Adverse Event Reporting in Cancer Clinical Trials: Incorporating Patient-Reported Methods. A Systematic Scoping Review.

BACKGROUND AND OBJECTIVE: The history of clinical trials is fraught with unethical practices. Since 1945, robust frameworks have evolved to standardise the collection and reporting of safety data, most notably, the Common Terminology Criteria for Adverse Events (CTCAE) from the National Cancer Institute; used by investigators to report side effects experienced by participants. As medicine moves into the patient-centred model, interest has been growing to collect data on adverse events directly from participants (patient-reported adverse events). The aim of this systematic scoping review was to investigate the inclusion of patient-reported adverse event data within safety/tolerability analyses and explore the collection and reporting of patient-reported adverse event data. METHODS AND RESULTS: A database search was undertaken and the Covidence platform was used to manage the review; results were analysed descriptively. Sixty-eight studies were included in the analysis. An increase in the number of studies that incorporate patient-reported adverse event data was seen by year. Seventy instruments were used for the collection of patient-reported adverse event data with recall period, mode, frequency and site of administration varying across studies; the duration of data collection ranged from 28 days to 6 years. Frequently, information on these details was omitted from publications. The number of instruments used by studies to collect patient-reported adverse event data ranged from one to seven instruments. CONCLUSIONS: Despite growing calls for the inclusion of patient-reported adverse events, this has not yet translated into published reports. The collection and reporting of these data were variable and conducted using instruments that were not designed for purpose. To address these inconsistencies, standardisation of data collection and reporting using a purpose-built validated instrument is required.

Systematic review of Aboriginal and Torres Strait Islander peoples' experiences and supportive care needs associated with cancer.

BACKGROUND: Persistent disparities exist between Aboriginal and Torres Strait Islander peoples (the Indigenous peoples of Australia) and non-Indigenous Australians associated with cancer, with Aboriginal and Torres Strait Islander peoples experiencing a longer time to treatment, higher morbidity rates, and higher mortality rates. This systematic review aimed to investigate findings and recommendations in the literature about the experiences and supportive care needs of Aboriginal and Torres Strait Islander peoples with cancer in Australia. METHODS: A qualitative systematic review was conducted using thematic analysis. Database searches were conducted in CINAHL, Informit, MEDLINE, ProQuest, Scopus, and Web of Science for articles published between January 2000 and December 2021. There were 91 included studies which were appraised using the Mixed Methods Appraisal Tool. The included studies reported on the experiences of cancer and supportive care needs in Aboriginal and Torres Strait Islander populations. RESULTS: Six key themes were determined: Culture, family, and community; cancer outcomes; psychological distress; access to health care; cancer education and awareness; and lack of appropriate data. Culture was seen as a potential facilitator to achieving optimal cancer care, with included studies highlighting the need for culturally safe cancer services and the routine collection of Aboriginal and Torres Strait Islander status in healthcare settings. CONCLUSION: Future work should capitalize on these findings by encouraging the integration of culture in healthcare settings to increase treatment completion and provide a positive experience for Aboriginal and Torres Strait Islander peoples with cancer.

Fear of Cancer Recurrence among Aboriginal and Torres Strait Islander Women Diagnosed with Breast Cancer.

Little is known about the fear of cancer recurrence (FCR) severity, coping strategies, or quality of life impacts for Indigenous populations. This mixed-methods study aimed to (1) quantify FCR levels among Indigenous Australian (i.e., Aboriginal and Torres Strait Islander) breast cancer survivors and (2) qualitatively explore experiences of FCR and the coping strategies used. Nineteen participants completed the Fear of Cancer Recurrence Inventory (FCRI); ten also completed a semi-structured interview. Interview transcripts were thematically analysed. Average FCR levels (Mean FCRI Total Score = 71.0, SD = 29.8) were higher than in previous studies of Australian breast cancer survivors, and 79% of participants reported sub-clinical or greater FCR (FCRI-Short Form ≥ 13/36). Qualitative themes revealed the pervasiveness of FCR, its impact on family, and exacerbation by experience/family history of comorbid health issues. Cultural identity, family, and a resilient mindset aided coping skills. Greater communication with healthcare providers about FCR and culturally safe and appropriate FCR care were desired. This study is the first to assess FCR among Aboriginal and Torres Strait Islander breast cancer survivors, extending the limited literature on FCR in Indigenous populations. Results suggest FCR is a significant issue in this population and will inform the development of culturally appropriate interventions to aid coping and improve quality of life.

A Prospective, Longitudinal and Exploratory Study of Head and Neck Lymphoedema and Dysphagia Following Chemoradiotherapy for Head and Neck Cancer.

The aim of the study was to examine the following: (a) the trajectory of external and internal head and neck lymphoedema (HNL) in patients with head and neck cancer (HNC) up to 12 months post-chemoradiotherapy (CRT) and (b) the relationship between HNL and swallowing function. Using a prospective longitudinal cohort study, external/internal HNL and swallowing were examined in 33 participants at 3, 6 and 12 months post-CRT. External HNL was assessed using the Assessment of Lymphoedema of the Head and Neck and the MD Anderson Cancer Centre Lymphoedema Rating Scale. Internal HNL was rated using Patterson's Radiotherapy Oedema Rating Scale. Swallowing was assessed via clinical, instrumental and patient-reported measures. Associations between HNL and swallowing were examined using multivariable regression models. External HNL was prevalent at 3 months (71%), improved by 6 months (58%) and largely resolved by 12 months (10%). In contrast, moderate/severe internal HNL was prevalent at 3 months (96%), 6 months (84%) and at 12 months (65%). More severe penetration/aspiration and increased diet modification were associated with higher severities of external HNL (p=0.006 and p=0.031, respectively) and internal HNL (p<0.001 and p=0.007, respectively), and more diffuse internal HNL (p=0.043 and p=0.001, respectively). Worse patient-reported swallowing outcomes were associated with a higher severity of external HNL (p=0.001) and more diffuse internal HNL (p=0.002). External HNL largely resolves by 12 months post-CRT, but internal HNL persists. Patients with a higher severity of external and/or internal HNL and those with more diffuse internal HNL can be expected to have more severe dysphagia.

A prospective observational cohort study examining the development of head and neck lymphedema from the time of diagnosis.

INTRODUCTION: Head and neck lymphedema can occur in the internal or external structures of the head and neck region. Little is known about the development of this condition over the course of treatment for head and neck cancer. This study aimed to observe the development of internal and external lymphedema from diagnosis to 12 weeks postacute treatment. METHODS: A single center, prospective observational cohort study assessed participants for external lymphedema, internal lymphedema, quality of life, and symptom burden. Assessments were conducted prior to starting radiotherapy (RT), at the end of RT, 6 and 12 weeks after RT. RESULTS: Forty-six participants were recruited. External lymphedema as measured by percentage water content, increased from 41.9 at baseline (95% CI: 39.3-44.4) to 50.4 (95% CI: 46.0-54.8) at 12 weeks following RT (p-value < .001). After adjusting for changes in weight and participant age at baseline, a general increase in tape measurements was observed over time with significant increases from baseline to 12 weeks post-RT for all measurement points. By 12 weeks post-RT, all participants had lymphedema present in eight of 13 internal sites assessed. CONCLUSIONS: Internal and external head and neck lymphedema was observed to increase from baseline to 12 weeks after completion of RT without abatement. People with head and neck cancer should be educated about the potentially extended duration of this treatment side effect. Further research is required to determine the point at which swelling symptoms recede.

Using dosimetric information to guide dysphagia management in patients with head and neck cancer: Clinicians' knowledge and experiences.

Purpose: The use of dosimetric information to guide the management of dysphagia related to head and neck cancer (HNC) treatment is an emerging area of practice. In order to better meet the needs of people with dysphagia in HNC, it is important to explore how clinicians use this information to guide practice and also to identify factors that influence/discourage the use of dosimetric information.Method: A descriptive qualitative method was chosen and purposeful sampling with additional snowball sampling were used to recruit clinicians working within Australian cancer centres. To facilitate participation, clinicians were offered either a focus group or individual interview as a means to collect their perspectives. A total of 20 clinicians with varying years of clinical experience (range 2.5 - 29 years) were recruited. Eight participants took part in a focus group and 12 elected to participate in an individual interview. Content analysis was used to analyse transcripts.Result: Three main themes emerged from the transcripts: (1) clinician factors such as experience, confidence and knowledge and (2) clinical service factors such as staffing levels, clinical management pathways and system access influence use of dosimetric information; (3) patient factors such as demographics, surgical history and education needs influence dysphagia management plans.Conclusion: Speech-language pathologists' (SLPs') use of dosimetric information within HNC settings to direct patient management is emerging and varies between clinicians and workplaces. Given that dosimetric information potentially enables specialised dysphagia management planning for patients during their radiotherapy treatment, further education and training for speech-language pathologists in this area should be prioritised.

Association Between Objective Ratings of Swallowing and Dysphagia-Specific Quality of Life in Patients Receiving (Chemo)radiotherapy for Oropharyngeal Cancer.

The pervasive nature of dysphagia in the head/neck cancer (HNC) population necessitates a comprehensive evaluation approach, including both objective assessment of dysphagia, and subjective patient-reported functional measures. However, the congruence between clinician-rated and patient-perceived function is still not well understood. The current study investigated the association between objective clinician-rated swallow physiology (using the MBSImP) and patient-reported measures of swallowing-related quality of life (using the MDADI) in a secondary analysis of patients with oropharyngeal HNC treated with (chemo)radiotherapy. Seventy-nine patients with oropharyngeal HNC receiving (chemo)radiotherapy completed a standardised videofluoroscopic swallow study (VFSS) rated using the MBSImP, and the MDADI, at pre-treatment (baseline), 6 weeks and 3 months post-treatment as per a previous prospective RCT. Data on n = 67 participants were analysed as part of the secondary analysis. Association between MBSImP oral and pharyngeal composite scores versus MDADI Global and subscale scores was examined using ordinary least squares regression and mixed-effects general linear modelling (GLM). Univariable analyses demonstrated significant associations between MBSImP oral composite scores and each of the MDADI subscales, as well as the MBSImP pharyngeal composite scores and all MDADI subscales. GLM analysis revealed significant associations were maintained between MBSImP pharyngeal scores and the MDADI global and emotional subscale scores at the multivariable level, with the physical subscale trending towards significance. No significant association was observed between the MBSImP oral composite scores and any of the MDADI subscales at the multivariable level. This study found significant associations between objective measures of pharyngeal swallow physiology and patient-perceived swallowing-related quality of life. These findings suggest a higher degree of concordance between clinician-rated and patient-reported measures up to 3 months post-(C)RT than previously reported.

Exploring the Interplay Between Radiotherapy Dose and Physiological Changes in the Swallowing Mechanism in Patients Undergoing (Chemo)radiotherapy for Oropharynx Cancer.

This study explored associative relationships between radiotherapy dose volumes delivered to the dysphagia aspiration risk structures (DARS) and swallowing physiological disturbance at 3 months post treatment in a homogenous cohort of patients who received (chemo)radiotherapy ((C)RT) for oropharyngeal head and neck cancer (HNC). Participants(n = 53) were a subgroup of patients previously recruited as part of a prospective randomised trial, and had undergone physiological swallowing assessment using videofluroscopic swallowing study (VFSS) at 3 months post (C)RT. The extended oral cavity (EOC), supraglottic larynx (SGL), glottic larynx (GL), cricopharyngeal inlet (CI), and pharyngeal constrictor muscles (PCM) were contoured as per international consensus guidelines and dose volume histograms (DVHs) were generated for each structure. Each DVH was analysed to reveal mean, maximum and partial radiotherapy doses of V40, V50 and V60 for each structure. Physiological swallowing function on VFSS was rated using the Modified Barium Swallow Impairment Profile (MBSImP). A binary logistic regression model was used to establish associative relationships between radiotherapy dose to the DARS and physiological changes within the swallowing mechanism. Structures that received the largest volumes of radiotherapy dose were the PCM and SGL. Significant relationships were found between the proportion of the EOC, SGL, GL and PCMs that received radiotherapy doses > 40 Gy, > 50 Gy and > 60 Gy and the likelihood of a moderate-severe physiological swallowing impairment (on the MBSImP). Whilst the current study was exploratory in nature, these preliminary findings provide novel evidence to suggest structure-specific associative relationships between radiotherapy dose and impacts to corresponding swallow physiology in patients with oropharyngeal HNC.

Conventional supportive cancer care services in Australia: A national service mapping study (The CIA study).

AIM: Cancer and its treatment produce significant acute and long-term adverse effects in cancer survivors, resulting in a range of supportive cancer care needs across the disease trajectory. To enhance supportive cancer care in Australia, this study sought to understand and describe conventional services offered nationwide, specific to their structure (ownership, setting, duration), process (participants, delivery mode, referral pathways), and outcomes (evaluation). METHODS: A survey canvassing 13 conventional supportive cancer care interventions was electronically distributed to 265 cancer organizations in all Australian states and territories over 2019 and 2020. Cancer organizations were invited to participate if they provided at least one cancer-directed treatment (ie, surgery, radiation therapy, or systemic therapies); or clinical cancer care to adults, adolescents, or children; or conventional supportive care interventions to cancer survivors. RESULTS: A response rate of 46% (n = 123/265) was achieved, with 72% of cancer organizations (n = 88) delivering at least one intervention. Most were provided as outpatient or inpatient services, with few at home (<13%) or via telehealth (<10%). Psychological therapy (90%), self-care (82%), exercise (77%), healthy eating (69%), and lymphedema (69%) services were most common. Fatigue management (51%) and pelvic health (32%) were less common. Services offering massage, return-to-work, cognitive therapy, sleep hygiene, and leisure were underrepresented (<31%). CONCLUSION: Provision of conventional supportive cancer care services continues to evolve in Australia. Multiple areas of care require development of dedicated services to address supportive cancer care intervention shortfalls across the country. Online resources and telemedicine are currently underutilized modalities that are available for further development.

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

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.

Rethinking the Meaning of "Wellness" for a Person with Cancer: A Qualitative Study to Explore What Elements Constitute "Wellness".

OBJECTIVE: This study explored what people with cancer and their family members define as wellness, and what they perceive to be the needs to support wellness during the cancer experience. METHODS: This study utilized qualitative focus groups underpinned by an interpretative descriptive design. Participants included people with a cancer diagnosis having completed/currently undergoing cancer treatment, and/or family/friends. Participants were invited to share their experience and perceptions of cancer wellness, which was then mapped in relation to Hettler's six dimensions of wellness. RESULTS: Twenty-six participants (16 people with cancer, ten family/friends) were involved in the process. All six dimensions of wellness were reported by the groups with 19 descriptive content categories that related to these domains. The data revealed that people with cancer and family/friends have individual and diverse meanings of wellness. Participants offered suggestions for strategies to promote wellness relating to the environment and supportive care interventions. CONCLUSIONS: People with cancer and their families experience wellness individually. Cancer wellness models should consider the personal nature of wellness in relation to the six domains of wellness when developing wellness programs, including health professional access, an environment that supports wellness, the provision and access to reliable information, and support the key needs of being physically active and financial security.

Setting a prioritized agenda to drive speech-language therapy research in health.

BACKGROUND: Prioritized research agendas are viewed internationally as an important method for ensuring that health research meets actual areas of clinical need. There is growing evidence for speech-language therapy-prioritized research agendas, particularly in disorder-specific areas. However, there are few general research priority agendas to guide speech-language therapy research. AIMS: To collaboratively develop a prioritized research agenda for an Australian public health context with clinical speech-language therapists (SLTs), academic SLTs and consumers of speech-language therapy services. METHODS & PROCEDURES: An initial stimulus list of potential research areas for prioritization was collected from SLTs via an online survey. Two categories (service delivery and expanded scope of practice) were selected from this list for prioritization due to their relevance across multiple health services. The Nominal Group Technique (NGT) was used to develop a prioritized research agenda for each of the two categories. One NGT session was conducted with each of the three participant groups (clinical SLTs, academic SLTs, consumers) for each category (total NGT sessions = six). The prioritization data for each group within each category were summed to give a single, ranked prioritized research agenda for each category. OUTCOMES & RESULTS: Two prioritized research agendas were developed. Within each agenda, SLTs and consumers prioritized a need for more research in areas related to specific practice areas (e.g., Alternative and Augmentative Communication, Communication Partner Training), as well as broader professional issues (e.g., telehealth, working with culturally and linguistically diverse families). CONCLUSIONS & IMPLICATIONS: The current findings support the need for funding proposals and targeted projects that address these identified areas of need. WHAT THIS PAPER ADDS: What is already known on this subject Evidence-based practice is a critical component of SLT practice. There is often a disconnect between the research evidence generated and areas of clinical need, and in some areas a lack of evidence. Prioritized research agendas can help drive research in areas of clinical need. What this paper adds to existing knowledge A collaborative, prioritized SLT research agenda was developed using the NGT according to the views of clinical SLTs, academic SLTs and consumers of speech-language therapy services in a conglomerate of public health services. SLTs and consumers identified a need for further research in specific areas of SLT practice as well as broader emerging professional issues What are the potential or actual clinical implications of this work? Targeted research projects funded on a large scale are required to address these identified areas of need. Other health services around the world could replicate this prioritization process to drive research in areas of clinical need.

Lymphoedema after head and neck cancer treatment: an overview for clinical practice.

Lymphoedema is a disorder of the lymphatic system that presents as an atypical swelling and accumulation of protein-rich fluid within the interstitial spaces. Head and neck lymphoedema (HNL) is highly prevalent in patients who have been treated for head and neck cancer (HNC) and may manifest externally on the face and neck; internally within the oral cavity, pharynx or larynx; or as a combination of both. HNL is known to contribute to a wide range of physical, functional and psychological issues, and presents several unique challenges in terms of its management. This review article provides an overview of HNL for clinicians and aims to improve awareness of this condition and the impact it has on patients.

Association between external and internal lymphedema and chronic dysphagia following head and neck cancer treatment.

BACKGROUND: To examine the relationship between chronic external and internal head and neck lymphedema (HNL) and swallowing function in patients following head and neck cancer (HNC) treatment. METHODS: Seventy-nine participants, 1-3 years post treatment were assessed for external HNL using the MD Anderson Cancer Centre Lymphedema Rating Scale, and internal HNL using Patterson's Radiotherapy Edema Rating Scale. Swallowing was assessed via instrumental, clinical and patient-reported outcome measures. RESULTS: HNL presented as internal only (68%), combined external/internal (29%), and external only (1%). Laryngeal penetration/aspiration was confirmed in 20%. Stepwise multivariable regression models, that accounted for primary site, revealed that a higher severity of external HNL and internal HNL was associated with more severe penetration/aspiration (P < .004 and P = .006, respectively), diet modification (P < .001 both), and poorer patient-reported outcomes (P = .037 and P = .014, respectively). CONCLUSION: Increased swallowing issues can be expected in patients presenting with more severe external HNL and/or internal HNL following HNC treatment.

A prospective study monitoring carer distress during (chemo)radiotherapy for head and neck cancer via an electronic platform.

INTRODUCTION: Research has shown that electronic platforms can assist data capture of patient-reported outcome measures (PROMs) to guide clinical care. In comparison, routine collection of carer-reported outcome measures (CROMs) to support the patient-carer dyad during cancer treatment has had limited attention. The current study utilised a novel electronic CROM (eCROM) system, ScreenIT Carer, to monitor the prevalence and nature of distress in carers of patients undergoing (chemo)radiotherapy ((C)RT) for head/neck cancer (HNC), and explore factors associated with carer distress. METHODS: Carers completed ScreenIT Carer weekly when attending patients' (C)RT treatment sessions from planning to 2 weeks post-treatment. ScreenIT Carer included the Distress Thermometer (DT) and Problem List, and a purpose-built Mealtime-Specific DT and Problem list. Data were first examined descriptively, then associations between demographic/treatment-related factors and distress severity were analysed using mixed-effects general linear modelling. RESULTS: 135 carers provided 434 ScreenIT Carer entries during the study period (mean entries = three/carer; yielding average adherence rate of 41% (range 11-100%)). A high prevalence of general (59%) and mealtime-specific distress (46%) was reported by carers. Nature of distress was multifactorial, with emotional problems and the patients' physical condition/symptoms common contributing factors. Based on multivariate analysis, tumour site, geographical location of residence and time during (C)RT when ScreenIT Carer was completed were significant predictors of carer distress severity. CONCLUSIONS: Carer distress is prevalent and multifactorial during (C)RT. This study highlights the feasibility of utilising eCROM platforms such as ScreenIT Carer, to monitor carer wellbeing and guide supportive care services as part of a holistic care pathway.

Comparing the prevalence, location, and severity of head and neck lymphedema after postoperative radiotherapy for oral cavity cancers and definitive chemoradiotherapy for oropharyngeal, laryngeal, and hypopharyngeal cancers.

BACKGROUND: This study aimed to examine the prevalence, location, and severity of chronic internal, external, and combined head and neck lymphedema (HNL) in patients with head and neck (HNC) who were treated with definitive chemoradiotherapy (CRT) or postoperative radiotherapy (PORT). METHODS: Sixty-two participants between 1 and 3 years post-treatment were recruited. Internal HNL was rated with Patterson's Scale. External HNL was graded with the MD Anderson Cancer Center Lymphedema Rating Scale. RESULTS: Ninety-eight percent of participants presented with some form of chronic HNL. Sixty-one percent had internal HNL only, 35% had combined HNL, and 2% had external HNL only. Participants treated with PORT were more likely to experience combined HNL (69% vs 24%, P = .001), whereas those treated with CRT were more likely to have internal HNL only (74% vs 25%, P = .001). CONCLUSIONS: Chronic HNL is highly prevalent following multimodal treatment, and differences in HNL presentations exist between treatment modalities.

Nutrition and swallowing therapy strategies for patients with head and neck cancer.

Patients with head and neck cancer experience many problems with eating which make them at high risk of malnutrition. Pre-habilitation swallowing exercises as overseen by a speech pathologist can improve swallowing function. A multidisciplinary approach to care, including effective nutritional screening, assessment and intervention has demonstrated improved outcomes in terms of meet nutritional requirements, improved nutritional status and quality of life. Nutritional recommendations are 1.2-1.5 g protein per kilogram per day and 125kJ/kg body weight per day but as these are guides close monitoring of intake and weight is important. Multidisciplinary teams and telehealth have shown better outcomes for nutrition and swallowing status for head and neck cancer patients and ongoing support is required for best patient care.

A prospective examination of mask anxiety during radiotherapy for head and neck cancer and patient perceptions of management strategies.

INTRODUCTION: Distress related to wearing an immobilisation mask for radiotherapy treatment (RT) is a common experience for the person undergoing RT for head and neck cancer (HNC). Described as 'mask anxiety', there is little known about the patterns of this distress through the course of the treatment or what strategies are being used by people to help alleviate mask anxiety. METHODS: The study used a prospective cohort design to examine the patterns of patient-reported mask anxiety during the course of RT, using a modified Distress Thermometer (DT) and a survey to explore strategies patients used to assist their mask anxiety. RESULTS: Thirty-five participants, who identified as experiencing mask anxiety, were followed throughout RT treatment. At baseline, females were more likely to experience higher mask anxiety (P = 0.03). Across the course of treatment, mask anxiety significantly (P < 0.001) reduced within the total cohort. In 72% of participants, the level of initial distress was found to reduce over time. Only 22% experienced mask anxiety that remained constant. Few (6%) experienced an increase in mask anxiety across the course of RT. Participants reported relying on intervention from health professionals, self-taught strategies, music, visualisation and medication to manage their mask anxiety. CONCLUSIONS: Due to its high prevalence and variable patterns over time, it is recommended that routine screening for mask anxiety be implemented as standard care throughout the course of RT for HNC. Multiple, diverse strategies are being used by patients and studies are needed to develop effective interventions for managing mask anxiety.

What Are We Really Measuring? A Content Comparison of Swallowing Outcome Measures for Head and Neck Cancer Based on the International Classification of Functioning, Disability and Health (ICF).

A combination of outcome measures are required to provide important information on the physiological profile and associated impact of dysphagia in head and neck cancer (HNC). Choosing the most appropriate tool can be a difficult and time-consuming process. The aim of this study was to identify and then compare the content of tools commonly used to assess swallowing post HNC care using the International Classification of Functioning Disability and Health (ICF) as a reference. A literature audit of 11 databases was conducted for relevant articles published between January 2004 and June 2017 and total of 502 papers met the inclusionary criteria. These papers were audited and 27 tools were identified which met the study criteria. The meaningful concepts contained in each tool were mapped to the ICF. Within the 27 tools, 898 meaningful concepts were identified and matched to 60 ICF categories. The most frequently matched ICF categories related to body functions, while comparatively few concepts matched to activity and participation and environmental factors. This study has identified that a large number of tools are currently being used in HNC research to measure swallowing outcomes. The sheer number of tools available to explore dysphagia post HNC highlights the lack of a uniform approach to outcome measurement which limits the potential to compare and combine research studies in order to strengthen treatment evidence. There is a need to develop an international consensus for a core outcome set of swallowing related measures, that capture the holistic impact of dysphagia, for HNC.