. 2019 Aug 12;14(2):254–266. doi: 10.1093/ecco-jcc/jjz131

Table 1.

Summary of publications identified by literature review [61] and by authors et al. [5] to support review.

Publication	N	Condition	Study design	Class of evidence^a	Main outcomes
Colombel J-F, 2017¹⁶	244	CD	Open-label phase 3 RCT	I	Endoscopic and deep remission outcomes
Colombel J-F, 2017¹⁷	244	CD	Open-label phase 3 RCT	I	Adverse outcomes [hospitalisations, surgeries]
Colombel J-F, 2013³⁶	778	CD	Analysis of data from RCT and open-label extension	I	QOL [SF-36, IBDQ]
Colombel J-F, 2018^b⁷⁵	244	CD	Open-label phase 3 RCT	I	Clinical and endoscopic outcomes, safety
de Jong MJ, 2017^b⁷⁶	909	IBD	Pragmatic RCT	I	Number of outpatient visits, patient-reported quality of care, safety
D’Haens G, 2018^b⁷⁸	122	CD	Double-blind RCT	I	Sustained corticosteroid-free clinical remission
Elkjaer M, 2010⁴²	333	UC	RCT	I	Feasibility of ‘constant care’ approach, influence on patients’ compliance, knowledge, QOL, disease outcomes, safety and health care costs
Hueppe A, 2014⁴¹	514	CD/UC	RCT	I	Health-related QOL, social participation
Khanna R, 2015²²	1982	CD	Open-label cluster RCT	I	Proportion of patients in corticosteroid-free remission; adverse outcomes
Lasson A, 2015³⁴	91	UC	Prospective, RCT	I	Relapse rate
Rutgeerts PJ, 2010³⁵	62	CD	Post-hoc analysis of randomised, placebo-controlled study	I	CDAI scores and clinical remission status
Steenholdt C, 2015⁵¹	69	CD	RCT, single-blind, multicentre study	I	Long-term economic outcomes
Steenholdt C, 2014⁵²	69	CD	RCT, single-blind, multicentre study	I	Response rate [CDAI], accumulated treatment-related costs
Vande Casteele N, 2015⁵⁰	263	CD/UC	RCT	I	Clinical and biochemical remission
Bougen G, 2014⁹	67	CD	Retrospective, chart review	II	Mucosal healing [defined as the absence of any ulcers in any segment of the gastrointestinal tract during the endoscopic procedure]
Bougen G, 2014¹⁵	60	UC	Retrospective, chart review	II	Mucosal healing (defined as unremarkable findings including absence of any type of friability [even mild] and with possible remaining slight and patchy loss of vascular pattern, or erythema from inactive disease equivalent to a zero Mayo endoscopic subscore)
Burke K, 2013⁶⁰	107	UC	Prospective observational cohort study	II	Long-term relapse rates and healthcare costs
Carter CT, 2011⁶¹	638	CD	Retrospective claims analysis	II	Adherence rates
Carter CT, 2012⁶²	448	CD	Retrospective claims analysis	II	Adherence rates, hospitalisations, length hospital stay, inpatient costs
Chavannes M, 2016⁴⁶	188	IBD	Single-centre retrospective cohort study	II	Serum levels of infliximab
Click BH, 2016³⁰	1600	IBD	Registry review	II	Financial health care use and disease activity
Cook PF, 2010⁷¹	524	UC	Structured patient interviews	II	Impact of telephone nurse counselling on adherence
David G, 2014⁵⁴	21076	IBD	Analysis of data from commercial databases	II	Adherence rates
D’Incà R, 2015⁷²	449	CD/UC	Patient survey	II	Adherence, quality of life, illness intrusiveness
Debanjali M, 2009⁶³	1693	UC	Analysis of data from claims database	II	Impact of medication adherence on costs and all-cause health care use
Feagan BG, 2014⁶⁴	945	CD	Analysis of data from claims database	II	Health care costs by adherence status
Hodgkins P, 2012⁶⁵	400	UC	Discrete-choice experiment	II	Differences in patient treatment preferences based on self-reported adherence
Kane S, 2008⁶⁶	4313	UC	Analysis of data from claims database	II	Adherence, health care costs
Kane SV, 2009⁶⁷	571	CD	Analysis of data from claims database	II	Adherence, health care use, costs
Lachaine J, 2011⁶⁸	1681	UC	Retrospective prescription and medical claims analysis	II	Adherence, health care use, costs
Little RD, 2016¹⁸	52	IBD	Retrospective observational study	II	Clinical response [biomarker and physician global assessment]
Michels S, 2014⁵⁹	173	CD	Analysis of data from claims database	II	Health care costs by different adherence thresholds
Mitra D, 2012⁵⁸	1693	UC	Retrospective analysis of insurance claims	II	Adherence, all-cause costs and health care use
Orlaith K, 2016⁴⁷	312	IBD	Single-centre retrospective study	II	Endoscopic remission
Papamichail K, 2016⁴⁸	43	UC	Single-centre retrospective study	II	Short-term mucosal healing [defined as Mayo endoscopic sub-score of ≤1, assessed at Weeks 8–14, with a baseline sub-score of ≥2]
Paul S, 2013⁴⁹	52	CD/UC	Prospective observational study	II	Mucosal healing [defined as faecal calprotectin <250 μg/g stools in CD and by an endoscopic Mayo score of 0 or 1 in UC]
Poillon L, 2018^b⁷⁷	226	CD/UC	Retrospective single-centre follow-up of ⁵⁰	II	Long-term outcome data [IBD-related hospitalisation, abdominal surgery, and systemic steroid use], continued use of infliximab, trough concentrations
Qiu Y, 2016⁴⁵	272	CD	Retrospective, observational cohort study	II	Mucosal healing [defined as a score of 0–2 using an endoscopic score system]
Ramos Rivers CM, 2014³³	1925	IBD	Prospective observational registry study	II	Patients calling out of hours
Ray I, 2013²⁹	650	CD	Single-centre, retrospective study	II	Severity of depression, pattern of outpatient service use, costs
Regueiro M, 2016³⁷	308	CD/UC	Observational study of patients enrolling in patient-centred medical home	II	QOL [SIBDQ], health care resource use [ER visits, hospitalisations]
Regueiro M, 2016³⁸	108	CD/UC	Observational study of patients enrolling in patient-centred medical home	II	IBD activity [UCAI and CD HBI], QOL [SIBDQ], depression [PHQ9]
Sandborn W, 2015²⁰	804	UC	Retrospective chart review, adalimumab vs infliximab	II	Real-world effectiveness [symptoms and disease activity] and resource use [hospitalisation and surgery rates]
Schechter A, 2015³¹	115	UC	Chart review	II	Sustained steroid-free remission, colectomy
Schifrien B, 2013⁶⁹	3406	CD	Retrospective claims database analysis	II	Adherence, health care costs
Selinger C, 2012⁵⁵	50	UC	Face-to-face structured interview with patients	II	Preferred mode of information delivery, thresholds for adherence
Seth N, 2014³²	542	CD	Prospective registry study	II	Persistent abdominal pain
Severs M, 2016⁵⁶	2612	CD/UC	Prospective observational cohort study	II	Factors associated with non-adherence, changes in adherence and associated disease outcomes
Severs M, 2016⁵⁷	2612	CD/UC	Prospective observational cohort study	II	Impact of medication adherence on the disease course, health care costs and health-related QOL
Taks M, 2017⁴³	33	IBD	Single-centre evaluation of treatment algorithm	II	Remission rates, drug costs
Van Deen WK, 2016³⁹	98 [plus 293 controls]	IBD	Observational control-matched study	II	IBD-specific outcomes including medication use, office visits, IBD-specific tests, ED visits, and hospitalisations
Van Deen WK, 2016⁴⁰	98 [plus 293 controls]	IBD	Observational control-matched study	II	IBD-specific outcomes including medication use, office visits, IBD-specific tests, ED visits, and hospitalisations
Wan GJ, 2014⁷⁰	1646	IBD	Database analysis	II	Adherence, health care costs
Yarur AJ, 2017²⁸	117	CD	Cross sectional study	II	Fistula healing/closure, mucosal healing [defined as the absence of ulcerations ≥5 mm in the colon and terminal ileum]
Zittan E, 2016²⁷	60	CD	Chart review/patient interview	II	Clinical and endoscopic remission
Ananthakrishnan AN, 2012²⁴		CD	Decision analytic model comparing treatment strategies	III	Clinical response, QALYs, ICER, NNT to prevent surgery/hospitalisation
Ananthakrishnan AN, 2013²⁵		CD	Decision analytic model comparing treatment strategies	III	Clinical response, QALYs, ICER, NNT to prevent surgery/hospitalisation
Mallow P, 2013²¹		UC	Cost-effectiveness modelling based on data from RCT	III	Cost per clinical response and NNT for clinical response
Panaccione R, 2017^b⁷⁹	244	CD	Cost-effectiveness modelling based on data from RCT	III	Remission rates, CD-related hospitalisations, adalimumab injections, direct medical costs, QALYs, ICER, NMB
Saini SD, 2012²³		UC	Markov cohort model	III	Cost utility outcomes
Thwaites PA, 2016⁴⁴		IBD	Economic modelling	III	Costs of intestinal ultrasound and colonoscopy to the patient and the hospital
Van Deen W, 2015²⁶	411	CD/UC	Validation of a 4-question smartphone app to monitor IBD activity	III	Clinical disease activity indices, QOL, endoscopic score
Van Deen W, 2014⁷⁴	642	IBD	Developing and testing multidisciplinary care programmes for IBD patients—case scenarios	III	Clinical disease activity indices [HBI for CD and partial Mayo score for UC]; quality of life scores; health care expenditures
Van Deen W, 2014¹⁹	642	IBD	Developing and testing multidisciplinary care programmes for IBD patients—case scenarios	III	Clinical disease activity indices [HBI for CD and partial Mayo score for UC]; quality of life scores; health care expenditures
Velayos FS, 2013⁵³		CD	Decision analytical model	III	Cost per QALY gained
Yen L, 2013⁷³		UC	Budget impact model	III	Direct costs

CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; ED, emergency department; ER, emergency room; HBI, Harvey-Bradshaw Index; IBD, inflammatory bowel disease; IBDQ, Inflammatory Bowel Disease Questionnaire; ICER, incremental cost effectiveness ratio; NMB, net monetary benefit; NNT, number needed to treat; QALY, quality-adjusted life year; QOL, quality of life; PHQ9, Patient Health Questionnaire-9; RCT, randomised controlled trial; SF-36, Short-Form 36; SIBDQ, Short Inflammatory Bowel Disease Questionnaire; UC, ulcerative colitis; UCAI, Ulcerative Colitis Activity Index.

^aClassification as follows: I, prospective RCT; II, observational/database study; III, modelling/other.

^bFive publications published since the search was conducted; identified by the authors as relevant to the review topic.