PROGETTO STILI DI VITAROBERTO DELLA VEDOVA
XXVII Congresso CSeRMEG 16-17 Ottobre 2015
•Stili di vita: perché?•Studio EFAR-FVG: Risultati di un’esperienza concreta di azione sugli stili di vita
•Descrizione di uno strumento integrativo per l’intervento efficace e integrato sugli stili di vita
RISCHIO DI MALATTIA CRONICA ESPRESSO IN DALYs
www.thelancet.com Published online September 11, 2015 http://dx.doi.org/10.1016/S0140-6736(15)00128-2
ITALY - BURDEN OF DISEASE ATTRIBUTABLE TO LEADING RISK FACTORS, 2013
LA MODIFICA DELLO STILE DI VITA È ALTAMENTE EFFICACE
MODELLO DI PROMOZIONE DELLA SALUTE (BEATTIE 1991)
Tipi di interventoAutoritarismo
Tecniche di persuasione alla salute Azione legislativa per la salute
Focu
s dell'intervento
Individuale Collettivo
Counselling personale per la salute Sviluppo della comunità orientato alla salute
Negoziazione
British Journal of General Practice, June 2000
BREAKING DOCTOR – PATIENT RELATIONSHIP
• Don‘t believe the effectiveness• Patients lie• Doctors drink• Lack of time• Not a job for GP/FM• Lack of knowledge and self-confidence
AGPFMSEE Conference Ljubljana 4.-6.6.2015 Marko Kolšek
A randomised controlled non-inferiority trial of primary care-based facilitated access to analcohol reduction website (EFAR-FVG) Italy:design and results
Roberto Della Vedova, MDRegional Centre for the Training in Primary Care (Ceformed)Centro Studi e Ricerche in Medicina Generale (CSeRMEG)
Research TeamPierluigi Struzzo, Emanuele Scafato, Donatella Ferrante, Nick Freemantle, Rachel Hunter, Harris Lygidakis, Richard MacGregor, Francesco Marcatto, Francesca Scafuri, Costanza Tersar and Paul Wallace
EFAR-Italy
EFAR-Italy
Aim of the study
To evaluate whether online facilitated access to an alcohol reduction
website for risky drinkers is as effective as face-to-face brief
intervention conducted by the GPs
EFAR-Italy
Patient eligibility to receive brochure
• All NON-selected as risky drinkers patients aged 18 and over who attend practice
• Exclusion criteria:– Severe psychiatric disorder, known
AD, visual impairment or terminal illness
– Inadequate command of Italian language
EFAR-Italy
The websiteGPs able to personalise pages with feedback text, upload their photo and signature
EFAR-Italy
Trial structure
In practice brochure distribution (Unique log-on code)
Access the website. (Trial information and consent)
AUDIT-C (>4 female, >5 male)
Not at risk At risk (Privacy consent)Baseline
data, AUDIT-10 and EQ-
5DRANDOMISATION
Face to Face
intervention
Follow up at 3m and 12m
Online intervention
EFAR-Italy
Practice Code Customization Brochures Patients % AUDIT-C % Risky % Randomised % Control % Interven
tion
Total GP 0 brochures 0
Total Yes Customisation 41Total No Customisation 17
Total 58 9080 4529 3841 822 763 416 347% Brochures 49,9 42,3 9,1 8,4
% Patients 84,8 18,1 16,8
% AUDIT C 21,4 19,9% Risky 92,8
% Randomised 54,5 45,5
TRIAL ACTIVITY
User pages wiews
TDR submissions TDR records TDR pages 3 m FU
invited3 m FU
completed% 1 y FU
invited1 y FU
completed% Drop outs
7729 1878 1520 707 762 698 92 762 620 81 27
EFAR-Italy
Trial Flow
Facilitated AccessN=347
Face to FaceN=416
Randomised N=763
3 MonthsN=317 1 protocol violation* 29 lost to follow up
3 MonthsN=381 1 protocol violation* 34 lost to follow up
12 MonthsN=285 1 protocol violation 61 lost to follow up
12 MonthsN=335 1 protocol violation 80 lost to follow up
* Note patient 00512294af was inadvertently randomised twice; once to each group, due to a software hitch
EFAR-Italy
Baseline Characteristics Item Facilitated Access n=346 Face to Face n=415 Male (%) 214 (62.0%) 255 (61.9%) Marital Status Single (%) 95 (27.9%) 116 (28.4%) Married (%) 208 (61.0%) 247 (60.4%) Separated (%) 28 (8.2%) 36 (8.8%) Widowed (%) 10 (2.9%) 10 (2.4%) Ethnicity Altro Caucasico (%) 8 (2.4%) 6 (1.5%) Bengalese (%) 1 (0.3%) 1 (0.25%) Indiano (%) 1 (0.3%) 2 (0.5%) Italiano (%) 320 (95.8%) 385 (96.3%) Magrebbino (%) 0 (0%) 1 (0.25%) Meticcio (%) 1 (0.3%) 1 (0.25%) Nero Africano (%) 3 (0.9%) 4 (1.0%) Familiarity with IT Not 58 (16.9%) 62 (15.2%) Fairly 84 (24.5%) 93 (22.8%) Familiar 91 (26.5%) 119 (29.2%) Very 110 (32.1%) 134 (32.8%) Qualifications Nessuna 2 (0.6%) 2 (0.5%) Scuola elementare/media 112 (32.9%) 126 (30.9%) Scuole superiori 174 (51.2%) 184 (45.1%) Università 45 (13.2%) 78 (19.1%) Specializzazione/Master Universitario 7 (2.1%) 18 (4.4%) Age, median (IQR) 49 (37, 59) 50 (35, 61) Number of Children, median (IQR) 1 (0, 2) 1 (0, 2) AUDIT 10, median (IQR) 5 (4, 8) 6 (4, 9) Risky Drinker (Audit 10 >7) (%) 95 (27.5%) 123 (29.6%) Health Utility – UK Weights, median (IQR) 0.84 (0.77, 1.0) 0.84 (0.77, 1.0)
EFAR-Italy
Primary Analysis
• The primary analysis is a comparison between the experimental conditions of the proportion of risky drinkers as classified by responses to the AUDIT-10 question scale at 3 months following randomisation.
• A score of 8 or more on the AUDIT-10 will define a risky or hazardous drinking.
EFAR-Italy
Odds Ratio (95% confidence interval)
Primary Outcome – Pre-specified Subgroup Analyses
0.2 0.3 0.5 1 2
Overall 0.63 (0.45, 0.89; p=0.008)
Odds Ratio (95% CI; P) P Interaction
Male 0.58 (0.39, 0.87; p=0.009)
Female 0.78 (0.36, 1.67; p=0.518)p=0.450
Age>50 0.45 (0.27, 0.74; p=0.002)
Age ≤50 0.95 (0.59, 1.53; p=0.825)p=0.028
High Computer Skills 0.46 (0.24, 0.89; p=0.021)
Low Computer Skills 0.75 (0.50, 1.12; p=0.163)p=0.137
Audit10 >5 0.76 (0.48, 1.18; p=0.213)
Audit10 ≤5 0.41 (0.21, 0.79; p=0.008)p=0.114
Benefits Facilitated Access Benefits Face to Face
EFAR-Italy
Comment
• EFAR Italy achieved its scientific objective; establishing non inferiority for the facilitated outcome group in comparison with face to face intervention for risky drinking on the primary outcome.
• The actual results indicated at least nominally a significantly better performance for patients in the facilitated intervention group.
EFAR-Italy
By products
• Randomised trials are feasible in GP• Internet and new information
technologies can be helpfull• Facilitated access is a promising
methodology
•Progetto per uno strumento integrativo dell’azione del medico
Entra
GRAZIE
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