Rationale: Most cancer patients require a totally-implanted Central Venous Catheter (CVC) for their treatment. We develop and validate a French-language questionnaire dubbed QASICC (Questionnaire for Acceptance of and Satisfaction with Implanted Central Venous Catheter) assessing patient satisfaction with and acceptance of their CVC. Method: The construction and first validation of the questionnaire was made using validated methodology consisting in four phases. Phase 1 aimed at collecting a comprehensive list of relevant items. Phase 2 consisted in converting items into questions followed by a first item selection procedure. Phase 3 tested the acceptance of the provisional module to a small number of patients. Phase 4 involved a first validation on patients to determine its psychometric characteristics. Results: Responses to the questionnaire were collected from 215 patients. The final tool included 27 questions assessing seven dimensions: pain, contribution to the comfort of the treatment, esthetics and privacy, impact on professional activities, social and sports, impact on daily activities, local discomfort and overall satisfaction.Conclusions: This first statistical validation seems very promising and allows us to confirm the structure and the psychometric properties of the tool. Further validation studies are required on standard and specific populations in order to confirm these first results.
Patient satisfaction with or acceptance of care assessment is increasingly taken into account in oncology. Most cancer and other critically-ill patients require a totally-implanted Central Venous Catheter (CVC) for their treatment consisting of a reservoir connected to a central venous catheter, which may or may not be valved. It is impossible to estimate the number of CVC used in oncology. However, some authors claim that, in 2005, over 7 million CVCs were placed in the United States [
The questionnaire construction and first validation process followed both the guidelines of the European Organization Research [
Firstly, the SC reviewed the literature to identify relevant existing instruments or items assessing the impact of CVC on patients’ daily life, as well as acceptance, quality of life and other relevant items. We set up a Focus Group (FG) of 15 persons including a broad range of health care and non-health care workers (2 nurses, 2 nurses’ aides, 1 medical oncologist, 1 radiologist, 1 surgeon, 1 methodologist, 1 communication manager, 1 quality man- ager, 1 psychologist) and 4 patients. The FG met 3 times and was interviewed in order to complete the list with additional questions of potential interest. This process yielded 47 relevant items altogether. Secondly, twenty consecutive patients were interviewed by members of the SC to analyze their perception and acceptance of their CVC. Patients were enrolled during their hospitalization for treatment, or in the event of adverse events related to their CVC. As we were more interested in the subjects’ perception of their CVC and its impact on their everyday life, these interviews were conducted one month after CVC placement. This period was sufficient for most patients to have experienced the CVC’s pros and cons and short enough to allow them to remember their life before CVC placement. Subjects were asked to detail specific events they had experienced or situations associated with healthcare and pleasant and unpleasant feelings related to their CVC. The interviews were conducted in chronological order of CVC placement, use and management. Patients expressing ideas not directly related to the CVC were invited to refocus on the questions. Each patient was then examined by the physician and could express other feelings related to their CVC. All the different formulations of a given idea were recorded and a second list of items was generated from their statements during a SC meeting. All these new items were worded by seeking maximum respect for the idea expressed by the patient. This yielded 55 additional items.
The final list of 102 items was then converted into questions. The SC transformed the items into precise, intuitive, understandable and unbiased sentences in French. Each item was scored on a Likert-type scale, a yes/no checkbox or an Analogic Visual Scale from 0 to 10. The questionnaire comprising 102 items was sent to a group of 30 experts representing a broad cultural mix of professional backgrounds and regions of France. The experts included physicians, radiologists, surgeons, nurses, epidemiologists and patients who were selected for their knowledge of and interest in the CVC or in cancer treatment, for their reputation, number of publications, and their experience in the field. This group was invited to provide feedback on the first survey content using the Delphi method [
This 62-item questionnaire was sent to the National League Against Cancer for review. This French nonprofit association is recognized as being of public interest as the first private and independent funder of cancer research in France. They checked acceptability, interest, wording and exhaustiveness of the item list. Then, the provisional module was tested on 20 patients representative of the target population. This was followed by structured interviews with each patient after completion of the questionnaire. This pilot study was conducted to check the comprehensibility, acceptability and response patterns. The list of 62 items extracted from this qualitative phase and the response modalities are shown in
. Results of the quantitative step of QASICC validation (items, results from factorial analysis, dimensions)
Item | Questions (standard response) | Floor-ceiling effect | Missing data | Factorial analysis | QASICC final | Factor | ||||
---|---|---|---|---|---|---|---|---|---|---|
No. | No. (%) | No. (%) | Fact. 1 | Fact. 2 | Fact. 3 | Fact. 4 | Fact. 5 | No. final | (Dimension) | |
1 | Is your device too visible? (b) | 56 (37.0) - 97 (63.0) | 62 (28.8) | 0.37 | Q11 | 1 | ||||
2 | Did it hurt when the device is inserted? (f) | [0-0.2-1.0-3.2-10]* | 71 (33.0) | Q1 | 6 | |||||
3 | Does your device hurt when the needle is inserted? (e) | 3 (1.9) - 88 (56.0) | 58 (27.0) | Q2 (G: 3, 4, 5) | 6 | |||||
4 | Does your device hurt during the drug infusion? (e) | 0 (0.0) - 131 (89.7) | 69 (32.1) | Q2 (G: 3, 4, 5) | 6 | |||||
5 | Does your device hurt when the needle is removed? (e) | 2 (1.4) - 112 (76.7) | 69 (32.1) | Q2 (G: 3, 4, 5) | 6 | |||||
6 | Does your device produce a feeling of: pulsing? (e) | 2 (1.4) - 105 (74.4) | 74 (34.4) | 0.90 | Q23 | 2 | ||||
7 | Penetration? (e) | 1 (0.7) - 117 (85.4) | 78 (36.3) | (R) | ||||||
8 | Stabbing? (e) | 3 (2.1) - 124 (89.8) | 77 (35.8) | (F/C) | ||||||
9 | Crushing? (e) | 1 (0.7) - 130 (94.8) | 78 (36.3) | (F/C) | ||||||
10 | Tugging? (e) | 2 (1.4) - 97 (71.3) | 79 (36.7) | 0.73 | Q24 | 2 | ||||
11 | Burning? (e) | 2 (1.4) - 122 (86.5) | 74 (34.4) | 0.78 | Q25 | 2 | ||||
12 | Pins and needles? (e) | 1 (0.7) - 117 (84.1) | 76 (35.3) | 0.72 | Q26 | 2 | ||||
13 | Heaviness? (e) | 2 (1.4) - 123 (89.1) | 77 (35.8) | (F/C) | ||||||
14 | Exhaustion? (e) | 1 (0.7) - 133 (96.3) | 77 (35.8) | (F/C) | ||||||
15 | Agony? (e) | 1 (0.7) - 118 (86.1) | 78 (36.3) | 0.52 | Q21 | 4 | ||||
16 | Obsessiveness? (e) | 1 (0.7) - 123 (89.1) | 77 (35.8) | (F/C) | ||||||
17 | Intolerableness? (e) | 0 (0.0) - 129 (94.8) | 79 (36.7) | (F/C) | ||||||
18 | Annoyance? (e) | 2 (1.4) - 114 (82.0) | 76 (35.3) | 0.76 | Q22 | 4 | ||||
19 | Troublesomeness? (e) | 1 (0.7) - 130 (95.5) | 79 (36.7) | (F/C) | ||||||
20 | Wretchedness? (e) | 3 (2.1) - 124 (89.8) | 77 (35.8) | (R) | ||||||
21 | Do you perceive your device as a foreign body? (c) | 57 (36.3) - 100(63.7) | 58 (27.0) | 0.60 | Q6 | 1 | ||||
22 | Physically. How easy is it for you to show your device for care? (d) | 0 (0.0) - 87 (55.0) | 57 (26.5) | 0.39 | Q5 (G: 22, 23) | 1 | ||||
23 | Psychologically. How easy is it for you to show your device for care? (d) | 1 (0.65) - 84 (54.2) | 60 (27.9) | 0.39 | Q5 (G: 22, 23) | 1 | ||||
24 | How easily do you feel the nurses manage to insert or remove the needle? (d) | 9 (5.8) - 147 (94.2) | 59 (27.4) | 0.44 | Q3 (G: 24, 44) | 5 | ||||
25 | Does your device causes you any trouble when you’re: Doing strenuous activities like carrying a heavy shopping bag or a suitcase? (e) | 12 (8.2) - 76 (52.1) | 69 (32.1) | 0.84 | Q14 (G: 25, 26, 27) | 3 | ||||
26 | Wearing a bag with a shoulder strap? (e) | 7 (5.1) - 83 (60.1) | 77 (35.8) | 0.84 | Q14 (G: 25, 26, 27) | 3 | ||||
27 | Wearing car seat belt? (e) | 12 (7.8) - 105 (68.6) | 62 (28.8) | 0.84 | Q14 (G: 25, 26, 27) | 3 | ||||
28 | Doing physical activities or sports? (e) | 7 (5.2) - 88 (65.7) | 81 (37.7) | 0.83 | Q20 | 3 | ||||
29 | Sitting at rest watching TV or reading? (e) | 2 (1.3) - 126 (81.8) | 61 (28.4) | 0.89 | Q16 (G: 29, 30) | 4 | ||||
30 | Sleeping? (e) | 3 (2.0) - 107 (70.4) | 63 (29.3) | 0.89 | Q16 (G: 29, 30) | 4 | ||||
31 | Does your device causes you any trouble when you’re: Engaged in social activities (shopping, going to movies, going out with friends…)? (e) | 0 (0.0) - 125 (87.4) | 72 (33.5) | 0.57 | Q18 (G: 31, 32) | 3 | ||||
32 | Engaged in professional activities? (e) | 5 (4.5) - 101 (90.2) | 103 (47.9) | 0.57 | Q18 (G: 31, 32) | 3 | ||||
33 | Concentrating on activities such as writing, reading a newspaper, …? (e) | 0 (0.0) - 138 (93.9) | 68 (31.6) | (F/C) | ||||||
34 | Speaking or eating in public? (e) | 1 (0.7) - 135 (93.8) | 71 (33.0) | (F/C) | ||||||
35 | When someone watching you or when someone talking to you? (e) | 1 (0.7) - 136 (89.5) | 63 (29.3) | (F/C) | ||||||
36 | Engaged in family life? (e) | 1 (0.7) - 142 (93.4) | 63 (29.3) | (F/C) |
Continued
Continued
37 | Engaged in intimacy with your spouse? (e) | 6 (4.2) - 109 (76.2) | 72 (33.5) | 0.72 | Q19 | 1 | ||||
---|---|---|---|---|---|---|---|---|---|---|
38 | For aesthetic reasons? (e) | 9 (0.1) - 98 (65.3) | 65 (30.2) | 0.80 | Q17 (G: 38, 41) | 1 | ||||
39 | Wearing a bra? (e) | 4 (3.1) - 100 (78.1) | 87 (40.5) | (R, M) | ||||||
40 | Dressing and undressing? (e) | 2 (1.4) - 113 (76.4) | 67 (31.2) | 0.47 | Q15 | 4 | ||||
41 | Looking at yourself in a mirror? (e) | 3 (2.0) - 112 (75.7) | 67 (31.2) | 0.89 | Q17 (G: 38, 41) | 1 | ||||
42 | Do you feel inferior to others? (e) | 2 (1.3) - 129 (0.9) | 65 (30.2) | (F/C) | ||||||
Advantages of your CVC | ||||||||||
43 | Does it spare your veins? (a) | 77 (49.7) - 78 (50.3) | 60 (27.9) | (O) | ||||||
44 | Does it facilitate the process for drug infusion? (b) | 88 (56.8) - 67 (43.2) | 60 (27.9) | 0.44 | Q3 (G: 24, 44) | 5 | ||||
45 | Bothers you when you do your local hygiene? (b) | 106 (68.4) - 49 (31.6) | 60 (27.9) | 0.65 | Q12 (G: 45, 47) | 5 | ||||
46 | Is it discrete? (b) | 122 (78.7) - 33 (21.3) | 60 (27.9) | (R) | ||||||
47 | Does it make washing yourself easier? (b) | 127 (81.9) - 28 (18.1) | 60 (27.9) | 0.65 | Q12 (G: 45, 47) | 5 | ||||
48 | Is it quick to use? (b) | 128 (82.6) - 27 (17.4) | 60 (27.9) | (R) | ||||||
49 | Is it comfortable during injections? (b) | 96 (61.9) - 59 (38.1) | 60 (27.9) | 0.42 | Q4 | 5 | ||||
50 | Does it give you freedom of movement? (b) | 125 (80.7) - 30 (19.4) | 60 (27.9) | (R) | ||||||
5a | Can you use it at home? (a) | 142 (91.6) - 13 (8.4) | 60 (27.9) | (F/C, R) | ||||||
52 | Is it stressful? (b) | 139 (89.7) - 16 (10.3) | 60 (27.9) | (F/C, R) | ||||||
Disadvantages of your CVC | ||||||||||
53 | Reminder of the disease? (c) | 118 (76.6) - 36 (23.4) | 61 (28.4) | 0.49 | Q8 | 1 | ||||
54 | It is difficult to find it? | 151 (98.1) - 3 (2.0) | 61 (28.4) | (F/C) | ||||||
55 | Globus sensation? (b) | 137 (89.0) - 17 (11.0) | 61 (28.4) | 0.27 | Q13 | 3 | ||||
56 | Fear of hurting or damaging CVC? (c) | 131 (85.1) - 23 (14.9) | 61 (28.4) | 0.34 | 7 | 5 | ||||
57 | Fear of your CVC being blocked? (c) | 142 (92.2) - 12 (7.8) | 61 (28.4) | Q10 | 5 | |||||
58 | Vulnerability and fragility of the CVC? (c) | 153 (99.4) - 1 (0.7) | 61 (28.4) | (F/C) | ||||||
59 | Discomfort on touching the CVC? (b) | 141 (91.6) - 13 (8.4) | 61 (28.4) | Q9 | 3 | |||||
60 | Discomfort in the shower? (b) | 149 (96.8) - 5 (3.3) | 61 (28.4) | (F/C, R) | ||||||
61 | Always thinking of your CVC? (c) | 151 (98.1) - 3 (2.0) | 61 (28.4) | (F/C, R) | ||||||
62 | Overall satisfaction with your CVC? (f) | [1.6-6.2-7.3-7.8-10]* | Q27 | 7 |
Item: Number of the 62 items collected in phases 2 and 3 of the qualitative step. Items retained for the final QASICC questionnaire are shown in bold. Question (response type): Questions have been translated into English only for the purpose of the article. The response types are described in brackets. Response types: (a) Binary (yes/no). (b) Likert: 0 (Not at all), 1 (Somewhat), 2 (A lot), 3 (Extremely). (c) Likert: 0 (Never), 1 (Sometimes), 2 (Often), 3 (Always). (d) Likert: 0 (Very easy), 1 (Rather easy), 2 (Rather difficult), 3 (Very difficult). (e) Likert: 0 (No), 1 (Low), 2 (Moderate), 3 (High). (f) Analogic Visual Scale (0 - 10). Floor-Ceiling effect: The floor and ceiling effects are described by using range and quartile for quantitative data (Analogic visual scale) or by showing the extreme response absolute and relative frequency for Likert scales. Missing data: Absolute and relative frequency for missing data. Factorial analysis: Factorial analysis with varimax rotation; only the highest factor is given in the table. QASICC final: Q(n) indicates the number of the final question in the QASICC questionnaire. In brackets: (R) This item has been removed to avoid repetition. When items showed high level correlation and evaluated the same characteristic, SC could removed this item consensually. (F/C) This item has been removed on account of a floor/ceiling effect. Too much patient the same answer to the question, the item is not relevant. (G) These items have been grouped together + number of the grouped items. When items showed high level correlation but evaluated the same characteristics by different point of view. (M) This item has been removed because of too much missing data. (O) This item has been removed because formulation was complicated and some patient didn’t really understand the sense of the item. Only well-informed patients could answer the item correctly. Factor (dimension): Indicates the factor (dimension) of the final tool. 1: Appearance, esthetics, privacy. 2: Local discomfort. 3: Professional, social activity and sport. 4: Daily personal activity. 5: Contribution to treatment and comfort. 6: Pain during placement and use. 7: Overall satisfaction.
The module of 62 items was then evaluated on a large cohort of patients (215). The questionnaire was administered during a monocentric randomized controlled trial aimed to compare surgically-inserted chest ports and radiologically-inserted arm ports for CVC in terms of mechanical, thrombotic and infectious adverse events. The questionnaire was administered once, four weeks after CVC placement. Were eligible: adults with a diagnosis of solid tissue malignancy, beginning a course of intermittent bolus intravenous chemotherapy with an expected life expectancy of 3 months or longer, WHO staging criteria <3. The type of catheter consisted of totally implantable ports with silicone-coated catheters (Districath 225PM, Districlass médical SA Saint-Etienne France) in the surgical group, and MRI-low profile BardPort, (Bard Access Systems, Salt Lake City UT, USA), in the radiological group. Qualified nurses were responsible for maintaining all of the catheters, which were flushed with heparin solution after each infusion using positive pressure at Huber needle retrieval. Before use, the checking procedure included blood return control at syringe suction and subsequent 10 ml saline solution flushing, and device filling with 5 ml of a solution containing 50 UI/ml of heparin sodium (Heparine Sodique; Dakota, Créteil, France). The study was approved by a French ethical committee. Informed written consent was obtained from all participants before enrolment in the study.
Item quality was evaluated using non-response, saturation effects (ceiling effect, floor effect) and redundancies. These features were evaluated using descriptive statistics: percentage of missing values, response rates, minimum, maximum, median, standard deviation, histograms, and paired correlations of items. The dimensional structure of the questionnaire was obtained using exploratory approaches such as diagrams of eigenvalues and eigenvalues, and maximum-likelihood factor analysis with varimax rotation. We also used multi-trait and multi- method analysis. This latter method is simpler and more robust and can be used to confirm the proposed structure of the instrument. The principle is that items belonging to the same subscale should be highly correlated with one another. The consistencies of the dimensions are estimated by Cronbach’s alpha and 95% confidence interval evaluated by the bootstrap method. Reliability of the questionnaire is not evaluated in this first validation procedure. Descriptive statistics and analysis were made by R.2.12.2 with a significance level of 5% in bilateral hypothesis. All these analyses were computed with both the original data and extrapolated missing data using multiple imputations. All the results presented are from database including data extrapolated by using multiple imputations. Only
ST literature searches and FG interviews revealed 47 relevant items. This provisional list was then completed with 55 items from patient interviews. At this step, the first draft of our questionnaire included 102 items of varying relevance or redundancy. Each item was then carefully evaluated and worded in precise question form by the ST. These 102 items were then presented to the group of experts to obtain feedback on the first survey content using the Delphi method [
A total of 215 adult patients with solid tissue malignancies were enrolled in a prospective randomized phase 3 study. Responses to the questionnaire were collected from all 215 patients 4 weeks after their inclusion in the study. The analyzed patients comprised 106 CVC (49.3%) assigned to the surgical insertion procedure (chest port insertion) and 109 CVC (50.7%) assigned to the radiological insertion procedure (arm port insertion) making a total of 32,075 and 29,007 CVC days, respectively. Median patient age was 59.4 years [range: 25.7 - 83.0], 120 men (55.8%) and 95 women (44.2%); 149 patients (71.3%) had an advanced stage 3 or 4 disease. Location of tumor site was: 69 breast (32.1%), 44 head and neck (20.5%), urology/gynecology 32 (14.9%), brain 28 (13.0%), lung 16 (7.4%), digestive 15 (7.0%) and other cancer 11 (5.1%).
A first selection of items was made by observing their characteristics and the distribution of each of them. All are summarized in
The number of dimensions of the instrument was first revealed by using scree plot analysis.
Scree plot of eigenvalues and 20 simulated data (multiple imputation). Graphical representation of eigenvalues of the correlation matrix. Si- mulations are proposed to assist interpretation. The graph shows a structure comprising 5 dimensions
The validity of our tool subscales was evaluated using a MultiTrait-Multimethod Matrix (MTMM).
After this first validation, the final tool shown in
Internal validity of the QASICC subscales by MultiTrait Multimethod Matrix (MTMM). Missing data are extrapolated by using multiple imputation.This function is destinated to assess the convergent and discriminant validity of subscales of a given scale (factor or dimension). Items belonging to the same scale should correlate highly amongst themselves. Items belonging to different scales should not correlate highly
. QASICC questionnaire scoring manual
Dimensions (abbreviation) | Number of items in the scale | Item number | Score calculation | Score interpretation |
---|---|---|---|---|
Pain during placement or use (DO) | 2 | Q1, Q2 | (Q1 + Q2)/2 | High score indicates strong pain during placement or use |
Contribution to treatment comfort (CO) | 5 | Q3, Q4, Q7, Q10, Q12 | (Q3 + Q4 + Q7 + Q10 + Q12)/5 | High score indicates a large contribution to treatment comfort |
Esthetics and privacy (ES) | 6 | Q5, Q6, Q8, Q11, Q17, Q19 | (Q5 + Q6 + Q8 + Q11 + Q17 + Q19)/6 | High score indicates a large change in esthetics and privacy |
Impact on professional activities, social life and sports (PR) | 5 | Q9, Q13, Q14, Q18, Q20 | (Q9 + Q13 + Q14 + Q18 + Q20)/5 | High score indicates a large change in professional activities, social life and sports |
Impact on daily activities (QU) | 4 | Q15, Q16, Q21, Q22 | (Q15 + Q16 + Q21 + Q22)/4 | High score indicates a large change in daily activities |
Local discomfort (IN) | 4 | Q23, Q24, Q25, Q26 | (Q23 + Q24 + Q25 + Q26)/4 | High score indicates high local discomfort |
Overall satisfaction (SA) | 1 | Q27 | Q27 | High score indicates high overall satisfaction |
Venous port device implantation techniques have been considered safe and effective procedures for chemotherapy infusion in cancer patients. Initiated by surgeons in the 80s [
Maurer et al. [
Our instrument could be used in routine practice or in clinical trials by most nurses or by physicians prescribing, placing or using CVC, by psychologist in order to assess patient acceptance of and satisfaction with their care or by pharmacists in order to help select the best material for their patients. This is the first self-adminis- tered French multi-dimensional validated questionnaire measuring the use, appearance and pros and cons of the device as well as quality of life as perceived by patients using a CVC for treatment. This questionnaire was constructed using validated methodology. The Steering Committee monitored the whole construction procedure and followed the work of the focus and patient groups. This first statistical validation on 215 patients seems very promising and the questionnaire shows very satisfactory psychometric properties. Further validation studies are required on standard or specific populations and with different devices/trade manufactured product in order to confirm this first validation phase.
The construction and validation of the QASICC questionnaire was a secondary objective of the clinical trial presented here. The main objective was to compare surgically-inserted chest ports and radiologically-inserted arm ports for CVC in terms of mechanical, thrombotic and infectious events. So, in order to conclude more precisely, a large prospective multicenter study was launched in 2011 and was completed in December 2012. We hope that this study designed specifically for QASICC validation and involving nearly 1000 patients will confirm these first results.
We thank M. Yann Chateau, data manager of Antoine Lacassagne Cancer Center for data management.
None declared.