THE SHORT FORM OF THE ENDOMETRIOSIS HEALTH PROFILE QUESTIONNAIRE (EHP-5) :

Transcription

1 1 THE SHORT FORM OF THE ENDOMETRIOSIS HEALTH PROFILE QUESTIONNAIRE () : EVALUATING RESPONSIVENESS TO CHANGE OF THE FRENCH VERSION AND COMPARISON WITH EQ-5D Gabrielle Aubry 1, Marion Ravit 1, Guillemette Thiollier 2, Cyrille Huchon 1,2, Pierre Panel 3, Arnaud Fauconnier 1,2 (1) Research unit EA 7285 RISCQ, Université Versailles St-Quentin, Montigny-le-Bretonneux, France (2) Department of Gynaecology & Obstetrics, Centre Hospitalier Intercommunal de Poissy Saint-Germain, Poissy, France (3) Department of Gynaecology & Obstetrics, Centre Hospitalier André Mignot, Versailles, France Disclosure of Interest This work was fonded by a grant from Nordic Pharma The EndoQual study was fonded by the DRCDI of Versailles, France

2 Dysmenorrhea Dyspareunia 2 Introduction Dyschezia Infertility Symptoms Chronic Pelvic Pain Sexual Life Mobility and daily activities Endometriosis Health Related Quality of Life Praticians Incomprehension Chronicity - Social impact - Psychological impact Therapies - Surgical - Medical Well being Social isolation Work productivity Side Effects Limits

3 3 Introduction Different scales available, : an attractive tool Simple design easy to fill for the patient Scoring system permits a PRO* measurement Not time consuming for the patient and the pratician *Patient reported outcome

4 English Version scale Range: French Version Jenkison C, Qual Life Res, 2008 Renouvel F. J Gynecol Obstet Biol Reprod 2009

5 Material and Methods 5 Population Study 254 women with proven endometriosis In two French tertiary referral centers Design Prospective study Medical or Surgical therapy Patients fulfilled the scale before (T0) and within 12 months after treatment (T1) For comparison: fulfilled at the same time the french version of the EQ-5D (range -0.59;1) Main outcomes measures Abbott, Fertility & Sterility, 2004 Rabin, Ann Med, Known group validity: exploring the ability of the scale to reflect differences between groups expected to differ due to known characteristics. 2-Responsiveness to change: evaluating the efficacy of the scale at detecting and describing changes in patient s health status over time 3-Minimal Clinically Important Difference (MCID): defining a threshold above which the outcome is experienced as relevant for the patient

6 Material and Methods-Statistics Evaluation of Known group validity and Responsiveness to change Effect Size (ES)= the magnitude of the difference between two groups - quantitative measure (Cohen s d) - Significant if the doesn t recover 0 - Interpretation: 0,2 = small 0,5 = medium 0,8 = large 3- MCID Mean score change = difference of score between T0 and T1 In a subgroup of patients whom reported a minimal change after treatment ( somewhat better or somewhat worse ) on a Global Response Rating Scale SPSS Statistics IBM Software Version22

7 Results Flow chart Inclusion N=254 Characteristics No (%) Mean+-SD Hospital Versailles Poissy 137 (60%) 91 (40%) Age (range years) 33 ± 6.7 BMI (range Kg/m2) 22 ± 4.6 Parity (range 0-3, N=205) Nulliparity 137 (67%) ± 0.8 Time 0 (T0) N=228 Exclusions: 12 (4.7%) Unfilled scales: 14 (5.5%) Treatment - medical = 40 (17.5%) - surgery= 188 (82.5%) (complete 82%, incomplete 12%, NR 6%) Gravidity (range 0-7,N=200) Nulligravidity 114 (57%) Previous abdominal surgery (N=220) 89 (44.5%) Previous surgery for endometriosis (N=224) 92 (41%) Infertility (N=221) 83 (37,5%) Pain (VAS; N=215) < (62%) 81 (38%) 0.82 ± 1.22 Time 1 (T1) N=137 (60%) AFSr Stage (N=142) I-II III-IV 44 (31%) 98 (69%)

8 8 Results: Known group validity EQ5-D Patients characteristics N Mean± SD ES CI 95% ES EQ5D N EQ5D Mean± SD ES CI 95% ES Pain VAS < ± ± ± ± Dysmenorrhea VAS < ± ± ± ± Dyschezia No Yes ± ± ± ± Duration of pain= Nb days/month < ± ± ± ± ± ± Automedication 1 >= ± ± ± ± Infertility No Yes ± ± ± ± Trend to a better known group validity for

9 Results: Responsiveness to change (1) 9 EQ5-D ES=0.93 ( ) ES=0.92 ( ) ES=1.02 ( ) 0,81 0,61 0,41 score Before After EQ-5D value 0,21 0,01-0,19 All patients Surgical Group Medical Group Before After 10-0,39 0 All patients Surgical Group Medical Group -0,59 ES=1.08 ( ) ES=1.10 ( ) ES=0,78 ( ) Figure 1. Comparison of score before and after for all patients and according type of treatment Figure 2. Comparison of EQ-5D value before and after for all patients and according type of treatment Both Scales show large and significant ES No significant differences between the 2 scales

10 Results: Responsiveness to change (2) The more symptomatic is the patient, the better is the responsiveness to change 10 EQ5-D score ES=0.90 ( ) N=134 Major pain VAS<7 ES=1.37 ( ) N=81 Major pain VAS>=7 Before After EQ_5D value 1,01 0,81 0,61 0,41 0,21 0,01-0,19-0,39-0,59 Pain ES= VAS 0.88 <7 Pain ES=1.29 VAS >=7 ( ) ( ) N=134 N=81 Before After Figure 3. Comparison of score before and after according to the initial VAS score Figure 4. Comparison of EQ-5D before and after according to the initial VAS score

11 Results: MCID (1) 11 In case of improvement* EQ5-D Mean change = SE= 2.65 Mean change = 0.25 SE=0.05 N=39 N=37 If your patient s score change reaches this amount of change, you can consider that she experienced a clinical amelioration *according to the response at the global rate of change scale

12 12 Conclusion Quality of life measurement is part of an optimal management and EQ-5D Useful tools may be of interest for research studies Permits a global and unique scoring measure May be easier to interpret Trend to a better external validity (known group validity) Particularly Suitable for daily pratice (MCID)

13 13 Improve quality of life in endometriosis : a real challenge Jacqueline with crossed hands, Picasso, 1954