Bringing Back Theorizing Medical Hypotheses to Spine Surgery Research in an Age of Overreliance on Randomized Controlled Trials

  • International Journal of Spine Surgery
  • October 2025,
  • 19
  • (5)
  • 555-564;
  • DOI: https://doi.org/10.14444/8802

Abstract

Background Randomized controlled trials (RCTs) are widely treated as the evidentiary gold standard in spine surgery. Yet their methodological control often underrepresents surgical variability, patient heterogeneity, learning-curve effects, and the iterative nature of procedural innovation, widening the gap between research outputs and real-world practice.

Objective To propose a hybrid evidence framework that preserves the strengths of RCTs while elevating hypothesis-driven observational research and surgeon-led insights to inform clinically relevant standards, guidelines, and policy in spine care.

Approach This perspective synthesizes conceptual and methodological arguments, drawing on examples from surgical innovation pathways and on evaluative tools (e.g., GRADE and Rasch-based methodologies). It examines how case series, prospective cohorts, registries, and conceptual models—when rigorously designed and transparently reported—can complement RCTs. Key insights include:

  1. Practicing surgeons are uniquely positioned to detect emerging techniques, define phenotypes, and iteratively refine indications through case series and cohort observations.

  2. Applying structured appraisal frameworks (GRADE) and measurement models (Rasch) can enhance the validity, comparability, and policy-readiness of observational data.

  3. Professional societies should formalize forums and pathways for early-stage innovation, coupled with standards for data quality, outcome harmonization, and ethical oversight.

  4. A hybrid model—integrating RCTs with high-quality real-world evidence—provides a more agile and clinically responsive basis for guideline development and payer/regulatory decisions.

Recommendations Establish society-endorsed research dissemination; guideline development; professional collaboration with core outcome sets; incentivize transparent, prospective observational designs; adopt GRADE for guideline synthesis that includes non-randomized data; and deploy Rasch-informed assessment where appropriate to improve measurement precision.

Conclusions A recalibrated, hybrid evidence ecosystem—combining RCT rigor with systematically evaluated observational science—can better capture the realities of spine surgery, accelerate safe innovation, and keep patient needs at the center of evidence generation.

Introduction

Evidence-based medicine (EBM) has reshaped modern clinical practice, positioning randomized controlled trials (RCTs) and meta-analyses as the gold standard for establishing high-grade evidence. In pharmacology and population-based medicine, these methods have yielded substantial insights.1,2 However, in skill-intensive disciplines like spine surgery, the rigid structure of RCTs often falls short. Strict inclusion and exclusion criteria,3 the impracticality of double-blinding, and the failure to account for surgeon expertise limit the applicability of RCT findings to real-world surgical care.4 This disconnect has created a “glass ceiling” effect (Figure 1),5,6 constraining the types of innovations that can be tested and validated within the RCT framework.6–9

This diagram illustrates the “glass ceiling effect” in spine surgery research—the structural limitations of RCTs that hinder validation of surgeon-driven innovations. Strict inclusion/exclusion criteria and the impracticality of double-blinding result in homogeneous study populations and introduce bias, limiting both internal validity and real-world applicability. In contrast, clinical expertise enables surgeons to adapt and refine techniques for complex, individualized cases. Bridging this gap requires a more balanced research paradigm that integrates real-world observations alongside RCT-based validation to support innovation in spine surgery.
Figure 1

This diagram illustrates the “glass ceiling effect” in spine surgery research—the structural limitations of RCTs that hinder validation of surgeon-driven innovations. Strict inclusion/exclusion criteria and the impracticality of double-blinding result in homogeneous study populations and introduce bias, limiting both internal validity and real-world applicability. In contrast, clinical expertise enables surgeons to adapt and refine techniques for complex, individualized cases. Bridging this gap requires a more balanced research paradigm that integrates real-world observations alongside RCT-based validation to support innovation in spine surgery.

Historically, spine surgery has advanced through clinical observation, intuitive reasoning, and hypothesis-driven innovation.10 Foundational procedures such as spinal fusion11–18 and total disc replacement19 began as clinician-led hypotheses, refined through years of iterative practice and ultimately validated through formal trials.20–25 Yet today, the dominance of RCTs in defining clinical guidelines, coverage decisions, and regulatory approvals threatens to marginalize the very process that enabled such innovations (Figure 2).26

 Over-reliance on randomized controlled trials (RCTs) can delay the adoption of valuable spine surgery innovations, despite strong observational and clinical evidence. Illustrated by the example of total disc replacement, the diagram highlights how real-world success was insufficient to prompt broader use without long-term RCT data. Incorporating the insights of front-line practitioners—who identify effective treatments through clinical experience—can help integrate real-world evidence into the research process and accelerate the adoption of beneficial techniques.
Figure 2

 Over-reliance on randomized controlled trials (RCTs) can delay the adoption of valuable spine surgery innovations, despite strong observational and clinical evidence. Illustrated by the example of total disc replacement, the diagram highlights how real-world success was insufficient to prompt broader use without long-term RCT data. Incorporating the insights of front-line practitioners—who identify effective treatments through clinical experience—can help integrate real-world evidence into the research process and accelerate the adoption of beneficial techniques.

Surgeons—uniquely positioned at the interface of technology and patient care—often identify effective techniques and patterns in outcomes long before these are recognized through formal studies. Case reports, cohort studies, and even speculative “thought experiments” can serve as precursors to meaningful discoveries. Unfortunately, such observational insights are frequently undervalued in the prevailing evidence hierarchy.

This perspective article advocates for a recalibration of how evidence is generated and valued in spine surgery. We propose integrating real-world data, observational studies, and hypothesis-driven reasoning alongside RCTs to build a more inclusive and dynamic research model. By empowering spine surgeons to contribute clinical insights and by supporting forums where lower-grade evidence can be rigorously debated, we can ensure that innovation in spine surgery continues to evolve in a scientifically grounded yet practically relevant manner.

Limitations Of RCTs In Spine Surgery

RCTs are widely regarded as the highest standard in clinical research due to their ability to minimize bias and establish causal relationships.27 Their influence has permeated guideline development, regulatory approval, and reimbursement policy across medical disciplines.28,29 A central limitation of RCTs in spine surgery is the inability to control for variability in surgical expertise. Unlike pharmacological studies, where the intervention (a drug) remains fixed, surgical outcomes depend heavily on the operator’s technical proficiency and decision-making. Two surgeons performing the same procedure may yield markedly different results, a variable that traditional RCTs do not adequately account for.30 This undermines both the internal and external validity of trial outcomes when generalized to a broader clinical audience.

Blinding—the cornerstone of bias reduction in clinical trials—is also inherently problematic in surgical research.6 Neither the patient nor the surgeon can be feasibly blinded to whether a procedure was performed, introducing expectation bias that can affect both care delivery and outcome reporting. Attempts at sham surgery raise ethical and methodological concerns and are rarely applicable at scale.

Another major concern is the reliance on strict inclusion and exclusion criteria to achieve internal validity.31 These criteria, while scientifically justifiable, often exclude patients with comorbidities, anatomic variations, or atypical presentations—the very patients spine surgeons treat daily. As a result, trial populations frequently do not reflect the complexity of real-world practice,32 and the findings may not translate meaningfully to broader patient care.

These structural limitations of RCTs have created what some have termed a “glass ceiling” in surgical research. The metaphor reflects the cap imposed by rigid trial designs on the types of innovations that can be studied or validated. Emerging technologies—such as endoscopic techniques, motion-preserving implants, or robotics-assisted procedures—often arise from clinical insight and iterative refinement. However, their diffusion into practice can be delayed or dismissed due to a lack of level I evidence, despite strong observational support and clear clinical utility (Figure 3).

 The key constraints of randomized controlled trials (RCTs) in spine surgery can be summarized into 4 major categories: surgical skill variability, impracticality of double blinding, strict inclusion/exclusion criteria, and the inability to address complex individualized cases. These factors limit the external validity and applicability of RCT findings to real-world surgical practice.
Figure 3

 The key constraints of randomized controlled trials (RCTs) in spine surgery can be summarized into 4 major categories: surgical skill variability, impracticality of double blinding, strict inclusion/exclusion criteria, and the inability to address complex individualized cases. These factors limit the external validity and applicability of RCT findings to real-world surgical practice.

Spine surgery is a field defined by individualization, adaptability, and constant evolution. While RCTs remain a critical pillar of scientific rigor, they must be contextualized within a broader evidentiary framework that values both methodological control and clinical reality. Only by acknowledging their limitations can we begin to build a more inclusive research paradigm—one that balances precision with practicality and innovation with accountability (Figure 3).

THE CASE FOR HYPOTHESIS-DRIVEN INNOVATION IN SPINE SURGERY

In the highly variable and skill-intensive environment of spine surgery, clinical progress often stems from individual surgeons observing patterns, testing refinements, and proposing new approaches long before these are formally studied. Hypothesis generation, rooted in direct patient care, is essential for identifying unmet needs, procedural gaps, and emerging innovations. Yet in the current research paradigm, early-stage clinical insights are frequently dismissed if not supported by high-grade evidence.

This creates a paradox: the field expects innovation but undervalues the conditions that foster it. Spine surgeons—those most attuned to procedural nuance and patient response—are rarely incentivized to share their observations unless accompanied by statistically powered studies. As a result, meaningful insights often remain unpublished, and the broader field misses opportunities to explore promising concepts in their formative stages.

Theorizing is not inherently unscientific; it is the first step in the scientific process. Whether derived from clinical experience, mechanistic reasoning, or procedural trial-and-error, medical hypotheses provide the foundation for structured inquiry. Encouraging surgeons to articulate such hypotheses—supported by well-documented case series, cohort observations, or even carefully reasoned proposals—can accelerate the identification of new therapeutic strategies and guide the design of more relevant formal studies.

In 1975, the loss of a vibrant, hypothesis-driven culture in medicine was recognized as a missed opportunity for progress. Innovation often requires the courage to explore uncharted territory before conclusive evidence is available. The Journal of Medical Hypotheses, founded by Dr. David Horrobin, was established as a forum to publish speculative and theoretical ideas that would not have met the publication standards of conventional journals. Though initially met with skepticism, the journal eventually became a valuable outlet for early-stage concepts, promoting scientific diversity and unconventional thinking. Today, it is indexed in leading databases—including PubMed, Scopus, and the Science Citation Index—and holds a 2024 impact factor (released in 2025) of 2.10 with an h-index of 106, and a Research Impact Score of 4.2, reflecting its sustained influence on scientific discourse. Its success affirms the value of institutional platforms that encourage theoretical exploration, even in the absence of immediate empirical validation.

For this spirit of exploration to take hold in spine surgery, the research culture must evolve. Journals, conferences, and professional societies should provide structured pathways for hypothesis-driven submissions, including formats that welcome case-based innovation and conceptual models. When combined with methodological rigor and ethical transparency, these contributions can enhance—not undermine—the credibility of the field.

Reintegrating hypothesis generation into the research continuum affirms the role of the practicing spine surgeon not just as a proceduralist, but as a scientific contributor. It allows the field to remain exploratory, adaptive, and aligned with the real-world complexities of patient care.

Observational Evidence and the Role of Spine Surgeons as Stakeholders

In spine surgery, where outcomes hinge on individual technique, patient variability, and intraoperative decision-making, observational studies provide indispensable insights that RCTs often overlook. Though traditionally ranked low on the evidence hierarchy, well-conducted cohort studies, case series, and surgeon-reported outcomes capture real-world complexity, document long-term durability, and reflect how surgical innovations perform in routine practice [Figure 4].

 From observational insight to guideline influence via the GRADE system, this diagram traces how spine surgeons’ real-world data—captured through case reports and cohort studies—enter an evidence pathway that can ultimately shape clinical guidelines.
Figure 4

 From observational insight to guideline influence via the GRADE system, this diagram traces how spine surgeons’ real-world data—captured through case reports and cohort studies—enter an evidence pathway that can ultimately shape clinical guidelines.

To strengthen the credibility of such evidence, modern frameworks such as GRADE allow for the elevation of observational data when findings are consistent, reproducible, and clinically relevant. Additionally, statistical tools like Rasch analysis—particularly differential item functioning—offer a way to detect and adjust for bias across subgroups,33 enhancing the rigor of observational research and its applicability to guideline development and identification of high-value spine surgeries (Figure 5).34

 This diagram outlines how Rasch analysis detects and adjusts for bias in observational research by analyzing subgroup response patterns. When differential item functioning (DIF) is found, biased items are identified and corrected, increasing study reliability. Whether confirming consistency or correcting bias, the process enhances the credibility and clinical value of traditional observational cohort studies—ultimately improving the quality of evidence often considered low-grade.
Figure 5

 This diagram outlines how Rasch analysis detects and adjusts for bias in observational research by analyzing subgroup response patterns. When differential item functioning (DIF) is found, biased items are identified and corrected, increasing study reliability. Whether confirming consistency or correcting bias, the process enhances the credibility and clinical value of traditional observational cohort studies—ultimately improving the quality of evidence often considered low-grade.

Surgeons are not simply consumers of evidence; they are also essential producers. Their proximity to both the patient and the evolving technology of spine care uniquely positions them to identify procedural gaps, generate hypotheses, and evaluate emerging techniques. Yet, despite their contributions, surgeons are often excluded from key decisions on value assessments, reimbursement structures, and health care policy.

The authors of this perspective have previously applied Rasch-based methodologies to elevate the perceived value of underrecognized spine procedures. By analyzing the relative difficulty, stress, and learning curve of various interventions—including undervalued CPT codes—they demonstrated how statistically transformed data can inform the AMA/Specialty Society RUC (RVS [Relative Value Scale] Update Committee) and ultimately influence Medicare reimbursement schedules.35–38 These efforts highlight the power of surgeon-led data to affect systemic change and underscore the importance of including clinicians in policy-shaping processes.

Recognizing spine surgeons as key stakeholders in health care decision-making is essential to ensuring that innovative procedures—often born from real-world observation and iterative refinement—are properly evaluated and accessible to patients. Their daily interaction with technology, pathology, and outcomes equips them to assess procedural impact with a depth that few others can match.

To support this paradigm, professional spine societies must step into a more active advocacy role. These organizations are uniquely positioned to engage with payers, policymakers, and industry partners to ensure that observational studies and surgeon-reported outcomes are recognized as valuable forms of evidence.39–43 While RCTs and meta-analyses remain indispensable, they cannot fully capture the spectrum of innovation, adaptation, and insight that practicing surgeons contribute. Elevating the role of observational data in clinical guidelines and policy discussions will close the gap between scientific evidence and surgical reality.

When collected rigorously and contextualized appropriately, real-world data authored by experienced surgeons should not be relegated to anecdote. It should be understood as a foundational component of a more inclusive, responsive, and clinically relevant evidence base—one that balances statistical precision with the nuances of human care.

The Role of Spine Societies in Advancing Clinical Innovation

Spine societies such as the International Society for the Advancement of Spine Surgery and the North American Spine Society play a central role in shaping the field through research dissemination, guideline development, and professional collaboration. To remain relevant, these organizations must broaden their definition of evidence to include the real-world contributions of practicing surgeons.

The persistent emphasis on RCTs risks sidelining valuable observational studies, case series, and clinical hypotheses.44 When professional societies uncritically adopt rigid hierarchies of evidence, they may discourage surgeons from sharing insights that fall outside traditional trial formats—despite those insights often representing the earliest signals of clinical innovation.

Rather than allowing these contributions to migrate to informal channels like social media—where context and nuance are often lost—societies should proactively create space for hypothesis-driven discussions within their journals, meetings, and working groups. Dedicated forums for presenting early-stage innovations and case-based insights would foster intellectual diversity and expand the field’s capacity for iterative improvement.

By validating observational data and surgeon-led theorizing as legitimate components of the research ecosystem, spine societies can bridge the gap between high-grade evidence and the realities of surgical practice. In doing so, they will empower their members to lead innovation and ensure that the future of spine care remains clinically grounded and forward-thinking.

Toward a Hybrid Evidence Model: Future Directions for Spine Surgery Research

While RCTs have contributed significantly to spine surgery—most notably through landmark efforts like the SPORT trial45–48—they remain constrained by issues such as treatment crossover, rigid eligibility criteria, and limited applicability to real-world patients. These challenges highlight the need for a more inclusive, hybrid approach to evidence generation—one that balances the internal validity of RCTs with the external relevance of observational studies.

A hybrid model leverages the complementary strengths of both methodologies. RCTs remain valuable for evaluating discrete interventions under controlled conditions. However, observational studies—such as cohort analyses, registries, and surgeon-reported outcomes—capture how techniques perform across diverse patient populations, evolving technologies, and varying levels of surgeon expertise. When supported by analytic rigor, such as Rasch differential item functioning analysis, these studies can provide high-quality insights that inform clinical decision-making and policy.

Surgeons are essential to this recalibrated paradigm. Their ability to observe trends, adapt techniques, and generate hypotheses positions them as frontline innovators. Encouraging surgeons to contribute to both hypothesis generation and outcomes reporting can accelerate the translation of clinical insight into practice-changing research.

Looking ahead, the future of evidence-based spine care will depend on more dynamic and responsive frameworks. Guidelines must evolve continuously—not in decade-long cycles—through real-time integration of observational data and clinical expertise. Structured surgeon surveys, practice-based registries, and living guideline models can support this shift, allowing evidence to adapt alongside technological and procedural advancements.

To support this future, journals, academic institutions, and professional societies must endorse diverse forms of evidence and foster a research culture that values both scientific rigor and practical relevance. Elevating observational research to its rightful place alongside RCTs ensures that innovation in spine surgery remains grounded in both empirical validation and clinical insight.

Discussion

In this article, we argue for the reintegration of hypothesis-driven research and observational insight into the mainstream of spine surgery scholarship. While RCTs remain foundational to EBM—particularly in fields where interventions are easily standardized—their limitations in surgical disciplines are increasingly evident. The complexity of spine surgery, including the variability in surgical technique, anatomy, and intraoperative decision-making, resists the homogenization required by RCT design. Moreover, exclusion criteria and artificial clinical equipoise further distance RCT findings from the heterogeneity of everyday clinical practice.

Historically, many of spine surgery’s most transformative innovations emerged not from RCTs but from clinical intuition and iterative experimentation. Hypothesis generation—once central to medical progress—has been sidelined by the demand for high-grade evidence before new ideas are even considered. Yet without the freedom to articulate and explore medical hypotheses, the field risks stagnation. Surgeons’ firsthand observations, case series, and cohort studies remain essential to identifying emerging trends, procedural refinements, and patient subgroups for whom standard protocols may not apply.

Spine societies and journals must do more to create intellectual space for such contributions. Elevating the role of lower-grade but rigorously collected data—and recognizing its value in complex, real-world scenarios—is essential to maintaining a vibrant and forward-looking research culture. Likewise, methodologies such as Rasch analysis and GRADE classification systems offer pathways to improve the rigor and credibility of observational studies, transforming them from anecdote to actionable evidence.

By restoring balance between formal trials and clinical insight, spine surgery can remain both innovative and evidence-informed. Empowering surgeons as contributors to theory—not just subjects of policy—ensures that scientific advancement remains rooted in practical, patient-centered care.

Conclusion

The current research landscape in spine surgery heavily emphasizes RCTs as the gold standard for producing high-grade evidence. While RCTs have proven invaluable in many aspects of medicine, their limitations are becoming increasingly apparent in complex surgical fields such as spine surgery. There is a growing need to bring back hypothesis-driven research, where clinical observations and real-world experiences complement RCT data. Theorizing based on direct clinical experience can uncover innovative ideas and treatment methods that may not fit neatly into the rigid frameworks of traditional trials.

Looking forward, the future of spine surgery research lies in embracing a more inclusive approach that balances the rigor of RCTs with the nuanced realities of clinical practice. A surgeon-led research paradigm, where hypothesis-driven studies and observational research are valued, can lead to a more dynamic and adaptable understanding of spine care. Surgeons, with their hands-on expertise and insights, should be empowered to guide innovations, providing crucial real-world evidence to shape patient outcomes.

Ultimately, the spine surgery community must embrace a multifaceted approach to research. Observational studies, case series, and hypothesis-driven inquiries should stand alongside RCTs as pillars of EBM. By fostering an environment where diverse forms of research are respected and utilized, the field can continue to innovate, ensuring that patient care is driven not only by statistical data but also by the experienced judgment of skilled surgeons. This integrated approach will keep spine surgery at the forefront of medical innovation while maintaining its practical effectiveness in real-world settings.

Footnotes

  • Funding The authors received no financial support for the research, authorship, and/or publication of this article.

  • Declaration of Conflicting Interests The authors declare no conflict of interest relevant to this research, and there was no personal circumstance or interest that may be perceived as inappropriately influencing the representation or interpretation of reported research results. This research was not compiled to enrich anyone.

  • Author Contributions The authors volunteered their time and internal resources to support the design and conduction of this research study. All authors aided in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

References

  1. 1.
    ↵
    Thoma A , Eaves FF . A brief history of evidence-based medicine (EBM) and the contributions of dr david sackett. Aesthet Surg J. 2015;35(8):NP261–NP263. 10.1093/asj/sjv130
    Google ScholarCrossRefPubMed
  2. 2.
    ↵
    Sullivan D , Chung KC , Eaves FF , Rohrich RJ . The level of evidence pyramid: indicating levels of evidence in plastic and reconstructive surgery articles. Plast Reconstr Surg. 2021;148(5S):68S–71S. 10.1097/01.prs.0000794868.07051.b4
    Google ScholarCrossRef
  3. 3.
    ↵
    Spieth PM , Kubasch AS , Penzlin AI , Illigens B-W , Barlinn K , Siepmann T . Randomized controlled trials - a matter of design. Neuropsychiatr Dis Treat. 2016;12:1341–1349. 10.2147/NDT.S101938
    Google ScholarCrossRef
  4. 4.
    ↵
    Krauss A . Why all randomised controlled trials produce biased results. Ann Med. 2018;50(4):312–322. 10.1080/07853890.2018.1453233
    Google ScholarCrossRefPubMed
  5. 5.
    ↵
    Solheim O . Randomized controlled trials in surgery and the glass ceiling effect. Acta Neurochir (Wien). 2019;161(4):623–625. 10.1007/s00701-019-03850-3
    Google ScholarCrossRef
  6. 6.
    ↵
    Kai-Uwe L , León JFR , Dowling Á , et al . Breaking through the glass ceiling effect of high-grade clinical evidence creation in orthopaedics & trauma. Revista Colombiana de Ortopedia y Traumatología. 2022;36(4):215–228. 10.1016/j.rccot.2022.10.003
    Google ScholarCrossRef
  7. 7.
    ↵
    Fries JF , Krishnan E . Equipoise, design bias, and randomized controlled trials: the elusive ethics of new drug development. Arthritis Res Ther. 2004;6(3):R250–R255. 10.1186/ar1170
    Google ScholarCrossRefPubMedWeb of Science
  8. 8.
    ↵
    Ratnani I . Gap Between Practices of Evidence-Based Medicine and Personalized Medicine: A Barrier in Learning [Thesis] . University of Houston; 2021.
    Google Scholar
  9. 9.
    ↵
    Boyd-Franklin N , Cleek EN , Wofsy M , Mundy B . Therapy in the Real World: Effective Treatments for Challenging Problems. Guilford Publications; 2015.
    Google Scholar
  10. 10.
    ↵
    Vigliani M , Eaton G , Hoose P . A History of Medicine in 50 Discoveries (History in 50)Ed. Tilbury House Publishers and Cadent Publishing; 2017.
    Google Scholar
  11. 11.
    ↵
    Leu H , Schreiber A . Endoscopy of the spine: minimally invasive therapy. Orthopade. 1992;21(4):267–272.
    Google ScholarPubMed
  12. 12.
    ↵
    Kambin P , McCullen G , Parke W , Regan JJ , Schaffer JL , Yuan H . Minimally invasive arthroscopic spinal surgery. Instr Course Lect. 1997;46:143–161.
    Google ScholarPubMed
  13. 13.
    ↵
    Kambin P , Gennarelli T , Hermantin F . Minimally invasive techniques in spinal surgery: current practice. Neurosurg Focus. 1998;4(2):e8.
    Google Scholar
  14. 14.
    ↵
    Fessler RG , Khoo LT . Minimally invasive cervical microendoscopic foraminotomy: an initial clinical experience. Neurosurgery. 2002;51(5 Suppl):S37–S45.
    Google ScholarPubMed
  15. 15.
    ↵
    Guiot BH , Khoo LT , Fessler RG . A minimally invasive technique for decompression of the lumbar spine. Spine (Phila Pa 1986). 2002;27(4):432–438. 10.1097/00007632-200202150-00021
    Google ScholarCrossRefPubMed
  16. 16.
    ↵
    Adamson TE . The impact of minimally invasive cervical spine surgery. J Neurosurg. 2004;1(1):43–46. 10.3171/spi.2004.1.1.0043
    Google ScholarCrossRef
  17. 17.
    ↵
    Foley KT , Holly LT , Schwender JD . Minimally invasive lumbar fusion. Spine (Phila Pa 1986). 2003;28(supplement):S26–S35. 10.1097/01.BRS.0000076895.52418.5E
    Google ScholarCrossRef
  18. 18.
    ↵
    Thongtrangan I , Le H , Park J , Kim DH . Minimally invasive spinal surgery: a historical perspective. Neurosurg Focus. 2004;16(1):E13. 10.3171/foc.2004.16.1.14
    Google ScholarCrossRefPubMed
  19. 19.
    ↵
    Serhan H , Mhatre D , Defossez H , Bono CM . Motion-preserving technologies for degenerative lumbar spine: the past, present, and future horizons. SAS J. 2011;5(3):75–89. 10.1016/j.esas.2011.05.001
    Google ScholarCrossRefAbstract/Full Text
  20. 20.
    ↵
    Yajun W , Yue Z , Xiuxin H , Cui C . A meta-analysis of artificial total disc replacement versus fusion for lumbar degenerative disc disease. Eur Spine J. 2010;19(8):1250–1261. 10.1007/s00586-010-1394-x
    Google ScholarCrossRefPubMed
  21. 21.
    ↵
    Ding F , Jia Z , Zhao Z , et al . Total disc replacement versus fusion for lumbar degenerative disc disease: a systematic review of overlapping meta-analyses. Eur Spine J. 2017;26(3):806–815. 10.1007/s00586-016-4714-y
    Google ScholarCrossRefPubMed
  22. 22.
    ↵
    Findlay C , Ayis S , Demetriades AK . Total disc replacement versus anterior cervical discectomy and fusion: a systematic review with meta-analysis of data from a total of 3160 patients across 14 randomized controlled trials with both short- and medium- to long-term outcomes. Bone Joint J. 2018;100-B(8):991–1001. 10.1302/0301-620X.100B8.BJJ-2018-0120.R1
    Google ScholarCrossRef
  23. 23.
    ↵
    Li YZ , Sun P , Chen D , Tang L , Chen CH , Wu AM . Artificial total disc replacement versus fusion for lumbar degenerative disc disease: an update systematic review and meta-analysis. Turk Neurosurg. 2020;30(1):1–10. 10.5137/1019-5149.JTN.24799-18.2
    Google ScholarCrossRef
  24. 24.
    ↵
    Rasouli MR , Rahimi-Movaghar V , Shokraneh F , Moradi-Lakeh M , Chou R . Minimally invasive discectomy versus microdiscectomy/open discectomy for symptomatic lumbar disc herniation. Cochrane Database Syst Rev. 2014;2014(9):CD010328. 10.1002/14651858.CD010328.pub2
    Google ScholarCrossRef
  25. 25.
    ↵
    Birkenmaier C , Komp M , Leu HF , Wegener B , Ruetten S . The current state of endoscopic disc surgery: review of controlled studies comparing full-endoscopic procedures for disc herniations to standard procedures. Pain Physician. 2013;16(4):335–344.
    Google ScholarPubMed
  26. 26.
    ↵
    Woolf SH , George JN . Evidence-based medicine. interpreting studies and setting policy. Hematol Oncol Clin North Am. 2000;14(4):761–784. 10.1016/s0889-8588(05)70310-5
    Google ScholarCrossRefPubMedWeb of Science
  27. 27.
    ↵
    Parfrey PS , Ravani P . On framing the research question and choosing the appropriate research design. Methods Mol Biol. 2021;2249:1–16. 10.1007/978-1-0716-1138-8_1
    Google ScholarCrossRef
  28. 28.
    ↵
    Grossman J , Mackenzie FJ . The randomized controlled trial: gold standard, or merely standard? Perspect Biol Med. 2005;48(4):516–534. 10.1353/pbm.2005.0092
    Google ScholarCrossRefPubMedWeb of Science
  29. 29.
    ↵
    Schulz KF . Methodological Quality and Bias in Randomised Controlled Trials [PhD Thesis] . London School of Hygiene & Tropical Medicine; 1994.
    Google Scholar
  30. 30.
    ↵
    Lewandrowski K-U , Yeung A . Meaningful outcome research to validate endoscopic treatment of common lumbar pain generators with durability analysis. J Spine Surg. 2019:S6–S13. 10.21037/jss.2019.09.07
    Google ScholarCrossRef
  31. 31.
    ↵
    Zulman DM , Sussman JB , Chen X , Cigolle CT , Blaum CS , Hayward RA . Examining the evidence: a systematic review of the inclusion and analysis of older adults in randomized controlled trials. J Gen Intern Med. 2011;26(7):783–790. 10.1007/s11606-010-1629-x
    Google ScholarCrossRefPubMed
  32. 32.
    ↵
    Saturni S , Bellini F , Braido F , et al . Randomized controlled trials and real life studies. approaches and methodologies: a clinical point of view. Pulm Pharmacol Ther. 2014;27(2):129–138. 10.1016/j.pupt.2014.01.005
    Google ScholarCrossRefPubMed
  33. 33.
    ↵
    Rouquette A , Hardouin J-B , Vanhaesebrouck A , Sébille V , Coste J . Differential item functioning (DIF) in composite health measurement scale: recommendations for characterizing DIF with meaningful consequences within the Rasch model framework. PLoS ONE. 2019;14(4):e0215073. 10.1371/journal.pone.0215073
    Google ScholarCrossRef
  34. 34.
    ↵
    Lewandrowski KU , Lorio MP , Burkhardt BW , Vaccaro AR . High-value procedures in endoscopic spine surgery: an analysis of clinical outcomes based on surgeon experience, skill, and training. Int J Spine Surg. 2025:8705. 10.14444/8705
    Google ScholarCrossRef
  35. 35.
    ↵
    Lorio M , Martinson M , Ferrara L . Paired comparison survey analyses utilizing Rasch methodology of the relative difficulty and estimated work relative value units of CPT® code 27279. Int J Spine Surg. 2016;10:40. 10.14444/3040
    Google ScholarCrossRefAbstract/Full Text
  36. 36.
    ↵
    Lorio D , Twetten M , Golish SR , Lorio MP . Determination of work relative value units for management of lumbar spinal stenosis by open decompression and interlaminar stabilization. Int J Spine Surg. 2021;15(1):1–11. 10.14444/8026
    Google ScholarCrossRefAbstract/Full TextPubMed
  37. 37.
    ↵
    Lewandrowski K-U , Alfaro Pachicano HH , Alvim Fiorelli RK , et al . Comparative analysis of learning curve, complexity, psychological stress, and work relative value units for CPT 62380 endoscopic lumbar spinal decompression vs traditional lumbar spine surgeries: a paired Rasch survey study. Int J Spine Surg. 2024;18(2):138–151. 10.14444/8594
    Google ScholarCrossRefAbstract/Full TextPubMed
  38. 38.
    ↵
    Lorio M , Lewandrowski KU , Yeager MT , Hallas K , Kube R , Yue J . Paired comparison survey analysis utilizing rasch methodology of the relative difficulty and estimated work relative value units of CPT code 0202T. Int J Spine Surg. 2024;18(2):130–137. 10.14444/8587
    Google ScholarCrossRefAbstract/Full TextPubMed
  39. 39.
    ↵
    Guyer R , Musacchio M , Cammisa FP , Lorio MP . ISASS recommendations/coverage criteria for decompression with interlaminar stabilization - coverage indications, limitations, and/or medical necessity. Int J Spine Surg. 2016;10:41. 10.14444/3041
    Google ScholarCrossRefFull Text
  40. 40.
    ↵
    Lorio MP . ISASS policy 2016 update - minimally invasive sacroiliac joint fusion. Int J Spine Surg. 2016;10:26. 10.14444/3026
    Google ScholarCrossRefAbstract/Full Text
  41. 41.
    ↵
    Lorio M , Clerk-Lamalice O , Beall DP , Julien T . International Society for the Advancement of Spine Surgery guideline-intraosseous ablation of the basivertebral nerve for the relief of chronic low back pain. Int J Spine Surg. 2020;14(1):18–25. 10.14444/7002
    Google ScholarCrossRefAbstract/Full TextPubMed
  42. 42.
    ↵
    Lorio M , Clerk-Lamalice O , Rivera M , Lewandrowski KU . ISASS policy statement 2022: literature review of intraosseous basivertebral nerve ablation. Int J Spine Surg. 2022;16(6):1084–1094. 10.14444/8362
    Google ScholarCrossRefAbstract/Full TextPubMed
  43. 43.
    ↵
    Lorio M , Lewandrowski KU , Coric D , Phillips F , Shaffrey CI . International Society for the Advancement of Spine Surgery statement: restorative neurostimulation for chronic mechanical low back pain resulting from neuromuscular instability. Int J Spine Surg. 2023;17(5):728–750. 10.14444/8525
    Google ScholarCrossRefAbstract/Full TextPubMed
  44. 44.
    ↵
    Eap S , Hall GCN . Relevance of RCTs to diverse groups. Evidence-Based Outcome Research: A Practical Guide to Conducting Randomized Controlled Trials for Psychosocial Interventions. Oxford University Press; 2008. 10.1093/med:psych/9780195304633.003.0020
    Google ScholarCrossRef
  45. 45.
    ↵
    Weinstein JN , Lurie JD , Tosteson TD , et al . Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007;356:2257–2270. 10.1056/NEJMoa070302
    Google ScholarCrossRefPubMedWeb of Science
  46. 46.
    ↵
    Radcliff K , Hilibrand A , Lurie JD , et al . The impact of epidural steroid injections on the outcomes of patients treated for lumbar disc herniation: a subgroup analysis of the SPORT trial. J Bone Joint Surg Am. 2012;94:1353–1358.
    Google ScholarCrossRefAbstract/Full TextPubMed
  47. 47.
    ↵
    Fritz JM , Lurie JD , Zhao W , et al . Associations between physical therapy and long-term outcomes for individuals with lumbar spinal stenosis in the SPORT study. Spine J. 2014;14:1611–1621.
    Google ScholarCrossRefPubMed
  48. 48.
    ↵
    Radcliff K , Freedman M , Hilibrand A , et al . Does opioid pain medication use affect the outcome of patients with lumbar disc herniation? Spine (Phila Pa 1986). 2013;38(14):E849–E860. 10.1097/BRS.0b013e3182959e4e
    Google ScholarCrossRef
View Abstract
Loading
Loading
PDF
Back to top
In this Issue
International Journal of Spine Surgery

Vol. 19, Issue 5

1 Oct 2025

Table of Contents Index by author

Jump to Section

Keywords

hypothesis-driven research, observational studies, evidence-based spine surgery, randomized controlled trials (RCTs), Rasch analysis, hybrid evidence model, clinical innovation