Acta Ophthalmologica 2016
Health-related quality of life after cataract surgery with the phacoemulsification technique and intraocular lens implantation Susanna Porela-Tiihonen,1,2,3 Risto P. Roine,4,5 Harri Sintonen,6 Kai Kaarniranta,3 Merja Kokki1,2 and Hannu Kokki1,2 1
Department of Anaesthesia and Operative Services, Kuopio University Hospital, Kuopio, Finland Department of Anaesthesiology and Intensive Care, School of Medicine, University of Eastern Finland, Kuopio, Finland 3 Department of Ophthalmology, School of Medicine, Kuopio University Hospital, University of Eastern Finland, Kuopio, Finland 4 Research Centre for Comparative Effectiveness and Patient Safety, University of Eastern Finland, Kuopio, Finland 5 Research and Development, Group Administration, Hospital District of Helsinki and Uusimaa, Helsinki, Finland 6 Department of Public Health, Hjelt Institute, University of Helsinki, Helsinki, Finland 2
ABSTRACT. Purpose: Disease-specific instruments have shown significant gains in measuring health-related quality of life (HRQoL) in subjects having cataract surgery. However, the usage of generic instruments has resulted in conflicting evidence. Methods: In this prospective study, we have evaluated the impact of cataract surgery on subjects’ HRQoL measured with a 15-dimension generic instrument, the 15D. The HRQoL of cataract subjects was compared with that of an ageand gender-standardized sample of the general population in Finland. A total of 152 subjects (mean age 74 years, 66% females) with a first-eye cataract surgery completed the 15D questionnaire both before and 12 months after cataract surgery. Results: When compared with the general population, cataract subjects had much lower HRQoL at baseline (mean difference 0.037 (95% CI: 0.020, 0.054), p < 0.001). At 12 months after cataract surgery, the overall utility index improved from the mean of 0.837 to 0.855 (mean difference 0.018 (95% CI: 0.007, 0.029), p = 0.002). Significant improvement was observed on the following five dimensions: seeing, moving, hearing, usual activities and discomfort/symptoms in the 15D questionnaire. Conclusion: Our data indicate that at 12 months after first-eye cataract surgery, patients’ HRQoL is slightly better than that before surgery. However, patients’ postoperative HRQoL may remain lower than that of an age-and gender-standardized control population. Key words: cataract – cataract surgery – quality of life – quality-adjusted life years
Acta Ophthalmol. 2016: 94: 21–25 ª 2015 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd
2011). However, the usage of generic instruments for health-related quality of life (HRQoL) assessment is necessary to be able to compare outcomes after cataract surgery with other procedures and health conditions from other medical specialties (Damiano et al. 1995; Gold et al. 1996; Ramsey et al. 2005; Nord et al. 2009; Wisløff et al. 2014). Previous analyses using generic instruments for HRQoL assessment have yielded inconsistent results in cataract subjects (Steinberg et al. 1994a; R€ as€ anen et al. 2006; Brown et al. 2013; Danquah et al. 2014). Due to conflicting evidence, we performed a prospective follow-up study in subjects having cataract surgery with a phacoemulsification technique in a tertiary hospital in Finland. The primary aim of this study was to evaluate the impact of cataract surgery on patients’ HRQoL measured with a 15dimension generic instrument, the 15D (Sintonen 1995). The second aim was to compare HRQoL of patients undergoing cataract surgery with that in an age- and gender-standardized sample of the general population in Finland.
doi: 10.1111/aos.12755
Introduction Cataract surgery is highly effective at reversing visual impairment. A significant improvement in cataract patients’
daily activities and in vision-related quality of life (QoL) has been shown with disease-specific instruments (Steinberg et al. 1994a; Lundstr€ om & Pesudovs 2009; McAlinden et al.
Materials and Methods The study design was a prospective follow-up study. The protocol was approved by the Research Ethics Committee of the Hospital District of
21
Acta Ophthalmologica 2016
The trial profile is presented as a flow chart in Fig. 1. For background information, we collected age and sex data. Furthermore, the patient records were searched for information on whether the subjects had a second-eye cataract surgery or other ophthalmological surgical procedures during the 12-month follow-up time. The HRQoL was measured at baseline before surgery and at 12 months after surgery with a selfadministered standardized instrument, the 15D (Sintonen 1994, 1995, 2001). The 15D includes the following 15 dimensions, which have five levels each: moving, seeing, hearing, breathing, sleeping, eating, speech, excretion, usual activities, mental function, discomfort and symptoms, depression, distress, vitality and sexual activity. The valuation system is based on an application of the multi-attribute utility theory. The single index score (15D score), representing the overall HRQoL on a 0–1 scale (1 = full health, 0 = being dead), and the dimension level values, reflecting the subject’s reported level relative to no problems on the dimension (=1) and to being dead (=0), are calculated from the health state descriptive system using a
Northern Savo, Kuopio, Finland (No. 40/2010), and the study was conducted in accordance with the principles presented in the Declaration of Helsinki. After providing verbal and written information about the study, written consent was obtained from all participants. The data were collected prospectively between 2010 and 2012 in the Kuopio University Hospital (KUH). The study is part of a large study setting, and some results have been previously published (Porela-Tiihonen et al. 2013, 2014). Initially, 303 consecutive patients who presented for cataract surgery were asked to participate. Of these, 196 (65%) agreed to participate and had an elective first-eye cataract surgery in the year 2010 or 2011. The follow-up questionnaire was mailed to subjects 12 months after surgery and included a prepaid envelope for returning the questionnaire. Cataract subjects who did not return the questionnaire within 2 weeks were contacted and interviewed by phone. Preoperative data were available for 182 (93%) subjects, and 152 returned the followup questionnaire at 12 months and were included in the final analysis, ending up to a response rate of 84%.
Trial profile 303 patients assessed for eligibility
59 declined to participate
244 agreed to participate
48 excluded 39 surgery delayed or cancelled 4 extensive eye surgery 5 other
196 with first-eye cataract surgery
14 excluded no preoperative data 182 with preoperative data included
30 excluded 25 lost to follow-up 5 died
152 with postoperative data at 12 months
Fig. 1. Flow chart.
22
set of population-based preference or utility weights (Sintonen 1995). The minimally important change of the 15D score is 0.015, and the distribution of changes of the 15D scores (postoperative score–baseline score) is divided into the following five categories: >0.035 for ‘much better’, 0.015– 0.035 for ‘slightly better’, > 0.015 and
Health-related quality of life after cataract surgery with the phacoemulsification technique and intraocular lens implantation Susanna Porela-Tiihonen,1,2,3 Risto P. Roine,4,5 Harri Sintonen,6 Kai Kaarniranta,3 Merja Kokki1,2 and Hannu Kokki1,2 1
Department of Anaesthesia and Operative Services, Kuopio University Hospital, Kuopio, Finland Department of Anaesthesiology and Intensive Care, School of Medicine, University of Eastern Finland, Kuopio, Finland 3 Department of Ophthalmology, School of Medicine, Kuopio University Hospital, University of Eastern Finland, Kuopio, Finland 4 Research Centre for Comparative Effectiveness and Patient Safety, University of Eastern Finland, Kuopio, Finland 5 Research and Development, Group Administration, Hospital District of Helsinki and Uusimaa, Helsinki, Finland 6 Department of Public Health, Hjelt Institute, University of Helsinki, Helsinki, Finland 2
ABSTRACT. Purpose: Disease-specific instruments have shown significant gains in measuring health-related quality of life (HRQoL) in subjects having cataract surgery. However, the usage of generic instruments has resulted in conflicting evidence. Methods: In this prospective study, we have evaluated the impact of cataract surgery on subjects’ HRQoL measured with a 15-dimension generic instrument, the 15D. The HRQoL of cataract subjects was compared with that of an ageand gender-standardized sample of the general population in Finland. A total of 152 subjects (mean age 74 years, 66% females) with a first-eye cataract surgery completed the 15D questionnaire both before and 12 months after cataract surgery. Results: When compared with the general population, cataract subjects had much lower HRQoL at baseline (mean difference 0.037 (95% CI: 0.020, 0.054), p < 0.001). At 12 months after cataract surgery, the overall utility index improved from the mean of 0.837 to 0.855 (mean difference 0.018 (95% CI: 0.007, 0.029), p = 0.002). Significant improvement was observed on the following five dimensions: seeing, moving, hearing, usual activities and discomfort/symptoms in the 15D questionnaire. Conclusion: Our data indicate that at 12 months after first-eye cataract surgery, patients’ HRQoL is slightly better than that before surgery. However, patients’ postoperative HRQoL may remain lower than that of an age-and gender-standardized control population. Key words: cataract – cataract surgery – quality of life – quality-adjusted life years
Acta Ophthalmol. 2016: 94: 21–25 ª 2015 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd
2011). However, the usage of generic instruments for health-related quality of life (HRQoL) assessment is necessary to be able to compare outcomes after cataract surgery with other procedures and health conditions from other medical specialties (Damiano et al. 1995; Gold et al. 1996; Ramsey et al. 2005; Nord et al. 2009; Wisløff et al. 2014). Previous analyses using generic instruments for HRQoL assessment have yielded inconsistent results in cataract subjects (Steinberg et al. 1994a; R€ as€ anen et al. 2006; Brown et al. 2013; Danquah et al. 2014). Due to conflicting evidence, we performed a prospective follow-up study in subjects having cataract surgery with a phacoemulsification technique in a tertiary hospital in Finland. The primary aim of this study was to evaluate the impact of cataract surgery on patients’ HRQoL measured with a 15dimension generic instrument, the 15D (Sintonen 1995). The second aim was to compare HRQoL of patients undergoing cataract surgery with that in an age- and gender-standardized sample of the general population in Finland.
doi: 10.1111/aos.12755
Introduction Cataract surgery is highly effective at reversing visual impairment. A significant improvement in cataract patients’
daily activities and in vision-related quality of life (QoL) has been shown with disease-specific instruments (Steinberg et al. 1994a; Lundstr€ om & Pesudovs 2009; McAlinden et al.
Materials and Methods The study design was a prospective follow-up study. The protocol was approved by the Research Ethics Committee of the Hospital District of
21
Acta Ophthalmologica 2016
The trial profile is presented as a flow chart in Fig. 1. For background information, we collected age and sex data. Furthermore, the patient records were searched for information on whether the subjects had a second-eye cataract surgery or other ophthalmological surgical procedures during the 12-month follow-up time. The HRQoL was measured at baseline before surgery and at 12 months after surgery with a selfadministered standardized instrument, the 15D (Sintonen 1994, 1995, 2001). The 15D includes the following 15 dimensions, which have five levels each: moving, seeing, hearing, breathing, sleeping, eating, speech, excretion, usual activities, mental function, discomfort and symptoms, depression, distress, vitality and sexual activity. The valuation system is based on an application of the multi-attribute utility theory. The single index score (15D score), representing the overall HRQoL on a 0–1 scale (1 = full health, 0 = being dead), and the dimension level values, reflecting the subject’s reported level relative to no problems on the dimension (=1) and to being dead (=0), are calculated from the health state descriptive system using a
Northern Savo, Kuopio, Finland (No. 40/2010), and the study was conducted in accordance with the principles presented in the Declaration of Helsinki. After providing verbal and written information about the study, written consent was obtained from all participants. The data were collected prospectively between 2010 and 2012 in the Kuopio University Hospital (KUH). The study is part of a large study setting, and some results have been previously published (Porela-Tiihonen et al. 2013, 2014). Initially, 303 consecutive patients who presented for cataract surgery were asked to participate. Of these, 196 (65%) agreed to participate and had an elective first-eye cataract surgery in the year 2010 or 2011. The follow-up questionnaire was mailed to subjects 12 months after surgery and included a prepaid envelope for returning the questionnaire. Cataract subjects who did not return the questionnaire within 2 weeks were contacted and interviewed by phone. Preoperative data were available for 182 (93%) subjects, and 152 returned the followup questionnaire at 12 months and were included in the final analysis, ending up to a response rate of 84%.
Trial profile 303 patients assessed for eligibility
59 declined to participate
244 agreed to participate
48 excluded 39 surgery delayed or cancelled 4 extensive eye surgery 5 other
196 with first-eye cataract surgery
14 excluded no preoperative data 182 with preoperative data included
30 excluded 25 lost to follow-up 5 died
152 with postoperative data at 12 months
Fig. 1. Flow chart.
22
set of population-based preference or utility weights (Sintonen 1995). The minimally important change of the 15D score is 0.015, and the distribution of changes of the 15D scores (postoperative score–baseline score) is divided into the following five categories: >0.035 for ‘much better’, 0.015– 0.035 for ‘slightly better’, > 0.015 and
