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Risk assessment of "other substances" – L-serine. Opinion of the Panel on Nutrition, Dietetic Products, Novel Food and Allergy of the Norwegian Scientific Committee for Food Safety. VKM report 2016:59
Get PDFAt the request of the Norwegian Food Safety Authority, the Norwegian Scientific Committee for Food Safety (VKM) has characterised the risk of daily doses of 50, 500, 1000, 1250, 1500 and 1750 mg/day L-serine in food supplements. In the absence of long-term studies in healthy individuals, VKM used a NOAEL of 3000 mg/kg bw per day from a 90-days toxicological study in rodents.
• In adults (≥18 years), the specified doses 50, 500, 1000, 1250, 1500 and 1750 mg/day L-serine in food supplements are unlikely to cause adverse health effects.
• In adolescents (14 to < 18 years), the specified doses 50, 500, 1000, 1250, 1500 and 1750 mg/day L-serine in food supplements are unlikely to cause adverse health effects.
• In children (10 to < 14 years), the specified doses 50, 500, 1000, 1500 and 1800 mg/day L-serine in food supplements are unlikely to cause adverse health effects.publishedVersio
Risk assessment of "other substances" - L-arginine and arginine alpha-ketoglutarate. Opinion of the Panel on Nutrition, Dietetic Products, Novel Food and Allergy of the Norwegian Scientific Committee for Food Safety
No full textThe Norwegian Scientific Committee for Food Safety (VKM) has, at the request of the Norwegian Food Safety Authority, assessed the risk of specified doses of L-arginine and arginine alpha-ketoglutarate in food supplements. VKM concludes that:
In adults (≥18 years), the specified doses of 3000, 3500, 4000, 4500, 5000, 5500 and 6000 mg/day of arginine in food supplements are considered unlikely to cause adverse health effects. The dose 6800 mg/day may represent a risk of adverse health effects.
In adolescents (14 to <18 years), the specified doses 3000, 3500, 4000, 4500, 5000, 5500 mg/day L-arginine in food supplements are considered unlikely to cause adverse health effects, whereas the doses 6000 and 6800 mg/day may represent a risk of adverse health effects.
In children (10 to <14 years), the specified doses 3000 and 3500 mg/day L-arginine in food supplements are considered unlikely to cause adverse health effects, whereas the doses 4000, 4500, 5000, 5500, 6000 and 6800 mg/day may represent a risk of adverse health effect.
No dosage of arginine alpha-ketoglutarate in food supplements can be evaluated, due to lack of data.publishedVersio
TIME – Targeted interdisciplinary model for evaluation and treatment of neuropsychiatric symptoms : protocol for an effectiveness-implementation cluster randomized hybrid trial
Get PDFBackground: Nearly all persons with dementia will experience neuropsychiatric symptoms (NPS) during the course of their disease. Clinicians and researchers emphasize the need for an evidence-informed standardized approach to managing NPS that integrates pharmacological and nonpharmacological treatments for real-world implementation. The Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME) represents such an approach and is a multicomponent intervention based on the theoretical framework of cognitive behavioural therapy. Methods/design: The trial is a 3-month cluster randomized trial conducted in 30 nursing homes including 168 participants with dementia and a high level of agitation. Each nursing home defined as a cluster will be randomized to receive either the TIME intervention (the intervention group) or a brief education-only intervention regarding dementia and NPS (the control group). TIME is a manual-based, multicomponent programme that includes a rigorous assessment, one or more case conferences and the treatment and evaluation of NPS. Patient-level measurements are taken at baseline (prior to randomization) and 8 and 12 weeks later. The primary outcome measure is the change in agitation, as defined by the Neuropsychiatric Inventory-Nursing Home Version, at 8 weeks from baseline. Secondary outcome measures include change in agitation at 12 weeks from baseline, and change from baseline at 8 and 12 weeks in other NPS, quality of life, and the use of psychotropic and analgesic medications. Mixed methods will be used to follow, measure and explore the implementation process and the effect of the intervention at the individual staff level and the organization level. Combining measurements of clinical effectiveness and implementation outcomes define this trial as an effectiveness-implementation hybrid trial. Discussion: Measuring the implementation and effect of complex interventions aimed at reducing NPS in nursing homes is challenging. In this study protocol, we describe a multicomponent program, TIME, and discuss how an effectiveness-implementation cluster randomized hybrid trial can meet these challenges. Trial registration: ClinicalTrials.gov identifier NCT02655003. Registered 6 January 2016. Keywords: dementia, neuropsychiatric symptoms, behavioural and psychological symptoms of dementia (BPSD), psychosocial interventions, nursing home, case conferenceFunding The trial is funded in total by a grant from the Innlandet Hospital Trust.acceptedVersionpublishedVersio
Cognitive Interventions and Nutritional Supplements (The CINS Trial): A Randomized Controlled, Multicenter Trial Comparing a Brief Intervention with Additional Cognitive Behavioral Therapy, Seal Oil, and Soy Oil for Sick-Listed Low Back Pain Patients
No full textSTUDY DESIGN: A randomized controlled trial. OBJECTIVE: The aim of this study was to evaluate whether a tailored and manualized cognitive behavior therapy (CBT) or nutritional supplements of seal oil and soy oil had any additional benefits over a brief cognitive intervention (BI) on return to work (RTW). SUMMARY OF BACKGROUND DATA: Brief intervention programs are clinically beneficial and cost-effective for patients with low back pain (LBP). CBT is recommended for LBP, but evidence on RTW is lacking. Seal oil has previously been shown to have a possible effect on muscle pain, but no randomized controlled trials have so far been carried out in LBP patients. METHODS: Four hundred thirteen adults aged 18 to 60 years were included. Participants were sick-listed 2 to 10 months due to LBP. Main outcome was objectively ascertained work participation at 12-month follow-up. Participants were randomly assigned to BI (n = 100), BI and CBT (n = 103), BI and seal oil (n = 105), or BI and soy oil (n = 105). BI is a two-session cognitive, clinical examination program followed by two booster sessions, while the CBT program is a tailored, individual, seven-session manual-based treatment. RESULTS: At 12-month follow-up, 60% of the participants in the BI group, 50% in the BI and CBT group, 51% in the BI and seal oil group, and 53% in the BI and soy oil group showed reduced sick leave from baseline, and had either partly or fully RTW. The differences between the groups were not statistically significant (χ = 2.54, P = 0.47). There were no significant differences between the treatment groups at any of the other follow-up assessments either, except for a significantly lower sick leave rate in the BI group than the other groups during the first 3 months of follow-up (χ = 9.50, P = 0.02). CONCLUSION: CBT and seal oil had no additional benefits over a brief cognitive intervention on sick leave. The brief cognitive intervention alone was superior in facilitating a fast RTW.Cognitive Interventions and Nutritional Supplements (The CINS Trial): A Randomized Controlled, Multicenter Trial Comparing a Brief Intervention with Additional Cognitive Behavioral Therapy, Seal Oil, and Soy Oil for Sick-Listed Low Back Pain PatientsThe Research Council of Norway, the GC Rieber Funds and Mills DA funds were received in support of this work.publishedVersio
Operational Integration in Health Care versus Mass Production
Get PDFOperational integration has been studied by several authors. However, still there are many research questions to be raised. Two value chains have been studied within two different sectors: the health sector and the car component industry (mass producer). The research methodology is based on semi-structured interviews with selected persons from different levels within the organizations. The data was transcribed, coded and further analyzed to find enablers or disablers to operational integration in both sectors. From this study, factors such as management commitment, colocation, and job-rotation can be seen as contributing factors in both organizations. Both experience disablers such as working as functional silos and little alignment of overall goals. Differences are seen in the greater use of job rotation within health care, while the mass producer had more mechanisms to facilitate working in cross functional teams. Practical implication: This paper presents empirical findings of success factors and pitfalls for operational integration within the value chain of two different types of organizations. Based on this mapping, recommendations on how to achieve better operational integration will be presented. The research initiative provides knowledge experiences from operational integration in two different Norwegian organizations representing two different sectors.publishedVersio
Genetic variation in catechol-O-methyltransferase modifies effects of clonidine treatment in chronic fatigue syndrome
Get PDFAbstract
Clonidine, an α2-adrenergic receptor agonist, decreases circulating norepinephrine and
epinephrine, attenuating sympathetic activity. Although catechol-O-methyltransferase (COMT)
metabolizes catecholamines, main effectors of sympathetic function, COMT genetic variation
effects on clonidine treatment are unknown. Chronic fatigue syndrome (CFS) is hypothesized to
result in part from dysregulated sympathetic function. A candidate gene analysis of COMT
rs4680 effects on clinical outcomes in the Norwegian Study of Chronic Fatigue Syndrome in
Adolescents: Pathophysiology and Intervention Trial (NorCAPITAL), a randomized doubleblinded
clonidine versus placebo trial, was conducted (N=104). Patients homozygous for rs4680
high-activity allele randomized to clonidine took 2,500 fewer steps compared to placebo
(pinteraction=0.04). There were no differences between clonidine and placebo amongst patients
with COMT low-activity alleles. Similar gene-drug interactions were observed for sleep
(pint=0.003) and quality of life (pint=0.018). Detrimental effects of clonidine in the subset of CFS
patients homozygous for COMT high-activity allele warrant investigation of potential clonidine-
COMT interaction effects in other conditions.Sources of support: KTH was supported by T32AT000051, 1K01HL130625 and Harvard Catalyst Faculty Fellowship. This study was supported by NLM grant # T15LM007092 and grant project (P300P1_158427) awarded to JK by the Swiss National Science Foundation. TJK was supported by NIH/NCCIH grant # 2K24 AT004095
A tailored intervention to implement guideline recommendations for elderly patients with depression in primary care: A pragmatic cluster randomised trial
Get PDFBackground
Elderly patients with depression are underdiagnosed, undertreated and run a high risk of a chronic course. General practitioners adhere to clinical practice guidelines to a limited degree. In the international research project Tailored Implementation for Chronic Diseases, we tested the effectiveness of tailored interventions to improve care for patients with chronic diseases. In Norway, we examined this approach to improve adherence to six guideline recommendations for elderly patients with depression targeting healthcare professionals, patients and administrators.
Methods
We conducted a cluster randomised trial in 80 Norwegian municipalities. We identified determinants of practice for six recommendations and subsequently tailored interventions to address these determinants. The interventions targeted healthcare professionals, administrators and patients and consisted of outreach visits, a website presenting the recommendations and the underlying evidence, tools to manage depression in the elderly and other web-based resources, including a continuous medical education course for general practitioners. The primary outcome was mean adherence to the recommendations. Secondary outcomes were improvement in depression symptoms as measured by patients and general practitioners. We offered outreach visits to all general practitioners and practice staff in the intervention municipalities. We used electronic software that extracted eligible patients from the general practitioners’ lists. We collected data by interviewing general practitioners or sending them a questionnaire about their practice for four patients on their list and by sending a questionnaire to the patients.
Results
One hundred twenty-four of the 900 general practitioners (14 %) participated in the data collection, 51 in the intervention group and 73 in the control group. We interviewed 77 general practitioners, 47 general practitioners completed the questionnaire, and 134 patients responded to the questionnaire. Amongst the general practitioners who provided data, adherence to the recommendations was 1.6 percentage points higher in the intervention group than in the control group (95 % CI −6 to 9).
Conclusions
The effectiveness of our tailored intervention to implement recommendations for elderly patients with depression in primary care is uncertain, due to the low response rate in the data collection. However, it is unlikely that the effect was large. It remains uncertain how best to improve adherence to evidence-based recommendations and thereby improve the quality of care for these patients
The association between anomalous self-experiences, self-esteem and depression in first episode schizophrenia
No full textFunding for this study was provided by Innlandet Hospital Trust (grant number 150229) and the Regional Health Authority of South-Eastern Norway (grant numbers, 2006258, 2008058, and 2011085). The funding sources had no further role in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication.acceptedVersio
First quality score for referral letters in gastroenterology—a validation study
Get PDFAbstract Objective To create and validate an objective and reliable score to assess referral quality in gastroenterology. Design An observational multicentre study. Setting and participants 25 gastroenterologists participated in selecting variables for a Thirty Point Score (TPS) for quality assessment of referrals to gastroenterology specialist healthcare for 9 common indications. From May to September 2014, 7 hospitals from the South-Eastern Norway Regional Health Authority participated in collecting and scoring 327 referrals to a gastroenterologist. Main outcome measure Correlation between the TPS and a visual analogue scale (VAS) for referral quality. Results The 327 referrals had an average TPS of 13.2 (range 1–25) and an average VAS of 4.7 (range 0.2–9.5). The reliability of the score was excellent, with an intra-rater intraclass correlation coefficient (ICC) of 0.87 and inter-rater ICC of 0.91. The overall correlation between the TPS and the VAS was moderate (r=0.42), and ranged from fair to substantial for the various indications. Mean agreement was good (ICC=0.47, 95% CI (0.34 to 0.57)), ranging from poor to good. Conclusions The TPS is reliable, objective and shows good agreement with the subjective VAS. The score may be a useful tool for assessing referral quality in gastroenterology, particularly important when evaluating the effect of interventions to improve referral quality.The PhD student salary was funded by the South-Eastern Norway Health Authority’s research grant (grant agreement number 2008040) and the Norwegian Medical Association grant for quality improvement and patient safety (grant agreement number 14/1689). Researchers were independent of the funder.publishedVersio
Signs of imminent dying and change in symptom intensity during pharmacological treatment in dying nursing home patients: a prospective trajectory study
Get PDFOBJECTIVES:
To investigate whether it is possible to determine signs of imminent dying and change in pain and symptom intensity during pharmacological treatment in nursing home patients, from day perceived as dying and to day of death.
DESIGN:
Prospective, longitudinal trajectory trial.
SETTING:
Forty-seven nursing homes within 35 municipalities of Norway.
PARTICIPANTS:
A total of 691 nursing home patients were followed during the first year after admission and 152 were assessed carefully in their last days of life.
MEASUREMENTS:
Time between admission and day of death, and symptom severity by Edmonton symptom assessment system (ESAS), pain (mobilization-observation-behavior-intensity-dementia-2), level of dementia (clinical dementia rating scale), physical function (Karnofsky performance scale), and activities of daily living (physical self-maintenance scale).
RESULTS:
Twenty-five percent died during the first year after admission. Increased fatigue (logistic regression, odds ratio [OR] 1.8, P = .009) and poor appetite (OR 1.2, P = .005) were significantly associated with being able to identify the day a person was imminently dying, which was possible in 61% of the dying (n = 82). On that day, the administration of opioids, midazolam, and anticholinergics increased significantly (P < .001), and was associated with amelioration of symptoms, such as pain (mixed-models linear regression, 60% vs 46%, P < .001), anxiety (44% vs 31%, P < .001), and depression (33% vs 15%, P < .001). However, most symptoms were still prevalent at day of death, and moderate to severe dyspnea and death rattle increased from 44% to 53% (P = .040) and 8% to 19% (P < .001), respectively. Respiratory symptoms were not associated with opioids or anticholinergics.
CONCLUSION:
Pharmacological treatment ameliorated distressing symptoms in dying nursing home patients; however, most symptoms, including pain and dyspnea, were still common at day of death. Results emphasize critical needs for better implementation of guidelines and staff education.
TRIAL REGISTRATION:
ClinicalTrials.govNCT01920100.publishedVersio