Statistical considerations for cardiovascular clinical trials straddling the continuum of pandemic phases.

In 2020, the NIH and FDA issued guidance documents that laid the foundation for human subject research during an unprecedented pandemic. To bridge these general considerations to actual applications in cardiovascular interventional device trials, the PAndemic Impact on INTErventional device ReSearch (PAIINTERS) Working Group was formed in early 2021 under the Predictable And Sustainable Implementation Of National CardioVascular Registries (PASSION CV Registries). The PAIINTER's Part I report, published by Rymer et al. [5], provided a comprehensive overview of the operational impact on interventional studies during the first year of the Pandemic. PAIINTERS Part II focused on potential statistical issues related to bias, variability, missing data, and study power when interventional studies may start and end in different pandemic phases. Importantly, the paper also offers practical mitigation strategies to adjust or minimize the impact for both SATs and RCTs, providing a valuable resource for researchers and professionals involved in cardiovascular clinical trials.

Patient Perceptions of Illness Causes and Treatment Preferences for Obsessive-Compulsive Disorder: A Mixed-Methods Study.

Obsessive-compulsive disorder (OCD) is a condition with high patient morbidity and mortality. Research shows that eliciting patient explanations about illness causes and treatment preferences promotes cross-cultural work and engagement in health services. These topics are in the Cultural Formulation Interview (CFI), a semi-structured interview first published in DSM-5 that applies anthropological approaches within mental health services to promote person-centered care. This study focuses on the New York City site of an international multi-site study that used qualitative-quantitative mixed methods to: (1) analyze CFI transcripts with 55 adults with OCD to explore perceived illness causes and treatment preferences, and (2) explore whether past treatment experiences are related to perceptions about causes of current symptoms. The most commonly named causes were circumstantial stressors (n = 16), genetics (n = 12), personal psychological traits (n = 9), an interaction between circumstantial stressors and participants' brains (n = 6), and a non-specific brain problem (n = 6). The most common treatment preferences were psychotherapy (n = 42), anything (n = 4), nothing (n = 4), and medications (n = 2). Those with a prior medication history had twice the odds of reporting a biological cause, though this was not a statistically significant difference. Our findings suggest that providers should ask patients about illness causes and treatment preferences to guide treatment choice.

Minimally invasive hallux valgus surgery using 3D printed patient specific instrumentation.

In this technical report study, we describe technique for performing the osteotomy and screw passage in minimally invasive fourth-generation hallux valgus surgery with transverse and akin extra-articular metaphyseal osteotomy (META) using a 3D-printed patient-specific surgical instrumentation guide. In an effort to minimize the learning curve and address the variability associated with technical corrections and screw placement, we have initiated the creation of personalized patient-specific instrumentation guides using 3D printing. Our hypothesis is that this approach will enhance safety, precision, decrease surgical time, and reduce exposure to radiation. Level of Evidence: Level V, expert opinion.

Validation of the IDDSI funnel for liquid flow testing.

In 2017, the International Dysphagia Diet Standardisation Initiative (IDDSI) introduced the IDDSI flow test which enables patients, clinicians, caregivers, food service professionals and researchers to classify liquid thickness into five levels based on the volume of liquid remaining in a standard 10 mL slip tip syringe after 10 s of flow under gravity. Within a few months of publishing the IDDSI flow test instructions, several barriers emerged: (1) the preferred model of syringe (BD 303134) was not equally accessible around the world, causing some users to perform flow tests with alternate models of syringe; (2) differences in syringe geometry across models led to variations in IDDSI flow test results; and (3) the need to use a second syringe for sample loading added complexity and cost to end users. To address these barriers, IDDSI designed the IDDSI funnel, a novel device, which combines the geometry of the BD 303134 syringe with a kitchen funnel to facilitate easy loading of liquid samples without need for a second syringe. In this report, we compare the IDDSI flow test results across two devices: syringe BD 303134 and IDDSI funnel. IDDSI level classifications were in complete agreement with the syringe reference test results in 67/73 (92%) of the test fluids and temperature conditions with mean difference of residual liquid across devices of 0.2 (2% full scale). These results demonstrate excellent correspondence between the two devices.

Impact of Sesamoid Coverage on Clinical Foot Function Following Fourth-Generation Percutaneous Hallux Valgus Surgery.

Background: The impact of pronation and sesamoid coverage on clinical outcomes following percutaneous hallux valgus surgery are not currently known. The aim of this study was to investigate if sesamoid coverage was associated with worse clinical outcomes at 12-month follow-up following percutaneous hallux valgus surgery. Methods: Retrospective comparative observational study of clinical and radiographic outcomes based on a previously published prospective dataset. Patients were stratified into 3 cohorts based on the degree of sesamoid coverage (normal, mild, or moderate) on 12-month weightbearing radiographs following fourth-generation percutaneous hallux valgus surgery. Primary outcome was a validated patient-reported outcome measure (PROM), the Manchester-Oxford Foot Questionnaire (MOXFQ). Secondary outcomes included Euroqol-5D, VAS Pain, and radiographic deformity correction. Results: Forty-seven feet underwent primary fourth-generation HV surgery and were stratified into 3 cohorts. There were 19, 16, and 12 feet in the normal, mild, and moderate cohorts respectively. There was no significant difference in either pre- or postoperative foot function (all MOXFQ domains, P > .05) or health-related quality of life (EQ-5D Index or VAS, P > .05). The MOXFQ Index preoperatively was as follows: normal cohort, 56.1 ± 26.9; mild cohort, 54.1 ± 17.9; and severe cohort, 49.6 ± 23.8; and postoperatively was as follows: normal cohort, 15.6 ± 21.5; mild cohort, 11.4 ± 15.5; and severe cohort, 11.4 ± 13.6 (P = .737-.908). There was significantly worse hallux valgus angle (HVA) and intermetatarsal angle (IMA) between the cohorts (P < .01). Although HVA and IMA were corrected to normal parameters following surgery in all cohorts, there was a significantly worse postoperative HVA in the moderate sesamoid coverage (5.3 ± 3.9 vs 7.9 ± 5.3 vs 11.4 ± 3.7, P < .01); however, IMA was not significantly different (3.4 ± 2.2 vs 4.1 ± 2.7 vs 5.2 ± 2.9, P = .168). Conclusion: This study found that cases where the sesamoids were not reduced had a poorer correction and had worse preoperative deformity. Clinical outcomes and foot function following fourth-generation percutaneous hallux valgus surgery were not affected by sesamoid coverage at the 12-month follow-up. The long-term implications in the difference in radiographic deformity between the 3 cohorts are not known, and further work should explore the relationship of first ray pronation and sesamoid position, particularly with regard to recurrence. Level of evidence: Level III, retrospective comparative study of prospectively collected data.

Life is precious: A quasi-experimental study of a community-based program to prevent suicide among Latina adolescents in New York City.

INTRODUCTION: Rising rates of suicidal thoughts and behaviors (STBs) among U.S. Latina adolescents urgently need attention. Life is Precious (LIP) is a culturally responsive, community-based, afterschool-model program offering wellness-support services to supplement outpatient mental health treatment for Latina adolescents experiencing STB's. This 12-month quasi-experimental pilot study explored LIP's impact on clinical outcomes. METHODS: Latina adolescents newly enrolled in LIP and receiving outpatient treatment (n = 31) and those newly starting outpatient treatment only (n = 12; Usual Care) were assessed for Suicidal Ideation (Suicidal Ideation Questionnaire; SIQ) and depressive symptoms (Patient Health Questionnaire-9). We estimated differences in mean scores using longitudinal linear mixed models and adjusted risk ratios (ARRs) of SIQ-25%, SIQ-50%, and PHQ-9-5-point improvements using exact logistic models. RESULTS: The direction of the estimated impact of LIP was positive [differences (95% CIs): -15.5 (-34.16, 3.15) for SIQ; -1.16 (-4.39, 2.07) for PHQ-9], with small-to-moderate nonsignificant effect sizes (0.19-0.34). LIP participants saw two to three times higher prevalence than controls of SIQ-25%, SIQ-50%, and PHQ-9-5-point improvements; ARRs (95% CIs) were 1.91 (0.61, 3.45), 3.04 (0.43, 11.33), and 1.97 (0.44, 5.07), respectively. Suicidal behaviors also decreased in LIP. CONCLUSION: The effects of LIP were in positive directions across clinical outcomes, warranting further research on its effectiveness in decreasing STBs.

Interface Fluid Syndrome Masquerading as Diffuse Lamellar Keratitis After Small Incision Lenticule Extraction.

A 34-year-old male with no past medical or ocular history underwent bilateral uncomplicated small incision lenticule extraction (SMILE). On day 1, uncorrected distance visual acuity (UDVA) was 20/25 in the right eye (OD) and 20/20 in the left eye (OS). The intraocular pressure (IOP) was 12 mmHg in both eyes (OU). On day 17, UDVA was 20/70 OD and 20/30+2 OS. Slit-lamp examination (SLE) revealed diffuse 2+ haze at the interface suspicious for diffuse lamellar keratitis (DLK). Topical difluprednate was added twice a day (BID). Vision decreased by day 20 with a significant myopic shift and 3+ interface haze OU. A washout of the interface was performed. Topical steroids were increased with oral prednisone. One day after the washout, vision and interface haze improved. On day 3 status post washout, UDVA decreased to 20/70 OD and 20/50 OS. IOP was 42 mmHg OU. A diagnosis of interface fluid syndrome (IFS) was confirmed. All steroids were stopped while adding ocular hypotensive medication. One month later, visual acuity was 20/20 OU with a complete resolution of interface haze. Only a handful of IFS has been documented in SMILE, an incidence that may increase as SMILE becomes more common. Among all SMILE cases, IFS was most commonly associated with steroid-induced ocular hypertension and a myopic shift around 21 days postoperatively. A fluid cleft at the interface may not always be visible with SLE, masquerading as DLK. Scheimpflug densitometry and anterior segment optical coherence tomography (AS-OCT) may aid in quantifying interface edema needed to confirm a diagnosis when IOP is unclear. A corneal washout can immediately improve corneal edema, but the preferred treatment is discontinuing all steroid medication and starting glaucoma drops.

Pupil dilation evaluation of two mydriatic dosing profiles delivered by the Optejet®.

Aim: To compare pupil dilation achieved by a single microdose versus two microdoses of tropicamide-phenylephrine fixed combination (TR-PH FC) delivered by the Optejet®. Patients & methods: In this assessor-masked, crossover, noninferiority study, 60 volunteers underwent two treatment visits and received either one (∼8 µl) or two sprays (∼16 µl) of TR-PH FC to both eyes in randomly assigned order. Results: At 35 min postdose, mean change in pupil diameter was 4.6 mm and 4.9 mm following one or two sprays, respectively. The estimated treatment group difference was -0.249 mm (standard error: 0.036; 95% CI: -0.320, -0.177). No adverse events were reported. Conclusion: A single microdose was noninferior to two microdoses of TR-PH FC and achieved clinically significant mydriasis in a timely manner. Clinical Trial Registration: NCT04907474 (ClinicalTrials.gov).

Pupil dilation efficacy and efficiency were evaluated using microdosing via the Optejet^®. The Optejet^® is a new ophthalmologic drug device that utilizes piezoelectric technology to deliver a fine, controlled, horizontal microdroplet spray with precise volume (∼8 µl), spray pattern and velocity. A single spray versus two sprays of tropicamide-phenylephrine fixed combination (TR-PH FC) were administered to both eyes anesthetic free. Efficacy and safety were evaluated at specific time intervals. The primary end point was the mean change in pupil diameter at 35 min compared with baseline. At 35 min, clinically relevant dilation was observed, with a mean change of 4.55 mm ± 0.68 for one spray and 4.88 ± 0.60 for two sprays. The treatment group difference of one spray of TR-PH FC was noninferior to two sprays (p < 0.001). Rapid dilation was observed at 15 min, and the proportions of eyes that achieved a pupil diameter of ≥6.0 mm were 74% and 83% of patients at 15 min with one spray and two sprays, respectively. The mydriatic agent was well tolerated with the delivery system even in the absence of topical anesthetic, with no ocular or system adverse events reported. Mydriasis is a vital component of routine eye healthcare, and the current standard-of-care mydriatic eye drops potentially have limitations, including contamination, spillage and burning/stinging. Delivery of a mydriatic with the Optejet^® may improve patient care flow in the clinical office setting.

Fourth-Generation Minimally Invasive Hallux Valgus Surgery With Metaphyseal Extra-Articular Transverse and Akin Osteotomy (META): 12 Month Clinical and Radiologic Results.

BACKGROUND: Fourth-generation minimally invasive surgery (MIS) includes the multiplanar rotational deformity correction achieved through manipulation of an extra-articular distal first metatarsal osteotomy that is held with rigid fixation using 2 fully threaded screws, of which one must be bicortical to provide rotational and biomechanical stability. The aim of this study is to report the clinical and radiologic outcomes of an evolved fourth-generation MIS hallux valgus technique. METHODS: A prospective single-surgeon series of consecutive patients undergoing fourth-generation MIS was performed using a distal transverse osteotomy with a minimum 12-month follow-up. The primary outcome was the Manchester-Oxford Foot Questionnaire (MOXFQ), a validated clinical patient-reported outcome measure (PROM). Secondary outcomes included radiographic deformity correction, clinical assessment, and EuroQol-5D-5L PROMs. RESULTS: Between September 2019 and June 2021, 50 feet underwent fourth-generation MIS. The mean age was 55.8±15.3 years with a mean follow-up of 1.4 years. Preoperative and minimum 12-month primary outcome data were available for 100% of feet. There was a significant improvement in all MOXFQ domain scores, with the index domain improving from 53.4 to 13.1 (P < .001). There was a significant improvement (P < .001) in hallux valgus angle (32.7 to 7.9 degrees), intermetatarsal angle (14.0 to 4.2 degrees) and distal metatarsal articular angle (18.5 to 5.6 degrees). There was a significant improvement in general health-related quality of life EQ-5D-5L index and EQ-VAS scores (P < .05). CONCLUSION: The fourth-generation MIS technique is a safe and effective approach to hallux valgus deformity correction with significant improvement in clinical and radiographic outcomes. LEVEL OF EVIDENCE: Level IV, prospective case series.

Five-Year Follow-up of Third-Generation Percutaneous Chevron and Akin Osteotomies (PECA) for Hallux Valgus.

BACKGROUND: Recent large studies of third-generation minimally invasive hallux valgus surgery (MIS) have demonstrated significant improvement in clinical and radiologic outcomes. It remains unknown whether these clinical and radiologic outcomes are maintained in the medium to long term. The aim of this study was to investigate the minimum 5-year clinical and radiologic outcomes following third-generation MIS hallux valgus surgery in the hands of a high-volume MIS surgeon. METHODS: A retrospective observational single highly experienced MIS surgeon case series of consecutive patients undergoing primary isolated third-generation percutaneous chevron and Akin osteotomies (PECA) for hallux valgus with a minimum 60-month clinical and radiographic follow-up. Primary outcome was radiographic assessment of the hallux valgus angle (HVA) and intermetatarsal angle (IMA) preoperatively, 6 months, and ≥60 months following PECA. Secondary outcomes included the Manchester-Oxford Foot Questionnaire, patient satisfaction, EuroQol-5D visual analog scale and the visual analog scale for pain. RESULTS: Between 2012 and 2014, 126 consecutive feet underwent isolated third-generation PECA, with complete data available for 78 (61.9%) feet. The median follow-up was 65.0 (IQR 64-69; range 60-88) months. There was a significant improvement in radiographic deformity correction; the median IMA improved from 12.0 degrees (interquartile range [IQR]: 10.8-14.2) to 6.0 degrees (IQR: 4.2-7.3) (P < .001), and the median HVA improved from 27.2 degrees (IQR: 20.6-34.4) to 7.2 degrees (IQR: 3.4-11.6). Median MOXFQ Index score at ≥60-month follow-up was 2.3 (IQR: 0.0-7.8). The radiographic recurrence rate (defined as HVA >15 degrees) was 7.7% at final follow-up. The complication rate was 4.8%. CONCLUSION: Radiologic deformity correction for the 78 feet we were able to follow that had third-generation PECA performed by a single highly experienced MIS surgeon was found to be maintained at a mean follow-up of average 66.8 months, with a radiographic recurrence rate of 7.7%. Clinical PROMs and patient satisfaction levels were high and comparable to other third-generation studies with shorter duration of follow-up. LEVEL OF EVIDENCE: Level IV, retrospective cohort study.

Differential Engagement by Race/Ethnicity in Experimental Trials of Mental Health Treatment Interventions: A Systematic Review.

Objective: Research on mental health interventions, largely from observational studies, suggests that individuals who are Black, Indigenous, and People of Color (BIPOC) have lower treatment engagement than non-Latino Whites. This systematic review focuses on prospective, experimental treatment trials, which reduce variability in patient and intervention characteristics and some access barriers (eg, cost), to examine the association of race/ethnicity and engagement.Data Sources: A systematic search of PubMed and PsycINFO through May 2020 using terms covering mental health treatment, engagement, and race/ethnicity.Study Selection: US-based, English-language, prospective experimental (including quasi-experimental) trials of adults treated for DSM-defined mental disorders were included. Studies had to compare engagement (treatment initiation and retention, medication adherence) across 2 or more ethnoracial groups. Fifty-five of 2,520 articles met inclusion criteria.Data Extraction: Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and the Cochrane Collaboration bias-risk assessment tool were used to report study findings.Results: Twenty-nine articles (53%) reported significant ethnoracial engagement differences, of which 93% found lower engagement among BIPOC groups compared largely to non-Latino Whites. The proportion of significant findings was consistent across quality of studies, covariate adjustments, ethnoracial groups, disorders, treatments, and 4 engagement definitions. Reporting limitations were found in covariate analyses and disaggregation of results across specific ethnoracial groups.Conclusions: Prospective experimental treatment trials reveal consistently lower BIPOC engagement, suggesting persisting disparities despite standardized study designs. Future research should improve inclusion of understudied groups, examine covariates systematically, and follow uniform reporting and analytic practices to elucidate reasons for these disparities.

Valgus Second Toe Deformity Treated With a Percutaneous Extracapsular Closing-Wedge Osteotomy of the Proximal Phalanx.

BACKGROUND: Coronal and sagittal plane deformities of the lesser toes are common yet challenging to treat. Traditional open releases and translational Weil osteotomies can be unpredictable and lead to postoperative stiffness. We present the results of a percutaneous closing wedge extracapsular osteotomy of the proximal phalanx to treat valgus deformity of the second toe. METHODS: Thirty-one patients underwent 40 percutaneous osteotomies at a median age of 58.6±9.4 years. Using a small dorsomedial incision, a percutaneous proximal metaphyseal medial closing-wedge extracapsular osteotomy of the second toe is performed, leaving the dorsolateral cortex intact. An irrigated low-speed, high-torque 2- × 8-mm burr is used under image guidance. The osteotomy is then closed to correct deformity and taped for 2 weeks. Patient-reported outcomes and weightbearing radiographs were obtained. RESULTS: Questionnaire data was available for 89.7% (n=35) of cases. Most cases (91.4%) were either satisfied or extremely satisfied with the procedure. Radiographs were available for 90.0% of osteotomies, with a median length from surgery to radiographic follow-up of 1.6 years (range 0.5-6.3; SD ±1.5). Median second-toe valgus angle (STVA) decreased from 16.2±10.7 degrees to 5.0±7.0 degrees (P < .001) at final follow-up. All osteotomies united with no delayed union. There were no wound complications or infections. We found 2 cases of radiographic recurrence. CONCLUSION: Percutaneous proximal phalanx base metaphyseal closing wedge extracapsular osteotomies of lesser toes to correct coronal plane deformity is useful adjunct to first-ray corrective surgery and is associated with high levels of patient satisfaction. LEVEL OF EVIDENCE: Level IV, retrospective case series.

Minimally Invasive Chevron Akin: Locking The Metatarsal-Cuneiform Joint.

INTRODUCTION: Minimally Invasive Chevron Akin (MICA) can be used to treat hallux valgus (HV) associated with a hypermobility of the first metatarsal-cuneiform joint (1MTCJ). The aim of this study was to perform a radiographic analysis of the MICA, focused on evaluating the 1MTCJ. METHODS: Forty patients (50 feet) with moderate to severe HV underwent a MICA procedure. Radiographic analysis included hallux valgus angle (HVA), intermetatarsal angles between the first and second rays (IMA), the intermetatarsal angle between the proximal fragment of the osteotomy and the second ray (IAPF) and the distance between a point 3 cm distal from the base of the second metatarsal and a point located at the same height for the first metatarsal base (Dist 1-2). The IAPF was compared with the preoperative IMA, and the other parameters were compared preoperatively and postoperatively. The radiographic complications were also recorded. RESULTS: Most patients were female (92%). The mean age was 50.4 years (SD = 16.1) and the mean follow-up was 16.1 months (SD = 3.5). The average HVA improved from 32.5° to 7.3°, and the average IMA from 14.2° to 4.2°. The IAPF and Dist1-2 values showed an increase of 4.8° and 4.0 mm respectively. There were no radiographic complications. Conclusion. Minimally invasive Chevron Akin promotes a great correction of the moderate to severe HV conventional parameters and increase the transversal stability of the 1MTCJ fixing this joint as medial as possible. LEVEL OF EVIDENCE: Level IV, case series.

Technique Tip: Medial prominence bone spur resection in the third-generation percutaneous Chevron-Akin Osteotomy Technique (PECA) for hallux valgus correction.

The third-generation percutaneous chevron and Akin osteotomy (PECA) technique for surgical management of hallux valgus has shown improvement in clinical and radiographic outcomes. During this procedure, lateral translation and fixation of the first metatarsal head results in the formation of a bony prominence on the medial side of the distal aspect of the first metatarsal which can cause pain and discomfort to the patient. We describe two techniques to address this bony prominence; either i) excision osteotomy and removal of the fragment or ii) a dorsal closing wedge osteotomy retaining the bony fragment. LEVEL OF EVIDENCE: Level V, expert opinion.

Implementing the Cultural Formulation Interview in a Community Clinic to Improve Appointment Retention: A Pilot Study.

Despite consensus that clinicians should receive cultural competence training to reduce mental health disparities among racial-ethnic minority groups, few studies have evaluated training in community settings. This column delineates implementation of the DSM-5 Cultural Formulation Interview (CFI) at a community hospital. Participating clinicians were able to implement the CFI after a single training session and offer administrative support and instructions on customizing care with lower- and middle-income, racially and ethnically diverse patients.

Percutaneous Chevron and Akin (PECA) Osteotomies for Severe Hallux Valgus Deformity With Mean 3-Year Follow-up.

BACKGROUND: Patients with severe hallux valgus deformity present technical and operative challenges with high rates of recurrence and residual deformity. The clinical and radiologic outcomes of percutaneous surgery for severe hallux valgus are not known. METHODS: A retrospective review of consecutive patients with a hallux valgus angle (HVA) >40 degrees or intermetatarsal angle (IMA) >20 degrees who underwent third-generation percutaneous chevron and Akin osteotomy (PECA) for hallux valgus deformity correction. RESULTS: Between December 2012 and August 2019, 59 feet in 50 patients underwent PECA. Preoperative and follow-up radiographic data were available for 53 feet (89.8%). Postoperative clinical patient-reported outcome measures and satisfaction results were available for 51 feet (86.4%). The mean clinical and radiographic follow-up was 3.1 years and the mean postoperative Manchester-Oxford Foot Questionnaire Index score was 15.1. There was a statistically significant improvement (P < .001) in both IMA and HVA following surgery (IMA 17.5-5.1 degrees; HVA 44.1-11.5 degrees). All patients reported they were satisfied with their outcome, with 76.8% reporting they were highly satisfied. The hallux valgus recurrence rate was 7.5%. CONCLUSION: Percutaneous surgery for severe hallux valgus deformity can achieve a large deformity correction, patient satisfaction, and quality of life, with reasonable rates of residual deformity and low rates of recurrence. LEVEL OF EVIDENCE: Level IV, case series.