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 Reference List 1. Cinti, D. and H. B. Hawkins. 1984. Aspiration biopsy of peripheral pulmonary masses using real-time sonographic guidance. AJR Am.J.Roentgenol. 142:1115-1116. 2. Das, D. K., C. S. Pant, J. N. Pant, and P. Sodhani. 1995. Transthoracic (percutaneous) fine needle aspiration cytology diagnosis of pulmonary tuberculosis. Tuber.Lung Dis. 76:84-89. 3. Diacon, A. H., M. M. Schuurmans, J. Theron, P. T. Schubert, C. A. Wright, and C. T. Bolliger. 2004. Safety and yield of ultrasound-assisted transthoracic biopsy performed by pulmonologists. Respiration 71:519-522. 4. Keske, U. 1999. Ultrasound-aided thoracentesis in intensive care patients. Intensive Care Med. 25:896-897. 5. Klein, J. S., S. Schultz, and J. E. Heffner. 1995. Interventional radiology of the chest: image-guided percutaneous drainage of pleural effusions, lung abscess, and pneumothorax. AJR Am.J.Roentgenol. 164:581-588. 6. Nicolaou, S., A. Talsky, K. Khashoggi, and V. Venu. 2007. Ultrasoundguided interventional radiology in critical care. Crit Care Med. 35:S186-S197. 7. Yang, P. C. 2000. Ultrasound-guided transthoracic biopsy of the chest. Radiol.Clin.North Am. 38:323-343. 7 8. Stavas, J., E. vanSonnenberg, G. Casola, and G. R. Wittich. 1987. Percutaneous drainage of infected and noninfected thoracic fluid collections. J.Thorac.Imaging 2:80-87. 9. Diacon, A. H., M. H. Brutsche, and M. Soler. 2003. Accuracy of pleural puncture sites: a prospective comparison of clinical examination with ultrasound. Chest 123:436-441. 10. Gryminski, J., P. Krakowka, and G. Lypacewicz. 1976. The diagnosis of pleural effusion by ultrasonic and radiologic techniques. Chest 70:33-37. 11. Kohlberger, E. and D. Waldmann. 1987. [Real-time controlled pleural puncture in surgical intensive care patients]. Chirurg 58:261-264. 12. Levinson, G. M. and D. W. Pennington. 2007. Intrapleural fibrinolytics combined with image-guided chest tube drainage for pleural infection. Mayo Clin.Proc. 82:407-413. 13. Kohan, J. M., R. H. Poe, R. H. Israel, J. D. Kennedy, R. B. Benazzi, M. C. Kallay, and D. W. Greenblatt. 1986. Value of chest ultrasonography versus decubitus roentgenography for thoracentesis. Am.Rev.Respir.Dis. 133:11241126. 14. Adams, F. V. and V. Galati. 1978. M-mode ultrasonic localization of pleural effusion. Use in patients with nondiagnostic physical and roentgenographic examinations. JAMA 239:1761-1764. 15. Lipscomb, D. J., C. D. Flower, and J. W. Hadfield. 1981. Ultrasound of the pleura: an assessment of its clinical value. Clin.Radiol. 32:289-290. 8 16. Rozycki, G. S., S. D. Pennington, and D. V. Feliciano. 2001. Surgeonperformed ultrasound in the critical care setting: its use as an extension of the physical examination to detect pleural effusion. J.Trauma 50:636-642. 17. Crouch, J. D., B. A. Keagy, and D. J. Delany. 1987. "Pigtail" catheter drainage in thoracic surgery. Am.Rev.Respir.Dis. 136:174-175. 18. Merriam, M. A., J. J. Cronan, G. S. Dorfman, R. E. Lambiase, and R. A. Haas. 1988. Radiographically guided percutaneous catheter drainage of pleural fluid collections. AJR Am.J.Roentgenol. 151:1113-1116. 19. Ravin, C. E. 1977. Thoracocentesis of loculated pleural effusions using grey scale ultrasonic guidance. Chest 71:666-668. 20. Collop, N. A., S. Kim, and S. A. Sahn. 1997. Analysis of tube thoracostomy performed by pulmonologists at a teaching hospital. Chest 112:709-713. 21. Colt, H. G., N. Brewer, and E. Barbur. 1999. Evaluation of patient-related and procedure-related factors contributing to pneumothorax following thoracentesis. Chest 116:134-138. 22. Davies, H. E., S. Merchant, and A. McGown. 2008. A study of the complications of small bore 'Seldinger' intercostal chest drains. Respirology. 13:603-607. 23. Horsley, A., L. Jones, J. White, and M. Henry. 2006. Efficacy and complications of small-bore, wire-guided chest drains. Chest 130:1857-1863. 9 24. Collins, T. R. and S. A. Sahn. 1987. Thoracocentesis. Clinical value, complications, technical problems, and patient experience. Chest 91:817-822. 25. Hunnam, G. R. and C. D. Flower. 1988. Radiologically-guided percutaneous catheter drainage of empyemas. Clin.Radiol. 39:121-126. 26. vanSonnenberg, E., S. K. Nakamoto, P. R. Mueller, G. Casola, C. C. Neff, P. J. Friedman, J. T. Ferrucci, Jr., and J. F. Simeone. 1984. CT- and ultrasound-guided catheter drainage of empyemas after chest-tube failure. Radiology 151:349-353. 27. Westcott, J. L. 1985. Percutaneous catheter drainage of pleural effusion and empyema. AJR Am.J.Roentgenol. 144:1189-1193. 28. Hersh, C. P., D. Feller-Kopman, M. Wahidi, R. Garland, F. Herth, and A. Ernst. 2003. Ultrasound guidance for medical thoracoscopy: a novel approach. Respiration 70:299-301. 29. Feller-Kopman, D., D. Berkowitz, P. Boiselle, and A. Ernst. 2007. Largevolume thoracentesis and the risk of reexpansion pulmonary edema. Ann.Thorac.Surg. 84:1656-1661. 30. Grogan, D. R., R. S. Irwin, R. Channick, V. Raptopoulos, F. J. Curley, T. Bartter, and R. W. Corwin. 1990. Complications associated with thoracentesis. A prospective, randomized study comparing three different methods. Arch.Intern.Med. 150:873-877. 10 31. Heidecker, J., J. T. Huggins, S. A. Sahn, and P. Doelken. 2006. Pathophysiology of pneumothorax following ultrasound-guided thoracentesis. Chest 130:1173-1184. 32. Lichtenstein, D., J. S. Hulot, A. Rabiller, I. Tostivint, and G. Meziere. 1999. Feasibility and safety of ultrasound-aided thoracentesis in mechanically ventilated patients. Intensive Care Med. 25:955-958. 33. Mayo, P. H., H. R. Goltz, M. Tafreshi, and P. Doelken. 2004. Safety of ultrasound-guided thoracentesis in patients receiving mechanical ventilation. Chest 125:1059-1062. 34. Seneff, M. G., R. W. Corwin, L. H. Gold, and R. S. Irwin. 1986. Complications associated with thoracocentesis. Chest 90:97-100. 35. Yu, C. J., P. C. Yang, D. B. Chang, and K. T. Luh. 1992. Diagnostic and therapeutic use of chest sonography: value in critically ill patients. AJR Am.J.Roentgenol. 159:695-701. 36. Hsu, W. H., C. D. Chiang, C. Y. Chen, P. C. Kwan, and J. Y. Hsu. 1998. Ultrasound-guided small-bore Elecath tube insertion for the rapid sclerotherapy of malignant pleural effusion. Jpn.J.Clin.Oncol. 28:187-191. 37. Duncan, D. R., T. I. Morgenthaler, J. H. Ryu, and C. E. Daniels. 2009. Reducing iatrogenic risk in thoracentesis: establishing best practice via experiential training in a zero-risk environment. Chest 135:1315-1320. 11 38. Afschrift, M., P. Nachtegaele, D. Voet, L. Noens, W. Van Hove, S. M. van der, and G. Verdonk. 1982. Puncture of thoracic lesions under sonographic guidance. Thorax 37:503-506. 39. Akhan, O., O. Ozkan, D. Akinci, A. Hassan, and M. Ozmen. 2007. Imageguided catheter drainage of infected pleural effusions. Diagn.Interv.Radiol. 13:204-209. 40. Atar, E., Z. Heyman, A. Coret, and Y. Itzchak. 1996. [Ultrasound-guided aspiration of pleural fluid]. Harefuah 130:16-7, 71. 41. Barnes, T. W., T. I. Morgenthaler, E. J. Olson, G. K. Hesley, P. A. Decker, and J. H. Ryu. 2005. Sonographically guided thoracentesis and rate of pneumothorax. J.Clin.Ultrasound 33:442-446. 42. Cantin, L., C. Chartrand-Lefebvre, L. Lepanto, D. Gianfelice, A. Rabbat, B. Aubin, P. Perreault, R. Dery, and M. Lafortune. 2005. Chest tube drainage under radiological guidance for pleural effusion and pneumothorax in a tertiary care university teaching hospital: Review of 51 cases. Can.Respir.J. 12:29-33. 43. Elyaderani, M. K. and O. F. Gabriele. 1982. Aspiration of thoracic masses and fluid collections under guidance of ultrasonography. South.Med.J. 75:536539. 44. Gervais, D. A., A. Petersein, M. J. Lee, P. F. Hahn, S. Saini, and P. R. Mueller. 1997. US-guided thoracentesis: requirement for postprocedure chest radiography in patients who receive mechanical ventilation versus patients who breathe spontaneously. Radiology 204:503-506. 12 45. Harnsberger, H. R., T. G. Lee, and D. H. Mukuno. 1983. Rapid, inexpensive real-time directed thoracentesis. Radiology 146:545-546. 46. Hirsch, J. H., J. V. Rogers, and L. A. Mack. 1981. Real-time sonography of pleural opacities. AJR Am.J.Roentgenol. 136:297-301. 47. Jones, P. W., J. P. Moyers, J. T. Rogers, R. M. Rodriguez, Y. C. Lee, and R. W. Light. 2003. Ultrasound-guided thoracentesis: is it a safer method? Chest 123:418-423. 48. Josephson, T., C. A. Nordenskjold, J. Larsson, L. U. Rosenberg, and M. Kaijser. 2009. Amount drained at ultrasound-guided thoracentesis and risk of pneumothorax. Acta Radiol. 50:42-47. 49. Keeling, A. N., S. Leong, P. M. Logan, and M. J. Lee. 2008. Empyema and effusion: outcome of image-guided small-bore catheter drainage. Cardiovasc.Intervent.Radiol. 31:135-141. 50. Lipscomb, D. J. and C. D. Flower. 1980. Ultrasound in the diagnosis and management of pleural disease. Br.J.Dis.Chest 74:353-361. 51. Marom, E. M., S. M. Palmer, J. J. Erasmus, J. E. Herndon, C. Zhang, and H. P. McAdams. 2003. Pleural effusions in lung transplant recipients: imageguided small-bore catheter drainage. Radiology 228:241-245. 52. McGahan, J. P. 1985. Aspiration and drainage procedures in the intensive care unit: percutaneous sonographic guidance. Radiology 154:531-532. 53. Morrison, M. C., P. R. Mueller, M. J. Lee, S. Saini, J. A. Brink, S. L. Dawson, E. D. Cortell, and P. F. Hahn. 1992. Sclerotherapy of malignant 13 pleural effusion through sonographically placed small-bore catheters. AJR Am.J.Roentgenol. 158:41-43. 54. Moulton, J. S., R. E. Benkert, K. H. Weisiger, and J. A. Chambers. 1995. Treatment of complicated pleural fluid collections with image-guided drainage and intracavitary urokinase. Chest 108:1252-1259. 55. Mynarek, G., K. Brabrand, J. A. Jakobsen, and A. Kolbenstvedt. 2004. Complications following ultrasound-guided thoracocentesis. Acta Radiol. 45:519-522. 56. O'Moore, P. V., P. R. Mueller, J. F. Simeone, S. Saini, R. J. Butch, P. F. Hahn, E. Steiner, D. D. Stark, and J. T. Ferrucci, Jr. 1987. Sonographic guidance in diagnostic and therapeutic interventions in the pleural space. AJR Am.J.Roentgenol. 149:1-5. 57. Parker, L. A., G. C. Charnock, and D. J. Delany. 1989. Small bore catheter drainage and sclerotherapy for malignant pleural effusions. Cancer 64:1218-1221. 58. Parulekar, W., G. Di Primio, F. Matzinger, C. Dennie, and G. Bociek. 2001. Use of small-bore vs large-bore chest tubes for treatment of malignant pleural effusions. Chest 120:19-25. 59. Patz, E. F., Jr., P. C. Goodman, and J. J. Erasmus. 1998. Percutaneous drainage of pleural collections. J.Thorac.Imaging 13:83-92. 14 60. Petersen, S., M. Freitag, W. Albert, S. Tempel, and K. Ludwig. 1999. Ultrasound-guided thoracentesis in surgical intensive care patients. Intensive Care Med. 25:1029. 61. Pihlajamaa, K., M. K. Bode, T. Puumalainen, A. Lehtimaki, S. Marjelund, and T. Tikkakoski. 2004. Pneumothorax and the value of chest radiography after ultrasound-guided thoracocentesis. Acta Radiol. 45:828-832. 62. Raptopoulos, V., L. M. Davis, G. Lee, C. Umali, R. Lew, and R. S. Irwin. 1991. Factors affecting the development of pneumothorax associated with thoracentesis. AJR Am.J.Roentgenol. 156:917-920. 63. Rasmussen, O. S. and P. Boris. 1989. Ultrasound guided puncture of pleural fluid collections and superficial thoracic masses. Eur.J.Radiol. 9:91-92. 64. Reinhold, C., F. F. Illescas, M. Atri, and P. M. Bret. 1989. Treatment of pleural effusions and pneumothorax with catheters placed percutaneously under imaging guidance. AJR Am.J.Roentgenol. 152:1189-1191. 65. Sartori, S., P. Tombesi, D. Tassinari, P. Ceccotti, I. Nielsen, L. Trevisani, and V. Abbasciano. 2004. Sonographically guided small-bore chest tubes and sonographic monitoring for rapid sclerotherapy of recurrent malignant pleural effusions. J.Ultrasound Med. 23:1171-1176. 66. Shankar, S., M. Gulati, M. Kang, S. Gupta, and S. Suri. 2000. Imageguided percutaneous drainage of thoracic empyema: can sonography predict the outcome? Eur.Radiol. 10:495-499. 15 67. Silverman, S. G., P. R. Mueller, S. Saini, P. F. Hahn, J. F. Simeone, B. H. Forman, E. Steiner, and J. T. Ferrucci. 1988. Thoracic empyema: management with image-guided catheter drainage. Radiology 169:5-9. 68. Weingardt, J. P., R. R. Guico, A. A. Nemcek, Jr., Y. P. Li, and S. T. Chiu. 1994. Ultrasound findings following failed, clinically directed thoracenteses. J.Clin.Ultrasound 22:419-426. 69. Ng, A. W., K. W. Chan, and S. K. Lee. 1994. Simple aspiration of pneumothorax. Singapore Med.J. 35:50-52. 16