Photobiomodulation in the management of oral mucositis for adult head and neck cancer patients receiving irradiation: the LiTEFORM RCT.

BackgroundOral mucositis is a debilitating and painful complication of head and neck cancer irradiation that is characterised by inflammation of the mucous membranes, erythema and ulceration. Oral mucositis affects 6000 head and neck cancer patients per year in England and Wales. Current treatments have not proven to be effective. International studies suggest that low-level laser therapy may be an effective treatment.ObjectivesTo assess the clinical effectiveness and cost-effectiveness of low-level laser therapy in the management of oral mucositis in head and neck cancer irradiation. To identify barriers to and facilitators of implementing low-level laser therapy in routine care.DesignPlacebo-controlled, individually randomised, multicentre Phase III superiority trial, with an internal pilot and health economic and qualitative process evaluations. The participants, outcome assessors and therapists were blinded.SettingNine NHS head and neck cancer sites in England and Wales.ParticipantsA total of 87 out of 380 participants were recruited who were aged ≥ 18 years and were undergoing head and neck cancer irradiation with ≥ 60 Gy.InterventionRandom allocation (1 : 1 ratio) to either low-level laser therapy or sham low-level laser therapy three times per week for the duration of irradiation. The diode laser had the following specifications: wavelength 660 nm, power output 75 mW, beam area 1.5 cm2, irradiance 50 mW/cm2, exposure time 60 seconds and fluence 3 J/cm2. There were 20-30 spots per session. Sham low-level laser therapy was delivered in an identical manner.Main outcome measureThe mean Oral Mucositis Weekly Questionnaire-Head and Neck Cancer score at 6 weeks following the start of irradiation. Higher scores indicate a worse outcome.ResultsA total of 231 patients were screened and, of these, 87 were randomised (low-level laser therapy arm, n = 44; sham arm, n = 43). The mean age was 59.4 years (standard deviation 8.8 years) and 69 participants (79%) were male. The mean Oral Mucositis Weekly Questionnaire-Head and Neck Cancer score at 6 weeks was 33.2 (standard deviation 10) in the low-level laser therapy arm and 27.4 (standard deviation 13.8) in the sham arm.LimitationsThe trial lacked statistical power because it did not meet the recruitment target. Staff and patients willingly participated in the trial and worked hard to make the LiTEFORM trial succeed. However, the task of introducing, embedding and sustaining new low-level laser therapy services into a complex care pathway proved challenging. Sites could deliver low-level laser therapy to only a small number of patients at a time. The administration of low-level laser therapy was viewed as straightforward, but also time-consuming and sometimes uncomfortable for both patients and staff, particularly those staff who were not used to working in a patient's mouth.ConclusionsThis trial had a robust design but lacked power to be definitive. Low-level laser therapy is relatively inexpensive. In contrast with previous trials, some patients found low-level laser therapy sessions to be difficult. The duration of low-level laser therapy sessions is, therefore, an important consideration. Clinicians experienced in oral cavity work most readily adapt to delivering low-level laser therapy, although other allied health professionals can be trained. Blinding the clinicians delivering low-level laser therapy is feasible. There are important human resource, real estate and logistical considerations for those setting up low-level laser therapy services.Future workFurther well-designed randomised controlled trials investigating low-level laser therapy in head and neck cancer irradiation are needed, with similar powered recruitment targets but addressing the recruitment challenges and logistical findings from this research.Trial registrationThis trial is registered as ISRCTN14224600.FundingThis project was funded by the National Institute for Health and Care Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 46. See the NIHR Journals Library website for further project information

Adapting the Multilingual Assessment Instrument for Narratives (MAIN) to Scottish Gaelic

This paper describes the rationale for the adaptation of the Multilingual Assessment Instrument for Narratives (LITMUS-MAIN) (Gagarina et al., 2012, 2015, 2019) to Scottish Gaelic (Gaelic) and presents some preliminary results from the macrostructure measures. Gaelic is a heritage minority language in Scotland being revitalised through immersion education, which spans across all levels of compulsory education (preschool, primary and secondary level). MAIN was adapted to Gaelic for two reasons: (i) to gauge the language abilities of children attending Gaelic immersion schools using an ecologically valid test, and (ii) to help identify areas of language impairment in children with Developmental Language Disorders within a broader battery of language tasks. Preliminary results from the macrostructure component indicate a wider range of Gaelic language abilities in six- to eight-year-old typically developing children in Gaelic-medium education. These results set the stage for future use of the tool within this context

Cross-cultural validation of expressed emotion in caregivers of Chinese patients with first episode psychosis in Singapore: A qualitative study

10.1177/0020764006067199International Journal of Social Psychiatry523199-213IJSP

Transformational leadership and moral reasoning.

Terms such as moral and ethical leadership are used widely in theory, yet little systematic research has related a sociomoral dimension to leadership in organizations. This study investigated whether managers’ moral reasoning (n 132) was associated with the transformational and transactional leadership behaviors they exhibited as perceived by their subordinates (n 407). Managers completed the Defining Issues Test (J. R. Rest, 1990), whereas their subordinates completed the Multifactor Leadership Ques-tionnaire (B. M. Bass & B. J. Avolio, 1995). Analysis of covariance indicated that managers scoring in the highest group of the moral-reasoning distribution exhibited more transformational leadership behav-iors than leaders scoring in the lowest group. As expected, there was no relationship between moral-reasoning group and transactional leadership behaviors. Implications for leadership development are discussed. There has been growing interest in the development and pro-motion of moral or ethical leadership in organizations. Recent attention to this somewhat ethereal notion has created inspiring profiles (e.g., Coles, 2000; H. E. Gardner, 1996; J. W. Gardner, 1990) of leaders celebrated for their actions in commerce and history; however, few systematic attempts have been made to operationalize this dimension in relation to everyday leadership in organizations. To date, organizational researchers interested in the moral potential of leadership (e.g., Bass & Steidlmeier, 1999

COS Ambassadors

A collection of materials and resources for COS ambassadors