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The use of the FACT-H&N (v4) in clinical settings within a developing country: a mixed method study

Bilal S, Doss JG, Rogers SN

J Craniomaxillofac Surg, 2014 Dec;42(8):1590-7.
PMID: 25224886 DOI: 10.1016/j.jcms.2014.04.015

In the last decade there has been an increasing awareness about 'quality of life' (QOL) of cancer survivors in developing countries. The study aimed to cross-culturally adapt and validate the FACT-H&N (v4) in Urdu language for Pakistani head and neck cancer patients. In this study the 'same language adaptation method' was used. Cognitive debriefing through in-depth interviews of 25 patients to assess semantic, operational and conceptual equivalence was done. The validation phase included 50 patients to evaluate the psychometric properties. The translated FACT-H&N was easily comprehended (100%). Cronbach's alpha for FACT-G subscales ranged from 0.726 - 0.969. The head and neck subscale and Pakistani questions subscale showed low internal consistency (0.426 and 0.541 respectively). Instrument demonstrated known-group validity in differentiating patients of different clinical stages, treatment status and tumor sites (p < 0.05). Most FACT summary scales correlated strongly with each other (r > 0.75) and showed convergent validity (r > 0.90), with little discriminant validity. Factor analysis revealed 6 factors explaining 85.1% of the total variance with very good (>0.8) Kaiser-Meyer-Olkin and highly significant Bartlett's Test of Sphericity (p < 0.001). The cross-culturally adapted FACT-H&N into Urdu language showed adequate reliability and validity to be incorporated in Pakistani clinical settings for head and neck cancer patients.
Quality of life associated factors in head and neck cancer patients in a developing country using the FACT-H&N

Bilal S, Doss JG, Cella D, Rogers SN

J Craniomaxillofac Surg, 2015 Mar;43(2):274-80.
PMID: 25555894 DOI: 10.1016/j.jcms.2014.11.024

Health-related quality of life (HRQoL) associated factors are vital considerations prior to treatment decision-making for head and neck cancer patients. The study aimed to identify potential socio-demographic and clinical prognostic value of HRQoL in head and neck cancer patients in a developing country. The Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N)-V4 in Urdu language was administered among 361 head and neck cancer patients. Data were statistically tested through multivariate analysis of variance (MANOVA) and regression modeling to identify the potentially associated factors. Treatment status, tumor stage and tumor site had the strongest negative impact on patients HRQoL, with a statistically significant decrement in FACT summary scales (effect size >0.15). Moderate associated factors of HRQoL included treatment type, marital status, employment status and age (effect size range 0.06-0.15). Weak associated factors of HRQoL with a small effect size (>0.01-0.06) included tumor size and type, gender, education level and ethnicity. This study reports 12 socio-demographic and clinical variables that have a significant impact on HRQoL of head, and neck cancer patients, and that should be considered during treatment decision-making by multidisciplinary teams and also in future HRQoL studies conducted in other developing countries.
The feasibility of using Patients Concerns Inventory (PCI) in managing Malaysian oral cancer patients

Hatta JM, Doss JG, Rogers SN

Int J Oral Maxillofac Surg, 2014 Feb;43(2):147-55.
PMID: 24074487 DOI: 10.1016/j.ijom.2013.08.006

The feasibility of using the Patients Concerns Inventory (PCI) to identify oral cancer patient concerns during consultation in oral and maxillofacial specialist clinics in Malaysia was assessed. A cross-sectional study was conducted using a consecutive clinical sampling technique of all new and follow-up oral cancer patients. Surgeons and counter staff were also recruited. Two-thirds of patients were elderly, 63.9% female, 55.6% Indian, 63.9% of lower-level education, and half had the lowest level household income. Patient status was mostly post-treatment (87.5%) and most were at cancer stage III/IV (63.9%); 59.7% had surgery. Patients took an average 5.9 min (95% CI 5.1-6.7 min) to complete the PCI. Physical domain appeared highest (94.4%); social/family relationship issues (4.2%) were lowest. Significant associations included patient age-personal function (P=0.02); patient education level-emotional status (P=0.05) and social/family relationship issues (P=0.04), and patient TNM staging-personal function (P=0.03). The patients' mean feasibility score for the PCI was 5.3 (95% CI 5.1-5.5) out of 6. Patients (93.1%) and surgeons (90%) found the PCI to be feasible. Only 57.1% of counter staff agreed on the use of the PCI during patient registration. Overall, the PCI was considered feasible, thus favouring its future use in routine oral cancer patient management.
Changes in health-related quality of life of oral cancer patients treated with curative intent: experience of a developing country

Doss JG, Ghani WMN, Razak IA, Yang YH, Rogers SN, Zain RB

Int J Oral Maxillofac Surg, 2017 Jun;46(6):687-698.
PMID: 28318871 DOI: 10.1016/j.ijom.2017.02.1269

This study aimed to assess changes in oral cancer patients' health-related quality of life (HRQOL) and the impact of disease stage on HRQOL scores. HRQOL data were collected from seven hospital-based centres using the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) version 4.0 instrument. The independent samples t-test, χ(2) test, and paired samples t-test were used to analyse the data. A total of 300 patients were recruited. The most common oral cancer sub-site was tongue and floor of mouth (42.6%). Surgical intervention (41.1%) was the most common treatment modality. Significant differences in ethnicity and treatment modality were observed between early and late stage patients. Pre-treatment HRQOL scores were significantly lower for late than early stage patients. At 1 month post-treatment, the functional and head and neck domains and the FACT-H&N (TOI) summary scores showed significant deterioration in both early and late stage patients. In contrast, the emotional domain showed a significant improvement for early and late stage patients at 1, 3, and 6 months post-treatment. Although HRQOL deterioration was still observed among early and late stage patients at 6 months post-treatment, this was not statistically significant. In conclusion, advanced disease is associated with poorer HRQOL. Although ethnic differences were observed across different disease stages, the influence of ethnicity on patient HRQOL was not evident in this study.
Histological assessment of extensive or unresectable central giant cell granulomas treated with denosumab - A case series

Patel V, Kumar M, Schache A, Hunter KD, Carey B, Rogers SN, et al.

Oral Surg Oral Med Oral Pathol Oral Radiol, 2024 Nov 28.
PMID: 39709299 DOI: 10.1016/j.oooo.2024.11.086

OBJECTIVE: The management of large central giant cell granuloma (CGCG) can pose a significant surgical challenge. In such circumstances, the use of denosumab has been proposed with the literature reporting varying degrees of success. Histopathological assessment of CGCG post-denosumab treatment remains unknown. The current case series aims to address this lack of information and supplement the literature and the debate with evidence.
STUDY DESIGN: The current case series is a retrospective review of historic cases accumulated from 3 different hospitals. Patients treated with denosumab for large or unresectable GCGC who subsequently underwent either surgical debulk or resection post drug treatment with histological tissue for assessment were included.
RESULTS: A total of 4 patients were included in this study. All cases showed radiographic response. However histological assessment identified giant cells in 3 of the 4 cases, 2 of which showed clinical recurrence. All cases demonstrated irregular woven bone formation toward the periphery of the lesion suggesting partial response.
CONCLUSIONS: The current case series provides some insight regarding the response of CGCG to denosumab and preliminary histopathological information toward the ongoing debate regarding the medical management of CGCG. (Oral Surg Oral Med Oral Pathol Oral Radiol YEAR;VOL:page range).
Fulltext Variations in concerns reported on the patient concerns inventory in patients with head and neck cancer from different health settings across the world

Rogers SN, Alvear A, Anesi A, Babin E, Balik A, Batstone M, et al.

Head Neck, 2020 03;42(3):498-512.
PMID: 31833121 DOI: 10.1002/hed.26027

BACKGROUND: The aim was to collate and contrast patient concerns from a range of different head and neck cancer follow-up clinics around the world. Also, we sought to explore the relationship, if any, between responses to the patient concerns inventory (PCI) and overall quality of life (QOL).
METHODS: Nineteen units participated with intention of including 100 patients per site as close to a consecutive series as possible in order to minimize selection bias.
RESULTS: There were 2136 patients with a median total number of PCI items selected of 5 (2-10). "Fear of the cancer returning" (39%) and "dry mouth" (37%) were most common. Twenty-five percent (524) reported less than good QOL.
CONCLUSION: There was considerable variation between units in the number of items selected and in overall QOL, even after allowing for case-mix variables. There was a strong progressive association between the number of PCI items and QOL.