Abstract
Introduction
External fixator care after limb reconstruction often involves pin-site cleaning and frame adjustments that can be painful and anxiety-provoking, particularly for paediatric patients. Virtual reality (VR) immersion may support procedural coping. This feasibility study evaluated the practicality and tolerability of VR during fixator care and explored pain and anxiety trends.
Patients and methods
A prospective, randomised feasibility study enrolled 29 patients aged 5–21 years undergoing limb lengthening or reconstruction with external fixators. Participants were randomised to ‘VR first’ or ‘no-VR first’ groups and attended four postoperative visits, alternating between visits with and without VR using Aqua VR (KindVR® platform). Pain and anxiety were assessed before, during, and after each procedure using Wong-Baker FACES and Children's Fear Scale (CFS). Parent proxy and provider assessments were collected using Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy, Face, Legs, Activity, Cry, and Consolability (FLACC), and CFS.
Results
Twenty-nine participants (16 male, 13 female; mean age, 14.5 ± 3.1 years) completed the study. Median pin sites numbered 7 (range, 7–14). Virtual reality was feasible and tolerated during fixator care. Patient-reported pain scores were similar between VR and non-VR visits. Virtual reality visits showed a trend toward lower anxiety, although differences were not statistically significant. Patients exposed to VR first showed more consistent decreases in pain and anxiety across subsequent visits, suggesting possible carryover.
Conclusion
Virtual reality immersion during fixator care appears feasible and well tolerated in paediatric and adolescent patients. Observed trends suggest potential benefit for anxiety reduction, particularly with early VR exposure; however, larger studies are needed to evaluate clinical efficacy.
Keywords: External fixator, Limb deformity correction, Limb reconstruction surgery, Virtual reality
Introduction
An external fixator is a versatile tool that has practical applications in limb reconstruction surgery and the management of orthopaedic trauma.1–3 It is invaluable in restoring function, increasing mobility, and improving the quality of life of patients with limb deformities, limb length discrepancies, and fractures. However, using external fixators for limb reconstruction procedures poses several challenges, including prolonged duration of treatment with the frame, the need for pins or wires to traverse through the soft tissue envelope from the external environment to the bone, and the cumbersome nature of wearing an external device. During the early phase of treatment, there are two additional frame-specific clinical factors that may lead to further stress and anxiety in these patients: (1) pin site care and (2) the need for adjustment of fixators to achieve the desired correction, which may be potentially painful following limb deformity surgery.
Virtual reality (VR) immersion represents a potential adjunct to postoperative multi-modal management of patients with external fixators. It uses head-mounted sets or goggles to provide an interactive, computer-generated three-dimensional environment. As a non-invasive, non-pharmacological distraction technique, it has shown potential in previous studies as a promising technique for pain and anxiety management during medical procedures.4–7 Its use avoids the risk of drug-associated complications, which is an important advantage of VR immersion over the use of anxiolytic or sedative medications during some medical procedures, especially when these procedures must be repeated frequently.
The use of VR in postoperative care of external fixators following limb reconstruction surgery has not been well explored previously. As such, this study was designed as a feasibility and hypothesis-generating investigation to assess the usability, acceptability, user satisfaction, and tolerability of virtual-reality immersion during outpatient external-fixator care procedures. A secondary exploratory aim was to observe whether VR was associated with favourable trends in patient-reported pain and anxiety, with the understanding that the study was not powered to determine definitive clinical efficacy or establish significant pain reduction.
Patients and Methods
This was a single-centre, prospective, randomised, controlled crossover study in which each patient acted as their own control. Following institutional review board approval, patients aged between 5 and 21 years who were scheduled to undergo a lower limb lengthening or reconstruction surgery with an external fixator at our institution were screened at the outpatient clinic to determine eligibility for inclusion. They were excluded if there was a history of a seizure disorder or visual disability resulting in an inability to interact with VR equipment/applications. We also excluded patients with developmental delay or cognitive disability deemed to result in an inability to understand survey questions and communicate study outcome measures. Written consent was obtained from all patients included in the study.
The Aqua VR application from the KindVR® platform was utilised for this study. KindVR® has been used in clinical trials at multiple hospitals in Canada and the United States of America without any major adverse outcomes or effects.6,8,9 The FDA considers KindVR® a HIPAA-compliant mobile app with a history of safety, as demonstrated in the published clinical trials. KindVR®'s Aqua application has been custom-designed specifically for paediatric patient safety and minimal body movement during medical procedures, which is especially important for pin site dressing changes in paediatric external fixator patients.
At study enrolment, the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety and the PROMIS Pediatric Pain Interference surveys were used to assess anxiety and pain in study subjects at baseline. Patients were seen during the first four consecutive outpatient postoperative visits for external fixator pin site care and dressing changes. Subjects were randomly assigned to a ‘VR immersion first’ group (study group I) or a ‘no-VR immersion first’ group (study group II) using a free online random sequence generator.10 This was done to explore possible carryover effects. Randomisation was done in batches of 10 to minimise uneven subject distribution during the study duration. Over four consecutive outpatient visits, subjects alternately underwent VR immersion procedures or ‘no-VR’ immersion procedures, depending on their assigned groups. The primary study endpoints of pain and anxiety levels in subjects undergoing external fixator pin site care procedures with and without VR immersion were assessed before, during, and after the procedure using the Wong-Baker (FACES) scale and Children's Fear Scale (CFS) for pain and anxiety scoring, respectively.11,12 Proxy scores for pain and anxiety were obtained from parents or legal guardians using the PROMIS Parent Proxy Numeric Rating Scale and the parent-reported CFS for pain and anxiety, respectively. We also obtained provider assessment of pain and anxiety using the Face, Legs, Activity, Cry, and Consolability (FLACC) survey and CFS.13 Secondary study endpoints were assessed using qualitative satisfaction surveys, the incidence of complications such as motion sickness during the procedure, and the duration of immersive VR exposure. A summary of the study surveys is presented in Table 1.
Table 1.
A summary of study-administered surveys
| Enrolment | Child-reported and parent-proxy PROMIS anxiety score Child-reported and parent-proxy PROMIS pain interference score | ||
|---|---|---|---|
| Study visits 1–4 | ‘No-VR’ protocol | VR protocol | |
| Before procedure* | • Child-reported CFS, FACES • Parent-reported CFS, pain intensity • Nurse-reported FLACC, CFS |
• Child-reported CFS, FACES • Parent-reported CFS, pain intensity • Nurse-reported FLACC, CFS |
|
| During procedure* | • Child-reported CFS, FACES • Parent-reported CFS, pain intensity • Nurse-reported FLACC, CFS |
• Child-reported CFS, FACES • Parent-reported CFS, pain intensity • Nurse-reported FLACC, CFS |
|
| After procedure* | • Child-reported CFS, FACES • Parent-reported CFS, pain intensity • Nurse-reported FLACC, CFS • At visit four only: – Child semi-structured interview – Parent semi-structured interview – Nurse semi-structured interview |
• Child-reported CFS, FACES • Parent-reported CFS, pain intensity • Nurse-reported FLACC, CFS • Child VR questionnaire: – VR satisfaction survey – Motion sickness survey – Qualitative questions • Nurse VR questionnaire: – Procedure satisfaction survey – Qualitative questions • At visit four only: – Child semi-structured interview – Parent semi-structured interview – Nurse semi-structured interview |
|
*External fixator care procedure; CFS, Children's Fear Scale; FACES, Wong-Baker Fear Scale; FLACC, Face, Legs, Activity, Cry and Consolability; Pain Intensity, PROMIS Parent Proxy Numeric Rating Scale v1.0; PROMIS Anxiety, PROMIS Paediatric /Parent Proxy Anxiety v2.0—8a; PROMIS Pain Interference, PROMIS Paediatric/Parent Proxy Short Form v2.0—Pain Interference 8a
The study included two groups. The VR first group (group I) used the VR protocol during the first and third postoperative visits and received the standard ‘no-VR’ protocol during the second and fourth visits. The no-VR first group (group II) received the standard ‘no-VR’ protocol during the first and third postoperative visits and used the VR protocol during the second and fourth visits. During the no-VR visits, all external fixator care procedures were performed according to the usual standard of care. Before the procedure began, study staff collected pain and anxiety scores from both the child and the parent. At the same time, the nurse performing the external fixator care procedure assessed the child's pain and anxiety. Immediately after the procedure, patients rated the pain and anxiety they experienced both during and after the procedure. Parents and the nurse also rated the child's observed pain and anxiety during and after the procedure.
During the VR visits, patients underwent the same external fixator care procedures and completed the same pain and anxiety assessments as they did during the no-VR visits. In addition, patients wore a stereoscopic head-mounted display, the Oculus Quest VR Headset, over the eyes and head. This headset is a commercially available, all-in-one, portable, wireless device that includes adjustable lenses, headphone speakers, and an integrated computer. Patients began the KindVR® Aqua VR immersion at least 1 minute before the external fixator care procedure started. The Aqua application provides an interactive scuba-diving simulation in which patients explore a calm underwater environment, discover sunken treasure, and feed whales, dolphins, fish, turtles, and other sea animals. The VR immersion continued until after the external fixator care procedure was completed. All study visits were supervised by a Child Life Specialist, who helped familiarise patients with the KindVR® system before and during use.
Data analysis was performed using GraphPad Prism version 10.1.0 (316). Given the feasibility and hypothesis-generating nature of this study, analyses were primarily descriptive and exploratory. Measures of central tendency were summarised using means and medians, with dispersion reported as standard deviations where appropriate. Exploratory between-group and between-condition comparisons were performed using the Mann–Whitney test or Kruskal–Wallis test, with Dunn's test used to adjust for multiple comparisons when applicable. Resulting p-values were interpreted cautiously and used to identify patterns or trends that may inform future adequately powered studies, rather than to draw definitive conclusions regarding efficacy. Statistical significance was defined as p-value < 0.05.
Results
Thirty-four patients were screened and eligible for inclusion in the study. Permission for study participation was declined by the parent of one potential study subject, while consent was obtained for the remaining 33 patients. Two patients did not start study activities for reasons unrelated to the study, while two further patients did not complete the study. A total of 29 patients (16 male and 13 female) completed all study activities and were fully evaluated (Fig. 1). Following randomisation, 16 patients were assigned to group I and 13 patients were assigned to group II.
Fig. 1.
Schematic diagram showing subject recruitment and study group assignment
The mean age at enrolment for the entire study group (29 patients) was 14.5 ± 3.1 years. Table 2 shows comparisons between enrolment survey outcomes for both groups. The median number of pin sites was 7 (range 7–14) for both groups. There were nine patients with genu varum deformity (three with associated length discrepancy), nine patients with torsional deformities (one internal torsion, two external torsion, and six with ‘miserable malalignment’), two patients with Blounts’ disease, two patients with malunited tibial fractures, two patients with post-traumatic physeal growth arrest, and one patient each with osteogenesis imperfecta, an equinus contracture of the ankle, a neglected clubfoot, a severe physiologic genu valgum, and achondroplasia. A circular fixator was used in all cases. All patients had gradual deformity correction.
Table 2.
Mean comparison of age, study visit duration, enrolment survey scores, and qualitative satisfaction/motion sickness surveys between VR first (group I) vs no-VR first (group II) patient groups
| Variable | Group I (n = 16) (VR at first visit) | Group II (n = 13) (No-VR at first visit) | p-value |
|---|---|---|---|
| Age at enrolment (years) | 14.4 ± 2.2 | 14.7 ± 4.0 | 0.9569 |
| VR immersion duration (minutes) | 15.5 ± 4.6 | 13.8 ± 7.3 | 0.0503 |
| PROMIS paediatric anxiety T-score | 52.4 ± 12.1 | 52.3 ± 10.7 | 0.9051 |
| PROMIS paediatric pain interference T-score | 53.6 ± 11.4 | 53.7 ± 7.2 | 0.5858 |
| VR satisfaction survey score* | 35.5 (32.3–39.8) | 38 (33–40) | 0.3804 |
| Motion sickness survey score* | 0 (0–0) | 0 (0–0) | >0.9999 |
*Scores are presented as median and interquartile range; VR, virtual reality
We analysed the data longitudinally for both groups and compared all VR immersion visits collectively with all non-VR visits. Pain and anxiety scores during VR and non-VR study visits for all patients are summarised in Figures 2 and 3. When all visits were considered together, patient-reported and nurse-reported pain scores were broadly similar between VR and non-VR visits. Parent proxy pain scores were lower during VR visits. Patient-reported anxiety scores also tended to be lower during VR immersion visits, a pattern that was consistent with parent and provider observations. These findings are illustrated in Figure 4.
Figs 2A to F.
Pain and anxiety score comparisons before, during, and after care procedures during VR immersion visits. (A) Wong-Baker score for patients; (B) Patient-reported CFS; (C) PROMIS parent pain intensity score; (D) CFS proxy score; (E) FLACC; and (F) CFS
*Statistical significance
Figs 3A to F.
Pain and anxiety score comparisons before, during, and after care procedures during no-VR immersion visits. (A) Wong-Baker score for patients; (B) Patient-reported CFS; (C) PROMIS parent pain intensity score; (D) CFS proxy score; (E) FLACC; and (F) CFS
*Statistical significance
Figs 4A to F.
Pain and anxiety score comparisons between the VR and no-VR groups during care procedures. (A) Wong-Baker score for patients; (B) patient-reported CFS; (C) PROMIS parent pain intensity score; (D) CFS proxy score; (E) FLACC; and (F) CFS
*Statistical significance
On longitudinal assessment, mean patient-reported pain and anxiety scores in both groups were highest at the first study visit and generally decreased at subsequent visits. Patients in group I, who received VR immersion at the first visit, demonstrated a more consistent downward trend in pain and anxiety scores across the study period (Table 3). In contrast, patients in group II, who did not receive VR at the first visit, showed a less consistent pattern after the initial visit (Fig. 5).
Table 3.
Comparison of pain and anxiety scores per visit for groups 1 and 2 study subjects
| Visit number | Grp 1 CFS | Visit type | Group II CFS | Visit type | p-value | Grp 1 WBS | Visit type | Grp 2 WBS | Visit type | p-value |
|---|---|---|---|---|---|---|---|---|---|---|
| V1 | 1.0 ± 0.9 | VR | 1.6 ± 1.4 | no-VR | 0.2304 | 2.6 ± 2.3 | VR | 3.2 ± 3.2 | no-VR | 0.7824 |
| V2 | 0.4 ± 0.6 | no-VR | 0.2 ± 0.6 | VR | 0.4729 | 0.8 ± 1.2 | no-VR | 1.6 ± 2.0 | VR | 0.2085 |
| V3 | 0.3 ± 0.6 | VR | 0.6 ± 0.8 | no-VR | 0.1519 | 1.5 ± 2.6 | VR | 2.2 ± 3.3 | no-VR | 0.7308 |
| V4 | 0.2 ± 0.5 | no-VR | 0.3 ± 0.8 | VR | 0.8030 | 0.6 ± 1.0 | no-VR | 0.9 ± 1.0 | VR | 0.5517 |
CFS, Children's Fear Scale, VR, virtual reality; WBS, Wong-Baker Score
Figs 5A to D.
Mean pain (A and B) and anxiety (C and D) scores during study visits for patients undergoing postoperative external fixator care procedures. Group I patients (A and C) only had VR immersion during visits 1 and 3. Group II patients (B and D) only had VR immersion during visits 2 and 4
Across matched study visits, group I patients also tended to report lower pain scores than group II patients, regardless of whether VR was used at that specific visit (Table 3). This pattern may suggest a possible carryover effect of early VR exposure, although these observations should be interpreted as exploratory and hypothesis-generating given the feasibility-focused design of the study.
Discussion
Virtual reality, an emerging three-dimensional interactive technology, has found increasing applications in healthcare, both in direct patient care and education.14–17 Its ability to provide realistic simulation environments is one of its major advantages. Its immersive and interactive nature engages multiple senses, directing and allowing greater focus of users’ attention toward the simulated tasks and environment and away from the discomfort of medical procedures. Some medical conditions and invasive procedures have the potential to cause fear, anxiety, and even post-traumatic stress disorder in patients.18,19 The distraction provided by immersive VR has been leveraged by several studies to manage anxiety and pain in these situations.20–23
The impact of VR immersion on pain scores during medical procedures has ranged from a statistically significant improvement in pain scores to no difference compared to other distraction techniques.4,21–24 The variations in reports in the literature may be attributable to factors like the nature of the different study designs, the type of medical procedure, and the expertise of the attending healthcare professional. When all VR visits were combined and compared with non-VR visits, pain scores were broadly similar between conditions. This may reflect the clinical setting of a high-volume limb reconstruction service, where pin-site and external fixator care is performed by an experienced nursing team skilled in minimising patient discomfort during dressing changes. In this context, any additional effect of VR on pain may be more subtle. However, longitudinal assessment showed a trend toward lower pain scores during visits involving VR immersion. This repeated measures approach provided useful exploratory insight into how patients' pain and anxiety responses may change over time and supports the feasibility of studying VR as an adjunct during serial postoperative external fixator care visits. In a systematic review involving pooled data from 83 randomised controlled trials (RCTs), Teh et al. found significantly reduced pain scores across several medical procedures.25 They found consistent results with no significant differences across subgroups when grouped by age, procedure type, or study design, suggesting that the impact of VR was similar across a heterogeneous study population.
Teh et al. reported reduced anxiety scores during VR immersion in their analysis of 31 RCTs.25 They also noted that children appeared to derive greater anxiety-related benefit than adults, while procedures such as dressing changes showed less pronounced effects on anxiety scores compared with more invasive procedures, such as venipuncture. Reduced anxiety scores have also been reported with VR immersion in children undergoing invasive or potentially distressing procedures, including laceration repair and cast removal using a motorised cast saw.6,26 This procedural context may help explain the more modest anxiety-related findings in the present study, as the care procedures primarily involved pin-site dressing changes and removal of pain catheters rather than more invasive interventions such as venipuncture or laceration repair. Nevertheless, we observed a consistent trend toward lower anxiety scores among patients, parents, and providers during VR immersion visits. The first study visit for both groups was typically longer and more involved, as it included removal of pain catheters and pin-site dressings, whereas subsequent visits involved pin-site dressing changes only. Consistent with this, the highest anxiety scores in both groups were observed during the first study visit. However, because this feasibility study was not designed to evaluate the effect of procedure type, procedure duration, or number of procedures on anxiety scores, these observations should be interpreted as exploratory.
Our findings also reveal that VR immersion impacts pain and anxiety differently. This pattern has previously been reported in studies that revealed that VR may have a lesser impact on the perception of pain compared to anxiety levels in patients undergoing medical procedures.27–29 This difference may also be attributable to the nature of the procedures, with VR immersion being more impactful on pain scores during invasive procedures. This is supported by the results of a systematic review, which found that VR was particularly effective in reducing moderate to severe pain in younger patients.30
One study reported that VR as a distraction tool was not more effective than non-interactive distraction techniques in reducing pain and anxiety in paediatric patients undergoing orthopaedic office procedures, suggesting that the distractive nature of the activity was probably more important than its interactive properties.24 We did not compare the outcomes of immersive VR distraction with other distraction methods; however, anecdotally, it is not uncommon to find paediatric patients focused on smartphones and iPads during care procedures as a form of distraction during office visits or care procedures. Reports have also suggested a synergistic effect between VR and pharmacologic intervention on the perception of pain.31 We did not assess the outcomes of a multimodal approach to managing pain and anxiety in this study.
Virtual reality has been reported to cause motion sickness, with the incidence of this being higher in the immersive forms of VR.32 This has been attributed to factors like the size of the field of view (increasing field of view, which tends to cause more postural instability), monitor size, display angle, and duration of VR experience. No patient in this study experienced motion sickness. Furthermore, all patients in both groups indicated they had a positive experience with the VR immersion and would be happy to use it again, buttressing the feasibility of VR use in patients undergoing external fixator care procedures. Comments from the proxies were similarly positive. Similar experiences relating to user-friendliness and satisfaction while using VR have been reported in the literature.9,28
One of the strengths of this study is its prospective and randomised design and the fact that we carried out a multidimen-sional data analysis. We analysed the data generated cumulatively and longitudinally. This provided multiple perspectives on the impact of VR immersion in postoperative external fixator care procedures. We also used patient and proxy scores for assessment and found similar trends for anxiety but not for pain assessment, suggesting that proxy scores are not necessarily an adequate alternative assessment tool for pain. Another strength of this study is the fact that the study population was homogeneous with respect to the nature of their postoperative procedures and their baseline pain and anxiety profiles, which were just above the population average of 50 per the PROMIS T-scores (Table 2). They also had similar VR satisfaction survey scores, with composite score interpretation ranging from ‘agree’ to ‘strongly agree’ for both groups. This reduced the effect of variables on the outcome measures in this study. This is especially important since more invasive procedures may be more likely to cause anxiety and pain, and having a mixture of patients who have undergone different procedures does not reveal the exact influence of VR immersion on specific procedures.
Limitations
This study had several limitations. The small sample size and the feasibility-focused design represent important limitations of this study. We also did not assess long-term patient-reported outcomes or compare VR immersion with other distraction techniques (like tablets, music, or smartphones) or pharmacological methods of analgesia and anxiolysis. We also did not perform physiologic measurements, such as pulse rate and oxygen consumption, during the care procedures. Another limitation was the inability to blind patients to the study intervention. Despite this limitation, a systematic review and meta-analysis found that VR significantly reduced pain in children during needle procedures.23 Nevertheless, we mitigated this by utilising a randomised crossover study design in which patients were their own ‘controls’.
Conclusion
This preliminary feasibility study suggests that VR immersion can be incorporated into postoperative external fixator care procedures and appears to be well tolerated by patients undergoing limb reconstruction. In this study, subjects requested VR headsets even when they were not scheduled for a VR immersion, demonstrating a preference for VR during their external fixator care procedures. While pain scores were broadly similar between VR and non-VR visits, anxiety scores showed a favourable trend during VR immersion. In addition, patients who used VR at the first postoperative visit demonstrated a more consistent pattern of reduced pain and anxiety scores across subsequent visits, including visits in which VR was not used. This observation raises the possibility that early VR exposure may have a carryover effect on subsequent procedural experiences; however, this finding should be interpreted with caution and regarded as hypothesis-generating.
Clinical Significance
Overall, immersive VR may represent a feasible and acceptable adjunct during external fixator care procedures, with potential benefit in reducing procedural anxiety. Larger, adequately powered RCTs are needed to further evaluate its clinical effectiveness, clarify its impact on pain and anxiety outcomes, and determine whether early VR exposure confers sustained benefit across repeated postoperative care visits.
Declarations
Ethical Approval
This study was approved by the Institutional Review Board of Nationwide Children's Hospital; approval number/reference: STUDY00001598; approval date: March 4, 2021. The study was conducted in accordance with institutional ethical standards and the principles of the Declaration of Helsinki. Written informed consent was obtained from all participants. For participants who were minors, consent was obtained from a parent or legal guardian, with assent obtained where appropriate.
Artificial Intelligence (AI) Disclosure
An AI-assisted writing tool (Grammarly) was used only to support language editing, grammar refinement, and readability improvement. The tool was not used to generate original scientific content, analyse data, interpret results, create images, or draw conclusions. All AI-assisted output was reviewed, verified, and edited by the authors, who take full responsibility for the accuracy and integrity of the final manuscript.
Authors' Contributions
Christopher Iobst and Anirejuoritse Bafor conceived and designed the study. Anirejuoritse Bafor, Mackenzie Cannon, and Ashley Curcio coordinated the prospective recruitment of participants and contributed to clinical evaluation and data collection. Anirejuoritse Bafor, Mackenzie Cannon, and Ashley Curcio curated the dataset and performed the statistical analysis. Anirejuoritse Bafor and Christopher Iobst interpreted the findings. Anirejuoritse Bafor and Christopher Iobst drafted the initial manuscript. All authors contributed to the critical revision of the manuscript, approved the final version for submission, and agree to be accountable for all aspects of the work.
Orcid
Anirejuoritse Bafor https://orcid.org/0000-0001-9278-5324
Christopher Iobst https://orcid.org/0000-0002-0329-5321
Footnotes
Source of support: Nil
Conflict of interest: None
Data Availability
The data supporting the findings of this prospective study are available from the corresponding author on reasonable request. The complete dataset is not publicly available due to the clinical nature of the data and the need to protect participant privacy and confidentiality. Any data shared will be de-identified and provided in accordance with applicable institutional, ethical, and data-sharing requirements.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The data supporting the findings of this prospective study are available from the corresponding author on reasonable request. The complete dataset is not publicly available due to the clinical nature of the data and the need to protect participant privacy and confidentiality. Any data shared will be de-identified and provided in accordance with applicable institutional, ethical, and data-sharing requirements.