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Background: Projections of the development of mobility limitations of older adults are needed for evidence-based policy making. The aim of this study was to generate projections of mobility limitations among older people in the United States, England, and Finland.Methods: We applied multiple imputation modelling with bootstrapping to generate projections of stair climbing and walking limitations until 2026. A physical activity intervention producing a beneficial effect on self-reported activities of daily living measures was identified in a comprehensive literature search and incorporated in the scenarios used in the projections. We utilised the harmonised longitudinal survey data from the Ageing Trajectories of Health - Longitudinal Opportunities and Synergies (ATHLOS) project (N = 24,982).Results: Based on the scenarios from 2012 to 2026, the prevalence of walking limitations will decrease from 9.4 to 6.4%. A physical activity intervention would decrease the prevalence of stair climbing limitations compared with no intervention from 28.9 to 18.9% between 2012 and 2026.Conclusions: A physical activity intervention implemented on older population seems to have a positive effect on maintaining mobility in the future. Our method provides an interesting option for generating projections by incorporating intervention-based scenarios. [ABSTRACT FROM AUTHOR]

Background: Loneliness is common among older adults in institutional settings. It leads to adverse effects on health and wellbeing, for which nature contact with peers in turn may have positive impact. However, the effects of nature engagement among older adults have not been studied in randomised controlled trials (RCT). The "Friends in Nature" (FIN) group intervention RCT for lonely older adults in Helsinki assisted living facilities (ALFs) aims to explore the effects of peer-related nature experiences on loneliness and health-related quality of life (HRQoL). In this study we aim describe the participants' baseline characteristics of the RCT, feasibility of FIN intervention and intervention participants' feedback on the FIN., Methods: Lonely participants were recruited from 22 ALFs in Helsinki area, Finland, and randomised into two groups: 1) nature-based social intervention once a week for nine weeks (n = 162) and 2) usual care (n = 157). Demographics, diagnoses and medication use were retrieved from medical records, and baseline cognition, functioning, HRQoL, loneliness and psychological wellbeing were assessed. Primary trial outcomes will be participants' loneliness (De Jong Giervald Loneliness Scale) and HRQoL (15D)., Results: The mean age of participants was 83 years, 73% were female and mean Minimental State Examination of 21 points. The participants were living with multiple co-morbidities and/or disabilities. The intervention and control groups were comparable at baseline. The adherence with intervention was moderate, with a mean attendance of 6.8 out of the nine sessions. Of the participants, 14% refused, fell ill or were deceased, and therefore, participated three sessions or less. General subjective alleviation of loneliness was achieved in 57% of the intervention participants. Of the respondents, 96% would have recommended a respective group intervention to other older adults. Intervention participants appreciated their nature excursions and experiences., Conclusions: We have successfully randomised 319 lonely residents in assisted living facilities into a trial about the effects of nature experiences in a group-format. The feedback from participants was favourable. The trial will provide important information about possibilities of alleviating loneliness with peer-related nature-based experiences in frail residents., Trial Registration: ClinicalTrials.gov, ID: NCT05507684. Registration 19/08/2022., (© 2024. The Author(s).)

Objectives: To assess the rates and secular trends of different joint arthroscopies-shoulder, elbow, wrist, hip, knee and ankle-in Finland between 1997 and 2016.Design: Retrospective nationwide registry study.Participants: All adults in Finland with any arthroscopic intervention procedure code for knee, shoulder, ankle, wrist, elbow or hip arthroscopy between 1 January 1997 and 31 December 2016 were included.Main Outcome Measures: Incidence rate of arthroscopic surgery per 100 000 person-years.Results: The rate of knee and shoulder arthroscopies declined after reaching a peak in 2006 and 2007, respectively. The rates of wrist, elbow and hip joint arthroscopies declined after their 2014 peak. At the same time, the median age of patients who had knee, ankle and hip arthroscopy decreased, whereas the age of patients who had shoulder arthroscopy increased.Conclusions: Numerous randomised controlled trials point to lack of efficacy of the most common knee and shoulder arthroscopic procedures. It should not be assumed that this has contributed to decreased rates of arthroscopic surgery. The concurrent decrease in most of the other joint arthroscopic procedures was unexpected. [ABSTRACT FROM AUTHOR]

Background: A better insight into older adults' understanding of and attitude towards cognitive disorders and their prevention, as well as expectations and reasons for participation in prevention trials, would help design, conduct, and implement effective preventive interventions. This qualitative study aimed at exploring the knowledge and perceptions of cognitive disorders and their prevention among participants in a prevention trial.Methods: Semi-structured interviews were conducted among the participants of a multinational randomised controlled trial testing the efficacy of a lifestyle-based eHealth intervention in preventing cardiovascular disease or cognitive decline in community dwellers aged 65+. Participants were probed on their reasons for participation in the trial and their views on general health, cardiovascular disease, ageing, and prevention. The subset of data focusing on cognitive disorders (15 interviewees; all in Finland) was considered for this study. Data were analysed using content analysis.Results: Participants' knowledge of the cause and risk factors of cognitive disorders and prevention was limited and superficial, and a need for up-to-date, reliable, and practical information and advice was expressed. Cognitive disorders evoked fear and concern, and feelings of hopelessness and misery were frequently expressed, indicating a stigma. Strong heredity of cognitive disorders was a commonly held belief, and opinions on the possibility of prevention were doubtful, particularly in relation to primary prevention. Family history and/or indirect experiences of cognitive disorders was a recurrent theme and it showed to be linked to both the knowledge of and feelings associated with cognitive disorders, as well as attitude towards prevention. Indirect experiences were linked to increased awareness and knowledge, but also uncertainty about risk factors and possibility of prevention. Distinct fear and concerns, particularly over one's own cognition/risk, and high motivation towards engaging in prevention and participating in a prevention trial were also identified in connection to this theme.Conclusions: Family history and/or indirect experiences of cognitive disorders were linked to sensitivity and receptiveness to brain health and prevention potential. Our findings may be helpful in addressing older adults' expectations in future prevention trials to improve recruitment, maximise adherence, and facilitate the successful implementation of interventions. [ABSTRACT FROM AUTHOR]

Background: Temporomandibular disorders (TMDs) include pain and dysfunction in masticatory muscles and temporomandibular joints (TMJs). Applied relaxation (AR) is a coping skill that may be applicable for treatment of TMD. Objectives: The aim of this randomised, controlled study was to evaluate the effectiveness of AR as compared to stabilisation splint (SS), for treatment of TMD during 12‐month follow‐up. Methods: The data were derived from 96 university students seeking treatment due to TMD symptoms at Finnish Student Health Service in Finland. The subjects were randomly divided into two treatment groups: SS (n = 41) and AR (n = 51) groups. Clinical TMD examinations (a modified version of DC/TMD, Axis I) were performed for both the groups at baseline and 3‐, 6‐ and 12‐month follow‐ups. Depressive and non‐specific physical symptoms (NSPS) were estimated with Axis II questionnaire (RDC/TMD), and a number of other pain sites were screened at baseline and 12‐month follow‐up. Data were analysed by means of chi‐square test for both groups on five variables, t test for VAS pain intensity and repeated measures ANOVA for palpation pain at follow‐up points. Statistical significance was set on P <.05. Results: Decrease in the number of painful masticatory muscles and TMJs and VAS on pain intensity did not differ between groups. During follow‐up, NSPS and number of body pain sites decreased significantly more in the AR than the SS group. The dropout was 56 patients. Conclusion: Neither of the treatments showed more benefit in decreasing local TMD pain. AR gave more benefit on psychological well‐being and general pain symptoms. [ABSTRACT FROM AUTHOR]

Objectives: The primary objective of this study is to evaluate the therapeutic potential of hydroxychloroquine (HCQ) in the treatment of adult patients with PCR-confirmed Covid-19 infection in a primary open-care setting, as compared to placebo. The study hypothesis is that treatment with HCQ will reduce the risk of hospitalization because of Covid-19 infection, and the sample size estimate of the study is based on the need to test this hypothesis. The secondary objectives of the study are: to evaluate the safety and tolerability of HCQ in the treatment of adult patients with PCR-confirmed Covid-19 infection in a primary open-care setting, as compared to placebo; to collect experience of the use of HCQ in the treatment of Covid-19 infection in outpatients, in order to be able to identify patient characteristics that predict specific treatment responses (favourable or unfavourable); this objective will also be addressed by post-hoc subgroup analysis of the study results and by meta-analysis of pooled patient data from other clinical trials of HCQ in outpatients; and to evaluate the impact of Covid-19 infection and its treatment on the mental health and well-being of the study participants. In addition, if the data allow, the study has the following exploratory objectives: to evaluate the extent and duration of SARS-CoV-2 viral shedding by PCR testing of nasopharyngeal swab samples in study subjects treated with HCQ, as compared to placebo; to evaluate the extent and time course of SARS-CoV-2 virus-specific antibody responses in serum of study subjects treated with HCQ, as compared to placebo; to evaluate other possible biomarker changes in blood in study subjects treated with HCQ, as compared to placebo; to explore the possible effects of genetic variation in drug metabolizing enzymes on HCQ-related outcomes in the study population; to explore the associations of HCQ-related outcome variables with other patient characteristics, e.g. HLA haplotypes, HCQ concentrations, demographic variables, disease history and concomitant medications.Trial Design: This is a phase 2, placebo-controlled, double-blind, randomized, parallel-group treatment trial comparing HCQ with placebo in outpatients with Covid-19 infection. Participants will be randomized in a 1:1 ratio to the two treatment arms.Participants: Main inclusion criteria: 1. Males and females >40 years of age, or 18-40 years of age with one or both of the following: i. diabetes mellitus (type 1 or type 2); ii. BMI > 35 kg/m2; 2. Valid independent informed consent obtained; 3. Symptoms typical of Covid-19 infection, according to criteria specified in the study protocol. The onset of symptoms must be within 5 days of enrolment; 4. Positive SARS-CoV-2 PCR test result of a nasopharyngeal swab sample. Main exclusion criteria: 1. Suspected severe or moderately severe pneumonia, presenting with any of the following: respiratory rate > 26 breaths/min; significant respiratory distress; or SpO2 ≤94% on room air; 2. Requiring treatment in the hospital, according to the treating physician's judgement; 3. Any contraindication to treatment with HCQ; 4. Pregnancy or lactation. The trial will be conducted at seven study sites in a primary public health care setting in the region of Satakunta, Finland.Intervention and Comparator: Participants will be randomized to receive either HCQ capsules at 300 mg twice a day for one day and then 200 mg twice a day for 6 days, or placebo capsules for 7 days.Main Outcomes: The primary endpoint of the study is the number of hospitalizations due to Covid-19 infection within four weeks of entry into the study. The secondary endpoints of the study include the following: duration and severity of Covid-19-related symptoms, as reported by daily self-assessments; number of Intensive Care Unit treatment episodes due to Covid-19 infection within four weeks of entry into the study; number of deaths due to Covid-19 infection within four weeks of entry into the study; number of treatment-related adverse events (AEs) and serious AEs (SAEs); all-cause hospitalizations and mortality within six months of entry into the study; and self-assessed symptoms of anxiety, as assessed with repeated administration of the Generalized Anxiety Disorder 7-item scale (GAD-7). The exploratory endpoints of the study include the following: extent and duration of SARS-CoV-2 viral shedding and virus-specific antibody responses in serum; and possible other blood biomarker changes.Randomisation: Eligible study participants are randomly allocated into two treatment arms (1:1 ratio). The randomization list has been generated using Viedoc™ (Viedoc Technologies AB, Uppsala, Sweden) that is used as an electronic data capture system for this study.Blinding (masking): The participants and all study personnel remain blinded to the treatment allocation by having both IMPs packed in identical containers. Masking of the treatments was performed by re-formulation of the IMPs so that the HCQ capsules and the placebo capsules have identical appearance.Numbers To Be Randomised (sample Size): 600 participants are to be randomised with 300 in each arm.Trial Status: Protocol version 2, dated 14 July 2020; recruitment is expected to start in December, 2020, and to be completed in June, 2021.Trial Registration: EudraCT 2020-002038-33 , registered 26 June 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). The protocol has been redacted to conform with privacy regulations by deleting the names and contact information of individuals mentioned in the protocol but not listed as authors in this communication. In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. [ABSTRACT FROM AUTHOR]

Objective This study evaluates how extended childbirth education intervention affects first-time mothers' fear of childbirth and its manifestation during pregnancy. Method A randomised controlled trial was conducted. A total of 659 first-time mothers were recruited before week 14 of gestation during the first ultrasound screening at the hospital's maternity outpatient clinic. The mothers were randomly assigned into an intervention group (n = 338) or a control group (n = 321). The control group received all available regular childbirth education. In addition, the intervention group received an enhanced 2-hour childbirth education at the maternity hospital. Outcome measurements and statistical analysis The objects of childbirth fears (childbirth-related fear, fear for the mother's and the child's well-being, fear related to Caesarean section) were the primary outcomes. The manifestations of childbirth fears (everyday life, stress symptoms and the wish to have a Caesarean section) were the secondary outcomes. These outcomes were measured over 34 weeks of gestation using two parts of the instrument 'Feelings of Fear and Security Associated with Pregnancy and Childbirth'. Logistic and ordinal linear regression models were used to model the effect of the intervention on the outcomes. Findings The mothers in the intervention group had less childbirth-related fear than those in the control group [odds ratio ( OR) 0.58, 95% confidence level ( CL) 0.38-0.88]. Also, fear influenced the mothers in the intervention group less in everyday life than it did the mothers in the control group [ OR 0.64, 95% CL 0.44-0.94]. Conclusion The effectiveness of the intervention can be considered moderate: one of three objects and one of three manifestations of fears were reduced. The intervention proved most efficient in alleviating relatively limited objects of fears. [ABSTRACT FROM AUTHOR]

Observational studies suggest that high iron intake during pregnancy is associated with the risk of gestational diabetes. As such studies are prone to bias, we re‐analysed data from a randomised controlled trial of iron supplementation to see whether it supports the risk found in observational studies. The trial was conducted in primary health care setting in five municipalities in Finland in 1985–1986. The participants were 2944 women (95% of pregnant women in the area) who were randomly allocated either to (1) the selective iron group (elemental iron 50 mg twice a day only if diagnosed as anaemic, continuing until their haemoglobin increased to 110 g L−1) or (2) the routine iron group (elemental iron 100 mg day−1 throughout the pregnancy regardless of haemoglobin level). The numbers of women in the analyses were 1358 and 1336, respectively. The main outcome measure was a composite variable including any glucose intolerance‐related outcome (e.g. glucosuria, gestational diabetes, large‐for‐gestational‐age child) in mothers' or children's patient records during pregnancy and post‐partum. There were no statistically significant differences in the incidence of the primary outcome between the selective iron and the routine iron groups (13.0 vs. 11.0%, P = 0.12). The most common outcome was large‐for‐gestational‐age calculated from children's hospital data (8.3 vs. 8.2%, P = 0.95). The results were mainly similar when stratified by the mothers' baseline haemoglobin level, body mass index or gestational weight gain. Routine iron supplementation throughout pregnancy did not increase the risk of glucose intolerance during pregnancy. The results need to be confirmed in future trials. [ABSTRACT FROM AUTHOR]

Summary The long-term effectiveness of a prefabricated oral appliance (R) was compared with a stabilisation appliance (S) in patients with myofascial pain. Sixty-five patients diagnosed with myofascial pain at two centres for Stomatognathic Physiology in Sweden and Finland were included in a randomised controlled trial using Research Diagnostic Criteria for Temporomandibular Disorders, with history questionnaires and clinical examinations performed by blinded examiners at baseline and at 6- and 12-month follow-ups. Patients were randomly assigned either to the R or the S group. Treatment outcome was measured according to IMMPACT for four chronic pain outcome domains: pain intensity, overall improvement, physical functioning and emotional functioning. Physical functioning was classified for Graded Chronic Pain severities and assessed by the Jaw Functional Limitation scale. Emotional functioning composed of scores of non-specific physical symptoms and depression. There were no differences between groups at baseline. At both follow-ups, all outcome domains showed significant within-group improvement, without significant differences between groups. At 12 months, 72% of all patients reported a 30% reduction in worst pain and 63% of the patients a 50% reduction in worst pain. Overall improvement 'better' to 'symptom-free' was observed in 81% in the R and 64% in the S group at the 12-month follow-up. Graded Chronic Pain, Functional Limitation of the Jaw, non-specific physical symptoms and depression showed statistically significant reduction at 12-month follow-up. Results support the hypothesis that the effectiveness of the prefabricated appliance is similar to that of the stabilisation appliance in the long-term when treating patients with myofascial pain. [ABSTRACT FROM AUTHOR]

Abstract: Background: There are scarce studies exploring effectiveness and feasibility of intensive and long-lasting exercise among patients with dementia. Purpose: To present baseline findings of a randomized controlled trial exploring effectiveness of intensive physical exercise among home-dwelling patients with Alzheimer disease (AD), and to evaluate feasibility of the intervention by exploring feedback from spousal caregivers. Subjects and methods: We used central AD registers in Finland to recruit AD patients (n =210) living with their spousal caregiver in the community. They were randomized into three arms: 1): tailored home-based exercise twice weekly (n =70); 2): group-based exercise in rehabilitation centers twice weekly in (n =70), and; 3): a control group with usual care and information of exercise and nutrition (n =70). Anonymous feedback from spousal caregivers was collected at 6 months of the intervention. Results: The mean age of AD patients was 78.1 years (SD 5.3), 81 (39%) were women, and 104 (50%) were at moderate stage of dementia according to the Clinical Dementia Rating Scale (CDR). Of the caregivers, 94% had made the decision to participate in the trial because of their spouse''s need for rehabilitation, and 93% felt that the study nurses’ assessments had been beneficial for them. Only 16 participants (8%) had dropped out before the first (3-month) follow-up assessment. Conclusion: We have successfully randomized 210 patients with Alzheimer''s disease and their spousal caregivers into an intensive exercise rehabilitation trial. The feedback from spousal caregivers was favourable and drop-out rate low at 6 months. [Copyright &y& Elsevier]

Background: antioxidants might protect against oxidative stress, which has been suggested as a cause of aging.Methods: the Alpha-Tocopherol-Beta-Carotene (ATBC) Study recruited males aged 50–69 years who smoked at least five cigarettes per day at the baseline. The current study was restricted to participants who were followed up past the age of 65. Deaths were identified in the National Death Registry (1,445 deaths). We constructed Kaplan–Meier survival curves for all participants, and for four subgroups defined by dietary vitamin C intake and level of smoking. We also constructed Cox regression models allowing a different vitamin E effect for low and high age ranges.Results: among all 10,837 participants, vitamin E had no effect on those who were 65–70 years old, but reduced mortality by 24% when participants were 71 or older. Among 2,284 men with dietary vitamin C intakes above the median who smoked less than a pack of cigarettes per day, vitamin E extended lifespan by 2 years at the upper limit of the follow-up age span. In this subgroup, the survival curves of vitamin E and no-vitamin E participants diverged at 71 years. In the other three subgroups covering 80% of the participants, vitamin E did not affect mortality.Conclusions: this is the first study to strongly indicate that protection against oxidative stress can increase the life expectancy of some initially healthy population groups. Nevertheless, the lack of effect in 80% of this male cohort shows that vitamin E is no panacea for extending life expectancy. [ABSTRACT FROM AUTHOR]

Loneliness among frail older people predicts increased use of health services, early institutionalisation and increased mortality. The objective of this study was to determine the effects of a new rehabilitation model on loneliness among frail older people. This randomised controlled multi-centre trial with a 12-month follow-up was implemented in Finland. A total of 708 community-dwelling people aged 65+ years with progressively decreasing functional capacity participated. Participants were randomly allocated to the intervention group (n = 343) or to the control group (n = 365). The intervention consisted of a network-based group rehabilitation programme designed for frail older people. A O.9-fold decrease in the proportion of participants feeling lonely was observed in the intervention group and a 1.1-fold increase in the control group. The results suggest that a physically orientated rehabilitation programme may reduce emotional loneliness. [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]

Specificity constitutes a component of validity for a screening test. The number of false-positive (FP) results has been regarded as one of major shortcomings in prostate cancer screening. We estimated the specificity of serum prostate-specific antigen (PSA) determination in prostate cancer screening using data from a randomised, controlled screening trial conducted in Finland with 32 000 men in the screening arm. We calculated the specificity as the proportion of men with negative findings (screen negatives, SN) relative to those with negative and FP results (SN/(SN+FP)). A SN finding was defined as either PSA4 ng ml−1 or PSA 3.0–3.9 ng ml−1 combined with a negative ancillary test (digital rectal examination, DRE or free/total, F/T PSA ratio). False positives were those with positive screening test followed by a negative diagnostic examination. Of the 30 194 eligible men, 20 794 (69%) attended the first screening round and 1968 (9.5%) had a screen-positive finding. A total of 508 prostate cancers were detected at screening (2.4%). Hence, the number of SN findings was 18 825 and the number of FP results 1358. Specificity was estimated as 0.933 (18 825 out of 20 183) with 95% confidence interval (CI) 0.929–0.936. Specificity decreased with age. Digital rectal examination as ancillary examination had similar or higher specificity than F/T PSA. In the second screening round, specificity was slightly lower (0.912, 95% CI 0.908–0.916). The specificity of PSA screening in the Finnish screening trial is acceptable. Further improvement in specificity could, however, improve acceptability of screening and decrease screening costs.British Journal of Cancer (2007) 96, 56–60. doi:10.1038/sj.bjc.6603522 www.bjcancer.com [ABSTRACT FROM AUTHOR]

Introduction: Although a great majority of patients with cervical radiculopathy syndrome can successfully be treated non-operatively, a considerable proportion experience persistent symptoms, severe enough to require neurosurgical intervention. During the past decade, cervical spine procedures have increasingly been performed on an outpatient basis and retrospective database analyses have shown this to be feasible and safe. However, there are no randomised controlled studies comparing outpatient care with inpatient care, particularly with emphasis on the patients' perception of symptom relief and their ability to return to normal daily activities and work., Methods and Analysis: This is a prospective, randomised, controlled, parallel group non-inferiority trial comparing the traditional hospital surveillance (inpatient, patients staying in the hospital for 1-3 nights after surgery) with outpatient care (discharge on the day of the surgery, usually within 6-8 hours after procedure) in patients who have undergone anterior cervical decompression and fusion procedure. To determine whether early discharge (outpatient care) is non-inferior to inpatient care, we will randomise 104 patients to these two groups and follow them for 6 months using the Neck Disability Index (NDI) as the primary outcome. We expect that early discharge is not significantly worse than the current care in terms of change in NDI. Non-inferiority will be declared if the mean improvement for outpatient care is no worse than the mean improvement for inpatient care, by a margin of 17.3%. We hypothesise that a shorter hospital stay results in more rapid return to normal daily activities, shorter duration of sick leave and decreased secondary costs to healthcare system. Secondary outcomes in our study are arm pain and neck pain using the Numeric Rating Scale, operative success (Odom's criteria), patient's satisfaction to treatment, general quality of life (EQ-5D-5L), Work Ability Score, sickness absence days, return to previous leisure activities and complications., Ethics and Dissemination: The study was approved by the institutional review board of the Helsinki and Uusimaa Hospital District on 6 June 2019 (1540/2019) and duly registered at ClinicalTrials.gov. We will disseminate the findings of this study through peer-reviewed publications and conference presentations., Trial Registration Number: NCT03979443., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Few empirical analyses of the impact of organised prostate cancer (PCa) screening on healthcare costs exist, despite cost-related information often being considered as a prerequisite to informed screening decisions. Therefore, we estimate the differences in register-based costs of publicly funded healthcare in the two arms of the Finnish Randomised Study of Screening for Prostate Cancer (FinRSPC) after 20 years., Methods: We obtained individual-level register data on prescription medications, as well as inpatient and outpatient care, to estimate healthcare costs for 80,149 men during the first 20 years of the FinRSPC. We compared healthcare costs for the men in each trial arm and performed statistical analysis., Results: For all men diagnosed with PCa during the 20-year observation period, mean PCa-related costs appeared to be around 10% lower in the screening arm (SA). Mean all-cause healthcare costs for these men were also lower in the SA, but differences were smaller than for PCa-related costs alone, and no longer statistically significant. For men dying from PCa, although the difference was not statistically significant, mean all-cause healthcare costs were around 10% higher. When analysis included all observations, cumulative costs were slightly higher in the CA; however, after excluding extreme values, cumulative costs were slightly higher in the SA., Conclusions: No major cost impacts due to screening were apparent, but the FinRSPC's 20-year follow-up period is too short to provide definitive evidence at this stage. Longer term follow-up will be required to be better informed about the costs of, or savings from, introducing mass PCa screening., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Objective: To assess the representativeness of the Heart Protection Study (HPS) and the Collaborative Atorvastatin Diabetes Study (CARDS) for incident statin users., Design: A population-based analysis with linked register data., Setting: Finland., Population: 56 963 patients with diabetes initiating statin use from 2005 to 2008., Main Outcome Measures: We determined the proportions of real-world patients who fulfilled the eligibility criteria for HPS and CARDS trials and assessed the cardiovascular disease (CVD) event rates, assumed to reflect the background CVD risk, for those eligible and ineligible. We used descriptive statistics to identify the patient characteristics, lipid-lowering interventions and adherence to statin therapy., Results: Of the real-world patients, 57% (N=32 582) fulfilled the eligibility criteria for HPS (DM) and 49% (N=20 499) of those without CVD for CARDS. The patients ineligible for HPS (DM) had a higher cumulative risk for CVD events than those eligible, whereas regarding CARDS the cumulative risks were of similar magnitude. The overall CVD event rates seemed to be comparable to those in the reviewed trials. Both trials were under-representative of women and users of antihypertensive agents and metformin. 27% and 29% of real-world patients had an initial statin dose corresponding to <20 mg of simvastatin. The proportions of patients who were deemed adherent were 57% in the real world and 85% in both trials., Conclusions: Only half of the real-world patients would have qualified for the HPS (DM) and CARDS, limiting their representativeness for clinical practice. Women and users of antihypertensive agents and metformin were under-represented in both trials. These deviations reflect the changes in diabetes treatment over the years and are not expected to modify the average treatment effects of statins on CVD. Prescribing of lower statin doses in clinical practice than used in the trials and lower adherence may, however, attenuate the benefits in the real world., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Objective: To investigate the anatomical cure rate and complications related to collagen-coated mesh for cystocele, compared with a conventional anterior colporrhaphy., Design: A randomised controlled study., Setting: Six departments of obstetrics and gynaecology in Norway, Sweden, Finland, and Denmark., Population: Women aged 55 years or older, referred for surgery with a prolapse of the anterior vaginal wall of stage 2 or higher., Methods: Women scheduled for primary cystocoele surgery were randomised to either anterior colporrhaphy or a collagen-coated Prolene mesh. Power analysis indicated that 130 patients had to be randomised. All patients were evaluated using the Pelvic Organ Prolapse-Quantification (POP-Q) measurement. Quality of life, symptoms, and sexual function were evaluated using the Pelvic Floor Impact Questionnaire, the Pelvic Floor Distress Inventory, and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire., Main Outcome Measures: The primary outcome was objective cure, defined as prolapse below POP-Q stage 2 at the 12-months follow-up. Secondary outcomes were quality of life, symptoms, and presence (or not) of complications., Results: In total, 161 women were randomised to either anterior colporrhaphy or mesh (participant ages 64.9 ± 6.4 years versus 64.7 ± 6.6 years, respectively; mean ± SD). The objective cure rate was 39.8% (95% CI 28.6-50.9%) in the anterior colporrhaphy group, compared with 88.1% (95% CI 80.7-95.6%) in the mesh group (P < 0.001). Vaginal mesh exposure occurred in ten women (13.3%) and dyspareunia occurred in two women (2.7%, not significant) in the mesh group at the 12-months follow-up. Questionnaires revealed no difference between the groups., Conclusions: Our study demonstrates a significantly improved objective cure rate associated with a high exposure rate among women with mesh surgery as opposed to conventional surgery., (© 2013 Royal College of Obstetricians and Gynaecologists.)

Background: Evidence of the potential impact of systematic screening for prostate cancer (PCa) on health-related quality of life (HRQoL) at a population-based level is currently scarce., Objective: This study aims to quantify the long-term HRQoL impact associated with screening for PCa., Design, Setting, and Participants: Postal questionnaire surveys were conducted in 1998, 2000, 2004, and 2011 among men in the Finnish PCa screening trial diagnosed with PCa (total n=7011) and among a random subsample of the trial population (n=2200). In 2011, for example, 1587 responses were received from men with PCa in the screening arm and 1706 from men in the control arm. In addition, from the trial subsample, 549 men in the screening arm and 539 in the control arm provided responses., Outcome Measurements and Statistical Analysis: Health-state-value scores were compared between the intervention and control arms using three distinct HRQoL measures (15D, EQ-5D, and SF-6D), and statistical significance was assessed using t tests. In addition, differences over repeated assessments of HRQoL between groups were evaluated using generalised estimating equations., Results and Limitations: In the 2011 survey, a small but statistically significant difference emerged between the trial arms among men diagnosed with PCa (mean scores, screening vs control arm: 15D: 0.872 vs 0.866, p=0.14; EQ-5D: 0.852 vs 0.831, p=0.03; and SF-6D: 0.763 vs 0.756, p=0.06). Such differences in favour of the screening arm were not found among the sample of men from the trial (15D: 0.889 vs 0.892, p=0.62; EQ-5D: 0.831 vs 0.852, p=0.08; and SF-6D: 0.775 vs 0.777, p=0.88). The slight advantage with screening among men with PCa was reasonably consistent across time in the longitudinal analysis and was strongest among men with early-stage disease., Conclusions: These results show some long-term HRQoL benefit from screening for men with PCa but suggest little impact overall in the trial population., (Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: Falls and related injuries are a major public health concern in elderly people. Multifactorial interventions may result in significant reduction in falls but their effectiveness in prevention of fall-induced injuries at centre-based falls clinics is unclear. This study assessed the effectiveness of the multifactorial Chaos Clinic Falls Prevention Programme on rate of falls and related injuries of home-dwelling older adults., Methods: This study was a pragmatic, randomised controlled trial concentrating on high risk individuals and their individual risk factors of falling. Home-dwelling elderly people aged 70 years or more were recruited to the Chaos falls clinics in the cities of Lappeenranta and Tampere in Finland between January 2005 and June 2009. 1314 participants with high-risk for falling and fall-induced injuries and fractures were randomised into intervention group (n=661) and control group (n=653). A multifactorial, individualized 12-month falls prevention programme concentrating on strength and balance training, medical review and referrals, medication review, proper nutrition (calcium, vitamin D), and home hazard assessment and modification was carried out in the intervention group. The main outcome measures were rates of falls, fallers, and fall-induced injuries., Results: During the one-year follow-up, 608 falls occurred in the intervention group and 825 falls in the control group. The rate of falls was significantly lower in the intervention group (95 falls per 100 person-years) than in the controls (131 falls per 100 person-years), the incidence rate ratio (IRR) being 0.72 (95% confidence interval (CI) 0.61-0.86, p<0.001, NNT 3). In the intervention group 296 participants fell at least once. In the controls the corresponding number was 349. The hazard ratio (HR) of fallers in the intervention group compared with the control group was 0.78 (95% CI 0.67-0.91, p=0.001, NNT 6). The number of fall-induced injuries in the intervention group was 351 with the corresponding rate (per 100 person-years) of 55. In the control group, these figures were higher, 468 and 75. The IRR of fall-induced injuries in the intervention group compared with the control group was 0.74 (95% CI 0.61-0.89, p=0.002, NNT 5)., Conclusions: The multifactorial Chaos Clinic Falls Prevention Programme is effective in preventing falls of older adults. The programme reduces the rate of falls and related injuries by almost 30%., (Copyright © 2013 Elsevier Ltd. All rights reserved.)