SPINE20 recommendations 2022: spine care-working together to recover stronger.

PURPOSE: Globally, spine disorders are the leading cause of disability, affecting more than half a billion individuals. However, less than 50% of G20 countries specifically identify spine health within their public policy priorities. Therefore, it is crucial to raise awareness among policy makers of the disabling effect of spine disorders and their impact on the economic welfare of G20 nations. In 2019, SPINE20 was established as the leading advocacy group to bring global attention to spine disorders. METHODS: Recommendations were developed through two Delphi methods with international and multi-professional panels. RESULTS: In 2022, seven recommendations were delivered to the leaders of G20 countries, urging them to: Develop action plans to provide universal access to evidence-based spine care that incorporates the needs of minorities and vulnerable populations. Invest in the development of sustainable human resource capacity, through multisectoral and inter-professional competency-based education and training to promote evidence-based approaches to spine care, and to build an appropriate healthcare working environment that optimizes the delivery of safe health services. Develop policies using the best available evidence to properly manage spine disorders and to prolong functional healthy life expectancy in the era of an aging population. Create a competent workforce and improve the healthcare infrastructure/facilities including equipment to provide evidence-based inter-professional rehabilitation services to patients with spinal cord injury throughout their continuum of care. Build collaborative and innovative translational research capacity within national, regional, and global healthcare systems for state-of-the-art and cost-effective spine care across the healthcare continuum ensuring equality, diversity, and inclusion of all stakeholders. Develop international consensus statements on patient outcomes and how they can be used to define and develop pathways for value-based care. Recognize that intervening on determinants of health including physical activity, nutrition, physical and psychosocial workplace environment, and smoking-free lifestyle can reduce the burden of spine disabilities and improve the health status and wellness of the population. At the third SPINE20 summit 2022 which took place in Bali, Indonesia, in August 2022, 17 associations endorsed its recommendations. CONCLUSION: SPINE20 advocacy efforts focus on developing public policy recommendations to improve the health, welfare, and wellness of all who suffer from spinal pain and disability. We propose that focusing on facilitating access to systems that prioritize value-based care delivered by a competent healthcare workforce will reduce disability and improve the productivity of the G20 nations.

OPerative versus non-opERAtive management of isolated ULNAr diaphyseal fractures (OPERA-Ulna): protocol for a randomized controlled trial.

Aims: Isolated fractures of the ulnar diaphysis are uncommon, occurring at a rate of 0.02 to 0.04 per 1,000 cases. Despite their infrequency, these fractures commonly give rise to complications, such as nonunion, limited forearm pronation and supination, restricted elbow range of motion, radioulnar synostosis, and prolonged pain. Treatment options for this injury remain a topic of debate, with limited research available and no consensus on the optimal approach. Therefore, this trial aims to compare clinical, radiological, and functional outcomes of two treatment methods: open reduction and internal fixation (ORIF) versus nonoperative treatment in patients with isolated ulnar diaphyseal fractures. Methods: This will be a multicentre, open-label, parallel randomized clinical trial (under National Clinical Trial number NCT01123447), accompanied by a parallel prospective cohort group for patients who meet the inclusion criteria, but decline randomization. Eligible patients will be randomized to one of the two treatment groups: 1) nonoperative treatment with closed reduction and below-elbow casting; or 2) surgical treatment with ORIF utilizing a limited contact dynamic compression plate and screw construct. The primary outcome measured will be the Disabilities of the Arm, Shoulder and Hand questionnaire score at 12 months post-injury. Additionally, functional outcomes will be assessed using the 36-Item Short Form Health Survey and pain visual analogue scale, allowing for a comparison of outcomes between groups. Secondary outcome measures will encompass clinical outcomes such as range of motion and grip strength, radiological parameters including time to union, as well as economic outcomes assessed from enrolment to 12 months post-injury. Ethics and dissemination: This trial has been approved by the lead site Conjoint Health Research Ethics Board (CHREB; REB14-2004) and local ethics boards at each participating site. Findings from the trial will be disseminated through presentations at regional, national, and international scientific conferences and public forums. The primary results and secondary findings will be submitted for peer-reviewed publication.

How to use an article about therapy.

PURPOSE: Most surgical interventions have inherent benefits and associated risks. Before implementing a new therapy we should ascertain the benefits and risks of the therapy and assure ourselves that the resources consumed in the intervention will not be exorbitant. MATERIALS AND METHODS: We suggest a 3-step approach to using an article from the urological literature to guide patient care. We recommend asking whether the study can provide valid results, reviewing the results and considering how the results can be applied to patient care. RESULTS: Key methodological characteristics that have an impact on the validity of a surgical trial include randomization, allocation concealment, stratification, blinding, completeness of followup and intent to treat analysis. To the extent that the quality is poor inferences from this study are weakened. However, if its quality is acceptable, one must determine the range within which the true treatment effect lies (95% CI). One must then consider whether this result can be generalized to a patient and whether the investigators have provided information about all clinically important outcomes. It is then necessary to compare the relative benefits of the intervention with its risks. If one perceives that the benefits outweigh the risks, the intervention may be of use to the patient. CONCLUSIONS: Given the time constraints of busy urological practices and training programs, applying this analysis to every relevant article would be challenging. However, the basics of this process are essentially what we all do hundreds of times each week when treating patients. Making this process explicit with guidelines to assess the strength of the available evidence will serve to improve patient care. It will also allow us to defend therapeutic interventions based on available evidence and not on anecdote.

The need for national medical licensing examination in Saudi Arabia.

BACKGROUND: Medical education in Saudi Arabia is facing multiple challenges, including the rapid increase in the number of medical schools over a short period of time, the influx of foreign medical graduates to work in Saudi Arabia, the award of scholarships to hundreds of students to study medicine in various countries, and the absence of published national guidelines for minimal acceptable competencies of a medical graduate. DISCUSSION: We are arguing for the need for a Saudi national medical licensing examination that consists of two parts: Part I (Written) which tests the basic science and clinical knowledge and Part II (Objective Structured Clinical Examination) which tests the clinical skills and attitudes. We propose this examination to be mandated as a licensure requirement for practicing medicine in Saudi Arabia. CONCLUSION: The driving and hindering forces as well as the strengths and weaknesses of implementing the licensing examination are discussed in details in this debate.

What every urologist should know about surgical trials Part I: Are the results valid?

UNLABELLED: Surgical interventions have inherent benefits and associated risks. Before implementing a new therapy, we should ascertain the benefits and risks of the therapy, and assure ourselves that the resources consumed in the intervention will not be exorbitant. MATERIALS AND METHODS: We suggest a three-step approach to the critical appraisal of a clinical research study that addresses a question of therapy. Readers should ask themselves the following three questions: Are the study results valid? What are the results? And can I apply them to the care of an individual patient? This first review article on surgical trials will address the question as to whether we consider a study valid or not. RESULTS: Once the reader has found an article of interest on a urological intervention, it is necessary to assess the quality of the evidence. According to the hierarchy of evidence, a randomized controlled trial is the study design which is the most likely to provide an unbiased estimate of the truth. Important methodological criteria which characterize a high-quality randomized trial include description of allocation concealment, blinding, intention-to-treat analysis, and completeness of follow-up. Failure of investigators to apply these principles may raise concerns about the validity of the study results, thereby making its finding irrelevant. CONCLUSION: Assessing the validity of a given study is a critical first step when evaluating a clinical research study. Making this process explicit with guidelines to assess the strength of the available evidence serves to improve patient care. It will also allow urologists to defend therapeutic interventions, based on available evidence and not anecdotes.

What every urologist should know about surgical trials Part II: What are the results and should I apply them to patient care?

UNLABELLED: Surgical interventions have inherent benefits and associated risks. Before implementing a new therapy, we should ascertain the benefits and risks of the therapy, and assure ourselves that the resources consumed in the intervention will not be exorbitant. MATERIALS AND METHODS: We suggest a three-step approach to the critical appraisal of a clinical research study that addresses a question of therapy. Readers should ask themselves the three following questions: Are the study results valid, what are the results and can I apply them to the care of an individual patient. This second review article on surgical trials will address the questions of how to interpret the results and whether to apply them to patient care. RESULTS: Once a study has been determined to be valid, one should determine how effective an intervention is using either relative (i.e. risk ratio, relative risk reduction) or absolute measures (i.e. absolute risk reduction, number-needed to treat) of effect size. The reader should then determine the range within which the true treatment effect lies (95% confidence intervals). Having found the results to be of a magnitude that is clinically relevant, one must then consider if the result can be generalized to one's own patient, and whether the investigators have provided information about all clinically important outcomes. Then, it is necessary to compare the relative benefits of the intervention with its risks. If one perceives the benefits to outweigh the risks, then the intervention may be of use to one's patient. CONCLUSION: Given the time constraints of a busy urological practice, applying this three-tiered approach to every article will be challenging. However, knowledge of the critical steps to assess the validity, impact and applicability of study results can provide important guidance to clinical decision-making and ultimately result in a more evidence-based practice of urology.

Driving Safety after Spinal Surgery: A Systematic Review.

This study aimed to assess driving reaction times (DRTs) after spinal surgery to establish a timeframe for safe resumption of driving by the patient postoperatively. The MEDLINE and Google Scholar databases were analyzed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) Statement for clinical studies that investigated changes in DRTs following cervical and lumbar spinal surgery. Changes in DRTs and patients' clinical presentation, pathology, anatomical level affected, number of spinal levels involved, type of intervention, pain level, and driving skills were assessed. The literature search identified 12 studies that investigated postoperative DRTs. Six studies met the inclusion criteria; five studies assessed changes in DRT after lumbar spine surgery and two studies after cervical spina surgery. The spinal procedures were selective nerve root block, anterior cervical discectomy and fusion, and lumbar fusion and/ordecompression. DRTs exhibited variable responses to spinal surgery and depended on the patients' clinical presentation, spinal level involved, and type of procedure performed. The evidence regarding the patients' ability to resume safe driving after spinal surgery is scarce. Normalization of DRT or a return of DRT to pre-spinal intervention level is a widely accepted indicator for safe driving, with variable levels of statistical significance owing to multiple confounding factors. Considerations of the type of spinal intervention, pain level, opioid consumption, and cognitive function should be factored in the assessment of a patient's ability to safely resume driving.

Effect of bisphosphonates on periprosthetic bone mineral density after total joint arthroplasty. A meta-analysis.

BACKGROUND: Periprosthetic bone loss following total joint arthroplasty may threaten the survival of the implant. Bisphosphonates are effective in reducing bone loss in conditions associated with accelerated bone turnover. To determine the current understanding of the effect of bisphosphonates on periprosthetic bone mineral density after total joint arthroplasty, we conducted computerized searches for randomized controlled trials evaluating the use of bisphosphonates in patients treated with primary total joint arthroplasty. METHODS: We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, the web site of the United Kingdom National Research Register, and the archives of the American Academy of Orthopaedic Surgeons annual meetings (1989 through 2003), and we conducted hand searches of the bibliographies of relevant articles. We assessed methodological quality and abstracted relevant data. When necessary, we contacted authors to provide additional information. RESULTS: Of 386 citations that were initially identified, six (five complete papers and one abstract), which included a total of 290 patients, met our inclusion criteria. Those papers showed that significantly less periprosthetic bone loss had occurred in the bisphosphonate-treated patients than in the control patients at three months (152 patients; weighted mean difference, 3.3%; 95% confidence interval, 1.9% to 4.7%; p < 0.01), six months (248 patients; weighted mean difference, 4.5%; 95% confidence interval, 1.6% to 7.4%; p < 0.001), and twelve months (197 patients; weighted mean difference, 4.2%; 95% confidence interval, 1.5% to 6.9%; p = 0.03). Bisphosphonates appeared to have a larger effect on bone loss following arthroplasties with cement than on bone loss following arthroplasties without cement (difference, 0.1%, 5%, and 5.4% at three, six, and twelve months; significant difference [p < 0.001] at one year only) and a larger effect on bone loss following total knee arthroplasties than on bone loss following total hip arthroplasties (difference, 4.1%, 11.5%, and 7.1% at three, six, and twelve months; significant difference [p < 0.001] at six months only). None of the studies related the effects of bisphosphonates on bone mineral density to clinically relevant outcomes. CONCLUSIONS: A meta-analysis of six randomized controlled trials suggested that bisphosphonates have a beneficial effect with regard to maintaining more periprosthetic bone mineral density than that in controls. However, the limitations of the available studies and the lack of analyses of clinically relevant outcomes (functional outcomes, revision rates, and quality of life) necessitate the planning and conduct of a sufficiently sized, methodologically sound study with clinically relevant end points. Until this has been done, the current evidence regarding the beneficial effects of bisphosphonates on periprosthetic bone after total joint arthroplasty should be interpreted with caution.

Displaced intra-articular calcaneal fractures.

BACKGROUND: Calcaneal fractures comprise 1 to 2 percent of all fractures. Approximately 75% of calcaneal fractures are intra-articular. The management of intra-articular calcaneal fractures remains controversial. Nonoperative treatment options include elevation, ice, early mobilization, and cyclic compression of the plantar arch. Operative treatment options include closed reduction and percutaneous pin fixation, open reduction and internal fixation, and arthrodesis. The effect of operative versus nonoperative treatment has been the focus of several comparative studies. OBJECTIVE: This study was designed to determine the effect of operative treatment compared with nonoperative treatment on the rate of union, complications, and functional outcome after intra-articular calcaneal fracture in adults.

Perceptions of authors' contributions are influenced by both byline order and designation of corresponding author.

OBJECTIVES: We explored how readers interpret authors' roles based on authorship order and corresponding author. STUDY DESIGN AND SETTING: We conducted a cross-sectional survey of all 291 Surgical and Medical Chairpersons across North America. We developed hypothetical study and authorship bylines with five authors varying the corresponding author as first or last author. Respondents reported their perceptions about the authors' roles in the study and the most prestigious authorship position. We used multinomial regression to explore the results. RESULTS: One hundred sixty-five chairpersons (response rate: 57%) completed our survey. When the first author was designated as corresponding author, most of the respondents assumed that this author had taken the lead in study design (55.3%) and analysis and interpretation of data (51.2%). When the last author (fifth) was designated as corresponding, perceptions of the first author's role in study concept and design (odds ratio [OR] = 0.25, 95% confidence interval [CI]: 0.15, 0.41) and analysis and interpretation of results (OR = 0.22, 95% CI: 0.13, 0.38) decreased significantly. Overall prestige of the last author position increased significantly when designated as corresponding author (OR = 4.0, 95% CI: 2.4, 6.4). CONCLUSIONS: Academic department chairs' perception of authors' contributions was influenced by corresponding author designation. Without authors' explicit contributions in research articles, many readers may draw false conclusions about author credit and accountability.

The development of a decision aid to elicit treatment preferences for displaced femoral neck fractures.

BACKGROUND: Decision aids help physicians convey information to patients and enable patients to be involved in the decision-making process. There is a lack of use of decision aids in the orthopedic literature. The purpose of this study was to develop a decision board to elicit preferences for treatment of displaced femoral neck fractures in patients over 60 years old. MATERIALS AND METHODS: We developed a decision board presenting descriptions and potential outcomes and complications of two treatment options, hemiarthroplasty (HA) and internal fixation (IF), for displaced femoral neck fractures. Five orthopedic surgeons evaluated the face and content validity of the decision board and 10 volunteers completed "scope tests" to determine the comprehensibility. We then presented the decision board to 108 study participants faced with the scenario of sustaining a displaced femoral neck fracture. Participants stated their preference for operative procedure and described the reasons for their choices. RESULTS: The decision board achieved good face and content validity. All participants in the scope tests appropriately switched their preference to the other modality when probabilities were altered. Most participants found the decision board easy to understand and helpful in making an informed decision. Also, most participants were satisfied with the amount of information presented and with the use of the decision board as a decision making tool. Sixty-one participants (56%) chose IF as their operative procedure of choice quoting less blood loss, shorter operative time, and less invasiveness as the top factors that contributed to this choice. Participants who preferred HA (44%) did so primarily due to the lower re-operation rate. CONCLUSIONS: The decision board is a useful and reliable tool to inform patients about the treatment options for displaced femoral neck fractures. They should be utilized by surgeons to incorporate patients' preferences into the decision-making process.

Clinical predictors of recovery after blunt spinal cord trauma: systematic review.

Several clinical, imaging, and therapeutic factors affecting recovery following spinal cord injury (SCI) have been described. A systematic review of the topic is still lacking. Our primary aim was to systematically review clinical factors that may predict neurological and functional recovery following blunt traumatic SCI in adults. Such work would help guide clinical care and direct future research. Both Medline and Embase (to April 2008) were searched using index terms for various forms of SCI, paraplegia, or quadri/tetraplegia, and functional and neurological recovery. The search was limited to published articles that were in English and included human subjects. Article selection included class I and II evidence, blunt traumatic SCI, injury level above L1-2, baseline assessment within 72 h of injury, use of American Spinal Injury Association (ASIA) scoring system for clinical assessment, and functional and neurological outcome. A total of 1526 and 1912 citations were located from Medline and Embase, respectively. Two surgeons reviewed the titles, abstracts, and full text articles for each database. Ten articles were identified, only one of which was level 1 evidence. Age and gender were identified as two patient-related predictors. While motor and functional recovery decreased with advancing age for complete SCI, there was no correlation considering incomplete ones. Therefore, treatment should not be restructured based on age in incomplete SCI. Among injury-related predictors, severity of SCI was the most significant. Complete injuries correlated with increased mortality and worse neurological and functional outcomes. Other predictors included SCI level, energy transmitted by the injury, and baseline electrophysiological testing.

Treatment of displaced femoral neck fractures in the elderly: a cost-benefit analysis.

BACKGROUND: The optimal treatment for displaced femoral neck fractures in elderly patients is controversial. Compared with hemiarthroplasty (HA), internal fixation (IF) is associated with less operative trauma, bleeding, and possibly lower mortality at the expense of a higher reoperation rate and possibly increased cost. METHODS: We estimated the costs from a third party payer perspective after 1 year of 2 strategies (HA and IF) for the treatment of femoral neck fractures in patients over the age of 60 years. Using a decision board, we elicited patient preferences for the 2 operative approaches and calculated the net benefit using the willingness-to-pay technique. RESULTS: The 1-year projected cost of 1 IF was $18,100, and that of 1 HA was $15,843 (incremental cost of $2257 for each IF). Of 108 participants, 61 (56.5%) chose IF as the preferred treatment option and were willing to pay an average of $3.33 per month to have this option available if needed. In Ontario, the total incremental cost of performing IF in patients that choose it was $64,714,103, and the total societal benefit was $289,263,600, yielding a net benefit of $224,549,497. CONCLUSION: The benefits of IF over HA outweigh the incremental costs from the perspective of a third-party payer. IF should be available to patients that choose it.

The use of calcium phosphate bone cement in fracture treatment. A meta-analysis of randomized trials.

BACKGROUND: Available options to fill fracture voids include autogenous bone, allograft bone, and synthetic bone materials. The objective of this meta-analysis was to determine whether the use of calcium phosphate bone cement improves clinical and radiographic outcomes and reduces fracture complications as compared with conventional treatment (with or without autogenous bone graft) for the treatment of fractures of the appendicular skeleton in adult patients. METHODS: Multiple databases, online registers of randomized controlled trials, and the proceedings of the meetings of major national orthopaedic associations were searched. Published and unpublished randomized controlled trials were included, and data on methodological quality, population, intervention, and outcomes were abstracted in duplicate. Data were pooled across studies, and relative risks for categorical outcomes and weighted mean differences for continuous outcomes, weighted according to study sample size, were calculated. Heterogeneity across studies was determined, and sensitivity analyses were conducted. RESULTS: We identified eleven published and three unpublished randomized controlled trials. Of the fourteen studies, six involved distal radial fractures, two involved femoral neck fractures, two involved intertrochanteric femoral fractures, two involved tibial plateau fractures, one involved calcaneal fractures, and one involved multiple types of metaphyseal fractures. All of the studies evaluated the use of calcium phosphate cement for the treatment of metaphyseal fractures occurring primarily through trabecular, cancellous bone. Autogenous bone graft was used in the control group in three studies, and no graft material was used in the remaining studies. Patients managed with calcium phosphate had a significantly lower prevalence of loss of fracture reduction in comparison with patients managed with autograft (relative risk reduction, 68%; 95% confidence interval, 29% to 86%) and had less pain at the fracture site in comparison with controls managed with no graft (relative risk reduction, 56%; 95% confidence interval, 14% to 77%). We were unable to compare pain at the bone-graft donor site between the studies because of methodological reasons. Three studies independently demonstrated improved functional outcomes when the use of calcium phosphate was compared with the use of no grafting material. CONCLUSIONS: The use of calcium phosphate bone cement for the treatment of fractures in adult patients is associated with a lower prevalence of pain at the fracture site in comparison with the rate in controls (patients managed with no graft material). Loss of fracture reduction is also decreased in comparison with that in patients managed with autogenous bone graft.