Patient-Initiated Follow-Up in Ovarian Cancer

Round 1

Reviewer 1 Report

Thank you for the hard work of completing this relevant study and asking me to review it

A minor review of use of English will help comprehension

The primary outcome variable is contentious - this should be further discussed.

- Cancer extent at recurrence detection is a key variable

- number of appointments required is a key pilot variable - this will be the concern of service managers. Time that is required from seeking an appointment to recieving one is also key in PIFU. Many patients will only represent when more symptomatic in PIFU and need more acute care then. 

- giving patients what they chose by way of mode of follow-up is a reasonable way to provide care,  but is not likely to reduce cancer fear

The follow-up seems rather short - this should be discussed - not enough events occurred to understand that aspect. 

Wider patient-reported outcomes are of value

The positive and negative predictive value of Ca125 in this population is a key thing for the background. What value is added (in the literature and your study) by physical examination, over and above marker bloods and symptoms?

Your definition of 'routine care' (what that actually entails in your practice) is also important in this case. Do you for example include patient-reported outcomes in routine cancer follow-up, as robust evidence suggests improves patients psychological well-being and quality of life?

  

 

Author Response

Please see the attachment.

Author Response File: Author Response.docx

Reviewer 2 Report

Abstract

The abstract and the body of the paper should provide additional information regarding the following questions: What was the final objective of the patient-initiated follow-up (PIFU)? Why would we establish a PIFU to reduce FCR, and what is the connection to meeting the needs for supportive care? Reducing FCR and enhancing the need for supportive care are, in my opinion, secondary objectives, and the conclusion of this study should not be to recommend PIFU on this basis alone. 

 

Introduction:

line 38 makes a strong claim. I suggest finding more recent epidemiological studies to support the claim made. “Majority of the studies concluded that regular FU in gynecological cancer did not improve survival [3-5].”

 

Line 40: Provide additional context and discuss the role and implications of the psychologist for this unmet need.. “Moreover, studies have reported that many survivors felt their doctors were unhelpful in addressing their psychological needs once active treatment was completed and often experience anxiety before their hospital appointments for cancer FU [6].”

On lines 65 and 66, this assertion must be supported by evidence. “A combination of PIFU with routine CA125 measurement may be an option that could reduce the number of hospital appointments while maintaining or improving patient reassurance.”

 

As well, empirical support is needed to claim that reducing the number of hospital appointments for women with ovarian cancer post-treatment is a goal. And to what end? In the manuscript, it is not clear. 

 

Lines 73–74:  Is it planned to make calls to both groups, intervention and control? Is there a plan in the PIFU to call the participants beforehand with their results? What is the current practice? That all in regular care get informed of their last lab results at their following follow-up assessment? If that is the case, what is new within the PIFU for sharing their results “Thus, the cancer survivors may feel more reassured if they are informed of their tumour marker results sooner, without waiting until the next clinic appointment.”

 

Line 76: It is unclear if the regular tumour marker monitoring is meant to be on an established schedule or per patient-initiated follow-up, as it is all in the same sentence and is not explained in the introduction “PIFU with regular tumour marker 76 monitoring”.

Moreover, the objective lacks an outcome. Other than "feasibility," what are the clinical primary and secondary outcomes of the testing of the PIFU? 

 

Methods

It is unclear what outcomes are being compared between PIFU and conventional hospital-based FU in line 85. 

 

Line 86: Is it empirically justifiable to implement a PIFU for ovarian cancer survivors for the purpose of wanting to increase patient satisfaction and reassurance, as the hypothesis suggests? “We hypothesized that PIFU would provide more 86 patient reassurance and satisfaction.”

 

Study population

Did women with treated ovarian cancer receive approval from their oncologist to initiate their own follow-up as part of the PIFU? I'd like to see ethical confirmation that the aforementioned actions were performed and approved. 

Study intervention

Lines 109–112: The definition of PIFU does not correspond to the one given in line 46. Can the authors provide an explanation? How, as currently stated in line 110, does a regular schedule every six months constitute "as needed"? If regular appointments are scheduled, it no longer fits the definition of PIFU. 

“For the PIFU group, women had FU less frequently at 6-monthly intervals (instead of 3-monthly) and had regular tumour marker monitoring according to routine care. In addition, they were given information on the symptoms of recurrence and a direct telephone line to contact our research assistant if they had any concerns.

 

What qualifications did the research assistant possess to address concerns? And by concerns, is it meant to address FCR concerns? 

 

Line 116: Regarding the timeline of the study. It says the study timeline was six months, and that participants in the PIFU returned to the standard schedule at this time. This meant that the majority would have had only one appointment within the PIFU arm, and this considering that it was a scheduled three-month visit and not a patient-initiated visit as well. 

 

The need to measure SCNS is unclear as the authors do not describe how the intervention is built to influence SCNS. Additional description of the intervention is required.

 

Line 136: Study outcome

I do not see the logic in constructing and evaluating a PIFU intervention to improve FCR and SCN. Furthermore, the study is presented as a feasibility study. Therefore, the primary objective of the study should be to determine the intervention's feasibility and acceptability and than have as a preliminary clinical purpose to determine x, y, z. 

Table 1

68% of participants were one to two years out from cancer treatment. Were these women than on a six-month follow-up schedule? If this is correct and the study lasted only six months, then how did delivering PIFU to the treatment arm make a difference in their follow-up? As well, was there only one opportunity to observe any sort of changes in their FCR and SCN? It does not make for reliable results to test if the follow-up “initiated” really took place.

 

Results: For FCR and SCN, the results indicate no difference between and among groups. Why is the conclusion in the abstract that PIFU is a feasible strategy for short-term outcomes in FCR and SCN? As it is unclear which aspect of the intervention targeted these outcomes, it is unsurprising that neither has had any effect.

 

Discussion.

Line 216 should begin by reiterating that this is a feasibility study and not merely a pilot project. 

The discussion would need to be refocused on the primary objective of a PIFU intervention and the results of their study testing the implementation and utilization of a PIFU in their population. 

 

Line 248: The authors address their RCT nurse-led telephone with reference 20. To my mind, this is a justifiable reason to conduct a study for evaluating PIFU as they did with evaluating the added value of routine FU as opposed to non-routine FU for detecting recurrence and other SCN issues. 

 

Most of the discussion section reads more like a review of PIFU studies. The discussion lacks integration of their findings and the significance of their findings in relation to previous research on PIFU.

 

Like 303: The authors should specify precisely what was examined in their PIFU study: “To our knowledge, this pilot study is the first study to examine the use of PIFU in 303 ovarian cancer”.

Author Response

Please see the attachment.

Author Response File: Author Response.docx