1 Introduction

Patient-Reported Outcome Measures (PROMs) are increasingly utilized in orthopaedic research. They facilitate collection of data to assess the patient's response to care, allow for assessment of the patient's overall health, and provide tools to promote the shared decision-making process.^3,11 PROMs can be collected by paper or electronically and can be completed in clinic or at any given time point in the postoperative period. PROMs have shifted the spectrum from volume-based care to value-based care by allowing the patient's voice to be heard in order to facilitate effective conversation and fostering a patient-physician decision making.^9,18 As the adoption of PROM collection improves in the orthopaedic foot and ankle subspecialty, it is important to understand how consistently patients respond to requests for PROMs, how long they are likely to respond, and what factors may influence their likelihood of compliance.

There are various PROMs instruments that are utilized across orthopaedic foot and ankle surgery.² Although there are many different PROMs instruments, the risk factors for non-compliance of PROMs remains our primary focus. Factors that have been shown to influence PROMs compliance in foot and ankle surgery include gender, age, race, BMI, comorbidities, primary language, type of surgery, and number of previous surgeries.¹⁶ Other factors could include the survey itself, for example, shorter, computerized adaptive testing may have quicker completion and higher responsiveness.^12,21 There are a limited number of studies on PROMs compliance in orthopaedic foot and ankle surgery. In addition, the threshold of acceptable compliance within foot and ankle has not been identified. The International Society of Arthroplasty Registries (ISAR) recommends a 60% compliance rate as the threshold for collection of meaningful data.^6,17

As our practice implemented the use of Surgical Outcomes System (SOS) in 2017, the purpose of this study was to analyze risk factors of non-compliance for PROMs following Achilles tendon surgery. Our hypothesis is that compliance decreases as age increases and time after surgery increases.

2 METHODS

A retrospective review of PROMs compliance was conducted from survey data collected by two private practice foot and ankle orthopedic surgeons from May 2017 to July 2021 with San Antonio, TX, USA. Inclusion criteria included patients undergoing an Achilles tendon surgery based on CPT Codes 27650 and 27654. This study was exempt from Institutional Review Board (IRB) approval as described under 45 CFR 46.104(d)(2)(ii). Patient demographic and procedure information were collected from the electronic medical records. The primary outcome measure was patient participation in PROM following Achilles tendon surgery at certain intervals. After surgical scheduling, each patient was automatically enrolled into the electronic outcomes reporting system (Surgical Outcomes System [SOS], Arthrex) and assigned to validated outcome modules based on their indications for surgical intervention. Prior to surgical intervention, patients received electronic notification via text and email with a link to complete their pre-operative patient reported outcomes survey. Survey could be completed in English or Spanish and there was no compliance due to language barriers to our knowledge. Upon surgical intervention, patients received PROMS at 3-month, 6-month, 1-year, and 2-years after surgery. The survey instruments administered were the Visual Analog Scale (VAS), the Foot Function Index (FFI), the Foot and Ankle Ability Measure (FAAM), and the Veterans Rand 12-Item Health Survey (VR-12). Patients had a set timeframe to complete each survey after the link was sent to them and varied based on each time point. Within each survey time point, a reminder was given to complete the survey. An individual's compliance was defined by the timepoint based on whether or not they completed the surveys in the allotted ascertainment window of ± 2 weeks from preoperative, 3-month, 6-month, 1-year, and 2-year follow-up with completion of the assigned outcome survey logged in SOS database. Patients were reminded to complete their PROM at follow-up visits by the orthopedic surgeons and medical assistants. Patients who did not respond to the survey request, or responded outside the designated response window were considered non-compliant. There was no loss to PROM completion due to death within our study population. Compliance by timepoint was calculated as the proportion of patients who completed the surveys within the allotted time relative to the total eligible cohort offered to participate in the survey. Significance was calculated at a threshold of <0.05 to minimize type 1 error.

3 RESULTS

In this study, 90 patients underwent Achilles tendon surgery during the 2.5-year period and met inclusion criteria. Patient demographic information is reported in Table 1. The median age at time of surgery was 50 years [IQR 38 to 61], and the majority were male (60%). In our study cohort 62% of patients identified their race as White, with 6.7% identifying as Black, 1.1% as Asian, and 26% as other and 4.4% declined to answer. Patients could also identify their ethnicity as Hispanic or Latino (38 %), Not Hispanic or Latino (40%), or decline to respond (22%). Compliance with PROMs was highest at 3-months postoperative (77%) and was lower at all other time points (Fig. 1). Altogether, 30% (27 of 90) of patients were compliant at all individual times points.

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Fig. 1 Compliance rates with patient-reported outcome measures (PROMs) after Achilles tendon repair to 2-year postoperative.

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We developed a logistic regression model examining demographic factors associated with survey non-compliance at 2 years. Both ethnicity and age at treatment were predictors. Patients who identified as “Not Hispanic or Latino” were approximately 3.22 times less likely to be non-compliant with the survey completion (OR = 0.31 95 % CI [0.97, 0.099], p = 0.046). Additionally, for every year increase in age at treatment, the odds of non-compliance decreased by approximately 4.1 % (OR = 0.96, 95 % CI [1.00, 0.93], p = 0.047). Self-reported race, language, and sex at birth did not demonstrate statistically significant effects on survey compliance at two years (p > 0.05).

4 Discussion

PROMs allow orthopaedic surgeons to measure surgical outcomes by providing an objective assessment of the patient's subjective surgical experience. It was the goal of this study to identify risk factors for compliance with PROMs with the hypothesis that compliance decreases as age increases and time after surgery increases. In this retrospective review of PROM compliance on Achilles surgery in a private practice setting, we found that there were 90 individuals that met inclusion criteria. The 3-month time point had the highest compliance with PROMs at 77%, and every time point after, the compliance decreased. The risk factors for non-compliance in this study were age and ethnicity, specifically younger age and those who identify as "Hispanic or Latino" were more likely to be non-complaint with PROMs at the 2-year time point. The other variables included in this model were self-reported race, language, and sex at birth which did not demonstrate statistically significant effects on survey non-compliance at two years. This study demonstrated that the 3-month follow-up period had the lowest non-compliance (23%), which differs from other studies that show that non-compliance is typically lowest in the preoperative period and decreases at every time point after.^16,17 Based on the results, our hypothesis is rejected in our cohort as younger patients were less compliant and time after surgery demonstrated variable compliance, as opposed to a linear decrease in compliance.

Other studies have identified risk factors for non-compliance for PROMs after an elective procedure which include >75 years of age, males, and non-White race. Other variables for PROM compliance that have been identified include: BMI, activity level, insurance type, language barriers, mode of delivery, and type of procedure.^4,17 Within foot and ankle orthopaedics, there have been limited studies to specifically address risk factors for PROMs non-compliance in relation to Achilles tendon surgery. However, a group of athletic trainers working with foot and ankle injuries did conclude that the mode of the PROMs impacted the compliance.¹⁰ Factors affecting PROM compliance have been reviewed within other orthopedic subspecialities. Neville, Baumhauer, and Houck addressed factors leading to responsiveness in patients attending physical therapy with foot and ankle diagnosis and found that the PROMs for function and pain interference were higher after interval care with physical therapy and dependent on starting score and diagnosis.¹⁴ This study points to having the patient be physically engaged in their own care leading to an activation to be more involved in PROM compliance. Issa et al. found that social determinants of health, specifically social economic status, was the biggest predictor of PROM compliance after spinal fusion which was an unmeasured criterion for our study. However, they also saw an increase in compliance in White populations which was consistent with our results.⁷ Smith et al. found that the length of time after surgery was a significant predictor of PROMs compliance whereas when time increases, compliance decreases at all time points.¹⁷ These results differed from our study as our highest compliance was identified at the 3-month time-point rather than preoperative as indicated in their study. Rucinski et al. found that PROMs compliance was associated with high success and lower revision/failure rates in meniscus transfer.¹⁵ Although success rates of Achilles tendon surgery compared to PROMs compliance was not measured, this is something that could be evaluated in future studies.

Within the practice clinic that this study was conducted, PROMs were collected digitally by email and text reminders were automatically sent out within each of the postoperative time points. Because of the wide range of PROMs delivery methods, results and compliance may differ. Acosta et al. conducted a meta-analysis of mode of delivery with PROMs and found that telephone survey had the highest compliance followed by postal, then tablet/tech-based surveying which was used in our study.¹ However, Meirte et al. found that the advantages to electronic PROMs (ePROMs) led to beneficial patient-clinician communication, faster completion time, and increased quality and completion rates compared to paper.¹³ Potentially have electronic devices at the clinic to give to patients while they wait to fill out PROMs could be beneficial to overall compliance.

This retrospective study is not without its limitations. The population size used in this study is limited which could lead to a type ll bias. Studies with larger samples need to be completed before results can be generalized. There were two different ways that PROMs were distributed to patients, by text and email. As previously stated, the mode of delivery affects compliance rates. A deep dive into other reasons for non-compliance due to other non-risk factor causes such as sickness, re-operation, and access to electrical devices to complete PROMs could be considered for future studies. Another limitation is that this study took place in San Antonio, TX where proportions of ethnicities may differ from other locations within the United States. Despite these limitations, this study lays the groundwork for future studies within the orthopedic foot and ankle subspecialty regarding PROMs.

5 Conclusion

Our retrospective case study sought to determine risk factors for PROMs non-compliance in a private practice orthopaedic foot and ankle clinic with 90 cases after Achilles tendon surgery. Our hypothesis was rejected because within our study, younger age and those 3-months post-operative treatment had had the highest non-compliance with PROMs. Another risk factor in our study cohort were those identifying their ethnicity as “Hispanic or Latino” which demonstrated increase non-compliance to PROMs. As the use of PROMs increases within clinical practice, surgeons need to identify those patients who are at risk for non-compliance and potentially take additional steps to ensure those patients participate in completion of the outcome instrument to help facilitate better shared-decision making between the patient and the physician.

Author contributions

All authors provided substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; all authors drafted the article or revised it critically for important intellectual content; all authors gave final approval for the version of the article to be published; and all authors agree 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.

Disclosures

There were no competing interests in this study or study design. This research received no external funding or competitive funding. No Artificial Intelligence (AI) software or writing tools were used in the research process of this study.

Institutional Review Board

Exempt (5 CFR 46.104(d)(2)(ii))

Data availability statement

Data is contained within the article.

Ethical statement

All research included within this study was designed to better the medical community and the patients that are served by the practitioner.

Guardian consent

Non needed as all individuals within this research, including authors, were above the age of 18 at the time of enrollment.

Disclosures

There were no competing interests in this study or study design. This research received no external funding or competitive funding. No Artificial Intelligence (AI) software or writing tools were used in the research process of this study. No conflicts of interests to report.

Funding statement

The authors did not receive any funding or sponsorship for our original research.