Participant recruitment and attrition in surgical randomised trials with placebo controls versus non-operative controls: a meta-epidemiological study and meta-analysis.

OBJECTIVE: To compare differences in recruitment and attrition between placebo control randomised trials of surgery, and trials of the same surgical interventions and conditions that used non-operative (non-placebo) controls. DESIGN: Meta-epidemiological study. DATA SOURCES: Randomised controlled trials were identified from an electronic search of MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials from their inception date to 21 November 2018. STUDY SELECTION: Placebo control trials evaluating efficacy of any surgical intervention and non-operative control trials of the same surgical intervention were included in this study. 25 730 records were retrieved from our systemic search, identifying 61 placebo control and 38 non-operative control trials for inclusion in analysis. OUTCOME MEASURES: Primary outcome measures were recruitment and attrition. These were assessed in terms of recruitment rate (number of participants enrolled, as a proportion of those eligible) and overall attrition rate (composite of dropout, loss to follow-up and cross-overs, expressed as proportion of total sample size). Secondary outcome measures included participant cross-over rate, dropout and loss to follow-up. RESULTS: Unadjusted pooled recruitment and attrition rates were similar between placebo and non-operative control trials. Study characteristics were not significantly different apart from time to primary timepoint which was shorter in studies with placebo controls (365 vs 274 days, p=0.006). After adjusting for covariates (follow-up duration and number of timepoints), the attrition rate of placebo control trials was almost twice as high compared with non-operative controlled-trials (incident rate ratio (IRR) (95% CI) 1.8 (1.1 to 3.0), p=0.032). The incorporation of one additional follow-up timepoint (regardless of follow-up duration) was associated with reduced attrition in placebo control surgical trials (IRR (95% CI) 0.64 (0.52 to 0.79), p<0.001). CONCLUSIONS: Placebo control trials of surgery have similar recruitment issues but higher attrition compared with non-operative (non-placebo) control trials. Study design should incorporate strategies such as increased timepoints for given follow-up duration to mitigate losses to follow-up and dropout. PROSPERO REGISTRATION NUMBER: CRD42019117364.

The subjective and objective quality of life score (SOQOLTM) for the quantification of general health status: a preliminary study with initial normative population values.

BACKGROUND: Established health-related quality of life scores do not consider both subjective and objective indices of health. We propose the subjective and objective quality of life score (SOQOL) for the comprehensive assessment of health-related quality of life and aim to provide normative population data. The SOQOL is compatible with smartphone applications, allowing widespread use on a global scale. METHODS: Normative SOQOL population data was sourced from pre-existing datasets on the EQ-5D-5L, daily step count, and walking speed. Normative values were calculated using weighted grand means. We trialled the SOQOL in a group of five patients presenting to a spinal neurosurgery clinic. RESULTS: SOQOL scores decreased with age, and women had lower scores in every age group. In our case series, the spine patients with the biggest SOQOL deficit compared to age- and sex-matched population averages were found to be surgical while the rest were non-surgical. CONCLUSIONS: The SOQOL shows promise as a simple and effective scoring tool that is compatible with smartphones, potentially useful for screening in primary and specialized care settings, and for assessment following healthcare interventions. This study, however, is preliminary, and the findings are primarily suggestive. They underline the necessity for future, more comprehensive studies to validate and expand upon these initial observations. The conclusion of both this abstract and the full paper will clearly state these limitations and the preliminary nature of the study.

Continuous data capture of gait and mobility metrics using wearable devices for postoperative monitoring in common elective orthopaedic procedures of the hip, knee, and spine: a scoping review.

BACKGROUND: Surgical procedures involving the hip, knee, or spine represent a majority of orthopaedic procedures performed electively in the health care system. Postoperative care is a key aspect of surgery and mobilisation without injury is the primary objective. Recent advances in wearable technologies allow objective evaluation of walking metrics to inform and guide postoperative care following orthopaedic surgery. PURPOSE: The aim of this scoping review is to explore current applications of wearable devices, objective data capture and gait analysis in monitoring postoperative recovery following commonly performed elective orthopaedic procedures of the hip, knee and spine. METHODS: A search against pre-defined criteria was performed on the following scientific databases from date of inception to February 28th, 2021: Medline (via OvidSP), Embase (via OvidSP) and Cochrane Library (via CENTRAL). Data were collected according to a predetermined checklist including study participants, surgery, wearable device (model), sensor location, and monitoring parameters such as mobility metrics, monitoring timepoints and monitoring duration for each study included in our review. Quality was assessed independently using the Newcastle Ottawa Scale (NOS). CONCLUSIONS: To our knowledge, this is the first review of wearable monitoring (of postoperative recovery) following hip, knee and spine surgery. Patients undergoing elective orthopaedic procedures may benefit from wearable monitoring of their walking health and mobility metrics.

Proposed objective scoring algorithm for clinical evaluation of walking asymmetry in lumbar disc herniation, based on relevant gait metrics from wearable devices: The Gait Symmetry Index (GSiTM) - Observational study.

•The proposed GSi algorithm aims to objectively evaluate the walking impairment associated with lumbar disc herniation (LDH).•GSi is calculated as deviation from mean (age-matched) normative values for gait velocity, step time asymmetry and step length asymmetry.•Clinical performance was assessed in a prospective, single surgeon series of 33 lumbar disc herniation (LDH) patients.•GSi was lower in LDH participants with significant distribution between surgical and conservative management subgroups.

Evaluating methodological quality of prognostic prediction models on patient reported outcome measurements after total hip replacement and total knee replacement surgery: a systematic review protocol.

BACKGROUND: Prediction models for poor patient-reported surgical outcomes after total hip replacement (THR) and total knee replacement (TKR) may provide a method for improving appropriate surgical care for hip and knee osteoarthritis. There are concerns about methodological issues and the risk of bias of studies producing prediction models. A critical evaluation of the methodological quality of prediction modelling studies in THR and TKR is needed to ensure their clinical usefulness. This systematic review aims to (1) evaluate and report the quality of risk stratification and prediction modelling studies that predict patient-reported outcomes after THR and TKR; (2) identify areas of methodological deficit and provide recommendations for future research; and (3) synthesise the evidence on prediction models associated with post-operative patient-reported outcomes after THR and TKR surgeries. METHODS: MEDLINE, EMBASE, and CINAHL electronic databases will be searched to identify relevant studies. Title and abstract and full-text screening will be performed by two independent reviewers. We will include (1) prediction model development studies without external validation; (2) prediction model development studies with external validation of independent data; (3) external model validation studies; and (4) studies updating a previously developed prediction model. Data extraction spreadsheets will be developed based on the CHARMS checklist and TRIPOD statement and piloted on two relevant studies. Study quality and risk of bias will be assessed using the PROBAST tool. Prediction models will be summarised qualitatively. Meta-analyses on the predictive performance of included models will be conducted if appropriate. A narrative review will be used to synthesis the evidence if there are insufficient data to perform meta-analyses. DISCUSSION: This systematic review will evaluate the methodological quality and usefulness of prediction models for poor outcomes after THR or TKR. This information is essential to provide evidence-based healthcare for end-stage hip and knee osteoarthritis. Findings of this review will contribute to the identification of key areas for improvement in conducting prognostic research in this field and facilitate the progress in evidence-based tailored treatments for hip and knee osteoarthritis. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number CRD42021271828.

The concept of recovery kinetics: an observational study of continuous post-operative monitoring in spine surgery.

Background: The spine surgeon's understanding of an individual patient's burden of disease and functional disability in daily life is shaped by patient-reported outcome measures (PROMs). Although PROMs are useful in understanding the patient's perception of their disease, the use of PROMs constitutes a "snapshot" approach of single timepoint data capture, omitting day-to-day fluctuations in functional status. We introduce the concept of kinetics when considering continuous and objective postoperative patient monitoring with wearable sensors. Methods: A prospective single-centre series was performed using patients either undergoing lumbar decompression for lumbar spinal stenosis (LSS) (n=12), or posterior lumbar fusion for degenerative spondylolisthesis (n=12). The Oswestry Disability Index (PROM) was conducted preoperatively and 12-weeks postoperatively. During this timeframe, continuous measurements of step count and distance travelled were made using a wrist-based wearable accelerometer. Results: Over the 12-week study period, mean daily step count for all participants improved from 4,700 to 7,700 steps per day (P=0.013), following an initial dip in total steps taken. The mean daily distance travelled improved from 3,300 to 5,300 meters per day (P=0.003). Decompression group recovered at a faster rate than the fusion group. Conclusions: Although overall improvement was similar between the decompression and fusion groups, the recovery kinetics varied. The recovery kinetics approach of continuous postoperative monitoring provides additional insight to postoperative patient progress.

Analysing gait patterns in degenerative lumbar spine diseases: a literature review.

Objectives: To collate the current state of knowledge and explore differences in the spatiotemporal gait patterns of degenerative lumbar spine diseases: lumbar spinal stenosis (LSS), lumbar disc herniation (LDH) and low back pain (LBP). Background: LBP is common presenting complaint with degenerative lumbar spine disease being a common cause. In particular, the gait patterns of LSS, LDH and mechanical-type (facetogenic and discogenic) LBP is not established. Methods: A search of the literature was conducted to determine the changes in spatial and temporal gait metrics involved with each type of degenerative lumbar spine disease. A search of databases including Medline, Embase and PubMed from their date of inception to April 18th, 2021 was performed to screen, review and identify relevant studies for qualitative synthesis. Seventeen relevant studies were identified for inclusion in the present review. Of these, 5 studies investigated gait patterns in LSS, 10 studies investigated LBP and 2 studies investigated LDH. Of these, 4 studies employed wearable accelerometry in LSS (2 studies) and LBP (2 studies). Conclusions: Previous studies suggest degenerative diseases of the lumbar spine have unique patterns of gait deterioration. LSS is characterised by asymmetry and variability. Spatiotemporal gait deterioration in gait velocity, cadence with increased double-support duration and gait variability are distinguishing features in LDH. LBP involves marginal abnormalities in temporal and spatial gait metrics. Previous studies suggest degenerative diseases of the lumbar spine have unique patterns of gait deterioration. Gait asymmetry and variability, may be relevant metrics for distinguishing between the gait profiles of lumbar spine diseases.

Tracking the disease progression of lumbar spinal stenosis using objective gait metrics: a case report.

We present the case of an 85-year-old woman who presented to our clinic with neurogenic claudication due to lumbar spinal stenosis (LSS) over a period of two years. During this time a series of walking metrics were monitored including daily step count, walking speed, and step length. All metrics showed a deterioration over time and objectively document the disease progression of LSS (initial: walking speed =1.03 m/s, step length =0.49 m, and daily step count =3,136; final: walking speed =0.49 m/s, step length =0.37 m, and daily step count =334). At this time, the patient had also begun experiencing bilateral lower limb weakness and paraesthesia upon exertion, preventing her from mobilizing for more than a few meters at a time. After a shared decision-making process with the patient and her family, surgical management was recommended. The deterioration of the patient's walking metrics matched their increasing requirement for walking assistance, with no walking assistance being needed initially, compared to a four-wheel walker being required in the weeks prior to her surgery. Therefore, the extent of walking deterioration may be able to inform clinical decision-making regarding appropriate walking assistance. To our knowledge, this is the first report that objectively documents the deterioration of LSS using walking metrics for such a prolonged duration of time.

Two-year continuous data capture using a wearable sensor to remotely monitor the surgical spine patient: a case report.

We report the case of a 46-year-old male with long-standing low back pain who presented with a deterioration of symptoms characterised by back and right leg pain corresponding to the L4 and L5 dermatomes. An MRI scan revealed severe central and lateral recess stenosis at L4/5 secondary to a large central disc protrusion. We remotely monitored activity and general health metrics over a time-period exceeding two years. This is the first study to monitor these metrics remotely and continuously in the surgical spine patient. Over this time, he received several interventions including a spinal cord stimulator implant, and an L4/5 microdiscectomy. We tracked his fluctuating health status using the Oura Ring [objectively measuring metrics including step count, sleep patterns, heart rate (HR), heart-rate variability (HRV), and respiratory rate (RR)] and with daily self-reported scores on the Visual Analogue Scale. The Oura Ring is a convenient and lightweight wearable device that is worn on any finger. Taken together, metrics provided a comprehensive picture of deterioration and recovery, paralleling key events in the patient's history. The use of wearable devices is feasible in enabling long-term remote continuous monitoring. This may assist surgeons and rehabilitation providers in identifying early deterioration and monitoring the post-intervention course of recovery.

Analysing Gait Patterns in Degenerative Lumbar Spine Disease Using Inertial Wearable Sensors: An Observational Study.

OBJECTIVE: Using a chest-based inertial wearable sensor, we examined the quantitative gait patterns associated with lumbar disc herniation (LDH), lumbar spinal stenosis (LSS), and chronic mechanical low back pain (CMLBP). 'Pathological gait signatures' were reported as statistically significant group difference (%) from the 'normative' gait values of an age-matched control population. METHODS: A sample of patients presenting to the Prince of Wales Private Hospital (Sydney, Australia) with primary diagnoses of LDH, LSS, or CMLBP were recruited. Spatial, temporal, asymmetry, and variability metrics were compared with age-matched (±2 years) control participants recruited from the community. Participants were fitted at the sternal angle with an inertial measurement unit, MetaMotionC, and walked unobserved (at a self-selected pace) for 120 m along an obstacle-free, carpeted hospital corridor. RESULTS: LDH, CMLBP, and LSS groups had unique pathological signatures of gait impairment. The LDH group (n = 33) had marked asymmetry in terms of step length, step time, stance, and single-support asymmetry. The LDH group also involved gait variability with increased step length variation. However, distinguishing the CMLBP group (n = 33) was gait variability in terms increased single-support time variation. The gait of participants with LSS (n = 22) was both asymmetric and variable in step length. CONCLUSIONS: Wearable sensor-based accelerometry was found to be capable of detecting the gait abnormalities present in patients with LDH, LSS, and CMLBP, when compared to age-matched controls. Objective and quantitative patterns of gait deterioration uniquely varied between these subtypes of lumbar spine disease. With further testing and validation, gait signatures may aid clinical identification of gait-altering pathologies.

Walking orientation randomness metric (WORM) score: pilot study of a novel gait parameter to assess walking stability and discriminate fallers from non-fallers using wearable sensors.

BACKGROUND: Musculoskeletal disorders can contribute to injurious falls and incur significant societal and healthcare burdens. Identification of fallers from non-fallers through wearable-based gait analysis can facilitate timely intervention to assist mobility and prevent falls whilst improving care and attention for high fall-risk patients. In this study, we use wearable sensor-based gait analysis to introduce a novel variable to assess walking stability in fallers and non-fallers - the Walking Orientation Randomness Metric. The WORM score quantifies the stability, or 'figure-of-eight' motion of a subject's trunk during walking as an indicator of a falls-predictive (pathological) gait. METHODS: WORM is calculated as the 'figure-of-eight' oscillation mapped out in the transverse-plane by the upper body's centre-point during a walking bout. A sample of patients presenting to the Prince of Wales Hospital (Sydney, Australia) with a primary diagnosis of "falls for investigation" and age-matched healthy controls (non-fallers) from the community were recruited. Participants were fitted at the sternal angle with the wearable accelerometer, MetaMotionC (Mbientlab Inc., USA) and walked unobserved (at self-selected pace) for 5-50 m along an obstacle-free, carpeted hospital corridor. RESULTS: Participants comprised of 16 fallers (mean age: 70 + 17) and 16 non-fallers (mean age: 70 + 9) based on a recent fall(s) history. The (median) WORM score was 17-fold higher (p < 0.001) in fallers (3.64 cm) compared to non-fallers (0.21 cm). ROC curve analyses demonstrate WORM can discriminate fallers from non-fallers (AUC = 0.97). Diagnostic analyses (cut-off > 0.51 cm) show high sensitivity (88%) and specificity (94%). CONCLUSION: In this pilot study we have introduced the WORM score, demonstrating its discriminative performance in a preliminary sample size of 16 fallers. WORM is a novel gait metric assessing walking stability as measured by truncal way during ambulation and shows promise for objective and clinical evaluation of fallers.

Impact of preoperative smoking on patients undergoing right hemicolectomies for colon cancer.

PURPOSE: The tobacco epidemic is one of the biggest global public health issues impacting quality of life and surgical outcomes. Although 30% of colon cancers warrant a right hemicolectomy (RH), there is no specific data on the influence of smoking on postoperative complications following RH for cancer. The aim of this study was to determine its effect on post-surgical outcomes. METHODS: Patients who underwent elective RH for colon cancer between 2016 and 2019 were identified from the ACS-NSQIP database. Propensity score matching (PSM) was used with a maximum absolute difference of 0.05 between propensity scores. Primary outcome was to assess the 30-day complication risk profile between smokers and non-smokers. Secondary outcomes included smoking impact on wound and major medico-surgical complication rates, as well as risk of anastomotic leak (AL) using multivariable logistic regression models. RESULTS: Following PSM, 5652 patients underwent RH for colon cancer with 1,884 (33.3%) identified as smokers. Smokers demonstrated a higher rate of organ space infection (4.1% vs 3.1%, p = 0.034), unplanned return to theatre (4.8% vs 3.7%, p = 0.045) and risk of AL (3.5% vs 2.1%, p = 0.005). Smoking was found to be an independent risk factor for wound complications (OR 1.32, 95% CI 1.03-1.71, p = 0.032), primary pulmonary complications (OR 1.50, 95% CI 1.06-2.13, p = 0.024) and AL (OR 1.66, 95% CI 1.19-2.31, p = 0.003). CONCLUSION: Smokers have increased risk of developing major post-operative complications compared to non-smokers. Clinicians and surgeons must inform smokers of these surgical risks and potential benefit of smoking cessation prior to undergoing major colonic resection.

Gait metrics analysis utilizing single-point inertial measurement units: a systematic review.

BACKGROUND: Wearable sensors, particularly accelerometers alone or combined with gyroscopes and magnetometers in an inertial measurement unit (IMU), are a logical alternative for gait analysis. While issues with intrusive and complex sensor placement limit practicality of multi-point IMU systems, single-point IMUs could potentially maximize patient compliance and allow inconspicuous monitoring in daily-living. Therefore, this review aimed to examine the validity of single-point IMUs for gait metrics analysis and identify studies employing them for clinical applications. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Guidelines (PRISMA) were followed utilizing the following databases: PubMed; MEDLINE; EMBASE and Cochrane. Four databases were systematically searched to obtain relevant journal articles focusing on the measurement of gait metrics using single-point IMU sensors. RESULTS: A total of 90 articles were selected for inclusion. Critical analysis of studies was conducted, and data collected included: sensor type(s); sensor placement; study aim(s); study conclusion(s); gait metrics and methods; and clinical application. Validation research primarily focuses on lower trunk sensors in healthy cohorts. Clinical applications focus on diagnosis and severity assessment, rehabilitation and intervention efficacy and delineating pathological subjects from healthy controls. DISCUSSION: This review has demonstrated the validity of single-point IMUs for gait metrics analysis and their ability to assist in clinical scenarios. Further validation for continuous monitoring in daily living scenarios and performance in pathological cohorts is required before commercial and clinical uptake can be expected.

Historical Note: The Evolution of Cortical Bone Trajectory and Associated Techniques.

Cortical bone trajectory (CBT) for posterior fixation with pedicle screws is considered a relatively new alternative trajectory that travels in the medio-lateral direction in the transverse plane and in the caudo-cephalad path in the sagittal plane. Various biomechanical studies have already validated its superior pullout strength and mechanical stability over the traditional trajectory of convergent pedicle screws. Due to the relatively medial starting point of this trajectory, the CBT also poses the clinical advantage of requiring a smaller surgical field of exposure, thus minimizing tissue and muscle injury while reducing operative time and intraoperative blood loss. The evolution of CBT through time has closely been linked to the unwavering philosophy of prioritizing patient outcomes, advancements in neuronavigational technology, and the mounting biomechanical, morphometric, and clinical evidence. In this historical review, we provide a unique perspective on how CBT surgical technique has developed through time, highlighting key milestones and attempting to explain its explosive rise in popularity.

The application of artificial intelligence and custom algorithms with inertial wearable devices for gait analysis and detection of gait-altering pathologies in adults: A scoping review of literature.

BACKGROUND: The purpose of this scoping review was to explore the current applications of objective gait analysis using inertial measurement units, custom algorithms and artificial intelligence algorithms in detecting neurological and musculoskeletal gait altering pathologies from healthy gait patterns. METHODS: Literature searches were conducted of four electronic databases (Medline, PubMed, Embase and Web of Science) to identify studies that assessed the accuracy of these custom gait analysis models with inputs derived from wearable devices. Data was collected according to the preferred reporting items for systematic reviews and meta-analysis statement guidelines. RESULTS: A total of 23 eligible studies were identified for inclusion in the present review, including 10 custom algorithms articles and 13 artificial intelligence algorithms articles. Nine studies evaluated patients with Parkinson's disease of varying severity and subtypes. Support vector machine was the commonest adopted artificial intelligence algorithm model, followed by random forest and neural networks. Overall classification accuracy was promising for articles that use artificial intelligence algorithms, with nine articles achieving more than 90% accuracy. CONCLUSIONS: Current applications of artificial intelligence algorithms are reasonably effective discrimination between pathological and non-pathological gait. Of these, machine learning algorithms demonstrate the additional capacity to handle complicated data input, when compared to other custom algorithms. Notably, there has been increasing application of machine learning algorithms for conducting gait analysis. More studies are needed with unsupervised methods and in non-clinical settings to better reflect the community and home-based usage.

Objectifying clinical gait assessment: using a single-point wearable sensor to quantify the spatiotemporal gait metrics of people with lumbar spinal stenosis.

BACKGROUND: Wearable accelerometer-containing devices have become a mainstay in clinical studies which attempt to classify the gait patterns in various diseases. A gait profile for lumbar spinal stenosis (LSS) has not been developed, and no study has validated a simple wearable system for the clinical assessment of gait in lumbar stenosis. This study identifies the changes to gait patterns that occur in LSS to create a preliminary disease-specific gait profile. In addition, this study compares a chest-based wearable sensor, the MetaMotionC© device and inertial measurement unit python script (MMC/IMUPY) system, against a reference-standard, videography, to preliminarily assess its accuracy in measuring the gait features of patients with LSS. METHODS: We conduct a cross-sectional observational study examining the walking patterns of 25 LSS patients and 33 healthy controls. To construct a preliminary disease-specific gait profile for LSS, the gait patterns of the 25 LSS patients and 25 healthy controls with similar ages were compared. To assess the accuracy of the MMC/IMUPY system in measuring the gait features of patients with LSS, its results were compared with videography for the 21 LSS and 33 healthy controls whose walking bouts exceeded 30 m. RESULTS: Patients suffering from LSS walked significantly slower, with shorter, less frequent steps and higher asymmetry compared to healthy controls. The MMC/IMUPY system had >90% agreement with videography for all spatiotemporal gait metrics that both methods could measure. CONCLUSIONS: The MMC/IMUPY system is a simple and feasible system for the construction of a preliminary disease-specific gait profile for LSS. Before clinical application in everyday living conditions is possible, further studies involving the construction of a more detailed disease-specific gait profile for LSS by disease severity, and the validation of the MMC/IMUPY system in the home environment, are required.