The magnitude of safety risks related to medications of the older adults has been evidenced by numerous studies, but less is known of how to manage and prevent these risks in different health care settings. The aim of this study was to coordinate resources for prospective medication risk management of home care clients =?65 years in primary care and to develop a study design for demonstrating effectiveness of the procedure.
Health care units involved in the study are from primary care in Lohja, Southern Finland: home care (191 consented clients), the public healthcare center, and a private community pharmacy. System based risk management theory and action research method was applied to construct the collaborative procedure utilizing each profession's existing resources in medication risk management of older home care clients. An inventory of clinical measures in usual clinical practice and systematic review of rigorous study designs was utilized in effectiveness study design.
The new coordinated medication management model (CoMM) has the following 5 stages: 1) practical nurses are trained to identify clinically significant drug-related problems (DRPs) during home visits and report those to the clinical pharmacist. Clinical pharmacist prepares the cases for 2) an interprofessional triage meeting (50-70 cases/meeting of 2 h) where decisions are made on further action, e.g., more detailed medication reviews, 3) community pharmacists conduct necessary medication reviews and each patients' physician makes final decisions on medication changes needed. The final stages concern 4) implementation and 5) follow-up of medication changes. Randomized controlled trial (RCT) was developed to demonstrate the effectiveness of the procedure. The developed procedure is feasible for screening and reviewing medications of a high number of older home care clients to identify clients with severe DRPs and provide interventions to solve them utilizing existing primary care resources.
The study is registered in the Clinical Trials.gov ( NCT02545257 ). Registration date September 9 2015.
Cites: J Am Geriatr Soc. 2015 Nov;63(11):2227-46 PMID 26446832
Pneumococcal conjugate vaccines have potential to prevent significant proportion of childhood pneumonia. Finnish Invasive Pneumococcal disease vaccine trial was designed to assess the vaccine effectiveness (VE) of the 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against several outcomes. We now report results for pneumonia.
In this nationwide, cluster-randomised, double-blind trial, children younger than 19?months received PHiD-CV10 in 52 clusters or hepatitis vaccines as control in 26 clusters. Infants younger than 7?months at the first vaccination received either 3+1 or 2+1 vaccination schedule, children aged 7-11?months received 2+1, and those 12-18?months of age two-dose schedule. All hospitalizations and outpatient visits to hospital associated with ICD-10 codes compatible with pneumonia were identified through the National Care Register and 1-3 frontal chest X-ray images per event were collected. External readers who were unaware of the patients' vaccination status retrospectively interpreted the images. The evaluated outcomes were hospital-diagnosed, hospital-treated pneumonia as primary diagnosis, and radiologically confirmed pneumonia during the blinded, intention-to-treat follow-up period from the first vaccination to the end of 2011. Total VE was calculated as 1 minus rate ratio of all pneumonia episodes.
47 366 children were enrolled from February 2009, to October 2010. VE against all episodes of hospital-diagnosed pneumonia was 27% (95% confidence interval [CI]: 14%, 38%), 32% (95% CI: 3%, 52%), and 23% (95% CI: -5%, 44%) in subjects enrolled at age
Effects of 12-month home-based physiotherapy on duration of living at home and functional capacity among older persons with signs of frailty or with a recent hip fracture - protocol of a randomized controlled trial (HIPFRA study).
Health concerns, such as frailty and osteoporotic fractures decrease functional capacity and increase use of health and social care services in the aging population. The ability to continue living at home is dependent on functional capacity, which can be enhanced by rehabilitation. We study the effects of a 12-month home-based physiotherapy program with 12-month follow-up on duration of living at home, functional capacity, and the use of social and health care services among older persons with signs of frailty, or with a recently operated hip fracture.
This is a non-blinded, parallel group, randomized controlled trial performed in South Karelia Social and Health Care District, Finland (population 131,000). Three hundred community-dwelling older persons with signs of frailty (age?=?65) and 300 persons with a recent hip fracture (age?=?60) will be recruited. Frailty is screened by FRAIL questionnaire and verified by modified Fried's frailty criteria. Both patient groups will be randomized separately to a physiotherapy and a usual care arm. Individualized, structured and progressive physiotherapy will be carried out for 60 min, twice a week for 12 months at the participant's home. The primary outcome at 24 months is duration of living at home. Our hypothesis is that persons assigned to the physiotherapy arm will live at home for six months longer than those in the usual care arm. Secondary outcomes are functional capacity, frailty status, health-related quality-of-life, falls, use and costs of social and health care services, and mortality. Assessments, among others Short Physical Performance Battery, Functional Independence Measure, Mini Nutritional Assessment, and Mini-Mental State Examination will be performed at the participant's home at baseline, 3, 6, and 12 months. Register data on the use and costs of social and health care services, and mortality will be monitored for 24 months.
Our trial will provide new knowledge on the potential of intensive, long-term home-based physiotherapy among older persons at risk for disabilities, to enhance functional capacity and thereby to postpone the need for institutional care, and diminish the use of social and health care services.
ClinicalTrials.gov Identifier: NCT02305433 , Registered Nov 28, 2014.
We explored the effectiveness of preventive home visits on the health-related quality-of-life (HRQoL) and mortality among independently community-dwelling older adults.
A randomised controlled trial.
Independently home-dwelling older adults 75 years and older, consisting of 211 in the intervention and 211 in the control group.
Hyvinkää town municipality, Finland.
We used the change in HRQoL measured by the 15D scale as our primary outcome. Mortality at two years was retrieved from central registers.
At the one-year time point, the HRQoL according to the 15D scores deteriorated in the control group, whereas we found no change in the intervention group. The difference between the 15D score changes between the groups was -0.015 (95% CI -0.029 to -0.0016; p?=?0.028, adjusted for age, sex, and baseline value). At the two-year time point as the visits ended, that difference diminished. There was no difference in mortality between the groups during the 24-month follow-up.
Preventive home visits implemented by a multidisciplinary team with CGA appear to help slow down the decline in HRQoL among older adults, although the effect diminishes when the visits end. Key points We are exploring preventive home visits as means to support the health-related quality-of-life (HRQoL) of home-dwelling older adults Multiprofessional preventive home visits in this intervention study helped to maintain the HRQoL when measured using 15D The effects on HRQoL diminished when the intervention ended, so could further benefits be attained with a longer intervention?The clinical trial registration number: ACTRN12616001411437.
Diabetic men have lowered overall risk of prostate cancer (PCa), but the role of hyperglycaemia is unclear. In this cohort study, we estimated PCa risk among men with diabetic fasting blood glucose level.
Participants of the Finnish Randomized Study of Screening for Prostate Cancer (FinRSPC) were linked to laboratory database for information on glucose measurements since 1978. The data were available for 17,860 men. Based on the average yearly level, the men were categorised as normoglycaemic, prediabetic, or diabetic. Median follow-up was 14.7 years. Multivariable-adjusted Cox regression was used to calculate hazard ratios (HRs) and 95% confidence intervals (95% CIs) for prostate cancer overall and separately by Gleason grade and metastatic stage.
In total 1,663 PCa cases were diagnosed. Compared to normoglycaemic men, those men with diabetic blood glucose level had increased risk of PCa (HR 1.52; 95% CI 1.31-1.75). The risk increase was observed for all tumour grades, and persisted for a decade afterwards. Antidiabetic drug use removed the risk association. Limitations include absence of information on lifestyle factors and limited information on BMI.
Untreated diabetic fasting blood glucose level may be a prostate cancer risk factor.
New interventions supporting health literacy and a tobacco-free lifestyle in adolescence are needed to narrow the widening gap in existing health inequalities. Health games offer potential and could be utilized for example in school healthcare, but more research is needed to increase the understanding of the effects of game elements in health interventions. The aim of this feasibility study is to determine the short-term effectiveness of the tobacco-related mobile health game Fume and a non-gamified website in comparison with a no-intervention control group, regarding tobacco-related health literacy among 10-13-year-old early adolescents. In addition, we compare the demand for and acceptability of Fume to that of the website.
In total, 151 early adolescents participated in this single-blinded, three-armed cluster randomized trial. The participants from three municipalities in southwest Finland were randomly allocated between a group with access to the health game Fume (n?=?61), a group with access to the website (n?=?47), and a group with no intervention (n?=?43). The intervention groups first participated in a 20-min training session with Fume/the website, and then had two weeks to use Fume/the website based on their own interest. Short-term effectiveness was measured by primary (anti-smoking self-efficacy) and secondary (smoking outcome expectations, attitudes towards tobacco use, tobacco-use motives, motivation to decline tobacco use in the future, and knowledge about tobacco) outcomes derived from the theory-based determinants of tobacco-related health literacy and evaluated with self-assessment questionnaires at baseline and post-intervention (after a two-week follow-up). For evaluating the demand, the actual use of Fume/the website was tracked during the two-week period. Regarding acceptability, the raised interest towards Fume/the website and opinions about the interventions were evaluated post-intervention. Differences were tested with the McNemar, Fisher exact, and non-parametric tests.
Statistically significant favorable changes during the study period were found for positive (P?=?0.002) and negative (P?=?0.02) smoking outcome expectations and attitudes towards cigarette smoking (P?=?0.01) within the group using Fume. No statistically significant changes were detected within the website or control groups. Statistically significant differences were not found for the change in outcome variables among the three groups. The number of visits (P?
Human papillomavirus (HPV) vaccine is efficacious but the real-life effectiveness of gender-neutral and girls-only vaccination strategies is unknown. We report a community-randomized trial on the protective effectiveness [(PE)?=?vaccine efficacy (VE)?+?herd effect (HE)] of the two strategies among females in virtually HPV vaccination naïve population. We randomized 33 Finnish communities into Arm A) gender-neutral vaccination with AS04-adjuvanted HPV16/18 vaccine (11 communities), Arm B) HPV vaccination of girls and hepatitis B-virus (HBV) vaccination of boys (11 communities) or Arm C) gender-neutral HBV vaccination (11 communities). All resident 39,420 females and 40,852 males born 1992-95 were invited in 2007-09. Virtually all (99%) 12- to 15-year-old participating males (11,662) and females (20,513) received three doses resulting in uniform 20-30% male and 50% female vaccination coverage by birth cohort. Four years later (2010-14) 11,396 cervicovaginal samples obtained from 18.5 year-old women were tested for HPV DNA, and prevalence of cervical HPV infections by trial arm and birth cohort was the main outcome measure. VEs against HPV16/18 varied between 89.2% and 95.2% across birth cohorts in arms A and B. The VEs against non-vaccine types consistent with cross-protection were highest in those born 1994-95 for HPV45 (VEA 82.8%; VEB 86.1%) and for HPV31 (VEA 77.6%, VEB 84.6%). The HEs in the non HPV-vaccinated were statistically significant in those born 1994-95 for HPV18 (HEA 51.0%; 95% CI 8.3-73.8, HEB 47.2%; 6.5-70.2) and for HPV31/33 in arm A (HEA 53.7%; 22.1-72.5). For HPV16 and 45 no significant herd effects were detected. PE estimates against HPV16/18 were similar by both strategies (PEA 58.1%; 45.1-69.4; PEB 55.7%; 42.9-66.6). PE estimates against HPV31/33 were higher by the gender-neutral vaccination (PEA 60.5%; 43.6-73.4; PEB 44.5%; 24.9-60.6). In conclusion, while gender-neutral strategy enhanced the effectiveness of HPV vaccination for cross-protected HPV types with low to moderate coverage, high coverage in males appears to be key to providing a substantial public health benefit also to unvaccinated females. Trial registration www.clinicaltrials.gov.com NCT000534638.
Objective Because colorectal cancer (CRC) has a long natural history, estimating the effectiveness of CRC screening programmes requires long-term follow-up. As an alternative, we here demonstrate the use of a temporal multi-state natural history model to predict the effectiveness of CRC screening. Methods In the Finnish population-based biennial CRC screening programme using faecal occult blood tests (FOBT), which was conducted in a randomised health services study, we estimated the pre-clinical incidence, the mean sojourn time (MST), and the sensitivity of FOBT using a Markov model to analyse data from 2004 to 2007. These estimates were applied to predict, through simulation, the effects of five rounds of screening on the relative rate of reducing advanced CRC with 6 years of follow-up, and on the reduction in mortality with 10 years of follow-up, in a cohort of 500,000 subjects aged 60 to 69. Results For localised and non-localised CRC, respectively, the MST was 2.06 and 1.36 years and the sensitivity estimates were 65.12% and 73.70%. The predicted relative risk of non-localised CRC and death from CRC in the screened compared with the control population was 0.86 (95% CI: 0.79-0.98) and 0.91 (95% CI: 0.85-1.02), respectively. Conclusion Based on the preliminary results of the Finnish CRC screening programme, our model predicted a 9% reduction in CRC mortality and a 14% reduction in advanced CRC.
To report the prevalence of glaucoma in the Northern Finland Birth Cohort (NFBC) Eye Study.
Subjects of the population-based Northern Finland 1966 Birth Cohort (NFBC), aged 45-49 years at the time of the field examination, were randomized to eye screening (50%) and control (50%) groups. The eye examination protocol included best corrected visual acuity (BCVA), measurements of intraocular pressure and central corneal thickness, Humphrey 24-2 perimetry, stereoscopic optic nerve head (ONH) and retinal nerve fibre layer (RNFL) photography and imaging with optical coherence tomography (OCT), scanning laser polarimetry (GDx) and scanning laser ophthalmoscopy (HRT). The diagnosis of glaucoma was made by two independent general ophthalmologists and three independent glaucoma experts based on the evaluation of the ONH and RNFL photographs and the visual fields.
Totally, 10 321 subjects of the NFBC main study were alive in Finland in 2011, and they were randomized to the NFBC Eye Study group (n = 5155) and the control group (n = 5166). Of the randomized subjects, 3039 of 5155 (59%) responded and had sufficient data for the study. Glaucoma was suspected in 172 subjects (5.7%) at the first phase of the evaluation protocol. The interobserver agreement between two screening ophthalmologists was moderately good (kappa value 0.54 [95% confidence intervals (CI) 0.46-0.61]). Finally, definite glaucoma was found in 33 subjects (1.1% [95% CI 0.8-1.5]).
The study provides up-to-date information on the prevalence of glaucoma in a middle-aged Caucasian population in Finland. The baseline data reported here allows the evaluation of the cost-effectiveness of screening later on.
To identify the prognostic factors of prostate cancer death among patients enrolled in a Finnish prostate cancer screening trial.
Data on TNM stage, Gleason score, serum prostate-specific antigen at diagnosis, comorbidity and primary treatment were collected from medical records, as well as date and cause of death from Statistics Finland. Four prognostic risk groups were defined based on TNM stage, Gleason score and prostate-specific antigen at diagnosis. Hazard ratios and their 95% confidence intervals for prostate cancer death were calculated using Cox regression and competing-risk analysis with follow up from randomization. The differences in the effects of prognostic factors were assessed using interaction terms.
The 15-year survival was significantly lower among cases in the control arm compared with the screening arm (0.90 vs 0.92). However, the survival advantage was limited to screen-detected cases (0.94 vs 0.91 in cases detected outside screening). The prognostic risk group was the strongest factor predicting survival in the control arm, but weaker in screen-detected cases. Advanced disease was associated with substantially poorer outcome in cases detected outside screening than in screen-detected disease. Primary treatment had a similar effect in all groups. Comorbidity had a small prognostic effect in the control arm only.
Prognostic factors had a different effect on the outcome of cases detected through screening as those diagnosed otherwise. A high diagnostic prostate-specific antigen and advanced disease carried a poor prognosis, especially among the cases detected outside screening, even when lead-time was eliminated. This shows that the screening resulted in earlier treatment among the cases in the screening arm.
CommentIn: Int J Urol. 2018 Mar;25(3):277 PMID 29569775