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Predictive Clinical Factors of Pain-Related Quality of Recovery Following Elective Gastrointestinal and Hepato-Pancreato-Biliary Surgery: An Observational Study in Norway
Full text linkPurpose: This observational cohort study aimed to identify predictive factors associated with pain-related quality of recovery among patients undergoing elective gastrointestinal and hepato-pancreato-biliary surgery.
Patients and methods: This study involved a secondary analysis of the data collected from five hospitals across all healthcare regions in Norway to validate the Norwegian version of the Quality of Recovery-15 (QoR-15NO). The sample consisted of 268 adult patients who underwent elective gastrointestinal and hepato-pancreato-biliary surgery between September 2021 and May 2022. Data were collected using QoR-15NO upon admission for surgery and on the first postoperative day, and surgery severity was classified using the Surgical Outcome Risk Tool. A linear mixed model and multivariate linear regression were used to investigate associations between postoperative scores and possible predictive clinically relevant factors.
Results: The results of this study showed that postoperative pain was significantly associated with age, gender, severity of surgery, and changes from pre- to postoperative status. Younger patients, compared to older patients (b=0.23, 95% CI: [0.03, 0.41]), female patients (b=-0.61, 95% CI: [-1.19, -0.04]), patients undergoing minor and intermediate surgeries compared to major surgeries (b=0.96, 95% CI: [0.00, 1.92]) all reported higher levels of postoperative pain. There was a significant decline in QoR post-surgery due to increased pain severity (b=-1.91, 95% CI: [-2.33, -1.50]; p <0.001). No clinically significant associations were found between ASA physical status, surgery duration, and pain-related QoR.
Conclusion: This study identified age, gender, and surgery severity as key predictors of postoperative pain. Younger and female patients and those undergoing minor surgeries are at higher risk for severe postoperative pain. Proactive approaches for minor surgeries and tailored pain management for younger patients and females might enhance recovery and postoperative pain outcomes. Thus, future research should focus on the long-term effects of individualized pain management and additional strategies for high-risk patient groups.publishedVersio
A 12-Week Strict Low FODMAP Diet Reduces the Severity Levels of Fatigue, Depression, Anxiety, and Inattention in Patients with Irritable Bowel Syndrome
Full text linkBackground: The low FODMAP diet (LFD) has been shown to alleviate gastrointestinal symptoms in patients with irritable bowel syndrome (IBS). However, the impact of the LFD on coexisting symptoms of fatigue, anxiety, depression, and cognitive functions remains unclear.
Objectives: This study aims to investigate the effects of a 12-wk strict LFD on symptoms of fatigue, depression, anxiety, and inattention in patients with moderate-to-severe IBS-D (diarrhea-predominant), and IBS-M (mixed diarrhea and constipation).
Methods: Participants with IBS were included in an open-label, single-center, 12-wk dietary intervention conducted at Haukeland University Hospital in Bergen, Norway. They followed a strict LFD guided by a registered dietitian and completed questionnaires assessing fatigue [Chalder Fatigue Scale (CFQ-11)] and anxiety and depression [Hospital Anxiety and Depression Scale (HADS)] and performed a test of attention [the third edition of the Connors' continuous performance test (CPT-3)] at baseline and 12-wk follow-up. Data were analyzed using Wilcoxon signed-rank tests to evaluate changes from baseline to post intervention.
Results: Thirty-six participants completed the intervention. Statistically significant reductions were observed in symptoms of fatigue (CFQ-11, P < 0.013) and symptoms of anxiety (HADS-A, P < 0.006). Most of the patients were defined as noncases of fatigue and anxiety following the intervention. Performance on the CPT-3 revealed improvements in measures of inattention.
Conclusions: A 12-wk strict LFD intervention significantly alleviated coexisting symptoms of fatigue, anxiety, and depression, and improved performance on a psychometric test of attention. These findings suggest that dietary management plays a crucial role in improving both physical and mental health in patients with IBS.This study was registered at clinical trial as NCT04296552 (https://clinicaltrials.gov/study/NCT04296552?term=NCT04296552&rank=1).This research was funded by the Research Council of Norway
(grant ID FRIMED-BIO276010) and Helse Vest’s Research
Funding (grant ID HV912243) and by the Trond Mohn Research
Foundation, grant number BFS2018TMT0, and from , project number 294594.publishedVersio
Infant Vitamin B12 Status and its Predictors – Cross-Sectional Baseline Results from an Ongoing Randomized Controlled Trial
Full text linkBackground: Vitamin B12 is a crucial micronutrient for infant growth and development.
Objective: The objective of this study was to describe vitamin B12 status in Norwegian infants aged 6-15 wk using multiple biomarkers and cut-off approaches, and to identify its predictors.
Methods: From November 2021 through August 2024, infants aged 6-15 wk and their mothers were recruited from public health clinics in Innlandet County, Norway, as part of an ongoing randomized controlled trial. Plasma cobalamin and methylmalonic acid (MMA) concentrations were analyzed among all infants in the cohort (n = 644), and total homocysteine (tHcy) concentrations were analyzed in a subgroup (n = 358). The combined indicator for vitamin B12 status (cB12) was calculated by Fedosov's equation. Low status was defined using multiple cut-off approaches. Potential predictors of infant vitamin B12 status were evaluated using regression models.
Results: Mean (standard deviation [SD]) infant age was 9.1 (1.8) wk. The median (interquartile range) concentrations were: cobalamin 242 (192, 322) pmol/L, tHcy 7.4 (6.2, 9.4) μmol/L, and MMA 0.34 (0.21, 0.77) μmol/L. The mean (SD) cB12 was -0.5 (0.7). Eight percent had cobalamin 6.5 μmol/L, 19% >10 μmol/L, and 4% >13 μmol/L. Sixty-four percent had MMA>0.26 μmol/L. Exclusively breastfed infants had 40% lower cobalamin and 30% higher tHcy compared with nonbreastfed infants. Partially breastfed infants had 21% lower cobalamin and 12% higher tHcy compared with nonbreastfed infants.
Conclusion: A substantial proportion of Norwegian infants have biochemical signs of low vitamin B12 status, given that the cut-offs were established in adults. Lower status was observed in partially and exclusively breastfed infants, compared with nonbreastfed infants. However, it is unclear whether these biomarker patterns have clinical significance. Further research is needed to determine consequences of low vitamin B12 biomarker concentrations in early infancy. This trial was registered as NCT05005897.This work was supported by South-Eastern Norway Regional
Health Authority (grant no. 2020096) (to TAS), by Norwegian
Regional Research Fund (grant no. 332775) (to KSB) and by Innlandet
Hospital Trust (grant no. 150455 and grant no. 150473) (to TAS).publishedVersio
The effect of donation frequency on donor health in blood donors donating plasma by plasmapheresis: study protocol for a randomized controlled trial
Full text linkBackground: The demand for plasma products is growing, necessitating an increase in plasma collection by plasmapheresis. While the 20th edition of the European Guidelines permits plasma donors in Europe to donate with 96-h donation intervals, the potential short- and long-term consequences of high-frequency plasma donations on donor health remain unknown. This study aims to measure the effect of plasma donation frequency on plasma protein composition, including total serum protein (TSP) and immunoglobulin G (IgG), in Norwegian male blood donors. Methods: This randomized controlled trial (RCT) included 120 male blood donors who were randomized into two intervention groups and one control group: high-frequency plasma donors (HFPDs) who donated 650 mL of plasma 3 times every 2 weeks, whereas regular-frequency plasma donors (RFPDs) who donated 650 mL of plasma 1 time every 2 weeks. The control group consisted of whole blood donors. The primary outcomes are the concentrations of TSP and IgG. Discussion: The findings from this study may have implications for recommendations related to donor health and plasma donation frequencies and may contribute to supporting the strategic independence of plasma products in Norway and Europe without compromising donor health.publishedVersio
Robotic Assisted Hernia Repair in Four Nordic Countries - Status and Challenges
Full text linkThe author(s) declare financial support was received for the research,
authorship, and/or publication of this article. The authors declare to
have received a grant from Intuitive to support publication of the
article. Intuitive had no influence on the research and did not
contribute, nor aproved the manuscriptpublishedVersio
Long-Term Safety of Dexamethasone Sodium Phosphate Encapsulated in Autologous Erythrocytes (EryDex) in Pediatric Patients with Ataxia Telangiectasia
Full text linkBackground: Dexamethasone sodium phosphate (DSP) encapsulated in autologous erythrocytes (EryDex) was developed as an alternative to standard glucocorticoids in an effort to eliminate chronic steroid toxicity while preserving efficacy. The primary objective of this report is to describe the safety of long-term use of EryDex in treatment of pediatric patients with ataxia telangiectasia. Methods: This is a post-hoc analysis of patients treated with EryDex for a minimum of 24 months in two prospective clinical trials. Outcomes include adverse events, growth, hemoglobin and serum iron, glucose levels, HbA1c, CD4+ lymphocytes, and bone mineral density. Results: Sixty-eight patients completed a minimum of 2 years of treatment with EryDex (mean treatment length 39 ± 11 months). Treatment-emergent adverse events (TEAE), reported in 67 (99%) out of 68 patients, were typically mild and did not cause discontinuation of treatment or death. Treatment-related TEAE were noted in 48 (71%) patients. Notable adverse events included transient pruritus reported in 23 (34%) patients and findings of low serum iron reported in 27 (40%) patients, while at baseline one fifth of patients had low serum iron. Anemia was reported in 9 (13%) patients. The mean hemoglobin level changed by −0.8 ± 1.0 g/dL after 6 months of therapy without subsequent decline. Longitudinal height and weight mean z-scores showed minimal change from baseline to month 24 for height (−0.06 ± 0.49), weight (−0.02 ± 0.71), and body mass index (0.03 ± 0.87). The mean bone mineral density (BMD) z-score showed a decline of 0.4 points over the 24 months of treatment. Values for glucose, HbA1c, cortisol, and CD4+ lymphocyte counts did not show clinically significant changes during prolonged treatment with EryDex. Conclusion: The most common treatment-related adverse events were transient infusion-related pruritus and iron deficiency. There was a decline in BMD which could not be distinguished from the natural course of disease. There were no adverse effects on height, weight and body mass index noted, as documented by stable z-scores throughout the 2 years of treatment. Adverse events typically observed with prolonged glucocorticoid use such as Cushingoid features, weight gain, hypertension, hirsutism, diabetes or stunted growth were rarely reported.The author(s) declare financial support was received for the research, authorship, and/or publication of this article. EryDel S.p.A. and Quince Therapeutics funded this study.publishedVersio
Biotin: a scoping review for Nordic Nutrition Recommendations 2023
Full text linkBiotin is a water-soluble B-vitamin with key roles in metabolism and are found in most foods at low concentrations. Symptomatic biotin deficiency is rare, and few studies have investigated biotin requirements in relation to health outcomes. Data to support the setting of dietary reference values for biotin are limited. Keywords: biotin; carboxylation; nutrition recommendations; vitamin B7.publishedVersio
International Delphi Study on Wound Closure and Incision Management in Joint Arthroplasty Part 2: Total Hip Arthroplasty
Full text linkBackground: This modified Delphi study aimed to develop a consensus on optimal wound closure and incision management strategies for total hip arthroplasty (THA). Given the critical nature of wound care and incision management in influencing patient outcomes, this study sought to synthesize evidence-based best practices for wound care in THA procedures. Methods: An international panel of 20 orthopedic surgeons from Europe, Canada, and the United States evaluated a targeted literature review of 18 statements (14 specific to THA and 4 related to both THA and total knee arthroplasty). There were 3 rounds of anonymous voting per topic using a modified 5-point Likert scale with a predetermined consensus threshold of ≥ 75% agreement necessary for a statement to be accepted. Results: After 3 rounds of voting, consensus was achieved for all 18 statements. Notable recommendations for THA wound management included (1) the use of barbed sutures over non-barbed sutures (shorter closing times and overall cost savings); (2) the use of subcuticular sutures over skin staples (lower risk of superficial infections and higher patient preferences, but longer closing times); (3) the use of mesh-adhesives over silver-impregnated dressings (lower rate of wound complications); (4) for at-risk patients, the use of negative pressure wound therapy over other dressings (lower wound complications and reoperations, as well as fewer dressing changes); and (5) the use of triclosan-coated sutures (lower risk of surgical site infection) over standard sutures. Conclusions: Through a structured modified Delphi approach, a panel of 20 orthopedic surgeons reached consensus on all 18 statements pertaining to wound closure and incision management in THA. This study provides a foundational framework for establishing evidence-based best practices, aiming to reduce variability in patient outcomes and to enhance the overall quality of care in THA procedures.publishedVersio
Stability and predictability of Bayley Scales of Infant and Toddler Development: evidence from a south Indian birth cohort prospective study
Full text linkObjectives: There is limited information about the stability and predictability of Bayley Scales of Infant and Toddler Development (BSID) assessing child development in low- and middle-income settings. The objective of the present study was to analyse stability and predictive validity of BSID using an existing birth cohort.
Design: Prospective birth cohort follow-up study.
Setting and participants: A community-based birth cohort of 251 newborns was recruited and followed-up in urban Vellore, South India, until 9 years of age. Using BSID-III, child development was measured at 6, 15, 24 and 36 months. Cognition was assessed using the Wechsler Preschool Primary Scales of Intelligence at 5 years, and the Malin's Intelligence Scale for Indian Children scale at 7 and 9 years of age. The stability of BSID measurements across time points was expressed by intraclass correlation (ICC) and concordance correlation coefficients. Linear regression was used to describe the predictability of BSID-III of cognition at 5, 7 and 9 years.
Results: The ICC for domain-wise BSID scores between time points of measurement suggested a weak correlation. The BSID scores at 36 months correlated best with Full-Scale Intelligence Quotient (FSIQ) at 5 years (r: 0.40-0.49), 7 years (r: 0.35-0.48) and 9 years (r: 0.36-0.38). BSID scores at 36 months predicted FSIQ better at 5, 7 and 9 years with R2 ranging from 23.3% to 28.6%, when compared with 24 months BSID scores (R2 - 16.0% to 25.9%).
Conclusion: Poor stability and predictability of BSID warrant caution in the predictive projection of early childhood assessments. Better predictability of future cognition of 36 months' BSID scores highlights its advantage over the 24 months' assessment.(1) The Etiology, Risk Factors and Interactions of Enteric Infections and Malnutrition and the Consequence for Child Health and Development Project (MAL ED) is carried out as a collaborative project supported by the Bill and Melinda Gates Foundation, the Foundation for the NIH and the National Institutes of Health/Fogarty International Center (grant number: GR-681).
(2) The 9-year follow-up of the MAL-ED India cohort was supported by an intermediate clinical and public health research fellowship awarded by the DBT/Wellcome Trust India Alliance to BK (fellowship grant number IA/CPHI/19/1/504611).publishedVersio
The effectiveness of virtual reality training on knowledge, skills and attitudes of health care professionals and students in assessing and treating mental health disorders: a systematic review
Full text linkBackground: Virtual reality (VR) training can enhance health professionals' learning. However, there are ambiguous findings on the effectiveness of VR as an educational tool in mental health. We therefore reviewed the existing literature on the effectiveness of VR training on health professionals' knowledge, skills, and attitudes in assessing and treating patients with mental health disorders. Methods: We searched MEDLINE, PsycINFO (via Ovid), the Cochrane Library, ERIC, CINAHL (on EBSCOhost), Web of Science Core Collection, and the Scopus database for studies published from January 1985 to July 2023. We included all studies evaluating the effect of VR training interventions on attitudes, knowledge, and skills pertinent to the assessment and treatment of mental health disorders and published in English or Scandinavian languages. The quality of the evidence in randomized controlled trials was assessed with the Cochrane Risk of Bias Tool 2.0. For non-randomized studies, we assessed the quality of the studies with the ROBINS-I tool. Results: Of 4170 unique records identified, eight studies were eligible. The four randomized controlled trials were assessed as having some concern or a high risk of overall bias. The four non-randomized studies were assessed as having a moderate to serious overall risk of bias. Of the eight included studies, four used a virtual standardized patient design to simulate training situations, two studies used interactive patient scenario training designs, while two studies used a virtual patient game design. The results suggest that VR training interventions can promote knowledge and skills acquisition. Conclusions: The findings indicate that VR interventions can effectively train health care personnel to acquire knowledge and skills in the assessment and treatment of mental health disorders. However, study heterogeneity, prevalence of small sample sizes, and many studies with a high or serious risk of bias suggest an uncertain evidence base. Future research on the effectiveness of VR training should include assessment of immersive VR training designs and a focus on more robust studies with larger sample sizes. Trial registration: This review was pre-registered in the Open Science Framework register with the ID-number Z8EDK. Keywords: Clinical skills; Health care professionals; Health care students; Mental health; Systematic review; Training; Virtual reality.Open access funding provided by Inland Norway University Of Applied Sciences The study forms a part of a collaborative PhD project funded by South-Eastern Norway Regional Health Authority through Innlandet Hospital Trust and the Inland University of Applied Sciences.publishedVersio