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• W2802995792 abstract "See editorial on page 624, and related articles on pages 637 and 648. See editorial on page 624, and related articles on pages 637 and 648. Patients seek medical care when they perceive a deterioration in their health. Gastroenterologists and health care providers are trained to seek out clinical, laboratory, radiologic, and endoscopic evidence of pathology. Conventional endpoints in inflammatory bowel disease (IBD) clinical trials and clinical care may fail to capture the full health status and disease experience from the patient perspective. The Food and Drug Administration (FDA) has called for the development of coprimary endpoints in research trials to include an objective measure of inflammation in conjunction with patient-reported outcomes (PROs). The objective is to support labelling claims and improve safety and effectiveness in the drug approval process.1Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.Health Qual Life Outcomes. 2006; 4: 79Crossref PubMed Scopus (1065) Google Scholar There is also growing recognition that high-value care includes management of biologic and psychosocial factors to enable patients with chronic diseases to regain their health. Clinicians might follow suit by incorporating valid, reliable PRO measures to usual IBD care in order better to achieve patient-centered care, inform decision making, and improve the quality of the care provided. The FDA defines a PRO as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.”2Burke L.B. Kennedy D.L. Miskala P.H. et al.The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval.Clin Pharmacol Ther. 2008; 84: 281-283Crossref PubMed Scopus (70) Google Scholar PROs are used to measure various aspects of health including physical, emotional, or social domains. PROs have emerged as tools that may foster a better understanding of the patient’s condition, which may go beyond disease activity or symptoms. In effect, incorporating PROs into clinical practice enables a model of “coproduction” of health care, and may contribute to a more reciprocal patient-provider interaction where the needs of the patient may be more fully understood and incorporated into decision-making that may lead to improved patient satisfaction and outcomes.3Batalden M. Baltalden P. Margolis P. et al.Coproduction of healthcare service.BMJ Qual Saf. 2016; 25: 509-517Crossref PubMed Scopus (522) Google Scholar, 4Johnson L.C. Melmed G.Y. Nelson E.C. et al.Fostering collaboration through creation of an IBD learning health system.Am J Gastroenterol. 2017; 112: 406-408Crossref PubMed Scopus (27) Google Scholar There are hundreds of available PROs in gastroenterology,5Khanna P. Agarwal N. Khanna D. et al.Development of an online library of patient reported outcome measures in gastroenterology: the GI-PRO database.Am J Gastroenterol. 2014; 109: 234-248Crossref PubMed Scopus (20) Google Scholar ranging from simple (characterizing pain with a basic numeric rating scale) to complex multidomain, multi-item instruments. PROs may cover symptom assessment, health-related quality of life, adherence to and satisfaction with treatment, and may be generic or disease-specific. Numerous PROs have been developed for patients with IBD to better understand the varied ways health can be affected by the disease. Commonly used PROs in IBD include severity scales for pain, defecatory urgency, and bloody stool, and several disease-specific and generic instruments assessing different health-related quality-of-life domains have been used in research studies for patients with IBD. IBD is a difficult disease to manage in-part because there is no known biomarker that accurately reflects the full spectrum of disease activity. Numerous indices have been developed to better quantify disease activity, measure response to treatment, and identify remission. Among the most frequently used indices in clinical trials are the Crohn’s Disease Activity Index (CDAI) and (for ulcerative colitis [UC]) the Mayo Clinic Score. These endpoints incorporate signs and symptoms, laboratory findings (in the CDAI), and endoscopic assessments. The CDAI is a suboptimal instrument because of a lack of correlation with endoscopic inflammation and potential confounding with concomitant gastrointestinal illnesses, such as irritable bowel syndrome.6Bruining D.H. Sandborn W.J. Do not assume symptoms indicate failure of anti-tumor necrosis factor therapy in January 2015 Emerging Treatment Goals in IBD Trials and Practice 45 REVIEWS AND PERSPECTIVES Crohn’s disease.Clin Gastroenterol Hepatol. 2011; 9: 395-399Abstract Full Text Full Text PDF PubMed Scopus (19) Google Scholar The Mayo Clinic Score is difficult to interpret because of some subjective elements (what is considered a normal number of stools per day?); vagueness (mostly bloody stools more than half the time?); and it requires a physician assessment, which often does not correspond with the patient’s perception of their disease.7Surti B. Spiegel B. Ippoliti A. et al.Assessing health status in inflammatory bowel disease using a novel single-item numeric rating scale.Dig Dis Sci. 2013; 58: 1313-1321Crossref PubMed Scopus (21) Google Scholar From a research perspective, this disconnect can compromise the quality of trial data. Clinically, it can negatively impact patients’ satisfaction of care and impair the patient-provider relationship.8Marshall S. Haywood K. Fitzpatrick R. Impact of patient-reported outcome measures on routine practice: a structured review.J Eval Clin Pract. 2006; 12: 559-568Crossref PubMed Scopus (430) Google Scholar To that end, regulatory agencies, scientific bodies, and healthcare payors are shifting toward a more “patient-centered” approach with an emphasis on PROs. However, although the FDA is incorporating the patient perspective in its trials, measuring meaningful outcomes in day-to-day clinical care is challenging. In the absence of active inflammation, more than 30% of patients with IBD still suffer from gastrointestinal symptoms because of a myriad of reasons.9Simren M. Axelsson J. Gillberg R. et al.Quality of life in inflammatory bowel disease in remission: the impact of IBD-like symptoms and associated psychological factors.Am J Gastroenterol. 2002; 97: 389-396Crossref PubMed Google Scholar Furthermore, physicians frequently underestimate the impact of depression, anxiety, fatigue, and sleep on patient health. Likewise, some patients with active small bowel Crohn’s disease (CD) may experience few gastrointestinal symptoms but have profound fatigue, weight loss, and impaired quality of life. A focused assessment for disease activity may fail to identify aspects of health most relevant or important to individual patient well-being. There is a need for effective, efficient, and standardized strategies to better understand the concerns of the individual seeking help. Although there are several PROs that measure disease activity primarily for clinical research trials,10De Jong M.J. Huibregtse R. Masclee A.A.M. et al.Patient-reported outcome measures for use in clinical trials and clinical practice in inflammatory bowel diseases: a systematic review.Clin Gastroenterol Hepatol. 2018; 16: 648-663Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar their prevalence in gastroenterology practices has not been systematically assessed. Most likely few clinical practices currently integrate standardized PROs in routine patient care. This may be because of several reasons, including lack of awareness of newly developed PROs, administrative burden including time and resources to collect PROs, potentially complex interpretation of results, and perhaps a reluctance among physicians to alter tried- and true traditional patient interview methods of obtaining information about the health status of their patients. For effective use in clinical care, PROs require simple and relevant interpretation to add value to the clinician’s practice, and must minimally impact clinical flow and resources. The use of Internet-enabled tablets has been shown to be a feasible, efficient, and effective means of PRO assessment in gastroenterology practices, with good levels of patient satisfaction.11Atreja A. Rizk M. Capturing patient reported outcomes and quality of life in routine clinical practice: ready to prime time?.Minerva Gastroenterol Dietol. 2012; 58: 19-24PubMed Google Scholar The National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) is an initiative developed to investigate and promote implementation of PRO measures among patients with chronic diseases. The collection of PROMIS measures has been shown to be feasible at a tertiary care IBD center, enabling a biopsychosocial model of care.12IsHak W.W. Pan D. Steiner A.J. et al.Patient reported outcomes of quality of life, functioning, and GI/psychiatric symptom severity in patients with inflammatory bowel disease.Inflamm Bowel Dis. 2017; 23: 798-803Crossref PubMed Scopus (42) Google Scholar Likewise, implementation of PROs in other clinical areas including oncology, orthopedics, and rheumatology has been robust. In an innovative orthopedic study, PROMIS measures collected and linked to the electronic medical record predicted the likelihood of a clinically meaningful benefit from foot and ankle surgery.13Ho B. Houck J.R. Flemister A.S. et al.Preoperative PROMIS scores predict postoperative success in foot and ankle patients.Foot Ankle Int. 2016; 37: 911-918Crossref PubMed Scopus (158) Google Scholar This has facilitated tailored patient-specific preoperative discussions about the expected benefit of surgery. In a study at a rheumatology clinic patients with rheumatoid arthritis were asked to identify their highest priority treatment targets using PROMIS domains (fatigue, pain, depression, social function). The highest priority domain was tracked over time as a patient-centered marker of health, essentially personalizing measures of success for the individual patient.14Bacalao E. Greene G.J. Beaumont J.L. et al.Standardizing and personalizing the treat to target (T2T) approach for rheumatoid arthritis using the Patient-Reported Outcomes Measurement Information System (PROMIS): baseline findings on patient-centered treatment priorities.Clin Rheumatol. 2017; 36: 1729-1736Crossref PubMed Scopus (22) Google Scholar PROs have the unique potential to affect multiple levels of health care. At the patient level, PRO data can identify specific concerns, manage expectations of recovery, and tailor treatment decisions to personal preference. At the population level, PRO data can be used to standardize aspects of care, to understand comparative health and disease among all patients in a practice or relative to outside practices, identify outliers, and drive improvement. PROs can thus offer an expanded armamentarium of clinical measurements in IBD care to facilitate personalized approaches to care. Developing standardized, validated instruments according to FDA guidance is a complex process. The lack of an FDA-approved PRO has resulted in substantial variability in the definitions of clinical response or remission in clinical trials to date.15Ma C. Panaccione R. Fedorak R.N. et al.Heterogeneity in definitions of endpoints for clinical trials of ulcerative colitis: a systematic review for development of a core outcome set.Clin Gastroenterol Hepatol. 2018; 16: 637-647Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar As a result, IBD-specific PROs (UC-PRO and CD-PRO) are being developed under FDA guidance for use in clinical trials.16Higgins P. Patient reported outcomes in IBD 2017. Available at: ibdctworkshop.files.wordpress.com/2017/01/patient-reported-outcomes-in-ibd___peter-higgins.pdf. Accessed August 27, 2017.Google Scholar Having achieved prequalification for open use, UC-PRO and CD-PRO will cover 5 IBD-specific outcomes domains or modules: (1) bowel signs and symptoms, (2) systemic symptoms, (3) emotional impact, (4) coping behaviors, and (5) IBD impact on daily life. The bowel signs and symptoms module may also incorporate a functional impact assessment. Each module includes numerous pertinent items (eg, “I feel worried,” “I feel scared,” “I feel alone” in the emotional impact module) and are currently being tailored and scored for practicality and relevance. It is hoped that UC-PRO and CD-PRO in final form will be relevant and applicable for clinical trials and gastroenterology practices alike. Because the development of the UC-PRO and the CD-PRO is still underway, interim PROs are being used in ongoing clinical trials. These interim measures were extracted from existing components of the CDAI, Mayo Clinic Score, and UC Disease Activity Index. The CD PRO-2 consists of 2 items: abdominal pain and stool frequency. The UC PRO-2 is composed of rectal bleeding and stool frequency. The PRO-3 adds an item regarding general well-being. The sensitivity of these PROs was tested in studies for CD and UC. Both PROs performed similarly to their respective parent instrument. Important limitations include the lack of validation, and the fact that these interim measures were derived from parent measures with acknowledged limitations as previously discussed. However, it is important to note that these PROs are solely the symptom components of existing instruments and not measures of patient outcomes. Current clinical trials are coupling these interim measures with endoscopic data as coprimary endpoints. Few instruments developed to date have been widely implemented into routine IBD clinical practice, and widespread adoption will likely require seamless electronic medical record integration. In the meantime clinicians are encouraged to incorporate existing PROs into their practice. Table 1 highlights commonly available or recently developed PROs for IBD care. As clinicians strive to more effectively integrate PROs into clinical practice, we propose a 3-step process to getting started: (1) select and administer a PRO instrument, (2) identify areas of impairment and create a targeted treatment strategy to focus on those areas, and (3) repeat the same PRO at follow-up to assess for improvement. The instrument can be administered before the visit or in the clinic waiting room. Focus a portion of the patient’s visit on discussing the results and identifying 1 or more domains to target for improvement. For example, the patient may indicate diarrhea as his/her most important area to target, triggering a symptom-specific investigation and therapeutic approach. The PRO may also highlight social or emotional impairment that may require an ancillary referral. The benefits of this PRO-driven approach to IBD care are 2-fold. First, the patient’s primary concerns are positioned at the forefront of the clinical visit. Second, aligning the clinician’s focus with the patient input may actually help to streamline each visit and improve overall visit efficiency and patient satisfaction.Table 1General and IBD-Specific PROsDomainInstrumentCommentsItems, nOverallwell-beingInflammatory Bowel Disease Questionnaire19Guyatt G. Mitchell A. Irvine E.J. et al.A new measure of health status for clinical trials in inflammatory bowel disease.Gastroenterology. 1989; 96: 804-810Abstract Full Text PDF PubMed Scopus (949) Google ScholarQOL: bowel, systemic, social, emotional32Inflammatory Bowel Disease QOL20Love J.R. Irvine E.J. Fedorak R.N. Quality of life in inflammatory bowel disease.J Clin Gastroenterol. 1992; 14: 15-19Crossref PubMed Scopus (185) Google Scholar36Inflammatory Bowel Disease Questionnaire-short form21Irvine E.J. Zhou Q. Thompson A.K. 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.Am J Gastroenterol. 1996; 91: 1571-1578PubMed Google Scholar10Cleveland Global QOL Score22Fazio V.W. O’Riordain M.G. Lavery I.C. et al.Long-term functional outcome and quality of life after stapled restorative proctocolectomy.Ann Surg. 1999; 230: 575-584Crossref PubMed Scopus (374) Google ScholarQOL after pouch surgery3DisabilityIBD-Disability Index23Gower-Rousseau C. Sarter H. Savoye G. et al.Validation of the inflammatory bowel disease disability index in a population-based cohort.Gut. 2017; 66: 588-596Crossref PubMed Scopus (100) Google ScholarPain, body image, education and work, emotions, energy, interpersonal, join pain, defecation, sexual function, sleep28IBD-Disk (Shorted Disability Index)18Gosh S. Louis E. Beaugerie L. et al.Development of the IBD-Disk: a visual self-administered tool assessing disability in inflammatory bowel diseases.Inflamm Bowel Dis. 2017; 23: 333-340Crossref PubMed Scopus (47) Google ScholarDisk has visual representation10Disease activityPRO224Khanna R. Zou G. D’Haens G. et al.A retrospective analysis: the development of patient reported outcome measures for the assessment of Crohn’s disease activity.Aliment Pharmacol Ther. 2015; 41: 77-86Crossref PubMed Scopus (115) Google ScholarBriefInterim use in clinical trials2Simple Clinical Colitis Activity Index25Walmsley R.S. Ayres R.C.S. Pounder P.R. et al.A simple clinical colitis activity index.Gut. 1998; 43: 29-32Crossref PubMed Scopus (907) Google ScholarInitial colitis diagnosis and relapse10IBD-Control Questionnaire17Bodger K. Ormerod C. Shackcloth D. et al.Development and validation of a rapid, general measure of disease control from the patient perspective: the IBD-Control questionnaire.Gut. 2014; 63: 1092-1102Crossref PubMed Scopus (92) Google ScholarPhysical symptoms, social and emotional functioning, treatment, and disease control perceptions13PainVisual analog scalePain intensity1Numeric rating scalePain intensity1Brief Pain Inventory26Cleeland C.S. Ryan K.M. Pain assessment: global use of the Brief Pain Inventory.Ann Acad Med Singapore. 1994; 23: 129-138PubMed Google ScholarIdentifies pain location on body diagram11Depression and anxietyPatient Health Questionnaire-927Kroenke K. Spitzer R.L. Williams J.B.W. The PHQ-9: validity of a brief depression severity measure.J Gen Intern Med. 2001; 16: 606-613Crossref PubMed Scopus (21954) Google Scholar9Hospital Anxiety and Depression Sale28Zigmond A.S. Snaith R.P. The Hospital Anxiety and Depression Scale.Acta Psychiatr Scand. 1983; 67: 361-370Crossref PubMed Scopus (31406) Google ScholarUsed in outpatient and inpatient settingsRequires access to use free of purchase14Generalized Anxiety Disorder-729Spitzer R.L. Korneke K. Williams J.B. et al.A brief measure for assessing generalized anxiety disorder: the GAD-7.Arch Intern Med. 2006; 166: 1092-1097Crossref PubMed Scopus (12949) Google Scholar7Work and productivityWork Productivity and Activity Impairment: Crohn’s Disease30Reilly M.C. Zbrozek A.S. Dukes E.M. The validity and reproducibility of a work productivity and activity impairment instrument.Pharmachoeconomics. 1993; 4: 353-365Crossref PubMed Scopus (1796) Google ScholarAbsenteeism, degree of reduced productivity caused by IBD6FatigueMultidimensional Fatigue Inventory31Smets E.M. Garssen B. Bonke B. et al.The Multidimensional Fatigue Inventory psychometric qualities of an instrument to assess fatigue.J Psychosom Res. 1995; 39: 315-325Crossref PubMed Scopus (2401) Google ScholarGeneral, physical, and mental fatigue; reduced activity and motivation20IBD-Fatigue Scale32Czuber-Dochan W. Norton C. Bassettt P. et al.Development and psychometric testing of inflammatory bowel disease fatigue (IBD-F) patient self-assessment scale.J Crohns Colitis. 2014; 8: 1398-1406Abstract Full Text Full Text PDF PubMed Scopus (67) Google ScholarSeverity and frequency of fatigue, impact on life30MiscellaneousRating Form of Patient Concerns33Drossman D.A. Leserman J. Li Z.M. et al.The rating form of IBD patient concerns: a new measure of health status.Psychosom Med. 1991; 53: 701-712Crossref PubMed Scopus (284) Google ScholarDisease activity, body stigma, sexual intimacy, interpersonal relationships25Perceived Stress Scale34Cohen S. Kamarck T. Mermelstein R. A global measure of perceived stress.J Health Soc Behav. 1983; 24: 385-396Crossref PubMed Scopus (17485) Google ScholarRelated to objective events and effectiveness of stress reduction interventions10IBD, inflammatory bowel disease; PRO, patient-reported outcomes; QOL, quality of life. Open table in a new tab IBD, inflammatory bowel disease; PRO, patient-reported outcomes; QOL, quality of life. The following are novel, potentially useful measures to consider for clinical use. The 13-item IBD-Control Questionnaire provides a rapid and user-friendly assessment of disease control from the patient’s perspective.17Bodger K. Ormerod C. Shackcloth D. et al.Development and validation of a rapid, general measure of disease control from the patient perspective: the IBD-Control questionnaire.Gut. 2014; 63: 1092-1102Crossref PubMed Scopus (92) Google Scholar Capturing physical symptoms and social function, it includes a visual analog scale of perceived disease control. It is practical and may identify patients in a quiescent state. This is enticing for clinicians looking to hone in on individual concerns or triage the urgency of a follow-up appointment. The IBD Disk is a shortened visual adaptation of the validated IBD-Disability Index.18Gosh S. Louis E. Beaugerie L. et al.Development of the IBD-Disk: a visual self-administered tool assessing disability in inflammatory bowel diseases.Inflamm Bowel Dis. 2017; 23: 333-340Crossref PubMed Scopus (47) Google Scholar Patients score their level of agreement with statements regarding pain, defecation, social interactions, education, work, sleep, energy, emotions, body image, sexual function, and joint pain over the previous week. The visual feedback allows patients and physicians to see changes in disease burden over time, highlight areas of persistent impairment, and potentially improve medication adherence. This may be useful for practices with few readily available ancillary services, such as a social worker or dedicated IBD nurse. As therapies for IBD improve, so should standards of patient-centered care. Clinicians must actively seek and then listen to the concerns of patients and be able to address the multiple facets of living with a chronic disease. Implementation of PROs into practice has the potential to benefit both the clinician and patient. PROs empower patients, helping them identify important topics for discussion at the clinical visit. This affords clinicians a better understanding of primary patient concerns before the visit, and potentially improves the quality and value of care. At first, the process of incorporating PROs into a busy clinical practice may be challenging, but targeted treatment plans have the potential to foster a better patient—and physician—experience." @default.
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• W2802995792 title "Making a Case for Patient-Reported Outcomes in Clinical Inflammatory Bowel Disease Practice" @default.
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