Primary physicians’ attitudes toward their patients receiving a proposal to participate in a vaccine trial

Figures & data

Table 1. Demographical characteristics of the panel population (n = 521).^a

	All respondents
Characteristics	n	%
Specialty
General practitioners (GP)	429	(82.3)
Others specialties^a	92	(17.7)
Age
<30 y	5	(0.9)
30 to 39 y	156	(29.9)
40–49 y	131	(25.1)
50–59 y	130	(24.9)
>60 y	99	(19)
Gender
Sex ratio (male/female)		0.98
Male	258	(49.5)
Place of practice
Private practice	424	(81.4)
Hospital center	97	(18.6)
Clinical research activity
Yes	102	(19.6)
No	419	(80.4)

Infectiologists = 6, cardiologists = 3, pediatrics = 5, internal medicine = 4, surgery = 11, dermatologist = 1, endocrinologists = 2, gastroenterologists = 2, pneumologist = 1, anaesthetists = 6, geriatrics = 1, gynaecologists = 2, emergency physicians = 7, urologists = 3, rheumatologists = 6, oncologists = 3, ophthalmologists = 2, neurologists = 6, nephrologists = 1, vascular physicians = 5, oto-rhino-laryngologists = 1, reproductive physicians = 3, rehabilitation physician = 3, psychiatrist = 1, addictologist = 1, nuclear physicians = 1, not reported = 5.

Table 2. Qualitative case table (n = 15)

Doctor	Gender	Age (y)	Specialty	Exercise place	Clinical research activity	Length of interview (min)
A	M	65	GP	Private practice	No	25
B	M	49	GP	Private practice	No	9
C	F	32	GP	Private practice	No	17
D	F	49	GP	Private practice	No	12
E	F	54	GP	Private practice	No	41
F	M	60	GP	Private practice	No	27
G	M	57	GP	Private practice	No	19
H	F	59	GP	Private practice	Yes	26
I	F	38	GP	Private practice	No	27
J	M	49	Nephrologist	University hospital	Yes	15
K	M	46	Rheumatologist	University hospital	Yes	17
L	F	43	Cardiologist	Hospital	No	17
M	M	31	Pneumologist	Private practice	No	16
N	F	51	Gastroenterologist	Both	Yes	12
O	M	56	Rheumatologist	Both	Yes	31

Table 3. Attitudes of attending physicians when one of their patients is approached by clinical center of research to participate in a preventive vaccine trial

Quantitative responses (n= 521) Likert scale representation	Qualitative verbatim sentences related
Do you spontaneously give your opinion?	-
If the patient asked your opinion, you do not wish to give an opinion	“If patients ask me for my opinion, I can eventually determine myself.” (Doctor F) “You can’t give advice if you don’t know what you’re talking about at all” (Doctor I)
If the patient asked your opinion, you want more information before you go ahead	“In order to give an opinion in a field, it is necessary to be informed and you have to be initiated”(Doctor A) “To give an advice, maybe there’s a need for more information for GPs” (Doctor I)
If the patient asked your opinion, you give him your opinion but leave him free of his choice	“I push them to accept if they are really excited but on the other hand I let them make their decision alone”(Doctor E)
If the patient asked your opinion, you discourage him from participating	“Often I encourage them to follow these protocols, for me it is an interesting method of analysis that must be maintained” (Doctor G) « If they have been asked to be included it is because they fit the profile so there is no reason why I can advise them against it. » (Doctor N)
You would have preferred that your colleague contact you in advance to present the study and send you the protocol in question	“I should be able to contact the doctor who sets up the trial to find out what he is expecting, because I know absolutely nothing at all’ (Doctor I) “Indeed, there are always difficulties often because the inform consent form (ICF) for patients are often extremely poorly written with terms not always understandable to the non-specialist “ (Doctor J) “Very often they do not ask the questions to the investigators, they ask them to us (attending physicians).”(Doctor D)
What factors could influence your opinion?
Available safety data	“ What might come into play in my decision to recommend or not to recommend participation is the progress of the study. To know if there had already interesting data and lead to an improvement”. (Doctor B) “ I have no fear about the old vaccines that we know about or those that are being put on the market. But participating in tests and it seems really complicated to me. Vaccinations you will often have a fallout at 20, 30 or 40 years old and I think it is more dangerous so you have to be more careful.” (Doctor E)
Patient’s clinical condition	“ My patient’s health condition is a factor I will consider” (Doctor B) « My opinion will depend on my patient’s health condition » (Doctor I)
Patient’s expected benefit	“One element is the individual benefit that it could have a posteriori” (Doctor B). “The potential gain, the potential benefit for the patient will be an element that will guide my recommendation” (Doctor F)
Infection targeted	“First element will be the usefulness of the vaccine (depending on the pathogenicity of the virus or bacteria involved). If we are dealing with a pathology that does not kill, I would say to myself that it would be less important to offer it to my patients” (Doctor C)
Patient initial decision	“ I will check that the patient is really aware of what he is making as a decision and why he has made it. The rest, no, in my opinion it wouldn’t concern me, it’s the patient’s decision! » (Doctor E)
Difficulties for the patient	“If it doesn’t require too many invasive tests for them, I think it advances science”(Doctor D) “They had the right to an electrocardiogram, a chest x-ray and a biological assessment. That’s why I told them it was good to participate, because it came in addition to what we could do as a GP.”(Doctor D)
Placebo-controlled study	“The terms used in the ICF are anxious and you have to try to make him understand that there will be a random draw and that maybe he will end up in the placebo arm. So in the majority of cases, his participation in clinical research does not directly benefit him.” (Doctor J)
If the trial proposed was a drug trial, not a vaccine trial, would your opinion have been different ?	It seems to me that a vaccine is a drug!”(Doctor K) “Oh no, it’s not invasive for me. A sting does not hurt that much.” (Doctor L) “So I do not have the fear about old vaccines we know.”(Doctor E) “ I think the drug trial seems a little less dangerous to me than the vaccine trial because in a vaccine trial we’re going to have a very long-term impact”(Doctor E)

Table 4. Univariate and multivariate analysis of physicians’ attitudes when one of their patients is approached by clinical center of research to participate in a preventive vaccine trial – Odds-ratio [IC]

			If patient asked for your opinion,
	Spontaneous opinion		Do not wish give your opinion		Want more information		Patient free of choice
	Univariate	Multivariate	Univariate	Multivariate	Univariate	Multivariate	Univariate	Multivariate
Male gender	1.97 [1.29, 2.99]***	1.58 [1.02, 2.44]**	0.68 [0.47, 0.99]**	0.76 [0.51,1.11]	0.44 [0.22, 0.88]**	0.47 [0.23, 0.95]**	0.91 [0.42,1.99]	-
Age ≥ 50	3.26 [2.07, 5.11]***	2.90 [1.82,4.60]**	0.69 [0.47, 1.00]*	0.75 [0.51,1.10]	0.76 [0.40, 1.44]	-	1.65 [0.73, 3.76]	-
Hospital center practice	0.70 [0.43, 1.17]*	0.80 [0.47,1.34]	0.87 [0.53, 1.42]	-	0.45 [0.22, 0.94]**	2.2 [0.21,23.16]	0.74 [0.29, 1.90]	-
GP	1.27 [0.77, 2.10]		1.19 [0.74, 1.94]	-	2.42 [1.20, 4.90]**	3.34 [0.302, 36.98]	1.31 [0.51, 3.34]	-
Have a clinical research activity	1.16 [0.69, 1.93]		0.60 [0.37, 0.97]**	0.62 [0.38,1.01]	0.37 [0.19, 0.73]**	0.53 [0.21, 1.35]	1.06 [0.39, 2.86]	-
	If patient asked for your opinion,
	Discourage patient		Prior contact
	Univariate	Multivariate	Univariate	Multivariate
Male gender	1.99 [0.67, 5.92]	-	0.79 [0.52, 1.22]	-
Age ≥ 50	0.86 [0.30, 2.46]	-	1.67 [1.08, 2.60]**	1.67 [1.08, 2.60]**
Hospital center practice	0.65 [0.14, 2.96]	-	0.75 [0.44, 1.29]	-
GP	3.43 [0.44, 26.45]	-	1.37 [0.81, 2.32]	-
Have a clinical research activity	0.96 [0.27, 3.49]	-	0.72 [0.43, 1.20]	-

* p< 0.2.

** p< 0.05.

*** p≤ 0.001.

Table 5. Univariate and multivariate analysis of the opinion’s influencing factors when one of their patients is approached by clinical center of research to participate in a preventive vaccine trial – odds-ratio [IC]

	Patient initial decision		Patient clinical condition		Difficulties for patient		Expected benefit
	Univariate	Multivariate	Univariate	Multivariate	Univariate	Multivariate	Univariate	Multivariate
Male gender	0.76 [0.49, 1.20]	-	0.88 [0.49, 1.60]	-	0.83 [0.54, 1.25]	-	1.27 [0.70, 2.31]	-
Age ≥ 50	0.75 [0.48, 1.18]	-	0.91 [0.50, 1.65]	-	0.92 [0.60, 1.40]	-	0.76 [0.42, 1.37]	-
Hospital center practice	0.50 [0.29, 0.86]**	0.99[0.00, ∞]	0.76 [0.36, 1.60]	-	0.52 [0.31, 0.86]**	4.08 [0.38, 43.74]	0.60 [0.30, 1.20]*	0.42 [0.01, 13.32]
GP	1.77 [1.03, 3.04]**	0.99[0.00, ∞]	1.26 [0.60, 2.65]	-	2.11 [1.28, 3.49]**	7.53 [0.68, 83.43]	1.62 [0.81, 3.25]*	0.60 [0.02, 22.04]
Have a clinical research activity	0.54 [0.32, 0.91]**	0.69 [0.34, 1.38]	0.55 [0.28, 1.07]*	0.55 [0.28, 1.07]*	0.57 [0.35, 0.94]**	0.88 [0.45, 1.71]	0.81 [0.40, 1.65]	-
	Vaccine targeted		Available safety data		Placebo-controlled study
Male gender	0.92 [0.48, 1.78]	-	0.26 [0.08, 0.79]**	0.22 [0.07, 0.70]**	1.00 [0.67, 1.52]	-
Age ≥ 50	0.77 [0.40, 1.49]	-	2.09 [0.73, 5.98]*	3.03 [1.02, 9.00]**	0.96 [0.63, 1.44]	-
Hospital center practice	0.39[0.19, 0.79]**	0.43[0.09, 20.51]	0.39 [0.14, 1.07]*	0.51 [0.01, 38.7]	0.61 [0.36, 1.00]*	1.07 [0.14, 8.18]
GP	2.54 [1.24, 5.18]**	1.06 [0.02, 50.85]	2.47 [0.90, 6.77]*	0.6 [0.01, 44.6]	0.67 [1.01, 2.76]**	1.48 [0.19, 11.50]
Have a clinical research activity	0.51 [0.25, 1.06]*	0.93 [0.34, 2.51]	0.29 [0.10, 0.73]**	0.33 [0.10, 1.12]*	0.61 [0.38, 0.99]**	0.76 [0.39, 1.46]

*p< 0.1.

**p< 0.05.