Trends in internet search activity,media coverage,and patient-centered health information after the FDA safety communications on surgical mesh for pelvic organ prolapse

Introduction

In July 2011, the US Food and Drug Administration (FDA) issued a safety communication regarding serious complications associated with surgical mesh for pelvic organ prolapse, prompting increased media and public attention. This study sought to analyze internet search activity and news article volume after this FDA warning and to evaluate the quality of websites providing patient-centered information.

Methods

Google Trends? was utilized to evaluate search engine trends for the term “pelvic organ prolapse” and associated terms between 1 January 2004 and 31 December 2014. Google News? was utilized to quantify the number of news articles annually under the term “pelvic organ prolapse.” The search results for the term “pelvic organ prolapse” were assessed for quality using the Health On the Net Foundation (HON) certification.

Results

There was a significant increase in search activity from 37.42 in 2010 to 57.75 in 2011, at the time of the FDA communication (p?=?0.021). No other annual interval had a statistically significant increase in search activity. The single highest monthly search activity, given the value of 100, was August 2011, immediately following the July 2011 notification, with the next highest value being 98 in July 2011. Linear regression analysis of news articles per year since the FDA communication revealed r²?=?0.88, with a coefficient of 186. Quality assessment demonstrated that 42 % of websites were HON-certified, with .gov sites providing the highest quality information.

Conclusions

Although the 2011 FDA safety communication on surgical mesh was associated with increased public and media attention, the quality of relevant health information on the internet remains of poor quality. Future quality assurance measures may be critical in enabling patients to play active roles in their own healthcare.

     

Recurrent pelvic organ prolapse: International Urogynecological Association Research and Development Committee opinion

Introduction and hypothesis

This committee opinion paper summarizes available evidence about recurrent pelvic organ prolapse (POP) to provide guidance on management.

Method

A working subcommittee from the International Urogynecological Association (IUGA) Research and Development Committee was formed. The literature regarding recurrent POP was reviewed and summarized by individual members of the subcommittee. Recommendations were graded according to the 2009 Oxford Levels of Evidence. The summary was reviewed by the Committee.

Results

There is no agreed definition for recurrent POP and evidence in relation to its evaluation and management is limited.

Conclusion

The assessment of recurrent POP should entail looking for possible reason(s) for failure, including persistent and/or new risk factors, detection of all pelvic floor defects and checking for complications of previous surgery. The management requires individual evaluation of the risks and benefits of different options and appropriate patient counseling. There is an urgent need for an agreed definition and further research into all aspects of recurrent POP.

     

Determination of the optimal frequency of injection of triamcinolone: monitoring change in volume of keloid lesions following injection of 40 mg of triamcinolone

Background

Different dosage protocols may be advocated by different clinicians for the same keloid lesion. The aim of this study was to determine the optimal frequency of injection of triamcinolone for the purpose of reducing the size of keloid, by monitoring volume change in lesions.

Methods

Volume of all lesions was measured, and 40 mg of triamcinolone was injected once. Lesion volume was thereafter monitored weekly for 6 weeks.

Results

Mean pretreatment volume was 6.4 ml. Following triamcinolone injection, mean lesion volume became 5.1, 3.7, 3.6, and 3.6 ml at 1, 2, 3, and 4 weeks postinjection, respectively. The mean lesion volume was 3.7 and 3.9 ml at 5 and 6 weeks postinjection. Mean lesion volume was 1.29 ml lower at 1 week than at pretreatment stage (SD?±?0.8797), 1.35 ml lower in volume at 2 weeks than 1 week (SD?±?1.0386), and 0.138 ml lower in volume at 3 weeks than 2 weeks (SD?±?0.159). Mean lesion volume was 0.0250 ml lower at 4 weeks than at 3 weeks (SD?±?0.3215), 0.1000 ml greater in volume at 5 weeks than 4 weeks (SD?±?0.1713), and 0.2000 ml greater in volume at 3 weeks than 2 weeks (SD?±?0.0418). There is a statistically significant difference between the mean volume at 1 week postinjection and that at pretreatment stage, between 2 and 1 week, and between 3 and 2 weeks (p?≤?0.05). Reduction in volume was found to be most profound and statistically significant within the first 2 weeks postinjection.

Conclusions

This study finds that the optimal frequency of intralesional injection of triamcinolone involves a 2-week injection interval.Level of Evidence: Level IV, therapeutic study

     

Critical choices in cleft surgery: 18-year single-surgeon retrospective review of 900 cases

Background

Multidisciplinary management of orofacial clefts may lead to a successful treatment outcome. However, it is quite usual that lack of long-term treatment planning and collaboration among various specialists and lack of standardized surgical protocols result in poor esthetic and functional treatment outcomes. This article aims to hypothesize some critical determinants of outcome in cleft surgery.

Methods

Throughout a period of 18 years, 900 patients with different clinical types of congenital cleft anomaly were subject to primary repair of cleft lip, nose, and palate by single surgeon using various procedures, including preoperative nasoalveolar molding, two-stage and one-stage repair of complete cleft lip and palate, two-flap and one-flap palatoplasty, open tip rhinoplasty, and postoperative nasal molding.

Results

Clinical results of preoperative nasoalveolar molding and surgical repair of lip, nose, and palate were satisfactory for most patients, parents, and surgeon panel.

Conclusions

Treatment based on the individual patient’s facial assets and deficits must be the controlling factor in designing therapy. The essential key to successful management of clefts is to figure out the three-dimensional dynamics that govern the deformity and to recognize a fourth dimension for time along these dynamics in order to envision how a small difference in the position of a single suture during the first surgery can bring about a giant deformity upon completion of facial growth, hence the crucial role of the first surgery and its related concepts, techniques, and tactics in dictating the final outcome of the case.Level of Evidence: Level IV, therapeutic study.

     

Computer-assisted analysis contour lines of aesthetic unit for the assessment of lip augmentation

Background

Lip augmentation and changing contour lines have become more popular ways of improving the appearance. However, validated measures of lip fullness for quantification of outcomes are needed; ethnic background and personal goals can optimise outcomes while tailoring lip enhancement treatment to each individual’s anatomy. The aim of this study is to analyse the morphological features of the lip in detail and to clarify the objective parameters in related with the subjective ones regarding the lip augmentation and lip reconstruction.

Methods

Standard photographs of the lips of 200 young Anatolian adults were calculated with linear and angular components. The features of the lower third of the face were analysed with the software program. Linear analyses (heights of the upper lip, the upper vermilion, the lower lip height, the lower vermillion and the chin height) and angular analyses (the upper lip, the lower lip, the apex and Cupid’s bow angles) were measured as reference points. The lip shape was classified into five groups: thin, very thin, medium, full and very full.

Results

The lower third of the face was divided into three segments (Sn–Sto, Sm–Me and Sto–Sm), and the largest portion of the lower face was occupied by the chin and the smallest by the lower lip height in both genders. The upper vermilion height was 8.07?±?1.8 mm in males and 7.08?±?1.5 mm in females. The lower vermilion height was 10.1?±?2.4 mm in males and 9.7?±?1.9 mm in females. The upper lip angle was calculated as 30.3?±?9.6° in males and 24.2?±?6.2°mm in females. The lower lip angle was calculated as 38.3?±?9.7° in males and 36.5?±?6.4° in females. Meanwhile, the angular measurements of Cupid’s bow (i.e., the apex and the central angle of Cupid’s bow) were smaller in men than in women. When the lip was analyzed, the medium and full types in upper and lower lips accounted for substantial fractions in men, whereas medium and thin types were predominant also in women.

Conclusions

With the help of certain software, this research has made possible to define the best cosmetical redesign solution of lip construction and augmentation with a natural appearance for the patient.Level of Evidence: Level III, diagnostic study.

     

Bilateral autologous microtia reconstruction: a simultaneous two-stage approach

Background

Traditionally, for cases of bilateral autologous ear reconstruction, each side is addressed independently in discrete operative sessions. Herein, we describe our approach to bilateral microtia reconstruction, where each stage is performed simultaneously on both sides.

Methods

All patients who underwent autologous ear reconstruction by a single surgeon (NWB) from April 2006 to January 2012 were retrospectively reviewed. Reconstruction was realized as a two-stage procedure, with each stage performed simultaneously on both sides in bilateral cases. Patient demographics, operative details and incidences of peri- and post-operative complications were collected. A cost comparison of two-stage versus four-stage bilateral auricular reconstruction was completed.

Results

Among a total of 182 patients who underwent autologous ear reconstruction, 18 patients (male, 10, median age, 11.4 years) had simultaneous bilateral auricular correction. Based on estimates derived from unilateral reconstruction theatre times, simultaneous bilateral reconstruction resulted in a savings of 56 min for the first stage and 97 min for the second stage of reconstruction. Moreover, surgical times decreased as operative experience with auricular reconstruction was accrued. There was no increased incidence of peri- or post-operative complications noted. Based on cost estimates at our institution, bilateral reconstruction as a two-stage procedure resulted in a health care cost savings of £10448.16 ($16790.72 USD) per patient with bilateral microtia.

Conclusions

Simultaneous bilateral autologous ear reconstruction is a practicable cost-effective treatment strategy with notable aesthetic and personal benefit to the patient with no increased morbidity.Level of Evidence Level III, therapeutic study.

     

Gluteal muscle fibrosis with abduction contracture of the hip

Purpose

Gluteal muscle fibrosis with hip contracture is a rare condition and causes major disability; literature reports are sparse. The aim of this study is to present, for the first time in Iraq and the region, a case series of gluteal fibrosis and the results of surgical treatment.

Methods

Seven children—six boys and one girl—diagnosed as having gluteal muscle fibrosis with hip contracture, were investigated and treated by open surgical release of fibrotic bands and physiotherapy.

Results

All patients improved dramatically over the subsequent weeks, and were able to sit and squat in the normal position.

Conclusions

Gluteal muscle fibrosis with hip contracture is present in Iraq and more awareness is needed for early diagnosis. Surgical treatment provided excellent results. More studies are needed to delineate the aetiology of the condition.

     

Surgical result of plate osteosynthesis using a locking plate system through an anterior humeral approach for distal shaft fracture of the humerus that occurred during a throwing motion

Purpose

This paper analyzed outcomes of the osteosynthesis with a locking plate system for the fractures of the humerus in throwers using the anterior humeral approach.

Methods

Retrospective case series including 31 patients. Bone union was assessed through follow-up radiographs. Results of visual analogue scale (VAS) for pain, range of motion in the elbow joint, time of return to work, and the Mayo Elbow Performance Score (MEPS) were evaluated to determine functional outcomes. Direction and length of the fracture, the distal cortical length, the humeral diameter, and the total humeral length were measured as part of fracture configuration analysis.

Results

Mean patient age was 25.8 (range, 18–34) years. The follow-up average was 16.0 months (range, 12–23). Delayed union was observed in one (3.1 %) patient. Mean final VAS was 0.4 (range, 0–2), mean time of return to work was 18.2 weeks (range, 13–36), and mean MEPS was 96.3 (range, 88–100) points. All fractures showed a spiral configuration. Mean fracture length was 79.7 (95 % CI, 72.6-86.7) mm, and mean distal cortical length was 48.3 (95 % CI, 37.8-58.8) mm.

Conclusions

The results of the current study indicates that plate osteosynthesis using a locking plate system combined with interfragmentary lag screws through anterior humeral approach may be a favorable option for the surgical treatment of humeral shaft fractures in throwers.

     

Pelvic tilt compensates for increased acetabular anteversion

Purpose

Pelvic tilt determines functional orientation of the acetabulum. In this study, we investigated the interaction of pelvic tilt and functional acetabular anteversion (AA) in supine position.

Methods

Pelvic tilt and AA of 138 individuals were measured by computed tomography (CT). AA was calculated in relation to the anterior pelvic plane (APP) and relative to the table plane. We analysed these parameters for gender-specific and age-related differences.

Results

The mean pelvic tilt was -0.1?±?5.5°. Pelvic sagittal rotation displayed no gender nor age related differences. Females showed higher angles of AA compared with males (20.0° vs 17.2°, p?<?0.001; AA relative to the APP). Anterior tilting of the pelvis positively correlated with AA and individuals with high AA had a higher anterior pelvic tilt compared with those with low AA (p?<?0.0001; AA relative to the APP).

Conclusions

AA has to be calculated regarding pelvic sagittal rotation for correct acetabular orientation. Pelvic tilt is dependent on acetabular orientation and compensates for increased AA.

     

Combination Drug Products for HIV—A Word of Caution for the Transplant Clinician

Modern‐day treatment regimens for human immunodeficiency virus (HIV) are not only highly effective, but are now more often available as convenient fixed‐dose combination products. Furthermore, as medication adherence is of utmost importance in this setting, national guidelines endorse the use of such products. Transplant providers of HIV‐infected patients will undoubtedly encounter these products, some of which contain medications known to drastically alter the metabolism of certain immunosuppressants. Herein, we describe an instance of drug interaction–induced calcineurin inhibitor (CNI) nephrotoxicity in a renal transplant recipient being started on a cobicistat‐containing combination product for HIV. CNI toxicity, in turn, was resolved with the aid of phenytoin as an inducer of drug metabolism. This case underscores the importance of familiarity with newer combination products on the market and constant communication with HIV‐positive transplant recipients and their providers.