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  • 1. Altman, Daniel
    et al.
    Geale, Kirk
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Dermatology and Venerology.
    Falconer, Christian
    Morcos, Edward
    A generic health-related quality of life instrument for assessing pelvic organ prolapse surgery: correlation with condition-specific outcome measures2018In: International Urogynecology Journal, ISSN 0937-3462, E-ISSN 1433-3023, Vol. 29, no 8, p. 1093-1099Article in journal (Refereed)
    Abstract [en]

    Introduction and hypothesis: The aim of this study was to investigate the use of a generic and globally accessible instrument for assessing health-related quality of life (HR-QoL) in pelvic organ prolapse (POP) surgery.

    Methods: In a prospective multicenter setting, 207 women underwent surgery for apical prolapse [stage ae<yen>2, Pelvic Organ Prolapse Quantificcation (POP-Q) system] with or without anterior wall defect. Demographic and surgical characteristics were collected before surgery. Results of the 15-dimensional (15D) instrument and condition-specific pelvic floor symptoms as assessed using the Pelvic Floor Distress Inventory questionnaire (PFDI-20), including its subscales Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), Colorectal-Anal Distress Inventory-8 (CRADI-8), and Urinary Distress Inventory-6 (UDI-6), were assessed preoperatively and 2 months and 1 year after surgery.

    Results: HR-QoL as estimated by 15D was improved 1 year after surgery (p < 0.001). Prolapse-related 15D profile-index measures (excretion, discomfort, sexual activity, distress, and mobility) were significantly improved after surgery (p < 0.05-0.001). Significant inverse associations were detected between increased 15D scores and a decrease in PFDI-20 and subscale scores (p < 0.001), indicating improvements on both instruments.

    Conclusions: Generic HR-QoL as estimated by 15D improved significantly after apical POP surgery and correlated with improvements of condition-specific outcome measures. These results suggest that a comprehensive evaluation of global HR-QoL is valid in assessing pelvic reconstructive surgery and may provide novel and important insights into previously understudied areas, such as cost-utility and cost-effectiveness analysis after urogynecological surgery.

  • 2.
    Gaele, Kirk
    et al.
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Dermatology and Venerology.
    Henriksson, Martin
    Schmitt-Egenolf, Marcus
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Dermatology and Venerology.
    Evaluating equality in psoriasis healthcare: a cohort study of the impact of age on prescription biologics2016In: British Journal of Dermatology, ISSN 0007-0963, E-ISSN 1365-2133, Vol. 174, no 3, p. 579-587Article in journal (Refereed)
    Abstract [en]

    BACKGROUND:

    Inequality in healthcare has been identified in many contexts. To the best of our knowledge, this is the first study investigating age inequity in the form of prescription patterns of biologics in psoriasis care.

    OBJECTIVE:

    To determine whether psoriasis patients have equitable opportunities to receive biologic medications as they age. If patients do not receive equitable treatment, a subsequent objective is to determine the magnitude of the disparity.

    METHODS:

    A cohort of biologic-naïve psoriasis patients were analysed using Cox proportional hazard models to measure the impact of each additional year of life on the likelihood of initiating biologic treatment, after controlling for sex, body mass index, comorbidities, disease activity, and education level. A supporting analysis used a non-parametric graphical method to study the proportion of patients initiating biologic treatment as age increases, after controlling for the same covariates.

    RESULTS:

    The Cox proportional hazards model results in a hazard ratio of a one year increase in age of 0.963 to 0.969 depending on calendar year stratification, which implies that an increase in age of 30 years corresponds to a reduced likelihood of initiating biologic treatment by 61.3-67.6%. The estimated proportion of patients initiating biologic medication is always decreasing as age increases, at a statistically significant level.

    CONCLUSIONS:

    Psoriasis patients have fewer opportunities to access biologic medications as they age. This result was shown to be applicable at all stages in a patient's life course and was not only restricted to the elderly, although it implies greater disparities as the age difference between patients increases. These results show that inequity in access to biologic treatments due to age is prevalent in clinical practice today. Further research is needed to investigate the extent to which this result is influenced by patient preferences. 

  • 3.
    Geale, Kirk
    et al.
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine. PAREXEL International, Stockholm, Sweden.
    Alvarez, Maria
    Polyzoi, Maria
    Malaga, Xavier
    Pineda, Cristina
    Hernandez, Cesar
    Budget impact analysis of demineralized bone matrix in combination with autograft in lumbar spinal fusion procedures for the treatment of lumbar degenerative disc disease in Spain2018In: Journal of Medical Economics, ISSN 1369-6998, E-ISSN 1941-837X, Vol. 21, no 10, p. 977-982Article in journal (Refereed)
    Abstract [en]

    Objective: To estimate the budget impact (BI) of introducing local autograft (LA) combined with demineralized bone matrix (LA + DBM) in lumbar spinal fusion (LSF) procedures to treat lumbar degenerative disc disease (LDDD) in Spain.

    Methods: A decision tree model was developed to evaluate the 4-year BI associated with introducing LA + DBM putty to replace currently available grafting methods, including iliac crest bone graft (ICBG), LA alone, and LA combined with beta-tricalcium phosphate (LA + ceramics), with 30%, 40%, and 30% market shares, respectively. The analysis was conducted for a hypothetical cohort of 100 patients with LDDD receiving LSF, assuming LA + DBM would replace 100% of the standard of care mix. The fusion rates extracted from the literature were validated by an expert panel. Costs ((sic)2017) were obtained from different Spanish sources. Budget impact and incremental cost per successful fusion were calculated from the perspective of the Spanish National Health System (NHS).

    Results: Over 4 years, replacing currently available options with LA + DBM for 100 patients resulted in an additional cost of (sic)12,330 ((sic)123/patient), and an additional 14 successful fusions, implying a cost of (sic)881 per additional successful fusion. When costs of productivity loss were included, the introduction of LA + DBM resulted in cost savings of (sic)70,294 ((sic)703/patient).

    Limitations: The lack of high-quality, homogeneous, head-to-head research studying the efficacy of grafting procedures available to patients undergoing LSF, in addition to a lack of long-term follow-up in existing studies. Therefore, the number of fusions occurring within the model's time horizon may be underestimated.

    Conclusions: Acquisition costs of DBM were partially offset by costs of failed fusions, adverse events and reoperation when switching 100 hypothetical LDDD patients undergoing LSF procedures from standard of care grafting methods to LA + DBM from the perspective of the Spanish NHS. DBM cost was entirely offset when costs of lost productivity were considered.

  • 4.
    Geale, Kirk
    et al.
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine.
    Corcoran, K.
    Virhage, M.
    Anell, B.
    Estimating the Value of A New Antibiotic: A Novel Approach Using Esbl As A Case Study2016Conference paper (Refereed)
  • 5.
    Geale, Kirk
    et al.
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine.
    Dibbern, T.
    Virhage, M.
    Medin, E.
    Swedish Perspective on Health Technology Assessments with Incrementally Lower Costs and Effects2016Conference paper (Refereed)
  • 6.
    Geale, Kirk
    et al.
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine.
    Henriksson, M.
    Schmitt-Egenolf, Marcus
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Dermatology and Venerology.
    The Relationship Between Disease Severity and Quality of Life In Patients With Moderate to Severe Psoriasis2015In: Value in Health, ISSN 1098-3015, E-ISSN 1524-4733, Vol. 18, no 7, p. A675-A675Article in journal (Refereed)
  • 7.
    Geale, Kirk
    et al.
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Dermatology and Venerology. PAREXEL Int, Stockholm, Sweden.
    Henriksson, Martin
    Linköping Univ, Dept Med & Hlth Sci, Linköping, Sweden.
    Schmitt-Egenolf, Marcus
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Dermatology and Venerology.
    How is disease severity associated with quality of life in psoriasis patients?: Evidence from a longitudinal population-based study in Sweden2017In: Health and Quality of Life Outcomes, ISSN 1477-7525, E-ISSN 1477-7525, Vol. 15, no 1, article id 151Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Assessing the impact of disease severity on generic quality of life (QOL) is a critical step in outcomes research and in the development of decision-analytic models structured around health states defined by clinical measures. While data from routine clinical practice found in healthcare registers are increasingly used for research, more attention should be paid to understanding the relationship between clinical measures of disease severity and QOL. The purpose of this work was therefore to investigate this relationship in psoriasis using a population-based dataset.

    METHODS: Severity was measured by the Psoriasis Area and Severity Index (PASI), which combines severity of erythema, induration, and desquamation into a single value ranging from 0 to 72. The generic EQ-5D-3L utility instrument, under the UK tariff, was used to measure QOL. The association between PASI and EQ-5D-3L was estimated using a population-based dataset of 2674 patients with moderate to severe psoriasis enrolled over ten years in the Swedish psoriasis register (PsoReg). Given the repeated measurement of patients in the register data, a longitudinal fixed-effects model was employed to control for unobserved patient-level heterogeneity.

    RESULTS: Marginal changes in PASI are associated with a non-linear response in EQ-5D-3L: Moving from PASI 10 to 9 (1 to 0) is associated with an increase of 0.0135 (0.0174) in EQ-5D-3L. Furthermore, unobserved patient-level heterogeneity appears to be an important source of confounding when estimating the relationship between QOL and PASI.

    CONCLUSIONS: Using register data to estimate the impact of disease severity on QOL while controlling for unobserved patient-level heterogeneity shows that PASI appears to have a larger impact on QOL than previously estimated. Routine collection of generic QOL data in registers should be encouraged to enable similar applications in other disease areas.

  • 8.
    Geale, Kirk
    et al.
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine. PAREXEL International, Stockholm, Sweden.
    Saridogan, Ertan
    Lehmann, Matthieu
    Arriagada, Pablo
    Hultberg, Marcus
    Henriksson, Martin
    Repeated intermittent ulipristal acetate in the treatment of uterine fibroids: a cost-effectiveness analysis2017In: ClinicoEconomics and Outcomes Research, ISSN 1178-6981, E-ISSN 1178-6981, Vol. 9, p. 669-676Article in journal (Refereed)
    Abstract [en]

    There are limited treatment options available for women with moderate to severe symptoms of uterine fibroids (UFs) who wish to avoid surgery. For these women, treatment with standard pharmaceuticals such as contraceptives is often insufficient to relieve symptoms, and patients may require surgery despite their wish to avoid it. Clinical trials demonstrate that ulipristal acetate 5 mg (UPA) is an effective treatment for this patient group, but its cost-effectiveness has not been assessed in this population. A decision-analytic model was developed to simulate a cohort of patients in this population under treatment with UPA followed by surgery as needed compared to treatment with iron and non-steroidal anti-inflammatory drug (NSAID) followed by surgery as needed (best supportive care, BSC). The analysis took the perspective of the National Health Service (NHS) in England, UK, and was based on the published UPA clinical trials. Results were calculated for the long-term costs and quality-adjusted life years (QALYs) for each treatment arm and combined into an incremental cost-effectiveness ratio (ICER) as the primary outcome. The impact of parameter uncertainty on the results was assessed using scenario, deterministic, and probabilistic sensitivity analyses. The results show that treating patients with the UPA strategy, instead of the BSC strategy, results in an additional cost of 1,115 pound and a gain of 0.087 QALYs, resulting in an ICER of 12,850 pound. Given commonly accepted cost-effectiveness thresholds in England, the use of UPA as a repeated, intermittent treatment for women with moderate to severe symptoms of UF wishing to avoid surgery is likely to be a cost-effective intervention when compared to BSC.

  • 9. Minacori, R.
    et al.
    Geale, Kirk
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine.
    Is there Evidence of a Difference Between Willingness to Pay and Willingness to Accept Thresholds?: A Review of Nice Technology Appraisals2016Conference paper (Refereed)
  • 10. Polyzoi, M.
    et al.
    Alvarez, M.
    Geale, Kirk
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine.
    Malaga, X.
    Pineda, C.
    Hernandez, C.
    The Budget Impact of Introducing Demineralised Bone Matrix Combined with Local Bone to Replace Currently Available Treatments for Lumbar Spinal Fusion Procedures in Spain2017In: Value in Health, ISSN 1098-3015, E-ISSN 1524-4733, Vol. 20, no 9, p. A530-A530Article in journal (Other academic)
    Abstract [en]

    Objectives: Estimate the budget impact (BI) of introducing demineralised bone matrix (DBM) combined with local bone (LB) in lumbar spinal fusion to treat lumbar degenerative disk disease in Spain. Methods: A decision tree model was developed to evaluate the 4-year BI associated with introducing LB combined with DBM putty (LB+DBM) to replace currently available treatment options including iliac crest bone graft (ICBG), LB alone, and LB combined with ceramic bone graft extenders (LB+ceramic). The market shares of the currently available treatments were 30% ICBG, 40% LB, and 30% LB+ceramic respectively. The analysis was conducted for 100 patients assuming LB+DBM would replace the currently administered treatment mix. Patients receiving DBM were administered 5cc and those receiving ceramics were administered 10cc beta-tricalcium phosphate. The model structure was based on previously published models identified through a structured literature search. The cost of DBM, ceramic, surgical procedures, adverse events, treatment failure, and reoperations were ncluded in the base-case analysis, and productivity loss was analysed in sensitivity analysis. Costs were sourced for Spain in €2017 and no discounting was applied. The model’s inputs and assumptions were validated by two Spanish clinical experts. Results: Over 4 years, replacing currently available treatments with LB+DBM spinal fusions resulted in an additional cost of €12,330 (€123/patient) and an additional 14 successful fusions, implying a cost of €881 per additional successful fusion. Initial procedure costs were higher for LB+DBM, but result in subsequent cost savings in terms of reoperations and adverse events. When including costs of productivity loss, the introduction of LB+DBM resulted in cost savings of €70,294 (€703/patient). Conclusions: For patients eligible for lumbar spinal fusion in Spain, replacing currently available treatments with LB+DBM results in increased costs for the payer but cost savings for society, while providing more successful fusions in both cases.

  • 11. Polyzoi, M.
    et al.
    Virhage, M.
    Geale, Kirk
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine.
    Anell, B.
    The Prevalence of Plaque Psoriasis, Psoriatic Arthritis And The Overlap Between Them In Norway2016Conference paper (Refereed)
  • 12. Spelman, T.
    et al.
    Geale, Kirk
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine.
    Anell, B.
    Hillert, J.
    Wong, S. L.
    The association between disease activity and health-related quality of life in RRMS patients2017In: Value in Health, ISSN 1098-3015, E-ISSN 1524-4733, Vol. 20, no 9, p. A728-A728Article in journal (Other academic)
    Abstract [en]

    Objectives: Relapse-remitting multiple sclerosis (RRMS) is the most common disease course of multiple sclerosis (MS) patients. Disease activity (DA) has been shown to impact intermediate clinical outcomes including relapse rates and disease progression. However, it is unclear to what extent DA is related to ultimate health outcomes such as health-related quality of life (HRQoL). This study investigates the association between HRQoL and DA. Methods: Generic HRQoL was measured using the EQ-5D-3L utility instrument index value under the United Kingdom tariff. A cohort of 3496 adult RRMS patients enrolled in the Swedish population-based MS register during 1996-2015 (inclusive) was included from the date of first recorded EQ-5D-3L assessment (baseline). Patients were grouped according to DA within +/- 12 months of baseline. Active disease was the reference group, defined as 1+ relapse or T2 lesion. Two high disease activity groups were considered: HDA-R defined as 2+ relapses recorded within 1 year of each other, or Highly Active RRMS (HA-RRMS) defined as 9+ T2 lesions or 1+ gadolinium-enhanced T1 lesion. Patients not fulfilling any DA criteria were labelled unclassified. A general estimating equation was used to analyse the association between longitudinal EQ-5D-3L and disease activity group; adjusting for age, sex, proportion of time treated with disease modifying treatment (%DMT), and time since registry enrolment. Results: HA-RRMS was associated with a statistically significant decrease in EQ-5D-3L (coefficient -0.01, p=0.04). HDA-R and unclassified patients were not statistically significantly associated with EQ-5D-3L. Female sex and increasing age were significantly associated with decreasing EQ-5D-3L, while %DMT and time since registry enrolment were significantly associated with increasing EQ-5D-3L. Conclusions: HA-RRMS is associated with lower HRQoL over time, although it is unclear whether it is clinically significant. Additional data and modelling may be required to uncover the subtleties of the relationship between DA and HRQoL.

  • 13. Virhage, M.
    et al.
    Polyzoi, M.
    Geale, Kirk
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine. Parexel International, Stockholm, Sweden.
    Corcoran, K.
    Anell, B.
    Review of health economic models for antibiotics2016In: ISPOR 19TH ANNUAL EUROPEAN CONGRESS RESEARCH ABSTRACTS, ELSEVIER SCIENCE INC , 2016, Vol. 19, no 7, p. A373-A373Conference paper (Refereed)
    Abstract [en]

    Objectives: Critically appraise published health economic models evaluating treatments of bacteria resistant to antibiotics, focusing on methicillin-resistant Staphylococcus aureus (MRSA) and extended spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae.

    Methods: A structured literature review was conducted in Embase, identifying relevant publications by combining search facets for MRSA or ESBL, economic models, and antibiotics, excluding publications including the terms “animal” or “farm”. All search facets were search in the abstract and title, resulting in 40 publications. Two reviewers, blinded to the other’s initial evaluation, evaluated each of the titles and abstracts and found that 25 were relevant for a full review.

    Results: The absolute majority of the identified studies presented cost-effectiveness models with a decision-analytic approach and a time horizon ranging from two to four weeks. The site of infection studied was dominated by nosocomial pneumonia as well as skin and soft tissue infections caused by MRSA. Only one model concerned gram-negative pathogens. No model was identified studying ESBL as the cause of infection. The most common antibiotic agents modelled were linezolid, vancomycin, daptomycin or their combination with a median of two treatment lines modelled. One model studies the cost-effectiveness of carbapenems. Sources used for informing antibiotic efficacy data were primarily published literature, clinical trials or clinical expert opinion. The most common outcome measures modelled were direct medical costs and resource utilization as well as efficacy measured by treatment success or antibacterial usage estimates. Four models (16%) included quality-adjusted life years (QALYs) as outcome measure.

    Conclusions: The cost-effectiveness of linezolid and vancomycin for treatment of MRSA has been well-studied in various types of infections. There is a need for further cost-effectiveness and cost-benefit studies on antibiotic failure in more than two treatment lines, especially in carbapenem treatment of infections caused by ESBL, as these pose a significant resistance threat today.

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