Literature DB >> 35983028

A scoping review of complication prediction models in spinal surgery: An analysis of model development, validation and impact.

Toros C Canturk1, Daniel Czikk1, Eugene K Wai2, Philippe Phan2, Alexandra Stratton2, Wojtek Michalowski3, Stephen Kingwell2.   

Abstract

Background: Predictive analytics are being used increasingly in the field of spinal surgery with the development of models to predict post-surgical complications. Predictive models should be valid, generalizable, and clinically useful. The purpose of this review was to identify existing post-surgical complication prediction models for spinal surgery and to determine if these models are being adequately investigated with internal/external validation, model updating and model impact studies.
Methods: This was a scoping review of studies pertaining to models for the prediction of post-surgical complication after spinal surgery published over 10 years (2010-2020). Qualitative data was extracted from the studies to include study classification, adherence to Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) guidelines and risk of bias (ROB) assessment using the Prediction model study Risk Of Bias Assessment Tool (PROBAST). Model evaluation was determined using area under the curve (AUC) when available. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement was used as a basis for the search methodology in four different databases.
Results: Thirty studies were included in the scoping review and 80% (24/30) included model development with or without internal validation. Twenty percent (6/30) were exclusively external validation studies and only one study included an impact analysis in addition to model development and internal validation. Two studies referenced the TRIPOD guidelines and there was a high ROB in 100% of the studies using the PROBAST tool. Conclusions: The majority of post-surgical complication prediction models in spinal surgery have not undergone standardized model development and internal validation or adequate external validation and impact evaluation. As such there is uncertainty as to their validity, generalizability, and clinical utility. Future efforts should be made to use existing tools to ensure standardization in development and rigorous evaluation of prediction models in spinal surgery.
© 2022 The Authors. Published by Elsevier Ltd on behalf of North American Spine Society.

Entities:  

Keywords:  Postoperative complications; Prediction model; Scoping review; Spinal surgery; model development; model validation; orthopedic procedures

Year:  2022        PMID: 35983028      PMCID: PMC9379667          DOI: 10.1016/j.xnsj.2022.100142

Source DB:  PubMed          Journal:  N Am Spine Soc J        ISSN: 2666-5484


Introduction

Predictive analytics is gaining popularity in the field of spine surgery in line with patient safety and quality improvement initiatives, and this is certainly evident in surgical decision-making [1,2]. Given that electronic medical records (EMRs) are heavily invested in and can store data on surgical outcomes and complications, there has been a subsequent surge in prediction model development which can help inform surgical decision-making [3,4]. EMRs and large multicentre databases are often used for model development but the data may not be standardized, may have missing values and could be at risk of bias [5,6]. Prediction model development requires that model features have clinical relevance, are feasible to measure, and impact the outcomes of interest [7,8]. Logistic regression has traditionally been used for model development but there is significant interest in applying machine learning algorithms to model development. Regardless of the algorithm selected, the model must have a balance of accuracy, transparency, and generalizability [7], [8], [9]. The model must then be rigorously tested and validated in different settings before it can be used on a larger scale [8], [9], [10]. Moons et al. described a framework for prediction model development and evaluation, which includes model development, internal validation, external validation, model updating, and model impact studies [8,10]. After development, the model should next undergo internal validation, which is the assessment of whether the predictive results accurately represent the studied population [8]. To ensure that the model is generalizable to distinct populations from those that developed the model, external validation must then occur [10]. The model should then be updated and evaluated with model impact studies to determine whether the model is being utilized correctly in clinical settings and is having its intended impact [10]. The current standard is that research groups presenting new models should be following the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) guidelines, which outline the necessary steps for reporting studies about the development, validation, and updating of prediction models [11]. With the increase in prediction model publications there has been an expected interest in analyzing and summarizing the quality and applicability of these models. The Prediction model study Risk Of Bias Assessment Tool (PROBAST) aims to assess the risk of bias and applicability of studies that develop, validate or update multivariable prognostic prediction models [12]. The objective of this review was to summarize existing complication prediction models in spinal surgery and to determine if the models are being adequately studied with external validation, model updating, and model impact studies. Prediction models developed for use in the pre-operative phase, and at the time of surgical or shared decision-making, for the prediction of post-operative complications in spinal surgery were the focus of this review. Secondary objectives of the review were to perform a risk of bias and applicability assessment using the PROBAST tool, to determine if the published research on prediction models in spinal surgery are adhering to the TRIPOD guidelines and to evaluate whether logistic regression or other machine learning algorithms are becoming the predominant approach to prediction model development.

Methods

Search strategy

The search methodology was completed in agreement with the Reporting Items of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement [11]. Our search identified studies on prediction models, calculators, and algorithms for spinal surgery complications. The search strategy used Medical Subject Headings (MeSH) terms determined with the assistance of a medical librarian for each database to ensure consistency. The search was a convenience sample limited to English studies published between 2010 and the search date (July 2020) in Web of Science, Embase (Ovid), MEDLINE (Ovid), and Scopus.

Inclusion and exclusion criteria

The inclusion criteria were: (1) studies with expressed purpose of developing, validating, updating or determining impact of models, calculators or algorithms used for predicting postoperative complications after spinal surgery; (2) model features including preoperative variables or planned intraoperative variables (i.e., instrumentation plan, use of bone morphogenic protein); (3) studies with patients over the age of 18. The exclusion criteria were: (1) models that used intraoperative features that would not be known or anticipated preoperatively (i.e., blood loss, medications); (2) models that were not developed from any spinal surgery patients (i.e., frailty index); (3) studies with exclusively traumatic, infectious or oncologic spinal diagnoses; (4) conference proceedings, poster presentations, letters to the editor, or abstracts; (5) non-English studies.

Data extraction and risk of bias and quality assessment

All identified studies through the database searches were uploaded to Covidence (2021 version), an online tool used for organization and data management of systematic and scoping reviews. Each study was independently reviewed by two of the authors (TC and DC), with conflicts resolved by the senior author (SK). As per Moons et al., the extracted studies were grouped into tables based on whether they were model development and/or internal validation studies (Tables 1 and 2) or external validation, model updating and/or model impact studies (Table 3) [[6], [7], [8],10]. Table 1 includes all studies that utilized logistic regression (LR) for model development and internal validation. Table 2 includes studies that used other machine learning algorithms for model development and internal validation.
Table 1

Studies that used logistic regression for model development and/or internal validation.

AuthorsYearCalculator nameStudy designNumber of casesRegistryDiagnostic/ procedural classificationComplications measuredStudy classificationModel evaluationTRIPOD
McGirt et al. [51]2015NoneProspective1,803Single centreLumbar spine surgeryOverall complicationsMD and IVAUC:Development: 0.72Validity: 0.82no
Yilgor et al. [52]2017Global Alignment and Proportion (GAP) ScoreRetrospective222MulticentrePosterior fusionMechanical complications (proximal junctional kyphosis or failure, distal junctional kyphosis or failure, rod breakage, and implant-related complications)MD and IVAUC:Development: 0.88Training: 0.92no
Passias et al. [53]2019NoneRetrospective123MulticentreCervical deformity surgeryMedical or surgical complicationsMD and IVAUC complications:Overall:0.79Medical: 0.77Surgical: 0.74no
Bekelis et al. [54]2014NoneRetrospective13,660NSQIPSpinal surgeryStroke, MI, death, infection, UTI, DVT, PE, return to OR, SSIMD and IVAUC: 0.65-0.95 (reported individually for each complication)no
Lee et al. [55]2014SpineSageRetrospective1,476MulticentreSpinal surgeryCardiac, pulmonary, GI, neurologic, hematologic, urologic; any medical complication and major medical complicationMD and IVAUC:Any medical complication: 0.76Major medical complications: 0.81no
Klemencsics et al. [56]2016NoneProspective1,030Single centreLumbar decompression, microdiscectomy, or instrumented fusionSSIMD and IVAUROC:Development: 0.71Validation :0.72no
Belykh et al. [57]2017NoneRetrospective350Single centreMicrodiscectomyRecurrence of lumbar disc herniationMD0.60-0.99 (Accuracy of prediction rate for different models)no
Han et al. [58]2019NoneRetrospective345,510 (MKS & MSM) and 760,724 (CMS)MKS, MSM, CMSSpinal surgeryOverall adverse event (AE) occurrence and types of AE occurrence during the 30-day postoperative follow-up.MD and IVAUC:Overall: 0.70Specific:0.76no
Fatima et al. [59]2020NoneRetrospective80,610NSQIPLumbar degenerative spondylolisthesisOverall adverse eventsMD and IVAUC: 0.7yes
Ratliff et al. [16]2016Spinal Risk Assessment ToolRetrospective279,135Truven Health Analytics MarketScan Commercial Claims and Encounters and Medicare Supplement and Coordination of Benefits DatabasesSpinal surgeryMajor complicationsMD and IVAUC: 0.7no
Kim et al. [60]2017NoneCross-sectional database22,629ACS-NSQIPPosterior lumbar spine fusionCardiac, wound complications, VTE, mortalityMD and IVAUC: 0.59-0.70no
Janssen et al. [61]2019NoneRetrospective898Single centreInstrumented thoracolumbar spineSSIMD and IVAUC: 0.72no
Kim et al. [62]2018NoneCross-sectional Database Study4,073ACS-NSQIPASDCardiac or wound complications, venous thromboembolism, mortalityMD and IVAUC: 0.55-0.79no
Li et al. [63]2020NoneRetrospective124Single centreASDMedical and surgical complicationsMDAUC: 0.82no
Passias et al. [53]2019NoneProspective117MulticentreCervical deformity surgeryDistal junctional kyphosisMD and IVAUC: 0.87no
Yagi et al. [64]2020PRISMRetrospective321MulticentreASDMechanical failureMD and IVAUC: 0.81 (mechanical failure and risk grade correlation)AUROC: 0.96 (predictive model accuracy 92%)no
Yagi et al. [28]2019NoneRetrospective151MulticentreASDNeurologic, implant related, SSI, other infection, cardiopulmonary, gastrointestinalMD, IV and EVAUC:Development: 0.82Validation: 0.75no
Yagi et al. [26]2018NoneRetrospective195MulticentreASDMajor complications (all post-op complications recorded)MD, IV and EVAUROC: 0.96(92% predictive model accuracy,84% external validation accuracy)no
Buchlak et al. [27]2017The Seattle spine scoreRetrospective136Single centreASDCardiopulmonary, wound, infection, thrombotic, unplanned return to surgery, death (30 days)MD, IV and Impact StudyAUROC: 0.71no

MD: model development; IV: internal validation; EV: external validation, LR: logistic regression, ML: machine learning, AUC: area under the curve, AUROC: area under the receiver operating characteristic, MI: myocardial infarction, UTI: urinary tract infection, DVT: deep vein thrombosis, PE: pulmonary embolism, SSI: surgical site infection, GI: gastrointestinal, ASD: adult spinal deformity, NSQIP: National Surgical Quality Improvement Program®, ACS-NSQIP: American College of Surgeons National Surgical Quality Improvement Program®, MKS: Truven MarketScan Database, MSM: MarketScan Medicaid Database, CMS: Centers for Medicare and Medicaid Services Database.

Table 2

Studies that used machine learning for model development and/or internal validation.

AuthorsYearCalculator nameStudy design# Of casesRegistryDiagnostic/ procedural classificationComplications measuredMoon's classificationModel evaluationTRIPOD
Scheer et al. [65]2018NoneRetrospective336MulticentreASDPseudarthrosis at 2 years postoperativelyMD and IVAUC Development: 0.97Training: 0.94No
Scheer et al. [66]2017NoneRetrospective557MulticentreASDMinor or major intraoperative and postoperative complicationsMD and IVAUROC: 0.89No
Hopkins et al. [67]2020NoneRetrospective4046Single centrePosterior spine fusionSurgical site infectionMD and IVAUC: 0.78No
Clark et al. [68]2020NZRISK-NeuroRetrospective18,375New Zealand registryNeuro or spinal surgeryMortalityMD and IVAUC:0.9 (30-day), 0.91 (1 year)0.91 (2 year)Yes

MD: model development; IV: internal validation; EV: external validation, LR: logistic regression, ML: machine learning, AUC: area under the curve, AUROC: area under the receiver operating characteristic ASD: adult spinal deformity, NZRISK-Neuro: The New Zealand Neurosurgical Risk Tool.

Table 3

External validation, impact and model update studies that used either logistic regression or machine learning.

AuthorsYearCalculator nameStudy design# Of casesRegistryDiagnostic/ procedural classificationComplications measuredMoon's classificationModel evaluationTRIPOD
Yagi et al. [28]2019NoneRetrospective151MulticentreASDNeurologic, implant related, SSI, other infection, cardiopulmonary, gastrointestinalMD, IV and EVAUC:Training: 0.82Validation: 0.75no
Sebastian et al. [29]2019ACS-NSQIP Surgical Risk CalculatorRetrospective2808ACS-NSQIPSingle-level posterior lumbar fusionNSQIP 30-day complicationsEV and performance assessmentC-statistic: 0.56-0.66no
Yagi et al. [64]2018NoneRetrospective145MulticentreASDProximal junctional failureEV and model updateAUC:Training: 0.98Testing: 1.00no
Janssen et al. [31]2018Spine SageRetrospective898Single centreInstrumented thoracolumbar spine casesSSIEVAUC: 0.61N/A
Kasparek et al. [32]2018Spine SageRetrospective273Single centreSpinal surgeryOverall medical complications and major medical complicationsEVAUC:Overall complication: 0.71Major complications: 0.85N/A
Wang et al. [30]2017ACS-NSQIP Surgical Risk CalculatorRetrospective242Single centreLumbar laminectomy without fusionPost-operative complications as per NSQIPEVAUC: All observed complications: 0.44Predicted complications: 0.14-See the paper for AUC of specific complications.N/A
Veeravagu et al. [69]2017Spinal Risk Assessment Tool (RAT) and ACS NSQIP surgical risk calculator2 cohorts: Retrospective and Prospective200 (retros-pective) 246 (prospe-ctive)Single centreSpine surgeryCardiac, wound, thrombotic, pulmonary, urinary tract infection, radiculopathy, dysphagia, delirium, otherEVAUC:Complications: 0.67 (for both SpinalRAT and ACS-NSQIP)N/A
Yagi et al. [26]2018noneRetrospective195MulticentreASDMajor complicationsMD, IV and EVAUROC: 0.96no
Buchlak et al. [27]2017The Seattle spine scoreRetrospective136Single centreASD30-day cardiopulmonary, wound, infection, thrombotic, unplanned return to surgery, and deathMD, IV and Impact StudyAUROC: 0.71no

MD: model development; IV: internal validation; EV: external validation, LR: logistic regression, ML: machine learning, AUC: area under the curve, AUROC: area under the receiver operating characteristic, SSI: surgical site infection, ASD: adult spinal deformity, NSQIP: National Surgical Quality Improvement Program®, ACS-NSQIP: American College of Surgeons National Surgical Quality Improvement Program®.

Studies that used logistic regression for model development and/or internal validation. MD: model development; IV: internal validation; EV: external validation, LR: logistic regression, ML: machine learning, AUC: area under the curve, AUROC: area under the receiver operating characteristic, MI: myocardial infarction, UTI: urinary tract infection, DVT: deep vein thrombosis, PE: pulmonary embolism, SSI: surgical site infection, GI: gastrointestinal, ASD: adult spinal deformity, NSQIP: National Surgical Quality Improvement Program®, ACS-NSQIP: American College of Surgeons National Surgical Quality Improvement Program®, MKS: Truven MarketScan Database, MSM: MarketScan Medicaid Database, CMS: Centers for Medicare and Medicaid Services Database. Studies that used machine learning for model development and/or internal validation. MD: model development; IV: internal validation; EV: external validation, LR: logistic regression, ML: machine learning, AUC: area under the curve, AUROC: area under the receiver operating characteristic ASD: adult spinal deformity, NZRISK-Neuro: The New Zealand Neurosurgical Risk Tool. External validation, impact and model update studies that used either logistic regression or machine learning. MD: model development; IV: internal validation; EV: external validation, LR: logistic regression, ML: machine learning, AUC: area under the curve, AUROC: area under the receiver operating characteristic, SSI: surgical site infection, ASD: adult spinal deformity, NSQIP: National Surgical Quality Improvement Program®, ACS-NSQIP: American College of Surgeons National Surgical Quality Improvement Program®. A risk of bias and quality assessment was completed for each article using the Prediction study Risk of Bias Assessment Tool (PROBAST) [12]. PROBAST divides the risk of bias (ROB) into four domains: (1) Participants (i.e., study design); (2) Predictors (i.e., standardized and transparent predictors); (3) Outcomes (i.e., defined and measured the outcomes within a timely manner); and (4) Analysis (i.e., proper model development, whether lost data was handled appropriately). A set of questions are answered for each domain with either a ‘yes’, ‘no’, or unclear response, allowing a low, high, or unclear ROB to be assigned to each domain within an article. Risk of bias analysis is important as it provides an alternative metric to evaluate the article's limitations in study design and validation process. Additionally, ROB analysis allows readers to be able to draw stronger conclusions from a study's results, if it has low ROB [13].The tool also has a section for applicability where it is determined whether the prediction model applies to the research question of the scoping review [12]. The ROB assessment should be consistent amongst reviewers; however, the applicability can vary as it is dependent on the primary systematic review question.

Results

Our search identified 1910 studies that were inserted in COVIDENCE for duplication removal and subsequent review steps. Details of the review process including abstract removal for duplication, relevance and full text-review of eligibility are found in Fig. 1. The top three reasons for exclusion at this step were wrong outcomes (84.4%), wrong setting (4.8%) and wrong study design (3.8%). After this step, we manually added one more study that met our criteria after a hand search of references.
Fig. 1

Scoping review screening and extraction.

Scoping review screening and extraction. There were 30 studies that met the inclusion and exclusion criteria. Three studies (10%) were published between 2010-2015 and 90% were published between 2016-2020. There were 24 studies that included model development with or without internal validation and this represented the majority of the studies (80%) that were identified. All 24 of these studies describe distinct prediction model; however, some models were developed using the same databases and/or had minor variations in feature selection or predicted outcomes. Seventy-nine percent (19/24) of these studies only included internal validation with model development, 8% (2/24) only focused on model development and 13% (3/24) included either external validation or impact study in addition to internal validation and model development. Twenty of the 24 studies (83%) used logistic regression for model development while 17% (4/24) used other machine learning methods. Table 1 summarizes the 20 model development and internal validation studies developed using LR. Table 2 includes the four prediction models that utilized ML algorithms during the model development. Table 3 summarizes the nine studies that included external validation, model updating or model impact analyses. Six studies were exclusively external validation studies and two of these studies evaluated the Spine sage tool [14] and ACS-NSQIP calculator [15] respectively and one study evaluated the spinal risk assessment tool [16]. While all nine studies included external validation, there was only one study that also conducted an impact study and another single study which conducted a model update in addition to the external validation.

PROBAST Results

The PROBAST assessment indicated high ROB for all 30 studies that we assessed. Seventy percent of studies (21/30) had low ROB for the participants domain as they met all the PROBAST criteria. PROBAST requires that appropriate data sources be used with appropriate inclusion/exclusion criteria, and this was generally the case. The predictor, outcomes, and analysis components of the PROBAST assessment showed the highest ROB. For the predictor domain 57% (17/30) of the studies had high ROB. Due to the retrospective nature of many studies the predictor definitions and assessments were not clearly distinct from the outcome assessment, thus introducing bias. There was high ROB in 83% (25/30) of the studies for the outcome domain and 87% (26/30) for the analysis domain. As per the PROBAST assessment, high ROB was introduced by low numbers of participants with the outcome, mishandling of continuous and categorical predictors or missing data, predictor selection primarily based on univariate analysis and a lack of accounting of model overfitting or optimism. Finally, the PROBAST guidelines recommend downgrading low ROB studies to high ROB if they have a small data set and/or the model was developed without external validation [12].

Discussion

With the overarching goals of improving health care quality and safety, research using large data sets and predictive analytics continues to expand and evolve [2,3,6,[17], [18], [19], [20], [21], [22], [23], [24]]. In particular, the field of spinal surgery has experienced an exponential increase in the development of prediction models [25]. Although more prediction models are being developed than ever before, this review confirms that only a small fraction of them undergo external validation, model updating and/or impact studies. This raises numerous concerns about their clinical utility, validity, and reliability in different populations. As highlighted by Moons et al., it is vital for prediction models to undergo a multifactorial design process, which includes internal validation, external validation, and impact studies in order for them to be optimally tested for their respective niche [[6], [7], [8],10]. This systematic review of complication prediction models for spinal surgery identified 30 articles and only 8 articles assessed specifically, or included, external validation. Moreover, there was only one model update [26] and one impact study [27]. Only two model development studies included external validation within their first publication based on the Moons criteria [26,28]. Additionally, only one study included an impact study with their model development and internal validation [27]. Given that most predictive models for spinal surgery complications don't undergo external validation, the large majority of models that are developed and internally validated are never tested on other patient populations, potentially limiting generalizability and clinical value of the model. External validation is important because different populations have unique, site-specific, unmeasurable features that may influence both patient complications and outcomes. This may lead to significant differences in model performance in various settings. The NSQIP surgical risk calculator is a readily available online tool [29], but it was not an accurate and reliable predictor of post-surgical complications in an elderly Chinese population [30]. Similarly, the SpineSage tool [14] demonstrated poor predictive performance in a European population [31]. Conversely, Kasparek et al.’s external validation study [32] demonstrated similar area under the curve (AUC) values as the internal validation [14], both for medical and major medical complications (0.85 and 0.71 respectively). External validation studies are critical to evaluate model performance in new settings and to determine whether re-calibration or other measures are warranted for local optimal performance [33,34]. Given the paucity of external validation studies and the variable model performance observed, this should give pause when applying the tools unreservedly and provide the impetus for further external validation research. Alternatively, other authors have advocated for site-specific prediction models, based on local data and features from EMRs, thus obviating the need for external validation [31]. It should be noted that 62% (13 of 20) of model development and internal validation studies included in our review were published between 2018-2020. This may limit the time for undertaking any external validation studies, however, it confirms the recent increase in spine surgery complication prediction model development. The identification of only one impact study in this review is notable as impact studies have a critical role in real world model evaluation. In the context of a complication prediction model for surgery, the model may impact surgeon or patient decision making, treatment outcomes, patient satisfaction with the decision-making process, clinic logistics or patient flow and interfacing with electronic health records to name a few [35], [36], [37], [38]. While adequate calibration, discrimination and classification of a prediction model may appear to indicate a successful clinical performance, multiple studies have shown that the real-life performance may not have any meaningful impacts in clinical decision making [39], [40], [41]. Furthermore, impact studies allow physicians to contextualize the true utility and effect of the developed model on patient care [42]. Kappen et al. highlight several potential reasons for why impact studies are difficult to undertake [42]. The ideal way to measure a model's clinical impact on real-life decision making, change in practice, and health outcomes is via large scale cluster-randomized studies. However, these studies have substantial cost and effort and may be impractical given growth of prediction models [10,[43], [44], [45]]. While significant efforts should be given to the model development, equal importance should be given to all levels of model validation, impact and updating in order for these models to be clinically valuable. The TRIPOD guidelines provide a comprehensive checklist for prediction model development and they are separated into ‘Model Development’ and ‘Model Validation’ [46]. There are numerous benefits in following TRIPOD guidelines including standardization of the model development process, transparency, and ensuring high quality research. Transparency provides the foundation for external validation studies, can help to avoid duplication, and can potentially improve clinical uptake. Even though the TRIPOD guidelines were initially published in 2015, the vast majority of the models that were developed after did not follow the TRIPOD-recommended steps. Only two out of 21 studies in this review pertaining to model development and published after 2015 referenced the use of TRIPOD guidelines during their development. PROBAST is a ROB assessment tool specifically developed for prediction models which differentiates it from other ROB approaches [12,47,48]. Flaws in study design, conduction, and/or analysis in the prediction model development should be identified in order to have a clear understanding and appreciation of the model's predictive performance [12]. Our PROBAST assessment indicated high ROB for 100% of the studies. Specifically, there was high ROB in 30%, 57%, 83% and 87% of the studies for the participant, predictor, outcomes, and analysis domains. All studies had a high ROB in at least one domain of outcomes or analysis and the PROBAST tool recommends downgrading model development studies from low to high ROB if external validation is not included as part of the study. Similar observations on ROB were reported by other studies including, White et al.’s PROBAST analysis in their systematic review, which found high ROB in all 13 of the studies that they analyzed [49]. Additionally, Vemena et al.’s study on 556 clinical prediction models (CPMs) found 529 (95%) of the CPMs had high, 20 (4%) had low,7(1%) had unclear ROB classification [50]. The primary objective of this review was to evaluate whether prediction models for postoperative spine surgery complications are being adequately studied with external validation, model updating, and model impact studies. Other published systematic reviews pertaining to postoperative complications in orthopedic surgery[25] and complications or outcomes in spinal surgery [49] have been descriptive and comprehensive but have not analyzed the existing research in this manner. This review has confirmed the increase in published complication prediction models in spinal surgery, but the studies are heavily weighted towards model development and internal validation. The lack of external validation and model impact studies represent significant potential limitations in their generalizability and clinical utility. There are limitations to this scoping review. The goal of the review was to identify all published complication prediction models in spinal surgery that a spine surgeon might want to apply to their own practice and to evaluate the existing research as it pertains to model development, validation, updating and impact. It became apparent that many studies reported on risk factors or multivariate predictors of various outcomes and these studies were excluded unless the expressed purpose of the study was to develop a prediction model. As such, it is possible some relevant models were erroneously excluded during the process, but it is unlikely that these models were at a stage where they were internally or externally validated or operational in a clinical practice. Similarly, it was felt that prediction models reported in abstracts, conference proceedings, letters or otherwise would not be able to undergo the evaluation utilized in this scoping review. There are some important limitations to the PROBAST assessment. A comprehensive external assessment of ROB is aided with tools such as PROBAST, but the assessment is generally rendered more difficult by a lack of explicit information rather than overt signs of bias. It is certainly important for all researchers publishing on prediction models to be aware of TRIPOD guidelines and the PROBAST assessment to ensure consistency and transparency in the reporting of prediction models.

Conclusions

The objective of this scoping review was to determine whether existing complication prediction models in spinal surgery have undergone adequate internal and external validation, model updating and evaluated with model impact studies. The majority of studies identified in this review pertained exclusively to model development and internal validation. A small number of external validation studies were conducted and only one impact study was identified. All studies had high ROB as determined using the PROBAST tool and very few studies referenced the TRIPOD guidelines. While complication prediction models in spinal surgery may be useful adjuncts to surgical decision-making questions will remain as to their validity, generalizability, and clinical utility unless the models undergo appropriate validation, updating and impact analysis. Users of prediction models in spinal surgery should be aware of their current, inherent limitations. Going forward, researchers with an interest in predictive analytics and the development of prediction models for spinal surgery should familiarize themselves with the TRIPOD guidelines and PROBAST tool in the earliest stages of model planning and focus additional research on the impact of prediction models.

Funding Disclosure

No funding was provided for this study.

Competing Interests

The authors have no competing interests to disclose.
  62 in total

Review 1.  Risk prediction models: I. Development, internal validation, and assessing the incremental value of a new (bio)marker.

Authors:  Karel G M Moons; Andre Pascal Kengne; Mark Woodward; Patrick Royston; Yvonne Vergouwe; Douglas G Altman; Diederick E Grobbee
Journal:  Heart       Date:  2012-03-07       Impact factor: 5.994

2.  Prognosis and prognostic research: what, why, and how?

Authors:  Karel G M Moons; Patrick Royston; Yvonne Vergouwe; Diederick E Grobbee; Douglas G Altman
Journal:  BMJ       Date:  2009-02-23

3.  Development of a preoperative predictive model for major complications following adult spinal deformity surgery.

Authors:  Justin K Scheer; Justin S Smith; Frank Schwab; Virginie Lafage; Christopher I Shaffrey; Shay Bess; Alan H Daniels; Robert A Hart; Themistocles S Protopsaltis; Gregory M Mundis; Daniel M Sciubba; Tamir Ailon; Douglas C Burton; Eric Klineberg; Christopher P Ames
Journal:  J Neurosurg Spine       Date:  2017-03-24

Review 4.  Prediction models: the right tool for the right problem.

Authors:  Teus H Kappen; Linda M Peelen
Journal:  Curr Opin Anaesthesiol       Date:  2016-12       Impact factor: 2.706

5.  Decision curve analysis: a novel method for evaluating prediction models.

Authors:  Andrew J Vickers; Elena B Elkin
Journal:  Med Decis Making       Date:  2006 Nov-Dec       Impact factor: 2.583

6.  Predicting complication risk in spine surgery: a prospective analysis of a novel risk assessment tool.

Authors:  Anand Veeravagu; Amy Li; Christian Swinney; Lu Tian; Adrienne Moraff; Tej D Azad; Ivan Cheng; Todd Alamin; Serena S Hu; Robert L Anderson; Lawrence Shuer; Atman Desai; Jon Park; Richard A Olshen; John K Ratliff
Journal:  J Neurosurg Spine       Date:  2017-04-21

7.  Development of a validated computer-based preoperative predictive model for pseudarthrosis with 91% accuracy in 336 adult spinal deformity patients.

Authors:  Justin K Scheer; Taemin Oh; Justin S Smith; Christopher I Shaffrey; Alan H Daniels; Daniel M Sciubba; D Kojo Hamilton; Themistocles S Protopsaltis; Peter G Passias; Robert A Hart; Douglas C Burton; Shay Bess; Renaud Lafage; Virginie Lafage; Frank Schwab; Eric O Klineberg; Christopher P Ames
Journal:  Neurosurg Focus       Date:  2018-11-01       Impact factor: 4.047

8.  Predicting Occurrence of Spine Surgery Complications Using "Big Data" Modeling of an Administrative Claims Database.

Authors:  John K Ratliff; Ray Balise; Anand Veeravagu; Tyler S Cole; Ivan Cheng; Richard A Olshen; Lu Tian
Journal:  J Bone Joint Surg Am       Date:  2016-05-18       Impact factor: 5.284

9.  Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD): explanation and elaboration.

Authors:  Karel G M Moons; Douglas G Altman; Johannes B Reitsma; John P A Ioannidis; Petra Macaskill; Ewout W Steyerberg; Andrew J Vickers; David F Ransohoff; Gary S Collins
Journal:  Ann Intern Med       Date:  2015-01-06       Impact factor: 25.391

10.  Use of electronic medical records in development and validation of risk prediction models of hospital readmission: systematic review.

Authors:  Elham Mahmoudi; Neil Kamdar; Noa Kim; Gabriella Gonzales; Karandeep Singh; Akbar K Waljee
Journal:  BMJ       Date:  2020-04-08
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