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101. The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trial

Author

Adams, Jo, primary, Barratt, Paula, additional, Rombach, Ines, additional, Arden, Nigel, additional, Barbosa Bouças, Sofia, additional, Bradley, Sarah, additional, Doherty, Michael, additional, Dutton, Susan J, additional, Gooberman-Hill, Rachael, additional, Hislop-Lennie, Kelly, additional, Hutt-Greenyer, Corinne, additional, Jansen, Victoria, additional, Luengo-Fernadez, Ramon, additional, Williams, Mark, additional, and Dziedzic, Krysia, additional

Published
2020
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102. Characteristics of L-PRP preparations for treating Achilles tendon rupture within the PATH-2 study

Author

Harrison, Paul, primary, Didembourg, Marie, additional, Wood, Alexander, additional, Devi, Amarpreet, additional, Dinsdale, Robert, additional, Hazeldine, Jon, additional, Alsousou, Joseph, additional, Keene, David J, additional, Hulley, Philippa, additional, Wagland, Susan, additional, Parsons, Scott, additional, Thompson, Jacqueline, additional, Byrne, Christopher, additional, Schlüssel, Michael Maia, additional, O’Connor, Heather, additional, Dutton, Susan J, additional, Lamb, Sarah E, additional, and Willett, Keith, additional

Published
2020
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103. Outpatient physiotherapy versus home-based rehabilitation for patients at risk of poor outcomes after knee arthroplasty: CORKA RCT

Author

Barker, Karen L, primary, Room, Jon, additional, Knight, Ruth, additional, Dutton, Susan J, additional, Toye, Fran, additional, Leal, Jose, additional, Kent, Seamus, additional, Kenealy, Nicola, additional, Schussel, Michael M, additional, Collins, Gary, additional, Beard, David J, additional, Price, Andrew, additional, Underwood, Martin, additional, Drummond, Avril, additional, Cook, Elaine, additional, and Lamb, Sarah E, additional

Published
2020
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104. Negative-pressure wound therapy compared with standard dressings following surgical treatment of major trauma to the lower limb: the WHiST RCT

Author

Costa, Matthew L, primary, Achten, Juul, additional, Knight, Ruth, additional, Png, May Ee, additional, Bruce, Julie, additional, Dutton, Susan, additional, Madan, Jason, additional, Vadher, Karan, additional, Dritsaki, Melina, additional, Masters, James, additional, Spoors, Louise, additional, Campolier, Marta, additional, Parsons, Nick, additional, Fernandez, Miguel, additional, Jones, Suzanne, additional, Grant, Richard, additional, and Nanchahal, Jagdeep, additional

Published
2020
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107. O03 The OA thumb therapy trial: a three arm multi-centre randomised controlled trial of the clinical effectiveness and efficacy of splints for symptomatic thumb base OA

Author

Adams, Jo, primary, Barratt, Paula, primary, Arden, Nigel K, primary, Bouças, Sofia Barbosa, primary, Bradley, Sarah, primary, Doherty, Michael, primary, Dutton, Susan, primary, Dziedzic, Krysia, primary, Gooberman-Hill, Rachael, primary, Hislop, Kelly, primary, Hutt-Greenyer, Corinne, primary, Jansen, Victoria, primary, Lunego, Ramon, primary, Rombach, Ines, primary, and Wiliams, Mark, primary

Published
2020
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109. Ten-year Mortality, Disease Progression, and Treatment-related Side Effects in Men with Localised Prostate Cancer from the ProtecT Randomised Controlled Trial According to Treatment Received

Author

Neal, David E., primary, Metcalfe, Chris, additional, Donovan, Jenny L., additional, Lane, J. Athene, additional, Davis, Michael, additional, Young, Grace J., additional, Dutton, Susan J., additional, Walsh, Eleanor I., additional, Martin, Richard M., additional, Peters, Tim. J., additional, Turner, Emma L., additional, Mason, Malcolm, additional, Bryant, Richard, additional, Bollina, Prasad, additional, Catto, James, additional, Doherty, Alan, additional, Gillatt, David, additional, Gnanapragasam, Vincent, additional, Holding, Peter, additional, Hughes, Owen, additional, Kockelbergh, Roger, additional, Kynaston, Howard, additional, Oxley, Jon, additional, Paul, Alan, additional, Paez, Edgar, additional, Rosario, Derek J., additional, Rowe, Edward, additional, Staffurth, John, additional, Altman, Doug G., additional, Hamdy, Freddie C., additional, Neal, David E., additional, Peters, Tim J., additional, Doble, Andrew, additional, Powell, Philip, additional, Prescott, Stephen, additional, Rosario, Derek, additional, Anderson, John B., additional, Aning, Jonathan, additional, Durkan, Garett, additional, Koupparis, Anthony, additional, Leung, Hing, additional, Mariappan, Param, additional, McNeill, Alan, additional, Persad, Raj, additional, Schwaibold, Hartwig, additional, Tulloch, David, additional, Wallace, Michael, additional, Bonnington, Susan, additional, Bradshaw, Lynne, additional, Cooper, Deborah, additional, Elliott, Emma, additional, Herbert, Phillipa, additional, Howson, Joanne, additional, Jones, Amanda, additional, Lennon, Teresa, additional, Lyons, Norma, additional, Moody, Hilary, additional, Plumb, Claire, additional, O'Sullivan, Tricia, additional, Salter, Elizabeth, additional, Thompson, Pauline, additional, Tidball, Sarah, additional, Blaikie, Jan, additional, Gray, Catherine, additional, Adam, Tonia, additional, Askew, Sarah, additional, Atkinson, Sharon, additional, Baynes, Tim, additional, Brain, Carole, additional, Breen, Viv, additional, Brunt, Sarah, additional, Bryne, Sean, additional, Bythem, Jo, additional, Clarke, Jenny, additional, Cloete, Jenny, additional, Dark, Susan, additional, Davis, Gill, additional, Rue, Rachael De La, additional, Denizot, Jane, additional, Dewhurst, Elspeth, additional, Dimes, Anna, additional, Dixon, Nicola, additional, Ebbs, Penny, additional, Emmerson, Ingrid, additional, Ferguson, Jill, additional, Gadd, Ali, additional, Geoghegan, Lisa, additional, Grant, Alison, additional, Grant, Collette, additional, Godfrey, Rosemary, additional, Goodwin, Louise, additional, Hall, Susie, additional, Hart, Liz, additional, Harvey, Andrew, additional, Hoult, Chloe, additional, Hawkins, Sarah, additional, Holling, Sharon, additional, Innes, Alastair, additional, Kilner, Sue, additional, Marshall, Fiona, additional, Mellen, Louise, additional, Moore, Andrea, additional, Napier, Sally, additional, Needham, Julie, additional, Pearse, Kevin, additional, Pisa, Anna, additional, Rees, Mark, additional, Richards, Ellie, additional, Robson, Lindsay, additional, Roxburgh, Janet, additional, Samuel, Nikki, additional, Sharkey, Irene, additional, Slater, Michael, additional, Smith, Donna, additional, Taggart, Pippa, additional, Taylor, Helen, additional, Taylor, Vicky, additional, Thomas, Ayesha, additional, Tomkies, Briony, additional, Trewick, Nicola, additional, Ward, Claire, additional, Walker, Christy, additional, Williams, Ayesha, additional, Woodhouse, Colin, additional, Wyber, Elizabeth, additional, Bahl, Amit, additional, Benson, Richard, additional, Beresford, Mark, additional, Ferguson, Catherine, additional, Graham, John, additional, Herbert, Chris, additional, Howard, Grahame, additional, James, Nick, additional, Kirkbride, Peter, additional, Law, Alastair, additional, Loughrey, Carmel, additional, McClaren, Duncan, additional, Patterson, Helen, additional, Pedley, Ian, additional, Roberts, Trevor, additional, Robinson, Angus, additional, Russell, Simon, additional, Symonds, Paul, additional, Thanvi, Narottam, additional, Vasanthan, Subramaniam, additional, Wilson, Paula, additional, Robinson, Mary, additional, Bhattarai, Selina, additional, Deshmukh, Neeta, additional, Dormer, John, additional, Fernando, Malee, additional, Goepel, John, additional, Griffiths, David, additional, Grigor, Ken, additional, Mayer, Nick, additional, Varma, Murali, additional, Warren, Anne, additional, Appleby, Helen, additional, Ash, Dominic, additional, Aston, Dean, additional, Bolton, Steven, additional, Chalmers, Graham, additional, Conway, John, additional, Early, Nick, additional, Geater, Tony, additional, Goddall, Lynda, additional, Heymann, Claire, additional, Hicks, Deborah, additional, Jones, Liza, additional, Lamb, Susan, additional, Lambert, Geoff, additional, Lawrence, Gill, additional, Lewis, Geraint, additional, Lilley, John, additional, MacLeod, Aileen, additional, Massey, Pauline, additional, McQueen, Alison, additional, Moore, Rollo, additional, Penketh, Lynda, additional, Potterton, Janet, additional, Roberts, Neil, additional, Showler, Helen, additional, Shuttleworth, Pam, additional, Slade, Stephen, additional, Steele, Alasdair, additional, Swinscoe, James, additional, Tiffany, Marie, additional, Townley, John, additional, Treeby, Jo, additional, Weston, Michael, additional, Wilkinson, Joyce, additional, Williams, Lorraine, additional, Wills, Lucy, additional, Woodley, Owain, additional, Yarrow, Sue, additional, Brindle, Lucy, additional, Davies, Linda, additional, Dedman, Dan, additional, Down, Elizabeth, additional, Khazragui, Hanan, additional, Noble, Sian, additional, Taylor, Hilary, additional, Tazewell, Marta, additional, Wade, Julia, additional, Walsh, Eleanor, additional, Baker, Susan, additional, Bellis-Sheldon, Elizabeth, additional, Bougard, Chantal, additional, Bowtell, Joanne, additional, Brewer, Catherine, additional, Burton, Chris, additional, Charlton, Jennie, additional, Christoforou, Nicholas, additional, Clark, Rebecca, additional, Coull, Susan, additional, Croker, Christine, additional, Currer, Rosemary, additional, Daisey, Claire, additional, Delaney, Gill, additional, Donohue, Rose, additional, Drew, Jane, additional, Farmer, Rebecca, additional, Fry, Susan, additional, Haddow, Jean, additional, Hale, Alex, additional, Halpin, Susan, additional, Harris, Belle, additional, Hattrick, Barbara, additional, Holmes, Sharon, additional, Hunt, Helen, additional, Jackson, Vicky, additional, Johnson, Donna, additional, Le Butt, Mandy, additional, Leworthy, Jo, additional, Liddiatt, Tanya, additional, Martin, Alex, additional, Mauree, Jainee, additional, Moore, Susan, additional, Moulam, Gill, additional, Mutch, Jackie, additional, Parker, Kathleen, additional, Pawsey, Christopher, additional, Purdie, Michelle, additional, Robson, Teresa, additional, Smith, Lynne, additional, Stenton, Carole, additional, Steuart-Feilding, Tom, additional, Stott, Beth, additional, Sully, Chris, additional, Sutton, Caroline, additional, Torrington, Carol, additional, Wilkins, Zoe, additional, Williams, Sharon, additional, Wilson, Andrea, additional, Weaver, Ashleigh, additional, Albertsen, Peter, additional, Adolfsson, Jan, additional, Baum, Michael, additional, McFarlane, Jon, additional, Reid, Colette, additional, Turner, Emma, additional, Zietman, Anthony, additional, Hill, Elizabeth, additional, Ng, Siaw Yein, additional, Williams, Naomi, additional, Toole, Jessica, additional, Davies, Charlotte, additional, Hughes, Laura, additional, Rowlands, Mari-Anne, additional, Bell, Lindsey, additional, Harrison, Sean, additional, Mauree, Jainnee, additional, Grant, Adrian, additional, Roberts, Ian, additional, Ashby, Deborah, additional, Cowan, Richard, additional, Fayers, Peter, additional, Mellon, Killian, additional, N’Dow, James, additional, O’Brien, Tim, additional, Sokhal, Michael, additional, Dearnaley, David, additional, Schröder, Fritz, additional, and Roberts, Tracy, additional

Published
2020
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110. Rehabilitation strategy after non-surgical treatment of Achilles tendon rupture : UKSTAR, a multicentre RCT

Author

Costa, Matthew L., Achten, Juul, Marian, Ioana R., Dutton, Susan J., Lamb, Sarah E., Ollivere, Benjamin, Maredza, Mandy, Petrou, Stavros, Kearney, Rebecca S., and HASH(0x5651c9dc5ac0)

Subjects
musculoskeletal diseases, RD
Abstract

Background\ud Achilles tendon rupture affects > 11,000 people each year in the UK, leading to prolonged periods away from work, sports and social activities. Traditionally, the ruptured tendon is held still in a plaster cast for ≥ 8 weeks. Functional bracing is an alternative treatment that allows patients to mobilise earlier, but there is little evidence about how bracing affects patients’ recovery.\ud \ud Objectives\ud To measure the Achilles Tendon Rupture Score, quality of life, complications and resource use of patients receiving non-operative treatment for an Achilles tendon rupture treated with plaster cast compared with those treated with functional bracing.\ud \ud Design\ud This was a multicentre, randomised, pragmatic, two-group superiority trial.\ud \ud Setting\ud The setting was 39 NHS hospitals.\ud \ud Participants\ud A total of 540 adult patients treated non-operatively for Achilles tendon rupture were randomised from July 2016 to May 2018. Exclusion criteria included presenting after 14 days, having had previous rupture and being unable to complete questionnaires.\ud \ud Interventions\ud A total of 266 participants had a plaster cast applied, with their toes initially pointing to the floor. The cast was changed over 8 weeks to bring the foot into a walking position. A total of 274 patients had a functional brace that facilitated immediate weight-bearing. The foot position was adjusted within the brace over the same 8-week period.\ud \ud Main outcome measures\ud Achilles Tendon Rupture Score is patient reported and assesses symptoms and physical activity related to the Achilles tendon (score 0–100, with 100 being the best possible outcome). The secondary outcomes were quality of life, complications and resource use at 8 weeks and at 3, 6 and 9 months.\ud \ud Results\ud Participants had a mean age of 48.7 years, were predominantly male (79%) and had ruptured their tendon during sports (70%). Over 93% of participants completed follow-up. There was no statistically significant difference in Achilles Tendon Rupture Score at 9 months post injury (–1.38, 95% confidence interval –4.9 to 2.1). There was a statistically significant difference in Achilles Tendon Rupture Score at 8 weeks post injury in favour of the functional brace group (5.53, 95% confidence interval 2.0 to 9.1), but not at 3 or 6 months post injury. Quality of life showed the same pattern, with a statistically significant difference at 8 weeks post injury but not at later time points. Complication profiles were similar in both groups. Re-rupture of the tendon occurred 17 times in the plaster cast group and 13 times in the functional brace group. There was no difference in resource use.\ud \ud Conclusions\ud This trial provides strong evidence that early weight-bearing in a functional brace provides similar outcomes to traditional plaster casting and is safe for patients receiving non-operative treatment of Achilles tendon rupture. The probability that functional bracing is cost-effective exceeds 95% for the base-case imputed analysis, assuming a cost-effectiveness threshold of £20,000 per quality-adjusted life-year. On average, functional brace is associated with lower costs (–£103, 95% confidence interval –£290 to £84) and more quality-adjusted life-years (0.015, 95% confidence interval –0.0013 to 0.030) than plaster cast.

Published
2020

115. Core Outcomes for Colorectal Cancer Surgery: A Consensus Study

Author

McNair, Angus G. K., Whistance, Robert N., Forsythe, Rachael O., Macefield, Rhiannon, Rees, Jonathan, Pullyblank, Anne M., Avery, Kerry N. L., Brookes, Sara T., Thomas, Michael G., Sylvester, Paul A., Russell, Ann, Oliver, Alfred, Morton, Dion, Kennedy, Robin, Jayne, David G., Huxtable, Richard, Hackett, Roland, Dutton, Susan J., Coleman, Mark G., Card, Mia, Brown, Julia, and Blazeby, Jane M.

Subjects
Management, Care and treatment, Analysis, Usage, Company business management, Mortality -- Analysis -- United Kingdom, Robotic surgery -- Usage, Medical care -- Management -- United Kingdom, Colorectal cancer -- Care and treatment
Abstract

Author(s): Angus G. K. McNair 1,2,*, Robert N. Whistance 1,3, Rachael O. Forsythe 1,3, Rhiannon Macefield 1, Jonathan Rees 1, Anne M. Pullyblank 4, Kerry N. L. Avery 1, Sara [...], Background Colorectal cancer (CRC) is a major cause of worldwide morbidity and mortality. Surgical treatment is common, and there is a great need to improve the delivery of such care. The gold standard for evaluating surgery is within well-designed randomized controlled trials (RCTs); however, the impact of RCTs is diminished by a lack of coordinated outcome measurement and reporting. A solution to these issues is to develop an agreed standard "core" set of outcomes to be measured in all trials to facilitate cross-study comparisons, meta-analysis, and minimize outcome reporting bias. This study defines a core outcome set for CRC surgery. Methods and Findings The scope of this COS includes clinical effectiveness trials of surgical interventions for colorectal cancer. Excluded were nonsurgical oncological interventions. Potential outcomes of importance to patients and professionals were identified through systematic literature reviews and patient interviews. All outcomes were transcribed verbatim and categorized into domains by two independent researchers. This informed a questionnaire survey that asked stakeholders (patients and professionals) from United Kingdom CRC centers to rate the importance of each domain. Respondents were resurveyed following group feedback (Delphi methods). Outcomes rated as less important were discarded after each survey round according to predefined criteria, and remaining outcomes were considered at three consensus meetings; two involving international professionals and a separate one with patients. A modified nominal group technique was used to gain the final consensus. Data sources identified 1,216 outcomes of CRC surgery that informed a 91 domain questionnaire. First round questionnaires were returned from 63 out of 81 (78%) centers, including 90 professionals, and 97 out of 267 (35%) patients. Second round response rates were high for all stakeholders (>80%). Analysis of responses lead to 45 and 23 outcome domains being retained after the first and second surveys, respectively. Consensus meetings generated agreement on a 12 domain COS. This constituted five perioperative outcome domains (including anastomotic leak), four quality of life outcome domains (including fecal urgency and incontinence), and three oncological outcome domains (including long-term survival). Conclusion This study used robust consensus methodology to develop a core outcome set for use in colorectal cancer surgical trials. It is now necessary to validate the use of this set in research practice.

Published
2016
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116. Platelet-rich plasma injection for acute Achilles tendon rupture

Author

Keene, David J., Alsousou, Joseph, Harrison, Paul, O’Connor, Heather M., Wagland, Susan, Dutton, Susan J., Hulley, Philippa, Lamb, Sarah E., and Willett, Keith

Abstract

AimsTo determine whether platelet-rich plasma (PRP) injection improves outcomes two years after acute Achilles tendon rupture.MethodsA randomized multicentre two-arm parallel-group, participant- and assessor-blinded superiority trial was undertaken. Recruitment commenced on 28 July 2015 and two-year follow-up was completed in 21 October 2019. Participants were 230 adults aged 18 years and over, with acute Achilles tendon rupture managed with non-surgical treatment from 19 UK hospitals. Exclusions were insertion or musculotendinous junction injuries, major leg injury or deformity, diabetes, platelet or haematological disorder, medication with systemic corticosteroids, anticoagulation therapy treatment, and other contraindicating conditions. Participants were randomized via a central online system 1:1 to PRP or placebo injection. The main outcome measure was Achilles Tendon Rupture Score (ATRS) at two years via postal questionnaire. Other outcomes were pain, recovery goal attainment, and quality of life. Analysis was by intention-to-treat.ResultsA total of 230 participants were randomized, 114 to PRP and 116 to placebo. Two-year questionnaires were sent to 216 participants who completed a six-month questionnaire. Overall, 182/216 participants (84%) completed the two-year questionnaire. Participants were aged a mean of 46 years (SD 13.0) and 25% were female (57/230). The majority of participants received the allocated intervention (219/229, 96%). Mean ATRS scores at two years were 82.2 (SD 18.3) in the PRP group (n = 85) and 83.8 (SD 16.0) in the placebo group (n = 92). There was no evidence of a difference in the ATRS at two years (adjusted mean difference -0.752, 95% confidence interval -5.523 to 4.020; p = 0.757) or in other secondary outcomes, and there were no re-ruptures between 24 weeks and two years.ConclusionPRP injection did not improve patient-reported function or quality of life two years after acute Achilles tendon rupture compared with placebo. The evidence from this study indicates that PRP offers no patient benefit in the longer term for patients with acute Achilles tendon rupture.Cite this article: Bone Joint J2022;104-B(11):1256–1265.

Published
2022
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117. Platelet rich plasma injection for acute Achilles tendon rupture: PATH-2 randomised, placebo controlled, superiority trial

Author

Keene, David J, Alsousou, Joseph, Harrison, Paul, Hulley, Philippa Anne, Wagland, Susan, Parsons, Scott R, Thompson, Jacqueline, O'Connor, Heather M, Schlussel, Michael Maia, Dutton, Susan J, Lamb, Sarah E, Willett, Keith, Handley, Robert, Lewis, Kathryn, Spoors, Louise, Zhang, Yuhan, Mestre, Maria, Muller, Doreeen, Prasath, Sangeetha, Austin, Martin, Bhatia, Maneesh, Attwal, Manjit, Christie, Carla, Brear, Tracy, Kelly, Andrew, Beacham, Keira, Brown, Sarah, Allen, James, Whitcher, Alison, James, Kate, Foster, Eliza, Hepple, Steve, Barnfield, Steven, Coates, Katherine, Halliday, Ruth, Hooper, Lucille, Hodgson, Paul, Hodgson, Helen, Cleary, Cheryl, Nott, Claire, Whiteman, Jessica, Carmont, Michael, Tonics, Louise, Heidari, Nima, Kassam, Jamila, Hilton, Catherine, Ahmad, Shanaz, Young, Sophie, Young, Jonathan, Clarkson, Louise, Turner, Sylvia, McGowan, Kerri, Lowe, Janet, Stables, Gareth, Bunworth, Kerry, de Feyter, Pascal, Ravindran, Ranjith, Vertue, Mark, Frostick, Simon, Maitland, Kate, Stokes-Denson, Joanne, Watson, Lisa, Scanlon, Deborah, Walker, Philip, Carmichael, James, O'Sullivan, Susie, Butcher, Deborah, Topliss, Claire, Hutchison, Anne-Marie, Storton, Sharon, Cook, Amanda, Quinn, Leanne, Mason, Lyndon, Earley, Joanne, Ballal, Moez, Bradley-Potts, Joanne, Williamson, Georgina, McCormick, Richard, Davies, Mark, Walker, Julie, Badloe, Joanne, Hughes, Adrian, Grice, Anna, Dark, Jayne, Barnes, Simon, Velpula, Jagan, Amor, Kelly, Brown, Janet, Solan, Matthew, and Grp, PATH-2 Trial

Subjects
Adult, Male, Heel, Visual analogue scale, Placebo, Conservative Treatment, Achilles Tendon, law.invention, Injections, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Quality of life, law, Tendon Injuries, medicine, Humans, Patient Reported Outcome Measures, Rupture, 030222 orthopedics, Intention-to-treat analysis, business.industry, Platelet-Rich Plasma, Research, Muscles, 030229 sport sciences, General Medicine, Recovery of Function, Middle Aged, United Kingdom, Tendon, medicine.anatomical_structure, Treatment Outcome, Anesthesia, Quality of Life, Female, Achilles tendon rupture, medicine.symptom, business
Abstract

Objective To determine whether an injection of platelet rich plasma improves outcomes after acute Achilles tendon rupture. Design Randomised, placebo controlled, two arm, parallel group, participant and assessor masked, superiority trial. Setting Secondary care trauma units across 19 hospitals in the United Kingdom’s health service. Participants Recruitment commenced in July 2015 and follow-up was completed in March 2018. 230 adults aged 18 years and over were included, with acute Achilles tendon rupture presenting within 12 days of injury and managed with non-surgical treatment. Exclusions were injury at the insertion or musculotendinous junction, major leg injury or deformity, diabetes mellitus, platelet or haematological disorder, systemic corticosteroids, anticoagulation treatment, and other contraindicating conditions. Interventions Participants were randomised 1:1 to platelet rich plasma (n=114) or placebo (dry needle; n=116) injection. All participants received standard rehabilitation care (ankle immobilisation followed by physiotherapy). Main outcomes and measures Primary outcome was muscle tendon function at 24 weeks, measured objectively with the limb symmetry index (injured/uninjured×100) in maximal work done during the heel rise endurance test (an instrumented measure of repeated single leg heel rises until fatigue). Secondary outcomes included patient reported function (Achilles tendon rupture score), quality of life (short form 12 version 2®), pain (visual analogue scale), goal attainment (patient specific functional scale), and adverse events. A central laboratory analysed the quality and content of platelet rich plasma. Analyses were by modified intention to treat. Results Participants were 46 years old on average, and 57 (25%) of 230 were female. At 24 weeks, 202 (88%) participants completed the heel rise endurance test and 216 (94%) the patient reported outcomes. The platelet rich plasma was of good quality, with expected growth factor content. No difference was detected in muscle tendon function between participants receiving platelet rich plasma injections and those receiving placebo injections (limb symmetry index, mean 34.7% (standard deviation 17.7%) v 38.5% (22.8%); adjusted mean difference −3.9% (95% confidence interval −10.5% to 2.7%)) or in any secondary outcomes or adverse event rates. Complier average causal effect analyses gave similar findings. Conclusions There is no evidence to indicate that injections of platelet rich plasma can improve objective muscle tendon function, patient reported function, or quality of life after acute Achilles tendon rupture compared with placebo, or that they offer any patient benefit. Trial registration ISRCTN54992179.

Published
2019

118. The Osteoarthritis Thumb Therapy (OTTER) II Trial: a study protocol for a three-arm multi-centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost-effectiveness of splints for symptomatic thumb base osteoarthritis

Author

Adams, Jo, Barratt, Paula, Arden, Nigel K, Barbosa Bouças, Sofia, Bradley, Sarah, Doherty, Michael, Dutton, Susan, Dziedzic, Krysia, Gooberman-Hill, Rachael, Hislop Lennie, Kelly, Hutt Greenyer, Corinne, Jansen, Victoria, Luengo-Fernandez, Ramon, Meagher, Claire, White, Peter, and Williams, Mark

Subjects
body regions, RC925, RC927
Abstract

Copyright © Author(s) (or their employer(s)) 2019. Introduction: The economic cost of osteoarthritis (OA) is high. At least 4.4 million people have hand OA in the UK. Symptomatic thumb base OA affects 20% of people over 55 years, causing more pain, work and functional disability than OA elsewhere in the hand. Most evidence-based guidelines recommend splinting for hand OA. Splints that support or immobilise the thumb base are routinely used despite there being limited evidence on their effectiveness. The potential effects of placebo interventions in OA are acknowledged, but few studies investigate the clinical efficacy of rehabilitation interventions nor the impact of any placebo effects associated with splints. Methods and analysis: Participants aged 30 years and over with symptomatic thumb base OA will be recruited into the trial from secondary care occupational therapy and physiotherapy centres. Following informed consent, participants will complete a baseline questionnaire and then be randomised into one of three treatment arms: a self-management programme, a self-management programme plus a verum thumb splint or a self-management programme plus a placebo thumb splint. The primary outcome is the Australian Canadian Osteoarthritis Hand Index (AUSCAN) hand pain scale. The study endpoint is 8 weeks after baseline. Baseline assessments will be carried out prior to randomisation and outcomes collected at 4, 8 and 12 weeks. Cost-effectiveness analysis will be conducted and individual qualitative interviews conducted with up to 40 participants after 8 weeks to explore perceptions and outcome expectations of verum and placebo splints and exercise. Ethics and dissemination: South Central—Oxford C Research Ethics Committee approved this study (16/SC/0188). The findings will be disseminated to health professional conferences, journals and lay publications for patient organisations. The research will contribute to improving the management of thumb base OA and help clinicians and patients make informed decisions about the value of different interventions. Trial registration number: ISRCTN54744256 Arthritis Research UK

Published
2019

119. The Osteoarthritis Thumb Therapy Trial (OTTER II): a study protocol for a three arm multi centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost effectiveness of splints for symptomatic thumb base osteoarthritis

Author

Adams, Joanna, Barratt, Paula, Arden, Nigel, Barbosa Boucas, Sofia, Bradley, Sarah, Doherty, Michael, Dutton, Susan, Dziedzic, Krysia, Gooberman-Hill, Rachael, Hislop Lennie, Kelly, Hutt Greenyer, Corinne, Jansen, Victoria, Luengo-Fernandez, Ramon, Meagher, Claire, White, Peter J, and Williams, Mark

Subjects
body regions
Abstract

Introduction: the economic cost of osteoarthritis (OA) is high. At least 4.4 million people have hand OA in the UK. Symptomatic thumb base OA affects 20% of people over 55 years, causing more pain, work and functional disability than OA elsewhere in the hand. Most evidence-based guidelines recommendsplinting for hand OA. Splints that support or immobilise the thumb base are routinely used despite there being limited evidence on their effectivenss. The potential effects of placebo interventions in OA are acknowledged, but few studies investigate the clinical efficacy of rehabilitation interventionsnor the impact of any placebo effects associated with splints.Methods and analysis: participants aged 30 years and over with symptomatic thumb base OA will be recruited into the trial from secondary care occupational therapy and physiotherapy centres. Following informed consent, participants will complete a baseline questionnaire and then be randomised into one of threetreatment arms: a self-management programme, a self-management programme plus a verum thumb splint, or a self-management programme plus a placebo thumb splint. The primary outcome is the AUSCAN hand pain scale. The study end point is 8 weeks after baseline. Baseline assessments will be carried out prior to randomisation and outcomes collected at 4; 8 and 12 weeks. Costeffectiveness analysis will be conducted and individual qualitative interviews conducted with up to 40 participants after 8 weeks to explore perceptions and outcome expectations of verum and placebo splints and exercise.Ethics and eissemination: South Central - Oxford C Research Ethics Committee approved this study (16/SC/0188). The findingswill be disseminated to health professional conferences, journals and lay publications for patientorganisations. The research will contribute to improving the management of thumb base OA andhelp clinicians and patients make informed decisions about the value of different interventions.

Published
2019

120. The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomised controlled clinical trial

Author

Adams, Jo, Barratt, Paula, Rombach, Ines, Arden, Nigel, Barbosa Bouças, Sofia, Bradley, Sarah, Doherty, Michael, Dutton, Susan J., Gooberman-Hill, Rachael, Hislop-Lennie, Kelly, Hutt-Greenyer, Corinne, Jansen, Victoria, Luengo-Fernadez, Ramon, Williams, Mark A., Dziedzic, Krysia, Adams, Jo, Barratt, Paula, Rombach, Ines, Arden, Nigel, Barbosa Bouças, Sofia, Bradley, Sarah, Doherty, Michael, Dutton, Susan J., Gooberman-Hill, Rachael, Hislop-Lennie, Kelly, Hutt-Greenyer, Corinne, Jansen, Victoria, Luengo-Fernadez, Ramon, Williams, Mark A., and Dziedzic, Krysia

Abstract

Objectives: To investigate the clinical effectiveness, efficacy and cost effectiveness of splints (orthoses) in people with symptomatic basal thumb joint osteoarthritis (BTOA). Methods: A pragmatic, multi-centre parallel group randomised controlled trial at 17 National Health Service (NHS) hospital departments recruited adults with symptomatic BTOA and at least moderate hand pain and dysfunction. We randomised participants (1:1:1) using a computer-based minimisation system to one of three treatment groups: a therapist supported self-management programme (SSM), a therapist supported self-management programme plus a verum thumb splint (SSM+S), or a therapist supported self-management programme plus a placebo thumb splint (SSM+PS). Participants were blinded to group allocation, received 90 minutes therapy over 8 weeks and were followed up for 12 weeks from baseline. AUSCAN hand pain at 8 weeks was the primary outcome, using intention to treat (ITT) analysis. We calculated costs of treatment. Results: We randomised 349 participants to SSM (n=116), SSM+S (n= 116) or SSM+PS (n=117) and 292 (84%) provided AUSCAN hand pain scores at the primary end point (8 weeks). All groups improved, with no mean treatment difference between groups: SSM+S vs. SSM -0.5 (95% CI -1.4 to 0.4, p=0.255), SSM+PS vs. SSM -0.1 (95% CI -1.0 to 0.8, p = 0.829) and SSM+S vs. SSM+PS -0.4 (95% CI -1.4 to 0.5, p=0.378). The average 12-week costs were: SSM £586; SSM+S £738; and SSM+PS £685. Conclusion: There was no additional benefit of adding a thumb splint to a high-quality evidence-based, supported self-management programme for thumb OA delivered by therapists.

Published
2020

121. Arthroscopic hip surgery compared with physiotherapy and activity modification for the treatment of symptomatic femoroacetabular impingement: multicentre randomised controlled trial

Author

Palmer, Antony J R, Ayyar Gupta, Vandana, Fernquest, Scott, Rombach, Ines, Dutton, Susan J, Mansour, Ramy, Wood, Simon, Khanduja, Vikas, Pollard, Tom C B, McCaskie, Andrew W, Barker, Karen L, Andrade, Tony J M D, Carr, Andrew J, Beard, David J, and Glyn-Jones, Sion

Subjects
Adult, Male, Adolescent, Research, Middle Aged, Exercise Therapy, Arthroscopy, Young Adult, Treatment Outcome, England, Activities of Daily Living, Femoracetabular Impingement, Humans, Female, Hip Joint, Patient Reported Outcome Measures, Physical Therapy Modalities
Abstract

Objective To compare arthroscopic hip surgery with physiotherapy and activity modification for improving patient reported outcome measures in patients with symptomatic femoroacetabular impingement (FAI). Design Two group parallel, assessor blinded, pragmatic randomised controlled trial. Setting Secondary and tertiary care centres across seven NHS England sites. Participants 222 participants aged 18 to 60 years with symptomatic FAI confirmed clinically and with imaging (radiography or magnetic resonance imaging) were randomised (1:1) to receive arthroscopic hip surgery (n=112) or a programme of physiotherapy and activity modification (n=110). Exclusion criteria included previous surgery, completion of a physiotherapy programme targeting FAI within the preceding 12 months, established osteoarthritis (Kellgren-Lawrence grade ≥2), and hip dysplasia (centre-edge angle Interventions Participants in the physiotherapy group received a goal based programme tailored to individual patient needs, with emphasis on improving core stability and movement control. A maximum of eight physiotherapy sessions were delivered over five months. Participants in the arthroscopic surgery group received surgery to excise the bone that impinged during hip movements, followed by routine postoperative care. Main outcome measures The primary outcome measure was the hip outcome score activities of daily living subscale (HOS ADL) at eight months post-randomisation, with a minimum clinically important difference between groups of 9 points. Secondary outcome measures included additional patient reported outcome measures and clinical assessment. Results At eight months post-randomisation, data were available for 100 patients in the arthroscopic hip surgery group (89%) and 88 patients in the physiotherapy programme group (80%). Mean HOS ADL was 78.4 (95% confidence interval 74.4 to 82.3) for patients randomised to arthroscopic hip surgery and 69.2 (65.2 to 73.3) for patients randomised to the physiotherapy programme. After adjusting for baseline HOS ADL, age, sex, and study site, the mean HOS ADL was 10.0 points higher (6.4 to 13.6) in the arthroscopic hip surgery group compared with the physiotherapy programme group (PConclusions Patients with symptomatic FAI referred to secondary or tertiary care achieve superior outcomes with arthroscopic hip surgery than with physiotherapy and activity modification.

Published
2019

122. Arthroscopic hip surgery compared with physiotherapy and activity modification for the treatment of symptomatic femoroacetabular impingement: multicentre randomised controlled trial

Author

Palmer, Antony, Ayyar Gupta, Vandana, Fernquest, Scott, Rombach, Ines, Dutton, Susan J, Mansour, Ramy, Wood, Simon, Khanduja, Vikas, Pollard, Tom CB, McCaskie, Andrew W, Barker, Karen L, Andrade, Tony JMD, Carr, Andrew J, Beard, David J, Glyn-Jones, Sion, FAIT Study Group, Palmer, Antony JR [0000-0003-4616-7482], and Apollo - University of Cambridge Repository

Subjects
Adult, Male, Adolescent, Middle Aged, Exercise Therapy, Arthroscopy, Young Adult, Treatment Outcome, England, Activities of Daily Living, Femoracetabular Impingement, Humans, Female, Hip Joint, Patient Reported Outcome Measures
Abstract

OBJECTIVE: To compare arthroscopic hip surgery with physiotherapy and activity modification for improving patient reported outcome measures in patients with symptomatic femoroacetabular impingement (FAI). DESIGN: Two group parallel, assessor blinded, pragmatic randomised controlled trial. SETTING: Secondary and tertiary care centres across seven NHS England sites. PARTICIPANTS: 222 participants aged 18 to 60 years with symptomatic FAI confirmed clinically and with imaging (radiography or magnetic resonance imaging) were randomised (1:1) to receive arthroscopic hip surgery (n=112) or a programme of physiotherapy and activity modification (n=110). Exclusion criteria included previous surgery, completion of a physiotherapy programme targeting FAI within the preceding 12 months, established osteoarthritis (Kellgren-Lawrence grade ≥2), and hip dysplasia (centre-edge angle

Published
2019

123. DCE_Appendix_2_online_supp – Supplemental material for Duration of Treatment Effect Should Be Considered in the Design and Interpretation of Clinical Trials: Results of a Discrete Choice Experiment

Author

Copsey, Bethan, Buchanan, James, Fitzpatrick, Raymond, Lamb, Sarah E., Dutton, Susan J., and Cook, Jonathan A.

Subjects
111708 Health and Community Services, 111799 Public Health and Health Services not elsewhere classified, 160807 Sociological Methodology and Research Methods, FOS: Health sciences, FOS: Sociology
Abstract

Supplemental material, DCE_Appendix_2_online_supp for Duration of Treatment Effect Should Be Considered in the Design and Interpretation of Clinical Trials: Results of a Discrete Choice Experiment by Bethan Copsey, James Buchanan, Raymond Fitzpatrick, Sarah E. Lamb, Susan J. Dutton and Jonathan A. Cook in Medical Decision Making

Published
2019
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124. MOESM1 of Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK): study protocol for a patient-blinded, randomised controlled superiority trial of liposomal bupivacaine

Author

Knight, Ruth, Poulton, Lisa, Strickland, Louise, Hamilton, Thomas, Beard, David, Cook, Jonathan, Dutton, Susan, Leal, Jose, Lamb, Sarah, Cushla Cooper, Barker, Karen, Murray, David, and Pandit, Hemant

Abstract

Additional file 1. SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documents*.

Published
2019
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125. Supplemental material for A study of community mortality at the weekend versus during the week. Is there a correlation with in-hospital mortality?

Author

Beaumont, Oliver, Willett, Matthew, Dutton, Susan, and Vadher, Karen

Subjects
111708 Health and Community Services, education, 111799 Public Health and Health Services not elsewhere classified, FOS: Health sciences
Abstract

Supplemental Material for A study of community mortality at the weekend versus during the week. Is there a correlation with in-hospital mortality? by Oliver Beaumont, Matthew Willett, Susan Dutton and Karen Vadher in Journal of Health Services Research & Policy

Published
2019
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126. Plaster cast versus functional bracing for Achilles tendon rupture: the UKSTAR RCT

Author

Costa, Matthew L, primary, Achten, Juul, additional, Wagland, Susan, additional, Marian, Ioana R, additional, Maredza, Mandy, additional, Schlüssel, Michael Maia, additional, Liew, Anna S, additional, Parsons, Nick R, additional, Dutton, Susan J, additional, Kearney, Rebecca S, additional, Lamb, Sarah E, additional, Ollivere, Benjamin, additional, and Petrou, Stavros, additional

Published
2020
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127. Plaster cast versus functional brace for non-surgical treatment of Achilles tendon rupture (UKSTAR): a multicentre randomised controlled trial and economic evaluation

Author

Costa, Matthew L, primary, Achten, Juul, additional, Marian, Ioana R, additional, Dutton, Susan J, additional, Lamb, Sarah E, additional, Ollivere, Benjamin, additional, Maredza, Mandy, additional, Petrou, Stavros, additional, Kearney, Rebecca S, additional, Abdallah, Amr, additional, Ballal, Moez, additional, Ballester, Jordi, additional, Beastall, James, additional, Bhattacharya, Rajarshi, additional, Burrt, Simon, additional, Deakin, Mark, additional, Deol, Rupe, additional, Dramis, Asterios, additional, El-Kawy, Sameh, additional, Eyre, Jason, additional, Forder, Justin, additional, Ghosh, Avijeet, additional, Guha, Anhijit, additional, Hancock, Nicholas, additional, Harrold, Fraser, additional, Harwood, Paul, additional, Hull, Peter, additional, Johnstone, Alan, additional, Kapoor, Sandeep, additional, Karagkevrekis, Babis, additional, Kelly, Andrew, additional, Kurdy, Nasser, additional, Kurup, Harish, additional, Lyle, Victoria, additional, Madan, Sanjeev, additional, Madeley, Jane, additional, Mahmood, Ansar, additional, Malik, Atif, additional, McAndrew, Andrew, additional, Mishra, Viren, additional, Modi, Nitin, additional, Nanda, Rajesh, additional, Reichert, Ines, additional, Reissis, Nikos, additional, Sampalli, Sridhar, additional, Scott, Andrea, additional, Walter, Richard, additional, and Westwood, Mark, additional

Published
2020
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129. EnROL: A multicentre randomised trial of conventional versus laparoscopic surgery for colorectal cancer within an enhanced recovery programme

Author

Kennedy Robin H, Francis Anne, Dutton Susan, Love Sharon, Pearson Sarah, Blazeby Jane M, Quirke Philip, Franks Peter J, and Kerr David J

Subjects
Laparoscopy, Colon cancer, Rectal cancer, Enhanced recovery programme, Fast track surgery, Health economics, Cosmetic assessment, Fatigue, Randomised controlled trial, EnROL, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background During the last two decades the use of laparoscopic resection and a multimodal approach known as an enhanced recovery programme, have been major changes in colorectal perioperative care. Clinical outcome improves using laparoscopic surgery to resect colorectal cancer but until recently no multicentre trial evidence had been reported regarding whether the benefits of laparoscopy still exist when open surgery is optimized within an enhanced recovery programme. The EnROL trial (Enhanced Recovery Open versus Laparoscopic) examines the hypothesis that laparoscopic surgery within an enhanced recovery programme will provide superior postoperative outcomes when compared to conventional open resection of colorectal cancer within the same programme. Methods/design EnROL is a phase III, multicentre, randomised trial of laparoscopic versus open resection of colon and rectal cancer with blinding of patients and outcome observers to the treatment allocation for the first 7 days post-operatively, or until discharge if earlier. 202 patients will be recruited at approximately 12 UK hospitals and randomised using minimization at a central computer system in a 1:1 ratio. Recruiting surgeons will previously have performed >100 laparoscopic colorectal resections and >50 open total mesorectal excisions to minimize conversion. Eligible patients are those suitable for elective resection using either technique. Excluded patients include: those with acute intestinal obstruction and patients in whom conversion from laparoscopic to open procedure is likely. The primary outcome is physical fatigue as measured by the physical fatigue domain of the multidimensional fatigue inventory 20 (MFI-20) with secondary outcomes including postoperative hospital stay; complications; reoperation and readmission; quality of life indicators; cosmetic assessments; standardized performance indicators; health economic analysis; the other four domains of the MFI-20. Pathological assessment of surgical quality will also be undertaken and compliance with the enhanced recovery programme will be recorded for all patients. Discussion Should this trial demonstrate that laparoscopic surgery confers a significant clinical and/or health economic benefit this will further support the transition to this type of surgery, with implications for the training of surgeons and resource allocation. Trial registration ISRCTN48516968.

Published
2012
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130. Progressive functional exercise versus best practice advice for adults aged 50 years or over after ankle fracture: protocol for a pilot randomised controlled trial in the UK - the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study

Author

Keene, David J, primary, Costa, Matthew L, additional, Tutton, Elizabeth, additional, Hopewell, Sally, additional, Barber, Vicki S, additional, Dutton, Susan J, additional, Redmond, Anthony C, additional, Willett, Keith, additional, and Lamb, Sarah E, additional

Published
2019
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131. Development of a core information set for colorectal cancer surgery: a consensus study

Author

McNair, Angus G K, primary, Whistance, Robert N, additional, Main, Barry, additional, Forsythe, Rachael, additional, Macefield, Rhiannon, additional, Rees, Jonathan, additional, Pullyblank, Anne, additional, Avery, Kerry, additional, Brookes, Sara, additional, Thomas, Michael G, additional, Sylvester, Paul A, additional, Russell, Ann, additional, Oliver, Alfred, additional, Morton, Dion, additional, Kennedy, Robin, additional, Jayne, David, additional, Huxtable, Richard, additional, Hackett, Roland, additional, Dutton, Susan, additional, Coleman, Mark G, additional, Card, Mia, additional, Brown, Julia, additional, and Blazeby, Jane, additional

Published
2019
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132. Platelet-rich plasma injection for adults with acute Achilles tendon rupture: the PATH-2 RCT

Author

Alsousou, Joseph, primary, Keene, David J, additional, Harrison, Paul, additional, Hulley, Philippa, additional, Wagland, Susan, additional, Thompson, Jacqueline Y, additional, Parsons, Scott R, additional, Byrne, Christopher, additional, Schlüssel, Michael M, additional, O’Connor, Heather M, additional, Dutton, Susan J, additional, Lamb, Sarah E, additional, and Willett, Keith, additional

Published
2019
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133. INtravenous Iron to Treat Anaemia following CriTical care (INTACT): A protocol for a feasibility randomised controlled trial

Author

Shah, Akshay, primary, Marian, Ioana, additional, Dutton, Susan J, additional, Barber, Vicki S, additional, Griffith, David M, additional, McKechnie, Stuart R, additional, Chapman, George, additional, Robbins, Peter A, additional, Young, Duncan, additional, Walsh, Timothy S, additional, and Stanworth, Simon J, additional

Published
2019
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134. Nocturnal temperature-controlled laminar airflow device for adults with severe allergic asthma: the LASER RCT

Author

Kapoor, Melissa, primary, Storrar, Will, additional, Balls, Lara, additional, Brown, Thomas P, additional, Mansur, Adel, additional, Hedley, Emma, additional, Jones, Tom, additional, Roberts, Claire, additional, Shirkey, Beverly, additional, Dutton, Susan, additional, Luengo-Fernandez, Ramon, additional, Little, Matthew, additional, Dewey, Ann, additional, Marshall, Sue, additional, Fogg, Carole, additional, Boughton, Keith, additional, Rahman, Najib, additional, Yu, Ly-Mee, additional, Bradding, Peter, additional, Howarth, Peter, additional, and Chauhan, Anoop J, additional

Published
2019
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136. 7 Platelet rich plasma for acute achilles tendon rupture: a double-blind, multicentre, randomised, placebo-controlled trial

Author

Keene, David, primary, Alsousou, Joseph, additional, Harrison, Paul, additional, Hulley, Philippa, additional, Wagland, Susan, additional, Parsons, Scott, additional, Thompson, Jacqueline, additional, O’Connor, Heather, additional, Schlüssel, Michael, additional, Dutton, Susan, additional, Lamb, Sarah, additional, and Willett, Keith, additional

Published
2019
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137. Quality of stepped-wedge trial reporting can be reliably assessed using an updated CONSORT: crowd-sourcing systematic review

Author

Hemming, Karla, primary, Carroll, Kelly, additional, Thompson, Jennifer, additional, Forbes, Andrew, additional, Taljaard, Monica, additional, Dutton, Susan J., additional, Madurasinghe, Vichithranie, additional, Morgan, Katy, additional, Stuart, Beth, additional, Fielding, Katherine, additional, Cornelius, Victoria, additional, Turner, Elizabeth L., additional, Hooper, Richard, additional, Giraudeau, Bruno, additional, Seed, Paul T., additional, Nickless, Alecia, additional, Grayling, Michael, additional, Prague, Melanie, additional, Kerry, Sally, additional, Bell, Lauren, additional, Watson, Eila, additional, Gafoor, Rafael, additional, Marlin, Nadine, additional, Yorganci, Emel, additional, Smith, Lesley, additional, Mbekwe, Murielle, additional, Teerenstra, Steven, additional, Chan, Claire, additional, Moerbeek, Mirjam, additional, Jacobsen, Pamela, additional, Bond, Simon, additional, Jones, Ben, additional, Preisser, John, additional, Kanaan, Mona, additional, Hewitt, Catherine, additional, Easter, Christina, additional, Pellatt-Higgins, Tracy, additional, Pankhurst, Laura, additional, Agbla, Schadrac C., additional, Eldridge, Sandra, additional, Lerner, Robin G., additional, Leyrat, Clémence, additional, Pilling, Mark, additional, Forman, Julia R., additional, Bhattacharya, Indrani, additional, Magill, Nicholas, additional, Candlish, Jane, additional, McDowell, Cliona, additional, Martin, James, additional, Kristunas, Caroline, additional, Allen, Elizabeth, additional, Seward, Nadine, additional, Nicholls, Elaine, additional, and Franklin, Bryony Dean, additional

Published
2019
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138. Reporting methods in studies developing prognostic models in cancer: a review

Author

Waters Rachel, Dutton Susan, Royston Patrick, Mallett Susan, and Altman Douglas G

Subjects
Medicine
Abstract

Abstract Background Development of prognostic models enables identification of variables that are influential in predicting patient outcome and the use of these multiple risk factors in a systematic, reproducible way according to evidence based methods. The reliability of models depends on informed use of statistical methods, in combination with prior knowledge of disease. We reviewed published articles to assess reporting and methods used to develop new prognostic models in cancer. Methods We developed a systematic search string and identified articles from PubMed. Forty-seven articles were included that satisfied the following inclusion criteria: published in 2005; aiming to predict patient outcome; presenting new prognostic models in cancer with outcome time to an event and including a combination of at least two separate variables; and analysing data using multivariable analysis suitable for time to event data. Results In 47 studies, prospective cohort or randomised controlled trial data were used for model development in only 33% (15) of studies. In 30% (14) of the studies insufficient data were available, having fewer than 10 events per variable (EPV) used in model development. EPV could not be calculated in a further 40% (19) of the studies. The coding of candidate variables was only reported in 68% (32) of the studies. Although use of continuous variables was reported in all studies, only one article reported using recommended methods of retaining all these variables as continuous without categorisation. Statistical methods for selection of variables in the multivariate modelling were often flawed. A method that is not recommended, namely, using statistical significance in univariate analysis as a pre-screening test to select variables for inclusion in the multivariate model, was applied in 48% (21) of the studies. Conclusions We found that published prognostic models are often characterised by both use of inappropriate methods for development of multivariable models and poor reporting. In addition, models are limited by the lack of studies based on prospective data of sufficient sample size to avoid overfitting. The use of poor methods compromises the reliability of prognostic models developed to provide objective probability estimates to complement clinical intuition of the physician and guidelines.

Published
2010
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139. Reporting performance of prognostic models in cancer: a review

Author

Dutton Susan, Waters Rachel, Royston Patrick, Mallett Susan, and Altman Douglas G

Subjects
Medicine
Abstract

Abstract Background Appropriate choice and use of prognostic models in clinical practice require the use of good methods for both model development, and for developing prognostic indices and risk groups from the models. In order to assess reliability and generalizability for use, models need to have been validated and measures of model performance reported. We reviewed published articles to assess the methods and reporting used to develop and evaluate performance of prognostic indices and risk groups from prognostic models. Methods We developed a systematic search string and identified articles from PubMed. Forty-seven articles were included that satisfied the following inclusion criteria: published in 2005; aiming to predict patient outcome; presenting new prognostic models in cancer with outcome time to an event and including a combination of at least two separate variables; and analysing data using multivariable analysis suitable for time to event data. Results In 47 studies, Cox models were used in 94% (44), but the coefficients or hazard ratios for the variables in the final model were reported in only 72% (34). The reproducibility of the derived model was assessed in only 11% (5) of the articles. A prognostic index was developed from the model in 81% (38) of the articles, but researchers derived the prognostic index from the final prognostic model in only 34% (13) of the studies; different coefficients or variables from those in the final model were used in 50% (19) of models and the methods used were unclear in 16% (6) of the articles. Methods used to derive prognostic groups were also poor, with researchers not reporting the methods used in 39% (14 of 36) of the studies and data derived methods likely to bias estimates of differences between risk groups being used in 28% (10) of the studies. Validation of their models was reported in only 34% (16) of the studies. In 15 studies validation used data from the same population and in five studies from a different population. Including reports of validation with external data from publications up to four years following model development, external validation was attempted for only 21% (10) of models. Insufficient information was provided on the performance of models in terms of discrimination and calibration. Conclusions Many published prognostic models have been developed using poor methods and many with poor reporting, both of which compromise the reliability and clinical relevance of models, prognostic indices and risk groups derived from them.

Published
2010
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140. The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trial.

Author

Adams, Jo, Barratt, Paula, Rombach, Ines, Arden, Nigel, Bouças, Sofia Barbosa, Bradley, Sarah, Doherty, Michael, Dutton, Susan J, Gooberman-Hill, Rachael, Hislop-Lennie, Kelly, Hutt-Greenyer, Corinne, Jansen, Victoria, Luengo-Fernadez, Ramon, Williams, Mark, and Dziedzic, Krysia

Subjects
OSTEOARTHRITIS treatment, RESEARCH, CONFIDENCE intervals, SELF-management (Psychology), SPLINTS (Surgery), MEDICAL cooperation, TREATMENT effectiveness, RANDOMIZED controlled trials, COMPARATIVE studies, THUMB, COST effectiveness, DESCRIPTIVE statistics
Abstract

Objectives To investigate the clinical effectiveness, efficacy and cost effectiveness of splints (orthoses) in people with symptomatic basal thumb joint OA (BTOA). Methods A pragmatic, multicentre parallel group randomized controlled trial at 17 National Health Service (NHS) hospital departments recruited adults with symptomatic BTOA and at least moderate hand pain and dysfunction. We randomized participants (1:1:1) using a computer-based minimization system to one of three treatment groups: a therapist supported self-management programme (SSM), a therapist supported self-management programme plus a verum thumb splint (SSM+S), or a therapist supported self-management programme plus a placebo thumb splint (SSM+PS). Participants were blinded to group allocation, received 90 min therapy over 8 weeks and were followed up for 12 weeks from baseline. Australian/Canadian (AUSCAN) hand pain at 8 weeks was the primary outcome, using intention to treat analysis. We calculated costs of treatment. Results We randomized 349 participants to SSM (n  = 116), SSM+S (n  = 116) or SSM+PS (n  = 117) and 292 (84%) provided AUSCAN Osteoarthritis Hand Index hand pain scores at the primary end point (8 weeks). All groups improved, with no mean treatment difference between groups: SSM+S vs SSM −0.5 (95% CI: −1.4, 0.4), P  = 0.255; SSM+PS vs SSM −0.1 (95% CI: −1.0, 0.8), P  = 0.829; and SSM+S vs SSM+PS −0.4 (95% CI: −1.4, 0.5), P  = 0.378. The average 12-week costs were: SSM £586; SSM+S £738; and SSM+PS £685. Conclusion There was no additional benefit of adding a thumb splint to a high-quality evidence-based, supported self-management programme for thumb OA delivered by therapists. Trial registration ISRCTN 54744256 (http://www.isrctn.com/ISRCTN54744256). [ABSTRACT FROM AUTHOR]

Published
2021
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141. SOURCE : A Registry-Based Prediction Model for Overall Survival in Patients with Metastatic Oesophageal or Gastric Cancer

Author

van den Boorn, Héctor G, Abu-Hanna, Ameen, Ter Veer, Emil, van Kleef, Jessy Joy, Lordick, Florian, Stahl, Michael, Ajani, Jaffer A, Guimbaud, Rosine, Park, Se Hoon, Dutton, Susan J, Bang, Yung-Jue, Boku, Narikazu, Mohammad, Nadia Haj, Sprangers, Mirjam A G, Verhoeven, Rob H A, Zwinderman, Aeilko H, van Oijen, Martijn G H, van Laarhoven, Hanneke W M, van den Boorn, Héctor G, Abu-Hanna, Ameen, Ter Veer, Emil, van Kleef, Jessy Joy, Lordick, Florian, Stahl, Michael, Ajani, Jaffer A, Guimbaud, Rosine, Park, Se Hoon, Dutton, Susan J, Bang, Yung-Jue, Boku, Narikazu, Mohammad, Nadia Haj, Sprangers, Mirjam A G, Verhoeven, Rob H A, Zwinderman, Aeilko H, van Oijen, Martijn G H, and van Laarhoven, Hanneke W M

Published
2019

142. SOURCE: A Registry-Based Prediction Model for Overall Survival in Patients with Metastatic Oesophageal or Gastric Cancer

Author

MS Medische Oncologie, Cancer, Externen Med. Onco, van den Boorn, Héctor G, Abu-Hanna, Ameen, Ter Veer, Emil, van Kleef, Jessy Joy, Lordick, Florian, Stahl, Michael, Ajani, Jaffer A, Guimbaud, Rosine, Park, Se Hoon, Dutton, Susan J, Bang, Yung-Jue, Boku, Narikazu, Mohammad, Nadia Haj, Sprangers, Mirjam A G, Verhoeven, Rob H A, Zwinderman, Aeilko H, van Oijen, Martijn G H, van Laarhoven, Hanneke W M, MS Medische Oncologie, Cancer, Externen Med. Onco, van den Boorn, Héctor G, Abu-Hanna, Ameen, Ter Veer, Emil, van Kleef, Jessy Joy, Lordick, Florian, Stahl, Michael, Ajani, Jaffer A, Guimbaud, Rosine, Park, Se Hoon, Dutton, Susan J, Bang, Yung-Jue, Boku, Narikazu, Mohammad, Nadia Haj, Sprangers, Mirjam A G, Verhoeven, Rob H A, Zwinderman, Aeilko H, van Oijen, Martijn G H, and van Laarhoven, Hanneke W M

Published
2019

143. The Osteoarthritis Thumb Therapy Trial (OTTER II): A study protocol for a three arm multi centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost effectiveness of splints for symptomatic thumb base osteoarthritis

Author

Adams, Jo, Barratt, Paula, Arden, Nigel, Barbosa Bouças, Sofia, Bradley, Sarah, Doherty, Michael, Dutton, Susan, Dziedzic, Krysia, Gooberman-Hill, Rachael, Hislop Lennie, Kelly, Hutt Greenyer, Corinne, Jansen, Victoria, Luengo-Fernandez, Ramon, Meagher, Claire, White, Peter, Williams, Mark, Adams, Jo, Barratt, Paula, Arden, Nigel, Barbosa Bouças, Sofia, Bradley, Sarah, Doherty, Michael, Dutton, Susan, Dziedzic, Krysia, Gooberman-Hill, Rachael, Hislop Lennie, Kelly, Hutt Greenyer, Corinne, Jansen, Victoria, Luengo-Fernandez, Ramon, Meagher, Claire, White, Peter, and Williams, Mark

Abstract

Introduction. The economic cost of osteoarthritis (OA) is high. At least 4.4 million people have hand OA in the UK. Symptomatic thumb base OA affects 20% of people over 55 years, causing more pain, work and functional disability than OA elsewhere in the hand. Most evidence-based guidelines recommend splinting for hand OA. Splints that support or immobilise the thumb base are routinely used despite there being limited evidence on their effectivenss. The potential effects of placebo interventions in OA are acknowledged, but few studies investigate the clinical efficacy of rehabilitation interventions nor the impact of any placebo effects associated with splints. Methods and Analysis. Participants aged 30 years and over with symptomatic thumb base OA will be recruited into the trial from secondary care occupational therapy and physiotherapy centres. Following informed consent, participants will complete a baseline questionnaire and then be randomised into one of three treatment arms: a self-management programme, a self-management programme plus a verum thumb splint, or a self-management programme plus a placebo thumb splint. The primary outcome is the AUSCAN hand pain scale. The study end point is 8 weeks after baseline. Baseline assessments will be carried out prior to randomisation and outcomes collected at 4; 8 and 12 weeks. Cost effectiveness analysis will be conducted and individual qualitative interviews conducted with up to 40 participants after 8 weeks to explore perceptions and outcome expectations of verum and placebo splints and exercise. Ethics and Dissemination. South Central - Oxford C Research Ethics Committee approved this study (16/SC/0188). The findings will be disseminated to health professional conferences, journals and lay publications for patient organisations. The research will contribute to improving the management of thumb base OA and help clinicians and patients make informed decisions about the value of different interventions.

Published
2019

144. Additional file 1: of Platelet-rich plasma in Achilles tendon healing 2 (PATH-2) trial: statistical analysis plan for a multicentre, double-blinded, parallel-group, placebo-controlled randomised clinical trial

Author

SchlĂźssel, Michael, Keene, David, Wagland, Susan, Alsousou, Joseph, Lamb, Sarah, Willett, Keith, and Dutton, Susan

Abstract

Table S1. Baseline characteristics of participants according to intervention groups. Table S2. Stratification factors and sociodemographic characteristics of participants according to intervention groups. Table S3. Baseline patient reported outcomes by intervention groups. Table S4. Academic/employment-related characteristics of participants according to intervention groups. Table S5. Physical activity of participants before injury according to intervention groups. Table S6. Injury-related characteristics of participants by intervention groups. Table S7. Clinical characteristics of participants by intervention groups. Table S8. Medications that may influence platelet function taken by participants by intervention groups. Table S9. Complications reported by participants during the 24 weeks after injury and treatment. (PDF 1944 kb)

Published
2018
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145. Cast versus functional brace in the rehabilitation of patients treated non-operatively for a rupture of the Achilles tendon: protocol for the UK study of tendo achilles rehabilitation (UK STAR) multi-centre randomised trial

Author

Achten, Juul, Parsons, Nick R., Kearney, Rebecca L., Liew, Anna S., Dutton, Susan, Petrou, Stavros, Ollivere, Benjamin, Lamb, Sarah E., and Costa, Matthew L.

Subjects
accident &emergency medicine, orthopaedic & trauma surgery
Abstract

INTRODUCTIONAchilles tendon rupture affects over 11 000 people yearly in the UK, and the incidence is increasing. Controversy remains with regard to the best rehabilitation strategy for these patients. In operatively treated patients, functional bracing provides better outcomes compared with plaster casts. However, the role of functional bracing in non-operatively managed patients is unclear. This is the protocol for a multicentre randomised trial of plaster cast immobilisation versus functional bracing for patients with a non-operatively managed Achilles tendon rupture.METHODS AND ANALYSISAll adults presenting with a primary rupture of the Achilles tendon will be screened. Non-operatively treated patients will be eligible to take part in the trial. Broad eligibility criteria will ensure that the results of the study can be generalised to the wider patient population. Randomisation will be on a 1:1 basis. Both rehabilitation strategies are widely used within the National Health Service. Standardised protocols will be followed, and details of plaster material and brace will be as per the site's usual practice.A minimum of 330 patients will be randomised to obtain 90% power to detect a difference of 8 points in Achilles Tendon Total Rupture Score at 9 months. Quality of life and resource use will be collected at 3, 6 and 9 months. The differences between treatment groups will be assessed on an intention-to-treat basis. The results of the trial-based economic evaluation will be expressed in terms of incremental cost per quality-adjusted life-year gained.ETHICS AND DISSEMINATIONThe National Research Ethic Committee approved this study on 18 March 2016 (16/SC/0109).The National Institute for Health Research Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted on completion of the trial (summer 2019). The results of this trial will substantially inform clinical practice on the clinical and cost-effectiveness of the treatment of this injury. This study has been registered on the International Standard Randomised Controlled Trial Number registry with reference no ISRCTN62639639.

Published
2017

146. SOURCE: A Registry-Based Prediction Model for Overall Survival in Patients with Metastatic Oesophageal or Gastric Cancer

Author

van den Boorn, Héctor, primary, Abu-Hanna, Ameen, additional, ter Veer, Emil, additional, van Kleef, Jessy, additional, Lordick, Florian, additional, Stahl, Michael, additional, Ajani, Jaffer, additional, Guimbaud, Rosine, additional, Park, Se, additional, Dutton, Susan, additional, Bang, Yung-Jue, additional, Boku, Narikazu, additional, Mohammad, Nadia, additional, Sprangers, Mirjam, additional, Verhoeven, Rob, additional, Zwinderman, Aeilko, additional, van Oijen, Martijn, additional, and van Laarhoven, Hanneke, additional

Published
2019
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147. Characteristics of L-PRP preparations for treating Achilles tendon rupture within the PATH-2 study.

Author

Harrison, Paul, Didembourg, Marie, Wood, Alexander, Devi, Amarpreet, Dinsdale, Robert, Hazeldine, Jon, Alsousou, Joseph, Keene, David J, Hulley, Philippa, Wagland, Susan, Parsons, Scott, Thompson, Jacqueline, Byrne, Christopher, Schlüssel, Michael Maia, O'Connor, Heather, Dutton, Susan J, Lamb, Sarah E, and Willett, Keith

Subjects
ACHILLES tendon rupture, BLOOD cell count, ERYTHROCYTES, LEUKOCYTE count, PLATELET-rich plasma
Abstract

Platelet-rich plasma (PRP) is an autologous preparation that has been claimed to improve healing and mechanobiological properties of tendons both in vitro and in vivo. In this sub-study from the PATH-2 (PRP in Achilles Tendon Healing-2) trial, we report the cellular and growth factor content and quality of the Leukocyte-rich PRP (L-PRP) (N = 103) prepared using a standardized commercial preparation method across 19 different UK centers. Baseline whole blood cell counts (red cells, leukocyte and platelets) demonstrated that the two groups were well-matched. L-PRP analysis gave a mean platelet count of 852.6 x 109/L (SD 438.96), a mean leukocyte cell count of 15.13 x 109/L (SD 10.28) and a mean red blood cell count of 0.91 x 1012/L (SD 1.49). The activation status of the L-PRP gave either low or high expression levels of the degranulation marker CD62p before and after ex-vivo platelet activation respectively. TGF-β, VEGF, PDGF, IGF and FGFb mean concentrations were 131.92 ng/ml, 0.98 ng/ml, 55.34 ng/ml, 78.2 ng/ml and 111.0 pg/ml respectively with expected correlations with both platelet and leukocyte counts. While PATH-2 results demonstrated that there was no evidence L-PRP is effective for improving clinical outcomes at 24 weeks after Achilles tendon rupture, our findings support that the majority of L-PRP properties were within the method specification and performance. [ABSTRACT FROM AUTHOR]

Published
2021
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148. Clinical effectiveness of symptomatic therapy compared with standard step-up care for the treatment of low-impact psoriatic oligoarthritis: the two-arm parallel group randomised POISE feasibility study.

Author

Rombach, Ines, Tucker, Laura, Tillett, William, Jadon, Deepak, Watson, Marion, Francis, Anne, Sinomati, Yvonne, Dutton, Susan J, and Coates, Laura C

Abstract

Introduction: In psoriatic arthritis (PsA), treatment recommendations support first-line use of disease-modifying antirheumatic drugs (DMARDs). There are few treatment strategy trials, and no previous studies have investigated tailored treatment choice by disease severity. Studies in oligoarthritis (<5 inflamed joints) are limited but have suggested that some can be managed without DMARDs, preventing unnecessary side effects. This study aimed to assess the feasibility and acceptability of a study comparing standard DMARD treatment against symptomatic therapy in patients with mild psoriatic oligoarthritis. Methods: This trial was embedded within the MONITOR-PsA cohort, which uses a Trials Within Cohorts (TWiCs) design. Patients with newly diagnosed psoriatic oligoarthritis, with low disease activity (PASDAS ⩽ 3.2) and the absence of poor prognostic factors [C reactive protein (CRP) < 5 mg/dL, HAQ < 1, no radiographic erosions] were randomised open-label to either standard care with 'step-up' DMARD therapy or to symptomatic therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) and local corticosteroid injections to inflamed joints. Key outcomes were the proportion of eligible cohort patients, consent and study completion rate. Results: Over the 15-month study period, only one eligible patient was randomised. Although oligoarthritis patients represented 45% of patients in this early PsA cohort, the majority did not have mild disease (24% raised CRP, 51% moderate disease activity, 13% radiographic damage and/or poor function). Of those meeting trial inclusion criteria, many patients refused treatment in the observational cohort prior to an invitation into the trial as they did not wish to be treated with DMARDs. Conclusion: The study was not feasible as designed. Oligoarthritis represents around half of initial PsA presentations, but the majority starting therapy have high-impact disease. A small proportion have mild oligoarticular disease but many are not keen on treatment with DMARDs, given the potential side effects of these medications. Further research is needed to support evidence-based treatment in this subgroup. Trial registration number: – ClinicalTrials.gov (NCT03797872) and EudraCT (2018-001085-42). [ABSTRACT FROM AUTHOR]

Published
2021
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149. Better Outcomes for Older people with Spinal Trouble (BOOST) trial: statistical analysis plan for a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication.

Author

Marian, Ioana R., Williamson, Esther, Garrett, Angela, Lamb, Sarah E., and Dutton, Susan J.

Subjects
RANDOMIZED controlled trials, OLDER people, STATISTICS, SPINAL stenosis, LUMBAR pain
Abstract

Background: Neurogenic claudication is a common spinal condition affecting older adults that has a major effect on mobility and implicitly independence. The effectiveness of conservative interventions in this population is not known. We describe the statistical analysis plan for the Better Outcomes for Older people with Spinal trouble (BOOST) randomised controlled trial.Methods/design: BOOST is a pragmatic, multicentre, parallel, two-arm, randomised controlled trial. Participants are community-dwelling adults, 65 years or older, with neurogenic claudication, registered prospectively, and randomised 2:1 (intervention to control) to the combined physical and psychological BOOST group physiotherapy programme or best practice advice. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the Short Physical Performance Battery, Swiss Spinal Stenosis Scale, 6 Minute Walk Test, Fear Avoidance Beliefs Questionnaire, and Tilburg Frailty Indicator. Outcomes are measured at 6 and 12 months by researchers blinded to treatment allocation. The primary statistical analysis is by intention to treat. Further study design details are published in the BOOST protocol.Discussion: The planned statistical analyses for the BOOST trial aim to reduce the risk of outcome reporting bias from prior data knowledge. Any changes or deviations from this statistical analysis plan will be described and justified in the final study report.Trial Registration: This study has been registered in the International Standard Randomised Controlled Trial Number registry, reference number ISRCTN12698674 . Registered on 10 November 2015. [ABSTRACT FROM AUTHOR]

Published
2020
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