The IDENTIFY study: the investigation and detection of urological neoplasia in patients referred with suspected urinary tract cancer - a multicentre observational study

Objective To evaluate the contemporary prevalence of urinary tract cancer (bladder cancer, upper tract urothelial cancer [UTUC] and renal cancer) in patients referred to secondary care with haematuria, adjusted for established patient risk markers and geographical variation. Patients and Methods This was an international multicentre prospective observational study. We included patients aged ≥16 years, referred to secondary care with suspected urinary tract cancer. Patients with a known or previous urological malignancy were excluded. We estimated the prevalence of bladder cancer, UTUC, renal cancer and prostate cancer; stratified by age, type of haematuria, sex, and smoking. We used a multivariable mixed-effects logistic regression to adjust cancer prevalence for age, type of haematuria, sex, smoking, hospitals, and countries. Results Of the 11 059 patients assessed for eligibility, 10 896 were included from 110 hospitals across 26 countries. The overall adjusted cancer prevalence (n = 2257) was 28.2% (95% confidence interval [CI] 22.3–34.1), bladder cancer (n = 1951) 24.7% (95% CI 19.1–30.2), UTUC (n = 128) 1.14% (95% CI 0.77–1.52), renal cancer (n = 107) 1.05% (95% CI 0.80–1.29), and prostate cancer (n = 124) 1.75% (95% CI 1.32–2.18). The odds ratios for patient risk markers in the model for all cancers were: age 1.04 (95% CI 1.03–1.05; P < 0.001), visible haematuria 3.47 (95% CI 2.90–4.15; P < 0.001), male sex 1.30 (95% CI 1.14–1.50; P < 0.001), and smoking 2.70 (95% CI 2.30–3.18; P < 0.001). Conclusions A better understanding of cancer prevalence across an international population is required to inform clinical guidelines. We are the first to report urinary tract cancer prevalence across an international population in patients referred to secondary care, adjusted for patient risk markers and geographical variation. Bladder cancer was the most prevalent disease. Visible haematuria was the strongest predictor for urinary tract cancer

Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study

Funder: European Society of Intensive Care Medicine; doi: http://dx.doi.org/10.13039/501100013347Funder: Flemish Society for Critical Care NursesAbstract: Purpose: Intensive care unit (ICU) patients are particularly susceptible to developing pressure injuries. Epidemiologic data is however unavailable. We aimed to provide an international picture of the extent of pressure injuries and factors associated with ICU-acquired pressure injuries in adult ICU patients. Methods: International 1-day point-prevalence study; follow-up for outcome assessment until hospital discharge (maximum 12 weeks). Factors associated with ICU-acquired pressure injury and hospital mortality were assessed by generalised linear mixed-effects regression analysis. Results: Data from 13,254 patients in 1117 ICUs (90 countries) revealed 6747 pressure injuries; 3997 (59.2%) were ICU-acquired. Overall prevalence was 26.6% (95% confidence interval [CI] 25.9–27.3). ICU-acquired prevalence was 16.2% (95% CI 15.6–16.8). Sacrum (37%) and heels (19.5%) were most affected. Factors independently associated with ICU-acquired pressure injuries were older age, male sex, being underweight, emergency surgery, higher Simplified Acute Physiology Score II, Braden score 3 days, comorbidities (chronic obstructive pulmonary disease, immunodeficiency), organ support (renal replacement, mechanical ventilation on ICU admission), and being in a low or lower-middle income-economy. Gradually increasing associations with mortality were identified for increasing severity of pressure injury: stage I (odds ratio [OR] 1.5; 95% CI 1.2–1.8), stage II (OR 1.6; 95% CI 1.4–1.9), and stage III or worse (OR 2.8; 95% CI 2.3–3.3). Conclusion: Pressure injuries are common in adult ICU patients. ICU-acquired pressure injuries are associated with mainly intrinsic factors and mortality. Optimal care standards, increased awareness, appropriate resource allocation, and further research into optimal prevention are pivotal to tackle this important patient safety threat

Correction to: Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study

The original version of this article unfortunately contained a mistake

Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study

Funder: European Society of Intensive Care Medicine; doi: http://dx.doi.org/10.13039/501100013347Funder: Flemish Society for Critical Care NursesAbstract: Purpose: Intensive care unit (ICU) patients are particularly susceptible to developing pressure injuries. Epidemiologic data is however unavailable. We aimed to provide an international picture of the extent of pressure injuries and factors associated with ICU-acquired pressure injuries in adult ICU patients. Methods: International 1-day point-prevalence study; follow-up for outcome assessment until hospital discharge (maximum 12 weeks). Factors associated with ICU-acquired pressure injury and hospital mortality were assessed by generalised linear mixed-effects regression analysis. Results: Data from 13,254 patients in 1117 ICUs (90 countries) revealed 6747 pressure injuries; 3997 (59.2%) were ICU-acquired. Overall prevalence was 26.6% (95% confidence interval [CI] 25.9–27.3). ICU-acquired prevalence was 16.2% (95% CI 15.6–16.8). Sacrum (37%) and heels (19.5%) were most affected. Factors independently associated with ICU-acquired pressure injuries were older age, male sex, being underweight, emergency surgery, higher Simplified Acute Physiology Score II, Braden score 3 days, comorbidities (chronic obstructive pulmonary disease, immunodeficiency), organ support (renal replacement, mechanical ventilation on ICU admission), and being in a low or lower-middle income-economy. Gradually increasing associations with mortality were identified for increasing severity of pressure injury: stage I (odds ratio [OR] 1.5; 95% CI 1.2–1.8), stage II (OR 1.6; 95% CI 1.4–1.9), and stage III or worse (OR 2.8; 95% CI 2.3–3.3). Conclusion: Pressure injuries are common in adult ICU patients. ICU-acquired pressure injuries are associated with mainly intrinsic factors and mortality. Optimal care standards, increased awareness, appropriate resource allocation, and further research into optimal prevention are pivotal to tackle this important patient safety threat

Developing a Diagnostic Multivariable Prediction Model for Urinary Tract Cancer in Patients Referred with Haematuria: Results from the IDENTIFY Collaborative Study

377siBackground: Patient factors associated with urinary tract cancer can be used to risk stratify patients referred with haematuria, prioritising those with a higher risk of cancer for prompt investigation. Objective: To develop a prediction model for urinary tract cancer in patients referred with haematuria. Design, setting, and participants: A prospective observational study was conducted in 10 282 patients from 110 hospitals across 26 countries, aged ≥16 yr and referred to secondary care with haematuria. Patients with a known or previous urological malignancy were excluded. Outcome measurements and statistical analysis: The primary outcomes were the presence or absence of urinary tract cancer (bladder cancer, upper tract urothelial cancer [UTUC], and renal cancer). Mixed-effect multivariable logistic regression was performed with site and country as random effects and clinically important patient-level candidate predictors, chosen a priori, as fixed effects. Predictors were selected primarily using clinical reasoning, in addition to backward stepwise selection. Calibration and discrimination were calculated, and bootstrap validation was performed to calculate optimism. Results and limitations: The unadjusted prevalence was 17.2% (n = 1763) for bladder cancer, 1.20% (n = 123) for UTUC, and 1.00% (n = 103) for renal cancer. The final model included predictors of increased risk (visible haematuria, age, smoking history, male sex, and family history) and reduced risk (previous haematuria investigations, urinary tract infection, dysuria/suprapubic pain, anticoagulation, catheter use, and previous pelvic radiotherapy). The area under the receiver operating characteristic curve of the final model was 0.86 (95% confidence interval 0.85-0.87). The model is limited to patients without previous urological malignancy. Conclusions: This cancer prediction model is the first to consider established and novel urinary tract cancer diagnostic markers. It can be used in secondary care for risk stratifying patients and aid the clinician's decision-making process in prioritising patients for investigation. Patient summary: We have developed a tool that uses a person's characteristics to determine the risk of cancer if that person develops blood in the urine (haematuria). This can be used to help prioritise patients for further investigation.noneopenKhadhouri, Sinan; Gallagher, Kevin M.; MacKenzie, Kenneth R.; Shah, Taimur T.; Gao, Chuanyu; Moore, Sacha; Zimmermann, Eleanor F.; Edison, Eric; Jefferies, Matthew; Nambiar, Arjun; Anbarasan, Thineskrishna; Mannas, Miles P.; Lee, Taeweon; Marra, Giancarlo; Gómez Rivas, Juan; Marcq, Gautier; Assmus, Mark A.; Uçar, Taha; Claps, Francesco; Boltri, Matteo; La Montagna, Giuseppe; Burnhope, Tara; Nkwam, Nkwam; Austin, Tomas; Boxall, Nicholas E.; Downey, Alison P.; Sukhu, Troy A.; Antón-Juanilla, Marta; Rai, Sonpreet; Chin, Yew-Fung; Moore, Madeline; Drake, Tamsin; Green, James S.A.; Goulao, Beatriz; MacLennan, Graeme; Nielsen, Matthew; McGrath, John S.; Kasivisvanathan, Veeru; Chaudry, Aasem; Sharma, Abhishek; Bennett, Adam; Ahmad, Adnan; Abroaf, Ahmed; Suliman, Ahmed Musa; Lloyd, Aimee; McKay, Alastair; Wong, Albert; Silva, Alberto; Schneider, Alexandre; MacKay, Alison; Knight, Allen; Grigorakis, Alkiviadis; Bdesha, Amar; Nagle, Amy; Cebola, Ana; Dhanasekaran, Ananda Kumar; Kondža, Andraž; Barcelos, André; Galosi, Andrea Benedetto; Ebur, Andrea; Minervini, Andrea; Russell, Andrew; Webb, Andrew; de Jalón, Ángel García; Desai, Ankit; Czech, Anna Katarzyna; Mainwaring, Anna; Adimonye, Anthony; Das, Arighno; Figueiredo, Arnaldo; Villers, Arnauld; Leminski, Artur; Chippagiri, Arvinda; Lal, Asim Ahmed; Yıldırım, Asıf; Voulgaris, Athanasios Marios; Uzan, Audrey; Oo, Aye Moh Moh; Younis, Ayman; Zelhof, Bachar; Mukhtar, Bashir; Ayres, Ben; Challacombe, Ben; Sherwood, Benedict; Ristau, Benjamin; Lai, Billy; Nellensteijn, Brechtje; Schreiter, Brielle; Trombetta, Carlo; Dowling, Catherine; Hobbs, Catherine; Benitez, Cayo Augusto Estigarribia; Lebacle, Cédric; Ho, Cherrie Wing Yin; Ng, Chi-Fai; Mount, Chloe; Lam, Chon Meng; Blick, Chris; Brown, Christian; Gallegos, Christopher; Higgs, Claire; Browne, Clíodhna; McCann, Conor; Plaza Alonso, Cristina; Beder, Daniel; Cohen, Daniel; Gordon, Daniel; Wilby, Daniel; Gordon, Danny; Hrouda, David; Lau, David Hua Wu; Karsza, Dávid; Mak, David; Martin-Way, David; Suthaharan, Denula; Patel, Dhruv; Carrion, Diego M; Nyanhongo, Donald; Bass, Edward; Mains, Edward; Chau, Edwin; Canelon Castillo, Elba; Day, Elizabeth; Desouky, Elsayed; Gaines, Emily; Papworth, Emma; Yuruk, Emrah; Kilic, Enes; Dinneen, Eoin; Palagonia, Erika; Xylinas, Evanguelos; Khawaja, Faizan; Cimarra, Fernando; Bardet, Florian; Kum, Francesca; Peters, Francesca; Kovács, Gábor; Tanasescu, Geroge; Hellawell, Giles; Tasso, Giovanni; Lam, Gitte; La Montagna, Giuseppe; Pizzuto, Giuseppe; Lenart, Gordan; MacLennan, Graeme; Özgür, Günal; Bi, Hai; Lyons, Hannah; Warren, Hannah; Ahmed, Hashim; Simpson, Helen; Burden, Helena; Gresty, Helena; Rios Pita, Hernado; Clarke, Holly; Serag, Hosam; Kynaston, Howard; Crawford-Smith, Hugh; Mostafid, Hugh; Otaola-Arca, Hugo; Koo, Hui Fen; Ibrahim, Ibrahim; Ouzaid, Idir; Puche-Sanz, Ignacio; Tomašković, Igor; Tinay, Ilker; Sahibzada, Iqbal; Thangasamy, Isaac; Cadena, Iván Revelo; Irani, Jacques; Udzik, Jakub; Brittain, James; Catto, James; Green, James; Tweedle, James; Hernando, Jamie Borrego; Leask, Jamie; Kalsi, Jas; Frankel, Jason; Toniolo, Jason; Raman, Jay D.; Courcier, Jean; Kumaradeevan, Jeevan; Clark, Jennifer; Jones, Jennifer; Teoh, Jeremy Yuen-Chun; Iacovou, John; Kelly, John; Selph, John P.; Aning, Jonathan; Deeks, Jon; Cobley, Jonathan; Olivier, Jonathan; Maw, Jonny; Herranz-Yagüe, José Antonio; Nolazco, Jose Ignacio; Cózar-Olmo, Jose Manuel; Bagley, Joseph; Jelski, Joseph; Norris, Joseph; Testa, Joseph; Meeks, Joshua; Hernandez, Juan; Vásquez, Juan Luis; Randhawa, Karen; Dhera, Karishma; Gronostaj, Katarzyna; Houlton, Kathleen; Lehman, Kathleen; Gillams, Kathryn; Adasonla, Kelvin; Brown, Kevin; Murtagh, Kevin; Mistry, Kiki; Davenport, Kim; Kitamura, Kosuke; Derbyshire, Laura; Clarke, Laurence; Morton, Lawrie; Martinez, Levin; Goldsmith, Louise; Paramore, Louise; Cormier, Luc; Dell'Atti, Lucio; Simmons, Lucy; Martinez-Piñeiro, Luis; Rico, Luis; Chan, Luke; Forster, Luke; Ma, Lulin; Moore, Madeline; Gallego, Maria Camacho; Freire, Maria José; Emberton, Mark; Feneley, Mark; Antón-Juanilla, Marta; Rivero, Marta Viridiana Muñoz; Pirša, Matea; Tallè, Matteo; Crockett, Matthew; Liew, Matthew; Trail, Matthew; Peters, Max; Cooper, Meghan; Kulkarni, Meghana; Ager, Michael; He, Ming; Li, Mo; Omran Breish, Mohamed; Tarin, Mohamed; Aldiwani, Mohammed; Matanhelia, Mudit; Pasha, Muhammad; Akalın, Mustafa Kaan; Abdullah, Nasreen; Hale, Nathan; Gadiyar, Neha; Kocher, Neil; Bullock, Nicholas; Campain, Nicholas; Pavan, Nicola; Al-Ibraheem, Nihad; Bhatt, Nikita; Bedi, Nishant; Shrotri, Nitin; Lobo, Niyati; Balderas, Olga; Kouli, Omar; Capoun, Otakar; Oteo Manjavacas, Pablo; Gontero, Paolo; Mariappan, Paramananthan; Marchiñena, Patricio Garcia; Erotocritou, Paul; Sweeney, Paul; Planelles, Paula; Acher, Peter; Black, Peter C.; Osei-Bonsu, Peter K; Østergren, Peter; Smith, Peter; Willemse, Peter-Paul Michiel; Chlosta, Piotr L.; Ul Ain, Qurrat; Barratt, Rachel; Esler, Rachel; Khalid, Raihan; Hsu, Ray; Stamirowski, Remigiusz; Mangat, Reshma; Cruz, Ricardo; Ellis, Ricky; Adams, Robert; Hessell, Robert; Oomen, Robert J.A.; McConkey, Robert; Ritchie, Robert; Jarimba, Roberto; Chahal, Rohit; Andres, Rosado Mario; Hawkins, Rosalyn; David, Rotimi; Manecksha, Rustom P.; Agrawal, Sachin; Hamid, Syed Sami; Deem, Samuel; Goonewardene, Sanchia; Swami, Satchi Kuchibhotla; Hori, Satoshi; Khan, Shahid; Mohammud Inder, Shakeel; Sangaralingam, Shanthi; Marathe, Shekhar; Raveenthiran, Sheliyan; Horie, Shigeo; Sengupta, Shomik; Parson, Sian; Parker, Sidney; Hawlina, Simon; Williams, Simon; Mazzoli, Simone; Grzegorz Kata, Slawomir; Pinheiro Lopes, Sofia; Ramos, Sónia; Rai, Sonpreet; Rintoul-Hoad, Sophie; O'Meara, Sorcha; Morris, Steve; Turner, Stacey; Venturini, Stefano; Almpanis, Stephanos; Joniau, Steven; Jain, Sunjay; Mallett, Susan; Nikles, Sven; Shahzad, null; Yan, Sylvia; Lee, Taeweon; Uçar, Taha; Drake, Tamsin; Toma, Tarq; Cabañuz Plo, Teresa; Bonnin, Thierry; Muilwijk, Tim; Wollin, Tim; Chu, Timothy Shun Man; Appanna, Timson; Brophy, Tom; Ellul, Tom; Austin, Tomas; Smrkolj, Tomaž; Rowe, Tracey; Sukhu, Troy; Patel, Trushar; Garg, Tullika; Çaşkurlu, Turhan; Bele, Uros; Haroon, Usman; Crespo-Atín, Víctor; Parejo Cortes, Victor; Capapé Poves, Victoria; Gnanapragasam, Vincent; Gauhar, Vineet; During, Vinnie; Kumar, Vivek; Fiala, Vojtech; Mahmalji, Wasim; Lam, Wayne; Fung Chin, Yew; Filtekin, Yigit; Chyn Phan, Yih; Ibrahim, Youssed; Glaser, Zachary A; Abiddin, Zainal Adwin; Qin, Zijian; Zotter, Zsuzsanna; Zainuddin, ZulkifliKhadhouri, Sinan; Gallagher, Kevin M.; Mackenzie, Kenneth R.; Shah, Taimur T.; Gao, Chuanyu; Moore, Sacha; Zimmermann, Eleanor F.; Edison, Eric; Jefferies, Matthew; Nambiar, Arjun; Anbarasan, Thineskrishna; Mannas, Miles P.; Lee, Taeweon; Marra, Giancarlo; Gómez Rivas, Juan; Marcq, Gautier; Assmus, Mark A.; Uçar, Taha; Claps, Francesco; Boltri, Matteo; La Montagna, Giuseppe; Burnhope, Tara; Nkwam, Nkwam; Austin, Tomas; Boxall, Nicholas E.; Downey, Alison P.; Sukhu, Troy A.; Antón-Juanilla, Marta; Rai, Sonpreet; Chin, Yew-Fung; Moore, Madeline; Drake, Tamsin; Green, James S. A.; Goulao, Beatriz; Maclennan, Graeme; Nielsen, Matthew; Mcgrath, John S.; Kasivisvanathan, Veeru; Chaudry, Aasem; Sharma, Abhishek; Bennett, Adam; Ahmad, Adnan; Abroaf, Ahmed; Suliman, Ahmed Musa; Lloyd, Aimee; Mckay, Alastair; Wong, Albert; Silva, Alberto; Schneider, Alexandre; Mackay, Alison; Knight, Allen; Grigorakis, Alkiviadis; Bdesha, Amar; Nagle, Amy; Cebola, Ana; Dhanasekaran, Ananda Kumar; Kondža, Andraž; Barcelos, André; Galosi, Andrea Benedetto; Ebur, Andrea; Minervini, Andrea; Russell, Andrew; Webb, Andrew; de Jalón, Ángel García; Desai, Ankit; Czech, Anna Katarzyna; Mainwaring, Anna; Adimonye, Anthony; Das, Arighno; Figueiredo, Arnaldo; Villers, Arnauld; Leminski, Artur; Chippagiri, Arvinda; Lal, Asim Ahmed; Yıldırım, Asıf; Voulgaris, Athanasios Marios; Uzan, Audrey; Oo, Aye Moh Moh; Younis, Ayman; Zelhof, Bachar; Mukhtar, Bashir; Ayres, Ben; Challacombe, Ben; Sherwood, Benedict; Ristau, Benjamin; Lai, Billy; Nellensteijn, Brechtje; Schreiter, Brielle; Trombetta, Carlo; Dowling, Catherine; Hobbs, Catherine; Benitez, Cayo Augusto Estigarribia; Lebacle, Cédric; Ho, Cherrie Wing Yin; Ng, Chi-Fai; Mount, Chloe; Lam, Chon Meng; Blick, Chris; Brown, Christian; Gallegos, Christopher; Higgs, Claire; Browne, Clíodhna; Mccann, Conor; Plaza Alonso, Cristina; Beder, Daniel; Cohen, Daniel; Gordon, Daniel; Wilby, Daniel; Gordon, Danny; Hrouda, David; Lau, David Hua Wu; Karsza, Dávid; Mak, David; Martin-Way, David; Suthaharan, Denula; Patel, Dhruv; Carrion, Diego M; Nyanhongo, Donald; Bass, Edward; Mains, Edward; Chau, Edwin; Canelon Castillo, Elba; Day, Elizabeth; Desouky, Elsayed; Gaines, Emily; Papworth, Emma; Yuruk, Emrah; Kilic, Enes; Dinneen, Eoin; Palagonia, Erika; Xylinas, Evanguelos; Khawaja, Faizan; Cimarra, Fernando; Bardet, Florian; Kum, Francesca; Peters, Francesca; Kovács, Gábor; Tanasescu, Geroge; Hellawell, Giles; Tasso, Giovanni; Lam, Gitte; La Montagna, Giuseppe; Pizzuto, Giuseppe; Lenart, Gordan; Maclennan, Graeme; Özgür, Günal; Bi, Hai; Lyons, Hannah; Warren, Hannah; Ahmed, Hashim; Simpson, Helen; Burden, Helena; Gresty, Helena; Rios Pita, Hernado; Clarke, Holly; Serag, Hosam; Kynaston, Howard; Crawford-Smith, Hugh; Mostafid, Hugh; Otaola-Arca, Hugo; Koo, Hui Fen; Ibrahim, Ibrahim; Ouzaid, Idir; Puche-Sanz, Ignacio; Tomašković, Igor; Tinay, Ilker; Sahibzada, Iqbal; Thangasamy, Isaac; Cadena, Iván Revelo; Irani, Jacques; Udzik, Jakub; Brittain, James; Catto, James; Green, James; Tweedle, James; Hernando, Jamie Borrego; Leask, Jamie; Kalsi, Jas; Frankel, Jason; Toniolo, Jason; Raman, Jay D.; Courcier, Jean; Kumaradeevan, Jeevan; Clark, Jennifer; Jones, Jennifer; Teoh, Jeremy Yuen-Chun; Iacovou, John; Kelly, John; Selph, John P.; Aning, Jonathan; Deeks, Jon; Cobley, Jonathan; Olivier, Jonathan; Maw, Jonny; Herranz-Yagüe, José Antonio; Nolazco, Jose Ignacio; Cózar-Olmo, Jose Manuel; Bagley, Joseph; Jelski, Joseph; Norris, Joseph; Testa, Joseph; Meeks, Joshua; Hernandez, Juan; Vásquez, Juan Luis; Randhawa, Karen; Dhera, Karishma; Gronostaj, Katarzyna; Houlton, Kathleen; Lehman, Kathleen; Gillams, Kathryn; Adasonla, Kelvin; Brown, Kevin; Murtagh, Kevin; Mistry, Kiki; Davenport, Kim; Kitamura, Kosuke; Derbyshire, Laura; Clarke, Laurence; Morton, Lawrie; Martinez, Levin; Goldsmith, Louise; Paramore, Louise; Cormier, Luc; Dell'Atti, Lucio; Simmons, Lucy; Martinez-Piñeiro, Luis; Rico, Luis; Chan, Luke; Forster, Luke; Ma, Lulin; Moore, Madeline; Gallego, Maria Camacho; Freire, Maria José; Emberton, Mark; Feneley, Mark; Antón-Juanilla, Marta; Rivero, Marta Viridiana Muñoz; Pirša, Matea; Tallè, Matteo; Crockett, Matthew; Liew, Matthew; Trail, Matthew; Peters, Max; Cooper, Meghan; Kulkarni, Meghana; Ager, Michael; He, Ming; Li, Mo; Omran Breish, Mohamed; Tarin, Mohamed; Aldiwani, Mohammed; Matanhelia, Mudit; Pasha, Muhammad; Akalın, Mustafa Kaan; Abdullah, Nasreen; Hale, Nathan; Gadiyar, Neha; Kocher, Neil; Bullock, Nicholas; Campain, Nicholas; Pavan, Nicola; Al-Ibraheem, Nihad; Bhatt, Nikita; Bedi, Nishant; Shrotri, Nitin; Lobo, Niyati; Balderas, Olga; Kouli, Omar; Capoun, Otakar; Oteo Manjavacas, Pablo; Gontero, Paolo; Mariappan, Paramananthan; Marchiñena, Patricio Garcia; Erotocritou, Paul; Sweeney, Paul; Planelles, Paula; Acher, Peter; Black, Peter C.; Osei-Bonsu, Peter K; Østergren, Peter; Smith, Peter; Willemse, Peter-Paul Michiel; Chlosta, Piotr L.; Ul Ain, Qurrat; Barratt, Rachel; Esler, Rachel; Khalid, Raihan; Hsu, Ray; Stamirowski, Remigiusz; Mangat, Reshma; Cruz, Ricardo; Ellis, Ricky; Adams, Robert; Hessell, Robert; Oomen, Robert J. A.; Mcconkey, Robert; Ritchie, Robert; Jarimba, Roberto; Chahal, Rohit; Andres, Rosado Mario; Hawkins, Rosalyn; David, Rotimi; Manecksha, Rustom P.; Agrawal, Sachin; Hamid, Syed Sami; Deem, Samuel; Goonewardene, Sanchia; Swami, Satchi Kuchibhotla; Hori, Satoshi; Khan, Shahid; Mohammud Inder, Shakeel; Sangaralingam, Shanthi; Marathe, Shekhar; Raveenthiran, Sheliyan; Horie, Shigeo; Sengupta, Shomik; Parson, Sian; Parker, Sidney; Hawlina, Simon; Williams, Simon; Mazzoli, Simone; Grzegorz Kata, Slawomir; Pinheiro Lopes, Sofia; Ramos, Sónia; Rai, Sonpreet; Rintoul-Hoad, Sophie; O'Meara, Sorcha; Morris, Steve; Turner, Stacey; Venturini, Stefano; Almpanis, Stephanos; Joniau, Steven; Jain, Sunjay; Mallett, Susan; Nikles, Sven; Shahzad, Null; Yan, Sylvia; Lee, Taeweon; Uçar, Taha; Drake, Tamsin; Toma, Tarq; Cabañuz Plo, Teresa; Bonnin, Thierry; Muilwijk, Tim; Wollin, Tim; Chu, Timothy Shun Man; Appanna, Timson; Brophy, Tom; Ellul, Tom; Austin, Tomas; Smrkolj, Tomaž; Rowe, Tracey; Sukhu, Troy; Patel, Trushar; Garg, Tullika; Çaşkurlu, Turhan; Bele, Uros; Haroon, Usman; Crespo-Atín, Víctor; Parejo Cortes, Victor; Capapé Poves, Victoria; Gnanapragasam, Vincent; Gauhar, Vineet; During, Vinnie; Kumar, Vivek; Fiala, Vojtech; Mahmalji, Wasim; Lam, Wayne; Fung Chin, Yew; Filtekin, Yigit; Chyn Phan, Yih; Ibrahim, Youssed; Glaser, Zachary A; Abiddin, Zainal Adwin; Qin, Zijian; Zotter, Zsuzsanna; Zainuddin, Zulkifl

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

Introduction: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. Methods: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. Results: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. Discussion: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal