After an analysis of the grant application for the proposed project “Patient preference ad clinical outcomes in patients receiving physiotherapy for back pain: A randomised controlled trial”, I must regretfully recommend that this grant not receive funding from our organisation at this time. There are several major flaws in both the methodology and the ethical considerations of the proposed study, as well as errors in some of the basic assumptions upon which the proposed methodology described in this grant has been based. Overall, it does not seem that the methodology suggested will answer the hypothesis for the project, nor have the ethical requirements for the informed consent and protection of the participants been fully met. One major ethical consideration in this proposal is the interview process, which then requests that the treating physician provide the requested treatment to the study group. While the methodology does state that the treatment requested cannot be given if the treating therapist believes that it may cause harm to the patient, it does not make allowances for the patient's best interest as viewed by the practitioner. Simply because the requested treatment does not cause harm does not mean that it is the most effective treatment for a given patient.
One basic assumption for this study is that patient-requested treatments will, in the end, approximate standard clinical treatment practices. However, this assumption puts a great amount of trust and faith in the educational
level of the average physiotherapy patient. Physiotherapists undergo years of training, followed by continuing education for the rest of their career. Patients cannot simply select a treatment, based on at best a limited understanding of the issues at hand and at worst direct-to-consumer medical advertising or anecdotal evidence, and have a practitioner simply provide such therapy. The ethical implications in this situation are quite clear: while the patient's desires should be foremost in the mind of any medical practitioner, it is not ethical to allow the patient to make decisions without assistance in evaluating the available options (Slowther, 2010). An additional ethical consideration falls under the modified informed consent plan listed in this grant. According to the grant, those consenting patients who are assigned to the intervention group “may choose standard consultation as a real option”. This statement seems nonsensical given the proposed methodology. Once the interview has been conducted and the therapist provided with the results of the interview, the information cannot be rescinded. It would become unethical for the practitioner to ignore the preferences stated by the patient during the interview. While the patients can withdraw consent for further participation in the study and for the use of their data, the effect of the study would already have occurred and could not be removed. Their care would be altered regardless of their final consent. Another major assumption of this grant is that a “normal consultation”, as it is described in this study, does not allow for patient choice. The converse to the ethical guidelines of best interest described above is the responsibility of a medical practitioner to respect the treatment wishes of a patient as long as that patient is capable of making autonomous decisions (Slowther, 2010; Appelbaum & Grisso, 1988). Any ethical consultation thus must include a discussion of the patient's choice in their treatment. This represents a major flaw in the methodology of the study, as the only true distinction between the study group and the control then becomes that the patient is directly asked to provide an opinion during the pre-consult interview. The possibility exists that a patient-directed practice will already include such direct questions as a matter of course! This issue would potentially invalidate the results of the study, since in this case there would be no actual “