Browsing by Subject "RANDOMIZED CONTROLLED-TRIAL"

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  • Mendes-Santo, Cristina; Weiderpass, Elisabete; Santana, Rui; Andersson, Gerhard (2019)
    Background: Internet-delivered interventions can provide remarkable opportunities in addressing breast cancer survivors' unmet support care needs, as they present an effective strategy to improve care coordination and provide access to efficacious, cost-efficient and convenient survivorship care. Nevertheless, research focusing on improving survivors' psychosocial needs using internet-based tools is scarce and its practical implementation is limited. Objectives: To study the acceptability, feasibility, efficacy and cost-effectiveness of iNNOVBC, a 10 weeks guided internet-delivered individually-tailored Acceptance and Commitment Therapy (ACT)-influenced cognitive behavioural (CBT) intervention developed to improve mild to moderate anxiety and depression in Breast cancer survivors when compared to treatment as usual (TAU) in a waiting list control group (WLC). Methods: A two-arm, parallel, open label, multicentre, waiting list randomized controlled trial will be conducted to investigate the efficacy and cost-effectiveness of INNOVBC. The primary outcomes in this research will be anxiety and depression. Secondary outcomes will include psychological flexibility, fatigue, insomnia, sexual dysfunction and Health Related Quality of Life (HRQoL). Ethical approval: This study has been reviewed and approved by Comisstio Nacional de Protectio de Dados; Instituto Portuguis de Oncologia do Porto Francisco Gentil; Unidade Local de Satide de Matosinhos, EPE; Centro Hospitalar de Sao Joao and Ordem dos Psicologos ethical committees. Expected results: It is anticipated that iNNOVBC will show to be an efficacious and cost-effective program in improving the outcomes of interest in this study, as opposed to a WLC under TAU. The results of this research will be published in accordance with CONSORT-EHEALTH guidelines. Conclusions: This study will inform on the acceptability, feasibility, efficacy and cost-effectiveness of iNNOVBC, in improving psychosocial outcomes in breast cancer survivors when compared to TAU in a WLC. Its conclusions will contribute to understand the idiosyncrasies of designing and implementing internet-delivered interventions in breast cancer survivors.
  • Sloan, Tim J.; Jalanka, Jonna; Major, Giles A. D.; Krishnasamy, Shanthi; Pritchard, Sue; Abdelrazig, Salah; Korpela, Katri; Singh, Gulzar; Mulvenna, Claire; Hoad, Caroline L.; Marciani, Luca; Barrett, David A.; Lomer, Miranda C. E.; de Vos, Willem M.; Gowland, Penny A.; Spiller, Robin C. (2018)
    Background & aims Ingestion of poorly digested, fermentable carbohydrates (fermentable oligo-, di-, mono-saccharides and polyols; FODMAPs) have been implicated in exacerbating intestinal symptoms and the reduction of intake with symptom alleviation. Restricting FODMAP intake is believed to relieve colonic distension by reducing colonic fermentation but this has not been previously directly assessed. We performed a randomised controlled trial comparing the effect of a low FODMAP diet combined with either maltodextrin or oligofructose on colonic contents, metabolites and microbiota. Methods A parallel randomised controlled trial in healthy adults (n = 37). All subjects followed a low FODMAP diet for a week and supplemented their diet with either maltodextrin (MD) or oligofructose (OF) 7g twice daily. Fasted assessments performed pre- and post-diet included MRI to assess colonic volume, breath testing for hydrogen and methane, and stool collection for microbiota analysis. Results The low FODMAP diet was associated with a reduction in Bifidobacterium and breath hydrogen, which was reversed by oligofructose supplementation. The difference in breath hydrogen between groups post-intervention was 27ppm (95% CI 7 to 50, P Conclusion A low FODMAP diet reduces total bacterial count and gas production with little effect on colonic volume.
  • Tan, Xiao; van Egmond, Lieve; Partinen, Markku; Lange, Tanja; Benedict, Christian (2019)
    Sleep and circadian disruptions are frequently observed in patients across hospital wards. This is alarming, since impaired nocturnal sleep and disruption of a normal circadian rhythm can compromise health and disturb processes involved in recovery from illness (eg, immune functions). With this in mind, the present narrative review discusses how patient characteristics (sleep disorders, anxiety, stress, chronotype, and disease), hospital routines (pain management, timing of medication, nocturnal vital sign monitoring, and physical inactivity), and hospital environment (light and noise) may all contribute to sleep disturbances and circadian misalignment in patients. We also propose hospital-based strategies that may help reduce sleep and circadian disruptions in patients admitted to the hospital. (C) 2018 The Authors. Published by Elsevier B.V.
  • Bellomo, Rinaldo; Kellum, John A.; Ronco, Claudio; Wald, Ron; Martensson, Johan; Maiden, Matthew; Bagshaw, Sean M.; Glassford, Neil J.; Lankadeva, Yugeesh; Vaara, Suvi; Schneider, Antoine (2017)
    Acute kidney injury (AKI) and sepsis carry consensus definitions. The simultaneous presence of both identifies septic AKI. Septic AKI is the most common AKI syndrome in ICU and accounts for approximately half of all such AKI. Its pathophysiology remains poorly understood, but animal models and lack of histological changes suggest that, at least initially, septic AKI may be a functional phenomenon with combined microvascular shunting and tubular cell stress. The diagnosis remains based on clinical assessment and measurement of urinary output and serum creatinine. However, multiple biomarkers and especially cell cycle arrest biomarkers are gaining acceptance. Prevention of septic AKI remains based on the treatment of sepsis and on early resuscitation. Such resuscitation relies on the judicious use of both fluids and vasoactive drugs. In particular, there is strong evidence that starch-containing fluids are nephrotoxic and decrease renal function and suggestive evidence that chloride-rich fluid may also adversely affect renal function. Vasoactive drugs have variable effects on renal function in septic AKI. At this time, norepinephrine is the dominant agent, but vasopressin may also have a role. Despite supportive therapies, renal function may be temporarily or completely lost. In such patients, renal replacement therapy (RRT) becomes necessary. The optimal intensity of this therapy has been established, while the timing of when to commence RRT is now a focus of investigation. If sepsis resolves, the majority of patients recover renal function. Yet, even a single episode of septic AKI is associated with increased subsequent risk of chronic kidney disease.
  • Manach, Claudine; Milenkovic, Dragan; Van de Wiele, Tom; Rodriguez-Mateos, Ana; de Roos, Baukje; Teresa Garcia-Conesa, Maria; Landberg, Rikard; Gibney, Eileen R.; Heinonen, Marina; Tomas-Barberan, Francisco; Morand, Christine (2017)
    Bioactive compounds in plant-based foods have health properties that contribute to the prevention of age-related chronic diseases, particularly cardiometabolic disorders. Conclusive proof and understanding of these benefits in humans is essential in order to provide effective dietary recommendations but, so far, the evidence obtained from human intervention trials is limited and contradictory. This is partly due to differences between individuals in the absorption, distribution, metabolism and excretion of bioactive compounds, as well as to heterogeneity in their biological response regarding cardiometabolic health outcomes. Identifying the main factors underlying inter-individual differences, as well as developing new and innovative methodologies to account for such variability constitute an overarching goal to ultimately optimize the beneficial health effects of plant food bioactives for each and every one of us. In this respect, this position paper from the COST Action FA1403-POSITIVe examines the main factors likely to affect the individual responses to consumption of plant food bioactives and presents perspectives for assessment and consideration of inter-individual variability.
  • Kanerva, Noora; Harald, Kennet; Männistö, Satu; Kaartinen, Niina E.; Maukonen, Mirkka; Haukkala, Ari; Jousilahti, Pekka (2018)
    Studies indicate that the healthy Nordic diet may improve heart health, but its relation to weight change is less clear. We studied the association between the adherence to the healthy Nordic diet and long-term changes in weight, BMI and waist circumference. Furthermore, the agreement between self-reported and measured body anthropometrics was examined. The population-based DIetary, Lifestyle and Genetic Determinants of Obesity and Metabolic syndrome Study in 2007 included 5024 Finns aged 25-75 years. The follow-up was conducted in 2014 (n 3735). One-third of the participants were invited to a health examination. The rest were sent measuring tape and written instructions along with questionnaires. The Baltic Sea Diet Score (BSDS) was used to measure adherence to the healthy Nordic diet. Association of the baseline BSDS and changes in BSDS during the follow-up with changes in body anthropometrics were examined using linear regression analysis. The agreement between self-reported and nurse-measured anthropometrics was determined with Bland-Altman analysis. Intra-class correlation coefficients between self-reported and nurse-measured anthropometrics exceeded 0.95. The baseline BSDS associated with lower weight (beta = -0.056, P = 0.043) and BMI (beta = -0.021, P=0.031) over the follow-up. This association was especially evident among those who had increased their BSDS. In conclusion, both high initial and improved adherence to the healthy Nordic diet may promote long-term weight maintenance. The self-reported/measured anthropometrics were shown to have high agreement with nurse-measured values which adds the credibility of our results.
  • Anderson, David R.; Morgano, Gian Paolo; Bennett, Carole; Dentali, Francesco; Francis, Charles W.; Garcia, David A.; Kahn, Susan R.; Rahman, Maryam; Rajasekhar, Anita; Rogers, Frederick B.; Smythe, Maureen A.; Tikkinen, Kari A. O.; Yates, Adolph J.; Baldeh, Tejan; Balduzzi, Sara; Brozek, Jan L.; Etxeandia-Ikobaltzeta, Itziar; Johal, Herman; Neumann, Ignacio; Wiercioch, Wojtek; Jose Yepes-Nunez, Juan; Schunemann, Holger J.; Dahm, Philipp (2019)
    Background: Venous thromboembolism (VTE) is a common source of perioperative morbidity and mortality. Objective: These evidence-based guidelines from the American Society of Hematology (ASH) intend to support decision making about preventing VTE in patients undergoing surgery. Methods: ASH formed a multidisciplinary guideline panel balanced to minimize bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline-development process, including performing systematic reviews. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess evidence and make recommendations, which were subject to public comment. Results: The panel agreed on 30 recommendations, including for major surgery in general (n = 8), orthopedic surgery (n = 7), major general surgery (n = 3), major neurosurgical procedures (n = 2), urological surgery (n = 4), cardiac surgery and major vascular surgery (n = 2), major trauma (n = 2), and major gynecological surgery (n = 2). Conclusions: For patients undergoing major surgery in general, the panel made conditional recommendations for mechanical prophylaxis over no prophylaxis, for pneumatic compression prophylaxis over graduated compression stockings, and against inferior vena cava filters. In patients undergoing total hip or total knee arthroplasty, conditional recommendations included using either aspirin or anticoagulants, as well as for a direct oral anticoagulant over low-molecular-weight heparin (LMWH). For major general surgery, the panel suggested pharmacological prophylaxis over no prophylaxis, using LMWH or unfractionated heparin. For major neurosurgery, transurethral resection of the prostate, or radical prostatectomy, the panel suggested against pharmacological prophylaxis. For major trauma surgery or major gynecological surgery, the panel suggested pharmacological prophylaxis over no prophylaxis.
  • Sarikaya, Hakan; da Costa, Bruno R.; Baumgartner, Ralf W.; Duclos, Kathleen; Touze, Emmanuel; de Bray, Jean M.; Metso, Antti; Metso, Tiina; Arnold, Marcel; Arauz, Antonio; Zwahlen, Marcel; Jueni, Peter (2013)
  • Haywood, Kirstie L.; Pearson, Nathan; Morrison, Laurie J.; Castren, Maaret; Lilja, Gisela; Perkins, Gavin D. (2018)
    Aim: High quality evidence of out-of-hospital cardiac arrest (OHCA) survivors' health-related quality of life (HRQoL) can measure the long-term impact of CA. The aim of this study was to critically appraise the evidence of psychometric quality and acceptability of measures used in the assessment of HRQoL in cardiac arrest survivors. Methods: Systematic literature searches (2004-2017) and named author searches to identify articles pertaining to the measurement of HRQoL. Data on study quality, measurement and practical properties were extracted and assessed against international standards. Results: From 356 reviewed abstracts, 69 articles were assessed in full. 25 provided evidence for 10 measures of HRQoL: one condition-specific; three generic profile measures; two generic index; and four utility measures. Although limited, evidence for measurement validity was strongest for the HUI3 and SF-36. However, evidence for reliability, content validity, responsiveness and interpretability and acceptability was generally limited or not available in the CA population for all measures. Conclusions: This review has demonstrated that a measure of quality of life specific to OHCA survivors is not available. Limited evidence of validity exists for one utility measure - the HUI3 - and a generic profile - the SF-36. Robust evidence of the quality and acceptability of HRQoL measures in OHCA was limited or not available. Future collaborative research must seek to urgently establish the relevance and acceptability of these measures to OHCA survivors, to establish robust evidence of essential measurement and practical properties over the short and long-term, and to inform future HRQoL assessment in the OHCA population. (C) 2017 Elsevier B.V. All rights reserved.
  • Jokelainen, Jarno; Mustonen, Harri; Kylänpää, Leena; Udd, Marianne; Lindström, Outi; Pöyhiä, Reino (2018)
    Background and aims: There is no consensus on how to assess the depth of sedation for endoscopic retrograde cholangiopancreatography (ERCP). This study was carried out in order to evaluate different methods of assessment of depth of sedation: bispectral index (BiS), modified Richmond Agitation/Sedation Scale (mRASS), modified Ramsay Sedation Scale (mRSS) and modified Observer Assessment of Alertness and Sedation (mOAAS) and their applicability to clinical practice.Methods: Two hundred patients were recruited. Sedation was given by standard clinical practice using propofol sedation or patient controlled sedation. Sedation was assessed on all patients using the above-mentioned methods. BiS was considered the reference point for sedation scales. Cronbach's alpha was calculated to determine the consistency of different scales in respect to each other and prediction probability and Spearman's correlation coefficients of sedation scales were calculated to show the relationship between sedation scales and BiS.Results: All scales showed high reliability with overall Cronbach's alpha 0.943. Dropping scales suggested better consistency between mOAAS, mRSS and mRASS than with BiS. Spearman's correlation and prediction probability showed similar results with all tested scales: mOAAS (0.695, 0.739), mRSS (0.673, 0.735), mRASS (0.683, 0.738), p
  • ISCOLE Res Grp; Zakrzewski-Fruer, Julia K.; Gillison, Fiona B.; Fogelholm, Mikael; Kivelä, Jemina; Räsänen, Sari; Roito, Sanna; Saloheimo, Taru; Valta, Leena (2019)
    BackgroundExisting research has documented inconsistent findings for the associations among breakfast frequency, physical activity (PA), and sedentary time in children. The primary aim of this study was to examine the associations among breakfast frequency and objectively-measured PA and sedentary time in a sample of children from 12 countries representing a wide range of human development, economic development and inequality. The secondary aim was to examine interactions of these associations between study sites.MethodsThis multinational, cross-sectional study included 6228 children aged 9-11years from the 12 International Study of Childhood Obesity, Lifestyle and the Environment sites. Multilevel statistical models were used to examine associations between self-reported habitual breakfast frequency defined using three categories (breakfast consumed 0 to 2days/week [rare], 3 to 5days/week [occasional] or 6 to 7days/week [frequent]) or two categories (breakfast consumed less than daily or daily) and accelerometry-derived PA and sedentary time during the morning (wake time to 1200h) and afternoon (1200h to bed time) with study site included as an interaction term. Model covariates included age, sex, highest parental education, body mass index z-score, and accelerometer waking wear time.ResultsParticipants averaged 60 (s.d. 25) min/day in moderate-to-vigorous PA (MVPA), 315 (s.d. 53) min/day in light PA and 513 (s.d. 69) min/day sedentary. Controlling for covariates, breakfast frequency was not significantly associated with total daily or afternoon PA and sedentary time. For the morning, frequent breakfast consumption was associated witha higher proportion of time in MVPA (0.3%), higher proportion of time in light PA (1.0%) and lower min/day and proportion of time sedentary (3.4min/day and 1.3%) than rare breakfast consumption (all p0.05). No significant associations were found when comparing occasional with rare or frequent breakfast consumption, or daily with less than daily breakfast consumption. Very few significant interactions with study site were found.ConclusionsIn this multinational sample of children, frequent breakfast consumption was associated with higher MVPA and light PA time and lower sedentary time in the morning when compared with rare breakfast consumption, although the small magnitude of the associations may lack clinical relevance.Trial registrationThe International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE) is registered at(Identifier NCT01722500).
  • Hui, David; Mori, Masanori; Meng, Yee-Choon; Watanabe, Sharon M.; Caraceni, Augusto; Strasser, Florian; Saarto, Tiina; Cherny, Nathan; Glare, Paul; Kaasa, Stein; Bruera, Eduardo (2018)
    Palliative care referral is primarily based on clinician judgment, contributing to highly variable access. Standardized criteria to trigger automatic referral have been proposed, but it remains unclear how best to apply them in practice. We conducted a Delphi study of international experts to identify a consensus for the use of standardized criteria to trigger automatic referral. Sixty international experts stated their level of agreement for 14 statements regarding the use of clinician-based referral and automatic referral over two Delphi rounds. A consensus was defined as an agreement of ae70% a priori. The response rate was 59/60 (98%) for the first round and 56/60 (93%) for the second round. Twenty-six (43%), 19 (32%), and 11 (18%) respondents were from North America, Asia/Australia, and Europe, respectively. The panel reached consensus that outpatient palliative care referral should be based on both automatic referral and clinician-based referral (agreement = 86%). Only 18% felt that referral should be clinician-based alone, and only 7% agreed that referral should be based on automatic referral only. There was consensus that automatic referral criteria may increase the number of referrals (agreement = 98%), facilitate earlier palliative care access, and help administrators to set benchmarks for quality improvement (agreement = 86%). Our panelists favored the combination of automatic referral to augment clinician-based referral. This integrated referral framework may inform policy and program development.
  • Friedland, Barbara A.; Stoner, Marie; Chau, Michelle M.; Plagianos, Marlena Gehret; Govender, Sumen; Morar, Neetha; Altini, Lydia; Skoler-Karpoff, Stephanie; Ahmed, Khatija; Ramjee, Gita; Monedi, Constance; Maguire, Robin; Lähteenmäki, Pekka (2016)
    A randomized, placebo-controlled, efficacy trial of Carraguard was unable to demonstrate a reduction in women's risk of HIV infection, which may have been due, in part, to low adherence (gel used in 42 % of vaginal sex acts, on average). A secondary analysis was undertaken to understand baseline factors associated with high adherence (gel used in aeyen85 % of sex acts). Women who reported aeyen1 vaginal sex act, returned aeyen1 opened applicator, and had aeyen1 conclusive post-enrollment HIV test (N = 5990) were included. Adherence was estimated as the ratio of average weekly applicator insertions (based on a dye stain assay indicating vaginal insertion)/average weekly sex acts (by self-report). Multivariate logistic regression modeling indicated that coital frequency, site, contraception, and partner age difference had a significant impact on adherence. Women reporting > 1 and aecurrency sign2 vaginal sex acts per week, on average, were half as likely to be adherent as those reporting 1 vaginal sex act per week or less [adjusted odds ratio (AOR): 0.48; 95 % CI 0.38-0.61]; women from the Western Cape had one-third the odds of being adherent compared to women from KZN (AOR: 0.31; 95 % CI 0.23-0.41); compared to women using injectable contraception, women using any other or no method were more likely to be adherent (AOR: 1.30; 95 % CI 1.04-1.63); and women who had a larger age gap from their partners were more likely to be adherent (AOR: 1.03; 95 % CI 1.01-1.05; p = 0.001). Despite low adherence, overall, 13 % of participants achieved nearly perfect adherence, indicating a potential niche for a coitally dependent microbicide. More research is needed on the impact of sexual patterns and HIV risk perception on product acceptability and adherence to improve counseling in ongoing trials and when products are eventually introduced.
  • Jolle, Anne; Asvold, Bjorn Olav; Holmen, Jostein; Carlsen, Sven Magnus; Tuomilehto, Jaakko; Bjorngaard, Johan Hakon; Midthjell, Kristian (2018)
    Objective Among individuals at high risk for diabetes identified through a population survey, we performed an intervention study with basic lifestyle advice aiming to prevent diabetes. Research design and methods Among 50 806 participants in the HUNT3 Survey (2006-2008), 5297 individuals with Finnish Diabetes Risc Score (FINDRISC >= 15 were invited to an oral glucose tolerance test (OGTT) and an education session with lifestyle advice, and 2634 (49.7%) attended. Among them, 2380 people without diabetes were included in the prevention study with repeated examinations and education sessions after 6, 12, and 24 months. We examined participation, diabetes incidence, glycemia, and adiposity during follow-up. Results Of 2380 participants, 1212 (50.9%) participated in >= 3 of the four examinations. Diabetes was detected in 3.5%, 3.1%, and 4.0% of individuals at the 6-month, 12-month, and 24-month examinations, respectively, indicating a 10.3% 2-year diabetes incidence. Mean (95% CI) increases from baseline to 2-year follow-up were 0.30 (0.29 to 0.32) percentage points (3.3 (3.2 to 3.5) mmol/mol) for Hemoglobin A 1c, 0.13 (0.10 to 0.16) mmol/L for fasting serum-glucose, 0.46 (0.36 to 0.56) mmol/L for 2-hour OGTT s-glucose, 0.30 (0.19 to 0.40) kg/m(2) forbody mass index (BMI) (all p<0.001) and -0.5 (-0.9 to -0.2) cm for waist circumference (p= 0.004), with broadly similar estimates by baseline age, sex, education, depressive symptoms, BMI, physical activity, and family history of diabetes. Only 206 (8.7%) participants had evidence of > 5% weight loss during follow-up; their fasting and 2-hour s-glucose did not increase, and HbA 1c increased less than in other participants. Conclusion Basic lifestyle advice given to high-risk individuals during three group sessions with 6-month intervals was not effective in reducing 2-year diabetes risk.
  • Di Saverio, Salomone; Coccolini, Federico; Galati, Marica; Smerieri, Nazareno; Biffl, Walter L.; Ansaloni, Luca; Tugnoli, Gregorio; Velmahos, George C.; Sartelli, Massimo; Bendinelli, Cino; Fraga, Gustavo Pereira; Kelly, Michael D.; Moore, Frederick A.; Mandala, Vincenzo; Mandala, Stefano; Masetti, Michele; Jovine, Elio; Pinna, Antonio D.; Peitzman, Andrew B.; Leppäniemi, Ari; Sugarbaker, Paul H.; Van Goor, Harry; Moore, Ernest E.; Jeekel, Johannes; Catena, Fausto (2013)
  • Castrén, Eero; Kojima, Masami (2017)
    Levels of brain-derived neurotrophic factor (BDNF) are reduced in the brain and serum of depressed patients and at least the reduction in serum levels is reversible upon successful treatment. These data, together with a wealth of reports using different animal models with depression-like behavior or manipulation of expression of BDNF or its receptor TrkB have implicated BDNF in the pathophysiology of depression as well as in the mechanism of action of antidepressant treatments. Recent findings have shown that posttranslational processing of BDNF gene product can yield different molecular entities that differently influence signaling through BNDF receptor TrkB and the pan-neurotrophin receptor p75(NTR). We will here review these data and discuss new insights into the possible pathophysiological roles of those new BDNF subtypes as well as recent findings on the role of BDNF mediated neuronal plasticity in mood disorders and their treatments. (C) 2016 Elsevier Inc All rights reserved.
  • Cano, Antonio; Chedraui, Peter; Goulis, Dimitrios G.; Lopes, Patrice; Mishra, Gita; Mueck, Alfred; Senturk, Levent M.; Simoncini, Tommaso; Stevenson, John C.; Stute, Petra; Tuomikoski, Pauliina; Rees, Margaret; Lambrinoudaki, Irene (2018)
    Introduction: Postmenopausal osteoporosis is a highly prevalent disease. Prevention through lifestyle measures includes an adequate calcium intake. Despite the guidance provided by scientific societies and governmental bodies worldwide, many issues remain unresolved. Aims: To provide evidence regarding the impact of calcium intake on the prevention of postmenopausal osteoporosis and critically appraise current guidelines. Materials and methods: Literature review and consensus of expert opinion. Results and conclusion: The recommended daily intake of calcium varies between 700 and 1200 mg of elemental calcium, depending on the endorsing source. Although calcium can be derived either from the diet or supplements, the former source is preferred. Intake below the recommended amount may increase fragility fracture risk; however, there is no consistent evidence that calcium supplementation at, or above, recommended levels reduces risk. The addition of vitamin D may minimally reduce fractures, mainly among institutionalised people. Excessive intake of calcium, defined as higher than 2000 mg/day, can be potentially harmful. Some studies demonstrated harm even at lower dosages. An increased risk for cardiovascular events, urolithiasis and even fractures has been found in association with excessive calcium intake, but this issue remains unresolved. In conclusion, an adequate intake of calcium is recommended for general bone health. Excessive calcium intake seems of no benefit, and could possibly be harmful.
  • Skrifvars, Markus B.; French, Craig; Bailey, Michael; Presneill, Jeffrey; Nichol, Alistair; Little, Lorraine; Durantea, Jacques; Huet, Olivier; Haddad, Samir; Arabi, Yaseen; McArthur, Colin; Cooper, D. James; Bellomo, Rinaldo; EPO-TBI Investigators & ANZICS (2018)
    The EPO-TBI study randomized 606 patients with moderate or severe traumatic brain injury (TBI) to be treated with weekly epoetin alfa (EPO) or placebo. Six month mortality was lower in EPO treated patients in an analysis adjusting for TBI severity. Knowledge of possible differential effects by TBI injury subtype and acute neurosurgical treatment as well as timing and cause of death (COD) will facilitate the design of future interventional TBI trials. We defined COD as cerebral (brain death, cerebral death with withdrawal, or death during maximal care) and non-cerebral (death following withdrawal or during maximal care, which had a non-cerebral cause). The study included 305 patients treated with EPO and 297 treated with placebo, with COD recorded in 77 (99%) out of 78 non-survivors. Median time to death in patients dying of cerebral COD was 8 days (interquartile range [IQR] 5-16) compared with 29 days (IQR 7-56) (p = 0.01) for non-cerebral COD. When assessing subgroups by admission CT scan injury findings, we found no significant differential effects of EPO compared with placebo. However, EPO appeared more effective in patients with an injury type not requiring a neurosurgical operation prior to intensive care unit (ICU) admission (odds ratio [OR] 0.29, 95% confidence interval [CI] 0.14-0.61, p = 0.001, p for interaction = 0.003) and in this subgroup, fewer patients died of cerebral causes in the EPO than in the placebo group (5% compared with 14%, p = 0.03). In conclusion, most TBI deaths were from cerebral causes that occurred during the first 2 weeks, and were related to withdrawal of care. EPO appeared to specifically reduce cerebral deaths in the important subgroup of patients with a diffuse type of injury not requiring a neurosurgical intervention prior to randomization.
  • Airo (Toivanen), Riikka; Korja, Riikka; Saisto, Terhi; Rouhe, Hanna; Muotka, Joona; Salmela-Aro, Katariina (2018)
    The changes in emotions, subjective fear of childbirth, and personal goals were examined during a group intervention to treat fear of childbirth (FOC). The objective was to gain a more detailed understanding of the changes occurring during the group intervention of FOC. The changes in emotions, subjective FOC, and personal goals were studied in primiparous pregnant women with severe FOC participating in a group intervention (n = 105). The group intervention contained six sessions during pregnancy and one after childbirth. At every session, the participants filled in a questionnaire regarding their experiences of current positive and negative emotions and the subjective FOC. The participants also set and reported their personal goals in their preparation for childbirth and parenthood. The negative emotions decreased from the beginning of the intervention. The change became significant after the fourth session. The amount of positive emotions increased but became statistically significant only after the delivery. The subjective FOC decreased significantly from the beginning of the intervention. Personal goals shifted from being mainly self-related to being mostly related to parenthood. The group intervention decreased FOC and promoted changes in emotions and personal goals that foster emotional preparedness for childbirth. It seems that the decrease in FOC was made possible through gaining a better capacity to regulate emotions, especially negative emotions. As negative emotions and fear decreased, personal goals simultaneously changed in the direction known to be adaptive for the new life situation as a parent of a newborn.
  • Kallio, Eeva-Liisa; Öhman, Hanna; Kautiainen, Hannu; Hietanen, Marja; Pitkala, Kaisu (2017)
    Background: Cognitive training (CT) refers to guided cognitive exercises designed to improve specific cognitive functions, as well as enhance performance in untrained cognitive tasks. Positive effects of CT on cognitive functions in healthy elderly people and persons with mild cognitive impairment have been reported, but data regarding the effects of CT in patients with dementia is unclear. Objective: We systematically reviewed the current evidence from randomized controlled trials (RCTs) to find out if CT improves or stabilizes cognition and/or everyday functioning in patients with mild and moderate Alzheimer's disease. Results: Altogether, 31 RCTs with CT as either the primary intervention or part of a broader cognitive or multi-component intervention were found. A positive effect was reported in 24 trials, mainly on global cognition and training-specific tasks, particularly when more intensive or more specific CT programs were used. Little evidence of improved everyday functioning was found. Conclusions: Despite some positive findings, the inaccurate definitions of CT, inadequate sample sizes, unclear randomization methods, incomplete datasets at follow-up and multiple testing may have inflated the results in many trials. Future high quality RCTs with appropriate classification and specification of cognitive interventions are necessary to confirm CT as an effective treatment option in Alzheimer's disease.