Validity, reliability, and responsiveness of the work productivity and activity impairment questionnaire in Crohn's disease. The relationship among multiple patient-reported outcomes measures for patients with ulcerative colitis receiving treatment with MMX® formulated delayed-release mesalamine A new validation of the Spanish Work Productivity and Activity Impairment Questionnaire-Crohn's disease version. The Validity and Reproducibility of a Work Productivity and Activity Impairment Instrument Patient‐Reported Outcomes Data From REVEAL at the Time of Enrollment (Baseline): A Prospective Observational Study of Patients With Polycythemia Vera in the United States The effects of adalimumab treatment and psoriasis severity on self-reported work productivity and activity impairment for patients with moderate to severe psoriasis. Response and remission are associated with improved quality of life, employment and disability status, hours worked, and productivity of patients with ulcerative colitis Effect of Adalimumab on Clinical Outcomes and Health-related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From InspirADA Construct Validity and Responsiveness of the Single-Item Presenteeism Question in Patients With Lower Back Pain for the Measurement of Presenteeism The effect of etanercept on work productivity in patients with early active rheumatoid arthritis: results from the COMET study. Acetyl-L-Carnitine Supplementation During HCV Therapy With Pegylated Interferon-α 2b Plus Ribavirin: Effect on Work Performance; A Randomized Clinical Trial The Short Inflammatory Bowel Disease Questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT Investigators. Canadian Crohn's Relapse Prevention Trial.
BACKGROUND Crohn 's disease ( CD ) is a chronic inflammatory bowel disease usually diagnosed in early adult life and characterized by unpredictable flares and debilitating symptoms such as diarrhea , abdominal pain , and fever , which can interfere with a patient 's ability to work and perform daily activities . OBJECTIVE The aim of this study was to assess the validity , reliability , and responsiveness of the Work Productivity and Activity Impairment question naire in CD ( WPAI : CD ) . METHODS The WPAI : CD was tested in CD patients enrolled in a 26-week r and omized clinical trial of cer-tolizumab pegol versus placebo . Discriminative validity of WPAI : CD absenteeism , presenteeism(reduced on-the-job effectiveness ) , overall work productivity loss ( absenteeism + presenteeism ) , and activity impairment scores was assessed relative to 5 measures of disease severity and health status : CD Activity Index ( CDAI ) , Short Form-36 physical component summary ( PCS ) and mental health component summary ( MCS ) scores , Inflammatory Bowel Disease Question naire ( IBDQ ) , and the 5-dimensional EuroQoL health-related quality -of-life visual analog scale ( EQ-VAS ) . Responsiveness was assessed by comparing changes in WPAI : CD scores from baseline to week 26 for patients in remission ( CDAI < 150 points ) versus no remission . St and ardized Response Means ( SRMs ) were calculated to evaluate the magnitude of the changes . RESULTS A total of 662 patients ( mean [ range ] age , 37.4 [ 18 - 77 ] years ; male , 288 [ 43.5 % ] ; white , 629 [ 95.0 % ] ) were enrolled in the study . Patients with CD of the worst severity ( CDAI > median ) showed significantly higher impairment in work ( + 10.5 % ) and activities ( + 10.4 % ) versus patients with " best health " ( no problems ) ( both , P < or = 0.001 ) . Patients with " worst " IBDQ , PCS , MCS , and EQ-VAS scores also showed significantly higher impairments in work ( IBDQ , VAS -24.2 % ; PCS , -24.1 % ; MCS , -15.9 % ; EQ-VAS , -16.5 % ) and activities ( IBDQ , -23.3 % ; PCS , -21.8 % ; MCS , -16.5 % ; EQ-VAS , -17.2 % ) versus " best " scores ( all , P < 0.05 ) . There were significant differences between WPAI : CD impairment scores for patients in remission versus patients failing to achieve remission ( P < 0.05 ) . SRMs were small ( ie , < 0.5 ) in the nonre-mission group , and moderate to large ( ie , > 0.5 ) for patients in remission . CONCLUSIONS The discriminative validity , reliability , and responsiveness of the WPAI : CD were demonstrated . The WPAI : CD may be useful for evaluating drug impact on CD Purpose Ulcerative colitis ( UC ) is associated with impaired health-related quality of life ( HRQL ) and work-related outcomes ( WRO ) . This analysis examined correspondences among measures of HRQL and WRO in patients with UC , as well as the magnitude of each measure ’s responsiveness to disease activity and treatment . Methods An open-label , prospect i ve trial of delayed-release mesalamine tablets formulated with MMX ® technology included 8 weeks of treatment for patients with active mild-to-moderate UC ( n = 137 ) and 12 months of maintenance treatment for patients with quiescent UC ( n = 206 ) . Spearman correlations ( ρ ) measured inter-domain associations across measures of generic HRQL [ 12-item Short-Form Health Survey ( SF-12v2 ) ] , disease-specific HRQL [ Short Inflammatory Bowel Disease Question naire ( SIBDQ ) ] , and disease-specific WRO [ Work Productivity and Activity Impairment for Specific Health Problems ( WPAI : SHP ) ] . Responsiveness to disease activity and treatment was assessed for each instrument . Results Changes in scores from baseline to week 8 were moderately correlated across all instrument domains : 65 of 80 ( 81 % ) between-instrument inter-domain correlations were of moderate magnitude ( 0.30 < ρ < 0.70 ) , with an average magnitude of 0.42 [ 95 % confidence interval ( CI ) 0.38–0.46 ] . Associations between symptom measures were stronger for SIBDQ ( |average ρ| = 0.41 ; 95 % CI 0.34–0.48 ) and WPAI : SHP ( 0.40 ; 0.30–0.47 ) than SF-12v2 ( 0.30 ; 0.27–0.34 ) . SIBDQ was most sensitive to treatment [ effect size ( dz ) for change from baseline to week 8 = 0.62 ; 95 % CI 0.35–0.89 ] , followed by WPAI : SHP ( dz = 0.43 ; 0.32–0.54 ) and SF-12v2 ( dz = 0.33 ; 0.27–0.39 ) . Conclusion While the SIBDQ showed the greatest overall responsiveness to disease activity and treatment , all three patient-reported outcomes instruments provided complementary interpretive information regarding the impact of UC treatment OBJECTIVES The Work Productivity and Activity Impairment Question naire ( WPAI ) is an instrument that measures work impairment in the setting of different diseases . One previous study validating the WPAI in Crohn 's disease ( CD ) patients suggested that its reproducibility may be unsatisfactory . This study evaluated the validity and reproducibility of the Spain Spanish version of the WPAI question naire in CD patients . METHODS In a prospect i ve study , convergent validity was tested comparing WPAI with quality of life and CD activity indices . Known-groups validity was assessed by comparing WPAI scores in CD patients with active versus inactive disease . Reproducibility of repeated tests was evaluated by comparing two WPAI measures obtained two to four weeks apart in stable patients . RESULTS One hundred eight patients were included in the various steps of the analysis . The WPAI showed adequate known groups validity and convergent validity . The reproducibility of the test and , specifically , that of the evaluation of presenteeism ( the impairment of productivity while working ) were good . CONCLUSIONS This study confirms the validity of WPAI for measuring work impairment  in CD patients . In contrast to previous studies , the test reproducibility was adequate Summary The construct validity of a quantitative work productivity and activity impairment ( WPAI ) measure of health outcomes was tested for use in clinical trials , along with its reproducibility when administered by 2 different methods . 106 employed individuals affected by a health problem were r and omised to receive either 2 self-administered question naires ( self administration ) or one self-administered question naire followed by a telephone interview ( interviewer administration ) . Construct validity of the WPAI measures of time missed from work , impairment of work and regular activities due to overall health and symptoms , were assessed relative to measures of general health perceptions , role ( physical ) , role ( emotional ) , pain , symptom severity and global measures of work and interference with regular activity . Multivariate linear regression models were used to explain the variance in work productivity and regular activity by validation measures . Data generated by interviewer-administration of the WPAI had higher construct validity and fewer omissions than that obtained by self-administration of the instrument . All measures of work productivity and activity impairment were positively correlated with measures which had proven construct validity . These validation measures explained 54 to 64 % of variance ( p < 0.0001 ) in productivity and activity impairment variables of the WPAI . Overall work productivity ( health and symptom ) was significantly related to general health perceptions and the global measures of interference with regular activity . The self-administered question naire had adequate reproducibility but less construct validity than interviewer administration . Both administration methods of the WPAI warrant further evaluation as a measure of morbidity Micro‐ Abstract Data from REVEAL ( Prospect i ve Observational Study of Patients With Polycythemia Vera in US Clinical Practice s ; n = 2309 ) , the first study of its kind , confirm that many patients experience quality of life and work productivity impairments that might negatively affect their lives . In the future , longitudinal data from REVEAL will be important for evaluating how such burdens change over time . Background Patients with polycythemia vera ( PV ) often experience symptoms that adversely affect their quality of life ( QoL ) . The ongoing , prospect i ve , observational REVEAL ( Prospect i ve Observational Study of Patients With Polycythemia Vera in US Clinical Practice s ) study was design ed to collect contemporary data regarding burden of disease , clinical management , patient‐reported outcomes ( PROs ) , and health care re source utilization from adult patients with PV in the United States . Patients and Methods Data on PROs were collected at enrollment using the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score ( MPN‐SAF TSS ; range , 0‐100 ) ; the European Organization for Research and Treatment of Cancer – Core Quality of Life Question naire , version 3.0 ( EORTC QLQ‐C30 ; range , 0‐100 ) ; and the Work Productivity and Activity Impairment Question naire – Specific Health Problem ( WPAI‐SHP ; range , 0%‐100 % ) . Results Among 2309 patients , mean ( SD ) disease duration was 5.8 ( 6.1 ) years and Charlson Comorbidity Index was 3.4 ( 0.8 ) ; 54.0 % ( 1247/2309 ) were male . Mean ( SD ) MPN‐SAF TSS was 18.8 ( 15.5 ) . The most common symptoms were fatigue ( 80.1 % [ 1844/2302 ] ) , early satiety ( 60.9 % [ 1402/2302 ] ) , and inactivity ( 57.6 % [ 1324/2302 ] ) . The most common severe symptoms were fatigue ( 16.8 % [ 387/2302 ] ) , itching ( 13.4 % [ 308/2302 ] ) , and inactivity ( 11.8 % [ 271/2302 ] ) . The mean ( SD ) EORTC QLQ‐C30 global health status/QoL score was 73.1 ( 23.2 ) : mean functional subscale scores ranged from 80.5 ( 23.9 ) for cognitive functioning to 85.7 ( 24.6 ) for social functioning . The mean WPAI‐SHP activity impairment score was 19.7 % ( n = 2300 ) . Employed patients had mean WPAI‐SHP scores for absenteeism , presenteeism , and overall work impairment of 3.2 % ( n = 810 ) , 12.1 % ( n = 807 ) , and 13.4 % ( n = 802 ) , respectively . Conclusion These data confirm that many patients with PV experience symptoms , QoL impairments , and work productivity impairments that negatively affect their lives . Longitudinal data from REVEAL will be important for evaluating how PROs change over time in these patients BACKGROUND Psoriasis significantly impairs work productivity and daily activities . OBJECTIVES We sought to examine the effects of adalimumab on psoriasis-related work productivity and activity impairment and associations between the impairment and psoriasis severity in patients with moderate to severe psoriasis . METHODS Data were from the first 16 weeks of the R and omized controlled EValuation of adalimumab Every other week dosing in moderate to severe psoriasis TriAL ( REVEAL ) . Outcomes as measured by the Work Productivity and Activity Impairment Question naire for Psoriasis ( WPAI-Psoriasis ) included employment status , total work productivity impairment , and total activity impairment . Logistic regression and analyses of covariance were used to assess the effects of adalimumab and treatment response ( ≥ 75 % improvement in Psoriasis Area and Severity Index responders ) on WPAI-Psoriasis outcomes . Longitudinal generalized estimating equations and Pearson correlation coefficients were used to assess associations between WPAI outcomes and psoriasis severity . RESULTS Greater improvements in total work productivity impairment and total activity impairment were observed with adalimumab treatment versus placebo ( 15.5 and 11.1 percentage points , respectively ; P < .001 ) . Unemployment rate , total work productivity impairment , and total activity impairment were significantly associated with greater baseline psoriasis severity . Changes in WPAI outcomes were significantly correlated with greater psoriasis severity . The Dermatology Life Quality Index had stronger associations with changes in WPAI outcomes compared with clinical severity measures ( Psoriasis Area and Severity Index and Physician Global Assessment ) . LIMITATIONS REVEAL only included WPAI data for 16 weeks . Therefore , long-term impact of adalimumab treatment on productivity outcomes could not be assessed . In addition , information on occupational job title or industry was not collected and data were not adjusted for psoriatic arthritis . CONCLUSIONS Adalimumab reduced psoriasis-related  work productivity and activity impairment in patients with moderate to severe psoriasis Background : Impairment of health‐related quality of life , employment , and productivity has been documented in patients with moderate to severe ulcerative colitis . Methods : Using prospect ively collected data from the Active Ulcerative Colitis Trials 1 and 2 , we examined the impact of clinical response or remission , as defined using the Mayo score , on health‐related quality of life , employment , disability , productivity , and hours worked per week . These analyses were based on observed data and included all 728 patients , regardless of their r and omized treatment group ( i.e. ,  placebo and infliximab patients were grouped for analysis ) . Changes in Inflammatory Bowel Disease Question naire ( IBDQ ) and Medical Outcomes Study 36‐Item Short Form ( SF‐36 ) scores among nonresponders , responders , and patients in remission were compared . In addition , changes in employment , disability status , productivity , and hours worked per week of patients in clinical remission and patients not in clinical remission were compared . Results : Ulcerative colitis patients in clinical response or remission had significantly improved IBDQ and SF‐36 scores at week 30 compared with those of nonresponders ( P < 0.001 ) . Among those not employed at baseline , including those receiving disability compensation , greater percentages of patients in remission at week 30 were employed ( 20.6 % ) and not receiving disability compensation ( 58.8 % ) than were those not in remission ( 8.3 % and 20.0 % , respectively ; P < 0.05 for both comparisons ) . At week 30 , improvements from baseline in productivity and both actual and fully productive hours worked per week were greater for patients in remission compared with those not in remission ( P < 0.05 for all three comparisons ) . Conclusions : These results confirm the validity of response and remission as defined using the Mayo score Abstract Background and Aims R and omised trials have described the benefits of adalimumab [ ADA ] for ulcerative colitis [ UC ] ; however , few data are available on health-related quality of life [ HRQL ] and health care costs in clinical practice . Methods InspirADA , a multicentre , prospect i ve study , evaluated the effect of ADA in patients with moderate to severe UC treated according to usual clinical practice . Outcomes assessed were : Simple Clinical Colitis Activity Index [ SCCAI ] response/remission rates ; changes in HRQL ; all-cause direct costs ; and UC-related direct and indirect costs from baseline to Week 26 . Results Data from 463 patients were analysed . At Week 26 , 67 % ( 95 % confidence interval [ CI ] : 62 % , 71 % ) of patients achieved response ; 48 % [ 95 % CI : 44 % , 53 % ] were in remission . For the overall population , significant [ all p < 0.001 ] improvements from baseline to Week 26 were observed for the Short Inflammatory Bowel Disease Question naire [ SIBDQ ] ( mean change ± st and ard deviation [ SD ] : 17.4 ± 14.5 ) and the European Quality of Life—5 Dimensions—5 Level [ EQ-5D-5L ] ( index : 0.1 ± 0.2 ; visual analogue scale [ VAS ] : 19.5 ± 25.8 ) . Parallel improvements were seen in work productivity [ 11 % absolute decrease in absenteeism ; 25 % absolute decrease in impairment while working ; and 27 % absolute decrease in impairment of ability to perform daily activities , all p < 0.001 ] . Among study completers , cumulative all-cause medical costs and UC-related medical costs were significantly [ both p < 0.001 ] reduced by 59 % and 77 % , respectively , 6 months after initiation of therapy compared with the preceding 6 months . The safety profile  of ADA was consistent with that observed in previous clinical trials . Conclusions ADA therapy in usual clinical practice is effective at improving and maintaining symptomatic control , improving HRQL , and decreasing costs of medical care among patients with UC Study Design . Validity and responsiveness study using a r and omized clinical trial and prospect i ve cohort study of patients with low back pain ( LBP ) . Objective . To provide evidence for construct validity and responsiveness to change of a single-item presenteeism question ( SIPQ ) in patients with LBP . Summary of Background Data . The SIPQ is a simple , easy to administer tool that has been used to measure the impact of back pain on reduced productivity at work ( presenteeism ) as a st and alone measure . Evidence supporting the validity and responsiveness of the SIPQ among patients with back pain is however lacking . Methods . The  SIPQ was administered to patients consulting for back pain in a r and omized controlled trial ( N = 851 ) and a cohort intervention study ( N = 922 ) . Construct validity was assessed using convergent , divergent , and known-group validity . The validity investigation included assessing associations between the SIPQ and pain , disability , psychological , health status , and quality of life measures . Responsiveness was assessed using external indicators of change as comparators , evaluating correlation of clinical change scores and effect size statistics . Results . Moderate to strong correlations were found between presenteeism and pain ( r : 0.44–0.77 ) , disability ( r : 0.53–0.70 ) , and 12-Item Short Form Health Survey physical dimensions ( r : −0.66 to −0.55 ) . Presenteeism was strongly associated with disease-specific pain and disability scales . The SIPQ was responsive to changes in productivity — presenteeism change scores indicated strong correlation with change scores , and high responsiveness in distribution- and anchor-based testing . Conclusion . The SIPQ is a potentially valid and responsive tool for assessing the impact of back pain on presenteeism . This SIPQ could , with relative ease , facilitate further research on the estimation of presenteeism within economic evaluation studies of musculoskeletal conditions , thus providing policymakers with estimates of economic impact of musculoskeletal disease . Further evidence is , however , merited to assess its relationship with st and ardized presenteeism question naires . Level of Evidence : OBJECTIVES To compare the impact of the combination of etanercept ( ETN ) and MTX with MTX alone on work productivity among  MTX-naïve patients with active early RA over a 12-month period . METHODS The COMET ( COmbination of Methotrexate and ETanercept ) trial was a 2-year double-blind r and omized clinical trial . Absenteeism during the first year was measured and it included : ( i ) number of missed workdays ; ( ii ) reduced working time ; and ( iii ) number of stopped workdays . Each absenteeism measure was estimated using a mixed model , and their variations were estimated by bootstrapping . As a sensitivity analysis , the lost workdays due to presenteeism ( reduced performance at work ) was also estimated . RESULTS Two hundred and five patients [ MTX ( n = 100 ) vs ETN + MTX ( n = 105 ) ] , who were working full time or part time at baseline and had at least one follow-up observation , were included in the analysis . Compared with the MTX group , the ETN + MTX group had a maximum of 37 fewer missed workdays or at minimum 22 fewer missed workdays . The associated productivity gain equalled 2586 pounds and 1555 pounds , respectively . When additionally accounting for presenteeism , the total improvement could be as high as 42 ( 95 % CI 16 , 69 ) fewer lost workdays representing a productivity gain of 2968 pounds . CONCLUSIONS Our results demonstrated that early treatment with ETN + MTX led to a significant attenuation of absenteeism among patients with early active RA . These productivity gains represent benefit beyond the traditional measures of clinical and radiographic improvements . Further research to simultaneously measure both absenteeism and presenteeism is warranted Background : The health status of employees with chronic hepatitis C has major implication s for organizations and labour market . Objectives : To assess the effects of Acetyl-L-Carnitine administration on work productivity , daily activity , and fatigue in subjects with chronic hepatitis C treated with Pegylated-Interferon-α2b and Ribavirin .  Patients and Methods : In this prospect i ve , r and omized , placebo controlled , double blind clinical trial , 30 subjects ( Group A ) with chronic hepatitis , received Pegylated-Interferon-α2b ( 1.5 mg/kg per week ) plus Ribavirin and placebo , while 32 subjects ( Group B ) received the same dosage of Pegylated-Interferon-α2b plus Ribavirin plus 2 g Acetyl-L-Carnitine twice per day , for 12 months . Work productivity loss , impairment in daily activities , presenteeism , absenteeism , have been assessed using the Work Productivity and Activity Impairment question naire . We also evaluated severity of fatigue , mental fatigue and physical fatigue . Results : Significant difference were observed in physical fatigue , mental fatigue and severity of fatigue , aspartate aminotransferase , alanine aminotransferase , and viremia after 12 months treatment . In Group B we observed a significant decrease of presenteeism and daily activity impairment after 6 months , 12 months and at follow up . A significant increase of work productivity was observed after 12 months and at follow up . Conclusions : Office workers with chronic hepatitis C , treated with Pegylated-Interferon-α2b plus Ribavirin , had work performance loss . In subjects treated with Acetyl-L-Carnitine supplementation we observed increased daily activity and reduced presenteeism and fatigue . Acetyl-L-Carnitinegroup had a smaller reduction of productivity comparing to placebo group OBJECTIVE Health-related quality of life ( HRQOL ) affects outcome in chronic diseases such as inflammatory bowel disease ( IBD ) . The inflammatory bowel disease question naire ( IBDQ ) , a disease-specific HRQOL question naire , can define changes in health status in IBD , but simple instruments are needed for daily application . The present study proposed to develop a short version of the IBDQ , the SIBDQ , for community physicians . METHODS Using data from a clinical trial in 149 patients with Crohn 's disease , 10 items were selected ( by forward stepwise regression ) that best explained the variance of the IBDQ or dimensional scores ( bowel , systemic , social , emotional ) . The validity , reliability , and responsiveness of the SIBDQ were then assessed in 150 different patients with Crohn 's disease and 45 with ulcerative colitis . All scores were reported with a 7-point scale ( 1 = poor HRQOL , 7 = optimum HRQOL ) . RESULTS Mean SIBDQ scores were similar ( p = 0.22 ) in Crohn 's patients among 14 participating centers at study entry . Mean scores were lower in active Crohn 's disease ( range 4.00 - 4.92 ) than inactive disease ( range 4.67 - 5.83 ; p = 0.0015 ) . In active ulcerative colitis , the mean SIBDQ was 4.79 + /- 1.17 compared to 5.90 + /- 0.80 ( p = 0.0006 ) in inactive disease . The SIBDQ explained 92 % and 90 % of the IBDQ variance in Crohn 's disease and ulcerative colitis , respectively . In patients with stable Crohn 's disease , the test-retest reliability coefficient was 0.65 and Crohnbach 's alpha was 0.78 , indicating good reliability . In patients with Crohn 's disease who relapsed during follow-up , the mean SIBDQ decreased by -0.93 + 0.55 ( p = 0.001 ) . CONCLUSION The SIBDQ is valid , reliable , and able to detect meaningful clinical changes in HRQOL that might occur in the office setting
The evidence supports the WPAI as having test-retest reliability ( reproducibility ) over time ; convergent validity , as indicated by moderate correlations with measures of quality of life and moderate-to-strong correlations with measures of disease activity ; known-groups validity , as indicated by differences in WPAI scores between patients with active and inactive disease ; ability ( sensitivity ) to detect change , as indicated by substantial improvement in scores for patients who achieve remission , accompanied by substantial worsening of scores for patients who relapse ; and , responsiveness to treatment , with improvements in scores following treatments that reduce disease activity .
Patients with ulcerative colitis , a type of inflammatory bowel disease , report negative impacts of disease symptoms on work-related outcomes , including absenteeism and presenteeism .
As a way to better underst and the impact of this disease and its treatment on work-related outcomes , the current review examines the use of the Work Productivity and Activity Impairment Question naire ( WPAI ) , a patient-reported outcomes measure of absenteeism , presenteeism , and impairment in other activities , in studies of patients with ulcerative colitis .
This review assesses the measurement properties of the WPAI in this patient population : its reliability , construct validity , ability to detect change , and responsiveness to effective treatments .