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