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1. A prospective prostate cancer screening programme for men with pathogenic variants in mismatch repair genes (IMPACT): initial results from an international prospective study.

Author

Bancroft E.K., Page E.C., Brook M.N., Thomas S., Taylor N., Pope J., McHugh J., Jones A.-B., Karlsson Q., Merson S., Ong K.R., Hoffman J., Huber C., Maehle L., Grindedal E.M., Stormorken A., Evans D.G., Rothwell J., Lalloo F., Brady A.F., Bartlett M., Snape K., Hanson H., James P., McKinley J., Mascarenhas L., Syngal S., Ukaegbu C., Side L., Thomas T., Barwell J., Teixeira M.R., Izatt L., Suri M., Macrae F.A., Poplawski N., Chen-Shtoyerman R., Ahmed M., Musgrave H., Nicolai N., Greenhalgh L., Brewer C., Pachter N., Spigelman A.D., Azzabi A., Helfand B.T., Halliday D., Buys S., Ramon y Cajal T., Donaldson A., Cooney K.A., Harris M., McGrath J., Davidson R., Taylor A., Cooke P., Myhill K., Hogben M., Aaronson N.K., Ardern-Jones A., Bangma C.H., Castro E., Dearnaley D., Dias A., Dudderidge T., Eccles D.M., Green K., Eyfjord J., Falconer A., Foster C.S., Gronberg H., Hamdy F.C., Johannsson O., Khoo V., Lilja H., Lindeman G.J., Lubinski J., Axcrona K., Mikropoulos C., Mitra A.V., Moynihan C., Ni Raghallaigh H., Rennert G., Collier R., Adams L., Adlard J., Alfonso R., Ali S., Andrew A., Araujo L., Azam N., Ball D., Barker Q., Basevitch A., Benton B., Berlin C., Bermingham N., Biller L., Bloss A., Bradford M., Bradshaw N., Branson A., Brendler C., Brennan M., Bulman B., Burgess L., Cahill D., Callard A., Calvo Verges N., Cardoso M., Carter V., Catanzaro M., Chamberlain A., Chapman C., Chong M., Clark C., Clowes V., Cogley L., Cole T., Compton C., Conner T., Cookson S., Cornford P., Costello P., Coulier L., Davies M., Dechet C., DeSouza B., Devlin G., Douglas F., Douglas E., Dudakia D., Duncan A., Ellery N., Everest S., Freemantle S., Frydenberg M., Fuller D., Gabriel C., Gale M., Garcia L., Gay S., Genova E., George A., Georgiou D., Gisbert A., Gleeson M., Glover W., Gnanapragasam V., Goff S., Goldgar D., Goncalves N., Goodman S., Gorrie J., Gott H., Grant A., Gray C., Griffiths J., Gupwell K., Gurasashvili J., Hanslien E., Haraldsdottir S., Hart R., Hartigan C., Hawkes L., Heaton T., Henderson A., Henrique R., Hilario K., Hill K., Hulick P., Hunt C., Hutchings M., Ibitoye R., Inglehearn T., Ireland J., Islam F., Ismail S., Jacobs C., James D., Jenkins S., Jobson I., Johnstone A., Jones O., Josefsberg Ben-Yehoshua S., Kaemba B., Kaul K., Kemp Z., Kinsella N., Klehm M., Kockelbergh R., Kohut K., Kosicka-Slawinska M., Kulkarni A., Kumar P., Lam J., LeButt M., Leibovici D., Lim R., Limb L., Lomas C., Longmuir M., Lopez C., Magnani T., Maia S., Maiden J., Male A., Manalo M., Martin P., McBride D., McGuire M., McMahon R., McNally C., McVeigh T., Melzer E., Mencias M., Mercer C., Mitchell G., Mora J., Morton C., Moss C., Murphy M., Murphy D., Mzazi S., Nadolski M., Newlin A., Nogueira P., O'Keefe R., O'Toole K., O'Connell S., Ogden C., Okoth L., Oliveira J., Paez E., Palou J., Park L., Patel N., Paulo Souto J., Pearce A., Peixoto A., Perez K., Petelin L., Pichert G., Poile C., Potter A., Preitner N., Purnell H., Quinn E., Radice P., Rankin B., Rees K., Renton C., Richardson K., Risby P., Rogers J., Ruderman M., Ruiz A., Sajoo A., Salvatore N., Sands V., Sanguedolce F., Sattar A., Saunders K., Schofield L., Scott R., Searle A., Sehra R., Selkirk C., Shackleton K., Shanley S., Shaw A., Shevrin D., Shipman H., Sidat Z., Siguake K., Simon K., Smyth C., Snadden L., Solanky N., Solomons J., Sorrentino M., Stayner B., Stephenson R., Stoffel E., Thomas M., Thompson A., Tidey L., Tischkowitz M., Torokwa A., Townshend S., Treherne K., Tricker K., Trinh Q.-D., Tripathi V., Turnbull C., Valdagni R., Van As N., Venne V., Verdon L., Vitellaro M., Vogel K., Walker L., Watford A., Watt C., Weintroub I., Weiss S., Weissman S., Weston M., Wiggins J., Wise G., Woodhouse C., Yesildag P., Youngs A., Yurgelun M., Zollo F., Offman J., Kote-Jarai Z., Eeles R.A., Bancroft E.K., Page E.C., Brook M.N., Thomas S., Taylor N., Pope J., McHugh J., Jones A.-B., Karlsson Q., Merson S., Ong K.R., Hoffman J., Huber C., Maehle L., Grindedal E.M., Stormorken A., Evans D.G., Rothwell J., Lalloo F., Brady A.F., Bartlett M., Snape K., Hanson H., James P., McKinley J., Mascarenhas L., Syngal S., Ukaegbu C., Side L., Thomas T., Barwell J., Teixeira M.R., Izatt L., Suri M., Macrae F.A., Poplawski N., Chen-Shtoyerman R., Ahmed M., Musgrave H., Nicolai N., Greenhalgh L., Brewer C., Pachter N., Spigelman A.D., Azzabi A., Helfand B.T., Halliday D., Buys S., Ramon y Cajal T., Donaldson A., Cooney K.A., Harris M., McGrath J., Davidson R., Taylor A., Cooke P., Myhill K., Hogben M., Aaronson N.K., Ardern-Jones A., Bangma C.H., Castro E., Dearnaley D., Dias A., Dudderidge T., Eccles D.M., Green K., Eyfjord J., Falconer A., Foster C.S., Gronberg H., Hamdy F.C., Johannsson O., Khoo V., Lilja H., Lindeman G.J., Lubinski J., Axcrona K., Mikropoulos C., Mitra A.V., Moynihan C., Ni Raghallaigh H., Rennert G., Collier R., Adams L., Adlard J., Alfonso R., Ali S., Andrew A., Araujo L., Azam N., Ball D., Barker Q., Basevitch A., Benton B., Berlin C., Bermingham N., Biller L., Bloss A., Bradford M., Bradshaw N., Branson A., Brendler C., Brennan M., Bulman B., Burgess L., Cahill D., Callard A., Calvo Verges N., Cardoso M., Carter V., Catanzaro M., Chamberlain A., Chapman C., Chong M., Clark C., Clowes V., Cogley L., Cole T., Compton C., Conner T., Cookson S., Cornford P., Costello P., Coulier L., Davies M., Dechet C., DeSouza B., Devlin G., Douglas F., Douglas E., Dudakia D., Duncan A., Ellery N., Everest S., Freemantle S., Frydenberg M., Fuller D., Gabriel C., Gale M., Garcia L., Gay S., Genova E., George A., Georgiou D., Gisbert A., Gleeson M., Glover W., Gnanapragasam V., Goff S., Goldgar D., Goncalves N., Goodman S., Gorrie J., Gott H., Grant A., Gray C., Griffiths J., Gupwell K., Gurasashvili J., Hanslien E., Haraldsdottir S., Hart R., Hartigan C., Hawkes L., Heaton T., Henderson A., Henrique R., Hilario K., Hill K., Hulick P., Hunt C., Hutchings M., Ibitoye R., Inglehearn T., Ireland J., Islam F., Ismail S., Jacobs C., James D., Jenkins S., Jobson I., Johnstone A., Jones O., Josefsberg Ben-Yehoshua S., Kaemba B., Kaul K., Kemp Z., Kinsella N., Klehm M., Kockelbergh R., Kohut K., Kosicka-Slawinska M., Kulkarni A., Kumar P., Lam J., LeButt M., Leibovici D., Lim R., Limb L., Lomas C., Longmuir M., Lopez C., Magnani T., Maia S., Maiden J., Male A., Manalo M., Martin P., McBride D., McGuire M., McMahon R., McNally C., McVeigh T., Melzer E., Mencias M., Mercer C., Mitchell G., Mora J., Morton C., Moss C., Murphy M., Murphy D., Mzazi S., Nadolski M., Newlin A., Nogueira P., O'Keefe R., O'Toole K., O'Connell S., Ogden C., Okoth L., Oliveira J., Paez E., Palou J., Park L., Patel N., Paulo Souto J., Pearce A., Peixoto A., Perez K., Petelin L., Pichert G., Poile C., Potter A., Preitner N., Purnell H., Quinn E., Radice P., Rankin B., Rees K., Renton C., Richardson K., Risby P., Rogers J., Ruderman M., Ruiz A., Sajoo A., Salvatore N., Sands V., Sanguedolce F., Sattar A., Saunders K., Schofield L., Scott R., Searle A., Sehra R., Selkirk C., Shackleton K., Shanley S., Shaw A., Shevrin D., Shipman H., Sidat Z., Siguake K., Simon K., Smyth C., Snadden L., Solanky N., Solomons J., Sorrentino M., Stayner B., Stephenson R., Stoffel E., Thomas M., Thompson A., Tidey L., Tischkowitz M., Torokwa A., Townshend S., Treherne K., Tricker K., Trinh Q.-D., Tripathi V., Turnbull C., Valdagni R., Van As N., Venne V., Verdon L., Vitellaro M., Vogel K., Walker L., Watford A., Watt C., Weintroub I., Weiss S., Weissman S., Weston M., Wiggins J., Wise G., Woodhouse C., Yesildag P., Youngs A., Yurgelun M., Zollo F., Offman J., Kote-Jarai Z., and Eeles R.A.

Abstract

Background: Lynch syndrome is a rare familial cancer syndrome caused by pathogenic variants in the mismatch repair genes MLH1, MSH2, MSH6, or PMS2, that cause predisposition to various cancers, predominantly colorectal and endometrial cancer. Data are emerging that pathogenic variants in mismatch repair genes increase the risk of early-onset aggressive prostate cancer. The IMPACT study is prospectively assessing prostate-specific antigen (PSA) screening in men with germline mismatch repair pathogenic variants. Here, we report the usefulness of PSA screening, prostate cancer incidence, and tumour characteristics after the first screening round in men with and without these germline pathogenic variants. Method(s): The IMPACT study is an international, prospective study. Men aged 40-69 years without a previous prostate cancer diagnosis and with a known germline pathogenic variant in the MLH1, MSH2, or MSH6 gene, and age-matched male controls who tested negative for a familial pathogenic variant in these genes were recruited from 34 genetic and urology clinics in eight countries, and underwent a baseline PSA screening. Men who had a PSA level higher than 3.0 ng/mL were offered a transrectal, ultrasound-guided, prostate biopsy and a histopathological analysis was done. All participants are undergoing a minimum of 5 years' annual screening. The primary endpoint was to determine the incidence, stage, and pathology of screening-detected prostate cancer in carriers of pathogenic variants compared with non-carrier controls. We used Fisher's exact test to compare the number of cases, cancer incidence, and positive predictive values of the PSA cutoff and biopsy between carriers and non-carriers and the differences between disease types (ie, cancer vs no cancer, clinically significant cancer vs no cancer). We assessed screening outcomes and tumour characteristics by pathogenic variant status. Here we present results from the first round of PSA screening in the IMPACT study. This

Published
2022

2. Psychosocial impact of undergoing prostate cancer screening for men with BRCA1 or BRCA2 mutations

Author

Bancroft, EK, Saya, S, Page, EC, Myhill, K, Thomas, S, Pope, J, Chamberlain, A, Hart, R, Glover, W, Cook, J, Rosario, DJ, Helfand, BT, Selkirk, CH, Davidson, R, Longmuir, M, Eccles, DM, Gadea, N, Brewer, C, Barwell, J, Salinas, M, Greenhalgh, L, Tischkowitz, M, Henderson, A, Evans, DG, Buys, SS, Eeles, RA, Aaronson, NK, Eeles, R, Bancroft, E, Page, E, Kote-Jarai, Z, Ardern-Jones, A, Bangma, C, Castro, E, Dearnaley, D, Falconer, A, Foster, C, Gronberg, H, Hamdy, FC, Johannsson, OT, Khoo, V, Eccles, D, Lilja, H, Evans, G, Eyfjord, J, Lubinski, J, Maehle, L, Mikropoulos, C, Millner, A, Mitra, A, Offman, J, Moynihan, C, Rennert, G, Suri, M, Dias, A, Taylor, N, D'Mello, L, James, P, Mitchell, G, Shanley, S, Richardson, K, McKinley, J, Petelin, L, Murphy, M, Mascarenhas, L, Murphy, D, Lam, J, Taylor, L, Miller, C, Stapleton, A, Chong, M, Suthers, G, Poplawski, N, Tucker, K, Andrews, L, Duffy, J, Millard, R, Ward, R, Williams, R, Stricker, P, Kirk, J, Bowman, M, Patel, M, Harris, M, O'Connell, S, Hunt, C, Smyth, C, Frydenberg, M, Lindeman, G, Shackleton, K, Morton, C, Susman, R, McGaughran, J, Boon, M, Pachter, N, Townshend, S, Schofield, L, Nicholls, C, Spigelman, A, Gleeson, M, Amor, D, Burke, J, Patterson, B, Swindle, P, Scott, R, Foulkes, W, Boshari, T, Aprikian, A, Jensen, T, Bojeson, A, Osther, P, Skytte, A-B, Cruger, D, Tondering, MK, Gerdes, A-M, Schmutzler, R, Rhiem, K, Wihler, P, Kast, K, Griebsch, C, Johannsson, O, Stefansdottir, V, Murthy, V, Sarin, R, Awatagiri, K, Ghonge, S, Kowtal, P, Mulgund, G, Gallagher, D, Bambury, R, Farrell, M, Gallagher, F, Kiernan, I, Friedman, E, Chen-Shtoyerman, R, Basevitch, A, Leibovici, D, Melzer, E, Ben-Yehoshua, SJ, Nicolai, N, Radice, P, Valdagni, R, Magnani, T, Gay, S, Teo, SH, Tan, HM, Yoon, S-Y, Thong, MK, Vasen, H, Ringleberg, J, van Asperen, C, Kiemeney, B, van Zelst-Stams, W, Ausems, MGEM, van der Luijt, RB, van Os, T, Ruijs, MWG, Adank, MA, Oldenburg, RA, Helderman-van den Enden, APTJM, Caanen, BAH, Oosterwijk, JC, Moller, P, Brennhovd, B, Medvik, H, Hanslien, E, Grindedal, EM, Cybulski, C, Wokolorczyk, D, Teixeira, M, Maia, S, Peixoto, A, Henrique, R, Oliveira, J, Goncalves, N, Araujo, L, Seixas, M, Souto, JP, Nogueira, P, Copakova, L, Zgajnar, J, Krajc, M, Vrecar, A, Capella, G, Ramon y Cajal, T, Fisas, D, Mora, J, Esquena, S, Balmana, J, Morote, J, Liljegren, A, Hjalm-Eriksson, M, Ekdahl, K-J, Carlsson, S, George, A, Kemp, Z, Wiggins, J, Moss, C, Van As, N, Thompson, A, Ogden, C, Woodhouse, C, Kumar, P, Bulman, B, Rothwell, J, Tricker, K, Wise, G, Mercer, C, McBride, D, Costello, P, Pearce, A, Torokwa, A, Paterson, J, Clowes, V, Taylor, A, Newcombe, B, Walker, L, Halliday, D, Stayner, B, Fleming-Brown, D, Snape, K, Hanson, H, Hodgson, S, Brice, G, Homfray, T, Hammond, C, Kohut, K, Anjum, U, Dearing, A, Mencias, M, Potter, A, Renton, C, Searle, A, Hill, K, Goodman, S, Garcia, L, Devlin, G, Everest, S, Nadolski, M, Douglas, F, Jobson, I, Paez, E, Donaldson, A, Tomkins, S, Langman, C, Jacobs, C, Pichert, G, Shaw, A, Kulkarni, A, Tripathi, V, Rose, S, Compton, C, Watson, M, Reinholtz, C, Brady, A, Dorkins, H, Melville, A, Kosicka-Slawinska, M, Cummings, C, Kiesel, V, Bartlett, M, Randhawa, K, Ellery, N, Side, L, Male, A, Simon, K, Rees, K, Tidey, L, Gurasashvili, J, Nevitt, L, Ingram, S, Howell, A, Rosario, D, Catto, J, Howson, J, Ong, K-R, Chapman, C, Cole, T, Heaton, T, Hoffman, J, Burgess, L, Huber, C, Islam, F, Watt, C, Duncan, A, Kockelbergh, R, Mzazi, S, Dineen, A, Sattar, A, Kaemba, B, Sidat, Z, Patel, N, Siguake, K, Birt, A, Poultney, U, Umez-Eronini, N, Mom, J, Sutton, V, Cornford, P, Bermingham, N, Yesildag, P, Treherne, K, Griffiths, J, Cogley, L, Gott, H, Rubinstein, WS, Hulick, P, McGuire, M, Shevrin, D, Kaul, K, Weissman, S, Newlin, A, Vogel, K, Weiss, S, Hook, N, Buys, S, Goldgar, D, Conner, T, Venne, V, Stephenson, R, Dechet, C, Domchek, S, Powers, J, Rustgi, N, Strom, S, Arun, B, Davis, JW, Yamamura, Y, Obeid, E, Giri, V, Gross, L, Bealin, L, Cooney, K, Stoffel, E, Okoth, L, Bancroft, EK, Saya, S, Page, EC, Myhill, K, Thomas, S, Pope, J, Chamberlain, A, Hart, R, Glover, W, Cook, J, Rosario, DJ, Helfand, BT, Selkirk, CH, Davidson, R, Longmuir, M, Eccles, DM, Gadea, N, Brewer, C, Barwell, J, Salinas, M, Greenhalgh, L, Tischkowitz, M, Henderson, A, Evans, DG, Buys, SS, Eeles, RA, Aaronson, NK, Eeles, R, Bancroft, E, Page, E, Kote-Jarai, Z, Ardern-Jones, A, Bangma, C, Castro, E, Dearnaley, D, Falconer, A, Foster, C, Gronberg, H, Hamdy, FC, Johannsson, OT, Khoo, V, Eccles, D, Lilja, H, Evans, G, Eyfjord, J, Lubinski, J, Maehle, L, Mikropoulos, C, Millner, A, Mitra, A, Offman, J, Moynihan, C, Rennert, G, Suri, M, Dias, A, Taylor, N, D'Mello, L, James, P, Mitchell, G, Shanley, S, Richardson, K, McKinley, J, Petelin, L, Murphy, M, Mascarenhas, L, Murphy, D, Lam, J, Taylor, L, Miller, C, Stapleton, A, Chong, M, Suthers, G, Poplawski, N, Tucker, K, Andrews, L, Duffy, J, Millard, R, Ward, R, Williams, R, Stricker, P, Kirk, J, Bowman, M, Patel, M, Harris, M, O'Connell, S, Hunt, C, Smyth, C, Frydenberg, M, Lindeman, G, Shackleton, K, Morton, C, Susman, R, McGaughran, J, Boon, M, Pachter, N, Townshend, S, Schofield, L, Nicholls, C, Spigelman, A, Gleeson, M, Amor, D, Burke, J, Patterson, B, Swindle, P, Scott, R, Foulkes, W, Boshari, T, Aprikian, A, Jensen, T, Bojeson, A, Osther, P, Skytte, A-B, Cruger, D, Tondering, MK, Gerdes, A-M, Schmutzler, R, Rhiem, K, Wihler, P, Kast, K, Griebsch, C, Johannsson, O, Stefansdottir, V, Murthy, V, Sarin, R, Awatagiri, K, Ghonge, S, Kowtal, P, Mulgund, G, Gallagher, D, Bambury, R, Farrell, M, Gallagher, F, Kiernan, I, Friedman, E, Chen-Shtoyerman, R, Basevitch, A, Leibovici, D, Melzer, E, Ben-Yehoshua, SJ, Nicolai, N, Radice, P, Valdagni, R, Magnani, T, Gay, S, Teo, SH, Tan, HM, Yoon, S-Y, Thong, MK, Vasen, H, Ringleberg, J, van Asperen, C, Kiemeney, B, van Zelst-Stams, W, Ausems, MGEM, van der Luijt, RB, van Os, T, Ruijs, MWG, Adank, MA, Oldenburg, RA, Helderman-van den Enden, APTJM, Caanen, BAH, Oosterwijk, JC, Moller, P, Brennhovd, B, Medvik, H, Hanslien, E, Grindedal, EM, Cybulski, C, Wokolorczyk, D, Teixeira, M, Maia, S, Peixoto, A, Henrique, R, Oliveira, J, Goncalves, N, Araujo, L, Seixas, M, Souto, JP, Nogueira, P, Copakova, L, Zgajnar, J, Krajc, M, Vrecar, A, Capella, G, Ramon y Cajal, T, Fisas, D, Mora, J, Esquena, S, Balmana, J, Morote, J, Liljegren, A, Hjalm-Eriksson, M, Ekdahl, K-J, Carlsson, S, George, A, Kemp, Z, Wiggins, J, Moss, C, Van As, N, Thompson, A, Ogden, C, Woodhouse, C, Kumar, P, Bulman, B, Rothwell, J, Tricker, K, Wise, G, Mercer, C, McBride, D, Costello, P, Pearce, A, Torokwa, A, Paterson, J, Clowes, V, Taylor, A, Newcombe, B, Walker, L, Halliday, D, Stayner, B, Fleming-Brown, D, Snape, K, Hanson, H, Hodgson, S, Brice, G, Homfray, T, Hammond, C, Kohut, K, Anjum, U, Dearing, A, Mencias, M, Potter, A, Renton, C, Searle, A, Hill, K, Goodman, S, Garcia, L, Devlin, G, Everest, S, Nadolski, M, Douglas, F, Jobson, I, Paez, E, Donaldson, A, Tomkins, S, Langman, C, Jacobs, C, Pichert, G, Shaw, A, Kulkarni, A, Tripathi, V, Rose, S, Compton, C, Watson, M, Reinholtz, C, Brady, A, Dorkins, H, Melville, A, Kosicka-Slawinska, M, Cummings, C, Kiesel, V, Bartlett, M, Randhawa, K, Ellery, N, Side, L, Male, A, Simon, K, Rees, K, Tidey, L, Gurasashvili, J, Nevitt, L, Ingram, S, Howell, A, Rosario, D, Catto, J, Howson, J, Ong, K-R, Chapman, C, Cole, T, Heaton, T, Hoffman, J, Burgess, L, Huber, C, Islam, F, Watt, C, Duncan, A, Kockelbergh, R, Mzazi, S, Dineen, A, Sattar, A, Kaemba, B, Sidat, Z, Patel, N, Siguake, K, Birt, A, Poultney, U, Umez-Eronini, N, Mom, J, Sutton, V, Cornford, P, Bermingham, N, Yesildag, P, Treherne, K, Griffiths, J, Cogley, L, Gott, H, Rubinstein, WS, Hulick, P, McGuire, M, Shevrin, D, Kaul, K, Weissman, S, Newlin, A, Vogel, K, Weiss, S, Hook, N, Buys, S, Goldgar, D, Conner, T, Venne, V, Stephenson, R, Dechet, C, Domchek, S, Powers, J, Rustgi, N, Strom, S, Arun, B, Davis, JW, Yamamura, Y, Obeid, E, Giri, V, Gross, L, Bealin, L, Cooney, K, Stoffel, E, and Okoth, L

Abstract

OBJECTIVES: To report the baseline results of a longitudinal psychosocial study that forms part of the IMPACT study, a multi-national investigation of targeted prostate cancer (PCa) screening among men with a known pathogenic germline mutation in the BRCA1 or BRCA2 genes. PARTICPANTS AND METHODS: Men enrolled in the IMPACT study were invited to complete a questionnaire at collaborating sites prior to each annual screening visit. The questionnaire included sociodemographic characteristics and the following measures: the Hospital Anxiety and Depression Scale (HADS), Impact of Event Scale (IES), 36-item short-form health survey (SF-36), Memorial Anxiety Scale for Prostate Cancer, Cancer Worry Scale-Revised, risk perception and knowledge. The results of the baseline questionnaire are presented. RESULTS: A total of 432 men completed questionnaires: 98 and 160 had mutations in BRCA1 and BRCA2 genes, respectively, and 174 were controls (familial mutation negative). Participants' perception of PCa risk was influenced by genetic status. Knowledge levels were high and unrelated to genetic status. Mean scores for the HADS and SF-36 were within reported general population norms and mean IES scores were within normal range. IES mean intrusion and avoidance scores were significantly higher in BRCA1/BRCA2 carriers than in controls and were higher in men with increased PCa risk perception. At the multivariate level, risk perception contributed more significantly to variance in IES scores than genetic status. CONCLUSION: This is the first study to report the psychosocial profile of men with BRCA1/BRCA2 mutations undergoing PCa screening. No clinically concerning levels of general or cancer-specific distress or poor quality of life were detected in the cohort as a whole. A small subset of participants reported higher levels of distress, suggesting the need for healthcare professionals offering PCa screening to identify these risk factors and offer additional information and support t

Published
2019

3. Prospective randomized trial of gene expression classifier utility in men at high risk of recurrence following radical prostatectomy (G-MINOR)

Author

Morgan, T., primary, Okoth, L., additional, Feng, F., additional, Johnson, A., additional, Lane, B., additional, Linsell, S., additional, Khurdish, G., additional, Montie, J., additional, Fishbane, N., additional, Marti, T., additional, Du Plessis, M., additional, Mehra, R., additional, Davicioni, E., additional, Maatman, T., additional, Wojno, K., additional, Burks, F., additional, Rodriguez, P., additional, Liu, N., additional, Sarle, R., additional, Miller, D., additional, and Cher, M., additional

Published
2019
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6. Seven core competencies and conditions for equitable partnerships and power sharing in community-based participatory research.

Author

Ozano K, Alam W, Aktar B, Okoth L, Chumo I, Quach JA, Muturi N, Saidu S, Gandi I, Wiltgen Georgi N, Otiso L, Conteh A, Theobald S, Dean L, Tolhurst R, Karuga R, Karki J, Garimella S, Rao V, Mwanki A, Islam N, Tengbe SM, Dash S, Saligram PS, Rashid S, and Steege R

Subjects
Humans, Cooperative Behavior, Professional Competence standards, Community-Based Participatory Research
Abstract

Equitable health research requires actively engaging communities in producing new knowledge to advocate for their health needs. Community-based participatory research (CBPR) relies on the coproduction of contextual and grounded knowledge between researchers, programme implementers and community partners with the aim of catalysing action for change. Improving coproduction competencies can support research quality and validity. Yet, frameworks and guidance highlighting the ideal competencies and conditions needed for all research partners to contribute meaningfully and equitably are lacking. This paper aims to advance CBPR by laying out seven core competencies and conditions that can promote power sharing in knowledge production, application and dissemination at the individual, community, organisational and systems levels.Competencies were developed through an iterative process, that synthesised pre-existing literature and frameworks with a wide range of tacit knowledge from researchers, activists, implementation partners and community researchers from Bangladesh, India, Kenya, Sierra Leone and the UK.The seven core competencies and conditions are: (1) capacity to interpret and respond to individual and relational identity, connection, uniqueness and inequities; (2) ability of communities and partners to work in the most suitable, inclusive and synergistic way; (3) aptitude for generating safe and inclusive spaces for multidirectional knowledge and skills exchange that goes beyond the research focus; (4) expertise in democratic leadership and/or facilitation to balance competing priorities and ensure shared decision-making; (5) capacity to analyse readiness for action, successes and areas for improvements throughout the research process; (6) ability to instigate sustainable change processes within the political dimensions of systems, policies and practices using advocacy, lobbying or activism approaches and (7) skills to interpret and disseminate findings and outputs that are understandable, respectful and promote community ownership. We present core competency and condition areas, individual and collective expertise associated with competencies, likely outcomes, examples of activities and sources of evidence., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Published
2024
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7. Mentorship in health research institutions in Africa: A systematic review of approaches, benefits, successes, gaps and challenges.

Author

Ng'oda M, Gatheru PM, Oyeyemi O, Busienei P, Karugu CH, Mugo S, Okoth L, Nampijja M, Kiwuwa-Muyingo S, Wado YD, Kitsao-Wekulo P, Asiki G, and Gitau E

Abstract

Background: In Africa, where the burden of diseases is disproportionately high, significant challenges arise from a shortage of skilled researchers, lack of research funding, and limited mentorship opportunities. The continent faces a substantial gap in research output largely attributed to the dearth of mentorship opportunities for early career researchers., Objective: To explore existing mentorship approaches, identify challenges, gaps, successes, and benefits, and provide insights for strengthening mentorship programs in African health research institutions., Methods: We registered the review protocol on the International Prospective Register of Systematic Reviews [CRD42021285018] and searched six electronic databases-EMBASE, AJOL, Web of Science, PubMed, DOAJ, and JSTOR from inception to 10 November 2023, for studies published in English reporting on approaches of mentorship in health research in African countries. We also searched grey literature repositories, institutional websites, and reference lists of included studies for additional literature. Two independent reviewers conducted screening of titles and abstracts of identified studies, full-text screening, assessment of methodological quality, and data extraction. We assessed study quality against the Mixed Methods Appraisal Tool (MMAT). We resolved any disagreements through discussion and consensus. We employed a narrative approach to synthesize the findings., Results: We retrieved 1799 articles and after screening, included 21 studies in the review. The reviewers identified 20 mentorship programs for health researchers (N = 1198) in 12 African countries mostly focusing on early-career researchers and junior faculty members. A few included mid-career and senior researchers. We categorized the programs under three key mentoring approaches: international collaborative programs, regional and in-country collaborations, and specialized capacity-building initiatives. Our review highlighted the following successes and benefits of health research mentorship programs: the establishment of collaborations and partnerships, development of research programs and capacities, improvement of individual skills and confidence, increased publications, and successful grant applications. The gaps identified were limited funding, lack of a mentorship culture, negative attitudes towards research careers, and lack of prioritization of research mentorship., Conclusion: Our review highlights a diverse landscape of health research mentorship aspects predominantly targeting early career researchers and heavily driven by the North. There is a need for locally driven mentorship initiatives in Africa to strengthen mentorship to advance health research in the region., Trial Registration: PROSPERO registration number: CRD42021285018., Competing Interests: The authors have declared that no competing interest exist., (Copyright: © 2024 Ng’oda et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Published
2024
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8. Exploring acceptability, opportunities, and challenges of community-based home pregnancy testing for early antenatal care initiation in rural Kenya.

Author

Otiso L, Alhassan Y, Odhong T, Onyango B, Muturi N, Hemingway C, Murray L, Ogwang E, Okoth L, Oguche M, Doyle V, Fomuso N, and Taegtmeyer M

Subjects
Humans, Female, Kenya, Pregnancy, Adult, Adolescent, Young Adult, Community Health Workers, Qualitative Research, Interviews as Topic, Home Care Services, Prenatal Care, Patient Acceptance of Health Care statistics & numerical data, Patient Acceptance of Health Care psychology, Rural Population, Pregnancy Tests
Abstract

Background: Many women in low- and middle-income countries, including Kenya, access antenatal care (ANC) late in pregnancy. Home pregnancy testing can enable women to detect pregnancy early, but it is not widely available. Our study explored the acceptability and potential of home pregnancy testing delivered by community health volunteers (CHV) on antenatal care initiation in rural Kenya., Methods: This study was part of a public health intervention to improve uptake and quality of ANC. Between November and December 2020, we conducted 37 in-depth interviews involving women who tested positive or negative for a urine pregnancy test provided by CHVs; CHVs and their supervisors involved in the delivery of the pregnancy tests; facility healthcare workers; and key informants. Using Sekhon et al.'s framework of acceptability, the interviews explored participants' perceptions and experiences of home pregnancy testing, including acceptability, challenges, and perceived effects on early ANC uptake. Data were analysed thematically in NVivo12 software., Results: Home pregnancy testing was well-received by women who trusted test results and appreciated the convenience and autonomy it offered. Adolescents cherished the privacy, preferring home testing to facility testing which could be a stigmatising experience. Testing enabled earlier pregnancy recognition and linkage to ANC as well as reproductive decision-making for those with undesired pregnancies. Community delivery of the test enhanced the reputation and visibility of the CHVs as credible primary care providers. CHVs in turn were motivated and confident to deliver home pregnancy testing and did not find it as an unnecessary burden; instead, they perceived it as a complement to their work in providing ANC in the community. Challenges identified included test shortages, confidentiality and safeguarding risks, and difficulties accessing facility-based care post-referral. Newly identified pregnant adolescents hesitated to seek ANC due to stigma, fear of reprimand, unwanted parental notification, and perceived pressure from healthcare workers to keep the pregnancy., Conclusion: Home pregnancy testing by CHVs can improve early ANC initiation in resource-poor settings. Mitigating privacy, confidentiality, and safeguarding concerns is imperative. Additional support for women transitioning from pregnancy identification to ANC is essential to ensure appropriate care. Future research should focus on integrating home pregnancy testing into routine community health services., (© 2024. The Author(s).)

Published
2024
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9. Four antenatal care visits by four months of pregnancy and four vital tests for pregnant mothers: impact of a community-facility health systems strengthening intervention in Migori County, Kenya.

Author

Alhassan Y, Otiso L, Okoth L, Murray L, Hemingway C, Lewis JM, Oguche M, Doyle V, Muturi N, Ogwang E, Barsosio HC, and Taegtmeyer M

Subjects
Female, Humans, Pregnancy, Kenya, Patient Acceptance of Health Care, Pregnancy Trimester, First, Mothers, Prenatal Care methods
Abstract

Background: Early attendance at antenatal care (ANC), coupled with good-quality care, is essential for improving maternal and child health outcomes. However, achieving these outcomes in sub-Saharan Africa remains a challenge. This study examines the effects of a community-facility health system strengthening model (known as 4byFour) on early ANC attendance, testing for four conditions by four months of pregnancy, and four ANC clinic visits in Migori county, western Kenya., Methods: We conducted a mixed methods quasi-experimental study with a before-after interventional design to assess the impact of the 4byFour model on ANC attendance. Data were collected between August 2019 and December 2020 from two ANC hospitals. Using quantitative data obtained from facility ANC registers, we analysed 707 baseline and 894 endline unique ANC numbers (attendances) based on negative binomial regression. Logistic regression models were used to determine the impact of patient factors on outcomes with Akaike Information Criterion (AIC) and likelihood ratio testing used to compare models. Regular facility stock checks were undertaken at the study sites to assess the availability of ANC profile tests. Analysis of the quantitative data was conducted in R v4.1.1 software. Additionally, qualitative in-depth interviews were conducted with 37 purposively sampled participants, including pregnant mothers, community health volunteers, facility staff, and senior county health officials to explore outcomes of the intervention. The interview data were audio-recorded, transcribed, and coded; and thematic analysis was conducted in NVivo., Results: There was a significant 26% increase in overall ANC uptake in both facilities following the intervention. Early ANC attendance improved for all age groups, including adolescents, from 22% (baseline) to 33% (endline, p = 0.002). Logistic regression models predicting early booking were a better fit to data when patient factors were included (age, parity, and distance to clinic, p = 0.004 on likelihood ratio testing), suggesting that patient factors were associated with early booking.The proportion of women receiving all four tests by four months increased to 3% (27/894), with haemoglobin and malaria testing rates rising to 8% and 4%, respectively. Despite statistical significance (p < 0.001), the rates of testing remained low. Testing uptake in ANC was hampered by frequent shortage of profile commodities not covered by buffer stock and low ANC attendance during the first trimester. Qualitative data highlighted how community health volunteer-enhanced health education improved understanding and motivated early ANC-seeking. Community pregnancy testing facilitated early detection and referral, particularly for adolescent mothers. Challenges to optimal ANC attendance included insufficient knowledge about the ideal timing for ANC initiation, financial constraints, and long distances to facilities., Conclusion: The 4byFour model of community-facility health system strengthening has the potential to improve early uptake of ANC and testing in pregnancy. Sustained improvement in ANC attendance requires concerted efforts to improve care quality, consistent availability of ANC commodities, understand motivating factors, and addressing barriers to ANC. Research involving randomised control trials is needed to strengthen the evidence on the model's effectiveness and inform potential scale up., (© 2024. The Author(s).)

Published
2024
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10. Safeguarding in practice: anticipating, minimising and mitigating risk in teenage pregnancy research in urban informal settlements in Nairobi, Kenya.

Author

Otiso L, Steege R, Njoroge I, Okoth L, Tubb P, Nyothach E, Phillips-Howard PA, Theobald S, and Taegtmeyer M

Subjects
Female, Pregnancy, Adolescent, Humans, Male, Kenya, Sexual Behavior, Gender Identity, Pregnancy in Adolescence prevention & control, Pregnancy in Adolescence psychology, Intimate Partner Violence
Abstract

Safeguarding challenges in global health research include sexual abuse and exploitation, physical and psychological abuse, financial exploitation and neglect. Intersecting individual identities (such as gender and age) shape vulnerability to risk. Adolescents, who are widely included in sexual and reproductive health research, may be particularly vulnerable. Sensitive topics like teenage pregnancy may lead to multiple risks. We explored potential safeguarding risks and mitigation strategies when studying teenage pregnancies in informal urban settlements in Nairobi, Kenya. Risk mapping was initiated by the research team that had prolonged engagement with adolescent girls and teen mothers. The team mapped potential safeguarding risks for both research participants and research staff due to, and unrelated to, the research activity. Mitigation measures were agreed for each risk. The draft risk map was validated by community members and coresearchers in a workshop. During implementation, safeguarding risks emerged across the risk map areas and are presented as case studies. Risks to the girls included intimate partner violence because of a phone provided by the study; male participants faced potential disclosure of their perceived criminal activity (impregnating teenage girls); and researchers faced psychological and physical risks due to the nature of the research. These cases shed further light on safeguarding as a key priority area for research ethics and implementation. Our experience illustrates the importance of mapping safeguarding risks and strengthening safeguarding measures throughout the research lifecycle. We recommend co-developing and continuously updating a safeguarding map to enhance safety, equity and trust between the participants, community and researchers., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Published
2024
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11. Voices and challenges of marginalized and vulnerable groups in urban informal settlements in Nairobi, Kenya: building on a spectrum of community-based participatory research approaches.

Author

Karuga R, Kabaria C, Chumo I, Okoth L, Njoroge I, Otiso L, Muturi N, Karki J, Dean L, Tolhurst R, Steege R, Ozano K, Theobald S, and Mberu B

Subjects
Aged, Child, Humans, Kenya, Social Marginalization, Urban Population, Community-Based Participatory Research, Vulnerable Populations, Urbanization
Abstract

Urbanization is rapidly increasing across Africa, including in Nairobi, Kenya. Many people, recent migrants and long-term residents, live within dense and dynamic urban informal settlements. These contexts are fluid and heterogeneous, and deepening the understanding of how vulnerabilities and marginalization are experienced is important to inform pointed action, service delivery and policy priorities. The aim of this paper is to explore vulnerabilities and marginalization within Korogocho and Viwandani informal settlements in Nairobi and generate lessons on the value of a spectrum of community based participatory research approaches for understanding health and well-being needs and pinpointing appropriate interventions. In the exploratory stages of our ARISE consortium research, we worked with co-researchers to use the following methods: social mapping, governance diaries, and photo voice. Social mapping (including the use of Focus Group Discussions) identified key vulnerable groups: marginalized and precarious child heads of households (CHHs), Persons with disability who face multiple discrimination and health challenges, and often isolated older adults; and their priority needs, including health, education, water and sanitation. The governance diaries generated an understanding of the perceptions of the particularly vulnerable and marginalized informal settlement residents regarding the various people and institutions with the power to influence health and wellbeing; while photo voice highlighted the lived experiences of vulnerability and marginality. Understanding and responding to fluid and intersecting marginalities and vulnerabilities within growing urban informal settlements is particularly critical to achieving inclusive urbanization, where no one is left behind, a theme central to the Sustainable Development Goals and Kenya's Vision 2030., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Karuga, Kabaria, Chumo, Okoth, Njoroge, Otiso, Muturi, Karki, Dean, Tolhurst, Steege, Ozano, Theobald and Mberu.)

Published
2023
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12. Policy and practices shaping the delivery of health services to pregnant adolescents in informal urban settlements in Kenya.

Author

Okoth L, Steege R, Ngunjiri A, Theobald S, and Otiso L

Subjects
Pregnancy, Humans, Adolescent, Female, Male, Kenya, Focus Groups, Reproductive Health, Policy, Reproductive Health Services
Abstract

In Kenya, the pregnancy rate of 15% among adolescents aged 15-19 years is alarmingly high. Adolescent girls living in informal urban settlements are exposed to rapid socio-economic transitions and multiple intersecting health risks and may be particularly disadvantaged in accessing sexual reproductive health services. Understanding vulnerabilities and service-seeking behaviours from different perspectives is important in order to support the development and implementation of progressive policies and services that meet adolescents' unique needs within urban informal settlements. This study explored policy makers, community health service providers' and community members' perceptions of access to, and delivery of, sexual reproductive health services for pregnant adolescents in one informal urban settlement in Nairobi. We employed qualitative methods with respondents throughout the health system, purposively sampled by gender and diversity of roles. We conducted focus group discussions with community members (n = 2 female-only; n = 2 male-only), key informant interviews with policy makers (n = 8), traditional birth attendants (n = 12), community health volunteers (CHVs) (n = 11), a nutritionist (n = 1), social workers (n = 2) and clinical officers (n = 2). We analysed the data using thematic analysis. Government policies and strategies on sexual and reproductive health for adolescents exist in Kenya and there are examples of innovative and inclusive practice within facilities. Key factors that support the provision of services to pregnant adolescents include devolved governance, and effective collaboration and partnerships, including with CHVs. However, inadequate financing and medical supplies, human resource shortages and stigmatizing attitudes from health providers and communities, mean that pregnant adolescents from informal urban settlements often miss out on critical services. The provision of quality, youth-friendly reproductive health services for this group requires policies and practice that seek to achieve reproductive justice through centring the needs and realities of pregnant adolescents, acknowledging the complex and intersecting social inequities they face., (© The Author(s) 2023. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine.)

Published
2023
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13. Implications of COVID-19 for safeguarding in international development research: learning, action and reflection from a research hub.

Author

Mansaray B, Dean L, Tubb P, Josyula KL, Okoth L, Chumo I, Waritu J, Klingel A, Manzoor F, Aktar B, Garimella S, Murthy S, Tolhurst R, Whittaker L, Gray L, Forsyth R, Elsey H, Waldman L, and Theobald S

Subjects
Bangladesh epidemiology, Health Services Research, Humans, India epidemiology, Pandemics, COVID-19
Abstract

COVID-19 brings uncertainties and new precarities for communities and researchers, altering and amplifying relational vulnerabilities (vulnerabilities which emerge from relationships of unequal power and place those less powerful at risk of abuse and violence). Research approaches have changed too, with increasing use of remote data collection methods. These multiple changes necessitate new or adapted safeguarding responses. This practice piece shares practical learnings and resources on safeguarding from the Accountability for Informal Urban Equity hub, which uses participatory action research, aiming to catalyse change in approaches to enhancing accountability and improving the health and well-being of marginalised people living and working in informal urban spaces in Bangladesh, India, Kenya and Sierra Leone. We outline three new challenges that emerged in the context of the pandemic (1): exacerbated relational vulnerabilities and dilemmas for researchers in responding to increased reports of different forms of violence coupled with support services that were limited prior to the pandemic becoming barely functional or non-existent in some research sites, (2) the increased use of virtual and remote research methods, with implications for safeguarding and (3) new stress, anxiety and vulnerabilities experienced by researchers. We then outline our learning and recommended action points for addressing emerging challenges, linking practice to the mnemonic 'the four Rs: recognise, respond, report, refer'. COVID-19 has intensified safeguarding risks. We stress the importance of communities, researchers and co-researchers engaging in dialogue and ongoing discussions of power and positionality, which are important to foster co-learning and co-production of safeguarding processes., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2022
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14. How to prevent and address safeguarding concerns in global health research programmes: practice, process and positionality in marginalised spaces.

Author

Aktar B, Alam W, Ali S, Awal A, Bayoh M, Chumo I, Contay Y, Conteh A, Dean L, Dobson S, Edstrom J, Elsey H, Farnaz N, Garimella S, Gray L, Gupte J, Hawkins K, Hollihead B, Josyula KL, Kabaria C, Karuga R, Kimani J, Leyland AH, Te Lintelo D, Mansaray B, MacCarthy J, MacGregor H, Mberu B, Muturi N, Okoth L, Otiso L, Ozano K, Parray A, Phillips-Howard P, Rao V, Rashid S, Raven J, Refell F, Saidu S, Sobhan S, Saligram PS, Sesay S, Theobald S, Tolhurst R, Tubb P, Waldman L, Wariutu J, Whittaker L, and Wurie H

Subjects
Bangladesh, Humans, India, Kenya, Global Health, Poverty
Abstract

Safeguarding is rapidly rising up the international development agenda, yet literature on safeguarding in related research is limited. This paper shares processes and practice relating to safeguarding within an international research consortium (the ARISE hub, known as ARISE). ARISE aims to enhance accountability and improve the health and well-being of marginalised people living and working in informal urban spaces in low-income and middle-income countries (Bangladesh, India, Kenya and Sierra Leone). Our manuscript is divided into three key sections. We start by discussing the importance of safeguarding in global health research and consider how thinking about vulnerability as a relational concept (shaped by unequal power relations and structural violence) can help locate fluid and context specific safeguarding risks within broader social systems. We then discuss the different steps undertaken in ARISE to develop a shared approach to safeguarding: sharing institutional guidelines and practice; facilitating a participatory process to agree a working definition of safeguarding and joint understandings of vulnerabilities, risks and mitigation strategies and share experiences; developing action plans for safeguarding. This is followed by reflection on our key learnings including how safeguarding, ethics and health and safety concerns overlap; the challenges of referral and support for safeguarding concerns within frequently underserved informal urban spaces; and the importance of reflective practice and critical thinking about power, judgement and positionality and the ownership of the global narrative surrounding safeguarding. We finish by situating our learning within debates on decolonising science and argue for the importance of an iterative, ongoing learning journey that is critical, reflective and inclusive of vulnerable people., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Published
2020
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