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Relton, C., O'Cathain, A., & Nicholl, J. (2012). A pilot 'cohort multiple randomised controlled trial' of treatment by a homeopath for women with menopausal hot flushes.. Contemp Clin Trials, 33(5), 853-859. doi:10.1016/j.cct.2012.04.003



Relton, C, Bissell, P, Smith, C, Blackburn, J, Cooper L, C, Nicholl, J, Tod, A, Copeland, R, Loban, A, Chater, T, Thomas, K, Young, T, Weir, C, Harrison, G, Milbourn, A, Manners, R.  South Yorkshire Cohort: a 'cohort trials facility' study of health and weight - Protocol for the recruitment phase. 2011 BMC Public Health. 11:640



Williams, A, Wiggers, J,  O'Brian, M, K, Wolfenden, L, Yoong, S, Campbell, E, Robson, E McAuley, J, Haskins, R, Kamper, J, S, Williams, M, C. A randomised controlled trial of a lifestyle behavioural intervention for patients with low back pain, who are overweight. 2016 BMC Musculoskeletal Disorders.

Mayo E, N, Brouillette, J-M, Fellows, K, L. Understanding and optimizing brain health in HIV now: protocol for a longitudinal cohort study with multiple randomized controlled trials, 2016. BMC Neurology

Williams, A, Wiggers, J,  O'Brian, M, K, Wolfenden, L, Yoong, S, Campbell, E, Robson, E McAuley, J, Haskins, R, Kamper, J, S, Williams, M, C. Randomised controlled trial of referral to a telephone-based weight management and healthy lifestyle programme for patients with knee osteoarthritis who are overweight or obese: a study protocol, 2016. BMJ Open 6:e010203

Johnson JA et al, Controlled trial of a collaborative primary care team model for patients with diabetes and depression: Rationale and design for a comprehensive evaluation



REFORM - Falls in the elderly

 UK - HTA funded (£1.44mn)

 Recruitment : mail out to 70 yrs + from podiatry clinic lists

 If 2 + falls then included – f/u at 3/12, information that ‘they may be offered a treatment in the future – if they were would they accept it, if yes then in the cohort

 Publications



 Trial 1: Random selection to podiatry insoles and exercise vs no random selection

 Patient information

o about intervention prior to random selection – yes

o that their treatment will be selected at random - no

CASPAR (operationalised as a comprehensive cohort design at the moment – not cmRCT)

 Collaborative care and active surveillance for screen-positive elders with sub-clinical depression: a pilot study and definitive and randomised evaluation.

 Mitchell N, Hewitt C, Adamson J, Parrott S, Torgerson D, Ekers D, Holmes J, Lester H, McMillan D, Richards D, Spilsbury K, Godfrey C, Gilbody S. A randomised evaluation of CollAborative care and active surveillance for Screen-Positive EldeRs with sub-threshold depression (CASPER): study protocol for a randomized controlled trial. Trials. 2011 Oct 11;12:225. doi: 10.1186/1745-6215-12-225.

 UK funded

 GP mail out age 65+ PHQ 9 – 3 groups – depression, at risk of depression, no risk of dep

 At risk group asked if they want to participate in a trial – full information given up front.... about a preventative tx – hence it’s really a comprehensive cohort design



BIBS - Barnsley Irritable Bowel Syndrome vs Supportive Listening vs usual care alone

 UK - Funded by Barnsley Small Grants Fund, Friends of Barnsley Hospital, Homeopathy Research Institute

 PI: Kapil Kapur

 Leeds East NHS Ethics approval obtained– who required full information to be provided to all participants L

· Recruitment: target 200; 100 identified - patients with IBS through GP mail out, recruitment on hold currently

 Trials planned: 1 = HIBS – Homeopathy vs Supportive Listening vs TAU for IBS



Back pain

 UK - Funded by DH Career Scientist Award (H. MacPherson) "Vivienne Dascanio" <> PhD student

 NHS Ethics approval obtained– who required a 2 stage recruitment process – 1) cohort and then 2) trial

 Recruitment: target 100; x identified - patients with back pain through GP mail out – included if they have reported back pain in last 5 years

 Trials planned: ?

 Info given about a range of txs (manual therapy/ or acupuncture – tick box) and patients asked for their preference – those who express pref are then randomised to either pref tx or usual care

 Dascanio VC, Birks Y, Torgerson D. A pilot factorial randomised cohort trial of manual therapy or acupuncture for low back pain. Trials. 2011; 12(Suppl 1): A150.



Cohorts and Trials within Cohorts

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