Development of a core outcome set for basal cell carcinoma.

BACKGROUND: There is variation in the outcomes reported in clinical studies of basal cell carcinoma. This can prevent effective meta-analyses from answering important clinical questions. OBJECTIVE: To identify a recommended minimum set of core outcomes for basal cell carcinoma clinical trials. METHODS: Patient and professional Delphi process to cull a long list, culminating in a consensus meeting. To be provisionally accepted, outcomes needed to be deemed important (score, 7-9, with 9 being the maximum) by 70% of each stakeholder group. RESULTS: Two hundred thirty-five candidate outcomes identified via a systematic literature review and survey of key stakeholders were reduced to 74 that were rated by 100 health care professionals and patients in 2 Delphi rounds. Twenty-seven outcomes were provisionally accepted. The final core set of 5 agreed-upon outcomes after the consensus meeting included complete response; persistent or serious adverse events; recurrence-free survival; quality of life; and patient satisfaction, including cosmetic outcome. LIMITATIONS: English-speaking patients and professionals rated outcomes extracted from English language studies. CONCLUSION: A core outcome set for basal cell carcinoma has been developed. The use of relevant measures may improve the utility of clinical research and the quality of therapeutic guidance available to clinicians.

Core Outcome Set for Actinic Keratosis Clinical Trials.

Importance: Although various treatments have been found in clinical trials to be effective in treating actinic keratosis (AK), researchers often report different outcomes. Heterogeneous outcome reporting precludes the comparison of results across studies and impedes the synthesis of treatment effectiveness in systematic reviews. Objective: To establish an international core outcome set for all clinical studies on AK treatment using systematic literature review and a Delphi consensus process. Evidence Review: Survey study with a formal consensus process. The keywords actinic keratosis and treatment were searched in PubMed, Embase, CINAHL, and the Cochrane Library to identify English-language studies investigating AK treatments published between January 1, 1980, and July 13, 2015. Physician and patient stakeholders were nominated to participate in Delphi surveys by the Measurement of Priority Outcome Variables in Dermatologic Surgery Steering Committee members. All participants from the first round were invited to participate in the second round. Outcomes reported in randomized controlled clinical trials on AK treatment were rated via web-based e-Delphi consensus surveys. Stakeholders were asked to assess the relative importance of each outcome in 2 Delphi survey rounds. Outcomes were provisionally included, pending the final consensus conference, if at least 70% of patient or physician stakeholders rated the outcome as critically important in 1 or both Delphi rounds and the outcome received a mean score of 7.5 from either stakeholder group. Data analysis was performed from November 5, 2018, to February 27, 2019. Findings: A total of 516 outcomes were identified by reviewing the literature and surveying key stakeholder groups. After deduplication and combination of similar outcomes, 137 of the 516 outcomes were included in the Delphi surveys. Twenty-one physicians and 12 patients participated in round 1 of the eDelphi survey, with 17 physicians (81%) retained and 12 patients (100%) retained in round 2. Of the 137 candidate outcomes, 9 met a priori Delphi consensus criteria, and 6 were included in the final outcomes set after a consensus meeting: complete clearance of AKs, percentage of AKs cleared, severity of adverse events, patient perspective on effectiveness, patient-reported future treatment preference, and recurrence rate. It was recommended that treatment response be assessed at 2 to 4 months and recurrence at 6 to 12 months, with the AK rate of progression to cutaneous squamous cell carcinoma reported whenever long-term follow-up was possible. Conclusions and Relevance: Consensus was reached regarding a core outcome set for AK trials. Further research may help determine the specific outcome measures used to assess each of these outcomes.

A retrospective review of cases preoperatively diagnosed by radiologic imaging as cavernous venous malformations.

The purpose of this study is to examine orbital lesions identified on preoperative radiologic imaging as cavernous venous malformations (CVMs), identify their imaging characteristics, and determine if these may help differentiate CVMs from other intraorbital masses. An IRB-approved retrospective chart review over 30 years was undertaken identifying lesions "consistent with cavernous hemangioma" on radiologic studies, which were subsequently surgically resected with a tissue diagnosis. All radiologic images (CT and MRI) obtained preoperatively were re-reviewed by a single masked neuroradiologist. The pattern of contrast enhancement on sequential MRI views was used to determine whether the enhancing characteristics helped identify CVMs compared to other intraorbital masses. Fifty-seven orbital lesions consistent with a CVM were identified on imaging. Fourteen (25%) of them were resected, of which nine (64%) were found to be CVMs on pathologic examination. Five (36%) were found to be a different lesion, most commonly schwannoma (21%). On imaging, CVMs tended to display heterogeneous progressive enhancement, whereas other tumors, in particular schwannomas, enhanced at their maximum level immediately. Based on these characteristics, on re-review, the masked neuroradiologist was able to differentiate a CVM versus other tumors for all 14 imaging cases. This study suggests that examining the pattern of contrast enhancement may help to correctly differentiate a CVM from other isolated, encapsulated orbital lesions on CT/MR imaging.

Nasoorbital Osteoma Presenting as Valsalva-Induced Orbital Emphysema.

An 18-year-old female athlete with a history of multiple traumatic concussions presented with complaints of recurrent bouts of right periorbital swelling that arose with Valsalva maneuvers such as nose-blowing or sneezing. The swelling resolved over hours to days. A CT scan of the sinuses revealed an osteoma originating from the right ethmoid roof involving the frontal recess and projecting into the orbit. She underwent excision of the osteoma via endoscopic transnasal and transcaruncular anterior orbitotomy approaches without complication.

Comparison of Fasanella-Servat and Small-Incision Techniques for Involutional Ptosis Repair.

PURPOSE: To compare the results of the classic Fasanella-Servat internal approach to the newer, small-incision external approach in the repair of involutional ptosis. METHODS: Retrospective review identified 93 patients (104 surgical procedures) at Northwestern Ophthalmology from June 2005 until October 2011 who underwent either the Fasanella-Servat or the small-incision approaches for involutional ptosis repair. Change in vertical palpebral fissure measurement, change in marginal reflex distance 1 (MRD1) measurement, patient satisfaction, surgical complications, operating time, and postoperative pain were compared between groups. RESULTS: Of the 93 patients, most were female with an average age of 69 years. Of the procedures, 48% were small incision and 52% were Fasanella-Servat approaches. Average postoperative follow up was 34.0 days. Vertical palpebral fissure height increased an average of 3.36 mm (±1.15) in the Fasanella-Servat group and 2.74 mm (±1.18) in the small-incision group (p = 0.003). Preoperative vertical palpebral fissure height was lower in the Fasanella-Servat group, but postoperative vertical palpebral fissure height was similar between the 2 groups (p=0.3). MRD1 increased an average of 3.42 mm (±0.86) in the Fasanella-Servat group and 2.68 mm (±0.93) in the small-incision group (p < 0.01). Preoperative MRD1 was lower in the Fasanella-Servat group, but postoperative MRD1 was similar between the 2 groups (p = 0.15). Average operating time was 53 minutes (±16) in the small-incision group and 27 minutes (±6) in the Fasanella-Servat group (p < 0.01). There were no surgical complications in either group with equivalent patient satisfaction between the 2 groups. More patients reported postoperative pain in the Fasanella-Servat group (p < 0.0001). CONCLUSIONS: Both the Fasanella-Servat and small-incision approaches lead to good surgical outcomes with equivalent patient satisfaction, although the Fasanella-Servat approach provides a shorter average operating time with satisfactory postoperative MRD1.

Potential correlation between menopausal status and the clinical course of orbital cavernous hemangiomas.

PURPOSE: To evaluate the clinical course of radiologically diagnosed orbital cavernous hemangiomas in the setting of presumed changes in estrogen/progesterone levels. METHODS: An institutional review board-approved retrospective cohort chart review of patients from January 1, 1983, to January 1, 2013, was undertaken searching both outpatient ophthalmology diagnoses and radiologic diagnoses, identifying 32 orbital cavernous hemangiomas, which were subsequently divided into group 1, presumed to have stable levels of estrogen/progesterone, and group 2, presumed to have decreasing levels of estrogen/progesterone. Patients were then categorized as having short-term, mid-range, or long-term follow up. Serial imaging studies were evaluated and graded as having increased, decreased, or remained stable in size. RESULTS: In group 1, no lesions decreased in size, 69% remained stable, and 31% increased in size. In group 2, no lesions increased in size, 45% remained stable, and 55% decreased in size. When evaluating only those patients with long-term follow up, many masses in group 1 increased in size, while the majority in group 2 decreased in size. CONCLUSIONS: In this study evaluating orbital cavernous hemangiomas over a span of 30 years, the authors found that in postmenopausal women with assumed decreasing levels of circulating estrogen/progesterone, the vast majority of lesions either remained stable or decreased in size, suggesting the effect of hormone levels on such vascular lesions and supporting the role for observation in asymptomatic individuals in this patient population.

Characterization of dacryops infections.

PURPOSE: The purpose of this study was to characterize the clinical entity of dacryops infections through imaging with or without histopathology in the differential of ocular adnexal masses in the setting of infection. METHODS: A retrospective chart review was performed on 5 patients seen at 1 clinical practice in which a complete ophthalmologic examination and imaging of the lesion had been obtained. Two of these patients additionally obtained surgical intervention with histopathologic examination. RESULTS: The main lacrimal gland was involved in all 5 patients with dacryops infection presenting unilaterally. The average age of the patients was 44.6 years. Predisposing factors of eyelid margin disease, conjunctivitis, and contact lens usage were highlighted. CT provided useful information on the location and size of the lesion. Excision with or without marsupialization appears to prevent recurrence and provides a histopathologic diagnosis although spontaneous (or self-induced) drainage of the cyst in addition to antibiotic therapy can successfully manage the infection and cyst size, wherein affected individuals may not pursue further surgical management. CONCLUSIONS: Dacryops infection is a rare but important consideration in the differential of a mass lesion in the upper fornix associated with inflammation that may be confused with orbital cellulitis or abscess. Orbital imaging is helpful in delineating the extent of the lesion, whereas surgical excision with histopathology can confirm the diagnosis. The authors described 5 cases with this acute presentation and highlighted concomitant factors that may predispose certain patients to the development of infection.

Lack of an association between Chlamydia psittaci and ocular adnexal lymphoma.

The objective of this study was to assess whether there is PCR evidence for C. psittaci DNA in ocular adnexal lymphoma specimens collected in an academic institution in the U.S. This was a retrospective, single-center study of patients from 1994 - 2004. We used 28 ocular adnexal lymphoma biopsy specimens from adult patients, 16 control lymphoma specimens from patients with systemic lymphomas not involving the ocular adnexa, and five control benign adnexal tissue samples. The presence of C. psittaci DNA was investigated by polymerase chain reaction (PCR) in each group. Two different assays were utilized: (1) conventional PCR/gel based assay targeting a 111-bp fragment of the 16S gene and (2) a real-time PCR assay amplifying a 148-bp portion of the 16S gene with detection via a specific fluorescent probe. Amplification was carried out to 60 cycles. Positive controls consisted of isolated DNA from C. psittaci strains VS1, CP3, and FP. A human DNA internal control was used to assess sample DNA quality and amplification success. Mean outcome measure was the presence of C. psittaci DNA. Using both assays, all patient samples in all categories yielded negative results. Both assays detected C. psittaci DNA from isolated strains. Internationally, Chlamydia psittaci has been associated with ocular adnexal lymphomas with great variability. Similar to several other recent studies in the USA, our study could not confirm the presence of C. psittaci in ocular adnexal lymphomas. Differences in the prevalence of C. psittaci infection in various geographic regions or technical differences in the application of the assays may underlie the variability in the association between C. psittaci and ocular adnexal lymphoma.