Extraoral Photobiomodulation for Prevention of Oral and Oropharyngeal Mucositis in Head and Neck Cancer Patients: Interim Analysis of A Randomized, Double-Blind, Clinical Trial

2021 ◽  
Author(s):  
Elisa Kauark-Fontes ◽  
Cesar Augusto Migliorati ◽  
Joel B Epstein ◽  
Nathaniel Simon Treister ◽  
Carolina Guimarães Bonfim Alves ◽  
...  
Keyword(s):  
Placebo Group ◽  
Double Blind ◽  
Oncological Outcomes ◽  
Double Blind Clinical Trial ◽  
First Occurrence ◽  
Anti Inflammatory ◽  
One Year ◽  
Oropharyngeal Mucositis

Abstract PurposeTo assess the safety and efficacy of prophylactic extraoral photobiomodulation (PBM) for the prevention of oral and oropharyngeal mucositis (OM) on clinical outcomes and survival in patients with oral cavity and oropharyngeal squamous cell carcinoma (OOPSCC).MethodsOOPSCC patients who received radiotherapy (RT) were prospectively randomized to two groups: prophylactic extraoral PBM and placebo. OM grade (NCI), pain (VAS), analgesia, and anti-inflammatory prescriptions were assessed weekly. Quality of life questionnaires (QoL) were performed at the first and last day of RT. Following RT, participants were evaluated quarterly for oncological outcomes follow-up.Results55 patients met the inclusion criteria. The first occurrence of OM was observed at week 1, for the placebo group (p = 0.014). Later OM onset and severity was observed for the PBM group, with first occurrence at week 2 (p = 0.009). No difference in severe OM incidence was observed (p > 0.05). Lower mean pain score was noted at week 7 for the PBM group (2.1) compared to placebo group (4.5) (p = 0.009). Less analgesics (week 3; p = 0.009/week 7; p = 0.02) and anti-inflammatory prescription (week 5; p = 0.0346) were observed for the PBM group. Better QoL scores were observed for the PBM group at last day of RT (p = 0.0034). No difference in overall survival among groups, was observed in one year of follow-up (p = 0.889).ConclusionProphylactic extraoral PBM can delay OM onset, reduce pain, as well as reduced analgesic and anti-inflammatory prescription requirements. Extraoral PBM was associated with better QoL. There was no evidence of PBM impact on oncological outcomes. TRN:RBR-4w4swx (date of registration: 01/20/2020)

scholarly journals Treatment with Diazepam in Acute Stroke Prevents Poststroke Seizures: A Substudy of the EGASIS Trial

2021 ◽  
pp. 1-6
Author(s):  
Julia H. van Tuijl ◽  
Elisabeth P.M. van Raak ◽  
Robert J. van Oostenbrugge ◽  
Albert P. Aldenkamp ◽  
Rob P.W. Rouhl
Keyword(s):  
Placebo Group ◽  
Acute Stroke ◽  
Incidence Rate Ratio ◽  
Day Treatment ◽  
Stroke Patients ◽  
Early Administration ◽  
Anterior Circulation ◽  
Double Blind

<b><i>Objective:</i></b> The frequency of seizures after stroke is high, with a severe impact on the quality of life. However, little is known about their prevention. Therefore, we investigated whether early administration of diazepam prevents the development of seizures in acute stroke patients. <b><i>Methods:</i></b> We performed a substudy of the EGASIS trial, a multicenter double-blind, randomized trial in which acute stroke patients were treated with diazepam or placebo for 3 days. Follow-up was after 2 weeks and 3 months. The occurrence of seizures was registered prospectively as one of the prespecified secondary outcomes. <b><i>Results:</i></b> 784 EGASIS patients were eligible for this substudy (389 treated with diazepam [49.6%] and 395 treated with placebo [50.4%]). Seizures were reported in 19 patients (2.4% of the total patient group). Seizures occurred less frequently in patients treated with diazepam (1.5 vs. 3.3% in the placebo group); however, this difference was only statistically significant in patients with a cortical anterior circulation infarction (0.9% in the diazepam group vs. 4.6% in the placebo group, incidence rate ratio 0.20, 95% CI: 0.05–0.78, <i>p</i> = 0.02, NNT = 27). <b><i>Conclusion:</i></b> We found that a 3-day treatment with diazepam after acute cortical anterior circulation stroke prevents the occurrence of seizures in the first 3 months following stroke.

scholarly journals Design and conduct of a multicenter randomized clinical trial on the impact of a post-intensive care unit multidisciplinary follow-up on the quality of life (suivi-rea) (Preprint)

2021 ◽  
Author(s):  
Friedman Diane ◽  
Lamiae Grimaldi ◽  
Alain Cariou ◽  
Philippe Aegerter ◽  
Stéphane Gaudry ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Intensive Care ◽  
Controlled Trial ◽  
Social Evaluation ◽  
Double Blind ◽  
Icu Discharge ◽  
One Year ◽  
The Impact

UNSTRUCTURED Introduction: Critically ill patients are at risk to develop a Post-Intensive Care Syndrome (PICS), which is characterized by physical, psychological and cognitive impairments and dramatically impacts the quality of life. No intervention has been shown to improve the quality of life (QoL). Because of the interdependency of its domains, we hypothesized that a medical, psychological and social follow-up would improve the QoL by mitigating the PICS. Methods and analysis: We conducted a multicenter, double-blind, randomized controlled trial comparing a multidisciplinary to a standard post-ICU follow-up. In the intervention arm, multidisciplinary follow-up consisted of medical, psychological and social evaluation at ICU discharge and at 3, 6 and 12 months after ICU discharge. In the placebo group, patients were seen only at 12 months by the multidisciplinary team. The baseline characteristics at ICU discharge were collected in all patients. The primary outcome was the quality of life at one year, assessed with help of EuroQoL 5 dimensions (EQ5D). Secondary outcomes were mortality, cognitive, psychological and functional status, the social and professional reintegration as well as the rate of re-hospitalization and outpatient consultations at one year. The first patient was randomized on 20/12/2012 and the last patient on 01/09/2017 out of 546 patients who were enrolled across 11 ICUs. At present, data management is still ongoing, and all parties involved in the trial remain blinded. Ethics and dissemination – Research Ethics Committee of Saint-Germain-en-Laye, France, initial approval received on 08/07/2011. Results will be disseminated via peer-reviewed publication and presentation at international conferences. Trial registration: Clinicaltrials.gov identifier NCT01796509 (registered on 21/02/2013).

Recombinant Versus High-sensitivity Conventional Thromboplastin: A Randomized Clinical Study in Patients on Oral Anticoagulation

1994 ◽  
Vol 72 (06) ◽  
pp. 804-807 ◽  
Author(s):  
Guido Finazzi ◽  
Anna Falanga ◽  
Monica Galli ◽  
Sergio Cortelazzo ◽  
Andrea Remuzzi ◽  
...  
Keyword(s):  
Oral Anticoagulation ◽  
Oral Anticoagulant Therapy ◽  
High Sensitivity ◽  
Single Center ◽  
Bleeding Events ◽  
Double Blind ◽  
Randomized Clinical Study ◽  
Double Blind Clinical Trial

SummaryA prospective, randomized, double-blind clinical trial was carried out in a single center to compare the clinical and laboratory quality of oral anticoagulant therapy monitored with recombinant tissue factor (RTF) or with a sensitive, human-derived, conventional thromboplastin (CT) in the PT test. Seven hundred and fifty-seven consecutive patients receiving oral anticoagulation for various indications were randomized to RTF (n = 379) or CT (n = 368) for 6 months. Total follow-up was 167 and 153 patient-years for RTF and TP groups respectively. Fifty-six bleeding events were observed: 31 in the RTF group and 25 in the TP group. The incidence of bleeding was 18.5 and 16.5% pt-yrs for RTF and TP patients respectively (n.s.). The event-free follow-up curves were not significantly different between the two groups. The laboratory quality of oral anticoagulation was evaluated with the “last check in file” method: therapeutic INR was found in the same propor-tipn of RTF and TP patients (70.2% vs 68.8%). Our study shows that RTF is as effective as a sensitive, conventional thromboplastin for monitoring oral anticoagulation.

scholarly journals Fear of Falling, Recurrence of Falls, and Quality of Life in Patients with a Low Energy Fracture—Part II of an Observational Study

Medicina ◽  
2021 ◽  
Vol 57 (6) ◽  
pp. 584
Author(s):  
Puck C. R. van der Vet ◽  
Jip Q. Kusen ◽  
Manuela Rohner-Spengler ◽  
Björn-Christian Link ◽  
Roderick M. Houwert ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Fall Risk ◽  
Fear Of Falling ◽  
Low Energy ◽  
Activity Levels ◽  
Activity Restriction ◽  
One Year ◽  
Falls In Elderly

Background and objective: Falls in elderly cause injury, mortality, and loss of independence, making Fear of Falling (FoF) a common health problem. FoF relates to activity restriction and increased fall risk. A voluntary intervention including fall risk assessment and prevention strategies was implemented to reduce falls in elderly patients with low energy fractures (LEF). The primary purpose of this study was to evaluate FoF and the number of subsequent falls in trauma patients one year after a LEF. The secondary aim was to examine how FoF affects patients’ lives in terms of Quality of Life (QoL), mobility, and activity levels. Finally, participation in the voluntary fall prevention program (FPP) was evaluated. Materials and Methods: Observational cohort study in one Swiss trauma center. LEF patients, treated between 2012 and 2015, were analyzed one year after injury. Primary outcomes were Falls-Efficacy Score-International (FES-I) and number of subsequent falls. Secondary outcomes were EuroQoL-5-Dimensions-3-Levels (EQ5D-3L), mobility, activity levels, and participation in the FPP. Subgroup analysis was performed for different age categories. Results: 411 patients were included for analysis. Mean age was 72 ± 9.3, mean FES-I was 21.1 ± 7.7. Forty percent experienced FoF. A significant negative correlation between FoF and QoL (R = 0.64; p < 0.001) was found. High FoF correlated with lower activity levels (R= −0.288; p < 0.001). Six percent visited the FPP. Conclusions: At follow-up, 40% suffered from FoF which seems to negatively affect patients’ QoL. Nevertheless, participation in the FPP was low. Simply informing patients about their susceptibility to falls and recommending participation in FPPs seems insufficient to motivate and recruit patients into FPPs. We suggest implementing repeated fall risk- and FoF screenings as standard procedures in the follow-up of LEF, especially in patients aged over 75 years.

scholarly journals Task-oriented exercises improve disability of working patients with surgically-treated proximal humeral fractures. A randomized controlled trial with one-year follow-up

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marco Monticone ◽  
Igor Portoghese ◽  
Daniele Cazzaniga ◽  
Valentina Liquori ◽  
Giuseppe Marongiu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Group Differences ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
One Year ◽  
Task Oriented

Abstract Background General physiotherapy is a common means of rehabilitation after surgery for proximal humeral fracture (PHF). Better-targeted exercises seem worthy of investigation and the aim of this study was to assess the efficacy of a rehabilitation program including task-oriented exercises in improving disability, pain, and quality of life in patients after a PHF. Methods By means of a randomized controlled trial with one-year follow-up, 70 working patients (mean age of 49 ± 11 years; 41 females), who were selected for open reduction and internal fixation with plates caused by PHF, were randomized to be included in an experimental (n = 35) or control group (n = 35). There was a permuted-block randomization plan, and a list of program codes was previously created; subsequently, an automatic assignment system was used to conceal the allocation. The first group underwent a supervised rehabilitation program of task-oriented exercises based on patients’ specific job activities, and occupational therapy. The second group underwent general physiotherapy, including supervised mobility, strengthening and stretching exercises. Both groups individually followed programs of 60-min session three times per week for 12 weeks in the outpatient setting. The Disability Arm Shoulder Hand questionnaire (DASH; scores range from 0 to 100; primary outcome), a Pain intensity Numerical Rating Scale (scores range 0 to 10; secondary outcomes), and the Short-Form Health Survey (scores range from 0 to 100; secondary outcomes) assessed the interventions. Participants were evaluated before surgery, before and after rehabilitation (primary endpoint), and at the one-year follow-up (secondary endpoint). A linear mixed model analysis for repeated measures was carried out for each outcome measure (p < 0.05). Results Time, group and time by group showed significant effects for all outcome measures in favour of the experimental group. The DASH and the DASH work achieved clinically important between-group differences of 16.0 points (95% confidence interval [C.I.] 7.3 to 24.7) and 19.7 (95% C.I. 9.0 to 30.5) at follow-up, respectively. The NRS achieved a between-group difference of 2.9 (95% C.I. 1.0 to 3.9) at follow-up. As for SF-36, there were between-group differences ranging from 17.9 to 37.0 at follow-up. Conclusions A rehabilitation program based on task-oriented exercises was useful in improving disability, pain, and quality of life in working patients after PHFs. Improvements lasted for at least 12 months. Trial registration On 16/12/2019, the trial was retrospectively registered in the ISRCTN registry with the ID number 17996552.

The twelve-month outcome of patients with neurotic illness in general practice

1981 ◽  
Vol 11 (3) ◽  
pp. 535-550 ◽  
Author(s):  
A. H. Mann ◽  
R. Jenkins ◽  
E. Belsey
Keyword(s):  
Social Life ◽  
Function Analysis ◽  
Psychiatric Morbidity ◽  
The Social ◽  
Assessment Measures ◽  
Psychiatric State ◽  
One Year

SYNOPSISOne hundred patients, selected to be representative of those attending general practitioners with non-psychotic psychiatric disorders were followed up for one year. standard assessments of mental state, personality, social stresses and supports were carried out for each patient at the outset and after a year.The outcome for this cohort determined both by the level of psychiatric morbidity at interview after one year and by the pattern of the psychiatric morbidity during the year has been analysed with reference to the assessment measures. Discriminant function analysis indicates that the initial estimate of the severity of the psychiatric morbidity and a rating of the quality of the social life at the time of follow-up are the only factors that significantly predict the psychiatric state after one year. Social measures also predict a pattern of illness charactorized by a rapid recovery after the initial assessemtn. Patients who reported continuous psychiatric morbidity during the year were, older, physically ill and very likely to have recevied psychotropic drugs. Receipt of this medication during the year was associated with initial assessments of abnormality of personality, older age, and a diagnosis of depression.The findings of this study are seen to support a triaxial assessment and classification of non-psychotic psychiatirc disorders, with symptoms, personality and social state being rated independently.

scholarly journals 357 Factors associated with changes in health-related quality of life in children with cystic fibrosis during one-year follow-up

2017 ◽  
Vol 16 ◽  
pp. S154
Author(s):  
M. Van Horck ◽  
B. Winkens ◽  
G. Wesseling ◽  
K. de Winter-de Groot ◽  
I. De Vreede ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cystic Fibrosis ◽  
Health Related Quality ◽  
Factors Associated ◽  
Related Quality ◽  
Health Related ◽  
One Year

Value of Whole-Body Washing With Chlorhexidine for the Eradication of Methicillin-ResistantStaphylococcus aureus:A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

2007 ◽  
Vol 28 (9) ◽  
pp. 1036-1043 ◽  
Author(s):  
C. Wendt ◽  
S. Schinke ◽  
M. Württemberger ◽  
K. Oberdorfer ◽  
O. Bock-Hensley ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Treatment Group ◽  
Solution Treatment ◽  
University Hospital ◽  
Whole Body ◽  
Double Blind ◽  
Antiseptic Solution ◽  
Double Blind Clinical Trial ◽  
Double Blinded

Background.Whole-body washing with antiseptic solution has been widely used as part of eradication treatment for colonization with methicillin-resistantStaphylococcus aureus(MRSA), but evidence for the effectiveness of this measure is limited.Objective.To study the efficacy of whole-body washing with chlorhexidine for the control of MRSA.Design.Randomized, placebo-controlled, double-blinded clinical trial.Setting.University Hospital of Heidelberg and surrounding nursing homes.Patients.MRSA carriers who were not treated concurrently with antibiotics effective against MRSA were eligible for the study.Intervention.Five days of whole-body washing with either 4% chlorhexidine solution (treatment group) or with a placebo solution. All patients received mupirocin nasal ointment and chlorhexidine mouth rinse. The outcome was evaluated 3, 4, 5, 9, and 30 days after treatment with swab samples taken from several body sites.Results.Of 114 patients enrolled in the study (56 in the treatment group and 58 in the placebo group), 11 did not finish treatment (8 from the treatment group and 3 from the placebo group [P= .02]). At baseline, the groups did not differ with regard to age, sex, underlying condition, site of MRSA colonization, or history of MRSA eradication treatment. Eleven patients were MRSA-free 30 days after treatment (4 from the treatment group and 7 from the placebo group [P= .47]). Only groin-area colonization was significantly better eradicated by the use of chlorhexidine. The best predictor for total eradication was a low number of body sites positive for MRSA. Adverse effects were significantly more frequent in the treatment group than in the placebo group (any symptom, 71% vs 33%) but were reversible in most cases.Conclusion.Whole-body washing can reduce skin colonization, but it appears necessary to extend eradication measures to the gastrointestinal tract, wounds, and/or other colonized body sites if complete eradication is the goal.Trial Registration.ClinicalTrials.gov identifier: NCT00266448.

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