Abstract
Background:
Long-term success remains a challenge for many who have undergone bariatric surgery, which suggests that there may be important, and as of yet, unmet needs of such recipients. The objective of this cross-sectional study was to gain an understanding of what bariatric surgery recipients perceive that they need to best support their long-term health and well-being in the province (Ontario, Canada) and thereafter internationally.
Methods:
A questionnaire, taking 30–45 min to complete, was designed in concert with members of the target audience and distributed via support group administrators. Descriptive statistics of participants' demographic/clinical background were analyzed for group comparisons by using a chi-square test and a two-sample t-test (p < 0.05). Open-ended responses were analyzed by using inductive content analysis and reviewed independently by the authors, who discussed any discrepancies in emerging themes until reaching an agreement.
Results:
One hundred and nineteen (59 provincial; 60 international) respondents completed the questionnaire. Themes for what was the most useful included encouragement from family, friends, bariatric team members, and peers. Access to immediate follow-up appointments after surgery for nutrition-specific and general postsurgery concerns was reported as needed but not received. Recommendations to address excess skin and creating a mentorship program were proposed.
Conclusions:
This study provides an understanding of the needs and experiences of bariatric surgery recipients, which may help clinicians to address gaps in bariatric programing, provide more effective treatment, and help to manage weight among surgery recipients for long-term health and well-being.
Introduction
I
Bariatric surgery has become a popular option, and it is currently considered the only effective long-term treatment for people living with severe obesity.5,6 Individuals who undergo bariatric surgery can experience significant losses of 40–75% of their excess body weight, depending on the type of procedure. 7 In fact, some individuals even experience a complete resolution of comorbid conditions such as diabetes, hyperlipidemia, hypertension, and obstructive sleep apnea.5,7 Furthermore, when compared (over a 10-year span) with conventional treatment, bariatric surgery has been associated with almost a 30% reduction in mortality.8,9 Bariatric surgery can also facilitate psychological gains such as improved overall quality of life and increased self-esteem.10,11
Despite the immediate physiological and psychological improvements that can result from bariatric surgery, not all recipients are able to maintain these benefits in the long term, with approximately one third experiencing excess weight regain over time.12–14 Maintaining long-term weight loss and the associated health-related benefits requires a lifelong commitment to lifestyle changes that include professional evaluation and rigorous self-monitoring.15–18 Though pre- and post-bariatric surgery programming and support groups have grown in popularity,19–23 long-term success remains a challenge for many, suggesting that there may be important needs, from the perspectives of bariatric surgery recipients, that are not being fully addressed.
A better understanding of patients' perspectives of their own needs and expectations is a critical component of intervention development. 24 The integration of patients' insights may assist clinical teams in efficaciously addressing the gaps in bariatric programing, which could help improve long-term weight management and the associated physiological and psychological benefits.
As advised by McKenzie et al., “[b] efore a need can be met, it must first be identified…” (p. 68). 24 Understanding what members of a target population perceive that they need to address their health concerns is an essential first step in future program/intervention planning; the subjective views of the target group tend to provide a fairly accurate barometer of what they are challenged by, struggling to overcome, and believe would help them better meet success. 24
For this particular study, needs were defined as support or services that were essential, required, or very important during the bariatric surgery process. With the exception of a study focused on Australian patients, where most received privately funded surgeries, 25 an assessment of bariatric recipients' needs in a publicly funded setting has not been previously conducted. Sharman et al. synthesized patient suggestions to improve the Australian bariatric surgery process and wanted to compare the experiences of publically versus privately funded recipients. However, low numbers of participants who had received a publicly funded surgery (only 22% of sample) prevented meaningful comparisons. 25
Given that 90% of Australian bariatric recipients complete their surgery in a private hospital, and use private health insurance or personal finances to cover the associated out-of-pocket costs for the procedure, 26 it is not surprising that Korda et al. found that Australians with a greater need for bariatric surgery had poorer access to receive it than those who could afford privately funded surgeries. 27 The Australian example emphasizes the need to understand whether a region's allocated healthcare provisions (e.g., public versus privately funded surgeries) impact bariatric surgery recipients' experiences, and their long-term health and well-being.
In Canada, bariatric surgery is covered by the provincial public healthcare system, with less than 15% of bariatric procedures performed in private clinics across the country. 2 According to a 2014 Canadian report, unlike Australian recipients, Canadian surgery recipients were more likely to reside in lower-income neighborhoods; specifically, more patients were found in the lowest income quintile (22%) compared with the highest income quintile (14%). 2 Understanding the needs of a bariatric community similar to the aforementioned and how healthcare provisions have impacted the community thus far is unknown. Examining the perspectives and needs of those from a publicly funded healthcare system, such as the province of Ontario, Canada, may provide a complementary view to Sharman et al.'s study of predominately privately funded surgery recipients. In addition, exploring the experiences of those receiving bariatric surgery internationally and how it varies from a funding-specific point of view may help to elucidate whether bariatric surgery recipients' experiences differ based on the type of funding source.
Currently, patient medical programs and surgical services in Ontario are provided by a network of 12 bariatric centers across the province and funded by the Ministry of Health and Long Term Care (MOHLTC). 2 What is lacking in the literature is an understanding of the needs and experiences of bariatric recipients with publicly funded care (such as in Ontario via the MOHLTC) and international bariatric experiences that could differ widely in terms of funding source. This information may assist in determining how best to tailor and prioritize weight management support and services, as well as offer insights about the relationship between the funding source and recipients' bariatric experiences. In addition, given the increased influx and capacity of bariatric surgery in Ontario in the past 6 years and worldwide, this study can provide a timely account of patients' experiences and perceptions of how to support their long-term health and well-being.
The purpose of this cross-sectional needs assessment survey study was twofold. First, our aim was to gain an understanding of what individuals who are engaged in the bariatric surgery process provincially (Ontario, Canada) perceive they need before, during, and after bariatric surgery to best support their long-term health and well-being. Second, because the provision of healthcare is unique to the province and country in which it is provided, our second aim was to explore the same question with an international sample, with the intention of exploring the extent to which these experiences were unique and/or similar.
Materials and Methods
On approval of the host institution's Ethics Board, the questionnaire for this study was designed in concert with members of the target audience before its provincial and then international administration. All those involved provided informed consent to participate in the study.
Questionnaire design
A review of current literature using a keyword-based search in the databases PubMed and PsychINFO was conducted, and it focused on uncovering previously established bariatric needs assessment surveys and bariatric surgery-related surveys. The following combinations of keywords were used: *bariatric surgery OR *weight loss surgery AND *survey OR *questionnaire OR *needs assessment AND *patients AND *services OR *support. All search queries were conducted “In all text/In all fields.” The search was limited to include subjects older than 18 years of age. Twenty-three articles were retrieved from PubMed and 51 articles were retrieved from PsychINFO, although no previously used surveys were found to fit the current study's purpose. Seven articles related to long-term health and well-being-related outcomes were reviewed and used to carefully create and compile survey questions related to bariatric surgery-related literature gaps, the study's target population, and the study's purpose. The initial literature-based questionnaire contained 37 open- and 2 close-ended questions.
An email invitation was sent (to those considering, waiting, or who had surgery) to a local bariatric support group known to the researchers. Nine members responded and were, therefore, invited to provide insights and feedback on each question's content, wording, meaning, and whether any questions needed to be removed or added. Amendments to question wording, formatting, order, and content were conducted for the majority of questions to ensure the questionnaire, as a whole, was written in the most comprehensible language possible and covered all aspects of the bariatric process that the target audience deemed suitable (face validity). Members' consensus was sought for each revision made until each question's content and wording satisfied all. After two 90-min group-based discussions (hosting three and four participants, respectively) and two 30-min individual interviews, data saturation was reached as no additional feedback for revision was received, 28 and as such, the final questionnaire contained 34 open- and 17 close-ended questions and was uploaded into SurveyMonkey® (SurveyMonkey, Palo Alto, CA), an online questionnaire software program.
The final questionnaire took ∼30–45 min to complete and its items pertained to respondents' experiences with bariatric surgery support services; perspectives on which services and information were the most useful and needed at different time points (before, during, after surgery, and overall); and perspectives about what information they needed for short-term, long-term, and overall support. Responders were also asked to comment on any support-related gaps that they felt needed to be addressed, and their recommendations on how the gaps could be addressed.
Data collection
Provincial survey
Recruitment to complete the survey was done via e-mail invitations through the lead administrator of a local bariatric support group network to various bariatric support groups across the province. The survey was open from May 2015 to July 2015 with biweekly e-mail reminders from the lead administrator. Personal identifiers and IP numbers were not collected; therefore, respondents' identities remained anonymous. Completion of the survey was considered as obtaining explicit consent.
International survey
After provincial administration, the questionnaire was amended, where suitable, to be distributed to an international sample of the target population (e.g., removing references to provincial-specific questions, and condensing the number of questions that evoked the same responses). The resultant 32 open- and 20 close-ended questions were uploaded by using Qualtrics Survey Software (Qualtrics, Provo, UT; the host institution had changed to this survey software platform by the time this survey was administered, with the explanation that Qualtrics offers an easy-to-use, flexible, scalable, and secure method for gathering data; the researchers were obligated to shift to the new software).
To recruit participants, site administrators of three Facebook Pages (representing more than 104,000 international subscribers) and four Facebook Groups (representing more than 58,000 international members) related to bariatric surgery support were contacted. On receiving permission, the invitation with the questionnaire link was posted from May 2016 to July 2016, and it was re-posted every week until the closing date.
Data analysis
All provincial and international data were pooled and aggregated from SurveyMonkey and Qualtrics Survey Software, respectively, into Microsoft Excel (Microsoft, Albuquerque, NM). The analysis procedure was identical for the provincial and international data, although it was run separately for each data set. Descriptive statistics of the clinical characteristics were analyzed. Thereafter, to contextualize the extent to which the two samples were similar with respect to their demographic and clinical characteristics, statistically significant differences between provincial and international samples were calculated by using the chi-square test for demographic characteristics in Table 1 and t-tests for clinical characteristics (where an alpha equal to or less than 0.05 denoted statistical significance) in Table 2.
p < 0.05, statistically significant difference between provincial and international samples.
GED, general education development.
p < 0.05, statistically significant mean difference between provincial and international samples.
MD, medical doctor; SD, standard deviation.
Responses to the open-ended questions were analyzed by using inductive content analysis, as described by Patton,29,30 and facilitated by hand.31,32 Burnard and colleagues asserted that it is the responsibility of the researcher(s), and not a data management program, to analyze the data, 31 and whether the data are managed by hand or using computer software, the process of inductive content analysis is the same. 31 Therefore, the researchers used their preferred method of analyzing the data by hand,31,32 which involved allowing the themes to emerge from the data. Inductive content analysis is often used when there are no previous studies focused on the particular research question that has been conducted.29,30,33,34
Themes were discovered by searching through the data and attempting to verify, confirm, and qualify themes by repeating the process, until themes and categories were exhausted.29,30,33,34 To ensure confirmability 35 of the findings, open-ended responses were reviewed independently by the authors, followed by a discussion of any discrepancies in emerging themes until an agreement was reached. Both authors identified parallel themes, and the discussion was primarily around determining the most reflective title for each. Using the guidance of Guba and Lincoln, 35 additional quality assurance steps were applied throughout data analysis, and they are detailed in Table 3.
To gain a comprehensive understanding of the experiences of those engaged in the bariatric surgery process and what might best support their long-term health and well-being, themes from the provincial and international data were categorized by question topics in the following manner:
i. What was the most useful (before, during, and after surgery)? ii. What was needed but not received (before, during, and after surgery)? iii. What overall expectations were met and not met? iv. What are the current support and service gaps, and related recommendations?
For the purposes of the study, needs were defined as support or services that were essential, required, or very important during the bariatric surgery process whereas expectations were defined as support or services that were anticipated to occur or regarded as likely to happen but did not necessarily happen. Themes that emerged within each category were noted, with those common to both the provincial and international data presented together for ease of presentation, and those unique to only one group presented on their own (see Table 4 for summary of themes). Themes presented spanned the entire surgery process (before, during, and after surgery), unless a time point was specified.
Bold terms refer to themes that were identified as common between provincial and international samples.
Results
Participants' characteristics
Fifty-nine provincial participants completed the survey. They were primarily women (93%), aged 40–49 years old (49%), Caucasian (68%), married or in a domestic partnership (73%), and worked full time (64%). A detailed summary of participants' demographic and clinical characteristics is provided in Tables 1 and 2, respectively. The 60 international participants who completed the survey were primarily women (93%), aged 18–39 years old (57%), Caucasian (52%), married or in a domestic partnership (42%), and worked full time (32%). Demographic characteristics that were statistically significant between the provincial and international samples were age, ethnicity, and education, p < 0.05. The provincial sample was primarily made up of older, Caucasian participants, and who had at least attended college or university in comparison with the international sample. However, it should be noted that for ethnicity and education, the proportion of international participants who provided a response was much lower than the proportion of provincial participants. Therefore, the pattern observed of the actual responses for ethnicity and education should be interpreted cautiously. Clinical characteristics that were statistically significant between the provincial and international samples were current weight (in lbs) and wait time at various time points (in months), p < 0.05. Provincial recipients were heavier and on average waited longer to be processed for surgery compared with the international recipients. The study's response rate was ∼6% from the provincial sample and 0.04% from the international sample.
Themes from open-ended questions
What was the most useful (before, during, and after surgery)?
The independent analysis of the provincial and then international data revealed three identical themes, which are presented together, followed by the one theme that is unique to the provincial data only. The most useful support and services that participants in both the provincial and international groups reportedly received were the expertise and encouragement of the bariatric team members; the experiences and encouragement from a peer or support group (in-person and/or online), and from online resources. Provincial participants noted these themes occurring predominantly “Before” and “After” surgery, whereas international participants expressed the themes occurring throughout the surgery process.
The support from family and friends was described as especially helpful in terms of ongoing encouragement and understanding throughout the entire surgical process. For the time point “During” surgery, the time between the previous appointment with the clinic team and up to the first postsurgical follow-up appointment, provincial participants emphasized the support from the hospital staff as among the most useful service that they received (see Table 5 for illustrative quotations).
What was needed but not received (before, during, and after surgery)?
On separate analysis of provincial and international data, only one theme was found to be similar between both groups, and two themes were unique in each data set. What both provincial and international groups consistently emphasized as needing “After” surgery was access to immediate follow-up for their questions to be answered about nutrition-specific information and for general postsurgery concerns. Participants felt that the aftercare information delivered immediately postsurgery would be more applicable and would better support their recovery and adjustment than when it was delivered before surgery.
For provincial participants, in-person and remote access to nearby professional support and flexibility in arranging appointments with various bariatric team members for the same time and with consistent providers were two unique unmet needs. For international participants, the theme of more support from family and friends was, in particular, a need “Before” the surgery; otherwise, there were no other services or support needed in the process (see Table 6 for quotations reflective of the themes identified).
What overall expectations were met and not met?
All themes regarding participants' met and unmet expectations were unique to the provincial and international samples. Three themes regarding provincial participants' expectations included: (1) the amount of information was sufficient, with the caveat that additional required information should be easy to access; (2) additional training and education in bariatric care is required by family doctors to improve understanding of bariatric-related concerns; and (3) more thorough disordered eating assessments and in-depth psychological counseling and support are needed.
Three different themes emerged from the international data regarding participants' expectations: (1) weight and health (comorbidities) expectations were met; (2) concerns about the cost for skin removal, and potential skin and body image issues; (3) concerns about slow weight loss, weight maintenance, and weight regain (see Table 7 for quotations that exemplify these themes).
Note: No shared themes regarding met and unmet expectations.
What are the current support and service gaps, and related recommendations?
Provincial and international data revealed that one shared current support and service gap as well as one similar recommendation, followed by two unique themes from each data set. Both provincial and international participants independently recommended the creation of a communication center and mentorship program between veteran recipients and prospective surgical candidates that is accessible in-person, by phone, and/or online to address current support and service gaps.
Themes about current support and service gaps that are unique to provincial participants included receiving misinformation about skin removal and requiring additional Ontario Health Insurance Plan (OHIP) assistance (i.e., Ontario's government-run health insurance plan for residents). They also underscored the importance of receiving credible information from a bariatric professional that is accessible in-person, by phone, and/or online. Several participants mentioned the caveats of receiving knowledge and advice from bariatric peers versus bariatric professionals, in which the latter could reliably provide more clinically accurate information. However, participants still recognized that the support and experiences shared by peers were invaluable.
For international participants, the provision of counseling and support beyond 1 year after surgery as well as the receipt of rigorous postsurgery programming (including education, nutrition instruction) were identified as two support and service gaps (see Table 8 for quotations supporting themes).
Overall, many of the themes detailing the experiences of those engaged in the bariatric process provincially overlapped the themes derived from the experiences of international surgery recipients. Although the provision of healthcare may be unique in different areas, many of the needs and experiences of bariatric surgery recipients were shared regardless of geographical location.
Discussion
The purpose of the cross-sectional needs assessment study was to gain an understanding of what individuals who are engaged in the bariatric surgery process believe they need before, during, and after bariatric surgery to best support their long-term health and well-being, both provincially in Canada and internationally. Themes for what was the most useful included encouragement from family, friends, bariatric team members, and peers. Access to immediate follow-up appointments after surgery for nutrition-specific and general postsurgery concerns was reported as needed but not received. Recommendations to address excess skin and creating a mentorship program were proposed.
Age, ethnicity, education, current weight, and wait time at various time points were statistically significant between the provincial and international samples. Generally, the provincial sample was made up of older, Caucasian participants who had attended college or university compared with the international sample that was made up of younger, non-Caucasian participants and with a smaller proportion that had attended college or university. However, given the lower proportion of international respondents who provided their ethnicity and education compared with the provincial respondents, the pattern observed of the actual responses for the two demographic characteristics should be interpreted cautiously. In terms of clinical characteristics, provincial participants had a higher current weight and generally waited longer throughout the surgery process. Although it was anticipated that more distinctly unique insights between the provincial and international samples given assumed differences in and influence of culture, including healthcare funding, many of the needs and experiences of bariatric surgery recipients were shared between both samples.
The initial step of the needs assessment was to identify themes regarding what served the respondents the most in the bariatric surgical process, an essential first step in future program planning. 24 Both provincial and international participants noted the expertise and encouragement from bariatric team members as one of three most useful support and services received. In fact, communication between a health professional and patient in a care setting has been shown to be associated with patient satisfaction, adherence to treatment, and improved health outcomes for various conditions.37,38
Provincial and international participants' appreciation for the encouragement received by their peer and support group members was another useful support and service in their surgery process. This theme complements Song et al.'s finding of regular support group attendance, potentially providing bariatric patients with a greater chance of achieving maximal weight loss. 23 Similarly, in Sharman et al.'s Australian perspective of bariatric needs, dietetic and peer support were identified as important factors that could help influence weight reduction and health improvements. 25
Another shared theme that served the target population was the support from family and friends. In Zwickert and Rieger's report examining obese women's experiences of social support and weight management, the researchers found that participants felt that their significant others' behaviors interfered with their weight control efforts, and, in turn, negatively compounded their weight management behaviors. Some participants experienced loved ones' weight-related comments to be unhelpful, because they tended to take the form of criticism or unsolicited advice. 39 Zwickert and Rieger's study highlights the importance of receiving positive and adequate support from family and friends, which the current study's participants reported as being the most useful support and service in the bariatric surgery process. 39
Themes involving what served the respondents the most in the bariatric surgical process assisted in completing the first step in future program planning; the next step was to identify what concerns or requirements were not received to proceed with the program planning process.
Most of the themes regarding what was needed but not received were unique between provincial and international participants. Provincial participants expressed the need for in-person and remote access to nearby professional support and the need for flexibility in arranging appointments with the same providers. Despite conflicting results in the literature about whether accessibility and travel distance were potential contributors to non-compliance,40,41 it was hard to ignore provincial participants' desire for greater access and flexibility in arranging appointments.
Both provincial and international survey respondents expressed their overwhelming need for access to immediate follow-up services after surgery for nutrition-related issues and for general questions. Participants felt that a review of the aftercare information closer to postoperative recovery, which mirrored the information received preoperatively, would better support their recovery and weight management goals. In a large cohort study by Spaniolas et al. that assessed the effect of postoperative follow-up on 12-month weight loss, the authors found that patient adherence to postoperative follow-up guidelines was independently associated with improved 12-month weight loss outcomes after surgery, such that complete follow-up (i.e., appointments at 3, 6, and 12 months) was associated with excess weight loss ≥50%, and total weight loss ≥30%. 42 Spaniolas and colleagues concluded that bariatric programs should strive to achieve complete follow-up for all patients, which would be useful for future program planning. 42
As discussed by Sharman et al., bariatric health professionals should discuss recipients' needs to ensure gaps in support and services are addressed and resolved. 25 The aforementioned research also coincided with provincial and international participants' desires for more immediate follow-up, which could, in turn, lead to improved long-term health and well-being outcomes among this population.
A common issue shared between both groups related to skin removal costs and concerns postsurgery. All participants were especially bothered by and concerned with how to deal with excess skin and skin folds, which are common in bariatric surgery patients after significant weight loss. 43 According to Lier et al., hanging skin can be problematic in daily life for those experiencing it postsurgery. 44 The authors mentioned that it is possible for former surgery recipients to feel a constant reminder of their former selves that can impact their body image. 44 In addition, according to Gilmartin, body image can influence a patient's emotional well-being after significant weight reduction, and these concerns can last over time and further contribute to psychological stress. 45
Currently, skin removal is only partially covered by some public and/or private insurance companies depending on certain qualifications and under special circumstances; thus, participants must cover the remainder cost of the procedure, if required. Therefore, addressing concerns about skin removal openly and honestly in bariatric programs with the bariatric team may alleviate potential postsurgery and financial stress experienced by provincial and international patients.
Provincial and international participants also shared an interest in establishing a mentorship program that could be accessible in-person, by phone, and/or online. Respondents proposed the idea of being paired up with someone who had already gone through the surgery and who could voluntarily provide them with one-on-one support. All participants felt that their questions and concerns could be more easily answered and their expectations could be better defined when speaking to a bariatric “veteran.” According to Zwickert and Rieger, the majority of bariatric recipients are more receptive to a “support person” who is able to balance acceptance and genuine care in pursuance of weight loss goals. 39 A bariatric mentor may be a potential “support person” who can provide encouragement and sympathize with the bariatric recipient having gone through the same process already along with sufficient knowledge about the bariatric process.
Participant recruitment from a local support group to pilot test the survey questions may have reduced the generalizability of the results to all bariatric surgery recipients (in Ontario and worldwide). The small size of the provincial and international study samples was another limitation in the current study. Our response rate was ∼6% from the provincial sample and 0.04% from the international sample; it is unknown whether all support group members listed were active, and/or whether the members saw the recruitment posting and chose not to participate from our various support group and online forum sampling. However, given that many of the themes overlapped between both samples, the meaning and richness of information provided in the surveys was of greater significance than the number of those who participated. The survey responses accumulated from each study sample provided a greater understanding of surgery recipients' perceptions of their met and unmet needs.
To our knowledge, this was the first study examining bariatric-related needs and experiences in both groups detailing themes that were unique provincially (from a publicly funded healthcare system point of view) or internationally, and themes that were shared among all bariatric surgery recipients. Whether or not bariatric programming and healthcare funding allocation differs around the world, a majority of the experiences and perceptions that were expressed in the current study were shared among recipients, regardless of their geographic locations.
Conclusions
Necessitating the implementation of a support system in the bariatric process may be required in future surgical programming. Moreover, ensuring more flexibility in scheduling, access to consistent providers, and immediate follow-up may be needed to better support individuals engaged in the bariatric process. The concern about skin folds and costs shared by recipients may require additional preparation and education during the orientation for future bariatric services. What bariatric surgery recipients believe they need before, during, and after bariatric surgery to best support their long-term health and well-being provincially in Ontario, Canada, and from around the world are, to an extent, widespread, regardless of funding type.
All the aforementioned findings can contribute to the medical programs and surgical services provided by the province's bariatric clinics, as well as provide considerations for healthcare frameworks that are similar to Ontario's experience of an increased need and capacity for bariatric surgery. This study provides a summary of patient needs and expectations, which can ultimately assist clinical teams in efficaciously addressing the gaps in bariatric programing, and help to prevent weight regain among surgery recipients. Future research and program planning should consider incorporating the findings of what bariatric recipients perceive they need for optimal health outcomes from the current study into bariatric surgical practice. In doing so, these bariatric programs can more efficiently provide effective prevention and treatment to surgery recipients in bariatric care settings.
Footnotes
Acknowledgments
The authors would like to thank all the participants and support groups for sharing their experiences in this study. They extend their appreciation to Dr. Chris Lee for his statistical support, Dr. Leigh Vanderloo for her editorial assistance in preparing this article, and Ms. Linda Terrio for her assistance with participant recruitment.
Author Disclosure Statement
No competing financial interests exist.
