Comparison of claims data on hospitalization rates and repeat procedures in patients receiving a bowel preparation prior to colonoscopy

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1 727999SMO / SAGE Open MedicineYoung et l. reserch-rticle2017 Originl Article SAGE Open Medicine Comprison of clims dt on hospitliztion rtes nd repet procedures in ptients receiving bowel preprtion prior to colonoscopy SAGE Open Medicine Volume 5: 1 8 The Author(s) 2017 Reprints nd permissions: sgepub.co.uk/journlspermissions.nv DOI: journls.sgepub.com/home/smo Lis E Young 1, Nomi C Scks 2,3, Philip L Cyr 2,4, Abhishek Shrm 2,5 nd Dvid N Dhdl 1 Abstrct Objectives: To evlute outcomes of colorectl screening using sodium picosulfte nd mgnesium citrte compred with other prescription bowel-preprtion gents. Primry endpoints were rtes of procedure-ssocited hospitliztions, dignosis t hospitliztion, nd rtes of erly repet screenings. Methods: This retrospective cohort study identified ptients using the Truven Helth Anlytics MrketScn dtbses, which contin fully djudicted, de-identified, medicl- nd prescription-drug clims, s well s demogrphic nd enrollment informtion for individuls with commercil, Medicid, nd Medicre supplementl insurnce coverge. Ptients who hd colonoscopy or sigmoidoscopy over 3-yer period were identified using Interntionl Clssifiction of Diseses Clinicl Modifiction procedure codes, recorded on clims from physicins nd fcilities. First, screening colonoscopy ws identified for ech ptient, nd the study ws limited to those ptients who could be observed for 6 months before nd 3 months fter the screening procedure. Totl number of hospitliztions nd rtes of erly repet screenings were evluted for ll ptients who received sodium picosulfte nd mgnesium citrte nd compred with those who received other bowel-preprtion gents. Individul prescription medictions tht could ffect the outcome of the clensing gent were identified; further evlutions were mde to estblish whether ptients hd comorbid conditions, such s chronic kidney disese, crdiovsculr disese, or psychitric illness. Sttisticl methods included descriptive sttistics, two-tiled t-tests, nd multivrite logistic regression. Results: A totl of 566,628 procedures were identified in the MrketScn dtbses nd included in the study. Sodium picosulfte nd mgnesium citrte performed well in terms of sfety outcomes, with no hospitliztions due to dignosis of hypontremi, dehydrtion, or other fluid disorders in the 10 dys fter procedure. Erly repet rtes mong sodium picosulfte nd mgnesium citrte ptients were comprble with rtes observed for ll other clensing gents. Conclusion: Outcomes of colorectl screening using sodium picosulfte nd mgnesium citrte were not significntly different compred with other prescription bowel-preprtion gents. Keywords Bowel preprtion, colonoscopy preprtion, colorectl cncer screening, helth economics, helth insurnce, outcomes reserch, Prepopik, sodium picosulfte nd mgnesium citrte Dte received: 16 June 2017; ccepted: 28 July 2017 Introduction Colorectl cncer (CRC) is currently the fourth most common cncer in the United Sttes. 1 3 The incidence is higher in men, nd compred with mny other forms of cncer, CRC hs reltively high mortlity rte with 5-yer survivl rte 1 Ferring Phrmceuticls Inc., Prsippny, NJ, USA 2 Precision Helth Economics, Boston, MA, USA 3 School of Medicine, Tufts University, Boston, MA, USA 4 University of North Crolin t Chrlotte, Chrlotte, NC, USA 5 Deprtment of Globl Helth nd Center for Globl Helth & Development, School of Public Helth, Boston University, Boston, MA, USA Corresponding uthor: Lis E Young, Ferring Phrmceuticls Inc., 100 Interpce Prkwy, Prsippny, NJ 07054, USA. Emil: lis.young@ferring.com Cretive Commons Non Commercil CC BY-NC: This rticle is distributed under the terms of the Cretive Commons Attribution-NonCommercil 4.0 License ( which permits non-commercil use, reproduction nd distribution of the work without further permission provided the originl work is ttributed s specified on the SAGE nd Open Access pges (

2 2 SAGE Open Medicine Supplementry Figure 1. Colorectl cncer incidence nd number of deths in the United Sttes from 1992 to Adpted from the Ntionl Cncer Institute, SEER Progrm. 3 CRC: colorectl cncer; SEER: Surveillnce, Epidemiology nd End Results. estimted t 65.1% (Supplementry Figure 1). 1 3 While the medin ge t CRC dignosis is 68 yers with disproportionte gender distribution, regulr screening of t-risk ptients improves the odds of detecting CRC t n erly stge. 4 Colonoscopy is the most sensitive method for the detection of CRC nd denomtous polyps, which lso llows the removl of precncerous lesions to prevent further development nd is thus the gold stndrd for CRC screening. 5,6 Adherence to colonoscopy screening guidelines with dequte bowel preprtion tht llows full visibility of the colon defined s the bility to identify lesions >5 mm 7 9 is ssocited with decresed CRC incidence nd mortlity rtes. 10,11 Adequte bowel preprtion is criticl not only for sfe nd effective colonoscopy screening, 12,13 but is lso ssocited with significnt decrese in the denom miss rtes, erly repet screenings, hospitliztions, nd other high-cost events While outcomes hve strong ssocition with successful preprtion, recent retrospective nlysis ssessing degree of bowel clensing in both inptients nd outptients undergoing colonoscopy found tht indequte clensing ws recorded in 11.2% of the ptients. 18 No significnt difference ws observed between inptients nd outptients. An dequte bowel preprtion involves the use of clensing gent prescribed prior to the procedure, such s high-volume (HV) bowel-preprtion products (i.e. 4-L polyethylene glycol (PEG) solutions), low-volume (LV) products (e.g. 2-L PEG solutions), or other over-the-counter (OTC) products (e.g. mgnesium citrte). Adverse events (AEs) following ingestion of bowel preprtions re uncommon, but cn be serious. 19 Regrding the sfety of colonoscopy nd bowel preprtion, recent study found the rte of AEs to be low even under severe conditions, lthough the mjority of these ptients would not hve been coded for screening procedure. 20 HV products hve been ssocited with AEs, such s nuse, vomiting, bloting, nd crmps, nd typiclly require ptients to consume up to 4 L of solution with n often unpltble slty tste. As result, ptients my be less tolernt of HV gents nd t greter risk for indequte preprtion. LV products re reportedly esier for the ptient to consume nd re generlly well tolerted with similr or better clensing qulity compred with HV gents. 12,21,22 Documented AEs with LV preprtions include dehydrtion, hypontremi, electrolyte imblnces, nd in rre cses, kidney dmge. 23 Prepopik (Ferring Phrmceuticls Inc., Prsippny, NJ, USA) is LV sodium picosulfte nd mgnesium citrte (P/ MC) bowel-preprtion gent pproved for colon clensing prior to colonoscopy or sigmoidoscopy in dults. 24 For ech bowel preprtion, the ptient is required to consume the drug dissolved in 5 oz of wter t two different times, followed by 40 or 24 oz, respectively, of cler liquid of the ptient s choice, to be consumed within 5 h. 24 In previous clinicl trils, bowel clensing using P/MC preprtions hve been demonstrted to be both sfe nd effective with the potentil to increse ptient dherence to colorectl screening guidelines The rtionle for this study ws bsed on misconception of efficcy concerning CRC procedures driven by the use of vrious bowel preprtion scles in clinicl trils. The objectives were to evlute rel-world clinicl outcomes of CRC screening by compring P/MC with different prescription bowel-preprtion gents, including the incidence of erly repet-screening events nd hospitliztion rtes, nd ssessment of the evidence in retrospective nlysis. Methods Study design Using employer-bsed helth insurnce clims filed between 1 Jnury 2012 nd 30 June 2014, this retrospective cohort study evluted outcomes of colorectl screening in ptients using P/MC compred with ptients who used other clensing gents. The ptients were identified using the Truven Helth Anlytics MrketScn dtbses (now prt of IBM Wtson Helth), which contin fully djudicted, de-identified, medicl- nd prescription-drug clims, s well s demogrphic nd enrollment informtion for individuls with commercil, Medicid, or Medicre supplementl insurnce coverge. Colonoscopies nd sigmoidoscopies were identified using the Interntionl Clssifiction of Diseses, 9th revision, Clinicl Modifiction (ICD-9-CM) procedure codes, recorded on clims from physicins nd fcilities (Supplementry Tble 1); the clims dt for this study were filed before the trnsition to ICD-10 on 1 October Becuse physicins performing these procedures cn file clims seprtely from the fcilities where procedures re performed, we grouped ll clims occurring within 1 dy of ech other nd considered them s one event. All ptient dt

3 Young et l. 3 Supplementry Tble 1. Codes used to identify colonoscopies nd sigmoidoscopies. ICD-9-CM codes Colonoscopy 44397, 45355, 45391, 45392, G0105, G0121, 44388, 44389, 44390, 44391, 44392, 44393, 44394, 45378, 45379, 45380, 45381, 45382, 45383, 45384, 45385, 45385, 45386, 45387, 45330, 45331, 45332, 45333, 45334, 45335, 45337, 45338, 45339, 45340, G0104 Sigmoidoscopy 4522, 4523, 4524, 4525, 4542, 4543 Screening procedure Procedure modifier 33, PT or 4522, 4524, 4523, 44355, 45391, 45392, G0105, G0121, G0104, , Procedure code Dignostic procedure All other ICD-9-CM: Interntionl Clssifiction of Diseses, 9th revision, Clinicl Modifictions. Tble 1. Clssifiction of bowel preprtions. LV products HV products Other bowel preprtions Prepopik Colyte b OsmoPrep c HlfLytely d GviLyte e Visicol c MoviPrep c GoLYTELY d Sucler d NuLYTELY d Suprep d Trilyte f HV: high-volume; LV: low-volume. Ferring Phrmceuticls Inc., Prsippny, NJ. b Phrmscience Inc., Montrel, QC, Cnd. c Slix Phrmceuticls, Inc., Rleigh, NC. d Brintree Lbortories, Inc., Brintree, MA. e GAVIS Phrmceuticls, Somerset, NJ. f Wllce Phrmceuticls Inc., Somerset, NJ. were trcked for 9 months, with ptients required to hve hd no colonoscopy or sigmoidoscopy in the 6 months prior to the initil screening nd repet screenings defined s secondry screenings tht occurred 3 months fter the initil screening. The bowel-preprtion gent used with ech procedure ws identified through phrmcy records of the closest filled prescription within 90 dys prior to the colonoscopy or sigmoidoscopy. All solution-bsed clensing gents were clssified s either HV ( 4-L solution) or LV (<4-L solution), bsed on their pproved lbeling nd directions for use (Tble 1). Tblet-bsed gents (OsmoPrep nd Visicol, Slix Phrmceuticls, Inc., Rleigh, NC, USA) were ctegorized s other bowel preprtions, nd OTC products were not included in this nlysis. Inclusion/exclusion criteri The purpose of this study ws to focus on verge-risk ptients. Key inclusion criteri were ge 18 yers, t lest one identified clim for colonoscopy or sigmoidoscopy within the study period, t lest one prescription for clensing gent filled within 90 dys before the procedure, nd the vilbility of medicl nd phrmcologicl dt for ech ptient ( 6 months prior nd 3 months fter the procedure). Supplementry Tble 2. ICD-9 codes used to indicte highrisk ptients. 30 Code Dignosis V10.05 Personl history of mlignnt neoplsm of lrge intestine high-risk screening code V10.06 Personl history of mlignnt neoplsm of rectum, recto sigmoid junction, nd nus high-risk screening code V12.72 Personl history of denomtous colonic polyps high-risk screening code V16.0 Fmily history of mlignnt neoplsm of gstrointestinl trct first degree reltive-sibling, prent, child high-risk screening code V18.51 Fmily history, denomtous colonic polyps highrisk screening code V76.41 Specil screening for mlignnt neoplsms of rectum V76.51 Specil screening for mlignnt neoplsms of colon V84.09 Genetic susceptibility to other mlignnt neoplsm not covered by ll pyers ICD-9: Interntionl Clssifiction of Diseses, 9th revision. Dt with no identifible prescription for clensing gent (e.g. use of OTC products or physicin smples) prior to the procedure were excluded from the nlysis. Ptient helth sttus ws estimted using the Chrlson Comorbidity Index (CCI), 28 which is widely used s mesure of ptient helth sttus tht summrizes comorbidities of ptients bsed on the dignosis codes found in dministrtive clims dt, with higher scores indictive of poorer helth. To minimize potentilly confounding comorbidities, ptients determined to be t high risk for CRC bsed on medicl clims were excluded. These high-risk ptients were identified through the colonoscopy procedure code G0105 nd selection of ICD-9 codes (Supplementry Tble 2). 29,30 Study mesures Ptient demogrphics (i.e. ge, sex, geogrphic region, nd risk sttus) nd clensing gent used for ech procedure were

4 4 SAGE Open Medicine Supplementry Tble 3. Codes used to identify hospitliztions for selected conditions. Condition ICD-9 codes Colon cncer 152, 1521, 1522, 1523, 1528, 1529, 1530, 1531, 1532, 1533, 1534, 1535, 1536, 1537, 1538, 1539, 1540, 1541, 1542, 1543, 1548, 1974, 2307, 209, 20901, 20902, 20903, 20910, 20911, 20912, 20913, 20914, 20915, 20916, 20917, 20926, 20927, 2094, 20941, 20942, 20943, 2095, 20951, 20952, 20953, 20954, 20955, 20956, 20957, 20967, 2113, 2114, 2303, 5564 Diverticulosis 5621, 56211, 56212, 56213, 7513 Injury 8634, 86341, 86342, 86343, 86344, 86346, 86349, 8635, 86351, 86352, 86353, 86354, 86356, 86359, 936 Hypontremi 276.0, Dehydrtion , , Other fluid or electrolyte disorder 276.2, 276.3, 276.4, , , 276.7, 276.8, ICD-9: Interntionl Clssifiction of Diseses, 9th revision. collected nd used to strtify the results. Primry endpoints were rtes of procedure-ssocited hospitliztions, dignosis t hospitliztion (i.e. CRC vs non-crc), nd rtes of erly repet screenings. Hospitliztions were defined s ny hospitl dmission tht occurred within 10 dys of procedure. Fluid levels re prticulr concern for LV gents, nd non-crc dignoses were defined s those directly indictive of product sfety tht could hve been ssocited with the procedure (i.e. diverticulitis, hypontremi, dehydrtion, nd other fluid or electrolyte disorders), bsed on principl dischrge dignosis code (Supplementry Tble 3). The totl number of hospitliztions nd the proportion of non-crc hospitliztions were compred between ptients who received P/MC nd those who used other LV products, HV products, or other bowel-preprtion gents. On the recommendtion from the US Multi-Society Tsk Force (MSTF) of CRC, ptients with CRC should undergo colonoscopy within 3 6 months fter surgery (for durtion of 2 3 yers). For ptients who hve undergone curtive resection of either CRC or rectl cncer, the MSTF recommends surveillnce colonoscopy 1 yer fter surgery. 31 In this study, erly repet screenings were defined s repet colonoscopies or sigmoidoscopies scheduled within 90 dys of previous procedure. The rtes of erly repet screenings were evluted for ll ptients who received P/MC nd compred with those who received other LV products, HV products, or other prescription bowel-preprtion gents. Individul prescription medictions tht could ffect the outcome of the clensing gent were identified, including those tht ffect renl function (e.g. loop nd thizide diuretics) nd those ssocited with hypoklemi or hypontremi (e.g. crdic glycosides nd corticosteroids). Further evlutions were mde to estblish whether ptients hd comorbid conditions, such s chronic kidney disese, crdiovsculr disese, or psychitric illness. Sttisticl methods Ptient demogrphics, ptient helth sttus, nd presence of repet procedures nd ssocited hospitliztions were summrized using descriptive sttistics, wheres significnce of subgroup differences ws evluted using chi-squre test. Multivrite logistic regression ws used to evlute the ssocition between ech bowel-preprtion group nd outcome, nd the likelihood of n erly repet screening or hospitliztion, with djustment for ge, sex, geogrphy, nd CCI score. These nlyses were conducted to evlute whether the rtes of erly repet screenings were significntly different for P/MC compred with other gents. Results Ptient popultion Out of 1,329,751 screenings of de-identified ptients in the MrketScn dtbses, totl of 566,628 procedures were deemed eligible to be included in the study (Tble 2). A mjority of these procedures were performed using LV preprtions defined s other LV gents (69.0%), followed by HV gents (21.9%), P/MC (5.9%), nd other gents (3.2%). Men ge for ll ptients ws 56.4 yers (stndrd devition (SD), 10.9), with slightly higher proportion of women thn men (53.5% vs 46.5%, respectively). The ptient popultion who used P/MC ws slightly younger thn verge (men ge, 55.1 yers; SD, 10.6; p < ), with lrger proportion of femle ptients (58.2%; p < ). Men CCI scores for the totl study popultion were low (0.41; SD, 0.97), indicting tht ptients were helthy, with reltively low overll comorbidity burden (Tble 2). P/MC ptients were helthier, with lower comorbidity burden nd lower men CCI scores (0.36; SD, 0.89), compred with ll others (0.41; SD, 0.97; p < ). Ptients who received P/ MC were generlly prescribed crdiovsculr medictions t lower rtes compred with the men overll rte mong ll ptient groups, including ngiotensin-converting enzyme inhibitors (14% vs 16.3%; p < ), loop diuretics (2% vs 3.1%; p < ), bet blockers (13% vs 14.8%; p < ), clcium chnnel blockers (9% vs 10.5%; p < ), nd sttins (27% vs 27.8%; p < ). Other clsses of mediction, including psychitric medictions, were prescribed t similr rtes cross ptients using ll bowel-preprtion gents.

5 Young et l. 5 Tble 2. Procedures nd ptient chrcteristics. Bowel-preprtion products P/MC Other LV HV Other All gents Number of procedures 33, , ,853 18, ,628 Men ge, yers (SD) 55.1 (10.6) 56.0 (10.8) 58.1 (11.2) 55.0 (10.7) 56.4 (10.9) Femle, % Men CCI score (SD) 0.36 (0.89) 0.39 (0.95) 0.47 (1.06) 0.36 (0.89) 0.41 (0.97) Geogrphic region, % Northest Midwest South West Other P/MC: sodium picosulfte nd mgnesium citrte; LV: low-volume; HV: high-volume; SD: stndrd devition; CCI: Chrlson Comorbidity Index. LV gents, except P/MC. Tble 3. Procedures nd hospitliztions within 10 dys of screening. Procedures nd Hospitliztions, n (%) Bowel-preprtion products P/MC Other LV HV Other All gents Totl procedures 33,574 (5.9) 391,063 (69.0) 123,853 (21.8) 18,138 (3.2) 566,628 (100) Totl hospitliztions b 154 (0.5) 2298 (2.5) 888 (6.4) 93 (0.5) 3433 (0.6) CRC-relted c 27 (17.5) 338 (14.7) 129 (14.5) 11 (11.8) 505 (14.7) Non-CRC-relted c 127 (82.5) 1960 (85.3) 759 (85.5) 82 (88.2) 2928 (85.3) Diverticulitis d 10 (7.9) 199 (10.1) 56 (7.4) 8 (9.8) 273 (9.3) Hypontremi d 0 (0.0) 13 (0.7) 1 (0.1) 1 (1.2) 15 (0.5) Dehydrtion d 0 (0.0) 7 (0.4) 1 (0.1) 0 (0.0) 8 (0.3) Other fluid or electrolyte disorders d 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) Other d 117 (92.1) 1741 (88.8) 701 (92.4) 73 (89.0) 2632 (89.9) P/MC: sodium picosulfte nd mgnesium citrte; LV: low-volume; HV: high-volume; CRC: colorectl cncer. LV gents, except P/MC. b Percentge of number of procedures by gent. c Percentge of totl hospitliztions by gent. d Percentge of non-crc-relted totl hospitliztions by gent. Efficcy/sfety outcomes Hospitliztions. Out of the 566,628 procedures in the study, totl of 3433 (0.6%) were ssocited with hospitliztion within 10 dys of screening, of which 505 cses (14.7%) were for dignoses of CRC, nd the remining 2928 cses (85.3%) were dmissions for ny cuse other thn CRC (Tble 3). The rtes of non-crc hospitliztion per 1000 screens were 3.78 for P/MC, 5.01 for other LV, nd 6.13 for HV preprtions. While non-crc dmissions potentilly relted to the use of clensing gent (i.e. hypontremi, dehydrtion, or other fluid/electrolyte disorders) were generlly infrequent in the 10 dys following the procedures (n = 23/2928 totl non- CRC hospitliztions; 0.8%), the mjority of these ptients used other LV gents (n = 20/23), wheres no dmissions were observed for P/MC ptients. All other non-crc dmissions were for dignoses unrelted to CRC screening. While ptients who used P/MC were hospitlized to lesser degree in the 10 dys following procedure compred with ll bowel-clensing gents (4.6 vs 6.1 per 1000 screenings, respectively), lrger proportion of P/MC ptients were hospitlized with dignosis of CRC compred with ll gents (n = 27/154 (17.5%) vs n = 505/3433 (14.7%) hospitliztions, respectively). Erly repet screenings. A totl of 4359 (0.8%) screenings were identified s erly repet events, defined s ny repet screening occurring within 90 dys of previous procedure (no code ws implemented), with the gretest erly repet rte ssocited with HV preprtions (0.9%; Tble 4). Adjusted nlyses Adjusted nlyses, controlling for ge, sex, geogrphic loction, nd helth sttus, showed tht ll bowel-clensing gents

6 6 SAGE Open Medicine Tble 4. Erly repet-screening events. Bowel-preprtion products P/MC Other LV HV Other All gents Number of procedures 33, , ,853 18, ,628 Repet screenings, n (%) 269 (0.77) 2859 (0.73) 1080 (0.87) 151 (0.83) 4359 (0.77) P/MC: sodium picosulfte nd mgnesium citrte; LV: low-volume; HV: high-volume. LV gents, except P/MC. Tble 5. Odds rtio estimtes. Comprison Odds rtio p-vlue Erly repet screenings, OR (95% CI) LV versus P/MC (0.973, 1.251) HV versus P/MC (0.793, 1.047) Other versus P/MC (0.783, 1.173) All LV versus HV (0.799, 0.921) < Age LV (1.004, 1.011) < Other (1.004, 1.023) HV (1.001, 1.01) All LV (1.004, 1.009) < CCI LV (1.257, 1.319) < Other (1.174, 1.358) < HV (1.194, 1.283) < All LV 1.27 (1.245, 1.297) < Sex LV (0.915, 1.054) Other (0.972, 1.454) HV (0.913, 1.133) All LV 0.98 (0.922, 1.042) CRC hospitliztions, OR (95% CI) P/MC versus LV (0.744, 1.124) P/MC versus Other (0.753, 1.508) P/MC versus HV 0.92 (0.734, 1.153) All LV versus HV (0.862, 1.065) 0.43 OR: odds rtio; CI: confidence intervl; P/MC: sodium picosulfte nd mgnesium citrte; HV: high-volume; LV: low-volume; CCI: Chrlson Comorbidity Index; CRC: colorectl cncer. LV gents, except P/MC. compred fvorbly with ech other. While estimtes on repet-procedure rtes for ptients who used P/MC were not significntly different compred with other LV products (odds rtio (OR), 1.103; 95% confidence intervl (CI), ; p = ), repet-procedure rtes for P/MC nd other LV gents were significntly lower when compred with HV bowel-preprtion products (OR, 0.858; 95% CI, ; p < ; Tble 5). In these nlyses, the only fctors significntly ssocited with higher rtes of erly repet screenings were older ge (ll estimtes, p < 0.03) nd poor helth sttus (ll estimtes, p < ). In djusted nlyses tht compred P/MC with other LV gents nd controlled for ge, sex, nd helth sttus, no significnt differences were detected in CRC hospitliztions within 30 dys of screening gents (Tble 5). Discussion In this retrospective study of rel-world clinicl outcomes ssocited with colonoscopy nd sigmoidoscopy procedures, we found tht P/MC compred similrly with other commonly used LV/HV gents nd stndrd-of-cre bowelclensing preprtions. P/MC performed well in terms of sfety outcomes, with no hospitliztions due to dignosis of hypontremi, dehydrtion, or other fluid disorders in the 10 dys fter procedure, nd the erly repet rte mong P/ MC ptients ws comprble with the rte observed for ll other bowel preprtions. Previous studies hve suggested tht the timing of the preprtion could influence the qulity of the clensing nd the outcome of the procedure. 22,32 According to these studies, shorter preprtion-to-colonoscopy intervl my be more fvorble thn longer intervl, which leds to more efficcious bowel clensing. The outcome ssocited with shorter preprtion-to-colonoscopy intervl 22,32 further suggests tht preprtions tht re esier to consume my hve n inherent dvntge. We found tht ptients using P/MC hd fewer concomitnt medictions, which could be indictive of generl helth sttus, ccompnied by lower rte of hospitliztion, higher comprtive proportion of CRC dignoses, nd no significnt differences in post-screen CRC-hospitliztion rtes. The results could be ssocited with explicit ptient chrcteristics, such s the reltive younger ge nd higher proportion of femle ptients within this popultion. While we hve estblished lrge smple size with rigorous identifiction of mesures nd outcomes, mjor limittion of the study is tht we used dt tht reflect experiences of reltively younger individuls (men ge, 56.4 yers) with insurnce nd s such, my not be generlizble to ll ptients who undergo colorectl screening. The short followup window should lso be considered limittion, s rtes of repet screenings nd CRC dignoses my be more ccurte when observed over n extended period. However, it remins uncler how hospitliztions tht occur 3 months fter screening should reflect on the outcome nd success of procedure. It my lso be considered limittion tht

7 Young et l. 7 cnceled or rescheduled procedures would not show up in clims dt, s the clims only reflect services rendered. Neither did this nlysis include OTC gents, which re the mjority of clensing gents used prior to colonoscopy. It is lso significnt limittion tht split-dose preprtions (stndrd of cre) cnnot be evluted in cross-group comprisons using clims-bsed nlysis. However, it is likely tht the repet screen rtes constitute mixture of split/nonsplit dose ptients. Another limittion of the clims dtbse is tht it is not possible to extrpolte which ptient popultions were given which products or identify how those products were dministered. However, given the lrge number of ptients screened, these fctors should be similr mong the different gents, nd would be fctored into the number of ptients returning for repet screen, despite being given the most pproprite bowel preprtion. Finlly, the use of clims dt my hve msked the influence of individul fctors on the outcome of the bowel preprtions nd the subsequent screening procedures. 11 While the sttistics from the Ntionl Cncer Institute hve demonstrted seemingly stedy decline of CRC incidence nd CRC mortlity between 1992 nd 2013 mong those ged 50 yers (Supplementry Figure 1), overll CRC incidence nd deth rtes hve incresed by lmost 2% per yer within the sme time frme. 2,3 This observtion is n indiction of n ongoing nd unmet need for dequte bowel preprtions nd more efficient nd timely screening procedures. As the medin ge of the Americn popultion is stedily incresing, 33 it hs been estimted tht costs ssocited with CRC nd the future economic burden to the Medicre progrm nd its beneficiries will be substntil, further highlighting the importnce of dequte colorectl screening preprtions. 34 Conclusion The findings presented herein my ssist physicins nd policymkers in modifying stndrd-of-cre screenings to reduce the negtive outcomes ssocited with indequte preprtions. P/MC nd LV products re well tolerted with similr clensing qulity nd AEs comprble with those of HV products. Future reserch my provide further guidnce on how the proper use of P/MC, LV, nd HV gents, or other bowel-clensing gents, my increse rtes of dequte preprtion nd subsequent successful screening procedures, s well s reduce rtes of hospitliztion nd erly repet events, ultimtely enhncing overll ptient cre. Acknowledgements Editoril support ws provided by The Curry Rockefeller Group, LLC, Trrytown, NY, USA. 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