Quality of life after operative treatment of sinonasal inverted papilloma - a prospective study.

BACKGROUND: Studies assaying morbidity related to sinonasal inverted papilloma (SNIP) and its treatment are lacking. We evaluated how operative treatment of SNIP affects patients' health-related quality of life (HRQoL) and symptoms. METHODS: We prospectively recruited consecutive patients (n=52) operated for SNIP at Helsinki University Hospital, between years 2016 and 2019. In total, 42 patients filled in the 15D, a generic HRQoL instrument and a symptom questionnaire preoperatively and at 1 year and at 2 years postoperatively. The 15D HRQoL scores were compared to those of age- and sex-standardized general population. RESULTS: Patients' mean baseline score for discomfort and symptoms (one of the 15D dimensions) was significantly better compared to general population, but this difference faded postoperatively. Frequency of epistaxis, nasal obstruction, lowered sense of smell, headache, tinnitus and epiphora decreased significantly during follow-up whereas frequency of numbness of the face or mouth increased. Difference in the mean 15D score of the patients compared with general population was insignificant at baseline and at 1 year and at 2 years postoperatively. CONCLUSIONS: Measured by a generic HRQoL questionnaire, the mean score for discomfort and symptoms deteriorated after operative treatment of SNIP. Despite a relief of many symptoms, care should be taken when operating a benign tumour, as surgery may cause morbidity.

Cost-analysis and quality of life after laparoscopic and robotic ventral mesh rectopexy for posterior compartment prolapse: a randomized trial.

BACKGROUND: The aim of this study was to assess, whether robotic-assistance in ventral mesh rectopexy adds benefit to laparoscopy in terms of health-related quality of life (HRQoL), cost-effectiveness and anatomical and functional outcome. METHODS: A prospective randomized study was conducted on patients who underwent robot-assisted ventral mesh rectopexy (RVMR) or laparoscopic ventral mesh rectopexy (LVMR) for internal or external rectal prolapse at Oulu University Hospital, Finland, recruited in February-May 2012. The primary outcomes were health care costs from the hospital perspective and HRQoL measured by the 15D-instrument. Secondary outcomes included anatomical outcome assessed by pelvic organ prolapse quantification method and functional outcome by symptom questionnaires at 24 months follow-up. RESULTS: There were 30 females (mean age 62.5 years, SD 11.2), 16 in the RVMR group and 14 in the LVMR group. The surgery-related costs of the RVMR were 1.5 times higher than the cost of the LVMR. At 3 months the changes in HRQoL were 'much better' (RVMR) and 'slightly better' (LVMR) but declined in both groups at 2 years (RVMR vs. LVMR, p > 0.05). The cost-effectiveness was poor at 2 years for both techniques, but if the outcomes were assumed to last for 5 years, it improved significantly. The incremental cost-effectiveness ratio for the RVMR compared to LVMR was €39,982/quality-adjusted life years (QALYs) at 2 years and improved to €16,707/QALYs at 5 years. Posterior wall anatomy was restored similarly in both groups. The subjective satisfaction rate was 87% in the RVMR group and 69% in the LVMR group (p = 0.83). CONCLUSIONS: Although more expensive than LVMR in the short term, RVMR is cost-effective in long-term. The minimally invasive VMR improves pelvic floor function, sexual function and restores posterior compartment anatomy. The effect on HRQoL is minor, with no differences between techniques.

Health-related quality-of-life outcome in patients with idiopathic normal-pressure hydrocephalus - a 1-year follow-up study.

BACKGROUND AND PURPOSE: This prospective study explored the factors affecting the health-related quality-of-life (HRQoL) outcome in patients with idiopathic normal-pressure hydrocephalus (iNPH) 1 year after the installation of the cerebrospinal fluid shunt. METHODS: The HRQoL outcome was evaluated using a 15D instrument, in which the minimum clinically significant change/difference has been estimated to be ±0.015. The follow-up data (15D, Mini-Mental State Examination, Beck Depression Inventory, iNPH Grading Scale), frontal cortical biopsy, Charlson Age Comorbidity Index and body mass index of 145 patients diagnosed with iNPH by clinical and radiological examination were analyzed. RESULTS: At 1-year follow-up, 63 (43%) patients had experienced a clinically significant improvement in HRQoL. Multivariate binary logistic regression analysis indicated that the absence of amyloid-ß and hyperphosphorylated tau pathology in the frontal cortical biopsy (53% vs. 33%; absolute risk difference, 20%; adjusted odds ratio, 2.27; 95% confidence interval, 1.07-4.84; P < 0.05) and lower body mass index (adjusted odds ratio, 0.90, 95% confidence interval, 0.82-0.98; P < 0.05) predicted favorable HRQoL outcome 1 year after the shunting. CONCLUSIONS: Less than half of the patients with iNPH experienced clinically significant favorable HRQoL outcome, partly explained by the patient's characteristics and comorbidities. The HRQoL approach reveals aspects that are important for the patient's well-being, but may also improve the quality of the outcome assessment of cerebrospinal fluid shunting. Study results may help clinicians to estimate which patients will benefit shunt surgery.

Health-related quality of life of patients with zygomatic fracture.

BACKGROUND: The objective was to evaluate health-related quality of life (HRQoL) before and after surgical treatment of zygomatic complex fracture and assess patients' perceptions of the aesthetic and functional outcomes of surgery. MATERIAL AND METHODS: A prospective study of 79 adult patients before and after surgery for zygomatic complex fracture was conducted. HRQoL was measured using the generic 15-dimensional (15D) instrument, and patient satisfaction was assessed by an additional questionnaire. RESULTS: The mean preoperative 15D score for patients was lower than for general population that was matched for age and gender (p=0.011). The mean 15D score was lowest on the first postoperative day (p<0.001) when patients were worse off for 6 of the 15 dimensions of the HRQoL instrument and better off for three dimensions. However, patients achieved, and even exceeded, the mean 15D score of the general population during the first month following surgery. Infraorbital sensory loss at the end of the six-month follow-up appeared to be the single most important factor that plagued the patients. CONCLUSIONS: HRQoL is significantly reduced after trauma but improves a few weeks after surgery. Infraorbital nerve sensory loss is a notable long-term factor that affects patients after zygomatic complex fracture.

Health outcomes and costs of ischemic stroke patients in Finland.

OBJECTIVES: Stroke case fatality is decreasing over time. Less, however, is known about patients' health-related quality of life (HRQoL), quality-adjusted life years (QALYs), and costs. We studied all these with two data sets collected in Finland 10 years apart. METHODS: A total of 468 and 355 first-ever ischemic stroke patients were followed up 1 year in two studies (Study 1 in 1989-1991 and Study 2 in 2001-2003). Case fatality, HRQoL measured by the 15D, QALYs, costs, and first-year cost/QALY were compared. Regression analysis was used to examine the effects of various factors on QALYs. RESULTS: In the later study, the case fatality rates were lower and the mean 15D scores higher. During the follow-up year, patients experienced on average 0.519 (95% CI 0.453-0.555) and 0.646 (95% CI 0.613-0.680) QALYs in Study 1 and Study 2, respectively (P < 0.001). Age, modified Rankin Scale before stroke onset, acute phase Scandinavian Stroke Scale, and the study group explained the variance of QALYs. The first-year mean total costs were 10 626 € and 14 603 € and the mean cost/QALY 20 474 € and 22 605 € in Study 1 and Study 2, respectively. The incremental cost-effectiveness ratio of Study 2 compared with Study 1 was 31 315 € without and 60 684 € with patient characteristics standardization. CONCLUSIONS: Stroke patients' improved outcome is clear, but it remains uncertain to what extent it is attributable to the development of care. More research is needed to study the cost-effectiveness of stroke care.

Trends in the 15D health-related quality of life over the first year following diagnosis of head and neck cancer.

Management of head and neck cancer influences both physical and mental wellbeing. Measuring the health-related quality of life (HRQoL) is important, as various treatment modalities are associated with significant morbidity and mortality. In this prospective cohort study, we tested the feasibility of the generic 15D HRQoL instrument in 214 head and neck cancer patients managed with surgery, definitive (chemo)radiotherapy, or with combined modality treatment. HRQoL was assessed at baseline and three times after treatment onset during 1 year, and compared with that of general population standardized for age and sex. At baseline, the patients' mean 15D score was significantly worse compared with general population. Overall HRQoL was at lowest at 3 months after treatment onset, it gradually improved towards 12 months but never reached baseline levels. The dimensions "vitality", "distress", "depression" and "sexual activity" showed marked deterioration at 3 months after the treatment onset, but improved gradually during 12 months. The 15D instrument seems useful for evaluation of HRQoL of head and neck cancer patients. Dimensions reflecting mental wellbeing improved gradually after 3 months, but they seldom reached baseline levels. The support for patients at the time of diagnosis, during treatment, and recovery is emphasized.

Comparing Effectiveness of Treatments for Borderline Personality Disorder in Communal Mental Health Care: The Oulu BPD Study.

The implementation of effective psychotherapies in community mental health care is challenging. This study aimed to create a well-structured and easily applicable treatment model for patients with severe borderline personality disorder (BPD). We integrated a schema therapy based psycho-educational group into an available individual therapy. Two groups were formed: (1) community treatment by experts (CTBE) patients (n = 24) receiving new treatment and (2) treatment as usual (TAU) patients (n = 47). Changes in symptoms were measured by Borderline Personality Disorder Severity Index-IV interview and quality of life by the 15D health-related quality of life questionnaire. After 1 year the CTBE patients showed a significant reduction in a wider range of BPD symptoms and better quality of life than TAU patients. The results of this study are encouraging. A well-structured treatment model was successfully implemented into community mental health care with improved patient adherence to treatment and superior treatment outcomes compared to TAU patients.

Health-related quality of life in patients with idiopathic normal pressure hydrocephalus.

BACKGROUND AND PURPOSE: Factors affecting health-related quality of life (HRQoL) were explored in patients with idiopathic normal pressure hydrocephalus (iNPH). METHODS: Using the 15D instrument HRQoL was evaluated in 132 patients diagnosed with iNPH by clinical and neuroradiological examinations. The severity of iNPH symptoms was measured with the iNPH grading scale (iNPHGS), depressive symptoms with the Beck Depression Inventory (BDI-21) and cognitive impairment with the Mini-Mental State Examination. RESULTS: The mean (SD) 15D score (on a 0-1 scale) of patients with iNPH was significantly lower than that of an age- and gender-matched sample of the general population [0.718 (0.103) vs. 0.870 (0.106); P < 0.001]. The mean 15D score was lower in iNPH patients with moderate or severe depressive symptoms than in patients without depressive symptoms (P = 0.003). According to stepwise multiple linear regression analysis, a higher total iNPHGS score (b = -0.62, P < 0.001) and a higher BDI-21 total score (ß = -0.201, P = 0.025) predicted a lower 15D score; in combination, these explained 51% of the variance in the 15D score (R(2)  = 0.506, P < 0.001). CONCLUSIONS: Idiopathic normal pressure hydrocephalus impairs patients' HRQoL on multiple dimensions, similarly to other chronic diseases. Potentially treatable depressive symptoms contribute greatly to the HRQoL impairment of iNPH patients, but only if they are moderate or severe. The 15D portrayed HRQoL dimensions affected by iNPH in a similar way to broader assessment batteries and thus is a potentially useful tool for treatment evaluation and cost-utility analysis.

Health-related quality of life of head and neck cancer patients with successful oncological treatment.

Oncological treatment of head and neck carcinoma is associated with high morbidity. Measuring of health-related quality of life (HRQoL) is crucial in this patient group but there is no consensus on which measure would be preferable to be used. In this study, HRQoL was measured with the generic 15D, which has not been used before for assessing this patient population. It is a prospective cohort study among 64 patients with laryngeal, pharyngeal or nasal cavity carcinoma treated with definitive (chemo) radiotherapy between November 2007-July 2012. HRQoL was assessed with the 15D before and at 3, 6 and 12 months after the treatment onset. HRQoL results of the patients were compared with those of the age-standardized general population. Overall HRQoL declined significantly during the first 3 months after the treatment onset but then gradually improved towards the end of the follow-up. At baseline or at 12 months, no significant differences were detected in overall HRQoL between the patients and the general population. Dimensions reflecting mental well-being showed gradual improvement, exceeding the baseline scores at the end of the follow-up. Nevertheless, on these dimensions, the patient group presented with consistently lower scores compared with the general population. The mean HRQoL was lower among patients with pharyngeal carcinoma compared with the laryngeal carcinoma patients. The 15D instrument is feasible for evaluation of HRQoL in oncologically treated head and neck cancer patients. It seems to detect differences among different patient subgroups. Multidisciplinary supportive management of this patient population is recommended to ensure improved mental well-being.

Health-related quality of life in colorectal cancer.

AIM: As a consequence of the improved survival of patients and of cost-effectiveness requirements for new treatments, health-related quality of life (HRQoL) issues have gained increasing attention in colorectal cancer (CRC). This cross-sectional study assesses HRQoL in several health states of CRC and explores factors influencing HRQoL. METHOD: Five hundred and eight Finnish CRC patients (aged 26-96 years; colon cancer 56%; women 47%) assessed their HRQoL using generic 15D and EQ-5D and cancer-specific EORTC QLQ-C30 questionnaires. Patients were divided into five groups: primary treatment, rehabilitation, remission, metastatic disease and palliative care. The patients' HRQoL was compared with population reference values. Multivariate modelling was used to find factors associated with HRQoL scores. RESULTS: The HRQoL of CRC patients is fairly good and comparable with that of the standardized general population except for those under palliative care. The mean 15D score of patients in the primary treatment group was 0.889 (95% CI 0.869-0.914), in rehabilitation 0.877 (0.855-0.907), in remission 0.886 (0.875-0.903), in metastatic disease 0.860 (0.844-0.878) and in palliative care 0.758 (0.716-0.808). The respective EQ-5D scores were 0.760 (0.699-0.823), 0.835 (0.777-0.881), 0.850 (0.828-0.882), 0.820 (0.783-0.858) and 0.643 (0.546-0.747). Multivariate analysis showed that fatigue, pain, age and financial difficulties had a marked negative impact on HRQoL. CONCLUSION: The mean HRQoL scores of CRC patients varied considerably depending on the HRQoL instrument used, but remained surprisingly good up to the palliative stage. In addition to age- and cancer-related symptoms, financial difficulties also had a clear negative impact on HRQoL, which needs to be taken into consideration when supporting patient HRQoL.

Cost-utility of bariatric surgery for morbid obesity in Finland.

BACKGROUND: The aim of this study was to evaluate the cost-utility of bariatric surgery (gastric bypass, sleeve gastrectomy and gastric banding) compared with ordinary treatment in the Finnish healthcare system. METHODS: Analysis was done from a healthcare provider's perspective using a combination of a decision tree and a Markov model, with a time horizon of 10 years. Health-related quality of life was estimated from a representative population survey, and other parameter values were based on registers, systematic reviews, controlled studies and expert opinion. RESULTS: In the base-case analysis, bariatric surgery was both more effective and less costly than the ordinary treatment. The mean costs were €33,870 and €50,495, and the mean number of quality-adjusted life-years 7·63 and 7·05, for bariatric surgery and ordinary treatment respectively. Uncertainty around the parameter values was tested comprehensively in sensitivity analyses, and the results were robust. CONCLUSION: Surgery for morbid obesity increases health-related quality of life, and reduces the need for further treatments and total healthcare costs. According to this analysis, non-operative care would be more costly for the Finnish healthcare system on average after 5 years following surgery.

Health-related quality of life of children with specific language impairment aged 8-11.

OBJECTIVE: To evaluate, in a clinical sample of children with a diagnosis of specific language impairment (SLI), the health-related quality of life (HRQoL). SUBJECTS AND METHODS: Fifty-five children, aged 8-11 years, filled out a generic HRQoL questionnaire, 17D, and another questionnaire about school and rehabilitation. The HRQoL comparison group was a sample of 244 typically developing schoolchildren. RESULTS: Response rate was 86%. Of the respondents, 80% were male. The total 17D score of the subjects did not differ from that of controls. The 17D profiles of the groups differed on several dimensions, but significant differences emerged only on the dimensions concerning speech, where the study group was worse off, and sleep, where the controls reported more problems. Respondents with low verbal IQ reported more distress. The vast majority of respondents were in special education or received extra educational support and one-third were still having speech therapy. CONCLUSION: In this clinical sample, despite the persisting need for extra support, the overall well-being of children with SLI was at age level. Still, some differences existed, and HRQoL measurement may prove a good tool for professionals to find those children with SLI at risk for diminished well-being and for later problems.

5-Year health-related quality of life outcome in patients with idiopathic normal pressure hydrocephalus.

BACKGROUND: Health-related quality of life (HRQoL) is severely impaired in persons with idiopathic normal pressure hydrocephalus (iNPH). The HRQoL improves in a number of patients after the placement of a cerebrospinal fluid (CSF) shunt, but long-term follow-up of HRQoL is rare. METHODS: Extended follow-up (60 months) of a prospective cohort study involving 189 patients with iNPH who underwent shunt surgery. Preoperative variables were used to predict favorable HRQoL outcome (improvement or non-deterioration) measured by the 15D instrument 5 years after shunting. RESULTS: Out of the 189 initially enrolled study participants, 88 had completed 5-year HRQoL follow-up (46%), 64 had died (34%), and 37 (20%) failed to complete the HRQoL follow-up but were alive at the end of the study. After initial post-operative HRQoL improvement, HRQoL deteriorated so that 37/88 participants (42%) had a favorable HRQoL outcome 5 years after shunting. Multivariate binary logistic regression analysis indicated that younger age (adjusted OR 0.86, 95% CI 0.77-0.95; p < 0.005), lower body mass index (adjusted OR 0.87, 95% CI 0.77-0.98; p < 0.05) and better Mini-Mental State Examination performance (adjusted OR 1.16, 95% CI 1.01-1.32; p < 0.05) before surgery predicted favorable 5-year outcome. CONCLUSIONS: This extended follow-up showed that the self-evaluated HRQoL outcome is associated with iNPH patients' pre-operative cognitive status, overweight and age. The post-operative deterioration may reflect the natural progression of iNPH, but also derive from aging and comorbidities. It indicates a need for long-term follow-up.

Health-related quality of life in severely and morbidly obese patients waiting for bariatric surgery in Finland.

BACKGROUND: important outcome measurements in bariatric surgery include the improvement or resolvement of medical comorbid conditions caused by obesity, and the possible changes in quality of life. The health-related quality of life (HRQoL) among Finnish obese subjects awaiting bariatric surgery has not previously been compared to age- and gender-standardized general population. METHODS: the HRQoL in 75 obese subjects waiting for bariatric surgery was assessed by the generic 15D instrument. The resulting 15D profile and single index score were compared to those of a sample of age- and gender-standardized general population (n = 4955). RESULTS: The patients were significantly worse off than the age- and gender-standardized general population on 11 of the 15 dimensions. The mean total 15D score among patients scheduled for bariatric surgery was 0.844 compared to 0.934 in the control group (P < 0.001). CONCLUSION: the Finnish patients awaiting bariatric surgery suffer from a very poor HRQoL compared with age- and gender-standardized general population.

Long-term quality of life after surgery of head and neck cancer with microvascular reconstruction: a prospective study with 4.9-years follow-up.

PURPOSE: The aim of this study was to evaluate the long-term health-related quality of life (HRQoL) of head and neck cancer patients with microvascular surgery. Surgical treatment causes great changes in patient HRQoL. Studies focusing on long-term HRQoL after microvascular reconstruction for head and neck cancer patients are scarce. METHODS: We conducted a prospective study of 93 patients with head and neck cancer and microvascular reconstruction in Helsinki University Hospital Finland. HRQoL was measured using the 15D instrument at baseline and after a mean 4.9-years follow up. Results were compared with those of an age-standardized general population. RESULTS: Of the 93 patients, 61 (66%) were alive after follow-up; of these, 42 (69%) answered the follow-up questionnaire. The median time between surgery and HRQoL assessment was 4.9 years (range 3.7-7.8 years). The mean 15D score of all patients (n = 42) at the 4.9-years follow up was statistically significantly (p = 0.010) and clinically importantly lower than at baseline. The dimensions of "speech" and "usual activities" were significantly impaired at the end of follow up. There was a significant difference at the 4.9-years follow-up in the mean 15D score between patients and the general population (p = 0.014). After follow up, patients were significantly (p < 0.05) worse off on the dimensions of "speech," "eating," and "usual activities." CONCLUSIONS: Long-term HRQoL was significantly reduced in the whole patient cohort. Speech and usual activities were the most affected dimensions in head and neck cancer patients with microvascular reconstruction at the end of the 4.9-years follow up.

The effect of waiting time on health and quality of life outcomes and costs of medication in hip replacement patients: a randomized clinical trial.

OBJECTIVE: To evaluate the effect of waiting time on health and quality of life outcomes and costs of medication in total hip replacement (THR) patients in a randomized clinical trial. METHODS: 395 THR patients were recruited into the study. When placed on the waiting list, patients were randomized into a short (< or =3 months) or a non-fixed waiting time (NFWT) (>3 months) group. In the final analyses 309 patients (179 women) with a mean age of 65 years were included. Health-related quality of life (HRQoL) (generic 15D), and pain and function (modified Harris Hip Score (HHS)) were calculated when placed on the waiting list, at hospital admission, and at 3 and 12 months postoperatively. The costs of disease-specific medication were calculated at the same measurement points. All analyses were performed using the intention-to-treat (ITT) principal. RESULTS: Of the recruited patients, 309 (78%) completed the follow-up (short group 140 and non-fixed group 169 patients). The mean waiting time was 74 days in the short and 194 days in the NFWT groups. In the ITT analyses there were no statistically significant differences between the groups in the weekly use and costs of medication, HRQoL or HHS at baseline, at admission, or 3 or 12 months after surgery. The only difference was in total medication costs during the waiting time period, at EUR 83 and 171, respectively. CONCLUSIONS: The length of the waiting time did not generate different effects on the studied health and quality of life outcomes of the randomized groups. However, those in short waiting time group reached earlier better HRQoL.

Health-related quality of life after oncological resection and reconstruction of the chest wall.

OBJECTIVES: There is limited information of the health-related quality of life (HRQoL) after surgical treatment of chest wall tumors. This cross-sectional study aimed to assess long-term HRQoL after chest wall reconstruction following oncological resection. METHODS: Seventy-eight patients having undergone chest wall tumor resection and reconstruction during 1997-2015 were invited to complete the 15D and QLQ-C30 HRQoL instruments. RESULTS: Altogether, 55 patients (17 men and 38 women), with a mean (SD) age of 68 (14) years, completed the questionnaires (response rate 71%). Patients had been operated due to soft tissue sarcoma (n = 16), advanced breast cancer (n = 15), osteo- or chondrosarcoma (n = 14), or other tumor (n = 10). Median time after primary surgery was 66 (IQR 38, 141) months. The resection was full thickness in 29/55 cases and partial thickness in 26/55 cases. Chest wall reconstruction was required for 47/55 cases (85%). Reconstruction was performed using soft-tissue flap in eight cases, skeletal stabilizations with mesh or mesh-cement-mesh (sandwich method) in 15 cases, and skeletal stabilizations and soft-tissue flap in 24 cases. Patients' mean 15D score (0.878, SD 0.111) was comparable to that of the age- and gender-standardized general population (0.891, SD 0.041). Limitations in breathing and usual activities were noted. The QLQ-C30 cancer-specific HRQoL was 72 points (maximum 100). Scores in the QLQ-C30 Functional scales ranged from 78 (Physical) to 91 (Social). CONCLUSIONS: Long-term HRQoL in patients after chest wall reconstruction following oncological resection is fair and comparable to that of the general population. Limitations in breathing and usual activities can occur.

Cost-effectiveness of sitagliptin-based treatment regimens in European patients with type 2 diabetes and haemoglobin A1c above target on metformin monotherapy.

OBJECTIVE: Sitagliptin is a novel oral incretin enhancer that acts by inhibiting the dipeptidyl peptidase 4 enzyme and is indicated in Europe as a treatment adjunct to metformin (MF), sulphonylurea (SU), MF plus SU and diet and exercise, in the management of type 2 diabetes mellitus. The objective of the current analysis was to evaluate the cost-effectiveness of adding sitagliptin to the regimens of patients with haemoglobin A1c (HbA1C) above the International Diabetes Federation goal (6.5%) while on MF in six European countries: Austria, Finland, Portugal, Scotland (United Kingdom), Spain and Sweden. METHODS: A discrete event simulation model, which employed the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model risk equations for predicting risks of diabetes-related complication, was used. Lifetime costs and benefits were projected for alternative treatment strategies of adding sitagliptin, compared with adding rosiglitazone or a SU to MF in patients not at HbA1C goal on MF monotherapy. Changes in HbA1C as well as side effects associated with these different treatment strategies were based on clinical trial data. Mean baseline values from local epidemiologic studies involving patients with type 2 diabetes not at HbA1C goal on MF monotherapy were included in the current analysis. Costs of medications, side effects and direct costs of diabetes-related complications were based on country-specific data. UKPDS-based disutility weights associated with diabetes complications were incorporated. Disutilities associated with medication side effects were based on published data. All future costs and benefits were discounted according to local guidelines on cost-effectiveness analysis. One-way sensitivity analyses were conducted by varying key input parameters. FINDINGS: The discounted incremental cost-effectiveness ratios (ICER) associated with the addition of sitagliptin to MF, compared with adding rosiglitazone, in the different countries analysed ranged from treatment with sitagliptin being dominant (cost saving with improved health outcome) to its being cost-effective [4,766 euros per quality-adjusted life year (QALY)]. Treatment with sitagliptin added to MF was cost-effective compared with adding a SU, with discounted ICER values ranging from 5949 euros/QALY to 20,350 euros/QALY across countries. Sensitivity analyses showed that these results were robust to changes in input parameters, including clinical efficacy, costs and utility weights for both diabetes-related complications and hypoglycaemia. CONCLUSIONS: Compared with adding rosiglitazone or a SU to MF, adding sitagliptin to MF is projected to be either cost saving or cost-effective for patients with type 2 diabetes who are not at HbA1C goal on MF.

An occupational health intervention programme for workers at high risk for sickness absence. Cost effectiveness analysis based on a randomised controlled trial.

OBJECTIVES: To determine whether, from a healthcare perspective, a specific occupational health intervention is cost effective in reducing sickness absence when compared with usual care in occupational health in workers with high risk of sickness absence. METHODS: Economic evaluation alongside a randomised controlled trial. 418 workers with high risk of sickness absence from one corporation were randomised to intervention (n = 209) or to usual care (n = 209). The subjects in the intervention group were invited to occupational health service for a consultation. The intervention included, if appropriate, a referral to specialist treatment. Register data of sickness absence were available for 384 subjects and questionnaire data on healthcare costs from 272 subjects. Missing direct total cost data were imputed using a two-part regression model. Primary outcome measures were sickness absence days and direct healthcare costs up to 12 months after randomisation. Cost effectiveness (CE) was expressed as an incremental CE ratio, CE plane and CE acceptability curve with both available direct total cost data and missing total cost data imputed. RESULTS: After one year, the mean of sickness absence was 30 days in the usual care group (n = 192) and 11 days less (95% CI 1 to 20 days) in the intervention group (n = 192). Among the employees with available cost data, the mean days of sickness absence were 22 and 24, and the mean total cost euro974 and euro1049 in the intervention group (n = 134) and in the usual care group (n = 138), respectively. The intervention turned out to be dominant-both cost saving and more effective than usual occupational health care. The saving was euro43 per sickness absence day avoided with available direct total cost data, and euro17 with missing total cost data imputed. CONCLUSIONS: One year follow-up data show that occupational health intervention for workers with high risk of sickness absence is a cost effective use of healthcare resources.

The effectiveness of two occupational health intervention programmes in reducing sickness absence among employees at risk. Two randomised controlled trials.

OBJECTIVES: To evaluate the effectiveness of two occupational health intervention programmes, both compared with usual care. METHODS: Based on a health survey, 1341 employees (88% males) in construction, service and maintenance work were classified into three groups: "low risk" (n = 386), "intermediate risk" (n = 537) and "high risk" (n = 418) of sickness absence. Two separate randomised trials were performed in the groups "high risk" and "intermediate risk", respectively. Those high risk subjects that were allocated to the intervention group (n = 209) were invited to occupational health service for a consultation. The intervention included, if appropriate, a referral to specialist treatment. Among the intermediate risk employees those in the intervention group (n = 268) were invited to call a phone advice centre. In both trials the control group received usual occupational health care. The primary outcome was sickness absence during a 12-month follow-up (register data). RESULTS: The high risk group, representing 31% of the cohort, accounted for 62% of sickness absence days. In the trial for the high risk group the mean sickness absence was 30 days in the usual care group and 19 days in the intervention group; the mean difference was 11 days (95% CI 1 to 20 days). In the trial for the intermediate risk group the mean sickness absence was 7 days in both arms (95% CI of the mean difference -2.3 to 2.4 days). CONCLUSIONS: The identification of high risk of work disability was successful. The occupational health intervention was effective in controlling work loss to a degree that is likely to be economically advantageous within the high risk group. The phone advice intervention for the intermediate risk group was not effective in controlling work loss primarily due to poor adherence.