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11. Development of clinical prediction models for outcomes of complicated intra-abdominal infection

Author

Ahmed, S, Bonnett, L, Melhuish, A, Adil, MT, Aggarwal, I, Ali, W, Bennett, J, Boldock, E, Burns, FA, Czarniak, E, Dennis, R, Flower, B, Fok, R, Goodman, A, Halai, S, Hanna, T, Hashem, M, Hodgson, SH, Hughes, G, Hurndalm, K-H, Hyland, R, Iqbal, MR, Jarchow-MacDonald, A, Kailavasan, M, Klimovskij, M, Laliotis, A, Lambourne, J, Lawday, S, Lee, F, Lindsey, B, Lund, JN, Mabayoje, DA, Malik, KI, Muir, A, Narula, HS, Ofor, U, Parsons, H, Pavelle, T, Prescott, K, Rajgopal, A, Roy, I, Sagar, J, Scarborough, C, Shaikh, S, Smart, CJ, Snape, S, Tabaqchali, M, Tennakoon, A, Tilley, R, Vink, E, White, L, Burke, D, and Kirby, A

Abstract

Methods A multicentre observational study was conducted from August 2016 to February 2017 in the UK. Adult patients diagnosed with cIAI were included. Multivariable logistic regression was performed to develop CPMs for mortality and cIAI relapse. The c-statistic was used to test model discrimination. Model calibration was tested using calibration slopes and calibration in the large (CITL). The CPMs were then presented as point scoring systems and validated further. Results Overall, 417 patients from 31 surgical centres were included in the analysis. At 90 days after diagnosis, 17.3 per cent had a cIAI relapse and the mortality rate was 11.3 per cent. Predictors in the mortality model were age, cIAI aetiology, presence of a perforated viscus and source control procedure. Predictors of cIAI relapse included the presence of collections, outcome of initial management, and duration of antibiotic treatment. The c-statistic adjusted for model optimism was 0.79 (95 per cent c.i. 0.75 to 0.87) and 0.74 (0.73 to 0.85) for mortality and cIAI relapse CPMs. Adjusted calibration slopes were 0.88 (95 per cent c.i. 0.76 to 0.90) for the mortality model and 0.91 (0.88 to 0.94) for the relapse model; CITL was −0.19 (95 per cent c.i. −0.39 to −0.12) and − 0.01 (− 0.17 to −0.03) respectively. Conclusion Relapse of infection and death after complicated intra-abdominal infections are common. Clinical prediction models were developed to identify patients at increased risk of relapse or death after treatment, although these require external validation.

Published
2021

13. Sofosbuvir in treatment-naïve patients with hepatitis C infection

Author

GANE, E J, LAWITZ, E, MANGIA, A, WYLES, D, RODRIGUEZ-TORRES, M, HASSANEIN, T, GORDON, S C, SCHULTZ, M, DAVIS, M N, KAYALI, Z, REDDY, K R, JACOBSON, I M, KOWDLEY, K V, NYBERG, L, SUBRAMANIAN, G M, HYLAND, R H, ARTERBURN, S, JIANG, D, MCNALLY, J, BRAINARD, D M, SYMONDS, W T, MCHUTCHISON, J G, SHEIKH, A M, and YOUNOSSI, Z

Published
2013

16. Development and internal validation of clinical prediction models for outcomes of complicated intra-abdominal infection

Author

Ahmed, S, primary, Bonnett, L, additional, Melhuish, A, additional, Adil, M T, additional, Aggarwal, I, additional, Ali, W, additional, Bennett, J, additional, Boldock, E, additional, Burns, F A, additional, Czarniak, E, additional, Dennis, R, additional, Flower, B, additional, Fok, R, additional, Goodman, A L, additional, Halai, S, additional, Hanna, T, additional, Hashem, M, additional, Hodgson, S H, additional, Hughes, G, additional, Hurndall, K-H, additional, Hyland, R, additional, Iqbal, M R, additional, Jarchow-MacDonald, A, additional, Kailavasan, M, additional, Klimovskij, M, additional, Laliotis, A, additional, Lambourne, J, additional, Lawday, S, additional, Lee, F, additional, Lindsey, B, additional, Lund, J N, additional, Mabayoje, D A, additional, Malik, K I, additional, Muir, A, additional, Narula, H S, additional, Ofor, U, additional, Parsons, H, additional, Pavelle, T, additional, Prescott, K, additional, Rajgopal, A, additional, Roy, I, additional, Sagar, J, additional, Scarborough, C, additional, Shaikh, S, additional, Smart, C J, additional, Snape, S, additional, Tabaqchali, M A, additional, Tennakoon, A, additional, Tilley, R, additional, Vink, E, additional, White, L, additional, Burke, D, additional, and Kirby, A, additional

Published
2021
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19. International guidelines for the diagnosis and management of hereditary haemorrhagic telangiectasia

Author

Faughnan, M E, Palda, V A, Garcia-Tsao, G, Geisthoff, U W, McDonald, J, Proctor, D D, Spears, J, Brown, D H, Buscarini, E, Chesnutt, M S, Cottin, V, Ganguly, A, Gossage, J R, Guttmacher, A E, Hyland, R H, Kennedy, S J, Korzenik, J, Mager, J J, Ozanne, A P, Piccirillo, J F, Picus, D, Plauchu, H, Porteous, M E M, Pyeritz, R E, Ross, D A, Sabba, C, Swanson, K, Terry, P, Wallace, M C, Westermann, C J J, White, R I, Young, L H, and Zarrabeitia, R

Published
2011
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27. Sofosbuvir-velpatasvir for 12 weeks is safe and effective in patients undergoing dialysis.

Author

Gane E., Markova S., Dvory-Sobol H., Osinusi A., Yoshida E., Calleja J., Pianko S., Borgia S., Dearden J., Lurie Y., Shafran S., Brown A., Hyland R., Lu S., Gane E., Markova S., Dvory-Sobol H., Osinusi A., Yoshida E., Calleja J., Pianko S., Borgia S., Dearden J., Lurie Y., Shafran S., Brown A., Hyland R., and Lu S.

Abstract

Background and Aim: Approved hepatitis C virus (HCV) treatments for patients on dialysis are associated with complexities, including drug-drug interactions, baseline resistance testing, use of ribavirin, and risk of hepatotoxicity. Despite higher concentrations of the primary circulating sofosbuvir (SOF) metabolite, GS-331007, in severe renal impairment, real-world case series showed substantial use of SOF-based regimens in this population, with no safety concerns identified. This study evaluated the safety, efficacy, and pharmacokinetics of sofosbuvir-velpatasvir (SOF/VEL) for 12 weeks in patients with HCV infection on dialysis. Method(s): Treatment-naive or -experienced patients, of any genotype, with or without compensated cirrhosis and undergoing hemodialysis or peritoneal dialysis, were enrolled to receive an open-label SOF/VEL (400 mg/100 mg daily) fixed-dose combination once daily for 12 weeks. The primary efficacy end-point was comparison of the sustained virological response 12 weeks after treatment (SVR12) to a prespecified historic control rate of 83%. The primary safety end-point was the proportion of patients who discontinued therapy due to adverse events (AEs). Secondary endpoints included safety, viral resistance, and pharmacokinetics. Result(s): A total of 59 patients were enrolled at 21 sites in Canada, the United Kingdom, Spain, Israel, Australia, and New Zealand. The median age was 60 years (range, 33-91), 59% were male, 53% white, 22% treatment-experienced, and 29% had cirrhosis. Most patients had HCV genotype 1 (42%), 2 (12%), or 3 (27%). Most (92%) were on hemodialysis, with a mean dialysis duration of 7.3 years (range, 0-40). Treatment was well tolerated; no one discontinued therapy due to AEs. One patient was discontinued from therapy on day 74 for non-compliance, with 48% study medication adherence by pill count. Overall, 56/59 patients (95%) achieved SVR12. Two (3%) had virological relapse (one with non-adherence). One patient did not achie

Published
2019

30. Prediction modelling using routine clinical parameters to stratify survival in Malignant Pleural Mesothelioma patients undergoing cytoreductive surgery.

Author

Harris, E., Kao, S., McCaughan, B., Nakano, T., Kondo, N., Hyland, R., Nowak, A., de Klerk, N., Brims, Fraser, Harris, E., Kao, S., McCaughan, B., Nakano, T., Kondo, N., Hyland, R., Nowak, A., de Klerk, N., and Brims, Fraser

Abstract

BACKGROUND: Malignant Pleural Mesothelioma (MPM) is an uncommon cancer with a poor prognosis and heterogeneous survival. Surgery for MPM is offered in some specialist centres to highly selected patients. A previously described classification and regression tree (CART) model stratified survival in unselected MPM patients using routinely collected clinical data. This study aimed to examine the performance of this CART model on a highly selected surgical population. METHODS: Data were collected from subjects undergoing cytoreductive surgery for MPM from specialist centres in Hyõgo, Japan and Sydney, Australia between 1991 and 2016. The CART model was applied using the combination of clinical variables to stratify subjects into risk groups (1-4); survival characteristics were then compared. RESULTS: 289 cases were included (205 from Australia, 84 from Japan). Overall median survival was 34.6 (IQR 17.5-56.1) months; median age 63.0 (IQR 57.0-67.8) years, 240/289 (83.0%) were male. There were no clinically meaningful differences between the two cohorts. Survival across the four risk groups was significantly different (p<0.0001); the model stratified survival well with a Harrell's c-statistic of 0.62 (96% CI 0.57-0.66) at 36 months. The group with the longest survival (median 82.5 months) had: no weight loss, Hb >153g/L and serum albumin >43g/L at time of referral to the surgical centre. CONCLUSION: Using routinely available clinical variables the CART model was able to stratify surgical patients into risk groups with statistically different survival characteristics with fair to good performance. Presence of weight loss, anaemia and low albumin should confer caution when considering surgical therapy for MPM.

Published
2018

36. Ledipasvir/Sofosbuvir with Ribavirin for 12 Weeks is Effective and Safe in Treatment-Naïve Genotype-3 Hepatitis C-Infected Patients in Canada

Author

Feld, J., primary, Ramji, A., additional, Shafran, S., additional, Willems, B., additional, Marotta, P., additional, Huchet, E., additional, Vachon, M.-L., additional, Svarovskaia, E., additional, Huang, K., additional, Hyland, R., additional, Yun, C., additional, Brainard, D., additional, McHutchison, J., additional, Tam, E., additional, Bailey, R., additional, Cooper, C., additional, Yoshida, E., additional, Greenbloom, S., additional, Elkhashab, M., additional, Borgia, S., additional, and Swain, M., additional

Published
2016
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39. P0773 : The prevalence and the effect of HCV NS5A resistance associated variants in subjects with compensated cirrhosis treated with ledipasvir/sofosbuvir +/- RBV

Author

Sarrazin, C., primary, Dvory-Sobol, H., additional, Svarovskaia, E.S., additional, Doehle, B., additional, Martin, R., additional, Zeuzem, S., additional, Lawitz, E., additional, Hyland, R., additional, Pang, P.S., additional, Knox, S., additional, Gane, E., additional, Reddy, R., additional, Afdhal, N., additional, Mizokami, M., additional, Omata, M., additional, Miller, M.D., additional, Mo, H., additional, and Bourlière, M., additional

Published
2015
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45. 1372 ONCE DAILY PSI-7977 PLUS PEG-IFN/RBV IN HCV GT1: 98% RAPID VIROLOGIC RESPONSE, COMPLETE EARLY VIROLOGIC RESPONSE: THE PROTON STUDY

Author

Nelson, D.R., primary, Lalezari, J., additional, Lawitz, E., additional, Hassanein, T., additional, Kowdley, K., additional, Poordad, F., additional, Sheikh, A., additional, Afdhal, N., additional, Bernstein, D., additional, Dejesus, E., additional, Freilich, B., additional, Dieterich, D., additional, Jacobson, I., additional, Jensen, D., additional, Abrams, G.A., additional, Darling, J., additional, Rodriguez-Torres, M., additional, Reddy, R., additional, Sulkowski, M., additional, Bzowej, N., additional, Demicco, M., additional, Strohecker, J., additional, Hyland, R., additional, Mader, M., additional, Albanis, E., additional, Symonds, W.T., additional, and Berrey, M.M., additional

Published
2011
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