A step-by-step guide for designing systematic reviews in spine surgery: a narrative review

Introduction

Systematic reviews, particularly those incorporating randomized controlled trials (RCTs), are considered level I evidence and occupy a central role in evidence-based spine surgery (1). Their ability to synthesize results from diverse studies makes them valuable tools for resolving conflicting outcomes, guiding clinical decision-making, and identifying gaps in the literature (1,2). However, their strength depends on rigorous methodological execution—such as protocol registration, reproducible search strategies, structured data extraction, and appropriate risk of bias assessment (3). These features distinguish high-impact reviews from those that contribute little meaningful evidence.

In spine surgery, systematic reviews are frequently used to evaluate surgical techniques, complication profiles, and patient outcomes across a range of procedures. Yet the methodological quality of these reviews has historically been variable (4). A recent analysis found that nearly one-third of spine surgery reviews had at least one critical methodological flaw, including unclear inclusion criteria, incomplete search strategies, or lack of quality appraisal (4). In this context, a “critical flaw” refers to deficiencies in key domains identified by the AMSTAR 2 tool—such as failure to register a protocol, inadequate literature search, or lack of consideration of publication bias—which can severely compromise a review’s reliability. Table 1 summarizes the typical strengths and limitations of systematic reviews in spine surgery and highlights the common pitfalls that can affect their reliability. While numerous general guides to systematic review methodology exist, few are tailored to the specific challenges of synthesizing evidence in this surgically complex and heterogeneous field (5,6).

This article serves as Part I of a two-part guide on conducting systematic reviews and meta-analyses in spine surgery, with a focus on study design. It outlines foundational elements such as formulating a focused research question, selecting databases, developing inclusion/exclusion criteria, and building a transparent screening strategy. The accompanying Part II, addresses execution, including study quality appraisal, risk of bias assessment, data extraction, and quantitative synthesis techniques such as meta-analysis. Together, these two parts aim to support spine researchers in producing transparent, reproducible, and methodologically sound systematic reviews that meet the highest standards of evidence synthesis. This guide is not intended to replace formal methodology manuals such as the Cochrane Handbook, but rather to serve as a concise and practical resource tailored to the needs of spine surgery researchers. We present this article in accordance with the Narrative Review reporting checklist (available at https://jss.amegroups.com/article/view/10.21037/jss-25-48/rc).

Methods

Search strategy

In order to compile a guide on designing impactful systematic reviews in spine surgery, we conducted a preliminary, illustrative search across several major databases, including PubMed/MEDLINE, Embase, the Cochrane Library, Scopus, and Web of Science, covering the period from January 1, 2000 to April 13, 2024 (Table 2). While not a formal systematic review, this exploratory search was used to identify representative high-quality systematic reviews and meta-analyses in spine surgery. It provided context for common reporting practices, methodological strategies, and gaps in the literature—such as consistent citation of PRISMA guidelines, variable use of protocol registration, and inconsistent approaches to risk of bias assessment. These findings reinforced the need for a structured, spine-specific guide to systematic review methodology, as outlined in this manuscript.

Search terms

The key search terms that were used to compile an expansive list of meta-analyses and systematic reviews throughout the field of spine surgery included “systematic review”, “meta-analysis”, “spine surgery”, “spinal surgery”, “surgical outcomes”, “surgical techniques”, “postoperative care”, and “patient outcomes”.

Inclusion/exclusion criteria

Upon identifying systematic reviews and meta-analyses in the field of spine surgery, the studies were scrutinized based on specific inclusion and exclusion criteria. Inclusion criteria focused on systematic reviews and meta-analyses related to spine surgery, publications in peer-reviewed journals, and studies detailing methodologies for conducting systematic reviews and meta-analyses. Conversely, exclusion criteria filtered out non-systematic reviews or narrative reviews, studies not focused on spine surgery, and case reports and editorial comments.

Screening process

The search results underwent a two-phase screening process. First, titles and abstracts were independently screened by two reviewers to identify potentially relevant articles. Discrepancies during this phase were resolved through discussion or by consulting a third reviewer. Following this, the full texts of selected articles were assessed for eligibility based on the predefined inclusion and exclusion criteria, with reasons for exclusion documented to ensure transparency.

Data extraction and synthesis

Information from the included studies was summarized, focusing on key findings, methodologies, and conclusions pertinent to spine surgery. The literature was reviewed to identify significant trends, innovations, and gaps within the field.

Narrative integration

The findings were woven into a cohesive narrative, providing an overview of the study design phase in spine surgery (Figure 1). Emphasis was placed on highlighting important advancements, areas of consensus, and ongoing debates within the field. By adopting this approach, the review aimed to provide a broad and insightful synthesis of the literature on spine surgery, contributing to the understanding of its complexities and guiding future research and clinical practice.

Figure 1 Overview of the major steps involved in designing a systematic review in spine surgery. This schematic illustrates the sequential process from formulating a research question to developing a protocol, selecting databases, applying inclusion/exclusion criteria, and preparing for quality appraisal and synthesis. These steps align with widely accepted methodological standards for high-quality evidence synthesis.

Discussion

Developing research question

This section outlines the types of questions in spine surgery research that are most appropriate for a systematic review and meta-analysis. Essentially, a systematic review, like any research endeavor, aims to address a question that is clinically relevant, innovative, and captivating. Due to their structured approach, systematic reviews are ideally suited to address questions such as:

• Synthesizing the outcomes of various studies that may have unclear results to ascertain which treatment option is likely more effective (5).
• Enhancing the statistical power of a study. Specifically, a meta-analysis combines the sample sizes of multiple studies into a singular, larger sample, which is particularly beneficial for studies with small sample sizes, such as those involving rare diseases or pilot studies (5).

Systematic reviews that merge findings from many studies stand out as some of the most significant and publishable forms of research. A strong example of systematic review methodology in spine surgery is the meta-analysis by Zhou et al., which analyzed 22,475 patients across 27 studies to investigate the incidence of surgical site infections (SSI) and identify causative microorganisms (7). The authors found an overall SSI incidence of 3.1%, with Staphylococcus aureus accounting for 37.9% of cases (7). The review incorporated diverse primary study designs, including a prospective cohort study by Saeedinia et al. (8), which followed patients undergoing clean spinal operations to evaluate postoperative infection rates and associated risk factors, and a RCT by Takeuchi et al. (9), which compared local vancomycin versus ampicillin powder application in thoracic and lumbar fusion to prevent SSIs. The inclusion of such varied study types underscores the need for careful handling of clinical heterogeneity in meta-analyses — particularly in spine surgery, where surgical approach, instrumentation, and patient factors can vary substantially. In another systematic review and meta-analysis, Salari et al. reviewed 23 studies involving 407 patients and discovered that while the extent of surgery did not significantly alter overall survival rates, complete resection of intramedullary ependymomas yielded the most favorable outcomes, with longer progression-free survival and better long-term neurological health than incomplete resection (10).

The strength of systematic reviews and meta-analyses lies in their ability to synthesize high-quality data from multiple studies, offering more definitive answers to complex clinical questions than individual investigations can provide. By pooling data, particularly from RCTs, they enhance statistical power and improve generalizability. For example, Rickers et al. conducted a network meta-analysis comparing surgical treatments for disc herniation, including innovative approaches such as annulus repair and dynamic stabilization (11). Their analysis suggested that while no single treatment method was superior to another, treatments such as percutaneous discectomy and conservative care were consistently less effective than other surgical options (11). Their findings indicated that while no single approach was clearly superior, percutaneous discectomy and conservative care were consistently less effective, offering evidence-based guidance to inform surgical decision-making and improve patient outcomes.

Critically evaluating the research question is crucial, as it significantly influences the success of a systematic review and meta-analysis. The breadth of the question impacts its validity; a broader question encompasses more studies and patients, potentially enhancing external validity. Yet, this expansion also introduces greater heterogeneity and can reduce internal validity. Conversely, narrowing the scope of the question can bolster internal validity, though this approach may prove challenging for less common conditions.

Within spine surgery, a systematic review can address a wide range of research questions and provide insights into the safety, effectiveness, and outcomes of various interventions (10,11). The following are examples of the kinds of studies that can be answered in the field of spine surgery:

• Comparative effectiveness of spinal implants (12,13).
• Surgical techniques and approaches for spine surgery (10,11).
• Patient-specific factors influencing spine surgery outcomes (14,15).
• Rehabilitation and peri-operative care in spine surgery (16).
• Pain management strategies in postoperative spine surgery (17-19).
• Complications and adverse events associated with spine surgery (7,20,21).
• Quality of life and patient-reported outcomes following spine surgery (22,23).

After determining a research question, it’s crucial to identify the variables and both primary and secondary outcomes for the investigation, taking into account the variables commonly reported by individual studies. A meta-analysis necessitates a minimum of three studies for each variable. When aiming for journal publication, the quality and quantity of the included studies are significant. Authors should generally include at least seven papers, with a minimum of level III evidence (retrospective case cohort) being desirable. Therefore, the selection of databases and the establishment of inclusion and exclusion criteria are particularly critical.

Database selection

The top 5 databases used to conduct systematic reviews in the field of spine surgery research are the following: (I) Pubmed/MEDLINE; (II) Embase; (III) Cochrane Library; (IV) Scopus; and (V) Web of Science (24). Authors should consider the use of at least two of these databases to identify and screen studies for potential inclusion. To achieve a comprehensive and nuanced literature review in spine surgery, researchers typically utilize a combination of these databases, taking into account their individual strengths in terms of accessibility, specialization, and overall utility.

PubMed/MEDLINE

PubMed/MEDLINE, created by the National Center for Biotechnology Information (NCBI), is a frequently used database for conducting systematic reviews in spine surgery (25). This database hosts a broad range of biomedical literature, with MEDLINE specifically targeting medical and healthcare topics. Its extensive content coverage, encompassing clinical studies, systematic reviews, and meta-analyses specific to spine surgery, provides researchers with valuable insights. The accessible interface and powerful search features of PubMed make it a fundamental tool for locating pertinent studies and evidence in the field of spine surgery. PubMed/MEDLINE, accessible at no cost, is celebrated for its wide-ranging collection of biomedical literature and its easy-to-use interface.

Embase

Embase is a detailed biomedical and pharmacological database extensively used in systematic reviews for spine surgery (26). Its significant advantage is the thorough inclusion of literature on drugs and medical devices, which is particularly useful for reviews centered on spinal implants and the pharmacological considerations of spine surgery. Researchers gain access to an abundant source of data regarding the efficacy and safety of diverse spinal interventions, encompassing studies that might not be listed in alternative databases. The addition of conference abstracts also increases the database’s utility for keeping abreast of the most recent developments in spine surgery research. Embase is distinguished by its specialized emphasis on biomedical and pharmacological data, making it a prime source for detailed information on medication-related aspects of spinal implants.

The Cochrane Library

The Cochrane Library, which encompasses the Cochrane Database of Systematic Reviews (CDSR), stands as a foundational resource for evidence-based practice and systematic reviews in spine surgery (27). Cochrane reviews are celebrated for their strict methodology, offering top-quality summaries of the existing evidence. Researchers have access to authoritative reviews on a myriad of subjects, such as comparisons between various spine surgery interventions, strategies for postoperative care, and patient outcomes. For anyone in search of detailed and reliable evidence in the field of spine surgery, the Cochrane Library serves as an essential reference. The Cochrane Library is recognized as a premier source, providing high-quality systematic reviews and meta-analyses vital for evidence-based spine surgery practice.

Scopus

Scopus is a versatile abstract and citation database frequently utilized for systematic reviews in spine surgery research (28). It offers wide-ranging coverage of scientific, technical, and medical literature, aiding in the discovery of various studies pertinent to spinal interventions. The database’s feature of including conference proceedings is notably advantageous for keeping up to date with the newest research introduced at spine surgery conferences, guaranteeing a thorough method of evidence gathering. Scopus stands out for its extensive coverage across multiple disciplines, including valuable conference proceedings that enrich the depth of evidence gathered.

Web of Science

Web of Science is a broadly utilized multidisciplinary database that incorporates the Science Citation Index, rendering it crucial for tracing citations and pinpointing key studies in spine surgery research (29). Researchers have the opportunity to investigate the interrelated nature of research across varied fields and find an abundance of information on surgical methods, implant materials, and patient outcomes. Through its powerful search functionalities and extensive range, Web of Science significantly aids systematic reviews aiming for an all-encompassing perspective of the literature on spine surgery. Web of Science is noted for its interdisciplinary approach and focus on citation tracking, making it indispensable for finding impactful studies in spine surgery.

Registering a protocol with International Prospective Register of Systematic Reviews (PROSPERO)

Systematic reviews can be registered with the PROSPERO, a platform designed to enhance transparency, minimize duplication, and reduce reporting bias in evidence synthesis (30). Before initiating a new review, researchers should search PROSPERO to ensure that a similar review is not already registered or in progress. If a substantially similar review is listed, authors should reconsider proceeding with the same topic to avoid redundancy.

To register a review, authors must create a free account on the PROSPERO website (30).

The protocol should include key components such as the review title, the main research question framed using the PICO structure (Population, Intervention, Comparison, Outcome), specific inclusion and exclusion criteria, the databases to be searched, and the primary and secondary outcomes of interest. In addition, authors must outline the planned approach for risk of bias assessment, methods of data synthesis, funding sources, and any potential conflicts of interest.

Once submitted, protocols are reviewed for completeness and then published with a unique registration number. Researchers are encouraged to cite this number in their final manuscript to support methodological transparency. PROSPERO’s collaborative platform facilitates communication among team members and ensures that all planned review methods are recorded and maintained as a permanent, citable record. This strengthens the integrity and credibility of the review process and enables direct comparison between the registered protocol and the completed review.

Screening studies

Searching multiple databases typically generates a large pool of studies. These studies undergo a dual-phase screening process as depicted in Figure 2. Initially, titles and abstracts are independently evaluated by two or more researchers to examine potentially relevant studies. Subsequently, a more comprehensive review of the full texts is conducted based on set criteria in the second phase. This screening strategy aims to reduce selection bias. Any disagreements regarding the inclusion of studies are resolved through discussion, or by consulting a third reviewer when necessary. It’s also important for researchers to record why certain studies were excluded to ensure the process remains transparent and reproducible. Tools such as Covidence Company (Melbourne, Victoria, Australia) or EndNote (Clarivate, Berkeley, CA, USA) can aid in streamlining this process by enhancing collaboration among reviewers and keeping a clear record of the decision-making process. Maintaining a rigorous and clear screening procedure is essential to uphold the methodological rigor of a systematic review, making sure that only studies of high quality and relevance are included in the evidence synthesis. These topics, including study quality assessment, data interpretation, and manuscript preparation, are covered in detail in a companion article.

Figure 2 Generic PRISMA 2020 flow diagram template illustrating a standard study selection process in systematic reviews. The diagram outlines the typical two-phase screening workflow, title/abstract review followed by full-text assessment, with placeholders for inclusion/exclusion counts and reasons. This blank template is provided for illustrative purposes and reflects current reporting standards recommended by the PRISMA 2020 guidelines. Adapted from: Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71.

An important consideration during the screening and inclusion process is clinical heterogeneity — variability across studies in terms of patient populations, surgical approaches, outcome definitions, and follow-up durations. This variability can introduce challenges in data comparability and synthesis. For example, Lee et al. conducted a prospective registry-based study of over 1,500 spine surgery patients and developed a validated model for predicting SSI risk (31). Their findings emphasized how comorbidity burden, operative time, and instrumentation substantially influenced infection rates, illustrating how such clinical factors can serve as key sources of heterogeneity in spine literature. Identifying and documenting these variations early enables reviewers to plan subgroup or sensitivity analyses, which are essential steps addressed in the execution phase of systematic reviews.

Key PRISMA principles and common pitfalls

The PRISMA guidelines provide a 27-item checklist that ensures transparency, completeness, and reproducibility in systematic reviews. Adherence to PRISMA is especially important in spine surgery research, where methodological inconsistencies may affect clinical interpretation. Table 3 outlines the major PRISMA domains, along with brief explanations and examples of common errors or omissions.

Critically appraising systematic reviews and meta-analyses

Beyond designing new reviews, researchers and clinicians must also be equipped to critically appraise existing systematic reviews and meta-analyses. This includes evaluating the clarity of the research question, thoroughness of the search strategy, risk of bias, and methods used to assess and address heterogeneity. Tools such as AMSTAR 2 provide structured criteria for assessing methodological rigor, while the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) framework offers guidance for evaluating the certainty of evidence and the strength of resulting recommendations. Incorporating these tools supports more transparent, high-quality evidence interpretation and strengthens the foundation for evidence-based decision-making in spine surgery.

Combining studies with different designs

In meta-analyses of surgical interventions, including in spine surgery, it is often necessary to include a mix of RCTs, prospective cohort studies, and retrospective studies due to the limited availability of high-level evidence. While this approach may improve generalizability and statistical power, it also introduces variability in study design, quality, and risk of bias. Such heterogeneity must be clearly justified and carefully addressed using subgroup analyses or sensitivity checks. Importantly, combining study types is not inherently flawed. Anglemyer et al. conducted a Cochrane methodological review of 15 meta-epidemiological studies and found that, on average, well-conducted observational studies produced effect estimates comparable to RCTs (32). Their findings suggest that while RCTs remain the gold standard, other designs can yield valid results, especially when the risk of bias is carefully assessed and addressed. This supports the inclusion of high-quality observational studies in spine surgery meta-analyses when RCTs are unavailable or infeasible.

Use of artificial intelligence (AI) in systematic reviews

Emerging AI tools, such as natural language processing algorithms and machine learning-based screening platforms, offer the potential to enhance efficiency in systematic reviews by automating literature screening, reducing reviewer burden, and identifying relevant articles based on learned patterns. However, reliance on AI can also introduce risks, including reduced transparency in selection decisions, inadvertent exclusion of relevant studies, and the propagation of biases inherent in training datasets. While promising, AI-based tools should currently be considered adjuncts, not replacements, for human oversight in systematic review methodology.

Limitations

This narrative review provides a design-focused guide for conducting systematic reviews in spine surgery, offering practical insights into early-stage best practices and common pitfalls. This review relied on a detailed examination of the most frequently utilized databases, search strategies, and study selection processes, ensuring a robust approach to synthesizing high-quality evidence. The emphasis on PRISMA guidelines and the discussion on reducing bias through careful study selection and data extraction demonstrate a commitment to the reliability and validity of the findings. Nevertheless, this review has inherent limitations. As a narrative review, this study does not encompass an exhaustive search of all literature in the field, which could lead to the omission of relevant studies. In addition, the reliance on existing studies means that the quality of this review is tied to the quality of the included studies. Variability in study designs and methodologies among the included studies could introduce heterogeneity, potentially affecting the generalizability of the findings. Despite these limitations, the review offers a valuable framework for researchers and clinicians aiming to conduct systematic reviews and meta-analyses in spine surgery.

Conclusions

This manuscript serves as an introductory, design-focused guide on planning a systematic review in spine surgery. It outlines the formulation of research questions, the selection of commonly used databases, and key considerations for literature search and study screening. While systematic reviews stand at the top of the evidence hierarchy, their quality depends heavily on rigorous methodology from the outset. By applying the principles discussed in this paper, researchers can establish a strong foundation for systematic reviews in spine surgery. Subsequent phases, including study appraisal and data synthesis, are addressed in a companion article.

Acknowledgments

None.

Footnote

Provenance and Peer Review: This article was commissioned by the editorial office, Journal of Spine Surgery, for the series “Cost, Healthcare Utilization, Patient-Reported Outcomes and Technology in Modern Spine Surgery”. The article has undergone external peer review.

Reporting Checklist: The authors have completed the Narrative Review reporting checklist. Available at https://jss.amegroups.com/article/view/10.21037/jss-25-48/rc

Peer Review File: Available at https://jss.amegroups.com/article/view/10.21037/jss-25-48/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jss.amegroups.com/article/view/10.21037/jss-25-48/coif). The series “Cost, Healthcare Utilization, Patient-Reported Outcomes and Technology in Modern Spine Surgery” was commissioned by the editorial office without any funding or sponsorship. A.K.E. served as the unpaid Guest Editor of the series and serves as an unpaid editorial board member of Journal of Spine Surgery from September 2024 to August 2026. M.K.N. is a paid consultant at Johnson & Johnson Ethicon Inc., CurvaFix Inc., Pacira BioSciences Inc., Sage Products Inc., Alafair Biosciences Inc., Next Science LLC, Bonutti Technologies Inc., Hippocrates Opportunities Fund LLC, and Ferghana Partners Inc. The authors have no other conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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