Riabilitazione Neurologica (2) PROGETTO FORMATIVO SPECIALE / C.L. FISIOTERPIA Riabilitazione Neurologica (2)

Cosa è la riabilitazione neurologica? Barnes, J Neurol Neurosurg Psychiat, 2003

Due principi sono fondamentali: RIABILITAZIONE NEUROLOGICA Due principi sono fondamentali: La riabilitazione è un processo attivo, distinto dal miglioramento spontaneo (recupero o convalescenza) e dal trattamento terapeutico (a pazienti non partecipanti). Gli obbiettivi perseguiti dalla riabilitazione sono centrati sulla persona

What is a model of illness? Illness refers to all aspects of ill health personal, family, society, etc Need a framework to analyse illness To describe it Need a model To plan rational interventions

WHO ICF model of illness The framework can be seen as a systems analytic approach, considering illness as a hierarchy of systems A MODEL In this model, illness comprises interacting systems which may have emergent properties

Rivisitata ICIDH  ICF: WHO ICF International Classification of Functioning, Disability and Health Rivisitata ICIDH  ICF: Aggiunta fattori di contesto : fisici (archittetonici, vestiti, etc) personali (experienze, attitudini, etc) sociali (familgia/amicizie, cultura, etc) Cambio parole (e concetti ?) disabilità -> attività handicap -> participazione Concetto globale di ‘functioning’

Interactions between the components of ICF (WHO 2001)

Well-being WHO ICF Model of illness Four Levels Three Contexts Organ (pathology) Personal Person (impairment) Physical Person in environment Behaviour (activities) Social Person in society Social position (Participation) Well-being

Riabilitazione neurologica: elementi per la definizione Scopi della riabilitazione Processo della riabilitazione Caratteristiche di un servizio di riabilitazione

Riabilitazione neurologica: elementi per la definizione Scopi della riabilitazione Processo della riabilitazione Caratteristiche di un servizio di riabilitazione

Rehabilitation of patients with cognitive deficits Dr Derick T Wade * Professor in Community Rehabilitation Faculteit der Geneeskunde, Universiteit Maastricht * Professor in Neurological Disability Oxford Centre for Enablement Windmill Road, Oxford OX3 7LD Effectiveness of Rehabilitation for Cognitive Deficits Cardiff 17 – 19 September, 2002

Rehabilitation aims (outcome) To maximise patient participation in society maximise role function in community maximise status in community To maximise patient well-being somatic and emotional achieving satisfaction (adaptation) To minimise stress on & distress of relatives

ICF e Obiettivi della Riabilitazione Massimizzare il repertorio comportamentale Ottimizzando i contesti personale, fisico, sociale Minimizzando le menomazioni tutte, ma specialmente quelli con impatto sulle attività Minimizzando il danno d’organo (pathology) Ottimizzando le opportunità di interazione sociale

ICF e Interventi Danno d’organo Impairments Diagnosi e trattamento della malattia Diagnosi e trattamento delle complicanze Diagnosi e trattamento di malattie incidentali Impairments Cognitivi (neglect, word finding) Altro deficit (motorio  scrittura) Impedire peggioramenti (eccesso di farmaci!!)

ICF e Interventi Attività Partecipazione Esercizio delle funzioni colpite, secondo gli obiettivi del paziente, in rapporto all’ambiente quotidiano Partecipazione Organizzare opportunità per inserimento sociale

ICF e Interventi Contesto personale Contesto fisico Contesto sociale Aumentare la fiducia in se stesso Ridurre i timori di insuccesso Contesto fisico Uso di ausili cognitivi (diari, sistemi di allarme-ricordo, post-it) Contesto sociale Lavoro stabile Inserimentonella comunità

Aims of the rehabilitation process Maximise patients’ participation in their social setting Minimise the risk of medical complication (e.g. contractures) Minimise the pain and distress experienced by the patient (maximise quality of life) Minimise the distress of and stress on the patient's family and/or carers DT Wade e BA de Jong, BMJ 2000;320:1385-1388

Approaches of the rehabilitation process Approaches that reduce disability Approaches designed to acquire new skills and strategies, which will maximise activity Approaches that help to alter the environment, both physical and social, so that a given disability carries with it minimal consequent handicap Barnes, J Neurol Neurosurg Psychiat, 2003

Riabilitazione neurologica: elementi per la definizione Scopi della riabilitazione Processo della riabilitazione Caratteristiche di un servizio di riabilitazione

Rehabilitaton Process Rehabilitation is a reiterative, active, educational, problem solving process focused on a patient's behaviour (disability/activity), with the following components: Assessment: the identification of the nature and extent of the patient's problems and the factors relevant to their resolution Goal setting Intervention, which may include either or both of treatments, which affect the process of change; support, which maintains the patient's quality of life and his or her safety Evaluation: to check on the effects of any intervention DT Wade e BA de Jong, BMJ 2000;320:1385-1388

Rehabilitaton Process To work in partnership with the disabled person and their family To give accurate information and advice about the nature of the disability, natural history, prognosis, etc To listen to the needs and perceptions of the disabled person and their family To work with other professional colleagues in an interdisciplinary fashion To liaise as necessary with key carers and advocates To assist with the establishment of realistic rehabilitation goals, which are both appropriate to that person’s disability and their family, social, and employment needs Barnes, J Neurol Neurosurg Psychiat, 2003

ICF e misure di risultato

ICF e assessment

MISURE DI DISABILITA’/ATTIVITA’ Indice di Barthel (BI) Misura di Indipenza Funzionale (FIM)

MISURA DI INDIPENDENZA FUNZIOALE

Le scale, come “misuratori di risultato” (outcome measure), devono soddisfare i seguenti criteri: Validità: deve essere una scala che misura ciò che si vuole misurare; Affidabilità: lo strumento deve essere accurato, stabile nel tempo, riproducibile; Sensibilità: la scale deve essere in grado di cogliere variazioni clinicamente significative; Semplicità: semplice da impiegarsi; Comunicabilità: lo strumento deve essere facilmente compreso anche dai non specialisti; Utilità clinica

Goal setting The process of rehabilitation is set around the establishment of goals. The first goal to be set is the long term strategic aim. Once a realistic and achievable long term goal has been established then the smaller steps needed to achieve that goal are determined. The goals must be precise and should be: Specific Measurable Achievable Relevant Time limited SMART

Riabilitazione neurologica: elementi per la definizione Scopi della riabilitazione Processo della riabilitazione Caratteristiche di un servizio di riabilitazione

Characteristics of a rehabilitation service It comprises a multi-disciplinary group (team) of people who focus their attention on a patient's disability, and: Work together towards common goals with each patient; Involve and educate the patient and family in the process; Have relevant expertise and experience (knowledge and skills); and Can, between them, resolve most of the common problems faced by their patients

The multidisciplinary team centered around patient and caregiver

Recent advances in rehabilitation DT Wade, BA de Jong Recent advances in rehabilitation DT Wade, BA de Jong BMJ 2000;320;1385-1388

Outcome measures for clinical rehabilitation trials: Impairment, function, quality of life, or value? Wade DT: Am J Phys Med Rehabil, 2003;82(Suppl):S26–S31. Outcome: What Is It? Nel campo della ricerca riabilitativa il termine “outcome” indica è una “variazione attesa” in un parametro o in uno “stato”. Outcome è il nuovo stato in cui il paziente si viene a trovare come risultato di un intervento (programma riabilitativo). Nella riabilitazione vi sono spesso molti inteverventi nel tempo e i relativi “outcomes” non sono sempre ovvi.

Outcome measures for clinical rehabilitation trials: Impairment, function, quality of life, or value? In un paziente con ictus, tutti gli “outcomes” della tabella possono essere pertinenti in ragione di cosa si vuole valutare e perché.

Outcome measures for clinical rehabilitation trials: Impairment, function, quality of life, or value? Wade DT: Am J Phys Med Rehabil, 2003;82(Suppl):S26–S31. In rehabilitation, outcome is more difficult to measure because usually several outcomes are relevant, relevant outcomes are affected by multiple factors in addition to treatment, and even good measures rarely reflect the specific interest of any individual patient or member of the rehabilitation team, leading to some dissent.

Comparison of physician outcome measures and patients' perception of benefits of inpatient neurorehabilitation BMJ 2002; 324:1493 Rating scales of impairment, disability, and handicap are often used but only partially reflect the rehabilitation process, tending to be "physician oriented." Physician outcome measures relate poorly with patients' perceived benefit from inpatient neurorehabilitation as measured on a visual analogue scale. The low correlation of visual analogue scale with the functional outcome measures indicates that these measures reflect only a small part of patients' perceived benefit.

Measurement in the Neurorehabilitation based on the ICF

Determine if the measures you find - are self completed by the patient (patient reported outcomes) or - performance-based, rated by a therapist

Are costs associated with the use of the measure? How long does it take to complete/ administer the measure? How much equipment is required? Is the measure available in the language of the patient?

General Standards for Use of Measures Validity Reliability Responsiveness Practicability

Validity If the test does indeed measure what it is intended to measure, then we can say that the test is valid Psychology Glossary Most important consideration, when selecting a measure Is regarded as the extent to which a test measures what it is intended to measure? Gold standard

Reliability It refers to the extent to which a test or other instrument is consistent in its measures Psychology Glossary Maybe defined as "the degree to which a measure is free from random error" Guidelines for how much is "good enough" are suggested to range from ccorrelations of 0.70 and more S. Schädler 2007

Reliability Intrarater reliability Interrater reliability is the degree to which scores on a measure obtained by one trained observer agree with the scores obtained when the same observer reapplies the measure at another time Interrater reliability is the degree to which scores on a measure obtained by one trained observer agree with the scores obtained by another observer

Threads of Reliability Fatigue Boredom Distraction Untrained raters Sh. Wood-Dauphinee 2005

Responsiveness Sensitivity to change The ability of the measure to assess and quantify clinically important change Two things are very important: - the minimal detectable change (MDC) - the minimal clinical important difference (MCID)

Practicability For which population? Easy to complete Manual (test instruction) Costs (material, license) Education (time, costs)

What kind of outcome measures should be chosen? For assessment/ problem analysis For treatment planning For outcome measure For prognosis

Recent advances in rehabilitation DT Wade, BA de Jong Recent advances in rehabilitation DT Wade, BA de Jong BMJ 2000;320;1385-1388

Medicina basata sulle evidenze e Riabilitazione

La medicina basata sulle prove (evidenze scientifiche) è: Integrazione di: Esperienza clinica individuale Miglior evidenza clinica esterna derivata da una ricerca sistematica della letteratura esistente Risorse disponibili Valori ed attese del paziente (Sackett 1997)

Archie Cochrane (1909-1988) “It is surely a great criticism of our profession that we have not organized a critical summary, by specialty or subspecialty, adapted periodically, of all relevant randomized controlled trials.”

Archie Cochrane (1909-1988) Monografia “Effectiveness and Efficiency” (1971) Randomized clinical trials (RCT) Evidence-based Medicine (EBM)

Evidence-based practice for stroke The conventional evidence-based practice approach to evaluate interventions has been divided into three components: efficacy : has it been shown to work in ideal circumstances?; effectiveness : has it been shown to have an important effect across a range of settings and circumstances?; and efficiency : has it been shown to provide value for money? The lancet neurology Vol 8 April 2009

Efficacia versus Efficienza

Basic elements of clinical decision making

Quali sono le caratteristiche degli RCTs inclusi nella revisione? Metodi: Randomizzazione, Cecità Partecipanti: tipo di pazienti, Storia di malattia Interventi: Dose, durata del trattamento, Co-trattamenti Outcomes

AAN evidence classification scheme for a therapeutic article Class II Class III Class IV

The Validity of Cognitive Rehabilitation Strategies for Evaluating Effectiveness and Translating Research to Clinical Practice Keith D. Cicerone, Ph.D.

REVIEW ARTICLE Evidence-Based Cognitive Rehabilitation: Recommendations for Clinical Practice Keith D. Cicerone et al., Arch Phys Med Rehabil 2000; 81:1596-615.

Levels of Evidence Class I Well designed, prospective, randomized controlled trials Well designed, prospective studies with ‘quasi-random’ assignment to treatment conditions (Ia)

Levels of Evidence Class II Prospective, non-randomized cohort studies Retrospective, non-randomized case control studies Clinical series with well-designed controls allowing between-subject comparisons

Levels of Evidence Class III Clinical series without concurrent controls Case studies with appropriate single-subject methodology and measurements

Practice Parameters Practice Standard Based on at least one, well-designed Class I study with adequate sample, or Overwhelming Class II evidence, that provides good evidence to support the effectiveness of the intervention

Practice Parameters Practice Guideline Based on well-designed Class II studies that provide fair evidence to support the effectiveness of the intervention

AAN system for translation of evidence to recommendations Rating of recommendations Translation of evidence to recommendations A = Established as useful/predictive or not useful/predictive for the given condition in the specified population Level A rating requires at least one convincing class I study or at least two consistent, convincing class II studies B = Probably useful/predictive or not useful/predictive for the given condition in the specified population Level B rating requires at least one convincing class II study or overwhelming class III evidence C = Possibly useful/predictive or not useful/predictive for the given condition in the specified population Level C rating requires at least two convincing class III studies U = Data inadequate or conflicting. Given current knowledge, test, predictor is unproven.  

Practice Parameters Practice Option Based on Class II or Class III studies, with additional grounds to support the effectiveness of the intervention, but with unclear clinical certainty

BIF/AIFA, 2006

META-ANALISI: combinare cosa con cosa ? DIVERSITA’ CLINICA Gli studi affrontano lo stesso problema? Gli studi sono diversi? Es. per: - luogo di ricovero e tipo di assistenza prestata - tipo di pazienti (età, sesso, gravità,…) - trattamenti (farmaco, dose, durata, frequenza,…) - definizione e misure degli esiti - durata del follow-up

META-ANALISI: combinare cosa con cosa ? DIVERSITA’ METODOLOGICA RCT a gruppi paralleli o crossover Qualità degli studi (per es. randomizzazione e modalità di assegnazione ai gruppi di trattamento, oppure cecità della misurazione degli outcomes Analisi (per es. ‘intenzione al trattamento’ vs. ‘trattati’ )

ETEROGENEITA’ STATISTICA META-ANALISI: combinare cosa con cosa ? ETEROGENEITA’ STATISTICA Vi è una diversità dei risultati degli studi maggiore di quella che ci si potrebbe aspettare per effetto del caso

Questa linea orizzontale è la scala che misura l’effetto del Questi titoli indicano quale confronto è stato fatto e qual’è l’outcome di interesse Questa linea verticale nel centro è dove il trattamento e il controllo hanno lo stesso effetto- non vi è differenza tra i due Copyright © Mediss 2001 All rights reserved Questa linea orizzontale è la scala che misura l’effetto del trattamento. A destra la scala è <1 e significa che il trattamento ha reso meno probabile la morte.

Per ogni studio vi è un id I dati di ogni studio sono qui, divisi nel gruppo dei trattati e dei controlli Questo è il peso % assegnato a questo studio nell’analisi aggregata Statistica utilizzata Dati numerici del grafico Ad ogni studio è assegnato un quadrato posto dove i dati misurano l’effetto. L’area del quadrato è proporzionale al peso % dello studio. La % di peso assegnata dipende dalla varianza dello studio (dimensioni e numero di eventi osservati). La linea orizzontale rappresenta l’intervallo di confidenza, una misura che ci indica di quanto il risultato può variare per effetto del caso. Quanto più l’intervallo di confidenza è ampio, tanto meno siamo confidenti nell’effetto osservato. Confidence intervals are calculated from a number known as a standard error. Standard errors are companions of all estimates. They describe the extent to which an estimate might be wrong due to random error. The smaller the standard error the more certain we are about the estimate. To get a feel for standard errors it is helpful to know that 95% confidence intervals are obtained by taking the estimate and creating limits that are 1.96 standard errors below it and 1.96 standard errors above it. Thus an estimate may be wrong by about a standard error, but to be 95% confident about where the true effect lies, we go roughly 2 standard errors either side. La varianza è il quadrato dello standard errore Copyright © Mediss 2001 All rights reserved

L’analisi aggregata dei risultati di tutti gli studi è rappresentata con un diamante (media pesata). Se l’intervallo di confidenza include l’unità significa che non abbiamo trovato una differenza statisticamente significativa tra i due trattamenti. Copyright © Mediss 2001 All rights reserved

Evidence-Based PM&R? Arch Phys Med Rehabil Vol78, November 1997

PM&R journals 9 major impact factor–rated Physical Medicine and Rehabilitation (PM&R) journals: Archives of Physical Medicine and Rehabilitation, American Journal of Physical Medicine and Rehabilitation, Physical Therapy, Scandinavian Journal of Rehabilitation Medicine, Journal of Rehabilitation Research and Development, Supportive Care in Cancer, Prosthetics and Orthotics International, Journal of Orthopaedic and Sports Physical Therapy, Journal of Manipulative and Physiological Therapeutics

Evidence-Based Practice and the Limits of Rational Rehabilitation Keith D. Cicerone, Ph.D Arch Phys Med Rehabil 2005; 86:1073-1074 E’ difficile applicare i principi della “evidence-practice-medicine” alla ricerca in riabilitazione (contemporaneità di interventi e di diversi “outcome”, problemi etici nella randomizzazione) ma è una via “obbligata”. Vanno rispettati 3 “pilastri”: attenta considerazione delle migliori “prove” scientifiche disponibili esperienza clinica e valutazione personale considerazione dei valori e delle convinzioni del paziente. Il “rispetto” del paziente pone comunque dei problemi da risolvere

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