Helen Kitchen

Cognitive Impairment Associated with Schizophrenia: A Review of the Humanistic Burden

IntroductionNearly every individual with schizophrenia is affected by cognitive decline. The aim of this literature review was to: (a) describe the humanistic burden of cognitive impairment associated with schizophrenia (CIAS); (b) develop a conceptual model that depicts the signs and symptoms of CIAS along with key concepts important to patients; and (c) consider the adequacy of potential patient-reported outcome (PRO) instruments for assessing future treatments.MethodsThe following electronic databases were searched for articles published between January 1999 and November 2009 related to CIAS and PROs, or cost of illness: Medline; Embase; PsycINFO; the Health Economic Evaluation Database; and the National Health Service Economic Evaluation Database and Health Technology Assessment databases at the Centre for Reviews and Dissemination, University of York.ResultsThe literature search revealed 3950 abstracts, of which 101 articles were reviewed in detail. Cognitive functions affected include memory, attention/concentration, problem solving, learning, executive function, processing speed, and social cognition. Cognitive impairment impacts the ability of individuals to carry out activities of daily living, work productively, function socially, and adhere to treatment. These effects have economic ramifications through increased direct and indirect costs associated with the treatment of schizophrenia. The literature revealed 39 PRO instruments that have been used to assess functioning. However, no single instrument captures all key concepts of importance to patients with schizophrenia.ConclusionThe significant burden from CIAS for patients and society has implications for designing future treatments and health strategies to improve functional outcomes.

Development of a conceptual model evaluating the humanistic and economic burden of Crohn’s disease: implications for patient-reported outcomes measurement and economic evaluation

The primary objective of this review is to develop a conceptual model for Crohn’s disease (CD) outlining the disease burden for patients, healthcare systems and wider society, as reported in the scientific literature. A search was conducted using MEDLINE, PsycINFO, EconLit, Health Economic Evaluation Database and Centre for Reviews and Dissemination databases. Patient-reported outcome (PRO) measures widely used in CD were reviewed according to the US FDA PRO Guidance for Industry. The resulting conceptual model highlights the characterization of CD by gastrointestinal disturbances, extra-intestinal and systemic symptoms. These symptoms impact physical functioning, ability to complete daily activities, emotional wellbeing, social functioning, sexual functioning and ability to work. Gaps in conceptual coverage and evidence of reliability and validity for some PRO measures were noted. Review findings also highlight the substantial direct and indirect costs associated with CD. Evidence from the literature confirms the substantial burden of CD to patients and wider society; however, future research is still needed to further understand burden from the perspective of patients and to accurately understand the economic burden of disease. Challenges with existing PRO measures also suggest the need for future research to refine or develop new measures.

Exploring the Humanistic and Economic Burden of Crohnʼs Disease: Considerations for Novel Compounds: P-68

data regarding the prevalence of CDI in newly diagnosed IBD, and its effect on disease course. As a basis for future studies to determine the impact of CDI on the course of IBD, we sought to determine rate of CDI and CDI testing at diagnosis of IBD. METHODS: Rhode Island patients diagnosed with IBD after January 2008 and within one year of diagnosis were eligible to enroll in the Ocean State Crohn’s and Colitis Area Registry (OSCCAR), a prospective cohort started January 2008. Medically trained personnel confirmed diagnosis of IBD by chart review using standard criteria. All patients completed a questionnaire regarding symptoms at diagnosis. This included self-report of diarrhea (loose or watery bowel movements and/or increased frequency of stool) within 4 weeks before diagnosis of IBD. Trained data abstractors recorded occurrence of CDI toxin or PCR assay testing and results from medical records of the gastroenterologist and/or surgeon who reported a new diagnosis, or inpatient records if diagnosed during hospitalization. RESULTS: Among 338 patients enrolled from January 2008 to June 2011, 260 (76.9%) reported diarrhea. Of the 260 patients, results of CDI testing were recorded in diagnosing physicians’ records for 120 patients (46.2%). CDI testing was not recorded or possibly not performed for the remaining 140 patients who presented with diarrhea. An additional 21 patients were tested for CDI but did not report having diarrhea or did not have a symptom inventory on record. Of the 141 patients tested for CDI, 74 were female; 65 were diagnosed with ulcerative colitis, 65 with Crohn’s disease, and 11 patients had IBD undetermined. Seven (4.9%) of the 141 patients tested were positive for CDI (2.1% of all patients). CONCLUSION(S): Testing for CDI is lower than expected at diagnosis of IBD especially among patients who presented with diarrhea. Although the prevalence of CDI among tested patients is only 5%, low rate of testing and possible delayed diagnosis of CDI in newly diagnosed IBD may be a significant quality issue. A limitation of the study is that we are unable to determine whether CDI testing was done prior to specialty referral and thus we may underestimate the rate of CDI testing.