Validation of new ultrasound algorithm for estimating prevalence of anal sphincter trauma in a urogynecological population.

OBJECTIVES: To estimate the prevalence of major perineal trauma in a urogynecological population, to test the predictive value of sonographic tear grading (Gillor algorithm) for anal incontinence (AI), AI bother score and St Mark's score, and to compare the predictive power of the Gillor algorithm with that of the residual-defect method. METHODS: This was a retrospective study of 721 women attending a tertiary urogynecology unit between February 2019 and May 2021. All women underwent a standardized interview, including determination of St Mark's score and visual analog scale (VAS) bother score for AI, as well as exoanal (translabial) ultrasound with later offline analysis. Results were reported as the presence of a residual defect of the external anal sphincter (EAS), i.e. a discontinuity of ≥ 30° in ≥ 4/6 tomographic slices, and according to the Gillor algorithm (normal, Grade 3a, Grade 3b or Grade 3c/4). RESULTS: Mean age at assessment was 57 (range, 19-93) years and mean body mass index was 30 (range, 17-57) kg/m2 . Six hundred and thirty-six (88.2%) women were vaginally parous and 161 (22.3%) had undergone at least one forceps delivery. AI was reported by 186/721 (25.8%) women, with a median St Mark's score of 10 (interquartile range (IQR), 6-14) and a median VAS score of 6.3 (IQR, 3.9-10). EAS defects were detected in 261 (36.2%) women, with a residual defect diagnosed in 88 (12.2%). On sonographic grading according to the Gillor algorithm, we identified 532 (73.8%) women with a normal sphincter, 66 (9.2%) with Grade-3a tear, 87 (12.1%) with Grade-3b tear and 36 (5.0%) with Grade-3c/4 tear. In total, the Gillor algorithm classified 189 (26.2%) women as having suffered a major perineal tear. The two grading systems were in moderate agreement (κ, 0.537 (95% CI, 0.49-0.56); P < 0.001). There were weak, albeit significant, associations between EAS defects and measures of AI (P = 0.009 to P = 0.047), both for residual defect as well as the Gillor algorithm. CONCLUSION: Neither the Gillor algorithm nor the residual-defect method of quantifying sphincter trauma on imaging is clearly superior in terms of predicting AI. © 2022 International Society of Ultrasound in Obstetrics and Gynecology.

All or nothing? A second look at partial levator avulsion.

OBJECTIVE: To define associations between partial levator trauma and symptoms and signs of pelvic organ prolapse (POP). METHODS: This was a retrospective study of 3484 women attending a tertiary urogynecology unit for symptoms of pelvic floor dysfunction between January 2012 and February 2020. All women underwent a standardized interview, clinical pelvic organ prolapse quantification (POP-Q) examination and tomographic ultrasound imaging of the pelvic floor. Women with full levator avulsion were excluded from analysis. Partial levator avulsion was quantified using the tomographic trauma score (TTS), in which slices 3-8 are scored bilaterally for abnormal insertions. Binomial multiple logistic regression was analyzed independently for the outcome variables prolapse symptoms, symptom bother and objective prolapse on clinical examination and imaging, with age and body mass index as covariates. Two continuous outcome variables, prolapse bother score and hiatal area on Valsalva, were analyzed using multiple linear regression. RESULTS: Of the 3484 women, ultrasound data were missing or incomplete in 164 due to lack of equipment, clerical error and/or inadequate image quality. Full levator avulsion was diagnosed in 807 women, leaving 2513 for analysis. TTS ranged from 0-10, with a median of 0. Partial trauma (TTS > 0) was observed in 667/2513 (26.5%) women. All subjective and objective measures of POP were associated significantly with TTS, most strongly for cystocele. Associations were broadly linear and similar for all slice locations but disappeared after accounting for hiatal area on Valsalva. CONCLUSION: Partial avulsion is associated with POP and prolapse symptoms. This association was strongest for cystocele, both on POP-Q and ultrasound imaging. The effect of partial avulsion on POP and prolapse symptoms is explained fully by its effect on hiatal area. © 2022 International Society of Ultrasound in Obstetrics and Gynecology.

Uniformity of content requirements for tablets and capsules.

Present pharmacopoeial requirements for uniformity of content of tablets and capsules are based on tests by attributes. A test for uniformity of content based on the root mean square deviation about target (ST) is more reliable than the pharmacopoeial tests and has the added convenience of using a single statistic to control both the mean content and the variation about the mean. Implications of the use of the statistic ST in uniformity requirements are discussed.

Analysis of hydrocortisone acetate ointments and creams by high-performance liquid chromatography.

High-performance liquid chromatographic (HPLC) methods for the analysis of hydrocortisone containing ointments and creams have been investigated. A method which uses a silica column and involves a minimum of sample pre-treatment has been shown to compare favourably with the triphenyltetrazolim chloride method of the British Pharmacopoeia. For hydrocortisone ointments the HPLC procedure provides results of equivalent precision and has advantages with respect to the time taken for each analysis and specificity. Application of the method to the analysis of hydrocortisone creams has been explored and the deviation between the HPLC and colorimetric method requires further investigation.

Analysis of some commercial preparations for migraine treatment using ion-pair high-performance liquid chromatography with addition of salts to the mobile phase.

When appropriate salts are added to the mobile phase in ion-pair high-performance liquid chromatography (HPLC) it is possible to arrive at an isocratic solvent with which complex mixtures of nitrogenous compounds of different pKa values and lipophilic characteristics may be separated. Selectivity in the manipulation of solute retention depends on the salt type, its concentration, the percentage of organic modifier in the mobile solvent and the solute itself. In addition to a dramatic reduction in analysis time, the use of salts can also improve the resolution of closely eluted peaks. With judicious control of the pH of the mobile solvent, the addition of salts to the mobile phase can cause the retention of compounds of different pKa values to alter in a contrasting manner. Under typical ion-pair HPLC conditions, an increase in salt concentration in the mobile solvent enhances the retention of neutral compounds and reduces the retention of ionized compounds. An inverse log-log relationship between the capacity factor of a solute and the salt concentration in the mobile phase was found. Examples are given of the use of salts in mobile solvents for ion-pair HPLC of a number of pharmaceutical preparations employed for the treatment of migraine.

Solvent-induced photodegradation as a source of error in the analysis of polycyclic aromatic hydrocarbons.

The photodegradation of seven common polycyclic aromatic hydrocarbons (PAHs) has been examined in a range of organic solvents. Reactions followed a first order equation with benzo[a]pyrene and benzo[a]anthracene being the most rapidly photodegraded. Generally, the more polar the solvent the faster is the degradation process. A number of photodegradation products were identified by gas chromatography-mass spectrometry. The identification of compounds such as 4-amino-1-naphthalenecarbonitrile and 1H,3H-naphtho[1,8-cd]pyran-1-one clearly indicated that the solvent molecules have taken part in the formation of these compounds. Solvent-induced photodegradation is shown to be an important consideration in choosing the optimum solvent for the best analytical recoveries of PAHs from various matrices.