Psychometric Validation of the CLEFT-Q Patient Reported Outcome Measure: A Prospective Study to Examine Cross-Sectional Construct Validity.

OBJECTIVE: CLEFT-Q is a condition-specific patient-reported outcome measure (PROM) for patients with cleft lip and/or palate (CL/P). The aim of this study was to examine the cross-sectional construct validity of the CLEFT-Q scales. DESIGN: Construct validity was assessed through a prospective study that tested hypotheses regarding correlations of scores with other PROMs that measure related constructs. SETTING: Seven cleft centres in Canada, the USA, and UK were involved. PATIENTS/PARTICIPANTS: Patients were aged eight to 29 years with CL/P. INTERVENTIONS: Before undergoing rhinoplasty, orthognathic, cleft lip scar revision, and alveolar bone graft, participants were asked to complete the following PROMs: CLEFT-Q (9 scales), Child Oral Health Impact Profile (socio-emotional subscale) and Cleft Hearing Appearance and Speech Questionnaire (features 1 subscale). MAIN OUTCOME MEASURE(S): The correlation coefficients examining the relationship between the scales were the main outcome measures. Correlations (Spearman) were calculated and interpreted as follows: <0.3 weak, 0.30 to 0.50 moderate, ≥0.50 strong. RESULTS: Participants (n = 177) were mostly male (61%) and aged between eight and 11 years (42%). Overall, 38 of 52 (73%) hypotheses tested were supported. More specifically, 20 of 26 (77%) hypotheses about correlations between the appearance scales were supported, two of three (67%) hypotheses about correlations between the health-related quality of life scales were supported, and 16 of 23 (70%) hypotheses about correlations between the appearance and health-related quality of life scales were supported. CONCLUSIONS: Cross-sectional construct validity of the CLEFT-Q scales adds further evidence of the psychometric properties of this instrument.

Surgical Performance Anxiety and Wellbeing Among Surgeons: A Cross-sectional Study in the United Kingdom.

OBJECTIVE: This national cross-sectional study aims to establish the prevalence and potential impact of performance anxiety among surgeons and investigate its association with psychological traits and wellbeing. SUMMARY AND BACKGROUND DATA: Despite a growing awareness that human factors, non-technical skills and wellbeing in healthcare affect patient outcomes, an area that has remained unexplored is surgical performance anxiety (SPA). METHODS: A prospectively registered, cross-sectional study using mixed methods was conducted across the United Kingdom. Data captured included demographics, surgical specialty, trait anxiety, trait perfectionism, SPA, and surgical perfectionism scores. Wellbeing was assessed using The Short Warwick-Edinburgh Mental Wellbeing Scale, whereas qualitative data were collected regarding surgeons' experiences of SPA. RESULTS: A total of 631 responses were collected. Mean age was 41·2 years and mean surgical experience 15·3 years. A total of 62% were male and 52% of consultant/attending grade. A total of 100% felt that SPA affected surgeons, with 87% having experienced it themselves. A total of 65% reported SPA negatively impacted surgical performance and 96% felt SPA negatively impacted surgeons' wellbeing. Male surgeons reported significantly better wellbeing than female surgeons. Surgeons with SPA reported significantly worse wellbeing compared with surgeons who did not experience SPA. Surgeons in general experienced significantly lower mental wellbeing compared with population norms. Thematic analysis highlighted a reticence to share SPA openly and need for cultural change. CONCLUSIONS: Surgical performance anxiety is a very common and significant challenge among surgeons across all specialties at all levels of experience in the United Kingdom. It is perceived by surgeons to affect surgical performance adversely and is associated with worse psychological wellbeing. A more open culture of sharing and acknowledgment has been identified to be beneficial.

The Effects of Maternal Mirroring on the Development of Infant Social Expressiveness: The Case of Infant Cleft Lip.

Parent-infant social interactions start early in development, with infants showing active communicative expressions by just two months. A key question is how this social capacity develops. Maternal mirroring of infant expressions is considered an important, intuitive, parenting response, but evidence is sparse in the first two months concerning the conditions under which mirroring occurs and its developmental sequelae, including in clinical samples where the infant's social expressiveness may be affected. We investigated these questions by comparing the development of mother-infant interactions between a sample where the infant had cleft lip and a normal, unaffected, comparison sample. We videotaped dyads in their homes five times from one to ten weeks and used a microanalytic coding scheme for maternal and infant behaviours, including infant social expressions, and maternal mirroring and marking responses. We also recorded maternal gaze to the infant, using eye-tracking glasses. Although infants with cleft lip did show communicative behaviours, the rate of their development was slower than in comparison infants. This group difference was mediated by a lower rate of mirroring of infant expressions by mothers of infants with cleft lip; this effect was, in turn, partly accounted for by reduced gaze to the infant's mouth, although the clarity of infant social expressions (indexed by cleft severity) and maternal self-blame regarding the cleft were also influential. Results indicate the robustness of parent-infant interactions but also their sensitivity to specific variations in interactants' appearance and behaviour. Parental mirroring appears critical in infant social development, likely supported by the mirror neuron system and underlying clinical and, possibly, cultural differences in infant behaviour. These findings suggest new avenues for clinical intervention.

17p13.3 microduplication, a potential novel genetic locus for nonsyndromic bilateral cleft lip and palate.

Cleft lip and palate (CLP) is a relatively common congenital malformation. The etiology is complex and postulated to be a combination of genetic and environmental factors. The genetic loci for nonsyndromic CLP remain poorly characterized. Two families have recently been reported with a chromosome 17p13.3 microduplication and CLP. We report a third family with four individuals affected by nonsyndromic bilateral CLP and a 350-kb chromosome 17p13.3 microduplication (17:1,113,102-1,461,838). Our family possesses the smallest overlapping chromosome 17p13.3 microduplication associated with CLP, narrowing down the critical region for this potential new genetic locus for CLP.

The pectus care guidelines: best practice consensus guidelines from the joint specialist societies SCTS/MF/CWIG/BOA/BAPS for the treatment of patients with pectus abnormalities.

Pectus defects are a group of congenital conditions found in approximately 1 in 250 people, where the sternum is depressed back towards the spine (excavatum), protrudes forwards (carinatum) or more rarely is a mixture of both (arcuatum or mixed defects). For the majority of patients, it is well tolerated, but some patients are affected psychologically, physiologically or both. The deformity becomes apparent at a young age due to the growth of the ribs and the cartilage that links them to the sternum. The majority of defects are mild and are well tolerated, i.e. they do not affect activity and do not cause psychological harm. However, some young people develop lower self-esteem and depression, causing them to withdraw from activities (such as swimming, dancing) and from interactions that might 'expose' them (such as sleepovers, dating, going to the beach and wearing fashionable clothes). This psychological harm occurs at a crucial time during their physical and social development. A small number of patients have more extreme depression of their sternum that impedes their physiological reserve, which can occur when engaging in strenuous exercise (such as running) but can also limit moderate activity such as walking and climbing stairs. The effects can be so extreme that symptoms occur at rest or cause life-threatening compression of the major blood vessels and organs. The group of patients with physiological impairment usually also suffer from low self-esteem and depression. This paper summarizes the current evidence for the different treatment strategies for this condition, including supportive care, psychological support and non-surgical techniques including bracing and vacuum bell therapy. We also consider surgical techniques including the Ravitch procedure, the Nuss procedure (minimally invasive repair of pectus excavatum), pectus implants and other rare procedures such as Pectus Up. For the majority of patients, supportive care is sufficient, but for a minority, a combination of the other techniques may be considered. This paper also outlines best practice guidance for the delivery of such therapies, including standardized assessment, consent to treatment, audit, quality assurance and long-term support. All the interventions have risks and benefits that the patient, parents and clinicians need to carefully consider and discuss when deciding on the most appropriate course. We hope this evidence review of 'Best Practice for Pectus' will make a significant contribution to those considerations and help all involved, from patients to national policy makers, to deliver the best possible care.

Application of human factors at hybrid meetings: facilitating productivity and inclusivity.

The COVID-19 pandemic has resulted in the widespread use of virtual meetings and conferences. As the healthcare sector attempts to return to normality, face-to-face meetings have started to resume. However, ongoing travel restrictions, risk of viral transmission, the Omicron variant, and requirements for self-isolation, have necessitated the use of novel hybrid meeting formats. These enable participants to attend either in person or virtually using various online platforms such as Microsoft Teams and Zoom. Well organised and facilitated hybrid meetings can combine the advantages of in-person meetings with virtual participation, although the dynamics of communication between attendees is considerably different. This article discusses the benefits and pitfalls of the hybrid format, the human factors that impact productivity and inclusivity, and how to address them in future meetings.

The effect of cleft lip on cognitive development in school-aged children: a paradigm for examining sensitive period effects.

BACKGROUND: Our previous investigation showed that infants with cleft lip who had undergone late (three-month) surgical repair (but not those with early, neonatal, repair) had significantly poorer cognitive development at 18 months than a group of unaffected control children. These differences were mediated by the quality of early mother-infant interactions. The present study examined whether this pattern persisted into later childhood. METHOD: At 7 years, 93 index (44 early, and 49 late repair) and 77 control children were followed up and their cognitive development assessed (IQ, language and school achievements). RESULTS: Index children (particularly those with late lip repair) scored significantly lower than controls on tests of cognitive development. Group differences in Verbal IQ were mediated by 2 months' maternal sensitivity; this was associated with 7-year Verbal IQ, even after controlling for later mother-child interactions. CONCLUSIONS: Social interactions in the first few months may be of especial importance for child cognitive development. Interventions for infants with cleft lip should be directed at fostering the best possible parental care in infancy.

FACE-Q Craniofacial Module: Part 1 validation of CLEFT-Q scales for use in children and young adults with facial conditions.

BACKGROUND: The CLEFT-Q includes 12 independently functioning scales that measure appearance (face, nose, nostrils, teeth, lips, jaws), health-related quality of life (psychological, social, school, speech distress), and speech function, and an eating/drinking checklist. Previous qualitative research revealed that the CLEFT-Q has content validity in noncleft craniofacial conditions. This study aimed to examine the psychometric performance of the CLEFT-Q in an international sample of patients with a broad range of facial conditions. METHODS: Data were collected between October 2016 and December 2019 from 2132 patients aged 8 to 29 years with noncleft facial conditions. Rasch measurement theory (RMT) analysis was used to examine Differential Item Function (DIF) by comparing the original CLEFT-Q sample and the new FACE-Q craniofacial sample. Reliability and validity of the scales in a combined cleft and craniofacial sample (n=4743) were examined. RESULTS: DIF was found for 23 CLEFT-Q items when the datasets for the two samples were compared. When items with DIF were split by sample, correlations between the original and split person locations showed that DIF had negligible impact on scale scoring (correlations ≥0.995). In the combined sample, RMT analysis led to the retention of original content for ten CLEFT-Q scales, modification of the Teeth scale, and the addition of an Eating/Drinking scale. Data obtained fit with the Rasch model for 11 scales (exception School, p=0.04). Person Separation Index and Cronbach alpha values met the criteria. CONCLUSION: The scales described in this study can be used to measure outcomes in children and young adults with cleft and noncleft craniofacial conditions.

The effect of cleft lip on socio-emotional functioning in school-aged children.

BACKGROUND: Children with cleft lip are known to be at raised risk for socio-emotional difficulties, but the nature of these problems and their causes are incompletely understood; longitudinal studies are required that include comprehensive assessment of child functioning, and consideration of developmental mechanisms. METHOD: Children with cleft lip (with and without cleft palate) (N = 93) and controls (N = 77), previously studied through infancy, were followed up at 7 years, and their socio-emotional functioning assessed using teacher and maternal reports, observations of social interactions, and child social representations (doll play). Direct and moderating effects of infant attachment and current parenting were investigated, as was the role of child communication difficulties and attractiveness. RESULTS: Children with clefts had raised rates of teacher-reported social problems, and anxious and withdrawn-depressed behaviour; direct observations and child representations also revealed difficulties in social relationships. Child communication problems largely accounted for these effects, especially in children with cleft palate as well as cleft lip. Insecure attachment contributed to risk in both index and control groups, and a poorer current parenting environment exacerbated the difficulties of those with clefts. CONCLUSIONS: Children with clefts are at raised risk for socio-emotional difficulties in the school years; clinical interventions should focus on communication problems and supporting parenting; specific interventions around the transition to school may be required. More generally, the findings reflect the importance of communication skills for children's peer relations.

Further construct validation of the CLEFT-Q: Ability to detect differences in outcome for four cleft-specific surgeries.

BACKGROUND: The CLEFT-Q is a patient-reported outcome measure developed for use in patients with cleft lip and/or palate. A significant indicator of the CLEFT-Q's validity relates to its ability to detect differences between the impact of specific aspects of clefting before and after surgery. This study compares relevant sub-scale scores of the CLEFT-Q for patients requiring four specific surgical treatments against those who either have had surgery or never needed surgery. METHODS: CLEFT-Q scores and clinical information regarding the past and future need for jaw surgery, lip revision, rhinoplasty, and speech surgery were obtained from the CLEFT-Q field-test data. Eight one-way analysis of variance (ANOVA) models were developed to compare mean scores of relevant CLEFT-Q scales between those who needed surgery, those who have had surgery, and those who never needed surgery. Only patients from high-income countries were included to minimize the impact of any economic confounders that could result in treatment variation. In the rhinoplasly and lip revision models, patients without a cleft lip were excluded. In the jaw surgery and speech surgery models, patients without a cleft palate or alveolus were excluded. RESULTS: The CLEFT-Q field test included 1938 participants from high-income countries. Participants who needed surgery scored significantly lower (worse) than those who have had surgery in each of the eight relevant CLEFT-Q scales (p < 0.001 in each ANOVA). CONCLUSION: The ability of the CLEFT-Q to detect differences between groups based on surgical status further supports its validity.

CLEFT-Q: Detecting Differences in Outcomes among 2434 Patients with Varying Cleft Types.

BACKGROUND: Measuring the patient perspective is important in evaluating outcomes of cleft care. Understanding how treatment outcomes vary depending on cleft type may allow for better planning of treatments, setting of expectations, and more accurate benchmarking efforts. The CLEFT-Q is a patient-reported outcome measure for patients with cleft lip and/or palate. METHODS: The 12 CLEFT-Q scales measuring appearance (i.e., face, nose, nostrils, lips, cleft lip scar, teeth, and jaws), function (i.e., speech), and health-related quality of life (i.e., psychological, school, social, and speech-related distress) were field tested in a cross-sectional study in 30 centers in 12 countries. Patients with cleft lip and/or cleft palate aged 8 to 29 years were recruited from clinical settings. Differences in CLEFT-Q scores by cleft subtypes were evaluated using one-way analysis of variance or Kruskal-Wallis H tests, with Tukey or Dunn procedure with Bonferroni corrections post hoc analyses, respectively. Scores are presented using radar charts to visualize all outcomes simultaneously. RESULTS: The field test included 2434 patients. Scores on all CLEFT-Q scales varied significantly with cleft subtype. Patients with unilateral or bilateral cleft lip and/or palate scored lower on all appearance scales compared with patients with cleft palate or unilateral incomplete cleft lip. Scores on the speech function and speech-related distress scales decreased with each progressive group in the Veau classification. Patients with complete bilateral cleft lip and palate scored lowest on the social, school, and psychological scales. CONCLUSIONS: Patient-reported outcomes measured with the CLEFT-Q vary significantly with cleft type. Visualizing multiple outcomes simultaneously with radar charts allows for an understanding of a patient's overall status in a single graph.

The effect of cleft lip and palate, and the timing of lip repair on mother-infant interactions and infant development.

BACKGROUND: Children with cleft lip and palate are at risk for psychological problems. Difficulties in mother-child interactions may be relevant, and could be affected by the timing of lip repair. METHOD: We assessed cognitive development, behaviour problems, and attachment in 94 infants with cleft lip (with and without cleft palate) and 96 non-affected control infants at 18 months; mother-infant interactions were assessed at two, six and 12 months. Index infants received either 'early', neonatal, lip repair, or 'late' repair (3-4 months). RESULTS: Index infants did not differ from controls on measures of behaviour problems or attachment, regardless of timing of lip repair; however, infants having late lip repair performed worse on the Bayley Scales of Mental Development; the cognitive development of early repair infants was not impaired. Difficulties in early mother-infant interactions mediated the effects of late lip repair on infant cognitive outcome. CONCLUSIONS: Early interaction difficulties between mothers and infants having late repair of cleft lip are associated with poor cognitive functioning at 18 months. Interventions to facilitate mother-infant interactions prior to surgical lip repair should be explored.

A Comparative Study of the Aesthetic Outcome of Two Techniques for Unilateral Complete Cleft Lip Repair.

BACKGROUND: Cleft lip repair aims to create symmetric nasolabial morphology with minimal scarring. Poor aesthetic outcomes may have damaging psychosocial implications. Determining the optimal method of recreating lip symmetry is a major goal of applied cleft clinical research. This study aims to determine whether subjective assessment could differentiate aesthetic outcome between two surgeons who use two different surgical techniques for unilateral cleft lip repair. METHODS: Surgeon A uses a modified rotation-advancement technique incorporating a supra-white roll flap and Noordhoff-style vermilion flap. Surgeon B uses an upper and lower triangle technique. Neither surgeon used presurgical orthopedics. Five-year postoperative frontal photographs (cropped according to the Asher-McDade aesthetic index) were analyzed by a panel of 40 blinded surgical and lay reviewers using a five-point Likert scale. The assessments were repeated after a 2-week interval to assess intrarater reliability. RESULTS: Thirty-nine consecutive complete unilateral cleft lip and palate patients were assessed for each surgeon. The mean Likert score for surgical/lay assessors was 3.07/3.00 for surgeon A and 2.67/2.61 for surgeon B. This difference was statistically significant (p < 0.05). The interrater reliability was excellent and the intrarater reliability was fair. There was good correlation between lay and surgical assessors. CONCLUSION: Subjective assessment of clinical photography provides a reliable method of differentiating aesthetic outcome after unilateral cleft lip repair and presents a rapid and straightforward clinically relevant method of comparing surgical outcomes.

Maternal gaze to the infant face: Effects of infant age and facial configuration during mother-infant engagement in the first nine weeks.

BACKGROUND: Adult gaze plays an important role in early infant development, and infants are highly sensitive to its presence and direction. Little is known, however, about how adults look at infants while interacting with them. Using eye-tracking technology, this study investigated maternal gaze during naturalistic interactions, and how it was influenced by infant age, focusing on the transition from the first to the second month when social expressiveness emerges, and by infant facial configuration, focusing on the effect of cleft lip. METHODS: Thirty infants (10 with a cleft lip), and their mothers, were seen at 1, 3, 5, 7, and 9 weeks. Mothers were asked to interact with their infants while wearing eye-tracking glasses. Fixation duration and count were calculated for general (infant face, body, and surrounding environment), and infant facial (eyes, mouth, other) areas. RESULTS: At all ages, mothers gazed almost exclusively towards their infant's face, but this was reduced in the presence of a cleft lip. Within the infant's face, the eyes attracted the greatest attention, for all mothers, at all ages. From the first to the second month, all mothers increased their visual attention towards their infant's mouth. Regardless of infant age, the presence of a cleft lip was associated with decreased maternal gaze to the infant's mouth. CONCLUSIONS: This study provides novel findings concerning maternal gaze to infant faces during naturalistic interactions. Maternal gaze changes with infant age, in line with established shifts in social development, and according to infant facial configuration. Decreased gaze to the mouth area associated with infant cleft lip might affect maternal responsiveness, and suggests new dimensions to target in supporting these mothers.

International multiphase mixed methods study protocol to develop a cross-cultural patient-reported outcome instrument for children and young adults with cleft lip and/or palate (CLEFT-Q).

INTRODUCTION: Patient-reported outcome (PRO) instruments should be developed according to rigorous guidelines in order to provide clinically meaningful, scientifically sound measurement. Understanding the methodology behind instrument development informs the selection of the most appropriate tool. This mixed methods protocol describes the development of an internationally applicable PRO instrument, the CLEFT-Q, for evaluating outcomes of treatment for cleft lip and/or palate (CL/P). METHODS AND ANALYSIS: The study includes three main phases that occur iteratively and interactively. In phase I, we determine what concepts are important to patients regarding their outcome. A conceptual framework for the CLEFT-Q is formed through a systematic review and an extensive international qualitative study. The systematic review ascertains what concepts have previously been measured in patients with CL/P. The qualitative study employs interpretive description and involves in-depth interviews with patients in high-income and lower-middle income countries. Preliminary items are generated from the qualitative data. Preliminary scales are then created for each theme in the framework. Cognitive debriefing interviews and expert clinician input are used to refine the scales in an iterative process. In phase II, the preliminary scales are administered to a large international group of patients with CL/P. The modern psychometric method of Rasch Measurement Theory analysis is employed to define the measurement characteristics. The preliminary scales are shortened based on these results. In phase III, further tests assess reliability, validity and responsiveness of the instrument. ETHICS AND DISSEMINATION: The study is approved by Research Ethics Boards for each participating site. Findings from this study will be published in open access peer-reviewed journals and presented at national and international conferences. Integrated knowledge translation is employed to engage stakeholders from the outset of the study. Successful execution of the CLEFT-Q will result in an internationally applicable PRO instrument for children and young adults with CL/P.

Establishing Content Validity of the CLEFT-Q: A New Patient-reported Outcome Instrument for Cleft Lip/Palate.

BACKGROUND: The CLEFT-Q is a new patient-reported outcome instrument designed to measure outcomes that matter to patients. The aim of this qualitative study was to establish content validity of the CLEFT-Q in patients who differ by age and culture. METHODS: Patients aged between 6 and 29 years were recruited from plastic surgery clinics in Canada, India, Ireland, the Philippines, the Netherlands and the United States. Healthcare providers and other experts participated in a focus group or provided individual feedback. Input was sought on all aspects of the CLEFT-Q (item wording, instructions, and response options), and to identify missing content. Patient interviews and expert feedback took place between September 2013 and September 2014. RESULTS: Sixty-nine patients and 44 experts participated. The first draft of the CLEFT-Q consisted of 163 items measuring 12 constructs. The first round of feedback identified 92 items that required revision. In total, 3 rounds of interviews, and the involvement of an artist to create pictures for 17 items, were needed to establish content validity. At the conclusion of cognitive interviews, the CLEFT-Q consisted of 13 scales (total 171 items) that measure appearance, health-related quality of life, and facial function. The mean Flesch-Kincaid readability statistic for items was 1.4 (0 to 5.2). CONCLUSION: Cognitive interviews and expert review allowed us to identify items that required re-wording, re-conceptualizing, or to be removed, as well as any missing items. This process was useful for refining the CLEFT-Q scales for further testing.

Trans-oral robotic cleft surgery (TORCS) for palate and posterior pharyngeal wall reconstruction: A feasibility study.

BACKGROUND/AIM: Robot-assisted surgery has become increasingly routine, replacing open and laparoscopic techniques in certain domains, with recent extension to head and neck surgery through trans-oral access. Some advantages of the robot-assisted surgery include the ability to access confined spaces, enhanced dexterity instrumentation with intuitive movement, motion scaling, tremor elimination and three-dimensional (3D) endoscopic viewing with true depth perception. The aim of this study was to investigate the technical feasibility of trans-oral robotic cleft surgery (TORCS) to access the posterior pharyngeal wall and palate for potential use in the cleft population. METHODS: All possible permutations of patient and robotic instrument configurations were used with the daVinci Si Surgical System® (Intuitive Surgical, USA) 0° and 30° 3D endoscopes and 8-mm training instruments to determine the optimal visualization and surgical access to the palate and posterior pharynx in a paediatric airway manikin, and to simulate posterior pharyngeal wall surgery. A full robot-assisted cadaveric Hynes pharyngoplasty was performed using 5-mm training instruments. Experiments were recorded with still and video photography. RESULTS: TORCS is technically feasible in the paediatric cleft population. We predict a short learning curve due to the intuitive instrumentation, easier dissection and the potential to limit secondary insult compared with traditional surgery, as well as improved ergonomics for the operating surgeon. CONCLUSIONS: The as-yet unreported use of robotic-assisted cleft palate surgery may considerably enhance a surgeon's ability to perform difficult procedures of the palate and posterior pharynx in selected patients with limited access as well as lay the foundation for potential novel techniques.

Use of autologous fat grafting for breast reconstruction: a systematic review with meta-analysis of oncological outcomes.

BACKGROUND: There is growing interest in the use of autologous fat grafting (AFG) for breast reconstruction. Concerns have been raised regarding its effectiveness and safety. OBJECTIVE: The primary objective was to determine the oncological, clinical, aesthetic and functional, patient reported, process and radiological outcomes of AFG. METHODS: A protocol was published on PROSPERO (CRD42013005254). Types of studies: All original studies. TYPES OF PARTICIPANTS: Women undergoing reconstruction after surgery for breast cancer. Types of Interventions: AFG techniques for reconstruction. Types of outcome measures: Oncological, clinical, aesthetic and functional, patient reported, process and radiological. Search terms and keywords: The search strategy was devised to find papers regarding AFG for breast reconstruction. DATA SOURCES: Electronic databases were searched from 1st January 1986 to 31st March 2014 including: PubMed, MEDLINE, EMBASE, SCOPUS, The Cochrane Library, and clinical trial registries. Identification and selection of studies: Title and abstract screening and full text assessment undertaken separately by independent researchers. Data extraction, collection and management: Data extracted by two researchers and stored in a standardised database. RESULTS: 35 studies were included (3624 patients) with a high degree of patient and surgeon satisfaction over a mean of 1.9 sessions at 18 month follow-up. Fat necrosis was the commonest reported complication (4.4%), biopsy of a subsequent breast lump was required in 2.7% and an interval mammogram in 11.5%. The weighted mean recurrence rate was 4.4% at 24.6 months. Meta-analysis of comparative studies showed no significant difference in oncological event rates between AFG and non-AFG groups (p=0.10). CONCLUSION: AFG is a potentially useful reconstructive tool, has a relatively low complication rate, with the majority of patients and clinicians satisfied or very satisfied with the results. Long term clinical and radiological follow-up is required. Further research is necessary to confirm oncological ramifications.

Elective lymph node dissection in patients with melanoma: systematic review and meta-analysis of randomized controlled trials.

HYPOTHESIS: Elective lymph node dissection does not improve survival in patients with melanoma without clinically detectable lymph node metastases. OBJECTIVE: To determine whether elective lymph node dissection in patients with melanoma without clinically detectable regional metastases decreases overall mortality. DESIGN: Systematic review and meta-analysis of randomized controlled trials comparing elective lymph node dissection with delayed lymphadenectomy at the time of clinical recurrence. SETTING: Randomized controlled trials available by February 2001. SUBJECTS: The included trials comprised 1533 participants. INTERVENTION: Elective lymph node dissection compared with delayed lymphadenectomy or no lymphadenectomy in patients with melanoma without clinically detectable regional metastases. MAIN OUTCOME MEASURE: Overall mortality in treatment groups as compared with control groups at the end of a 5-year follow-up period. RESULTS: Three randomized controlled trials met the inclusion criteria. The pooled odds ratio for overall mortality for the 3 trials was 0.86 (95% confidence interval, 0.68-1.09). Results are statistically nonsignificant, but they have potential clinical significance. CONCLUSIONS: This systematic review of randomized controlled trials comparing elective lymph node dissection with surgery delayed until the time of clinical recurrence shows no significant overall survival benefit for patients undergoing elective lymph node dissection. Trials included in this review, however, contain significant bias. The question is not answered for all patients, and the results do not exclude the possibility that some subgroups may benefit from elective lymph node dissection. Further research is required.