QoL in psychiatry of ID Lisbon 2010 - Fenacerci · OUTCOMES IN PSYCHIATRY OF ID Marco Bertelli ... Bioetica e Riabilitazione. Governo Italiano, marzo 2006. ETHICS OF CARE ... AIDS

QOL AND OTHER PATIENT-RELATED OUTCOMES IN PSYCHIATRY OF ID

Marco BertelliPsychiatrist, Psychotherapist

Consultant for Intellectual Disability and Autistic Spectrum Disorders

CREA (Centro di Ricerca ed Evoluzione AMG) Director

WPA-SPID (World Psychiatric Association – Section Intellectual Disability) Chair

SIRM (Società Italiana per lo studio del Ritardo Mentale)

Dott. Marco BertelliDeclaration of Interest

Medico ChirurgoPsichiatra – Psicoterapeuta

Libero Professionista

Consulente AMG FirenzeConsulente Consorzio Zenit FirenzeResponsabile Sanitario Cooperativa Sociale WORK 2000 Castiglion Fiorentino (AR)Direttore MAPPsi (Medici Associati per la Psichiatria e la Psicoterapia) FirenzeDirettore CREA (Centro di Ricerca ed Evoluzione AMG), Firenze

Presidente della sezione Psichiatria della Disabilità Intellettiva dell’Associazione Mondiale di Psichiatria (WPA-SPID)Segretario della Società Italiana per lo studio del Ritardo Mentale (SIRM)Segretario e Fondatore dell’Associazione Italiana per lo studio della Qualità di Vita (AISQuV)

Ha avuto rapporti di collaborazione con le seguenti case farmaceutiche:FarmadesNovartisJanssenAttualmente è consulente ad incarico di Eli Lilly Italia

Effectiveness

Quality of Life

Subjective Wellbeing

Long-term cost/benefits

ASSESSING USEFULNESS OF MEDICATION:NEW OUTCOME MEASURES

Efficacy on symptoms / PBs

Normalization

Clinical improvement

Short-term costs

Bertelli M., 2006

MEETING EVERYDAY CHALLENGES:ANTIPSYCHOTIC THERAPY

IN THE REAL WORLD

• Methanalysis of RCT

• RCT with large sample

• RCT with small sample

• Non-randomized trials controlled with current control group

• Non-randomized trials controlled with historical control group

• Non-randomized trials without control group

• Expert consensus

• Case report

Bertelli 2006, modified from Sackett, 1989

REAL WORLD

IDEAL EXPERIMENTAL EFFICACY

IL CONCETTO DI EFFICIENZA DI TRATTAMENTO

Efficacy Tolerability and Safety

Adeherence/Stay on treatment

Effectiveness

Lieberman JA, et al. N Engl J Med. 2005;353(12):1209-1223; Lehman AF, et al. Am J Psychiatry. 2004;161(2 suppl):1-56; Swartz MS, et al. Schizophr Bull. 2003;29(1):33-43.

SCHIZOPHRENIA PATIENTS STAYING ON TREATMENT SHOW BETTER TREATMENT

RESPONSE COMPARED TO PATIENTS DISCONTINUING TREATMENT

Liu-Seifert H, et al. Schizophr Bull 2005;31(2):487.

† Early response predicted study completion: A 20% improvement in PANSS total score by 2 weeks was associated with an approximately 80% greater likelihood of study completion (odds ratio 1.76, confidence interval (1.4, 2.21), p<.0001).

50

60

70

80

90

100

0 2 4 6 8 10 12 14 16 18 20 22 24 26 28

Weeks

Completers

Discontinued

*

**

** * *

*p<.001

Mean P

AN

SS

Tota

l S

core

(O

C)

Impro

vem

ent

Study Methodology

♦ 4 clinical trials, duration of 24 to 28 weeks

♦ N=1627

♦ Diagnosis

• Schizophrenia 78.5%

• Schizoaffective 20.84%

• Schizophreniform 0.6%

♦ Mean age 39.53 ± 10.85

♦ Age of onset of illness:

23.48 ± 8.26

♦ 64.4% Male

♦ 53.3% Caucasian

SCHIZOPHRENIC PATIENTS COMPLETINGTHE TREATMENT HAVE A QoL IMPROVEMENT

Zhao F, et al. Schizophr Bull 2005;31(2):508.

45

50

55

60

65

0 4 8 12 16 20 24

Weeks on Antipsychotic Therapy

QLS

Tota

l S

core

(O

C)

Completers

Discontinued

Number of patients at each time point:

Completers: 856 851 844 838

Discontinued:

961 707 274 83

*

*p<.05

WHAT IS QUALITY OF LIFE?

A. a sociological concept

B. a media phenomenon

C. a new outcome measure for medical and rehabilitative interventions

D. a new definition of health

E. all the previous

F. none of the previous

QoL: PRINCIPLES AND IMPLICATIONS

• human entitlement to a life of quality

• Universality of human characteristics

• Uniqueness of human needs, behaviours and

performances (choice)

• Human attitude to self-fulfilment (self

perception, self image)

• Holism in human life

• Dynamic nature of human life (growth,

improvement, life-span)

R.I. Brown and I.Brown. Principles of quality of life and their application: an overview. JIDR, 2004, 48; 4-5; 447

1. Burns T. and Patrick D. Acta Psychiatr Scand, 2007; Patterson TL. and Leeuwenkamp OR. Schiz Res, 2008 2. Wehmeier P. et al. Pr Neu Biol Psych, 2007; Dunayevich E. et al., J Cl Psych, 2007

social skills (1)

quality of life (2)

- subjective well-being

- clinician-rated measures

ANTIPSYCHOTIC TREATMENT:NEW OUTCOME MEASURES

QoL: A POLYSEMIC CONCEPT

Mass-Media meaninga universal ideal of high quality of most material and most marketableareas of life (i.e. objects owned, success in career, money to spend,social environment, holidays and free-time, physical performances)

the individual perception of satisfaction with the ‘being in the world’.It can be evaluated only trough the person’s opinion. Auto-evaluation.

Medicalmeaning

objective

subjective

a person’s life conditions as they appear to an external observer.Hetero-evaluation.

the patient’s perception of his own health status(aspects of life related to wellbeing and functionement)

Bertelli M. e Brown I. Quality of Life for PWID. Current Opinion in Psychiatry, 2006; 19:508-513

WHO FOR QoL

Quality of life is defined as individual’s perceptions of their position in life in the

context of the culture and value system where they live, and in relation to their

goals, expectations, standards and concerns.

Orley J., Saxena S., Herrman H. BJP, 1998Health Promotion Glossary. World Health Organization, 1998Preamble to the Constitution of the World Health Organization as adopted by the International Health Conference, New York, 19-22 June, 1946

HEALTH: a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.(WHO, 1948)

QoL vs SUBJECTIVE WELL-BEING

Subjective well-being concerns itself primarily with affective states, positive or negative.

QOL implies a broader assessment and although affect-laden, it represents a subjective evaluation of oneself and one's social and material world.The exploration refers to those areas of life that are applicable to anybody’s life.

Orley J., Saxena S., Herrman H. Quality of life and mental illness. Reflections from the perspective of the WHOQOL. BJP, 1998

HEALTH AS A WAY OF BEING

It is not a given status but a conquest; it is not a definitive achievement but a pursue, a task, a life-style, enriched by that ethical dimension which encompasses all other human dimensions (physical, psychic,and ecological)

HEALTH DISEASE

capacity to live in a mindful and free way, increasing the

value of all one's own energies

incapacity to live in a mindful and free way, and to increase the value

of one's own skills and energies

National (Italian) Committee for Bioethics. Bioetica e Riabilitazione. Governo Italiano, marzo 2006

ETHICS OF CARE/REHABILITATION

Functionalist approach

Health practice aimed at restoring physical ability and autonomy

Contractualistic approach

Health practice aimed at adding further ability or autonomy (i.e. self-sufficiency, self-consciousness, or self-determination)

THERAPEUTIC ABANDON

OVERTREATMENT

approach based on Human Rights QoL

QoLIntegral approach

National (Italian) Committee for Bioethics. Bioetica e Riabilitazione. Governo Italiano, marzo 2006

restitution of all the structures damaged by the illness and their normal functioning

help to be satisfied with one’s own life

Normalization

Quality of Life approach

A NEW APPROACH TO THESYSTEM PATIENT-PERSON


SOCIO-DEMOGRAPHIC AND CLINICAL DETERMINANTSOF QUALITY OF LIFE IN SCHIZOPHRENIA

Xiang YT, Wang CY, Wang Y, et al. Socio-demographic and clinical determinants of quality of life in Chinese patients with schizophrenia: a prospective study. Qual Life Res. 2010 Apr;19(3):317-22. Epub 2010 Feb 5.

AbstractPURPOSE: The aim of the study was to assess the changes in the quality of life

(QOL) of Chinese schizophrenia patients and to identify their predictors over a 1-

year follow-up. METHODS: A cohort of 116 schizophrenia patients was recruited,

and their socio-demographic and clinical characteristics including psychotic and

depressive symptoms, drug-induced side effects, social functioning, and QOL

were assessed with standardized rating instruments. The patients received

standard psychiatric care and were followed up for 1 year. RESULTS: The

psychotic and depressive symptoms, extrapyramidal side effects, and QOL

domains of physical functioning, role limitations due to physical problems, social

functioning, and role limitations due to emotional problems all improved

significantly. Social functioning was a predictor of baseline QOL and change at 1-

year follow-up. CONCLUSIONS: Routine clinical management was effective in

improving schizophrenia patients' psychopathology and several domains of QOL.

QOL was related to the level of social functioning and had only a weak

association with socio-demographic factors.

GENERIC QOL VS HR QOL

Generic: subjective modulation in those areas of life that are applicable to anybody’s life

Health-Related: mixture of clinical or dysfunctioning aspects, compared to normality


ESEMPI DI ITEM IN STRUMENTI HR QOL

CCD HRQOL-141

Number of days in which you felt sad or depressed ___Number of days in which you felt worry or anxious ___

Functional Assessment of Cancer Therapy (FACT-G – 27 item)2

Physical Well-Being:I feel lack of energyI have nauseaI feel painI feel sickI’m obliged to spend my time in bed

AIDS QoL Assessment Questionnaire – AIDS-HAQ3

Area Item Descrption

Disabilities 23/116 Misures of the level to wich health status impact on 9 activities of basic autonomy (i.e. to stand up, to eat, to handle)

Symptoms 68/116 presence/absence during last week

1. U.S. Center for Chronic Disease Prevention and Health Promotion; 2. Cella DF., et al. Journal of Clinical Oncology, 1993; 11(3): 570-579; 3. Ludeck DP. and Fries JF. Quality of Life Research, 1992; 1: 359-366

INSTRUMENTS TO ASSESS QoL IN SCHIZOPHRENIA

GENERIC

WHOQoL;

SF-36 (HR-QdV);

EQ-5D (HR-QdV).

SPECIFIC

Instrument conceptual model items rater

QLS deficit syndrome 21 clinicians

QoLI general QoL model 143 patient

LQoLP general QoL model 105 patient

SQLQ sub. sick person’s life 59 patient

PETiT symptoms, SE and perf. 30 patient

S-QoL Calman’s approach 41 patient

Bobes J. et al. Quality of life measures in schizophrenia. Eur Psychiatry, 2005; 20 (3): S313-7

LIMITS OF THE INSTRUMENTS TO ASSESS QoL IN SCHIZOPHRENIA

• Lack of a specific theoretic basis

• Unclear and overlapped definitions

• Lack of data on measures sensitivity, as treatment outcome

• Confounding potential with symptomatology and

functionement

• Lack of a normative reference for target population

Bobes et al., 2005

SATISFACTION MODEL(Lehman et al., 1982; Baker e Intagliata, 1982)Calman’ gap between what one is and what he would like to be.

FUNCTIONALITY OF ROLE (Bigelow, 1982)Happiness and satisfaction are strictly related to the achievement of those social and environmental conditions (role) that human being needs.

IMPORTANCE / SATISFACTION MODEL (Becker, 1993)Satisfaction is related to importance.

THEORETICAL MODEL OF QoL


Variables indicator of Subjective Well-Being should be considered as the least sensitive subjective measures

AFFECTIVE-COGNITIVEHOMEOSTATIC SYSTEM

OVERLOADUNDERLOAD

THE BALANCE OF SWB

Cummins R.A. Moving from the quality of life concept to a theory. Journal of Intellectual Disability Research 2005; 49(10):699-706

“…there is good agreement that the measurement should be based on both qualitative and quantitative variable from both subjective and objective positions

also dependently on the aim an evaluation is conducted to”.


QUALITY OF LIFE:SUBJECTIVE OR OBJECTIVE?

• Importance attribuited by the individue

• Satisfaction perceived by the individue

• Opportunities available

• Choises made by the individue

QoL: CHARACTERISTICS

Brown I. et al., Centre of Public Health, University of Toronto, 1995

EQ-5D

Rabin R. and de Charro F. Ann Med, 2001; 33(5): 337-43

Mobility

Self-care

Usual Activites

Pain/Discomfort

Anxiety/Depression

Usual Activities (e.g. work, study, housework, family or leisure activities)

I have no problems with performing my usual activities �

I have some problems with performing my usual activities �

I am unable to perform my usual activities �

GENERIC QoL IN PDs:DEPRESSION vs SCHIZOPHRENIA

* = stat. signif. difference between schizophrenic subjects IR and MDD subjects IR° = stat. signif. difference between schizophrenic subjects IR and controls^ = stat. signif. difference between MDD subjects IR and controls

Bertelli et al. Minerva Psichiatrica, 2003

SCHIZOFRENIC MDDs CONTROL

IN REMISSION IN REMISSION

Physical Being 10,12 (21,51) 12,14 (26,41) 26,75 (18,36)^°

Psychological Being 11,71 (23,66) 1,64 (31,43) 25,98 (25,98)^°

Spiritual Being 5,76 (23,00) 11,78 (30,19) 22,01 (16,66)°

Physical Belonging 15,47 (25,13) 20,64 (26,36) 25,37 (20,87)

Social Belonging -4,59 (13,53)* 17,57 (34,81) 20,41 (22,40)°

Belonging to -0,53 (21,63) 12,21 (18,99) 12,91 (19,75)°

the Community

Practical Becoming 7,29 (22,91) 7,2 (22,35) 22,95 (21,50)°

Leisure Time -7,76 (18,09)* 9,35 (26,22) 13,54 (25,25)°

Growth -5,65 (15,41) -5,64 (31,93) 16,57 (23,52)^°

QoL Total 31,82 (126,53) 86,92 (178,44) 185,85 (113,90)^°

1. physical (e.g. energy, fatigue)

2. psychological (e.g. positive feelings)

3. level of independence (e.g. mobility)

4. social relationships (e.g. practical social support)

5. environment (e.g. Accessibility of health care)

6. personal beliefs/spirituality (e.g. meaning in life)

WHO CROSS-CULTURAL CORE DOMAINSFOR QUALITY OF LIFE

The domains of health and quality of life are complementary and overlapping

Health Promotion Glossary. World Health Organization, 1998What Quality of Life? The WHOQOL Group. In: World Health Forum. WHO, Geneva, 1996.

BEINGWho the patient is as a person.

PHYSICAL BEINGIt concerns such things as physical health, personal hygiene, nutrition, exercise, grooming and clothing, and general physicalappearance.

PSYCHOLOGICAL BEING It concerns such things as psychological health and adjustment, cognition, feelings, self-esteem, self-concept and self-control.

SPIRITUAL BEINGIt concerns such things as personal values, personal standards of conduct, and spiritual beliefs.


THE 9 AREAS OF LIFE OF THE QOL-IP

BELONGINGBelonging relates to connections with one's environments.

PHYSICAL BELONGINGPhysical Belonging concerns such places as in the home, workplace, school, neighborhood and community.

SOCIAL BELONGINGSocial Belonging concerns relationships with intimate others, family, friends, co-workers, neighborhood and community.

COMMUNITY BELONGINGCommunity Belonging concerns having an adequate income, health and social services, employment, educational programs, recreational programs, community events and activities.



BECOMINGBecoming relates to achieving personal goals, hopes and aspirations.

PRACTICAL BECOMINGPractical Becoming concerns domestic activities, paid work, school or volunteer activities, seeing to health or social needs.

LEISURE BECOMINGLeisure Becoming concerns activities that promote relaxation andstress reduction.

GROWTH BECOMINGGrowth Becoming concerns activities that promote the maintenance or improvement of knowledge and skills, as well as adapting to change.



QUALITY OF LIFE: FOR WHO?

A. The individue

B. The community

C. The family

D. The individue within the family

E. all the previous

F. none of the previous

• Importance• Satisfaction• Attainment• Initiative• Stability• Opportunity

FAMILY QOL

Werner S. et al. J Intellect Disabil Res, 2009; 53(6): 501-11

ASSESSING QoL: BY WHO?

A. the person herself

B. their relatives

C. their friends

D. their acquaintances

E. their health professionals

F. all the previous

G. a specific combination of the previous

• Direct interview

• Proxy Questionnaire

• External Assessor Questionnaire

person herself

other person

other person

QoL: ARTICULATION OF THE ASSESSMENT


• le persone con DIG esprimono i loro vissutiattraverso repertori di comportamenti ricorrenti

• questi comportamenti possono essere organizzati ed interpretati dai familiari e dalle altre persone più vicine

• questi comportamenti possono essere confermati da altri osservatori esterni

• i repertori comportamentali permettono di individuare preferenze

Life Satisfaction Matrix

Lyons G. J Intellect Disabil Res, 2000; 49(10): 766-9

Documents

QoL in psychiatry of ID Lisbon 2010 - Fenacerci · OUTCOMES IN PSYCHIATRY OF ID Marco Bertelli ... Bioetica e Riabilitazione. Governo Italiano, marzo 2006. ETHICS OF CARE ... AIDS