Patient DOI 10.1007/s40271-017-0275-3

ORIGINAL RESEARCH ARTICLE

Patient-Reported Outcomes Following Ventral Hernia Repair: Designing a Qualitative Assessment Tool Martin J. Carney1 • Kate E. Golden2 • Jason M. Weissler1 • Michael A. Lanni1 Andrew R. Bauder1 • Brigid Cakouros2 • Fabiola Enriquez1 • Robyn Broach1 • Frances K. Barg2,3 • Marilyn M. Schapira4 • John P. Fischer1

•

 Springer International Publishing AG 2017

Abstract Background Current hernia patient-reported outcome (PRO) measures were developed without patient input, greatly impairing their content validity. Objective The purpose of this study was to develop a conceptual model for PRO measures for ventral hernia (VH) patients. Methods Fifteen semi-structured, concept elicitation interviews and two focus groups employing nominal group technique were conducted with VH patients. Patients were recruited between November 2015 and July 2016 over the telephone from a five-surgeon patient cohort at our institution. Iterative thematic analysis identified domains. Reliability and validation were achieved using inter-rater reliability checks and triangulation. Results Seven framework domains were established: (1) expectations; (2) self and others; (3) surgeon and surgical team; (4) sensation; (5) function; (6) appearance; and (7) overall satisfaction. Overall patient satisfaction was associated with two themes: (1) provider–patient relationship; and (2) patient assessment of post-repair improvement.

& John P. Fischer [email protected] 1

Division of Plastic Surgery, Department of Surgery, Penn Presbyterian Medical Center, University of Pennsylvania, Perelman School of Medicine, 2nd Floor Wright-Saunders Building, 51 N. 39th Street, Philadelphia, PA 19104, USA

2

Mixed Methods Research Lab, University of Pennsylvania, Philadelphia, PA, USA

3

Department of Family Medicine and Community Health, University of Pennsylvania, Philadelphia, PA, USA

4

Division of General Internal Medicine, University of Pennsylvania, Philadelphia, PA, USA

Conclusions VH patients experience a profoundly broad range of reactions to VH repair. A patient-informed PRO instrument that addresses the spectrum of patient-identified outcomes can guide practice, optimizing care targeting VH patients’ needs.

Key Points for Decision Makers In an effort to create a ventral hernia patient-reported outcome (PRO) survey, we discuss the first portion of our prospective data collection. We contribute the framework for a novel PRO tool for future study and publication. This initial phase evaluation for PRO development confirms seven domains must be included: (1) expectations; (2) self and others; (3) surgeon and surgical team; (4) sensation; (5) function; (6) appearance; and (7) overall satisfaction.

1 Introduction Ventral hernia (VH) repair (VHR) is a common and challenging surgical procedure. Current estimates suggest that nearly 350,000 VHs are repaired each year, costing over US$3 billion in the USA [1, 2]. Even when the best techniques are employed, approximately one in three repaired hernias will recur and each subsequent repair carries increased complexity and risk. Thus, VH remains a public health issue with a need for improved treatments or

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preventative efforts [3, 4]. While many surgeons would agree that outcomes are judged by morbidity and recurrence, it is vital to include the patient perspective in what defines a successful outcome. Patient-reported outcomes (PROs) are becoming more popular in various practices and research studies [5, 6]. PROs are technically a subset of patient-reported measures, but will be used here as encompassing all aspects of patient preference and qualitative outcomes. The existing validated PRO instruments that have been applied to VHR are limited in number and quality [7–12]. Older measures often lack disease specificity, while newer ones have been generated without patient input, and thus are believed to have limited content validity [10]. The provider-only-based input represents a knowledge gap as patient concerns may not be addressed in the existing instruments. These instruments can also be cumbersome and too time intensive for effective integration into care [13]. When short enough to be implementable in clinical care, currently available PROs fail to focus on several domains that are critical across other PROs in reconstructive surgery, such as expectation, aesthetics, and satisfaction with care [6–8]. Patient-centeredness and engagement are the cornerstones of developing a valid and reliable PRO instrument, and this is currently missing in the field of hernia surgery. For these reasons, there is a significant need for the generation and validation of a disease-specific hernia PROs. Qualitative research methods, which are gaining in popularity in surgical literature, are particularly well-suited to capture patient and stakeholder perceptions [14]. The goal of this study is to develop a PRO that includes patients’ perspectives on VH so that a more patient-centered instrument can be developed and tested. Defining an accurate conceptual framework is the first step to this ultimate goal. Semi-structured interviews and patient collaboration in this study will lead to a reliable PRO instrument specific to VH with substantial content validity, built from the onset with patient partnership.

2 Methods 2.1 Study Context and Overview This research was approved by our Institutional Review Board (protocol #823282) at the University of Pennsylvania in the USA, where all of the interviews were conducted. A pool of patients with a VH diagnosis who were repaired by five surgeons within our institution between 1 January 2007 and 1 January 2015 were identified by the Data Analytics Centers using the Current Procedural Terminology (CPT) and International Classification of Diseases, Ninth Revision (ICD-9) diagnostic codes. One author (ML) reviewed the electronic medical records of the patient pool to ensure accuracy of the subjects to be invited and to characterize their medical history. We sought to identify 15 patients through purposive sampling. Recruitment was done on a rolling basis to maximize subject variation and allow adequate patient representation in terms of age, sex, race, hernia etiology, success of primary fascial closure, complications, and recurrence. Eligible patients were invited via mail with a follow-up telephone call. Semistructured interviews were conducted over the telephone with VH patients between November 2015 and July 2016 by trained, qualitative interviewers (KG and BC). Interview length averaged 41.2 min (range 24–59 min) (Table 1). Semi-structured questions were developed by the research team and were based on a preliminary conceptual hernia framework developed by a team member (AB). The framework’s goal was to articulate ‘what matters’ to hernia patients via a clinically derived set of domains. Domains were informed by plastic surgery principles relating to appearance and function as well as the senior authors’ experiences treating hernia patients. Interview questions were grouped into the following broad categories: (1) expectation of surgery and recovery; (2) quality of life, including mobility and motility; (3) abdominal wall health related to function, appearance, and pain; and (4) satisfaction with VHR (see example interview questions).

1. Why did you have the surgery? 2. Describe what life was like for you aer you got the hernia but before you had surgery with Dr. ______________. 3. Tell me about your experience having surgery. Describe your thoughts immediately aer surgery, when you woke up in the hospital. How did those thoughts change in those early days of recovery, if at all? 4. What did you think recovery would be like?

Ventral Hernia Patient-Reported Outcomes Table 1 Current Procedural Terminology (CPT) and International Classification of Diseases, 9th Revision (ICD-9) code search

Code

Description

551.20

Unspecified ventral hernia with gangrene

551.21

Incisional hernia with gangrene

551.29

Other abdominal wall hernia with gangrene

552.20

Unspecified ventral hernia with obstruction

552.21

Incisional hernia with gangrene

552.29

Other abdominal wall hernia with gangrene

553.20

Unspecified ventral hernia

553.21

Incisional hernia

553.29

Other abdominal wall hernia

49560

Repair initial incisional or ventral hernia; reducible

49561

Repair initial incisional or ventral hernia; incarcerated or strangulated

49565

Repair recurrent incisional or ventral hernia; reducible

49566

Repair recurrent incisional or ventral hernia; incarcerated or strangulated

In addition to predetermined questions, trained qualitative interviewers used inductive probing to elicit emergent concepts. The interview used open-ended questions to elicit reactions to or descriptions of patient experience in difference areas (i.e., appearance, pain). Generally, however, the nuanced concepts, particularly psycho-social ideas, that patients often relayed were spontaneous. As data were collected, additional probes and two additional questions relating to provider role were added to the interview guide to deepen our understanding of emergent concepts. All interviews were audio-recorded, transcribed verbatim, deidentified, and checked for accuracy against the original recording. Transcription was managed by a professional transcription agency (ADA Transcription, Mt Holly, NJ, USA). Cleaned transcripts were then entered into NVivo10, a software program that facilitates qualitative analysis. Two focus groups conducted at our institution on 14 June 2016 and 16 August 2016 included patients recruited from the interview pool. The first group of three patients and their respective partners (n = 6) utilized nominal group technique (NGT) to identify the relative importance of concepts related to VH repair, recovery, and satisfaction that emerged during interviews. The second group of seven VH patients employed NGT to gain group consensus on concepts related to physical appearance. The team used a preliminary conceptual hernia PRO framework (Fig. 1) as a starting point. This original framework included clinically derived domains from plastic surgery principles as well as the senior author’s experiences treating hernia patients. The framework guided topics for inclusion in the interview. 2.2 Data Analysis The team drew from Constructivist Ground Theory principles [15], using various iterative methodologies to

Fig. 1 Description of the proposed, novel, disease-specific domain within our preliminary patient-reported outcomes model called abdominal wall health. ADL activities of daily living, AWH abdominal wall health

examine a priori and emergent concepts related to patients’ pre- and post-hernia repair experiences. Simultaneous data collection and analysis were used to identify and compare high-level, domain-centered and emergent themes. We tracked the presence and nature of themes during the data collection period using memo-ing, a technique used to document the progression from idea to theme [16]. This resulted in nine themes, similar to, but distinct from, those identified in the original framework. We operationalized definitions per theme and two team members (KG and BC) applied them to existing interview data to assess their fit across the dataset. Application of the codes proved limiting as domains did not reflect the depth and breadth of participant perspectives. To resolve this, two team members (KG and BC) separately conducted open coding on two

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randomly selected uncoded transcripts to improve the representativeness of our approach. Memo-ing documented this process and addressed discrepancies. After revising our interview guide to intentionally explore emergent concepts, adaptations were again made and documented using memos, resulting in a revised set of seven thematic codes. After operationalizing definitions, codes were applied to all 15 transcripts. Inter-coder reliability, a measurement used to assess how accurately separate coders apply codes to the data, was completed using Cohen’s kappa statistic across 20% of the sample or four transcripts (mean kappa = 0.99), indicating high reliability [17]. Thematic saturation was determined at 15 interviews when no new themes emerged, as evidenced by the quantity and comprehensiveness of associated, coded narrative [18, 19]. Queries also demonstrated that all seven codes were referenced by each respondent, indicating their robustness. Triangulation was then completed to determine the trustworthiness of findings through comparison to relevant data sources [20, 21]. This was achieved in two ways. First, two focus groups composed of ten VH patients and three partners (n = 13) were asked to react to, rank, and revise pilot survey items generated from, and grouped by, themes using NGT to establish consensus on the items most relevant to a pilot hernia survey measure. Respondents reacted positively to the items and their groupings, indicating that their individual hernia experiences were aligned. Secondly, four VH patients performed member checking, a participant-driven technique for assessing the representativeness of qualitative findings ascertained by the research team [22]. In this case, respondents were explicitly asked to critique a draft hernia PRO tool organized by domain and comment on its applicability to their experience. They expressed support for its inclusivity and representation of the patient hernia experience.

3 Results To achieve our sample of 15 participants, a pool of 295 patients operated on by five different surgeons were identified by CPT and ICD-9 codes as potential respondents. A subset of 110 patients was invited via mail. Follow-up telephone calls were made to 79 patients, of whom 18 agreed and seven refused. Two who agreed later refused. The team contacted patients who ranged in age, sex, hernia etiology, and success of primary fascial closure to ensure sample variation. A rolling approach was used to maximize variation. Sixteen semi-structured interviews were conducted with VH patients between November 2015 and July 2016, although there was one instance of an audiorecording malfunction, resulting in 15 usable interviews.

Table 2 Patient demographics Patient information

Value

N

15

Age at interview [years (range)]

60.8 (44–86)

Years post-operative (range)

3.3 (1–7)

Male sex [n (%)]

5 (33%)

BMI [kg/m2 (range)]

34.8 (23–43)

Primary fascial closure

9

Number of repairs (range)

2.7 (1–5)

BMI body mass index

Patient demographics are described in Table 2. Patients’ self-reported frequency of hernia surgery averaged 2.1 (range 1–5, standard deviation 1.4). This included surgery by providers outside the University of Pennsylvania Hospital System. Seven domains were identified that represent patientinformed VH experience: (1) expectations; (2) self and others; (3) surgeon and surgical team; (4) sensation; (5) function; (6) appearance; and (7) overall satisfaction. All 15 patients mentioned each concept, with the exception of the surgeon and surgical team, which was mentioned by 14 of 15 respondents. A patient-informed framework (Fig. 2) was developed that describes relevant quality-of-life, physical, and psychosocial concerns that patients associated with VH and its repair. 3.1 Expectations The Expectations domain highlights the significance of VH repair and recovery expectations to the overall patient VH experience. Some reported feeling prepared while others were surprised by unanticipated outcomes of the surgery and/or the repair. Two groups of expectations emerged, one primarily relating to the patient and the other to the surgical team. First, most patients (14/15 or 93%) had a history of abdominal surgeries that colored their expectation of, and approach to, VHR surgery. Past surgical experiences could assuage or generate anxieties about recovery. Second, patients discussed the degree of preparation relative to hernia repair and recovery offered by their surgeon or surgical team. This preparation was central to addressing surgical procedure questions, forecasting complications that may impact recovery, or providing clarity about the nature of the repair outcome. ‘‘I was aware that it could happen…I mean, it wouldn’t have been so bad if the infections and the lesions didn’t develop and I didn’t have the bouts of MRSA [methicillin-resistant Staphylococcus aureus] and all.’’

Ventral Hernia Patient-Reported Outcomes Fig. 2 Patient-informed framework for a ventral hernia patient-reported outcome

3.2 Self and Others The self and others domain references the psychosocial effect that VH or its repair can have on the patient, his/her sense of self, or relationships with others across social contexts including family and intimate partnerships. In general, patients described anxiety related to the surgical procedure and the possibility of recurrence. Many also referenced embarrassment of their pre-repair body. The recovery period was marked by emotional reactions to modified social roles and to an altered quality of life. One patient explained how her sense of self and her relationship with her parents changed after moving in with them to recover: ‘‘…I couldn’t leave my bed for six months and then two months for two years in a row. I was living with people in their late 60 s and so I became mentally almost geriatric. And then when it was time to leave the coop, I struggled with that transition.’’ Post-recovery, patients described the varying effects of the VHR on one’s sense of self. One explained its impact on her sexuality, ‘‘I don’t feel sexy any more. I got a scar. Who wants to look at a scar? I mean, I know it’s probably all in my mind. But I mean it’s there, and it’s something that I can’t put no salve on or I can’t hide it, it’s there’’. Others felt better about themselves, ‘‘You know, life has its problems and stuff, but as far as that—ups and downs and stuff, I just feel a lot better. Physically, emotionally…[The hernia]’s not been to the front anymore. It’s good’’. 3.3 Surgeon and Surgical Team The Surgeon and Surgical Team domain underscores the crucial role attributed primarily to surgeons, but also included nurses and others associated with patient care

during the VHR procedure and recovery period. Two groups of characteristics related to provider quality emerged: technical skills and interpersonal skills, including responsiveness, sensitivity, and investment. Many patients attributed the success of their surgeries to the quality of care provided by knowledgeable, technically proficient providers. About one-third of patients reported that their VH was unusually difficult and would require specialized expertise. Although rarely mentioned, a negative clinical experience could impact the patient’s view of doctor’s competency. In one patient’s experience, providers’ lack of efficiency with medication management tainted her assessment of the quality of her experience: ‘‘…the surgeon, Dr. [Last Name 1] felt very confident. However, it didn’t work out that way, and the surgical team did not really support him in the matter of making sure medicines, such as an anticonvulsant was delivered on time or things of that nature’’. Most patient descriptions of providers, however, focused primarily on interpersonal factors. Patient reflections on engagement with providers reflected a perception of sensitive, patient-focused care. In general, care that engendered a feeling of being cared about, or invested in, was consistently noted in provider descriptions. Intentional, customized care was meaningful: ‘‘… I thought I could die. I thought I was—I had panic attacks. He was able to help me by—we had a plan in place. And so that helped me calm down…it couldn’t have gone better.’’ 3.4 Sensation The term ‘pain’ was found insufficient for capturing the range of descriptive terminology used by patients. Those

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who did use pain as a descriptor typically characterized it as an intense intermittent or episodic feeling that often necessitated immediate alleviation using patient-identified techniques (see Function domain; Sect. 3.5). Conversely, a few challenged the description of the hernia as painful at all. For example, one patient who had an untreated hernia for 12 years explained, ‘‘No, there was no pain. It wasn’t that kind of a thing’’. Pre-repair descriptions included it being sore, annoying, uncomfortable, constant pressure, sharp, throbbing, terrible, or extreme. Post-repair descriptions included discomfort, burning, pulling (attributed to the mesh attachment point), itching, like a ‘‘pulled muscle’’, tender, numb, tight, taut, or as though there were something ‘‘that wasn’t supposed to be in there’’. 3.5 Function Patients described how the repair impacted movement or strength, affecting activities of daily living (ADL), work, or sexual activity. This domain represented both pre- and post-hernia repair status. During the pre-hernia repair period, patients referenced a variety of self-taught methods for mitigating the discomfort, pain, or inconvenience associated with the hernia, improving function. About half of patients would ‘‘push [the hernia] back in’’. Other techniques included wearing support garments, altering sleeping positions, or ‘‘…laying down a lot because that took the pressure off and helped get things back in where they belonged’’. The effect of the hernia ranged from impacting eating or drinking, limiting work to reducing the frequency of, or positions used, during sexual activity: ‘‘…not to get personal, but sexual—it’s been—because I’ve had tubes,—so that has been hard with my husband because of certain movements, I’m afraid of—so that has been hard’’. Daily activities were affected such as lifting household items, bending over to tie shoes, or sitting up from a prone position. For most the effect was manageable: ‘‘Well, I wore a lot of loafers. I couldn’t really tie shoes because I’d have to bend over for too long’’. For a few, the impact was described as life altering, ‘‘It’s tough. It’s changed. Your whole life is changed’’. After the repair, patients generally reported improved function, although some reported a degree of limitation. As one patient explained, ‘‘I’ve adapted as to how I can move, and that’s just a way of life now’’. These lifestyle changes were not typically viewed as problematic but were more often conceptualized as a new normal. Patients also reported feeling openly cautious about the type of movement or activities undertaken to reduce the likelihood of recurrence. Patients who experienced complications often reported co-morbidities (e.g., diabetes mellitus, pancreatitis) or other medical conditions (e.g., infected mesh, motorcycle accident) that were perceived to exacerbate

function difficulties. Drains were a typical problem and in one patient’s experience were an intermittent issue for 4 years post-repair, worsened by bouts of pancreatitis. 3.6 Appearance The Appearance domain was divided into two temporal categories relating to pre- and post-VHR. Within those categories, themes relating to the physicality of the abdomen and dress emerged. Appearance was inextricably linked to the patient’s view of him/herself and how s/he connected to others in social contexts including the workplace, family and, to some degree, sexual relationships. In terms of pre-hernia repair themes, first, the physicality of the hernia including any bulging or protruding was described. Second, psychosocial impacts of this on the patient’s style of dress were discussed. For example, patients cited issues of privacy and embarrassment inciting many to ‘‘cover up’’ protrusions. In terms of post-repair experience, patients described changes to the abdomen, including its size, dimensions, contour, scarring, and presence or absence of navel. While some patients expressed sensitivity about the way that the changes to their bodies were perceived or viewed, in general, patients expressed little concern about these aesthetic changes. Patients also described changes to dress post-repair and its effect on their sense of normalcy, citing both improvements and frustrations with the type of clothing they might comfortably be able to wear (Table 3). 3.7 Overall Satisfaction Across these domains, patterns emerged suggesting that overall patient satisfaction was related to two emergent themes. The first theme focused on the patient–surgeon relationship which characterized the vast majority of patient reflections on their overall VHR experience. Respondents attributed satisfaction with their surgery, regardless of the complexity of recovery or manifestation of a recurrence, to their providers. The patients who characterized their experience positively, even in the presence of a less than optimal outcome, felt strongly about their provider as both an individual and as a surgeon, ‘‘That’s why I went back to him. So like I said, I’m pretty high on the guy’s ability’’. Similarly, an unanticipated, problematic outcome could affect the patient’s satisfaction with the outcome of surgery but tended not to affect the patient’s general happiness with the provider. One patient who felt that her surgeon ‘‘messed me up’’ still described him positively, ‘‘You can’t blame the doctors or the hospital’’. The second pattern related to overall satisfaction involved a patient’s individual assessment of his/her post-

Ventral Hernia Patient-Reported Outcomes Table 3 Framework domains and dimensions Domain

Dimensions

Example quotation

1. Expectations

Impact of patient surgical history

Yeah, because now that I got experience and I know a little more about it now, whereas the first time, I didn’t know nothing about it, so I was a little paranoid

Provider’s impact on patient expectations

I kinda suspected that was gonna happen, but nobody actually said anything about [loss of navel] before the surgery. …You should always be told…

Adapting to modified conceptualization of self

Oh, I feel a lot better about myself, just because it’s gone It’s been really a blessing, yes. Impacted greatly. I feel better about myself. I’m not like a person that, I have to look like this or have—no. Especially like, I’m older and stuff, but I just feel more comfortable

Experiencing shifting relationships across social contexts

My wife was more like my nurse… She changed my bandages… It was kind of hard for her to do those things because she didn’t like what it looked like. Like I said, at one point in time, she was reaching in my stomach with her whole hand. So you can imagine

2. Self and others

So that, I think, has affected my relationship with—some friends will be like, oh, you’re not back to work yet? Because I look presentable and I look like I’m all together. Meanwhile, I’m in excruciating pain and I have this tube sticking out of me 3. Sensation

Range of sensation felt at hernia or hernia repair site

It wasn’t really pain. It was sore… Annoying… All of the time

Mesh sensation

You still feel some pain in the incision area, some pulling inside where I guess they put the mesh… Feels like little burns. They always told me that was where they hooked it to the other muscles, the mesh, to repair it

4. Function

Effects on activities of daily living or quality of life

Well, I can’t really do any exercises with that, so no. It’s about the same. It’s good. I do them when I can, yes. But I can’t do any core. But otherwise, yeah. I can do any of that

5. Appearance

Bodily appearance (e.g., scar, contour, navel) and effects on patient

I don’t like the way my stomach looks now, you know what I mean, because it got the scar. When people see the scar, they—everybody want to know how I got the scar… So no, I don’t like it… It brings back, you know what I mean, what happened. But I deal with it So we tease, oh, I’m an alien, I don’t have a belly button. But you don’t realize how much something like that—you just feel—I don’t know

Dress and its effect on patient

6. Surgeon and surgical team

7. Overall Satisfaction

Technical skills

But I still struggle with wearing pantyhose or tights in the winter. And I’m a professional so I had to change my wardrobe… I’m restricted a lot fashion-wise, and for me that’s a big deal. I’m a consultant and a sales person and it’s important how I look We tried to find him, because he was the only one that would take on my case… That’s how bad it was. He was the only one that would do it

Interpersonal skills

…he’s a pretty good guy. Like I said, if you ever met him, he just—he has the demeanor of my grandfather… But he just has that calm—he don’t have the arrogant, cocky doctor attitude

Patient–surgeon relationship

…we had a plan and I felt completely supported by the team, and even the aftercare, I felt really supported, that I would have told you, you would have never gotten me back into a hospital for surgery. And I was able to do it. So that was a good thing about it

Patient assessment of post-repair quality of life

I just want to be well. I can’t do what I used to. I just want to go back to the way I was. And I thought doing the—getting the hernia fixed would make me feel better. Are you kidding? I should have left it alone. Oh, my God And the results. I mean, my stomach was—even though, again, it’s pretty ugly looking, but the fact that it wasn’t like this—I mean, it hurt. The hernia hurt. It was a big strain and it was ugly. So I think that it looked better and I felt better

repair improvement. This varied widely among respondents, implying that this highly personal perspective reflected each individual’s personality, lifestyle, preferences, and age. Notably, individuals’ views did not depend on the outcome of the repair but focused on the patient’s

ability to live his/her life on his/her own terms. For example, one patient described having to manage ‘‘7 or 8’’ years of infections stemming from a series of reconstructive surgeries complicated by his hernia repair. A frequent work traveler, he discussed continued embarrassment with

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the Transportation Security Administration (TSA) over his drains and general frustrations related to his health state. He questioned the technique used during his original surgery, a bowel resection that led to his hernia repair, and described how it harmed his quality of life and recommended that providers be ‘‘a little bit more honest’’. Another patient with a lifetime history of surgeries resulting in a post-traumatic stress disorder (PTSD) diagnosis described having to manage debilitating pancreatitis made worse by the mesh implanted for her VHR. She referenced the negative emotional impact of repeat surgeries on herself, her young children, and her husband. Yet, she characterized her overall experience more positively. These examples illustrate how overall satisfaction is often assessed in accordance to individual perspectives and is not necessarily dependent on the presence or absence of complications or, in some instances, recurrence.

4 Discussion We discovered tremendous variability in individual patient perception of experience regarding hernia repair. These unique perspectives demonstrate the complexity of PRO framework development within a heterogeneous surgical population. This initial-phase evaluation for PRO development confirms seven domains must be included: (1) expectations; (2) self and others; (3) surgeon and surgical team; (4) sensation; (5) function; (6) appearance; and (7) overall satisfaction. The final grouping of patient satisfaction is further divided into two themes: (1) provider–patient relationship; and (2) patient assessment of post-repair improvement. These pillars of the PRO provide a foundation for subsequent stages of PRO development including psychometric testing. Complex abdominal wall reconstruction patients present a unique challenge for PRO development when multiple surgeries and complications ensue. Whether an initial hernia, recurrence, or surgical complication, these disease states severely impact abdominal wall function, ADL, return to work, health-related quality of life, and sexual well-being, while creating long-term pain [8–11, 23–25]. Without a working PRO validated through patient input, surgical experience will never be captured adequately. The future of this tool might open provider–patient dialog and influence change at the point of care. Combining patientdriven outcomes along with hernia technique improvement, the entire healthcare picture can be accounted for. Clearly, a disease-specific, validated PRO is necessary to understand these complex and challenging issues. The downstream effects of integrating a PRO measure into daily practice are likely to be profound. Clinical integration of these tools allows for the collection of

prospective quality-of-life data that can eventually be incorporated into a health system’s outcomes in a similar fashion as surgical results. This inclusion essentially redefines the meaning of a successful hernia repair, with the patient in the center of the discussion. As seen with PROs in other health states, a rigorously developed tool stands to directly impact a clinical experience by improving provider–patient interactions using data-driven techniques to optimally deliver care. Conceptualizing a working framework for thoughtful survey creation is paramount to building a functional model. PRO creation requires methodical testing broken up into three stages. Stage 1 involves framework inception as well as drafting of the items and answer choices. During this initial phase, the form should be fluid with room for continual modification in lieu of rigorous qualitative patient interviewing, focus groups, literature review, as well as consistent physician–champion feedback. Our tool has completed this first stage of patient–provider assessment. We will then create a subset of questions for each domain and determine their relevance through further cognitive interviewing. Our experience with Stage 1 has demonstrated more domains than are currently included in PRO measures in practice. We also hope that this will be the first truly validated PRO used for clinical hernia research. Stage 2 focuses on strict refinement of the tool itself through comprehensive cognitive interviewing. This stage allows for item synthesis as well as individual patient perception to generate immediate feedback and a cleaned product. Finally, Stage 3 involves psychometric testing in which large analysis of the questionnaire provides wide-ranging feedback. This analysis includes validity, reliability, scaling assumptions, data quality, and responsiveness [26]. However, there are certainly limitations to the current study. All patients were recruited from a single site within a high-volume academic medical center in the USA. This single sample is a limited representation, but certainly a first step in creating a functional PRO. Likewise, the conceptualization of domains is a necessary step to achieving our ultimate goal of creating a PRO that can be implemented in practice. Future work needs psychometric testing on a much larger scale to validate our PRO. We envision there to be both a pre-operative and post-operative survey encompassing all domains elucidated in this paper. This form will ideally be short enough (\10 min) to fill out in the clinical setting prior to visiting with the surgical attending. VH represents a substantial burden for both individual patients and healthcare systems, yet there is no comprehensive PRO measure in VH to guide practice, optimize care, and perform comparative effectiveness studies. Moreover, the existing PROs in VH suffer from a number of methodologic flaws [7, 8, 10–12, 27]. Patient advocacy

Ventral Hernia Patient-Reported Outcomes

for evidence-driven practice techniques incorporates a rounded dynamic to clinical care. Routine collection of this kind of data can assist individual physicians in measuring satisfaction and identifying problems with a clear opportunity to formulate a shared solution from the very beginning. The development and implementation in clinical practice of this tool stands to significantly impact care delivery and enhance the patient experience. This holistic approach to hernia repair may help redefine standards of care, putting patient safety and perspective as the keystone to successful outcomes.

5 Conclusions Current indices of hernia outcomes do not encompass the patient’s entire experience during VHR. Patients and surgeons share many goals throughout this process, yet categorization and synthesis of these topics have yet to be described and implemented. We propose the first stage of creating a PRO tool for better assessment of the patient perspective as a shared outcome to operative success. Acknowledgements We would like to thank the Penn Data Store for their assistance in assembling the information used in this study. Thank you to Rachel Russell from the Mixed Methods Research Lab at our institution for her support with data collection. Author contributions MC, KG, JW, ML, AB, BC, FE, RB, FB, MS, and JF: substantial contributions to conception and design, review and interpretation of references, drafting the article critically for important intellectual content, final approval of the version to be published, and agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All authors have given approval of the version to be published. Compliance with Ethical Standards Funding This research received Grant funding from the Edwin and Fannie Gray Hall Center for Human Appearance (CHA). Conflict of interest MC, KG, JW, ML, AB, BC, FE, RB, FB, and MS declare no conflict of interest. JF declares a Grant from Edwin and Fannie Gray Hall Center for Human Appearance during the conduct of this study. He is also a paid speaker and consultant for Bard Davol, Integra Lifesciences, and Misonix. Ethical approval This study was approved by the Institutional Review Board at the University of Pennsylvania in the USA for all portions of consenting, surveying, and data analysis (protocol #823282). Informed consent All participants in the study were consented in an informed manner as dictated and approved by the Institutional Review Board at the University of Pennsylvania. Patients were given the option to opt out at any point in the study.

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