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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
0
10
20
30
40
50
60
Premenopausal Postmenopausal< 3 a.
Postmenopausal> 3 a.
Anxiety/fears
Attractiveness
Depressed mood
Memory/concentration
Menstrual symptoms
Sexual behaviour
Sleep problems
Somatic symptoms
Vasomotor symptoms
CONSEGUENZE DELLA MENOPAUSA
A breve termine A medio termine A lungo termine
ArtralgieAnsiaSudorazioni
Vampate AtrofiaParestesie genito-urinariaPalpitazioniAsteniaDepressioneCefaleaInsonniaVertiginiPrecordialgie
Osteoporosi
Malattie
cardiovascolari
Peggioramento
funzioni cognitive
Danni cutanei e oculari
Progetto Menopausa Italia sotto il patrocinio ed il coordinamento
dell’AOGOI
Obiettivi1) 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 SPAC185 U.O.
1 CED
PROGETTO DONNA QUALITÀ DI VITA
PROGETTO DONNA QUALITÀ DI VITA
74 Centri Universitari e Ospedalieri sul territorio NazionalePresidente
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)
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 WOMEN’S HEALTH QUESTIONNAIREWHQ (by Myra Hunter)
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 MOS 36-Item Short-Form Health Survey (SF- 36)
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
10
20
30
40
Chronic disease
noHRT
HRT
0.0003
0
20
40
60
80
100
<3 >3 YRS
Duration of menopause
noHRT HRT
0.00002
Percent distribution of the 2760 PMW according to geographic area.
0
20
40
60
80
<45 45-54 >54
age (yrs)
nordcentresud
0
10
20
30
40
<5 6-8 9-13 >13
School education (years)
0.00007
0
10
20
30
40
1 2 3 4 5 6
Socio-economic score
0.000001
0.00001
0
20
40
60
80
<3 >3
YSM (years)
0.00006
PMW attending menopause centres in northern Italy are older, with lower
education, lower socio-economic score and longer menopause duration.
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
0 20 40 60 80 100
Bodily pain
General health
Mental health
Physical activity
Role emotional
Role physical
Social function
Vitality
MCS
PCSHRT No
HRT Sì
*p< 0.05*
*
**
*
*
*
**
*
Stepwise logistic regression analyses with SF-36 scores as dependent
variables.
NS
PCS
NSNSNSNS0.005
1.01.3
NS
NSNSNS
HRTYes
No
MCS
Vitality
Social functio
n
Role physic
al
Role emotion
al
Attività
fisica
Salutementa
le
Salutegenera
le
Dolore
corp.
the use of HRT represents an independent predictor for limitations due to emotional problems
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
0 20 40 60
Anxiety/ fears
Attractiveness
Depressed mood
Memory/ concentration
Menstrual symptoms
Sexual behaviour
Sleep problems
Somatic symptoms
Vasomotor symptoms
HRT Sì HRT No
*
**
**
*
*
Results of the stepwise logistic regression analyses with WHQ scores as dependent variables
according to HRT
1.02.6
.000
NSNS
1.01.5
.003
NSNSNSNS
1.01.4
.0001
HRT
Yes
No
p
Vasomotor sympt.
Odds Ratio
Somatic sympt.
Sleep problems
Sexual problems
Odds Ratio
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
0 20 40 60 80 100
Mobility
Self- care
Usual activity
Pain/discomfort
Anxiety/depression HRT No
HRT Sì
* p< 0.05
*
*
*
EQ-5D Results of the stepwise logistic regression analyses
Mobility Self-care Usual
activities
Pain/discomfort Anxiety/ depression
Thermometer
p NS NS 0.02 0.03 NS NS
HRT No
1.0 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
1301 Ospedale S. Anna Divisione O. G. Como 10 91302 Istituti Ospedalieri Carlo Poma Divisone O. G. Mantova 136 591303 Clinica Ostetrico Ginecologica Spedali Civili. Ente Osp. Reg. Brescia 1045 9151304 Ospedale S. Giuseppe Divisione O. G. Milano 691 4421305 Ospedale Maggiore Divisione O. G. Lodi 886 7231306 Ospedale di Treviglio Divisione O. G. Treviglio (BG) 234 1951307 Osp. Fornaroli Magenta (MI) 276 2401308 Istituto Nazionale Tumori Milano 41 401309 Ospedale Civile Sondrio 292 2411310 Ospedale Niguarda Ca' Granda Divisione O. G. Milano 104 941311 Osp. Morelli Divisione O. G. Sondalo (SO) 249 1901312 Ospedale Vimercate Divisione O. G. Vimercate (MI) 464 2511313 Ospedale di Saronno Divisione O. G. Saronno (VA) 344 2781314 Ospedale di Melegnano Divisione O. G. Melegnano (MI) 380 2361315 Ospedale di Lecco Divisone O. G. Lecco 892 8491316 Ospedale Sesto S. Giovanni Divisione O.G. Sesto S. Giovanni (MI) 332 2621318 Casa di Cura S. Anna Divisione O.G. Brescia 71 70
1319 Clinica S. Carlo Divisione O.G. Paderno Dugnano (MI) 181 170
Situazione delle 18 SPAC della Lombardia al 24/02/2000
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 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
29%
71%
CONTROLLI
SOLO 1° VISITA
FREQUENZA ALL’AMBULATORIO
39%
7%
54%
NESSUNA TERAPIA
TERAPIA IN CORSO
TERAPIA PREGRESSA
SITUAZIONE NELLE DONNE CHE HANNO EFFETTUATO SOLO 1° VISITA
0 5 10 15 20 25 30
ESTROGENI TRANSD.
EP COMBINATI
ESTROGENI TOPICI
BIFOSFONATI ECC
VERALIPRIDEGIA' IN CORSO
PRESCRITTA
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– No 1+
– Sì 1,02 (0,95 - 1,10)
SOSPENSIONE TERAPIA NELLE DONNE CHE HANNO EFFETTUATO PIU’ CONTROLLI
92%
8%
TERAPIACONTINUATA
TERAPIA SOSPESA
MOTIVI DI SOSPENSIONE DELLA TERAPIA
0
2
4
6
8
10
12
14
16
18
20
ESTROGENI TRANSDERMICI (82%)
MASTODINIARITENZIONE IDRICADIFFIDENZA-PAURAPAURA CAFLUSSO ANOMALOALLERGIA GENERALIZZATAIRRITAZIONE LOCALE
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 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
Lombardia Terapie e Peso
0
200
400
600
800
1000
1200
1400
1600
ND <50 51<>60 61<>70 71<>80 81<>90 >90
Fascie di Peso
Progetto Menopausa Italia
Statistiche per la regione Lombardia
Situazione al 24/02/2000
Spac Struttura CittàTotale
CartellePazienti
Reclutate1300 Ospedale S. Carlo Borromeo Divisione O. G. Milano 1156 7081301 Ospedale S. Anna Divisione O. G. Como 10 91302 Istituti Ospedalieri Carlo Poma Divisone O. G. Mantova 136 591303 Clinica Ostetrico Ginecologica Spedali Civili. Ente Osp. Reg. Brescia 1045 9151304 Ospedale S. Giuseppe Divisione O. G. Milano 691 4421305 Ospedale Maggiore Divisione O. G. Lodi 886 7231306 Ospedale di Treviglio Divisione O. G. Treviglio (BG) 234 1951307 Osp. Fornaroli Magenta (MI) 276 2401308 Istituto Nazionale Tumori Milano 41 401309 Ospedale Civile Sondrio 292 2411310 Ospedale Niguarda Ca' Granda Divisione O. G. Milano 104 941311 Osp. Morelli Divisione O. G. Sondalo (SO) 249 1901312 Ospedale Vimercate Divisione O. G. Vimercate (MI) 464 2511313 Ospedale di Saronno Divisione O. G. Saronno (VA) 344 2781314 Ospedale di Melegnano Divisione O. G. Melegnano (MI) 380 2361315 Ospedale di Lecco Divisone O. G. Lecco 892 8491316 Ospedale Sesto S. Giovanni Divisione O.G. Sesto S. Giovanni (MI) 332 2621318 Casa di Cura S. Anna Divisione O.G. Brescia 71 70
1319 Clinica S. Carlo Divisione O.G. Paderno Dugnano (MI) 181 170
Situazione SPAC Lombardia al 24/02/2000
4226
499341
3532
168
1228
17 31
303
467
0
500
1000
1500
2000
2500
3000
3500
4000
4500
Estrogenica Transdermica
Estrogenica per OS
Estrogenica topica
Progestinica per OS
Estroprogestinica transdermica
Associazioni estroprogestinica per OS
Associazioni estrogeni-androgeni
Antiestrogeni
Bifosfonati e altri
Veralipride
Calcio
HRT AND QoL
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 freeHRT
•Women on HRT were significantly more likely to have a menopause duration >3 years and significantly less likely to suffer from chronic diseases.
“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
Obiettivomigliorare 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)
Campione UK(n=682)
Campione Italia(n=416)
Età (media DS) 52.3 4.9 53.4 4.9
Punteggi scale WHQ:Depressed mood 0.220.23 0.270.23Somatic Symptoms 0.390.25 0.460.24Vasomotor symptoms 0.430.44 0.480.44Anxiety/fears 0.350.28 0.400.31Sexual behaviour 0.320.32 0.380.34Sleep problems 0.450.36 0.500.36Menstrual symptoms 0.380.29 0.370.30Memory/concentration 0.470.36 0.530.37Attractiveness 0.380.29 0.370.40
* M. Hunter. Psychology and Health 1992; 7: 45-54
PROGETTO DONNA QUALITÀ DI VITA
Confronto fra popolazione Italiana e Inglese*
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
Aree SF-36 Popolazionegenerale
(504 donne)
Centri per lamenopausa(424 donne)
p*
Attività fisica 87.9 15.7 83.6 17.1 n.s.
Ruolo e salute fisica 77.9 32.1 70.0 35.1 n.s.
Ruolo emotivo 74.5 35.0 66.6 38.0 0.01
Vitalità 57.7 18.2 57.0 18.2 n.s.
Salute mentale 64.4 19.8 63.1 19.3 n.s.
Salute in generale 65.5 17.4 64.8 17.8 n.s.
Dolore fisico 68.5 23.4 67.8 25.0 n.s.
Attività sociali 72.2 22.3 74.9 22.1 n.s.
PROGETTO DONNA QUALITÀ DI VITAValori SF-36 nelle due popolazioni
*Mann-Whitney U-test
“Progetto Donna Qualità di Vita” Prima Fase
“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
p=0.008
49±848±8
PCS
p=0.03
45±11
44±11
p=0.03
59±19
57±19
p=0.02
74±2172±22
p=0.009
74±3569±37
p=0.003
71±3766±39
p=0.003
85±1782±19
p=0.03
64±19
62±20
p=0.001
64±1861±18
p=0.005
67±2464±23
HRTYes
No
MCS Vitalit
y
Social functi
on
Role phys
Role emoti
o
Physical
activity
Mental
health
General
health
Bodily
pain
HRT associated with better QoL in all of the areas investigated, including also the two summary
measures (physical and mental component scores).
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=0.02p=0.01
NSNSHRT
Anxiety/ depressi
on
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
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
p=0.006
0.34±0.30.38±0.3
NS
0.23±0.30.24±0.3
NS
0.48±0.40.50±0.4
p=0.03
0.26±0.2
0.29±0.2
p=0.02
0.33±0.40.37±0.4
p=0.0008
0.36±0.3
0.41±0.3
HRT
Yes
No
Vasomotor sympt.
Somatic
sympt.
Sleep problem
s
Sexual problem
s
Menstrual
symptoms
Memory/ concent
r.
Depression
Attractiveness
Anxiety/ fears
A high score (lower QoL) is associated with low school education, low SES, living in Southern Italy and presence
of chronic diseases