Measuring side effects after radiotherapy for pharynx cancer

Figures & data

Figure 1.  Illustration of the cause effect chain and the trade off between relevance and specificity of different measures of side effects.

Table I.  Important available tools for retrieving patient-reported morbidity data.

Name of first author and questionnaire	Population/symptom	Items	Scales
Aaronson, EORTC-C30 [105]	Cancer patients	30	9
Cella, FACT-G [77]	Cancer patients	28	5
Chang, Edmonton Symptom Assessment System [106]	Palliative care patients	10	–
Bjordal, EORTC H&N35 [76]	Head and neck cancer patients	35	7
D'Antonio, FACT-H&N, Head and neck radiotherapy Questionnaire [107]	Head and neck cancer patients	22	6
Hassan, UW-QOL University of Washington Head and neck Cancer [108]	Head and neck cancer patients	*	9
Terrel, Head and Neck Cancer-Specific QoL (HNQoL) [109]	Head and neck cancer patients	37	4
Henson, Xerostomia Related QoL XeQoLS [110]	Xerostomia in head and neck cancer patients treated with radiotherapy	15	–
Chen, M. D. Anderson dysphagia Inventory (MADI) [111]	Dysphagia in head and neck cancer patients	20	4
McHorney, SWAL-QoL and SWAL-CARE [112]	Quality of life and quality of care in dysphagia patients of both benign and malignant aetiology	44 + 15	10 + 2
Taylor, Neck dissection impairment index (NDII) [113]	Quality of life after neck dissection	10	–

*3–5 possible answers for each scale.

Figure 2.  Illustration of a cause-effect chain and different approaches to measuring side effects. Swallowing as an example.

Table II.  Questions to ask before selecting methods for measuring side effects.

• What

○ Analytical endpoints

▪ Use if feasible and available

▪ Must be relevant to

• Physiology

• Patient

▪ Use analytical endpoint to evaluate organ specific prevention or treatment until principles have been established*

○ Subjective endpoints

▪ Use patient assessed data if feasible

▪ Use validated questionnaires

○ Objective endpoint

▪ Use accepted scoring criteria's

• When

○ Register baseline toxicity

○ Time points during and after the treatment course must be relevant in order to determine

▪ Expected peak intensity

▪ Duration of side effect

○ Follow up time must be sufficient to establish long term time trend (recovery, progression)

• Who

○ Patients should register subjective symptoms

○ Trained and motivated doctors or nurses should register the remaining data

• How

○ Well planned logistics

▪ Unambiguous measures and forms

▪ Reminders for missing data

▪ Electronic forms to avoid typing errors

• E.g. patient registered data retrieved using touch screens

○ Central database for research and quality assurance

○ Analyse and report using accepted statistics

▪ Actuarial analysis or other analysis taking patients at risk and follow up time into account

▪ Report measure of cumulated toxicity

• Patients finishing at planned time, finishing planned number of treatments etc.

• Over all measure of quality of life

• Weight loss

• Numbers of grade 3–4 toxicity at any given time

*Measure parotid flow to show that parotid sparing below a certain threshold dose results in increased salivary flow before examining effects on xerostomia.

Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993; 85: 365–76

 PubMed Web of Science ®Google Scholar

Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, et al. The Functional Assessment of Cancer Therapy scale: Development and validation of the general measure. J Clin Oncol 1993; 11: 570–9

 PubMed Web of Science ®Google Scholar

Chang VT, Hwang SS, Feuerman M. Validation of the Edmonton Symptom Assessment Scale. Cancer 2000; 88: 2164–71

 PubMed Web of Science ®Google Scholar

Bjordal K, Hammerlid E, Ahlner-Elmqvist M, de Graeff A, Boysen M, Evensen JF, et al. Quality of life in head and neck cancer patients: Validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35. J Clin Oncol 1999; 17: 1008–19

 PubMed Web of Science ®Google Scholar

D'Antonio LL, Zimmerman GJ, Cella DF, Long SA. Quality of life and functional status measures in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg 1996; 122: 482–7

 PubMed Web of Science ®Google Scholar

Hassan SJ, Weymuller EA, Jr. Assessment of quality of life in head and neck cancer patients. Head Neck 1993; 15: 485–96

 PubMed Web of Science ®Google Scholar

Terrell JE, Nanavati KA, Esclamado RM, Bishop JK, Bradford CR, Wolf GT. Head and neck cancer-specific quality of life: Instrument validation. Arch Otolaryngol Head Neck Surg 1997; 123: 1125–32

 PubMed Web of Science ®Google Scholar

Henson BS, Inglehart MR, Eisbruch A, Ship JA. Preserved salivary output and xerostomia-related quality of life in head and neck cancer patients receiving parotid-sparing radiotherapy. Oral Oncol 2001; 37: 84–93

 PubMed Web of Science ®Google Scholar

Chen AY, Frankowski R, Bishop-Leone J, Hebert T, Leyk S, Lewin J, et al. The development and validation of a dysphagia-specific quality-of-life questionnaire for patients with head and neck cancer: The M. D. Anderson dysphagia inventory. Arch Otolaryngol Head Neck Surg 2001; 127: 870–6

 PubMedGoogle Scholar

McHorney CA, Robbins J, Lomax K, Rosenbek JC, Chignell K, Kramer AE, et al. The SWAL-QOL and SWAL-CARE outcomes tool for oropharyngeal dysphagia in adults: III. Documentation of reliability and validity. Dysphagia 2002; 17: 97–114

 PubMed Web of Science ®Google Scholar

Taylor RJ, Chepeha JC, Teknos TN, Bradford CR, Sharma PK, Terrell JE, et al. Development and validation of the neck dissection impairment index: A quality of life measure. Arch Otolaryngol Head Neck Surg 2002; 128: 44–9

 PubMedGoogle Scholar