scholarly journals Epithelium-off corneal cross-linking surgery compared with standard care in 10- to 16-year-olds with progressive keratoconus: the KERALINK RCT

2021 ◽  
Vol 8 (15) ◽  
pp. 1-46
Author(s):  
Daniel FP Larkin ◽  
Kashfia Chowdhury ◽  
Caroline J Doré ◽  
Catey Bunce ◽  
Jennifer M Burr ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Contact Lens ◽  
Odds Ratio ◽  
Standard Care ◽  
Young Patients ◽  
Care Group ◽  
Cross Linking ◽  
Standard Care Group ◽  
Post Randomisation

Background Keratoconus is a disease of the cornea affecting vision that is usually first diagnosed in the first three decades. The abnormality of corneal shape and thickness tends to progress until the patient reaches approximately 30 years of age. Epithelium-off corneal cross-linking is a procedure that has been demonstrated to be effective in randomised trials in adults and observational studies in young patients. Objectives The KERALINK trial examined the efficacy and safety of epithelium-off corneal cross-linking, compared with standard care by spectacle or contact lens correction, for stabilisation of progressive keratoconus. Design In this observer-masked, randomised, controlled, parallel-group superiority trial, 60 participants aged 10–16 years with progressive keratoconus were randomised; 58 participants completed the study. Progression was defined as a 1.5 D increase in corneal power measured by maximum or mean power (K2) in the steepest corneal meridian in the study eye, measured by corneal tomography. Setting Referral clinics in four UK hospitals. Interventions Participants were randomised to corneal cross-linking plus standard care or standard care alone, with spectacle or contact lens correction as necessary for vision, and were monitored for 18 months. Main outcome measures The primary outcome was K2 in the study eye as a measure of the steepness of the cornea at 18 months post randomisation. Secondary outcomes included keratoconus progression, visual acuity, keratoconus apex corneal thickness and quality of life. Results Of 60 participants, 30 were randomised to the corneal cross-linking and standard-care groups. Of these, 30 patients in the corneal cross-linking group and 28 patients in the standard-care group were analysed. The mean (standard deviation) K2 in the study eye at 18 months post randomisation was 49.7 D (3.8 D) in the corneal cross-linking group and 53.4 D (5.8 D) in the standard-care group. The adjusted mean difference in K2 in the study eye was –3.0 D (95% confidence interval –4.93 D to –1.08 D; p = 0.002), favouring corneal cross-linking. Uncorrected and corrected differences in logMAR vision at 18 months were better in eyes receiving corneal cross-linking: –0.31 (95% confidence interval –0.50 to –0.11; p = 0.002) and –0.30 (95% confidence interval –0.48 to –0.11; p = 0.002). Keratoconus progression in the study eye occurred in two patients (7%) randomised to corneal cross-linking compared with 12 (43%) patients randomised to standard care. The unadjusted odds ratio suggests that, on average, patients in the corneal cross-linking group had 90% (odds ratio 0.1, 95% confidence interval 0.02 to 0.48; p = 0.004) lower odds of experiencing progression than those receiving standard care. Quality-of-life outcomes were similar in both groups. No adverse events were attributable to corneal cross-linking. Limitations Measurements of K2 in those eyes with the most significant progression were in some cases indicated as suspect by corneal topography device software. Conclusions Corneal cross-linking arrests progression of keratoconus in the great majority of young patients. These data support a consideration of a change in practice, such that corneal cross-linking could be considered as first-line treatment in progressive disease. If the arrest of keratoconus progression induced by corneal cross-linking is sustained in longer follow-up, there may be particular benefit in avoiding the later requirement for contact lens wear or corneal transplantation. However, keratoconus does not continue to progress in all patients receiving standard care. For future work, the most important questions to be answered are whether or not (1) the arrest of keratoconus progression induced by corneal cross-linking is maintained in the long term and (2) the proportion of those receiving standard care who show significant progression increases with time. Trial registration Current Controlled Trials ISRCTN17303768 and EudraCT 2016-001460-11. Funding This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 8, No. 15. See the NIHR Journals Library website for further project information. The trial sponsor is University College London. This research was otherwise supported in part by the NIHR Moorfields Biomedical Research Centre and the NIHR Moorfields Clinical Research Facility, London, United Kingdom.

scholarly journals Effect of tocilizumab on clinical outcomes at 15 days in patients with severe or critical coronavirus disease 2019: randomised controlled trial

BMJ ◽  
2021 ◽  
pp. n84 ◽  
Author(s):  
Viviane C Veiga ◽  
João A G G Prats ◽  
Danielle L C Farias ◽  
Regis G Rosa ◽  
Leticia K Dourado ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Confidence Interval ◽  
Clinical Outcomes ◽  
Odds Ratio ◽  
Standard Care ◽  
Controlled Trial ◽  
Data Monitoring Committee ◽  
Ordinal Scale ◽  
Care Group ◽  
Standard Care Group

Abstract Objective To determine whether tocilizumab improves clinical outcomes for patients with severe or critical coronavirus disease 2019 (covid-19). Design Randomised, open label trial. Setting Nine hospitals in Brazil, 8 May to 17 July 2020. Participants Adults with confirmed covid-19 who were receiving supplemental oxygen or mechanical ventilation and had abnormal levels of at least two serum biomarkers (C reactive protein, D dimer, lactate dehydrogenase, or ferritin). The data monitoring committee recommended stopping the trial early, after 129 patients had been enrolled, because of an increased number of deaths at 15 days in the tocilizumab group. Interventions Tocilizumab (single intravenous infusion of 8 mg/kg) plus standard care (n=65) versus standard care alone (n=64). Main outcome measure The primary outcome, clinical status measured at 15 days using a seven level ordinal scale, was analysed as a composite of death or mechanical ventilation because the assumption of odds proportionality was not met. Results A total of 129 patients were enrolled (mean age 57 (SD 14) years; 68% men) and all completed follow-up. All patients in the tocilizumab group and two in the standard care group received tocilizumab. 18 of 65 (28%) patients in the tocilizumab group and 13 of 64 (20%) in the standard care group were receiving mechanical ventilation or died at day 15 (odds ratio 1.54, 95% confidence interval 0.66 to 3.66; P=0.32). Death at 15 days occurred in 11 (17%) patients in the tocilizumab group compared with 2 (3%) in the standard care group (odds ratio 6.42, 95% confidence interval 1.59 to 43.2). Adverse events were reported in 29 of 67 (43%) patients who received tocilizumab and 21 of 62 (34%) who did not receive tocilizumab. Conclusions In patients with severe or critical covid-19, tocilizumab plus standard care was not superior to standard care alone in improving clinical outcomes at 15 days, and it might increase mortality. Trial registration ClinicalTrials.gov NCT04403685 .

scholarly journals One-year intensive lifestyle intervention and improvements in health-related quality of life and mental health in persons with type 2 diabetes: a secondary analysis of the U-TURN randomized controlled trial

2021 ◽  
Vol 9 (1) ◽  
pp. e001840
Author(s):  
Christopher Scott MacDonald ◽  
Sabrina M Nielsen ◽  
Jakob Bjørner ◽  
Mette Y Johansen ◽  
Robin Christensen ◽  
...  
Keyword(s):  
Lifestyle Intervention ◽  
Standard Care ◽  
Controlled Trial ◽  
Care Group ◽  
Standard Care Group ◽  
Intensive Lifestyle Intervention ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

IntroductionThe effects of lifestyle interventions in persons with type 2 diabetes (T2D) on health-related quality of life (HRQoL) and subjective well-being are ambiguous, and no studies have explored the effect of exercise interventions that meet or exceed current recommended exercise levels. We investigated whether a 1-year intensive lifestyle intervention is superior in improving HRQoL compared with standard care in T2D persons.Research design and methodsWe performed secondary analyses of a previously conducted randomized controlled trial (April 2015 to August 2016). Persons with non-insulin-dependent T2D (duration ≤10 years) were randomized to 1-year supervised exercise and individualized dietary counseling (ie, ‘U-TURN’), or standard care. The primary HRQoL outcome was change in the 36-item Short Form Health Survey (SF-36) physical component score (PCS) from baseline to 12 months of follow-up, and a key secondary outcome was changes in the SF-36 mental component score (MCS).ResultsWe included 98 participants (U-TURN group=64, standard care group=34) with a mean age of 54.6 years (SD 8.9). Between-group analyses at 12-month follow-up showed SF-36 PCS change of 0.8 (95% CI −0.7 to 2.3) in the U-TURN group and deterioration of 2.4 (95% CI −4.6 to −0.1) in the standard care group (difference of 3.2, 95% CI 0.5 to 5.9, p=0.02) while no changes were detected in SF-36 MCS. At 12 months, 19 participants (30%) in the U-TURN group and 6 participants (18%) in the standard care group achieved clinically significant improvement in SF-36 PCS score (adjusted risk ratio 2.6, 95% CI 1.0 to 4.5 corresponding to number needed to treat of 4, 95% CI 1.6 to infinite).ConclusionIn persons with T2D diagnosed for less than 10 years, intensive lifestyle intervention improved the physical component of HRQoL, but not the mental component of HRQoL after 1 year, compared with standard care.Trial registration numberNCT02417012.

scholarly journals Reduced Need for Rescue Antiemetics and Improved Capacity to Eat in Patients Receiving Acupuncture Compared to Patients Receiving Sham Acupuncture or Standard Care during Radiotherapy

2017 ◽  
Vol 2017 ◽  
pp. 1-11 ◽  
Author(s):  
Anna Enblom ◽  
Gunnar Steineck ◽  
Mats Hammar ◽  
Sussanne Börjeson
Keyword(s):  
Relative Risk ◽  
Confidence Interval ◽  
Standard Care ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Care Group ◽  
Standard Care Group ◽  
Nonspecific Effects ◽  
Sham Acupuncture Group

Objective. To evaluate if consumption of emesis-related care and eating capacity differed between patients receiving verum acupuncture, sham acupuncture, or standard care only during radiotherapy. Methods. Patients were randomized to verum (n=100) or sham (n=100) acupuncture (telescopic blunt sham needle) (median 12 sessions) and registered daily their consumption of antiemetics and eating capacity. A standard care group (n=62) received standard care only and delivered these data once. Results. More patients in the verum (n=73 of 89 patients still undergoing radiotherapy; 82%, Relative Risk (RR) 1.23, 95% Confidence Interval (CI) 1.01–1.50) and the sham acupuncture group (n=79 of 95; 83%, RR 1.24, CI 1.03–1.52) did not need any antiemetic medications, as compared to the standard care group (n=42 out of 63; 67%) after receiving 27 Gray dose of radiotherapy. More patients in the verum (n=50 of 89; 56%, RR 1.78, CI 1.31–2.42) and the sham acupuncture group (n=58 of 94 answering patients; 62%, RR 1.83, CI 1.20–2.80) were capable of eating as usual, compared to the standard care group (n=20 of 63; 39%). Conclusion. Patients receiving acupuncture had lower consumption of antiemetics and better eating capacity than patients receiving standard antiemetic care, plausible by nonspecific effects of the extra care during acupuncture.

scholarly journals Effects of Supervised Early Resistance Training versus standard care on cognitive recovery following cardiac surgery via median sternotomy (The SEcReT study): Protocol for a randomised controlled pilot study

2019 ◽  
Author(s):  
Jacqueline Marie Stacey Pengelly ◽  
Alistair Royse ◽  
Adam Bryant ◽  
Gavin Williams ◽  
Lynda Tivendale ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Resistance Training ◽  
Standard Care ◽  
Median Sternotomy ◽  
Exercise Program ◽  
Moderate Intensity ◽  
Care Group ◽  
Standard Care Group ◽  
Randomised Controlled

Abstract Introduction: Mild cognitive impairment is considered a precursor to dementia and significantly impacts upon quality of life. The prevalence of mild cognitive impairment is higher in the post-surgical cardiac population than the general population, with older age and co-morbidities further increasing the risk of cognitive decline. This significantly impacts upon quality of life. Exercise improves neurogenesis, synaptic plasticity and inflammatory and neurotrophic factor pathways, which may help to augment the effects of cognitive decline. However, the effects of resistance training on cognitive, functional and overall patient-reported recovery have not been investigated in the surgical cardiac population. This study aims to determine the safety and feasibility of early moderate intensity resistance training in people undergoing cardiac surgery via a median sternotomy, compared to standard care. The effect of this exercise program on cognitive and functional recovery will also be examined. Methods: This study will be a prospective, pragmatic, pilot randomised controlled trial comparing a standard care group (low-intensity aerobic exercise) and a moderate-intensity resistance training group. Participants aged 18 years and older with coronary artery and/or valve disease requiring surgical intervention will be recruited pre-operatively and randomised 1:1 to either the resistance training or standard care group post-operatively. Feasibility and safety will be assessed through recruitment and retention rates; exercise program adherence; dropout rate; exercise and session stoppages due to pain, any adverse event or incident; and, any major adverse cardiac and cerebral events. Secondary measures include cognitive function, muscular strength, physical function, multiple-domain recovery, balance and patient satisfaction. Assessments will be conducted at baseline (pre-operatively) and post-operatively at 2 weeks, 8 weeks, 14 weeks and 6 months. Discussion: The results of this study will inform the safety and feasibility of early intervention resistance training for patients following cardiac surgery. In addition, this study will provide insights into the effect of resistance training on postoperative cognitive recovery to inform rehabilitation guidelines. Trial registration: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), ID: ACTRN12617001430325p. Registered on 9 October 2017. Universal Trial Number (UTN):U1111-1203-2131. Keywords: Median sternotomy, resistance training, cognition, cardiac surgery, recovery, rehabilitation, exercise

scholarly journals Effects of Supervised Early Resistance Training versus standard care on cognitive recovery following cardiac surgery via median sternotomy (The SEcReT study): Protocol for a randomised controlled pilot study

2019 ◽  
Author(s):  
Jacqueline Marie Stacey Pengelly ◽  
Alistair Royse ◽  
Adam Bryant ◽  
Gavin Williams ◽  
Lynda Tivendale ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Resistance Training ◽  
Standard Care ◽  
Median Sternotomy ◽  
Exercise Program ◽  
Moderate Intensity ◽  
Care Group ◽  
Standard Care Group ◽  
Randomised Controlled

Abstract Introduction: Mild cognitive impairment is considered a precursor to dementia and significantly impacts upon quality of life. The prevalence of mild cognitive impairment is higher in the post-surgical cardiac population than the general population, with older age and co-morbidities further increasing the risk of cognitive decline. This significantly impacts upon quality of life. Exercise improves neurogenesis, synaptic plasticity and inflammatory and neurotrophic factor pathways, which may help to augment the effects of cognitive decline. However, the effects of resistance training on cognitive, functional and overall patient-reported recovery have not been investigated in the surgical cardiac population. This study aims to determine the safety and feasibility of early moderate intensity resistance training in people undergoing cardiac surgery via a median sternotomy, compared to standard care. The effect of this exercise program on cognitive and functional recovery will also be examined. Methods: This study will be a prospective, pragmatic, pilot randomised controlled trial comparing a standard care group (low-intensity aerobic exercise) and a moderate-intensity resistance training group. Participants aged 18 years and older with coronary artery and/or valve disease requiring surgical intervention will be recruited pre-operatively and randomised 1:1 to either the resistance training or standard care group post-operatively. Feasibility and safety will be assessed through recruitment and retention rates; exercise program adherence; dropout rate; exercise and session stoppages due to pain, any adverse event or incident; and, any major adverse cardiac and cerebral events. Secondary measures include cognitive function, muscular strength, physical function, multiple-domain recovery, balance and patient satisfaction. Assessments will be conducted at baseline (pre-operatively) and post-operatively at 2 weeks, 8 weeks, 14 weeks and 6 months. Discussion: The results of this study will inform the safety and feasibility of early intervention resistance training for patients following cardiac surgery. In addition, this study will provide insights into the effect of resistance training on postoperative cognitive recovery to inform rehabilitation guidelines. Trial registration: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), ID: ACTRN12617001430325p. Registered on 9 October 2017. Universal Trial Number (UTN):U1111-1203-2131. Keywords: Median sternotomy, resistance training, cognition, cardiac surgery, recovery, rehabilitation, exercise

Does a Patient-Held Quality-of-Life Diary Benefit Patients With Inoperable Lung Cancer?

2009 ◽  
Vol 27 (1) ◽  
pp. 70-77 ◽  
Author(s):  
Moyra E. Mills ◽  
Liam J. Murray ◽  
Brian T. Johnston ◽  
Chris Cardwell ◽  
Michael Donnelly
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Palliative Care ◽  
Health Care Professionals ◽  
Standard Care ◽  
Care Quality ◽  
Care Group ◽  
Consistent Difference ◽  
Life Questionnaire

Purpose To examine the effect of weekly completion of a patient-held quality-of-life (QOL) diary in routine oncology practice for palliative care patients. Patients and Methods In a pragmatic randomized controlled trial, 115 patients with inoperable lung cancer were randomly assigned to receive either standard care or a structured QOL diary (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and the related lung cancer module LC13) that they completed at home each week for 16 weeks. Patients were encouraged to share the QOL information with health professionals involved in their care. Changes in QOL over time (measured by the Functional Assessment of Cancer Therapy–Lung questionnaire and the Palliative Care Quality of Life Index), discussion of patient problems, and satisfaction with communication and general care were assessed at baseline and at 2 and 4 months after baseline. Results Analysis of QOL indicated a small but consistent difference between patients in the diary group and the standard care group. The diary group had a poorer QOL in many domains. Two different QOL summary scores (total and overall QOL) indicated a statistically significant between-group difference. No effects were found in relation to satisfaction with care, communication, or the discussion of patient problems. Conclusion The regular completion of a QOL questionnaire without appropriate feedback to health care professionals and without the provision of appropriate support may have a negative impact on inoperable lung cancer patients. Further research should focus on identifying features such as feedback loops that are required for the successful and meaningful use of QOL questionnaires in routine patient care.

Contact lens wear in strabismic and non-strabismic young patients: sensorial and oculomotor study and quality of life outcome

2008 ◽  
Vol 86 ◽  
pp. 0-0
Author(s):  
A CARDON ◽  
A SULTANIM ◽  
S ARSENE ◽  
M GEORGET ◽  
M SANTALLIER ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Contact Lens ◽  
Young Patients ◽  
Contact Lens Wear ◽  
Lens Wear

scholarly journals Food insecurity and overweight among government-backed economy restaurant workers

2019 ◽  
Vol 32 ◽  
Author(s):  
Bruna Vieira de Lima COSTA ◽  
Paula Martins HORTA ◽  
Sabrina Alves RAMOS
Keyword(s):  
Quality Of Life ◽  
Confidence Interval ◽  
Food Insecurity ◽  
Odds Ratio ◽  
Capita Income ◽  
The Body ◽  
Per Capita Income ◽  
Per Capita ◽  
Belo Horizonte

Abstract Objective The objective was to analyze the occurrence and the associated factors with food insecurity and overweight among government-backed economy restaurant workers in one of the biggest cities in Brazil. Methods A sample comprised of 180 individuals and represented 76.0% of all economy restaurant workers in the city of Belo Horizonte. Food insecurity was identified through the Brazilian Food Security Scale, and excess weight was identified by the body mass index. Data collection included sociodemographic and occupational information, and also health and quality of life perception. Logistic regression models were applied to identify the association. Results Food insecurity and overweight prevalence levels were 24.0% and 66.7%, respectively. The odds of identifying food insecurity were 2.34 times higher among workers that perceived their quality of life to be regular/poor/very poor and 62.0% and 74.0% lower among workers from the 2nd and 3rd tertile of per capita income, respectively. Individuals ≥40 years old (Odds Ratio=2.69, Confidence Interval 95%:1.33-5.43) and food handlers (Odds Ratio=3.62, Confidence Interval 95%:1.68-7.81) had higher odds of being classified as overweight compared to reference categories. Workers with higher per capita income presented lower odds of being classified as overweight (Odds Ratio=0.40, Confidence Interval 95%:0.17-0,96). Conclusion It was evidenced an occurrence of overweight among government-backed economy restaurant workers, which was associated with age, income and job position. Food insecurity prevalence was associated with income and quality of life perception. Although the sample work in a food and nutritional security promotion program, it is necessary to recommend actions aimed at the promotion of healthy eating habits.

scholarly journals Laparoscopy Combined with Enhanced Recovery Pathway in Ileocecal Resection for Crohn’s Disease: A Randomized Study

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Yibin Zhu ◽  
Jianjian Xiang ◽  
Wei Liu ◽  
Qian Cao ◽  
Wei Zhou
Keyword(s):  
Hospital Stay ◽  
Standard Care ◽  
Enhanced Recovery ◽  
Hospital Costs ◽  
Laparoscopic Approach ◽  
Postoperative Hospital Stay ◽  
Ileocecal Resection ◽  
Care Group ◽  
Standard Care Group ◽  
Enhanced Recovery Pathway

Background and Aims. Laparoscopic approach is recommended as the first-choice option for simple ileocecal resections. However, there are no randomized trials that have focused on patients with Crohn’s disease (CD) treated by laparoscopy and enhanced recovery pathway. The aim of the present study is to prospectively evaluate the feasibility, safety, and short-term outcomes of laparoscopy with enhanced recovery pathway for CD patients undergoing ileocecal resection. Methods. A consecutive cohort of 32 CD patients who underwent laparoscopic ileocecal resection between December 2015 and December 2016 was randomized to enhanced recovery after surgery (ERAS) group or standard care group. Primary outcome was total postoperative hospital stay. Secondary outcomes were time to first flatus and stool, pain scores, morbidity, reoperation rate, readmission rate, and in-hospital costs. Results. Compliance with the ERAS was high for all items (≥90%) except the items of abdominal drains and early fluid intake. A significantly earlier return of bowel function was observed in the ERAS group. Compared with the standard care group, patients in the ERAS group had shorter postoperative hospital stay and lower in-hospital costs (5.19 ± 1.28 versus 9.94 ± 3.33 days, P<0.001; 2.70 ± 0.50 versus 3.73 ± 0.75 ten thousand RMB, P<0.001, respectively). Other parameters did not show any significant differences between the two groups. Conclusions. Laparoscopic approach within an ERAS perioperative care program is a safe and effective treatment combination for CD patients requiring ileocecal resection. This study is registered at ClinicalTrials.gov (NCT02777034).

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