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

CONSEGUENZE DELLA MENOPAUSA A breve termine A medio termine A lungo termine Artralgie Ansia Sudorazioni Vampate Atrofia Parestesie genito-urinaria Palpitazioni Astenia Depressione Cefalea Insonnia Vertigini Precordialgie Osteoporosi 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

1 CED 240 SPAC 99.363 donne arruolate al 02/02/02 Progetto Menopausa Italia sotto il patrocinio ed il coordinamento dell’AOGOI 99.363 donne arruolate al 02/02/02 1 CED 240 SPAC 185 U.O.

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

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. 0.00002 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. 0.00007 0.000001 0.00001 0.00006

QUALITY OF LIFE EVALUATION IN ITALIAN MENOPAUSAL WOMEN Correlates of QoL were first investigated with a series of bivariate analyses 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 * * * * * * * * * * *p< 0.05

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 NS PCS 0.005 1.0 1.3   HRT Yes No MCS Vitality Social function Role physical Role emotional Attività fisica Salute mentale generale Dolore corp.

WHQ scores according to HRT use A high score (lower QoL) is associated with: low school education low SES living in Southern Italy presence of chronic diseases * * * * * * *

Results of the stepwise logistic regression analyses with WHQ scores as dependent variables according to HRT   1.0 2.6 .000 NS 1.5  .003 1.4    .0001 HRT Yes No p Vasomotor sympt. Odds Ratio Somatic sympt. Sleep problems Sexual problems Menstrual symptoms Memory/ concentr. Depression Attractiveness Anxiety/ fears Odds Ratio 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 * * * * p< 0.05

EQ-5D Results of the stepwise logistic regression analyses Mobility Self-care Usual activities Pain/discomfort Anxiety/ depression Thermometer p NS  0.02 0.03  HRT No 1.0 HRT Yes 1.4 1.2 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 in Lombardia Coordinatore: Massimo Luerti

Situazione delle 18 SPAC della Lombardia al 24/02/2000

Età: media e deviazione standard Numero soggetti: 5820

Età Menopausa spontanea Media: 49,15 Deviazione standard: 4,30 Numero soggetti: 3247

Età media d’insorgenza della menopausa in Europa

DETERMINANTI DELL’ETA’ DELLA MENOPAUSA FUMO non fumatrici 50,8 anni < 10 50,7 anni 10 - 20 50,5 anni > 20 50,0 anni ETA’ AL MENARCA <11 50,4 anni 12-13 50,7 anni  14 51,2 anni

FREQUENZA ALL’AMBULATORIO

FREQUENZA ALL’AMBULATORIO

SITUAZIONE NELLE DONNE CHE HANNO EFFETTUATO SOLO 1° VISITA

RELAZIONE FRA USO DI HRT PRIMA DELLA VISITA E FATTORI SELEZIONATI Odds Ratio (IC 95%) ISTRUZIONE Nessuna/elementare 1+ Media 1,33 (1,22 - 1,46) Superiore/università 1,39 (1,27 - 1,53) IMC (kg/m2) <23,8 1+ 23,8 - 27,2 0,76 (0,70 - 0,83)  27,2 0,60 (0,55 - 0,65)

RELAZIONE FRA USO DI HRT PRESCRITTO ALLA VISITA E FATTORI SELEZIONATI Odds Ratio (IC 95%) OSTEOPOROSI No 1+ Sì 1,42 (1,26 -1,61) CVD Sì 1,02 (0,95 - 1,10)

SOSPENSIONE TERAPIA NELLE DONNE CHE HANNO EFFETTUATO PIU’ CONTROLLI

MOTIVI DI SOSPENSIONE DELLA TERAPIA

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

HRT users CONCLUSIONI 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 socio-economic 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 EQ-5D

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

Progetto Menopausa Italia Statistiche per la regione Lombardia Situazione al 24/02/2000

Situazione SPAC Lombardia al 24/02/2000

HRT AND QoL 0.0003 409 (29%) 306 (23%) Chronic diseases 0.00002 Women on HRT were significantly more likely to have a menopause duration >3 years and significantly less likely to suffer from chronic diseases. 0.0003 409 (29%) 306 (23%) Chronic diseases 0.00002   782 (64%) 444 (36%) 627 (55%) 510 (45%) Duration of menopause < 3 years > 3 years HRT free HRT “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)

* M. Hunter. Psychology and Health 1992; 7: 45-54 PROGETTO DONNA QUALITÀ DI VITA Confronto fra popolazione Italiana e Inglese* * M. Hunter. Psychology and Health 1992; 7: 45-54

PROGETTO DONNA QUALITÀ DI VITA Valori SF-36 nelle due popolazioni *Mann-Whitney U-test

“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). p=0.008 49±8 48±8 PCS p=0.03 45±11 44±11 59±19 57±19 p=0.02 74±21 72±22 p=0.009 74±35 69±37 p=0.003 71±37 66±39 85±17 82±19 64±19 62±20 p=0.001 64±18 61±18 p=0.005 67±24 64±23 HRT Yes No MCS Vitality Social function Role phys Role emotio Physical activity Mental health General health Bodily pain

EQ-5D : Percentages of respondents referring absence of problems and mean values of the thermometer, according to HRT use 73.9±15 33% 40% 86% 97% 88% Yes 72.7±16 NS Thermometer 28% 34% 82% 96% 85% No p=0.04 p=0.02 p=0.01 HRT Anxiety/ depression Pain/discomfort Usual activity Self-care Mobility 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 p<0.0001 0.28±0.4 0.48±0.4 p=0.006 0.44±.3 0.47±.4 p=0.0004 0.47±0.4 0.53±0.4 0.34±0.3 0.38±0.3 NS 0.23±0.3 0.24±0.3 0.50±0.4 p=0.03 0.26±0.2 0.29±0.2 p=0.02 0.33±0.4 0.37±0.4 p=0.0008 0.36±0.3 0.41±0.3 HRT Yes No Vasomotor sympt. Somatic sympt. Sleep problems Sexual problems Menstrual symptoms Memory/ concentr. Depression Attractiveness Anxiety/ fears