Prospective Assessment of the Abdominal Hernia-Q... : Annals of Surgery (2025)

Ventral hernias (VH) are a common, chronic surgical problem facing any patient undergoing abdominal surgery.^1,2 Although traditionally thought of as a simple surgical issue, clinicians have come to recognize VH as a complex, multi-dimensional disease. For instance, patients with VH experience negative effects on whole-body fitness, including reduced truncal and extremity strength, creating significant downstream effects including restricted motion, increased pain, and difficulties completing activities of daily living.^3–6 Similarly, VH leads to adverse effects on psychosocial well-being and a negative impact on body image and mental health.⁷ Unfortunately, traditional clinical outcome measures incompletely capture and measure the complex disease burden associated with VH, including its impact on function, body image, and, subsequently, patient quality-of-life (QoL).^7,8

Patient-reported outcome measures (PROMs) have garnered growing support as a means of holistically characterizing a patient's health state.^9–11 When properly designed, developed, and tested, PROMs provide insight into a patient's QoL, enable monitoring of disease progression, and facilitate personalized care.^11–14 This is critically important in surgery, as patient perspective can guide clinical decision making and improve pre- and postoperative counseling.^10,13,15,16 Consequently, providers incorporated PROMs into VH patient's care, initially employing generic, nonspecific instruments - examples of these include the Visual Analog Scale¹⁷ and, more commonly, the 12-Item (SF-12) and 36-Item (SF-36) Short Form surveys.^18–20 However, to be useful to VH surgeons, PROMs must be tailored to capture disease-specific aspects of QoL and demonstrably measure changes after intervention.^21,22 Furthermore, they must be designed with content validity, psychometrically validated, and perhaps most importantly, easily implementable in practice.²³

To address these aforementioned needs, we designed the abdominal hernia-Q (AHQ) and detailed its development, from foundational qualitative work to extensive psychometric validation (Link: https://links.lww.com/SLA/B544).²² Although there are other hernia-specific PROMs available, namely the hernia-related-quality of life survery (HerQLes) and Carolinas Comfort Scale (CCS), the AHQ is unique in that it was rigorously designed for implementation with broad stakeholder input at all stages of development, underscoring the AHQ's fundamental content validity.^22,24–27 The AHQ is further differentiated from the HerQLes and CCS by measuring QoL in distinct hernia-related domains, including physical function, body image, and satisfaction with surgical care, all of which have been shown to be critical components of successful repair.^6,7 The multidimensional measurement offered by the AHQ facilitates targeted improvements in clinical practice, which may be critical as PROMs are utilized as performance measures and metrics for quality.^22,28,29 Although newly developed PROMs have emerged for a variety of surgical diseases, few have undergone rigorous testing of their clinical usability, including assessment of user burden in a diverse population, reliability of measurements, and sensitivity to change.^{15,26,27,30–33} Thus, we evaluated the AHQ, by measuring user burden, testing internal reliability through rigorous test-retest-ing, and explored the AHQ's psychometric properties through longitudinal, prospective administration throughout key timepoints in the surgical management of VH. These critical steps set the stage for widescale dissemination of the AHQ as a standardized PROM in an emerging area of surgery, termed Abdominal Core Health, in which VH is a critical area of surgical focus.³⁴

Methods

Patient Identification and Clinic Flow

This study was approved by the Institutional Review Board and all research subjects provided informed consent. Inclusion criteria for this study was any adult, English-speaking patient (>18 years) seen in clinic from January 2017 to December 2019 with a diagnosis of ventral, umbilical, parastomal, paramedian or epigastric hernia. Patients were eligible for the preoperative AHQ if they were scheduled for ventral hernia repair (VHR) within 6 months and for the postoperative instrument if they had undergone repair in the last 24 months. Patients meeting our inclusion criteria were identified by an advanced practice provider (APP) from the daily clinic schedule. At the start of each appointment, the APP administered the relevant AHQ form either on paper or with an iPad. IPads were purchased for research purposes, and locked onto the AHQ screen, preventing patients from scrolling to different pages. After completion, the iPads were wiped with disinfectant, and the APP recorded completed responses within the electronic medical record (EMR) as a part of the encounter note. Once uploaded, surgeons could view QoL data and individual item responses within the EMR.

Patient Burden

APPs provided the appropriate AHQ form to the corresponding patient and allowed sufficient time for completion. All preoperative and over 6-month postoperative patients completed the AHQ on an iPad, while patients within 6 months of VHR completed a paper form. Patients were manually timed, beginning from the moment they began reading and ending with completion of the final item. A retrospective chart review was conducted on all patients who were enrolled in this portion of the study. Demographic variables such as age, race, and ethnicity were abstracted from the medical record. Additionally, median income was estimated based on patient Zip Codes.³⁵ Krus-kal-Wallis tests were used to examine the association of demographics, median income, and administration method with patient burden.

Inter-test Reliability

Patients participating in patient burden testing were asked if they would be willing to be tested again at a later date. If so, repeat online testing was conducted within 5-7 days after their clinic visit to assess for inter-test reliability. This arm of the study only included pre- and postoperative patients that were at least 6 months removed from VHR. We chose to limit the postoperative patients with this criterion, so that test-retesting would not be affected by changes in QoL during the acute healing process. Pearson reliability coefficient tests were completed for the preoperative and postoperative instruments, in addition to individual items from each.

Longitudinal Validation

We aimed to longitudinally validate the AHQ as a metric sensitive to changes in QoL after VHR. To do so, we prospectively compared its performance to other commonly used QoL metrics. We chose to administer only 2 comparative PROMs (1-disease specific and 1 generic), as we believed that adding any additional surveys would greatly reduce patient responses. We chose the SF-12 as the generic instrument, as it is the most widely used nonspecific PROM in hernia repair.³⁶ For the hernia-specific comparative PROM, we opted to use the HerQLes, as opposed to the CCS, since the CCS includes mesh specific questions that limits its use preoperatively or in patients for whom mesh was not used.^26,27 Patients seen in consultation between August 2017 and May 2018, with plans to undergo VHR within the next 6 months were contacted via email after their initial visit with a hernia surgeon. If consented, we administered the preoperative AHQ, HerQLes, and SF-12. Following VHR, we periodically administered the 3 PROMs during clinic visits and by email, with 2 email reminders and 3 phone reminders. Due to variable response rates, patients were only included in the longitudinal analysis if they had completed at least 1 pre- and postoperative AHQ and HerQLes instruments. SF-12 completion was not a part of the inclusion criteria, but this data has been included, when available.

Postoperative intervals were designed to capture responses around standard follow-up periods, with flexible windows to accommodate variations in scheduling. AHQ and HerQLes raw scores were converted to QoL metrics out of a 100%,^37,38 for ease of interpretation, and Pearson correlations were completed to compare the AHQ to the HerQLes and SF-12. Effect sizes were calculated for each questionnaire in the various postoperative time intervals.²² Analysis of normal variance was used to compare effect sizes of various instruments, with Tukey test used for post-hoc comparisons.

The PROMs’ sensitivities to 30-day and 90-day complications, readmission, and recurrence were compared. A composite complication outcome was created, which included infection, seroma, venous thromboembolism, and mesh infection. To accurately determine if the metrics were sensitive to the aforementioned complications, QoL scores were only included if they were captured within 3 months of the outcome of interest. For patients without the defined complications, an average of all their postoperative responses was used for comparison. Patients who suffered a complication, but did not have a QoL response within the 3-month window were excluded from analysis. Cohort QoL scores were tested for equivalent variance using Kolmogorov-Smirnov tests, and Wilcoxon rank sum and t-tests were used accordingly. Finally, paired Wilcoxon Rank Sum were used to determine if there were changes in AHQ scores in the postoperative windows. Statistical significance was set at P < 0.05. All analyses were performed in R Studio 4.0 (RStudio, Boston, MA).

Results

Patient Burden

We obtained patient burden data from 419 completed AHQs (209 preoperative and 210 postoperative). The median time to instrument completion was 67 seconds [interquartile range (IQR) 51-86] preoperatively and 161 seconds (IQR 119-215) postoperatively (Table 1). In both groups, older patients (≥65 years) took longer to complete the AHQ (P < 0.05). Electronic administration of the AHQ with an iPad significantly reduced postoperative burden (150 vs 181 seconds, P = 0.005). Notably, in sub-group analysis, the older patients also completed the postoperative instrument in a significantly shorter time when using an iPad (165 vs 205 seconds, P = 0.02), but no difference was detected in the preoperative instrument. No differences in time to completion were noted across race, ethnicity, and adjusted gross income.

Inter-test Reliability

For test-retest reliability, we obtained data for 173 patients, 88 preoperatively and 85 postoperatively. Median time to retest was 9 (IQR 6–15) and 10 days (IQR 7-16), respectively. Median preoperative AHQ scores were 2.5 (IQR 2.1–3.1) versus 2.44 (IQR 1.9–3.1) in the re-test, with a high reliability coefficient (r = 0.91, P < 0.0001). Postoperative AHQ showed similarly high correlations (r = 0.89, P < 0.0001), with retest median score of 3.69 (IQR 3.2-3.9), compared to initial test score of 3.68 (IQR 3.3–3.8) (Fig. 1). Preoperative correlation coefficients for test-retest ranged from 0.67 to 0.84 (all P < 0.0001) across the 8 items, whereas postoperative correlation coefficients ranged from 0.57 to 0.86 (all P < 0.0001) across each of the 16 items.

Longitudinal Validation

After consent, a total of 106 patients met the inclusion criteria, having completed at least 1 AHQ and HerQLes study, pre- and postoperatively (Supplemental Figure 1, https://links.lww.com/SLA/C863). Median age at the time of surgery was 55.6, and 43 patients (41%) were male (Supplemental Table 1, https://links.lww.com/SLA/C864). There was a significant increase in AHQ QoL scores immediately postoperatively (51.9 vs 83.3, P < 0.0001) (Fig. 2). The scores continued to rise until the 7.5 month to 13.5 months postoperative window, and then dropped after 13.5 months post-VHR, although this difference was not significant (89.6 vs 83.3, P = 0.15). Additionally, there were no significant differences found between the immediate postoperative score and any of the subsequent time periods.

Overall, the AHQ demonstrated high correlation to the HerQLes and SF-12 in both the preoperative and postoperative period (Table 2). The AHQ was significantly correlated with the HerQLes in 5 out of 5 time points (100%), ranging from the preoperative period to over 13.5 months postoperatively (r = 0.47–0.76). Similarly, the AHQ showed good correlation with the SF-12, with significant correlations with 4/5 time points (80%) of the SF-12 PS scores and 5/5 (100%) of the SF-12 MS scores. The AHQ did not correlate to the SF-12 PS score 13.5 months after VHR.

The AHQ demonstrated greater effect sizes in each of the postoperative windows (Table 3). Analysis of normal variance analysis showed a significant difference between the effect sizes of various instruments (F (3,12) = 12.7, P < 0.0001). Post-hoc Tukey tests showed that the AHQ effect size was significantly greater than the HerQLes (P = 0.04), SF-12 PS (P < 0.0001) and the SF-12 MS (P = 0.001) (Fig. 3). Further, the HerQLes had significantly greater effect size when compared to the SF-12 PS (P = 0.03), but not the SF-12 MS (P = 0.37), and no difference was detected between the 2 SF-12 component scores (P > 0.05).

The AHQ was sensitive to negative clinical outcomes, with significantly lower scores for patients who had 30- and 90-day complications, readmissions, and importantly, recurrence (P < 0.05) (Table 4). The HerQLes, SF-12 PS, and SF-12 MS were all sensitive to readmissions, with patients with readmissions demonstrating significantly lower scores (P < 0.05). However, these 3 metrics did not show discriminatory ability between patients with 30-day complications, 90-day complications, or recurrence (P > 0.05).

Discussion

The AHQ is a hernia-specific, stakeholder-informed PROM enabling hernia surgeons to assess patient QoL, in both the pre- and postoperative periods. Our group previously validated the AHQ’s ability to capture patient perspectives in the perioperative period. In this pivotal prospective follow-up, we have shown the AHQ performs with high internal stability, low response burden, appropriate sensitivity to changes in QoL after VHR, and a large effect size. Additionally, the AHQ is sensitive to important clinical outcomes, like recurrence, suggesting it can be used to monitor patients after VHR. Further bolstering its clinical utility, the AHQ captures changes in patient QoL through specific domains uniquely tailored to the pre- and postoperative experiences of patients. Considering the AHQ’s low patient burden, sensitivity to patient QoL, and our intuitional experience, this study shows the feasibility of employing the AHQ in diverse clinical settings and patient populations.

PROMs have become increasingly popular in medicine, as they allow clinicians to gather insight into patient perspectives when weighing treatment options.³⁹ However, reliability, or internal consistency, is essential before any clinical tool can be used to inform medical decision making.⁴⁰ Furthermore, PROMs that are utilized to assess patients on an individual basis, as opposed to a population level, generally require high reliability coefficients to be effective.³⁹ In this study, the AHQ showed high retest reliability, with both the pre- and postoperative instruments reaching reliability coefficients of approximately 0.9, indicating excellent agreement.⁴¹ This result shows that the AHQ is precise in capturing PROs related to VH, and supports its use on an individual level to monitor patients with VH ^30,31,33,41

Interestingly, the stability of the AHQ in the pre and postoperative periods also sheds light on the hernia-health state, itself The finding that preoperative AHQ scores are so highly correlated in restretesting, suggests that patients are indeed experiencing the complex, multi-dimensional effects of VH, and that the AHQ is accurately measuring these components^6,42 Similarly, the finding that AHQ scores remain stable in patients 6-months postoperative from VHR speaks to the dramatic impact this intervention can have in improving patient QoL Taken together, this is a highly important finding, corroborating the complexity of the hernia-health state and the importance of VHR in treating it

Given that PROMs with high burden can lead to low response rates, patient burden significantly impacts clinical usability, with time to completion reported as the most important factor^43,44. Our results demonstrate that the AHQ exhibits very low patient burden, with median completion times of 1.1 and 2.6 minutes for the preoperative and postoperative instruments, respectively. Importantly, results were consistent across racial and socioeconomic groups. Unsurprisingly, older patients (>65 years) required significantly more time to complete the AHQ, and this is of particular concern, as patients with higher levels of cognitive impairment suffer from greater levels of patient burden.⁴⁵ However, this effect can be partially mitigated by the use of iPads, or other electronic tablets, which we found decreased the overall response time, and thereby, patient burden. Regardless, older patients completed the longer postoperative instrument with a median time of just over 3 minutes, which further demonstrates the low patient burden of the AHQ overall.

Beyond patient burden, the short response times speaks to the usability of the AHQ in surgeon's practice. In a recent survey of surgeons, implementation obstacles have been cited as one of the most significant barriers to PROM usage, with concerns that administering the PROM would disrupt clinic flow.¹⁵ In this study, we included a description of how we have implemented departmental administration of the AHQ, with minimal disruption of flow. Notably, the EMR in our clinic allows APPs to quickly enter discrete values into pre-made templates, streamlining the process and limiting disruption to clinic flow. Additionally, we have created shortcuts within the EMR that extract longitudinal AHQ responses and display them in an easy-to-read format, allowing surgeons to asses patient trajectory using PROM data. This is consistent with recent literature suggesting that user-friendly IT systems promote the usage of PROM.^46–48

Previously, we psychometrically validated the AHQ in the pre- and immediate postoperative period, by correlating it to the HerQLes and SF-12.²² In this study, we found that the AHQ continues to be significantly correlated to the HerQLes and SF-12 longitudinally over a year after surgery, with the exception of a single SF-12 PS window that had a small survey sample. This data suggests that the AHQ performed with high accuracy when compared to other QoL metrics and demonstrates the validity of the AHQ in capturing hernia related outcomes longitudinally over a year postoperatively.^31–33

As a proxy for clinical significance, effect size is used to measure the sensitivity of a PROM to changes in health of a given patient population.^49,50 In this study, the SF-12 PS and MS consistently demonstrated the lowest effect sizes in each postoperative time window, underscoring the low-sensitivity of generic PROMs when compared to disease-specific instruments.²² In previous testing, we found that the AHQ demonstrated the largest effect size in the immediate perioperative period.²² Here, we further expand on that result by showing the AHQ continues to perform with the greatest effect sizes postoperatively over a year after VHR. Importantly, the AHQ's postoperative effects sizes were all above 0.8, which is generally accepted as the cut off for large effect size, substantively demonstrating its ability to truly measure hernia-specific QoL.^49,50

The finding that the AHQ significantly correlates with the HerQLes throughout the postoperative period validates the well-documented use of the HerQLes to measure hernia-related QoL.^37,38 Although the HerQLes was not designed with stakeholder input, it seems to have arrived at a metric that captures VH QoL data, nonetheless.²⁶ Still, the AHQ is unique, in that it was developed systematically with patient perspectives at the forefront, bolstering its content validity.²³ The importance of this is shown through the AHQ’s sensitivity to poor clinical outcomes like complications, readmission, and recurrence, as opposed to the HerQLes which is only sensitive to changes in QoL after readmission.^49,50 This builds on findings from our initial comparison of the PROMs which showed that AHQ had superior discriminatory ability between patients with and without perioperative complications.²² Although the QoL data for outcomes is somewhat limited, we show the AHQ outperforms the other metrics, even in this small sample. Furthermore, the fact that AHQ scores significantly decrease in patients with recurrence, suggest that it may have utility in monitoring patients for this dreaded complication, even though more rigorous testing is needed to validate this claim. Additionally, unlike the HerQLes, the AHQ provides both preoperative and postoperative instruments, with a simple scoring system, allowing for granular and easy-to-interpret QoL data.²² The AHQ is further differentiated from the HerQLes by measuring QoL in important hernia-related domains, including body image and satisfaction with surgical care. With this in mind, we believe that the AHQ is superior in capturing VH-related QoL information, and with the results of this study, can uniquely substantiate the practicality of implementing the AHQ in a surgical practice.

Limitations

Limitations of the study to note are that the data presented for the patient burden and test-retest reliability arm and the longitudinal validation arm of the study stem from different, but sometimes overlapping, patient populations. This occurred because longitudinal data is drawn from patients for whom we were collecting AHQ responses, in addition to the HerQLes and SF-12, enabling longitudinal validation. These patients were enrolled before we set out to test the AHQ's internal reliability and quantify its patient burden. However, the authors would argue that the conclusions drawn from the data are still valid, as the 3 aspects of the AHQ being tested, are independent of each other, and are not affected by the underlying patient population. Additionally, the patient burden data is limited in generalizability by the population our hospitals serves, but with over 400 responses, we feel that the conclusions drawn from this data are likely true for other patient subsets. As a means to truly compare the sensitivity of the PROMs to a poor clinical outcome, we created 3-month window around the complication and compared it to an average of all postoperative scores for those who did not have a complication. Although we concede that this does not take into account the changes in QoL during various postoperative intervals, we believe this was necessary to account for variable survey responses. Furthermore, HerQLes and SF-12 responses for patients with complications were collected on the same day as the AHQ, and these metrics did not show discriminatory ability, underscoring the sensitivity of the AHQ.

Conclusions

The AHQ is a validated, patient-informed instrument to capture the multi-dimensional aspects of the hernia health state that can accurately quantify changes in QoL after VHR. Here, we have shown that it performs with high reliability, low user burden, and continues to accurately capture longitudinal QoL data over a year after VHR. With this, we have now completed the multi-stage cycle of PROM development, starting with foundational qualitative work to real world, prospective testing. The AHQ is now ready for dissemination and widescale adoption as the universal PROM for VH patients.

Acknowledgments

The authors thank the University of Pennsylvania Center for Human Appearance and the Harrison Department of Surgical Research for their generous support in the completion of this study. The authors express their appreciation to Dr. Jon Morris, Dr. Stephen Kovach, Dr. Sean Harbison, Dr. Steven Raper, Dr. Daniel Dempsey, Dr. Kristoffel Dumon, Dr. Najjia Mahmoud, Dr. Alan Schuricht, Dr. Noel Williams, Dr David Wernsing, and all other partners within the Department of Surgery at the University of Pennsylvania for contributing patients to the development and testing of the Abdominal Hernia-Q.

REFERENCES

Supplemental Digital Content

• SLA_2020_12_08_FISCHER_ANNSURG-D-20-03343_SDC1.docx; [Word] (61 KB)
• SLA_2020_12_08_FISCHER_ANNSURG-D-20-03343_SDC2.docx; [Word] (63 KB)
• SLA_2018_12_13_FISCHER_ANNSURG-D-18-01326_SDC1.pdf; [PDF] (173 KB)