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In the Nordic countries, as in the rest of the world, particle therapy as a radiotherapy modality, is evolving, albeit the hard evidence for the clinical benefit still is scarce. However, a common goal for the Nordic countries is to include a minimum of 80% of the patients treated with particle therapy into clinical trials. In this paper, we summarize the current status of clinical trials involving particle therapy in the Nordic countries, with an overview of both active and coming trials. So far, one is closed for inclusion and data are being analyzed, seven trials are actively recruiting patients and several more trials are underway. No common Nordic trial has yet been designed, nor is in the planning phase, and the authors will discuss the obstacles as well as the opportunities a common Nordic platform may represent. [ABSTRACT FROM AUTHOR]

Background: Regular physical activity (PA) promotes and excessive sedentary behavior (SB) deteriorates health. Yet the Finnish working-aged population spends most of the day sitting. A 1-year Moving To Business (MTB) -intervention supported small and medium-size workplaces to combat sedentariness. This paper reports the changes in employees' PA and SB from before MTB (baseline) to 1 year after baseline (follow-up).Methods: Twelve workplaces with a total of 396 employees participated. Each workplace nominated a team to promote PA and reduce SB at organizational, working unit and employee level. The teams were mentored regionally through meetings, workshop and tools. Changes in PA and SB were assessed with a questionnaire and an accelerometer. Wald Confidence Interval (Cl) for a difference of proportions with matched pairs was used in the questionnaire data (%-points with 95% CI) and linear mixed model in the accelerometer data (minutes and % of wear-time with 95% CI).Results: The mean age of the respondents to the questionnaire (N = 296; 75%) was 42.6 (SD 10.9), 64% were women, 95% had some education after high school, 74% worked in the day shift, 71% did sedentary work and 51% were overweight. The mean number of actions implemented in the workplaces was 6.8 and the multilevel approach was fully applied in 6 workplaces. Based on the questionnaire the time spent in SB decreased from baseline to follow-up 16% (95% CI -29 to -3) in total and 22% (-41 to -3) at work. The accelerometer showed daily increases of 33.7 min (15.3 to 52.1) and 6.8% (3.1 to 10.4) in total PA, 30.9 min (15.3 to 46.5) and 6.1% (2.9 to 9.2) in light PA and 673 (209 to 1139) more steps at work. Daily SB at work decreased 44.9 min (-68.0 to -21.8) and 7.6% (-11.9 to -3.2). Daily leisure PA declined 11.0 min (-24.9 to 2.9) and 3.2% (-6.2 to -0.2). Number of levels or actions had no effect on changes.Conclusions: Employees' PA increased and SB reduced at work during the intervention. At the same time leisure PA decreased slightly. Workplaces can achieve meaningful changes in employees' PA and SB if assisted systematically. Controlled studies are needed to confirm the present findings.Trial Registration: NCT01999205 , registration date 11/01/2013. [ABSTRACT FROM AUTHOR]

The AGE study is a national randomised, long-term, multicentre research project aimed at comparing a new network-based rehabilitation programme with the use of standard health and social services. The use of home help services is associated with increasing age, living alone and having difficulties with activities of daily living. During a rehabilitation intervention the elderly participants’ need for care can be assessed. The focus of this paper is to investigate the possible effects of the network-based rehabilitation programme on the use of informal and formal support among home-dwelling elderly at a high risk of long-term institutionalisation. The randomised controlled trial with a 12-month follow-up was implemented in 7 rehabilitation centres and 41 municipalities in Finland. The participants were recruited between January and October 2002. A total of 708 home-dwelling persons aged 65 years or older with progressively decreasing functional capacity and at the risk of being institutionalised within 2 years participated. Persons with acute or progressive diseases or poor cognitive capacity (Mini Mental State Examination < 18 points), and those who had participated in any inpatient rehabilitation during the preceding 5 years, were excluded. Participants were randomly allocated to the intervention group ( n = 343) or to the control group ( n = 365). The intervention consisted of a network-based rehabilitation programme specifically designed for frail elderly people. Main outcome measures included the help received from relatives and municipal or private services. The use of municipal services increased more in the intervention group ( P < 0.05) than in the control group. Support from relatives decreased in the control group. The rehabilitees’ ability to manage with daily activities decreased and they received additional help; hence, in this respect the rehabilitation model seems successful. A longer follow-up within the still ongoing AGE study is needed to verify whether the programme actually can delay long-term care. [ABSTRACT FROM AUTHOR]

Background: Radium‐233 dichloride is an alpha emitter that specifically targets bone metastases in prostate cancer. Results of a previously reported phase III randomized trial showed survival benefit for radium‐223 compared to best supportive care in castration‐resistant prostate cancer (CRPC) with bone metastases. However, real‐world data are also needed with wider inclusion criteria. Methods: We report results of a retrospective multicenter study including all patients with metastatic CRPC treated with radium‐223 in all five university hospitals in Finland since the introduction of the treatment. We identified 160 patients who had received radium‐223 in Finland in 2014–2019. Results: The median overall survival (OS) was 13.8 months (range 0.5–57 months), and the median real‐world progression‐free survival (rwPFS) was 4.9 months (range 0.5–29.8 months). Alkaline phosphatase (ALP) values within the normal range before and during the radium‐223 treatment or the reduction of elevated ALP to normal range during treatment were associated with better OS when compared to elevated ALP values before and during treatment (p < 0.0001). High prostate‐specific antigen (PSA) level (≥100 μg/L) before radium‐223 treatment was associated with poor OS compared to low PSA level (<20 μg/L) (p = 0.0001). Most patients (57%) experienced pain relief. Pain relief indicated better OS (p = 0.002). Radium‐223 treatment was well tolerated. Toxicity was mostly low grade. Only 12.5% of the patients had grade III–IV adverse events, most commonly anemia, neutropenia, leucopenia, and thrombocytopenia. Conclusion: Radium‐223 was well tolerated in routine clinical practice, and most patients achieved pain relief. Pain relief, ALP normalization, lower baseline PSA, and PSA decrease during radium‐223 treatment were prognostic for better survival. The efficacy of radium‐223 in mCRPC as estimated using OS was comparable to earlier randomized trial in this retrospective real‐world study. Our results support using radium‐223 for mCRPC patients with symptomatic bone metastases even in the era of new‐generation androgen receptor‐targeted agents. [ABSTRACT FROM AUTHOR]

Mepolizumab treatment provides clinical benefits for patients with severe eosinophilic asthma in randomized controlled trials. However, real-world data for patients in Finland are lacking. This retrospective, non-interventional, chart review study included patients with severe eosinophilic asthma ≥18 years of age initiating mepolizumab between January 1, 2016 and January 31, 2019 at three investigational sites in Finland. Patient characteristics during the 12 months prior to mepolizumab initiation (baseline) were recorded and primary and secondary endpoints included changes from baseline in disease outcomes during follow-up (up to 24 months following mepolizumab initiation). Exploratory endpoints included association between patient characteristics and exacerbation frequency/annual cumulative oral corticosteroid (OCS) dose. Overall, 51 patients were included (mean 17.8 months follow-up). At baseline, patients had a mean (standard deviation) blood eosinophil count of 550 (410) cells/µL; impaired lung function and health-related quality of life; poor symptom control; frequent exacerbations (2.78/year); and 90% were using OCS (mean: 9.80 mg/day). At the last follow-up visit, reductions from baseline in blood eosinophil count (84%) and fractional exhaled nitric oxide (26%) were observed, as were improvements in Asthma Quality of Life Questionnaire score (36%) and Asthma Control Test score (34%). Reductions in the mean number of annual exacerbations (82%) and mean daily OCS dose (39%) were also seen; reductions were observed even after adjustment for several patient baseline characteristics. Results are consistent with previous randomized clinical trials, indicating that Finnish patients experience clinically relevant improvements when treated with mepolizumab in real-world clinical practice. [ABSTRACT FROM AUTHOR]

Aims: Use of nonsteroidal anti‐inflammatory drugs (NSAIDs) can cause damage to the gastric and duodenal mucosa. Some probiotics have proven useful in ameliorating the harmful side‐effects of NSAIDs. Our aim was to evaluate whether oral administration of Bifidobacterium animalis ssp. lactis 420 (B420) can attenuate the increase of calprotectin excretion into faeces induced by intake of diclofenac sustained‐release tablets. Methods: A double‐blind, parallel‐group, placebo‐controlled and randomized clinical study was performed in 50 healthy male and female volunteers aged 20–40 years, in Finland. Study participation consisted of 4 phases: run‐in, intervention with B420 or placebo, B420 or placebo + NSAID treatment, and follow‐up. The primary outcome was the concentration of calprotectin in faeces. Secondary outcomes were haemoglobin and microbial DNA in faeces and blood haemoglobin levels. Results: Intake of diclofenac increased the faecal excretion of calprotectin in both groups. The observed increases were 48.19 ± 61.55 μg/g faeces (mean ± standard deviation) in the B420 group and 31.30 ± 39.56 μg/g in the placebo group (difference estimate 16.90; 95% confidence interval: −14.00, 47.77; P =.276). There were no significant differences between the treatment groups in changes of faecal or blood haemoglobin. Faecal B. lactis DNA was much more abundant in the B420 group compared to the placebo group (ANOVA estimate for treatment difference 0.85 × 109/g faeces; 95% confidence interval: 0.50 × 109, 1.21 × 109; P <.0001). Conclusions: Short‐term administration of the probiotic B420 did not protect the healthy adult study participants from diclofenac‐induced gastrointestinal inflammation as determined by analysis of faecal calprotectin levels. [ABSTRACT FROM AUTHOR]

Aims: The aim of this study was to evaluate the effects of nurse-led health coaching on adherence to health regimens and lifestyle factors among frequent attenders in primary health care. Methods: One hundred and ten patients were enrolled in the quasi-experimental study. The experimental group (n = 52) received nurse-led health coaching and the control group (n = 58) received conventional care at primary healthcare centres between 2015 and 2016. Data were collected before the intervention and 12 months afterwards using a questionnaire on adherence to health regimens and lifestyle factors. The intervention consisted of individual health coaching provided by a nurse, healthcoaching sessions, and a written action plan. [ABSTRACT FROM AUTHOR]

Overweight and obesity are increasing globally. General practitioners (GP's) are at the first point of contact for medical support and consequently have a major role in resolving this overwhelming problem. The aim of this study was to assess the effectiveness of a brief lifestyle counselling on weight management and on the participants' quality of life (QoL). A cohort study with a one-year follow-up. Occupational health care, city of Pori in southwestern Finland. Female municipal employees (n = 625) with a mean age of 48 (SD 9) years. A nurse and a physiotherapist gave lifestyle counselling to all the participants; however, only the overweight/obese subjects were recommended to lose at least 5% of their initial weight. Success in weight management and quality of life. At the follow-up visit, 10.4% (95% CI: 7.5–14.0) of the overweight/obese subjects had lost at least 5% of their weight, but 10.0% (95% CI: 6.7–14.3) of the normal-weight participants had become overweight. The mean weight change was +0.1 kg (95% CI: −0.3–0.5) in the overweight/obese group and +0.5 kg (95% CI: 0.2–0.8) in the normal weight group. The change in QoL was inversely correlated with relative weight change in overweight/obese subjects, albeit the effect size was small. Weight management counselling should also be directed to individuals with a normal weight. Even with brief lifestyle counselling it may be possible to stabilize weight gain. Successful weight loss may improve the QoL of overweight/obese individuals. Primary health care has to deal with the increasing problem of overweight and obesity. Brief lifestyle counselling performed by a nurse and a physiotherapist seems to be quite effective in weight stabilization, considering the effort needed. People with normal weight tend to gain weight and weight management counselling should also be directed to them. Successful weight management may improve the quality of life of overweight/obese people. [ABSTRACT FROM AUTHOR]

Clinical trials for the treatment of schizophrenia now often include cognitive assessments in addition to clinical ratings of symptoms. Recently, these trials have included cross-national assessments. It is not clear if translated psychological tests produce consistent results across different languages. This paper presents the results of a study of the comparability of the results of cognitive assessments in different English-speaking countries and a number of countries where tests were translated into other languages. Performance on tests of executive functioning, verbal and visuo-spatial learning and memory, language skills, psychomotor speed, and vigilance was compared across the first episode patients with schizophrenia (n=301) assessed in six different languages (English, French, Finnish, German, Hebrew, and Afrikaans), including two different countries where patients were assessed in English and other languages: Canada (French) and South Africa (Afrikaans). The variance in performance across the sites tested in English was as large as the variance between English and non-English speakers when all tests were considered. Performance differences across English and other languages were found only for executive functions, vigilance, and psychomotor speed, with executive functioning differences nonsignificant when education was considered. No differences were found between English and non-English speakers in Canada. These results suggest that the translation of tests of memory and verbal skills can lead to consistent results across translated versions of the tests. Differences between countries were greater than differences between languages, suggesting the need to consider representativeness of patient samples in terms of local educational attainment. In general, these data support the validity of cross-national neuropsychological assessments. [Copyright &y& Elsevier]

This article is a review of four major studies that were conducted about physical activity and type 2 diabetes. These landmark clinical trials that assessed the affects of physical activity on type 2 diabetes were conducted in Sweden, China, Finland, and the United States. Results from the studies showed that diabetes development decreased across all age groups, genders, and across ethnic groups as a result of physical activity. These results showed that a lifestyle of moderate intensive aerobic physical activity played a life-sustaining role in type 2 diabetes reduction and prevention.

Objectives: To assess the long-term efficacy of arthroscopic subacromial decompression (ASD) by comparing it with diagnostic arthroscopy (primary comparison), a placebo surgical intervention, and with a non-operative alternative, exercise therapy (secondary comparison).Methods: We conducted a multicentre, three group, randomised, controlled superiority trial. We included 210 patients aged 35-65 years, who had symptoms consistent with shoulder impingement syndrome for more than 3 months. 175 participants (83%) completed the 5 years follow-up. Patient enrolment began on 1 February 2005 and the 5-year follow-up was completed by 10 October 2018. The two primary outcomes were shoulder pain at rest and on arm activity measured with Visual Analogue Scale (VAS). Minimally important difference (MID) was set at 15. We used a mixed-model repeated measurements analysis of variance with participant as a random factor, the baseline value as a covariate and assuming a covariance structure with compound symmetry.Results: In the primary intention to treat analysis (ASD vs diagnostic arthroscopy), there were no between-group differences that exceeded the MID for the primary outcomes at 5 years: the mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -2.0 (95% CI -8.5 to 4.6; p=0.56) at rest and -8.0 (-17.3 to 1.3; p=0.093) on arm activity. There were no between-group differences in the secondary outcomes or adverse events that exceeded the MID. In our secondary comparison (ASD vs exercise therapy), the mean differences between groups (ASD minus exercise therapy) in pain VAS were 1.0 (-5.6 to 7.6; p=0.77) at rest and -3.9 (-12.8 to 5.1; p=0.40) on arm activity. There were no significant between-group differences for the secondary outcomes or adverse events.Conclusions: ASD provided no benefit over diagnostic arthroscopy (or exercise therapy) at 5 years for patients with shoulder impingement syndrome. [ABSTRACT FROM AUTHOR]

BACKGROUND: Over-ground robotic lower limb exoskeletons are safe and feasible in rehabilitation with individuals with spinal cord injury (SCI) and stroke. Information about effects on stroke rehabilitees is scarce and descriptions of learning process and user experience is lacking. OBJECTIVE: The objectives of this study were to describe how rehabilitees learn exoskeleton use, to study effects of exoskeleton assisted walking (EAW) training, and to study rehabilitees' user experiences. METHODS: One-group pre-test post-test pre-experimental study involved five rehabilitees with stroke or traumatic brain injury (TBI). Participants in chronic phase underwent twice a week an 8-week training intervention with Indego exoskeleton. Process of learning to walk and the level of assistance were documented. Outcome measurements were conducted with 6-minute and 10-meter walk tests (6 MWT, 10 mWT). User experience was assessed with a satisfaction questionnaire. RESULTS: Rehabilitees learnt to walk using the exoskeleton with the assistance from 2–3 therapists within two sessions and progressed individually. Three participants improved their results in 10 mWT, four in 6 MWT. The rehabilitees felt comfortable and safe when using and exercising with the device. CONCLUSION: Indego exoskeleton may be beneficial to gait rehabilitation with chronic stroke or TBI rehabilitees. The rehabilitees were satisfied with the exoskeleton as a rehabilitation device. [ABSTRACT FROM AUTHOR]

Biobank operations started officially in Finland in 2013 when the Biobank Act defining and regulating biobank operations came into force. Since then, ten biobanks have been established and they have started to collect new prospective samples with broad consent. The main corpus of biobank samples, however, consists of approximately 10 million "legacy samples". These are old diagnostic or research samples that were transferred to biobanks in accordance with the Biobank Act. The focus of this article is on ambiguities concerning these legacy samples and their transfer in terms of legality, human rights, autonomy, and social sustainability. We analyse the Finnish biobank operations in the context of international regulation, such as the European Convention of Human Rights, the Oviedo Convention, European Charter of Fundamental Rights, the GDPR, and EU Clinical Trials Regulation, and show that the practice of using legacy samples is at times problematic in relation to this regulatory framework. We argue that the prevailing interpretations of these regulations as translated into the Finnish biobank practices undermine the autonomy of individuals by not giving individuals a right to consent or an actionable right to opt-out of the transfer of these legacy samples to the biobank. This is due to the fact that individuals are not given effective notification of such transfers. Thus, issues regarding the legal status of the biobank samples and the social sustainability of biobank operations remain a challenge for biobanks in Finland despite governmental efforts to create pioneering, comprehensive, and enabling legislation. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article "Cross-sectional studies and methodology," by R. Patil and colleagues in the September, 2012 issue.

BACKGROUND: In this study, we examined the development of children's moderate to vigorous physical activity (MVPA) and physical education (PE) enjoyment through the Physical Activity as Civil Skill Program 2012‐2014. METHODS: Participants were 661 (265 intervention, 396 control) elementary school children in central and northeast Finland. The program was implemented across 2 years with 3 measurement phases using self‐reported MVPA and PE enjoyment, and accelerometer‐determined MVPA of a random subsample (N = 76). RESULTS: The proportion of children meeting the current MVPA guidelines declined from 38% to 22% (intervention) and 14% to 9% (control), whereas PE enjoyment was stable in both groups. Boys were more physically active than girls only within control group children. Teachers' feedback indicated that violence and bullying among intervention students reduced during the program, which can be considered as an additional benefit. CONCLUSIONS: It may be that both MVPA and PE enjoyment may require more tailored actions to be increased across a long‐term program. It is important to ensure that school‐based physical activity programs, especially including transition from elementary to middle school level, provide all children positive experiences, and thus, may improve their motivation, and MVPA participation during school days and leisure time. [ABSTRACT FROM AUTHOR]

High-intensity interval training (HIIT)- related neuromuscular adaptations, changes in force production, and on-ice performance were investigated in female ice-hockey players during preseason. Fourteen Finnish championship level ice-hockey players (average age 22 ± 3 years) participated in 2 1/2-week HIIT. Both spinal (H-reflex) and supraspinal (V-wave) neuromuscular responses of the soleus muscle were recorded before and after the training period. Static jump (SJ) and countermove¬ment jump heights, plantarflexor maximum voluntary contraction (MVC), and rate of force development (RFD) were measured. In addition, soleus and tibialis anterior muscle activations (electromyography) were measured during MVC and RFD tests. During on-ice training, skating speed and acceleration tests were performed. Subjects significantly improved their plantarflexion MVC force (11.6 ± 11.2%, p < 0.001), RFD (15.2 ± 15.9%, p < 0.01), and SJ (4.8 ± 7.6%, p ≤ 0.05). Voluntary motor drive to the soleus muscle (V-wave amplitude) increased by 16.0 ± 15.4% (p < 0.01), and coactivation of the tibialis anterior muscle during the plantarflexion RFD test was reduced by -18.9 ± 22.2% (p < 0.05). No change was observed in spinal a-motoneuron excitability (H-reflex) during MVC or in on-ice performance. These results indicate that HIIT can be used to improve athletes' capability to produce maximal and explosive forces, likely through enhanced voluntary activation of their muscles and reduced antagonist coactivation. Therefore, HIIT can be recommended in preseason training to improve neuromuscular performance. However, a longer than 2 1/2-week HIIT period is needed to improve on-ice performance in female ice-hockey players. [ABSTRACT FROM AUTHOR]

Objective: To determine the safety and effectiveness of female sterilisation in the Finnish population.Design: A national register-based study using record linkage.Setting: National data from Finland.Sample: A total of 16 272 female sterilisations performed in 2009-2014.Methods: The Register of Sterilisations was linked with the Hospital Discharge Register, Termination of Pregnancy Register, and the Medical Birth Register in order to investigate the occurrence of re-sterilisations, other surgical operations, and unwanted pregnancies after sterilisation, per method.Main Outcome Measures: Outcome measures included all pregnancies after sterilisation (births, miscarriages, terminations of pregnancy, and ectopic pregnancies) and operations (repeat sterilisations, other hysteroscopic and laparoscopic procedures, hysterectomies, and re-operations for a complication). The outcomes were presented by method as risk ratio (RR) with 95% confidence intervals (95% CIs).Results: There was no significant difference in all spontaneous pregnancies between the groups. The risk ratio for any pregnancy was 1.27 (95% Cl 0.80-2.02) for Filshie® versus Essure® and 1.35 (95% Cl 0.92-1.96) for Pomeroy versus Essure® . In total, 1394 (8.6%) selected operations were identified after primary sterilisation. Re-sterilisations and hysteroscopies were most frequent among Essure® patients.Conclusions: Patients undergoing hysteroscopic or laparoscopic sterilisation have a similar risk of unintended pregnancy. All sterilisations are safe, and the risk of re-operations because of complications is low. Women with Essure® have a higher risk of undergoing re-sterilisation compared with patients undergoing laparoscopic sterilisation.Tweetable Abstract: Essure® , Filshie® , and Pomeroy sterilisations are equally effective and safe. [ABSTRACT FROM AUTHOR]

Background: Clinical trials (CTs) are the "gold standard" to ensure the development of new effective treatments in medicine. A study was conducted to assess knowledge of, and attitudes toward, clinical trials among patients with Parkinson's disease (PD), along with factors that motivate them to participate.Methods: A 50-item questionnaire on the views of patients with PD about CTs was developed. It included statements that the respondents assessed on a Likert scale from 1 ("strongly disagree") to 5 ("strongly agree"). The questionnaire was mailed to a random sample (n = 2000) of members of the patient organization the Finnish Parkinson Association. In all, 708 response forms were returned, of which 681 were accepted after exclusion (a 34% response rate).Results: In general, attitudes of patients with PD toward CTs were positive. Older subjects and patients with lower education levels had inadequate knowledge of general issues related to CTs. Older age, low level of education, and lower number of PD medications were significant predictors for failure to understand the nature and purpose of clinical research. Additionally, significant positive correlation was found between education level and willingness to participate in CTs.Conclusions: Patients with PD have important gaps in their knowledge of methodological issues associated with CTs. The oldest subjects and those with a low level of education have the greatest information needs. Investigators should pay more attention to ensuring the comprehensibility of the information provided to potential CT participants. [ABSTRACT FROM AUTHOR]

Background: Atrial fibrillation (AF) is often asymptomatic and undiagnosed until an ischaemic stroke occurs. An irregular pulse is a key manifestation of AF. We assessed whether pulse self-palpation is feasible in screening of AF.Methods: Altogether 205 residents of Lieto municipality aged ≥75 years were randomized in 2012 to receive brief education on pulse palpation focusing on evaluating rhythm regularity. Self-detected pulse irregularity and new AF diagnoses were recorded, and the subjects' quality of life and use of health care services were assessed during a three-year follow-up.Results: The subjects' median age was 78.2 [3.8] years, and 89 (43.4%) were men. Overall, 139 (68%) subjects had initial good motivation/capability for regular palpation. At four months, 112 (80.6%) subjects with good and 26 (39.4%) with inadequate motivation/capability palpated their pulse daily. At 12 months, 120 (58.5%) and at 36 months, 69 (33.7%) subjects palpated their pulse at least weekly. During the intervention, 67 (32.7%) subjects reported pulse irregularity. New AF was found in 10 (4.9%) subjects, 7 (70%) of whom had reported pulse irregularity. Pulse irregularity independently predicted new AF, but only one (0.5%) subject with new AF sought undelayed medical attention due to pulse irregularity. Quality of life and number of outpatient clinic visits remained unchanged during follow-up.Conclusion: Pulse palpation can be learned also by the elderly, but it is challenging to form a continuing habit. The low persistence of pulse self-palpation limits its value in the screening of AF, and strategies to promote persistence and research on alternative screening methods are needed.Trial Registration: http://www.ClinicalTrials.gov identifier: NCT01721005. The trial was registered retrospectively on October 26, 2012. [ABSTRACT FROM AUTHOR]

BackgroundDiscontinuity of spirometry reference values from childhood into adulthood has been a problem with traditional reference values, thus modern modelling approaches using smoothing spline functions to better depict the transition during growth and ageing have been recently introduced. Following the publication of the new international Global Lung Initiative (GLI2012) reference values also new national Finnish reference values have been calculated using similar GAMLSS-modelling, with spline estimates for mean (Mspline) and standard deviation (Sspline) provided in tables. The aim of this study was to produce polynomial estimates for these spline functions to use in lieu of lookup tables and to assess their validity in the reference population of healthy non-smokers.MethodsLinear regression modelling was used to approximate the estimated values for Mspline and Sspline using similar polynomial functions as in the international GLI2012 reference values. Estimated values were compared to original calculations in absolute values, the derived predicted mean and individually calculated z-scores using both values.ResultsPolynomial functions were estimated for all 10 spirometry variables. The agreement between original lookup table-produced values and polynomial estimates was very good, with no significant differences found. The variation slightly increased in larger predicted volumes, but a range of −0.018 to +0.022 litres of FEV1 representing ± 0.4% of maximum difference in predicted mean.ConclusionsPolynomial approximations were very close to the original lookup tables and are recommended for use in clinical practice to facilitate the use of new reference values. [ABSTRACT FROM PUBLISHER]

In a randomised clinical trial with a longitudinal outcome, analyses of the efficacy of the study treatments may be complicated by both non-trial interventions, which have not been administered by the researcher, and sparsely measured outcome values. The delay between the change in outcome and the starting of the non-trial intervention may be much shorter than the time intervals between the actual measurements. We propose a model that accounts for the possible dynamic interdependence between the longitudinal outcome and time-to-event data. The model is based on discretising time into short intervals. This results in a missing data problem, which we tackle using Bayesian inference and data augmentation. The method is based on the assumption that decisions to initiate non-trial interventions are not confounded by unobservable factors. The Helsinki Psychotherapy Study data are used as an illustration. Different psychotherapies were compared, and possible episodes of psychotropic medication were viewed as non-trial interventions. Simulation studies suggest that our method provides reasonable estimates of the effects of both the study treatment and the non-trial intervention also showing some robustness against possible latent background factors. An application of marginal structural modelling, however, appeared to underestimate the differences between the treatments. [ABSTRACT FROM AUTHOR]

Objectives: To describe the process and feasibility of our randomised, controlled intervention study (NuAD trial) that positively affected the nutrition and quality of life, and prevented falls of home-dwelling persons with Alzheimer disease (AD). Design, setting, participants: This qualitative study comprised 40 persons with AD and spousal caregivers of our trial. Our intervention during one year involved tailored nutritional guidance for these couples. The nutritionist's field notes (about 100 pages) and the participant feedback questionnaires (N = 28) served to analyse the feasibility of intervention, factors promoting the application of intervention and challenges hindering it. Thematic content analysis served to analyse our data with the grounded theory approach. Results: We identified several positive elements promoting better nutrition: positive attitudes on nutrition to participants including a participant-centred approach, positive feedback, findings of food diaries and practical suggestions. Home visits by the nutritionist were convenient and participants felt that someone cares. Group meetings which included protein-rich snacks strengthened the nutritional message by enabling discussions and socialising. The oral nutritional supplements (ONS) helped participants to regain their energy and to motivate them to exercise and make changes in their diets. Obstacles to making changes in diets included participants' false ideas about nutrition, especially with regard to weight gain. Health problems and functional limitations hampered food management, and some families had inveterate eating habits. The positive feedback from participants indicated the feasibility of our tailored nutritional guidance. Conclusions: Assessment-based, tailored nutritional guidance implemented with a personal and positive approach may inspire and empower AD families to make positive changes in their diets, leading them to improved nutrition and quality of life. [ABSTRACT FROM AUTHOR]

The article reports on research which was conducted to investigate whether the drug gefitinib could delay prostate specific antigen (PSA) progression, increase PSA doubling time (PSADT) and postpone the need for hormonal or radiation salvation therapy in patients with rising PSA. Researchers found that gefitinib appeared to increase the PSA doubling time (PSADT) in most patients.

Animal models have contributed significantly to our understanding of the underlying biological mechanisms of Alzheimer's disease (AD). As a result, over 300 interventions have been investigated and reported to mitigate pathological phenotypes or improve behavior in AD animal models or both. To date, however, very few of these findings have resulted in target validation in humans or successful translation to disease-modifying therapies. Challenges in translating preclinical studies to clinical trials include the inability of animal models to recapitulate the human disease, variations in breeding and colony maintenance, lack of standards in design, conduct and analysis of animal trials, and publication bias due to under-reporting of negative results in the scientific literature. The quality of animal model research on novel therapeutics can be improved by bringing the rigor of human clinical trials to animal studies. Research communities in several disease areas have developed recommendations for the conduct and reporting of preclinical studies in order to increase their validity, reproducibility, and predictive value. To address these issues in the AD community, the Alzheimer's Drug Discovery Foundation partnered with Charles River Discovery Services (Morrisville, NC, USA) and Cerebricon Ltd. (Kuopio, Finland) to convene an expert advisory panel of academic, industry, and government scientists to make recommendations on best practices for animal studies testing investigational AD therapies. The panel produced recommendations regarding the measurement, analysis, and reporting of relevant AD targets, the choice of animal model, quality control measures for breeding and colony maintenance, and preclinical animal study design. Major considerations to incorporate into preclinical study design include a priori hypotheses, pharmacokinetics-pharmacodynamics studies prior to proof-of-concept testing, biomarker measurements, sample size determination, and power analysis. The panel also recommended distinguishing between pilot 'exploratory' animal studies and more extensive 'therapeutic' studies to guide interpretation. Finally, the panel proposed infrastructure and resource development, such as the establishment of a public data repository in which both positive animal studies and negative ones could be reported. By promoting best practices, these recommendations can improve the methodological quality and predictive value of AD animal studies and make the translation to human clinical trials more efficient and reliable. [ABSTRACT FROM AUTHOR]

The aim is to document the effectiveness of a preventive family intervention (Family Talk Intervention, FTI) and a brief psychoeducational discussion with parents (Let's Talk about the Children, LT) on children's psychosocial symptoms and prosocial behaviour in families with parental mood disorder, when the interventions are practiced in psychiatric services for adults in the finnish national health service. Patients with mood disorder were invited to participate with their families. Consenting families were randomized to the two intervention groups. The initial sample comprised 119 families and their children aged 8-16. Of these, 109 completed the interventions and the baseline evaluation. Mothers and fathers filled out questionnaires including standardized rating scales for children's symptoms and prosocial behaviour at baseline and at 4, 10 and 18 months post-intervention. The final sample consisted of parental reports on 149 children with 83 complete data sets. Both interventions were effective in decreasing children's emotional symptoms, anxiety, and marginally hyperactivity and in improving children's prosocial behaviour. The FTI was more effective than the LT on emotional symptoms particularly immediately after the intervention, while the effect of the LT emerged after a longer interval. The study supports the effectiveness of both interventions in families with depressed parents. The FTI is applicable in cultural settings other than the USA. Our findings provide support for including preventive child mental health measures as part of psychiatric services for mentally ill parents. [ABSTRACT FROM AUTHOR]

Abstract There are only a few large, population-based epidemiological studies on hearing impairment (HI) in adults. The objective of this study was to investigate the prevalence of HI and possible differences between ears in older adults. The subjects (n = 850), aged 54-66 years, were randomly sampled from the population register. A questionnaire survey, an otological examination, and pure-tone audiometry were performed. Another questionnaire was mailed to collect information on non-participants. The prevalence of HI averaged over the frequencies of 0.5, 1, 2, and 4 kHz for the better ear ≥20 dB HL was 26.7% (men: 36.8%, women: 18.4%). There was no difference between left and right ear pure-tone averages over the frequencies 0.5, 1, 2, and 4 kHz (PTA0.5-4 kHz), but a significant difference of −0.8 dB HL was found for the low frequencies 0.125, 0.25, and 0.5 kHz (PTA0.125-0.5 kHz), and 4.4 dB HL for the high frequencies over 4, 6, and 8 kHz (PTA4-8 kHz). In conclusion, HI was a highly prevalent finding in this age group. Sumario Existen pocos estudios epidemiológicos grandes, basados en la población, sobre impedimentos auditivos (HI) en adultos. El objetivo de este estudio fue investigar la prevalencia de HI y posibles diferencias entre los oídos de adultos mayores. La muestra de sujetos (n = 850), con edades de 54-66 años, se hizo al azar, a partir de registros de población. Se aplicó un cuestionario y se realizó un examen otológico y una audiometría de tonos puros. Otro cuestionario fue enviado por correo para colectar información de los no participantes. La prevalencia de HI promediada en las frecuencias de 0.5, 1, 2, y 4 kHz en el mejor oído, >20 dB HL, fue de 26.7% (hombres: 36.8%; mujeres: 18.4%). No hubo diferencia entre los promedios con tonos puros en oídos derecho o izquierdo en las frecuencias de 0.5, 1, 2, y 4 kHz (PTA 0.5-4 kHz), pero si una diferencia significativa de -0.8 dB HL, encontrada en las frecuencias graves de 0.125, 0.25 y 0.5 kHz (PTA 0.125-0.5 kHz), y 4.4 dB HL en las frecuencias agudas de 4, 6 y 8 kHz (PTA 4-8 kHz). En conclusión, el HI fue un hallazgo altamente prevalente en este grupo de edad. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to investigate the effect of antivirals ritonavir and lopinavir/ritonavir on the pharmacokinetics and pharmacodynamics of oral oxycodone, a widely used opioid receptor agonist used in the treatment of moderate to severe pain. Methods: A randomized crossover study design with three phases at intervals of 4 weeks was conducted in 12 healthy volunteers. Ritonavir 300 mg, lopinavir/ritonavir 400/100 mg, or placebo b.i.d. for 4 days was given to the subjects. On day 3, 10 mg oxycodone hydrochloride was administered orally. Plasma concentrations of oxycodone, noroxycodone, oxymorphone, and noroxymorphone were determined for 48 h. Pharmacokinetic parameters were calculated with standard noncompartmental methods. Behavioral effects and experimental cold pain analgesia were assessed for 12 h. ANOVA for repeated measures was used for statistical analysis. Results: Ritonavir and lopinavir/ritonavir increased the area under the plasma concentration-time curve of oral oxycodone by 3.0-fold (range 1.9- to 4.3-fold; P <0.001) and 2.6-fold (range 1.9- to 3.3-fold; P <0.001). The mean (± SD) elimination half-life increased after ritonavir and lopinavir/ritonavir from 3.6 ± 0.6 to 5.6 ± 0.9 h ( P <0.001) and 5.7 ± 0.9 h ( P <0.001), respectively. Both ritonavir ( P <0.001) and lopinavir/ritonavir ( P <0.05) increased the self-reported drug effect of oxycodone. Conclusions: Ritonavir and lopinavir/ritonavir greatly increase the plasma concentrations of oral oxycodone in healthy volunteers and enhance its effect. When oxycodone is used clinically in patients during ritonavir and lopinavir/ritonavir treatment, reductions in oxycodone dose may be needed to avoid opioid-related adverse effects. [ABSTRACT FROM AUTHOR]

Scand J Caring Sci; 2010; 24; 592–599 Effects of the implementation of the web-based patient support system on staff’s attitudes towards computers and IT use: a randomised controlled trial Utilisation of information technology (IT) in the treatment of people with severe mental health problems is an unknown area in Europe. Use of IT and guiding patients to relevant sources of health information requires that nursing staff have positive attitudes toward computers and accept IT use as a part of daily practises. The aim of the study was to assess the effects of the implementation of a web-based patient support system on staff’s attitudes towards computers and IT use on psychiatric wards. Hundred and forty-nine nurses in two psychiatric hospitals in Finland were randomised to two groups to deliver patient education for patients with schizophrenia and psychosis with a web-based system (n = 76) or leaflets (n = 73). After baseline nurses were followed-up for 18 months after the introduction of the system. The primary outcome was nurses’ motivation to utilise computers, and the secondary outcomes were nurses’ beliefs in and satisfaction with computers, and use of computer and internet. There were no statistically significant differences between study groups in attitudes towards computers (motivation p = 0.936, beliefs p = 0.270, satisfaction p = 0.462) and internet use (p = 0.276). However, nurses’ general computer use (p = 0.029) increased more in the leaflet group than in the IT intervention group. We can conclude that IT has promise as an alternative method in patient education, as the implementation of the web-based patient support system in daily basis did not have a negative effect on nurses’ attitudes towards IT. [ABSTRACT FROM AUTHOR]

A new human parvovirus, human bocavirus, has recently been identified in respiratory secretions, feces and serum. It is associated with lower and most likely also upper respiratory tract infections. Most commonly reported symptoms are cough, rhinorrhea, expiratory wheezing and fever, and the virus is preferentially detected in young children. We report three children with acute lymphoblastic leukemia who had acute febrile episodes with concomitant detection of human bocavirus in their respiratory secretions. One of them had five consecutive febrile episodes during 6 months, all associated with the presence of human bocavirus at varying viral loads, suggesting prolonged shedding or reactivation of the virus. [ABSTRACT FROM AUTHOR]

Background: Evaluating complex interventions in health services faces various difficulties, such as making practice changes and costs. Ways to increase research capacity and decrease costs include making research an integral part of health services and using routine data to judge outcomes. The purpose of this article is to report the feasibility of a pilot trial relying solely on routinely collected register data and being based on ordinary health services. Methods: The example intervention was education to public health nurses (PHN) (childbirth classes) to reduce caesarean section rates via pre-delivery considerations of pregnant women. 20 maternity health centers (MHC) were paired and of each 10 pairs, one MHC was randomly allocated to an intervention group and the other to a control; 8 pairs with successful intervention were used in the analyses (1601 mothers). The women visiting to the study maternity centers were identified from the Customer Register of Helsinki City. A list of the study women was made using the mother's personal identification number, visit date, the maternity center code, birth date and gestation length. The mode of delivery and health outcomes were retrieved from the Finnish Medical Birth Register (MBR). Process data of the intervention are based on observations, written feedback and questionnaires from PHNs, and project correspondence. Results: It took almost two years to establish how to obtain permissions and to actually obtain it for the trial. Obtaining permissions for the customer and outcome data and register linkages was unproblematic and the cluster randomization provided comparable groups. The intervention did not succeed well. Had the main aim of the trial been to cause a change in PHNs behavior, we would have very likely intensified the intervention during the trial. Conclusion: Our experiences encourage the use of trials that obtain their outcomes from registers. Changing the behavior of ordinary health service providers is a challenging intervention. Trial registration number: not registered (see Results) [ABSTRACT FROM AUTHOR]

Current international legal instruments recognise the use of advance directives to carry on the will of the dementing research participant beyond the boundaries of her present legal capacity. Advance directives are gaining greater recognition in patient care than in medical research, where their legal status is still somewhat unclear. In particular, the three major international documents on medical research - the Council of Europe Convention on Biomedicine and Human Rights (ETS 164), its Additional Protocol on Biomedical Research (ETS 195), and Directive 2001/20/EC on Clinical Trials on Medicinal Products--give conflicting messages on the legal status of advance directives in medical research. This article examines the provisions in these documents and their national applications in Finland and the United Kingdom. [ABSTRACT FROM AUTHOR]

Background: Candidate human papillomavirus (HPV) vaccines have demonstrated almost 90%-100% efficacy in preventing persistent, type-specific HPV infection over 18 mo in clinical trials. If these vaccines go on to demonstrate prevention of precancerous lesions in phase III clinical trials, they will be licensed for public use in the near future. How these vaccines will be used in countries with national cervical cancer screening programmes is an important question. Methods and Findings: We developed a transmission model of HPV 16 infection and progression to cervical cancer and calibrated it to Finnish HPV 16 seroprevalence over time. The model was used to estimate the transmission probability of the virus, to look at the effect of changes in patterns of sexual behaviour and smoking on age-specific trends in cancer incidence, and to explore the impact of HPV 16 vaccination. We estimated a high per-partnership transmission probability of HPV 16, of 0.6. The modelling analyses showed that changes in sexual behaviour and smoking accounted, in part, for the increase seen in cervical cancer incidence in 35- to 39-y-old women from 1990 to 1999. At both low (10% in opportunistic immunisation) and high (90% in a national immunisation programme) coverage of the adolescent population, vaccinating women and men had little benefit over vaccinating women alone. We estimate that vaccinating 90% of young women before sexual debut has the potential to decrease HPV type-specific (e.g., type 16) cervical cancer incidence by 91%. If older women are more likely to have persistent infections and progress to cancer, then vaccination with a duration of protection of less than 15 y could result in an older susceptible cohort and no decrease in cancer incidence. While vaccination has the potential to significantly reduce type-specific cancer incidence, its combination with screening further improves cancer prevention. Conclusions: HPV vaccination has the potential to significantly decrease HPV type-specific cervical cancer incidence. High vaccine coverage of women alone, sustained over many decades, with a long duration of vaccine-conferred protection, would have the greatest impact on type-specific cancer incidence. This level of coverage could be achieved through national coordinated programmes, with surveillance to detect cancers caused by nonvaccine oncogenic HPV types. [ABSTRACT FROM AUTHOR]

The purpose of this commentary is to describe the unintended effects ethics committees may have on research and to analyse the regulatory and administrative problems of clinical trials. Discussion: The Finnish law makes an arbitrary distinction between medical research and other health research, and the European Union's directive for good clinical trials further differentiates drug trials. The starting point of current rules is that clinical trials are lesser in the interest of patients and society than routine health care. However, commercial interests are not considered unethical. The contrasting procedures in research and normal health care may tempt physicians to continue introducing innovations into practice by relying on unsystematic and uncontrolled observations. Tedious and bureaucratic rules may lead to the disappearance of trials initiated by researchers. Trying to accommodate the special legislative requirements for new drug trials into more complex interventions may result in poor designs with unreliable results and increased costs. Meanwhile, current legal requirements may undermine the morale of ethics committee members. Conclusion: The aims and the quality of the work of ethics committees should be evaluated, and a reformulation of the EU directive on good clinical trials is needed. Ethical judgement should consider the specific circumstance of each trial, and ethics committees should not foster poor research for legal reasons. [ABSTRACT FROM AUTHOR]

The effectiveness of lifestyle intervention for the prevention of type 2 diabetes has recently been demonstrated. Four clinical trials using lifestyle interventions comprised of weight loss, physical activity, and diet have successfully prevented or delayed the onset of diabetes development in high-risk individuals. As we attempt to translate these results from the clinical trial to the community, it is important to understand the various components of the lifestyle intervention efforts used. After a description of the key lifestyle components of these clinical trials is provided, a discussion of possible suggestions for implementing these findings in the broader community setting is presented. [ABSTRACT FROM AUTHOR]

There have so far been few telemedical applications in orthopaedics. This experiment involved clinicians in three different locations, two in Helsinki and the third in Tampere, consulting one another simultaneously. We used an ATM network to transfer X-ray pictures, digitized by a 12-bit CCD scanner and archived in a central image server. The consultations between the clinicians and the examination of the patient were transmitted by a videoconferencing system using the ISDN. We found that telemedicine offers new possibilities in orthopaedics, for clinical work, for training and for research. [ABSTRACT FROM AUTHOR]

Editorial. Discusses the effect of clinical trials on treatment in myocardial infarction in Finland. Increase in the use of thrombolytics, intravenous nitrates during hospitalization and beta-blockers both during hospitalization and discharge; Acceptance of antiplatelet agents; Decrease in the use of calcium-channel blockers; Increased use of revascularization procedures.

Background: The StopDia study is based on the convincing scientific evidence that type 2 diabetes (T2D) and its comorbidities can be prevented by a healthy lifestyle. The need for additional research is based on the fact that the attempts to translate scientific evidence into actions in the real-world health care have not led to permanent and cost-effective models to prevent T2D. The specific aims of the StopDia study following the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework are to 1) improve the Reach of individuals at increased risk, 2) evaluate the Effectiveness and cost-effectiveness of the digital lifestyle intervention and the digital and face-to-face group lifestyle intervention in comparison to routine care in a randomized controlled trial (RCT), and 3) evaluate the Adoption and Implementation of the StopDia model by the participants and the health care organizations at society level. Finally, we will address the Maintenance of the lifestyle changes at participant level and that of the program at organisatory level after the RCT.Methods: The StopDia study is carried out in the primary health care system as part of the routine actions of three provinces in Finland, including Northern Savo, Southern Carelia, and Päijät-Häme. We estimate that one fifth of adults aged 18-70 years living in these areas are at increased risk of T2D. We recruit the participants using the StopDia Digital Screening Tool, including questions from the Finnish Diabetes Risk Score (FINDRISC). About 3000 individuals at increased risk of T2D (FINDRISC ≥12 or a history of gestational diabetes, impaired fasting glucose, or impaired glucose tolerance) participate in the one-year randomized controlled trial. We monitor lifestyle factors using the StopDia Digital Questionnaire and metabolism using laboratory tests performed as part of routine actions in the health care system.Discussion: Sustainable and scalable models are needed to reach and identify individuals at increased risk of T2D and to deliver personalized and effective lifestyle interventions. With the StopDia study we aim to answer these challenges in a scientific project that is fully digitally integrated into the routine health care.Trial Registration: ClinicalTials.gov . Identifier: NCT03156478 . Date of registration 17.5.2017. [ABSTRACT FROM AUTHOR]

This is an informative article, which describes a clinical trial, conducted using multiple data sources, which provide better case ascertainment than single sources, but less complete ascertainment than community based surveys with cognitive screening. Although studies of young onset dementia differ in methodology and may be based on small numbers which produce less stable estimates, a community based survey in Finland, that included only cases of severe dementia and excluded associated depression reported 4.8 times higher prevalence for all cause dementias in people aged 30-64 years.