Swedish Translation and Cultural Adaptation of the Head and Neck Patient Symptom Checklist: An Instrument to Screen for Nutrition Impact Symptoms in Clinical Practice and Research.

BACKGROUND: The Head and Neck Patient Symptom Checklist (HNSC) is a validated 2-part instrument used to ask patients with head and neck cancer about the nutrition impact symptoms they experience (part 1) and how these interfere with their eating (part 2). PURPOSE: The purpose of this work was to translate and culturally adapt the HNSC into Swedish in accordance with the guidelines of the International Society for Health Economics and Outcomes Research (ISPOR). METHODS: The ISPOR guidelines include 10 steps, and these were thoroughly followed. In step 7, 9 health care professionals from the field of head and neck cancer assessed the perceived relevance (content validity) of each item in the HNSC, as well as the full HNSC. A total of 522 participants with head and neck cancer were included and followed up on 7 occasions using the HNSC to assess internal consistency. RESULTS: The HNSC was translated from English into Swedish, ensuring accuracy through forward and backward translation and harmonization in the research team. Content validity for each part of the HNSC was rated excellent (scale content validity index 0.96). Internal consistency demonstrated a good Cronbach's alpha score (>0.8) across the 7 follow-up time points (from baseline [before the start of treatment] and up to 24 months posttreatment). CONCLUSIONS: The HNSC has been successfully translated and culturally adapted into Swedish. The HNSC can be used in both clinical practice and research to screen for nutrition impact symptoms and symptoms that interfere with eating in patients with head and neck cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT03343236 (date of registration: November 17, 2017).

Swedish translation and cultural adaptation of the scored Patient-Generated Subjective Global Assessment (PG-SGA©)-A validated tool for screening and assessing malnutrition in clinical practice and research.

INTRODUCTION: The scored Patient-Generated Subjective Global Assessment (PG-SGA©) is a validated tool for the screening, assessment and monitoring of malnutrition, and triaging of interventions. It contains a patient-generated component and a healthcare professional (HCP)-generated component. AIM: To translate the PG-SGA into Swedish, assess the linguistic and content validity of the Swedish version, and ensure conceptional, semantic and operational equivalence to the original English PG-SGA. METHODS: In line with the methodology used in previously translated and culturally adapted versions, the standardised 10-step process suggested by the International Society for Health Economics and Outcomes Research (ISPOR) was followed. In step 7, a cross-sectional study targeting patients n = 51 and HCPs n = 52 was performed at a university hospital in Sweden. Using separate questionnaires, patients assessed the patient component and HCPs, the professional component regarding perceived comprehensibility and difficulty (linguistic validity). The HCPs also assessed perceived relevance (content validity) of all items on the PG-SGA. Item indices for comprehensibility (I-CI), difficulty (I-DI) and content validity (I-CVI) were calculated and averaged into scale indices (S-CI, S-DI and S-CVI). Cut-off standards for item and scale indices were used as reference. RESULTS: The Swedish version of the PG-SGA rated excellent for comprehensibility (S-CI 0.96) and difficulty (S-DI 0.93) for the patient component. The professional component rated acceptable for comprehensibility (S-CI 0.89) and below acceptable for difficulty (S-DI 0.70), with the physical examination rated most difficult (I-DI 0.39 to 0.69). Content validity for the full Swedish PG-SGA was rated excellent (S-CVI 0.94). CONCLUSION: The patient component was considered clear and easy to complete. The full Swedish PG-SGA was considered relevant by HCPs for screening and assessment of malnutrition. Due to perceived difficulty with the physical examination, training of Swedish HCPs in using the PG-SGA is essential before implementing the professional component into clinical practice or research.

Mapping the impact of malnutrition as defined by the Global Leadership Initiative on Malnutrition and nutrition impact symptoms on the possibility of returning to work after treatment for head and neck cancer.

PURPOSE: This study aimed to investigate whether malnutrition or nutrition impact symptoms (NIS) affect the possibility of returning to work after treatment for head and neck cancer. METHODS: Patients of working age with head and neck cancer were followed up from treatment initiation to 3 months (n = 238), 1 year (n = 182), and 2 years (n = 130) after treatment completion. The observed decrease in the number of patients over time was due to retirement, lack of follow-up, or death. Returning to work was dichotomised as yes or no. Malnutrition was diagnosed 7 weeks after treatment initiation using the Global Leadership Initiative on Malnutrition (GLIM) criteria. This time-point corresponds to the end of chemoradiotherapy or radiotherapy (with or without prior surgery), except for patients who underwent exclusive surgery. NIS were scored on a Likert scale (1-5) at each follow-up using the Head and Neck Patient Symptom Checklist© (HNSC©). Nonparametric tests were used to analyse the ability of patients with/without malnutrition and high/low NIS scores to return to work. RESULTS: At 3 months, 1 year, and 2 years after treatment completion, 135/238 (56.7%), 49/182 (26.9%), and 23/130 (17.7%) patients had not returned to work. Patients with malnutrition at 7 weeks after treatment initiation were more likely to not return to work at 3 months than those without malnutrition, 70.5% compared to 47.1% (p < 0.001). At all three follow-up time-points, patients reporting high scores for a number of NIS had more often not returned to work, with this pattern being most distinct at 2 years. CONCLUSION: Malnutrition according to the GLIM criteria at 7 weeks after treatment initiation and NIS assessed by the HNSC© at subsequent follow-ups were predictors of the return-to-work process after treatment for up to 2 years. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT03343236 (date of registration 17/11/2017).

Mapping Health-Related Quality of Life, Anxiety, and Depression in Patients with Head and Neck Cancer Diagnosed with Malnutrition Defined by GLIM.

Patients with cancer deal with problems related to physical, psychological, social, and emotional functions. The aim was to investigate malnutrition defined by the Global Leadership Initiative on Malnutrition (GLIM) criteria in relation to health-related quality of life, anxiety, and depression in patients with head and neck cancer. This was a prospective observational research study with 273 patients followed at the start of treatment, seven weeks, and one year. Data collection included nutritional status and support, and the questionnaires: European Organization for Research and Treatment of Cancer Head and neck cancer module (EORTC QLQ-H&N35) and the Hospital Anxiety and Depression Scale (HADS). Malnutrition was defined using the GLIM criteria. The study showed that patients with malnutrition had significantly greater deterioration in their health-related quality of life at seven weeks. On a group level, health-related quality of life was most severe at this time point and some scores still implied problems at one year. Significantly, more patients reported anxiety at the start of treatment whereas significantly more patients reported depression at seven weeks. Over the trajectory of care, the need for support often varies. Psychosocial support is imperative and at the end of treatment extra focus should be put on nutritional interventions and managing treatment-related symptoms to improve nutritional status and health-related quality of life. In the long-term, head and neck cancer survivors need help to find strategies to cope with the remaining sequel.

Mapping impact factors leading to the GLIM diagnosis of malnutrition in patients with head and neck cancer.

BACKGROUND & AIMS: In head and neck cancer, the combination of weight loss and elevated C-reactive protein levels means that patients have malnutrition as defined by the Global Leadership Initiative on Malnutrition (GLIM). This study aimed to identify impact factors for malnutrition as defined by the GLIM criteria among patients with head and neck cancer at the start of treatment and up to 12 months post-treatment. METHODS: In a prospective, observational study, patient, tumour, treatment, and nutritional data from 229 patients with head and neck cancer were collected at the start of treatment and at three follow-ups (7 weeks after the start of treatment and at 3 and 12 months after the termination of treatment). These clinical variables were statistically analysed in relation to malnutrition at each follow-up using univariate and multivariate analyses. Malnutrition was defined according to the two GLIM criteria of >5% body weight loss during the last 6 months and C-reactive protein >5 mg/L. RESULTS: The following factors were predictive for malnutrition in the multivariate analysis performed 7 weeks after the start of treatment: moderate or severe mucositis, chemoradiotherapy ± surgery, and the need for nutritional support (total or partial use of tube feeding/parenteral nutrition). Advanced tumour stage (III-IV) was significant for malnutrition at the start of treatment and at the 7 week and 3 month follow-ups, but not at 12 months. CONCLUSIONS: Severe mucositis, chemoradiotherapy ± surgery, and advanced tumour stage were found to be impact factors for the diagnosis of malnutrition using GLIM at different follow-up times from the start of treatment up to 12 months after the end of treatment. Few patients with head and neck cancer are diagnosed with malnutrition according to the GLIM criteria in a long-term perspective after the termination of treatment. Research on the validity of the GLIM criteria is needed to build a comprehensive evidence base of impact factors for malnutrition in head and neck cancer.

Mapping the frequency of malnutrition in patients with head and neck cancer using the GLIM Criteria for the Diagnosis of Malnutrition.

BACKGROUND & AIMS: Patients with head and neck cancer are defined as high-risk patients for malnutrition, but the inconsistent practice of diagnosing malnutrition is a barrier in comparing studies and in assessing patients in clinical practice. The aim of the study was to describe the frequency of malnutrition over time in patients treated for head and neck cancer using the GLIM Criteria for the Diagnosis of Malnutrition. METHODS: Data from a prospective observational study on patients with head and neck cancer were used (n = 210). Patients were assessed for malnutrition using the combination of one phenotypic and one etiologic criterion. The following phenotypic criteria for malnutrition were used: body weight loss (either >5% within the past six months or >10% beyond six months), body mass index (<20 kg/m2 if <70 years or <22 kg/m2 if ≥70 years), and fat free mass index measured by bioelectrical impedance analysis (<17 FFM/m2 for males and <15 FFM/m2 for females). The following etiologic criteria for malnutrition were used: reduced food intake (partial or no food intake with the need for artificial nutrition) and C-reactive protein (>5 mg/L). RESULTS: For all eight possible combinations of GLIM, the frequency of malnutrition reached its highest point at seven weeks after the start of treatment. A total of 32% of the patients fulfilled the criteria for malnutrition using weight loss >5% within the past six months (phenotypic) in combination with C-reactive protein >5 mg/L (etiologic). CONCLUSIONS: GLIM Criteria for the Diagnosis of Malnutrition can be used to assess malnutrition in patients with head and neck cancer during treatment. Using the same criteria to define malnutrition in nutritional research will make it possible to produce multiple lines of evidence on malnutrition in head and neck cancer and its adverse effects on treatment, prognosis, and survival.

An explorative study on energy balance in patients with head and neck cancer.

Background: Involuntary body weight loss in head and neck cancer is common. Fundamental for weight loss is an energy imbalance where total energy expenditure exceeds energy intake.Aim: To map energy intake and parameters of energy expenditure at the start of and after radiotherapy, and their relation to weight change, body mass index, and immune markers in patients with head and neck cancer.Materials and Methods: Data from 20 patients on energy intake (24-hour dietary intake recalls), total energy expenditure (SenseWear Armband Pro3), resting energy expenditure (indirect calorimetry), body weight, body mass index, and immune markers in serum (C-reactive protein and Interleukin-6) were collected at the start of and after radiotherapy (median 8 mo, range 5-13).Results: No statistical significance was shown between the two measurement points for energy intake or for the different parameters of energy expenditure. Median values for energy balance were 0.93 and 0.96 for the start of treatment and follow-up, respectively. Twelve and 13 patients had a negative energy balance at the start of radiotherapy and at follow-up, respectively.Conclusion: A negative energy balance was seen for the majority of patients, which stresses the importance of nutritional treatment at the start of and after radiotherapy.

Experiences and coping strategies related to food and eating up to two years after the termination of treatment in patients with head and neck cancer.

The purpose was to describe how patients with head and neck cancer experience and cope with difficulties related to food and eating up to two years after the termination of treatment. One hundred and thirty-five patients were followed with thematically structured interviews. The patients' responses of nutritional issues were categorised using similarities and differences technique. In the analysis, six categories emerged describing the process of eating and drinking from the end of treatment up to two years after treatment: The constant battle-eating and drinking over time, Food alterations and nutritional support-both pros and cons, Standing aside and not joining in when eating together with others, Finding ways to cope and to make the new a part of everyday life, Relationships and social support-hindrances and facilitators, and Longing for "normality." Results imply that patients struggle with physiological, psychological and social aspects related to food and eating, and use coping mechanisms to facilitate their eating problems. The best practice for rehabilitation and follow-up must be established in order to meet the multifaceted needs of head and neck cancer survivors.