PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

Transcription

1 PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form ( and are provided with free text boxes to elaborate on their assessment. These free text comments are reproduced below. ARTICLE DETAILS TITLE (PROVISIONAL) AUTHORS African American cancer patients Talking About Clinical Trials (TACT) with oncologists during consultations: Evaluating the efficacy of tailored health messages in a randomized controlled trial- the TACT study protocol. Brown, Richard; Davis, Rachel; Wilson-Genderson, Maureen; Grant, Steven; Cadet, Debbie; Lessard, Margaret; Alpert, Jordan; Ward, Jamesha; Ginder, Gordon VERSION 1 - REVIEW REVIEWER REVIEW RETURNED Dana L. Alden University of Hawaii at Manoa USA 30-Jun-2016 GENERAL COMMENTS This is a well-designed study that addresses important research objectives. I have only a few suggestions. The authors argue that the improved effectiveness of tailoring versus non-tailoring is established (Noar et al Psych Bull). They also note the need for more research on the intensity of tailoring (depth of tailoring). Given stated research objectives, which address limitations in the literature reviewed, the authors employ a 2x2design (shallow versus deep tailoring X no physician involvement versus physician involvement). Thus, the study design does not include a control group (nontailoring with or without physician involvement. Of course, a 3x2 design would reduce power or require additional sample participants and hence, added costs. Perhaps the authors have decided that a control group is not necessary given past research. Whatever the reason may be, I believe it is important for the authors to provide their rationale for not using a 3x2. In addition, I find myself questioning whether it is important to include the second factor in the current study design no physician versus physician involvement. A key concept in shared decision making is involvement of both patient (to the level desired) and physician in equipoise decisions. In this case, given that cancer trial participation is dependent on patient preference and given that the benefits versus costs of participating/not participating in a cancer trial may not clearly point to an optimal decision, shared decision making appears very important. Of course, ultimately, whether or not to participate in a cancer trial is the individual s decision to make, but the physician can play an important role in sharing expertise and offering opinions regarding possible benefits/costs.

2 With this in mind, I wonder why a clinic wouldn t always want to provide the physician with a summary of the THMs that are provided to the patients. Certainly, the great majority of conceptual and research papers on patient decision support tools like the THM brochure assume that physicians will receive a paper or digital copy of the patient s value clarification results and other pre-decision measures. Indeed, an important research objective for many of us involves developing and testing ways to include patient responses to decision aid questions and exercises in EMRs so that both the patient and the physician dyad can have a conversation about treatment options that includes values and preferences. Following up on this thought, an alternative approach might involve a 1 factor, 3-level study design as follows: 1) control group: non-tailored, generic brochure regarding participation in a cancer clinical trial, shared with the physician as part of the patient s file. 2) shallow tailoring: tailoring as described in the manuscript, shared with the physician. 3) deep tailoring: tailoring as described in the manuscript, share with the physician. This design would allow increased power or smaller sample size than a 2x2 or 3x2. It also would allow testing of the effectiveness of THM versus no THM interventions in the context of cancer trial participation with African American patients. In addition, from a normative perspective, the resulting manuscript would be more consistent with the field s emphasis on facilitating shared decision making in equipoise situations by informing both the patient and physician. Second, prior to running the experiment, a pretest (or at least, a focus group of African Americans) that provides empirical evidence of the efficacy of message concepts in the THM would be helpful. In many studies, experts develop the content and such content is then evaluated using qualitative and/or quantitative methods of obtaining feedback from the targeted patient population. Third, I may have missed this, but manipulation checks should be included in the design to establish that participants actually read and understood the materials provided. Good luck with your study! REVIEWER REVIEW RETURNED Radha Rajan and Lawrence Cheskin Johns Hopkins Bloomberg School of Public Health, USA 13-Jul-2016 GENERAL COMMENTS This research protocol is interesting and the findings will be valuable to clinical practice, especially if disseminated in turnkey fashion. Overall, the manuscript requires a thorough review for spelling and grammar. Specifically, note the following: spelling of study on page 3 line 7, health on page 3 line 13, page 4 line 8 there is an extra

3 comma, page 3 line 23 should read cancer center, page 4 line 8 comma after Americans, Page 6 line 6 spelling of efficacy, page 20 line 8 delete patients and, page 10 line 34, add an apostrophe to patient s and page 20 line 30 add a comma after Center. Also suggest rewording a few sentences to reduce awkwardness or improve clarity. Specifically, page 3 line 21 between Phase I, II and III clinical trials to improve clarity, page 8 lines reword as develop the three necessary components for tailored messages to make less awkward, page 9 lines 6-8 reword developed a design template to visualize the message layout to improve clarity and make less awkward, page 19 line 8 reword to inform scientific knowledge and influence optimal use of tailored health messages to improve clarity. In the introduction, it would be useful to indicate the extent to which mortality statistics cited are a function of race as opposed to SES. For example, reference study findings that control for SES but still find race is an important predictor of differing mortality/survival outcomes. Alternatively, recognize how race may correlate with other variables that could negatively affect cancer survival. In the second paragraph of the introduction authors note low AA representation in CT results in inequitable access to the latest cancer treatments. While in trial, we still do not know and are testing whether these latest treatments are better or worse than prior treatments, so this disparity may not actually affect mortality. I would remove this and just emphasize the issues of limited generalizability and positive or negative treatment effects in underrepresented subpopulations. Page 4 line 51 we commend the authors for including reference to mistrust of medical research as an important influence in AA clinical trial participation. We must consider this issue within a historical context in which AA populations have not always been treated ethically within CT settings (e.g., Tuskeegee). The implications of this mistreatment may include justifiable mistrust of researcher s intentions. Page 8, lines 8-15 We suggest moving examples of extracted information on patient demographics, disease variables and clinical trial experience up from the measures section into this paragraph. The page 8 description does not presently describe the message development process clearly enough for me to know what information was used so that we could replicate this process. The measures description adds clarity and would be more useful to move here. Page 9, line 18 message concepts is not clear. Could the authors provide an example of this? This message development step is still quite vague. Page 9, line 25 decision rules are unclear. We suggest a brief figure or table to indicate the main points of the algorithm so that these rules are clear for researchers who wish to replicate this approach to message development. Page 10, lines physician involvement. Are physicians provided any training or instruction on what o do with the summary information, or how to incorporate it into their practice? If not, this may be an area for future research and could be a limitation to this

4 study design since physician aptitude to incorporate this information in their communication could confound the effect of THM on CT participation. This issue is only slightly assuaged if the physician demographic information are being used as control variables representing their ability to communicate about CTs. Page 11, line 15 why would trials not be discussed in consultations with recruited participants? Please explain briefly. Page 12, line 23 physician eligibility. Please clarify physicians are eligible if AA are eligible for the trials that the physicians run, or if the physicians have a record of recruiting AA into their trials? I assume the former, as the latter would affect validity of the study. Page 15, lines Amy hypotheses associated with Aim 3? Page 15, lines As noted previously, suggest moving some of this description to the message development section. Page 16, lines In what way are the physician demographics being used in the analysis? I assume some of these may be control variables for Aims 1 and 2, but it is not stated. Page 19, lines Suggest softening this language. The study and potential increased involvement of AA in CTs would ameliorate racial disparities in CT involvement and could optimize the benefits of CTs, but increased involvement of AAs in CTs alone may not ameliorate health disparities as there are many more factors at play. Page 19, line 22 revise cancer patients are unwilling to participate to few cancer patients participate. The authors seem to be referencing the low participation rates in CTs, so the most faithful summary of these data is that few participate, rather than adding in a conclusion about willingness. Page 20, lines As previously noted, the lack of training provided to participating physicians is a limitation that requires explanation. Why would this not be part of the study design? If physician involvement based on THM summary information is not managed in a systematic way then involvement is very dependent on the physician s psychographic characteristics and aptitude for tailoring communication in practice settings. Not all physicians may know how to interpret the THM summary information and incorporate it into their consultation sessions. Page 27, figure 1, line 51 Should the line point from the box where oncologists receive summary to the lefthand box for patients receive newsletter? Where the line is now it does not clearly indicate the two groups that include physician involvement. Page 27, figure 1, line 56 after the consultation is audio recorded, the procedures indicate there could be some dropout if the physician indicates CTs were not discussed. This should be included in the figure. Page 28, figure 2 For clarity when referencing the figure and reading the text, label the boxes Group 1, Group 2, etc. This will help in referring to the figure when reading the aims and hypotheses. Page 28, table 1 We suggest adding in the Chronbach s alpha

5 scores for each scale from the referenced study so readers have an easy way to assess these scales. VERSION 1 AUTHOR RESPONSE Reviewer 1 Point 1. We thank the reviewer for their thoughtful comments regarding the design of this funded protocol. In response, we did consider different levels in our factorial design. As noted by the reviewer, one of our primary considerations in choosing a 2x2 factorial design, which did not include a standard of care control group, were our concerns over equipoise. Given prior research evidence about the efficacy of Tailored Health Messages we did not consider that a standard of care control was ethical as we anticipate that the intervention would produce behavior change beyond no intervention and was thus not an ethical comparison. Instead we decided to offer a very mild level of intervention, tailoring by demographic variables alone. In addition, we completely agree with the reviewer s points about the inclusion of the second randomization related to physician involvement. However, as there are no data, in the Tailored Health Communication literature about the potential for added efficacy by including the physician in the intervention we opted to either involve the physician or not. We certainly agree that, if we are able to provide evidence that the provision of a summary of the patients concerns to their physician changes communication behavior, the 3 x2 design suggested by the reviewer is an optimal design for future studies. Point 2. The reviewer notes the importance of gathering feedback about the content of the intervention from the target population. We completely agree and in response we note that we have conducted feedback sessions with African American cancer patients These were completed prior to commencement of the intervention and changes were incorporated into the wording content. We did describe these sessions in the successful grant application but not in the protocol as we ran theses session in a series of patient support groups, which did not require IRB approval or informed consent to participate. Point 3. We have included a series of manipulation checks and a fidelity plan in the project. As the Journals word count limits are 4000 words for the protocol description we prioritized the inclusion of other information in this submission other than the fidelity plan. The fidelity plan is provided in full below. Fidelity Plan Our formative evaluation plan is designed not only to understand the fidelity with which the program was implemented but also to ensure ongoing implementation and quality monitoring and improvement. Dr. Brown and the Project Coordinator (PC) will conduct systematic monitoring of the standardized procedures involved in implementing the intervention. This monitoring will include regular checks to ensure that participants complete the phone administered tailoring survey. Dr.

6 Brown and the PC will monitor trends in item non-completion. We will also use a brief pre-consultation questionnaire to monitor whether participants received and understood the tailored message booklet. The PC and the RAs will maintain a log of dates of participant contact to record fidelity to the questionnaire completion and return time frames indicated above. Dr. Brown and the PC will review the log monthly. RAs will enter all patient questionnaire data into a database. Dr. Brown and the PC will conduct regular audits of the database to ensure that data entry is accurate. At the completion of the consultation Oncologists of participants randomized to Groups 2 and 4 will be asked whether or not they read the patients brochure. Dr. Brown and the PC will monitor these responses and, in the event that an oncologist has not read the Brochure, he will meet with the oncologist, identify difficulties and develop a corrective plan In response to the reviewers comment we have now provided a summary of these steps in the submitted document. (See pages and 11 and 12). Reviewer 2 Point 1. We have made the editorial corrections and helpful word changes suggested by the reviewer throughout the manuscript. Point 2. As suggested by the reviewer we have removed the statement regarding low AA representation in Clinical trials results in inequitable access to the latest cancer treatments. (See page 4, paragraph 2) Point 3, We thank the reviewers for their comments re; our inclusion of mistrust of medical research as an influence on AA trial participation. Point 4. We thank the reviewers for this helpful comment and have now added examples of extracted information about patients to page 8 (See page 8 paragraph 1) Point 5. We have now added a brief example of a message concept as requested. (See page 9 paragraph 1) Point 6. We thank the reviewer for this helpful suggestion and have added a figure that exemplifies an algorithm. (See page 9 paragraph 1

7 Point 7. In response to the reviewer s question, we are not training physicians in how to incorporate the THM summary into their practice. We agree that this would be an excellent area for future research. We are audiorecording and transcribing the consultations. We will then code the transcripts using the Street Coding system which quantifies some physician communication behaviors. We are powered to explore differences in these behaviors depending on group assignment. Point 8. In order to join this communication study and participate in the intervention, potential participants need to be eligible to join a therapeutic clinical trial. In our experience it is possible that, for various reasons e.g the last minute discovery of a co-morbidity, some participants are not offered a clinical trial at the last minute. We will not know this until after the consultation in discussion with the patient. Point 9. In answer to the reviewer s helpful question if AA are eligible to participate in trials that they run and is not dependent on their record of recruiting AA to research studies. Point 10. Again we, thank the reviewer for the opportunity to clarify. As Aim 3 is exploratory we do not have directional hypotheses. Point 11. Please see changes made in response to point 5 above. Point 12. In answer to the reviewer s question regarding our use of the physician demographic data for the analysis, we will compare the physician characteristics using non-parametric statistics (small n) to assess variation between them. The multilevel models will iteratively attempt to include salient physician characteristics as the model convergence permits. We will not include attempt to include physician characteristics in the models an effort to explain the role of these characteristics (too few physicians for that the be plausible/robust) but rather to account for variation between physicians and thereby decrease unexplained error variance. Point 13. In response to the reviewers concerns we have now removed the sentence In doing so we aim to ameliorate health disparities and optimize the benefits of clinical trials. (See page 19 Para 2) Point 14. As suggested by the reviewer have altered the opening sentence of the discussion to read: Therapeutic clinical trials test the efficacy of newly emerging cancer treatments, yet few cancer patients participate, thus slowing the progress of new treatments and their implementation to fight cancer. (See page 19 Para 1).

8 Point 15. In response to the reviewers comment we have now added two sentences that note the lack of physician communication training as a limitation. Third, physician training in how to utilize the summary of the patients THMs will not be provided. Future research could usefully add an additional training component and asses the efficacy of training to impact sustained changes in communication. (See page 20 para 2) Point 16 and 17. The reviewer has suggested changes to Figure 1 to accurately reflect a) that physicians receive a summary only in cases where there is physician involvement in the intervention and b) the possibility of patient dropout after the consultation. We have now made these changes to figure 1. See page 27 Figure 1 Point 18. As requested by the reviewer we have now labelled each box in Figure 2 with appropriate Group number. (See page 29 Table 1) Point 19. As requested by the reviewer we have now included an example of a decision rule in Figure 3. This Decision rule exemplifies that, if patients answer that they are mistrustful of their doctors opinion, they receive a high priority message about mistrust as part of their Tailored Messages. (See Page 28 Figure 3) VERSION 2 REVIEW REVIEWER REVIEW RETURNED Dana L. Alden William R. Johnson Jr. Distinguished Professor University of Hawaii, USA 08-Nov-2016 GENERAL COMMENTS The authors have addressed my concerns and, in my opinion, the concerns of R2 as well I have no further comments or suggestions. Good luck with your study! I look forward to seeing the results.