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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Strategies to minimise and monitor biases and imbalances by arm in surgical cluster randomised trials: evidence from ChEETAh, a trial in seven low- and middle-income countries
Trials, Volume 24, No. 1, Article 259, Year 2023
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Description
Background: Cluster randomised controlled trials (cRCT) present challenges regarding risks of bias and chance imbalances by arm. This paper reports strategies to minimise and monitor biases and imbalances in the ChEETAh cRCT. Methods: ChEETAh was an international cRCT (hospitals as clusters) evaluating whether changing sterile gloves and instruments prior to abdominal wound closure reduces surgical site infection at 30 days postoperative. ChEETAh planned to recruit 12,800 consecutive patients from 64 hospitals in seven low-middle income countries. Eight strategies to minimise and monitor bias were pre-specified: (1) minimum of 4 hospitals per country; (2) pre-randomisation identification of units of exposure (operating theatres, lists, teams or sessions) within clusters; (3) minimisation of randomisation by country and hospital type; (4) site training delivered after randomisation; (5) dedicated ‘warm-up week’ to train teams; (6) trial specific sticker and patient register to monitor consecutive patient identification; (7) monitoring characteristics of patients and units of exposure; and (8) low-burden outcome-assessment. Results: This analysis includes 10,686 patients from 70 clusters. The results aligned to the eight strategies were (1) 6 out of 7 countries included ≥ 4 hospitals; (2) 87.1% (61/70) of hospitals maintained their planned operating theatres (82% [27/33] and 92% [34/37] in the intervention and control arms); (3) minimisation maintained balance of key factors in both arms; (4) post-randomisation training was conducted for all hospitals; (5) the ‘warm-up week’ was conducted at all sites, and feedback used to refine processes; (6) the sticker and trial register were maintained, with an overall inclusion of 98.1% (10,686/10,894) of eligible patients; (7) monitoring allowed swift identification of problems in patient inclusion and key patient characteristics were reported: malignancy (20.3% intervention vs 12.6% control), midline incisions (68.4% vs 58.9%) and elective surgery (52.4% vs 42.6%); and (8) 0.4% (41/9187) of patients refused consent for outcome assessment. Conclusion: cRCTs in surgery have several potential sources of bias that include varying units of exposure and the need for consecutive inclusion of all eligible patients across complex settings. We report a system that monitored and minimised the risks of bias and imbalances by arm, with important lessons for future cRCTs within hospitals. © 2023, The Author(s).
Authors & Co-Authors
Gbéhadé, Oswald
Unknown Affiliation
Hessou, Thierry K.
Unknown Affiliation
Gandaho, Isidore
Unknown Affiliation
Hadonou, Armel A.
Unknown Affiliation
Dossou, Francis Moïse
Unknown Affiliation
Lawani, Ismaïl
Unknown Affiliation
Seto, Djifid Morel
Unknown Affiliation
Hussey, Romeo
Unknown Affiliation
Amoako-Boateng, Mabel Pokuah
Unknown Affiliation
Appiah, Anthony Baffour
Unknown Affiliation
Dayie, Makafui S.C.J.K.
Unknown Affiliation
Koggoh, Patience
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Kpankpari, Richard
Unknown Affiliation
Mensah, Samuel
Unknown Affiliation
Morna, Martin Tangnaa
Unknown Affiliation
Nortey, Michael
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Ofori, Emmanuel Owusu
Unknown Affiliation
Yigah, Makafui
Unknown Affiliation
Agyemang, Eric O.
Unknown Affiliation
Akoto-Ampaw, Arko
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Amponsah-Manu, Forster
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Arkorful, Temitope Ebenezer
Unknown Affiliation
Dokurugu, Moses A.
Unknown Affiliation
Ofosu-Akromah, Richard
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Adam-Zakariah, Leslie Issa
Unknown Affiliation
Asabre, Esther
Unknown Affiliation
Boateng, Ruby Acheampong
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Koomson, Barbara
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Armah, Ralph
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Awere-Kyere, Lawrence K.B.
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Robertson, Zelda
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Acheampong, Dorcas Otuo
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Acquaye, Jane
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Appiah, Juliana
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Arthur, Joshua A.
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Boakye-Yiadom, Jonathan
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Agbeko, Anita Eseenam
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Gyamfi, Frank Enoch
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Nyadu, Bertina Beauty
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Adu-Aryee, Nii Armah
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Agboadoh, Nelson
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Amoako, Joachim Kwaku A.
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Aperkor, Nicholas T.
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Bediako-Bowan, A. A.A.
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Boakye-Yiadom, Kwaku
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Dedey, Florence
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Etwire, Victor Kobby
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Fenu, Benjamin Sena
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Kumassah, Philemon Kwame
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Nsaful, Josephine
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Tsatsu, Sandra Enyonam
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Wordui, Theodore
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Adobea, Vivian
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Bennin, Amos
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Doe, Stanley
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Kantanka, Ruth Sarfo
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Kobby, Ephraim
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Owusu, Prince Yeboah
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Owusu, Frank
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Sie-Broni, Clement Ayum
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Zume, Marshall
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Acquah, Daniel Kwesi
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Amadu, Munira
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Malechi, Hawa
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Mohammed, Sheriff
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Mumuni, Kareem
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Seidu, Anwar Sadat
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Tabiri, Stephen
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Boakye, Percy
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Coompson, Christian Lari
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Kontor, Bismark Effah
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Manu, Ruth
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Mensah, Elijah
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Misra, S.
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Ghosh, Dhruva Nath
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Singh, Prashant Kumar
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Prasad, Soosan S.
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Sharma, Srujan Lam
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Attri, Ashok Kumar
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Kumar, Vijay Senthil
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Alexander, Philip Vareed
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Ismavel, Vijay Anand
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Peters, Nitin J.
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Mehraj, Asif
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Sharma, Rajeev M.
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Barbosa-Camacho, Francisco José
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Miranda-Ackerman, Roberto Carlos
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de la Medina, Antonio Ramos
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Delano-Alonso, Roberto
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Herrera-Esquivel, Jesus De
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Abdullahi, Aisha Abdirahman
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Aliyu, Mohammed Salele
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Awaisu, Mudi
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Bakari, Fadimatu
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Bashir, Mohammed
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Daniyan, Muhammad A.
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Koledade, Afolabi Korede
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Ogunsua, Oluseyi
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Oyelowo, Nasir
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Sholadoye, Tunde Talib
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Tolani, Musliu Adetola
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Umar, Aminatu Makarfi
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Usman, Muhammad Shariq
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Yahya, Anisah
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Yakubu, Alfa
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Abdullahi, Lawal Barau L.B.
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Abdullahi, Muzzammil M.
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Anyanwu, Lofty John Chukwuemeka
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Daneji, Sulaiman Muhammad
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Magashi, Mahmood K.
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Muhammad, Saminu S.
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Sheshe, Abdulrahman Abba
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Takai, Idris Usman I.U.
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Adze, Joel Amwe
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Airede, Lydia R.
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Bature, Stephen B.
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Hamza, Babatunde Kolapo
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Kache, Stephen Akau
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Makama, Jerry Godfrey
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Mohammed, Caleb
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Mohammed-Durosinlorun, Amina A.
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Sale, Danjuma
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Taingson, Matthew C.
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Adegoke, Folasade A.
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Odunafolabi, Tunde Adebowale
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Abiola, Paul O.
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Adebara, Idowu O.
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Adeniyi, Adebayo Augustine
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Adewara, Olumide Emmanuel
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Adeyemo, Olabisi Timothy
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Adeyeye, Ademola A.
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Ariyibi, Abimbola L.
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Awoyinka, Babatunde S.
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Ayankunle, Olumide Mojisola
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Babalola, Olakunle Fatai
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Bakare, Tajudeen Ishola Babatunde
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Banjo, Omotola Oluwaseyi
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Egharevba, Peter A.
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Fatudimu, Oluwafemi S.
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Obateru, John A.
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Ojo, Owolabi Dele
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Okunlola, Abiodun Idowu
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Okunlola, Cecilia Kehinde
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Olajide, Adewale T.
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Orewole, Olayinka T.
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Salawu, Adedayo I.
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Abdulsalam, Moruf Adekunle
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Ajai, Olalekan Temitope
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Atobatele, Kazeem M.
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Faboya, Omolara Morounkeji
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Ogunyemi, Ayokunle A.
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Oludara, Mobolaji Adewale
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Omisanjo, Olufunmilade Akinfolarin
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Oshodi, Olabode A.
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Abunimye, Esther
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Ademuyiwa, Adesoji O.
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Akinajo, Opeyemi Rebecca
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Atoyebi, Oluwole Ayoola
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Balogun, Olanrewaju Samuel
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Elebute, Olumide Abiodun
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Fatuga, Adedeji Lukman
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Ihediwa, George C.
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Ladipo-Ajayi, Oluwaseun Abiola
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Lawal, Abdulrazzaq Oluwagbemiga
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Makanjuola, Ayomide
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Ogunjimi, Moses Adebisi
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Ohazurike, Ephraim Okwudiri
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Ojewola, Rufus Wale
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Okeke, Chike John
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Okunowo, Adeyemi Adebola
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Olajide, Thomas Olagboyega
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Osinowo, Adedapo Olumide
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Osunwusi, Benedetto Oluwaseun
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Owie, Emmanuel
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Oyegbola, Christianah Bidemi
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Seyi-Olajide, Justina Onyioza
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Soibi-Harry, Adaiah Priscillia
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Ugwu, Aloy Okechukwu
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Egwuonwu, Ochomma Amobi
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Ekwunife, Okechukwu Hyginus
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Modekwe, Victor Ifeanyichukwu
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Obiechina, Sylvester O.
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Obiesie, Ahuizechukwu E.
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Okoro, Chukwuemeka Chukwubuikem
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Okoye, Odili Aloysius
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Onu, Onyekachi Amos
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Onyejiaka, Chukwudubem Chinagorom
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Ugwu, Jideofor Okechukwu
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Ugwunne, Chuka Abunike
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Adepiti, Akinfolarin C.
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Aderounmu, Adewale Abdulwasiu
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Adesunkanmi, Abdulhafiz Hafiz Oladapo
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Adisa, Adewale O.
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Ajekwu, Samuel Chibuzo
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Ajenifuja, Olusegun Kayode
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Alatise, Olusegun Isaac
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Badmus, Tajudeen Adeniran
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Mohammed, Tajudeen Olakunle
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Olasehinde, Olalekan O.
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Salako, Ayo Abdulkadir
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Sowande, Oludayo Adedapo
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Talabi, Ademola Olusegun
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Wuraola, Funmilola Olanike
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Adegoke, Paul Aderemi
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Ogundoyin, Olakayode Olaolu
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Olulana, Dare Isaac
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Adumah, Collins Chijioke
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Eziyi, Amogu Kalu
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Fasanu, Adeniyi Olanipekun
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Ojewuyi, Olufemi Olayide
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Abdullahi, Habiba Ibrahim
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Adewole, Nathaniel Daniel
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Agida, Teddy Eyaofun
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Aisuodionoe-Shadrach, Oseremen Inohkoife
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Akaba, Godwin Otuodichinma
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Atim, Terkaa
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Chinda, John Y.
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Eniola, Sefiu B.
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Mshelbwala, Philip Mari
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Ohemu, Alexander Akogwu
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Olori, Samson Dr
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Osagie, Olabisi O.
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Agbonrofo, Peter I.
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Arekhandia, Alexander I.
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Iribhogbe, Oseihie I.
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Irowa, Omorodion O.
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Isikhuemen, Maradona Ehikioya
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Osagie, Osasumwen T.
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Osemwegie, Osarenkhoe Omorefosa
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Abdus-Salam, Rukiyat Adeola
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Adebayo, Sikiru Adekola
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Ajagbe, Oluwaseyi A.
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Ajao, Akinlabi Emmanuel
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Ayandipo, Omobolaji Oladayo
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Egbuchulem, Kelvin Ifeanyichukwu
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Ekwuazi, Hyginus O.
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Elemile, Peter O.
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Idowu, Oluwasegun Caleb
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Irabor, David Omoareghan
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Lawal, Taiwo Akeem
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Sanusi, Akinsola Teslim
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Takure, Augustine Oghenewyin
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Abdur-Rahman, Lukman Olajide
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Adeleke, Nurudeen Abiola
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Aremu, Isiaka Ishola
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Bello, Jibril O.
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Raji, Hadijat Olaide
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Igwe, Patrick Okechukwu
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Okoro, Philemon Ekemenye
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Oriji, Vaduneme Kingsley
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Niyongombwa, Irénée
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Mpirimbanyi, Christophe
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Seneza, Celestin
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Habumuremyi, Sosthene
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Tubasiime, Ronald
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Uwimana, Jean Claude
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Rwagahirima, Elisee
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Sibomana, Isaie
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Hirwa, Aimé Dieudonne
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Utumatwishima, Jean Nepo A.
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Bucyibaruta, Georges
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Ingabire, Allen Jc
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Munyaneza, Emmanuel
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Ncogoza, Isaie
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Ntirenganya, Faustin
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Nyirasebura, Dancilla
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Urimubabo, Christian Jean
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Munyaneza, Robert
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Fourtounas, Maria
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Ede, Chikwendu Jeffrey
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Hyman, Gabriella Yael
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Moore, Rachel L.
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Nyatsambo, Chido
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Ojo, Victor
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Pswarayi, Rudo
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Statistics
Authors: 281
Identifiers
Doi:
10.1186/s13063-022-06852-2
ISSN:
17456215
Research Areas
Health System And Policy
Study Design
Randomised Control Trial