Farah Moustafa

A Model for Predicting Gastrostomy Tube Placement in Patients Undergoing Surgery for Upper Aerodigestive Tract Lesions

IMPORTANCE Identifying high-risk patients in the preoperative period can allow physicians to optimize nutritional status early for better outcomes after head and neck cancer resections. OBJECTIVE To develop a model to predict preoperatively the need for gastrostomy tube (G-tube) placement in patients undergoing surgery of the upper aerodigestive tract. DESIGN, SETTING, AND PARTICIPANTS This retrospective medical record review included all adult patients diagnosed with head and neck cancers who underwent tumor resection from 2007 through 2012 at Wake Forest Baptist Health, a level 1 tertiary care center. Records were screened for patient demographics, tumor characteristics, surgical treatment type, and postoperative placement of G-tube. A total of 743 patients underwent resection of head and neck tumors. Of these, 203 were excluded for prior G-tube placement, prior head and neck resection, G-tube placement for chemoradiotherapy, and resection for solely nodal disease, leaving 540 patients for analysis. MAIN OUTCOMES AND MEASURES Placement of postoperative G-tube. RESULTS Of the 540 included patients, 23% required G-tube placement. The following variables were significant and independent predictors of G-tube placement: preoperative irradiation (odds ratio [OR], 4.1; 95% CI, 2.4-6.9; P < .001), supracricoid laryngectomy (OR, 26.0; 95% CI, 4.9-142.9; P < .001), tracheostomy tube placement (OR, 2.6; 95% CI, 1.5-4.4; P < .001), clinical node stage N0 vs N2 (OR, 2.4; 95% CI, 1.4-4.2; P = .01), clinical node stage N1 vs N2 (OR, 1.6; 95% CI, 0.8-3.3; P = .01), preoperative weight loss (OR, 2.0; 95% CI, 1.2-3.2; P = .004), dysphagia (OR, 2.0; 95% CI, 1.2-3.2; P = .005), reconstruction type (OR, 1.9; 95% CI, 1.1-2.9; P = .02), and tumor stage (OR, 1.8; 95% CI, 1.1-2.9; P = .03). A predictive model was developed based on these variables. In the validation analysis, we found that the average predicted score for patients who received G-tubes was statistically different than the score for the patients who did not receive G-tubes (P = .01). CONCLUSIONS AND RELEVANCE We present a validated and comprehensive model for preoperatively predicting the need for G-tube placement in patients undergoing surgery of the upper aerodigestive tract. Early enteral access in high-risk patients may prevent complications in postoperative healing and improve overall outcomes, including quality of life.

Prevalence of Rosacea in Community Settings

Background The prevalence of rosacea is poorly characterized. Because selection bias may affect prevalence estimates, there is a need to characterize the prevalence of rosacea outside the clinic setting. Objective To assess the prevalence of rosacea in community settings. Methods A clinical research fellow and a medical student stood in public places (a mall, the Department of Motor Vehicles, a grocery store) and examined consecutive individuals who passed by ≤ 2 yards away. They tallied demographic and descriptive data on the subject and included the subject in one of three categories: clearly rosacea, possible rosacea, and definitely no rosacea. Subanalyses by perceived gender, age, race, and rosacea subtype were also performed. Comparisons between groups were made using the Fisher exact test. Results Considering the prevalence of rosacea among all observed individuals in the community setting, 5.4% (95% CI 3.6-7.8) of individuals had “possible” rosacea and 6% (95% CI 4.1-8.5) of individuals had “definite” rosacea. Older, white individuals with fairer skin types (Fitzpatrick skin types I, II, and III) were more likely to have rosacea. There was no gender predisposition. Limitations Distance from subjects made it difficult to assess patients with mild rosacea or a few telangiectasias, as well as ocular rosacea. The study could not assess those individuals who were too embarrassed by their rosacea to be in the public settings observed. Additionally, some subjects may have applied significant makeup in an effort to conceal their rosacea, making assessment difficult. Conclusions Based on direct observation of individuals in community settings, rosacea is more common than previously reported in the United States.

Pharmacological treatments in pregnant women with psoriasis in the U.S.A.

1 Dumont P, Denoyer A, Robin P. Long-term results of thoracoscopic sympathectomy for hyperhidrosis. Ann Thorac Surg 2004; 78:1801–7. 2 Gossot D, Galetta D, Pascal A et al. Long-term results of endoscopic thoracic sympathectomy for upper limb hyperhidrosis. Ann Thorac Surg 2003; 75:1075–9. 3 Chang Y-T, Li H-P, Lee J-Y et al. Treatment of palmar hyperhidrosis: T4 Level compared with T3 and T2. Ann Surg 2007; 246:330–6. 4 Jeganathan R, Jordan S, Jones M et al. Bilateral thoracoscopic sympathectomy: results and long-term follow-up. Interact Cardiovasc Thorac Surg 2008; 7:67–70. 5 Smidfelt K, Drott C. Late results of endoscopic thoracic sympathectomy for hyperhidrosis and facial blushing. Br J Surg 2011; 98:1719–24. 6 Walles T, Somuncuoglu G, Steger V et al. Long-term efficiency of endoscopic thoracic sympathicotomy: survey 10 years after surgery. Interact Cardiovasc Thorac Surg 2009; 8:54–7. 7 Wolosker N, de Campos JRM, Kauffman P et al. Evaluation of quality of life over time among 453 patients with hyperhidrosis submitted to endoscopic thoracic sympathectomy. J Vasc Surg 2012; 55:154–6. 8 Solish N, Bertucci V, Dansereau A et al. A comprehensive approach to the recognition, diagnosis, and severity-based treatment of focal hyperhidrosis: recommendations of the Canadian Hyperhidrosis Advisory Committee. Dermatol Surg 2007; 33:908–23. 9 Grob JJ, Auquier P, Martin S et al. Development and validation of a quality of life measurement for chronic skin disorders in French: VQ-Dermato. The R eseau d’Epid emiologie en Dermatologie. Dermatology 1999; 199:213–22. 10 Wolosker N, Yazbek G, de Campos JRM et al. Quality of life before surgery is a predictive factor for satisfaction among patients undergoing sympathectomy to treat hyperhidrosis. J Vasc Surg 2010; 51:1190–4.

Treatments of Primary Basal Cell Carcinoma of the Skin: A Systematic Review and Network Meta-analysis

Basal cell carcinoma (BCC) is the most common cancer in the United States, with an annual incidence approaching 2 million cases (1). Most cases are not aggressive, but the tumors and their treatment can cause disfigurement or disability, which can adversely affect quality of life (2). The Surgeon Generals recent call to action to prevent skin cancer at the population level emphasizes the public health importance of dealing with BCC (3). Choosing a management strategy for an individual patient with a specific type of BCC from among the many available interventions is complex. Considerations include patient factors (such as age, frailty, immunosuppression, and personal preference), tumor factors (such as histologic subtype, size, and location), and the availability and cost of health care resources. The lack of clarity about the comparative efficacy and safety of the available options overall and in specific circumstances further complicates treatment decision making for both physicians and patients. Surgical removal is widely considered the gold standard and is therefore the most common treatment. However, despite several dozen randomized controlled trials (RCTs) and nonrandomized comparative studies (NRCSs), the relative performance of various surgical techniques and other therapeutic options is unclear. Payers are faced with increased use of costly therapies, such as brachytherapy, without clear evidence about relative benefits to justify increased costs (4). The purpose of this systematic review and network meta-analysis is to evaluate the comparative effectiveness and safety of treatments of primary BCC. Methods This article updates and summarizes the findings on BCC from a comparative effectiveness review for the Agency for Healthcare Research and Quality (AHRQ) on treatments of BCC and cutaneous squamous cell carcinoma (4). We followed the approach outlined in the AHRQ Methods Guide for Effectiveness and Comparative Effectiveness Reviews (5). The protocol was developed with input from stakeholders (providers, researchers, payers, patients, and funders) and was prospectively registered with PROSPERO (CRD42016043353). Data Sources and Searches We searched PubMed, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and Embase up to 8 May 2018 to identify eligible studies (the full report [4] gives search strategies, search terms, and search and selection figures). We queried ClinicalTrials.gov (most recently in August 2016) to identify ongoing or completed yet unpublished trials. We limited searches to English-language publications and supplemented them with suggestions from stakeholders and by perusing reference lists of eligible articles and of pertinent systematic reviews and guidelines. Study Selection We screened titles, abstracts, and full texts of eligible studies in duplicate. The population of interest was adult patients with primary BCC. Patient subgroups were specified in the protocol and were defined by tumor location (such as face, hands, trunk, or extremities) and histologic subtype (such as superficial or nodular BCC). We excluded subpopulations with rare genetic disorders associated with increased BCC risk (for example, basal cell nevus syndrome). With input from stakeholders, we identified 22 eligible interventions, which we organized into 9 categories (Table 1). Outcomes of interest included tumor recurrence and lack of histologic tumor clearance (proxies for failure to cure), cosmetic appearance (patient- or observer-reported), quality of life, mortality, and costs. Table 1. Intervention Categories and Specific Interventions We evaluated RCTs and comparative NRCSs. We included NRCSs only if they took steps to control for patient- or lesion-level confounders. We excluded studies that had fewer than 5 lesions per treatment group. Data Extraction and Risk-of-Bias Assessment One reviewer extracted information from eligible studies, and a second reviewer verified the extraction. Any disagreements were resolved by discussion among the team. Data extractions were done on and are publicly accessible through the Systematic Review Data Repository (http://srdr.ahrq.gov) (6). We recorded information on country of origin; population (mean age; sex distribution; and lesion histology, size, and location); interventions; outcomes (at the longest follow-up and at the follow-up closest to but not longer than 2 years); funding source; and attributes of study design, conduct, and analysis addressed in the Cochrane Risk of Bias Tool (7). For RCTs, at least 2 reviewers critically examined sources of bias and their likely effect and finalized their assessments in discussions with the whole team. We examined the effect of missing data by calculating mathematical bounds for effect estimates (8). This was accomplished by examining extreme scenarios in which all missing observations in one group had the outcome of interest and all missing observations in another group did not. For lack of histologic clearance, input from a pathologist informed our assessments of whether each treatment can be successfully masked. For each observational study, we used the Newcastle-Ottawa Scale (9) to guide our deliberations about sources and risk of bias. Data Synthesis, Analysis, and Assessments of Strength of Evidence We summarized all studies qualitatively and described important features of the population (including tumor characteristics), design, intervention, outcomes, and results. In each outcome, the evidence comprises 1 or more connected networks of 2 or more treatments. For each connected network in each outcome, we did frequentist (maximum likelihood) pairwise and network meta-analyses with mixed-effects (random intercepts and fixed intervention slopes) or full random-effects (random intercepts and slopes) multilevel models within the generalized linear and latent mixed-model framework. The network meta-analysis approach models the proportion of events in each trial group and thus can estimate not only the mean treatment effects (odds ratios) between treatments but also the mean proportion of events with each treatment using all of the available data. In Part G of the Supplement, we describe the models and their estimation and provide access to the data and code. Supplement. Supplementary Material We assessed consistency qualitatively and deemed direct and indirect effects to be in agreement when they were in the same direction and the CI of one included the point estimate of the other. We also used a node-split approach to assess for consistency quantitatively (10). In main analyses, we included data from the longest follow-up for each outcome in each trial. We excluded trials that compared versions of the same intervention (for example, different imiquimod treatment schedules). When data were available, we did subgroup analyses by lesion histologic subtype, location, and size (not shown) (4). The unit of analysis was the patient. A minority of studies reported results about lesions (where individual patients had several lesions), which were included as if each lesion belonged to a different patient. We did not correct for clustering of lesions by patient because the requisite estimates of intraclass correlation coefficients were not available. In sensitivity analyses, we included only trial data on outcomes closest to 1 year within the window of 0 to 2 years, and we fitted network meta-analysis models in the Bayesian framework (not shown). Network meta-analyses of intervention categories were congruent with the main analyses that focused on specific interventions (not shown). All analyses were done in R, version 3.4.4, using the igraph, lme4, metafor, and gemtc packages (1115). We report 95% CIs with no corrections to control for type I error. We summarized analyses as key findings and assessed the overall strength of evidence in terms of the risk of bias of the associated evidence base and the directness, precision, and consistency of the evidence, following the AHRQ methods guidance. Role of the Funding Source This report is based on research conducted by the Brown Evidence-based Practice Center under contract to the AHRQ. The funders role was limited to ensuring adherence to administrative requirements, including timelines and fidelity to the written protocol. The AHRQ was not involved in the design, conduct, or interpretation of the analyses. Results The literature searches returned 16154 citations, of which 519 were retrieved and screened in full text. Forty RCTs and 5 NRCSs were eligible (Supplement Figure and Supplement Tables 1 and 2). The randomized evidence base is sparse (Part B of the Supplement). Across all outcomes, the RCTs examined 18 interventions and provided data on 34 head-to-head comparisons, out of 153 possible comparisons. Of the 34 comparisons, 33 were informed by at most 3 trials. The evidence graphs in Figures 1, 2, 3, and 4 depict the head-to-head comparisons in RCTs for recurrence, lack of histologic clearance, and cosmetic outcomes assessed by patients and observers, respectively. They have the same layout to show the partial coverage of the evidence base per outcome. For all outcomes, the evidence base comprises between 2 and 4 connected networks. No comparisons are made between treatments that belong to unconnected networks, and each connected network is sparse. For example, in Figure 1, the largest connected network for recurrence comprises 14 treatments. Of these, 4 were compared with only 1 other treatment and 5 with only 2. Treatments that were compared with the most other treatments were surgical excision (n= 7) and photodynamic therapy (PDT) using methyl-aminolevulinic acid (n= 6). For lack of histologic clearance, aside from PDT using methyl-aminolevulinic acid (compared with 6 other treatments), all treatments were compared with at most 3 other treatments (6 treatments were compared with only 1 other treatment) (Figure 2). Figure 1. Ev

A Pilot Study Characterizing Factors in Adherence to Cutaneous Lupus Treatment

Cutaneous lupus erythematosus (CLE) is an autoimmune skin disease that manifests as scarring, dyspigmentation, erythema, and pain. Topical corticosteroids are a mainstay of treatment. Irritation, messiness, and tediousness may deter use. Thus, nonadherence, rather than nonresponse, can result in treatment failure. Prior adherence studies were limited to systemic lupus erythematosus. We performed a single-center, open-label pilot study to assess adherence to topical medication in patients with CLE. CLE adherence to topical medications is suboptimal and declines over time. Shorter treatment duration and greater patient perception of disease severity may contribute to higher adherence. Improving adherence to existing treatments could be as or more valuable than new therapies for the disease.

Systemic treatment of papular dermatitis: A retrospective study

Abstract Background: Papular dermatitis is an intensely pruritic eruption that is often refractory to conventional therapy. Aim: The aim of this study was to evaluate the efficacy of different non-steroidal systemic therapies for long-term control of disease in patients with papular dermatitis. Methods: This was a single center, retrospective study involving a chart review of patients with a diagnosis of papular dermatitis who were prescribed systemic therapy between 1 January 2002 and 31 December 2012. Results: Fourteen patients were identified that were treated with a systemic agent. Median duration of treatment was 25 months. Methotrexate was used first line in 12 patients, with control of disease achieved in eight patients with a dose between 2.5 and 10 mg weekly. Azathioprine and mycophenolate mofetil also provided control of disease when used as first-line therapy in the remaining two patients. While azathiopurine was effective in patients who failed methotrexate, gastrointestinal side effects limited its use long term. Conclusions: Low dose weekly methotrexate, as well as, azathioprine and mycophenolate mofetil are long-term treatment options for patients with papular dermatitis refractory to other therapies.

Is Safety Psoriasis Patients' Overriding Concern?

To the Editor: With expanding psoriasis treatment options, patients face increasingly complex treatment decisions. We created an algorithm that incorporates treatment characteristics and patient preferences to assist patients in finding treatments that best fit their needs. We anticipated that safety concerns would be a major factor driving treatment decisions. We report that our model overestimated patients’ concern for safety. The algorithm concept assumed that patients vary in how much importance they ascribe to the various characteristics of psoriasis treatments. We created a list of psoriasis medications and, for each medication, assigned intrinsic values to 11 characteristics based on published clinical trials. Patients rated how important each of the 11 characteristics was to them and ranked the characteristics in order of importance. The intrinsic value (V Mi ), patient’s importance scores (P i ), and characteristic ranking values (R i ) were multiplied and then summed to generate scores for each medication (Figure 1). The top three scoring treatments were discussed with patients using a treatment overview tool that described the characteristics of each treatment.

Characterizing the Treatment of Autoimmune Bullous Disorders from 1993 through 2010: a NAMCS Study

Autoimmune blistering diseases, though uncommon, are associated with considerable morbidity. There is no established therapeutic ladder for the treatment of blistering disorders. Data from the National Ambulatory Medical Care survey from 1993 to 2010 was analyzed to determine the number of visits for blistering diseases, patient demographics, the specialty of treating physicians, and the most frequently prescribed treatments. Patients with autoimmune blistering disorders were primarily elderly, female, and non-Hispanic white. The majority of patients were managed by dermatologists. There has been no significant change in the number of patients diagnosed with bullous diseases over the observed time period. Oral prednisone was the primary treatment prescribed for patients with both bullous pemphigoid and pemphigus. Though prednisone is the primary medication prescribed for patients with blistering disorders, immunosuppressive therapies are associated with increased morbidity in elderly patients. Alternative therapies should be considered for the treatment of autoimmune bullous disorders when feasible taking into account the associated risks and side effect profile of these medications