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Schizophrenia trails - past, present, future Mahesh Jayaram

Schizophrenia trails - past, present, future Mahesh Jayaram. Cochrane Schizophrenia Group. Cochrane Schizophrenia Group. Schizophrenia trials....the past. 100. R. 2. = 0.59. 90. 80. 70. 60. 50. Number of trials. 40. 30. 20. 10. 0. 1970. 1980. 1960. 1990.

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Schizophrenia trails - past, present, future Mahesh Jayaram

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  1. Schizophrenia trails -past, present, futureMahesh Jayaram

  2. Cochrane Schizophrenia Group

  3. Cochrane Schizophrenia Group

  4. Schizophrenia trials....the past

  5. 100 R 2 = 0.59 90 80 70 60 50 Number of trials 40 30 20 10 0 1970 1980 1960 1990 Number of reports per year* * Thornley & Adams. BMJ, 1998

  6. Number of reports per year* * Updated Jayaram 2007

  7. Source of trials* Source of trials (past) 2% Australia Africa-Asia 5% South & Central America 1% North America 54% Europe 37% * Thornley & Adams. BMJ, 1998

  8. Source of trials* Source of trials (New Slide) Unclear 8.5% Africa 0.5% Multinational 1% Rest of Asia 7% South America 1% China 16% Australia & NZ 2% North America 36% Europe 29% * Updated Jayaram 2007

  9. 120 100 80 60 40 20 0 Average size of trial over time* Number of trials R 2 = 0.57 1960 1970 1980 1990 * Thornley & Adams. BMJ, 1998

  10. Average size of trial over time* * Updated Jayaram 2007

  11. Frequency of trial size 500 400 300 Number of studies 200 100 0 0-20 401+ 41-60 61-80 21-40 81-100 101-120 121-140 141-160 161-180 181-200 201-220 221-240 241-260 261-280 281-300 301-320 321-340 341-360 361-380 381-400 Number of participants

  12. 801 (40%) 538 (27%) 279 (14%) 169 (8%) 115 (6%) 89 (4%) 9 (5%) Numbers of trials by duration 800 700 600 500 Number of trials 400 300 200 100 0 < 1 week 1-6 week >6wk-6mo >6mo-1yr >1yr-5yr 5+ yr Unknown

  13. 60% 50% 40% 30% 20% 10% 0% Loss to follow-up Clozapine Quetiapine Olanzapine Risperidone

  14. Schizophrenia trials....the present • Trials present - does systematically reviewing current and past studies help?

  15. Two types of reviews

  16. Two types of reviews Traditional Systematic

  17. Two types of reviews Traditional Systematic Winter, Don River

  18. Two types of reviews Traditional Systematic Winter, Don River Winter, Don River; AJ Casson

  19. Thrombolytic therapy for acute MI Textbook/Review recommendations Date RCT No 1 1 2 3 4 10 22 33 70 23 65 149 * * * * * * * * 6k 22k 47k 1960 1970 1980 1990 R / Sp Exp Nm 21 5 10 2 8 7 8 12 4 3 1 1 1 1 1 7 23 7 1 1 2 8 7 2 p<.01 p<.001 p<.00001 Treatment Better Treatment Worse From Antman et al, 1992

  20. Increasing impact of systematic reviews

  21. Increasing impact of systematic reviews

  22. Increasing impact of systematic reviews

  23. Increasing impact of systematic reviews Jayaram, Hosalli & Stroup

  24. Schizophrenia trials....future

  25. Explanatory vs pragmatic trials • Participants - rigorously diagnosed vs clinical diagnosis • Interventions - rigid regimens vs clinical judgement • Outcomes - meticulously measured outcomes vs outcomes that you would be embarrassed not to record in the notes

  26. CUtLASS and CATIE

  27. CUtLASS and CATIE

  28. $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$ CUtLASS and CATIE ££

  29. RCTs n/N n/N RR (random) CI (95%) Risperidone vs Olanzapine - before 9 228/657 174/667 1.33 (1.14, 1.55) vs Olanzapine - after 12 594/1178 498/1212 1.19 (1.10, 1.28) vs Quetiapine - before 1 59/175 176/553 1.06 (0.83, 1.35) vs Quetiapine - after 3 321/538 465/913 0.92 (0.84, 1.00) vs Perphenazine - before 1 4/55 15/52 0.88 (0.47, 1.64) vs Perphenazine - after 2 267/396 211/313 0.99 (0.90, 1.08) vs Amisulpride - before 1 32/113 37/115 0.88 (0.59, 1.31) vs Amisulpride - after 2 41/135 40/128 1.02 (0.58, 1.80) vs Sulpiride 1 27/58 9/22 1.14 (0.64, 2.02) Olanzapine vs amisulpride - before 1 42/188 39/189 1.08 (0.74, 1.59) vs amisulpride - after 2 55/245 42/202 1.07 (0.74, 1.54) Sulpiride vs Amisulpride 1 27/58 3/13 2.02 (0.72, 5.65) vs Olanzapine 1 27/58 13/50 1.79 (1.04, 3.08) vs Perphenazine 2 10/55 16/56 0.67 (0.24, 1.87) vs Quetiapine 1 27/58 12/23 0.89 (0.55, 1.44) Leaving the study early 0.5 0.7 1.0 1.5 2.0 Outcome: Leaving the study early – before and after

  30. Forrest Plot

  31. Forrest Plot Study IDs

  32. Forrest Plot Sample sizes

  33. Forrest Plot Line of no difference Line of no difference

  34. Forrest Plot Line of no difference Line of no difference Pooled result

  35. RCTs n/N n/N RR (random) CI (95%) Risperidone vs Olanzapine - before 9 228/657 174/667 1.33 (1.14, 1.55) vs Olanzapine - after 12 594/1178 498/1212 1.19 (1.10, 1.28) vs Quetiapine - before 1 59/175 176/553 1.06 (0.83, 1.35) vs Quetiapine - after 3 321/538 465/913 0.92 (0.84, 1.00) vs Perphenazine - before 1 4/55 15/52 0.88 (0.47, 1.64) vs Perphenazine - after 2 267/396 211/313 0.99 (0.90, 1.08) vs Amisulpride - before 1 32/113 37/115 0.88 (0.59, 1.31) vs Amisulpride - after 2 41/135 40/128 1.02 (0.58, 1.80) vs Sulpiride 1 27/58 9/22 1.14 (0.64, 2.02) Olanzapine vs amisulpride - before 1 42/188 39/189 1.08 (0.74, 1.59) vs amisulpride - after 2 55/245 42/202 1.07 (0.74, 1.54) Sulpiride vs Amisulpride 1 27/58 3/13 2.02 (0.72, 5.65) vs Olanzapine 1 27/58 13/50 1.79 (1.04, 3.08) vs Perphenazine 2 10/55 16/56 0.67 (0.24, 1.87) vs Quetiapine 1 27/58 12/23 0.89 (0.55, 1.44) Leaving the study early 0.5 0.7 1.0 1.5 2.0 Outcome: Leaving the study early – before and after

  36. RCTs n/N n/N RR (random) CI (95%) Risperidone vs Olanzapine - before 9 228/657 174/667 1.33 (1.14, 1.55) vs Olanzapine - after 12 594/1178 498/1212 1.19 (1.10, 1.28) vs Quetiapine - before 1 59/175 176/553 1.06 (0.83, 1.35) vs Quetiapine - after 3 321/538 465/913 0.92 (0.84, 1.00) vs Perphenazine - before 1 4/55 15/52 0.88 (0.47, 1.64) vs Perphenazine - after 2 267/396 211/313 0.99 (0.90, 1.08) vs Amisulpride - before 1 32/113 37/115 0.88 (0.59, 1.31) vs Amisulpride - after 2 41/135 40/128 1.02 (0.58, 1.80) vs Sulpiride 1 27/58 9/22 1.14 (0.64, 2.02) Olanzapine vs amisulpride - before 1 42/188 39/189 1.08 (0.74, 1.59) vs amisulpride - after 2 55/245 42/202 1.07 (0.74, 1.54) Sulpiride vs Amisulpride 1 27/58 3/13 2.02 (0.72, 5.65) vs Olanzapine 1 27/58 13/50 1.79 (1.04, 3.08) vs Perphenazine 2 10/55 16/56 0.67 (0.24, 1.87) vs Quetiapine 1 27/58 12/23 0.89 (0.55, 1.44) Leaving the study early Jayaram, 2007, in press 0.5 0.7 1.0 1.5 2.0 Outcome: Leaving the study early – before and after

  37. Cochrane Schizophrenia Group

  38. Cochrane Schizophrenia Group

  39. Cochrane Schizophrenia Group

  40. Cochrane Schizophrenia Group

  41. Cochrane Schizophrenia Group

  42. Cochrane Schizophrenia Group

  43. I-IV TREC-Rio-1 (n=300) TREC-India-1 (n=200) TREC-Rio-2 (n=316) TREC-India-2 (n=300)

  44. The UK PROMPTS (n=764) I-IV TREC-Rio-1 (n=300) TREC-India-1 (n=200) TREC-Rio-2 (n=316) TREC-India-2 (n=300)

  45. The UK PROMPTS (n=764) I-IV TREC-Rio-1 (n=300) TREC-India-1 (n=200) TREC-Rio-2 (n=316) TREC-India-2 (n=300) LEEDS - Leeds Evaluation of Efficacy of Detoxification Study – Homeless (n=60) – HMP Armley (n=90) – Multi-prison (n=340)

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