Abstract Background The objective of this study was to review our clinical experience on the safety and efficacy of anidulafungin, an echinocandin antifungal, in the treatment of invasive fungal infections (IFIs) in patients with moderate to severe abnormal liver function tests or multiorgan failure and IFI, in a large United Kingdom Liver Centre. Methods The clinical records of the first 50 consecutive patients treated for IFI with anidulafungin between January 7, 2009 and March 2, 2011 were analyzed. Data were collected on demographics, underlying disease, disease characteristics, hematological and biochemical parameters, IFI, concomitant bacterial and viral infections, response to anidulafungin, and anidulafungin-related adverse events. Results The patients’ median age was 54.3 years (range, 19.6–75.9); 60% were male. Twenty-two (44%) patients were liver transplant recipients. Others had hepatopancreaticobiliary disease (n = 15, 30%) or chronic liver disease (n = 11, 22%). Invasive fungal infection (predominantly Candida spp) was proven in 36 (72%) patients, probable in 14 (28%). Of 46 evaluable patients, 35 (76%) had a favorable anidulafungin treatment outcome. Forty-nine (98%) had abnormal liver function tests (LFTs) pretreatment; 31 (62%) had ≥1 LFT raised to ≥2× baseline during anidulafungin treatment. Conclusions In this highly specialized group of patients, anidulafungin treatment was efficacious and well tolerated by those with decompensated liver disease, multiorgan failure, and high-risk liver transplant with proven or probable IFI.

Background: The fixed, progressive disability associated with late Multiple Sclerosis (MS) is known to have a major impact on patients and their families, but the impact of relapse earlier in the disease course is less well documented, particularly from the patient's perspective. This study aimed to understand the effects of relapse for people with MS (PwMS), focussing on the years immediately after starting disease modifying therapy (DMT) when experience of a relapse may particularly influence a patient's opinions of their disease and its therapy.Methods: This was a multi-centre, retrospective, observational research study, recruiting patients from 7 UK NHS Hospital Trusts. Consenting patients with relapsing-remitting MS (RRMS), who had started a DMT more than 36 months before screening, were sent a study questionnaire. Data on MS relapses and treatments over 3 years were collected simultaneously from medical records.Results: One hundred and three patients completed the questionnaires. Relapses were under-reported to health care professionals, with 28% of respondents failing to report their most recent attack and 46% declaring they had failed to report an attack in the past. During their most recent relapse, 67% of those in paid employment reported taking time off sick, 48% reduced working hours temporarily, and 41% worked reduced hours and took time off sick. Sixty-six percent required additional support to undertake routine daily tasks during their most recent relapse. A range of effects of relapse which cannot be measured in financial terms were also reported, including effects on physical abilities, mental health and family roles and relationships.Conclusion: This contemporary UK-based study provides an insight into the experience of relapse early in the treatment of RRMS from the patient perspective. The comparison of documented patient reported relapses reveals some deficiencies in the recording of relapses which is important to address in view of the reported impact of individual relapses, and emphasises relapse reduction as a worthy treatment aim. (C) 2014 The Authors. Published by Elsevier B.V.

Abstract Aim: To quantify active healthcare professional (HCP) time and costs associated with subcutaneous (SC) and intravenous (IV) infusion administration of trastuzumab (Herceptin) in the treatment of patients with HER2-positive early breast cancer within the adjuvant PrefHer trial; secondly, to measure patient time in the care unit and patient chair time for both routes of administration. Methods: A UK multi-centre prospective, observational time and motion study was conducted alongside the PrefHer trial (ClinicalTrials.gov id: NCT01401166). Trained observers measured the duration of each SC and IV related task HCPs undertook and recorded patient time in the chemotherapy unit and treatment chair. The type and quantity of medical consumables used with each route of administration were also collected. 24 patient episodes were recorded (12 SC, 12 IV). Mean total administration time was calculated as the mean sum of task times, for both IV and SC formulations. The mean cost of each route of administration was calculated as the mean cost of HCP time plus the mean cost of consumables used. HCP time was costed using data from the Personal Social Services Research Unit. Consumables were costed using hospital pharmacy data and online sources. Results: Mean active HCP time for IV preparation and administration was 92.6 minutes compared with 24.6 minutes for SC administration. The mean cost for IV preparation and administration was £144.96 (£132.05 of HCP time and £12.92 of consumables) versus £33.15 (£31.99 of HCP time and £1.17 of consumables) for SC administration. Mean time spent by patients in the care unit and treatment chair was 94.5 minutes and 75 minutes respectively for IV, and 30.3 minutes and 19.8 minutes for SC. SC administration of trastuzumab could translate to a HCP time saving of 68 minutes (34.5 minutes of preparation time and 33.5 minutes of administration time) (versus IV) with a total cost saving of £111.81 per patient episode. This equates to a potential saving of £2012.58 over a full course of adjuvant trastuzumab treatment (18 cycles). Conclusion: Substituting IV infusion with SC administration of trastuzumab may lead to a substantial reduction in active HCP time, consumable use and overall cost. The reduced patient chair and unit time could provide increased capacity within existing resources. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P4-12-23.

OBJECTIVE:The aim of this study was to evaluate the "real world" effects of the monoclonal antibody omalizumab (OMB) when used to treat severe persistent allergic asthma in UK clinical practice.METHODS:A 10-center retrospective observational study was carried out to compare oral corticosteroid (OCS) use and exacerbation frequency in 12 months pre- versus post-OMB initiation in 136 patients aged ≥12 years with severe persistent allergic asthma. All patients received ≥1 dose of OMB. Patients who had received OMB in a clinical trial were excluded. Data were obtained from hospital and if necessary general practitioners' (GPs') records on OCS use, lung function, hospital resource use, and routinely used quality of life (QoL) measures at baseline (pre-OMB), 16 weeks, and up to 12 months post-OMB initiation.RESULTS:Mean total quantity of OCS prescribed per year decreased by 34% between the 12 months pre- and post-OMB initiation. During the 12 months post-OMB initiation, 87 patients (64%) stopped/reduced OCS use by 20% or more and 66 (49%) stopped OCS completely. Mean percent predicted forced expiratory volume in one second (FEV(1)) increased from 66.0% at baseline to 75.2% at week 16 of OMB therapy. The number of asthma exacerbations decreased by 53% during the 12 months post-initiation. Accident and emergency visits reduced by 70% and hospitalizations by 61% in the 12 months post-OMB initiation.CONCLUSION:This retrospective analysis showed a reduction in exacerbations and improved QoL as per previous studies with OMB. However, the total reduction in annual steroid burden and improved lung function in this severely ill group of patients taking regular or frequent OCS is greater than that seen in previous trials.

Introduction and Objectives There are limited data on the healthcare resource use that arises as a consequence of idiopathic pulmonary fibrosis (IPF). Navaratnam et al1 have recently reported rising hospital admissions due to IPF but utilisation of other health related services by individuals with IPF is unknown. As part of a real world assessment of the clinical experience of pirfenidone via the UK Named Patient Program data were collected to determine the burden placed on healthcare resources as a consequence of IPF. Methods A multi-centre, retrospective, cohort review was undertaken across 4 NHS Trusts. Hospital resource use data were collected from the clinical records of individuals starting pirfenidone for IPF through the NPP before June 2012. Results Data were available from 100 patients (76% male) at baseline and 67 through to nine months from baseline. At baseline, the mean ± S.D. age was 69.3 ± 7.5 years, mean ± S.D. FVC% predicted was 70% ± 19% and 62 patients were on oxygen therapy. In the first 6 months from baseline, 11 patients had 15 IPF-related hospitalisations of which 6 were for an acute exacerbation. One patient was hospitalised in the 6–9 months period. The mean ± S.D. and median (IQR) hospital bed days in the first 6 months were 11.0 ± 7.5 and 11.0 (6.0–13.5) days respectively for hospitalised patients and mean ± S.D. 1.2 ± 4.2 days for all patients. One patient was admitted to the Intensive Care Unit, for 5 days. Eighteen patients had IPF-related Accident and Emergency department visits, 3 had an IPF-related day-case and 67 outpatient clinic visits, with a mean of 2.1 ± 2.0 outpatient clinic visits per patient in the first 6 months of the observation period. Conclusion IPF is a terminal disease associated with significant morbidity and mortality. This is reflected in the high level of resource use and frequent accessing of health care services by this severely ill cohort of patients. Whether resource use has been positively impacted by the introduction of pirfenidone is unknown but merits prospective assessment. Reference Navaratnam V, Fogarty AW, McKeever T, Hubbard RB. The Increasing Secondary Care Burden of Idiopathic Pulmonary Fibrosis Hospital Admission Trends in England >From 1998 to 2010. CHEST 2013; 143(4):1078–1084

Introduction: The aim of the study was firstly, to quantify active healthcare professional (HCP) time and costs associated with subcutaneous (SC) administration of trastuzumab (Herceptin'A) compared with the standard intravenous infusion (IV) in the treatment of patients with HER2-positive early breast cancer within the adjuvant PrefHer trial setting; secondly, to measure patient time in the care unit and patient infusion chair time for both routes of administration.Material and methods: A UK multi-centre prospective, observational Time and Motion study was conducted alongside the PrefHer trial (ClinicalTrials.gov id: NCT01401166). Trained observers measured the duration of each SC and IV related task that HCPs undertook and recorded patient time in the chemotherapy unit and infusion chair. The type and quantity of medical consumables used with each route of administration were also collected. Twenty-four patient episodes were recorded (12 SC, 12 IV). Mean total administration time was calculated as the mean sum of task times, both for IV and SC formulations. The mean cost of each route of administration was calculated as the mean cost of HCP time plus the mean cost of consumables used. HCP time was costed using Personal Social Services Research Unit. Consumables were costed using hospital pharmacy data and online sources.Results: Mean active HCP time for IV. administration was 92.6 minutes compared with 24.6 minutes for SC administration. The mean cost for IV preparation and administration was 144.96 pound (132.05 pound of HCP time and 12.92 pound of consumables) versus 33.15 pound (31.99 pound of HCP time and 1.17 pound of consumables) for SC administration. Mean time spent in the care unit and in the infusion chair was 94.5 minutes and 75 minutes respectively for IV, and 30.3 minutes and 19.8 minutes for SC. SC administration of trastuzumab could translate to a time saving of 68 minutes (versus IV) with a total cost saving of 111.81 pound per patient episode. This equates to a potential saving of 2012.58 pound over a full course of adjuvant treatment (18 cycles).Conclusion: Substituting IV infusion with SC administration of trastuzumab may lead to a substantial reduction in active HCP time, patient chair and unit time, consumable use and overall costs. The reduced patient chair and unit time could provide increased capacity within existing resources.

BACKGROUND:NHS Stop Smoking Services provide various options for support and counselling. Most services have evolved to suit local needs without any retrospective evaluation of their efficiency.Three local service evaluations were carried out at Bournemouth & Poole Teaching Primary Care Trust (PCT) (PCT1), NHS South East Essex (PCT2) and NHS Warwickshire (PCT3) to describe the structure and outcomes associated with different services.RESULT:Standardised interviews with key personnel in addition to analysis of data from 400 clients accessing the service after 1st April 2008 in each PCT. The PCTs varied in geography, population size and quit rate (47%-63%). Services were delivered by PCT-led specialist teams (PCT1), community-based healthcare providers (PCT3) and a combination of the two (PCT2) with varying resources and interventions in each.Group support resulted in the highest quit rates (64.3% for closed groups v 42.6% for one-to-one support (PCT1)). Quit rates were higher for PCT (75.0%) v GP (62.0%) and pharmacist-delivered care (41.0%) where all existed in the same model (PCT2). The most-prescribed therapy was NRT (55.8%-65.0%), followed by varenicline (24.5%-34.3%), counselling alone (6.0%-7.8%) and bupropion (2.0%-4.0%).CONCLUSION:The results suggest that service structure, method of support, healthcare professional involved and pharmacotherapy all play a role in a successful quit. Services must be tailored to support individual needs with patient choice and access to varied services being key factors.

Background. Quality of life self-rating using a web-based survey has not previously been evaluated for psoriasis in the UK. Aim. To use an open-access web-based survey to assess the effect of psoriasis on patients daily life. Methods. The survey was conducted using a dedicated website endorsed by a UK psoriasis patient charity. Results. In total, 1760 patients (1102 women, 658 men; median age range 4044 years) assessed their psoriasis using the website. Psoriasis was very or extremely active in 52%, and 71% had been diagnosed > 10 years previously. Psoriasis had negatively affected the working life of 59% of patients, and the educational performance of 31%. Conclusions. The use of an open-access web-based survey may address potential bias in previous studies, but may itself introduce a bias towards younger patients. This is the first report of a web-based survey of UK patients with psoriasis, providing further recent evidence of how psoriasis affects patients lives.

Background. Psoriasis affects 1-2% of the UK population, with 20-30% of those affected having severe psoriasis managed with systemic therapies. Biological agents are a useful option when other systemic therapies have failed. The National Institute for Health and Clinical Excellence (NICE) in the UK has published three sets of guidance relating to the use of biological agents.Aim. To establish whether biological agents were being used in line with NICE guidance.Methods. The study was conducted in seven specialist dermatology units, and involved the retrospective collection of data from patients treated with biological agents since the introduction of the NICE guidance.Results. In total, 176 patients with 212 episodes of treatment were included in the study. Biologics were started for appropriately severe disease in 85% of cases (n = 180) and only after failure, intolerance or contraindication to standard systemic therapies in 97% of cases (n = 206). Etanercept was discontinued appropriately in responders before week 24 in only 12% (five of 60 responders). Across all agents, 40% (72 of 178 with continuity status) were continued on treatment despite not achieving an adequate response according to NICE criteria.Conclusions. In the seven sites audited, compliance with national guidance was entirely appropriate in terms of therapy initiation; however, the requirement to discontinue etanercept in responders was rarely followed. Similarly, discontinuation of biologicals in nonresponders was not routine practice. This may indicate a reluctance of both patients and clinicians to withdraw an at least partly effective therapy from these refractory patients.

NHS Stop Smoking Services provide various options for support and counselling. Most services have evolved to suit local needs without any retrospective evaluation of their efficiency. Objective was to describe the structure and outcomes associated with different services. Local service evaluations were done in three primary Care Trusts (PCTs) by conducting standardised interviews with key personnel in addition to extraction and analysis of data from 400 clients accessing the service after 1st April 2008 in each PCT. The PCTs varied in geography, population size and quit rate (47%-63%). Services were delivered by PCT-led specialist teams (PCT1), community-based health care providers (PCT3) and a combination of the two (PCT2) with varying resources and interventions in each. Group support resulted in the highest quit rates (64.3% for closed groups v 42.6% for one-to-one support (PCT1)). Quit rates were higher for PCT (75%) versus GP (60%) and pharmacist-delivered care (40%) where all existed in the same model (PCT2). The most-prescribed therapy was NRT (56%-65%), followed by varenicline (25%-34%), counselling alone (6%-8%) and bupropion (2%-4%). Quit rates for NRT at 4 weeks were 43%-55% across the 3 PCTs; 60% -81% for varenicline and 38%-91% for bupropion. The results suggest that service structure, method of support, healthcare professional involved and pharmacotherapy all play a role in a successful quit. Services must be tailored to support individual needs with patient choice and access to varied services being key factors.

Introduction Previous studies with anti-TNF drugs1–3 for Crohn9s disease (CD) showed a reduction in cost by reducing hospitalisations, examinations under anaesthetic (EUA) and diagnostic procedures. However no study has looked at the effect of anti-TNF drug dosing schedule on outcomes and resource use. Methods Retrospective study using patient records, in 5 UK hospitals. Consenting patients aged>18 with a diagnosis of CD who had started any anti-TNF drug >1 year prior to study, with records for >2 years pre-anti-TNF were included. Data were collected for 2 years pre-anti-TNF and 1 year post-anti-TNF initiation on hospital resource use associated with CD. Outcomes measured were change in steroid use, rates of surgery and change in disease state at 1 year versus baseline. Results Of 142 patients in the study (61% female) 121 (85%) started anti-TNF drug in 2005–2009. The prescribing pattern changed from 78% episodic dosing (ED) in 2003 to 79% maintenance dosing (MD) in 2009. Anti-TNF was started a median of 8.7 years (IQR 12.6 years) after diagnosis, with patient median age at initiation 34 years (IQR 18 years). At 1 year, 77% of patients had improved disease, 12% worse and 11% remained the same. Steroids were stopped in 23% and reduced in 23% at 1 year; more in the MD group (32%) than in the ED group (12%). Rates of major abdominal surgery were similar pre-anti-TNF and post-anti-TNF (0.06 in Y-1 and 0.10 in Y+1). Overall, NHS resource use was similar pre-anti-TNF and post-anti-TNF, for all visit types except day case visits which increased (mean 0.7/year pre vs 5.9/year post) for infliximab infusions. In the MD group there was a NS trend to fewer admissions (mean 0.65/year pre vs 0.42/year post), bed days (4.9 vs 3.6/year), OP visits (7.5 vs 6.4), EUA (1.1 vs 0.8) and A&E visits (0.2 vs 0.1) post-anti-TNF and 72% of MD patients had reduced non-drug direct costs in the post-anti-TNF year. Conclusion In this study CD of patients treated with anti-TNFs improved and steroid use was reduced, particularly with MD but it did not show the reduction in resource use or major surgery seen in previous work.1–3 Results were affected by two very high cost patients, highlighting variability in disease course. Prospective studies are needed to fully explore differences between ED and MD. However, this study suggests that outcomes and costs may be better with MD than ED, supporting latest NICE guidance.4

The efficacy and safety of omalizumab for the treatment of severe persistent allergic asthma have been demonstrated in randomised controlled clinical trials. However, there are limited ‘real world' data on its effects on healthcare resource utilisation or health-related quality of life (QoL) in UK clinical practice. A 10 centre retrospective observational study (APEX) compared 12 months pre- versus 12 months post-omalizumab initiation in patients aged ≥12 years with severe persistent allergic asthma. All patients received ≥1 dose of omalizumab. Hospital records were reviewed to obtain data on hospital resource use and routinely used QoL measures e.g. Asthma Quality of Life Questionnaire (AQLQ ) at baseline (pre-omalizumab), 16 weeks and up to 12 months following omalizumab initiation. Mean Accident and Emergency department attendances fell by 70% from 1.52 per patient in the 12 months pre-omalizumab to 0.46 in the 12 months post-omalizumab (p<0.001). Similarly, mean in-patient hospital admissions fell by 61% from 1.30 to 0.51 (p<0.001) and mean in-patient bed days fell by 70% from 9.10 to 2.74 (p<0.001) per patient. In the subgroup of patients hospitalised for asthma in the 12-months pre-omalizumab (n=81), mean in-patient hospital admissions fell by 70% from 2.19 to 0.65 (p<0.001) and mean in-patient bed days fell by 74% from 14.86 to 3.83 (p<0.001) per patient. Other resource use, such as outpatient attendances (excluding visits made solely for omalizumab administration), nurse appointments and telephone consultations remained unchanged following omalizumab initiation. QoL data were not available for all patients at every time point. However, where data were available, mean AQLQ scores increased from 3.09 at baseline to 5.01 at 16 weeks (n=90) and to 5.22 at 12 months (n=29). Treatment with omalizumab is associated with a significant reduction in unplanned hospital resource utilisation and significant improvements in patients' QoL.

AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat We read with great interest the recent study by Koleva et al. (2010), in which they documented the healthcare costs associated with the treatment of multiple myeloma (MM) in Italy. Although the addition of bortezomib and lenalidomide (newer agents) to MM treatment regimens has greatly improved response rates in relapsed and de novo disease (Weber et al. 2007; San Miguel et al. 2008), these drugs are expensive with significant implications for healthcare resource planning. Thus, in the UK, bortezomib has only been available to NHS MM patients in first relapse since October 2007, with lenalidomide being available to those in second relapse since June 2009. Placing the cost of treatment with newer agents in the context of the cost of treating MM in the era before their availability is made difficult by the lack of available data. Therefore, we carried out a multi-centre, retrospective study to define the treatment pathways for MM patients from first relapse (RMM) and to describe the impact on secondary healthcare resource use associated with the treatment of RMM before the introduction of newer agents. This study was conducted between February and December 2007 in five hospitals across a wide geographical area in the UK with ethical approval from Eastern MREC (ref. 06/MRE05/61). Patients with RMM were included if the first episode of relapse occurred between February 2001 and December 2007, providing data just before the introduction of the newer agents. Collected data included: chemotherapy regimen at each relapse, hospital attendance/admissions, blood products transfused and supportive treatments (e.g. radiotherapy, dialysis). Seventy-eight patients were included (46 male, 32 female) with a median age of 62.8 years (range 43–89 years). The most common isotypes were IgG-κ (35.5%) and IgA-κ (16.5%). Co-morbidities were present in 87.2% of patients with cardiovascular disease (37%) and diabetes (24%) the most common. At the time of data collection, 73 patients were deceased and seven had received treatment with newer agents (and were thus excluded from further analysis). Data were available for second and third relapse episodes from 25 and seven patients respectively. The most common initial treatment regimens were vincristine–doxorubicin–dexamethasone-type, or alkylator-based (25.6% and 26.9% respectively, Table 1). Twenty patients (25.7%) received consolidation with high-dose chemotherapy and autologous stem cell transplantation (HDT + auto-SCT), including two patients who underwent HDT + auto-SCT on two occasions. Eight patients failed to harvest adequate stem cell numbers and two further patients underwent allogeneic stem cell transplantation. For salvage therapy at first, second and third relapses, a thalidomide-containing regimen was the most frequently prescribed regimen (48.7%, 52.0% and 50% respectively). Table 1. Treatment regimens Regimen Initial therapy (%; n= 78) First relapse (%; n= 78) Second relapse (%; n= 25) VAD/VAMP ± C 25.6 5.1 4.0 Alkylating agent ± steroid 26.9 19.2 12.0 Thalidomide-containing regimens 15.4 48.7 52.0 More than one line/regimen (refractory) 19.2 9.0 12.0 Other 6.4 9.0 16.0 None 5.1 9.0 4.0 Not known 1.3 0 0 C, cyclophosphamide; VAD, vincristine–adriamycin–dexamethasone; VAMP, vincristine and adriamycin with high-dose methylprednisolone. The median time from diagnosis to first relapse was 19.2 months (range 65–2191 days), from first to second relapse 10.2 months (range 80–1085 days) and from second to third 16.6 months (84–580 days). Figure 1A shows the median relapse-free intervals between completion of chemotherapy and diagnosis of a further relapse. The overall median survival from diagnosis was 32.8 months (range 105–4020 days) and from first relapse was 10.1 months (range 2–1376 days). Following all relapse episodes, at least half of all patients required at least one inpatient admission to hospital (Fig. 1B). Figure 1C summarises outpatient attendances following each relapse episode and shows that the proportion of patients making more than five clinic visits remained unchanged through first and second relapse but did increase following third relapse, 52.5%, 51.6% and 100% respectively. The proportion of patients receiving red cell transfusions remained consistent through first and second relapse (41.2% and 41.3% respectively) but increased to 57.1% following third relapse (Table 2). Transfusion of platelets and fresh frozen plasma was required less often. Three patients developed renal failure requiring temporary dialysis (all second relapse) with two further patients requiring plasma exchange. Twenty patients received radiotherapy at first relapse, none at second relapse and two patients at third relapse. Figure 1Open in figure viewerPowerPoint (A) Kaplan–Meier curve comparing the time intervals between relapse periods for all patients. , diagnosis to first relapse; , first to second relapse; , second to third relapse. (B) Proportions of patients requiring inpatient admission following each relapse episode. Number of admissions: , 0; , 1; , 2; , 3; , 4; , 5+. (C) Proportions of patients attending haematology outpatient clinic divided according to the number of visits made. Number of attendances: , 0–5; , 6–10; , 11–15; , 16–20; , 21+. First relapse, n= 78; second relapse, n= 25; third relapse, n= 7. Table 2. Transfusion products given at each relapse Relapse First Second Third Blood product Patients requiring transfusion (%; n= 78) No. of transfusion events Patients requiring transfusion (%; n= 25) No. of transfusion events Patients requiring transfusion (%; n= 7) No. of transfusion events Red cells 41.2 137 48.0 62 57.1 37 Platelets 6.4 42 4.0 4 28.6 6 FFP 1.3 2 0 0 0 0 Total 48.7 181 44.8 66 85.7 43 FFP, fresh frozen plasma. This multi-centre retrospective study provides important data regarding the management of RMM in the UK prior to the availability of newer agents. In our study group, the median overall survival was 32.8 months, with a median survival from first relapse of 10.1 months. In general, our data accord with those of Kumar et al. (2004), who described the clinical course of 576 patients with RMM and found an overall median survival of 28.4 months and a median time to second relapse of 7.3 months. Surprisingly, in our study group the median time to third relapse at 16.6 months was slightly longer than the median time to second relapse (10.2 months) unlike Kumar et al., who found that the duration of response to treatment decreased with each subsequent relapse. However, 58% of our patients died following first relapse, a higher proportion than we would expect today, given the success of current salvage regimens containing newer agents. We found that at least 50% of all patients required at least one inpatient admission, although surprisingly, the proportions of patients requiring inpatient admission and transfusion did not increase significantly with subsequent relapse episodes. This may reflect the fact that patients who survived to experience subsequent disease relapse were generally of better performance status and had less aggressive disease. In conclusion, these results provide baseline data on the outcomes in patients with RMM before the era of newer agents in the UK. Furthermore, we believe that analyses like ours and that of Koleva et al. (2010) will play an important role in determining the impact of these agents on healthcare resource use in the context of increased survival recently seen in MM patients (Brenner et al. 2008; Kumar et al. 2008). ACKNOWLEDGEMENTS Funding: Janssen-Cilag Ltd, and statistical analysis: pH Associates. REFERENCES Brenner H., Gondos A. & Pulte D. (2008) Recent major improvement in long-term survival of younger patients with multiple myeloma. Blood 111, 2521– 2526. CrossrefCASPubMedWeb of Science®Google Scholar Koleva D., Cortelazzo S., Toldo C. & Garattini L. (2010) Healthcare costs of myeloma: an Italian study. European Journal of Cancer Care 20, 330– 336. Wiley Online LibraryWeb of Science®Google Scholar Kumar S.K., Therneau T.M., Gertz M.A., Lacy M.Q., Dispenzieri A., Rajkumar S.V., Fonseca R., Witzig T.E., Lust J.A., Larson D.R., Kyle R.A. & Greipp P.R. (2004) Clinical course of patients with relapsed multiple myeloma. Mayo Clinic Proceedings 79, 867– 874. CrossrefCASPubMedWeb of Science®Google Scholar Kumar S.K., Rajkumar S.V., Dispenzieri A., Lacy M., Hayman S., Buadi F., Zeldenrust S.R., Dingli D., Russell S.J., Lust J.A., Greipp P.R., Kyle R.A. & Gertz M.A. (2008) Improved survival in multiple myeloma and the impact of novel therapies. Blood 111, 2516– 2520. CrossrefCASPubMedWeb of Science®Google Scholar San Miguel J.F., Schlag R., Khuageva N.K., Dimopoulos M.A., Shpilberg O., Kropff M., Spicka I., Petrucci M.T., Palumbo A., Samoilova O.S., Dmoszynska A., Abdulkadyrov K.M., Schots R., Jiang B., Mateos M.V., Anderson K.C., Esseltine D.L., Liu K., Cakana A., van de Velde H., Richardson P.G. & VISTA Trial Investigators (2008) Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma. The New England Journal of Medicine 359, 906– 917. CrossrefCASPubMedWeb of Science®Google Scholar Weber D.M., Chen C., Niesvizky R., Wang M., Belch A., Stadtmauer E.A., Siegel D., Borrello I., Rajkumar S.V., Chanan-Khan A.A., Lonial S., Yu Z., Patin J., Olesnyckyj M., Zeldis J.B., Knight R.D. & Multiple Myeloma (009) Study Investigators (2007) Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. The New England Journal of Medicine 357, 2133– 2142. CrossrefCASPubMedWeb of Science®Google Scholar Volume20, Issue5September 2011Pages 697-699 FiguresReferencesRelatedInformation

Objectives The efficacy and safety of omalizumab for the treatment of severe persistent allergic asthma have been demonstrated in randomised controlled clinical trials. However, there are limited “real world” data on its effects on healthcare resource utilisation or health-related quality of life (QoL) in UK clinical practice. Methods A 10 centre retrospective observational study (APEX) compared 12 months pre- vs 12 months post-omalizumab initiation in patients aged =12 years with severe persistent allergic asthma. All patients received =1 dose of omalizumab. Patients who had received omalizumab in a clinical trial were excluded. Hospital records were reviewed to obtain data on hospital resource use and routinely used QoL measures for example, Asthma Quality of Life Questionnaire (AQLQ) at baseline (pre-omalizumab), 16 weeks and up to 12 months following omalizumab initiation. Results Mean in-patient hospital admissions fell by 61% from 1.30 to 0.51 (p<0.001) and mean in-patient bed days fell by 70% from 9.10 to 2.74 (p<0.001) per patient. In the subgroup of patients hospitalised for asthma in the 12 months pre-omalizumab (n=81), mean in-patient hospital admissions fell by 70% from 2.19 to 0.65 (p<0.001) and mean in-patient bed days fell by 74% from 14.86 to 3.83 (p<0.001) per patient. Similarly, mean Accident and Emergency department attendances fell by 70% from 1.52 per patient in the 12 months pre-omalizumab to 0.46 in the 12 months post-omalizumab (p<0.001). Other resource use, such as outpatient attendances (excluding visits made solely for omalizumab administration), nurse appointments and telephone consultations remained unchanged following omalizumab initiation. QoL data were not available for all patients at every time point. However, where data were available, mean AQLQ scores increased from 3.09 at baseline to 5.01 at 16 weeks (n=90) and to 5.22 at 12 months (n=29). Conclusions Treatment with omalizumab is associated with a clinically and statistically significant reduction in unplanned hospital resource utilisation and improvements in patients9 QoL.

The burden of constipation from the patient's perspective has been well described. The aim of this study was to evaluate the cost of managing constipation in patients taking opioids in a specialist palliative care inpatient unit. A retrospective review of the medical records of 58 patients (70 admissions) who died during a six-month period was undertaken to identify prescribing patterns for opioids and oral laxatives and tasks associated with managing constipation in these patients. A prospective time and motion study also was undertaken, whereby staff recorded the time and resources required to perform each task. These data were then applied to the actual frequency recorded in the retrospective review to calculate the direct cost of managing constipation in those 70 admissions during that six-month period. There was no discernable pattern in oral laxative prescribing. The mean cost of managing constipation was £29.81 (48.74 USD) per admission, with staff time accounting for 85% of the cost. The most time-consuming activity was staff discussion about bowel management, which occurred at least once daily for doctors and twice for nurses and involved up to eight members of staff at a time. The cost of managing constipation is skewed in that it costs £30 (49 USD) or less in 71% of admissions but exceeded £100 (163 USD) in 5%. In the latter group, earlier and/or more effective intervention for constipation could lead to clinical and economic benefits.

AIMS:To describe renal function monitoring practice in patients with metastatic bone disease (MBD) treated with IV zoledronic acid (ZA) and oral ibandronic acid (IA), the management pathways and NHS hospital resources used.METHODS:Medical records of 189 patients; IA (91), ZA (98) with primary breast cancer and MBD were reviewed, and data collected on renal monitoring and hospital visits during bisphosphonate therapy. Time and motion review of resources to administer the bisphosphonates was also conducted.RESULTS:Only 30% of patients given ZA and no patient given IA had baseline creatinine clearance (CrCl) recorded. Calculated baseline CrCl suggested impaired renal function in 33% ZA and 29% IA patients. Dose reductions were not made correctly in 29 ZA and 2 IA patients whose monitoring suggested it. ZA patients made more clinic and day care attendances than IA-treated patients, at twice the cost. Staff activity and patient time per visit was higher with ZA than IA.CONCLUSION:Although limited by retrospective design, these results demonstrate that in many patients, CrCl is not calculated before or during treatment with bisphosphonates. Renal function deteriorated in many patients during therapy. In view of these effects, practice should be reviewed to ensure appropriate dosing.

Recent availability of active drugs (proteasome inhibitor (PI) and IMiDs) for the treatment of multiple myeloma (MM) has changed the outlook for patients who relapse from plateau phase. While new regimens incorporating these agents prolong survival, they are relatively costly and may result in toxicities that impact on patient-centred outcomes and resource use. These health economic issues remain to be clarified in clinical practice. To better understand the treatment pathways and resource use in MM before the era of PI and IMiDs, a retrospective analysis was carried out in MM patients who experienced a 1st relapse between Feb 2001 and Dec 2007. Five UK centres were selected to ensure adequate geographical coverage and to provide observational data for patients being treated at secondary centres (ie not in trials or tertiary centres). Patient demographics, all medical interventions from 1st relapse until death, including hospital visits, and blood product use were obtained from medical records. Any treatment phases following the point at which patients received PI or IMiDs were excluded from the study. Data were collected from 78 patients in 1st relapse of whom 73 had died at the time of the study; data in 2nd relapse were available from 25 patients (of the 78 patients, 45 died before a 2nd relapse, and 8 were excluded from the analysis at 2nd relapse). Median age at 1st relapse was 62.8yrs (range: 43–89). Main isotypes were: IgG Kappa 35.5%, IgA Kappa 16.5%, IgA Lambda 15%, light chain 14%, IgG Lambda 13%. Almost two thirds of patients (64.1%) did not have an initial transplant, 25.7% had one or two transplants and 11.6% failed one or more bone marrow harvests. Median time to relapse was 19.2 months (IQ range: 2.2–130.3) from diagnosis and 10.3 months (IQ range: 2.7–36.2) from 1st relapse. As first line, the majority of patients had received alkylator ± steroid (26.9%) or VAD-based (25.6%), and only 15.4% had received Thalidomide-based regimens. In contrast, Thalidomide-based regimens were the most commonly used regimens at first relapse (n=38, 48.7%), followed by alkylator ± steroid (n=15, 19.2%). Progression free survival (PFS) from 1st relapse was 8.5 months (IQ range: 0.6–43.7). At 2nd relapse the most common regimen was Thalidomide-based (n=13, 52%). PFS from 2nd relapse was 10.6 months (0.5–31.2). Median treatment free interval (TFI) was 17.5 months (range 0–130.3) from end of initial treatment to 1st relapse and 9.7 months (range 1–47.7) from end of 1st relapse to 2nd relapse. Median overall survival was 32.8 months (IQ range: 14.2–49.6) from diagnosis and 10.1 months (IQ range: 3.6–20.9) from 1st relapse. These figures were comparable with published data, indicating that our group of patients was representative of MM patients receiving treatment at relapse. The mean number of hospital visits per patient per year was 14.8 (SD 12.1) for patients in 1st relapse and 10.1 (SD 4.2) for those in 2nd relapse. Blood products were administered in 38 (49%) patients in 1st relapse, and these patients received a mean of 8.5 units per patient per year. Thirteen (52%) patients at 2nd relapse required blood transfusions. These results provided baseline real-life data on the outcomes in MM patients relapsing from plateau phase before the era of PI and IMiDs. Similar analyses in patients treated with PI and IMiDs at relapse will help to determine the impact of these agents on healthcare resource use in the context of increased survival.

AIMS:The natural history of ovarian cancer has changed over the last 10 years due to more effective drug treatments. The aim of this multicentre audit of the management of recurrent ovarian cancer was to examine the usage of newer drugs in light of the publication of National Institute of Clinical Excellence guidance.MATERIALS AND METHODS:All patients presenting with a first or subsequent relapse of ovarian cancer between August 2001 and February 2003 in nine UK National Health Service centres were identified. Data were recorded retrospectively and prospectively from point of entry into the study and included the modality of primary cancer treatment, the treatment of each subsequent relapse and outcome.RESULTS:In total, 245 evaluable patients were entered on to the database. The mean age was 62 years. All patients received a platinum-based chemotherapy regimen as first-line treatment. One hundred and fifty-five patients (63%) went on to receive third-line chemotherapy and 82 (34%) received fourth-line chemotherapy. The median survival from first relapse was estimated to be in excess of 12 months from our data. The efficacies of the chemotherapy agents used are comparable with the results of published phase III trials.CONCLUSION:This study shows that multicentre audit is feasible and provides useful information on current clinical practice on which to base future research.