Gussgard Anne Margrete, Jokstad Asbjørn, Hope Andrew J, Wood Robert, Tenenbaum Howard
The Arctic University of Norway, 9037 Tromsø, Norway.
J Can Dent Assoc. 2015;81:f11.
To improve understanding of how patient-reported outcomes following radiation therapy for head and neck cancer may be influenced by factors beyond the local effects of the radiotherapy.
Initially, 50 patients with head and neck cancer who were scheduled to undergo radiation therapy consented to participate in this prospective observational study. The participants underwent an oral examination before commencement of therapy and twice weekly over the therapy period. The 33 participants who finished the therapy underwent one more examination 4 to 6 weeks after its completion. At each session, clinical signs of oral mucositis were recorded with clinician-based scoring tools, and participants completed a questionnaire based on a visual analogue scale to record the perceived degree of impairment of common oral functions caused by oral mucositis. The strength of the correlation between these signs and symptoms at various points throughout the study period was appraised using a linear mixed model with robust repeated measures. The study participants with the most extensive manifestations of oral mucositis but only minor pain and limited adverse effects on oral functions (n=6) were contrasted with those who had limited mucositis but more severe pain and adverse effects (n=7). In addition, study participants with poor to moderate correlations between signs and symptoms (n=5) were contrasted with those who had very good correlations (n=10). Simple bivariate tests were used for these comparisons.
Correlations between various signs and symptoms at all time points varied markedly at the individual level. The characteristics of study participants in the 2 subcohorts defined by poor to moderate and very good correlations between signs and symptoms were comparable, except perhaps in terms of age (p<0.05, t test). Similarly, the participants in the 2 subcohorts defined by high manifestation with minor complaints and vice versa did not differ with regard to the variables recorded.
Patients with head and neck cancer often report adverse effects of radiation-related oral mucositis on daily oral functions that are discordant with objective clinical findings. Patient-reported outcomes should be included in any interventional studies of oral mucositis, and trends over time should be analyzed within individuals, rather than between individuals.
加深对头颈癌放疗后患者报告结局如何受到放疗局部效应以外因素影响的理解。
最初，50名头颈癌患者同意参与这项前瞻性观察研究，他们计划接受放疗。参与者在治疗开始前进行了口腔检查，并在治疗期间每周进行两次检查。完成治疗的33名参与者在治疗结束后4至6周又接受了一次检查。在每次检查时，使用基于临床医生的评分工具记录口腔黏膜炎的临床体征，参与者完成一份基于视觉模拟量表的问卷，以记录口腔黏膜炎导致的常见口腔功能受损程度。在整个研究期间，使用具有稳健重复测量的线性混合模型评估这些体征和症状在不同时间点之间的相关性强度。将口腔黏膜炎表现最广泛但疼痛轻微且对口腔功能不良影响有限的研究参与者（n = 6）与黏膜炎有限但疼痛更严重且不良影响更大的参与者（n = 7）进行对比。此外，将体征和症状之间相关性较差至中等的研究参与者（n = 5）与相关性非常好的参与者（n = 10）进行对比。这些比较采用简单双变量检验。
在个体水平上，所有时间点各种体征和症状之间的相关性差异显著。除年龄外（p<0.05，t检验），由体征和症状之间相关性较差至中等和非常好所定义的两个亚组中研究参与者的特征具有可比性。同样，由表现高但主诉轻微以及反之表现低但主诉严重所定义的两个亚组中的参与者在记录的变量方面没有差异。
头颈癌患者经常报告放疗相关口腔黏膜炎对日常口腔功能的不良影响，这些影响与客观临床发现不一致。在任何口腔黏膜炎的干预研究中都应纳入患者报告结局，并且应在个体内部而非个体之间分析随时间的趋势。
