Translation, validation, and cultural adaptation of the Rhinosinusitis Disability Index and the Chronic Sinusitis Survey into Arabic.

BACKGROUND: Disease-specific quality of life instruments assess the impact of chronic rhinosinusitis on patients' quality of life (QoL). To the extent of our knowledge, there are no Arabic versions of two instruments-the Rhinosinusitis Disability Index (RSDI) and the Chronic Sinusitis Survey (CSS). OBJECTIVE: Develop an Arabic-validated version of both instruments, thus allowing its use among the Arabic population. DESIGN: Prospective cross-sectional study for instrument validation. SETTING: Tertiary university hospital. SUBJECTS AND METHODS: This study was conducted between September 2015 and October 2016. We followed the international comprehensive guidelines for translation and cross-cultural adaptation of QoL instruments. MAIN OUTCOME MEASURES: Test-retest reliability, discriminant validity, and responsiveness ability of both the RSDI and CSS Arabic versions. SAMPLE SIZE: 124. RESULTS: The sample comprised 75 patients diagnosed with chronic rhinosinusitis and 49 healthy control subjects. The Arabic version of both instruments showed high internal consistency (Cronbach's alpha: RSDI=0.97, CSS=.88) and the ability to differentiate between diseased and healthy volunteers (P less than .0001). The translated versions also detected significant change in response to an intervention (P less than .0001). CONCLUSION: These Arabic validated versions of the RSDI and CSS can be used for both clinical and research purposes. LIMITATIONS: This study was performed in only one tertiary hospital. CONFLICT OF INTEREST: None.

Burnout among plastic surgery residents. National survey in Saudi Arabia.

OBJECTIVES: To develop a more comprehensive explanation and understanding of the prevalence of and factors associated with burnout for residents of the Saudi Plastic Surgery Residency Program.  Methods: This is a cross sectional study. Data was gathered using a survey, which was distributed during April 2015, among all 57 plastic surgery residents enrolled in training programs across all regions of Saudi Arabia, 38 of whom responded (60% response rate). The dependent variable was professional burnout, which was measured by 3 subscales of the validated Maslach Burnout Inventory (MBI). High scores on emotional exhaustion (EE) or depersonalization (DP) or low scores on personal accomplishment (PA) were taken to be indicative of professional burnout. Variables evaluating possible predictors of burnout, such as sociodemographic and professional characteristics, were also included. Results: The validated rate of high burnout status was 18%. Nearly three quarters (71%) of residents scored high in emotional exhaustion, and half (50%) scored high in depersonalization. A third (34%) scored low in personal accomplishment. However, only 5% were dissatisfied with the plastic surgery specialty as a career, and 69% would choose the same specialty again. Workload was not found to play a significant role in the development of burnout (mean 70 hours per week).  Conclusion: Approximately half of plastic surgery trainees in the Kingdom of Saudi Arabia have signs of professional burnout.

Outcome of Nasal Valve Obstruction After Functional and Aesthetic-Functional Rhinoplasty.

INTRODUCTION: Nasal valve insufficiency is distinct from other anatomic causes of nasal obstruction. Functional rhinoplasty refers to the collective techniques used to reconstruct the lateral nasal wall, typically achieved with the use of spreader and alar grafts. Patients undergoing functional rhinoplasty can also have aesthetic desires and goals achievable with combined aesthetic-functional rhinoplasty. OBJECTIVE: To evaluate the improvement in nasal obstruction symptoms after cartilage graft reconstruction in patients with nasal valve insufficiency and to compare the postoperative improvement between patients undergoing functional and aesthetic-functional rhinoplasty. DESIGN, SETTING, AND PARTICIPANTS: In this prospective multicenter cohort study, 12 participating surgeons enrolled 79 consecutive patients diagnosed as having nasal valve insufficiency as the primary cause of nasal obstruction. Patients underwent functional or aesthetic-functional rhinoplasty. The study collected demographic, clinical, and surgical data from March 2006 to September 2008. Nasal symptoms were evaluated using a validated, disease-specific, quality-of-life instrument. The Nasal Obstruction Symptom Evaluation (NOSE) scale was administered to participants at baseline and 3, 6, and 12 months postoperatively. Follow-up was completed on September 2008, and data were analyzed in September 2009 and in September 2013. MAIN OUTCOMES AND MEASURES: Changes in NOSE scale score (range, 0 to 100, with a higher score indicating greater severity of obstruction) at 3 months between the functional and aesthetic-functional groups. RESULTS: Of the 79 patients, 31 underwent functional and 48 underwent aesthetic-functional rhinoplasty. Overall, an improvement was found in nasal breathing, with a mean decrease of 48.6 points (95% CI, 41.9-55.2; P < .001) at the 3-month assessment compared with the preoperative baseline NOSE scale score (mean [SD], 67.1 [19.7]). The improvement in nasal breathing was similar whether patients underwent functional or aesthetic-functional rhinoplasty (mean [95% CI] NOSE scale score change, 51.4 [42.1-60.7] and 46.6 [37.1-56.1], respectively; P = .49). CONCLUSIONS AND RELEVANCE: Nasal valve reconstruction with spreader and alar grafts is effective in treating patients with nasal valve insufficiency. Combining aesthetic interventions with functional rhinoplasty did not seem to affect the magnitude of improvement in nasal breathing outcome. LEVEL OF EVIDENCE: 2.

Systematic Review and Meta-Analysis in Facial Plastic Surgery.

Systematic reviews and meta-analyses hold a unique position in the pyramid of evidence. They can provide transparent and rigorous summaries to answer many clinical questions in facial plastic surgery. They can also identify areas of research deficiency, create new knowledge, and support guidelines or policies. A well-conducted systematic review follows a structured process to minimize bias and ensure reproducibility. When appropriate, a meta-analysis is incorporated to provide a statistical synthesis that combines the results of individual studies. This powerful quantitative method is becoming more prevalent in facial plastic surgery. This article provides a practical framework to understand and conduct this valuable type of research.

Ultrasound to differentiate thyroglossal duct cysts and dermoid cysts in children.

OBJECTIVES/HYPOTHESIS: To determine if ultrasound could differentiate between thyroglossal duct cysts (TGDC) and midline dermoid cysts (DC). STUDY DESIGN: Cohort study. METHODS: A search of pathology reports yielded 91 patients with TGDC or midline DC. Ultrasound images were presented to a radiologist blinded to pathology who evaluated the following: 1) depth of lesion from skin, 2) maximum diameter, 3) dimensions, 4) midline location, 5) distance from base of tongue, 6) tract, 7) wall regularity, 8) wall thickness, 9) margin definition, 10) heterogeneity, 11) internal septae, 12) solid components, 13) intralesional Doppler flow, and 14) posterior enhancement. The predictive power of these variables was evaluated in a multiple logistic regression model. RESULTS: There were 53 TGDC and 38 DC. TGDC were significantly more likely than DC to have the following features: 1) smaller distance from base of tongue, 2) tract, 3) irregular wall, 4) ill-defined margin, 5) internal septae, 6) solid components, and 7) intralesional Doppler flow. Three clinically reliable ultrasound variables were independently able to discriminate between TGDC and DC. A predictive model was fashioned whereby each variable was scored as 0 or 1, with a total score calculated (septae + irregular wall + solid components = TGDC [or SIST] score). We propose a scoring system whereby 0 = suggestive of DC; 1 = suggestive of TGDC; and ≥2 = highly suggestive of TGDC. CONCLUSIONS: It may be possible to differentiate between TGDC and midline DC preoperatively using ultrasound.

Lasers, fillers, and neurotoxins: avoiding complications in the cosmetic facial practice.

Lasers, injectable fillers, and neurotoxins are widely used in facial restoration and rejuvenation by a variety of practitioners. Although they are less invasive than traditional surgical modalities, they still carry risks for both transient as well as permanent complications. It is paramount for the practitioner to understand these complications, optimize their prevention, and initiate appropriate treatment when they are encountered. This article reviews early, often transient, complications as well as delayed, often prolonged or permanent, complications, with particular focus on prevention and management.

Randomized trials published in higher vs. lower impact journals differ in design, conduct, and analysis.

OBJECTIVE: To compare methodological characteristics of randomized controlled trials (RCTs) published in higher vs. lower impact Core Clinical Journals. STUDY DESIGN AND SETTING: We searched MEDLINE for RCTs published in 2007 in Core Clinical Journals. We randomly sampled 1,140 study reports in a 1:1 ratio in higher (five general medicine journals with the highest total citations in 2007) and lower impact journals. RESULTS: Four hundred sixty-nine RCTs proved eligible: 219 in higher and 250 in lower impact journals. RCTs in higher vs. lower impact journals had larger sample sizes (median, 285 vs. 39), were more likely to receive industry funding (53% vs. 28%), declare concealment of allocation (66% vs. 36%), declare blinding of health care providers (53% vs. 41%) and outcome adjudicators (72% vs. 54%), report a patient-important primary outcome (69% vs. 50%), report subgroup analyses (64% vs. 26%), prespecify subgroup hypotheses (42% vs. 20%), and report a test for interaction (54% vs. 27%); P < 0.05 for all differences. CONCLUSION: RCTs published in higher impact journals were more likely to report methodological safeguards against bias and patient-important outcomes than those published in lower impact journals. However, sufficient limitations remain such that publication in a higher impact journal does not ensure low risk of bias.

Credibility of claims of subgroup effects in randomised controlled trials: systematic review.

OBJECTIVE: To investigate the credibility of authors' claims of subgroup effects using a representative sample of recently published randomised controlled trials. DESIGN: Systematic review. DATA SOURCE: Core clinical journals, as defined by the National Library of Medicine, in Medline. STUDY SELECTION: Randomised controlled trials published in 2007. Using prespecified criteria, teams of trained reviewers independently judged whether authors claimed subgroup effects and the strength of their claims. Reviewers assessed each of these claims against 10 predefined criteria, developed through a search of existing criteria and a consensus process. RESULTS: Of 207 randomised controlled trials reporting subgroup analyses, 64 (31%) made claims for the primary outcome. Of those, 20 were strong claims and 28 claims of a likely effect. Authors included subgroup variables measured at baseline in 60 (94%) trials, used subgroup variable as a stratification factor at randomisation in 13 (20%), clearly prespecified their hypotheses in 26 (41%), correctly prespecified direction in 4 (6%), tested a small number of hypotheses in 28 (44%), carried out a test of interaction that proved statistically significant in 6 (9%), documented replication of a subgroup effect with previous related studies in 21 (33%), identified consistency of a subgroup effect across related outcomes in 19 (30%), and provided a compelling indirect evidence for the effect in 14 (22%). In the 19 trials making more than one claim, only one (5%) checked the independence of the interaction. Of the 64 claims, 54 (84%) met four or fewer of the 10 criteria. For strong claims, more than 50% failed each of the individual criteria, and only three (15%) met more than five criteria. CONCLUSION: Authors often claim subgroup effects in their trial report. However, the credibility of subgroup effects, even when claims are strong, is usually low. Users of the information should treat claims that fail to meet most criteria with scepticism. Trial researchers should report the conduct of subgroup analyses and provide sufficient evidence when claiming a subgroup effect or suggesting a possible effect.

Pain management in post-craniotomy patients: a survey of canadian neurosurgeons.

INTRODUCTION: Despite the growing recognition for analgesic needs in post-craniotomy patients, this remains a poorly studied area in neurological surgery. The class and regimen of analgesia that is most suitable for these patients remains controversial. The objective of this study is to examine the current beliefs and practices of Canadian neurosurgeons when managing post-craniotomy pain. METHODS: A survey was sent to all practicing Canadian neurosurgeons to examine the following aspects of analgesia in craniotomy patients: type of analgesics used, common side effects encountered, satisfaction with current regimen and the rationale for their practice. RESULTS: Of 156 potential respondents, 103 neurosurgeons (66%) completed the survey. Codeine (59%) was the most prescribed first line analgesic followed by morphine (38%). The use of a second-line opioid was significantly higher among codeine prescribers compared to morphine, 53% compared to 28% (p < 0.001). Nausea, constipation and neurologic depression were reported as common side effects by 76%, 66% and 27% of respondents respectively. Of the respondents, 90% reported a high level of satisfaction with their current choice of analgesia; nonetheless, they predominantly described their practice as personal preference or protocol driven rather than evidence-based. CONCLUSIONS: Codeine - a weak opioid - is the most common first-line analgesic prescribed to craniotomy patients. This practice is associated with substantially increased reliance on potent opioids for rescue analgesia. Whether novel regimens can provide optimal pain control while minimizing neurologic and gastrointestinal side effects remains to be addressed by future trials.

The influence of study characteristics on reporting of subgroup analyses in randomised controlled trials: systematic review.

OBJECTIVE: To investigate the impact of industry funding on reporting of subgroup analyses in randomised controlled trials. DESIGN: Systematic review. DATA SOURCES: Medline. STUDY SELECTION: Randomised controlled trials published in 118 core clinical journals (defined by the National Library of Medicine) in 2007. 1140 study reports in a 1:1 ratio by high (five general medicine journals with largest number of total citations in 2007) versus lower impact journals, were randomly sampled. Two reviewers, independently and in duplicate, used standardised, piloted forms to screen study reports for eligibility and to extract data. They also used explicit criteria to determine whether a randomised controlled trial reported subgroup analyses. Logistic regression was used to examine the association of prespecified study characteristics with reporting versus not reporting of subgroup analyses. RESULTS: 469 randomised controlled trials were included, of which 207 (44%) reported subgroup analyses. High impact journals (adjusted odds ratio 2.64, 95% confidence interval 1.62 to 4.33), non-surgical (versus surgical) trials (2.10, 1.26 to 3.50), and larger sample size (3.38, 1.64 to 6.99) were associated with more frequent reporting of subgroup analyses. The strength of association between trial funding and reporting of subgroups differed in trials with and without statistically significant primary outcomes (interaction P=0.02). In trials without statistically significant results for the primary outcome, industry funded trials were more likely to report subgroup analyses (2.29, 1.30 to 4.72) than non-industry funded trials. This was not true for trials with a statistically significant primary outcome (0.79, 0.46 to 1.36). Industry funded trials were associated with less frequent prespecification of subgroup hypotheses (31.3% v 38.0%, adjusted odds ratio 0.49, 0.26 to 0.94), and less use of the interaction test for analyses of subgroup effects (41.4% v 49.1%, 0.52, 0.28 to 0.97) than non-industry funded trials. CONCLUSION: Industry funded randomised controlled trials, in the absence of statistically significant primary outcomes, are more likely to report subgroup analyses than non-industry funded trials. Industry funded trials less frequently prespecify subgroup hypotheses and less frequently test for interaction than non-industry funded trials. Subgroup analyses from industry funded trials with negative results for the primary outcome should be viewed with caution.

Tetrathiomolybdate promotes tumor necrosis and prevents distant metastases by suppressing angiogenesis in head and neck cancer.

Angiogenesis is well recognized as an essential process that influences not only the growth of head and neck squamous cell carcinoma (HNSCC) but also promotes its invasive and metastatic behavior. The critical role of copper in multiple facets of angiogenesis makes it an important therapeutic target. Tetrathiomolybdate is a potent copper chelator, which has shown remarkable ability to suppress angiogenesis. Although this may involve multiple mechanisms, the effects on vascular endothelial growth factor (VEGF) are pivotal. In previous work, tetrathiomolybdate suppressed production of several proangiogenic cytokines by HNSCC cell lines. Given these results, we hypothesized that tetrathiomolybdate would impair tumor growth and metastasis by HNSCC. To test this concept, we evaluated the effects of long-term tetrathiomolybdate treatment on the growth and metastatic progression of HNSCC using a xenograft animal model. The results showed that tetrathiomolybdate treatment is able to maintain effective inhibition of angiogenesis. There was a significant reduction in the tumor size and vascularity with evident gross necrosis in the tetrathiomolybdate-treated animals. These effects were highly correlated with suppression of human VEGF expressed in the developing tumors as well as the mouse VEGF levels detected in the plasma. Moreover, tetrathiomolybdate treatment drastically suppressed the development of lung metastases. Taken together, these results show that tetrathiomolybdate can act long-term as a suppressor of vascularity and inhibit the growth of metastasis in this model of HNSCC.