scholarly journals Change in psoriatic arthritis outcome measures impacts SF-36 physical and mental component score differently: an observational cohort study

Author(s):  
Marie Skougaard ◽  
Tanja S Jørgensen ◽  
Mia J Jensen ◽  
Christine Ballegaard ◽  
Jørgen Guldberg-Møller ◽  
...  

Abstract OBJECTIVES The objective was to investigate interplay between change (Δ) in health-related quality of life (HRQoL) quantified by physical component score (PCS) and mental component score (MCS) retrieved from short-form health survey (SF-36), change in disease activity (ΔDAS28CRP) and manifestations of Psoriatic Arthritis (PsA). METHODS PsA patients initiating new medical therapy were enrolled. Independent disease measures evaluating disease activity, enthesitis, psoriasis, pain and fatigue were collected at treatment initiation and after 4 months. Interplay between independent disease measures and dependent outcome measures; ΔPCS and ΔMCS was described with univariate regression analyses. Multivariate regression analyses were applied to assess impact of independent variables e.g. individual disease outcome measures versus ΔDAS28CRP on ΔPCS and ΔMCS. RESULTS 108 PsA patients were included. In the univariate regression analyses, improvement in fatigue, pain, and disability were associated with improvement in ΔPCS (β; -2.08, -0.18, -13.00, respectively, all; p < 0.001) and ΔMCS (β; -1.59, -0.12, -6.07, respectively, and p < 0.001, p < 0.001, p = 0.003, respectively). When PROs were included in the final multivariate models, improvements in ΔPCS and ΔMCS were associated with improvements in pain, fatigue and disability (p < 0.001). Improvement in enthesitis positively impacted ΔPCS (β -0.31, p < 0.001). No association was found between change in skin psoriasis, ΔPCS and ΔMCS (β 0.15, p = 0.056 and β 0.05, p = 0.561, respectively). CONCLUSION In this PsA patient cohort, diminishing pain, disability and fatigue improved PCS and MCS significantly. Changes in enthesitis and psoriasis, did not grossly impact HRQoL compared to DAS28CRP. Individual PsA manifestations influence HRQoL differently which is clinically important when targeting treatment.

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Maya H Buch ◽  
David Walker ◽  
Patrick D W Kiely ◽  
Christopher J Edwards ◽  
Jane Barry ◽  
...  

Abstract Background/Aims  Filgotinib is an oral, preferential janus kinase 1 inhibitor. FINCH 1 (NCT02889796) was a phase III, double-blind, placebo- and active-controlled study evaluating filgotinib efficacy and safety in patients with rheumatoid arthritis (RA) after inadequate response to methotrexate (MTX; MTX-IR). Methods  MTX-IR patients with moderately or severely active RA were randomised (3:3:2:3) to filgotinib 200 mg daily, filgotinib 100 mg daily, adalimumab 40 mg every 2 weeks, or placebo on a background of stable MTX for up to 52 weeks. An exploratory subgroup analysis of FINCH 1 was conducted in patients with moderately active RA based on Disease Activity Score in 28 joints with C-reactive protein (DAS28[CRP])>3.2-≤5.1 at baseline. Proportion of patients achieving 20%/50%/70% improvement from baseline in American College of Rheumatology core criteria (ACR20/50/70), DAS28(CRP)≤3.2, DAS28(CRP)<2.6, change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI), Short Form-36 Physical Component Score (SF-36 PCS), patient-reported pain, and modified total Sharp/van der Heijde score (mTSS) were assessed at week (W)12 and W24. All analyses were exploratory without multiplicity adjustment; nominal P-values are reported. Results  Of 1,755 treated patients, 24% had moderate disease at baseline with similar proportions (21.9%-26.9%) across treatment groups. In each treatment arm, baseline characteristics were well balanced for the moderate disease activity subpopulation. The majority (77%) were female, mean (standard deviation [SD]) duration of RA was 7.8 (7.7) years; mean (SD) baseline DAS28(CRP) was 4.6 (0.42). At W12 and W24, proportions achieving ACR20/50/70, DAS28(CRP)<2.6, and DAS28(CRP)≤3.2 were significantly higher for both filgotinib doses relative to placebo (Table). Improvement in HAQ-DI was significantly greater vs placebo at W12 but not W24 for both filgotinib doses (Table 1). For both doses of filgotinib vs placebo, SF-36 PCS and pain were significantly improved and there was numerically less radiographic progression as assessed by mTSS at W12 and W24 (Table). Composite disease activity, HAQ-DI, and mTSS scores with both filgotinib doses were comparable to adalimumab. P128 Table 1:Efficacy outcomes at week 12 and week 24Week 12Week 24FIL 200 mg (n = 104)FIL 100 mg (n = 121)ADA (n = 72)PBO (n = 128)FIL 200 mg (n = 104)FIL 100 mg (n = 121)ADA (n = 72)PBO (n = 128)ACR2077.9***67.8***65.343.872.1**75.2***68.154.7ACR5043.3***37.2***41.716.452.9***47.1**56.930.5ACR7019.2***17.4***15.33.932.7***29.8**29.213.3DAS28 (CRP)<2.647.1***37.2***44.415.661.5***46.3***50.023.4DAS28 (CRP)≤3.267.3***63.6***66.739.174.0***73.6***62.549.2ΔHAQ-DI−0.51a,***−0.40b,*−0.47c−0.28d−0.57e−0.53f−0.65g−0.48hΔmTSS0.02i0.06j0.03k0.16l−0.04m,*0.11n−0.01o0.21pΔSF-36 PCS7.8q,***6.4r,***7.0s3.7t8.8u,**7.2v,*9.5w5.8xΔPain, mm−24***−23***−23−12−28***−28***−28−21***P<0.001 vs PBO;**P<0.01 vs PBO;*P<0.05 vs PBO; all P-values are nominal. Binary efficacy endpoints were compared between FIL and PBO using Fisher's exact test. Comparisons of change from baseline between FIL vs PBO were conducted using mixed-effects models for repeated measures including treatment group, visit, treatment group by visit, baseline value as fixed effects, and subjects as random effect.an = 98;bn = 114;cn = 67;dn = 117;en = 89;fn = 108;gn = 61;hn = 100;in = 94;jn = 113;kn = 62;ln = 112;mn = 89;nn = 105;on = 60;pn = 97;qn = 99;rn = 116;sn = 67;tn = 118;un = 91;vn = 109;wn = 62;xn = 100.ΔHAQ-DI, change from baseline in Health Assessment Questionnaire-Disability Index; ΔmTSS, change from baseline in modified total Sharp/van der Heijde score; ΔSF-36 PCS, change from baseline in Short Form-36 Physical Component Score; ACR, American College of Rheumatology; ADA, adalimumab; DAS28(CRP), Disease Activity Score in 28 joints with C-reactive protein; FIL, filgotinib; PBO, placebo. Conclusion  In a subgroup of patients from FINCH 1 with baseline moderately active RA, significantly greater improvements in disease activity were observed with both filgotinib doses over placebo and associated with lower radiographic progression and reduced functional deficit. Disclosure  M.H. Buch: Consultancies; MHB reports serving as a consultant for AbbVie; Eli Lilly; Gilead Sciences, Inc.; Sandoz; Sanofi; and Serono. Grants/research support; MHB reports grants or research support from Pfizer, Roche, and UCB. D. Walker: Grants/research support; DW has received funding from Bristol-Myers Squibb; Eli Lilly; Gilead Sciences, Inc.; Novartis; and Pfizer, Inc. P.D.W. Kiely: Other; PK has attended advisory boards, been part of a speakers bureau, or received support to attend educational meetings from AbbVie, Gilead, Lilly, Novartis, and Sanofi. C.J. Edwards: Consultancies; CJE has provided consultancy for AbbVie; Biogen; Bristol-Myers Squibb; Celgene; Eli Lilly; Fresenius; Gilead Sciences, Inc.; GSK; Janssen; MSD; Mundipharma; Pfizer; Roche; Samsung; and Sanofi. Member of speakers’ bureau; CJE has served on speaker's bureaus for AbbVie; Biogen; Bristol-Myers Squibb; Celgene; Eli Lilly; Fresenius; Gilead Sciences, Inc.; GSK; Janssen; MSD; Mundipharma; Pfizer; Roche; Samsung; and Sanofi. Grants/research support; CJE reports grants from AbbVie; Biogen; Bristol-Myers Squibb; Celgene; Eli Lilly; Fresenius; Gilead Sciences, Inc.; GSK; Janssen; MSD; Mundipharma; Pfizer; Roche; Samsung; and Sanofi. J. Barry: Corporate appointments; JB is an employee of Gilead Sciences Ltd. G. McCaughey: Corporate appointments; GMcC is an employee of Gilead Sciences Ltd. L. Akroyd: Corporate appointments; LA is an employee of Gilead Sciences Ltd. I. Tiamiyu: Corporate appointments; IT is an employee of Gilead Sciences, Inc. L. Ye: Corporate appointments; LY is an employee of Gilead Sciences, Inc. K. Chen: Corporate appointments; KC is an employee of Gilead Sciences, Inc. P.C. Taylor: Consultancies; PCT has served as a consultant to AbbVie, Biogen, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Pfizer, BMS, Roche, Sanofi, Nordic Pharma, Fresenius, and UCB. Grants/research support; PCT reports research grants from Gilead Sciences, Inc.; Galapagos, and Celgene.


2020 ◽  
pp. 109980042098237
Author(s):  
Alsaeedi L. Albanaqi ◽  
Gholam Rasul Mohammad Rahimi ◽  
Neil A. Smart

Background: Pulmonary hypertension (PH) is a chronic disease with a notable health burden; regular exercise may improve specific health outcome measures. Objective: The objective of this meta-analysis was to estimate the effectiveness of exercise training for PH patients. Data sources: PubMed, CINAHL, SportDiscuss and Google Scholar databases and reference lists of included studies were searched. Study selection: The selection criteria were randomized controlled trials (RCTs) employing an exercise training intervention. Data were extracted from the entered studies for analysis. The primary outcomes were peak oxygen uptake (VO2peak), anaerobic threshold (AT), 6-minute walk distance (6-MWD), and quality of life (QoL) measures (physical component score and mental component score). The analysis included 9 articles with a total of 302 participants: intervention (n = 154), and control (n = 148). Results: In the pooled analysis, improvements were seen in: VO2peak, mean difference (MD) 2.79 ml/kg/min (95% CI 2.00 to 3.59, p < 0.00001); AT, MD 107.83 ml/min (95% CI 39.64 to 176.00, p = 0.002); and 6-MWD, MD 46.67 meters (95% CI 32.39 to 60.96, p < 0.00001). Differences were found in the SF-36 physical component score MD 3.57 (95% CI 2.04 to 5.10, p < 0.00001) and the SF-36 mental component score MD 3.92 (95% CI 1.92 to 5.91, p = 0.001). Conclusion: This meta-analysis demonstrates exercise training has a beneficial effect on fitness, walking performance, and self-reported QoL in PH patients.


2008 ◽  
Vol 26 (16) ◽  
pp. 2754-2760 ◽  
Author(s):  
Carrie A. Karvonen-Gutierrez ◽  
David L. Ronis ◽  
Karen E. Fowler ◽  
Jeffrey E. Terrell ◽  
Stephen B. Gruber ◽  
...  

Purpose The purpose of this study was to examine whether quality of life (QOL) scores predict survival among patients with head and neck cancer, controlling for demographic, health behavior, and clinical variables. Patients and Methods A self-administered questionnaire was given to 495 patients being treated for head and neck cancer while they were waiting to be seen for a clinic appointment. Data collected from the survey included demographics, health behaviors, and QOL as measured by Short Form-36 (SF-36) physical and mental component scores and the Head and Neck QOL scores. Clinical measures were collected by chart abstraction. Kaplan-Meier plots and univariate and multivariate Cox proportional hazards models were used to determine the association between QOL scores and survival time. Results After controlling for age, time since diagnosis, marital status, education, tumor site and stage, comorbidities, and smoking, the SF-36 physical component score and three of the four Head and Neck QOL scales (pain, eating, and speech domains) were associated with survival. Controlling for the same variables, the SF-36 mental component score and the emotional domain of the Head and Neck QOL were not associated with survival. Conclusion QOL instruments may be valuable screening tools to identify patients who are at high risk for poor survival. Those with low QOL scores could be followed more closely, with the potential to identify recurrence earlier and perform salvage treatments, thereby possibly improving survival for this group of patients.


2010 ◽  
Vol 8 (4) ◽  
pp. 449-454
Author(s):  
Tomer T. Levin ◽  
John Riskind ◽  
Yuelin Li

AbstractObjective:Looming cognitive styles (LCS) bias the velocity of potential threats and have been implicated in anxiety and depression vulnerability. This study aims to explore their contribution to impaired quality of life (QOL), beyond that of depression and anxiety, in a cancer cohort.Method:In a cross-sectional design, an ambulatory chronic lymphocytic leukemia (CLL) cohort completed a psychological battery that included the Beck Depression and Anxiety Inventories, the SF-36 Health Survey, the Functional Assessment of Chronic Illness Therapy (FACT), the Looming Cognitive Style Questionnaire (LCSQ), and the Looming Cancer measure.Results:The Looming Cancer measure correlated significtly with overall QOL (FACT-G, p = 0.005). This effect was largely due to the contribution of emotional QOL (Mental Component Score: SF-36, p = 0.001; FACT-emotional, p = 0.001) and functional QOL (FACT-functional, p = 0.001). Looming, unlike anxiety and depression, did not correlate with a worse physical QOL (Physical Component Score: SF-36, FACT-physical). Looming did not impact on social QOL. Hierarchical regression analysis showed that looming predicted 5.4% of the varience on the FACT-emotional, 5.1% on the Mental Component Score (SF-36), and 9.3% on the mental health subscale (SF-36), above and beyond the varience predicted by a constellation of psychosocial factors (including age, marital status, education, income) and the combined effect of depression and anxietySignificance of results:LCS predicts worse emotional and functional QOL, above and beyond the contribution of anxiety, depression, and other psycho-social variables. This suggests that it makes a unique contribution to a worse QOL. Nevertheless, the looming construct still remains primarily a research tool in psycho-oncology at this time.


2009 ◽  
Vol 36 (6) ◽  
pp. 1209-1216 ◽  
Author(s):  
ROHIT AGGARWAL ◽  
CAITLYN T. WILKE ◽  
A. SIMON PICKARD ◽  
VIKRANT VATS ◽  
RACHEL MIKOLAITIS ◽  
...  

Objective.Health related quality of life (HRQOL) is an important patient-reported outcome in systemic lupus erythematosus (SLE). We evaluated the psychometric properties of 2 widely used preference-based generic HRQOL measures, EuroQol-5D (EQ-5D) and Short Form-6D (SF-6D), among United States patients with SLE.Methods.Patients with SLE enrolled at an academic institution were assessed for self-reported generic HRQOL (EQ-5D, Medical Outcomes Study SF-36), disease activity, and disease damage SF-6D. Physical Component Score (PCS) and Mental Component Score (MCS) were calculated from SF-36. Criterion validity, convergent validity, and known-groups comparisons were evaluated for EQ-5D and SF-6D. Sensitivity to change (t tests, effect size) was evaluated in a subset of the cohort followed longitudinally.Results.One hundred sixty-seven patients with SLE were enrolled. Related domains on the EQ-5D and SF-36 correlated strongly, e.g., mobility and physical functioning (r = 0.60), whereas unrelated domains showed weak to moderate correlation. EQ-5D index, EQ-5D visual analog scale, and SF-6D score correlated strongly among each other as well as with most domains of SF-36. Both EQ-5D and SF-6D indices differentiated among patients of varied disease severity. EQ-5D and SF-6D were found to be sensitive to self-reported change in health but insensitive to change in disease activity longitudinally. Disease activity and damage showed weak correlation with HRQOL measures.Conclusion.The SF-6D and EQ-5D exhibited satisfactory psychometric properties for use among US patients with SLE. Measures of disease activity and damage were weakly correlated with HRQOL, suggesting that HRQOL is an important complementary source of information about patients with SLE.


Author(s):  
Ji-Hyoun Kang ◽  
Min-Ho Shin ◽  
Sung-Eun Choi ◽  
Haimuzi Xu ◽  
Dong-Jin Park ◽  
...  

Abstract Objectives Three definitions of low-level disease activity in patients with SLE have been proposed by different groups. These include minimal disease activity (MDA), low disease activity (LDA) and the lupus low disease activity state (LLDAS). We investigated the performance of these definitions in SLE patients. Methods We recruited 299 SLE patients who were followed up annually for 4 consecutive years. We compared the three definitions of low disease activity via longitudinal analysis; we used a generalized, linear-mixed effects model and generalized estimating equations. Results The LLDAS was significantly associated with a lower SLICC/ACR damage index (β coefficient=−0.064, 95% CI: −0.129, −0.002, P=0.050), reduced flare (odds ratio = 0.090, 95% CI: 0.034, 0.239, P&lt;0.001), an improved SF-36 physical component score (β coefficient=0.782, 95% CI: 0.046, 1.519, P=0.037), and an improved SF-36 mental component score (β coefficient=1.522, 95% CI: 0.496, 2.547, P=0.004). Neither the MDA nor the LDA were associated with these variables. Conclusion The LLDAS definition performs better than the MDA and LDA definitions, showing that LLDAS is associated with less organ damage and flare, and a better quality of life, during follow-up.


2017 ◽  
Vol 34 (4) ◽  
pp. 337-343 ◽  
Author(s):  
Gislene C. Erbs ◽  
Marco F. Mastroeni ◽  
Mauro S. L. Pinho ◽  
Álvaro Koenig ◽  
Geonice Sperotto ◽  
...  

Purpose: To assess how preexisting disabling comorbidities (DC) affect the recovery rate of quality of life (QOL) over time in sepsis survivors. Methods: A prospective study was conducted on sepsis survivors who answered the 36-Item Short Form Health Survey (SF-36) 7 days after discharge from the intensive care unit. Subsequent interviews were held at 3, 6, and 12 months. The results of the physical component score (PCS) and mental component score (MCS) of the SF-36 were evaluated. Patients were divided into 2 groups to compare patients with DC (DC group) and without DC (no-DC group). Quantile regression was used to model changes in PCS and MCS between different time points. Results: Seventy-nine sepsis survivors were enrolled. After controlling for baseline age and QOL, the QOL scores were lower among patients with DC than in no-DC patients. The QOL of DC group got worse when compared to no-DC group. Recovery rate of PCS and MCS was higher in the DC group than in the no-DC group (PCS: 20.51 vs 16.96, P < .01; MCS: 19.24 vs 9.66, P < .01). Their baseline QOL was recovered only by 6 months after the sepsis episode. Conclusion: Quality-of-life impairment and its recovery rhythm in patients with sepsis appear to be conditioned by coexisting DC.


2021 ◽  
Vol 103-B (3) ◽  
pp. 542-546
Author(s):  
Stefan Milosevic ◽  
Gustav Ø. Andersen ◽  
Mads M. Jensen ◽  
Mikkel M. Rasmussen ◽  
Leah Carreon ◽  
...  

Aims The aim of this study was to investigate the efficacy of coccygectomy in patients with persistent coccydynia and coccygeal instability. Methods The Danish National Spine Registry, DaneSpine, was used to identify 134 consecutive patients who underwent surgery, performed by a single surgeon between 2011 and 2019. Routine demographic data, surgical variables, and patient-reported outcomes, including a visual analogue scale (VAS) (0 to 100) for pain, Oswestry Disability Index (ODI), EuroQol five-dimension questionnaire (EQ-5D), and the Physical Component Score (PCS) and Mental Component Score (MCS) of the 36-Item Short-Form Health Survey questionnaire (SF-36) were collected at baseline and one-year postoperatively. Results A total of 112 (84%) patients with a minimum follow-up of one year had data available for analysis. Their mean age was 41.9 years, and 15 (13%) were males. At 12 months postoperatively, there were statistically significant improvements (p < 0.001) from baseline for the mean VAS for pain (70.99 to 35.34), EQ-5D (0.52 to 0.75), ODI (31.84 to 18.00), and SF-36 PCS (38.17 to 44.74). A total of 78 patients (70%) were satisfied with the outcome of treatment. Conclusion Patients with persistent coccydynia and coccygeal instability resistant to nonoperative treatment may benefit from coccygectomy. Cite this article: Bone Joint J 2021;103-B(3):542–546.


2021 ◽  
Vol 2 ◽  
Author(s):  
Katherine A. Collins ◽  
Liezl B. Fos ◽  
Leanna M. Ross ◽  
Cris A. Slentz ◽  
Paul G. Davis ◽  
...  

Purpose: The main purpose of this study was to determine the differential effects of aerobic training (AT), resistance training (RT), and a combination of aerobic and resistance training (AT/RT) on changes in self-rated HrQoL measures, including the Short-Form 36 (SF-36) survey and Satisfaction with Physical Function and Appearance survey. We also sought to determine if combination training (AT/RT) has a more or less additive effect compared to AT or RT alone on self-rated HrQoL measures.Materials and Methods: Participants (n = 137) completed one of three 8-month exercise interventions: (1) AT: 14 kcal exercise expenditure per kg of body weight per week (KKW; equivalent to roughly 12 miles/week) at 65–80% of peak oxygen consumption; (2) RT: 3 days per week, 8 exercises, 3 sets per exercise, 8–12 repetitions per set; (3) AT/RT: full combination of the AT and RT interventions. The SF-36 survey, Satisfaction with Physical Function and Appearance survey, physical fitness, and anthropometrics were assessed at baseline and post-intervention. Paired t-tests determined significant pre- vs. post-intervention scores within groups (p &lt; 0.05). Analyses of covariance determined differences in change scores among groups (p &lt; 0.05).Results: On average, participants were 49.0 ± 10.6 years old, obese (BMI: 30.6 ± 3.2 kg/m2), female (57.7%), and Caucasian (84.7%). Following the 8-month intervention, exercise groups improved peak VO2 (all groups), strength (RT and AT/RT), and anthropometric measures (AT and AT/RT). For the SF-36, RT (p = 0.03) and AT/RT (p &lt; 0.001) significantly improved their physical component score; only AT/RT (p &lt; 0.001) significantly improved their mental component score. Notably, all groups significantly improved both their satisfaction with physical function and appearance scores (All Groups: p &lt; 0.001 for both outcomes).Conclusions: We found that aerobic, resistance, or combination exercise training improves several components of self-rated HrQoL, including physical function, appearance, and mental well-being.Clinical Trial Registration: No. NCT00275145.


Neurosurgery ◽  
2017 ◽  
Vol 83 (4) ◽  
pp. 700-708 ◽  
Author(s):  
Peter G Passias ◽  
Cyrus M Jalai ◽  
Virginie Lafage ◽  
Gregory W Poorman ◽  
Shaleen Vira ◽  
...  

Abstract BACKGROUND Prior studies have observed similar health-related quality of life (HRQL) in revisions and nonrevision (NR) patients following adult spinal deformity (ASD) correction. However, a novel comparison approach may allow better comparisons in spine outcomes groups. OBJECTIVE To determine if ASD revisions for radiographic and implant-related complications undergo a different recovery than NR patients. METHODS Inclusion: ASD patients with complete HRQL (Oswestry Disability Index, Short-Form-36 version 2 (SF-36), Scoliosis Research Society [SRS]-22) at baseline, 6 wk, 1 yr, 2 yr. Generated revision groups: nonrevision (NR), revised-complete data (RC; with follow-up 2 yr after revision), and revised-incomplete data (RI; without 2-yr follow-up after revision). In a traditional analysis, analysis of variance (ANOVA) compared baseline HRQLs to follow-up changes. In a novel approach, integrated health state was normalized at baseline using area under curve analysis before ANOVA t-tests compared follow-up statuses. RESULTS Two hundred fifty-eight patients were included with 50 undergoing reoperations (19.4%). Rod fractures (n = 15) and proximal joint kyphosis (n = 9) were most common. In standard HRQL analysis, comparing RC index surgery and RC revision surgery HRQLS revealed no significant differences throughout the 2-yr follow-up from either the initial index or revision procedure. Using normalized HRQL/integrated health state, RI displayed worse scores in SF-36 Physical Component Score, SRS activity, and SRS appearance relative to NR (P &lt; .05), indicating less improvement over the 2-yr period. RC were significantly worse than RI in SF-36 Mental Component Score, SRS mental, SRS satisfaction, and SRS total (P &lt; .05). CONCLUSION ASD patients indicated for revisions for radiographic and implant-related complications differ significantly in their overall 2-yr recovery compared to NR, using a normalized integrated health state method. Traditional methods for analyzing revision patients' recovery kinetics may overlook delayed improvements.


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