Section A – Context and guidelines
Context and objectives of the questionnaire
INESSS recognizes that patients and caregivers have first-hand knowledge of life with a disease or specific health condition. They can describe the benefits and drawbacks of currently available treatments, which are not always reported in the published literature, and assess new treatments.
This questionnaire was created to help patient and caregiver associations and groups contribute information to the evaluation of a specific drug. Their knowledge on the subject may influence the recommendations of INESSS.
Completing this questionnaire requires significant resources. We are therefore committed to making all contributions available to everyone involved in the evaluation process. Our notice will explain how your answers will be used in developing recommendations.
Responses to this questionnaire may be published on our website; any personal and financial information that may allow respondents to be identified will be removed.
How to complete the questionnaire
In this questionnaire, the term “patient” refers to a person who has or had a disease or health condition that requires the prescription of the drug. The term “caregiver” refers to a person who takes care of a patient by providing, for example, care, support and assistance, and includes family members, friends and any other support person.
The first section of the questionnaire concerns information about your patient or caregiver association or group. This information is required so we can get to know the associations that respond to our questionnaire, and their representatives, in the interest of transparency. This section also includes questions about conflicts of interest, since INESSS asks that all participants in the evaluation procedure, whether individuals or organizations, disclose any conflicts of interest they may have in order to ensure an objective and credible procedure. This information will not be used to reject questionnaires or any of the information provided.
The second section of the questionnaire is made up of three major subsections that deal with the impact of the disease, currently available treatments and drugs under study. More specifically, in sections B-2 to B-6, we ask you to describe the difficulties faced by patients and caregivers, experiences with current treatments, expectations of the drug under study and, if you are aware of them, the potential benefits or drawbacks of this drug.
For each of these questions, please think about any existing issues that could be useful for evaluating the drug and making a decision. The issues listed beneath each question are given as examples; these lists are not exhaustive. Identify which issues your association or group thinks are important, and describe any other relevant issue that is not mentioned. Please describe the facts, provide information and summarize the experience of the patient and their family in order to give balanced and specific insight into their perspective. Please specify the source of this information by providing references. For each section of the document, please specify any groups you think should be given particular consideration (e.g., men, women or children; ethnic groups; people living in a specific region; people with disabilities; subtypes of the disease), and indicate their particular needs or problems.
There is no need to send us scientific articles, as we already have access to this type of information. However, if you have a particular interpretation of specific clinical trials, we would be interested in hearing about it.
If you have any questions about this questionnaire, please write us at: plan.commentaires.inscription@inesss.qc.ca
Once you have completed the questionnaire, please send us a digital copy at the above-noted email address, or a hard copy at the following mailing address:
Institut national d’excellence en santé et en services sociaux (INESSS)
Direction du médicament
2535 Laurier Boulevard, 5th Floor
Québec, Québec G1V 4M3
Section B – Feedback about a drug
- Information about the organization and conflict-of-interest declaration
Name of the drug and indication:
Name of the organization:
Website :
Name of the respondent to the questionnaire:
Name of the contact person :
Email address :
Telephone :
Mailing address :
1.1 Information about the organization
Type of organization (check all that apply):
Association: Group of persons brought together with a common interest, other than that of making profits to be shared among its members, whose activities promote the study, defense and development of the economic, social or moral interests of its members (Registraire des entreprises, Gouvernement du Québec)
Group of persons: Any aggregation, other than an association, which joins two or more persons who share a common interest (pecuniary or not). (Registraire des entreprises, Gouvernement duQuébec)
Non-profit legal person: Group of individuals that engages in non-profit activities (Registraire des entreprises, Gouvernement du Québec)
Community organization subsidized by the MSSS: Group of persons from the community that is supported by the community and mobilized around shared objectives in the field of health care and social services, and which is subsidized through the Programme de soutien aux organismes communautaires of the Ministère de la santé et des services sociaux (MSSS) of Québec
Registered charitable organization: Charitable organization registered with the Canada Revenue Agency or Revenu Québec
Public foundation: Foundation operated for charitable purposes; the majority of its administrators or other managers deal with each other at arm’s length (Ministère du Travail, de l’Emploi et de la Solidarité sociale)
Private foundation : Foundation in which more than half of the administrators are related persons or have a non-arm’s length relationship, and for which over 50% of the funding comes from a single person or group of persons that have a non-arm’s length relationship (Ministère du Travail, de l’Emploi et de la Solidarité sociale)
Mixed association or group: Association or group that brings together patients and professionals
Group of associations: Union, federation, coalition or any other type of group of associations, community organizations, groups of persons, charitable organizations, etc.
Other, please specify:
Jurisdiction
National
Provincial
Regional
Other, please specify:
Mandate/role (check all that apply)
Defense of members’ rights and promotion of their interests
Improvement of access to new treatments
Support for individuals
Research funding
Research promotion and support
Training
Information and awareness campaigns
Other, please specify:
Describe the make-up of the main branches of your organization, and give the names of managers and their titles.
For example:
- Organization chart (provide a reference to the organization’s website, where applicable)
- Main branches, units, departments, etc.
- Board of directors (BOD), where applicable
Describe your members.
For example:
- Number and types of members
- Regions served
- Demographic data
1.2. Conflict-of-interest declaration
A conflict of interest arises when a person is in a situation in which, objectively, their judgment in a particular role may be or appear to be influenced by other considerations, whether personal, financial or professional. A conflict of interest may be real, potential or apparent. Organizations may also have financial or reputational interests that are in conflict with their obligations under their mission or mandate.
Please list all the companies or organizations that have provided you with resources (financial, human, material or other services, including consulting, communications, representation or research) in the last two years AND that have an interest in the drug under evaluation. Your list should not be limited to the manufacturer of the drug under evaluation but also include any organization involved directly or indirectly with this drug.
Reminder: This information is not used to reject questionnaires or any information provided.
Organizations
Amounts
Organizations
Amounts
Organizations
Amounts
Organizations
Amounts
Has your organization, or one of its managers, ever published or publicly expressed (e.g., in a press release, media interview, online) a clear opinion about the treatment under evaluation? If so, of what nature ? Reminder: This information is not used to reject questionnaires or any information provided.
Opinion published or publicly expressed
Reference (if applicable)
Opinion published or publicly expressed
Reference (if applicable)
Opinion published or publicly expressed
Reference (if applicable)
Opinion published or publicly expressed
Reference (if applicable)
Does your association or any of its managers have any other conflicts of interest to disclose?
Yes No
If so, of what nature ?
For example:
- Personal benefits received from a manufacturer or organization with an interest in the INESSS evaluation (donation, gifts, promotional items, trips, services, shares, call options, etc.)
- Activities funded by a manufacturer or organization with an interest in the INESSS evaluation (research grant or scholarship, consultant fees, conference participation or organization, committee, salary, etc.)
- Support for the association from a manufacturer or organization with an interest in the INESSS evaluation
- Affiliation
- Personal or business relationship with a manufacturer or other interest group
1.3 Information on the method, help received and sources of information used to complete the questionnaire, if applicable
Indicate whether you received help to complete this questionnaire, and, if so, specify what kind of help, who provided it and in what capacity.
Indicate the nature of the information and the method used to complete the questionnaire.
For example:
- Number of participants
- Method used: solicitation of members; investigation online or elsewhere; comments on social media, in working groups or discussion groups; testimonials; analysis of calls to a telephone help line; medical files; conversations with patients or family members of patients during clinical trials; stories told by patients or their families; etc.
- References
2. Impact of the disease or health condition
2.1. How does the disease or health condition treated by the drug under evaluation affect patients’ quality of life? Which aspects cause the most difficulty?
For example:
- Primary symptoms to control
- Impact on daily activities and domestic life
- Need for assistance in daily life
- Impact on social life and relationships
- Family balance
- Intimate relationships, sexual issues
2.2 How does the disease or health condition affect patients’ families and friends?
For example:
- Emotional/psychological effects
- Family balance
- Intimate relationships, sexual life
3. Experience with currently available treatments (other than the one under evaluation)
3.1. To what extent do the patients, with the help of their families, where applicable, manage their health condition with current treatments? Treatment refers to any form of intervention, such as drugs, rehabilitation, psychological support or hospital procedures. If no treatment is available, this should be stated.
For example, list the main treatments used and their effects in terms of:
- Procedure for administering/taking the treatment (frequency, treatment at home or at the hospital, access, route of administration)
- Difficulties taking a drug as prescribed (swallowing, use of a device, schedule, etc.)
- Specific actions involved in current medications (tablets, injections, checkup, review of dosage and frequency, etc.)
- Required consultations and complementary examinations (checkup, biological and X-ray exams), related treatment (kinesitherapy, psychiatry), need for hospitalization or other treatments
- Effectiveness for controlling or diminishing the most difficult aspects of the disease
- Adverse effects, specifying the effects that are acceptable and those that are most difficult to tolerate
- Control or reduction of symptoms (primary benefits and adverse effects of this drug, etc.)
- Impacts on daily life and domestic activities
- Impacts on personal and social life and relationships (work interruptions, changes in physical appearance, difficulty getting around, etc.)
- Concerns regarding long-term use of the existing treatment
- Ease of access
3.2 What are the main expectations patients and their families have for the new treatment?
For example:
- Expectations of effectiveness for relieving certain symptoms
- Expectations with regard to adverse effects
- Expectations with regard to other characteristics of the treatment
- Expectations with regard to access
- Deficiencies the ideal drug should address
- Alternative to current treatments
4. Experience with the drug under study
4.1. For those who have tried the drug under study, what effects did it have (positive or negative)? What differences did using this drug make in their lives?
For example, in terms of:
- Benefits and drawbacks compared to currently available treatments
- Ease of use or observance (procedures for administering/taking the treatment, use of the drug as prescribed)
- Effectiveness, quality of life (e.g., improvement of symptoms)
- Adverse effects (e.g., aggravation of symptoms)
- Effects on daily life and domestic activities
- Effects on personal or social life or relationships (e.g., financial impact)
5. Additional information
Please provide any additional information that may be useful for the drug evaluation.
For example:
- Ethical or social issues, relationship conflicts with family members or health care professionals
6. Key points
In a maximum of five statements, list the most important elements of your responses to this questionnaire. These statements will be quoted and highlighted in the evaluation of the drug.
1.
2.
3.
4.
5.
INESSS thanks you for your participation!
This questionnaire was based on the “Questionnaire de recueil du point de vue des patients et usagers pour l’évaluation d’un médicament” (2016), by the French National Authority for Health, and the “Patient Input Template for CADTH CDR and pCODR Programs” (2017), by the Canadian Agency for Drugs and Technologies in Health.
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