Publications by authors named "Pasi Aronen"

23 Publications

  • Page 1 of 1

Return to work after subacromial decompression, diagnostic arthroscopy, or exercise therapy for shoulder impingement: a randomised, placebo-surgery controlled FIMPACT clinical trial with five-year follow-up.

BMC Musculoskelet Disord 2021 Oct 19;22(1):889. Epub 2021 Oct 19.

Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Töölö Hospital, P.O. Box 266, 00029 HUS, Helsinki, Finland.

Background: Arthroscopic subacromial decompression is one of the most commonly performed shoulder surgeries in the world. It is performed to treat patients with suspected shoulder impingement syndrome, i.e., subacromial pain syndrome. Only few studies have specifically assessed return-to-work rates after subacromial decompression surgery. All existing evidence comes from open, unblinded study designs and this lack of blinding introduces the potential for bias. We assessed return to work and its predictors in patients with shoulder impingement syndrome in a secondary analysis of a placebo-surgery controlled trial.

Methods: One hundred eighty-four patients in a randomised trial had undergone arthroscopic subacromial decompression (n = 57), diagnostic arthroscopy, a placebo surgical intervention, (n = 59), or exercise therapy (n = 68). We assessed return to work, defined as having returned to work for at least two follow-up visits by the primary 24-month time point, work status at 24 and 60 months, and trajectories of return to work per follow-up time point. Patients and outcome assessors were blinded to the assignment regarding the arthroscopic subacromial decompression vs. diagnostic arthroscopy comparison. We assessed the treatment effect on the full analysis set as the difference between the groups in return-to-work rates and work status at 24 months and at 60 months using Chi-square test and the predictors of return to work with logistic regression analysis.

Results: There was no difference in the trajectories of return to work between the study groups. By 24 months, 50 of 57 patients (88%) had returned to work in the arthroscopic subacromial decompression group, while the respective figures were 52 of 59 (88%) in the diagnostic arthroscopy group and 61 of 68 (90%) in the exercise therapy group. No clinically relevant predictors of return to work were found. The proportion of patients at work was 80% (147/184) at 24 months and 73% (124/184) at 60 months, with no difference between the treatment groups (p-values 0.842 and 0.943, respectively).

Conclusions: Arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy or exercise therapy on return to work in patients with shoulder impingement syndrome. We did not find clinically relevant predictors of return to work either.

Trial Registration: ClinicalTrials.gov identifier NCT00428870 .
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http://dx.doi.org/10.1186/s12891-021-04768-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8527687PMC
October 2021

Exploring safety culture in the Finnish ambulance service with Emergency Medical Services Safety Attitudes Questionnaire.

Scand J Trauma Resusc Emerg Med 2021 Oct 12;29(1):148. Epub 2021 Oct 12.

LAB University of Applied Sciences, Lappeenranta, Finland.

Background: Emergency Medical Services (EMS) is, by its nature, a challenging context that may create risks for both patients and employees. It is also known that an organisation's safety culture has an influence on both patient and employee safety. Finnish EMS organisations lack knowledge of how their safety culture is perceived by their employees.

Aim: This study aims to test the psychometric properties of the Emergency Medical Services Safety Attitudes Questionnaire (EMS-SAQ) in a Finnish EMS setting. We also explore the connections between individual- and organisation-based characteristics and safety attitudes in the Finnish EMS.

Methods: A cross-sectional survey study design was used. The EMS-SAQ was used to collect data via social media. The instrument measures six domains of workplace safety culture: safety climate, teamwork climate, perceptions of management, job satisfaction, working conditions and stress recognition. The 5-point Likert scale was converted to a 100-point scale and mean ≥ 75 was dichotomized as a positive. Confirmatory factor analysis (CFA) was carried out to validate the EMS-SAQ in a Finnish setting. Other results were analysed by using non-parametric tests.

Results: 327 responses were included in the analysis. CFA showed that the total EMS-SAQ model had acceptable goodness-of-fit values in the Finnish EMS setting. Total mean scores for each safety culture domain were identified non-positively (mean score < 75); safety climate 60.12, teamwork climate 60.92, perceptions of management 56.31, stress recognition 64.55, working conditions 53.43 and job satisfaction 70.36. Higher education was connected to lower job satisfaction and the teamwork climate within the individual characteristics. All organisation-based characteristics caused at least one significant variation in the safety culture domain scores. Working area significantly affected (p < 0.05) five out of the six safety culture domain scores.

Conclusions: The EMS-SAQ is a valid tool to evaluate safety culture among the Finnish EMS organisations; it offers a novel method to evaluate safety and patient safety within the Finnish EMS organisations. According to the findings, the organisation-based characteristics more likely had an impact on safety attitudes than did the individual-based characteristics. Therefore, it is suggested that the Finnish EMS organisations undertake safety culture development at the organisational level.
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http://dx.doi.org/10.1186/s13049-021-00960-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8507218PMC
October 2021

Use of thiopurines is not a risk factor for post-ERC pancreatitis in patients with primary sclerosing cholangitis.

Dig Liver Dis 2021 Aug 8;53(8):1020-1027. Epub 2021 Jun 8.

Department of Gastroenterology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.

Introduction: Risk of post-ERC pancreatitis (PEP) in patients with primary sclerosing cholangitis (PSC) is 1-7.8%. PSC is often associated with inflammatory bowel disease and autoimmune hepatitis, which are usually treated with thiopurines. The role of thiopurines in PEP risk is still unclear.

Aims And Methods: We evaluated the thiopurine use in PEP. The data of 354 PSC patients who underwent 985 ERCs between 2009 and 2018 were collected. 177 patients treated with thiopurines (study group, SG) and 177 controls (CG) were matched with a propensity score (PSM). Odds ratios (ORs) with 95% confidence interval (95% CI) were calculated. Multivariable logistic regression analysis and generalized linear mixed model were performed. The P-value <0.05 was significant.

Results: In matched data, 472 ERCs were performed in SG and 513 in CG. Thiopurines were used in 373/472 (79.0%) ERCs in SG. The PEP rate was 5.3% in SG and 5.7% in CG (p = 0.889). Unintentional pancreatic duct cannulation (OR 1.28, 95%CI 1.07-1.51, p = 0.004), and periampullary diverticulum (OR 4.87, 95%CI 1.72-11.98, p = 0.001) increased the risk of PEP.

Conclusion: Prior or present thiopurine use did not increase the risk of PEP.
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http://dx.doi.org/10.1016/j.dld.2021.05.009DOI Listing
August 2021

Accuracy of 1-Hour Plasma Glucose During the Oral Glucose Tolerance Test in Diagnosis of Type 2 Diabetes in Adults: A Meta-analysis.

Diabetes Care 2021 04;44(4):1062-1069

Public Health Promotion Unit, Finnish Institute for Health and Welfare, Helsinki, Finland.

Objective: One-hour plasma glucose (1-h PG) during the oral glucose tolerance test (OGTT) is an accurate predictor of type 2 diabetes. We performed a meta-analysis to determine the optimum cutoff of 1-h PG for detection of type 2 diabetes using 2-h PG as the gold standard.

Research Design And Methods: We included 15 studies with 35,551 participants from multiple ethnic groups (53.8% Caucasian) and 2,705 newly detected cases of diabetes based on 2-h PG during OGTT. We excluded cases identified only by elevated fasting plasma glucose and/or HbA. We determined the optimal 1-h PG threshold and its accuracy at this cutoff for detection of diabetes (2-h PG ≥11.1 mmol/L) using a mixed linear effects regression model with different weights to sensitivity/specificity (2/3, 1/2, and 1/3).

Results: Three cutoffs of 1-h PG, at 10.6 mmol/L, 11.6 mmol/L, and 12.5 mmol/L, had sensitivities of 0.95, 0.92, and 0.87 and specificities of 0.86, 0.91, and 0.94 at weights 2/3, 1/2, and 1/3, respectively. The cutoff of 11.6 mmol/L (95% CI 10.6, 12.6) had a sensitivity of 0.92 (0.87, 0.95), specificity of 0.91 (0.88, 0.93), area under the curve 0.939 (95% confidence region for sensitivity at a given specificity: 0.904, 0.946), and a positive predictive value of 45%.

Conclusions: The 1-h PG of ≥11.6 mmol/L during OGTT has a good sensitivity and specificity for detecting type 2 diabetes. Prescreening with a diabetes-specific risk calculator to identify high-risk individuals is suggested to decrease the proportion of false-positive cases. Studies including other ethnic groups and assessing complication risk are warranted.
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http://dx.doi.org/10.2337/dc20-1688DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8578930PMC
April 2021

Minimal important difference and patient acceptable symptom state for pain, Constant-Murley score and Simple Shoulder Test in patients with subacromial pain syndrome.

BMC Med Res Methodol 2021 03 6;21(1):45. Epub 2021 Mar 6.

Finnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Topeliuksenkatu 5, HUS, 00029, Helsinki, Finland.

Background: The results of clinical trials should be assessed for both statistical significance and importance of observed effects to patients. Minimal important difference (MID) is a threshold denoting a difference that is important to patients. Patient acceptable symptom state (PASS) is a threshold above which patients feel well.

Objective: To determine MID and PASS for common outcome instruments in patients with subacromial pain syndrome (SAPS).

Methods: We used data from the FIMPACT trial, a randomised controlled trial of treatment for SAPS that included 193 patients. The outcomes were shoulder pain at rest and on arm activity, both measured with the 0-100 mm visual analogue scale (VAS), the Constant-Murley score (CS), and the Simple Shoulder Test (SST). The transition question was a five-point global rating of change. We used three anchor-based methods to determine the MID for improvement: the receiver operating characteristic (ROC) curve, the mean difference of change and the mean change methods. For the PASS, we used the ROC and 75th percentile methods and calculated estimates using two different anchor question thresholds.

Results: Different MID methods yielded different estimates. The ROC method yielded the smallest estimates for MID: 20 mm for shoulder pain on arm activity, 10 points for CS and 1.5 points for SST, with good to excellent discrimination (areas under curve (AUCs) from 0.86 to 0.94). We could not establish a reliable MID for pain at rest. The PASS estimates were consistent between methods. The ROC method PASS thresholds using a conservative anchor question threshold were 2 mm for pain at rest, 9 mm for pain on activity, 80 points for CS and 11 points for SST, with AUCs from 0.74 to 0.83.

Conclusion: We recommend the smallest estimate from different methods as the MID, because it is very unlikely that changes smaller than the smallest MID estimate are important to patients: 20 mm for pain VAS on arm activity, 10 points for CS and 1.5 points for SST. We recommend PASS estimates of 9 mm for pain on arm activity, 80 points for CS, and 11 points for SST.

Trial Registration: ClinicalTrials.gov NCT00428870 (first registered January 29, 2007).
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http://dx.doi.org/10.1186/s12874-021-01241-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7937213PMC
March 2021

Oncolytic Adenovirus Type 3 Coding for CD40L Facilitates Dendritic Cell Therapy of Prostate Cancer in Humanized Mice and Patient Samples.

Hum Gene Ther 2021 Feb 22;32(3-4):192-202. Epub 2021 Jan 22.

Cancer Gene Therapy Group, Translational Immunology Research Program and Department of Oncology, University of Helsinki, Helsinki, Finland.

Dendritic cell (DC)-based vaccines have shown some degree of success for the treatment of prostate cancer (PC). However, the highly immunosuppressive tumor microenvironment leads to DC dysfunction, which has limited the effectiveness of these vaccines. We hypothesized that use of a fully serotype 3 oncolytic adenovirus (Ad3-hTERT-CMV-hCD40L; TILT-234) could stimulate DCs in the prostate tumor microenvironment by expressing CD40L. Activated DCs would then activate cytotoxic T cells against the tumor, resulting in therapeutic immune responses. Oncolytic cell killing due to cancer cell-specific virus replication adds to antitumor effects but also enhances the immunological effect by releasing tumor epitopes for sampling by DC, in the presence of danger signals. In this study, we evaluated the companion effect of Ad3-hTERT-CMV-hCD40L and DC-therapy in a humanized mouse model and PC histocultures. Treatment with Ad3-hTERT-CMV-hCD40L and DC resulted in enhanced antitumor responses . Treatment of established histocultures with Ad3-hTERT-CMV-hCD40L induced DC maturation and notable increase in proinflammatory cytokines. In conclusion, Ad3-hTERT-CMV-hCD40L is able to modulate an immunosuppressive prostate tumor microenvironment and improve the effectiveness of DC vaccination in PC models and patient histocultures, setting the stage for clinical translation.
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http://dx.doi.org/10.1089/hum.2020.222DOI Listing
February 2021

Ad5/3 is able to avoid neutralization by binding to erythrocytes and lymphocytes.

Cancer Gene Ther 2021 05 12;28(5):442-454. Epub 2020 Sep 12.

Cancer Gene Therapy Group, Translational Immunology Research Program and Department of Oncology, University of Helsinki, Helsinki, Finland.

Oncolytic adenoviruses are promising cancer therapeutic agents. Clinical data have shown adenoviruses' ability to transduce tumors after systemic delivery in human cancer patients, despite antibodies. In the present work, we have focused on the interaction of a chimeric adenovirus Ad5/3 with human lymphocytes and human erythrocytes. Ad5/3 binding with human lymphocytes and erythrocytes was observed to occur in a reversible manner, which allowed viral transduction of tumors, and oncolytic potency of Ad5/3 in vitro and in vivo, with or without neutralizing antibodies. Immunodeficient mice bearing xenograft tumors showed enhanced tumor transduction following systemic administration, when Ad5/3 virus was bound to lymphocytes or erythrocytes (P < 0.05). In conclusion, our findings reveal that chimeric Ad5/3 adenovirus reaches non-injected tumors in the presence of neutralizing antibodies: it occurs through reversible binding to lymphocytes and erythrocytes.
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http://dx.doi.org/10.1038/s41417-020-00226-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8119244PMC
May 2021

Perioperative Dexamethasone Is Associated With Higher Short-Term Mortality in Reconstructive Head and Neck Cancer Surgery.

J Oral Maxillofac Surg 2020 Oct 13;78(10):1835-1845. Epub 2020 May 13.

Department Head and Docent, Department of Plastic Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.

Purpose: Studies of the effects of perioperative dexamethasone (DEX) during oncologic surgery are scarce. The first aim of the present study was to clarify whether perioperative DEX affects the short-term mortality in patients with head and neck cancer (HNC). The second aim was to analyze the causes of death and predictors affecting long-term mortality.

Patients And Methods: The present prospective, double-blind randomized, controlled study included patients with HNC who had undergone microvascular reconstruction from 2008 through 2013. The patients were randomized into 2 groups: the receipt of perioperative DEX for 3 days (study group) or no DEX (control group). The patients' data and cause of death were registered until the end of 2017. The primary cause of death was used in the analyses.

Results: A total of 93 patients were included in the present study: 51 in the DEX group (study group) and 42 in the NON-DEX group (control group). Altogether 38 patients died during a median follow-up period of 5.3 years. During the first year, more deaths had occurred in the DEX group than in the NON-DEX group: at 1 month, 4% versus 0%; at 6 months, 14% versus 0%; and at 12 months, 22% versus 5% (P = .043). The overall survival rate for all patients was 59%. HNC was the primary cause of death for most of the patients who died. On univariate analysis, the deceased patients had more advanced disease (higher T classification, P = .002; higher stage, P = .008), a greater need for a gastrostoma (P = .002), more often received postoperative chemotherapy (P = .005), and more often had locoregional (P = .025) or distal (P < .001) metastases. In the multivariate Cox model, the most important long-term predictors of death were the presence of distant metastases (P < .001), a Charlson comorbidity index (CCI) of 5 to 9 (P < .001), and the use of perioperative DEX (P = .004).

Conclusions: The use of perioperative DEX was associated with higher short-term mortality after reconstructive HNC surgery. The most important long-term predictors of death were the receipt of DEX, the presence of distant metastases, and a CCI of 5 to 9. These findings do not encourage the routine use of perioperative DEX for these patients.
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http://dx.doi.org/10.1016/j.joms.2020.05.004DOI Listing
October 2020

Finnish Trial on Practices of Anterior Cervical Decompression and Fusion (FACADE): a protocol for a prospective randomised non-inferiority trial comparing outpatient versus inpatient care.

BMJ Open 2019 11 26;9(11):e032575. Epub 2019 Nov 26.

Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland.

Introduction: Although a great majority of patients with cervical radiculopathy syndrome can successfully be treated non-operatively, a considerable proportion experience persistent symptoms, severe enough to require neurosurgical intervention. During the past decade, cervical spine procedures have increasingly been performed on an outpatient basis and retrospective database analyses have shown this to be feasible and safe. However, there are no randomised controlled studies comparing outpatient care with inpatient care, particularly with emphasis on the patients' perception of symptom relief and their ability to return to normal daily activities and work.

Methods And Analysis: This is a prospective, randomised, controlled, parallel group non-inferiority trial comparing the traditional hospital surveillance (inpatient, patients staying in the hospital for 1-3 nights after surgery) with outpatient care (discharge on the day of the surgery, usually within 6-8 hours after procedure) in patients who have undergone anterior cervical decompression and fusion procedure. To determine whether early discharge (outpatient care) is non-inferior to inpatient care, we will randomise 104 patients to these two groups and follow them for 6 months using the Neck Disability Index (NDI) as the primary outcome. We expect that early discharge is not significantly worse than the current care in terms of change in NDI. Non-inferiority will be declared if the mean improvement for outpatient care is no worse than the mean improvement for inpatient care, by a margin of 17.3%. We hypothesise that a shorter hospital stay results in more rapid return to normal daily activities, shorter duration of sick leave and decreased secondary costs to healthcare system. Secondary outcomes in our study are arm pain and neck pain using the Numeric Rating Scale, operative success (Odom's criteria), patient's satisfaction to treatment, general quality of life (EQ-5D-5L), Work Ability Score, sickness absence days, return to previous leisure activities and complications.

Ethics And Dissemination: The study was approved by the institutional review board of the Helsinki and Uusimaa Hospital District on 6 June 2019 (1540/2019) and duly registered at ClinicalTrials.gov. We will disseminate the findings of this study through peer-reviewed publications and conference presentations.

Trial Registration Number: NCT03979443.
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http://dx.doi.org/10.1136/bmjopen-2019-032575DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6886918PMC
November 2019

Treatment of gynecological malignancies: long-term follow-up of health-related quality of life and healthcare costs.

J Comp Eff Res 2019 05 29;8(7):475-486. Epub 2019 Mar 29.

External Evaluation Unit, University of Helsinki & Helsinki University Hospital, PO Box 440 FI-00029 HUS, Finland.

To assess long-term health-related quality of life (HRQoL) and treatment-related costs in gynecological cancer patients, and to compare HRQoL between cancer types and to age-standardized general female population. A prospective 8-10-year follow-up of 218 patients treated in Helsinki University Hospital in 2002-2004. The most common malignancies were uterine, ovarian and cervical cancers. The mean HRQoL scores were 0.880 (baseline), 0.885 (6 months) and 0.884 for survivors in the end of the study. Depression, vitality and sexual activity were impaired at baseline but improved during follow-up. Total secondary healthcare costs during the follow-up averaged EUR 41342. The long-term HRQoL of surviving gynecological cancer patients was good and similar to that of age-standardized general female population.
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http://dx.doi.org/10.2217/cer-2018-0125DOI Listing
May 2019

Cost-effectiveness of biologic compared with conventional synthetic disease-modifying anti-rheumatic drugs in patients with rheumatoid arthritis: a Register study.

Rheumatology (Oxford) 2016 Oct 27;55(10):1803-11. Epub 2016 Jun 27.

Faculty of Pharmacy, University of Helsinki, Helsinki.

Objective: The aim of this study was to explore the cost-effectiveness of biological DMARDs (bDMARDs) compared with conventional synthetic DMARDs (csDMARDs) for RA using real-world data from Finnish registers.

Methods: RA patients starting their first bDMARD and comparator patients using csDMARDs during 2007-11 were obtained from the National register of biologic treatments in Finland and the Jyväskylä Central Hospital patient records. Propensity score matching was applied to adjust for differences between bDMARD and csDMARD users. Effectiveness was measured in quality-adjusted life years (QALY) and based on the register of biologic treatments in Finland and Jyväskylä Central Hospital patient records, whereas the direct costs were obtained from relevant Finnish national registers. Patients were followed up for 2 years, and both costs and effectiveness for the second year were discounted at 3%. The incremental cost-effectiveness ratio (ICER) with 95% CI was calculated based on bootstrapped mean costs and effectiveness.

Results: Of 1581 RA patients meeting study inclusion criteria, 552 bDMARD and 220 csDMARD users were included in analyses after matching. Mean costs for bDMARDs and csDMARDs were €55 371 and €24 879, while mean effectiveness was 1.23 and 1.20 QALYs, respectively. Consequent ICER was €902 210/QALY. Results were confirmed in sensitivity analyses.

Conclusion: The high incremental cost and the small, non-significant difference in effectiveness resulted in high ICER, suggesting that bDMARDs are not cost-effective. Regardless of matching, latent confounders may introduce bias to the results.
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http://dx.doi.org/10.1093/rheumatology/kew264DOI Listing
October 2016

Rates of serious infections and malignancies among patients with rheumatoid arthritis receiving either tumor necrosis factor inhibitor or rituximab therapy.

J Rheumatol 2015 Mar 15;42(3):372-8. Epub 2015 Jan 15.

From the University of Helsinki, and the Helsinki University Central Hospital, Helsinki; Jyväskylä Central Hospital, Jyväskylä; Tampere University Hospital, Tampere; Turku University Central Hospital, Turku; South Karelia Central Hospital, Lappeenranta; Kanta-Häme Central Hospital, Hämeenlinna, Finland.K.J. Aaltonen, MSc (pharm); J.T. Joensuu, MSc (pharm); L. Virkki, MSc (pharm); P. Aronen, MSc; M. Blom, PhD, Professor, University of Helsinki; T. Sokka, MD, PhD, Adj. Professor, Jyväskylä Central Hospital; H. Relas, MD, PhD; H. Valleala, MD, PhD, Adj. Professor, Helsinki University Central Hospital; V. Rantalaiho, MD, PhD, Tampere University Hospital; L. Pirilä, MD, PhD, Turku University Central Hospital; K. Puolakka, MD, PhD, Adj. Professor, South Karelia Central Hospital; T. Uusitalo, MD, Kanta-Häme Central Hospital; Y.T. Konttinen, MD, PhD, Professor; D. Nordström, MD, PhD, Adj. Professor, University of Helsinki, and the Helsinki University Central Hospital.

Objective: Because of the role of tumor necrosis factor (TNF) in host defense, it was hypothesized that its inhibition might lead to an increased risk of malignancies and infections. The objective of our study was to assess the incidence of serious infections leading to hospitalization and malignancies among patients with rheumatoid arthritis (RA) receiving either TNF inhibitor or rituximab (RTX) therapy.

Methods: The study population was identified from the National Register for Biologic Treatment in Finland and the hospital records of Central Finland Central Hospital for conventional disease-modifying antirheumatic drug (cDMARD) users. Data on infections and malignancies were acquired from national healthcare registers. A Poisson model was used to calculate the adjusted incidence rate ratios (aIRR) and was composed of age, sex, time from diagnosis, year of the beginning of the followup, rheumatoid factor status, Disease Activity Score at 28 joints, Health Assessment Questionnaire, prior malignancy, prior serious infection, prior biologic use, and time-updated use of methotrexate, sulfasalazine, hydroxychloroquine, and oral corticosteroids as confounders.

Results: In total, during the followup of 10,994 patient-years, 92 malignancies and 341 serious infections were included in the analyses. The aIRR of infections compared to cDMARD users were 1.2 (95% CI 0.63-2.3), 0.84 (95% CI 0.53-1.3), 0.98 (95% CI 0.60-1.6), and 1.1 (95% CI 0.59-1.9) for the patients treated with infliximab (IFX), etanercept, adalimumab, and RTX, respectively. The crude rates of malignancies were highest among the users of cDMARD and RTX, and lowest among patients treated with IFX with no differences in aIRR.

Conclusion: Our results provide some reassurance of the safety of biologic treatments in the treatment of RA.
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http://dx.doi.org/10.3899/jrheum.140853DOI Listing
March 2015

Health-related quality of life after kidney transplantation: who benefits the most?

Transpl Int 2014 Nov 28;27(11):1143-51. Epub 2014 Aug 28.

Division of Nephrology, Department of Internal Medicine, Helsinki University Central Hospital, Helsinki, Finland.

The influence of dialysis modalities on HRQoL before and after kidney transplantation (KT) and the role of adherence to medication on HRQoL have not been fully studied. Sixty four dialysis patients who answered the 15D HRQoL survey during dialysis were surveyed again after KT. Adherence and employment were also investigated. The mean 15D score was highest among home hemodialysis patients (HHD) and lowest among in-center hemodialysis patients (icHD). After KT, the mean 15D score improved significantly in 78.6% of peritoneal dialysis patients (PD), 47.6% of HHD, and 53.8% of icHD. Then, mean 15D score remained unchanged in 28.6% of HHD and in 23.1% of icHD patients. A deterioration in the 15D score occurred in 14.3% of PD, 23.1% of icHD, and 23.8% of HHD patients, and this was influenced by the number of pills (P = 0.04). Adherence to medication was the lowest in PD, timing being the most challenging task showing a connection to higher creatinine concentration (never forgot 1.41 mg/dl vs. forgot 2.08 mg/dl P = 0.05). Employed patients had a higher mean 15D score. The icHD and PD patients benefited the most from KT and HHD the least. Low pill burden and employment were linked to a better HRQoL.
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http://dx.doi.org/10.1111/tri.12394DOI Listing
November 2014

The effectiveness of urinary incontinence treatments measured using the 15D Health-Related Quality of Life instrument.

Int Urogynecol J 2014 Mar 6;25(3):359-67. Epub 2013 Sep 6.

Department of Gynecology and Pediatrics, Helsinki University Central Hospital HUCH, P.O. Box 140, 00029, Helsinki, Finland,

Introduction And Hypothesis: The health-related quality of life (HRQoL) is significantly impaired among urinary incontinent women and the effectiveness of urinary incontinence (UI) treatment should be measured using an HRQoL instrument.

Methods: A prospective, observational study evaluating the HRQoL of 178 non-selected UI patients referred for routine treatment at the Helsinki University Central Hospital between the years 2004 and 2010. HRQoL was assessed using the generic 15D questionnaire on four occasions: before treatment, 6 and 18 months after treatment, and after a median follow-up of 5 years. The HRQoL of the patients was compared with that of an age-standardized Finnish female population.

Results: Compared with the general population, the baseline total HRQoL score of the patients was significantly impaired (p < 0.001). It was worse among the urge or mixed (UUI (±SUI)) incontinence patients than among the stress incontinence (SUI) patients (p = 0.035). During follow-up, HRQoL improved and the improvement was more substantial among the operatively than among the conservatively treated patients (p = 0.027). Statistically significant improvement was only seen in the SUI group (Δ + 0.021, 95 % CI 0.005-0.036), but clinically relevant improvement was also found in the operatively treated UUI (±SUI) group. The maximum benefit of treatment was reached between at 2 and 3 years.

Conclusions: 15D is a sensitive tool for monitoring the change in HRQoL and could be implemented into clinical practice. Operative treatment of UI is effective when measured by improved HRQoL. Not only SUI patients, but also selected patients with an urgency component may benefit from surgery.
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http://dx.doi.org/10.1007/s00192-013-2206-8DOI Listing
March 2014

Cost-utility of waiting time in total joint replacements: a randomized clinical trial.

Int J Technol Assess Health Care 2013 Jan 7;29(1):27-34. Epub 2013 Jan 7.

The Social Insurance Institution, Research Department, Helsinki, Finland.

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http://dx.doi.org/10.1017/S0266462312000657DOI Listing
January 2013

Economic evaluation of multidisciplinary rehabilitation after primary total knee arthroplasty based on a randomized controlled trial.

Arthritis Care Res (Hoboken) 2011 Mar 15;63(3):335-41. Epub 2010 Nov 15.

Oulu University Hospital, Finland.

Objective: To conduct an economic evaluation of a multidisciplinary, biopsychosocial outpatient rehabilitation program implemented 2-4 months after total knee arthroplasty (TKA), compared with conventional orthopedic care.

Methods: After surgery, 86 patients were randomized to a multidisciplinary rehabilitation group (n = 44) or a conventional orthopedic care group (n = 42). Alongside the randomized controlled trial, we estimated the costs of rehabilitation, health care resource use, and community support. Information about resource use was collected by means of a questionnaire together with data from hospital records. The primary outcome (effectiveness) measure was change in self-reported functional capacity and the secondary measure was quality-adjusted life years (QALYs) gained during the 12-month followup. Cost-effectiveness was assessed from between-group differences in costs, change in functional capacity, and QALYs gained.

Results: Both protocols of providing rehabilitation services turned out to be equally effective, but the conventional orthopedic care protocol was unequivocally cost saving: the saving was €1,830 per patient (95% confidence interval -548, 3,623) using the available direct cost data.

Conclusion: Multidisciplinary rehabilitation for unselected osteoarthritis patients in the subacute period of recovery after TKA is not a cost-effective use of health care resources. Similar rehabilitation protocols cannot be recommended for clinical pathways of TKA in the future.
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http://dx.doi.org/10.1002/acr.20398DOI Listing
March 2011

Cost-effectiveness of an experimental caries-control regimen in a 3.4-yr randomized clinical trial among 11-12-yr-old Finnish schoolchildren.

Eur J Oral Sci 2009 Dec;117(6):728-33

Department of Community Dentistry, University of Oulu, Oulu, Finland.

The aim of this study was to assess the cost-effectiveness of an experimental caries-control regimen in a randomized clinical trial (RCT) conducted in Pori, Finland, in 2001-2005. Children (n = 497) who were 11-12 yr of age and had at least one active initial caries lesion at baseline were studied. The children in the experimental group (n = 250) were offered an individually designed patient-centered regimen for caries control. The children in the control group (n = 247) received standard dental care. Furthermore, the whole population was exposed to continuous community-level oral health promotion. Individual costs of treatment procedures and outcomes (DMFS increment score) for the follow-up period of 3.4 yr were calculated for each child in both groups. The incremental cost-effectiveness ratio was euro 34.07 per averted DMF surface. The experimental regimen was more effective, and also more costly. However, the total costs decreased year after year, and for the last 2 yr the experimental regimen was less expensive than the standard dental care. The experimental regimen would probably have been more cost-effective than standard dental care if the follow-up period had been longer, the regimen less comprehensive, and/or if dental nurses had conducted the preventive procedures.
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http://dx.doi.org/10.1111/j.1600-0722.2009.00687.xDOI Listing
December 2009

Effectiveness of a targeted occupational health intervention in workers with high risk of sickness absence: baseline characteristics and adherence as effect modifying factors in a randomized controlled trial.

J Occup Rehabil 2010 Mar;20(1):14-20

Evalua International, Espoo, Finland.

Introduction: In a recently published randomized controlled trial (RCT), a targeted occupational health (OH) intervention was found effective in an intention-to-treat analysis in controlling sickness absence among workers with high risk of sickness absence, compared to usual care. We performed an exploratory subgroup analysis in order to detect possible effect modifiers and mediators.

Methods: Age, gender, working status, severity of physical impairment, depression score, self-rated working ability, co-morbidity, and sickness absence characteristics in the previous 12 months were identified as potential effect modifiers (n = 382). We conducted regression analyses with the potential effect modifiers and a mediator (treatment attendance as intended) as explanatory variables. The difference of sickness absence days during the previous year and the follow-up year was the dependent variable.

Results: The intervention was especially effective in the subgroups of workers who were certain that they will not be able to continue working in their current job due to health-related reasons (-74 days; 95% CI -105 to -43), had co-morbidities (-22.5 days; 95% CI -35.5 to -9.5), or severe physical impairment at work (-17.5 days; 95% CI -28.5 to -6.5). A modifying effect of age, gender, working status, depressive symptoms, or prior sickness absence on the effectiveness of this OH intervention was not found.

Conclusions: This targeted OH intervention seems especially suitable for workers who consider that they are no longer able to continue working due to health reasons and have high level of physical impairment or co-morbidities. The findings from these exploratory analyses should be tested in future RCTs.
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http://dx.doi.org/10.1007/s10926-009-9221-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2832907PMC
March 2010

Cost-effectiveness analysis of guidelines for antihypertensive care in Finland.

BMC Health Serv Res 2007 Oct 24;7:172. Epub 2007 Oct 24.

Tampere School of Public Health, University of Tampere, Tampere, Finland.

Background: Hypertension is one of the major causes of disease burden affecting the Finnish population. Over the last decade, evidence-based care has emerged to complement other approaches to antihypertensive care, often without health economic assessment of its costs and effects. This study looks at the extent to which changes proposed by the 2002 Finnish evidence-based Current Care Guidelines concerning the prevention, diagnosis, and treatment of hypertension (the ACCG scenario) can be considered cost-effective when compared to modelled prior clinical practice (the PCP scenario).

Methods: A decision analytic model compares the ACCG and PCP scenarios using information synthesised from a set of national registers covering prescription drug reimbursements, morbidity, and mortality with data from two national surveys concerning health and functional capacity. Statistical methods are used to estimate model parameters from Finnish data. We model the potential impact of the different treatment strategies under the ACCG and PCP scenarios, such as lifestyle counselling and drug therapy, for subgroups stratified by age, gender, and blood pressure. The model provides estimates of the differences in major health-related outcomes in the form of life-years and costs as calculated from a 'public health care system' perspective. Cost-effectiveness analysis results are presented for subgroups and for the target population as a whole.

Results: The impact of the use of the ACCG scenario in subgroups (aged 40-80) without concomitant cardiovascular and related diseases is mainly positive. Generally, costs and life-years decrease in unison in the lowest blood pressure group, while in the highest blood pressure group costs and life-years increase together and in the other groups the ACCG scenario is less expensive and produces more life-years. When the costs and effects for subgroups are combined using standard decision analytic aggregation methods, the ACCG scenario is cost-saving and more effective.

Conclusion: The ACCG scenario is likely to reduce costs and increase life-years compared to the PCP scenario in many subgroups. If the estimated trade-offs between the subgroups in terms of outcomes and costs are acceptable to decision-makers, then widespread implementation of the ACCG scenario is expected to reduce overall costs and be accompanied by positive outcomes overall.
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http://dx.doi.org/10.1186/1472-6963-7-172DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2174470PMC
October 2007

Economic evaluation of drug-eluting stents: a systematic literature review and model-based cost-utility analysis.

Int J Technol Assess Health Care 2007 ;23(4):473-9

Finnish Office for Health Technology Assessment, Stakes, PO Box 220, FIn-00531, Helsinki, Finland.

Objectives: The aim of this study was to systematically review economic analyses comparing drug-eluting stents (DES) to bare metal stents (BMS) in patients who undergo percutaneous coronary intervention to form an overall view about cost-effectiveness of DES and to construct a simple decision analysis model to evaluate the cost-utility of DES.

Methods: Electronic databases searched from January 2004 to January 2006 were Cochrane Database of Systematic Reviews; DARE, HTA, EED (NHS CRD); MEDLINE(R) In-Process, Other Non-Indexed Citations, MEDLINE(R). References of the papers identified were checked. We included randomized controlled trials (RCT) or model-based cost-effectiveness analyses comparing DES to BMS in patients with coronary artery disease. The methodological quality of the papers was assessed by Drummond's criteria. Baseline characteristics and results of the studies were extracted and data synthesized descriptively. A decision tree model was constructed to evaluate the cost-utility of DES in comparison to BMS, where health-related quality of life was measured by the 15D.

Results: We identified thirteen good-quality economic evaluations. In two of these based on RCTs, DES was found cost-effective. In six studies, it was concluded that DES might probably be a cost-effective strategy in some circumstances, but not as a single strategy, and four studies concluded that DES is not cost-effective. One study did not draw a clear conclusion. In our analysis, the overall incremental cost-effectiveness ratio was Euros 98,827 per quality-adjusted life-years gained. Avoiding one revascularization with DES would cost Euros 4,794, when revascularization with BMS costs Euros 3,260.

Conclusions: The evidence is inconsistent of whether DES would be a cost-effective treatment compared with BMS in any healthcare system where evaluated. A marked restenosis risk reduction should be achieved before use of DES is justifiable at present prices. When considering adoption of a new health technology with a high incremental cost within a fixed budget, opportunity cost in terms of untreated patients should be seriously considered as a question of collective ethics.
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http://dx.doi.org/10.1017/S0266462307070560DOI Listing
January 2008

Cost effectiveness and cost utility of an organized screening programme for glaucoma.

Acta Ophthalmol Scand 2007 Aug;85(5):508-18

Department of Ophthalmology, Turku City Hospital, Turku, Finland.

Purpose: To assess the cost effectiveness and cost utility of an organized screening programme for glaucoma. The previous cost-effectiveness studies of screening show inconsistent results, and the cost utility of screening has not been assessed.

Methods: An organized screening programme was simulated using Markov modelling in a population aged 50-79 years at 5 year intervals. The programme ended when the subjects reached the age of 80 years. The comparator was opportunistic case finding. The main outcome measures were cases and years of severe visual disability avoided, quality-adjusted life years (QALYs) gained and direct healthcare and non-healthcare costs.

Results: The incremental cost of 1 year of avoided visual disability by screening was euro32 602. The cost of one QALY gained by screening was euro9023 with a discount rate of 5%. During the average 20 year time horizon considered, the cumulative incremental costs of screening in a population of 1 million people would be euro30 million, producing 3360 incremental QALYs and 930 years of avoided visual disability for 701 persons. The results were sensitive to the estimates of several parameters, especially screening cost and specificity of screening tests (96-99% specificity required).

Conclusion: An organized screening programme could be a cost-effective strategy especially in older age groups, in which screening is clearly more likely to be acceptable to decision makers at any level in terms of their willingness to pay for a QALY. Modelling includes some uncertainty especially concerning the specificity of diagnostic tests and screening cost.
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http://dx.doi.org/10.1111/j.1600-0420.2007.00947.xDOI Listing
August 2007
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