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Nursing Activities Score as a predictor of family satisfaction inan adult Intensive Care Unit in Greece

SOTIRIA GERASIMOU-ANGELIDI RN , M S c , P h D1, PAVLOS MYRIANTHEFS MD , P h D

2,3,ACHILEAS CHOVAS MD , P h D

4, GEORGE BALTOPOULOS MD , P h D3,5 and APOSTOLOS KOMNOS MD , P h D

6

1ICU Nurse, Department of Critical Care Medicine, General Hospital of Larissa, Larissa, 2Associate Professor,Faculty of Nursing, National and Kapodistrian University of Athens, Athens, 3Department of Intensive Care atAgioi Anargyroi General Hospital, Athens, 4Consultant, Department of Intensive Care, General Hospital ofLarissa, Larissa, 5Professor, Faculty of Nursing, National and Kapodistrian University of Athens, Athens and6Principal Director, Department of Intensive Care, General Hospital of Larissa, Biomed/Cereteth, ResearchInstitution of Larissa, Larissa, Greece

Correspondence

Apostolos Komnos

Department of Intensive Care

General Hospital of Larissa

Axenidou 9

41222 Larissa

Greece

E-mail: [email protected]

GERASIMOU-ANGELIDI S., MYRIANTHEFS P., CHOVAS A., BALTOPOULOS G. & KOMNOS A.

(2014) Journal of Nursing Management 22, 151–158.Nursing Activities Score as a predictor of family satisfaction in an adult

Intensive Care Unit in Greece

Aim To study family satisfaction with care in an Intensive Care Unit (ICU) and itsassociation with nursing workload estimated by the Nursing Activities Score (NAS).

Background Few previous studies have investigated the association between

workload in ICUs and family satisfaction.Methods Family Satisfaction ICU 24 (FS ICU-24) questionnaires were distributed to

161 family members (106 respondents). Questionnaires’ score, NAS measurements

and Simplified Acute Physiology Score II (SAPS-II) data were analysed.Results The mean total level of family satisfaction was equal to 80.72% (�9.59).

Family members were more satisfied with the level of care compared withdecision making. NAS values revealed a shortage of nurses in the morning shift.

Moreover, there was a statistically significant positive correlation between NAS

and total satisfaction after adjusting for age, length of stay and SAPS-II.Conclusions Improvements in clinical practice require the measurement of care

quality which particularly includes family satisfaction. Our results indicated that

family members were less satisfied with decision making.Implications for nursing management Nurse managers should plan for the

successful involvement of family members in the decision-making process. Higher

levels of nurse staffing might improve the care provided.

Keywords: critical care, family satisfaction, Intensive Care Unit, Nursing Activities

Score

Accepted for publication: 1 March 2013

Introduction

The main characteristics of health care include safety,

efficiency, effectiveness and equitability which should

be patient-centred in order to fulfil quality demands

(Mitchell 2008, Kourti et al. 2011). Patients’ experi-

ence and health status are recognized as health care

outcome measures in terms of quality and quantity

(Griffiths et al. 2008). Nursing workload and adequate

staffing are also important parameters of health care

quality. Moreover, management interventions resulting

in favourable modifications of work environment lead

DOI: 10.1111/jonm.12089

ª 2013 John Wiley & Sons Ltd 151

Journal of Nursing Management, 2014, 22, 151–158

to improvements in nursing care. However, these

efforts usually have to overcome serious obstacles,

such as workforce shortages. The success of these

interventions is reflected in patient satisfaction as an

index of health care quality (Kutney-Lee et al. 2009).

The association between nursing workload and patient

satisfaction has been investigated in previous studies

(Pascale & Ayse 2008, Aiken et al. 2012).

Critically ill patients in Intensive Care Units (ICUs)

are unable to make decisions about their care (Ely

et al. 2004), or they usually rely on their family mem-

bers to make decisions (Gooding et al. 2012). Given

the involvement of families as decision makers during

hospitalization, family satisfaction should be taken

into account when quality of care is assessed in the

ICUs (Wall et al. 2007a, Gerstel et al. 2008). There-

fore, nursing care should be both family and patient

centred, adding another quality demand in the evalua-

tion process (Hickman et al. 2012). Unfortunately, a

high incidence of conflicts between patients’ relatives

and staff members has been documented in previous

studies, such as team–family disputes, ineffective or

inappropriate communication by the health care team

and unclear or insufficient information (Davidson

2009, Roberti & Fitzpatrick 2010). Τhe aim of the

present study was to explore family satisfaction with

care in an adult ICU in Greece and its association

with nursing workload. Family satisfaction was esti-

mated by Family Satisfaction ICU 24 (FS ICU-24)

questionnaires and nursing workload was measured

by the Nursing Activities Score (NAS). A better under-

standing of the association between nursing workload

in the ICUs and family satisfaction may be of great

importance for nursing management, especially under

the present financial limitations of healthcare systems

as a result of austerity measures in many countries.

Literature review

Client satisfaction is an important index for all services

provision, including hospital health care (Bull et al.

2000). In a large study, Aiken et al. (2012) calculated a

hospital’s nurse staffing as the ratio of patients to nurses

and assessed the nurse work environment using the

Practice Environment Scale of the Nursing Work Index.

They found that, nurse staffing and work environment

were significantly related to patient satisfaction and

quality of care. Interestingly, better staffing was shown

to improve patient outcomes only if it was combined

with a good work environment (Aiken et al. 2011).

In general, a poor nurse work environment has been

linked to higher risk-adjusted mortality, increased

failure-to-rescue rates and worse patient outcomes

(Kutney-Lee et al. 2009). Moreover, promotion of the

work environment has been associated with lower rates

of nurse burnout and job dissatisfaction (Aiken et al.

2011).

In a critical care setting, nursing workload seems to

influence overall quality of care (Tucker 2002, Polder-

man et al. 2003). Also, staffing requirements increase

in parallel with nursing workload (Moura et al.

2011). During the last decades various scoring systems

have been used to measure nursing workload (Kalafati

& Paikopoulou 2006, Kiekkas et al. 2007). One of

the latest proposed scoring systems is NAS, created by

Miranda et al. (2003). However, the quality of care

depends on adequate staffing not only regarding the

number of nurses per shift but also regarding their

professional qualifications. Cutbacks in healthcare

usually affect both parameters (Ambrose 2002, Fawzi

2007). Costs regarding the employment of nursing

personnel account for about 50% of the total ICU

expenditure (Stricker et al. 2003, Cudak & Dyk

2010). Notably, Aiken et al. (2012) suggested that

efforts to improve the work environment may consti-

tute a relatively low cost strategy in order to improve

healthcare.

Finally, given patients’ health status in the ICUs, rel-

atives’ involvement is a crucial factor for health care

evaluation. Measuring family satisfaction may contrib-

ute to the assessment of care provided (Wall et al.

2007b) and family members may serve as important

evaluators in the complex process of improving ICU

care (Wall et al. 2007a, Gerstel et al. 2008). The asso-

ciation between family satisfaction and the health care

provided has been investigated in previous studies

(Heyland et al. 2002, Karlsson et al. 2011).

Methods

Setting and procedure

This retrospective study was carried out in our nine-

bed adult ICU of the General Hospital of Larissa, in

central Greece. Three evaluation tools were used in

the study: FS ICU-24, NAS and Simplified Acute Phys-

iology Score II (SAPS-II).

The FS ICU-24 questionnaire is a reliable, validated,

widely available and well-tested tool for measuring

family satisfaction in the ICUs (Heyland & Tranmer

2001). It has been used in several Canadian and US

studies (Heyland et al. 2002, Curtis et al. 2008, Hen-

rich et al. 2011, Lewis-Newby et al. 2011) and the

full questionnaire with instructions for researchers is

available online (http://www.thecarenet.ca). Also, FS

ª 2013 John Wiley & Sons Ltd

152 Journal of Nursing Management, 2014, 22, 151–158

S. Gerasimou-Angelidi et al.

ICU-24 has been translated into Spanish, German,

French and Greek. Validity of the FS ICU-24 Greek

version has already been validated by Malliarou et al.

(2012).

FS-ICU 24 encompasses 24 items. Fourteen items

rate satisfaction of care, including two questions

regarding quality of care and quantity (frequency) of

nurses’ communication with family members. Ten

items evaluate satisfaction with decision making, such

as frequency, honesty, completeness and consistency

of given information and participation of family mem-

bers in decision making. Participants select one of four

choices for each item. Each choice corresponds to a

percentage score, i.e. ‘excellent or completely satis-

fied’: 100%, ‘very good or very satisfied’: 75%, ‘good

or mostly satisfied’: 50%, ‘poor or slightly dissatis-

fied’: 25% and ‘very poor or very dissatisfied’: 0%

(N/A items are excluded) (Heyland et al. 2002, Wall

et al. 2007b). The total score for the 24 items (total

satisfaction, TS24) and subscale scores (satisfaction

with care or decision making) were calculated by aver-

aging available items, provided that a participant

selects at least 70% of the 24 items. TS24 ranges from

0 to 100% (Wall et al. 2007b).

NAS measures nursing workload based on various

nursing intervention categories defined by Miranda

et al. (2003). NAS calculates a 24-hour total percent-

age score which corresponds to the time spent by

nurses on direct care, regardless of the severity of

the disease (Padilha et al. 2008). Measurement of an

8-hour workload is also possible, provided that there

is large number of shifts, the data are collected and

analysed per shift and there is no change in the items

defined (Miranda et al. 2003). NAS consists of 23

items: general nursing interventions (e.g. hygiene pro-

cedures and enteral feeding), specific nursing interven-

tions (e.g. monitoring and titration and care of

artificial airways), administration of medications and

fluids, diagnostic procedures (e.g. laboratory), sup-

port and care of relatives and administrative or man-

agerial tasks. Each item has a ‘yes–no’ answer,

except for items no. 1 (monitoring and titration), no.

4 (hygiene procedures), no. 6 (mobilization and posi-

tioning) and no. 8 (administrative and managerial

tasks) for which there are three different answers.

Each answer corresponds to a percentage (%) score,

which corresponds to different time-consuming nurs-

ing tasks in everyday practice. The total percentage

score is calculated by adding partial scores and

ranges from 0 to 177% (Miranda et al. 2003). A

patient scoring of 100% utilises the work of one

nurse per shift (or one nursing full-time equivalent

per shift) on that day. One nursing full-time equiva-

lent per shift corresponds to the care of two patients

having a 50% score each. Thus, more than one nurse

can meet nursing requirements of a patient scoring

over 100% on a given day (Miranda et al. 2003).

One NAS point per cent is equal to 14.4 minutes per

24 hour or to 4.8 minute if the measurement of

nursing workload has been performed on an 8-hour

shift (Dias 2006, Giakoumidakis et al. 2009).

According to Miranda et al. (2003), the total time

consumed for nursing activities which are not evalu-

ated by NAS is equal to 94.1 minutes in an 8-hour

shift. This category includes personal activities (e.g.

lunch break, toilet break) and activities that are not

assessed using the NAS instrument (e.g. activities

that are not related directly to the patient or are not

medical).

SAPS-II estimates the risk of death without specifica-

tion of the primary diagnosis. SAPS-II includes 12

physiology variables, three underlying disease vari-

ables, type of admission and the patient’s age (Le Gall

et al. 1993). SAPS-II score ranges from 0 to 163

points. The calculation method results in a predicted

mortality, ranging from 0 to 100%.

In our physicians-led ICU, nursing staff consists

of 26 nurses. Eighteen nurses were university or

technological institute graduates (4-year curriculum)

whereas eight nurses were graduates from other nursing

schools (2-year curriculum). Five nurses had ICU or

emergency departments experience and 24 nurses in

internal medicine or surgical departments. Nurses

work in 8-hour shifts (morning shift 07:00–15:00,

evening shift 15:00–23:00 and night shift 23:00–

07:00 hours), without on-call personnel available in

case of necessity. Nursing staff have multiple roles in

everyday practice:

● Nursing care organisation. In case of difficulties,

nurses may appeal to their head nurse or present

their concerns in regular ICU staff meetings.● Provision of patients care.● Support to the families. One aspect of family sup-

port includes consultation to family members. Fam-

ily members can visit their relatives at noon for

1 hour and/or in the afternoon for 1–3 hour.

Participants

A combination of diagnostic procedures and aggres-

sive treatments take place in the department, such as

neurosurgical interventions and hypothermia after car-

diac arrest resuscitation. From January to the end of

December 2009, 161 patients were hospitalised. The

main disease categories were:


Journal of Nursing Management, 2014, 22, 151–158 153

Association of NAS and family satisfaction in ICU

● Diseases of the circulatory system (29.9%), average

length of stay (LOS) 19.2 days.● Diseases of the respiratory system (20.8%), average

LOS 16.2 days.● Diseases of the digestive system (14.3%), average

LOS 11.1 days.● Diseases by external causes (13%), such as multiply

injury and traumatic brain injury, average LOS

31.2 days.

Based on the following inclusion criteria, 106 of

161 patients were enrolled in the study:

● Time of admission and discharge (transfer to other

department or death) during 2009. Seven patients

were excluded.● Presence of family members during ICU stay (first

visit within 24 hours after admission) and on the

day of discharge. No one was excluded.● ICU stay for more than 24 hours. Two patients

were excluded.● Respondents’ answers for the FS ICU-24 survey

were � 70% of the respective items (Wall et al.

2007a). Forty-six patients were excluded.

Data collection methods

SAPS-II data were recorded on ICU admission by the

attending physician in charge and inserted into the

SAPS-II calculator provided by the OPUS 12 Founda-

tion (an organisation that supports education and

research activities: http://opus12.org). The score was

automatically calculated and the extracted predicted

mortality was stored separately in our database. NAS

values were collected per shift. The nurse/patient ratio

was documented per day. The validated Greek version

of the FS ICU-24 questionnaire was distributed to fam-

ily members by the attending physician on ICU dis-

charge. Therefore, the whole period of ICU care was

evaluated by the participants. The attending physician

informed all participants regarding the confidentiality

of their responses and collected the questionnaires the

same day.

Data analysis

Data analysis for descriptive and inferential statistics

was performed using the Statistical Package for Social

Sciences for WINDOWS 17.0 (SPSS Inc., Chicago, IL,

USA). The satisfaction score for each FS ICU-24 sub-

scale was dichotomized into relatively ‘high’ and ‘low’

based on a median split. LOS and SAPS-II data were

used as covariates to investigate the possible association

between NAS and family satisfaction. A logistic regres-

sion model adjusted for SAPS II, patient’s age, LOS and

NAS with the Total Satisfaction Score (high/low) as a

dependent variable was applied. Statistical significance

was set at P < 0.05. The Cronbach a-value coefficient inthe present study was equal to 0.9, thus indicating a high

internal consistency (Ouzouni & Nakakis 2011).

Ethical considerations

The study protocol was approved by the Faculty of

Nursing, National and Kapodestrian University of

Athens (Number of Approval: 1217) and the hospital

local ethics committee. Written informed consent was

obtained from the family members.

Documentation for each of the 106 patients were

stored separately. Every participant was given a

unique serial number. This number was the only

combining factor for data collected during the study,

protecting the anonymity of the patients.

Results

Included in the study were 73 male and 33 female

patients with a mean age of 58.2 � 19.1 years (range

18–88). The mean LOS was 19.3 � 24.7 days (range

2–129) and the mean SAPS-II was 46.2 � 18.6 points

(range 7–96). Mortality during the study period was

12.3% (13 patients). Ninety-three patients (87.7%)

were discharged to other departments.

Demographic of family members

Accordingly we included 106 participants (51 men, 55

women) in the FS ICU-24 survey (one family member

for each patient) with a mean age of 47.6 years. Sev-

enty-four participants reported first-time ICU admis-

sion of their relatives. Twenty-four participants

reported a marital relationship with the patient and

59 that were living with the patient (Table 1).

Family satisfaction

The mean total level of satisfaction calculated was

80.7% (� 9.6) (Table 2). Family members were more

satisfied with the level of care (91.8% � 13.0) com-

pared with decision making (65.2% � 8.5). Higher

levels of satisfaction were reported regarding interest

and caring by ICU staff to the patient (96.1% � 10.5),

nursing skill and competence (95.7% � 11.9), interest

and caring given to family members (94.6% � 16.1)

and pain management (93.9% � 14.8). Participants

were less satisfied regarding the atmosphere of the depart-




ment or its waiting room (89.9% � 17.3 and

81.6% � 27.6, respectively).

When TS24 was dichotomized at 83% (median

value), the transformed variable was coded (‘low’ :

TS24 � 83 = 1, ‘high’ : TS24 > 83 = 2) and applied

as the dependent variable in a logistic regression

model. Age, SAPS, LOS and total NAS were included

in the model as they are critical parameters for the

patient’s outcome and are linked to nursing workload.

NAS was the only variable that correlated significantly

with a ‘high’ TS24 (P = 0.044). The probability of a

‘high’ TS24 increased by approximately 13.7% for

every NAS point increase (odds ratio 1.137; 95% con-

fidence interval 1.003–1.289) when the model was

adjusted for all other co-variables (Table 3).

Nursing workload

The average nurse/patient ratio was 1/2. The NAS

was calculated at 42.5% � 6.2 for the morning shift,

36.6% � 6.6 for the evening shift and 29.1% � 6.7

for the night shift. The average workload calculated

was 36.1% � 5.2. Therefore, given the above-men-

tioned nurse/patient ratio, the average workload per

shift/24 hours was 5 hours and 46.08 minutes,

whereas the workload calculated was 6.9 hours in the

morning shift (Table 4).

Discussion

According to the results of the present study, total

family satisfaction was high. Family members were

most satisfied with the level of care. Regarding nurs-

ing workload a shortage of nurses in the morning shift

was documented. A statistically significant positive

correlation between NAS and total satisfaction was

also found.

Recent studies showed several crucial factors related

to family satisfaction regarding ICU care: quality of

staff, overall quality of medical care, compassion and

respect to the patient and family, communication with

physicians, the waiting room and patient room

(Stricker et al. 2009, Rothen et al. 2010). Interest-

ingly, high satisfaction rates with ICU services are not

unusual. Stricker et al. (2009) reported a TS24 of

78% � 14 (satisfaction with care: 79% � 14, satisfac-

tion with information/decision making: 77% � 15). In

a study conducted by Heyland et al. (2002), respon-

dents scored >80% in overall care and >75% in deci-

sion making, whereas family members gave the

highest ratings for nursing skills and competence

(92.4% � 14.0). A study performed by Kourti et al.

(2011) at a university ICU in Greece, demonstrated

scores of 71–72.0%, 71.3–76.3% and 70.0–70.7% for

total satisfaction, care and decision making, respec-

tively. Karlsson et al. (2011) reported that relatives

seemed to be quite satisfied with flexible visiting hours

and the quality of treatment, although they would like

Table 1

Demographics of family members according to family satisfaction

(FS) ICU-24

N %

Gender

Male 51 48.1

Female 55 51.9

Total 106 100.0

Age

Mean � SD 47.56 � 16

Minimum 18

Maximum 82

Relationship with the patient

Husband/Wife 24 22.6

Daughter 16 15.1

Son 14 13.2

Mother 12 11.3

Other 40 37.7

Total 106 100.0

First time of patient in ICU

Yes 74 69.8

No 32 30.2

Total 106 100.0

Live with the patient

Yes 59 55.7

No 41 44.3

Total 106 100.0

Frequency of visit at home

More than weekly 39 36.8

Weekly 18 17.0

Monthly 27 25.5

Less than once a year 3 2.8

Missing 19 17.9

Total 106 100.0

Location of stay

In the city 54 50.9

Out of town 52 49.1

Total 106

SD, standard deviation.

Table 2

Family satisfaction (FS) subscales and total score

N

Mean (%) � SD

(median) Minimum Maximum

Satisfaction

with care

106 91.79 � 13.04 (98.00) 26.10 100.00

Satisfaction

with decision

making

106 65.22 � 8.45 (65.00) 38.44 87.50

Total

satisfaction

106 80.72 � 9.59 (83.00) 38.98 94.79

SD, standard deviation.




physicians to be more available for regular consulta-

tion (up to 50% of participants had not fully under-

stood information regarding diagnosis or options for

further care). Other authors have also noted that deci-

sion making is characterised by the lowest family sat-

isfaction ratings (Azoulay et al. 2004, Pochard et al.

2005). In the study by Stricker et al. (2009), lower

overall satisfaction was linked to a higher nurse/

patient ratio, a finding also confirmed by Johnson et al.

(1998). Inadequate staffing tended to be inversely

related to family satisfaction and a nurse/patient ratio

of >3 was associated with lower satisfaction ratings

(Valentin & Ferdinande 2011).

NAS values in our study revealed a shortage of

nurses in the morning shift. Workload was estimated

at 6 hour and 51 minute. Therefore, each staff mem-

ber had to work over 8 hours (8 hours and 22 min-

utes) given the time consumed for activities that are

not included in NAS items (Miranda et al. 2003). This

is in agreement with the high level of nurse burnout

reported by a substantial proportion of Greek nurses

(Aiken et al. 2012).

Our findings regarding total family satisfaction and

satisfaction with care or decision making support

results from previous studies. Notably, we demon-

strated that satisfaction with decision making was

characterised by lower ratings. Finally, in a model

adjusted for the severity of illness on admission (as

expressed by SAPS-II), LOS and age, we found that a

higher NAS was related to higher satisfaction. Possi-

bly, intensity of care was highly appreciated by family

members and overwork was positively reflected in par-

ticipants’ responses. This finding does not compensate

for the shortage of nurses but may underline the high

activity of the nursing staff.

Study limitations

The over-representation of traumatic brain injury and

cerebral strokes may create biases and thus should be

regarded as a study limitation. The regional distribu-

tion of units providing intensive care in Central

Greece may account for this imbalance, as the depart-

ment is the only ICU performing thrombolysis in

the region. Additional research with larger samples

and more precise measurements of errors is also

suggested.

Conclusions

In the present study, we applied FS ICU-24 and NAS

in order to investigate the possible association

between nursing workload and family satisfaction.

Assessing family members’ satisfaction in critical care

settings may be quite complicated. An improvement in

clinical practice requires measurement of care quality

which includes family satisfaction. Our results indi-

cated that family members were less satisfied with

decision making. An objective instrument, such as the

NAS, may add valuable information regarding the

Table 3

Association between NAS and total satisfaction: Logistic Regression Model

B SE Wald d.f. Sig. Odds ratio

95% CI for EXP(B)

Lower Upper

Age 0.012 0.012 0.878 1 0.349 10.012 0.988 1.036

SAPS II �0.018 0.014 1.592 1 0.207 0.982 0.954 1.010

LOS 0.005 0.009 0.252 1 0.616 1.005 0.986 1.023

NAS total 0.128 0.064 4.050 1 0.044 1.137 1.003 1.289

Constant �4.169 2.218 3.534 1 0.060 0.015

NAS, Nursing Activities Score; SE, standard error, d.f., degrees of freedom; CI, confidence interval; LOS, length of stay.

Table 4

Accessing nursing workload with a Nursing Activities Score (NAS)

per 8-hour shift

Shift Translating NAS into minute*

Morning

(07.00–15.00)

42.48% NAS 9 4.8΄= 3 hours 24΄ per patient3 hours 24΄ 9 2 = 6 hours 48΄ per nurse(6 hours 48΄+ 1 hour 34.08 minutes =8 hours 22΄)

Evening

(15.00–23.00)

36.62% NAS 9 4.8 = 2 hours 56΄ per patient2 hours 56΄ 9 2 = 5 hours 52΄ per nurse(5 hours 52΄ + 1 hour 34.08 minutes =7 hours 26΄)

Night

(23.00–07.00)

29.05% NAS 9 4.8΄ = 2 hours 19΄ per patient2 hours 19΄ 9 2 = 4 hours 39΄ per nurse(4 hours 39΄+ 1 hour 34.08 minutes =6 hours 13΄)

Total

score

36.05% NAS 9 4.8΄= 2 hours 53΄ per patient2 hours 53΄ 9 2 = 5 hours 46΄ per nurse(5 hours 46΄+ 1 hours 34.08 minutes =7 hours 20΄)

*Nursing time is equal to double the patients’ time as the nurse/

patient ratio is 1/2.




association between nursing activity and family satis-

faction.

Implications for nursing management

In accordance with the literature, we found that fam-

ily satisfaction regarding decision making was rated

with lower scores, which may affect quality of health-

care. Therefore, nurse managers should develop more

effective strategies aimed at increasing the involvement

of family members in decision making. These initia-

tives could take place during the evening shifts as the

nursing workload is usually lower. Moreover, the

association between nursing workload and family sat-

isfaction was found to be more complex than

expected. Additional factors, such as nursing over-

work, seemed to influence these results. In spite of

limited financial resources, nurse managers should

take into account that an improvement in staffing lev-

els may eventually have positive financial conse-

quences by achieving favourable patient outcomes

through the prevention of adverse events.

Acknowledgements

We would like to thank Dr George Krommidas for

statistical advice and Dr George Angelidis for editing

and linguistic review.

Source of funding

We would like to thank GlaxoSmithKline Pharmaceu-

ticals for financial support of this work.

Ethical approval

Ethical approval was granted by No. 1217, National

and Kapodestrian University of Athens.

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