Developing a core battery of outcome measures

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1 Developing a core battery of outcome measures Markus Reuber Professor of Clinical Neurology Academic Neurology Unit University of Sheffield Royal Hallamshire Hospital Sheffield, M. Reuber / 1

2 Background Reasons for using quantitative self-report measures As a problem / psychopathology screening tool. To plan therapeutic intervention. To look for treatment-associated change for quality control purposes. To demonstrate treatment-associated change to patients. To provide data for commissioning purposes. To generate data for research / service improvement. M. Reuber / 2

3 Aetiology of Functional Neurological Symptoms Predisposing Precipitating Perpetuating Genetic constitution (vulnerability, resilience) Early experience (abuse, neglect) Later experience (interpersonal problems, models) Usual Functioning (vulnerable state) Stressful experience, conflicts, dilemmas Physical / mental health symptoms FNS Avoidance, isolation, distress, anger, misattributions, sick role, financial / social disincentives misdiagnosis, mistreatment M. Reuber / 3

4 Aetiology of Functional Neurological Symptoms Predisposing & precipitating factors % NES: N=30 OFS: N=29 * : p=0.02 Howlett S, Grünewald R, Reuber M. Nonepileptic seizures and other functional neurological symptoms: predisposing, precipitating and perpetuating factors. Psychosomatics 2007; 48: Markus.Reuber@sth.nhs.uk M. Reuber / 4

5 Perpetuating factors % Outcome measures Aetiology of Functional Neurological Symptoms Howlett S, Grünewald R, Reuber M. Nonepileptic seizures and other functional neurological symptoms: predisposing, precipitating and perpetuating factors. Manuscript in preparation. Markus.Reuber@sth.nhs.uk M. Reuber / 5

6 Clinical picture Functional Neurological Symptoms may be the tip of the iceberg M. Reuber / 6

7 Clinical picture Other psychiatric disorders (patients with nonepileptic seizures) Commonest comorbid psychiatric diagnoses Other somatoform disorder % Wider dissociative disorder % Depressive disorders % Personality disorders % Anxiety disorders % PTSD % Reuber M. Zur Ätiologie psychogener nichtepileptischer Anfälle. Akt Neurol 2004; 31: markus.reuber@sth.nhs.uk M. Reuber / 7

8 Clinical picture Other physical disorders: Comorbid epilepsy in patients with NES Study Group Prospective Diagnosis Prevalence Cohen RJ IP yes clinical 12% Lesser R IP/OP no EEG (+interictal) 10% Krumholz IP no clinical 37% Gates JR IP no v-eeg / (clinical) 20% (56%) Lempert IP/OP no v-eeg / (clinical) 8% (22%) Leis IP no v-eeg (+interictal) 23% Betts IP no clinical 36% Devinsky IP No v-eeg (clinical) 20% (32%) Sigurdardottir IP/OP yes v-eeg 50% Benbadis IP no v-eeg (+interictal) 9% Reuber IP/OP no clinical 32% M. Reuber / 8

9 Clinical picture FNS often have a social dimension markus.reuber@sth.nhs.uk M. Reuber / 9

10 Patient characteristics Demographics of patients with FNS seen in Sheffield Feature Howlett et al Reuber et al N % Female 71.4% 82% Mean age (range) 40.5 (17-72) 44.2 (24-76) Symptoms (median /range) 2 (1-7) 2 (1-5) Symptom duration 7.7 years 6.7 years Previous counselling N/A 35.6% Howlett et al. Engagement in psychological treatment for functional neurological symptoms. Psychotherapy Theory, Research, Practice, Training 2007;44: Reuber et al. Tailored psychotherapy for patients with functional neurological symptoms: results of a pilot study. Journal of Psychosomatic Research 2007; 63: M. Reuber / 10

11 Patient characteristics FNS mix of patients referred for psychotherapy in Sheffield % of all patients N= NES Pain Fatigue Invol. Movements Cognitive Impairment Gait disturbance Headache Sens. disturbance Weakness Dizziness Reuber et al. Tailored psychotherapy for patients with functional neurological symptoms: results of a pilot study. Journal of Psychosomatic Research 2007; 63: M. Reuber / 11

12 Patient characteristics Socio-economic status of psychotherapy patients with FNS 16% 14% 26% 4% 4% Disability benefits Unemployed Retired Employed Self-employed Education 36% Reuber et al. Tailored psychotherapy for patients with functional neurological symptoms: results of a pilot study. Journal of Psychosomatic Research 2007; 63: M. Reuber / 12

13 Use of measures Outcome six months after communication of diagnosis of NES 51 patients newly diagnosed with NES recruited consecutively in four centres. 6 months follow-up information on 36 patients (70.5%) Median seizure frequency declined from 10 to 7.5 per month. 16% seizure-free, plus 23% improved (>50% PNES reduction) Mayor R. et al. Short-term outcome of Psychogenic Nonepileptic Seizures following communication of the diagnosis. Epilepsy and Behavior 2012;25: M. Reuber / 13

14 Use of measures Outcome six months after 4 session psycho-education about NES 20 patients newly diagnosed with NES recruited in three centres. 6 months follow-up information on 13 patients (65.0%). Median seizure frequency unchanged (8 per month). 30.7% seizure-free, an additional 15% had >50% improvement in frequency. Mayor R, Brown R, House A, Howlett S, Cock H, Smith P, Reuber M. A feasibility study of a brief psycho-educational intervention for psychogenic nonepileptic seizures. Seizure 2013; 22: M. Reuber / 14

15 Use of measures Outcome six months after 4 session psycho-education about NES Mayor R, Brown R, House A, Howlett S, Cock H, Smith P, Reuber M. A feasibility study of a brief psycho-educational intervention for psychogenic nonepileptic seizures. Seizure 2013; 22: M. Reuber / 15

16 Use of measures Psychotherapy Goldstein et al LaFrance et al Howlett & Reuber 2009 CBT Engagement, cognitivehehavioural assessment, diary keeping, distraction and refocussing techniques, relaxation / breathing techniqes, graded exposure to avoided situations, cognitive restructuring, relapse prevention (discharge plan), carer involvement CBT informed psychotherapy Understanding NES, deciding to take control, getting support, observing triggers, channeling negative emotions, relaxation training, identifying preseizure symptoms, dealing with life stresses, dealing with dilemmas, reducing tension, other seizure symptoms, taking control: an ongoing process Augmented brief PIT Engagement, mind-body link, develop formulation (PPPT), symptom control techniques, increasing tolerance of emotions, discover and chance unhelpful patterns of interpersonal relationships, process trauma (mental exposure, linking memories with symptoms, EMDR, EFT) LaFrance W.C., Reuber M., Goldstein L., Management of psychogenic nonepileptic seizures. Epilepsia 2013; 54 Suppl 1: M. Reuber / 16

Use of measures Psychotherapy Goldstein et al. 2003 LaFrance et al.

17 Use of measures Psychotherapy Goldstein et al LaFrance et al Howlett & Reuber 2009 CBT CBT Augmented brief PIT Engagement, cognitivehehavioural assessment, diary keeping, distraction and refocussing techniques, relaxation / breathing techniqes, graded exposure to avoided situations, cognitive restructuring, relapse prevention (discharge plan), carer involvement Understanding NES, deciding to take control, getting support, observing triggers, channeling negative emotions, relaxation training, identifying preseizure symptoms, dealing with life stresses, dealing with dilemmas, reducing tension, other seizure symptoms, taking control: an ongoing process Engagement, mind-body link, develop formulation (PPPT), symptom control techniques, increasing tolerance of emotions, discover and change unhelpful patterns of interpersonal relationships, process trauma (mental exposure, linking memories with symptoms, EMDR, EFT) LaFrance W.C., Reuber M., Goldstein L., Management of psychogenic nonepileptic seizures. Epilepsia 2013; 54 Suppl 1: M. Reuber / 17

18 Use of measures Augmented brief Psychodynamic Interpersonal Therapy for NES 47 consecutive psychotherapy patients with NES months (median 42) after end of treatment Median duration of NES 4 yrs (median of 6 NES/month) 25.5% seizure-free plus 40.4% improved (>50%) Significant decline in GP visits (0.66 contacts/ months, p=0.039), estimated annual savings of 245. Only baseline predictor or seizure-free outcome: economic activity (OR 5.1) Mayor R et al. Long-term outcome of brief augmented psychodynamic interpersonal therapy for psychogenic nonepileptic seizures: seizure control and health care utilization. Epilepsia 2010;51: M. Reuber / 18

19 Measure (N=63) Mean (SD) pre therapy Outcome measures Use of measures Augmented brief PIT: Outcome after treatment for FNS / NES Mean (SD) post therapy Mean (SD) 6/12 follow-up Pre vs. post CORE OM 51.1 (25.7) 40.4 (29.5) 33.2 (27.0) p=0.003 n. s. Post vs. FU SF (17.1) 89.3 (25.0) 89.0 (28.0) p<0.001 n. s. PHQ-15 / Symptoms 13.8 (5.5)/ (9.1) 11.6 (6.2)/ (7.9) 11.0 (6.5) / (8.2) p=0.001 (p=0.08) n. s. Reuber et al. Tailored psychotherapy for patients with functional neurological symptoms results of a pilot study. J Psychosom Res 2007;63: M. Reuber / 19

20 Use of measures Augmented brief PIT: Distribution of change Measure (N=63) Patients improved by 1 SD ( winners ) Patients worse by 1SD CORE OM (>25.7 points) SF-36 (>14.9 points) PHQ-15 (>5.5 points) 14 (22.6%) 4 (6.5%) 29 (47.5%) 1 (1.6%) 17 (27.9%) 3 (5.0%) Any measure 32 (50.8%) 5 (7.9%) Reuber et al. Tailored psychotherapy for patients with functional neurological symptoms results of a pilot study. J Psychosom Res 2007;63: M. Reuber / 20

21 Change in SF36 subscores Outcome measures Use of measures Measure (N=63) Mean (SD) before therapy Mean (SD) after therapy Treatment effect (multiples of SD) Physical functioning 18.2 (6.5) 18.7 (6.2) -0.1 n. s. Role limitation (physical problems) 5.0 (1.5) 5.4 (1.7) -0.3 n. s. Bodily pain 5.9 (2.7) 6.2 (2.8) 0.04 n. s. Significance General health 12.0 (3.6) 13.2 (4.9) 0.3 p=0.024 Vitality 9.2 (3.7) 11.9 (5.5) 0.7 p<0.001 Social functioning 5.3 (2.3) 6.8 (3.0) 0.7 p<0.001 Role limitation (emotional problems) 4.1 (1.3) 4.5 (1.3) 0.4 p=0.013 Mental health 17.3 (5.8) 19.9 (6.3) 0.5 p=0.001 M. Reuber / 21

22 Use of measures Baseline factors predicting treatment response Economically inactive Non-winner 19 3 Winner Economically active N=47 LR: Chi 2 =5.429 p=0.02 Sensitivity: 86.4% Specifity: 44.0% Correct Classification: 63.8% No effect: Age, symptom duration, gender, NES, CORE OM (T1), SF-36 (T1), PHQ-15 (T1) Reuber et al. Tailored psychotherapy for patients with functional neurological symptoms results of a pilot study. J Psychosom Res 2007;63: M. Reuber / 22

23 Use of measures Health economic assessment of brief augmented PIT for FNS Treatment cost: Health utility gain: Cost / utility analysis: 35,628 (incl 25% on-costs):52:37.5 Hourly treatment cost Median therapy cost Pre- treatment SF6D index: Post-treatment SF6D index: Difference 0.04 (p=0.004) Assumed maintenance of benefit: 1 year 3,197 / QUALY Reuber et al. Tailored psychotherapy for patients with functional neurological symptoms results of a pilot study. J Psychosom Res 2007;63: M. Reuber / 23

24 Domain Measure Subscores Items License HRQoL Short Form 12 (SF-12) MHS, PHS, 8 subscales 12 Yes Depression Patient Health Questionnaire (PHQ-9) None 9 No Anxiety Outcome measures Current use Range of measures for treatment evaluation of patients with FNS Generalised Anxiety Disorder Assessment (GAD-7) None 7 No Trauma PTSD CheckList Civilian Version (PCL-C) None 17 No Physical symptoms Work / Social functioning Healthcare utilisation Patient Health Questionnaire (PHQ-15) None 15 No Work and Social Adjustment Scale Self-designed healthcare utilisation checklist for last three months Work / home / leisure / social activities & relationships 5 No None 15 No M. Reuber / 24

25 The End There are known knowns. These are things we know that we know. There are known unknowns. That is to say, there are things that we know we don't know. But there are also unknown unknowns. There are things we don't know we don't know. Donald Rumsfeld M. Reuber / 25

Nothing Explains Everything

Nothing Explains Everything NES: Psychiatric Comorbidities Diagnosis LaFrance 2005 Lifetime Current MDD 80% 47% Any Affective d/o 98% 64% PTSD 58% 49% Any anxiety d/o except PTSD 51% 47% Any Somatoform