Clinical trial management: a profession in crisis?

Clinical trial managers play a vital role in the design and conduct of clinical trials in the UK. There is a current recruitment and retention crisis for this specialist role due to a complex set of factors, most likely to have come to a head due to the COVID-19 pandemic. Academic clinical trial units and departments are struggling to recruit trial managers to vacant positions, and multiple influences are affecting the retention of this highly skilled workforce. Without tackling this issue, we face major challenges in the delivery on the Department of Health and Social Care's Future of UK Clinical Research Delivery implementation plan. This article, led by a leading network of and for UK Trial Managers, presents some of the issues and ways in which national stakeholders may be able to address this.

Lateral Domal Translocation and Medial Crural Transection: A Reliable Method for Nasal Tip Deprojection.

SUMMARY: Nasal tip deprojection is a common goal in rhinoplasty. Several techniques have been described, many of which require destructive techniques that compromise the intrinsic integrity and morphology of the lateral crura. Through lateral translocation of the domes and shortening of the medial crura, nasal tip deprojection can be achieved without disrupting the integrity of the lateral crura. The domes are recreated lateral to the intrinsic domes with a standard transdomal suture, and excess length of the middle and medial crura is managed through transection and shortening of the medial crura. This technique preserves the morphology of the nasal base without altering the position of the medial crural footplates. Deprojection of 4 to 5 mm can be readily achieved with this technique.

A Simplified Approach to Nasal Tip Shaping: The Five-Suture Technique.

Techniques for nasal tip shaping have evolved from destructive to nondestructive techniques. These techniques have proven to be effective, yet they are often applied incrementally and require repeated intraoperative evaluation and manipulation to assess their efficacy. We describe a simple, effective, and reliable five-suture technique to achieve consistent results in tip shaping based on previously described ideals for nasal tip aesthetics.

Extended Alar Contour Grafts: An Evolution of the Lateral Crural Strut Graft Technique in Rhinoplasty.

Modification of the lower lateral cartilage complex is the sine qua non of modern rhinoplasty, and the open approach to rhinoplasty has expanded the number of techniques available to help achieve an aesthetically pleasing tip. The ideal tip has been described as having a diamond-shaped configuration, with the lateral points formed by the tip-defining points, the superior point by the supratip, and the inferior point by the columellar break point. Over the years, various techniques have been described to minimize isolation of the tip and to help achieve the ideal tip configuration: lateral crural strut grafts, alar contour grafts (i.e., rim grafts), alar strut grafts, subdomal grafts, and suturing techniques such as alar flaring sutures. The authors present their technique of the extended alar contour graft, which represents an evolution of the lateral crural strut graft and its marriage with the alar contour graft. Lateral crural abnormalities do not usually occur singularly, but rather are the result of an interplay of several factors. Nevertheless, the recurring theme of orientation and alar support to prevent isolation of the tip by extended alar grooves remains. Extended alar contour grafts are a versatile technique to optimize tip shape and orientation by combining the many positive attributes of lateral crural strut grafts and alar contour grafts.

Visual sign phonology: insights into human reading and language from a natural soundless phonology.

Among the most prevailing assumptions in science and society about the human reading process is that sound and sound-based phonology are critical to young readers. The child's sound-to-letter decoding is viewed as universal and vital to deriving meaning from print. We offer a different view. The crucial link for early reading success is not between segmental sounds and print. Instead the human brain's capacity to segment, categorize, and discern linguistic patterning makes possible the capacity to segment all languages. This biological process includes the segmentation of languages on the hands in signed languages. Exposure to natural sign language in early life equally affords the child's discovery of silent segmental units in visual sign phonology (VSP) that can also facilitate segmental decoding of print. We consider powerful biological evidence about the brain, how it builds sound and sign phonology, and why sound and sign phonology are equally important in language learning and reading. We offer a testable theoretical account, reading model, and predictions about how VSP can facilitate segmentation and mapping between print and meaning. We explain how VSP can be a powerful facilitator of all children's reading success (deaf and hearing)-an account with profound transformative impact on learning to read in deaf children with different language backgrounds. The existence of VSP has important implications for understanding core properties of all human language and reading, challenges assumptions about language and reading as being tied to sound, and provides novel insight into a remarkable biological equivalence in signed and spoken languages. WIREs Cogn Sci 2016, 7:366-381. doi: 10.1002/wcs.1404 For further resources related to this article, please visit the WIREs website.

Spirituality and personality: understanding their relationship to health resilience.

A growing body of research suggests there are important relationships among spirituality, certain personality traits, and health (organismic) resilience. In the present study, 83 college students from two southeastern universities completed a demographic questionnaire, the NEO Five Factor Inventory, and the Resilience Questionnaire. The Organismic resilience and Relationship with something greater subscales of the Resilience Questionnaire were used for analyses. Health resilience was associated with four of the Big Five personality variables and the spirituality score. Health resilience was positively correlated with ratings of extraversion, agreeableness, conscientiousness, and spirituality and negatively correlated with neuroticism. Forty-three percent of the variance of the health resilience score was accounted for by two of the predictor variables: spirituality and neuroticism. These findings are consistent with the literature and provide further support for the idea that spirituality and health protective personality characteristics are related to and may promote better health resilience.

Use of the ultrasonic bone aspirator for lateral osteotomies in rhinoplasty.

UNLABELLED: There remains considerable debate over the optimal method and approach to performing lateral osteotomies. Current methods rely on mechanical energy for performance of osteotomies, which can lead to soft-tissue injury and/or disruption of the bony or cartilaginous framework. The authors report the novel use of an ultrasonic bone aspirator device for performance of lateral osteotomies in rhinoplasty. The authors have found this technology to be safe and effective in a series of five consecutive patients. The main benefits of the device include avoidance of soft-tissue/mucosal injury, minimal bleeding/bruising, and the ability to avoid mechanical force to create bony cuts, which can destabilize the bony and/or cartilaginous construct of the nose. Being able to minimize tissue trauma with its associated morbidity while maintaining efficacy makes the ultrasonic bone aspirator an attractive option for lateral osteotomies in rhinoplasty that warrants further investigation. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Correlation of abdominal rSO2 with superior mesenteric artery velocities in preterm infants.

OBJECTIVE: Near-infrared spectroscopy (NIRS) is used to monitor brain and kidney perfusion in at-risk premature and term neonates. Although NIRS holds potential for bedside monitoring of intestinal perfusion, there is insufficient evidence showing correlation with mesenteric blood flow. To determine if an association exists between abdominal regional oxygen saturation (A-rSO2) and mesenteric blood flow, we compared changes in A-rSO2 to changes in blood flow velocity in the superior mesenteric artery (SMA) before and after feedings in very-low birthweight infants. STUDY DESIGN: A-rSO2 was continuously monitored midline below the umbilicus for 3 days in 18 stable 25 to 31 week bolus-fed infants (median BW 1203 g, median age 5 days). We compared change in SMA velocity from immediately before to 10 min and 60 to 120 min after feeding with change in A-rSO2 over the same time. Spearman's rank correlation was used to ascertain if a significant association existed. RESULT: Change in A-rSO2 was significantly associated with change in systolic, diastolic, and mean SMA velocity from fasting to 60 to 120 min after feeding (P=0.016, 0.021, 0.010) and from 10 min after a feed to 60 to 120 min after feeding (P=0.009, 0.035, 0.032). CONCLUSION: In very preterm infants, A-rSO2 reflects blood flow in the SMA and can provide non-invasive continuous monitoring of intestinal perfusion. Further studies are indicated to determine the sensitivity of NIRS to detect early intestinal pathology in this population.

Conservative treatment for urinary incontinence in Men After Prostate Surgery (MAPS): two parallel randomised controlled trials.

OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of active conservative treatment, compared with standard management, in regaining urinary continence at 12 months in men with urinary incontinence at 6 weeks after a radical prostatectomy or a transurethral resection of the prostate (TURP). BACKGROUND: Urinary incontinence after radical prostate surgery is common immediately after surgery, although the chance of incontinence is less after TURP than following radical prostatectomy. DESIGN: Two multicentre, UK, parallel randomised controlled trials (RCTs) comparing active conservative treatment [pelvic floor muscle training (PFMT) delivered by a specialist continence physiotherapist or a specialist continence nurse] with standard management in men after radial prostatectomy and TURP. SETTING: Men having prostate surgery were identified in 34 centres across the UK. If they had urinary incontinence, they were invited to enroll in the RCT. PARTICIPANTS: Men with urinary incontinence at 6 weeks after prostate surgery were eligible to be randomised if they consented and were able to comply with the intervention. INTERVENTIONS: Eligible men were randomised to attend four sessions with a therapist over a 3-month period. The therapists provided standardised PFMT and bladder training for male urinary incontinence and erectile dysfunction. The control group continued with standard management. MAIN OUTCOME MEASURES: The primary outcome of clinical effectiveness was urinary incontinence at 12 months after randomisation, and the primary measure of cost-effectiveness was incremental cost per quality-adjusted life-year (QALY). Outcome data were collected by postal questionnaires at 3, 6, 9 and 12 months. RESULTS: Within the radical group (n = 411), 92% of the men in the intervention group attended at least one therapy visit and were more likely than those in the control group to be carrying out any PFMT at 12 months {adjusted risk ratio (RR) 1.30 [95% confidence interval (CI) 1.09 to 1.53]}. The absolute risk difference in urinary incontinence rates at 12 months between the intervention (75.5%) and control (77.4%) groups was -1.9% (95% CI -10% to 6%). NHS costs were higher in the intervention group [£ 181.02 (95% CI £ 107 to £ 255)] but there was no evidence of a difference in societal costs, and QALYs were virtually identical for both groups. Within the TURP group (n = 442), over 85% of men in the intervention group attended at least one therapy visit and were more likely to be carrying out any PFMT at 12 months after randomisation [adjusted RR 3.20 (95% CI 2.37 to 4.32)]. The absolute risk difference in urinary incontinence rates at 12 months between the intervention (64.9%) and control (61.5%) groups for the unadjusted intention-to-treat analysis was 3.4% (95% CI -6% to 13%). NHS costs [£ 209 (95% CI £ 147 to £ 271)] and societal costs [£ 420 (95% CI £ 54 to £ 785)] were statistically significantly higher in the intervention group but QALYs were virtually identical. CONCLUSIONS: The provision of one-to-one conservative physical therapy for men with urinary incontinence after prostate surgery is unlikely to be effective or cost-effective compared with standard care that includes the provision of information about conducting PFMT. Future work should include research into the value of different surgical options in controlling urinary incontinence.

Auricular cartilage: harvest technique and versatility in rhinoplasty.

OBJECTIVES/HYPOTHESIS: This study aims to present an improved technique for auricular cartilage harvest that maximizes graft volume while preserving auricular cosmesis. Also discussed is the versatility of auricular cartilage utilization in rhinoplasty. STUDY DESIGN: A retrospective review of a single surgeon's experience. METHODS: All auricular cartilage harvest and rhinoplasty operations performed by the senior author (CSC) from December 2006 through December 2009 cartilage were reviewed. RESULTS: Twenty-two cases were identified in which the described technique was used to harvest auricular cartilage for the purpose of functional or aesthetic rhinoplasty. There was sufficient tissue harvested in all operations, and no patients required costal cartilage harvest. Pain at the donor site after surgery was minimal and well controlled with oral medication. There were no donor-site complications and no cases of wound infection. CONCLUSIONS: The proposed technique allows for optimal auricular cartilage harvest. By applying this method, the ear retains the preoperative appearance while the surgeon is able to obtain the largest graft possible. Auricular cartilage is a versatile source of grafting material in primary and secondary rhinoplasty.

Secondary rhinoplasty and the use of autogenous rib cartilage grafts.

Postoperative rhinoplasty deformities--such as displacement or distortion of anatomic structures, inadequate surgery resulting in under-resection of the nasal framework, or over-resection caused by overzealous surgery--require a secondary rhinoplasty. Success in secondary rhinoplasty, therefore, relies on an accurate clinical diagnosis and analysis of the nasal deformities, a thorough operative plan to address each abnormality, and a meticulous surgical technique. Septal cartilage is the grafting material of choice for rhinoplasty; however, auricular cartilage and rib cartilage are used in secondary rhinoplasty. This article discusses the steps involved in the external approach to secondary rhinoplasty.

Current concepts in the postoperative care of the rhinoplasty patient.

This is a systematic review of the available literature and our own personal experience regarding the optimal management of the rhinoplasty patient. The routine utilization of nasal splinting, casting and perioperative antibiotics is supported. The management of a number of common early complications is also discussed. Meticulous technique based on sound structural principles and coupled with preoperative planning and attention to wound care will result in a favorable outcome in most individuals undergoing rhinoplasty.

Prevention and management of rhinoplasty complications.

LEARNING OBJECTIVES: After studying this article, the participant should be able to: 1. Identify potential hemorrhagic, infectious, traumatic, functional, or aesthetic complications arising from rhinoplasty. 2. Gain a better understanding of the prevention of these complications. 3. Have a thorough knowledge of the principles of postoperative management of these complications, so as to minimize their deleterious effects and preserve aesthetic outcomes in rhinoplasty. SUMMARY: Meticulous attention to detail in the operating room and in the postoperative period is paramount to achieving success in rhinoplasty. Nevertheless, both complications and suboptimal results do occur, even for experienced surgeons.

Tragal cartilage grafts in rhinoplasty: a viable alternative in the graft-depleted patient.

OBJECTIVE: To describe a simple technique for harvesting tragal cartilage and describe its use in rhinoplasty. STUDY DESIGN: Retrospective review. SUBJECTS AND METHODS: Rhinoplasties performed between January 2005 and June 2007 in which tragal cartilage grafts were utilized by the senior author (CSC) were reviewed to assess type of graft, preservation of tragal contour, and donor-site morbidity. RESULTS: Tragal cartilage grafts were used in three primary and three secondary rhinoplasty patients. Postoperative follow-up ranged from six months to 12 months. Tragal cartilage was used as five alar contour grafts, one lateral crural onlay graft, one dorsal onlay graft, and one infratip lobule graft. Tragal cartilage was used to close the septal perforation of one patient. Tragal contour was preserved in all patients, and there were no complications noted with this procedure. CONCLUSION: The tragus provides a simple, convenient alternative source of cartilage for rhinoplasty in graft-depleted patients.

Dorsal augmentation with autogenous rib cartilage.

Reconstruction of the nasal osseocartilaginous framework is the foundation of successful primary and secondary rhinoplasty. When adequate septal cartilage is unavailable, the rib provides the most abundant source of cartilage for graft fabrication and is the most reliable when structural support is needed. We present the senior author's (J.P.G.) experience and evolution of techniques of dorsal augmentation with autogenous rib cartilage grafts with internal K-wire stabilization in rhinoplasty.

Insulinoma induced hypoglycaemia in a Jamaican patient.

Herein reported is the case of a young woman who had hyperinsulinaemic hypoglycaemia which was biochemically consistent with an insulinoma. Initial imaging was negative and definitive treatment was delayed until repeat imaging localized the tumour several years later. This case demonstrates the importance of clinical judgment and biochemical testing in the diagnosis of insulinoma despite negative imaging.

External auditory canal hemangioma: case report.

A patient with a hemangioma completely within the external auditory canal is reported.

Restorative rhinoplasty in the aging patient.

OBJECTIVE: The objective of this study is to review our favorable experience in performing rhinoplasty in aging patients. METHODS: All patients aged 65 years or greater who underwent rhinoplasty, either esthetic or functional, by the senior author (Y.D.) from August 1997 to July 2005 with a minimum follow up of 1 year were retrospectively reviewed. RESULTS: A total of 51 patients met the inclusion criteria and had complete records available for review. The average age was 69.5 years (range, 65-82 years) with 24 female and 27 male patients. All but two patients underwent open rhinoplasty. Eighteen procedures represented secondary rhinoplasties. Seven patients required auricular cartilage grafts, and 11 patients required costal cartilage grafts. One costal cartilage graft was aborted as a result of excessive calcification. All patients underwent columellar strut placement, 92% underwent internal valve grafts, and 80.4% underwent grafting of the external nasal valves. Nasal osteotomies were performed in only 23.5% of patients, all with the percutaneous technique. Revision surgery was necessary in only three (5.8%) patients, all of whom required grafting of the external valve (not performed primarily). In each of these cases, no significant external valve collapse was noted preoperatively. Premaxillary augmentation with diced or crushed cartilage grafts was performed in 81.8% (n = 18) of patients with an edentulous maxillary arch. CONCLUSIONS: Aging patients present unique technical challenges in rhinoplasty that warrant a comprehensive approach to restore internal and external valve competency and tip support. Consideration of prophylactic external valve grafts in addition to the routine use of internal valve grafts and columellar struts may help decrease the need for revision surgery in this patient population. Reasonable functional and esthetic outcomes can be expected in the aging patient.

Rethinking nasal osteotomies: an anatomic approach.

OBJECTIVES: To review our experience with our anatomic (medial, transverse, and lateral) nasal osteotomy technique for correcting the asymmetric bony nasal vault in esthetic and functional rhinoplasty. METHODS: All patients undergoing anatomic nasal osteotomy technique by the senior author (y.d.) from August 1997 to August 2005 with a minimum follow-up of 6 months were reviewed. Preoperative and postoperative photographs and clinical examination were analyzed to determine restoration of a symmetric bony nasal vault configuration. RESULTS: A total of 322 patients met the inclusion criteria. Percent of patients who had favorable results with restoration of a symmetric bony nasal vault configuration was 98.1%. Six (1.9%) patients required revision surgery at the level of the nasal bones with repeat osteotomies or dorsal rasping. All six of these patients had favorable outcomes after revision surgery. CONCLUSIONS: The anatomic nasal osteotomy technique represents an effective, simple, and logical approach for correcting asymmetric bony nasal vault.