The effect of physiological concentrations of bile acids on in vitro growth of Mycobacterium tuberculosis

Background. Intestinal tuberculosis occurs mainly in the terminal ileum and caecum, where the concentration of bile acids is lowest, and rarely in the upper digestive tract. Objectives. We examined the effect of physiological concentrations of bile acids on the in vitro growth of Mycobacterium tuberculosis (MTB). Methods. The 4 major bile acids, lithocolic acid, cholic acid, deoxycholic acid and chenodeoxycholic acid, were added to individual Lowenstein-Jensen (LJ) culture media at physiological concentrations. A combined LJ medium was also prepared using all 4 bile acids. These were double-diluted 4 times by the addition of LJ media. Each culture medium was inoculated with the H37Rv strain of MTB and incubated at 37°C for 8 weeks. MTB growth was measured at 2 and 8 weeks in a semiquantitative fashion using cut-offs of >5, >10, >20, >100 colony-forming units. Results. All lithocolic acid cultures showed uninhibited TB growth at 2 and 8 weeks. Chenodeoxycholic acid, deoxycholic acid and cholic acid alone, and in combination, showed concentration-dependent inhibition of MTB growth at 2 and 8 weeks. Four cultures were lost to contamination. Conclusions. Certain bile acids alone and in combination, at physiological concentrations, inhibit the growth of MTB in vitro. This might explain why intestinal TB occurs in the ileocaecum in the majority of cases and why gallbladder TB is very rare

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

A Mucinous Cystic Neoplasm of the Mesocolon Showing Features of Malignancy

Mucinous cystic neoplasms are rare tumours of uncertain histogenesis. They arise from the ovaries, pancreas, and other intra-abdominal sites but more unusually from the mesocolon. They can present with abdominal pain, distension, or a palpable mass but are commonly an incidental finding. We describe the case of a 48-year-old woman who was found to have an incidental left pelvic cyst on computed tomography. Subsequent laparoscopic excision and histological analysis demonstrated the cyst to be a borderline malignant mucinous tumour arising from the mesocolon. Mucinous tumours should be considered in the differential diagnosis of all intra-abdominal cysts and treatment should be by surgical complete excision

The "Is mpMRI Enough" or IMRIE Study: a multicentre evaluation of prebiopsy multiparametric magnetic resonance imaging compared with biopsy.

Background: Multiparametric magnetic resonance imaging (mpMRI) is now recommended prebiopsy in numerous healthcare regions based on the findings of high-quality studies from expert centres. Concern remains about reproducibility of mpMRI to rule out clinically significant prostate cancer (csPCa) in real-world settings. Objective: To assess the diagnostic performance of mpMRI for csPCa in a real-world setting. Design, setting, and participants: A multicentre, retrospective cohort study, including men referred with raised prostate-specific antigen (PSA) or an abnormal digital rectal examination who had undergone mpMRI followed by transrectal or transperineal biopsy, was conducted. Patients could be biopsy naïve or have had previous negative biopsies. Outcome measurements and statistical analysis: The primary definition for csPCa was International Society of Urological Pathology (ISUP) grade group (GG) ≥2 (any Gleason ≥7); the accuracy for other definitions was also evaluated. Results and limitations: Across ten sites, 2642 men were included (January 2011–November 2018). Mean age and PSA were 65.3 yr (standard deviation [SD] 7.8 yr) and 7.5 ng/ml (SD 3.3 ng/ml), respectively. Of the patients, 35.9% had “negative MRI” (scores 1–2); 51.9% underwent transrectal biopsy and 48.1% had transperineal biopsy, with 43.4% diagnosed with csPCa overall. The sensitivity and negative predictive value (NPV) for ISUP GG ≥ 2 were 87.3% and 87.5%, respectively. The NPVs were 87.4% and 88.1% for men undergoing transrectal and transperineal biopsy, respectively. Specificity and positive predictive value of MRI were 49.8% and 49.2%, respectively. The sensitivity and NPV increased to 96.6% and 90.6%, respectively, when a PSA density threshold of 0.15 ng/ml/ml was used in MRI scores 1–2; these metrics increased to 97.5% and 91.2%, respectively, for PSA density 0.12 ng/ml/ml. ISUP GG ≥ 3 (Gleason ≥4 + 3) was found in 2.4% (15/617) of men with MRI scores 1–2. They key limitations of this study are the heterogeneity and retrospective nature of the data. Conclusions: Multiparametric MRI when used in real-world settings is able to rule out csPCa accurately, suggesting that about one-third of men might avoid an immediate biopsy. Men should be counselled about the risk of missing some significant cancers

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

Adaptation of the Wound Healing Questionnaire universal-reporter outcome measure for use in global surgery trials (TALON-1 study): mixed-methods study and Rasch analysis

BackgroundThe Bluebelle Wound Healing Questionnaire (WHQ) is a universal-reporter outcome measure developed in the UK for remote detection of surgical-site infection after abdominal surgery. This study aimed to explore cross-cultural equivalence, acceptability, and content validity of the WHQ for use across low- and middle-income countries, and to make recommendations for its adaptation.MethodsThis was a mixed-methods study within a trial (SWAT) embedded in an international randomized trial, conducted according to best practice guidelines, and co-produced with community and patient partners (TALON-1). Structured interviews and focus groups were used to gather data regarding cross-cultural, cross-contextual equivalence of the individual items and scale, and conduct a translatability assessment. Translation was completed into five languages in accordance with Mapi recommendations. Next, data from a prospective cohort (SWAT) were interpreted using Rasch analysis to explore scaling and measurement properties of the WHQ. Finally, qualitative and quantitative data were triangulated using a modified, exploratory, instrumental design model.ResultsIn the qualitative phase, 10 structured interviews and six focus groups took place with a total of 47 investigators across six countries. Themes related to comprehension, response mapping, retrieval, and judgement were identified with rich cross-cultural insights. In the quantitative phase, an exploratory Rasch model was fitted to data from 537 patients (369 excluding extremes). Owing to the number of extreme (floor) values, the overall level of power was low. The single WHQ scale satisfied tests of unidimensionality, indicating validity of the ordinal total WHQ score. There was significant overall model misfit of five items (5, 9, 14, 15, 16) and local dependency in 11 item pairs. The person separation index was estimated as 0.48 suggesting weak discrimination between classes, whereas Cronbach's α was high at 0.86. Triangulation of qualitative data with the Rasch analysis supported recommendations for cross-cultural adaptation of the WHQ items 1 (redness), 3 (clear fluid), 7 (deep wound opening), 10 (pain), 11 (fever), 15 (antibiotics), 16 (debridement), 18 (drainage), and 19 (reoperation). Changes to three item response categories (1, not at all; 2, a little; 3, a lot) were adopted for symptom items 1 to 10, and two categories (0, no; 1, yes) for item 11 (fever).ConclusionThis study made recommendations for cross-cultural adaptation of the WHQ for use in global surgical research and practice, using co-produced mixed-methods data from three continents. Translations are now available for implementation into remote wound assessment pathways