Publications by authors named "Michael P Kelly"

229 Publications

Administrative Data are Unreliable for Ranking Hospital Performance Based on Serious Complications after Spine Fusion.

Authors:
Jacob K Greenberg Margaret A Olsen John Poe Christopher F Dibble Ken Yamaguchi Michael P Kelly Bruce L Hall Wilson Z Ray

Spine (Phila Pa 1976) 2021 Apr 5. Epub 2021 Apr 5.

Departments of Neurological Surgery Medicine Orthopaedic Surgery Surgery Washington University in St. Louis, St. Louis, MO. Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI. Centene Corporation, St. Louis, MO.

Study Design: Retrospective analysis of administrative billing data.

Objective: To evaluate the extent to which a metric of serious complications determined from administrative data can reliably profile hospital performance in spine fusion surgery.

Summary Of Background Data: While payers are increasingly focused on implementing pay-for-performance measures, quality metrics must reliably reflect true differences in performance among the hospitals profiled.

Methods: We used State Inpatient Databases from nine states to characterize serious complications after elective cervical and thoracolumbar fusion. Hierarchical logistic regression was used to risk-adjust differences in case mix, along with variability from low case volumes. The reliability of this risk-stratified complication rate (RSCR) was assessed as the variation between hospitals that was not due to chance alone, calculated separately by fusion type and year. Finally, we estimated the proportion of hospitals that had sufficient case volumes to obtain reliable (> 0.7) complication estimates.

Results: From 2010-2017 we identified 154,078 cervical and 213,133 thoracolumbar fusion surgeries. 4.2% of cervical fusion patients had a serious complication, and the median RSCR increased from 4.2% in 2010 to 5.5% in 2017. The reliability of the RSCR for cervical fusion was poor and varied substantially by year (range 0.04-0.28). Overall, 7.7% of thoracolumbar fusion patients experienced a serious complication, and the RSCR varied from 6.8%-8.0% during the study period. Although still modest, the RSCR reliability was higher for thoracolumbar fusion (range 0.16-0.43). Depending on the study year, 0-4.5% of hospitals had sufficient cervical fusion case volume to report reliable (> 0.7) estimates, whereas 15-36% of hospitals reached this threshold for thoracolumbar fusion.

Conclusion: A metric of serious complications was unreliable for benchmarking cervical fusion outcomes and only modestly reliable for thoracolumbar fusion. When assessed using administrative datasets, these measures appear inappropriate for high-stakes applications, such as public reporting or pay-for-performance.Level of Evidence: 3.
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http://dx.doi.org/10.1097/BRS.0000000000004017DOI Listing
April 2021

Patient-related and radiographic predictors of inferior health-related quality-of-life measures in adult patients with nonoperative spinal deformity.

Authors:
Peter G Passias Haddy Alas Shay Bess Breton G Line Virginie Lafage Renaud Lafage Christopher P Ames Douglas C Burton Avery Brown Cole Bortz Katherine Pierce Waleed Ahmad Sara Naessig Michael P Kelly Richard Hostin Khaled M Kebaish Khoi D Than Pierce Nunley Christopher I Shaffrey Eric O Klineberg Justin S Smith Frank J Schwab

J Neurosurg Spine 2021 Apr 2:1-7. Epub 2021 Apr 2.

3Department of Orthopedics, Hospital for Special Surgery, New York, New York.

Objective: Patients with nonoperative (N-Op) adult spinal deformity (ASD) have inferior long-term spinopelvic alignment and clinical outcomes. Predictors of lower quality-of-life measures in N-Op populations have yet to be sufficiently investigated. The aim of this study was to identify patient-related factors and radiographic parameters associated with inferior health-related quality-of-life (HRQOL) scores in N-Op ASD patients.

Methods: N-Op ASD patients with complete radiographic and outcome data at baseline and 2 years were included. N-Op patients and operative (Op) patients were propensity score matched for baseline disability and deformity. Patient-related factors and radiographic alignment parameters (pelvic tilt [PT], sagittal vertical axis [SVA], pelvic incidence [PI]-lumbar lordosis [LL] mismatch, mismatch between cervical lordosis and T1 segment slope [TS-CL], cervical-thoracic pelvic angle [PA], and others) at baseline and 2 years were analyzed as predictors for moderate to severe 2-year Oswestry Disability Index (ODI > 20) and failing to meet the minimal clinically importance difference (MCID) for 2-year Scoliosis Research Society Outcomes Questionnaire (SRS) scores (< 0.4 increase from baseline). Conditional inference decision trees identified predictors of each HRQOL measure and established cutoffs at which factors have a global effect. Random forest analysis (RFA) generated 5000 conditional inference trees to compute a variable importance table for top predictors of inferior HRQOL. Statistical significance was set at p < 0.05.

Results: Six hundred sixty-two patients with ASD (331 Op patients and 331 N-Op patients) with complete radiographic and HRQOL data at their 2-year follow-up were included. There were no differences in demographics, ODI, and Schwab deformity modifiers between groups at baseline (all p > 0.05). N-Op patients had higher 2-year ODI scores (27.9 vs 20.3, p < 0.001), higher rates of moderate to severe disability (29.3% vs 22.4%, p = 0.05), lower SRS total scores (3.47 vs 3.91, p < 0.001), and higher rates of failure to reach SRS MCID (35.3% vs 15.7%, p < 0.001) than Op patients at 2 years. RFA ranked the top overall predictors for moderate to severe ODI at 2 years for N-Op patients as follows: 1) frailty index > 2.8, 2) BMI > 35 kg/m2, T4PA > 28°, and 4) Charlson Comorbidity Index > 1. Top radiographic predictors were T4PA > 28° and C2-S1 SVA > 93 mm. RFA also ranked the top overall predictors for failure to reach 2-year SRS MCID for N-Op patients, as follows: 1) T12-S1 lordosis > 53°, 2) cervical SVA (cSVA) > 28 mm, 3) C2-S1 angle > 14.5°, 4) TS-CL > 12°, and 5) PT > 23°. The top radiographic predictors were T12-S1 Cobb angle, cSVA, C2-S1 angle, and TS-CL.

Conclusions: When controlling for baseline deformity in N-Op versus Op patients, subsequent deterioration in frailty, BMI, and radiographic progression over a 2-year follow-up were found to drive suboptimal patient-reported outcome measures in N-Op cohorts as measured by validated ODI and SRS clinical instruments.
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http://dx.doi.org/10.3171/2020.9.SPINE20519DOI Listing
April 2021

Choroidal neovascularization in a child with infantile primary hyperoxaluria treated with bevacizumab.

Authors:
Suzanne M Michalak Lucas Bonafede Michael P Kelly Cindy X Cai Xi Chen

J AAPOS 2021 Mar 15. Epub 2021 Mar 15.

Department of Ophthalmology, Duke University, Durham, North Carolina. Electronic address:

Fundus manifestations of primary hyperoxaluria include crystalline deposits, focal or diffuse macular hyperpigmentation, and subretinal fibrosis. Choroidal neovascularization has been hypothesized to underlie the pathogenesis of subretinal fibrosis, yet its manifestations are rarely observed. We report a case of infantile primary hyperoxaluria type 1 in a 17-month-old infant with macular subretinal fluid and subretinal hemorrhage\ that was associated with leakage on fluorescein angiography and responded to bevacizumab treatment, consistent with choroidal neovascularization. This case suggests that choroidal neovascularization may contribute to subretinal fibrosis and subsequent vision loss in infantile primary hyperoxaluria and may benefit from antivascular endothelial growth factor therapy.
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http://dx.doi.org/10.1016/j.jaapos.2020.12.004DOI Listing
March 2021

Public understanding of COVID-19 antibody testing and test results: A qualitative study conducted in the U.K. early in the pandemic.

Authors:
Jan Lecouturier Michael P Kelly Fiona Graham Carly Meyer Mei Yee Tang Louis Goffe Chris Bonell Susan Michie Falko F Sniehotta

Soc Sci Med 2021 03 16;273:113778. Epub 2021 Feb 16.

Population and Health Sciences Institute, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle Upon Tyne, NE2 4AX, UK. Electronic address:

Background: During the COVID-19 pandemic, antibody testing was proposed by several countries as a surveillance tool to monitor the spread of the virus and potentially to ease restrictions. In the UK, antibody testing originally formed the third pillar of the UK Government's COVID-19 testing programme and was thought to offer hope that those with a positive antibody test result could return to normal life. However, at that time scientists and the public had little understanding of the longevity of COVID-19 antibodies, and whether they provided immunity to reinfection or transmission of the virus.

Objective: This paper explores the UK public's understanding of COVID-19 testing, perceived test accuracy, the meaning of a positive test result, willingness to adhere to restrictive measures in response to an antibody test result and how they expect other people to respond.

Methods: On-line synchronous focus groups were conducted in April/May 2020 during the first wave of the pandemic and the most stringent period of the COVID-19 restrictive measures. Data were analysed thematically.

Results: There was confusion in responses as to whether those with a positive or negative test should return to work and which restrictive measures would apply to them or their household members. Participants raised concerns about the wider public response to positive antibody test results and the adverse behavioural effects. There were worries that antibody tests could create a divided society particularly if those with a positive test result were given greater freedoms or chose to disregard the restrictive measures.

Conclusion: Should these tests be offered more widely, information should be developed in consultation with the public to ensure clarity and address uncertainty about test results and subsequent behaviours.
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http://dx.doi.org/10.1016/j.socscimed.2021.113778DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7884253PMC
March 2021

Representation of behaviour change interventions and their evaluation: Development of the Upper Level of the Behaviour Change Intervention Ontology.

Authors:
Susan Michie Robert West Ailbhe N Finnerty Emma Norris Alison J Wright Marta M Marques Marie Johnston Michael P Kelly James Thomas Janna Hastings

Wellcome Open Res 2020 6;5:123. Epub 2021 Jan 6.

Centre for Behaviour Change, University College London, London, UK.

Behaviour change interventions (BCI), their contexts and evaluation methods are heterogeneous, making it difficult to synthesise evidence and make recommendations for real-world policy and practice. Ontologies provide a means for addressing this. They represent knowledge formally as entities and relationships using a common language able to cross disciplinary boundaries and topic domains. This paper reports the development of the upper level of the Behaviour Change Intervention Ontology (BCIO), which provides a systematic way to characterise BCIs, their contexts and their evaluations. Development took place in four steps. (1) Entities and relationships were identified by behavioural and social science experts, based on their knowledge of evidence and theory, and their practical experience of behaviour change interventions and evaluations. (2) The outputs of the first step were critically examined by a wider group of experts, including the study ontology expert and those experienced in annotating relevant literature using the initial ontology entities. The outputs of the second step were tested by (3) feedback from three external international experts in ontologies and (4) application of the prototype upper-level BCIO to annotating published reports; this informed the final development of the upper-level BCIO. The final upper-level BCIO specifies 42 entities, including the BCI scenario, elaborated across 21 entities and 7 relationship types, and the BCI evaluation study comprising 10 entities and 9 relationship types. BCI scenario entities include the behaviour change intervention (content and delivery), outcome behaviour, mechanism of action, and its context, which includes population and setting. These entities have corresponding entities relating to the planning and reporting of interventions and their evaluations. The upper level of the BCIO provides a comprehensive and systematic framework for representing BCIs, their contexts and their evaluations.
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http://dx.doi.org/10.12688/wellcomeopenres.15902.2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7868854PMC
January 2021

Patient-Reported Outcomes After Complex Adult Spinal Deformity Surgery: 5-Year Results of the Scoli-Risk-1 Study.

Authors:
Scott L Zuckerman Meghan Cerpa Lawrence G Lenke Christopher I Shaffrey Leah Y Carreon Kenneth M C Cheung Michael P Kelly Michael G Fehlings Christopher P Ames Oheneba Boachie-Adjei Mark B Dekutoski Khaled M Kabeaish Stephen J Lewis Yukihiro Matsuyama Ferran Pellisé Yong Qiu Frank J Schwab Justin S Smith

Global Spine J 2021 Feb 9:2192568220988276. Epub 2021 Feb 9.

University of Virginia, Charlottesville, VA, USA.

Study Design: Prospective cohort.

Objective: To prospectively evaluate PROs up to 5-years after complex ASD surgery.

Methods: The Scoli-RISK-1 study enrolled 272 ASD patients undergoing surgery from 15 centers. Inclusion criteria was Cobb angle of >80°, corrective osteotomy for congenital or revision deformity, and/or 3-column osteotomy. The following PROs were measured prospectively at intervals up to 5-years postoperative: ODI, SF36-PCS/MCS, SRS-22, NRS back/leg. Among patients with 5-year follow-up, comparisons were made from both baseline and 2-years postoperative to 5-years postoperative. PROs were analyzed using mixed models for repeated measures.

Results: Seventy-seven patients (28.3%) had 5-year follow-up data. Comparing baseline to 5-year data among these 77 patients, significant improvement was seen in all PROs: ODI (45.2 vs. 29.3, < 0.001), SF36-PCS (31.5 vs. 38.8, < 0.001), SF36-MCS (44.9 vs. 49.1, = 0.009), SRS-22-total (2.78 vs. 3.61, < 0.001), NRS-back pain (5.70 vs. 2.95, < 0.001) and NRS leg pain (3.64 vs. 2.62, = 0.017). In the 2 to 5-year follow-up period, no significant changes were seen in any PROs. The percentage of patients achieving MCID from baseline to 5-years were: ODI (62.0%) and the SRS-22r domains of function (70.4%), pain (63.0%), mental health (37.5%), self-image (60.3%), and total (60.3%). Surprisingly, mean values ( > 0.05) and proportion achieving MCID did not differ significantly in patients with major surgery-related complications compared to those without.

Conclusions: After complex ASD surgery, significant improvement in PROs were seen at 5-years postoperative in ODI, SF36-PCS/MCS, SRS-22r, and NRS-back/leg pain. No significant changes in PROs occurred during the 2 to 5-year postoperative period. Those with major surgery-related complications had similar PROs and proportion of patients achieving MCID as those without these complications.
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http://dx.doi.org/10.1177/2192568220988276DOI Listing
February 2021

Ontologies relevant to behaviour change interventions: a method for their development.

Authors:
Alison J Wright Emma Norris Ailbhe N Finnerty Marta M Marques Marie Johnston Michael P Kelly Janna Hastings Robert West Susan Michie

Wellcome Open Res 2020 18;5:126. Epub 2020 Dec 18.

Centre for Behaviour Change, University College London, London, UK.

Behaviour and behaviour change are integral to many aspects of wellbeing and sustainability. However, reporting behaviour change interventions accurately and synthesising evidence about effective interventions is hindered by lacking a shared, scientific terminology to describe intervention characteristics. Ontologies are standardised frameworks that provide controlled vocabularies to help unify and connect scientific fields. To date, there is no published guidance on the specific methods required to develop ontologies relevant to behaviour change. We report the creation and refinement of a method for developing ontologies that make up the Behaviour Change Intervention Ontology (BCIO). (1) To describe the development method of the BCIO and explain its rationale; (2) To provide guidance on implementing the activities within the development method. The method for developing ontologies relevant to behaviour change interventions was constructed by considering principles of good practice in ontology development and identifying key activities required to follow those principles. The method's details were refined through application to developing two ontologies. The resulting ontology development method involved: (1) defining the ontology's scope; (2) identifying key entities; (3) refining the ontology through an iterative process of literature annotation, discussion and revision; (4) expert stakeholder review; (5) testing inter-rater reliability; (6) specifying relationships between entities, and; (7) disseminating and maintaining the ontology. Guidance is provided for conducting relevant activities for each step.  We have developed a detailed method for creating ontologies relevant to behaviour change interventions, together with practical guidance for each step, reflecting principles of good practice in ontology development. The most novel aspects of the method are the use of formal mechanisms for literature annotation and expert stakeholder review to develop and improve the ontology content. We suggest the mnemonic SELAR3, representing the method's first six steps as Scope, Entities, Literature Annotation, Review, Reliability, Relationships.
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http://dx.doi.org/10.12688/wellcomeopenres.15908.3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7786424.3PMC
December 2020

Effect of prosocial public health messages for population behaviour change in relation to respiratory infections: a systematic review protocol.

Authors:
Aikaterini Grimani Chris Bonell Susan Michie Vivi Antonopoulou Michael P Kelly Ivo Vlaev

BMJ Open 2021 01 13;11(1):e044763. Epub 2021 Jan 13.

NIHR Policy Research Unit in Behavioural Science, Newcastle University, Newcastle upon Tyne, UK.

Introduction: The COVID-19 pandemic represents a major societal challenge that requires large-scale behaviour change, widespread collective action and cooperation to reduce viral transmission. Existing literature indicates that several messaging approaches may be effective, including emphasising the benefits to the recipient, aligning with the recipient's moral values and focusing on protecting others. Current research suggests that prosocial public health messages that highlight behaviours linked to societal benefits (eg, protecting 'each other'), rather than focusing on behaviours that protect oneself (eg, protecting 'yourself'), may be a more effective method for communicating strategies related to infectious disease. To investigate this we will conduct a systematic review that will identify what messages and behaviour change techniques have the potential to optimise the effect on population behaviour in relation to reducing transmission of respiratory infections.

Methods And Analysis: A systematic literature search of published and unpublished studies (including grey literature) in electronic databases will be conducted to identify those that meet our inclusion criteria. The search will be run in four electronic databases: MEDLINE, EMBASE, PsycINFO and Scopus. We will also conduct supplementary searches in databases of 'grey' literature such as PsycEXTRA, Social Science Research Network and OSF PREPRINTS, and use the Google Scholar search engine. A systematic approach to searching, screening, reviewing and data extraction will be applied based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Titles, abstracts and full texts for eligibility will be examined independently by researchers. The quality of the included studies will be assessed using the Cochrane Risk of Bias Tool and the Risk of Bias in Non-randomized Studies-of Interventions tool. Disagreements will be resolved by a consensus procedure.

Ethics And Dissemination: This protocol has been registered with PROSPERO. No ethical approval is required, as there will be no collection of primary data. The synthesised findings will be disseminated through peer-reviewed publication.

Prospero Registration Number: CRD42020198874.
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http://dx.doi.org/10.1136/bmjopen-2020-044763DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7812082PMC
January 2021

Fighting Words in the Antipodes.

Authors:
Cherie Lacey Michael P Kelly Annemarie Jutel

Perspect Biol Med 2020 ;63(4):669-682

In this commentary, written in two bursts-the first completed in April 2020, and the second at the end of July-we explore how media metaphors of COVID-19 constitute the pandemic in Australia and New Zealand. We argue that the media's rhetorical strategies play an important role not only in describing the illness, but in influencing and shaping individual and collective responses to the pandemic, with significant consequences for mental health and well-being in the context of crisis. We align this commentary with the tenets of the sociology of diagnosis, which argue that even though there are material realities of disease, their social form and consequence cannot be separated from the tangible nature of illness and its management. We also lean on Derrida's approach to metaphor, which underlines how even observable viral entities such as COVID-19 are simultaneously material, abstract, and in flux. We describe the metaphors used by local media to describe the pandemic-including combat, bush fires, earthquakes, and other natural disasters-and we explore how and why these metaphors construct the pandemic locally and farther afield.
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http://dx.doi.org/10.1353/pbm.2020.0054DOI Listing
January 2021

Inequalities in mental health: predictive processing and social life.

Authors:
Michael P Kelly Carol Brayne Ann Louise Kinmonth Natasha Kriznik John Ford Paul C Fletcher

Curr Opin Psychiatry 2021 03;34(2):171-176

Department of Psychiatry, University of Cambridge, Herchel Smith Building, Addenbrooke's Hospital, Cambridge, UK, Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK, Wellcome Trust MRC Institute of Metabolic Science, University of Cambridge, Cambridge Biomedical Campus, Cambridge, UK.

Purpose Of Review: The paper applies recent conceptualisations of predictive processing to the understanding of inequalities in mental health.

Recent Findings: Social neuroscience has developed important ideas about the way the brain models the external world, and how the interface between cognitive and cultural processes interacts. These resonate with earlier concepts from cybernetics and sociology. These approaches could be applied to understanding some of the dynamics leading to the patterning of mental health problems in populations.

Summary: The implications for practice are the way such thinking might help illuminate how we think and act, and how these are anchored in the social world.
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http://dx.doi.org/10.1097/YCO.0000000000000680DOI Listing
March 2021

Verteporfin treatment controls morphology, phenotype, and global gene expression for cells of the human nucleus pulposus.

Authors:
Bailey V Fearing Julie E Speer Liufang Jing Aravind Kalathil Michael P Kelly Jacob M Buchowski Lukas P Zebala Scott Luhmann Munish C Gupta Lori A Setton

JOR Spine 2020 Dec 30;3(4):e1111. Epub 2020 Jul 30.

Department of Biomedical Engineering Washington University in St. Louis St. Louis Missouri USA.

Cells of the nucleus pulposus (NP) are essential contributors to extracellular matrix synthesis and function of the intervertebral disc. With age and degeneration, the NP becomes stiffer and more dehydrated, which is associated with a loss of phenotype and biosynthetic function for its resident NP cells. Also, with aging, the NP cell undergoes substantial morphological changes from a rounded shape with pronounced vacuoles in the neonate and juvenile, to one that is more flattened and spread with a loss of vacuoles. Here, we make use of the clinically relevant pharmacological treatment verteporfin (VP), previously identified as a disruptor of yes-associated protein-TEA domain family member-binding domain (TEAD) signaling, to promote morphological changes in adult human NP cells in order to study variations in gene expression related to differences in cell shape. Treatment of adult, degenerative human NP cells with VP caused a shift in morphology from a spread, fibroblastic-like shape to a rounded, clustered morphology with decreased transcriptional activity of TEAD and serum-response factor. These changes were accompanied by an increased expression of vacuoles, NP-specific gene markers, and biosynthetic activity. The contemporaneous observation of VP-induced changes in cell shape and prominent, time-dependent changes within the transcriptome of NP cells occurred over all timepoints in culture. Enriched gene sets with the transition to VP-induced cell rounding suggest a major role for cell adhesion, cytoskeletal remodeling, vacuolar lumen, and MAPK activity in the NP phenotypic and functional response to changes in cell shape.
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http://dx.doi.org/10.1002/jsp2.1111DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7770208PMC
December 2020

Improvement in SRS-22R Self-Image Correlate Most with Patient Satisfaction after 3-Column Osteotomy.

Authors:
Jeffrey L Gum Mark Shasti Samrat Yeramaneni Leah Y Carreon Richard A Hostin Michael P Kelly Virginie Lafage Justin S Smith Peter G Passias Khaled Kebaish Christopher I Shaffrey Douglas L Burton Christopher P Ames Frank J Schwab Themistocles Protopsaltis R Shay Bess

Spine (Phila Pa 1976) 2020 Dec 17;Publish Ahead of Print. Epub 2020 Dec 17.

Norton Leatherman Spine Center, 210 East Gray Street, Louisville, KY 40202 Inova Loudoun Hospital, Lansdowne, VA 2017 Sarah Cannon Research Institute, Nashville, TN 37203 Department of Orthopaedic Surgery, Baylor Scoliosis Center, Plano, Texas Department of Orthopaedic Surgery, Washington University, St Louis, Missouri Department of Orthopaedic Surgery, Hospital for Special Surgery, New York City, New York Department of Neurosurgery, University of Virginia, Charlottesville, Virginia Department of Orthopaedic Surgery, NYU Hospital for Joint Diseases, New York, New York Department of Orthopaedic Surgery, Johns Hopkins University, Baltimore, Maryland Department of Orthopaedic Surgery, Spine Division, Duke University Medical Center Department of Orthopaedic Surgery, University of Kansas Medical Center, Kansas City, Kansas Department of Neurological Surgery, University of California, San Francisco, San Francisco, California Presbyterian/St. Luke's Medical Center, Rocky Mountain Hospital for Children, Denver, Colorado International Spine Study Group Foundation, Brighton, Colorado.

Study Design: Longitudinal Cohort.

Objectives: To examine the relationship between patient satisfaction, Patient Reported Outcome Measures (PROMs) and radiographic parameters in Adult Spine Deformity (ASD) patients undergoing 3 Column Osteotomies (3CO).

Summary Of Background Data: Identifying factors that influence patient satisfaction in ASD is important. Evidence suggests SRS22R Self-Image domain correlates with patient satisfaction in patients with ASD.

Methods: This is a retrospective review of ASD patients enrolled in a prospective, multicenter database undergoing a 3CO with complete SRS22R pre-op and minimum 2-years postop. Spearman correlations were used to evaluate associations between the 2-yr SRS Satisfaction score and changes in SRS22R domain scores, Oswestry Disability Index (ODI), and radiographic parameters.

Results: Of 135 patients eligible for 2-year follow-up, 98 patients (73%) had complete pre- and 2-yr postop data. The cohort was mostly female (69%) with mean BMI of 29.7 kg/m2 and age of 61.0 yrs. Mean levels fused was 12.9 with EBL of 2695cc and OR time of 407 minutes; 27% were revision surgeries. There was a statistically significant improvement between pre- and 2-year post-op PROMs and all radiographic parameters except Coronal Vertical Axis. The majority of patients had an SRS Satisfaction score of ≥ 3.0 (90%) or ≥ 4.0 (68%), consistent with a moderate ceiling effect. Correlations of patient satisfaction was significant for Pain (0.43, p < 0.001), Activity (0.39, p < 0.001), Mental (0.38, p = 0.001) Self-Image (0.52, p < 0.001). ODI and SF-36 PCS had a moderate correlation as well, with MCS being weak. There was no statistically significant correlations between any radiographic or operative parameters and patient satisfaction.

Conclusion: There was statistically significant improvement in all PROMs and radiographic parameters, except CVA at 2-years in ASD patients undergoing 3CO. Improvement in SRS Self-Image domain has the strongest correlation with patient satisfaction.Level of Evidence: 3.
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http://dx.doi.org/10.1097/BRS.0000000000003897DOI Listing
December 2020

Occipital-Cervical Fusion and Ventral Decompression in the Surgical Management of Chiari-1 Malformation and Syringomyelia: Analysis of Data From the Park-Reeves Syringomyelia Research Consortium.

Authors:
Travis S CreveCoeur Alexander T Yahanda Cormac O Maher Gabrielle W Johnson Laurie L Ackerman P David Adelson Raheel Ahmed Gregory W Albert Phillipp R Aldana Tord D Alden Richard C E Anderson Lissa Baird David F Bauer Karin S Bierbrauer Douglas L Brockmeyer Joshua J Chern Daniel E Couture David J Daniels Robert C Dauser Susan R Durham Richard G Ellenbogen Ramin Eskandari Herbert E Fuchs Timothy M George Gerald A Grant Patrick C Graupman Stephanie Greene Jeffrey P Greenfield Naina L Gross Daniel J Guillaume Gabe Haller Todd C Hankinson Gregory G Heuer Mark Iantosca Bermans J Iskandar Eric M Jackson Andrew H Jea James M Johnston Robert F Keating Michael P Kelly Nickalus Khan Mark D Krieger Jeffrey R Leonard Francesco T Mangano Timothy B Mapstone J Gordon McComb Arnold H Menezes Michael Muhlbauer W Jerry Oakes Greg Olavarria Brent R O'Neill Tae Sung Park John Ragheb Nathan R Selden Manish N Shah Chevis Shannon Joshua S Shimony Jodi Smith Matthew D Smyth Scellig S D Stone Jennifer M Strahle Mandeep S Tamber James C Torner Gerald F Tuite Scott D Wait John C Wellons William E Whitehead David D Limbrick

Neurosurgery 2021 01;88(2):332-341

Department of Neurological Surgery, Washington University School of Medicine, St. Louis, Missouri.

Background: Occipital-cervical fusion (OCF) and ventral decompression (VD) may be used in the treatment of pediatric Chiari-1 malformation (CM-1) with syringomyelia (SM) as adjuncts to posterior fossa decompression (PFD) for complex craniovertebral junction pathology.

Objective: To examine factors influencing the use of OCF and OCF/VD in a multicenter cohort of pediatric CM-1 and SM subjects treated with PFD.

Methods: The Park-Reeves Syringomyelia Research Consortium registry was used to examine 637 subjects with cerebellar tonsillar ectopia ≥ 5 mm, syrinx diameter ≥ 3 mm, and at least 1 yr of follow-up after their index PFD. Comparisons were made between subjects who received PFD alone and those with PFD + OCF or PFD + OCF/VD.

Results: All 637 patients underwent PFD, 505 (79.2%) with and 132 (20.8%) without duraplasty. A total of 12 subjects went on to have OCF at some point in their management (PFD + OCF), whereas 4 had OCF and VD (PFD + OCF/VD). Of those with complete data, a history of platybasia (3/10, P = .011), Klippel-Feil (2/10, P = .015), and basilar invagination (3/12, P < .001) were increased within the OCF group, whereas only basilar invagination (1/4, P < .001) was increased in the OCF/VD group. Clivo-axial angle (CXA) was significantly lower for both OCF (128.8 ± 15.3°, P = .008) and OCF/VD (115.0 ± 11.6°, P = .025) groups when compared to PFD-only group (145.3 ± 12.7°). pB-C2 did not differ among groups.

Conclusion: Although PFD alone is adequate for treating the vast majority of CM-1/SM patients, OCF or OCF/VD may be occasionally utilized. Cranial base and spine pathologies and CXA may provide insight into the need for OCF and/or OCF/VD.
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http://dx.doi.org/10.1093/neuros/nyaa460DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7803430PMC
January 2021

Multicenter assessment of surgical outcomes in adult spinal deformity patients with severe global coronal malalignment: determination of target coronal realignment threshold.

Authors:
Thomas J Buell Justin S Smith Christopher I Shaffrey Han Jo Kim Eric O Klineberg Virginie Lafage Renaud Lafage Themistocles S Protopsaltis Peter G Passias Gregory M Mundis Robert K Eastlack Vedat Deviren Michael P Kelly Alan H Daniels Jeffrey L Gum Alex Soroceanu D Kojo Hamilton Munish C Gupta Douglas C Burton Richard A Hostin Khaled M Kebaish Robert A Hart Frank J Schwab Shay Bess Christopher P Ames

J Neurosurg Spine 2020 Dec 4:1-14. Epub 2020 Dec 4.

18Department of Neurological Surgery, University of California, San Francisco, California.

Objective: The impact of global coronal malalignment (GCM; C7 plumb line-midsacral offset) on adult spinal deformity (ASD) treatment outcomes is unclear. Here, the authors' primary objective was to assess surgical outcomes and complications in patients with severe GCM, with a secondary aim of investigating potential surgical target coronal thresholds for optimal outcomes.

Methods: This is a retrospective analysis of a prospective multicenter database. Operative patients with severe GCM (≥ 1 SD above the mean) and a minimum 2-year follow-up were identified. Demographic, surgical, radiographic, health-related quality of life (HRQOL), and complications data were analyzed.

Results: Of 691 potentially eligible operative patients (mean GCM 4 ± 3 cm), 80 met the criteria for severe GCM ≥ 7 cm. Of these, 62 (78%; mean age 63.7 ± 10.7 years, 81% women) had a minimum 2-year follow-up (mean follow-up 3.3 ± 1.1 years). The mean ASD-Frailty Index was 3.9 ± 1.5 (frail), 50% had undergone prior fusion, and 81% had concurrent severe sagittal spinopelvic deformity with GCM and C7-S1 sagittal vertical axis (SVA) positively correlated (r = 0.313, p = 0.015). Surgical characteristics included posterior-only (58%) versus anterior-posterior (42%) approach, mean fusion of 13.2 ± 3.8 levels, iliac fixation (90%), 3-column osteotomy (36%), operative duration of 8.3 ± 3.0 hours, and estimated blood loss of 2.3 ± 1.7 L. Final alignment and HRQOL significantly improved (p < 0.01): GCM, 11 to 4 cm; maximum coronal Cobb angle, 43° to 20°; SVA, 13 to 4 cm; pelvic tilt, 29° to 23°; pelvic incidence-lumbar lordosis mismatch, 31° to 5°; Oswestry Disability Index, 51 to 37; physical component summary of SF-36 (PCS), 29 to 37; 22-Item Scoliosis Research Society Patient Questionnaire (SRS-22r) Total, 2.6 to 3.5; and numeric rating scale score for back and leg pain, 7 to 4 and 5 to 3, respectively. Residual GCM ≥ 3 cm was associated with worse SRS-22r Appearance (p = 0.04) and SRS-22r Satisfaction (p = 0.02). The minimal clinically important difference and/or substantial clinical benefit (MCID/SCB) was met in 43%-83% (highest for SRS-22r Appearance [MCID 83%] and PCS [SCB 53%]). The severity of baseline GCM (≥ 2 SD above the mean) significantly impacted postoperative SRS-22r Satisfaction and MCID/SCB improvement for PCS. No significant partial correlations were demonstrated between GCM or SVA correction and HRQOL improvement. There were 89 total complications (34 minor and 55 major), 45 (73%) patients with ≥ 1 complication (most commonly rod fracture [19%] and proximal junctional kyphosis [PJK; 18%]), and 34 reoperations in 22 (35%) patients (most commonly for rod fracture and PJK).

Conclusions: Study results demonstrated that ASD surgery in patients with substantial GCM was associated with significant radiographic and HRQOL improvement despite high complication rates. MCID improvement was highest for SRS-22r Appearance/Self-Image. A residual GCM ≥ 3 cm was associated with a worse outcome, suggesting a potential coronal realignment target threshold to assist surgical planning.
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http://dx.doi.org/10.3171/2020.7.SPINE20606DOI Listing
December 2020

Neurological Complications and Recovery Rates of Patients With Adult Cervical Deformity Surgeries.

Authors:
Han Jo Kim Yu-Cheng Yao Christopher I Shaffrey Justin S Smith Michael P Kelly Munish Gupta Todd J Albert Themistocles S Protopsaltis Gregory M Mundis Peter Passias Eric Klineberg Shay Bess Virginie Lafage Christopher P Ames

Global Spine J 2020 Nov 23:2192568220975735. Epub 2020 Nov 23.

Department of Neurological Surgery, University of California, San Francisco, CA, USA.

Study Design: Retrospective cohort study.

Objective: This study aims to report the incidence, risk factors, and recovery rate of neurological complications (NC) in patients with adult cervical deformity (ACD) who underwent corrective surgery.

Methods: ACD patients undergoing surgery from 2013 to 2015 were enrolled in a prospective, multicenter database. Patients were separated into 2 groups according to the presence of neurological complications (NC vs no-NC groups). The types, timing, recovery patterns, and interventions for NC were recorded. Patients' demographics, surgical details, radiographic parameters, and health-related quality of life (HRQOL) scores were compared.

Results: 106 patients were prospectively included. Average age was 60.8 years with a mean of 18.2 months follow-up. The overall incidence of NC was 18.9%; of these, 68.1% were major complications. Nerve root motor deficit was the most common complication, followed by radiculopathy, sensory deficit, and spinal cord injury. The proportion of complications occurring within 30 days of surgery was 54.5%. The recovery rate from neurological complication was high (90.9%), with most of the recoveries occurring within 6 months and continuing even after 12 months. Only 2 patients (1.9%) had continuous neurological complication. No demographic or preoperative radiographic risk factors could be identified, and anterior corpectomy and posterior foraminotomy were found to be performed less in the NC group. The final HRQOL outcome was not significantly different between the 2 groups.

Conclusions: Our data is valuable to surgeons and patients to better understand the neurological complications before performing or undergoing complex cervical deformity surgery.
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http://dx.doi.org/10.1177/2192568220975735DOI Listing
November 2020

Interobserver and intraobserver reliability of determining the deformity angular ratio in severe pediatric deformity curves.

Authors:
Scott L Zuckerman Lawrence G Lenke Meghan Cerpa Michael P Kelly Burt Yaszay Paul Sponseller Mark Erickson Sumeet Garg Joshua Pahys Patrick Cahill Brenda Sides Munish Gupta

Spine Deform 2021 Mar 17;9(2):435-440. Epub 2020 Nov 17.

Department of Orthopaedics, Washington University, St. Louis, MO, USA.

Study Design: Cross-sectional reliability study.

Objective: The deformity angular ratio (DAR) is a means of quantifying magnitude of the coronal (C-DAR) and sagittal (S-DAR) plane of deformity curves to produce a total DAR (T-DAR). It has been shown to predict the risk of spinal cord monitoring alerts and actual neurologic deficits. We sought to assess the reliability of determining the C-DAR and S-DAR among pediatric spinal deformity surgeons.

Methods: Twelve preoperative anterior-posterior (AP) and lateral X-rays from the Fox multi-center pediatric deformity study were de-identified and sent to7 pediatric spinal deformity surgeons. Each surgeon measured: coronal/sagittal Cobb angles, upper/lower endplate vertebrae (UEV/LEV), apices, and number of vertebrae included in the main curve. The C-DAR and S-DAR were then calculated by dividing the Cobb angles by the number of vertebrae included in the curve. Intra- and interobserver reliability was calculated using interclass correlation (ICC).

Results: The mean C-DAR was 14.9 (range 1.3-51.5) with a mean Cobb angle of 88.8° (range 15.0-163.0) over a mean of 7.5 (range 2.0-14.0) levels. The mean S-DAR was 8.6 (range 1.0-19.6), with a mean Cobb angle of 68.0° (range 10.0-137.0) over a mean of 7.5 (range 3-11) levels. The intraobserver reliability of the C-DAR was ICC = 0.908 (range 0.846-0.960) and the S-DAR 0.914 (range 0.815-0.961). The interobserver reliability of the C-DAR was ICC = 0.868 (range 0.846-0.938), and the S-DAR was ICC = 0.848 (range 0.815-0.961). Despite poor reliability among UEV, LEV, and apex selection (aggregated range 0.340-0.724), the C-DAR and S-DAR were demonstrated to be reliable in our study CONCLUSIONS: Reliability was good to excellent for C-DAR and S-DAR, despite poor to moderate reliability among UEV, LEV, and apex selection. These data support the use of the C-DAR, S-DAR, and combined T-DAR as a means of quantifying deformity magnitude.
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http://dx.doi.org/10.1007/s43390-020-00239-6DOI Listing
March 2021

Inequalities in the uptake of, adherence to and effectiveness of behavioural weight management interventions: systematic review protocol.

Authors:
Jack Michael Birch Simon J Griffin Michael P Kelly Amy L Ahern

BMJ Open 2020 11 14;10(11):e039518. Epub 2020 Nov 14.

MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, Cambridgeshire, UK.

Introduction: It has been suggested that interventions focusing on individual behaviour change, such as behavioural weight management interventions, may exacerbate health inequalities. These intervention-generated inequalities may occur at different stages, including intervention uptake, adherence and effectiveness. We will synthesise evidence on how different measures of inequality moderate the uptake, adherence and effectiveness of behavioural weight management interventions in adults.

Methods And Analysis: We will update a previous systematic literature review from the United States Preventive Services Taskforce to identify trials of behavioural weight management interventions in adults aged 18 years and over that were, or could feasibly be, conducted in or recruited from primary care. Medline, Cochrane database (CENTRAL) and PsycINFO will be searched. Only randomised controlled trials (RCTs) and cluster-RCTs will be included. Two investigators will independently screen articles for eligibility and conduct risk of bias assessment. We will curate publication families for eligible trials. The PROGRESS-Plus acronym (place of residence, race/ethnicity, occupation, gender, religion, education, socioeconomic status, social capital, plus other discriminating factors) will be used to consider a comprehensive range of health inequalities. Data on trial uptake, intervention adherence, weight change and PROGRESS-Plus-related data will be extracted. Data will be synthesised narratively. We will present a Harvest plot for each PROGRESS-Plus criterion and whether each trial found a negative, positive or no health inequality gradient. We will also identify potential sources of unpublished original research data on these factors which can be synthesised through a future individual participant data meta-analysis.

Ethics And Dissemination: Ethical approval is not required as no primary data are being collected. The completed systematic review will be disseminated in a peer-reviewed journal, at conferences, and contribute to the lead author's PhD thesis. Authors of trials included in the completed systematic review may be invited to collaborate on a future individual participant data meta-analysis.

Prospero Registration Number: CRD42020173242.
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http://dx.doi.org/10.1136/bmjopen-2020-039518DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7668382PMC
November 2020

Differences in Functional Treadmill Tests in Patients With Adult Symptomatic Lumbar Scoliosis Treated Operatively and Nonoperatively.

Authors:
Leah Y Carreon Steven D Glassman Elizabeth L Yanik Michael P Kelly Jon D Lurie Keith H Bridwell

Spine (Phila Pa 1976) 2020 Nov;45(22):E1476-E1482

Departments of Medicine and Orthopaedics, Dartmouth-Hitchcock Medical Center, Lebanon.

Study Design: Prospective longitudinal cohort.

Objectives: The aim of this study was to determine whether functional treadmill testing (FTT) demonstrates differences between patients treated operatively and nonoperatively for adult symptomatic lumbar scoliosis (ASLS).

Summary Of Background Data: ASLS has become increasingly prevalent as the population ages. ASLS can be accompanied by neurogenic claudication, leading to difficulty walking. FTT may provide a functional tool to evaluate patients with ASLS.

Methods: One hundred and eighty-seven patients who underwent nonoperative (n = 88) or operative treatment (n = 99) of ASLS with complete baseline and 2-year post-treatment FTTs and concurrent patient-reported outcomes were identified. FTT parameters included maximum speed, time to onset of symptoms, distance ambulated, time ambulated, and Back and Leg pain severity before and after testing.

Results: At baseline, patients treated operatively reported worse post-FTT back pain (4.39 vs. 3.45, P = 0.032) than those treated nonoperatively, despite similar ODI, SRS-22 Pain and Activity domain scores. Mean time ambulated (+2.15 vs. -1.20 P = 0.001), pre-FTT back pain (+0.19 vs. -1.60, P < 0.000) and leg pain (+0.25 vs. -0.54, P = 0.024) improved in the operative group but deteriorated in the nonoperative group. On the 2-year follow-up FTT, both groups showed improvement in post-FTT back pain (-0.53 vs. -2.64, P < 0.000) and leg pain (-0.13 vs. -1.54, P = 0.001) severity but the improvement was statistically significantly greater in the operative compared to the nonoperative group.

Conclusion: FTT results at baseline were worse in patients treated operatively than those treated non-operatively. FTT may be a useful adjunct to assess treatment outcomes in patients with ASLS and may help surgeons counsel patients regarding expectations 2 years after operative or nonoperative treatment for ASLS. At 2-year follow-up, time ambulated deteriorated in patients treated nonoperatively but improved in patients treated operatively. Although both groups showed improvement in post-FTT Back and Leg pain at 2 years, the improvement was greater in the operative compared to the nonoperative group.

Level Of Evidence: 2.
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http://dx.doi.org/10.1097/BRS.0000000000003640DOI Listing
November 2020

Comprehensive classification system for multirod constructs across three-column osteotomies: a reliability study.

Authors:
Mostafa H El Dafrawy Owoicho Adogwa Adam M Wegner Nicholas A Pallotta Michael P Kelly Khaled M Kebaish Keith H Bridwell Munish C Gupta

J Neurosurg Spine 2020 Oct 9:1-7. Epub 2020 Oct 9.

5Department of Orthopedic Surgery, Washington University School of Medicine in St. Louis, Missouri; and.

Objective: In this study, the authors' goal was to determine the intra- and interobserver reliability of a new classification system that allows the description of all possible constructs used across three-column osteotomies (3COs) in terms of rod configuration and density.

Methods: Thirty-five patients with multirod constructs (MRCs) across a 3CO were classified by two spinal surgery fellows according to the new system, and then were reclassified 2 weeks later. Constructs were classified as follows: the number of rods across the osteotomy site followed by a letter corresponding to the type of rod configuration: "M" is for a main rod configuration, defined as a single rod spanning the osteotomy. "L" is for linked rod configurations, defined as 2 rods directly connected to each other at the osteotomy site. "S" is for satellite rod configurations, which were defined as a short rod independent of the main rod with anchors above and below the 3CO. "A" is for accessory rods, defined as an additional rod across the 3CO attached to main rods but not attached to any anchors across the osteotomy site. "I" is for intercalary rod configurations, defined as a rod connecting 2 separate constructs across the 3CO, without the intercalary rod itself attached to any anchors across the osteotomy site. The intra- and interobserver reliability of this classification system was determined.

Results: A sample estimation for validation assuming two readers and 35 subjects results in a two-sided 95% confidence interval with a width of 0.19 and a kappa value of 0.8 (SD 0.3). The Fleiss kappa coefficient (κ) was used to calculate the degree of agreement between interrater and intraobserver reliability. The interrater kappa coefficient was 0.3, and the intrarater kappa coefficient was 0.63 (good reliability). This scenario represents a high degree of agreement despite a low kappa coefficient. Correct observations by both observers were 34 of 35 and 33 of 35 at both time points. Misclassification was related to difficulty in determining connectors versus anchors.

Conclusions: MRCs across 3COs have variable rod configurations. Currently, no classification system or agreement on nomenclature exists to define the configuration of rods across 3COs. The authors present a new, comprehensive MRC classification system with good inter- and intraobserver reliability and a high degree of agreement that allows for a standardized description of MRCs across 3COs.
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http://dx.doi.org/10.3171/2020.6.SPINE20678DOI Listing
October 2020

Clinicopathologic correlation of aniridia: Optical coherence tomography angiography and histopathologic observations.

Authors:
Anthony Therattil Andrea Naranjo S Tammy Hsu Michael P Kelly Sharon F Freedman Sander R Dubovy Lejla Vajzovic

Am J Ophthalmol Case Rep 2020 Dec 11;20:100919. Epub 2020 Sep 11.

Department of Ophthalmology, Duke University, Durham, NC, USA.

Purpose: To describe optical coherence tomography angiography (OCTA) findings in a patient with aniridia and correlate with representative histopathology.

Observations: OCTA images of the macula of a pediatric aniridic patient, who has nystagmus and impaired vision bilaterally, demonstrate a complete absence of the foveal avascular zone (FAZ) in both the superficial and deep vascular complexes (SVC and DVC). In addition, larger superficial blood vessels were found to be abnormally diving from the SVC into the DVC. Similarly, immunofluorescence with confocal microscopy imaging of a retinal histopathology specimen from a 2 month old aniridic patient demonstrated larger vessels diving in the same manner.

Conclusions And Importance: This study highlights the clinical, imaging and histopathologic findings of aniridia. Supine OCTA imaging, performed during examination under anesthesia, allowed for visualization of retinal microvasculature in eyes with nystagmus. The histopathology images helped validate OCTA findings that, with further investigation, may lead to new information about the development of abnormal retinal microvasculature.
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http://dx.doi.org/10.1016/j.ajoc.2020.100919DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7522690PMC
December 2020

Is It Justifiable to Make Self-Determination Illusory to Motivate a Specific Health Outcome?

Authors:
Michael P Kelly

AMA J Ethics 2020 09 1;22(9):E767-772. Epub 2020 Sep 1.

Visiting fellow at the Institute of Public Health at the University of Cambridge in Cambridge, United Kingdom.

A is an intervention designed to prompt people to "voluntarily" make the choice intended by those who altered the choice environment or situation, and therefore using nudges is thought to undermine self-determination. Evidence for this assumption is weak, however, and sets aside much of what we know about human conduct sociologically. This paper argues that the practical consciousness that people have about their own actions and reasons for executing those actions can inform our thinking about motivating compliance with treatments in clinical settings and the ethical issues involved.
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http://dx.doi.org/10.1001/amajethics.2020.767DOI Listing
September 2020

Development of an Intervention Setting Ontology for behaviour change: Specifying where interventions take place.

Authors:
Emma Norris Marta M Marques Ailbhe N Finnerty Alison J Wright Robert West Janna Hastings Poppy Williams Rachel N Carey Michael P Kelly Marie Johnston Susan Michie

Wellcome Open Res 2020 10;5:124. Epub 2020 Jun 10.

Centre for Behaviour Change, University College London, London, UK.

: Contextual factors such as an intervention's setting are key to understanding how interventions to change behaviour have their effects and patterns of generalisation across contexts. The intervention's setting is not consistently reported in published reports of evaluations. Using ontologies to specify and classify intervention setting characteristics enables clear and reproducible reporting, thus aiding replication, implementation and evidence synthesis. This paper reports the development of a Setting Ontology for behaviour change interventions as part of a Behaviour Change Intervention Ontology, currently being developed in the Wellcome Trust funded Human Behaviour-Change Project. : The Intervention Setting Ontology was developed following methods for ontology development used in the Human Behaviour-Change Project: 1) Defining the ontology's scope, 2) Identifying key entities by reviewing existing classification systems (top-down) and 100 published behaviour change intervention reports (bottom-up), 3) Refining the preliminary ontology by literature annotation of 100 reports, 4) Stakeholder reviewing by 23 behavioural science and public health experts to refine the ontology, 5) Assessing inter-rater reliability of using the ontology by two annotators familiar with the ontology and two annotators unfamiliar with it, 6) Specifying ontological relationships between setting entities and 7) Making the Intervention Setting Ontology machine-readable using Web Ontology Language (OWL) and publishing online. The Intervention Setting Ontology consists of 72 entities structured hierarchically with two upper-level classes: including , (including , ) and (including and sub-levels), as well as . Inter-rater reliability was found to be 0.73 (good) for those familiar with the ontology and 0.61 (acceptable) for those unfamiliar with it. The Intervention Setting Ontology can be used to code information from diverse sources, annotate the setting characteristics of existing intervention evaluation reports and guide future reporting.
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http://dx.doi.org/10.12688/wellcomeopenres.15904.1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7489274PMC
June 2020

Do Combinations of Behavior Change Techniques That Occur Frequently in Interventions Reflect Underlying Theory?

Authors:
Lauren Connell Bohlen Susan Michie Marijn de Bruin Alexander J Rothman Michael P Kelly Hilary N K Groarke Rachel N Carey Joanna Hale Marie Johnston

Ann Behav Med 2020 11;54(11):827-842

Aberdeen Health Psychology Group, Institute of Applied Health Sciences, College of Life Sciences and Medicine, University of Aberdeen, Aberdeen, UK.

Background: Behavioral interventions typically include multiple behavior change techniques (BCTs). The theory informing the selection of BCTs for an intervention may be stated explicitly or remain unreported, thus impeding the identification of links between theory and behavior change outcomes.

Purpose: This study aimed to identify groups of BCTs commonly occurring together in behavior change interventions and examine whether behavior change theories underlying these groups could be identified.

Methods: The study involved three phases: (a) a factor analysis to identify groups of co-occurring BCTs from 277 behavior change intervention reports; (b) examining expert consensus (n = 25) about links between BCT groups and behavioral theories; (c) a comparison of the expert-linked theories with theories explicitly mentioned by authors of the 277 intervention reports.

Results: Five groups of co-occurring BCTs (range: 3-13 BCTs per group) were identified through factor analysis. Experts agreed on five links (≥80% of experts), comprising three BCT groups and five behavior change theories. Four of the five BCT group-theory links agreed by experts were also stated by study authors in intervention reports using similar groups of BCTs.

Conclusions: It is possible to identify groups of BCTs frequently used together in interventions. Experts made shared inferences about behavior change theory underlying these BCT groups, suggesting that it may be possible to propose a theoretical basis for interventions where authors do not explicitly put forward a theory. These results advance our understanding of theory use in multicomponent interventions and build the evidence base for further understanding theory-based intervention development and evaluation.
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http://dx.doi.org/10.1093/abm/kaaa078DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7646153PMC
November 2020

Metabolomics, physical activity, exercise and health: A review of the current evidence.

Authors:
Rachel S Kelly Michael P Kelly Paul Kelly

Biochim Biophys Acta Mol Basis Dis 2020 12 19;1866(12):165936. Epub 2020 Aug 19.

Physical Activity for Health Research Center (PAHRC), University of Edinburgh, St Leonard's Land, Edinburgh EH8 8AQ, UK. Electronic address:

Physical activity (PA) and exercise are among the most important determinants of health. However, PA is a complex and heterogeneous behavior and the biological mechanisms through which it impacts individuals and populations in different ways are not well understood. Genetics and environment likely play pivotal roles but further work is needed to understand their relative contributions and how they may be mediated. Metabolomics offers a promising approach to explore these relationships. In this review, we provide a comprehensive appraisal of the PA-metabolomics literature to date. This overwhelmingly supports the hypothesis of a metabolomic response to PA, which can differ between groups and individuals. It also suggests a biological gradient in this response based on PA intensity, with some evidence for global longer-term changes in the metabolome of highly active individuals. However, many questions remain and we conclude by highlighting future critical research avenues to help elucidate the role of PA in the maintenance of health and the development of disease.
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http://dx.doi.org/10.1016/j.bbadis.2020.165936DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7680392PMC
December 2020

Selecting the "Touched Vertebra" as the Lowest Instrumented Vertebra in Patients with Lenke Type-1 and 2 Curves: Radiographic Results After a Minimum 5-Year Follow-up.

Authors:
Eduardo C Beauchamp Lawrence G Lenke Meghan Cerpa Peter O Newton Michael P Kelly Kathy M Blanke

J Bone Joint Surg Am 2020 Nov;102(22):1966-1973

Department of Orthopedic Surgery, The Daniel and Jane Och Spine Hospital, Columbia University, New York, NY.

Background: The selection of the lowest instrumented vertebra (LIV) in patients with adolescent idiopathic scoliosis (AIS) is still controversial. Although multiple radiographic methods have been proposed, there is no universally accepted guideline for appropriate selection of the LIV. We developed a simple and reproducible method for selection of the LIV in patients with Lenke type-1 (main thoracic) and 2 (double thoracic) curves and investigated its effectiveness in producing optimal positioning of the LIV at 5 years of follow-up.

Methods: The radiographs for 299 patients with Lenke type-1 or 2 AIS curves that were included in a multicenter database were evaluated after a minimum duration of follow-up of 5 years. The "touched vertebra" (TV) was selected on preoperative radiographs by 2 independent examiners. The LIV on postoperative radiographs was compared with the preoperative TV. The final LIV position in relation to the center sacral vertical line (CSVL) was assessed. The CSVL-LIV distance and coronal balance in patients who had fusion to the TV were compared with those in patients who had fusion cephalad and caudad to the TV. The sagittal plane was also reviewed.

Results: In 86.6% of patients, the LIV was selected at or immediately adjacent to the TV. Among patients with an "A" lumbar modifier, those who had fusion cephalad to the TV had a significantly greater CSVL-LIV distance than those who had fusion to the TV (p = 0.006) or caudad to the TV (p = 0.002). In the groups with "B" (p = 0.424) and "C" (p = 0.326) lumbar modifiers, there were no differences among the TV groups.

Conclusions: We recommend the TV rule as a third modifier in the Lenke AIS classification system. Selecting the TV as the LIV in patients with Lenke type-1 and 2 curves provides acceptable positioning of the LIV at long-term follow-up. The position of the LIV was not different when fusion was performed caudad to the TV but came at the expense of fewer motion segments. Patients with lumbar modifier "A" who had fusion cephalad to the TV had greater translation of the LIV, putting these patients at risk for poor long-term outcomes.

Level Of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
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http://dx.doi.org/10.2106/JBJS.19.01485DOI Listing
November 2020

Development of an online tool for linking behavior change techniques and mechanisms of action based on triangulation of findings from literature synthesis and expert consensus).

Authors:
Marie Johnston Rachel N Carey Lauren E Connell Bohlen Derek W Johnston Alexander J Rothman Marijn de Bruin Michael P Kelly Hilary Groarke Susan Michie

Transl Behav Med 2020 Aug 4. Epub 2020 Aug 4.

Department of Clinical, Educational and Health Psychology, University College London, London, UK.

Researchers, practitioners, and policymakers develop interventions to change behavior based on their understanding of how behavior change techniques (BCTs) impact the determinants of behavior. A transparent, systematic, and accessible method of linking BCTs with the processes through which they change behavior (i.e., their mechanisms of action [MoAs]) would advance the understanding of intervention effects and improve theory and intervention development. The purpose of this study is to triangulate evidence for hypothesized BCT-MoA links obtained in two previous studies and present the results in an interactive, online tool. Two previous studies generated evidence on links between 56 BCTs and 26 MoAs based on their frequency in literature synthesis and on expert consensus. Concordance between the findings of the two studies was examined using multilevel modeling. Uncertainties and differences between the two studies were reconciled by 16 behavior change experts using consensus development methods. The resulting evidence was used to generate an online tool. The two studies showed concordance for 25 of the 26 MoAs and agreement for 37 links and for 460 "nonlinks." A further 55 links were resolved by consensus (total of 92 [37 + 55] hypothesized BCT-MoA links). Full data on 1,456 possible links was incorporated into the online interactive Theory and Technique Tool (https://theoryandtechniquetool.humanbehaviourchange.org/). This triangulation of two distinct sources of evidence provides guidance on how BCTs may affect the mechanisms that change behavior and is available as a resource for behavior change intervention designers, researchers and theorists, supporting intervention design, research synthesis, and collaborative research.
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http://dx.doi.org/10.1093/tbm/ibaa050DOI Listing
August 2020

A new modular radiographic classification of adult idiopathic scoliosis as an extension of the Lenke classification of adolescent idiopathic scoliosis.

Authors:
James D Lin Joseph A Osorio Griffin R Baum Richard P Menger Patrick C Reid Marc D Dyrszka Louis F Amorosa Zeeshan M Sardar Christopher E Mandigo Peter D Angevine Michael P Kelly Meghan Cerpa Lawrence G Lenke

Spine Deform 2021 Jan 3;9(1):175-183. Epub 2020 Aug 3.

Department of Orthopedic Surgery, Columbia University Medical Center, New York, NY, USA.

Purpose: To propose and test the reliability of a radiographic classification system for adult idiopathic scoliosis.

Methods: A three-component radiographic classification for adult idiopathic scoliosis consisting of curve type, a lumbosacral modifier, and a global alignment modifier is presented. Twelve spine surgeons graded 30 pre-marked cases twice, approximately 1 week apart. Case order was randomized between sessions.

Results: The interrater reliability (Fleiss' kappa coefficient) for curve type was 0.660 and 0.798, for the lumbosacral modifier 0.944 and 0.965, and for the global alignment modifier 0.922 and 0.916, for round 1 and 2 respectively. Mean intrarater reliability was 0.807.

Conclusions: This new radiographic classification of adult idiopathic scoliosis maintains the curve types from the Lenke classification and introduces the lumbosacral and global alignment modifiers. The reliability of the lumbosacral modifier and global alignment modifier shows near perfect agreement, and sets the foundation for further studies to validate the reliability, utility, and applicability of this classification system.
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http://dx.doi.org/10.1007/s43390-020-00181-7DOI Listing
January 2021

Rod fractures and nonunions after long fusion to the sacrum for primary presentation adult spinal deformity: a comparison with and without interbody fusion in the distal lumbar spine.

Authors:
Mostafa El Dafrawy Keith Bridwell Owoicho Adogwa Max Shlykov Jonathan Koscso Lawrence G Lenke Thamrong Lertudomphonwanit Michael P Kelly Munish Gupta

Spine Deform 2021 Jan 28;9(1):231-237. Epub 2020 Jul 28.

Department of Orthopaedic Surgery, Washington University School of Medicine, St. Louis, MO, USA.

Study Design: Retrospective cohort study.

Objectives: To investigate the prevalence and incidence rate of rod fractures (RF) in patients undergoing surgery for correction of adult spinal deformity (ASD) with or without the use of interbody fusions in the caudal levels of the fusion construct.

Background: Data: Pseudarthrosis and rod fracture after long spinal fusion to the sacrum for correction of ASD remain a concern.

Methods: We reviewed clinical records of patients who underwent surgery for correction of ASD between 2004 and 2014. All cases were primary (no prior spine fusion) surgeries with long fusion to the sacrum and bilateral spinopelvic fixation. Patients were dichotomized into one of two groups based on whether an interbody fusion was performed at the caudal levels of the fusion construct. The primary outcome of interest was the prevalence and incidence rate of RFs.

Results: A total of 230 patients underwent a long segment fusion for correction of ASD with mean follow-up of 55 months. 117 patients had an interbody fusion (IF) while 113 patients did not (NIF). At last follow-up, there was no significant difference in the prevalence of RFs between the cohort of patients IF vs NIF (IF cohort: n = 20, 17.9% vs NIF cohort: n = 15, 14.2%, p = 0.49). However, the incidence rate for bilateral rod fractures was 1.6%/year for IF group vs 1.0%/year for NIF group (p = 0.02). Location of RF was different between the two groups; RF (unilateral and bilateral) above L4 was the most common location in the IF group (n = 17/20; 85%) compared to L4-S1 in the NIF group (n = 11/15; 73%) (p = 0.02).

Conclusion: Interbody fusion does not fully protect against rod failure in the lumbar spine in ASD patients with long posterior spinal fusion and may encourage failure at L2-L4, the levels above the interbody fusion.

Level Of Evidence: III.
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http://dx.doi.org/10.1007/s43390-020-00174-6DOI Listing
January 2021

The use of mechanistic reasoning in assessing coronavirus interventions.

Authors:
Jeffrey K Aronson Daniel Auker-Howlett Virginia Ghiara Michael P Kelly Jon Williamson

J Eval Clin Pract 2020 Jul 15. Epub 2020 Jul 15.

Department of Philosophy and Centre for Reasoning, School of European Culture and Languages, University of Kent, Canterbury, UK.

Rationale: Evidence-based medicine (EBM), the dominant approach to assessing the effectiveness of clinical and public health interventions, focuses on the results of association studies. EBM+ is a development of EBM that systematically considers mechanistic studies alongside association studies.

Aims And Objectives: To explore examples of the importance of mechanistic evidence to coronavirus research.

Methods: We have reviewed the mechanistic evidence in four major areas that are relevant to the management of COVID-19.

Results And Conclusions: (a) Assessment of combination therapy for MERS highlights the need for systematic assessment of mechanistic evidence. (b) That hypertension is a risk factor for severe disease in the case of SARS-CoV-2 suggests that altering hypertension treatment might alleviate disease, but the mechanisms are complex, and it is essential to consider and evaluate multiple mechanistic hypotheses. (c) Confidence that public health interventions will be effective requires a detailed assessment of social and psychological components of the mechanisms of their action, in addition to mechanisms of disease. (d) In particular, if vaccination programmes are to be effective, they must be carefully tailored to the social context; again, mechanistic evidence is crucial. We conclude that coronavirus research is best situated within the EBM+ evaluation framework.
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http://dx.doi.org/10.1111/jep.13438DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7405225PMC
July 2020