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Clin Trials. 2009 Oct;6(5):416-29. doi: 10.1177/1740774509344440. Epub 2009 Sep 8.

Constructing common cohorts from trials with overlapping eligibility criteria: implications for comparing effect sizes between trials.

Collaborators (1448)

Brancati F, Celnik D, Honas J, Clark J, Charleston J, Cheskin L, Stewart K, Rubin R, Horak K, Bray GA, Rau K, Strate A, Greenway FL, Ryan DH, Williamson D, Tucker E, Armand B, Shipp M, Landry K, Perault J, Lewis CE, Thomas S, DiLillo V, Safford M, Glasser S, Smith C, Roche C, Bragg C, Webb N, Gilbert S, Dobelstein A, Oden C, Johnsey T, Nathan DM, Turgeon H, Schumann KP, Cagliero E, Hayward K, Delahanty L, Steiner B, Goldman V, Anderson E, Bissett L, McNamara A, Ginsburg R, Harlan V, Michel T, Horton ES, Jackson SD, Hamdy O, Caballero AE, Ledbury S, Malloy M, Goebel-Fabbri A, Ovalle K, Bain S, Bovaird E, Lambert L, Blackburn G, Mantzoros C, McNamara A, McCormick H, Hill JO, Miller M, VanDorsten B, Regensteiner J, Schwartz R, Hamman R, McDermott M, Phillipp J, Reddin P, Wallace K, Cohrs P, Hamilton A, Benchekroun S, Green S, Rome L, Munkwitz L, Foreyt JP, Reeves RS, Pownall H, Jones P, Balasubramanyam A, Gee M, Saad MF, Chiu KC, Ghazarian S, Szamos K, Perpetua M, Chan M, Botrous M, Johnson KC, Carmichael L, Lichtermann L, Kitabchi AE, Day J, Lambeth H, Force D, Clark D, Crisler A, Green D, Cunningham G, Sun M, Kores R, Rosenthal R, Soberman J, Jeffery RW, Thorson C, Bantle JP, Bruce Redmon J, Crow RS, Carls J, Campbell C, James LD, Ockenden T, Brelje K, Patricia Snyder M, Keranen A, Walcheck C, Finch E, Rice BI, Maddy VA, Skarphol T, Pi-Sunyer X, Patricio J, Mayer J, Heshka S, Pal C, Holowaty MA, Hirsch D, Wadden TA, Maschak-Carey BJ, Foster GD, Berkowitz RI, Schwartz S, Kumanyika SK, Mullen M, Hesson L, Lipschutz P, Fabricatore A, Crerand C, Kuehnel R, Carvajal R, Davenport R, Chomentowski H, Kelley DE, Wesche-Thobaben J, Kuller L, Kriska A, Edmundowicz D, Klem ML, Bonk J, Rush J, Danchenko R, Elnyczky B, Vujevich K, Krulia J, Wolf D, Mancino J, Harper P, Mathews A, Wing RR, Pera V, Jakicic J, Tate D, Gorin A, Bright R, Coward P, Robinson N, Monk T, Gallagher K, Bertorelli A, Daly M, Charron T, Nicholson R, Patterson E, Currin J, Foss L, Robles D, Bancroft B, Gauvin J, Maier D, Egan C, Phelan S, Raynor H, Kieffer D, Raynor D, Lessard L, Chula-Maguire K, Ferguson E, Carey R, Tavares J, Chenot H, Massaro JP, Haffner S, Montez M, Mobley C, Lorenzo C, Kahn SE, Montgomery B, Knopp RH, Lipkin EW, Maciejewski ML, Trence DL, Murillo RM, Barrett T, Knowler WC, Bolin P, Killean T, Manus C, Percy C, Donaldson R, Todacheenie B, Glass J, Michaels S, Krakoff J, Curtis J, Bennett PH, Morgan T, Johnson R, Smiley J, Sangster S, Begay S, Roanhorse M, Fallis D, Scurlock N, Shovestull L, Espeland MA, Bahnson J, Wagenknecht L, Reboussin D, Jack Rejeski W, Lang W, Bertoni A, Vitolins M, Miller G, Ribisi P, Dotson K, Hodges A, Hogan P, Lane K, Combs C, Speas C, West DS, Herman W, Nevitt M, Schwartz A, Shepherd J, Maeda J, Hayashi C, Rahorst M, Palermo L, Marcovina SM, Strylewicz G, Prineas RJ, Zhang ZM, Campbell C, Hall S, Mayer-Davis EJ, Farach C, Harrison B, Yanovski SZ, Hubbard VS, Cooper LS, Obarzanek E, Simons-Morton D, Williamson DF, Gregg EW, Friedewald WT, Buse JB, Bigger JT, Byington RP, Cushman WC, Genuth S, Gerstein HC, Ginsberg HN, Goff DC Jr, Grimm RH, Probstfield JL, Simons-Morton DG, Gerstein HC, Yusuf S, Punthakee Z, Russo R, Anand S, Cracknell B, Cukierman-Yaffe T, Gafni A, Guyat G, Hall S, Kaszyca J, Lonn E, Reiding V, Shehadeh N, Tadeson B, Thompson K, Vallis M, Vasudeva V, Wilderman I, Punthakee Z, Smith A, Stanton I, Capes S, Manjoo P, Valla T, Danby S, Harper W, Harvey P, Hunt D, Moroso A, Otto R, Prebtani A, Punthakee Z, Davis A, Capes S, Hill KL, McCarthy V, Edwards AL, Mitchell DJ, Clearwaters MA, Dielissen C, Gillam M, Hammond B, Jensen H, Kherani A, Lau D, Pringle V, Rabi D, Sigal R, Smith C, Walker M, Williams G, Joyce C, Parsons M, Rowe B, Burton J, Chandurkar V, Coady-McDonald S, Gibbons D, Kovacs C, Murphy B, Smart R, Varghese S, Mereu L, Ryan E, Senior P, Kirkland P, Abe J, Dalton K, Gendall W, Germsheid J, Hartman D, Jeffrys A, Mac-Donald C, Makhani N, Mawani S, Morales F, Paty B, Pick M, Schwanke B, Stark A, Tennant M, Varma S, Werbiski-Wood P, Woloschuk B, Zimmerman W, Belanger A, Gauthier S, Bahsali G, Barbeau C, Caponi E, Duchesne R, Dumas R, Gauthier P, Girouard J, Kandalaft N, Labbe M, Palardy J, Pilon M, Raymond J, Schiffrin A, Hramiak I, Tereschyn S, Driscoll M, Gehring M, Gonder J, Lincoln C, McBeth W, McDonald C, McDonald T, Pauli P, Paul T, Powers S, Ronald N, Trinh V, Vancer L, Walsh G, Lochnan H, Ooi TC, Maranger J, Bate R, Bradley L, Buhrmann R, Cyr M, Gilchrist C, Hanlon B, Harley M, Jay K, Leech T, Malcolm J, McLean M, Parker E, Sigal R, Sullivan K, Yale JF, Segal SA, Renouf N, Allaire N, Alawadhi MA, Belfer B, Blank DW, Bouchard F, Buoy-Phang S, Carter J, Coppin L, Dalpe D, Delpech I, Doran PM, Emmian F, Fortin S, Garfield N, Gosselin M, Horan S, Kalergis M, Koutelias S, Legare C, Lombardo A, Morais JA, Quigley M, Renouf N, Riopel C, Riopel S, Rivera JA, Rochon G, Roy M, Salera M, Sherman MH, Shingler M, Staples HE, Ulyatt L, Yared Z, Leiter LA, Booth G, Sparrow L, Choi H, Bedard DC, Berger A, Berndl LA, Cheng A, Evalmplev V, Goguen J, Hanna A, Josse RG, Kalas JA, Perry S, Pike A, Elliott T, Dawson K, Kong J, Inducil M, Al Amoudi R, Broughton T, Hall L, Harrison B, Hirvi N, Lee R, Norman E, Paty B, Potter M, Stevenson D, Vafadaran A, Woo V, Berard L, Anderlic T, Austman K, Bernard A, Catte D, Hak D, Hutchison K, Janzen L, Klopak T, Mandock C, Mathen M, Mawani S, Mawani A, Murphy L, Nyomba G, Penner B, Pockett S, Russell S, Stockl F, Studney J, Sukkau R, Abbott C, Ur E, Yuille M, Archibald M, Cruess A, Davis N, Fong H, Frizzell S, Hanway B, Hoskin-Mott A, Imran A, Ingraham C, McCarthy G, Murdock H, Palmer T, Patterson AM, Ransom T, Shu D, Tuttle J, Probstfield JL, Kingry C, Line AS, Corson MA, Knopp R, Lipkin E, Sullivan MD, Johnson J, Griswold C, Liebert K, Brown A, Juliano D, Kurashige EM, Moberg S, Ariani K, Karunaratne K, Azizad M, Chow C, Gutierrez H, Partamian J, Toven J, Mular J, Sanders S, Haywood LJ, Kamdar V, DeQuattro DL, Wang L, Song Z, Miller C, Becerra L, Qi Cai A, Pruitt C, DeQuattro V, Failor R, Ellsworth A, Jackson N, Miller C, Lusk S, Britt D, Dobie S, Hirsch I, Khakpour D, Quaempts R, Stoffel W, Wilcox T, Neighbor W, Cappocia K, Force R, Macdonald M, Pettingill K, Liday C, Koester S, Pettinger T, Solbrig R, Waldron C, Woodhouse W, Hoover B, Linz PE, Pepper PV, Kozlowski J, Chase C, Griffin C, Samuelson D, Gutierrez P, Gonzales C, Engle M, Coopersmith J, Griffin S, Lammers R, Leon J, Riddle MC, Hanavan KA, McDaniel PA, Swift R, Ahmann AJ, Gammell-Matthews SC, Karl DM, Burden V, MacNeil B, MacMurray M, Weiss J, Carlson C, DesRochers SK, Negreanu D, Stephens EA, Wysham C, Weeks D, Kuntsmann L, Maxwell L, Yedinak S, Pena H, White J, Dudl J, Lyons L, House B, Murray M, Stevenson R, Wu P, Palma A, Briere S, Wilson T, Becker D, Harden K, Hawley C, Dailey G, Baron M, Gianella A, Jacobson M, Farro E, Philis-Tsimikas A, Banares A, Bravo-Medina A, Horne J, Esquer E, Morrissey R, Grimm RH Jr, Kirpach BR, Bartkoske MM, Boyce CM, Druckman N, Gillett AM, Levin JA, Livingston GJ, Murray AM, Wood H, Margolis KL, Kempainen S, Madden M, Tariq Fareed M, Hall K, Moor R, Wood K, Bergenstal R, Cuddihy R, Davick B, Hokanson J, Johnson M, Lausch M, List S, Monk A, Robinson R, Smith K, Whipple D, Damberg G, Hahn R, Koenig V, Magadan M, Sabin- Smith S, Stewart P, Strock E, Peremislov D, Gunyou K, Passi R, Seaquist ER, Mech MV, Benedict LE, Demmon DJ, Kumar AF, Martinson SM, Miller SA, Pease C, Rao JP, Redmon JB, Swanson JE, Wimmer JK, Peterson K, Seaquist LA, Boese C, Cruciani M, Dodds E, Parenteau Ek F, Feldman JL, Fontaine P, Lange CJ, Mendenhall TJ, Peterson AM, Rudelt A, Schrock TM, Spielman DP, Velasco S, Weinhandl JC, Sperl-Hillen JM, O'Connor PJ, Busch ME, Chung A, Klein BK, Krugen N, Bunkers-Lawson T, Ekstrom HL, Gunderson HS, Johnson BM, MacIndoe JH, Prewedo DJ, Rawl JL, Roethke CM, Sivitz WI, Wayson SM, Lower TA, Larson L, Ahrens LA, Bayless M, Beck SE, Chahal J, Chenard C, Doelle GC, Guzman VM, Kabadi UM, Ochs KA, Rahhal A, Spanheimer RG, Snetselaar L, Smith K, Wells D, Genuth S, Ismail-Beigi F, Thibonnier M, Vargo L, Kelly C, Bongorno T, Dolish A, Pavlik L, Tiktin M, Isteitieh S, Ismail-Beigi F, Krikorian A, Moore L, Richardson L, Coles-Herman E, Yee K, Frankino J, Jing M, Sood A, Hustak L, Julius M, Pavlik L, Ross T, Long L, Schwing W, Tiktin M, Sullivan MK, Strauss L, Behm K, Eskandari F, Hall C, Hayes D, Horowitz K, Isteitieh S, Madhun Z, Seeholzer E, Shina J, Taylor H, Schnall A, Huang S, Heeg M, Tang J, Belkin J, Lee MS, Joly T, Sadler LS, Griffith M, Hornsby A, Klyn K, Ospelt E, Long L, DeSmit M, McCann P, Schmidt NP, Gottfried C, Kulow T, Zaletal J, Kapadia MS, Schnall AM, Dragmen L, Ellert R, Smith J, Leksan J, Sussman T, Huang S, Heeg M, Tang J, Belkin J, Lee MS, Joly T, Ismail-Beigi F, Hustak L, Julius M, Schwing W, Tiktin M, Anselmo J, Eskandari F, Daymeyer S, Hall C, Hayes D, Horowitz K, Isteitieh S, Johnson C, Kern E, Richmond MA, Richardson L, Roberts K, Shina J, Sood A, Suhan P, Taylor H, Watts S, Martin J, Moor L, Burtch B, Ober S, Strauss GJ, Leone A, Belkin J, Huang S, Frank K, Stephens D, Lee MS, Joly T, Hoogwerf BJ, Brakeman J, Matzinger M, Newsome J, Becker J, Bizjack S, Clingman B, Curtas S, Depietro G, Ellert R, Horner C, Bunae G, Hamrahian A, Hawkins A, Head T, Iannica S, Jones L, Kaiser P, McCoy R, Mehta A, Olansky L, Orasko A, Reddy S, Ross D, Shockley L, Siraj E, Williams M, Zimmerman R, Weiss D, Fagan KA, Hanslik TM, Farrell J, Brys P, Oligny M, Prokop K, Lenardic K, Karapanzcik T, Huang S, Heeg M, Tang J, Belkin J, Lee MS, Joly T, Akpunonu B, Franco-Saenz R, Gilmore J, Gilmore M, Godfrey L, Ross P, Bauer B, Chrisstie M, Lopez A, Mulrow P, Peters C, Pop-Busui R, Roman J, Smith C, Bick J, Blust Z, Nelsen PT, Marcus D, Osei K, Dziengelewski EA, Breedlove H, Boland D, Casey Boyer C, Cataland S, Green PA, Irwin JE, Schuster DP, Varga-Spangler JL, Bowles T, Weiland K, Arnold K, Evans T, Bouttamy J, Letson A, Craig E, Davidorf F, Cohen RM, Burton K, Craig J, Carter B, Harrer J, Hurd R, Lopez-Stickney D, Pritchard C, Pfefferman A, Ramlo-Halsted BA, McCormick C, Riley C, Strominger M, Knittel A, Groff G, Bailey C, Howald A, Anderson N, Laver Bierschbach J, Tyzinski M, Smith B, Krug S, Hershberger V, Hutchins RK, Raymond LA, Kahkonen DM, Cushman T, Roman M, Stys AM, White K, Austin M, Chatterton C, Francis JK, Jones C, Kruger D, McLellan A, Whitehouse F, Higgins E, Levy S, Schoenherr A, Edwards P, Grunberger G, Aman LC, Bandagi AH, Russell KM, Tucker C, Abidova Y, Amirikia A, Bigger JT, Lopez-Jimenez CR, Bornholdt R, Busaca L, Ginsberg HN, Gonzales P, Gosh D, Love P, Kosok A, Robinson E, Steinman R, Watson C, Reyes G, Schubart UK, Mendoza M, Goswami G, Laufer A, Russo J, Vincenty N, Alderman MH, Carroll L, Sanguily MJ, Gorkin JU, Mayer AC, Ramos L, Sessoms V, Fritts Stewart A, Brillon D, Cordero J, Richardson MA, Wei E, Ganz F, Meyer BR, Paley J, Anderson S, Charles C, Dwoskin A, Chiong R, Hyams K, Lorber DL, Arenstein T, Depree P, Elmorsy AA, Wendel JM, Zintl LL, August P, Beck M, Goldberg MD, Hofacker MJ, Marotta-Kollarus M, Ocampo EJ, Resta CA, Tibaldi JM, Bastien A, Grudzinski S, Niblack P, Abreu L, Brobyn T, Brown K, Casale M, Dougherty D, Haddad G, Heintz K, Kelly M, Linneman D, Olivia C, Salvador MA, Zee P, Hyman D, Bastien A, Grudzinski S, Niblack P, Abreu L, Brobyn T, Brown K, Casale M, Dougherty D, Haddad G, Heintz K, Kelly M, Linneman D, Olivia C, Salvador MA, Zee P, Hyman D, Brautigam DF, Fischer R, Chiarot JM, Scharf DM, Nunn B, Carlson J, Flanders C, Hagen MR, Newman S, Gordon TA, Goland R, Tuck CH, Kringas P, Hey-Hadavi J, Montes J, Vargas-Jerez J, Salas-Spiegel J, Getaneh A, Ramirez J, Vasquez EF, Kranwinkel G, Donovan DS, Febres G, Hernandez C, Jonaitis MA, Mesa L, Banerji MA, Norton M, Patel P, Daly V, Hirsch S, Jazmin C, Khillan R, Mendonca D, Relingado A, Sandoval E, Tiewala M, Banerji MA, Norton M, Patel P, Daly V, Hirsch S, Jazmin C, Khillan R, Mendonca D, Relingado A, Sandoval E, Tiewala M, Bastien A, Grudzinski S, Niblack P, Abreu L, Brobyn T, Brown K, Casale M, Dougherty D, Haddad G, Heintz K, Kelly M, Linneman D, Olivia C, Salvador MA, Zee P, Hyman D, Goff DC Jr, Summerson JH, Crago L, Blackwell CS, Bertoni A, Blaine RL, Kirk JK, Spach RL, Williamson J, Calles J, Katula J, Wishnietsky DB, Feinglos MN, Jones J, Mason MB, Furst MA, Bean WJ, Gedon-Lipscomb G, Green JB, Parham T, Satterwhite BM, Thacker CR, Padhiar D, Noel R, Padhiar N, West S, Braden J, Francis A, Atkinson HH, Dibari M, Allen J, Stanfield J, Delvalle-Fagan T, Gordineer LJ, Gordon L, Gordon M, Smith SL, Yates H, Pedley CF, Zurek G, Baird M, Dunn B, Kinder W, Mauney S, Buse JB, Duclos MD, Kirby RE, Largay JF, McDermott NM, Goley A, Braithwaite SS, Dostou JM, Fasy EA, Kelly DC, Metz CE, Jeffries J, Rubin D, Miller JL, Norton SM, Weatherly J, Bishop S, Cross B, Nuss K, Surgenor M, Wood Y, Barringer T, Hoffman C, Morris C, Tochiki P, Reinblatt G, Bruner P, Peace R, Stuart DO, Strickland J, Cummings L, Craig D, Stanfield J, Julian T, Peace R, Stuart DO, Strickland J, Cummings L, Craig D, Stanfield J, Crouse JR, Menon L, Marion S, Davis D, Davis B, Calles J, Chandler T, Ellis J, Kouba E, Riddle P, Myers E, Fonseca V, McDuffie RH, Asafu-Adjaye NO, Leger SM, Reilly P, Afner G, Arrey F, Asnani S, Borshard E, Boyd D, Cemo A, Chennur S, Dupart P, Garg R, Girindra GP, Gouda B, Itoua-N'Ganongo W, Innocent-Ituah I, Johnson C, Kuhadiya N, Kukreja M, Mangan-Mbondi I, Mason S, McLain C, Naylyanya J, Nazereth K, Nazereth S, Singh S, Thethi T, Varnado K, Williams R, Barzilay JI, Eley M, Bader K, Curry-Ball D, Goodman S, Stevens M, Cushman WC, Geraci TS, Walsh SM, Coley LG, Elam MB, Pickering DI, Elam MB, Thompson CW, Lichtermann L, Peeples S, Turner-Bates J, Heimberg M, Childress D, Turner J, Jasper J, Coley J, Hamilton BP, Hamilton J, Kuzbida G, Hatten W Jr, Lancaster A, Haywood J, Felicetta J, Bourne- Collo M, Svoboda ME, Clothier D, Deitz M, Flaugher C, Hayward P, Scheibe T, Velarde S, Heritage S, 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Miller ME, Reboussin D, Rushing S, Sanders L, Sims L, Stowe C, Walkup M, Wilmoth S, Wilson K, Woolard N, Raisch D, Ringer R, Sather M, DelCurto B, Garnand D, Prineas R, Campbell C, Zhang Z, Selph L, Hall S, Hensley S, Li Y, Mills M, Marcovina S, Chmielewski J, Gadbois K, Gaur V, Strylewicz G, Ramirez M, Waddell S, Mehan M, Bryan RN, Davatzkios C, Moonis G, Desiderio L, D'Arcy S, Davis M, Danis R, Johnson S, Robinson N, Hubbard L, Esser B, Thayer D, Neider M, Glader K, Burger M, Simons-Morton DG, Cooper L, Domanski M, Nwachuku C, Rosenberg Y, Salive M, Savage P, Fleg JL, Cutler JA, Geller N, Follmann D, Proschan M, Jennings C, Schaeffer E, Mills P, Bittner J, Kirby R, Frommer P, Fine L, Chan J, Fradkin J, Malozowski S, Meyers C, Hostetter T, Launer L, Chew EY, Albright A, Narayan KM, Engelgau M, Zhang P.

Author information

  • 1Wake Forest University School of Medicine, Winston-Salem, NC, USA.

Abstract

BACKGROUND:

Comparing findings from separate trials is necessary to choose among treatment options, however differences among study cohorts may impede these comparisons.

PURPOSE:

As a case study, to examine the overlap of study cohorts in two large randomized controlled clinical trials that assess interventions to reduce risk of major cardiovascular disease events in adults with type 2 diabetes in order to explore the feasibility of cross-trial comparisons

METHODS:

The Action for Health in Diabetes (Look AHEAD) and The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trials enrolled 5145 and 10,251 adults with type 2 diabetes, respectively. Look AHEAD assesses the efficacy of an intensive lifestyle intervention designed to produce weight loss; ACCORD tests pharmacological therapies for control of glycemia, hyperlipidemia, and hypertension. Incidence of major cardiovascular disease events is the primary outcome for both trials. A sample was constructed to include participants from each trial who appeared to meet eligibility criteria and be appropriate candidates for the other trial's interventions. Demographic characteristics, health status, and outcomes of members and nonmembers of this constructed sample were compared.

RESULTS:

Nearly 80% of Look AHEAD participants were projected to be ineligible for ACCORD; ineligibility was primarily due to better glycemic control or no early history of cardiovascular disease. Approximately 30% of ACCORD participants were projected to be ineligible for Look AHEAD, often for reasons linked to poorer health. The characteristics of participants projected to be jointly eligible for both trials continued to reflect differences between trials according to factors likely linked to retention, adherence, and study outcomes.

LIMITATIONS:

Accurate ascertainment of cross-trial eligibility was hampered by differences between protocols.

CONCLUSIONS:

Despite several similarities, the Look AHEAD and ACCORD cohorts represent distinct populations. Even within the subsets of participants who appear to be eligible and appropriate candidates for trials of both modes of intervention, differences remained. Direct comparisons of results from separate trials of lifestyle and pharmacologic interventions are compromised by marked differences in enrolled cohorts.

PMID:
19737845
[PubMed - indexed for MEDLINE]
PMCID:
PMC3254056
Free PMC Article

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