Factors associated with uptake of guideline-recommended cardiovascular implantable electronic device management: a nationwide, retrospective cohort study.

Clinical guidelines recommend device removal for cardiovascular implantable electronic device (CIED) infection management. In this retrospective, nationwide cohort, 60.8% of CIED infections received guideline-concordant care. One-year mortality was higher among those without procedural management (25% vs 16%). Factors associated with receipt of device procedures included pocket infections and positive microbiology.

A Novel Informatics Tool to Detect Periprocedural Antibiotic Allergy Adverse Events for Near Real-time Surveillance to Support Audit and Feedback.

Importance: Standardized processes for identifying when allergic-type reactions occur and linking reactions to drug exposures are limited. Objective: To develop an informatics tool to improve detection of antibiotic allergic-type events. Design, Setting, and Participants: This retrospective cohort study was conducted from October 1, 2015, to September 30, 2019, with data analyzed between July 1, 2021, and January 31, 2022. The study was conducted across Veteran Affairs hospitals among patients who underwent cardiovascular implantable electronic device (CIED) procedures and received periprocedural antibiotic prophylaxis. The cohort was split into training and test cohorts, and cases were manually reviewed to determine presence of allergic-type reaction and its severity. Variables potentially indicative of allergic-type reactions were selected a priori and included allergies entered in the Veteran Affair's Allergy Reaction Tracking (ART) system (either historical [reported] or observed), allergy diagnosis codes, medications administered to treat allergic reactions, and text searches of clinical notes for keywords and phrases indicative of a potential allergic-type reaction. A model to detect allergic-type reaction events was iteratively developed on the training cohort and then applied to the test cohort. Algorithm test characteristics were assessed. Exposure: Preprocedural and postprocedural prophylactic antibiotic administration. Main Outcomes and Measures: Antibiotic allergic-type reactions. Results: The cohort of 36 344 patients included 34 703 CIED procedures with antibiotic exposures (mean [SD] age, 72 [10] years; 34 008 [98%] male patients); median duration of postprocedural prophylaxis was 4 days (IQR, 2-7 days; maximum, 45 days). The final algorithm included 7 variables: entries in the Veteran Affair's hospitals ART, either historic (odds ratio [OR], 42.37; 95% CI, 11.33-158.43) or observed (OR, 175.10; 95% CI, 44.84-683.76); PheCodes for "symptoms affecting skin" (OR, 8.49; 95% CI, 1.90-37.82), "urticaria" (OR, 7.01; 95% CI, 1.76-27.89), and "allergy or adverse event to an antibiotic" (OR, 11.84, 95% CI, 2.88-48.69); keyword detection in clinical notes (OR, 3.21; 95% CI, 1.27-8.08); and antihistamine administration alone or in combination (OR, 6.51; 95% CI, 1.90-22.30). In the final model, antibiotic allergic-type reactions were identified with an estimated probability of 30% or more; positive predictive value was 61% (95% CI, 45%-76%); and sensitivity was 87% (95% CI, 70%-96%). Conclusions and Relevance: In this retrospective cohort study of patients receiving periprocedural antibiotic prophylaxis, an algorithm with a high sensitivity to detect incident antibiotic allergic-type reactions that can be used to provide clinician feedback about antibiotic harms from unnecessarily prolonged antibiotic exposures was developed.

Clinical Significance of Lateral Pedicle Screw Malposition in Lumbar Spine Fusion.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Our objective was to determine whether lateral pedicle screw breach affects fusion rates and patient-reported outcomes in lumbar fusion surgery. SUMMARY OF BACKGROUND DATA: Although lateral pedicle screw malposition is considered relatively benign, few studies have focused specifically on clinical outcomes or fusion rates associated with lateral screw malposition. METHODS: Twelve-month postoperative computed tomography scans were reviewed for lateral breach, severity of breach, and fusion status. Patients with lateral breach were compared with patients with no breach. Outcome measures included Numerical Pain Rating Scale for back and leg pain, Oswestry Disability Index, and SF-36 physical function (SF-36 PF). Multivariable linear and logistic regression and were adjusted for age, procedure, level, and/or baseline pain score. RESULTS: Forty-five patients (31%) demonstrated 1 or more lateral breaches as compared with 99 patients without breach. After adjusting for baseline scores and fusion level, patients with 2 or more screw breaches experienced SF-36 PF score improvements that were 3.43 points less ( P =0.016) than patients with no lateral breach. After adjusting for baseline Numerical Pain Rating Scale, there was also a significant decrease in the odds of achieving minimally clinical important difference in back pain relief in these patients. There was no observed effect of lateral breach on the odds of successful fusion. CONCLUSIONS: The current study did not observe an association between laterally malpositioned pedicle screws and nonunion. However, results are consistent with a negative effect on SF-36 PF scores and self-reported back pain at 12 months.

Drivers of Cost in Primary Single-Level Lumbar Fusion Surgery.

STUDY DESIGN: Retrospective cohort. OBJECTIVES: Allocating cost is challenging with traditional hospital accounting. Time-driven activity-based costing (TDABC) is an efficient method to accurately assign cost. We sought to characterize the variation in direct total hospital cost (THC) among both lumbar fusion approaches and surgeons. METHODS: Patients were treated with single-level anterior interbody (ALIF), lateral interbody (LLIF), transforaminal interbody (TLIF), instrumented posterolateral (PLF) or in-situ fusion (ISF) for degenerative disease. Process maps were developed for preoperative, intraoperative and postoperative care. THC was composed of implant, medication, other supply, and personnel costs. Linear regression and descriptive statistics were used to analyze THC variation. RESULTS: A total of 696 patients underwent surgery by 8 surgeons. Approximately 50% of THC variation was associated with procedure choice while patient characteristics explained 10%. Implants (including biologics) accounted for 45% of cost. With reference to PLF, THC ranged from 0.6x (ISF) to 1.7x (LLIF). Implant cost ranged from 2.5x reference (LLIF) to 0.1x (ISF). There was a 1.7x difference between the highest THC surgeon and the lowest. The fusion type with the highest THC variation was TLIF. The surgeon with the highest TLIF THC was 1.5x more expensive than the surgeon with the lowest. CONCLUSIONS: Surgeon-based choices have the greatest effect on THC variation and represent the largest opportunities for cost savings. Primary single-level lumbar fusion THC is driven primarily by fusion type. Implants, including biologics, account for nearly half this cost. Future work should incorporate outcomes data to characterize the differential value conferred by higher THC fusions.

Promoting de-implementation of inappropriate antimicrobial use in cardiac device procedures by expanding audit and feedback: protocol for hybrid III type effectiveness/implementation quasi-experimental study.

BACKGROUND: Despite a strong evidence base and clinical guidelines specifically recommending against prolonged post-procedural antimicrobial use, studies indicate that the practice is common following cardiac device procedures. Formative evaluations conducted by the study team suggest that inappropriate antimicrobial use may be driven by information silos that drive provider belief that antimicrobials are not harmful, in part due to lack of complete feedback about all types of clinical outcomes. De-implementation is recognized as an important area of research that can lead to reductions in unnecessary, wasteful, or harmful practices, such as excess antimicrobial use following cardiac device procedures; however, investigations into strategies that lead to successful de-implementation are limited. The overarching hypothesis to be tested in this trial is that a bundle of implementation strategies that includes audit and feedback about direct patient harms caused by inappropriate prescribing can lead to successful de-implementation of guideline-discordant care. METHODS: We propose a hybrid type III effectiveness-implementation stepped-wedge intervention trial at three high-volume, high-complexity VA medical centers. The main study intervention (an informatics-based, real-time audit-and-feedback tool) was developed based on learning/unlearning theory and formative evaluations and guided by the integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) Framework. Elements of the bundled and multifaceted implementation strategy to promote appropriate prescribing will include audit-and-feedback reports that include information about antibiotic harms, stakeholder engagement, patient and provider education, identification of local champions, and blended facilitation. The primary study outcome is adoption of evidence-based practice (de-implementation of inappropriate antimicrobial use). Clinical outcomes (cardiac device infections, acute kidney injuries and Clostridioides difficile infections) are secondary. Qualitative interviews will assess relevant implementation outcomes (acceptability, adoption, fidelity, feasibility). DISCUSSION: De-implementation theory suggests that factors that may have a particularly strong influence on de-implementation include strength of the underlying evidence, the complexity of the intervention, and patient and provider anxiety and fear about changing an established practice. This study will assess whether a multifaceted intervention mapped to identified de-implementation barriers leads to measurable improvements in provision of guideline-concordant antimicrobial use. Findings will improve understanding about factors that impact successful or unsuccessful de-implementation of harmful or wasteful healthcare practices. TRIAL REGISTRATION: ClinicalTrials.gov NCT05020418.

The Majority of Patients Aged 40 and Older Having Allograft Anterior Cruciate Ligament Reconstruction Achieve a Patient Acceptable Symptomatic State.

PURPOSE: To evaluate patient satisfaction, retear rates, and patient-reported outcomes (PROs) in patients aged 40 and older undergoing allograft anterior cruciate ligament reconstruction (ACLR). The secondary goal was to compare these parameters between groups of patients with intact versus failed grafts, and to evaluate these in relation to a historically reported International Knee Documentation Committee (IKDC) patient-acceptable symptoms state (PASS) score. METHODS: Records of patients aged 40 and older who underwent ACLR between 2005 and 2016 at a single institution with a minimum 2-year follow-up were retrospectively reviewed. Patient-reported satisfaction, outcome scores, and failure rates were analyzed. The rate of achieving a previously defined IKDC PASS score based on younger cohorts was reported, and an updated PASS threshold for older patients was calculated. RESULTS: 201 patients were included with a mean age of 48.6 years (range: 40-68) and mean follow-up of 6.2 years (range: 2.8-11.2). 182 (90.5%) patients reported satisfaction following surgery. 16 (8.0%) patients experienced failure of their ACLR, 10 of which underwent revision ACLR. The median IKDC score in the intact ACLR group was 86.2, compared to 66.7 in the failure group (P < .001). In total, 134 (72.4%) patients in the intact group achieved the historical PASS score of 75.9 on IKDC compared to only 4 (25%) in the failure group (χ2 = 15.396, P < .001). An updated IKDC PASS threshold for older cohorts was calculated to be 66.7. CONCLUSION: Patients aged 40 and older who underwent allograft ACLR had an 8.0% failure rate at a mean follow-up of 6 years. Graft failure in patients aged 40 and older was associated with worse PROs. The majority of patients achieved the historically reported IKDC PASS threshold. Additionally, an updated age-appropriate IKDC PASS score of 66.7 was calculated to aid in future ACLR studies assessing older patients. STUDY DESIGN: Level IV.

Reassessing the minimum two-year follow-up standard after total shoulder arthroplasty-Is one year sufficient?

BACKGROUND: US Food and Drug Administration Investigation Device Exemption studies and academic journals emphasize the importance of two-year follow-up data in reporting outcomes of total shoulder arthroplasty, but there is limited data evaluating appropriate follow-up length. We aim to evaluate change in postoperative outcomes and complications between one and two years following anatomic and reverse total shoulder arthroplasties. METHODS: We retrospectively identified 250 patients who underwent anatomic and reverse total shoulder arthroplasties between 2013 and 2016 from a single surgeon arthroplasty registry. Patients without both one- and two-year follow-up data were excluded. We compared American Shoulder and Elbow Surgeons (ASES) score, Visual Analog Scale for pain, and goniometer-measured range of motion. RESULTS: Patient-reported outcome measurements (p > 0.05) did not change between one and two years postoperatively following both reverse (n = 146) and anatomic (n = 104) total shoulder arthroplasties. Range of motion increased slightly (p < 0.05), but this change was not clinically relevant. There were no additional complications. DISCUSSION: Minimum two-year clinical follow-up may not be necessary for future shoulder arthroplasty Investigation Device Exemption and other peer-reviewed investigations. Patient-reported outcomes (ASES and pain score) and range of motion plateau at one year postoperatively without additional complications. One-year follow-up is an acceptable minimum follow-up length. LEVEL OF EVIDENCE: Level III-retrospective analysis.

The Flexion Initiation Test and an Evidence-Based Diagnostic Algorithm for Distal Biceps Tendon Tears.

PURPOSE: The purpose of this study was (1) to assess the flexion initiation test's (FIT) ability to detect distal biceps tendon tears (DBTT) in a cohort of consecutive patients presenting with elbow pain and (2) to generate a reliable evidence-based diagnostic algorithm using a combination of both the FIT and hook tests. METHODS: We performed a retrospective review of 125 consecutive patients who presented with elbow pain, all of which had the FIT and hook test performed prior to imaging/further intervention. The integrity of the tendon was determined during surgery or by magnetic resonance imaging. Sensitivity, specificity, positive predictive value, and negative predictive value were determined for the FIT and hook test. RESULTS: Our evidence-based diagnostic algorithm showed that when both test results are in agreement, there is a 100% diagnostic accuracy for detecting what prior authors have termed surgically indicated tears (complete ruptures and high-grade partial tears) and biceps pathology that can be treated with nonoperative management. The FIT demonstrated 100% sensitivity for surgically indicated tears. The hook test demonstrated 100% sensitivity for complete ruptures, but 18% sensitivity for diagnosing partial tears. CONCLUSIONS: The FIT, which is aimed at improving diagnostic acuity of high-grade partial thickness tears, demonstrated a 93% sensitivity and 96% specificity overall and a 100% sensitivity for complete ruptures and high-grade partial tears. The evidence-based diagnostic algorithm using the combination of the FIT and hook test demonstrates high accuracy for the diagnosis of both complete and high-grade partial DBTTs. The methodology may help to prevent diagnosis delays, improve patient education, and preserve the option for timely primary surgical repair in the treatment of DBTTs. LEVEL OF EVIDENCE: Level IV, diagnostic.

Reassessing glenoid inclination in reverse total shoulder arthroplasty with glenosphere lateralization.

AIMS: Existing literature indicates that inferiorly inclined glenoid baseplates following reverse total shoulder arthroplasty (RSA) produce better outcomes compared to superiorly inclined baseplates. We aim to compare clinical outcomes for RSAs with superiorly and neutrally/inferiorly inclined lateralized glenospheres. METHODS: We retrospectively reviewed 154 consecutive patients undergoing RSA between July 2015 and July 2017 by one single-fellowship trained surgeon (AJ). Two raters (KAM and MVS) independently measured glenoid inclination in preoperative and minimum two year follow-up radiographs (anteroposterior/Grashey) using the RSA angle. Inclination was then compared to patient-reported outcomes, range of motion (ROM), and independently assessed degree of scapular notching and staging of heterotopic ossification at two year follow-up. RESULTS: Median postoperative inclination for each group was found to be -3.6° (interquartile range (IQR) -2.1 to -6.9) and 6.0° (3.2° to 10.1°) for the neutrally/inferiorly and superiorly inclined cohorts, respectively. Preoperative inclination was highly associated with postoperative inclination (p = 0.004). When comparing superiorly and neutrally/inferiorly inclined glenospheres, there were no differences in heterotopic ossification (p = 0.606), scapular notching (p = 0.367), American Shoulder and Elbow Surgeons score (p = 0.419), Single Assessment Numeric Evaluation (p = 0.417), Visual Analogue Scale (VAS) pain score (p = 0.290), forward elevation (p = 0.161), external rotation (p = 0.537), or internal rotation (p = 0.656). CONCLUSION: Compared to neutral and inferior inclination, up to 6° ± 3° of superior glenoid baseplate inclination on a lateralized RSA design produces no differences in postoperative ROM or patient-reported outcomes, and produces similar levels of scapular notching and heterotopic ossification. Additionally, the degree of preoperative inclination represents an important factor in surgical decision-making as it is strongly associated with postoperative inclination. It is important to note that the findings of this study are only reflective of lateralized RSA prostheses. Cite this article: Bone Joint J 2021;103-B(2):360-365.

Pinnacle Ultamet metal-on-metal total hip arthroplasty survivorship: average 10-year follow-up.

BACKGROUND: It is unclear whether a connection exists between femoral head size, offset, neck length, and cup abduction angles, and rate of revision in metal-on-metal (MoM) total hip arthroplasty (THA) implant systems. METHODS: A retrospective review of MoM THA completed by a single surgeon with a single implant between 2003 and 2008 was conducted. Patient demographics, implant data, radiographs, and revision details were collected at follow-up. Incidence rates for revision and osteolysis were calculated in regard to the femoral head size, stem offset, neck length, and cup abduction angles. RESULTS: Six hundred and ninety two THAs were identified, with 79% of patients returning for a median follow-up of 10.3 years (interquartile range = 6.0-12.3). The median time to revision was 7.5 years (interquartile range = 5.3-9.9) among 27 total revision surgeries. The overall incidence rate of revision was 5.4 revisions per 1000 person-years, 3.0 revisions per 1000 person-years for adverse local tissue reaction. Hips with a cup abduction angle of ≤40° had revisions at nearly twice the rate of those with an angle of 41°-50° (incidence rate ratio = 1.98, 95% confidence interval: 0.92, 4.29). Hips with a 9 mm neck length had an increased rate of revision (incidence rate ratio = 5.94, 95% confidence interval: 1.33, 26.55) relative to those with a neck length of 0 mm. Rates of osteolysis were similar between implants of different head sizes, neck lengths and cup abduction angles. CONCLUSIONS: MoM implant systems with longer necks and smaller cup abduction angles may lead to increased need for revision. Results from this study suggest a need for closer long-term follow-up of MoM THA systems.

Association between a history of depression and anti-müllerian hormone among late-reproductive aged women: the Harvard study of moods and cycles.

BACKGROUND: There is conflicting evidence regarding the association between a history of depression and risk of early menopause. In a cohort of premenopausal women, we investigated the association between depression history and ovarian reserve, as measured by anti-müllerian hormone (AMH). METHODS: The Harvard Study of Moods and Cycles (HSMC) was a prospective cohort study of women living in the Boston, MA metropolitan-area (1995-1999). Women aged 36-45 years at cohort entry (1995) were sampled from seven Boston metropolitan-area communities using census directories. We measured serum AMH in early-follicular phase venous blood specimens from 141 women with a Structured Clinical Interview for DSM-IV (SCID)-confirmed history of depression and 228 without such a history. We calculated prevalence ratios (PR) for the association between characteristics of depression history and low AMH (≤1.4 ng/mL), adjusting for several potential confounders. RESULTS: The prevalence of low AMH was similar among depressed (57.5%) and non-depressed (57.9%) women (Adjusted [Adj] PR = 0.90, 95% CI: 0.75, 1.08). Among depressed women, results were not appreciably different among those who had ever used antidepressants and those with comorbid anxiety. Modest inverse associations between depression and low AMH were seen among women aged 36-40 years (Adj PR = 0.75, 95% CI: 0.52, 1.09) and nulliparous women (Adj PR = 0.77, 95% CI: 0.59, 1.00). No dose-response association with greater duration or length of depressive symptoms was observed. CONCLUSIONS: Overall, the prevalence of low AMH was similar for depressed and non-depressed women 36-45 years of age. Surprisingly, among younger and nulliparous women, those with a history of depression had a slightly reduced prevalence of low AMH relative to those without such a history. These results do not indicate reduced ovarian reserve among women with a history of depression.

The Effect of a Skin Barrier Film on the Incidence of Dressing-Related Skin Blisters After Spine Surgery.

Tension blisters from adhesive dressings may lead to pain and delayed surgical wound healing for surgical patients and cause an institutional cost burden. Commercial skin barrier film products may reduce dressing-related postoperative skin blistering in surgical patients. Project investigators at an orthopedic specialty hospital randomized 185 surgical spine patients to receive either a standard wound dressing (ie, control group) or a dressing with the addition of a skin barrier film applied beneath it (eg, treatment group). During the first postoperative dressing change, the participants' skin was assessed for redness, soreness, blistering, or tearing. Approximately 15% of participants in the treatment group and 15% of participants in the control group developed a postoperative skin injury (P = .98). Multivariable analyses did not indicate the skin barrier film provided a protective effect. Additionally, there was no association between patient-specific characteristics and skin blisters among the participants. These results do not support the use of a skin barrier film in surgical spine patients.

Anatomic and Patient Risk Factors for Postoperative Periprosthetic Hip Fractures: A Case-Control Study.

BACKGROUND: Periprosthetic fracture remains a major source of reoperation following total hip arthroplasty (THA). Within 90 days of surgery, fractures may occur spontaneously or with minor injury and are therefore more likely related to patient factors including anatomic variation. METHODS: From 2008 to 2018, 16,254 primary THAs were performed at our institution; of those, 48 were revised for periprosthetic fracture within 90 days of surgery. A control group of 193 patients undergoing THA for hip osteoarthritis (OA) was randomly selected from the source population. We excluded patients with genetic bone disease and THA performed for hip fracture. We used logistic regression to analyze associations between patient factors (demographics, anatomical factors, comorbidities, surgical technique, and implants) and odds of 90-day periprosthetic fracture. RESULTS: Increased age was significantly associated with fracture (P = .002), as was female gender (P = .046). After adjusting for age and gender, absence of contralateral OA was associated with increased odds of fracture relative to patients with contralateral OA (odds ratio [OR] 3.85, 95% confidence interval [CI] 1.60-9.29), as was having a contralateral THA in place (OR 3.70, 95% CI 1.59-8.60). The neck-shaft angle, femoral offset, and the Dorr classification were not associated with increased odds of fracture. Additionally, the distance from the tip of the trochanter to the top of the femoral head was associated with increased odds of fracture per half centimeter (OR 1.48, 95% CI 1.14-1.93). CONCLUSION: Risk of early postoperative periprosthetic fracture following THA is increased with age, female gender, and increasing distance from the greater trochanter to the top of the femoral head; and decreased in the setting of contralateral hip OA. The trochanter-head distance correlation with periprosthetic hip fracture indicates that the preoperative anatomy may influence PPF, particularly regarding how that anatomy is reconstructed.

General health status in army personnel: relations with health behaviors and psychosocial variables.

PURPOSE: Poor self-rated health (SRH) is linked to an increased risk of injury, future healthcare services utilization, and morbidity and mortality. This study aimed to identify correlates of a single-item measure of health in 8070 US Army personnel. METHODS: Responses were collected from the Army's global assessment tool (GAT) 2.0, an online questionnaire that assesses physical and psychosocial health. SRH was measured by the item, "How do you consider your health?" (four response categories: "poor," "fair," "good," and "excellent"). Ordinal logistic regression (OLR) was used to evaluate how various health and psychosocial factors contribute to Soldiers' ratings of SRH. Unadjusted and adjusted cumulative odds ratios (ORs) are presented and discussed. RESULTS: Most participants reported "good" health (57%), followed by "excellent" (24%), "fair" (17%), and "poor" (2%). Sleep quality (OR 2.48; 95% CI 2.34, 2.63) was the largest correlate of SRH, followed by obesity (OR 0.50; 95% CI 0.43, 0.58), emotional fitness (OR 1.68, 95% CI 1.56, 1.82), and Army physical fitness test (APFT) scores (OR 1.43; 95% CI 1.36, 1.51). CONCLUSIONS: Single-item measures of self-reported health can cover a broad spectrum across physical and mental health. Among a large US Army sample, sleep quality was most strongly associated with SRH, followed by emotional fitness and APFT scores. In contrast, service-component and other sociodemographic characteristics had relatively small effects on general health. Military investigators and leaders who must rely on various subjective general health measures should interpret them as a combination of these factors.

Psychometric Properties of Disaster Event Reaction Items From the Crisis Counseling Individual/Family Encounter Log.

OBJECTIVE: The purpose of this article was to examine the psychometric properties of the Crisis Counseling Assistance and Training Program (CCP) data collection instrument, the Individual/Family Encounter Log (IFEL). Data collected from disaster survivors included how they reacted to events in emotional, behavioral, physical, and cognitive domains. These domains are based on conceptual categorization of event reactions and allow CCP staff to provide survivors with referrals to appropriate behavioral health support resources, if warranted. METHODS: This study explored the factor structure of these survey items to determine how best to use the available information as a screen of disaster-related behavioral health indicators. Specifically, our first research question explored and confirmed the optimal factor structure of the event reaction items, and our second question examined whether the new factor structure was similar across disaster types: hurricanes, tornadoes, floods, and wildfires. Using a factor analytic technique, we tested whether our event reaction outcomes achieved consistent and reliable measurement across different disaster situations. Finally, we assessed how the new subscales were correlated with the type of risk to which CCP disaster survivors were exposed. RESULTS: Our analyses revealed 3 factors: (1) depressive-like, (2) anxiety-like, and (3) somatic. In addition, we found that these factors were coherent for hurricanes, floods, and wildfires, although the basic factor structure was not equivalent for tornadoes. CONCLUSION: Implications for use of the IFEL in disaster preparedness, response, and recovery are discussed. (Disaster Med Public Health Preparedness. 2016;10:822-831).