Validation of the EORTC information (QLQ-INFO25) and satisfaction with care (IN-PATSAT32) modules in Polish cancer patients’ population

doi:10.21203/rs.3.rs-3240036/v1

Background: The IN-PATSAT32 and QLQ-INFO25 are questionnaires which can be applied to assess and improve communication with cancer patients, as well as for research and clinical trials aimed at assessing patients’ satisfaction and perception of the information received from nurses and other healthcare providers. Given the recently passed “Polish oncological network” act of law, the issue of patient satisfaction and its regular assessment is finally acknowledged in the socioeconomic and cultural context of Poland. The aim of this study was to perform validation of EORTC satisfaction with care QLQ-INFO25 and quality of information IN-PATSAT32 modules.

Methods: The prospective cross-sectional study included patients from cancer reference center from Krakow, Poland. The translated and pilot-tested module QLQ-INFO25 was used together with core questionnaire QLQ-C30 and satisfaction module IN-PATSAT32. Adult patients with histological confirmation of any malignancy and ability to understand the questionnaire were included into the study.

Results: 187 patients were enrolled, including 111 women and 76 men (mean age ± SD; 59.32 ± 10.4). Cronbach's alpha coefficients, range 0.83-0.85 for QLQ-INFO25 and 0.82-0.94 for IN-PATSAT32 showed positive internal consistency. Acceptable convergent and discriminant validity in multi-trait scaling analyses was seen for both modules with r<0.3 for all calculations. Interclass correlations proved satisfactory test-retest reliability.

Conclusions: Polish versions of IN-PATSAT32 and QLQ-NFO25 are reliable and valid instruments providing domains not covered by core EORTC module. Tools are suitable for use in daily clinical practice, in research as well as in clinical trials in order to obtain data regarding patients’ perception of and satisfaction with received information within the socioeconomic and cultural context of Poland.

Patients satisfaction

Information

Quality of life

Validity

Reliability

Cancer

Cancer is one of the leading causes of death worldwide, with its incidence increasing year by year. In 2020 around 19.3 million new cases were diagnosed − 1.2 million cases more than in 2018. Cancer mortality reached almost 10 million cases worldwide in 2020 [1].

The majority of cancer patients see the need to improve communication with health care professionals [2, 3]. The quality of this communication process correlates with the level of stress connected to cancer and its treatment [4]. This connection is also noticed in case of other aspects such as: experiencing some symptoms during the treatment, level of anxiety, risk of depression, the willingness to participate in clinical trials or even the survival [2, 4–9].

The subject of the scope and type of information that should be received by the patient in the course of diagnosis and treatment of neoplastic disease needs to be explored [10–12]. The results remain inconclusive in terms of whether sociodemographic data such as: sex, age, education or type of treatment received should influence the quantity of information received [4, 9, 13, 14]. Research suggests that older patient may have altered needs for communication process e.g. including family to a greater extent, using geriatric assessment prior to discussion with patient [12, 13, 15]. Another group with special communication needs may comprise lonely patients with worsening general condition [16].

The literature seems conclusive regarding the need to disclose the information about their illness to the patients [4, 9, 17]. Yet, it should not be restricted to the diagnosis and treatment, but it should also include information about other places of care, self-help and psychological aid [9]. Potential benefits resulting from proper communication are the improvement in patients satisfaction regarding treatment and diagnostic process, better cooperation with health-care providers, treatment compliance, lower distress [2, 7, 18–22].

There are numerous tools used for research on exploring patients perception of information and satisfaction with care. The studies are heterogeneous, commonly using instruments that are not validated and hence, the results are difficult to compare [8, 23]. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Group has developed and validated an information module (QLQ-INFO25) to assess perception of information received by cancer patients [24] and satisfaction with care module (IN-PATSAT32) [25]. International studies regarding these topics claim that cultural, political and social differences are important factors that determine patients’ needs in numerous populations and thus potential tools for information and satisfaction studies have to undergo full validation process [26, 27].

The aim of this study was to perform cultural adaptation and psychometric validation of EORTC QLQ-INFO25 and IN-PATSAT32 modules used together with the core questionnaire.

Ethical consent

Permission was obtained from the EORTC for the translation of QLQ-INFO25 and validation of both instruments: QLQ-INFO25 and IN-PATSAT32. This study was approved by the Jagiellonian University Collegium Medicum Bioethics Committee (registry KBET/253/B/2011). Informed consent was obtained from all the participants. The study followed the Declaration of Helsinki with its amendments.

Study tools

The two instruments validated in this study were the EORTC Information (QLQ-INFO25) and EORTC Patient Satisfaction with Care (IN-PATSAT32) questionnaires. They were used together with core questionnaire (QLQ-C30) and basic patient’s information form (age, sex, time from diagnosis, line of treatment received, education level, marital status, tumor type and stage, type of therapy, possibility of being cured and presence of comorbidities). Permission was obtained previously from the EORTC for the translation and/or validation of the tools.

EORTC QLQ-C30 is a 30-item tool classified into 15 domains: (1) 5 functional scales: physical, role, emotional, cognitive and social; (2) 3 symptom scales: fatigue, pain and nausea and vomiting; (3) six single items (about symptoms: dyspnea, appetite loss, diarrhea, constipation and sleep disturbances as well as about financial issues) and (4) quality of life and global health subscale. The scoring is based on a 4-Point Likkert scale. Global health and quality of life scale is scored based on 7-point scale.
EORTC IN-PATSAT32 is a 32-item tool classified into 11 domains: (1) 8 scales including health care providers (physician and nurses) technical skills, interpersonal skills, providing information, availability, other hospital workers’ interpersonal abilities, waiting time, access to hospital service; and (2) 3 single items about hospital comfort, information exchange and overall satisfaction. Each item can be assessed with 5 options (from poor to excellent).
EORTC QLQ-INFO25 is a 25-item tool classified into: (1) 4 multi-item scales including information about the disease, medical tests, the treatment and other services; (2) 8 single items about different places to receive care, possibility of self-help, receiving information (written or digital), satisfaction with obtained information,

a desire to obtain more information, a desire to obtain less information and the usefulness of the information obtained.

Translation of study tools and pilot testing

The core EORTC Questionnaire (QLQ-C30) has been previously validated by our group [28, 29]. IN-PATSAT32 was provided with translation by EORTC team. QLQ-INFO25 was translated following EORTC translation procedures with forward and back translation. Its intermediate version was pilot-tested after introducing the required changes. The final version of information module was approved by EORTC [23].

Study participants

Participants were recruited among patients treated in a Cancer Reference Center in Krakow, Poland between 2015 and 2018. Inclusion criteria were: pathological confirmation of malignancy, ability to understand the questionnaire, age ≥ 18years; lack of consent to participate in the study, presence of concurrent malignancy or being non-native Polish speaking were exclusion criteria. There was no restriction in terms of type of malignancy, stage of the disease, treatment received, line of therapy, time from cancer diagnosis or sex. A minimum of 176 patients were planned to include in the study.

Interview procedure

All study participants signed a consent form. The patients were interviewed by staff members (not by a treating physician to assure comfort during survey completion). All three EORTC tools were administered with a total time around 25–30 minutes for survey completion. Patients’ socioclinical data were obtained from the medical records.

Statistical analysis

Statistical analysis was performed following EORTC guidelines [30]. Each subscale or single item was scored ranging from 0 to 100. The greater the value, the greater the severity of the symptoms; for global health and quality of life as well as functioning subscales QLQ-C30: better quality of life and functioning and for QLQ-INFO25 and IN-PATSAT32 higher level of information received or higher satisfaction with it.

For data analysis descriptive statistics elements were used including: mean, standard deviation (SD), median, minimal and maximal values 95% confidence interval (CI). Shapiro-Wilk test was used for the assessment of the normality of the data distribution and t-Student, Chi2, U Mann-Whitney or ANOVA tests for assessment of differences between groups as appropriate. Internal consistency of every multi-item scale was evaluated by Cronbach’s alpha coefficient.

Group comparison was performed to check the differences between subgroups of patients in terms of the characteristics of the patients. Pearson’s and Spearmann’s correlations were used for correlations between results obtained for different scales and sociodemographic data depending on the data distribution.

A group (n = 30) of randomly selected patients completed the tools twice for test–retest reliability assessment with interclass correlations (ICC) > 0.70 assessed as ‘good’.

P < 0.05 was assessed statistically significant. Data were analysed using STATISTICA (v.13.3) software.

We recruited 187 patients. Two patients rejected participation in the study due to length of the questionnaires, one person refused due to unknown cause. All patients completed the QLQ-INFO25, IN-PATSAT32 and core QLQ-C30 module. 30 randomly selected participants answered the retest after 2 weeks following the initial interview (range 14–21 days).

Participant characteristics

Patients sociodemographic data are presented in Table 1.

Table 1

Patients sociodemographic data
Parameter		Total (N = 187)
Time since diagnosis [months]	Mean (SD)	19.39 (30.65)
	Median (quartiles)	7 (4–20)
	Range	1-223
	Missing	1
Sex	Female	111 (59.36%)
Sex	Male	76 (40.64%)
Age [years]	Mean (SD)	59.32 (10.4)
	Median (quartiles)	60 (53.5–67)
	Range	21–80
	Missing	0
Treatment line	I line	109 (58.29%)
Treatment line	> I line	78 (41.71%)
Education	Primary	19 (10.16%)
	Secondary	57 (30.48%)
	Vocational	60 (32.09%)
	University	48 (25.67%)
	Unknown	3 (1.60%)
Marital status	Single	10 (5.35%)
	Married	133 (71.12%)
	Widow(er)	23 (12.30%)
	Divorced	15 (8.02%)
	Unknown	6 (3.21%)
Diagnosis	Colorectal cancer	71 (37.97%)
	Gastric cancer	22 (11.76%)
	Oesophageal cancer	4 (2.14%)
	Breast cancer	40 (21.39%)
	Lung cancer	14 (7.49%)
	Head/neck cancer	8 (4.28%)
	Others	28 (14.97%)
Treatment intention	Currative	123 (65.77%)
Treatment intention	Palliative Unknown	62 (33.16%) 2 (1.07%)
Treatment place	Ward	151 (80.75%)
	Clinic	28 (14.97%)
	Unknown	8 (4.28%)
SD – standard deviation

Descriptive statistics

QLQ-INFO25 and IN-PATSAT32 modules descriptive statistics are presented in Tables 2 and 3.

Table 2

QLQ-INFO25 module descriptive statistic
Parameter	N	Mean	SD	Median	Max	Q1	Q3
Information about the disease	184	69.97	20.34	66.67	100	58.33	83.33
Information about medical tests	182	77.47	19.5	77.78	100	66.67	100
Information about treatments	184	65.69	21.93	66.67	100	53.33	80
Information about other services	184	47.16	27.06	41.67	100	25	66.67
Information about different places of care	174	51.34	32.18	66.67	100	33.33	66.67
Information about things you can do to help yourself get well	179	59.59	30.39	66.67	100	33.33	66.67
Written information	181	64.64	47.94	100	100	0	100
Recorded information	175	28.57	45.31	0	100	0	100
Satisfaction with the information received	179	71.51	24.76	66.67	100	66.67	100
Wish to receive more information	180	54.44	49.94	100	100	0	100
Wish to have received less information	170	12.94	33.66	0	100	0	0
Overall the information has been helpful	146	75.57	23.91	66.67	100	66.67	100

SD - standard deviation, Q1 - lower quartile, Q3 - upper quartile

Table 3

IN-PATSAT32 module descriptive statistic
Parameter	N	Mean	SD	Median	Min	Max	Q1	Q3
Doctors’ technical skills	184	79.62	18.39	75	0	100	72.92	100
Doctors’ interpersonal skills	183	75.71	21.55	75	0	100	66.67	100
Doctors’ information provision	181	78.15	19.56	75	0	100	75	100
Doctors’ availability	182	74.59	21.26	75	0	100	62.5	100
Nurses’ technical skills	183	82.74	16.74	83.33	33.33	100	75	100
Nurses’ interpersonal skills	184	79.48	18.31	75	25	100	66.67	100
Nurses’ information provision	183	75.36	18.94	75	25	100	66.67	91.67
Nurses’ availability	182	80.98	18.29	75	12.5	100	75	100
Information exchange	179	73.74	20.06	75	25	100	50	100
Other hospital staff members’ interpersonal skills	183	76.94	18.08	75	25	100	66.67	91.67
Waiting times	182	70.19	22.7	75	0	100	50	87.5
Hospital access	180	57.92	24.57	50	0	100	37.5	75
Hospital comfort	181	68.51	22.42	75	0	100	50	75
Overall satisfaction	182	81.73	17.8	75	25	100	75	100

SD - standard deviation, Q1 - lower quartile, Q3 - upper quartile

Multi-trait scaling analysis

Multi-trait scaling analyses for QLQ-INFO25 and IN-PATSAT32 modules are presented in Tables 4 and 5.

Table 4

QLQ-INFO25 Multi-trait scaling analysis
Item	Information about the disease	Information about medical tests	Information about treatments	Information about other services
31	0,67	0,69	0,62	0,45
32	0,69	0,64	0,56	0,33
33	0,54	0,42	0,47	0,44
34	0,69	0,59	0,54	0,42
35	0,60	0,67	0,61	0,39
36	0,59	0,76	0,69	0,41
37	0,58	0,67	0,61	0,37
38	0,54	0,76	0,64	0,41
39	0,63	0,63	0,65	0,51
40	0,51	0,62	0,60	0,33
41	0,60	0,69	0,77	0,54
42	0,55	0,55	0,72	0,57
43	0,35	0,34	0,53	0,56
44	0,40	0,35	0,47	0,72
45	0,35	0,31	0,47	0,72
46	0,58	0,62	0,66	0,52
47	0,35	0,31	0,51	0,58

Table 5

IN-PATSAT32 Multi-trait scaling analysis
Item	Doctors’ technical skills	Doctors’ interpersonal skills	Doctors’ information provision	Doctors’ availability	Nurses’technical skills	Nurses’ interpersonal skills	Nurses’ information provision	Nurses’ availability	Other hospital staff members’ interpersonal skills	Waiting times	Hospital access
31	0,82	0,72	0,74	0,69	0,72	0,69	0,65	0,65	0,62	0,62	0,41
32	0,85	0,72	0,76	0,71	0,72	0,72	0,64	0,64	0,63	0,66	0,41
33	0,69	0,80	0,73	0,77	0,69	0,71	0,67	0,65	0,72	0,66	0,43
34	0,79	0,86	0,76	0,77	0,68	0,73	0,70	0,63	0,76	0,70	0,47
35	0,83	0,89	0,80	0,80	0,69	0,77	0,71	0,66	0,78	0,73	0,45
36	0,73	0,86	0,78	0,72	0,62	0,72	0,69	0,59	0,72	0,69	0,46
37	0,74	0,79	0,85	0,71	0,65	0,65	0,67	0,53	0,69	0,66	0,49
38	0,77	0,80	0,89	0,74	0,71	0,73	0,70	0,62	0,69	0,70	0,52
39	0,75	0,76	0,87	0,76	0,65	0,68	0,71	0,60	0,73	0,70	0,55
40	0,76	0,78	0,72	0,83	0,66	0,68	0,66	0,65	0,71	0,70	0,51
41	0,77	0,78	0,77	0,83	0,69	0,70	0,70	0,68	0,77	0,72	0,59
42	0,75	0,65	0,65	0,66	0,87	0,81	0,70	0,73	0,68	0,62	0,39
43	0,70	0,61	0,65	0,63	0,85	0,76	0,69	0,69	0,63	0,59	0,39
44	0,69	0,67	0,67	0,63	0,80	0,84	0,77	0,72	0,68	0,64	0,52
45	0,76	0,74	0,72	0,68	0,83	0,83	0,74	0,76	0,77	0,69	0,49
46	0,68	0,72	0,65	0,64	0,79	0,80	0,74	0,70	0,70	0,69	0,43
47	0,62	0,61	0,56	0,54	0,72	0,65	0,70	0,72	0,65	0,52	0,41
48	0,64	0,67	0,68	0,65	0,75	0,76	0,85	0,70	0,73	0,63	0,51
49	0,69	0,67	0,65	0,64	0,75	0,78	0,85	0,71	0,69	0,65	0,47
50	0,68	0,74	0,71	0,70	0,70	0,75	0,87	0,70	0,77	0,64	0,52
51	0,59	0,52	0,53	0,57	0,69	0,69	0,65	0,74	0,62	0,54	0,42
52	0,71	0,69	0,61	0,70	0,74	0,80	0,76	0,74	0,73	0,63	0,47
54	0,68	0,74	0,68	0,68	0,68	0,75	0,75	0,68	0,83	0,70	0,47
55	0,70	0,78	0,68	0,75	0,67	0,76	0,72	0,69	0,84	0,72	0,54
56	0,63	0,69	0,65	0,70	0,63	0,68	0,68	0,65	0,81	0,67	0,51
57	0,69	0,73	0,70	0,72	0,66	0,70	0,69	0,63	0,75	0,86	0,59
58	0,69	0,72	0,70	0,70	0,66	0,69	0,64	0,62	0,71	0,86	0,58
59	0,41	0,45	0,52	0,51	0,43	0,43	0,48	0,37	0,46	0,52	0,71
60	0,46	0,49	0,55	0,57	0,47	0,51	0,55	0,52	0,60	0,63	0,71

Convergent validity

Convergent validity for QLQ-INFO25 and IN-PATSAT32 modules are presented in Table 6.

Table 6

QLQ-INFO25 and IN-PATSAT32 convergent validity
QLQ-INFO25	IN-PATSAT32	r	p
Information about the disease	The information doctors gave you about your illness	0.595	p < 0.001
Information about the disease	The information other hospital personnel provided on your admission	0.438	p < 0.001
Information about medical tests	The information doctors gave you about your medical tests	0.575	p < 0.001
Information about medical tests	The information nurses gave about your medical tests	0.52	p < 0.001
Information about medical tests	The information other hospital personnel provided on your admission to the hospital	0.509	p < 0.001
Information about treatments	The information doctors gave you about your treatment	0.554	p < 0.001
Information about treatments	The information nurses gave you about your treatment	0.546	p < 0.001
Information about other services	The information other hospital personnel provided on your discharge from the hospital	0.344	p < 0.001
Information about things you can do to help yourself get well from the hospital	The information other hospital personnel provided on your discharge from the hospital	0.345	p < 0.001
Satisfaction with the information received	Doctors’ information provision	0.607	p < 0.001
Satisfaction with the information received	Nurses’ information provision	0.546	p < 0.001
Satisfaction with the information received	Other hospital staff members’ interpersonal skills	0.436	p < 0.001
r - correlation coefficient

Divergent validity

Divergent validity for QLQ-INFO25 and IN-PATSAT32 modules are presented in Tables 7 and 8.

Table 7

QLQ-INFO25 module divergent validity
	Global health status	Physical functioning	Role functioning	Emotional functioning	Cognitive functioning	Social functioning	Fatigue	Nausea and vomiting	Pain	Dyspnoea	Insomnia	Appetite loss	Constipation	Diarrhoea	Financial difficulties
Information about the disease	r = 0.119, p = 0.108	r=-0.096, p = 0.198	r=-0.033, p = 0.657	r = 0.015, p = 0.837	r = 0.114, p = 0.124	r = 0.138, p = 0.063	r = 0.056, p = 0.448	r = 0.131, p = 0.078	r = 0.071, p = 0.337	r = 0.188, p = 0.011 *	r=-0.015, p = 0.843	r = 0.03, p = 0.685	r=-0.083, p = 0.263	r = 0.161, p = 0.03 *	r = 0.03, p = 0.687
Information about medical tests	r = 0.212, p = 0.004 *	r=-0.083, p = 0.269	r = 0.014, p = 0.854	r = 0.064, p = 0.393	r = 0.056, p = 0.457	r = 0.115, p = 0.125	r = 0.003, p = 0.97	r = 0.085, p = 0.253	r = 0, p = 0.997	r = 0.109, p = 0.144	r=-0.007, p = 0.924	r=-0.008, p = 0.914	r=-0.089, p = 0.233	r = 0.112, p = 0.135	r=-0.059, p = 0.432
Information about treatments	r = 0.172, p = 0.02 *	r = 0.027, p = 0.718	r = 0.073, p = 0.323	r = 0.079, p = 0.287	r = 0.117, p = 0.115	r = 0.12, p = 0.107	r=-0.063, p = 0.396	r = 0.017, p = 0.823	r=-0.011, p = 0.879	r = 0.045, p = 0.55	r=-0.026, p = 0.73	r = 0.001, p = 0.987	r=-0.104, p = 0.164	r = 0.141, p = 0.058	r=-0.034, p = 0.652
Information about other services	r=-0.012, p = 0.874	r=-0.093, p = 0.211	r=-0.042, p = 0.574	r = 0.02, p = 0.791	r = 0.01, p = 0.892	r = 0.056, p = 0.455	r = 0.017, p = 0.821	r = 0.036, p = 0.629	r = 0.071, p = 0.34	r = 0.058, p = 0.439	r=-0.002, p = 0.984	r = 0.023, p = 0.755	r=-0.133, p = 0.072	r = 0.139, p = 0.061	r = 0.042, p = 0.577
Information about different places of care	r = 0.007, p = 0.927	r=-0.145, p = 0.056	r=-0.087, p = 0.255	r = 0.006, p = 0.942	r=-0.017, p = 0.828	r=-0.047, p = 0.539	r = 0.112, p = 0.143	r = 0.042, p = 0.585	r = 0.129, p = 0.089	r = 0.145, p = 0.057	r = 0.074, p = 0.332	r = 0.05, p = 0.515	r=-0.139, p = 0.07	r = 0.185, p = 0.015 *	r = 0.092, p = 0.228
Information about things you can do to	r = 0.101, p = 0.18	r=-0.046, p = 0.542	r = 0.003, p = 0.973	r = 0.13, p = 0.083	r = 0.128, p = 0.088	r = 0.102, p = 0.174	r=-0.062, p = 0.408	r = 0.051, p = 0.495	r = 0.08, p = 0.288	r = 0.066, p = 0.385	r=-0.018, p = 0.809	r=-0.077, p = 0.311	r=-0.129, p = 0.088	r = 0.122, p = 0.103	r = 0.102, p = 0.176
Written information	r = 0.08, p = 0.287	r=-0.069, p = 0.357	r = 0.051, p = 0.492	r=-0.078, p = 0.297	r=-0.064, p = 0.396	r = 0.047, p = 0.532	r=-0.093, p = 0.213	r = 0.015, p = 0.844	r = 0.022, p = 0.77	r = 0.042, p = 0.576	r=-0.044, p = 0.564	r=-0.013, p = 0.861	r = 0.073, p = 0.333	r=-0.094, p = 0.209	r=-0.058, p = 0.442
Recorded information	r = 0.221, p = 0.003 *	r=-0.109, p = 0.15	r=-0.003, p = 0.971	r=-0.047, p = 0.539	r=-0.084, p = 0.273	r = 0.084, p = 0.271	r=-0.054, p = 0.477	r = 0.053, p = 0.488	r = 0.063, p = 0.406	r = 0.156, p = 0.039 *	r = 0.076, p = 0.32	r=-0.101, p = 0.184	r=-0.008, p = 0.922	r = 0.061, p = 0.423	r=-0.012, p = 0.871
Satisfaction with the information received	r = 0.185, p = 0.014 *	r=-0.041, p = 0.587	r=-0.035, p = 0.642	r = 0.05, p = 0.505	r = 0.081, p = 0.287	r = 0.116, p = 0.125	r = 0.021, p = 0.782	r = 0.093, p = 0.218	r = 0.037, p = 0.626	r = 0.059, p = 0.431	r=-0.061, p = 0.421	r=-0.089, p = 0.239	r=-0.064, p = 0.399	r = 0.15, p = 0.046 *	r = 0.021, p = 0.778
Wish to receive more information	r=-0.097, p = 0.196	r = 0.002, p = 0.981	r = 0.047, p = 0.533	r=-0.158, p = 0.034 *	r=-0.111, p = 0.141	r=-0.068, p = 0.37	r = 0.021, p = 0.782	r=-0.048, p = 0.522	r=-0.03, p = 0.69	r = 0.038, p = 0.617	r = 0.169, p = 0.024 *	r = 0.007, p = 0.925	r = 0.1, p = 0.184	r=-0.053, p = 0.484	r = 0.067, p = 0.378
Wish to have received less information	r = 0.157, p = 0.041 *	r = 0.054, p = 0.487	r = 0.035, p = 0.648	r = 0.038, p = 0.623	r = 0.07, p = 0.369	r=-0.024, p = 0.761	r=-0.097, p = 0.207	r=-0.115, p = 0.138	r=-0.225, p = 0.003 *	r=-0.036, p = 0.642	r = 0.111, p = 0.153	r = 0.034, p = 0.666	r=-0.098, p = 0.203	r=-0.077, p = 0.319	r=-0.064, p = 0.411
Overall the information has been helpful	r = 0.073, p = 0.383	r = 0.011, p = 0.893	r=-0.041, p = 0.627	r=-0.022, p = 0.796	r = 0.034, p = 0.684	r = 0.037, p = 0.661	r = 0.05, p = 0.553	r=-0.028, p = 0.735	r=-0.044, p = 0.602	r = 0.014, p = 0.869	r=-0.085, p = 0.309	r=-0.124, p = 0.136	r = 0.012, p = 0.883	r = 0.089, p = 0.288	r=-0.084, p = 0.317
*statistically relevant results

Table 8

IN-PATSAT32 module divergent validity
	Global health status	Physical functioning	Role functioning	Emotional functioning	Cognitive functioning	Social functioning	Fatigue	Nausea and vomiting	Pain	Dyspnoea	Insomnia	Appetite loss	Constipation	Diarrhoea	Financial difficulties
Doctors’ technical skills	r = 0.137, p = 0.064	r=-0.075, p = 0.315	r=-0.004, p = 0.96	r = 0.02, p = 0.792	r = 0.107, p = 0.151	r = 0.115, p = 0.123	r = 0.06, p = 0.416	r = 0.004, p = 0.956	r=-0.033, p = 0.653	r = 0.13, p = 0.079	r=-0.021, p = 0.782	r=-0.096, p = 0.199	r = 0, p = 0.998	r = 0.175, p = 0.018 *	r=-0.056, p = 0.455
Doctors’ interpersonal skills	r = 0.153, p = 0.04 *	r = 0.016, p = 0.829	r = 0.063, p = 0.399	r = 0.109, p = 0.142	r = 0.15, p = 0.044 *	r = 0.171, p = 0.021 *	r=-0.012, p = 0.869	r=-0.027, p = 0.714	r=-0.093, p = 0.213	r=-0.001, p = 0.986	r=-0.012, p = 0.87	r=-0.071, p = 0.343	r=-0.104, p = 0.163	r = 0.198, p = 0.007 *	r=-0.1, p = 0.18
Doctors’ information provision	r = 0.164, p = 0.028 *	r=-0.025, p = 0.735	r = 0.062, p = 0.405	r = 0.07, p = 0.349	r = 0.141, p = 0.06	r = 0.158, p = 0.034 *	r = 0.022, p = 0.77	r = 0.023, p = 0.763	r=-0.012, p = 0.871	r = 0.135, p = 0.072	r=-0.062, p = 0.41	r=-0.061, p = 0.416	r=-0.032, p = 0.667	r = 0.141, p = 0.061	r=-0.108, p = 0.15
Doctors’ availability	r = 0.114, p = 0.128	r=-0.007, p = 0.927	r = 0.076, p = 0.309	r = 0.085, p = 0.251	r = 0.155, p = 0.038 *	r = 0.125, p = 0.094	r = 0.003, p = 0.966	r = 0.064, p = 0.396	r=-0.027, p = 0.72	r = 0.101, p = 0.177	r=-0.065, p = 0.39	r=-0.087, p = 0.246	r = 0.017, p = 0.817	r = 0.159, p = 0.033 *	r=-0.115, p = 0.126
Nurses’ technical skills	r = 0.17, p = 0.022 *	r = 0.01, p = 0.893	r = 0.054, p = 0.465	r = 0.065, p = 0.382	r = 0.153, p = 0.039 *	r = 0.177, p = 0.017 *	r=-0.028, p = 0.711	r=-0.051, p = 0.499	r=-0.078, p = 0.295	r = 0.013, p = 0.857	r=-0.104, p = 0.165	r=-0.132, p = 0.076	r=-0.037, p = 0.619	r = 0.128, p = 0.085	r=-0.08, p = 0.288
Nurses’ interpersonal skills	r = 0.141, p = 0.058	r = 0.003, p = 0.963	r = 0.071, p = 0.335	r = 0.082, p = 0.27	r = 0.127, p = 0.088	r = 0.193, p = 0.009 *	r = 0.001, p = 0.994	r=-0.016, p = 0.83	r=-0.068, p = 0.363	r = 0.051, p = 0.492	r=-0.063, p = 0.401	r=-0.087, p = 0.243	r=-0.116, p = 0.119	r = 0.177, p = 0.017 *	r=-0.09, p = 0.229
Nurses’ information provision	r = 0.191, p = 0.01 *	r=-0.016, p = 0.829	r = 0.006, p = 0.937	r = 0.079, p = 0.29	r = 0.118, p = 0.112	r = 0.214, p = 0.004 *	r = 0.017, p = 0.816	r = 0.015, p = 0.843	r=-0.056, p = 0.456	r = 0.06, p = 0.421	r=-0.069, p = 0.354	r=-0.072, p = 0.334	r=-0.119, p = 0.11	r = 0.102, p = 0.172	r=-0.071, p = 0.347
Nurses’ availability	r = 0.081, p = 0.282	r=-0.01, p = 0.897	r = 0.035, p = 0.641	r = 0.011, p = 0.879	r = 0.087, p = 0.244	r = 0.105, p = 0.161	r = 0.006, p = 0.938	r = 0.047, p = 0.534	r=-0.039, p = 0.606	r = 0.064, p = 0.389	r=-0.044, p = 0.559	r=-0.068, p = 0.36	r=-0.042, p = 0.575	r = 0.159, p = 0.033 *	r=-0.047, p = 0.532
Information exchange	r = 0.173, p = 0.021 *	r = 0.073, p = 0.336	r = 0.132, p = 0.079	r = 0.115, p = 0.126	r = 0.184, p = 0.013 *	r = 0.147, p = 0.05	r=-0.092, p = 0.223	r=-0.071, p = 0.346	r=-0.117, p = 0.118	r=-0.045, p = 0.549	r=-0.065, p = 0.393	r=-0.129, p = 0.087	r=-0.116, p = 0.125	r = 0.095, p = 0.208	r=-0.103, p = 0.172
Other hospital staff members’ interpersonal skills	r = 0.149, p = 0.045 *	r = 0.015, p = 0.845	r = 0.077, p = 0.303	r = 0.107, p = 0.148	r = 0.142, p = 0.056	r = 0.196, p = 0.008 *	r=-0.056, p = 0.453	r = 0.034, p = 0.644	r=-0.083, p = 0.268	r = 0.018, p = 0.812	r=-0.049, p = 0.514	r=-0.077, p = 0.302	r=-0.104, p = 0.164	r = 0.153, p = 0.04 *	r=-0.1, p = 0.181
Waiting times	r = 0.18, p = 0.016 *	r = 0.045, p = 0.551	r = 0.049, p = 0.508	r = 0.125, p = 0.092	r = 0.166, p = 0.025 *	r = 0.187, p = 0.012 *	r=-0.061, p = 0.415	r = 0.008, p = 0.918	r=-0.061, p = 0.417	r = 0.061, p = 0.415	r=-0.071, p = 0.341	r=-0.131, p = 0.078	r=-0.13, p = 0.082	r = 0.133, p = 0.076	r=-0.103, p = 0.172
Hospital access	r = 0.121, p = 0.108	r=-0.027, p = 0.717	r=-0.003, p = 0.963	r=-0.066, p = 0.381	r = 0.034, p = 0.647	r = 0.106, p = 0.157	r = 0.009, p = 0.902	r = 0.111, p = 0.141	r = 0.083, p = 0.266	r = 0.115, p = 0.125	r=-0.034, p = 0.653	r=-0.047, p = 0.532	r = 0.053, p = 0.479	r = 0.143, p = 0.057	r=-0.123, p = 0.103
Hospital comfort	r = 0.185, p = 0.013 *	r=-0.04, p = 0.59	r = 0.103, p = 0.169	r = 0.095, p = 0.202	r = 0.174, p = 0.02 *	r = 0.176, p = 0.018 *	r=-0.053, p = 0.482	r = 0.036, p = 0.634	r=-0.055, p = 0.459	r = 0.17, p = 0.022 *	r=-0.09, p = 0.231	r=-0.102, p = 0.172	r=-0.109, p = 0.145	r = 0.103, p = 0.172	r=-0.12, p = 0.11
Overall satisfaction	r = 0.134, p = 0.073	r=-0.016, p = 0.834	r = 0.102, p = 0.169	r = 0.026, p = 0.73	r = 0.124, p = 0.097	r = 0.132, p = 0.077	r = 0.005, p = 0.952	r = 0.005, p = 0.95	r=-0.015, p = 0.84	r = 0.005, p = 0.949	r=-0.078, p = 0.296	r=-0.059, p = 0.433	r=-0.078, p = 0.296	r = 0.136, p = 0.07	r=-0.041, p = 0.59
*statistically relevant results

Internal consistency reliability

Internal consistency reliability for QLQ-INFO25 and IN-PATSAT32 modules is presented in Tables 9 and 10.

Table 9

QLQ-INFO25 internal consistency reliability
Scale	Cronbach's alpha
Information about the disease	0,828
Information about medical tests	0,833
Information about treatments	0,850
Information about other services	0,831

Table 10

IN-PATSAT32 internal consistency reliability
Scale	Cronbach's alpha
Doctors’ technical skills	0,891
Doctors’ interpersonal skills	0,940
Doctors’ information provision	0,937
Doctors’ availability	0,871
Nurses’ technical skills	0,923
Nurses’ interpersonal skills	0,873
Nurses’ information provision	0,932
Nurses’ availability	0,874
Other hospital staff members’ interpersonal skills	0,922
Waiting times	0,910
Hospital access	0,817

Test-retest reliability

ICC was used for test–retest evaluation. For the QLQ-INFO25 ICC ranged from 0.76 to 0.92 and for the IN-PATSAT32 from 0.80 to 0.91. All scales in both modules’ demonstrated ‘good’ reliability [31, 32].

Our study describes the psychometric validation process for EORTC modules: QLQ-INFO25 and IN-PATSAT32 together with the core EORTC HRQoL questionnaire for Polish population. We have previously published data for tools’ translation, pilot testing and preliminary validation [23, 28, 29].

Patients’ socioclinical characteristics (Table 1) reveal that different groups of patients are represented in the study, including these treated radically as well as palliative patients with various types of malignances. Completion rate for the questionnaires was high (98.4%). The response rate for particular questions ranged from 78–98.4%. for QLQ-INFO25 and from 94.7–98.4% for IN-PATSAT32. The completion rate along with lack of similar studies in Polish oncology is what makes this study scientifically relevant. Even though the mean overall satisfaction in both questionnaires is good (75.57 and 81.73 respectively), the results prove that there is still room for improvement. More information should be provided to patients about other services, self-help and different care providers. Another problem, especially relevant in Polish healthcare, is the access to hospitals and the conditions in them.

Descriptive statistics (Tables 2 and 3) show good modules’ sensitivity with high variability of the distribution of results.

Multi-trait scaling as well as internal consistency analyses for QLQ-INFO25 and IN-PATSAT32 modules (Tables 4 and 5) confirmed high correlation between items and their sub-scales and high level of internal consistency. The discriminant validity in both questionnaires was also satisfactory. That generally confirms the results obtained for the international study and follows data for Iranian and Spanish version for QLQ-INFO25 [24, 33, 34]. The high correlation between some items with scales other than their own (i.e. items 31, 38, 40 and 43 for QLQ-INFO25) argues in favor of using a global score the same as in Spanish study [34]. Items 33 (The attention doctors paid to physical problems) and 44 (The attention nurses paid to physical problems) for IN-PATSAT32 correlated stronger with doctors/nurses interpersonal skills than their technical skills. That can be partially explained as in Poland communication between patient and healthcare professionals, obtaining patient’s perspective and other technical skills related to medical interview have quite a short history of their presence in medical schools curricula [35, 36].

Convergent validity was high and the same was seen for divergent validity of both modules. All correlations between (theoretically) similar areas of both questionnaires are statistically significant (p < 0.001) and 10 out of 12 of them are strong (r > 0.4) (Table 6) as was seen in the original EORTC study [24, 34]. Week correlations (r < 0.3) shown in Tables 7 and 8 confirm that neither QLQ-INFO25 nor IN-PATSAT32 repeat information collected by core QLQ-C30 module. Also previous studies validating this questionnaire for other populations claimed that all these tools measure different concepts [24, 33, 34].

Internal consistency reliability for QLQ-INFO25 and IN-PATSAT32 (Tables 9 and 10) showed Cronbach’s alpha coefficients for each domain ≥ 0.7. That means the tools can be used to compare various groups. The test-retest reliability for both modules was good as it was in other studies [24, 33, 34].

There is little research on quality of communication in Central and Eastern European countries [23] and Polish cancer patient’s perspective, even though the demand has been many times articulated [37–39]. Indeed, professional contact with oncological patients can be a difficult task. Even more difficult due to insufficient amount of training programs and unfamiliarity with patients’ needs in post-communist populations [23, 40]. With the upcoming creation of National Oncological Network, passed by the Polish government in March 2023, the issue of patients’ perspective seems to be finally acknowledged. According to this law, patient’s satisfaction will be regularly assessed during their oncological treatment [41].

In Poland, the greatest authority to the patient is a doctor, and it is an oncologist who is the source of information for cancer patients [42]. Traditionally the family was informed, even when it meant keeping the patient out of the conversation [43, 44]. On the other hand presenting too optimistic scenarios or concealing some unpleasant aspects of the illness, while convincing oneself that it is for the good of the patient, had been practiced until not long ago [44]. However, it is nowadays known that such communication with patients does not satisfy their needs for information [6, 45, 46]. Available data show that physicians pass information basing on their subjective criteria influenced by culture and personal experience. Some justify this with a generation gap between the elderly, who lived in communist country with limited access to information, and the younger generation, who expects the information to be delivered properly [43]. Yet, this hypothesis has not been properly researched. Bearing all that in mind, it does not come as a surprise that patients from Poland are less willing than those from France or Germany to be included in their treatment process [28]. However, it is mostly attributable to incorrect assessment of the patients’ needs and shortcomings in the training of health professionals [10, 47]. After all, studies show that only 28% of medical students and 24% of internal medicine practitioners in Poland feel capable of informing a patient about an oncological diagnosis [48]. As a result, communication difficulties, which cannot be avoided, are considered by physicians personal and professional failures [2, 20, 49].

Available research on patient-healthcare provider communication remains inconclusive and delivers only partial knowledge on the needs of patients at this difficult time [14]. The few conducted studies on this topic prove that not only the healthcare workers, but also growing percentage of population notices the need to properly convey information to the patient [44]. What makes the learning process more challenging, is that patients tend to misunderstand information given to them [47], partially because of their defense mechanisms, such as denial, or the accompanying stress. Studies also suggest that patients experiencing health deterioration during treatment tend to be less interested in the decision-making process and that the need for information does not depend on the diagnosis [18, 19]. In addition to that there is no distinction between palliative patients or those radically treated as well as between treatment in out- and inpatient clinics [9, 50]. Some mention, that woman with breast cancer prefer a more passive role in their choice of treatment [18], but then again studies show, that woman want to receive more information about their illness than men [51]. Others argue that patients with hematological illnesses are better informed and more aware of their condition [52]. The most common approach is adjusting information given to patients according to age and level of education [13, 14]. All in all, modern sources propose division of patients into groups depending on their urge for information and addressing those needs in further healthcare provider-patient communication [14].

Study limitations

Our study has few limitations. (1) That is a single center study; (2) more than half of the patients had diagnosis of colorectal or breast patients, while the most common cancer worldwide, lung cancer, was underrepresented; nevertheless it is a validation study and there is sufficient variety of tumors included, such as melanoma, sarcoma, brain cancer which comprised almost 15% of all tumors; (3) the cross-sectional design of the study did not allow to show tools’ responsiveness to changes as was shown in the original study [24], (4) test-retest was performer on a minimal group of 30 participants, however the results allow to consider good test-retest reliability.

Results obtained for Polish patients population confirm acceptable psychometric properties for the EORTC QLQ-INFO25 information and IN-PATSAT32 satisfaction modules. Both QLQ-INFO25 and IN-PATSAT32 modules are valid and reliable tools which ought to be used among Polish oncological patients, not only in research, but also in everyday clinical practice, so as to learn more about patients’ expectations and improve on communication skills of healthcare professionals. Reaching for such tools is of extreme importance, while the discussion on proper patient-healthcare professional communication is still in its early stages and results of such questionnaires can have a great impact on changes in approach to patients. It is the first published psychometric validation study of the IN-PATSAT32 and QLQ-INFO25 in an Eastern and Central European population.

EORTC - the European Organization for Research and Treatment of Cancer

SD - standard deviation

CI - confidence interval

ICC - interclass correlations

Q1 – lower quartile

Q3 – upper quartile

Ethics approval and consent to participate

This study was approved by the Jagiellonian University Collegium Medicum Bioethics Committee (registry KBET/253/B/2011). Informed consent was obtained from all the participants. The study followed the Declaration of Helsinki with its amendments.

Consent for publication

Not applicable.

Availability of data and materials

All data generated or analysed during this study are included in this published article.

Competing interests

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Authors' contributions

Agnieszka Rudzińska: Writing – original draft, Investigation, Formal Analysis, Data Curation; Patryk Kukla: Writing – original draft, Formal Analysis, Data Curation, Software; Visualisation; Aneta L. Zygulska: Methodology, Investigation, Resources, Supervision; Aleksandra Grela-Wojewoda: Writing – review & editing; Renata Pacholczak-Madej: Writing – review & editing. Supervision; Małgorzata Gaweł: Project administration, Data Curation; Beata Zuchowska-Vogelgesang: Writing – review & editing, Supervision; Anna Streb-Smolen: Investigation, Software; Anna Mucha-Małecka: Writing – review & editing; Iwona M. Tomaszewska: Conceptualization, Investigation, Supervision; Marek Ziobro: Supervision; Mirosława Püsküllüoğlu: Conceptualization, Methodology, Formal analysis, Investigation, Data curation, Writing – review & editing, Supervision.

Acknowledgements

Not applicable.

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No competing interests reported.

Validation of the EORTC information (QLQ-INFO25) and satisfaction with care (IN-PATSAT32) modules in Polish cancer patients’ population

Status:

Version 1

Abstract

Background

Methods

Ethical consent

Study tools

Translation of study tools and pilot testing

Study participants

Interview procedure

Statistical analysis

Results

Participant characteristics

Descriptive statistics

Multi-trait scaling analysis

Convergent validity

Divergent validity

Internal consistency reliability

Test-retest reliability

Discussion

Study limitations

Conclusions

Abbreviations

Declarations

References

Additional Declarations

Status:

Version 1