MRCP
Authors:
Aran Singanayagam1 MRCP
Helen E Davies1 MRCP
John M Wrightson1 MRCP
Eleanor K Mishra1 MRCP
Y C Gary Lee1, 4 PhD FRACP
Rachel Benamore2 FRCR
Robert J O Davies1,3 DM FRCP*
Fergus V Gleeson2,3 FRCR*
Affiliations:
1Oxford
Centre for Respiratory Medicine and Oxford Pleural Diseases Unit,
Churchill Hospital, Oxford, OX3 7LJ
2Department
of Radiology, Oxford Centre for Respiratory Medicine, Churchill
Hospital, Oxford, OX3 7LJ
3NIHR
Oxford Biomedical Research Centre, University of Oxford, Oxford, U.K.
4University
of Western Australia, Department of Medicine
Correspondence:
Dr Najib Rahman
Oxford Centre for Respiratory Medicine
Churchill Hospital
Oxford, OX3 7LJ
naj_rahman@yahoo,.co.uk
Ph: 0044 1865 225205
Fax: 0044 1865 857209
Funding:
No funding specific to this study
NMR is funded by the UK Medical Research Council
1
EKM is funded by the UK National Cancer Research Institute
RJOD is funded by the NIHR Biomedical Research Centre
Short Title: Safety and efficacy of physician delivered thoracic ultrasound
Conflict of Interest Statement:
The authors have no conflicts of interest to declare on the subject of this
paper
2
1. Details of statistical methods
Linear regression analysis was used to assess the change in activity of
the thoracic ultrasound service over time and the proportion of radiology
referred scans over time. For assessment of activity over time, linear
regression was performed using the number of scans as the outcome variable
and a time factor (3 month period sequentially) as the explanatory variable.
No covariates were used in the model. For assessment of radiology referral
over time, the proportion of scans referred to radiology (number of referred
scans to radiology as a proportion of all scans conducted excepting those prethoracoscopy) was the outcome variable, and a time factor (1 month period
sequentially) was used as the explanatory variable. No covariates were used
in the model.
Sensitivity and specificity of the detection of pleural fluid and technical
feasibility of fluid aspiration was calculated using results of blinded ultrasound
clip assessment by the radiologist. The opinion of the radiologist (i.e. pleural
fluid present or not and fluid technically possible to aspirate or not) was taken
as the reference standard for calculation of sensitivity and specificity.
Chance corrected agreement between radiologist and physician
opinion of the thoracic ultrasound clips (fluid present, fluid technically possible
to aspirate) was conducted using a kappa statistic.
3
2. Literature Review search Strategy
PubMed was searched using the following (including MESH) terms, no
limits:
(("Pleural Effusion"[Mesh]) OR ("Pleura"[Mesh])) AND ((ASPIRATION OR
THORACEN* OR THORACOCE*) OR ("Chest Tubes"[Mesh])) AND
("Ultrasonography"[Mesh] OR "Ultrasonography, Interventional"[Mesh])
A total of 90 citations resulted from this search strategy. Twenty one
citations were discarded immediately due to lack of relevance to the topic
concerned. The remaining 69 abstracts were assessed, and 28 further papers
discarded on the basis of the following criteria:
Reason study discarded
Studies discarded
Lung biopsy / lung aspiration / pleural biopsy
3
Review article
5
Complications not clearly reported
6
Diagnostic ultrasound (no intervention) only
2
Less than 10 patients underwent ultrasound imaging
3
No ultrasound guidance used
5
Combination of CT and ultrasound imaging used
3
Pre-thoracoscopy ultrasound only
1
Total
28
Table E1. Reasons for non-inclusion of studies in comparison of
complications of thoracic ultrasound guided procedures. A total of 69 – 28 =
41 studies were therefore included in the assessment of complications of
ultrasound guided pleural procedures.
4
3. Referenced Literature Review of US guided complications
Formal systematic review and data synthesis of studies was not
attempted. A Medline review of published studies on ultrasound guided
procedures for the diagnosis / treatment of pleural effusion (via Medline
search – see Table E1) identified 69 relevant publications. Of these, 28 were
discounted (3 studies assessing lung / pleural biopsy1-3, 5 review articles4-8, 6
complications not clearly reported9-14, 2 diagnostic only15;16, 3 small (<10
patients undergoing ultrasound) studies17-19, 5 non-ultrasound guided20-24, 3
combined imaging modalities (i.e. ultrasound and CT / fluoroscopy used)25-27
and 1 assessing ultrasound in pre-thoracoscopy patients only28), leaving 41
studies for assessment of complications from US guided pleural fluid
procedures.
Of the 41 studies, 9 were conducted by non-radiologists29-37
(respiratory or intensive care physicians) and 32 conducted by radiologists3869.
Complications reported in these studies were recorded if considered major
on the same criteria as listed above (intrapleural bleed or pneumothorax
requiring any form of intervention, pleural infection, visceral pleura or viscus
perforation). Combing the results of these studies, the overall major
complication rate was 137 complications in 6836 procedures (2.0%, 95% CI
1.7 to 2.3). The major complication rate of radiology studies (121/5530 =
2.2%, 95% CI 1.8 to 2.6) was comparable to that of the physician conducted
studies (16/1306 = 1.2%, 95% CI 0.7 to 2.0) (2 1df = 5.0, p=0.03). The
proportion of complications seen in this study was significantly lower than the
proportion in published studies (this study 3/558, 0.5% versus 137/6836,
5
2.0%; 2 1df = 6.0, p=0.01, difference 1.5%, 95% confidence interval for the
difference = 0.8 to 2.2%) (Figure 3). (Figure E1).
Figure 3. Major complication rates of studies using ultrasound for pleural fluid
procedures, assessing studies by size and whether conducted by a radiologist
or non-radiologist, in comparison to the current study. Individual studies are
shown with filled triangles, and summary complication rates (non-weighted)
and 95% CI (confidence intervals) are shown with dots and bars (see legend,
* = current study)
6
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