QUALITY OF LIFE - A FEW DEFINITIONS “.….gap between expectations and achievement: the smaller the gap, the higher the quality of life” Calman …..ability to function cognitively, physically, socially and sexually, to perform usual daily activities” Stewart & King “…..overall satisfaction with life and sense of personal well-being” Shumaker QUALITA’ DI VITA Salvaguardare la salute di un individuo significa non solo assicurare il suo benessere fisico ma anche quello psicologico Menopause: factors that can affect QoL vasomotor and sleep disturbances psychological and emotional stress genitourinary and sexual complaints changes in body image op: backache, fractures CVD: angina Alzheimer disease QUALITA’ DI VITA •Uno dei principali sforzi del ginecologo dovrebbe essere quello di eliminare o migliorare questi sintomi • HRT può essere utilizzata per mantenere l’efficienza fisica e psicologica quotidiana della donna in menopausa Women’s Health Questionnaire (WHQ) scores according to menopausal status in 928 women 60 Anxiety/fears Attractiveness 50 Depressed mood 40 Memory/concentration 30 Menstrual symptoms Sexual behaviour 20 Sleep problems 10 Somatic symptoms 0 Premenopausal Postmenopausal Postmenopausal < 3 a. > 3 a. Vasomotor symptoms CONSEGUENZE DELLA MENOPAUSA A breve termine A medio termine Artralgie Ansia Sudorazioni Vampate Parestesie Palpitazioni Astenia Depressione Cefalea Insonnia Vertigini Precordialgie A lungo termine Osteoporosi Atrofia genito-urinaria Malattie cardiovascolari Peggioramento funzioni cognitive Danni cutanei e oculari Progetto Menopausa Italia sotto il patrocinio ed il coordinamento dell’AOGOI Obiettivi 1) descrivere l’epidemiologia dell’approccio diagnostico- terapeutico alla menopausa nei centri specialistici in Italia 2) descrivere le conseguenze della menopausa stessa sulla salute della donna. Eleggibili per lo studio tutte le donne osservate per la prima volta nel periodo di reclutamento presso i centri collaboranti Progetto Menopausa Italia sotto il patrocinio ed il coordinamento dell’AOGOI 99.363 donne arruolate al 02/02/02 240 SPAC 185 U.O. 1 CED PROGETTO DONNA QUALITÀ DI VITA 74 Centri Universitari e Ospedalieri sul territorio Nazionale Presidente Prof. A. R. Genazzani (Pisa) Comitato Scientifico Segreteria Scientifica Prof. C. Campagnoli (Torino) Prof .C. Nappi (Napoli) Dr. M. Gambacciani (Pisa) Prof. GiovanBatttista Serra(RM) Comitato di Coordinamento Prof. D. de Aloysio (Bologna) Prof. C. Donati Sarti (Perugia) Prof. S. Guaschino (Trieste) Prof. A. Cianci (Catania) Prof. F. Petraglia (Udine) Prof. S.. Schonauer (Bari) Prof. A. Volpe (Modena) Prof . G. Palumbo (Catania) Dr. A. Genazzani (Modena) Prof. F. Bottiglioni (Bologna) The WOMEN’S HEALTH QUESTIONNAIRE WHQ (by Myra Hunter) 36 items combined into nine factors describing: • somatic symptoms • depressed mood • cognitive difficulties • anxiety/fear • sexual function • vasomotor symptoms • sleeps problems • menstrual symptoms • attraction All the questions are rated on four-point scale. The MOS 36-Item Short-Form Health Survey (SF- 36) 36 items combined into eight factors • physical function • physical role • bodily pain • general health • vitality • social function • mental health and two summarizing measures • physical health • mental health The European Quality of Life Questionnaire EQ-5D Simple, generic measure Minimum number of questions It produces an overall single number, “an index” of health status Includes 5 dimensions: • mobility • personal care • usual activities • pain/discomfort • anxiety/depression) (with 5 questions, 3 levels of response for each dimension) QUALITY OF LIFE EVALUATION IN ITALIAN MENOPAUSAL WOMEN •Multicentric study on the quality of life (QoL ) in women aged between 45 and 65 years, attending menopause centres in Italy. •Each of 64 menopause centres involved recruited up to 50 women, using random lists stratified by HRT (yes – no). QoL variables • Age • marital status • employment, partners’ employment • Employment was considered as a proxy for socio-economic status. To this purpose, a socio-economic score (SES) was created, ranging from 1 to 6. The score was assigned as follows: unemployed, housewife=1; retired=2; unskilled worker=3; skilled worker, artisan=4; technical, clerical=5; professional, managerial=6. For married women, the profession scoring higher between wife and husband was considered. • • • • geographic area menopause duration presence of chronic diseases presence of HRT Percent distribution of the 2760 PMW according to HRT ( on HRT, n=1342, 49%). Women on HRT were significantly more likely to have a menopause duration >3 years and significantly less likely to suffer from chronic diseases. Chronic disease Duration of menopause noHRT 100 80 40 HRT HRT 0.00002 30 60 40 20 20 0 <3 >3 noHRT 10 YRS 0 0.0003 Percent distribution of the 2760 PMW according to geographic area. PMW attending menopause centres in northern Italy are older, with lower education, lower socio-economic score and longer menopause duration. nord centre sud 80 60 0.00007 30 40 20 20 10 0 0 <45 0.000001 40 45-54 <5 >54 6-8 9-13 >13 School education (years) age (yrs) 0.00001 40 80 0.00006 60 30 40 20 20 10 0 0 1 2 3 4 5 Socio-economic score 6 <3 >3 YSM (years) QUALITY OF LIFE EVALUATION IN ITALIAN MENOPAUSAL WOMEN 1. Correlates of QoL were first investigated with a series of bivariate analyses 2. To adjust for the possible confounding effects, multiple logistic regression analyses were applied to evaluate the independent role of variables investigated in predicting QoL Results of the stepwise logistic regression analyses with SF-36 scores as dependent variables. • school education (the higher the education, the better the QoL), • socio-economic score (the higher the SES, the better the QoL), • geographic area (women in southern Italy showing worse QoL), • presence of chronic conditions (associated with poorer QoL) • marital status and menopause duration are not related with any of the SF-36 areas Independent predictors of SF-36 domains HRT associated with better QoL in all of the areas investigated PCS * * MCS Vitality Social function HRT No HRT Sì * * * Role physical Role emotional Physical activity * * * * Mental health General health Bodily pain 0 20 40 * *p< 0.05 60 80 100 Stepwise logistic regression analyses with SF-36 scores as dependent variables. the use of HRT represents an independent predictor for limitations due to emotional problems Dolore corp. Salute generale Salute mental e Attività fisica Role physica l Social function Vitality MCS PCS NS NS NS NS NS 0.005 HRT Yes No Role emotional NS NS NS NS 1.0 1.3 WHQ scores according to HRT use HRT Sì HRT No * Vasomotor symptoms Somatic symptoms * Sleep problems * Sexual behaviour Menstrual symptoms * Attractiveness Anxiety/fears 0 20 • low school education * •low SES Memory/concentration Depressed mood A high score (lower QoL) is associated with: •living in Southern Italy * • presence of chronic diseases * 40 60 Results of the stepwise logistic regression analyses with WHQ scores as dependent variables according to HRT Anxiety/ fears Attractive ness Depression Memory/ concentr. Menstrual symptoms Odds Ratio HRT Sexual problems Somatic sympt. Odds Ratio NS NS NS NS No 1.0 1.5 p .0001 .003 Vasomotor sympt. Odds Ratio NS 1.0 1.4 Yes Sleep problems NS 1.0 2.6 .000 Untreated women showed a 40% increased risk of reporting anxiety/fears, a 50% increased risk of sexual problems and a more than two-fold increased risk of vasomotor symptoms EQ-5D: Percentages of respondents referring absence of problems Anxiety/depression * Pain/discomfort HRT No HRT Sì * Usual activity * Self-care Mobility * p< 0.05 0 20 40 60 80 100 EQ-5D Results of the stepwise logistic regression analyses Mobility Self-care Usual activities Pain/discomfort 0.02 0.03 HRT No 1.0 1.0 HRT Yes 1.4 1.2 p NS NS Anxiety/ Thermometer depression NS NS The presence of chronic conditions and the geographic area represent the most important predictors. After adjusting for the other variables investigated, women not treated with HRT show an increased risk of reporting problems in the areas of usual activities and pain/discomfort Progetto Menopausa Italia Lombardia in Coordinatore: Massimo Luer Situazione delle 18 SPAC della Lombardia al 24/02/2000 1301 1302 1303 1304 1305 1306 1307 1308 1309 1310 1311 1312 1313 1314 1315 1316 1318 1319 Ospedale S. Anna Divisione O. G. Istituti Ospedalieri Carlo Poma Divisone O. G. Clinica Ostetrico Ginecologica Spedali Civili. Ente Osp. Reg. Ospedale S. Giuseppe Divisione O. G. Ospedale Maggiore Divisione O. G. Ospedale di Treviglio Divisione O. G. Osp. Fornaroli Istituto Nazionale Tumori Ospedale Civile Ospedale Niguarda Ca' Granda Divisione O. G. Osp. Morelli Divisione O. G. Ospedale Vimercate Divisione O. G. Ospedale di Saronno Divisione O. G. Ospedale di Melegnano Divisione O. G. Ospedale di Lecco Divisone O. G. Ospedale Sesto S. Giovanni Divisione O.G. Casa di Cura S. Anna Divisione O.G. Clinica S. Carlo Divisione O.G. Como Mantova Brescia Milano Lodi Treviglio (BG) Magenta (MI) Milano Sondrio Milano Sondalo (SO) Vimercate (MI) Saronno (VA) Melegnano (MI) Lecco Sesto S. Giovanni (MI) Brescia Paderno Dugnano (MI) 10 136 1045 691 886 234 276 41 292 104 249 464 344 380 892 332 71 181 9 59 915 442 723 195 240 40 241 94 190 251 278 236 849 262 70 170 Età: media e deviazione standard Media: 54,31 Deviazione standard: 7,72 Numero soggetti: 5820 Età Menopausa spontanea Media: 49,15 Deviazione standard: 4,30 Numero soggetti: 3247 Età media d’insorgenza della menopausa in Europa Nazione Età media Inghilterra 50,8 Cecoslovacchia 51,2 Svezia 50,4 Scozia 50,1 Germania Est 51,1 Olanda 51,5 Italia 50,8 DETERMINANTI DELL’ETA’ DELLA MENOPAUSA • FUMO –non fumatrici –< 10 –10 - 20 –> 20 50,8 anni 50,7 anni 50,5 anni 50,0 anni • ETA’ AL MENARCA –<11 –12-13 – 14 50,4 anni 50,7 anni 51,2 anni FREQUENZA ALL’AMBULATORIO CONTROLLI SOLO 1° VISITA 29% 71% FREQUENZA ALL’AMBULATORIO 7% NESSUNA TERAPIA TERAPIA IN CORSO TERAPIA PREGRESSA 39% 54% SITUAZIONE NELLE DONNE CHE HANNO EFFETTUATO SOLO 1° VISITA VERALIPRIDE GIA' IN CORSO BIFOSFONATI ECC PRESCRITTA ESTROGENI TOPICI EP COMBINATI ESTROGENI TRANSD. 0 5 10 15 20 25 30 RELAZIONE FRA USO DI HRT PRIMA DELLA VISITA E FATTORI SELEZIONATI Odds Ratio (IC 95%) • ISTRUZIONE – Nessuna/elementare – Media – Superiore/università 1+ 1,33 (1,22 - 1,46) 1,39 (1,27 - 1,53) • IMC (kg/m2) – <23,8 – 23,8 - 27,2 – 27,2 1+ 0,76 (0,70 - 0,83) 0,60 (0,55 - 0,65) RELAZIONE FRA USO DI HRT PRESCRITTO ALLA VISITA E FATTORI SELEZIONATI Odds Ratio (IC 95%) • OSTEOPOROSI – No – Sì 1+ 1,42 (1,26 -1,61) • CVD – No – Sì 1+ 1,02 (0,95 - 1,10) SOSPENSIONE TERAPIA NELLE DONNE CHE HANNO EFFETTUATO PIU’ CONTROLLI TERAPIA CONTINUATA 8% TERAPIA SOSPESA 92% MOTIVI DI SOSPENSIONE DELLA TERAPIA 20 18 16 14 MASTODINIA RITENZIONE IDRICA DIFFIDENZA-PAURA PAURA CA FLUSSO ANOMALO ALLERGIA GENERALIZZATA IRRITAZIONE LOCALE 12 10 8 6 4 2 0 ESTROGENI TRANSDERMICI (82%) IDENTIKIT DELLE UTILIZZATRICI DI HRT • reddito familiare e livelli di scolarità superiore • più magre, praticano più esercizio fisico, hanno un assetto lipidico più favorevole • fumano di più e assumono più alcoolici • sono più spesso isterectomizzate • lamentano più spesso una sintomatologia climaterica (specie artralgie) CONCLUSIONI “Perceptions of well-being in healthy, post- menopausal women depend less upon biology than on socio-economic circumstances, individual experiences, resources and cultural morals” Hunt SM. Quality of Life Res 2000;9:709-719 Cross-sectional Evaluation of QoL, Menopause and HRT • different factors play an important role – low education is associated with a higher risk of reporting somatic and vasomotor symptoms, – low Social Economic Scores exerts a negative effect on attractiveness, depression and sleep problems • HRT is a factor that can modify at least some aspects of QoL in symptomatic PMW CONCLUSIONI HRT users • have a shorter duration of menopause • have less chronic diseases • tend to be slightly more educated and to belong to higher socio-economic classes, but these differences were marginal CONCLUSIONI • At univariate analyses, HRT users showed a significantly better QoL in all the areas investigated by the SF-36, in three of the six items of the EQ-5D and in all the symptoms scores of the WHQ, with the only exceptions of menstrual symptoms and memory/concentration. • After adjusting the analyses for a large array of different socioeconomic and clinical variables, several associations between HRT use and QoL became not significant, suggesting that they were mediated by the other factors considered in this study. • Nevertheless, HRT users showed a lower probability of reporting role limitations due to emotional problems (SF-36) and anxiety/fears (WHQ). • HRT was also associated with a lower probability of reporting problems in the usual activities and pain/discomfort items of the EQ5D CONCLUSIONI • When looking at menopause symptoms, HRT users showed highly significant better outcomes in vasomotor symptoms and sexual problems (particularly vaginal dryness). • HRT can be of benefit for many of the postmenopausal mood changes, pain perception and social functioning, sexual problems and vasomotor symptoms • untreated women have a 40-50% increase in the risk of suffering from anxiety and sexual problems, with an almost 3- fold increase in the incidence of hot flushes and sweats Lombardia Terapie e Peso 1600 1400 1200 1000 800 600 400 200 0 ND <50 51<>60 61<>70 71<>80 Fascie di Peso 81<>90 >90 Progetto Menopausa Italia Statistiche per la regione Lombardia Situazione al 24/02/2000 Situazione SPAC Lombardia al 24/02/2000 Spac 1300 1301 1302 1303 1304 1305 1306 1307 1308 1309 1310 1311 1312 1313 1314 1315 1316 1318 1319 Struttura Ospedale S. Carlo Borromeo Divisione O. G. Ospedale S. Anna Divisione O. G. Istituti Ospedalieri Carlo Poma Divisone O. G. Clinica Ostetrico Ginecologica Spedali Civili. Ente Osp. Reg. Ospedale S. Giuseppe Divisione O. G. Ospedale Maggiore Divisione O. G. Ospedale di Treviglio Divisione O. G. Osp. Fornaroli Istituto Nazionale Tumori Ospedale Civile Ospedale Niguarda Ca' Granda Divisione O. G. Osp. Morelli Divisione O. G. Ospedale Vimercate Divisione O. G. Ospedale di Saronno Divisione O. G. Ospedale di Melegnano Divisione O. G. Ospedale di Lecco Divisone O. G. Ospedale Sesto S. Giovanni Divisione O.G. Casa di Cura S. Anna Divisione O.G. Clinica S. Carlo Divisione O.G. Città Milano Como Mantova Brescia Milano Lodi Treviglio (BG) Magenta (MI) Milano Sondrio Milano Sondalo (SO) Vimercate (MI) Saronno (VA) Melegnano (MI) Lecco Sesto S. Giovanni (MI) Brescia Paderno Dugnano (MI) Totale Pazienti Cartelle Reclutate 1156 10 136 1045 691 886 234 276 41 292 104 249 464 344 380 892 332 71 181 708 9 59 915 442 723 195 240 40 241 94 190 251 278 236 849 262 70 170 4500 4226 4000 3532 3500 Estrogenica Transdermica Estrogenica per OS 3000 Estrogenica topica 2500 Progestinica per OS Estroprogestinica transdermica 2000 Associazioni estroprogestinica per OS Associazioni estrogeni-androgeni 1500 Antiestrogeni 1228 Bifosfonati e altri 1000 Veralipride Calcio 499 500 341 303 168 17 0 31 4 67 HRT AND QoL •Women on HRT were significantly more likely to have a menopause duration >3 years and significantly less likely to suffer from chronic diseases. HRT HRT free Duration of menopause < 3 years 627 (55%) 782 (64%) > 3 years 510 (45%) 444 (36%) Chronic diseases 306 (23%) 409 (29%) 0.00002 0.0003 “Healthy user effect” should be considered when we evaluate the HRT effects in Italy Progetto Menopausa Italia sotto il patrocinio ed il coordinamento dell’AOGOI Obiettivo migliorare la qualità di assistenza alle donne in menopausa favorendo la diffusione culturale tra medici, istituzione e diverse componenti del tessuto sociale, organizzando relazioni e programmi interdisciplinari. Si propone inoltre di istituire un laboratorio di epidemiologia al fine di valutare l'adeguatezza e la compliance delle strategie mediche, promuovere, partecipare e monitorare trials sperimentali VALUTAZIONE DELLA QUALITA’ DI VITA NELLE DONNE ITALIANE IN MENOPAUSA Questionario WHQ (Women’s Health Questionnaire) Questionario sviluppato in Inghilterra per valutare un ampio spettro di sintomi fisici e della sfera emotiva nelle donne di mezza età, con particolare attenzione alle modificazioni nello stato di salute e di benessere, legate alla menopausa. Il questionario è costituito di 36 domande con risposte su una scala a 4 punti. Le 36 domande si combinano in 9 fattori. VALUTAZIONE DELLA QUALITA’ DI VITA NELLE DONNE ITALIANE IN MENOPAUSA SF36 Health Survey Instrument Strumento generico più utilizzato in diversi paesi per la valutazione della QdV Contiene 36 items che concorrono a formare 8 scale (physical function, role physical, bodily pain, general health, vitality, social function, role emotional, mental health) e 2 misure riassuntive (stato di salute fisico e mentale) PROGETTO DONNA QUALITÀ DI VITA Confronto fra popolazione Italiana e Inglese* Età (media DS) Punteggi scale WHQ: Depressed mood Somatic Symptoms Vasomotor symptoms Anxiety/fears Sexual behaviour Sleep problems Menstrual symptoms Memory/concentration Attractiveness Campione UK (n=682) Campione Italia (n=416) 52.3 4.9 53.4 4.9 0.220.23 0.390.25 0.430.44 0.350.28 0.320.32 0.450.36 0.380.29 0.470.36 0.380.29 0.270.23 0.460.24 0.480.44 0.400.31 0.380.34 0.500.36 0.370.30 0.530.37 0.370.40 * M. Hunter. Psychology and Health 1992; 7: 45-54 Women’s Health Questionnaire (WHQ) scores according to menopausal status in 928 women Premenopausal Postmenopausal, <3 yrs Postmenopausal, >3 yrs WHQ scales Mean+SD Mean+SD Mean+SD p* Anxiety/fears 0.35+0.31 0.44+0.31 0.35+0.32 0.001 Attractiveness 0.31+0.38 0.42+0.41 0.34+0.37 0.003 Depressed mood 0.25+0.23 0.29+0.23 0.24+0.23 0.02 Memory/concentration 0.42+0.37 0.54+0.37 0.48+0.36 0.0002 Menstrual symptoms 0.41+0.30 0.39+0.31 0.11+0.13 0.01 Sexual behaviour 0.25+0.30 0.37+0.33 0.41+0.37 0.0001 Sleep problems 0.47+0.37 0.54+0.37 0.47+0.39 n.s. Somatic symptoms 0.43+0.25 0.48+0.24 0.41+0.23 0.008 Vasomotor symptoms 0.33+0.40 0.52+0.44 0.40+0.42 0.0001 * Kruskall-Wallis one-way ANOVA PROGETTO DONNA QUALITÀ DI VITA Valori SF-36 nelle due popolazioni Aree SF-36 Attività fisica Ruolo e salute fisica Ruolo emotivo Vitalità Salute mentale Salute in generale Dolore fisico Attività sociali *Mann-Whitney U-test Popolazione Centri per la generale menopausa (504 donne) (424 donne) 87.9 77.9 74.5 57.7 64.4 65.5 68.5 72.2 15.7 32.1 35.0 18.2 19.8 17.4 23.4 22.3 83.6 70.0 66.6 57.0 63.1 64.8 67.8 74.9 17.1 35.1 38.0 18.2 19.3 17.8 25.0 22.1 p* n.s. n.s. 0.01 n.s. n.s. n.s. n.s. n.s. “Progetto Donna Qualità di Vita” Prima Fase Risultati Lo studio ha dimostrato che : – la versione Italiana del WHQ è valida e riproducibile – non esistono differenze sostanziali in termini di percezione della qualità della vita tra la popolazione italiana e popolazioni dei Centri della Menopausa Independent predictors of SF-36 domains HRT associated with better QoL in all of the areas investigated, including also the two summary measures (physical and mental component scores). Bodily pain General health Mental health Physical activity Role emotio Role phys Social Vitality function HRT p=0.005 p=0.001 p=0.03 p=0.003 p=0.003 p=0.009 p=0.02 Yes No 67±24 64±23 64±18 61±18 64±19 62±20 85±17 82±19 71±37 66±39 74±35 69±37 74±21 72±22 MCS PCS p=0.03 p=0.03 p=0.008 59±19 57±19 45±11 44±11 49±8 48±8 EQ-5D : Percentages of respondents referring absence of problems and mean values of the thermometer, according to HRT use Mobility Self-care Usual activity Pain/discomfort Anxiety/ depression Thermometer HRT NS NS p=0.01 p=0.02 p=0.04 NS No 85% 96% 82% 34% 28% 72.7±16 Yes 88% 97% 86% 40% 33% 73.9±15 Women on HRT reported less often to have problems in the areas of usual activities, pain/discomfort and anxiety/depression WHQ scores according to HRT use A high score (lower QoL) is associated with low school education, low SES, living in Southern Italy and presence of chronic diseases HRT Yes No Anxiety/ fears Attractiv eness Depressi on Memory/ concent r. Menstru al sympto ms Sexual problem s Sleep problem s Somati c sympt. Vasomoto r sympt. p=0.0008 p=0.02 p=0.03 NS NS p=0.006 p=0.0004 p=0.006 p<0.0001 0.36±0.3 0.41±0.3 0.33±0.4 0.37±0.4 0.26±0.2 0.48±0.4 0.50±0.4 0.23±0.3 0.24±0.3 0.34±0.3 0.38±0.3 0.47±0.4 0.53±0.4 0.44±.3 0.47±.4 0.28±0.4 0.48±0.4 0.29±0.2