Development and Validation of an Information Leaflet on Oral Care for Irradiated Patients

Figures & data

Table 1 Results of the Panel of Experts’ Voting on the Main Topics of the Patient Information Leaflet

Topic	Essential	Useful, but Not Essential	Irrelevant	Content Validity Ratio
Medical basic knowledge of radiotherapy	7	2	3	0.16
Indication for radiotherapy	11	1	0	0.83
Combination of radiotherapy with operation or chemotherapy	6	2	4	0
Side effects	12	0	0	1
Xerostomia	12	0	0	1
Taste loss	12	0	0	1
Mucositis	12	0	0	1
Increased risk for candida infections	9	2	1	0.5
Radiation caries	12	0	0	1
Osteoradionecrosis	12	0	0	1
Dental pre-treatment
Extraoral examination	9	1	2	0.5
Dental examination	12	0	0	1
Dental radiograph	12	0	0	1
Professional dental cleaning	12	0	0	1
Impressions for radiation splints	12	0	0	1
Dental pre-therapy (fillings, deep scaling, etc.)	8	3	1	0.33
Indications for teeth extractions	12	0	0	1
Importance of daily oral hygiene	12	0	0	1
Dental care during radiotherapy				1
Regular even in cases of sulcus bleeding and pain	12	0	0	1
Gum line	12	0	0	1
Interdental spaces	12	0	0	1
Soft toothbrush	12	0	0	1
Palate/tongue massage	12	0	0	1
Possibility to clean teeth without toothpaste	11	1	0	0.83
Cleaning methods	8	2	2	0.33
Cleaning the toothbrush with Chlorhexidine solution	12	0	0	1
Handling removable dentures
No dentures during the radiotherapy	12	0	0	1
Handling/storage	12	0	0	1
Start of dental rehabilitation three months after completion of therapy	11	0	0	0.83
Radiation splints as radiation protection
Radiation scatter	12	0	0	1
Cleaning/care/storage	11	1	0	0.83
Handling	11	1	0	0.83
Radiation splints for fluoride application
Effect	12	0	0	1
Fluoride application	12	0	0	1
Period of application	11	1	0	0.83
Handling	10	1	1	0.67
Cleaning/care/storage	10	2	0	0.67
Restoration by the dentist if necessary	8	4	0	0.33
Mucositis
Adequate dental care	12	0	0	1
Mouth rinses with water, saline solution, or sage tea	12	0	0	1
No chamomile	11	0	1	0.83
Ice cubes	12	0	0	1
Pineapple	12	0	0	1
Pilocarbin	8	1	3	0.33
Painkillers	8	4	0	0.33
Abstinence from alcohol and nicotine	9	3	0	0.5
Xerostomia
Stimulate salivation	12	0	0	1
Water uptake	11	1	0	0.83
Saline flush	11	1	0	0.83
Sugar free candy and chewing gum	12	0	0	1
Saliva substitute	12	0	0	1
Vaseline for lips and corners of the mouth	11	1	0	0.83
Trismus
Exercise	9	1	2	0.5
Physiotherapy	9	3	0	0.5
Nutrition
Small meals	12	0	0	1
Water uptake	12	0	0	1
Vitamin A rich juices	12	0	0	1
Edible oil with fruit juices	12	0	0	1
Low acid fruit and vegetables	12	0	0	1
Milk products (calcium)	12	0	0	1
More fish than meat	12	0	0	1
Fibers	11	0	1	0.83
Mild spices	10	0	2	0.67
Tube feeding if necessary	9	2	1	0.5
Aftercare
Appointments with radiotherapists/operation aftercare/dental follow-up	8	2	2	0.33

Note: Dark shaded fields indicate topics that have not been included in the content of the PIL.

Table 2 Readability Score (FRE: Flesch-Reading-Ease)

	Sentences	Words	Syllables	FREGerman
Version 1	94	1.313	2.863	38.5
Version 2	127	1.254	2.548	51.4

Table 3 Design Characteristics of the Patient Information Leaflet

Design Characteristics	Value
	A6	A4
Lines 50–89 mm	1	0
Separation between lines	1	3
Lines unjustified	1	1
Serif typeface	0	0
Type size	2	3
First line indented	0	0
Titles (headings) lower case	1	1
Italics	0	0
Positive advice (“do” instead of “do not”)	2	2
Headings stand out	2	2
Numbers are all Arabic	1	1
Boxed text	1	1
Pictures (not including cover pictures)	3	3
Number of colors	3	3
White space	3	3
Paper quality	3	3
Total	24	26

Table 4 Groups and Number of Probands

Group	Questionnaire A		Questionnaire B		Questionnaire C		Total
	Access to PIL	No Access to PIL	Access to PIL	No Access to PIL	Access to PIL	No Access to PIL
1	25	25	25	25	26	24	150
2	26	25	27	27	23	26	154
3	23	22	30	27	30	26	158
4	29	24	30	26	30	31	170
Total	103	96	112	105	109	107	632

Abbreviation: PIL, patient information leaflet.

Table 5 Descriptive Statistics of the Probands

Group	Age		Sex
			Male		Female		No information provided
	M	SD	n	%	n	%	n	%
Dentistry students	24.66	3.53	122	40.1	176	57.9	6	2.0
Students from other disciplines	29.10	11.67	29	18.4	119	75.3	10	6.3
Patients	46.73	15.70	80	47.1	85	50.0	5	2.9
Total	31.96	13.63	231	36.6	380	60.1	21	3.3

Abbreviations: PIL, patient information leaflet; SD, standard deviation; n, number.

Table 6 Percentage of Correctly Answered Items

Group	No Access to the PIL		Access to the PIL		Mean Difference	p
	Percentage of Correctly Answered Items	SD	Percentage of Correctly Answered Items	SD
Questionnaire A
1	76.17	9.04	83.50	10.58	7.33	< 0.001
2	59.38	15.46	84.03	16.61	24.65	< 0.001
3	62.12	17.15	77.54	13.57	15.45	0.002
4	52.43	16.62	83.19	19.37	30.76	< 0.001
Questionnaire B
1	64.42	12.65	87.79	15.69	23.37	< 0.001
2	57.69	11.19	88.11	12.77	30.42	< 0.001
3	54.58	9.92	81.05	13.30	26.47	< 0.001
4	48.99	13.87	75.44	13.28	26.45	< 0.001
Questionnaire C
1	73.61	15.65	88.89	9.56	15.28	< 0.001
2	68.80	12.77	71.74	18.12	2.94	0.436
3	69.26	10.18	83.98	9.34	14.72	< 0.001
4	58.07	15.64	60.93	13.80	2.86	0.258

Abbreviations: PIL, patient information leaflet; SD, standard deviation; p, p-value.

Figure 1 Percentage of correctly answered items on questionnaires A, B, and C.