Work-Related Productivity Loss and Associated Indirect Costs in Patients With Crohn's Disease or Ulcerative Colitis in the United States.

Background: Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), affects an estimated 1.6 million US adults, and results in humanistic and economic burden even among mild patients, which grows with increasing disease activity. Methods: Gastroenterologists and their IBD patients provided real-world data via US IBD Disease Specific Programmes 2014-2018. Patients with physician- and patient-reported data completing a Work Productivity and Activity Impairment questionnaire were categorized by disease activity, defined using Crohn's Disease Activity Index (CD) and partial Mayo scores (UC), respectively. Associations of disease activity with patient-reported productivity loss and indirect costs were assessed. Results: The analyses included 281 patients with CD and 282 patients with UC. Mean ages were 40.0 and 40.5 years, and mean disease durations 7.1 and 5.4 years, for CD and UC, respectively. In CD, absenteeism (0.95%-14.6%), presenteeism (11.7%-44.9%), and overall work impairment (12.4%-51.0%) increased with increasing disease activity (all P < .0001). In UC, absenteeism (0.6%-11.9%), presenteeism (7.1%-37.1%), and overall work impairment (7.5%-41.9%) increased with increasing disease activity (all P < .0001). Annual indirect costs due to total work impairment increased with increasing disease activity (all P < .0001), from $7169/patient/year (remission) to $29 524/patient/year (moderately-to-severely active disease) in CD and $4348/patient/year (remission) to $24 283/patient/year (moderately-to-severely active disease) in UC. Conclusions: CD and UC patients experienced increased absenteeism, presenteeism, and overall work impairment with increasing disease activity, resulting in higher indirect costs. Treatments significantly reducing IBD disease activity could provide meaningful improvements in work productivity and associated costs.

Real-world treatment patterns and outcomes of patients with stage IV squamous cell carcinoma of the head and neck.

AIM: To understand the treatment patterns and outcomes for stage IV squamous cell carcinoma of the head and neck, patients receiving second-line or later drug therapy. MATERIALS & METHODS: Real-world data were collected from 1152 patients in the USA, France, Germany and the UK through a retrospective chart analysis and patient-reported outcomes were collected using validated questionnaires in a subgroup of patients. RESULTS: Forty-four percent of patients had stage IVA/B disease. A total of 77, 19 and 3% of patients had received two, three and four plus lines of active drug treatment. Platinum- and cetuximab-based regimens were common at early treatment lines. Time to progression was short (5.2 months post first line), survival rates low and patient-reported health status poor. CONCLUSION: Novel therapies that could improve clinical and patient-reported outcomes would address a significant unmet need.

Confidence in correct inhaler technique and its association with treatment adherence and health status among US patients with chronic obstructive pulmonary disease.

BACKGROUND: Improper use of bronchodilators is associated with poor disease control, nonadherence to long-term therapy, and poor clinical outcomes. Our current understanding of factors associated with correct inhaler use and adherence is limited. We measured physician-and patient-reported confidence in device usage and associations with treatment adherence and COPD-related health status. METHODS: This was an analysis of a US observational, point-in-time survey of physicians and patients. Physicians who met study eligibility criteria completed surveys for 5 consecutive, eligible patients who were then invited to respond to questionnaires. We assessed patient demographics, type of prescribed inhaler device(s), device training, COPD severity, comorbidities, physician-and patient self-reported confidence in device usage, treatment adherence, and health status. RESULTS: Completed questionnaires for 373 patients were provided by 134 physicians. Complete confidence in device usage was observed for 22% and 17% of patients as reported by patients and physicians, respectively. Greater confidence was associated with higher self-reported adherence to inhaler usage. Physicians were more likely than patients to report lower levels of patient confidence in device usage. High physician- and patient-reported confidence were associated with more favorable health status. Predictors of confidence in device usage included fewer comorbidities, no depression, and higher education levels. CONCLUSION: Low confidence in inhaler usage was associated with lower adherence and poor COPD-related health status. Choice of inhaler device tailored to patients' ability to use specific devices and ongoing education to support optimal inhaler usage may improve patient confidence and enhance both adherence and health status.

Trends in medication use in patients with type 2 diabetes mellitus: a long-term view of real-world treatment between 2000 and 2015.

BACKGROUND: Despite the availability of a variety of treatments, many patients with type 2 diabetes mellitus (T2DM) are not achieving glucose control. We analyzed successive waves of the Adelphi Real World Diabetes Disease Specific Programmes (DSPs) to assess treatment patterns reported by primary care physicians (PCPs) and specialists and the effect of treatment on levels of glucose control. METHODS: Data were collected between 2000 and 2015 in the US and EU5 (France, Germany, Italy, Spain, and the UK). Physicians completed patient record forms for the next 10 patients consulting with T2DM. Key aspects captured were change over time in therapy usage, time to insulin introduction, and glycated hemoglobin (HbA1c) levels. RESULTS: Over 12 DSP waves, 3,555 specialists and 5,109 PCPs completed questionnaires for 70,657 patients. Treatment patterns changed considerably over time as new agents were introduced. The number of agents prescribed per patient increased over time, as did HbA1c levels at which physicians stated they would introduce insulin. The greatest improvements in HbA1c levels occurred during 2000-2008, with little improvement since 2008. CONCLUSION: In this real-world setting, the proportion of patients with T2DM achieving good glucose control has not increased greatly since 2008. A better understanding of how to individualize treatment pathways may be required to improve control in these patients.

Satisfaction with control of systemic lupus erythematosus and lupus nephritis: physician and patient perspectives.

PURPOSE: Patient satisfaction with disease control of systemic lupus erythematosus (SLE) is an important component of medical management. This analysis evaluated patient and physician satisfaction with disease control of SLE, factors associated with satisfaction/dissatisfaction, and the degree of physician-patient concordance of these parameters. PATIENTS AND METHODS: Data were extracted from the US Adelphi Real World Lupus Disease Specific Programme®, a cross-sectional survey of 50 rheumatologists, 25 nephrologists, and their patients with non-nephritis SLE (NNSLE) or lupus nephritis (LN). RESULTS: Physicians reported moderate or severe disease activity in 25.0% of patients with NNSLE and in 50.5% of patients with LN, and were satisfied with disease control in 78.6% (132/168) and 73.8% (152/206) of patients, respectively. For patients, 75.8% (75/99) with NNSLE were satisfied with their current treatment, compared with 65.5% (74/113) with LN. Physician-patient agreement (70.7%) on the level of satisfaction was "slight" (kappa =0.1445) for NNSLE; patients were more frequently dissatisfied than physicians with regard to joint tenderness, fatigue, anxiety, pain on movement, malar rash, and photosensitivity. Physician-patient agreement (71.4%) on the level of satisfaction was "fair" (kappa =0.3695) for LN; patients expressed greater dissatisfaction than physicians for headache, photosensitivity, and anxiety, whereas physicians were more dissatisfied with regard to joint swelling, kidney function, and blood pressure control. In general, patients with NNSLE or LN who were dissatisfied (or whose physicians were dissatisfied) were more likely to have joint swelling, joint stiffness, malar rash, hair loss, depression, and fatigue, have moderate or severe disease, or to be currently experiencing disease flare. CONCLUSION: These data highlight the patient and physician dissatisfaction with real-world disease control of SLE.

The symptom burden of non-small cell lung cancer in the USA: a real-world cross-sectional study.

PURPOSE: Disease symptom management in patients with advanced non-small cell lung cancer (NSCLC) is a critical aspect of therapy. The main objective of our study was to assess patient-reported outcomes and the degree of concordance between physician and patient perceptions of symptom severity in advanced NSCLC in the USA. METHODS: Patients with advanced (stage IIIB/IV) NSCLC (N = 450) were recruited in a nationwide (USA) lung cancer study. Patients and their oncologists completed patient and physician versions of the Lung Cancer Symptom Scale (LCSS). Patient-reported lung cancer-specific quality of life was assessed with the Functional Assessment of Cancer Therapy--Lung (FACT-L). Concordance was assessed using the kappa-statistic. Regression analysis was performed with FACT-L total score as the dependent variable and patient-reported LCSS symptom scores as predictors. RESULTS: A high proportion of patients experienced lung cancer symptoms: fatigue (100 %), loss of appetite (97 %), shortness of breath (95 %), cough (93 %), pain (92 %), and blood in sputum (63 %). Concordance between physician and patients was lowest for loss of appetite (kappa 0.1701) and greatest for hemoptysis (kappa 0.4586). Loss of appetite (ß = -0.204; p < 0.001), cough (ß = -0.145; p < 0.01), pain (ß = -0.265; p < 0.001), and shortness of breath (ß = -0.145; p < 0.01) were found to be significant predictors of the quality of life. CONCLUSIONS: Symptom burden in patients with advanced NSCLC is high and has a negative impact on the quality of life. Patient-reported outcomes data could help optimize disease outcomes and therapy management in NSCLC.

Symptom burden and quality of life in advanced non-small cell lung cancer patients in France and Germany.

BACKGROUND: To assess patient reported symptom burden and impact on disease specific health related quality of life (HRQOL) in advanced non-small cell lung cancer (NSCLC) patients. METHODS: Patients with advanced (stage IIIB/IV) NSCLC in France (n = 613) and Germany (n = 600) were recruited into a multicenter, patient record-based cross-sectional study. Patient reported symptoms using the Lung Cancer Symptom Scale, which assesses fatigue, loss of appetite, shortness of breath, cough, pain and blood in sputum on a 0-100 visual analog scale. Disease specific and generic HRQOL were assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L) and the EuroQol five-dimensional questionnaire (EQ-5D) respectively. A multivariate regression analysis was performed with total FACT-L score as the dependent variable and symptom scores as predictors. Age, gender, stage and performance status were used as control variables. RESULTS: Majority of the patients were male (67%), Caucasian (93%) with an average age of 63 years. Fatigue, loss of appetite, shortness of breath, cough and pain were reported by ≥ 90% of patients. The mean health utility index score was found to be 0.58 and the mean general health status score was 58.0. Fatigue (ß = -0.122; p < 0.001), loss of appetite (ß = -0.170; p < 0.001), pain (ß = -0.145; p < 0.001), shortness of breath (ß = -0.118; p < 0.001) were found to be significant predictors of lung cancer specific quality of life as measured by the FACT-L total score. CONCLUSION: Fatigue, loss of appetite, shortness of breath and pain have a significant negative impact on patient reported disease specific HRQOL in advanced NSCLC patients.