Exploration of the Utility of the Generic ICHOM Standard Set Measures in Evaluating the Speech of Patients with Cleft Lip/Palate.

Background: The International Consortium of Health Outcome Measurements (ICHOM) standard set for cleft care appraisal recommends clinicians assess articulation with percentage consonants correct (PCC) and velopharyngeal function with velopharyngeal competency rating (VPC-R). This study explores the utility and limitations of these generic measures in detecting cleft speech sound disorders by comparing them with two cleft-specific speech-rating systems, cleft audit protocol of speech-augmented Americleft modification (CAPS-A-AM) and Pittsburgh weighted speech scale (PWSS). Methods: Consecutive children with repaired, nonsyndromic cleft lip/palate, aged 5 years or older (n = 27) underwent prospective speech evaluations conducted at a single academic institution. These evaluations were conducted, recorded, and evaluated by blinded speech-language pathologists experienced with all tools. Results: When comparing measures of articulation, PCC scores correlated better with scores for relevant subcomponents of CAPS-A-AM than PWSS. When comparing measures of velopharyngeal function, VPC-R scores correlated well with relevant components of both scales. Using a "screening test versus diagnostic test" analogy, VPC-R ratings were 87.5% sensitive and 73.7% specific for detecting velopharyngeal dysfunction according to subcomponents of CAPS-A-AM, and 70.6% sensitive and 100% specific according to subcomponents of PWSS. Conclusions: This exploratory study demonstrates that PCC and VPC-R perform moderately well in detecting articulatory and velopharyngeal dysfunction in patients with cleft lip/palate; however, these tools cannot describe nuances of cleft speech sound disorder. Thus, although PCC and VPC-R adequately track basic minimum outcomes, we encourage teams to consider extending the standard set by adopting a cleft-specific measurement system for further evaluation of the tools.

Lymphovenous Coupler-Assisted Bypass for Immediate Lymphatic Reconstruction.

BACKGROUND: Breast cancer-related lymphedema is the most common cause of lymphedema in the United States and occurs in up to 50% of individuals receiving axillary lymph node dissection (ALND). Lymphovenous bypass (LVB) at the time of ALND may prevent lymphedema, but long-term results and anastomotic patency are unclear. This study evaluates the feasibility and outcomes of performing immediate lymphatic reconstruction via coupler-assisted bypass (CAB). METHODS: This is a retrospective review of all patients undergoing prophylactic LVB following ALND at two tertiary care centers between 2018 and 2022. Patients were divided into cohorts based on whether they received the "standard" end-to-end (E-E) suturing or CAB technique. The primary outcome of interest was development of lymphedema. Quantitative and qualitative assessments for lymphedema were performed preoperatively and at 3, 6, 12, and 24 months postoperatively. RESULTS: Overall, 63 LVBs were performed, of which 24 lymphatics underwent immediate reconstruction via "CAB" and 39 lymphatics via "standard" end-to-end suture. Patient characteristics, including body mass index, and treatment characteristics, including radiation therapy, did not significantly differ between groups. CAB was associated with a greater mean number of lymphatics bypassed per vein (standard 1.7 vs. CAB 2.6, p = 0.0001) and bypass to larger veins (standard 1.2 vs. CAB 2.2 mm, p < 0.0001). At a median follow-up of 14.7 months, 9.1% (1/11) of individuals receiving CAB developed lymphedema. These rates were similar to those seen following standard bypass at 4.8% (1/21), although within a significantly shorter follow-up duration (standard 7.8 vs. CAB 14.7 months, p = 0.0170). CONCLUSION: The CAB technique is a viable, effective technical alternative to the standard LVB technique. This comparative study of techniques in prophylactic LVB suggests that CABs maintain long-term patency, possibly due to the ease of anastomosing several lymphatics to single large caliber veins while reducing the technical demands of the procedure.

What is the optimal assessment of speech? A multicentre, international evaluation of speech assessment in 2500 patients with a cleft.

OBJECTIVES: Speech problems in patients with a cleft palate are often complex and multifactorial. Finding the optimal way of monitoring these problems is challenging. The International Consortium of Health Outcomes Measurement (ICHOM) has developed a set of standardised outcome measures at specific ages for patients with a cleft lip and/or palate, including measures of speech assessment. This study evaluates the type and timing of speech outcome measures currently included in this ICHOM Standard Set. Additionally, speech assessments in other cleft protocols and initiatives are discussed. DESIGN, SETTING AND PARTICIPANTS: An international, multicentre study was set up including centres from the USA and the Netherlands. Outcomes of clinical measures and Patient Reported Outcome Measures (PROMs) were collected retrospectively according to the ICHOM set. PROM data from a field test of the CLEFT-Q, a questionnaire developed and validated for patients with a cleft, were collected, including participants from countries with all sorts of income statuses, to examine the value of additional moments of measurement that are used in other cleft initiatives.Data from 2500 patients were included. Measured outcomes contained univariate regression analyses, trend analyses, t-tests, correlations and floor and ceiling effects. RESULTS: PROMs correlated low to moderate with clinical outcome measures. Clinical outcome measures correlated low to moderate with each other too. In contrast, two CLEFT-Q Scales correlated strongly with each other. All PROMs and the Percent Consonants Correct (PCC) showed an effect of age. In patients with an isolated cleft palate, a ceiling effect was found in the Intelligibility in Context Scale. CONCLUSION: Recommendations for an optimal speech outcome assessment in cleft patients are made. Measurement moments of different cleft protocols and initiatives are considered in this proposition. Concerning the type of measures, adjustment of the current PCC score outcome seems appropriate. For centres with adequate resources and specific interest in research, translation and validation of an upcoming tool, the Cleft Audit Protocol for Speech Augmented, is recommended.

Using "Real-World Data" to Study Cleft Lip/Palate Care: An Exploration of Speech Outcomes from a Multi-Center US Learning Health Network.

OBJECTIVE: To assess the ability of a cleft-specific multi-site learning health network registry to describe variations in cleft outcomes by cleft phenotypes, ages, and treatment centers. Observed variations were assessed for coherence with prior study findings. DESIGN: Cross-sectional analysis of prospectively collected data from 2019-2022. SETTING: Six cleft treatment centers collected data systematically during routine clinic appointments according to a standardized protocol. PARTICIPANTS: 714 English-speaking children and adolescents with non-syndromic cleft lip/palate. INTERVENTION: Routine multidisciplinary care and systematic outcomes measurement by cleft teams. OUTCOME MEASURES: Speech outcomes included articulatory accuracy measured by Percent Consonants Correct (PCC), velopharyngeal function measured by Velopharyngeal Competence (VPC) Rating Scale (VPC-R), intelligibility measured by caregiver-reported Intelligibility in Context Scale (ICS), and two CLEFT-Q™ surveys, in which patients rate their own speech function and level of speech distress. RESULTS: 12year-olds exhibited high median PCC scores (91-100%), high frequency of velopharyngeal competency (62.50-100%), and high median Speech Function (80-91) relative to younger peers parsed by phenotype. Patients with bilateral cleft lip, alveolus, and palate reported low PCC scores (51-91%) relative to peers at some ages and low frequency of velopharyngeal competency (26.67%) at 5 years. ICS scores ranged from 3.93-5.0 for all ages and phenotypes. Speech Function and Speech Distress were similar across phenotypes. CONCLUSIONS: This exploration of speech outcomes demonstrates the current ability of the cleft-specific registry to support cleft research efforts as a source of "real-world" data. Further work is focused on developing robust methodology for hypothesis-driven research and causal inference.

Can Mentorship Shatter the Glass Ceiling in Academic Microsurgery? A National Survey of Microsurgery Fellowship-Trained Women.

BACKGROUND: The "leaky pipeline" phenomenon has caused women to remain underrepresented at higher levels of academic plastic surgery. No study has considered the availability of mentorship within any subset of academic plastic surgery. The purpose of this study was to evaluate the current representation of women in academic microsurgery and to determine the impact of mentorship on career progression. METHODS: An electronic survey was designed to determine the availability and quality of mentorship respondents received at different stages of their career (from medical student to attending physician). The survey was distributed to women who completed a microsurgery fellowship and were current faculty at an academic plastic surgery program. RESULTS: Twenty-seven of 48 survey recipients participated (56.3% response rate). Most held an associate professor (20.0%) or assistant professor (40.0%) position. Respondents had an average of 4.1 ± 2.3 mentors throughout their entire training. A minority of mentors were microsurgery trained (28.3%), and only 29.2% of respondents reported female mentorship throughout their training. Attending physicians least often received formative mentorship (52.0%). Fifty percent of respondents sought female mentors, citing that they desired female insight. Of those who did not seek female mentors, 72.7% cited a lack of access to female mentors. CONCLUSIONS: Evidenced by female trainees being unable to find female mentors and low rates of mentorship at the attending physician level, there is currently not enough capacity to meet the demand for female mentorship by women pursuing academic microsurgery. Many individual and structural barriers to quality mentorship and sponsorship exist within this field.

Direct-to-Implant versus Immediate Free Flap Reconstruction after Nipple-Sparing Mastectomy: A Propensity Score-Matched Analysis.

BACKGROUND: Both direct-to-implant (DTI) and immediate free flap (FF) breast reconstruction following nipple-sparing mastectomy (NSM) have been described in the literature. However, there is a paucity of comparative studies between these two techniques. Furthermore, existing studies do not control for factors influencing ischemic complications. METHODS: A retrospective review of all NSMs performed at a single institution between January of 2014 and January of 2020 was performed. Immediate FF reconstructions were propensity score matched using probit regression to identify a comparable DTI cohort based on mastectomy weight, smoking, age, and history of radiotherapy. Primary outcomes of interest were 30-day ischemic complications. RESULTS: One hundred eight NSMs performed in 79 patients were included. Average age was 45.7 ± 10.5 years and mean body mass index was 27.1 ± 4.8 kg/m 2 . There were 54 breasts in both the DTI group and the immediate FF group. Median mastectomy weight in the DTI group was 508 g (interquartile range, 264 g) as compared with 473 g (interquartile range, 303 g) in the FF group ( P = 0.792). There was no significant difference in the rate of partial nipple-areola complex necrosis in the DTI and FF groups (5.6% versus 3.7%, respectively; P = 0.500) or mastectomy flap necrosis (5.6% versus 11.1%; P = 0.297). Both the DTI and FF groups had a total nipple-areola complex necrosis rate of 1.9% ( P = 0.752). CONCLUSION: Both DTI and immediate FF reconstruction can be safely offered to patients undergoing NSM while providing the benefit of a single reconstructive procedure. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Evaluating the Role of Mentorship in Career Advancement: A Survey of Women in Academic Hand Surgery.

PURPOSE: Despite the increasing percentage of women within the American Society for Surgery of the Hand, women remain underrepresented within leadership in academic hand surgery. Although this disparity in leadership representation may be improving, we aimed to investigate the role mentorship plays in advancing women in academic hand surgery. METHODS: This is a survey-based, mixed-methods study. A written survey assessing themes in personal and professional experiences with mentorship was sent to hand fellowship-trained women. Inclusion criteria were the completion of a hand fellowship and current affiliation with an academic institution. An evolved grounded theory framework was used to evaluate the responses. Themes were identified based on common responses. RESULTS: Of 186 eligible participants, 144 (85.2%) received the survey. The response rate was 48.6%. Respondents indicated that residency was the stage at which mentorship was most impactful (n = 25, 37%), and half of the respondents identified their desire to work in academic hand surgery during residency (n = 35, 50%). Obstacles to finding a mentor included lack of availability (n = 46, 67.7%), hesitance in searching for a mentor (n = 16, 23.5%), and searching for a mentor within an environment that was not conducive to success for trainees (n = 7, 10.3%). Most (84%) cited instances were the ones having the advice of a woman mentor was more impactful than that of a mentor who is a man. The reported need for same-sex mentorship fell into three categories: (1) insight into shared experiences, (2) assistance with conflict/bias management, and (3) support during career navigation. CONCLUSIONS: The findings of this study demonstrate the need for high-quality mentorship during the residency with a specific emphasis on same-sex mentorship. CLINICAL RELEVANCE: Our findings provide clear objectives related to improving access to and quality of mentorship. This foundational understanding will enrich mentor-mentee relationships, allowing for greater personal and professional success and satisfaction for both parties.

Expanding Criteria for Limb Salvage in Comorbid Patients with Nonhealing Wounds: The MedStar Georgetown Protocol and Lessons Learned after 200 Lower Extremity Free Flaps.

BACKGROUND: Lower extremity salvage in the setting of nonhealing wounds requires a multidisciplinary approach for successful free tissue transfer. Patients with comorbidities including diabetes mellitus and peripheral vascular disease were previously considered poor candidates for free tissue transfer. However, amputation leads to functional decline and severely increased mortality. The authors present their institutional perioperative protocol in the context of 200 free tissue transfers performed for lower extremity salvage in a highly comorbid population. METHODS: The authors reviewed an institutional database of 200 lower extremity free tissue transfers performed from 2011 to 2019. Demographics, comorbidities, wound cause and location, intraoperative details, flap outcomes, and complications were compared between the first and second 100 flaps. The authors document the evolution of their institutional protocol for lower extremity free tissue transfers, including standard preoperative hypercoagulability testing, angiography, and venous ultrasound. RESULTS: The median Charlson Comorbidity Index was 3, with diabetes mellitus and peripheral vascular disease found in 48 percent and 22 percent of patients, respectively. Thirty-nine percent of patients tested positive for more than three hypercoagulable genetic conditions. The second group of 100 free tissue transfers had a higher proportion of patients with decreased vessel runoff (35 percent versus 47 percent; p < 0.05), rate of endovascular intervention (7.1 percent versus 23 percent; p < 0.05), and rate of venous reflux (19 percent versus 64 percent; p < 0.001). Flap success (91 percent versus 98 percent; p < 0.05) and operative time (500 minutes versus 374 minutes; p < 0.001) improved in the second cohort. CONCLUSIONS: Standardized evidence-based protocols and a multidisciplinary approach enable successful limb salvage. Although there is a learning curve, high levels of salvage can be attained in highly comorbid patients with improved institutional knowledge and capabilities. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Are US Plastic Surgery Residents Equipped to Face the Opioid Epidemic? A National Survey.

The United States opioid epidemic is among this century's most profound threats to public health and demands that all physicians consider their role in reversing its trajectory. Previous literature demonstrated that plastic surgery trainees lack vital practices that promote opioid stewardship. However, it is not understood why this practice gap exists. This is a national survey-based study evaluating the availability and effectiveness of opioid education in US plastic surgery programs. A total of 91 residents completed the survey. Our study found that there is an unmet need for practical and comprehensive training regarding safe opioid prescribing among plastic surgery trainees. "Informal training," defined as the "learn as you go" method, was found to be more common than formal training and considerably more valuable according to trainees. Trainees cited real-world applicability of informal training and that it comes from teachers whom they know and trust as valuable attributes of this type of education. Furthermore, the severity of the opioid epidemic has not translated into improved trainee education, as there was no significant difference in knowledge on safe opioid prescribing practices between junior and senior residents. To change the course of the epidemic, plastic surgery programs need to better train younger generations who believe they are critical stakeholders. This study lays the framework for the "formalization of informal training," and the creation of practical and efficacious educational initiatives.

Risk Factors for Loss to Follow-Up in the Lower Extremity Limb Salvage Population.

BACKGROUND: Limb salvage for chronic lower extremity wounds requires long-term care best delivered by specialized multidisciplinary centers. This optimizes function, reduces amputation rates, and improves mortality. These centers may be limited to urban/academic settings, making access and appropriate follow-up challenging. Therefore, the authors hypothesize that both system- and patient-related factors put this population at exceedingly high risk for loss to follow-up. METHODS: Records were reviewed retrospectively for 200 new patients seen at the Georgetown Center for Wound Healing in 2013. The primary outcome was loss to follow-up, defined as three consecutive missed appointments despite explicit documentation indicating the need for return visits. Demographic, clinical, and geographic data were compared. Multivariate logistic regression analysis for loss to follow-up status controlled for variables found significant in the bivariate analysis. Spatial dependency was evaluated using variograms. RESULTS: Over a 6.5-year-period, 49.5 percent of patients followed were lost to follow-up. Male sex and increased driving distance to the limb salvage center were risk factors for loss to follow-up. Wound-specific characteristics including ankle and knee/thigh location were also associated with higher rates of loss to follow-up. There was no spatial dependency or discrete clustering of at-risk patients. CONCLUSIONS: This study is the first of its kind to investigate the demographic and clinical characteristics that predispose chronic lower extremity wound patients to loss to follow-up. These findings inform stakeholders of the high rates of loss to follow-up and support decentralized specialty care, in the form of telemedicine, satellite facilities, and/or dedicated case managers. Future work will focus on targeting vulnerable populations through focused interventions to reduce patient and system burden. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Time-Driven, Activity-Based Costing of Presurgical Infant Orthopedics: A Critical Component of Establishing Value of Latham Appliance and Nasoalveolar Molding.

BACKGROUND: Value-based health-care reform requires assessment of outcomes and costs of medical interventions. In cleft care, presurgical infant orthopedics is still being evaluated for clinical benefits and risks; however, the cost of these procedures has been largely ignored. This study uses robust accounting methods to quantify the cost of providing two types of presurgical infant orthopedics: Latham appliance treatment and nasoalveolar molding. METHODS: This is a prospective study of patients with nonsyndromic cleft lip and/or palate who underwent treatment with presurgical infant orthopedics from 2017 to 2019 at two academic centers. Costs were measured using time-driven activity-based costing. Personnel costs, facility costs (operating room, clinic, and inpatient ward), and equipment costs were included. Travel expenses were incorporated as an estimate of direct costs borne by the family, but indirect costs (e.g., time off from work) were not considered. RESULTS: Twenty-three patients were treated with Latham appliance treatment and 14 were treated with nasoalveolar molding. For Latham appliance treatment, average total cost was $7553 per patient ($1041 for personnel, $637 for equipment, $4871 for facility, and $1004 for travel over 6.5 visits). Unilateral and bilateral costs were $6891 and $8860, respectively. For nasoalveolar molding, average cost totaled $2541 ($364 for personnel, $151 for equipment, $300 for facility, and $1726 for travel over 13 visits); $2120 for unilateral and $3048 for bilateral treatment. CONCLUSIONS: The major difference in cost is attributable to operative placement of the Latham device. Travel cost for nasoalveolar molding is often higher because of frequent clinical encounters required. Future investigation should focus on whether outcomes achieved by presurgical infant orthopedics justify the $2100 to $8900 expenditure for these adjunctive procedures.

Intraoperative Utility of the Implantable Doppler in Lower Extremity Reconstruction: A Matched Case-control Study.

Patients with diabetes mellitus and peripheral vascular disease have high rates of thrombogenic vessels. The implantable (Cook) Doppler in lower extremity reconstruction can optimize microsurgical outcomes in this population. METHODS: Patients undergoing lower extremity free flap reconstruction who did not have an implantable Doppler probe placed were matched with patients who received an implantable Doppler probe. Groups were matched based on wound location, history of peripheral vascular disease, number of vessel runoffs, and number of venous anastomoses and postoperative outcomes compared. RESULTS: Thirty patients were included: 15 in the control group and 15 in the implantable Doppler group. Mean age was 60.2 ±10.2 years, and mean BMI was 28.7 ± 5.0 kg/m2. There was a high prevalence of diabetes mellitus (13; 43.3%) and peripheral vascular disease (4; 13.3%). Takebacks due to vascular compromise were significantly higher in the control than in the implantable Doppler group (26.7% versus 0.0%, P = 0.032). Among flaps that required takeback to the operating room, the majority were muscle-based without a skin paddle (75.0%). Vascular compromise was due to arterial insufficiency in 2 cases and venous thrombosis in 1 case. The salvage rate among the takebacks of the non-implantable Doppler group was 0.0%, resulting in a 26.7% flap failure rate in the non-implantable Doppler group when compared with 0.0% flap loss in the implantable Doppler group (P = 0.032). CONCLUSION: The implantable Doppler probe optimizes flap inset intraoperatively in lower extremity free flap reconstruction and can significantly decrease takebacks due to vascular complications, thereby increasing flap success.

Anatomical Variability Predisposed a Child to Permanent Brachial Plexopathy following Incidental Trauma.

Anatomic variations in peripheral nerves and the perineural environment are common and can contribute to acute or chronic neuropathy in certain individuals. Awareness of these variants is relevant to understanding both the etiopathogenesis and the increased susceptibility to nerve injury in some patients. We present a 4-year-old boy who sustained a permanent injury to the upper brachial plexus from a relatively minor trauma. Surgical exploration revealed a variation in upper trunk anatomy that likely contributed to this outcome.

Occurrence of Symptomatic Hypotension in Patients Undergoing Breast Free Flaps: Is Enhanced Recovery after Surgery to Blame?

BACKGROUND: Enhanced recovery after surgery (ERAS) initiatives improve postoperative function and expedite recovery, leading to a decrease in length of stay. The authors noted a high rate of postoperative symptomatic hypotension in patients undergoing abdominal free flap breast reconstruction and wished to explore this observation. METHODS: Subjects undergoing abdominal free flap breast reconstruction at the authors' institution from 2013 to 2017 were identified. The ERAS protocol was initiated in 2015 at the authors' hospital; thus, 99 patients underwent traditional management and 138 patients underwent ERAS management. Demographics and perioperative data were collected and analyzed. Postoperative symptomatic hypotension was defined as mean arterial pressure below 80 percent of baseline with symptoms requiring evaluation. RESULTS: A significantly higher rate of postoperative symptomatic hypotension was observed in the ERAS cohort compared with the traditional management cohort (4 percent versus 22 percent; p < 0.0001). Patients in the ERAS cohort received significantly less intraoperative intravenous fluid (4467 ml versus 3505 ml; p < 0.0001) and had a significantly increased amount of intraoperative time spent with low blood pressure (22 percent versus 32 percent; p =0.002). Postoperatively, the ERAS cohort had significantly lower heart rate (77 beats per minute versus 88 beats per minute; p < 0.0001) and mean arterial pressure (71 mmHg versus 78 mmHg; p < 0.0001), with no difference in urine output or adverse events. CONCLUSIONS: The authors report that ERAS implementation in abdominal free flap breast reconstruction may result in a unique physiologic state with low mean arterial pressure, low heart rate, and normal urine output, resulting in postoperative symptomatic hypotension. Awareness of this early postoperative finding can help better direct fluid resuscitation and prevent episodes of symptomatic hypotension. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Incidence of Postoperative Adverse Events after Rhinoplasty: A Systematic Review.

BACKGROUND: Adverse events after rhinoplasty vary in etiology and severity, a fact that is reflected in the current American Society of Plastic Surgeons rhinoplasty consent form. However, there is currently no literature providing a comprehensive summation of evidence-based quantifiable risk of adverse events after rhinoplasty. Given this limitation, patients considering rhinoplasty are unable to fully ascertain preoperative risk, and the ability of physicians to obtain true informed consent is similarly flawed. This systematic review provides the first rigorous, comprehensive, and quantitative reporting of adverse events after rhinoplasty. METHODS: This review was registered on the International Prospective Register of Systematic Reviews (PROSPERO) database (registration no. CRD42018081826) in April of 2018. Eligible articles were published in peer-reviewed journals with available abstracts and full-text articles. Interventions included primary functional, aesthetic, and combined functional/aesthetic rhinoplasty. The following data were extracted: study size, population characteristics, indication, surgical approach, concomitant procedures, and incidence of adverse events. RESULTS: A search yielded 3215 publications for title and abstract screening. Three hundred twenty-two were eligible for full-text review. Thirty-six met final inclusion criteria. A total of 13 adverse events were reported among these studies and included need for revision (0 to 10.9 percent), infection (0 to 4 percent), dehiscence (0 to 5 percent), bleeding (0 to 4.1 percent), septal perforation (0 to 2.6 percent), nasal airway obstruction requiring revision (0 to 3 percent), and hypertrophic scarring (0 to 1.5 percent). CONCLUSIONS: This systematic review presents the first comprehensive and quantitative reporting of adverse event frequency after rhinoplasty. This is a crucial tool for preoperative patient counseling and an essential adjunct in the acquisition of informed consent. Future investigations will benefit from transparency and standardization of reporting to further quantify adverse event rates.

A Double-Blind Randomized Placebo-Controlled Trial of Citalopram Adjunctive to Stimulant Medication in Youth With Chronic Severe Irritability.

OBJECTIVE: Despite the clinical importance of chronic and severe irritability, there is a paucity of controlled trials for its pharmacological treatment. Here, we examine the effects of adding citalopram (CTP) to methylphenidate (MPH) in the treatment of chronic severe irritability in youth using a double-blind randomized placebo-controlled design. METHOD: After a lead-in phase of open treatment with stimulant, 53 youth meeting criteria for severe mood dysregulation (SMD) were randomly assigned to receive CTP or placebo (PBO) for 8 weeks. A total of 49 participants, 48 of them (98%) meeting disruptive mood dysregulation disorder (DMDD) criteria, were included in the intent-to-treat analysis. The primary outcome measure was the proportion of response based on improvements of irritability at the week 8 of the trial. RESULTS: At the end of the trial, a significantly higher proportion of response was seen in those participants randomly assigned to CTP+MPH compared to PBO+MPH (35% CTP+MPH versus 6% PBO+MPH; odds ratio = 11.70, 95% CI = 2.00-68.16, p = 0.006). However, there were no differences in functional impairment between groups at the end of the trial. No differences were found in any adverse effect between treatment groups, and no trial participant exhibited hypomanic or manic symptoms. CONCLUSION: Adjunctive CTP might be efficacious in the treatment of chronic severe irritability in youth resistant to stimulant treatment alone. CLINICAL TRIAL REGISTRATION INFORMATION: A Controlled Trial of Serotonin Reuptake Inhibitors Added to Stimulant Medication in Youth With Severe Mood Dysregulation; https://clinicaltrials.gov; NCT00794040.