human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: PURPOSE The Comparison of Ophthalmic Medications for Tolerability ( COMTOL ) question naire was developed for use in clinical trials to compare the tolerability of topical ophthalmic medications used in the treatment of glaucoma . The question naire captures the frequency and bother of common side effects ( i.e. , ocular and other local effects , and effects on visual function ) of topical therapy for lowering intraocular pressure . In addition , the question naire measures the extent to which these side effects and any associated limitations in routine living activities interfere with health-related quality of life , medication compliance , and patient satisfaction with the medication . This study was design ed to assess the measurement characteristics of the COMTOL question naire . METHODS The internal consistency , reliability , reproducibility , construct validity , discriminant validity , and responsiveness of the question naire were assessed in 70 adult patients with glaucoma in a clinical trial comparing timolol and pilocarpine . RESULTS The question naire showed good-to-excellent internal consistency ( 0.73 to 0.98 ) , reliability ( 0.76 to 0.94 ) , and reproducibility ( 0.75 to 0.93 ) . In general , there was a strong correlation in the expected direction between the frequency and bother of side effects and patient-perceived global measures . The question naire discriminated between patients receiving timolol and patients receiving pilocarpine . The question naire demonstrated significant responsiveness to change . CONCLUSIONS The COMTOL question naire showed acceptable measurement characteristics for inclusion as a tolerability measure to supplement spontaneous adverse event reporting in clinical trials of topical ophthalmic therapy Purpose To provide initial validation of the Treatment Satisfaction Survey-Intraocular Pressure ( TSS-IOP ) quality -of-life survey that analyses specific issues related to side effects , patient satisfaction , and compliance . Methods A prospect i ve , observational cohort of 250 consecutive patients with primary open-angle glaucoma or ocular hypertension was administered the TSS-IOP survey . Results Factors that correlated with patient satisfaction included perceived effectiveness of the medicine ( F=7.47 , P<0.001 ) , ocular irritation ( F=6.06 , P<0.001 ) , conjunctival hyperaemia ( F=4.40 , P<0.001 ) , ease of use ( F=8.52 , P<0.001 ) , and convenience of use ( F=6.90 , P<0.001 ) . Patient compliance , acceptance of their illness , and knowledge of glaucoma were also related to perceived effectiveness of the medicine ( P<0.001 ) , ease of use ( P<0.05 ) and convenience ( P<0.001 ) . Physician ratings of patient pressure control , side effects , and instillation problems also were significantly correlated to patient satisfaction ( R=0.13–0.26 , P=0.05–0.001 ) . The physician ratings of patient compliance , however , were not significantly related to any dimension of patient satisfaction ( P>0.05 ) . Among monotherapy prostagl and in treatments , latanoprost demonstrated statistically greater satisfaction than bimatoprost or travoprost regarding conjunctival hyperaemia ( P<0.05 ) and eye irritation ( P<0.01 ) . Conclusions This study provides initial evidence that patient satisfaction may be related to compliance , perceived effectiveness of treatment , adverse side effects , ease and convenience of use , acceptance of illness , and knowledge of glaucoma PURPOSE To verify the quality of life in a Brazilian glaucoma population and the influence of possible modifiers ( e.g. , visual acuity , visual field impairment ) . METHODS Forty-five consecutive patients from CEROF - Federal University of Goiás , Brazil were included prospect ively in the study . The quality of life was assessed using the Portuguese version of the VFQ . Possible modifiers were evaluated , initially separately with the Spearman 's Correlation and then together in a regression model . RESULTS The mean age was 59.6 ± 12.4 years .  The mean quality of life score was 79 ± 15 ( range 45 - 100 ) . Age ( r = −0.402 , p = 0.006 ) , visual acuity in the better eye ( r = −0.497 , p = 0.001 ) and in the worse eye ( r = −0.608 , p < 0.001 ) , Hodapp-Parrish- And erson visual field grading scale in the better ( r = −0.353 , p = 0.01 ) and worse eye ( r = −0.387 , p = 0.009 ) , visual field Mean Deviation ( MD ) in the better ( r = 0.355 , p = 0.01 ) and worse eye ( r = 0.320 , p = 0.04 ) and ability to perform a visual field test in both eyes ( r = −0.397 , p = 0.007 ) were significantly correlated with the quality of life scores . However , only age ( younger , better quality of life , p = 0.008 ) and visual acuity in the better eye ( direct relation , p = 0.04 ) were significant in the regression model ( r = 0.633 , r2 = 0.401 ) . CONCLUSIONS The VFQ may be a useful tool to assess the quality of life in glaucoma patients . The preliminary results indicate that age and visual acuity in the better eye are the main factors related to the quality of life in these patients PURPOSE To evaluate the relationship between visual disability and the remaining visual field in glaucoma patients . DESIGN Prospect i ve noncomparative survey . PARTICIPANTS One hundred forty-seven Japanese patients with glaucoma were examined . METHODS Using a previously developed question naire , we assessed the relationship between visual disability indices and both the visual field examined using program 30 - 2 of the Humphrey Field Analyzer and visual acuity . MAIN OUTCOME MEASURES Pearson 's correlation coefficients between visual disability indices and the 22 visual field and 2 visual acuity measurements were calculated . Multiple regression analysis with stepwise variable selection identified factors significantly contributing to visual disability . RESULTS We identified a significant correlation between visual disability and both the visual field and visual acuity measurements collected . Of the factors examined , retinal sensitivity in the lower hemifield within 5 degrees of the fixation and visual acuity in the better eye significantly contributed to all the item and total disability indices ( DIs ) , measurements of the degree of visual disability as evaluated by the question naire ; visual acuity in the worse eye contributed to two of the seven item DIs , as well as the total DI . The R value for total DI ( R = 0.87 , P < 0.0001 ) indicated that approximately 76 % of the visual disability could be explained by these factors . CONCLUSIONS The Japanese glaucoma patients ' visual disability is explained primarily by retinal sensitivity in the lower hemifield within 5 degrees of the fixation and visual acuity in the better eye and secondarily by visual acuity in the worse eye PURPOSE To evaluate the effect of treatment , visual function , and other factors on vision-targeted health-related quality of life ( HRQOL ) of patients with early glaucoma . DESIGN R and omized clinical trial . PARTICIPANTS Two hundred fifty-five patients with newly detected open-angle glaucoma and repeatable early visual field ( VF ) defects , 50 to 80 years old ( 66 % female ) . METHODS Patients were r and omized to receive either betaxolol plus laser trabeculoplasty in eligible eye(s ) or no initial treatment and had ophthalmologic examinations every 3 months . A Swedish translation of the 25-item National Eye Institute Visual Function Question naire ( NEI VFQ-25 ) was self-administered at 2 follow-up visits ( 3 and 6 years after r and omization ) . MAIN OUTCOME Multiple linear regression analyses determined the effect of treatment and other factors on ( 1 ) VFQ-25 composite scores at the first administration and ( 2 ) change in scores between administrations . RESULTS Two hundred thirty-three patients had 1 NEI VFQ-25  administration and 167 patients had 2 administrations . Internal consistency reliability was high for the composite VFQ-25 score ( Cronbach alpha = 0.88 ) and satisfactory ( alpha > or = 0.76 ) for most subscale scores . At the first administration , the composite score was high ( 88.8+/-11.7 ) . Mean subscale scores were also generally high ( 98.0 - 58.3 ) and were similar for each study group when analyzed separately . Most lower subscale scores were modestly but significantly related to worse visual acuity ( VA ) or mean deviation ( MD ) ( better eye , r = 0.15 - 0.35 ) . Composite scores were similar for treated and untreated patients . Lower composite scores were associated with low VA in the better eye ( worse than 0.70 ) and worse perimetric MD ( < 4.16 decibels ) and nuclear lens opacities ( Lens Opacities Classification System II grade > or = 2 ) , but not with age , gender , VF progression , intraocular pressure , cardiovascular disease , or hypertension . Between VFQ-25 administrations , larger decreases in the composite score were associated with larger decreases in VA ( P<0.05 ) , female gender ( P = 0.001 ) , and older age at first administration ( P = 0.006 ) . Treatment ( assigned at r and omization or later in the study ) was not associated with change in HRQOL . CONCLUSIONS Results suggest that absence or delay of treatment did not influence vision-targeted HRQOL in these newly diagnosed glaucoma patients . However , visual function affected vision-targeted quality of life up to 6 years after Early Manifest Glaucoma Trial enrollment The final development of the Sickness Impact Profile ( SIP ) , a behaviorally based measure of health status , is presented . A large field trial on a r and om sample of prepaid group practice enrollees and smaller trials on sample s of patients with hyperthyroidism , rheumatoid arthritis and hip replacements were undertaken to assess reliability and validity of the SIP and provide data for category and item analyses . Test-retest reliability ( r = 0.92 ) and internal consistency ( r = 0.94 ) were high . Convergent and discriminant validity was evaluated using the multitrait – multi method technique . Clinical validity was assessed by determining the relationship between clinical measures of disease and the SIP scores . The relationship between the SIP and criterion measures were moderate to high and in the direction hypotheszed . A technique for describing and assessing similarities and differences among groups was developed using profile and pattern analysis . The final SIP contains 136 items in 12 categories . Overall , category , and dimension scores may be calculated PURPOSE The Tube Versus Trabeculectomy ( TVT ) Study will compare the safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in patients with previous intraocular surgery . DESIGN Multicenter r and omized clinical trial . METHODS SETTING 17 Clinical Centers . STUDY POPULATION Patients 18 to 85 years of age who have undergone previous trabeculectomy , cataract extraction with intraocular lens implantation , or both and have inadequately controlled glaucoma with intraocular pressure ( IOP ) > or=18 mm Hg and < or=40 mm Hg on tolerated medical therapy . INTERVENTIONS Study patients were r and omized to undergo placement of a 350-mm(2 ) Baerveldt glaucoma implant or trabeculectomy with mitomycin C ( 0.4 mg/ml for 4 minutes ) . MAIN OUTCOME MEASURES IOP , complication rates , visual acuity , visual field , quality of life , reoperations for glaucoma , and need for supplemental medical therapy . RESULTS A total of 212 patients were enrolled between October 1999 and April 2004 . The age of the study population was 71.0 + /- 10.4 years ( mean + /- SD ) , and 53 % were women . The baseline  IOP  was 25.3 + /- 5.3 mm Hg ( mean + /- SD ) . There were no significant differences in the demographic and ocular characteristics between the 2 treatment groups . CONCLUSIONS Practice patterns vary in the surgical management of glaucoma , and there are differing opinions among glaucoma surgeons regarding the preferred surgical approach in patients who have undergone previous cataract extraction and /or failed filtering surgery . Forthcoming data from the TVT Study should provide valuable information comparing two surgical procedures commonly used in this patient population This 3-month multicenter , open-label study of 89 geriatric patients with glaucoma evaluated the substitution of brimonidine twice daily for topical beta blockers that had been used for at least 6 months . The primary outcome measures were reduction in intraocular pressure ( IOP ) from baseline at 2 hours postdose , change in cardiac and respiratory function , quality of life , and patient satisfaction . Patients were queried about adverse events at each visit and completed a  quality -of-life question  naire at the final evaluation . In this cohort with a mean age of 75.4 years , the average duration of topical beta-blocker therapy was 5 years . Brimonidine twice daily produced an additional mean reduction in IOP of 8.2 % ( 1.4 mm Hg;P < .001 ) . Eighty-eight percent of patients ( 60/68 ) reported being at least as satisfied with brimonidine as with their previous beta-blocker regimen , and 46 % ( 31/68 ) reported 
    Output:
    
agent
The National Eye Institute Visual Function Question naire-25 , Impact of Vision Impairment and Treatment Satisfaction Survey-Intraocular Pressure had the highest number of positive ratings in the content validity assessment .
Conclusion This study provides a descriptive catalogue of vision-specific PRO instruments , to inform the choice of an appropriate measure of patient-reported outcomes in a glaucoma context
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: PURPOSE The Comparison of Ophthalmic Medications for Tolerability ( COMTOL ) question naire was developed for use in clinical trials to compare the tolerability of topical ophthalmic medications used in the treatment of glaucoma . The question naire captures the frequency and bother of common side effects ( i.e. , ocular and other local effects , and effects on visual function ) of topical therapy for lowering intraocular pressure . In addition , the question naire measures the extent to which these side effects and any associated limitations in routine living activities interfere with health-related quality of life , medication compliance , and patient satisfaction with the medication . This study was design ed to assess the measurement characteristics of the COMTOL question naire . METHODS The internal consistency , reliability , reproducibility , construct validity , discriminant validity , and responsiveness of the question naire were assessed in 70 adult patients with glaucoma in a clinical trial comparing timolol and pilocarpine . RESULTS The question naire showed good-to-excellent internal consistency ( 0.73 to 0.98 ) , reliability ( 0.76 to 0.94 ) , and reproducibility ( 0.75 to 0.93 ) . In general , there was a strong correlation in the expected direction between the frequency and bother of side effects and patient-perceived global measures . The question naire discriminated between patients receiving timolol and patients receiving pilocarpine . The question naire demonstrated significant responsiveness to change . CONCLUSIONS The COMTOL question naire showed acceptable measurement characteristics for inclusion as a tolerability measure to supplement spontaneous adverse event reporting in clinical trials of topical ophthalmic therapy Purpose To provide initial validation of the Treatment Satisfaction Survey-Intraocular Pressure ( TSS-IOP ) quality -of-life survey that analyses specific issues related to side effects , patient satisfaction , and compliance . Methods A prospect i ve , observational cohort of 250 consecutive patients with primary open-angle glaucoma or ocular hypertension was administered the TSS-IOP survey . Results Factors that correlated with patient satisfaction included perceived effectiveness of the medicine ( F=7.47 , P<0.001 ) , ocular irritation ( F=6.06 , P<0.001 ) , conjunctival hyperaemia ( F=4.40 , P<0.001 ) , ease of use ( F=8.52 , P<0.001 ) , and convenience of use ( F=6.90 , P<0.001 ) . Patient compliance , acceptance of their illness , and knowledge of glaucoma were also related to perceived effectiveness of the medicine ( P<0.001 ) , ease of use ( P<0.05 ) and convenience ( P<0.001 ) . Physician ratings of patient pressure control , side effects , and instillation problems also were significantly correlated to patient satisfaction ( R=0.13–0.26 , P=0.05–0.001 ) . The physician ratings of patient compliance , however , were not significantly related to any dimension of patient satisfaction ( P>0.05 ) . Among monotherapy prostagl and in treatments , latanoprost demonstrated statistically greater satisfaction than bimatoprost or travoprost regarding conjunctival hyperaemia ( P<0.05 ) and eye irritation ( P<0.01 ) . Conclusions This study provides initial evidence that patient satisfaction may be related to compliance , perceived effectiveness of treatment , adverse side effects , ease and convenience of use , acceptance of illness , and knowledge of glaucoma PURPOSE To verify the quality of life in a Brazilian glaucoma population and the influence of possible modifiers ( e.g. , visual acuity , visual field impairment ) . METHODS Forty-five consecutive patients from CEROF - Federal University of Goiás , Brazil were included prospect ively in the study . The quality of life was assessed using the Portuguese version of the VFQ . Possible modifiers were evaluated , initially separately with the Spearman 's Correlation and then together in a regression model . RESULTS The mean age was 59.6 ± 12.4 years .  The mean quality of life score was 79 ± 15 ( range 45 - 100 ) . Age ( r = −0.402 , p = 0.006 ) , visual acuity in the better eye ( r = −0.497 , p = 0.001 ) and in the worse eye ( r = −0.608 , p < 0.001 ) , Hodapp-Parrish- And erson visual field grading scale in the better ( r = −0.353 , p = 0.01 ) and worse eye ( r = −0.387 , p = 0.009 ) , visual field Mean Deviation ( MD ) in the better ( r = 0.355 , p = 0.01 ) and worse eye ( r = 0.320 , p = 0.04 ) and ability to perform a visual field test in both eyes ( r = −0.397 , p = 0.007 ) were significantly correlated with the quality of life scores . However , only age ( younger , better quality of life , p = 0.008 ) and visual acuity in the better eye ( direct relation , p = 0.04 ) were significant in the regression model ( r = 0.633 , r2 = 0.401 ) . CONCLUSIONS The VFQ may be a useful tool to assess the quality of life in glaucoma patients . The preliminary results indicate that age and visual acuity in the better eye are the main factors related to the quality of life in these patients PURPOSE To evaluate the relationship between visual disability and the remaining visual field in glaucoma patients . DESIGN Prospect i ve noncomparative survey . PARTICIPANTS One hundred forty-seven Japanese patients with glaucoma were examined . METHODS Using a previously developed question naire , we assessed the relationship between visual disability indices and both the visual field examined using program 30 - 2 of the Humphrey Field Analyzer and visual acuity . MAIN OUTCOME MEASURES Pearson 's correlation coefficients between visual disability indices and the 22 visual field and 2 visual acuity measurements were calculated . Multiple regression analysis with stepwise variable selection identified factors significantly contributing to visual disability . RESULTS We identified a significant correlation between visual disability and both the visual field and visual acuity measurements collected . Of the factors examined , retinal sensitivity in the lower hemifield within 5 degrees of the fixation and visual acuity in the better eye significantly contributed to all the item and total disability indices ( DIs ) , measurements of the degree of visual disability as evaluated by the question naire ; visual acuity in the worse eye contributed to two of the seven item DIs , as well as the total DI . The R value for total DI ( R = 0.87 , P < 0.0001 ) indicated that approximately 76 % of the visual disability could be explained by these factors . CONCLUSIONS The Japanese glaucoma patients ' visual disability is explained primarily by retinal sensitivity in the lower hemifield within 5 degrees of the fixation and visual acuity in the better eye and secondarily by visual acuity in the worse eye PURPOSE To evaluate the effect of treatment , visual function , and other factors on vision-targeted health-related quality of life ( HRQOL ) of patients with early glaucoma . DESIGN R and omized clinical trial . PARTICIPANTS Two hundred fifty-five patients with newly detected open-angle glaucoma and repeatable early visual field ( VF ) defects , 50 to 80 years old ( 66 % female ) . METHODS Patients were r and omized to receive either betaxolol plus laser trabeculoplasty in eligible eye(s ) or no initial treatment and had ophthalmologic examinations every 3 months . A Swedish translation of the 25-item National Eye Institute Visual Function Question naire ( NEI VFQ-25 ) was self-administered at 2 follow-up visits ( 3 and 6 years after r and omization ) . MAIN OUTCOME Multiple linear regression analyses determined the effect of treatment and other factors on ( 1 ) VFQ-25 composite scores at the first administration and ( 2 ) change in scores between administrations . RESULTS Two hundred thirty-three patients had 1 NEI VFQ-25  administration and 167 patients had 2 administrations . Internal consistency reliability was high for the composite VFQ-25 score ( Cronbach alpha = 0.88 ) and satisfactory ( alpha > or = 0.76 ) for most subscale scores . At the first administration , the composite score was high ( 88.8+/-11.7 ) . Mean subscale scores were also generally high ( 98.0 - 58.3 ) and were similar for each study group when analyzed separately . Most lower subscale scores were modestly but significantly related to worse visual acuity ( VA ) or mean deviation ( MD ) ( better eye , r = 0.15 - 0.35 ) . Composite scores were similar for treated and untreated patients . Lower composite scores were associated with low VA in the better eye ( worse than 0.70 ) and worse perimetric MD ( < 4.16 decibels ) and nuclear lens opacities ( Lens Opacities Classification System II grade > or = 2 ) , but not with age , gender , VF progression , intraocular pressure , cardiovascular disease , or hypertension . Between VFQ-25 administrations , larger decreases in the composite score were associated with larger decreases in VA ( P<0.05 ) , female gender ( P = 0.001 ) , and older age at first administration ( P = 0.006 ) . Treatment ( assigned at r and omization or later in the study ) was not associated with change in HRQOL . CONCLUSIONS Results suggest that absence or delay of treatment did not influence vision-targeted HRQOL in these newly diagnosed glaucoma patients . However , visual function affected vision-targeted quality of life up to 6 years after Early Manifest Glaucoma Trial enrollment The final development of the Sickness Impact Profile ( SIP ) , a behaviorally based measure of health status , is presented . A large field trial on a r and om sample of prepaid group practice enrollees and smaller trials on sample s of patients with hyperthyroidism , rheumatoid arthritis and hip replacements were undertaken to assess reliability and validity of the SIP and provide data for category and item analyses . Test-retest reliability ( r = 0.92 ) and internal consistency ( r = 0.94 ) were high . Convergent and discriminant validity was evaluated using the multitrait – multi method technique . Clinical validity was assessed by determining the relationship between clinical measures of disease and the SIP scores . The relationship between the SIP and criterion measures were moderate to high and in the direction hypotheszed . A technique for describing and assessing similarities and differences among groups was developed using profile and pattern analysis . The final SIP contains 136 items in 12 categories . Overall , category , and dimension scores may be calculated PURPOSE The Tube Versus Trabeculectomy ( TVT ) Study will compare the safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in patients with previous intraocular surgery . DESIGN Multicenter r and omized clinical trial . METHODS SETTING 17 Clinical Centers . STUDY POPULATION Patients 18 to 85 years of age who have undergone previous trabeculectomy , cataract extraction with intraocular lens implantation , or both and have inadequately controlled glaucoma with intraocular pressure ( IOP ) > or=18 mm Hg and < or=40 mm Hg on tolerated medical therapy . INTERVENTIONS Study patients were r and omized to undergo placement of a 350-mm(2 ) Baerveldt glaucoma implant or trabeculectomy with mitomycin C ( 0.4 mg/ml for 4 minutes ) . MAIN OUTCOME MEASURES IOP , complication rates , visual acuity , visual field , quality of life , reoperations for glaucoma , and need for supplemental medical therapy . RESULTS A total of 212 patients were enrolled between October 1999 and April 2004 . The age of the study population was 71.0 + /- 10.4 years ( mean + /- SD ) , and 53 % were women . The baseline  IOP  was 25.3 + /- 5.3 mm Hg ( mean + /- SD ) . There were no significant differences in the demographic and ocular characteristics between the 2 treatment groups . CONCLUSIONS Practice patterns vary in the surgical management of glaucoma , and there are differing opinions among glaucoma surgeons regarding the preferred surgical approach in patients who have undergone previous cataract extraction and /or failed filtering surgery . Forthcoming data from the TVT Study should provide valuable information comparing two surgical procedures commonly used in this patient population This 3-month multicenter , open-label study of 89 geriatric patients with glaucoma evaluated the substitution of brimonidine twice daily for topical beta blockers that had been used for at least 6 months . The primary outcome measures were reduction in intraocular pressure ( IOP ) from baseline at 2 hours postdose , change in cardiac and respiratory function , quality of life , and patient satisfaction . Patients were queried about adverse events at each visit and completed a  quality -of-life question  naire at the final evaluation . In this cohort with a mean age of 75.4 years , the average duration of topical beta-blocker therapy was 5 years . Brimonidine twice daily produced an additional mean reduction in IOP of 8.2 % ( 1.4 mm Hg;P < .001 ) . Eighty-eight percent of patients ( 60/68 ) reported being at least as satisfied with brimonidine as with their previous beta-blocker regimen , and 46 % ( 31/68 ) reported 
    Output:
    