成人脊柱侧弯诊治国际专家共识

An international consensus on the appropriate evaluation and treatment for adults with spinal deformity

Sigurd H. Berven¹ • Steven J. Kamper² • Niccole M. Germscheid³ •

Benny Dahl⁴ • Christopher I. Shaffrey⁵ • Lawrence G. Lenke⁶ • Stephen J. Lewis⁷ • Kenneth M. Cheung⁸ • Ahmet Alanay⁹ • Manabu Ito¹⁰ • David W. Polly¹¹ • Yong Qiu¹² • Marinus de Kleuver¹³ • AOSpine Knowledge Forum Deformity

Received: 28 March 2017 / Revised: 15 July 2017 / Accepted: 23 July 2017

Springer-Verlag GmbH Germany 2017

Abstract

Purpose Evaluation and surgical management for adult spinal deformity (ASD) patients varies between health care providers. The purpose of this study is to identify appro-priateness of specific approaches and management strate-gies for the treatment of ASD.

Methods From January to July 2015, the AOSpine Knowledge Deformity Forum performed a modified Delphi survey where 53 experienced deformity surgeons from 24 countries, rated the appropriateness of management strategies for multiple ASD clinical scenarios. Four roundswere performed: three surveys and a face-to-face meeting. Consensus was achieved with C70% agreement.

Results Appropriate surgical goals are improvement of function, pain, and neural symptoms. Appropriate preop-erative patient evaluation includes recording information on history and comorbidities, and radiographic workup, including long standing films and MRI for all patients. Preoperative pulmonary and cardiac testing and DEXA scan is appropriate for at-risk patients. Intraoperatively, appropriate surgical strategies include long fusions with deformity correction for patients with large deformity and sagittal imbalance, and pelvic fixation for multilevel fusions with large curves, sagittal imbalance, and osteo-porosis. Decompression alone is inappropriate in patients with large curves, sagittal imbalance, and progressivedeformity. It is inappropriate to fuse to L5 in patients with symptomatic disk degeneration at L5–S1.

Conclusions These results provide guidance for informed decision-making in the evaluation and management of ASD. Appropriate care for ASD, a very diverse spectrum of disease, must be responsive to patient preference and values, and considerations of the care provider, and the healthcare system. A monolithic approach to care should be avoided.

Keywords Adult spinal deformity Surgery Appropriateness Consensus Delphi

Electronic supplementary material The online version of this article (doi:10.1007/s00586-017-5241-1) contains supplementary material, which is available to authorized users.

&Sigurd H. Berven bervens@orthosurg.ucsf.edu

¹Department of Orthopaedic Surgery, University of California San Francisco, 500 Parnassus Ave, MU320W, San Francisco, CA 94143-0728, USA

²Musculoskeletal Division, The George Institute for Global Health, Sydney, Australia

³Research Department, AOSpine International, Davos, Switzerland

⁴Spine Unit, Department of Orthopedic Surgery, Rigshospitalet and University of Copenhagen, Copenhagen, Denmark

⁵Department of Neurosurgery and Orthopaedic Surgery, University of Virginia, Charlottesville, VA, USA

⁶Department of Orthopedic Surgery, Columbia University College of Physicians and Surgeons, New York, NY, USA

⁷Department of Surgery, Toronto Western Hospital, Toronto, ON, Canada

⁸Department of Orthopaedics and Traumatology, The University of Hong Kong, Pokfulam Road, Hong Kong, China

⁹Faculty of Medicine, Acibadem University, Istanbul, Turkey

¹⁰Department of Orthopedic Surgery, National Hospital Organization Hokkaido Medical Center, Sapporo, Japan

¹¹Department of Orthopaedic Surgery, University of Minnesota, Minneapolis, MN, USA

¹²Department of Spine Surgery, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China

¹³Department of Orthopedics, Radboud University Medical Center, Nijmegen, The Netherlands

Introduction

Spinal deformity in adults is common and has a significant and measurable impact on health-related quality of life (HRQOL) [1]. The burden of adult spinal deformity (ASD) on society and the healthcare system is large and increasing [2]. However, the management of ASD is characterized by significant variability without consensus [3–5]. Indications for surgery, preoperative preparations, intraoperative strategies, and postoperative care vary within the commu-nity of physicians who care for patients with ASD [6–8]. The clinical presentations of ASD patients vary, and may include symptoms of pain, functional limitations, neural compromise, and cosmetic problems. Consequently, the patient cohort is heterogeneous and classifications of ASD have included considerations of curve patterns, sagittal plane alignment, and clinical impact of deformity on health status [9–12]. A high level evidence-based approach to the appropriate evaluation and management of ASD patients is not available and may improve management. Achieving consensus on appropriate evaluation and management should encompass the broad range of approaches and strategies available, and be responsive to relevant consid-erations, including patient values and preference, physician preferences and skills, and cost and value considerations [13, 14]. The appropriate treatment strategy is the approach that leads to the largest improvement in HRQOL with the least risk and cost. Expert panels can help identify appro-priateness criteria as decision-making tools to provide actionable guidance for specific clinical scenarios and pathologies [15, 16]. Recommendations that define rea-sonable and appropriate care, developed by a panel of experienced surgeons from geographically diverse regions with distinct training and specialties, would empower patients and physicians to make informed decisions regarding appropriate care without mandating a monolithic approach. The purpose of this study is to define appropri-ateness of specific approaches and management strategies for the treatment of ASD patients.

Materials and methods

Design

A modified Delphi survey was performed, similarly to the approach applied by de Kleuver et al. for adolescent idio-pathic scoliosis [17]. The scoring system is based upon the RAND/UCLA appropriateness method [15]. The study included three web-based surveys (January to June 2015) and one face-to-face meeting (July 2015).

Panelists

Invitation to participate was sent by email to all AO Spine Members (n = 5482). A total of 155 members applied, 53 were selected, and 46 agreed to participate. Eligibility was based on number of years in practice (minimum of

6years), clinical practice focus (minimum of 35% focus on adult spine), and estimated number of ASD cases examined (minimum of 50 patients) and operated (minimum of 20 patients) per year. Seven members of the AOSpine Deformity Knowledge Forum Steering Committee who also met the above criteria contributed as panelists. The panel consisted of 53 spine deformity surgeons from 24 countries from different geographic locations. All panelists were male, mean age was 50 years, and over 90% had been practicing spine surgery for 10 or more years (Table 1). The research team MdK, SB, SK, NG, BD and CS did not participate as panelists.

Delphi rounds

The study consisted of four rounds: three rounds were web-based surveys and the final round was a face-to-face meeting. Survey questions were divided into four sections: goals of care, preoperative considerations, intraoperative considerations, and postoperative considerations. In each round, panelists answered specific questions and could then provide additional comments and opinions, either through an open text field, which appeared below every survey question or through discussions during the final meeting. After each round, every panelist received a de-identified summary of all responses, along with their individual ratings.

In the first round, panelists reviewed two peer-reviewed manuscripts that defined ASD and were asked to answer a series of questions which required them to rate the appro-priateness of various clinical considerations and scenarios for the ASD patient [9, 18].

In the second round, to increase granularity, four patient cases were presented, representing the spectrum of ASD,

Table 1 Demographic profile of panelists

Values are presented as N (%)

from mild to severe. For each case, six hypothetical clinical scenarios were created by combining patient characteristics (e.g., age, osteoporosis, comorbidities) that influence risks and benefits of surgery.

In the third round, questions from the previous rounds which required additional clarification were re-worded. The operative techniques actually performed for the four clinical cases from the second round were also presented and panelists were asked to rate the appropriateness of the selected treatment strategies.

In the final round, 20 panelists met face-to-face, which provided an interactive platform to exchange and express opinions. The research team moderated the discussion. For areas which were ambiguous and required further clarifi-cation, questions were developed in real-time. Using an electronic audience response system, anonymous voting was performed.

Rating process and analysis

The goals of care were ranked according to their relative importance; results are presented as mean rank. With respect to the pre-, intra- and postoperative considerations, panelists rated appropriateness of procedures and man-agement strategies according to the RAND/UCLA appro-priateness method using the definitions described by Fitch et al. [15]. Procedures and strategies were rated on a nine-point rating scale, collapsed into three categories: ‘inap-propriate’ where the expected negative consequences

exceed the expected health benefit such that the procedure should not be performed (scores of 1–3); ‘reasonable’ where the balance of risk and benefit is unknown, but there is a reasonable chance of benefit with limited risk (4–6); and ‘appropriate’ where the expected health benefit exceeds the expected negative consequences by a wide margin such that the procedure is worth doing (7–9). For each question, the percentage of responses in each category was calculated. Consensus was defined as C70% of responses in either the appropriate or inappropriate cate-gory for a particular question. Thus, each proposed man-agement strategy was defined; appropriate (consensus achieved), inappropriate (consensus achieved), or no consensus.

Results

All panelists completed the first round and 96% completed the second and third rounds.

Goals of care

The highest ranked goals of care in treating ASD patients were functional improvement (mean rank of 2.1 from a total of 10 options), pain improvement (mean rank of 2.6), and neural improvement (mean rank of 3.5). Radiographic improvement, prevention of deformity progression, or avoidance of complications were the lowest ranked (mean

rank C6.0) of the options presented. All data are presented in Supplementary Table 1.

Preoperative management

Assessment of risk factors for surgery and poor prognosis

Table 2 summarizes the consensus regarding preoperative assessment. The panel rated as appropriate specific ele-ments of patient history, physical exam, and circumstances for use of preoperative testing including bone health and cardiopulmonary status.

Preoperative imaging

Table 3 summarizes the consensus regarding preoperative imaging, including use of MRI, CT, and myelography.

Intraoperative management

Surgical strategies

Table 4 summarizes the areas of consensus regarding specific surgical strategies for ASD.

Decompression and length of fusion Decompression alone was inappropriate if there was any spinal sagittal imbalance, or proven radiological curve progression, in larger curves. Decompression with limited fusion was inappropriate if the curve was 60L, and with sagittal imbalance. There was no consensus regarding the appro-priateness of decompression with limited fusion. Perform-ing a decompression with long fusion in patients with large coronal deformity ([60L), or sagittal imbalance was appropriate, as long as there were no comorbidities (coronary artery disease, osteoporosis). In the presence of comorbidities, there was no consensus.

Lowest instrumented vertebra

L5–S1 fusion When performing a long lumbar fusion from the lower thoracic spine distally to the lumbar spine, it was appropriate not to fuse L5–S1 in conditions of well-maintained sagittal global alignment, non-osteoporotic vertebra, and no disk degeneration at L5–S1. Conversely, if disk degeneration or symptomatic pathology presented at L5–S1, then it was inappropriate to stop at L5, regardless of sagittal balance and bone quality.

L5–S1 interbody support If a long lumbar fusion from T12 or higher is extended to the sacrum, then it was appropriate to perform interbody support (through anterior or posterior approach) at L5–S1.

Pelvic fixation When performing a long lumbar fusion from the lower thoracic spine to the sacrum (e.g., T10–S1), it was appropriate to perform pelvic fixation if the patient is osteoporotic, or if the patient has a severe deformity (coronal trunk shift [4 cm, sagittal vertical axis offset [5 cm). There was no consensus regarding the appropri-ateness of pelvic fixation in the presence of isolated sagittal imbalance and good bone quality. When performing a shorter lumbar fusion from the upper lumbar spine to the sacrum (e.g., L2–S1), it was appropriate to perform a pelvic fixation if the patient is osteoporotic and with sagittal imbalance.

Upper instrumented vertebra Ending a lumbar fusion in the lower thoracic spine (e.g., T9–12) was appropriate in cases with small thoracic kyphosis (\30L), adequate sagittal balance, and non-osteoporotic bone. If the thoracic kyphosis is larger ([50L), even with sagittal balance, and non-osteoporotic bone, then there was no consensus on where to end the fusion proximally.

Novel techniques

Table 5 summarizes areas of consensus regarding novel techniques including cement augmentation, percutaneous instrumentation, and osteotomies.

Cement augmentation Cement augmentation at the upper instrumented vertebra (UIV) or UIV ? 1 is inappropriate in non-osteoporotic patients. There was no consensus for when cement augmentation was appropriate.

Percutaneous instrumentationPercutaneous fixation was

inappropriate in patients with severe coronal deformity

([60L) and severe sagittal imbalance ([100 mm). There was no consensus for when percutaneous fixation was appropriate.

Osteotomies It was inappropriate to perform a Ponte osteotomy in patients with a rigid lumbar hypolordosis with an ankylosed anterior column. It was appropriate to perform a pedicle subtraction osteotomy (PSO) in patients with a rigid lumbar hypolordosis, sagittal imbalance, age 40–65 years, with no comorbidities, and with or without coronal imbalance.

Implant materials, grafts, and neuromonitoring

Local autogenous bone graft was appropriate. It was appropriate to use intraoperative neuromonitoring in cor-rection surgery with levels of fusion above the conus. There was no consensus on which implant and rod mate-rials were appropriate in diverse scenarios.

Table 2 Consensus findings for preoperative assessment of risk factors for surgery and poor prognosis for ASD patients

Family history of degenerative adult deformity

Prior hospitalization

Patient smoking historyPatient’s smoking history through patient reporting

Collecting and evaluatingPatient’s smoking cessation in patients who smoke[1 pack per day (for elective

surgery)

No

consensus

Appropriate

Patient’s smoking cessation—never inquireInappropriate

Patient’s smoking history through urine/blood testingNo

consensus

Cardiovascular condition

Performing a cardiac stress test (chemical or exercised-based) in patients with

Significant co-morbidity (i.e., remote myocardial infarction, blood pressure, andAppropriate

cholesterol medications)

History of congestive heart failure

No pulmonary complaints (no shortness of breath, good tolerance to walking 3 No

flights of stairs), healthy, 40–65 years oldconsensus

Pulmonary condition

Performing a pulmonary function test with spirometry in patients with

History of pulmonary co-morbidity (i.e., chronic obstructive pulmonary disease,Appropriate

asthma), C40 years old

No pulmonary complaints (no shortness of breath, good tolerance to walking 3 No

flights of stairs), healthy, 40–65 years oldconsensus

Body mass index (BMI)

Evaluating

Bone quality

Evaluating

Patient physical exam

Evaluating

BMI to stratify risk or to guide treatmentNo

consensus

Bone mineral density with DEXA in patients with history of insufficiencyAppropriate

fracture (low energy fracture of extremity and spine)

Bone quality/presence of osteoporosis in patients with known risk factors for

osteoporosis

Bone quality/presence of osteoporosis- Never inquireInappropriate

Bone mineral density with DEXA in a [65 years old female patient with noNo

known history of osteoporosis (no history of fragility fractures)consensus

Gross motor function and knee and ankle reflexes by performing a neurologicalAppropriate

exam

Gait (ability to walk)

Pelvic tilt (physical assessment of pelvic version)

Hip flexion contracture

Skin (surgical site, legs for pigmentation and signs of venous stasis and arterial

disease)

Peripheral pulses

Postoperative management

Consensus regarding deep venous thrombosis (DVT) prophylaxis and return to activity after surgery is pre-sented in Table 6. Use of postoperative mechanical pro-phylaxis (i.e., compression stockings, pneumatic compression devices) was appropriate for all patients, and chemical prophylaxis (i.e., low molecular weight heparin, unfractionated heparin) was appropriate for patients with high risk of DVT.

Many postoperative strategies explored by the panel were considered reasonable as approaches, but did not meet the a priori consensus criteria.

Discussion

Goals of care

Literature in ASD surgery supports the goals of care to include radiographic correction of deformity, prevention of

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progression of the deformity, neural decompression, safety, and improvement of HRQOL in domains including pain, function, self-image, and mental health [3, 6, 19, 20]. The panel ranked improvement of function, pain, and neural status to be the most important, and there is good evidence that surgery results in reliable improvement in these domains [5, 21, 22]. Pekmezci et al. reported that baseline functional limitations in daily life were the most important concern for patients choosing surgery over non-operative care [23]. Acaroglu et al. demonstrated that surgery was more effective than non-operative care in improving health-related quality of life measured as quality adjusted life expectancy, and the effect size of surgery is most in patients with greatest preoperative disability [58]. The panel ranked radiographic improvement, prevention of deformity progression, and avoidance of complications as less important goals. Although the ultimate aim is to improve functional status, it has been shown that functional improvement is correlated with radiographic outcomes such as magnitude of radiographic correction in the sagittal and coronal planes and improvement of spinopelvic and global sagittal alignment [24, 25]. Therefore, it is difficult to separate clinical and radiographic goals, and both are considered appropriate in the surgical management of ASD.

Preoperative considerations

Patient-related factors are important for risk assessment and surgical planning in ASD. Age, BMI, and cardiac and pulmonary comorbidities have been shown to be predictors of perioperative complications, readmissions, and mortality in patients undergoing surgery for ASD [26–28]. Hu and Berven identified a comprehensive list of these variables, including medical conditions, prior surgery, and social

support networks which should be recognized prior to elective surgery for ASD to optimize patients preopera-tively, thereby reducing the risk of surgical complications [29]. Besides comorbidities, smoking is a predictor of poor patient satisfaction and reduced postoperative fusion rates, and smoking cessation for more than 6 months prior to spinal fusion surgery has been shown to reverse these negative effects [26, 30]. Consistent with the literature, the panel reached consensus on the importance of assessing cardiac and pulmonary function, bone density, and comorbidities in all patients with these comorbidities, as well as identifying smoking habits.

Preoperative imaging is important to assess the magni-tude of deformity in the coronal, sagittal, and axial planes, and for planning the surgical strategy. The panel reached consensus that it is appropriate for all ASD patients to be evaluated with preoperative full spine standing anterior– posterior and lateral radiographs. This is in agreement with evidence which consistently shows that full-length standing films is critical for accurate preoperative planning and classification, including visualization of C7 and the femoral heads [25, 31, 32].

Intraoperative considerations

The panel recognized the broad spectrum of surgical approaches for ASD patients, and consensus was reached in only a few scenarios. Consensus was more often reached on inappropriate, as opposed to appropriate, surgical approaches. Specifically, decompression alone is inappro-priate in curves of 30L with either a progressive deformity or sagittal imbalance. This is supported by the literature which shows that decompression alone is associated with high rates of progressive deformity and poor outcome in patients with segmental instability and deformity [33]. In

Table 4 Consensus findings for surgical procedures for ASD patients

ALIF anterior lumbar interbody fusion

line with previous literature, decompression with a limited fusion was considered inappropriate for patients with large coronal deformity ([60L), or sagittal imbalance [34].

Regarding the length of fusion, the choice of upper and lower instrumented vertebra, and distal fixation techniques remains controversial.

Distal fusion level and fixation

For long fusions from the thoracic spine to L5, high rates of subsequent advanced degeneration at L5–S1, high revision surgery rates, and worse outcomes have been reported [35]. Conversely, other research has concluded that patients

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fused to S1 have a higher risk of complications than patients fused to L5, and that the latter have an increased risk of developing sagittal imbalance [36, 37]. The panel recommended selection of L5 as a lowest instrumented vertebra as appropriate in patients with intermediate fusions (lower thoracic spine to L5) who have good sagittal balance and good bone stock and have no disk degenera-tion at L5–S1. In patients with longer fusions ([7 seg-ments) or symptomatic pathology at L5–S1, fusion to S1 is appropriate.

The role of interbody support and pelvic fixation in patients fused to the sacrum is an important consideration. Interbody fusion and pelvic fixation reduce strain on pos-terior implants, and potentially improve fusion and main-tenance of deformity correction [38–41], but there is conflicting evidence regarding the requirement for this strategy [42–44]. The panel found the use of interbody support, through either an anterior or posterior approach at L5–S1, to be appropriate in all fusions extending from T12 or higher to the sacrum. In patients with osteoporosis or with severe deformity (coronal trunk shift [4 cm, sagittal

vertical axis offset [5 cm), the panel also found supple-mental pelvic fixation to be appropriate in patients under-going fusion from L2 or above to the sacrum.

Proximal fixation

The choice of an UIV in ASD is thought to impact prox-imal junctional pathology. The literature provides limited guidance for extension of fusion to the upper thoracic spine [45–48]. The only area of consensus was for a lumbar degenerative scoliosis fusion to the lower thoracic spine (rather than higher) is appropriate in patients who meet the strict criteria of adequate sagittal balance and no evidence of osteoporosis and with a thoracic kyphosis less than 30L.

The role of osteotomies

The use of three-column osteotomies has increased sig-nificantly over the past decade. While osteotomies of the spine provide a powerful technique for posterior-based deformity correction [49], osteotomies have been

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Table 6 Consensus findings for postoperative management strategies for ASD patients

associated with high rates of complications, including junctional pathology, nonunion, and perioperative compli-cations [50–52]. Specifically, LaMaida et al. demonstrated high rates of complications in elderly ASD patients treated with osteotomies [50], and Smith et al. identified three-column osteotomies as an independent risk factor for major complications [52]. The panel reached consensus that it is appropriate to perform a PSO on patients with sagittal imbalance due to a rigid lumbar hypolordosis if aged 40–65 years, with no comorbidities, with or without coronal imbalance. In contrast, the panel agreed that per-forming a Ponte osteotomy in a patient with a rigid deformity and ankylosed spine is inappropriate. Other clinical scenarios for when to perform the Ponte, PSO, or vertebral column resection osteotomies did not reach con-sensus, largely because of the variability in patients.

The use of novel surgical techniques, including cement augmentation of screws and adjacent vertebra, and percu-taneous fixation for deformity did not reach consensus for any scenario. There is limited literature to guide an evi-dence-based approach to novel techniques in spinal deformity surgery.

Postoperative considerations

DVT is a significant postoperative complication related to morbidity and mortality following ASD surgery [53, 54]. The panel achieved consensus that it is appropriate to use

mechanical prophylaxis in all surgical ASD patients, and chemical prophylaxis in patients who are at a high risk for DVT. Patients undergoing surgical treatment for adolescent idiopathic scoliosis have been shown to return to full, unrestricted activity including sports by 1 year postopera-tive without adverse effects [55, 56]. In contrast, there is little evidence to guide time to return to work and recre-ational activities for adults, and there is substantial vari-ability in reported return-to-activity rates [57].

Clinical relevance and limitations

The strength of this study is that it addressed a broad spectrum of scenarios and decision points that physicians and patients encounter routinely in management of patients with ASD. Many decision points simply cannot be addressed practically with empirical studies or randomized trials, leading to limited evidence in the literature, and significant variability in approaches to care. By employing an international experienced panel, we provided guidance in defining appropriate and inappropriate approaches to care where possible. It turned out that it was very difficult to reach consensus. We believe that this is due not so much to lack of evidence, but due to the complexity of the dis-ease combined with almost endless permutations of con-founding comorbidities. Furthermore, patient preference, patient risk aversion, and patient perception of preoperative health status complicate decision-making even more.

Despite providing panelists with multiple realistic scenar-ios, even this modified Delphi methodology could not take into account this degree of granularity.

The study provides high levels of consensus regarding the appropriate preoperative evaluation of patients, limited con-sensus on negative recommendations (i.e., consensus on inappropriate care), and very few positive recommendations (i.e., consensus on appropriate care). The majority of surgical approaches, and intraoperative options, are considered as reasonable, without a clear consensus regarding appropriate or inappropriateness. Panel consensus regarding inappropriate care, especially for intraoperative strategies, can function as negative directives and ‘‘what not to do’’. Guidance on what to avoid may be useful as this may help avoid poor outcomes and surgical failures, thereby reducing health care costs, and improving value of care. Acaroglu et al. demonstrated that surgical treatment of adult deformity is associated with sig-nificant complications compared with non-operative care, and a decision analysis regarding the appropriateness of surgical care must include consideration of complications of surgery and the expected benefit of surgery on health-related quality of life [59]. The absence of consensus on appropriate approaches to many surgical scenarios, and the predominance of ‘‘rea-sonable’’ as a response, supports the conclusion that surgeon preference and patient values remain central to decision-making, and a monolithic or dogmatic approach to care (in-cluding practice guidelines) should be avoided.

Appropriate care for ASD must be responsive to specific considerations of the patient, the care provider, and the healthcare system. The areas where there is no consensus regarding appropriate approaches may also guide future research to provide an evidence-based treatment.

Acknowledgements We are grateful to the 53 panelists (Supple-mentary Table 2) for contributing to this study. This research was supported by AOSpine International through a grant to the AOSpine Deformity Knowledge Forum. AOSpine is a clinical division of the AOFoundation- an independent, medically guided not for profit organization.

Compliance with ethical standards

Funding This study received financial support from AOSpine International through the AOSpine Deformity Knowledge Forum.

Conflict of interest The authors do have funding related to the study, and conflicts that are not directly related to the study.

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