Maxime DOUGADOS Paris-Descartes University, Medicine Faculty; UPRES EA-4058; AP-HP, Cochin Hospital, Rheumatology B Dpt PARIS, France Status versus Changes:

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Presentation transcript:

Maxime DOUGADOS Paris-Descartes University, Medicine Faculty; UPRES EA-4058; AP-HP, Cochin Hospital, Rheumatology B Dpt PARIS, France Status versus Changes: Feeling Good versus Feeling Better

Variable PAIN (VAS 0-100) Pain Patient # months (60) 30 Pain Patient # months (60) 30 Pain Patient # months (60) 30 Pain Patient # months (60)  =50

Status versus Changes: Feeling Good versus Feeling Better Points to consider a)How to present the results b)How to switch a continuous variable into a dichotomous variable? c)How to evaluate the clinical relevance of the technic of reporting?

Status versus Changes: Feeling Good versus Feeling Better Points to consider a)How to present the results b)How to switch a continuous variable into a dichotomous variable? c)How to evaluate the clinical relevance of the technic of reporting?

Status versus Changes: Feeling Good versus Feeling Better Responder:change in VAS (0-100) during the study >MCII (Minimum Clinically Important Improvement) Remission/satisfied:absolute value of VAS (0-100) at the end of the study <PASS (Patient Acceptable Symptom State) Continuous variable mean change Binary variable (changes) Binary variable (status) weeks Pain (0-100 mm VAS) % responders* % satisfied/ remission** Placebo Active How to present the results

Status versus Changes: Feeling Good versus Feeling Better Technics of reporting  Mean changes versus percentage patients It’s good to feel better but it’s better to feel good It’s better to feel better/good AS SOON AS POSSIBLE It’s even better to feel better/good as soon as possible and FOR AS LONG AS POSSIBLE It’s good to feel better/good for as long as possible  Percentage patients

Status versus Changes: Feeling Good versus Feeling Better Presentation of continuous variables  Table (example: NSAID in painful shoulder*)  Figure (example: TICORA trial**) *Dougados M et al. Plos Clin trials2007,2(3),e9 **Grigor C et al. Lancet, 2004;364: Treatment groupBaselineChanges Active 68   26 Placebo 68   25 DAS Groupe A =traitement selon les habitudes du rhumatologue (« pratique quotidienne ») Groupe B =traitement selon les résultats du DAS (« pratique guidée »)

Status versus Changes: Feeling Good versus Feeling Better Presentation of dichotomous variables To feel better To feel good EULAR responders % patients* DAS < 3.2 % patients *Cohen SB et al. Arthritis Rheum 2006; It’s good to feel better but it’s better to feel good (example: Rituximab versus placebo in RA: REFLECT study)

Status versus Changes: Feeling Good versus Feeling Better Presentation of dichotomous variables It’s better to feel better/good as soon as possible (example: TEMPO trial). Copyright ©2006 BMJ Publishing Group Ltd. van der Heijde, D et al. Ann Rheum Dis 2006;65: Figure 3 Kaplan-Meier estimation of time to HAQ disability scores & lt; =0.5 and sustained for 6 months.

Status versus Changes: Feeling Good versus Feeling Better Presentation of dichotomous variables It’s even better to feel better/good as soon as possible for AS LONG AS POSSIBLE (example: NSAIDs versus placebo in acute shoulder pain). Dougados M et al. Plos Clin trials2007,2(3),e9 Success* * % patients with a pain VAS <30 over time p= Success* * % patients with a sustained pain VAS <30 p=0.0036

Status versus Changes: Feeling Good versus Feeling Better Presentation of dichotomous variables It’s good to feel better/good for AS LONG AS POSSIBLE.  % patients with a « success » during 2 or 3 consecutive visits.  % patients with a « success » during 6 consecutive monthly visits in a one/two years trial.  ConRew Scores

Status versus Changes: Feeling Good versus Feeling Better Presentation of continuous variables  Patient #x months  Evaluation of patient #x Major Clinical Response (FDA proposal) MCR = yes if success at 6 consecutive visits x x x x x x x = YES Con Rew System  Unweighted 0 I I 0 I I I I I I I 0 I = I0  Weighted 1 0 I I+I 0 I+I I+I I+I I+I I+I I+I I+I 0 I = I7  Weighted 2 0 I I+I 0 I I+I I+2 I+3 I+4 I+5 I+6 0 I = 32

Status versus Changes: Feeling Good versus Feeling Better ACR20-MCR (% patients) It’s good to feel good/better for as long as possible (example: TEMPO trial*) Con Rew Unweighted (% patietns) Con Rew Weighted MTX n = 228 ETN n = 223 ETN + MTX n = 231 MTX n = 228 ETN n = 223 ETN + MTX n = 231 n = 228 n = 223 n = 231 *van der Heijde D et.al. Ann Rheum Dis 2006;64:1582-7

Status versus Changes: Feeling Good versus Feeling Better Points to consider a)How to present the results b)How to switch a continuous variable into a dichotomous variable? c)How to evaluate the clinical relevance of the technic of reporting?

Status versus Changes: Feeling Good versus Feeling Better How to switch a continuous into a dichotomous variable?  Doctor’s perspective  Patient’s perspective  Trialist’s perspective

Status versus Changes: Feeling Good versus Feeling Better How to switch a continuous into a dichotomous variable?  Doctor’s perspective  Patient’s perspective  Trialist’s perspective

Status versus Changes: Feeling Good versus Feeling Better How to switch a continuous into a dichotomous variable?  Trialist’s perspective  Objective:to propose a cut-off which takes into account the variability of the technic.  Methods:Bland & Altman (Smallest Detectable Difference)

Status versus Changes: Feeling Good versus Feeling Better Smallest Detectable Difference (SDD) or Minimal Individual Difference (MID)* Patient *Bland & Altman, Lancet 1986;i: Analysis 1 a 1. x 1 Analysis 2 a 2. x 2 Delta (a 1 -a 2 ) m(x 1 -x 2 ) ± SD (x 1 -x 2 ) How to switch a continuous into a dichotomous variable?  Trialist’s perspective

Status versus Changes: Feeling Good versus Feeling Better -2 -1,5 -0,5 0 0,5 1 1, Mean-2SD Mean+2SD Mean Mean JSW (mm) Smallest Detectable Difference Example: Radiological hip joint space width *Auleley GR…Dougados M, Ann Rheum Dis, 2000;59:422-7 How to switch a continuous into a dichotomous variable?  Trialist’s perspective

Status versus Changes: Feeling Good versus Feeling Better How to switch a continuous into a dichotomous variable?  Doctor’s perspective  Patient’s perspective  Trialist’s perspective

Status versus Changes: Feeling Good versus Feeling Better How to switch a continuous into a dichotomous variable?  Doctor’s perspective  Objective:to propose a cut-off which takes into account the capacity to predict a « hard » end-point.  Methods:- Longitudinal study - R.O.C. technic

Status versus Changes: Feeling Good versus Feeling Better Example: Radiological hip joint space width (mm)* Study design: X-rays: Requirement to THR: N = 384 ROC curve analysis / / / / / / / / / / / / / / / / / Years *Maillefert JF, …, Dougados M. Rheumatology (Oxford) 2002;41:142-7 How to switch a continuous into a dichotomous variable?  Doctor’s perspective (Predictive validity)

Status versus Changes: Feeling Good versus Feeling Better Doctor’s perspective (Predictive validity) Example: Radiological hip joint space width (mm)* Se = % patients with a change in JSW (mm) over a specific cut-off between baseline and year 2 requiring a Total Hip Replacement between year 2 and year 5. 1-Spe = % patients with a change in JSW (mm) below a specific cut-off between baseline and year 2 not requiring a Total Hip Replacement between year 2 and year 5. Absolute changes in JSW between baseline and 2 year follow-up Sensitivity (%) 1- specificity How to switch a continuous into a dichotomous variable? *Maillefert JF, …, Dougados M. Rheumatology (Oxford) 2002;41:142-7

Status versus Changes: Feeling Good versus Feeling Better Patients without THA (%) Time from baseline (months Decrease in JSW ≤ 0.4 mm Decrease in JSW > 0.4 mm Example: Radiological hip joint space width (mm)* Patients with a radiological JSW change over 0.4 mm between baseline and year 2 (n = 171). Patients with a radiological JSW change below 0.4 mm between baseline and year 2 (n = 213). 1 How to switch a continuous into a dichotomous variable? Doctor’s perspective (Predictive validity) *Maillefert JF, …, Dougados M. Rheumatology (Oxford) 2002;41:142-7

Status versus Changes: Feeling Good versus Feeling Better Number of patients X-rays (Change in joint space width: mm) N = ,4 0,0 -0,4 -0,8 -1,0 -1,4 -1,8 -3,0 How to switch a continuous into a dichotomous variable? Example: change in JSW in hip OA

Status versus Changes: Feeling Good versus Feeling Better % patients Radiological progression YES n = 90 NO n = How to switch a continuous into a dichotomous variable? Example: change in JSW in hip OA

Status versus Changes: Feeling Good versus Feeling Better How to switch a continuous into a dichotomous variable?  Doctor’s perspective  Patient’s perspective  Trialist’s perspective

Status versus Changes: Feeling Good versus Feeling Better How to switch a continuous into a dichotomous variable?  Patient’s perspective  Objective:to propose a cut-off which takes into account the patient’s opinion.  Methods: Study design Cross-sectional (PASS) Longitudinal (MCII) Technic R.O.C. 75 th percentile

Status versus Changes: Feeling Good versus Feeling Better Determination of the optimal cut-offs in changes in changes (MCII) and/or absolute values (PASS) in symptomatic OA variables

Status versus Changes: Feeling Good versus Feeling Better  4 weeks duration  Baseline – final visits  At baseline and final visits, outcome measures  At final visit, « gold standard » questions  Pain  Function  Global  Improvement  Status MCII - PASS  Patient’s perspective

Status versus Changes: Feeling Good versus Feeling Better Aspects of the cumulative distribution function used to determine the PASS (pain scores in patietns with knee OA)

Status versus Changes: Feeling Good versus Feeling Better *Tubach F, …, Dougados M et al. Ann Rheum Dis 2005;64:28-33,34-7 Pain VAS How to evaluate the clinical relevance of the technic of reporting? Responder versus Status: the patient’s perspective

Status versus Changes: Feeling Good versus Feeling Better *Tubach F, …, Dougados M et al. Ann Rheum Dis 2005;64:28-33,34-7 How to evaluate the clinical relevance of the technic of reporting? Responder versus Status: the patient’s perspective Pain VAS  Baseline value – MCII = PASS

Status versus Changes: Feeling Good versus Feeling Better How to evaluate the clinical relevance of the technic of reporting? Responder versus Status: the patient’s perspective *Tubach F, …, Dougados M et al. Ann Rheum Dis 2005;64:28-33,34-7 MCII PASS Baseline absolute value

Status versus Changes: Feeling Good versus Feeling Better Points to consider a)How to present the results b)How to switch a continuous variable into a dichotomous variable? c)How to evaluate the clinical relevance of the technic of reporting?

Status versus Changes: Feeling Good versus Feeling Better How to evaluate the clinical relevance of the technic of reporting?  The doctor’s perspective  The patient’s perspective  The trialist’s perspective

Status versus Changes: Feeling Good versus Feeling Better How to evaluate the clinical relevance of the technic of reporting?  The doctor’s perspective  The patient’s perspective  The trialist’s perspective

Status versus Changes: Feeling Good versus Feeling Better How to evaluate the clinical relevance of the technic of reporting?  Objective:To decrease the number of patients to be recruited in a trial.  Methods:Sample size calculation based on the proposed technic of reporting  The trialist’s perspective

Status versus Changes: Feeling Good versus Feeling Better How to evaluate the clinical relevance of the technic of reporting?   = 5%,  = 10%, two tailed test  Expected placebo effect: the one observed in a previous trial with the proposed technic of reporting.  Expected active effect: the one observed in a previous trial with the proposed technic of reporting.  The trialist’s perspective (Number Need to Study) The lowest NNS, the highest value of the technic.

Status versus Changes: Feeling Good versus Feeling Better How to evaluate the clinical relevance of the technic of reporting?  The trialist’s perspective (NNS: Number Need to Study) (example: AIM trial*) *Dougados M et al., Ann Rheum Dis 2009;68:484-9 Technic of reportingL.R.+ DAS28-CRP-AUC23 % responders (ACR20))69 % good condition (DAS < 3.2)71 Time to better (ACR20) condition71 Time to good (DAS < 3.2) condition113 Time to sustained better (ACR20) condition39 Time to sustained good (DAS < 3.2) condition57 Durability (unweighted Con Rew)79

Status versus Changes: Feeling Good versus Feeling Better How to evaluate the clinical relevance of the technic of reporting?  The doctor’s perspective  The patient’s perspective  The trialist’s perspective

Status versus Changes: Feeling Good versus Feeling Better How to switch a continuous into a dichotomous variable?  The doctor’s perspective (predictive validity)  Objective:to predict a subsequent « hard » end-point.  Methods: Longitudinal study Technic:Likelihood ratio: Se/1-Spe Success yes/no Radiological progression yes/no

Status versus Changes: Feeling Good versus Feeling Better Example:AIM trial Analysis Radiological progression at year 1 yesno yes ab no cd Success at month 6 The highest L.R.+, the highest value of the technic Radiological progression:changes after 1 year Success at 6 months Se = a/a+c Spe = d/b+d L.R. + = Se/1-Spe  The doctor’s perspective (predictive validity)

Status versus Changes: Feeling Good versus Feeling Better How to evaluate the clinical relevance of the technic of reporting?  The doctor’s perspective (capacity to predict a subsequent radiological progression) (example: AIM trial*) Technic of reportingL.R.+ DAS28-CRP-AUC0.54 % responders (ACR20))0.94 % good condition (DAS < 3.2)1.37 Time to better (ACR20) condition1.11 Time to good (DAS < 3.2) condition1.30 Time to sustained better (ACR20) condition1.24 Time to sustained good (DAS < 3.2) condition1.34 Durability (unweighted Con Rew)1.31 *Dougados M et al., Ann Rheum Dis 2009;68:484-9

Status versus Changes: Feeling Good versus Feeling Better How to evaluate the clinical relevance of the technic of reporting?  The doctor’s perspective  The patient’s perspective  The trialist’s perspective

Status versus Changes: Feeling Good versus Feeling Better How to switch a continuous into a dichotomous variable?  The patient’s perspective (face validity)  Objective:to correlate with the patient’s opinion.  Methods: Longitudinal study Technic:Likelihood Ratio Success yes/no Patient’s good condition yes/no

Status versus Changes: Feeling Good versus Feeling Better Patient’s opinion: at month 6, SF36 question #1: « in general, would you say that your health is poor, fair versus good, very good, excellent » Patient’s good condition at month 6 yesno yes ab no cd Success at month 6 The highest L.R.+, the highest value of the technic  The patient’s perspective (capacity to correlate with the patient’s opinion) Example:AIM trial Evaluation: Se = a/a+c Spe = d/b+d L.R.+ = Se/1-Spe

Status versus Changes: Feeling Good versus Feeling Better How to evaluate the clinical relevance of the technic of reporting?  The patient’s perspective (capacity to correlate with the patient’s opinion) (example: AIM trial*) *Tubach F, …, Dougados M et al. Ann Rheum Dis 2005;64:34-7 Technic of reportingL.R.+ DAS28-CRP-AUC0.40 % responders (ACR20))1.27 % good condition (DAS < 3.2)1.77 Time to better (ACR20) condition1.31 Time to good (DAS < 3.2) condition1.70 Time to sustained better (ACR20) condition1.65 Time to sustained good (DAS < 3.2) condition3.09 Durability good condition (unweighted Con Rew)1.70

Status versus Changes: Feeling Good versus Feeling Better Conclusions (1/2) 1.Evaluation of binary variables (% success) is more clinically meaningful than evaluation of continuous variables (mean changes). 2.Evaluation of status is more clinically meaningful than evaluation of changes. 3.Time to success and sustainability of the success are important points to consider.

Status versus Changes: Feeling Good versus Feeling Better Conclusions (2/2) It’s good to feel better but it’s better to feel good and even better if as soon as possible and for as long as possible.