Informed consent
A new informed consent form model for cancer patients: Preliminary results of a prospective study by the Italian Association of Medical Oncology (AIOM)

https://doi.org/10.1016/j.pec.2011.08.008Get rights and content

Abstract

Objectives

To document the preliminary validity of a new informed consent form (ICF) model in terms of face/content validity and feasibility, to collect patients’ and oncologists’ opinions on it, and to explore physicians’ and patients’ “knowledge”, “opinions” about “the information exchanged”.

Methods

The working group for informed consent promoted by the Italian Association of Medical Oncology developed a new ICF model which was tested in ten Italian cancer centers. Patients and physicians received questionnaires on the new ICF model. Twenty-six independent oncologists were interviewed to collect their opinions.

Results

Seventy eight cancer patients were enrolled: about 90% reported having received information about diagnosis and therapy and 80% about prognosis. About 63% of oncologists had no difficulty in administering the ICF. Oncologists used “correct terms” about diagnosis in 92% of patients with localized disease and in 90% with metastasis and about therapy in respectively 75.7% and 80%. About prognosis, oncologists used “vague” and “no information–no pertinent terms” in 79% of patients with localized disease and 92.5% of patients with metastasis.

Conclusions

The ICF seemed to have sufficient validity and feasibility.

Practice implication

This ICF model could mean that patients require oncologists to spend more time explaining the diagnosis, prognosis and treatment, increasing patient's opportunities to participate actively in the care process

Introduction

High quality care needs good communication between doctors and patients as it influences the patient's compliance with treatment, psychological functioning, the rate of recovery and pain control [1].

Correct information regarding diagnosis, therapy and prognosis is therefore essential in order to reach an informed consent, with the aims to respect and promote patients’ autonomy [2]. An informed consent form (ICF)–defining which kind of information taking into account during the consultation – could be an instrument to guide this process. It should standardize the information, increase the exchange of questions and answers between the physician and the patient and improve their communication. This is true both for clinical care and for clinical research, even if these two settings are very different. Clinical research is more controlled by regulatory codes and by ethics committees compared with informed consent in clinical care [2]. Research is increasingly focusing on the quality and efficacy of ICF in clinical trials. In the experimental setting informed consent is defined by regulations, even so, misunderstandings about the nature of cancer clinical trials are common among patients [3]. Moving from clinical trials to clinical practice, informed consent and the communication between the physician and the patient are only scantily regulated, resulting in inadequacies in the information conveyed to the patient.

Oncology offers a good model of the role of communication in care. The lack or partial disclosure of a cancer diagnosis and prognosis has heavy consequences on a patient's life and can prevent the patient making decisions about therapy, palliative care and end of life [4], [5]. Many patients with cancer want to know their chances of a cure and the extent of the disease spread; they want to discuss life expectancy with the specialist and seek detailed, clearly communicated information about prognosis [6], [7]. Nevertheless, while the communication about cancer diagnosis and therapy has improved in recent years, patients often have difficulty in understanding prognostic information and may overestimate the prognosis [7], [8].

A standard informed consent form lacks a slot for feedback on how well the patient has understood the information about diagnosis, prognosis and treatment. Physicians therefore cannot grasp how much of their information has been “absorbed”. Physicians’ interviews take many forms and there are also wide differences in patients’ needs to receive information regarding their disease, diagnosis and prognosis, or not.

To improve communications between oncologists and patients, in 2007 the Working Group for Informed Consent promoted by the Italian Association of Medical Oncology (AIOM) defined an ICF to guide the information process.

Two main aspects led the group to this document:

(a) Lack of agreement on information between the patient and care team:

When patients are informed of their diagnosis, prognosis and treatment, they find no space in a standard ICF to specify what they want/do not want to know and discuss.

The novelty in the proposed model is the addition of a slot (“the information agreement”) where patients can specify whether they want/do not want some or all information. Patients can therefore express their desire to receive information or not, but it is also useful for the treating team who can learn the patient's opinion and relate correctly to them.

(b) Lack of feedback regarding how well the communication had been understood:

A standard ICF does not have a slot for the patient's feedback to assess what the patient has or has not really understood. The proposed AIOM ICF model is designed to get the patient's feedback on each information issue in order to assess how much she/he has taken in about diagnosis, prognosis and treatment.

This study is part of a larger project divided into four steps:

  • 1)

    drawing up and developing ICF

  • 2)

    testing the content and face validity of the new form and evaluating the feasibility of the new model

  • 3)

    distributing the form and the model among oncologists, through the AIOM website and at meetings and conferences

  • 4)

    evaluating oncologists’ knowledge and use of the ICF model.

The present article deals with the first and second steps of this project. The objectives of the study were to document the preliminary validity of the new informed consent form (ICF) in terms of face/content validity, evaluate the feasibility of the model, collect patients’ and oncologists’ opinions on it, and to explore the knowledge, opinions and attitudes of physicians’ and patients’ on the quantity and quality of information exchanged.

Section snippets

Materials and methods

We carried out two separate tests. First, we assembled a group of oncologists and a convenience sample of patients and tested the new ICF model in both samples through two questionnaires, one submitted to oncologists and one to the patients. Second, a further independent sample of oncologists filled in a questionnaire to collect further opinions and ratings about the new ICF model.

Results

From May 2007 to January 2008, 33 oncologists from ten Medical Oncology Departments administered the new ICF model to 78 patients. Preliminary results have already been reported [11]. Patients’ and physicians’ characteristics are shown in Table 1. Most patients were female (67.9%), married (74.4%), retired (50.7%) with pre/high school education (55.8%). Breast and colon-rectal cancer were the most frequent (41.0% and 24.4% respectively); the disease was metastatic in 51.3%. Physicians were

Discussion

The AIOM project was launched to produce a new ICF model to improve the quality of information given – in terms of accordance to the patient's information needs – and the relationship between physicians and patients. This new ICF and the information agreement form were drawn to serve as two different tools to help patients and their clinicians respect their desire to be or not to be informed of their diagnosis, treatment and prognosis.

This study has some limitations related to the small samples

Competing interest

The authors declare that they have no competing interests

Acknowledgements

The authors thank the patients for to participating in this study and colleagues for their opinions on the informed consent form.

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1

Tel.: +39 02 39014540.

2

Tel.: +39 02 39014575.

3

Tel.: +39 02 39014515.

4

Tel.: +39 0498215953 5909.

5

See Appendix A for AIOM Group for Informed Consent in Medical Oncology (I.C.M.O).

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