Head and neck lymphoedema—research challenges during the COVID-19 pandemic

2021 ◽  
Vol 26 (Sup10) ◽  
pp. S6-S15
Author(s):  
Amanda Pigott ◽  
Bena Brown ◽  
Megan Trevethan ◽  
Sandra Porceddu ◽  
Andrew McCann ◽  
...  
Keyword(s):  
Head And Neck ◽  
Controlled Trial ◽  
Lymphatic Drainage ◽  
Clear Understanding ◽  
Clinical Effects ◽  
Tissue Water ◽  
Therapeutic Modalities ◽  
Secondary Objective ◽  
Receive Treatment ◽  
Randomised Controlled

Management of secondary head and neck lymphoedema has undergone little research investigation. Its treatment is time and labour intensive and involves multiple therapeutic modalities without a clear understanding of which is most effective. This study aimed to determine the feasibility of a randomised controlled trial comparing two therapeutic modalities to manage head and neck lymphoedema. The secondary objective was to evaluate the clinical effects of these treatments. Participants were randomised to receive treatment with manual lymphatic drainage or compression over 6 weeks, with the primary outcome—percentage tissue water—measured 12 weeks after treatment. Six participants were recruited until the study was ceased due to restrictions imposed by the COVID-19 pandemic. Some 86% of required attendances were completed. Percentage tissue water increased in all participants at 12 weeks. No consistent trends were identified between internal and external lymphoedema. The small number of people recruited to this study informs its feasibility outcomes but limits any conclusions about clinical implications.

Randomised controlled trial of Lugol's iodine in head and neck cancer surgery (LIHNCS trial)

2009 ◽  
Vol 47 (7) ◽  
pp. e52
Author(s):  
James Anthony McCaul ◽  
D.N. Sutton ◽  
J.C. Devine ◽  
D. Gouldesbrough ◽  
G. Bryson ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Randomised Controlled Trial ◽  
Head And Neck ◽  
Neck Cancer ◽  
Controlled Trial ◽  
Cancer Surgery ◽  
Lugol’S Iodine ◽  
Randomised Controlled

scholarly journals Effect of dexamethasone in patients with ARDS and COVID-19 – prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial

2021 ◽  
Author(s):  
Jan Maláska ◽  
Jan Stašek ◽  
František Duška ◽  
Martin Balík ◽  
Jan Máca ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Primary Objective ◽  
Efficacy And Safety ◽  
Open Label ◽  
Parallel Group ◽  
Secondary Objective ◽  
Randomised Controlled

Abstract ObjectivesThe primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg. The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days.

scholarly journals Acupuncture for cancer pain: protocol for a pilot pragmatic randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e025564
Author(s):  
Yihan He ◽  
Brian H May ◽  
Anthony Lin Zhang ◽  
Xinfeng Guo ◽  
Yihong Liu ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cancer Pain ◽  
Clinical Guidelines ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Control Group ◽  
Clinical Effects ◽  
Phone Calls ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

IntroductionAlthough acupuncture has been recommended for alleviating cancer pain by clinical guidelines, the level of the supporting evidence needs to be improved. A pragmatic randomised controlled trial (pRCT) in a hospital setting would provide real-world assessments of the overall clinical effects of acupuncture. This pilot trial aims to explore the feasibility and provide data for sample size calculations for a pRCT evaluating the effectiveness of acupuncture as an adjunctive therapy to routine medical care for cancer pain.Methods and analysisThirty patients with cancer admitted to the oncology department with moderate or severe pain will be recruited. Participants will be randomised at a ratio of 1:1 to the adjunctive acupuncture group or a control group which receives routine pain management without acupuncture. The standardised section of the acupuncture protocol will be developed based on the results of reviews of the literature, recommendations in clinical guidelines and interviews with clinical experts. The acupuncturist will be allowed to tailor the protocol according to the individual situation of each participant. Primary outcomes relevant to the feasibility of conducting a fully powered trial include: numbers and proportions of participants recruited, screened, consented and randomised; numbers and reasons for withdrawals and dropouts; numbers and types of adverse events; feasibility of implementing the trial procedures; evaluation of the comprehensiveness and ease-of-use of the case report form. Secondary outcomes are clinical measurements of the effectiveness of the treatment that are intended for use in the full-scale trial. Analysis of feasibility will be descriptive and pain intensity measures will be analysed using mixed-effects regression.Ethics and disseminationEthics approval was obtained from the Institutional Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (approval no: Z2017-184-01) and RMIT University Human Research Ethics Committee (reference no: 21361). Results will be disseminated in a peer-reviewed journal, and trial participants will be informed via email and/or phone calls.Trial registration numberChiCTR1800017023

scholarly journals An Enhanced Social Networking Intervention for Young People with Active Suicidal Ideation: Safety, Feasibility and Acceptability Outcomes

2020 ◽  
Vol 17 (7) ◽  
pp. 2435 ◽  
Author(s):  
Eleanor Bailey ◽  
Mario Alvarez-Jimenez ◽  
Jo Robinson ◽  
Simon D’Alfonso ◽  
Maja Nedeljkovic ◽  
...  
Keyword(s):  
Suicidal Ideation ◽  
Young People ◽  
Social Networking ◽  
Controlled Trial ◽  
A Priori ◽  
Self Report ◽  
Online Social Networking ◽  
Clinical Effects ◽  
Randomised Controlled

Online social networking interventions have potential to support young people who experience suicidal thoughts by specifically addressing interpersonal risk factors for suicide, but may also pose a risk of harm. This uncontrolled, single-group pilot study aimed to evaluate the safety, feasibility, and acceptability of an enhanced online social networking intervention (“Affinity”) among a sample of young people who experienced active suicidal ideation, and to explore potential changes in clinical outcomes and the therapeutic targets of the intervention. Twenty young people with current or recent suicidal ideation who were receiving treatment for depression at a tertiary-level mental health service were given access to Affinity for two months. Participants were assessed at baseline and 8-week follow-up; 90 percent reported clinical suicidal ideation at baseline. A priori criteria related to feasibility, safety and acceptability were satisfied. In terms of potential clinical effects, significant and reliable pre-post improvements were found on self-report outcomes including suicidal ideation. This study provides initial world-first evidence to support the use of an online intervention incorporating social networking as an adjunct to treatment for young people who experience suicidal ideation. The effectiveness of Affinity needs to be evaluated in a randomised controlled trial.

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