scholarly journals Differentiated approach to pancreatic-enteroanastomosis in pancreaticoduodenal resection: a clinical experimental controlled trial

2021 ◽  
Vol 28 (5) ◽  
pp. 29-46
Author(s):  
Anton Yu. Barannikov ◽  
Vladimir D. Sakhno ◽  
Vladimir M. Durleshter ◽  
Laura G. Izmailova ◽  
Andrei V. Andreev ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Additional Treatment ◽  
Ultrasound Elastography ◽  
Control Cohort ◽  
Class B ◽  
Clinically Significant ◽  
Immediate Surgery ◽  
Randomised Controlled ◽  
And Control ◽  
Significant Class

Background. Despite decreasing mortality in pancreaticoduodenal resection, the incidence of postoperative complications in such patients remains high. The choice and formation of “reliable” pancreatic-enteroanastomosis remain relevant.Objectives. The improvement of immediate surgery outcomes in pancreaticoduodenal resection via development of a differentiated algorithm for pancreatic-enteroanastomosis formation.Methods. A prospective non-randomised controlled trial enrolled 90 patients with a pancreaticoduodenal resection surgery. The patients were divided in three cohorts, A (n = 30), B (n = 30) and control C (n = 30). Pancreatic shear wave ultrasound elastography was conducted pre-surgery in main cohorts A and B. Average parenchymal stiffness and intraoperative data decided between the two pancreatico-enteric anastomosis techniques, end-to-side or the original pancreatic-enteroanastomosis. Control cohort C had pancreatico-enteric anastomosis without taking into account the pancreas stiffness and macrocondition.Results. Class A postoperative pancreatic fistula was registered in 2 (6.7%) of 30 patients in cohort B; it was transient, asymptomatic, not requiring additional treatment or a longer postoperative period. No class B and C pancreatic-enteroanastomosis failures or stump pancreonecroses were observed in main cohorts A and B. Clinically significant class B and C postoperative pancreatic fistulae were registered in 5 (16.7%) of 30 patients in control cohort C (inter-cohort comparison statistically significant).Conclusion. The proposed differentiated approach to pancreatic-enteroanastomosis formation associates with a reliably low postoperative complication frequency and lack of clinically significant class B and C postoperative pancreatic fistulae.

scholarly journals Estimating the minimum important difference in the DEMQOL instrument in people with dementia

2021 ◽  
Author(s):  
Ellen C. Lee ◽  
Jessica Wright ◽  
Stephen J. Walters ◽  
Cindy L. Cooper ◽  
Gail A. Mountain
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Minimum Important Difference ◽  
Absolute Change ◽  
People With Dementia ◽  
Related Quality ◽  
Registration Number ◽  
Clinically Significant ◽  
Randomised Controlled

Abstract Purpose The Dementia-Related Quality of Life (DEMQOL) measure and the DEMQOL-Utility Score (DEMQOL-U) are validated tools for measuring quality of life (QOL) in people with dementia. What score changes translate to a clinically significant impact on patients’ lives was unknown. This study establishes the minimal important differences (MID) for these two instruments. Methods Anchor-based and distribution-based methods were used to estimate the MID scores from patients enrolled in a randomised controlled trial. For the anchor-based method, the global QOL (Q29) item from the DEMQOL was chosen as the anchor for DEMQOL and both Q29 and EQ-5D for DEMQOL-U. A one category difference in Q29, and a 0.07 point difference in EQ-5D score, were used to classify improvement and deterioration, and the MID scores were calculated for each category. These results were compared with scores obtained by the distribution-based methods. Results A total of 490 people with dementia had baseline DEMQOL data, of these 386 had 8-month data, and 344 had 12-month DEMQOL data. The absolute change in DEMQOL for a combined 1-point increase or decrease in the Q29 anchor was 5.2 at 8 months and 6.0 at 12 months. For the DEMQOL-U, the average absolute change at 8 and 12 months was 0.032 and 0.046 for the Q29 anchor and 0.020 and 0.024 for EQ-5D anchor. Conclusion We present MID scores for the DEMQOL and DEMQOL-U instruments obtained from a large cohort of patients with dementia. An anchored-based estimate of the MID for the DEMQOL is around 5 to 6 points; and 0.02 to 0.05 points for the DEMQOL-U. The results of this study can guide clinicians and researchers in the interpretation of these instruments comparisons between groups or within groups of people with dementia. Trial Registration Number and date of registration: ISRCTN17993825 on 11th October 2016.

scholarly journals Prevalence of Vitamin D Deficiency and Its Relationship with Clinical Outcomes in Patients with Fibromyalgia: a Systematic Review of the Literature

2022 ◽  
Vol 4 (1) ◽  
Author(s):  
Omar M. E. Ali
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Patient Flow ◽  
Controlled Trial ◽  
Cost Effective ◽  
Therapeutic Benefit ◽  
Vitamin D Supplementation ◽  
Effective Interventions ◽  
Randomised Controlled ◽  
And Control

Abstract Fibromyalgia is a debilitating chronic condition which poses a therapeutic challenge to the clinician. With a large backlog in patient flow subsequent to the COVID-19 pandemic and rising numbers of patients with post-acute sequelae of COVID-19 (PASC) presenting with fibromyalgia-like clinical features, there is an increasingly pressing need to identify broad cost-effective interventions. Low levels of vitamin D have previously been reported in patients with fibromyalgia, though any causative link has been difficult to establish. A systematic literature review on the association between vitamin D deficiency and fibromyalgia was performed examining retrospective evidence both for and against an association between vitamin D deficiency (VDD) and fibromyalgia and evaluating the therapeutic benefit from supplementation. A group of six studies were selected based on relevance, use of controls, quality of research and citations. Four primary studies assessing the prevalence of VDD in fibromyalgia patients versus controls were evaluated with a total 3,496 subjects. Three included females only and one larger study assessed males. Two (n = 313) concluded the presence of a statistically significant association, and two (n = 161) found none. Two randomised controlled trials assessing the effect of vitamin D supplementation in a total of 80 subjects found conflicting results, with pain reduction in one and none in the other. It is likely there exists an association between VDD deficiency and fibromyalgia in a large subset of patients, although establishing primary causation is difficult. There is a need for larger randomised controlled trial designs with more effective comparison with healthy subjects and control for confounding factors. Given VDD is a major problem in the general population, we recommend supplementation be recommended by healthcare professionals to fibromyalgia patients for the purpose of maintaining bone health given their potentially increased susceptibility to developing deficiency and its sequelae.

scholarly journals The effect of text messaging on latent tuberculosis treatment adherence: a randomised controlled trial

2018 ◽  
Vol 51 (2) ◽  
pp. 1701488 ◽  
Author(s):  
James C. Johnston ◽  
Mia L. van der Kop ◽  
Kirsten Smillie ◽  
Gina Ogilvie ◽  
Fawziah Marra ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Treatment Adherence ◽  
Text Messaging ◽  
Controlled Trial ◽  
Latent Tuberculosis ◽  
Completion Rates ◽  
Ltbi Treatment ◽  
Data Analyst ◽  
Randomised Controlled ◽  
And Control

There is limited high-quality evidence available to inform the use of text messaging to improve latent tuberculosis infection (LTBI) treatment adherence.We performed a parallel, randomised controlled trial at two sites to assess the effect of a two-way short message service on LTBI adherence. We enrolled adults initiating LTBI therapy from June 2012 to September 2015 in British Columbia, Canada. Participants were randomised in a 1:1 ratio to standard LTBI treatment (control) or standard LTBI treatment plus two-way weekly text messaging (intervention). The primary outcome was treatment completion, defined as taking ≥80% prescribed doses within 12 months (isoniazid) or 6 months (rifampin) of enrolment. The trial was unblinded except for the data analyst.A total of 358 participants were assigned to the intervention (n=170) and control (n=188) arms. In intention-to-treat analysis, the proportion of participants completing LTBI therapy in the intervention and control arms was 79.4% and 81.9%, respectively (RR 0.97, 95% CI 0.88–1.07; p=0.550). Results were similar for pre-specified secondary end-points, including time-to-completion of LTBI therapy, completion of >90% of prescribed LTBI doses and health-related quality of life.Weekly two-way text messaging did not improve LTBI completion rates compared to standard LTBI care; however, completion rates were high in both treatment arms.

P5307A consumer-direct digital health intervention for cardiovascular risk management in primary care: the Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) randomised controlled trial

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J Redfern ◽  
T Usherwood ◽  
G Coorey ◽  
J Mulley ◽  
A Scaria ◽  
...  
Keyword(s):  
Digital Health ◽  
Controlled Trial ◽  
Health Interventions ◽  
Control Group ◽  
Physically Active ◽  
Ehealth Literacy ◽  
Health Strategy ◽  
Randomised Controlled ◽  
And Control

Abstract Background Digital health interventions linked to electronic health records offer patients an innovative approach to support cardiovascular disease (CVD) risk management. Purpose Test the effectiveness of a consumer-directed digital health strategy on medication adherence and cardiovascular health outcomes in patients presenting to primary care who are at moderate to high risk of CVD. Methods Randomised controlled trial (RCT) with 12 month follow-up. Intervention group received an interactive digital health strategy for CVD management. The intervention was integrated with patient's electronic health record to enable automated population of risk factor and medication data (Figure). Control group received usual care. Primary outcome was the proportion of patients taking guideline-recommended BP and cholesterol-lowering medications on at least 80% of days (administrative data). Secondary outcomes included mean SBP, LDL-cholesterol, BMI and proportion meeting risk targets for physical activity, achieving smoking cessation, quality of life (EQ5D) and ehealth literacy (eHEALS). Results Intervention (n=486) and control (n=448) groups were well matched at baseline (Table). Mean age of participants was 67±8.1 years, 77% were male, 41% had existing CVD. At 12 months, there was no significant difference between the groups for medication days covered or mean cholesterol and BP (Table). However, there were significantly more patients in the intervention than control group who were physically active and had high ehealth literacy (Table). Table 1. Primary and Secondary Outcomes Baseline 12 months Outcome Control (n=448) Intervention (n=486) Control (n=431) Intervention (n=460) p value* Taking BP and cholesterol medication on ≥80% of days, % 29.7 28.9 29.9 32.8 0.485 SBP (mmHg), mean±SD 139.0±16.6 137.3±15.9 136.3±16.1 136.4±17.6 0.921 LDL (mmol/L), mean±SD 2.6±1.0 2.6±1.0 2.5±0.9 2.4±1.0 0.240 BMI (kg/m2), mean±SD 29.7±5.1 29.9±5.7 29.4±5.0 29.7±5.7 0.508 Proportion achieving BP and LDL target, % 11.2 12.3 11.7 16.5 0.065 Physically active, % 84.0 85.4 79.7 87.0 0.016 Current smoker, % 12.9 13.0 12.0 8.1 0.087 eHEALS, mean±SD 27.0±6.4 27.0±6.4 26.4±7.5 28.3±6.3 0.002 *Comparing intervention and control at 12 month follow-up. Conclusions The integrated digital health strategy did not significantly impact on days of medication covered however, patients in the intervention had higher physical activity and ehealth literacy. The RCT highlights the importance of conducting robust research if we are to understand the potential value of digital health interventions. Acknowledgement/Funding This work was supported by a Project Grant from the National Health and Medical Research Council of Australia

scholarly journals The effects of a lutein-based supplement on objective and subjective measures of retinal and visual function in eyes with age-related maculopathy – a randomised controlled trial

2012 ◽  
Vol 109 (11) ◽  
pp. 2008-2014 ◽  
Author(s):  
Emma J. Berrow ◽  
Hannah E. Bartlett ◽  
Frank Eperjesi ◽  
Jonathan M. Gibson
Keyword(s):  
Visual Function ◽  
Controlled Trial ◽  
Treated Group ◽  
Macular Disease ◽  
Significance Level ◽  
Age Related ◽  
Clinically Significant ◽  
Randomised Controlled ◽  
Oral Supplement ◽  
Reduced Risk

Lutein and zeaxanthin are lipid-soluble antioxidants found within the macula region of the retina. Links have been suggested between increased levels of these carotenoids and reduced risk for age-related macular disease (ARMD). Therefore, the effect of lutein-based supplementation on retinal and visual function in people with early stages of ARMD (age-related maculopathy, ARM) was assessed using multi-focal electroretinography (mfERG), contrast sensitivity and distance visual acuity. A total of fourteen participants were randomly allocated to either receive a lutein-based oral supplement (treated group) or no supplement (non-treated group). There were eight participants aged between 56 and 81 years (65·50 (sd 9·27) years) in the treated group and six participants aged between 61 and 83 years (69·67 (sd 7·52) years) in the non-treated group. Sample sizes provided 80 % power at the 5 % significance level. Participants attended for three visits (0, 20 and 40 weeks). At 60 weeks, the treated group attended a fourth visit following 20 weeks of supplement withdrawal. No changes were seen between the treated and non-treated groups during supplementation. Although not clinically significant, mfERG ring 3 N2 latency (P= 0·041) and ring 4 P1 latency (P= 0·016) increased, and a trend for reduction of mfERG amplitudes was observed in rings 1, 3 and 4 on supplement withdrawal. The statistically significant increase in mfERG latencies and the trend for reduced mfERG amplitudes on withdrawal are encouraging and may suggest a potentially beneficial effect of lutein-based supplementation in ARM-affected eyes.

scholarly journals Non-pharmacological interventions for agitation in dementia: systematic review of randomised controlled trials

2014 ◽  
Vol 205 (6) ◽  
pp. 436-442 ◽  
Author(s):  
Gill Livingston ◽  
Lynsey Kelly ◽  
Elanor Lewis-Holmes ◽  
Gianluca Baio ◽  
Stephen Morris ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Skills Training ◽  
Light Therapy ◽  
Care Homes ◽  
Pharmacological Interventions ◽  
Clinically Significant ◽  
Randomised Controlled ◽  
Care Mapping ◽  
Sensory Intervention

BackgroundAgitation in dementia is common, persistent and distressing and can lead to care breakdown. Medication is often ineffective and harmful.AimsTo systematically review randomised controlled trial evidence regarding non-pharmacological interventions.MethodWe reviewed 33 studies fitting predetermined criteria, assessed their validity and calculated standardised effect sizes (SES).ResultsPerson-centred care, communication skills training and adapted dementia care mapping decreased symptomatic and severe agitation in care homes immediately (SES range 0.3–1.8) and for up to 6 months afterwards (SES range 0.2–2.2). Activities and music therapy by protocol (SES range 0.5–0.6) decreased overall agitation and sensory intervention decreased clinically significant agitation immediately. Aromatherapy and light therapy did not demonstrate efficacy.ConclusionsThere are evidence-based strategies for care homes. Future interventions should focus on consistent and long-term implementation through staff training. Further research is needed for people living in their own homes.

scholarly journals Early intervention in panic: pragmatic randomised controlled trial

2010 ◽  
Vol 196 (4) ◽  
pp. 326-331 ◽  
Author(s):  
Peter Meulenbeek ◽  
Godelief Willemse ◽  
Filip Smit ◽  
Anton van Balkom ◽  
Philip Spinhoven ◽  
...  
Keyword(s):  
Early Intervention ◽  
Panic Disorder ◽  
Group Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Report ◽  
Control Group ◽  
Cognitive Behavioural ◽  
Clinically Significant ◽  
Randomised Controlled

BackgroundMany people suffer from subthreshold and mild panic disorder and are at risk of developing more severe panic disorder.AimsThis study (trial registration: ISRCTN33407455) was conducted to evaluate the effectiveness of an early group intervention based on cognitive–behavioural principles to reduce panic disorder symptomatology.MethodParticipants with subthreshold or mild panic disorder were recruited from the general population and randomised to the intervention (n = 109) or a waiting-list control group (n = 108). The course was offered by 17 community mental health centres.ResultsIn the early intervention group, 43/109 (39%) participants presented with a clinically significant change on the Panic Disorder Severity Scale–Self Report (PDSS–SR) v. 17/108 (16%) in the control group (odds ratio (OR) for favourable treatment response 3.49, 95% CI 1.77–6.88, P = 0.001). The course also had a positive effect on DSM–IV panic disorder status (OR = 1.96, 95% CI=1.05–3.66, P = 0.037). The PDSS–SR symptom reduction was also substantial (between-group standardised mean difference of 0.68). The effects were maintained at 6-month follow-up.ConclusionsPeople presenting with subthreshold and mild panic disorder benefit from this brief intervention.

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