The Diagnostic Odyssey of Patients with Chronic Neuropathic Pain-Expert Opinion of Greek Pain Specialists.

The diagnosis of chronic neuropathic pain requires a laborious process and can be a very long journey for the patients, one that can be characterized as an "odyssey." Our aim was to describe the "diagnostic odyssey" associated with chronic neuropathic pain in the Greek context. Specialized clinicians working at dedicated chronic pain and palliative care centers were asked to participate in a survey regarding the diagnostic process in Greece. In total, 44 respondents provided information on the organization of their centers, the diagnostic process, and the perceived obstacles involved in the diagnosis of chronic neuropathic pain. Most respondents reported that their centers were not fully or efficiently organized and believed that additional specialized healthcare personnel should be employed. Raising public awareness about the existence of such centers was also considered key. The two main obstacles in reaching a diagnosis were the difficulty non-experts had in recognizing chronic neuropathic pain and the lack of acknowledgement that chronic neuropathic pain is a condition that needs to be addressed. When considering these responses in light of the extended socioeconomic burden associated with chronic neuropathic pain, efforts should be made to limit the "diagnostic odyssey" of chronic neuropathic pain in Greece. The aim of this study is to explore the experience of patients with chronic neuropathic pain in Greece from the viewpoint of pain specialists. A better organization of pain and palliative care centers, facilitation of communication with previously treating clinicians, increased personnel, utilization of a chronic pain registry, and guidelines development can aid in this venture. Keypoints: The diagnosis of chronic neuropathic pain in Greece is a laborious and time-consuming process that needs to be refined; Greek clinicians believe that their centers were not fully or efficiently organized and think that additional specialized healthcare personnel should be employed; Patient comorbidities and retards in visiting a clinic at the onset of symptoms delay the diagnosis of neuropathic pain and may complicate subsequent care; The diagnostic delay has been reported as three years between the onset of symptoms and seeking general medical help and another nine years before a referral to a pain specialist; Neuropathic pain is associated with patient distress and socioeconomic burdens, and diagnostic delays prolong the condition, may allow it to worsen, and utilize valuable healthcare resources without providing effective solutions.

Cost-utility analysis of life-long prophylaxis with recombinant factor VIIIFc vs recombinant factor VIII for the management of severe hemophilia A in Sweden.

AIMS: Prophylaxis with recombinant factor VIII (rFVIII) is the standard of care for severe hemophilia A in Sweden. The need for frequent injections with existing rFVIII products may, however, result in poor adherence to prophylaxis, leading to increased bleeding and long-term joint damage. Recombinant FVIIIFc (rFVIIIFc) is an extended half-life fusion protein which can offer prolonged protection and reduced dosing frequency. The objective of this study was to evaluate the cost-utility of prophylaxis with rFVIIIFc in severe hemophilia A from the perspective of the Swedish health system. METHODS: A Markov model was built to estimate lifetime costs and benefits of prophylaxis with rFVIIIFc vs rFVIII products. Clinical outcomes were represented by annualized bleeding rate (ABR) and quality of life via disutility applied to bleeding events and injection frequency. Costs included the cost of FVIII for routine prophylaxis and bleed resolution. The pooled comparator was costed by weighting the cost of individual products by their market share. RESULTS: In the base case, rFVIIIFc was dominant vs the pooled comparator. Savings of SEK 9.0 million per patient resulted from lower factor consumption for prophylaxis and bleed resolution. Fewer bleeds and reduced injection frequency yielded an estimated 0.59 quality-adjusted life years (QALYs). Results were sensitive to drug dosage and robust to variation in other parameters. Probabilistic sensitivity analysis suggested a greater than 85% probability of rFVIIIFc being cost-effective at a willingness-to-pay threshold of 500,000 SEK/QALY. LIMITATIONS: Due to unavailibilty of patient-level data, treatment benefit was based on a non-adjusted indirect comparison. Dosing and treatment outcomes were assumed to persist over the model duration in the absence of long-term outcome data. CONCLUSION: The results suggest that rFVIIIFc may be a cost-effective option for hemophilia A prophylaxis, generating greater quality of life and reduced costs for the Swedish payer compared to more frequently administered rFVIII alternatives.

An observational time and motion study of denosumab subcutaneous injection and zoledronic acid intravenous infusion in patients with metastatic bone disease: results from three European countries.

PURPOSE: Denosumab (administered via subcutaneous injection) demonstrated superior efficacy versus the intravenously administered zoledronic acid in the prevention of skeletal-related events in an integrated analysis of three head-to-head phase III trials in patients with bone metastases secondary to solid tumors. To date, no studies have evaluated treatment administration duration endpoints of these two agents. METHODS: A multinational, multi-site, observational time and motion study conducted in 10 day oncology units (DOUs) across Belgium, Germany, and Italy. Observations of process time included task time and active healthcare professional (HCP) time for pre-defined tasks. Patient time measurements included entering/exiting the DOU, treatment room, and treatment chair or examination table. RESULTS: A total of 189 patients were enrolled (82 received zoledronic acid and 107 received denosumab) and 238 observations were recorded (104 for zoledronic acid and 134 for denosumab). Mean total task time was reduced by 81% when denosumab was used versus zoledronic acid (8.4 versus 44.2 min; p < 0.0001; pooled analysis across all countries). Pooled estimates for active HCP time were 12.2 min for zoledronic acid and 6.9 min for denosumab (44% reduction; p < 0.0001). CONCLUSIONS: In the countries studied, using denosumab compared with zoledronic acid reduced total task time and active HCP time. Thus, HCPs have more time to dedicate to other patients or care activities. An ability to increase the volume of appointments within DOUs could reduce waiting lists in sites operating at full capacity and increase overall productivity and efficiency in hospital processes.

Time Savings with Rituximab Subcutaneous Injection versus Rituximab Intravenous Infusion: A Time and Motion Study in Eight Countries.

BACKGROUND: Rituximab is a standard treatment for non-Hodgkin lymphoma. The SABRINA trial (NCT01200758) showed that a subcutaneous (SC) rituximab formulation did not compromise efficacy or safety compared with intravenous (IV) infusion. We aimed to quantify active healthcare professional (HCP) time and patient chair time for rituximab SC and IV, including potential time savings. METHODS: This non-interventional time and motion study was run in eight countries and 30 day oncology units. Rituximab SC data were collected alongside the MabCute trial (NCT01461928); IV data were collected per routine real-world practice. Trained observers recorded active HCP time for pre-specified tasks (stopwatch) and chair time (time of day). A random intercept model was used to analyze active HCP time (by task and for all tasks combined) in the treatment room and drug preparation area, drug administration duration, chair time and patient treatment room time by country and/or across countries. Active HCP and chair time were extrapolated to a patient's first year of treatment (11 rituximab sessions). RESULTS: Mean active HCP time was 35.0 and 23.7 minutes for IV and SC process, respectively (-32%, p <0.0001). By country, relative reduction in time was 27-58%. Absolute reduction in extrapolated active HCP time (first year of treatment) was 1.1-5.2 hours. Mean chair time was 262.1 minutes for IV, including 180.9 minutes infusion duration, vs. 67.3 minutes for SC, including 8.3 minutes SC injection administration (-74%, p <0.0001). By country, relative reduction was 53-91%. Absolute reduction in extrapolated chair time for the first year of treatment was 3.1-5.5 eight-hour days. CONCLUSIONS: Compared with rituximab IV, rituximab SC was associated with reduced chair time and active HCP time. The latter could be invested in other activities, whereas the former may lead to more available appointments, reducing waiting lists and increasing the efficiency of day oncology units. TRIAL REGISTRATION: ClinicalTrials.gov NCT01200758.

Resource utilization and costs for treatment of stroke patients in an acute stroke unit in Greece.

BACKGROUND: Stroke comprises the leading cause of death in Greece, and more than 40% of the overall lifetime cost for stroke care, represents the acute phase hospitalization. The aim of the present study was to assess the resource utilization and estimate the costs for treatment of stroke patients in an Acute Stroke Unit (ASU). METHODS: Patients with first-ever stroke treated in the ASU of an academic hospital in Athens during 2003-2009 were included in the analysis. The National Institutes of Health Stroke Scale (NIHSS), and the modified Rankin Scale (mRS) were employed to assess the neurological impairment on admission and the handicap at discharge, respectively. The cost categories measured were: diagnostic investigations, medications, medical and nursing staff, and overhead costs. A generalized linear model was used to predict the mean cost per patient, based on the clinical characteristics of the patients on admission, and during their hospitalization. RESULTS: In total, 784 patients were included in the analysis, with mean age of 72.2 (11.2) and mean length of hospital stay of 12.3 (9.5) days. The mean cost per patient was estimated at €2,864 (2,198), and the mean cost per day at €244 (54). The relevant cost for the mildly handicapped patients was €1,573 (625), while for the severely handicapped patients it was €4,136 (2,538). Delayed discharge was associated with a mean cost of €362 (634) per patient, while the cost for the acute phase management of the patients was €2,445 (2,471). The neurological impairment on admission (NIHSS score) and the delayed discharge, were strong predictors of the mean cost per patient. CONCLUSIONS: The costs for treatment of stroke patients in an ASU comprise a significant burden in Greece. Further research should be performed to explore the long-term costs for the treatment of the disease at a nation-wide level.

A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer.

Within PrefHer (NCT01401166), patients and healthcare professionals (HCPs) preferred subcutaneous (SC) over intravenous (IV) trastuzumab. We undertook a prospective, observational time and motion study to quantify patients' time in infusion chairs and active HCP time in PrefHer. Patients with HER2-positive early breast cancer received four adjuvant cycles of SC trastuzumab (600 mg fixed dose via SC single-use injection device [SID, Cohort 1] or SC handheld syringe [HHS, Cohort 2]) then four cycles of standard IV trastuzumab or the reverse sequence. Generic case report forms for IV and SC management, both in the treatment room and the drug preparation area, were tailored to reflect center practices. Patient chair time and active HCP time were recorded. We compared pooled Cohort 1 + 2 IV with Cohort 1 SC SID and Cohort 2 SC HHS mean times across eight countries and individually within them utilizing a random intercept generalized linear mixed-effects model. Per session, the SC SID saved a mean of 57 min of patient chair time versus IV (range across countries: 47-86; P < 0.0001); the SC HHS saved 55 min (40-81; P < 0.0001). Active HCP time was reduced by a mean of 13 min per session with the SC SID (range across countries: 4-16; P < 0.0001) and 17 min with the SC HHS (5-28; P < 0.0001) versus IV. SC trastuzumab, delivered via SID or HHS, saved patient chair and active HCP times versus IV infusion, supporting a transition to either SC method.

Time Savings with Once-Monthly C.E.R.A.: A Time and Motion Study Conducted in 13 Haemodialysis Centres in Italy.

BACKGROUND: We sought to document the time required by health care professionals to administer erythropoiesis-stimulating agents (ESAs) and continuous erythropoiesis receptor activator (C.E.R.A.) in the management of renal anaemia. METHODS: A Time and Motion study was conducted in 13 centres in Italy. The time spent on preparation, distribution, and injection for both ESA and C.E.R.A. groups was measured. A multilevel model was run to account for the centre-clustering effect. RESULTS: The average number of ESA injections/patient/year was 89. The average uptake of C.E.R.A. was 26%. The average time per session was 1.54 min for ESA (95% CI 1.21-1.86) vs. 1.64 min for C.E.R.A. (95% CI 1.31-1.97). Estimated time/patient/year was 137 min for ESA and 20 min for C.E.R.A. Assuming a 100% uptake of C.E.R.A., annual time savings/centre would be 84% (194 h). CONCLUSIONS: Substantial annual time savings on frequent anaemia management-related tasks were found when a switchover was made from ESAs to C.E.R.A.

Inequalities in access to cancer treatment: an analysis of cross-regional patient mobility in Greece.

PURPOSE: The quest of specialized oncology services represents an inelastic need for cancer patients that often leads to traveling in order to receive adequate care. The present survey assesses patient geographic mobility to access services for the prevention and treatment of neoplasmatic diseases in Greece, a country where the National Health System is characterized by severe misdistribution of oncology-specific resources. METHODS: Based on data from the National Statistical Service for 1999-2005 (last available), we estimated geographic mobility as the difference between oncology patients residing in a specific region and those receiving care in National Health System (NHS) facilities located in the region, for the ten administrative districts of Greece. Especially for Attica, we performed a sub-analysis according to cancer diagnosis. RESULTS: The most significant mobility is towards Attica, where patients receiving care within the region outnumber the patients actually residing by 48.9% annually, on average. Positive flows are also observed towards Macedonia (8.4%) and Epirus (7.8%). Negative flows are recorded in all remaining regions, the highest noticed in Sterea (-76.2%), Ionian Islands (-63.3%), Aegean Islands (-45.2%), and Thessaly (-37.3%). The largest flow towards Attica is for cases of malignant neoplasms of the skin, uterus, male genital organs, and for Hodgkin's lymphomas. CONCLUSIONS: Misallocation of oncology-specific resources creates "two-tier" cancer patients based on ability to pay for traveling/accommodation. The severity and the consequences of the disease necessitate a bold approach to resource allocation and the establishment of integrated patient support networks that ensure all cancer patients are offered equal opportunities to effective treatment.