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| 2. |
- Altman, Daniel, et al.
(författare)
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A generic health-related quality of life instrument for assessing pelvic organ prolapse surgery : correlation with condition-specific outcome measures
- 2018
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Ingår i: International Urogynecology Journal. - : Springer. - 0937-3462 .- 1433-3023. ; 29:8, s. 1093-1099
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Tidskriftsartikel (refereegranskat)abstract
- 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 ae2, 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.
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| 3. |
- Geale, Kirk, et al.
(författare)
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Association of Skin Psoriasis and Somatic Comorbidity With the Development of Psychiatric Illness in a Nationwide Swedish Study
- 2020
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Ingår i: JAMA dermatology. - : American Medical Association. - 2168-6068 .- 2168-6084. ; 156:7, s. 795-804
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Tidskriftsartikel (refereegranskat)abstract
- Importance: Psoriasis is a complex systemic disease with skin involvement, somatic comorbidity, and psychiatric illness (PI). Although this view of psoriasis is widely accepted, potential synergies within this triad of symptoms have not been adequately investigated.Objectives: To investigate the independent association of skin psoriasis and somatic comorbidity with the development of PI and to assess whether skin psoriasis and somatic comorbidity act synergistically to produce a risk of PI that is greater than the additive associations.Design, Setting, and Participants: Participants were enrolled between January 2005 and December 2010, in this retrospective matched case-control study using secondary (ie, administrative), population-based registry data from Swedish patients in routine clinical care. The dates of analysis were March 2017 to December 2019. Participants were patients with skin psoriasis and control participants without psoriasis matched on age, sex, and municipality, who were all free of preexisting PI.Exposures: Presence of skin psoriasis and somatic comorbidity (captured through the Charlson Comorbidity Index and the Elixhauser Comorbidity Index).Main Outcomes and Measures: Risk of PI onset (composite of depression, anxiety, and suicidality) is shown using Kaplan-Meier curves stratified by the presence of skin psoriasis and somatic comorbidity. Adjusted associations of skin psoriasis and somatic comorbidity with the development of PI were analyzed using Cox proportional hazards regression models, including interactions to assess synergistic associations. The 3 components of PI were also assessed individually.aResults: A total of 93 239 patients with skin psoriasis (mean [SD] age, 54 [17] years; 47 475 men [51%]) and 1 387 495 control participants (mean [SD] age, 54 [16] years; 702 332 men [51%]) were included in the study. As expected, patients with skin psoriasis were more likely to have somatic comorbidity and PI than control participants. Compared with those without skin psoriasis or somatic comorbidity, patients with psoriasis without somatic comorbidity had a 1.32 times higher risk of PI onset (hazard ratio [HR], 1.32; 95% CI, 1.27-1.36; P < .001), whereas patients with psoriasis with somatic comorbidity had a 2.56 times higher risk of PI onset (HR, 2.56; 95% CI, 2.46-2.66; P < .001). No synergistic associations of skin psoriasis and somatic comorbidity with the development of PI were found (HR, 0.93; 95% CI, 0.81-1.04; P = .21).Conclusions and Relevance: This study found that somatic comorbidity appeared to alter PI onset even more than skin psoriasis. The observed association of skin psoriasis and somatic comorbidity with the development of PI reinforces the need for proactive, holistic treatment of patients with psoriasis.
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| 4. |
- Geale, Kirk, et al.
(författare)
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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 Spain
- 2018
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Ingår i: Journal of Medical Economics. - : Taylor & Francis. - 1369-6998 .- 1941-837X. ; 21:10, s. 977-982
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 5. |
- Geale, Kirk, et al.
(författare)
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Estimating the Value of A New Antibiotic : A Novel Approach Using Esbl As A Case Study
- 2016
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Ingår i: Value in Health. - : Elsevier. - 1098-3015 .- 1524-4733. ; 19:7, s. A422-A423
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: Develop a model capable of estimating the value of a new antibiotic for use in treating last-line patients not eligible for, or having failed on, all currently available antibiotic treatments.Methods: Ten annual cohorts of incident last-line patients (total of 314) infected with extended spectrum beta-lactamase (ESBL) -producing bacteria were modelled from the onset of the last-line infection over the course of their remaining life, in a scenario where a new antibiotic was available and one where it was not. Efficacy was measured by mortality, where 5% (95%) of patients died due to the infection in the scenario with(out) a new antibiotic. In the scenario with a new antibiotic, the mortality rate increased by 0.5% annually. Costs including lab tests, hospital stays, and productivity loss were calculated in both scenarios. Quality-adjusted life-years gained (QALYs) were estimated using weights for patients with an infection (0.61) and after recovery (0.84), in addition to disutility incurred by one caregiver per patient (-0.14). Differences in costs, QALYs, deaths, and days off work were calculated between the two arms; costs and QALYs were discounted to the present year. The value of a new antibiotic is reflected in the incremental results.Results: In the last-line ESBL population of 314 patients over 10 years, the availability of a new antibiotic resulted in SEK 20.4 million in cost saving, 2795 QALYs gained, 273 fewer infection-caused deaths, and 2198 fewer days off work.Conclusions: Valuation of a new antibiotic is a high public health priority due to increasing antibiotic resistance and decreasing rates of development of new antibiotics. Access to a new antibiotic for last-line patients provides a large benefit to society, using ESBL as case-study. The results are conservative as they exclude factors that are relatively difficult to estimate such as the risk of an outbreak.
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| 6. |
- Geale, Kirk, et al.
(författare)
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How is disease severity associated with quality of life in psoriasis patients? : Evidence from a longitudinal population-based study in Sweden
- 2017
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Ingår i: Health and Quality of Life Outcomes. - : Springer Science and Business Media LLC. - 1477-7525 .- 1477-7525. ; 15:1
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 7. |
- Geale, Kirk, et al.
(författare)
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Late Breaking Abstract - NORdic Database for aSThmA Research (NORDSTAR) : Swedish and Finnish patients
- 2018
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Ingår i: European Respiratory Journal. - : European Respiratory Society. - 0903-1936 .- 1399-3003. ; 52
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Background: A cross-border research collaboration was recently initiated across the Nordic countries. These countries maintain population-based registers containing a variety of patient-level health and socioeconomic variables, providing a basis for nation-wide, longitudinal research.Aims and objectives: Describe key characteristics of Swedish and Finnish asthma populations in 2014.Methods: NORDSTAR is a research platform with ethical approval based on Nordic register data. Patients with an asthma diagnosis (ICD-10: J45/46) at any age in specialist care, or ≥2 dispensed respiratory prescriptions (ATC: R03) while aged 6-44, during 2004-2014 were included. Those with diagnosis and treatment pairs unlikely to be asthma were excluded. Demographics (age, sex, income, education level, and urban residence), treatment, comorbidities, and asthma specialist visits in 2014 were described using summary statistics.Results: Finnish comorbidity levels appeared higher than in Sweden. More Finnish patients filled OCS prescriptions (24%) than Swedish patients (20%). Most Swedish patients lived in an urban setting, and the distribution of education level was similar to the general population. Mean family income was 49,960 and 42,840 EUR in Sweden and Finland respectively, while 31% and 44% of patients visited an asthma specialist. Prevalence of asthma was highest among women in both countries, and age distributions were similar.Conclusions: NORDSTAR is a platform for conducting asthma outcomes research in the Nordics. Swedish and Finnish patients appear to be similar in many dimensions except for prevalence of asthma specialist care contacts.
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| 8. |
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| 9. |
- Geale, Kirk, et al.
(författare)
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Persistence of biologic treatment in psoriatic arthritis : a population-based study in Sweden
- 2020
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Ingår i: Annals of the Rheumatic Diseases. - : BMJ Publishing Group Ltd. - 0003-4967 .- 1468-2060. ; 79, s. 37-38
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Psoriatic arthritis (PsA) is a chronic, heterogeneous, immune-mediated seronegative arthritis characterized by joint inflammation in people with skin psoriasis (PsO). In recent years several effective biologic treatments such as tumour necrosis factor inhibitors (TNFi), interleukin (IL) 12 and 23 inhibitors (IL-12/23i), and IL 17 inhibitors (IL-17i) have been introduced for PsA. Discontinuation (non-persistence) of therapy is usually a consequence of lack of effect and intolerability.Objectives:Compare time to discontinuation of TNFi (adalimumab, ADA), IL-17i (secukinumab, SEC), and IL-12/23i (ustekinumab, UST) treatment exposures and the association with previous biologic treatment experience.Methods:Population-based national health data from the Swedish Patient Registry, Prescribed Drug Registry and Cause of Death Registry were linked at the patient level and used to identify treatment exposures in PsA patients initiating ADA, SEC, or UST between January 2008 and September 2018. Discontinuation was defined as a treatment switch to any other PsA-indicated biologic, or failure to re-dispense treatment within a grace period following end of drug supplied. The grace period, defined as the number of days between end of drug supply and re-dispensation during which a patient is considered to be on active treatment, was set dynamically to the number of days of drug supplied in the primary analysis. As a sensitivity analysis, a fixed 90-day grace period was used. Supply was calculated as total milligrams dispensed divided by maintenance dose posology, where the following assumptions were made due to the limitations of the administrative data used: UST patients’ weight corresponded to the amount of drug dispensed (both 45mg and 90mg dispensations last 84 days), SEC patients with prior TNFi experience consumed 300mg/28 days and all others consumed 150mg/28 days, and ADA patients consumed 40mg/14 days. Adjusted hazard ratios (HR) for time to discontinuation were calculated using a Cox proportional hazards model. Covariates for age, marital status, and previous biologic treatment experience were assessed at the initiation of treatment exposure, while comorbidity including skin PsO was assessed during the two years prior. Exposures without discontinuation events were censored at death or end of follow-up. The study was approved by the Stockholm Regional Ethical Review Board.Results:3,620 discontinuation events were observed in the main analysis across 4,649 treatment exposures (ADA: 3,255; SEC: 887; UST: 507) (Figure 1, unadjusted). 3,162 events were observed in the sensitivity analysis. Average age at treatment initiation was 50, 54% were female, 47% were biologic treatment naïve, and 39% had skin PsO. In the multivariate main analysis, UST exhibited lower discontinuation rates vs ADA (HR=0.56, 95% CI: 0.49-0.64) while there was no significant difference between SEC and ADA (HR=1.01, 95% CI: 0.88-1.15). In the multivariate sensitivity analysis, both UST (HR=0.81, 95% CI: 0.70-0.94) and SEC (HR=0.82, 95% CI: 0.70-0.95) were associated with significantly lower discontinuation rates ratio relative to ADA. Overall, patients with more biologic treatment experience were statistically significantly (p<0.05) associated with higher risk of treatment discontinuation.Figure 1.Unadjusted Kaplan-Meier curves of time to treatment discontinuation (main analysis, dynamic grace period)Conclusion:UST exhibits a favourable treatment persistency profile relative to ADA, regardless of the grace period definition. The relative risk of discontinuing SEC vs ADA is sensitive to the grace period. Treatment discontinuation was higher in treatment exposures with more biologic experience.Disclosure of Interests:Kirk Geale Consultant of: Quantify Research, Speakers bureau: Indirectly as a consultant, Ingrid Lindberg Consultant of: Quantify Research, Emma Paulsson Consultant of: Quantify Research, Christina Wennerström Employee of: Janssen-Cilag Sweden AB, Anna Tjärnlund Employee of: Janssen-Cilag Sweden AB, Virginia Taliadouros Shareholder of: JnJ, Employee of: Janssen Pharmaceuticals NV, Wim Noel Employee of: Janssen Pharmaceuticals NV, Dana Enkusson Employee of: Janssen-Cilag AB, Elke Theander Employee of: Janssen-Cilag Sweden AB, Sara Bruce Wirta Employee of: Janssen-Cilag Sweden AB
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| 10. |
- Geale, Kirk, et al.
(författare)
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Persistence of biologic treatments in psoriatic arthritis : a population-based study in Sweden
- 2020
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Ingår i: Rheumatology. - : Oxford University Press. - 2514-1775. ; 4:2
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: TNF inhibitors (TNFis) and IL inhibitors are effective treatments for PsA. Treatment non-persistence (drug survival, discontinuation) is a measure of effectiveness, tolerability and patient satisfaction or preferences in real-world clinical practice. Persistence on these treatments is not well understood in European PsA populations. The aim of this study was to compare time to non-persistence for either ustekinumab (IL-12/23 inhibitor) or secukinumab (IL-17 inhibitor) to a reference group of adalimumab (TNFi) treatment exposures in PsA patients and identify risk factors for non-persistence.Methods: A total of 4649 exposures of adalimumab, ustekinumab, and secukinumab in 3918 PsA patients were identified in Swedish longitudinal population-based registry data. Kaplan-Meier curves were constructed to measure treatment-specific real-world risk of non-persistence and adjusted Cox proportional hazards models were estimated to identify risk factors associated with non-persistence.Results: Ustekinumab was associated with a lower risk of non-persistence relative to adalimumab in biologic-naive [hazard ratio (HR) 0.48 (95% CI 0.33, 0.69)] and biologic-experienced patients [HR 0.65 (95% CI 0.56, 0.76)], while secukinumab was associated with a lower risk in biologic-naive patients [HR 0.65 (95% CI 0.49, 0.86)] but a higher risk of non-persistence in biologic-experienced patients [HR 1.20 (95% CI 1.03, 1.40)]. Biologic non-persistence was also associated with female sex, axial involvement, recent disease onset, biologic treatment experience and no psoriasis.Conclusion: Ustekinumab exhibits a favourable treatment persistency profile relative to adalimumab overall and across lines of treatment. The performance of secukinumab is dependent on biologic experience. Persistence and risk factors for non-persistence should be accounted for when determining an optimal treatment plan for patients.
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