6 results on '"Hedley EL"'
Search Results
2. A PHASE I TOXICITY, DOSE FINDING AND PRELIMINARY EFFICACY ASSESSMENT OF LIPOTEICHOIC ACID-T FOR PLEURODESIS IN MALIGNANT PLEURAL EFFUSION
- Author
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Rahman, NM, Davies, HE, Salzberg, M, Hedley, EL, Truogg, P, Midgley, R, Kerr, D, Clelland, C, and Davies, RJO
- Published
- 2016
3. S20 Primary Result of the 1st Therapeutic Interventions in Malignant Effusion (TIME1) Trial: A 2 × 2 factorial, randomised trial of chest tube size and analgesic strategy for pleurodesis in malignant pleural effusion
- Author
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Rahman, NM, primary, Pepperell, J, additional, Rehal, S, additional, Saba, T, additional, Tang, A, additional, Ali, N, additional, West, A, additional, Hettiarachchi, G, additional, Mukherjee, D, additional, Samuel, J, additional, Bentley, A, additional, Dowson, L, additional, Miles, J, additional, Ryan, F, additional, Yoneda, K, additional, Chauhan, A, additional, Corcoran, J, additional, Psallidas, I, additional, Wrightson, JM, additional, Hallifax, R, additional, Davies, HE, additional, Lee, YCG, additional, Hedley, EL, additional, Seaton, D, additional, Russell, N, additional, Chapman, M, additional, McFadyen, BM, additional, Shaw, RA, additional, Davies, RJO, additional, Maskell, NA, additional, Nunn, AJ, additional, and Miller, RF, additional
- Published
- 2015
- Full Text
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4. Prospective validation of the RAPID clinical risk prediction score in adult patients with pleural infection: the PILOT study.
- Author
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Corcoran JP, Psallidas I, Gerry S, Piccolo F, Koegelenberg CF, Saba T, Daneshvar C, Fairbairn I, Heinink R, West A, Stanton AE, Holme J, Kastelik JA, Steer H, Downer NJ, Haris M, Baker EH, Everett CF, Pepperell J, Bewick T, Yarmus L, Maldonado F, Khan B, Hart-Thomas A, Hands G, Warwick G, De Fonseka D, Hassan M, Munavvar M, Guhan A, Shahidi M, Pogson Z, Dowson L, Popowicz ND, Saba J, Ward NR, Hallifax RJ, Dobson M, Shaw R, Hedley EL, Sabia A, Robinson B, Collins GS, Davies HE, Yu LM, Miller RF, Maskell NA, and Rahman NM
- Subjects
- Adult, Humans, Length of Stay, Pilot Projects, Prospective Studies, Risk Factors, Pleural Diseases
- Abstract
Background: Over 30% of adult patients with pleural infection either die and/or require surgery. There is no robust means of predicting at baseline presentation which patients will suffer a poor clinical outcome. A validated risk prediction score would allow early identification of high-risk patients, potentially directing more aggressive treatment thereafter., Objectives: To prospectively assess a previously described risk score (the RAPID (Renal (urea), Age, fluid Purulence, Infection source, Dietary (albumin)) score) in adults with pleural infection., Methods: Prospective observational cohort study that recruited patients undergoing treatment for pleural infection. RAPID score and risk category were calculated at baseline presentation. The primary outcome was mortality at 3 months; secondary outcomes were mortality at 12 months, length of hospital stay, need for thoracic surgery, failure of medical treatment and lung function at 3 months., Results: Mortality data were available in 542 out of 546 patients recruited (99.3%). Overall mortality was 10% at 3 months (54 out of 542) and 19% at 12 months (102 out of 542). The RAPID risk category predicted mortality at 3 months. Low-risk mortality (RAPID score 0-2): five out of 222 (2.3%, 95% CI 0.9 to 5.7%); medium-risk mortality (RAPID score 3-4): 21 out of 228 (9.2%, 95% CI 6.0 to 13.7%); and high-risk mortality (RAPID score 5-7): 27 out of 92 (29.3%, 95% CI 21.0 to 39.2%). C-statistics for the scores at 3 months and 12 months were 0.78 (95% CI 0.71-0.83) and 0.77 (95% CI 0.72-0.82), respectively., Conclusions: The RAPID score stratifies adults with pleural infection according to increasing risk of mortality and should inform future research directed at improving outcomes in this patient population., Competing Interests: Conflict of interest: J.P. Corcoran reports grants from the UK Medical Research Council (MRC; grant number G1001128), during the conduct of the study. Conflict of interest: I. Psallidas reports grants from the UK MRC (grant number G1001128), during the conduct of the study, as well as grants and personal fees from the European Respiratory Society (ERS), outside the submitted work. Conflict of interest: S. Gerry has nothing to disclose. Conflict of interest: F. Piccolo has nothing to disclose. Conflict of interest: C.F. Koegelenberg has nothing to disclose. Conflict of interest: T. Saba has nothing to disclose. Conflict of interest: C. Daneshvar has nothing to disclose. Conflict of interest: I. Fairbairn has nothing to disclose. Conflict of interest: R. Heinink has nothing to disclose. Conflict of interest: A. West has nothing to disclose. Conflict of interest: A.E. Stanton has nothing to disclose. Conflict of interest: J. Holme has nothing to disclose. Conflict of interest: J.A. Kastelik has nothing to disclose. Conflict of interest: H. Steer has nothing to disclose. Conflict of interest: N.J. Downer has nothing to disclose. Conflict of interest: M. Haris has nothing to disclose. Conflict of interest: E.H. Baker has nothing to disclose. Conflict of interest: C.F. Everett has nothing to disclose. Conflict of interest: J. Pepperell has nothing to disclose. Conflict of interest: T. Bewick has nothing to disclose. Conflict of interest: L. Yarmus has nothing to disclose. Conflict of interest: F. Maldonado has nothing to disclose. Conflict of interest: B. Khan has nothing to disclose. Conflict of interest: A. Hart-Thomas has nothing to disclose. Conflict of interest: G. Hands has nothing to disclose. Conflict of interest: G. Warwick has nothing to disclose. Conflict of interest: D. De Fonseka has nothing to disclose. Conflict of interest: M. Hassan reports grants from the UK MRC (grant number G1001128), during the conduct of the study. Conflict of interest: M. Munavvar has nothing to disclose. Conflict of interest: A. Guhan has nothing to disclose. Conflict of interest: M. Shahidi has nothing to disclose. Conflict of interest: Z. Pogson has nothing to disclose. Conflict of interest: L. Dowson has nothing to disclose. Conflict of interest: N.D. Popowicz has nothing to disclose. Conflict of interest: J. Saba has nothing to disclose. Conflict of interest: N.R. Ward has nothing to disclose. Conflict of interest: R.J. Hallifax reports grants from the UK MRC (grant number G1001128), during the conduct of the study. Conflict of interest: M. Dobson reports grants from the UK MRC (grant number G1001128), during the conduct of the study. Conflict of interest: R. Shaw reports grants from the UK MRC (grant number G1001128), during the conduct of the study. Conflict of interest: E.L. Hedley reports grants from the UK MRC (grant number G1001128), during the conduct of the study. Conflict of interest: A. Sabia reports grants from the UK MRC (grant number G1001128), during the conduct of the study. Conflict of interest: B. Robinson reports grants from the UK MRC (grant number G1001128), during the conduct of the study. Conflict of interest: G.S. Collins has nothing to disclose. Conflict of interest: H.E. Davies has nothing to disclose. Conflict of interest: L-M. Yu has nothing to disclose. Conflict of interest: R.F. Miller has nothing to disclose. Conflict of interest: N.A. Maskell has nothing to disclose. Conflict of interest: N.M. Rahman reports grants from the UK MRC (grant number G1001128), during the conduct of the study, as well as personal fees from the UK National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, outside the submitted work., (Copyright ©ERS 2020.)
- Published
- 2020
- Full Text
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5. Continuous positive airway pressure versus standard care for the treatment of people with mild obstructive sleep apnoea (MERGE): a multicentre, randomised controlled trial.
- Author
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Wimms AJ, Kelly JL, Turnbull CD, McMillan A, Craig SE, O'Reilly JF, Nickol AH, Hedley EL, Decker MD, Willes LA, Calverley PMA, Benjafield AV, Stradling JR, and Morrell MJ
- Subjects
- Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Quality of Life, Sleep, Treatment Outcome, Young Adult, Continuous Positive Airway Pressure methods, Counseling methods, Sleep Apnea, Obstructive therapy, Standard of Care
- Abstract
Background: The evidence base for the treatment of mild obstructive sleep apnoea is limited and definitions of disease severity vary. The MERGE trial investigated the clinical effectiveness of continuous positive airway pressure in patients with mild obstructive sleep apnoea., Methods: MERGE, a multicentre, parallel, randomised controlled trial enrolled patients (≥18 years to ≤80 years) with mild obstructive sleep apnoea (apnoea-hypopnoea index [AHI] ≥5 to ≤15 events per h using either AASM 2007 or AASM 2012 scoring criteria) from 11 UK sleep centres. Participants were assigned (1:1) to either 3 months of continuous positive airway pressure plus standard care (sleep counselling), or standard care alone, by computer-generated randomisation; neither participants nor researchers were blinded. The primary outcome was a change in the score on the Short Form-36 questionnaire vitality scale in the intention-to-treat population of patients with mild obstructive sleep apnoea diagnosed using the American Academy of Sleep Medicine 2012 scoring criteria. The study is registered with ClinicalTrials.gov, NCT02699463., Findings: Between Nov 28, 2016 and Feb 12, 2019, 301 patients were recruited and randomised. 233 had mild obstructive sleep apnoea using AASM 2012 criteria and were included in the intention-to-treat analysis: 115 were allocated to receive continuous positive airway pressure and 118 to receive standard care. 209 (90%) of these participants completed the trial. The vitality score significantly increased with a treatment effect of a mean of 10·0 points (95% CI 7·2-12·8; p<0·0001) after 3 months of continuous positive airway pressure, compared with standard care alone (9·2 points [6·8 to 11·6] vs -0·8 points [-3·2 to 1·5]). Using the ANCOVA last-observation-carried-forward analysis, a more conservative estimate, the vitality score also significantly increased with a treatment effect of a mean of 7·5 points (95% CI 5·3 to 9·6; p<0·0001) after 3 months of continuous positive airway pressure, compared with standard care alone (7·5 points [6·0 to 9·0] vs 0·0 points [-1·5 to 1·5]). Three serious adverse events occurred (one allocated to the continuous positive airway pressure group) and all were unrelated to the intervention., Interpretation: 3 months of treatment with continuous positive airway pressure improved the quality of life in patients with mild obstructive sleep apnoea. These results highlight the need for health-care professionals and providers to consider treatment for patients with mild obstructive sleep apnoea., Funding: ResMed Ltd., (Copyright © 2020 Elsevier Ltd. All rights reserved.)
- Published
- 2020
- Full Text
- View/download PDF
6. Effect of Opioids vs NSAIDs and Larger vs Smaller Chest Tube Size on Pain Control and Pleurodesis Efficacy Among Patients With Malignant Pleural Effusion: The TIME1 Randomized Clinical Trial.
- Author
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Rahman NM, Pepperell J, Rehal S, Saba T, Tang A, Ali N, West A, Hettiarachchi G, Mukherjee D, Samuel J, Bentley A, Dowson L, Miles J, Ryan CF, Yoneda KY, Chauhan A, Corcoran JP, Psallidas I, Wrightson JM, Hallifax R, Davies HE, Lee YC, Dobson M, Hedley EL, Seaton D, Russell N, Chapman M, McFadyen BM, Shaw RA, Davies RJ, Maskell NA, Nunn AJ, and Miller RF
- Subjects
- Aged, Algorithms, Analgesia methods, Analgesics, Opioid adverse effects, Anti-Inflammatory Agents, Non-Steroidal adverse effects, Confidence Intervals, Equipment Design, Female, Humans, Male, Pain Measurement methods, Pleural Effusion, Malignant complications, Salvage Therapy methods, Salvage Therapy statistics & numerical data, Thoracoscopy instrumentation, Treatment Failure, Analgesics, Opioid therapeutic use, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Chest Tubes adverse effects, Pain Management methods, Pleural Effusion, Malignant therapy, Pleurodesis methods
- Abstract
Importance: For treatment of malignant pleural effusion, nonsteroidal anti-inflammatory drugs (NSAIDs) are avoided because they may reduce pleurodesis efficacy. Smaller chest tubes may be less painful than larger tubes, but efficacy in pleurodesis has not been proven., Objective: To assess the effect of chest tube size and analgesia (NSAIDs vs opiates) on pain and clinical efficacy related to pleurodesis in patients with malignant pleural effusion., Design, Setting, and Participants: A 2×2 factorial phase 3 randomized clinical trial among 320 patients requiring pleurodesis in 16 UK hospitals from 2007 to 2013., Interventions: Patients undergoing thoracoscopy (n = 206; clinical decision if biopsy was required) received a 24F chest tube and were randomized to receive opiates (n = 103) vs NSAIDs (n = 103), and those not undergoing thoracoscopy (n = 114) were randomized to 1 of 4 groups (24F chest tube and opioids [n = 28]; 24F chest tube and NSAIDs [n = 29]; 12F chest tube and opioids [n = 29]; or 12F chest tube and NSAIDs [n = 28])., Main Outcomes and Measures: Pain while chest tube was in place (0- to 100-mm visual analog scale [VAS] 4 times/d; superiority comparison) and pleurodesis efficacy at 3 months (failure defined as need for further pleural intervention; noninferiority comparison; margin, 15%)., Results: Pain scores in the opiate group (n = 150) vs the NSAID group (n = 144) were not significantly different (mean VAS score, 23.8 mm vs 22.1 mm; adjusted difference, -1.5 mm; 95% CI, -5.0 to 2.0 mm; P = .40), but the NSAID group required more rescue analgesia (26.3% vs 38.1%; rate ratio, 2.1; 95% CI, 1.3-3.4; P = .003). Pleurodesis failure occurred in 30 patients (20%) in the opiate group and 33 (23%) in the NSAID group, meeting criteria for noninferiority (difference, -3%; 1-sided 95% CI, -10% to ∞; P = .004 for noninferiority). Pain scores were lower among patients in the 12F chest tube group (n = 54) vs the 24F group (n = 56) (mean VAS score, 22.0 mm vs 26.8 mm; adjusted difference, -6.0 mm; 95% CI, -11.7 to -0.2 mm; P = .04) and 12F chest tubes vs 24F chest tubes were associated with higher pleurodesis failure (30% vs 24%), failing to meet noninferiority criteria (difference, -6%; 1-sided 95% CI, -20% to ∞; P = .14 for noninferiority). Complications during chest tube insertion occurred more commonly with 12F tubes (14% vs 24%; odds ratio, 1.91; P = .20)., Conclusions and Relevance: Use of NSAIDs vs opiates resulted in no significant difference in pain scores but was associated with more rescue medication. NSAID use resulted in noninferior rates of pleurodesis efficacy at 3 months. Placement of 12F chest tubes vs 24F chest tubes was associated with a statistically significant but clinically modest reduction in pain but failed to meet noninferiority criteria for pleurodesis efficacy., Trial Registration: isrctn.org Identifier: ISRCTN33288337.
- Published
- 2015
- Full Text
- View/download PDF
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