negative impact of reduced first undisturbed sleep period ... · negative impact of reduced first...

Negative impact of reduced first undisturbed sleep period on utility, productivity and health-related quality of life: results of a real world survey of patients in Europe and USA

Bliwise DL,1 Anderson P,2 Wood R,2 Holm-Larsen T 3 1 Emory University School of Medicine, Dept. of Neurology, Atlanta, USA; 2 Adelphi Real World (ARW), Macclesfield, UK;

3 University of Copenhagen, Dept. of Drug Design & Pharmacology, Denmark

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Presented at the 29th Annual EAU Congress Stockholm, Sweden 11-15 April 2014

Introduction and objectives • Fragmentation of sleep, particularly disruption of

restorative slow wave sleep in the first four hours, is a serious consequence of nocturia.1

• It is hypothesised that a negative correlation exists between nocturia severity (measured by duration of first undisturbed sleep period - FUSP) and utility, productivity, sleep quality and health-related quality of life (HRQL).

• The aim of this analysis was to investigate this association in practice settings.

Materials and methods • Data were drawn from the Adelphi Lower Urinary

Tract Symptoms (LUTS) Disease Specific Programme® (DSP), a cross-sectional survey of physicians and their consulting patients conducted in Q1 2013.

• Primary care physicians (PCPs) and urology specialists (urologists/gynaecologists) in France, Germany, Spain, UK and USA, actively managing urinary patients, were asked to complete patient record forms prospectively for the next 14 OAB/BPH/nocturia patients consulting their clinic.

• The same patients were asked to fill in a self-completion questionnaire (PSC) including duration of FUSP, how refreshed they feel the next day (using a 1-10 scale where 1 = poor and 10 = excellent) and how many times per day, on average, they take a nap (of 5 minutes or longer).

• The PSC also included measures of utility, HRQL and impact on work/activities - EuroQol 5-D (EQ-5D),2 Overactive Bladder Questionnaire (OAB-q),3 Nocturia Impact (NI) Diary®4 and Work Productivity and Activity Index (WPAI).5

• The methodology, including limitations, has been outlined previously.6

• A Kruskal-Wallis test was used to test for dependence between the measures and duration of FUSP. Mann-Whitney tests with Bonferroni-adjusted p values were performed to test pairwise comparisons.

Conclusions • Reduced duration of first undisturbed

sleep period (before waking to urinate) has strong negative associations with HRQL, utility, work productivity, activities, feeling refreshed and naps taken during a day.

• These findings demonstrate that the sleep problems associated with nocturia should be taken seriously and the condition treated accordingly.

References 1. Andersson F, Goble S, Holm-Larsen T, Norgaard JP. Patients with

nocturia – increasing time to first void improves sleep quality. Value Health. 2013; 16:A183.

2. The EuroQol Group (1990). EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 16(3):199-208

3. Coyne K et al. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res. 2002 Sep;11(6):563-74

4. Holm-Larsen T et al. The Nocturia impact diary® - a new patient reported outcome (PRO) instrument developed in close dialog with the FDA. Value Health 2013; 16(3):A41

5. Reilly MC et al. The validity and reproducibility of a work productivity and activity impairment instrument. PharmacoEconomics 1993; 4(5):353-65

6. Anderson P, Benford M, Harris N et al. Real-world physician and patient behaviour across countries: Disease-Specific Programmes – a means to understand. Curr Med Res Opin 2008; 24(11):3063-3072

Abstract number: AM14-2672 Poster number: 591

Results • A total of 635 physicians (264 PCPs and 371

specialists) completed records on 8738 patients, of whom 5335 filled out a PSC.

• For all measures, deterioration in putative outcome was linearly dependent on reduced duration of first undisturbed sleep period (FUSP).

• EQ-5D 5L state rose significantly when FUSP lasted beyond 2 hours – Figure 1.

• EQ Visual Analogue Scale (VAS) score and OAB-q total HRQL score both also rose significantly beyond two hours FUSP and again beyond three and four hours of undisturbed sleep.

Fig 3: 1st undisturbed sleep period (FUSP) vs Nocturia Impact (NI) Diary Score

* N/S = not significant

Fig 1: 1st undisturbed sleep period (FUSP) vs EQ-5D/OAB-Q

0.78 0.81 0.84 0.85 0.85

0

0.2

0.4

0.6

0.8

1

<1 1 to 2 2 to 3 3 to 4 > 4

(n=137) (n=862) (n=1366) (n=547) (n=168)

First undisturbed sleep period (hours)

EQ

-5D

5L

stat

e va

luat

ion

5L/VAS Significant difference 1-2 vs >2 hours

VAS 65

VAS 67

VAS 72

VAS 75

VAS 77

N/S p=0.0014

N/S

FUSP versus EQ-5D 5L State/VAS

Better HRQL

Worse HRQL

N/S

N/S p<0.0001 p=0.0281 p=0.0097

42 39

31

25

18

0

10

20

30

40

50

<1 1 to 2 2 to 3 3 to 4 > 4(n=137) (n=846) (n=1364) (n=541) (n=165)

FUSP versus OAB-q total HRQL score

N/S

p<0.0001

p<0.0001

p<0.0001

Significant difference beyond 1 hour (p<0.0001)

Better HRQL

Worse HRQL

OA

B-q

tota

l HR

QL

scor

e


Less Impact

More impact


43 39

32

25

18

0

10

20

30

40

50

<1 1 to 2 2 to 3 3 to 4 > 4(n=122) (n=802) (n=1291) (n=518) (n=155)

FUSP versus NI Diary (overall score)

NI D

iary

ove

rall

scor

e N/S

p<0.0001

p<0.0001

p<0.0001

Significant difference beyond 2 hours (p<0.0001)

Fig 4: 1st undisturbed sleep period (FUSP) versus number of daytime naps/feeling poorly refreshed the next day


1.8 1.9

1.4

1.1 1.2

0.0

0.5

1.0

1.5

2.0

<1 1 to 2 2 to 3 3 to 4 > 4(n=118) (n=746) (n=1203) (n=500) (n=138)

FUSP versus number of daytime naps

Num

ber o

f day

time

naps

N/S

p<0.0001

p=0.0072 N/S

Significant difference <1/1-2 vs 2-3 vs 3-4 hours

p=0.026

Less Impact

More impact

Poorly refreshed

Excellent


5.6 5.9 6.4 7.1 7.5

0

2

4

6

8

10

<1 1 to 2 2 to 3 3 to 4 > 4(n=139) (n=851) (n=1368) (n=551) (n=165)

FUSP versus feeling refreshed the next day

Mea

n sc

ore

(1-1

0 sc

ale)

N/S p<0.0001

p<0.0001 p=0.048

Significant difference 1-2 vs 2-3 vs 3-4 vs >4 hours

Less Impact

More Impact 36%

33%

27%

22%

12%

0%

10%

20%

30%

40%

<1 1 to 2 2 to 3 3 to 4 > 4

(n=27) (n=181) (n=300) (n=128) (n=43)


FUSP versus % overall work impairment

% o

vera

ll w

ork

impa

irmen

t

N/S

N/S

N/S

N/S

Overall difference (p<0.0001)

Less Impact

More Impact

FUSP versus % activity impairment

47% 43%

35% 30%

22%

0%

10%

20%

30%

40%

50%

<1 1 to 2 2 to 3 3 to 4 > 4

(n=127) (n=825) (n=1311) (n=534) (n=167)


WP

AI:

% a

ctiv

ity im

pairm

ent

N/S

p<0.0001

p<0.0001

p<0.0001

Significant difference 1-2 vs 2-3 vs 3-4 vs >4 hours


Fig 2: 1st undisturbed sleep period (FUSP) versus Work Productivity and Activity Index (WPAI)

• Number of daytime naps fell significantly for patients achieving more than two hours FUSP while the mean score for how refreshed they feel the next day rose significantly beyond two hours – Figure 4.

• For OAB-q, WPAI and NI Diary score, improvement for patients getting >4 hours FUSP was highly significant versus those getting ≤4 hours sleep. Significant difference was also seen between these patients for EQ-5D VAS and feeling refreshed.

• Mean percentage overall work impairment fell linearly from 36% (first undisturbed sleep <1 hour) to 12% (> 4 hours) with high overall significance – Figure 2.

• Mean percentage activity impairment (outside work) also fell linearly from 47% (< 1 hour FUSP) to 22% (> 4 hours FUSP) with highly significant falls beyond two hours FUSP - Figure 2.

• Note: overall work impairment is calculated from % impairment while working and work time missed.

• Mean percentage impairment while working (not shown) fell from 35% (<1 hour FUSP) to 11% (>4 hours FUSP) with a significant drop between 3-4 hours and >4 hours FUSP (p=0.0467).

• While mean percentage work time missed (not shown) fell from 6.8% (<1 hour FUSP) to 2.8% (>4 hours FUSP), the difference was not significant.

• Nocturia Impact Diary scores rose linearly as the duration of FUSP increased, with significant differences observed beyond two hours – Figure 3.



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