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2. Stimulated Emission of Radiation in a Single Mode for both Resonance and Non-resonance for Various Initial Photon Distributions

Author

Tavis, M. T. and Cummings, F. W.

Subjects
Quantum Physics
Abstract

This paper reexamines the results of Cummings in which the quantum mechanical two-level-system (TLS) interacts with the electromagnetic field with various initial distributions and extends that work for both resonant and non-resonant to times large enough to display multiple photon echoes. The results presented here include the initial pure coherent state, the field whose initial density matrix is the Gaussian superposition of coherent states (blackbody radiation) and density matrices of the field represented by various combinations of mixed coherent and thermal states with and without squeezing This paper provides, in addition to the matrix elements to the various states, both the algebraic and graphical representation for the first order correlation function G= for resonance and non-resonance. It is found that in all case, the application of non-resonance leads to oscillations in the first order correlation which was thought only to apply for the coherent state even for the case of the pure thermal state., Comment: 26 pages, 14 tables many of which contain multiple figures or equations

Published
2012

4. Phyllotaxis, a model

Author

Cummings, F. W.

Subjects
Quantitative Biology - Tissues and Organs, Quantitative Biology - Cell Behavior
Abstract

A model of the regular arrangement of leaves on a plant stem (phyllotactic patterns) is proposed, based on a new plant pattern algorithm. Tripartite patterning is proposed to occur by the interaction of two signaling pathways. Each pathway produces stimulated extracellular emission of like ligand upon activation of its respective receptor, as well as inhibiting such emission from the other pathway. Patterns arise spontaneously from zero density of activated receptor. All known phyllotactic patterns are reproduced, Fibonacci, distichous, decussate, and whorls, as well as the rare monostichy, with only one leaf directly above the previous., Comment: 11 pages, two figures, one table

Published
2009

6. Quantum Entangled Supercorrelated States in the Jaynes-Cummings Model

Author

Rajagopal, A. K., Jensen, K. L, and Cummings, F. W.

Subjects
Quantum Physics, Condensed Matter - Statistical Mechanics
Abstract

The regions of independent quantum states, maximally classically correlated states, and purely quantum entangled (supercorrelated) states described in a recent formulation of quantum information theory by Cerf and Adami are explored here numerically in the parameter space of the well-known exactly soluable Jaynes-Cummings model for equilibrium and nonequilibrium time-dependent ensembles., Comment: 12 pages, 3 figures

Published
1999
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12. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis

Author

Sands, B. E., Sandborn, W. J., Panaccione, R., O'Brien, C. D., Zhang, H., Johanns, J., Adedokun, O. J., Li, K., Peyrin-Biroulet, L., Van Assche, G., Danese, S., Targan, S., Abreu, M. T., Hisamatsu, T., Szapary, P., Brown S, Marano C., Connor, S, De Cruz, P, Ding, Nj, Florin, T, Hendy, P, Leong, R, Moore, G, Pavli, P, Sparrow, M, Gassner, S, Vogelsang, H, Baert, F, Colard, A, De Vos, M, D'Heygere, F, Ferrante, M, Louis, E, Staessen, D, Berova, T, Churchev, J, Draganova, R, Gancheva, D, Ivanova, N, Marinova, I, Markov, M, Nikolov, R, Tsonev, N, Vassileva, G, Afif, W, Berstein, C, Bressler, B, Jairath, V, Lachance, Jr, Singh, R, Tilbe, K, Komarek, V, Kozeluhova, J, Lukas, M, Volfova, M, Dahlerup, J, Altwegg, R, Beorchia, S, Bouguen, G, Cadiot, G, Dupas, Jl, Desreumaux, P, Flourie, B, Grimaud, Jc, Guillaud, O, Moreau, J, Roblin, X, Zerbib, F, Baumgart, D, Beckebaum, S, Bokemeyer, B, Ebert, M, Hasselblatt, P, Lügering, A, Maaser, C, Schiefke, I, Schreiber, S, Seidler, U, Altorjay, I, Kiss, Gg, Literati-Nagy, B, Patai, A, Pecsi, G, Salamon, A, Schnabel, R, Székely, A, Tulassay, Z, Varga, M, Fich, A, Fishman, S, Konikoff, F, Lichtenstein, L, Rainis, T, Sbeit, W, Schwartz, D, Annese, V, Biancone, L, Bossa, F, Costintino, R, Danese, S, Fries, W, Gasbarrini, A, Guidi, L, Kohn, A, Maconi, G, Rocca, R, Rogai, F, Villa, E, Zoli, G, Akiho, H, Aoyama, N, Arisawa, T, Hidaka, H, Hisamatsu, T, Horiki, N, Inaba, T, Inoue, S, Ishida, T, Ishida, H, Ishiguro, Y, Ishihara, S, Iwabuchi, M, Kato, J, Katsushima, S, Kobayashi, T, Kojima, Y, Kurihara, H, Masuo, T, Matsui, T, Matsumoto, T, Matsuoka, K, Mitsuyama, K, Motoya, S, Nakagawa, T, Nakai, K, Nakamura, S, Niihara, T, Ohnishi, Y, Ohta, A, Osada, T, Ryuichi, I, Sakai, Y, Sakata, Y, Sameshima, Y, Sano, K, Shibatoge, M, Shibuya, T, Suzuki, Y, Takeshima, F, Tanaka, S, Taruishi, M, Tokito, S, Ueo, T, Watanabe, K, Yamagami, H, Cheon, Jh, Cho, Kb, Knowles, Kim, Kim, Hj, Kim, Y, Lee, Km, Yang, Sk, D'Haens, G, Pierik, M, Gearry, R, Inns, S, Rowbotham, D, Schultz, M, Bochenek, A, Gawdis-Wojnarska, B, Kleczkowski, D, Leszczyszyn, J, Malecka-Panas, E, Mamos, A, Petryka, R, Regula, J, Rozciecha, J, Stefanuik, P, Wozniak-Stolarska, B, Cimpoeru, N, Craciun, E, Ovidiu, Cf, Goldis, E, Ionita-Radu, F, Lazar, D, Suciu, I, Abdulkhakov, R, Alikhanov, B, Apartsin, K, Bakulin, I, Belousova, E, Gofman, A, Grinevich, V, Kulyapin, A, Nizov, A, Osipenko, M, Simanenkov, V, Tkachev, A, Uspenskiy, Y, Valuyskikh, E, Jovanovic, I, Nagorni, A, Svorcan, P, Zdravkovic, N, Bunganic, I, Abrahamovych, O, Bilianskyi, L, Datsenko, O, Golovchenko, O, Kharchenko, N, Klymenko, V, Levchenko, O, Lozynskyy, Y, Murenets, N, Oliinyk, O, Prystupa, L, Pyrogovskyi, V, Reznikova, V, Rishko, I, Stanislavchuk, M, Vizir, V, Yatsyshyn, R, Arasaradnam, R, Bloom, S, Cummings, F, Iqbal, T, Irving, P, Kaser, A, Shonde, A, Subramanian, S, Aberra, F, Aguilar, H, Araya, V, Bakken, A, Beaulieu, D, Cappa, Ja, Chiorean, M, Cohen, N, Dryden, G, Duvall, G, Ehrlich, A, Eisner, M, Ertan, A, Fogel, R, Friedenberg, K, Gatof, D, Glover, S, Grosman, I, Gunaratnam, N, Gupta, N, Haynes, P, Hemaidan, A, Higgins, P, Hou, J, Hudesman, D, Iskandar, H, Jazrawi, S, Jones, M, Karnam, U, Khurana, S, Killpack, M, Kreines, M, Lawlor, G, Lee, S, Loftus, E, Lukin, Dj, Marcet, J, Mattar, M, Melmed, G, Minor, T, Mirkin, K, Mutlu, E, Nichols, M, Nudell, J, Rai, R, Ramos, C, Mcleod, Randall, Rausher, D, Ritter, T, Singh Saini, S, Salzberg, B, Saubermann, L, Scherl, E, Sedghi, S, Sellin, J, Shafran, I, Sorrentino, D, Suiter, D, Swaminath, A, Tiongco, F, Vrabie, R, Walp, K, Warner, N, Winstead, N, Wolf, Dc, Woods, J, Yen, E, Younes, Z., Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Humanitas Clinical and Research Center [Rozzano, Milan, Italy], RS: NUTRIM - R2 - Liver and digestive health, MUMC+: MA Maag Darm Lever (9), Interne Geneeskunde, Sands, Be, Sandborn, Wj, Panaccione, R, O'Brien, Cd, Zhang, H, Johanns, J, Adedokun, Oj, Li, K, Peyrin-Biroulet, L, Van Assche, G, Danese, S, Targan, S, Abreu, Mt, Hisamatsu, T, Szapary, P, and Marano, C

Subjects
Adult, Male, Infusions, [SDV]Life Sciences [q-bio], Injections, Subcutaneous, Anti-Inflammatory Agents, Ulcerative, Klinikai orvostudományok, Article, Injections, Maintenance Chemotherapy, Dose-Response Relationship, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, INFLIXIMAB, Colitis, Ulcerative, Dose-Response Relationship, Drug, Female, Humans, Induction Chemotherapy, Infusions, Intravenous, Patient Acuity, Remission Induction, Ustekinumab, ComputingMilieux_MISCELLANEOUS, ACTIVITY INDEXES, Subcutaneous, Orvostudományok, General Medicine, EFFICACY, Colitis, 3. Good health, INFECTIONS, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Drug, Intravenous
Abstract

The efficacy of ustekinumab, an antagonist of the p40 subunit of interleukin-12 and interleukin-23, as induction and maintenance therapy in patients with ulcerative colitis is unknown.We evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. A total of 961 patients were randomly assigned to receive an intravenous induction dose of ustekinumab (either 130 mg [320 patients] or a weight-range-based dose that approximated 6 mg per kilogram of body weight [322]) or placebo (319). Patients who had a response to induction therapy 8 weeks after administration of intravenous ustekinumab were randomly assigned again to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 12 weeks [172 patients] or every 8 weeks [176]) or placebo (175). The primary end point in the induction trial (week 8) and the maintenance trial (week 44) was clinical remission (defined as a total score of ≤2 on the Mayo scale [range, 0 to 12, with higher scores indicating more severe disease] and no subscore1 [range, 0 to 3] on any of the four Mayo scale components).The percentage of patients who had clinical remission at week 8 among patients who received intravenous ustekinumab at a dose of 130 mg (15.6%) or 6 mg per kilogram (15.5%) was significantly higher than that among patients who received placebo (5.3%) (P0.001 for both comparisons). Among patients who had a response to induction therapy with ustekinumab and underwent a second randomization, the percentage of patients who had clinical remission at week 44 was significantly higher among patients assigned to 90 mg of subcutaneous ustekinumab every 12 weeks (38.4%) or every 8 weeks (43.8%) than among those assigned to placebo (24.0%) (P = 0.002 and P0.001, respectively). The incidence of serious adverse events with ustekinumab was similar to that with placebo. Through 52 weeks of exposure, there were two deaths (one each from acute respiratory distress syndrome and hemorrhage from esophageal varices) and seven cases of cancer (one each of prostate, colon, renal papillary, and rectal cancer and three nonmelanoma skin cancers) among 825 patients who received ustekinumab and no deaths and one case of cancer (testicular cancer) among 319 patients who received placebo.Ustekinumab was more effective than placebo for inducing and maintaining remission in patients with moderate-to-severe ulcerative colitis. (Funded by Janssen Research and Development; UNIFI ClinicalTrials.gov number, NCT02407236.).

Published
2019

13. Golimumab induction and maintenance for moderate to severe ulcerative colitis: results from GO-COLITIS (Golimumab: a Phase 4, UK, open label, single arm study on its utilization and impact in ulcerative Colitis)

Author

Probert, CSJ, Sebastian, S, Gaya, DR, Hamlin, PJ, Gillespie, G, Rose, A, Tate, H, Wheeler, C, Irving, PM, Probert, C, Gaya, D, Hart, A, Irving, P, Ahmad, T, Pollok, R, Orchard, T, Arasaradnam, R, Iqbal, T, Johnson, M, Kaser, A, Allen, P, Gordon, J, Preston, C, Shenderey, R, Hoque, S, Bloom, S, Ansari, A, Mowat, C, Hamlin, J, Arnott, I, Shaw, I, Steed, H, Butterworth, J, Robinson, A, Mawdsley, J, Creed, T, Cummings, F, and GO-COLITIS Study Grp

Abstract

Objective GO-COLITIS aimed to measure the effectiveness of subcutaneous golimumab in tumour necrosis factor-α antagonist–naive patients with moderate to severe ulcerative colitis (UC) despite conventional treatment.\ud \ud Design GO-COLITIS was an open label, single arm, phase 4 study with a pragmatic design which reflected UK clinical practice. Adult patients were eligible if diagnosed with UC ≥3 months, partial Mayo score (PMS) 4–9. Patients received subcutaneous golimumab induction (200 mg initially and 100 mg at week 2) followed at week 6 by 50 mg or 100 mg (depending on weight) every 4 weeks until week 54 with a 12-week follow-up. Efficacy was measured by PMS at baseline, week 6, 30, 54 and 66. Health-related quality of life (HRQoL; Inflammatory Bowel Disease Questionnaire (IBDQ) and EuroQol Group 5 Dimensions Health Questionnaire (EQ-5D)) was assessed at baseline, week 6 and week 54. All safety adverse events (AEs) were recorded.\ud \ud Results 207 patients were enrolled and 205 received golimumab (full analysis set (FAS)205). At week 6, 68.8% (95% CI 62.0% to 75.1%) and 38.5% (95% CI 31.8% to 45.6%) of patients were in response and remission, respectively, using PMS. At the end of the induction phase, 140/141 patients in clinical response continued into the maintenance phase (Maintenance FAS). Sustained clinical response through week 54 was achieved in 51/205 (24.9%) of the FAS205 population and 51/140 (36.4%) of the Maintenance FAS population. Statistically significant improvements from baseline to week 6 were observed for the IBDQ total score and for each IBDQ domain score (bowel symptoms, emotional function, systemic symptoms and social function), as well as the EQ-5D index score and associated visual analogue scale score (p

Published
2018

15. Mercaptopurine versus placebo to prevent recurrence of Crohn's disease after surgical resection (TOPPIC): a multicentre, double-blind, randomised controlled trial

Author

Mowat, C, Arnott, I, Cahill, A, Smith, M, Ahmad, T, Subramanian, S, Travis, S, Morris, J, Hamlin, J, Dhar, A, Nwokolo, C, Edwards, C, Creed, T, Bloom, S, Yousif, M, Thomas, L, Campbell, S, Lewis, SJ, Sebastian, S, Sen, S, Lal, S, Hawkey, C, Murray, C, Cummings, F, Goh, J, Lindsay, JO, Arebi, N, Potts, L, McKinley, AJ, Thomson, JM, Todd, JA, Collie, M, Dunlop, MG, Mowat, A, Gaya, DR, Winter, J, Naismith, GD, Ennis, H, Keerie, C, Lewis, S, Prescott, RJ, Kennedy, NA, Satsangi, J, and TOPPIC Study Group

Abstract

BACKGROUND: Up to 60% of patients with Crohn's disease need intestinal resection within the first 10 years of diagnosis, and postoperative recurrence is common. We investigated whether mercaptopurine can prevent or delay postoperative clinical recurrence of Crohn's disease. METHODS: We did a randomised, placebo-controlled, double-blind trial at 29 UK secondary and tertiary hospitals of patients (aged >16 years in Scotland or >18 years in England and Wales) who had a confirmed diagnosis of Crohn's disease and had undergone intestinal resection. Patients were randomly assigned (1:1) by a computer-generated web-based randomisation system to oral daily mercaptopurine at a dose of 1 mg/kg bodyweight rounded to the nearest 25 mg or placebo; patients with low thiopurine methyltransferase activity received half the normal dose. Patients and their carers and physicians were masked to the treatment allocation. Patients were followed up for 3 years. The primary endpoint was clinical recurrence of Crohn's disease (Crohn's Disease Activity Index >150 plus 100-point increase in score) and the need for anti-inflammatory rescue treatment or primary surgical intervention. Primary and safety analyses were by intention to treat. Subgroup analyses by smoking status, previous thiopurines, previous infliximab or methotrexate, previous surgery, duration of disease, or age at diagnosis were also done. This trial is registered with the International Standard Randomised Controlled Trial Register (ISRCTN89489788) and the European Clinical Trials Database (EudraCT number 2006-005800-15). FINDINGS: Between June 6, 2008, and April 23, 2012, 240 patients with Crohn's disease were randomly assigned: 128 to mercaptopurine and 112 to placebo. All patients received at least one dose of study drug, and no randomly assigned patients were excluded from the analysis. 16 (13%) of patients in the mercaptopurine group versus 26 (23%) patients in the placebo group had a clinical recurrence of Crohn's disease and needed anti-inflammatory rescue treatment or primary surgical intervention (adjusted hazard ratio [HR] 0·54, 95% CI 0·27-1·06; p=0·07; unadjusted HR 0·53, 95% CI 0·28-0·99; p=0·046). In a subgroup analysis, three (10%) of 29 smokers in the mercaptopurine group and 12 (46%) of 26 in the placebo group had a clinical recurrence that needed treatment (HR 0·13, 95% CI 0·04-0·46), compared with 13 (13%) of 99 non-smokers in the mercaptopurine group and 14 (16%) of 86 in the placebo group (0·90, 0·42-1·94; pinteraction=0·018). The effect of mercaptopurine did not significantly differ from placebo for any of the other planned subgroup analyses (previous thiopurines, previous infliximab or methotrexate, previous surgery, duration of disease, or age at diagnosis). The incidence and types of adverse events were similar in the mercaptopurine and placebo groups. One patient on placebo died of ischaemic heart disease. Adverse events caused discontinuation of treatment in 39 (30%) of 128 patients in the mercaptopurine group versus 41 (37%) of 112 in the placebo group. INTERPRETATION: Mercaptopurine is effective in preventing postoperative clinical recurrence of Crohn's disease, but only in patients who are smokers. Thus, in smokers, thiopurine treatment seems to be justified in the postoperative period, although smoking cessation should be strongly encouraged given that smoking increases the risk of recurrence.

Published
2017

18. Ustekinumab as induction and maintenance therapy for Crohn's disease

Author

Feagan, Bg, Sandborn, Wj, Gasink, C, Jacobstein, D, Lang, Y, Friedman, Jr, Blank, Ma, Johanns, J, Gao, Ll, Miao, Y, Adedokun, Oj, Sands, Be, Hanauer, Sb, Vermeire, S, Targan, S, Ghosh, S, de Villiers WJ, Colombel, Jf, Tulassay, Z, Seidler, U, Salzberg, Ba, Desreumaux, P, Lee, Sd, Loftus EV Jr, Dieleman, La, Katz, S, Rutgeerts, P, Bampton, P, Chung, A, Connor, S, Debinski, H, Leong, R, Macrae, F, Pavli, P, Sorrentino, D, van den Bogaerde, J, Vogel, W, Vogelsang, H, Louis, E, Mana, F, Zaltman, C, Aumais, G, Bernstein, C, Bressler, B, Dhalla, S, Dieleman, L, Feagan, B, Marshall, J, Panaccione, R, Ropeleski, M, Stehlik, J, Volfova, M, Brynskov, J, Glerup, H, Abitbol-Selinger, V, Allez, M, Beaugerie, L, Bourreille, A, Cadiot, G, Dupas, J, Grimaud, J, Laharie, D, Lerebours, E, Moreau, J, Baumgart, D, Brand, S, Ebert, M, Ehehalt, R, Hasselblatt, P, Howaldt, S, Klaus, J, Krummenerl, P, Kucharzik, T, Lügering, A, Mudter, J, Preiss, J, Schreiber, S, Stallmach, A, Stein, J, Strauch, U, Salamon, A, Patchett, S, Lahat-Zok, A, Rachmilewitz, D, Annese, V, Bossa, F, Guidi, L, Kohn, A, Rocca, R, Ando, A, Ashida, T, Hanai, H, Ishida, T, Ito, H, Matsumoto, T, Motoya, S, Nakamura, S, Sameshima, Y, Suzuki, Y, Watanabe, K, Yamagami, H, Yamamoto, T, Yao, K, Kim, H, Kim, Y, D'Haens, G, Pierik, M, van Bodegraven, A, van der Woude CJ, Gearry, R, Ciecko-Michalska, I, Malecka-Panas, E, Jojic, N, Aboo, N, Wright, J, Arranz, M, Viso, L, Ahmad, T, Bloom, S, Campbell, S, Creed, T, Cummings, F, Hawthorne, B, Iqbal, T, Ireland, A, Parkes, M, Pollok, R, Shaw, I, Shonde, A, Smith, M, Steel, A, Subramanian, S, Travis, S, Tremelling, M, Aberra, F, Abraham, B, Barish, C, Behm, B, Birbara, C, Bochner, R, Bologna, S, Brant, S, Charles, R, Cohen, N, de Villers, W, Dryden, G, Duvall, A, Flasar, M, Fleisher, M, Florez, D, Fogel, R, Gagneja, H, Gross, C, Hamilton, J, Hanauer, S, Hanson, J, Hardi, R, Higgins, P, Isaacs, K, Katz, J, Kaur, N, Khan, N, Lee, S, Leman, B, Levenson, S, Lichtiger, S, Loftus, E, Malik, P, Mcnair, A, Melmed, G, Miner, P, Nichols, M, Noar, M, Oikonomou, I, Oubre, B, Peterson, K, Pruitt, R, Quirk, D, Safdi, A, Safdi, M, Salzberg, B, Sandborn, W, Saubermann, L, Scherl, E, Schwartz, D, Schwarz, R, Sedghi, S, Selby, L, Shafran, I, Siegel, C, Sninsky, C, Stern, M, Stockwell, D, Stone, C, Swaminath, A, Swoger, J, Taormina, M, Williams, E, Winstead, N, Wolf, D, Wolosin, J, Yacyshyn, B, Yajnik, V, Yen, E, Hetzel, D, Muls, V, Bafutto, M, Francesconi, C, Sipahi, A, Steinwurz, F, Churchev, J, Kotzev, I, Marinova, I, Penchev, P, Spassova, Z, Stoinov, S, Takov, D, Vassileva, G, Fowler, S, Greenberg, G, Jones, J, Saibil, F, Salh, B, Banić, M, Duvnjak, M, Stimac, D, Goujon, G, Pelletier, A, Peyrin-Biroulet, L, Aldinger, V, Bokemeyer, B, Büning, C, Konturek, J, Krummenerl, T, Ochsenkuehn, T, Altorjay, I, Kis, J, Pecsi, G, Székely, A, Varga, M, Vincze, A, Wacha, J, Oddsson, E, Orvar, K, Avni-Biron, I, Fishman, S, Fraser, G, Konikoff, F, Melzer, E, Oren, R, Shirin, H, Danese, S, Marino, M, Sturniolo, Gc, Horiki, N, Iijima, H, Iwabuchi, M, Kanai, T, Kunisaki, R, Maemoto, A, Matsuoka, K, Osada, T, Sugimoto, K, Tanaka, S, Cheon, Jh, Han, Ds, Jang, Bi, Kim, Hj, Kim, Js, Kim, Yh, Park, Sj, Yang, Sk, Arnold, M, Claydon, A, Haines, M, Hill, J, Rowbotham, D, Schultz, M, Wallace, I, Bochenek, A, Niezgoda, K, Szura, M, Arutyunov, G, Baranovsky, A, Khalif, I, Osipenko, M, Milinic, N, Bloch, H, Kruger, Fc, Prins, M, Watermeyer, G, Ziady, C, Calvo, Xc, Domínguez-Muñoz, Je, Gisbert, Jp, Arsenescu, R, Beaulieu, D, Bedford, R, Behrend, C, Cleavinger, P, Cohen, J, Ertan, A, Freilich, B, Friedenberg, K, Glover, S, Gordon, G, Gunaratnam, N, Gupta, N, Holbrook, R, Jones, M, Kaufman, B, Khan, Nh, Khurana, S, Legnani, P, Mutlu, E, Phillips, R, Rai, R, Reichelderfer, M, Ritter, T, Safdi, Ma, Sands, B, Schulman, M, Smith, J, Suiter, D, Taylor, D, Vasudeva, R, Winstead, T, Zwick, A, Savoye, G, Atreya, R, Ochsenkuhn, T, Ott, C, Goldin, E, Motohiro, E, Takanori, K, Park, S, James, B, Cummings, J, Tariq, A, Willert, R, Allan, M, Bulat, R, Devilliers, W, Eaker, E, Hou, J, Mendu, S, Nicols, M, Proctor, D, Thosani, N, Zhang, C, and UNITI-IM-UNITI Study Group

Subjects
030203 arthritis & rheumatology, Adult, Male, Infusions, Medicine (all), Remission Induction, Crohn Disease, Female, Humans, Induction Chemotherapy, Infusions, Intravenous, Maintenance Chemotherapy, Middle Aged, Ustekinumab, General Medicine, Orvostudományok, Klinikai orvostudományok, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Intravenous
Abstract

Ustekinumab, a monoclonal antibody to the p40 subunit of interleukin-12 and interleukin-23, was evaluated as an intravenous induction therapy in two populations with moderately to severely active Crohn's disease. Ustekinumab was also evaluated as subcutaneous maintenance therapy.We randomly assigned patients to receive a single intravenous dose of ustekinumab (either 130 mg or approximately 6 mg per kilogram of body weight) or placebo in two induction trials. The UNITI-1 trial included 741 patients who met the criteria for primary or secondary nonresponse to tumor necrosis factor (TNF) antagonists or had unacceptable side effects. The UNITI-2 trial included 628 patients in whom conventional therapy failed or unacceptable side effects occurred. Patients who completed these induction trials then participated in IM-UNITI, in which the 397 patients who had a response to ustekinumab were randomly assigned to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 8 weeks or every 12 weeks) or placebo. The primary end point for the induction trials was a clinical response at week 6 (defined as a decrease from baseline in the Crohn's Disease Activity Index [CDAI] score of ≥100 points or a CDAI score150). The primary end point for the maintenance trial was remission at week 44 (CDAI score150).The rates of response at week 6 among patients receiving intravenous ustekinumab at a dose of either 130 mg or approximately 6 mg per kilogram were significantly higher than the rates among patients receiving placebo (in UNITI-1, 34.3%, 33.7%, and 21.5%, respectively, with P≤0.003 for both comparisons with placebo; in UNITI-2, 51.7%, 55.5%, and 28.7%, respectively, with P0.001 for both doses). In the groups receiving maintenance doses of ustekinumab every 8 weeks or every 12 weeks, 53.1% and 48.8%, respectively, were in remission at week 44, as compared with 35.9% of those receiving placebo (P=0.005 and P=0.04, respectively). Within each trial, adverse-event rates were similar among treatment groups.Among patients with moderately to severely active Crohn's disease, those receiving intravenous ustekinumab had a significantly higher rate of response than did those receiving placebo. Subcutaneous ustekinumab maintained remission in patients who had a clinical response to induction therapy. (Funded by Janssen Research and Development; ClinicalTrials.gov numbers, NCT01369329 , NCT01369342 , and NCT01369355 .).

Published
2016

19. Genome-wide and fine-resolution association analysis of malaria in West Africa

Author

Muminatou, Jallow, Yik Ying Teo, Small, Kerrin S., Rockett, Kirk A., Panos, Deloukas, Clark, Taane G., Katja, Kivinen, Bojang, Kalifa A., Conway, David J., Margaret, Pinder, Giorgio, Sirugo, Fatou Sisay Joof, Stanley, Usen, Sarah, Auburn, Bumpstead, Suzannah J., Susana, Campino, Alison, Coffey, Andrew, Dunham, Fry, Andrew E., Angela, Green, Rhian, Gwilliam, Hunt, Sarah E., Michael, Inouye, Jeffreys, Anna E., Alieu, Mendy, Aarno, Palotie, Simon, Potter, Jiannis, Ragoussis, Jane, Rogers, Kate, Rowlands, Elilan, Somaskantharajah, Pamela, Whittaker, Claire, Widden, Peter, Donnelly, Bryan, Howie, Jonathan, Marchini, Andrew, Morris, Miguel, Sanjoaquin, Eric Akum Achidi, Tsiri, Agbenyega, Angela, Allen, Olukemi, Amodu, Patrick, Corran, Abdoulaye, Djimde, Amagana, Dolo, Doumbo, Ogobara K., Chris, Drakeley, Sarah, Dunstan, Jennifer, Evans, Jeremy, Farrar, Hien Tt, Fernando D., Horstmann, R. D., Ibrahim, M., Karunaweera, N., Kokwaro, G., Koram, K. A., Lemnge, M., Makani, J., Marsh, K., Michon, P., David, Modiano, Molyneux, M. E., Mueller, I., Parker, M., Peshu, N., Plowe, C. V., Puijalon, O., Reeder, J., Reyburn, H., Riley, E. M., Sakuntabhai, A., Singhasivanon, P., Sirima, S., Tall, A., Taylor, T. E., Thera, M., Troye Blomberg, M., Williams, T. N., Wilson, M., Wellcome Trust Case Control Consortium Kwiatkowski, D. P., Epidemiology Network: Achidi, Malaria Genomic E. A., Agbenyega, T., Ahmad, T., Alcock, D., Allen, S., Amenga Etego, L., Amodu, O., Apinjoh, T. O., Attwood, A. P., Auburn, S., Ball, S. G., Balmforth, A. J., Ban, M., Barbour, J., Barnwell, D., Barrett, J. C., Barrett, J. H., Barton, A., Bentley, D., Bishop, D. T., Bojang, K., Boorman, J. P., Bougouma, E., Bradbury, L. A., Braga Marcano, C. A., Braund, P. S., Bredin, F., Breen, G., Brown, M. A., Brown, M. J., Bruce, I. N., Bryan, C., Bull, S., Bumpstead, S. J., Burke, B., Burton, P. R., Caesar, S., Campino, S., Cant, B., Cardin, N. J., Cardon, L. R., Carucci, D., Caulfield, M., Chaney, A., Clark, T., Clayton, D. G., Collier, D. A., Compston, A., Compston, D. A., Connell, J., Conway, D., Cook, K., Corran, P., Craddock, N., Cummings, F. R., Davison, D., Deloukas, P., Devries, J., Dewasurendra, R., Diakite, M., Dixon, R. J., Djimde, A., Dobson, R., Dolo, A., Dominiczak, A., Donnelly, P., Donovan, H., Doumbo, O., Downes, K., Doyle, A., Drakeley, C., Drummond, H., Duffy, P., Duncanson, A., Dunger, D. B., Dunstan, S., Duombo, O., Easton, D., Elkin, A., Elliott, K. S., Elzein, A., Enimil, A., Evans, D., Evans, J., Everson, U., Eyre, S., Farmer, A., Farrall, M., Farrar, C., Farrar, J., Fernando, D., Ferreira, T., Ferrier, I. N., Fisher, S. A., Fitzpatrick, K., Forbes, A., Franklyn, J. A., Fraser, C., Frayling, T. M., Freathy, R. M., Ghansah, A., Ghori, J., Gilbert, P. D., Gordon Smith, K., Goris, A., Gottlieb, M., Gough, S. C., Green, A., Green, E. K., Groves, C. J., Grozeva, D., Gungadoo, J., Gwilliam, R., Hall, A. S., Hallgrimsdóttir, I. B., Hamshere, M. L., Hart, L., Hattersley, A. T., Heward, J. M., Hider, S. L., Tran Tinh Hien, Hill, A. V., Hilton, E., Hinks, A. M., Hitman, G. A., Holmans, P. A., Horstmann, Rolf D., Howie, B. N., Hubbart, C., Hughes, C., Hunt, S. E., Hussein, A., Hussey, J. M., Muntaser, Ibrahim, Iles, M. M., Inouye, M., Ishengoma, D., Jallow, M., Jeffreys, A. E., Jewell, D. P., John, Sl, Jolley, J. D., Jones, I. R., Jones, L., Jones, R. W., Nadira, Karunaweera, Keniry, A., King, E., Kirov, G., Kivinen, K., Knight, A. S., Koch, K., Gilbert, Kokwaro, Koram, Kwadwo A., Lango, H., Lathrop, G. M., Lee, K. L., Lees, C. W., Martha, Lemnge, Leung, H. T., Lewis, C. M., Lin, E., Lindgren, C. M., Ly, A., Macinnis, B., Julie, Makani, Mangano, Valentina, Mangino, M., Manjurano, A., Manning, L., Mansfield, J. C., Manske, M., Maqbool, A., Marchini, J. L., Kevin, Marsh, Maslen, G., Mathew, C. G., Mcardle, W. L., Mccarthy, M. I., Mccreight, M., Mcginnis, R., Mcguffin, P., Meech, E., Mendy, A., Pascal, Michon, Mohiuddin, M. K., Molyneux, Malcolm E., Morris, A. P., Moskvina, V., Moyes, C., Ivo, Mueller, Munroe, P. B., Mutabingwa, T., Ndila, C. M., Newhouse, S. J., Newport, M., Nikolov, I., Nimmo, E. R., Nutland, S., Nyirongo, V., O'Donovan, M. C., Oluoch, T., Onipinla, A., Onnie, C. M., Ouwehand, W. H., Owen, M. J., Michael, Parker, Parkes, M., Pembrey, M., Pereira Gale, J., Perry, J. R., Norbert, Peshu, Plowe, Christopher V., Pointon, J. J., Potter, C., Potter, S., Prescott, N. J., Prowse, C. V., Odile, Puijalon, Quyen, N. T., Ragoussis, J., Rahman, N., Ravindrarajah, R., Rayner, N. W., John, Reeder, Hugh, Reyburn, Riley, Eleanor M., Ring, S. M., Risley, P., Rockett, K. A., Rogers, J., Rowlands, K., Anavaj, Sakuntabhai, Samani, N. J., Sanderson, J., Sanjoaquin, M., Satsangi, J., Sawcer, S. J., Seal, S., Shields, B. M., Silman, A. J., Simmonds, M. J., Pratap, Singhasivanon, Sodiomon, Sirima, Sirugo, G., Small, K. S., Somaskantharajah, E., Spencer, C. C., St Clair, D., Stevens, H. E., Stevens, M., Stevens, S., Strachan, D. P., Stratton, M. R., Su, Z., Suriyaphol, P., Symmons, D. P., Adama, Tall, Taylor, N. C., Taylor, Terrie E., Teo, Y., Teo, Y. Y., Mahamadou, Thera, Thompson, J. R., Thomson, W., Timpson, N. J., Tobin, M. D., Todd, J. A., Todhunter, C. E., Toure, O., Tremelling, M., Marita Troye Blomberg, Vanderwal, A., Vukcevic, D., Walker, M., Walker, N. M., Wallace, C., Walters, G. R., Walton, R., Watkins, N. A., Watson, R., Webster, J., Weedon, M. N., Whittaker, P., Widmer, B., Williams, Thomas N., Williamson, R., Michael, Wilson, Winzer, T., Withers, D., Wordsworth, P., Worthington, J., Wrigley, R., Xue, M., Young, A. H., Yuldasheva, N., and Zeggini, E.

Subjects
Linkage disequilibrium, Hemoglobin, Sickle, Population, Genome-wide association study, Locus (genetics), Biology, Population stratification, Polymorphism, Single Nucleotide, Severity of Illness Index, Linkage Disequilibrium, Article, Gene mapping, Reference Values, Ethnicity, Genetics, Humans, education, Genetic association, education.field_of_study, Polymorphism, Genetic, Chromosome Mapping, Genetic Variation, Malaria, Gambia, Imputation (genetics), Genome-Wide Association Study
Abstract

We report a genome-wide association (GWA) study of severe malaria in The Gambia. The initial GWA scan included 2,500 children genotyped on the Affymetrix 500K GeneChip, and a replication study included 3,400 children. We used this to examine the performance of GWA methods in Africa. We found considerable population stratification, and also that signals of association at known malaria resistance loci were greatly attenuated owing to weak linkage disequilibrium (LD). To investigate possible solutions to the problem of low LD, we focused on the HbS locus, sequencing this region of the genome in 62 Gambian individuals and then using these data to conduct multipoint imputation in the GWA samples. This increased the signal of association, from P = 4 × 10(-7) to P = 4 × 10(-14), with the peak of the signal located precisely at the HbS causal variant. Our findings provide proof of principle that fine-resolution multipoint imputation, based on population-specific sequencing data, can substantially boost authentic GWA signals and enable fine mapping of causal variants in African populations.

Published
2009

27. Integrated disease control initiatives: polio eradication and neonatal tetanus elimination in Egypt

Author

Esmat Mansour, Cummings F, and Aylward Rb

Subjects
Adult, medicine.medical_specialty, Flaccid paralysis, Adolescent, macromolecular substances, medicine.disease_cause, complex mixtures, Pregnancy, Poliomyelitis eradication, Environmental health, medicine, Tetanus Toxoid, Immunology and Allergy, Humans, Tetanus, business.industry, Immunization Programs, Poliovirus, Public health, Infant, Newborn, virus diseases, Middle Aged, medicine.disease, Poliomyelitis, Vaccination, Neonatal tetanus, Infectious Diseases, Poliovirus Vaccine, Oral, Population Surveillance, Immunology, Egypt, Female, medicine.symptom, business
Abstract

Accelerated disease control initiatives, such as polio eradication by the year 2000, may substantially benefit public health programs in general. In Egypt, the control of other vaccine-preventable diseases, most noticeably neonatal tetanus (NT), has been facilitated by the polio eradication initiative. Linking NT reporting with the acute flaccid paralysis (AFP) surveillance system, which had been established for polio eradication, markedly improved the capacity to identify NT high-risk areas and target supplementary immunization activities appropriately. While the close integration of surveillance activities was to the benefit of both programs, mass immunization activities were not conducted simultaneously because of differences in the objectives, target populations, and operational aspects of oral polio vaccine and tetanus toxoid campaigns. In addition to substantial progress toward polio eradication in Egypt since 1988, there has been an 80% reduction in annual NT cases, in part due to the integration of appropriate aspects of these two disease control initiatives.

Published
1997

28. Concurrent Oral 4 - Basic Science [OP24-OP31]: OP24. Hdac Activity: A Therapeutic Target in Rheumatoid Arthritis?

Author

Gillespie, J., primary, Savic, S., additional, Wong, C., additional, Emery, P., additional, Grigg, R., additional, McDermott, M. F., additional, Goodall, J. C., additional, Wu, C., additional, Zhang, Y., additional, Ellis, L., additional, O'Brien, L., additional, Gaston, H., additional, Kollnberger, S., additional, Ridley, A., additional, Shaw, J., additional, Chan, A. T., additional, Cummings, F., additional, Fleming, M., additional, Bowness, P., additional, Mattey, D. L., additional, Nixon, N. B., additional, Dawes, P. T., additional, Karasawa, R., additional, Kato, T., additional, Ozaki, S., additional, Yudoh, K., additional, Wythe, S. E., additional, DiCara, D., additional, Finucane, C., additional, Man, S., additional, Jones, R., additional, Nissim, A., additional, Mather, S. J., additional, Chernajovsky, Y., additional, Costantino, P., additional, Bosma, A., additional, Vasconcellos, R., additional, Carter, N. A., additional, Isenberg, D. A., additional, Jury, E. C., additional, Mauri, C., additional, Sherwood, J. C., additional, Achan, P., additional, Ramachandran, M., additional, Pitzalis, C., additional, and Dell'Accio, F., additional

Published
2010
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29. Primed And Boosted Anti-Breast Cancer Tumor Immunity After Autologous Peripheral Blood Stem Cell Transplant (PBSCT): In Vivo Priming With T Cells Armed With Anti-CD3 X anti-Her2/neu Bispecific Antibody (Her2Bi) Pre PBSCT And Boosting After PBSCT With Activated T Cells (ATC)

Author

Lum, L.G., primary, Thakur, A., additional, Al-Kadhimi, Z., additional, Abidi, M., additional, Ayash, L., additional, Cummings, F., additional, Rathore, R., additional, Uberti, J.P., additional, and Ratanatharathorn, V., additional

Published
2010
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37. Cigarette purchase patterns in four countries and the relationship with cessation: findings from the International Tobacco Control (ITC) Four Country Survey.

Author

Hyland, A., Laux, F. L., Higbee, C., Hastings, G., Ross, H., Cummings, F. J., Fong, G. T., and Chaloupka, K. M.

Subjects
CONSUMER behavior research, WILLINGNESS to pay, CONSUMER attitudes, HEALTH surveys, CIGARETTE smokers, SMOKING, CIGARETTE tax
Abstract

The article discusses a study which investigated the patterns of cigarette purchase in four nations and its association with smoke cessation using the results from the International Tobacco Control Four Country Survey (ITC-4). It reveals that smokers who bought from a low/untaxed source on their recent purchase have lesser chance to have tried to cease smoking. It notes that smoke cessation attempts are lower among purchasers of low/untaxed cigarettes than those buyers of full-priced cigarettes. INSET: What this paper adds.

Published
2006
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42. A highly responsive NH3 sensor based on Pd-loaded ZnO nanoparticles prepared via a chemical precipitation approach.

Author

Mhlongo, G. H., Motaung, D. E., Cummings, F. R., Swart, H. C., and Ray, S. S.

Abstract

The gas-detecting ability of nanostructured ZnO has led to significant attention being paid to the development of a unique and effective approach to its synthesis. However, its poor sensitivity, cross-sensitivity to humidity, long response/recovery times and poor selectivity hinder its practical use in environmental and health monitoring. In this context, the addition of noble metals, as dopants or catalysts to modify the ZnO surface has been examined to enhance its sensing performance. Herein, we report preparation of Pd-loaded ZnO nanoparticles via a chemical precipitation approach. Various Pd loadings were employed to produce surface-modified ZnO nanostructure sensors, and their resulting NH3 sensing capabilities both in dry and humid environments were investigated. Through a comparative gas sensing study between the pure and Pd-loaded ZnO sensors upon exposure to NH3 at an optimal operating temperature of 350 °C, the Pd-loaded ZnO sensors were found to exhibit enhanced sensor responses and fast response/recovery times. The influence of Pd loading and its successful incorporation into ZnO nanostructure was examined by X-ray diffraction, high resolution-transmission electron microscopy, and X-ray photoelectron spectroscopy. XPS studies demonstrated that in all samples, Pd existed in two chemical states, namely Pd° and Pd2+. The possible sensing mechanism related to NH3 gas is also discussed in detail. [ABSTRACT FROM AUTHOR]

Published
2019
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44. Anti-TNF biosimilars in Crohn’s Disease: a patient-centric interdisciplinary approach

Author

Laurent Peyrin-Biroulet, Taegyun Kang, Fraser Cummings, Kay Greveson, Silvio Danese, Raja Atreya, Burkhard Pieper, Peyrin-Biroulet, L, Danese, S, Cummings, F, Atreya, R, Greveson, K, Pieper, B, and Kang, T

Subjects
medicine.medical_specialty, Anti-Inflammatory Agents, MEDLINE, Drug Costs, 03 medical and health sciences, 0302 clinical medicine, Crohn Disease, Patient-Centered Care, Adalimumab, Humans, Medicine, Intensive care medicine, Biosimilar Pharmaceuticals, Patient Care Team, Crohn's disease, Patient care team, Hepatology, Tumor Necrosis Factor-alpha, business.industry, Gastroenterology, Antibodies, Monoclonal, Biosimilar, Inflammatory Bowel Diseases, medicine.disease, Infliximab, Early Diagnosis, Patient centric, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Tumor necrosis factor alpha, Drug Monitoring, business, medicine.drug
Abstract

Introduction: The purpose of this review is to highlight the role of biosimilars in early treatment in IBD and introduce ways to facilitate a patient-centric switching process through multi...

Published
2019

46. Lessons from shelter homes that help children in especially difficult circumstances: case studies in northern Mexico

Author

Gonzalez Ponce, Sandra M., Cebotarev, Eleanora, and Cummings, F. Harry

Subjects
shelter homes, Children in Especially Difficult Circumstances, experiences, Casas Hogares, routines
Abstract

This paper examines issues surrounding shelters (Casas Hogares) that help Children in Especially Difficult Circumstances (CEDC). The literature states that there is a need to "systematically document and learn more from the current efforts in helping children in order to improve program effectiveness at both the country and regional levels" (UNICEF, 1990). This research addresses the aforementioned concern and provides information on what can be learned from the children that live in these shelters, how these shelters function, and what can be learned by studying the experience of these shelters. The investigation was conducted at two shelter homes that help CEDC in a border town in Mexico's north. Interviews and participant observation techniques were used. A total of eighteen staff members were interviewed, and information for over 100 children was acquired. The information on the children was obtained through interviews as well as by asking staff members about the child's particular case. Documenting the routines and the experiences of these shelters, provides valuable lessons that can be taken into consideration for those who wish to work with CEDC. Amongst some of the issues that arose in this study were reasons why children arrive at the shelter home, as well as some of the challenges these organizations face; for example, when dealing with donors and when trying to obtain funds.

Published
2001

47. Establishing key performance indicators for inflammatory bowel disease in the UK.

Author

Quraishi MN, Dobson E, Ainley R, Din S, Wakeman R, Cummings F, Sebastian S, Bloom S, Limdi JK, Dhar A, Speight RA, Bodger K, Kennedy NA, Lamb CA, Arnott ID, and Selinger CP

Abstract

Background and Aims: Healthcare quality improvement (QI) is the systematic process to continuously improve the quality of care and outcomes for patients. The landmark Inflammatory Bowel Disease (IBD) UK National Audits provided a means to measure the variation in care, highlighting the need to define the standards of excellence in IBD care. Through a consensus approach, we aimed to establish key performance indicators (KPIs), providing reliable benchmarks for IBD care delivery in UK., Methods: KPIs that measure critical aspects of a patient journey within an IBD service were identified though stakeholder meetings. A two-stage Delphi consensus was then conducted. The first involved a multidisciplinary team of IBD clinicians and patients to refine definitions and methodology. The second stage assessed feasibility and utility of the proposed QI process by surveying gastroenterology services across UK., Results: First, the four proposed KPIs were refined and included time from primary care referral to diagnosis in secondary care, time to treatment recommendation following a diagnosis, appropriate use of steroids and advanced therapies prescreening and assessment. Second, the Delphi consensus reported >85% agreement on the feasibility of local adoption of the QI process and >75% agreement on the utility of benchmarking of the KPIs., Conclusions: Through a structured approach, we propose quantifiable KPIs for benchmarking to improve and reduce the individual variation in IBD care across the UK., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2023
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48. Patient perspectives of successful adalimumab biosimilar transitioning in Crohn's disease: an interview study.

Author

Young D, Cummings F, and Latter S

Abstract

Objectives: Transition from originator biological medicines to their biosimilar equivalents is now part of routine clinical practice, but there is little understanding of patient experiences, which influence adherence and overall satisfaction with care. Understanding this will help ensure future switches adequately address patients' concerns and expectations leading to better outcomes for all stakeholders., Method: 35 patients participating in a clinical trial including an open-label transition event from originator to biosimilar adalimumab, mimicking what would be encountered in a real-world setting, took part in semi-structured interviews exploring their experience of biosimilar transition., Results: Opinions expressed were often heterogeneous, but common experiences and themes were identified. Five themes were identified following thematic analysis. (1) Understanding and awareness of biosimilars: prior awareness of biosimilars and knowledge of the biosimilar concept was low, indicating a disparity between healthcare professionals and patients. (2) Motivation to undertake transition: patients accept a biosimilar transition to minimise drug expenditure. (3) Initial concerns: before undertaking biosimilar transition away from the brand they had experienced, anticipated loss of efficacy and adverse effects from the biosimilar were common concerns for patients. (4) Reassuring factors: trust in the healthcare team is critical to patient acceptance of biosimilars. Important reassurances include a point of contact, education about biosimilars and monitoring. (5) Experiences during the transition: on reflection, participants described consistent efficacy and tolerability (although 22 participants specifically mentioned injection pain) following brand transition., Conclusion: The majority of patients felt comfortable with future transition to another adalimumab biosimilar. Injection experience was an important component of patient satisfaction., Competing Interests: Competing interests: FC has served as consultant, advisory board member, or speaker for AbbVie, Amgen, Celltrion, Falk, Ferring, Janssen, MSD, Napp Pharmaceuticals, Pfizer, Pharmacosmos, Sandoz, Biogen, Samsung, Takeda, Bristol Myers Squibb and Galapagos. He has received research funding from Biogen, Amgen, Hospira/Pfizer, Celltrion, Janssen, GSK and AZ. SL has received funding for speaking at a symposium sponsored by MSD. DY has received support for travel, accommodation and conference attendance from Sandoz., (© European Association of Hospital Pharmacists 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2022
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49. Preparation of biological monolayers for producing high-resolution scanning electron micrographs.

Author

Mentor S, Cummings F, and Fisher D

Subjects
Animals, Carbon, Gold, Mice, Microscopy, Electron, Scanning, Electrons, Endothelial Cells
Abstract

Scanning electron microscopy (SEM) provides a technical platform for nanoscopic mapping of biological structures. Correct preparation of SEM samples can provide an unprecedented understanding of the nexus between cellular morphology and topography. This comparative study critically examines two coating methods for preparing biological samples for scanning electron microscopy, while also providing novel advice on how to prepare in vitro epithelial or endothelial samples for high-resolution scanning-electron microscopy (HR-SEM). Two obstacles often confront the biologist when investigating cellular structures grown under tissue culture conditions, namely., how to prepare and present the biological samples to the HR-SEM microscope without affecting topographical membrane and cellular structural alterations. Firstly, our use of the Millicell cellulose inserts on which to grow our cellular samples in preparation for HR-SEM is both novel and advantageous to comparing the permeability function of cells to their morphological function. Secondly, biological material is often non-conducting, thermally sensitive and fragile and, therefore, needs to be fixed correctly and coated with thin conducting metal to ensure high-resolution detail of samples. Immortalized mouse brain endothelial cells (bEnd5) was used as a basis for describing the preferences in the use of the protocol. We compare two biological sample coating modalities for the visualizing and analysis of texturized, topographical, membranous ultrastructures of brain endothelial cell (BEC) confluent monolayers, namely, carbon and gold:palladium (Au:Pd) sputter coating in preparation for HR-SEM. BEC monolayers sputter-coated with these two modalities produced three-dimensional micrographs which have distinctly different topographical detail from which the nanostructural cellular data can be examined. The two coating methods display differences in the amount of nanoscopic detail that could be resolved in the nanosized membrane cytoarchitecture of BEC monolayers. The micrographical data clearly showed that Au:Pd sputter-coated samples generate descript imagery, providing useful information for profiling membrane nanostructures compared to carbon-coated samples. The recommendations regarding the contrast in two modalities would provide the necessary guidance to biological microscopists in preparing tissue culture samples for HR-SEM., Competing Interests: The authors have declared that no competing interests exist.

Published
2022
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50. Impact of direct-access IBD physician delivered endoscopy on clinical outcomes: a pre-implementation and post-implementation study.

Author

Stammers M, Rahmany S, Downey L, Borca F, Harris C, Harris R, McDonnell M, Sartain S, Coleman N, Stacey B, Smith TR, Cummings F, Felwick R, and Gwiggner M

Abstract

Introduction: Patients with suspected inflammatory bowel disease (IBD) referred from primary care often face diagnostic and treatment delays. This study aimed to compare a novel direct-access IBD endoscopy pathway with the traditional care model., Method: Single centre real-world study analysing primary care referrals with suspected IBD. Group A: patients triaged to direct-access IBD endoscopy. Group B: patients undergoing traditional outpatient appointments before the availability of direct-access IBD endoscopy. Demographics, fecal calprotectin (FCP), C-reactive protein (CRP), disease activity score, endoscopy findings, treatment and follow-up were collected and statistically analysed. Ranked semantic analysis of IBD symptoms contained within referral letters was performed., Results: Referral letters did not differ significantly in Groups A and B. Demographic data, FCP and CRP values were similar. Referral to treatment time (RTT) at the time of IBD endoscopy was reduced from 177 days (Group B) to 24 days (Group A) (p<0.0001). Diagnostic yield of IBD was 35.6% (Group B) versus 62.0% (Group A) (p=0.0003). 89.2% of patients underwent colonoscopy in Group B versus 46.4% in Group A. DNA rates were similar in both groups. The direct to IBD endoscopy pathway saved 100% of initial IBD consultant clinics with a 2.5-fold increase in IBD nurse-led follow-up., Conclusion: Our novel pathway resulted in an 86% reduction in RTT with associated increased diagnostic yield while saving 100% of initial IBD consultant outpatient appointments. Replication in other trusts may improve patient experience and accelerate time to diagnosis/treatment while optimising the use of healthcare resources., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2022
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