The compatibility of oxytocin and tranexamic acid injection products when mixed for co-administration by infusion for the treatment of postpartum haemorrhage: An in vitro investigation.

OBJECTIVE: To investigate the compatibility of oxytocin and tranexamic acid injection products when mixed for the purpose of co-administration by intravenous infusion. DESIGN: Compatibility testing. SETTING: Hospitals taking part in a multicentre postpartum haemorrhage treatment (E-MOTIVE) trial in Kenya, Nigeria, Tanzania and South Africa. SAMPLE: Oxytocin and tranexamic acid products. METHODS: The compatibility of two sentinel products of oxytocin injection and tranexamic acid injection in 200-mL infusion bags of both 0.9% w/v saline and Ringer's lactate solution was assessed. We analysed all tranexamic acid-oxytocin combinations, and each evaluation was conducted for up to 3 h. Subsequently, the compatibility of multiple tranexamic acid products with reference oxytocin products when mixed in 0.9% w/v saline over a period of 1 h was investigated. MAIN OUTCOME MEASURES: Concentration of oxytocin over time after mixing with tranexamic acid products. RESULTS: We found significant interaction between certain oxytocin and tranexamic acid products after mixing them in vitro and observing for 1 h. The interaction substantially impacted oxytocin content leading to reduction in concentration (14.8%-29.0%) immediately on mixing (t = 0 min). In some combinations, the concentration continued to decline throughout the stability assessment period. Oxytocin loss was observed in 7 out of 22 (32%) of combinations tested. CONCLUSIONS: In a clinical setting, mixing certain oxytocin and tranexamic acid products before administration may result in an underdosing of oxytocin, compromising care in an emergency life-threatening situation. The mixing of oxytocin and tranexamic acid injection products for co-administration with intravenous infusion fluids should be avoided until the exact nature of the observed interaction and its implications are understood.

Science and agriculture: promoting beneficial symbiosis.

While fundamental research into key mechanisms and interactions is important, the practical investigations that scientists also undertake have additional considerations, since the results are applicable in the real world but need disseminating in a way that reaches the intended audience. Worldwide, rapid population growth produces multiple pressures on land, meaning agriculture must become more efficient and productive. Other pressures on farmers are also increasing: to meet environmental quality standards, to follow legislation about application of chemical products, to remain financially viable against uncertain markets, and more. Applied research addresses specific aspects, but often reports do not describe local contexts or are too restricted, lacking details that enable an understanding of their wider application. We illustrate from our experience within UK agriculture, with a particular focus on soil, the identification of current shortcomings in many research publications; provide examples of good practice; and make suggestions for how scientists can help agriculturalists use their work to address the global issues currently faced. Specifically, we recommend that communication between science and agricultural communities is nurtured, to improve mutual understanding and facilitate two-way flow of ideas. In scientific publications, provision of as much contextual information as possible, and consideration for climatic/temporal/location influences, will enable investigations and results to be used for maximum practical effect and should increase citations.

Acromioclavicular joint reconstruction with the LARS ligament in professional versus non-professional athletes.

PURPOSE: To compare outcomes of acromioclavicular (AC) joint reconstruction with ligament augmentation and reconstruction system (LARS) ligament in professional and non-professional athletes at 2-year minimum follow-up. METHODS: Forty-three patients (men; mean age 30, range 19-54 years) with Rockwood type III to V chronic AC joint dislocations underwent AC joint reconstruction with LARS ligament and standardized rehabilitation. Patients were divided into two groups: professionals (22) and non-professionals (21). Clinical and radiological evaluations were performed preoperatively, at 3- and 24-month follow-up. RESULTS: All clinical (Oxford and Constant) scores and patient satisfaction improved significantly from preoperative to follow-up intervals (p < 0.00001). However, professionals showed nonsignificant improvements from 3- to 24-month follow-up in Constant. Although groups differed preoperatively in Constant (p = 0.037), they were not different in preoperative-to-postoperative differences in clinical scores, postoperative final satisfaction and median time to return to unrestricted activity [4 (interquartiler range 3-5) months to return to full sport in professionals]. Follow-up radiographs revealed an AC joint ratio (clavicle inferior-to-superior translation as ratio of AC joint height) of 0.09 and 0.16 in 8/22 professionals, 0.19 and 0.31 in 9/21 non-professionals, 0.14 and 0.24 in 17/43 overall patients at 3- and 24-month follow-up, respectively. Slight loss of reduction (0.25 < AC joint ratio < 0.50): 21 %. There were no significant clinical-radiographic correlations. Complication: one coracoid fracture at follow-up and one wound infection. CONCLUSIONS: AC joint reconstruction with LARS ligament did not reveal differences in clinical outcomes between groups, with 2 % of failures (re-dislocations) at 2-year minimum follow-up. Superior radiological outcomes in professionals were not correlated to clinical results. LEVEL OF EVIDENCE: Therapeutic study-prospective comparative study, Level II.

Current landscape of direct-to-consumer genetic testing and its role in ophthalmology: a review.

The sequencing of the human genome has seen the emergence of the direct-to-consumer (DTC) genetic-testing market, which allows individuals to obtain information about their genetic profile and its many health and lifestyle implications. Genetics play an important role in the development of many eye diseases, however, little information is available describing the influence of the DTC industry in ophthalmology. In this review, we examined DTC companies providing genetic test products for eye disease. Of all eye conditions, the majority of DTC companies provided susceptibility testing or risk assessment for age-related macular degeneration (AMD). For the 15 companies noted to offer products, we found considerable variation in the cost, scope and clarity of informational content of DTC genetic testing for ophthalmic conditions. The clinical utility of these tests remains in question, and the American Academy of Ophthalmology recommendations against routine testing for many conditions probably still apply.

Electromagnetic interference from lasers and intense light sources in the treatment of patients with artificial pacemakers and other implantable cardiac devices.

Measurements of the electric and magnetic field strengths surrounding six laser systems and one intense pulsed light system were carried out. The results were compared to exposure limits published by cardiac device manufacturers to assess the risk of electromagnetic interference to implantable cardiac devices such as pacemakers or implantable cardioverter defibrillators. The majority of lasers assessed in this study were found to produce electric and magnetic field strengths below the published exposure limits for cardiac devices. However, the low-frequency electric field and static magnetic field of both the CO2 laser and the ruby laser were found to exceed these limits. Ensuring that a small separation is maintained at all times between the laser unit and any patient with a pacemaker or implantable cardioverter defibrillator appears to be a sensible expedient in avoiding overexposure of an implantable cardiac device to electromagnetic interference. Due to the single-shot fast discharge nature of the intense pulsed light system, changes in electromagnetic field strength were too fast for some of the measuring equipment used in this study to register accurate readings during operation.

An alternative injection technique for performing MR ankle arthrography: the lateral mortise approach.

OBJECTIVES: This study evaluates whether the recently described lateral mortise (LM) approach to therapeutic ankle injections can also be used to inject the ankle prior to magnetic resonance arthrography (MRA) without impairing the evaluation of the anterior talofibular ligament (ATFL). MATERIALS AND METHODS: An IRB-approved, retrospective review of ankle MRAs performed using the LM approach between April 2009 and April 2011 was conducted. The MRAs were independently evaluated by three musculoskeletal radiologists for: ATFL assessment (well assessed, limited or unable to assess), amount of fluid in the anterolateral soft tissues (none to large), and capsular distention (underdistended to overdistended). Patient age, gender, fluoroscopy time, injection location, degree of ankle arthritis, and ankle joint narrowing on radiographs were recorded. Statistical analysis was performed using exact binomial confidence limits. RESULTS: Fifteen MRAs were successfully performed on 13 patients (mean age: 27 years, 11 male, 2 female). Mean fluoroscopic time was 39 s (range 9­108) and mean volume injected was 7 mL (range 5­9 mL). The ATFL was well assessed on all MRAs. A moderate to large amount of fluid was noted in the anterolateral soft tissues on 5 out of 15 MRAs. No ankle joints were underdistended, but 3 out of 15 were overdistended. CONCLUSION: Since the ATFL is inferior to the location used for the LM injection, the interpretation of the ankle MRA, specifically ATFL evaluation, was not compromised in any patient. Therefore, the LM approach can be used as an alternative to the anteromedial approach for ankle MRA without sacrificing diagnostic quality.

Lateral mortise approach for therapeutic ankle injection: an alternative to the anteromedial approach.

OBJECTIVE: The purpose of this study was to evaluate the lateral mortise approach for performing therapeutic ankle injections. MATERIALS AND METHODS: Fluoroscopically guided ankle joint injections performed from November 2009 through June 2011 using the lateral ankle mortise approach were retrospectively reviewed. Data recorded included age, sex, fluoroscopic time, person performing the procedure, injection location, and preprocedure and postprocedure pain levels. Radiographs were reviewed for arthritis on a modified Kellgren-Lawrence scale, and the degree of anterior tibiotalar and lateral mortise narrowing was graded from none to severe. Univariate and multivariate statistical analyses were performed. RESULTS: Fifty-three injections were performed on 46 patients (mean age, 50.2 years; mean fluoroscopic time, 44.3 ± 47.3 seconds). Fifty injections in 44 patients were successful with the lateral mortise approach. The degrees of arthritis and anterior tibiotalar joint narrowing were moderate in 22.6% and 20.8% of cases and severe in 39.6% and 32.1% of cases. Lateral mortise narrowing was moderate in 9.4% and severe in 1.9% of cases. Average pre-procedure and postprocedure pain levels were 5.3/10 ± 2.4/10 and 1.7/10 ± 2.3/10. Multivariate analysis showed that increased fluoroscopic time was associated with moderate to severe lateral mortise narrowing (p = 0.011) but that arthritis score (p = 0.811) and degree of anterior tibiotalar joint narrowing (p = 0.416) were not. Pain reduction was associated with a higher preinjection pain score (p ≤ 0.001). CONCLUSION: The lateral mortise approach is an effective alternative to the anterior medial approach for performing therapeutic ankle injections. It is especially useful when moderate to severe ankle arthritis or anterior tibiotalar joint narrowing is present.

Finite element analysis of thermal and acoustic processes during laser tattoo removal.

BACKGROUND AND OBJECTIVE: Q-switched laser therapy is commonly used for the removal of tattoos. However, despite ever increasing demand for this intervention, a better understanding of the mechanisms that result in pigment reduction is required in order to optimise outcomes and reduce the number of treatment episodes. STUDY DESIGN: A finite element analysis computer simulation was developed to model the fragmentation response of ink granules during irradiation of a professional black tattoo using a Q-switched Nd:YAG laser. Thermal and acoustic mechanisms were considered, allowing the optimal laser settings to be predicted throughout the course of treatment. Changes in the thermal properties of the ink during heating were taken into account to improve the reliability of the results obtained. RESULTS: The simulated results are in close agreement with clinical observations. Thermal fragmentation was shown to be the dominant mechanism in pigment reduction when using a 6 nanoseconds pulse at 1,064 nm. In order to provide maximum clearance whilst maintaining acceptable levels of tissue thermal damage, later treatments were shown to benefit from higher fluence levels than initial treatments. Larger spot diameters were also preferable throughout the course of treatment. CONCLUSIONS: The results from the simulation build upon previous work carried out in the field, applying ink thermal coefficients which vary with temperature for the first time. These results compliment clinical knowledge, suggesting that a proactive increase in fluence during a course of treatments is likely to improve the response to laser therapy.

Determination of the thermal and physical properties of black tattoo ink using compound analysis.

Despite the widespread use of laser therapy in the removal of tattoos, comparatively little is known about its mechanism of action. There is a need for an improved understanding of the composition and thermal properties of the tattoo ink in order that simulations of laser therapy may be better informed and treatment parameters optimised. Scanning electron microscopy and time-of-flight secondary ion mass spectrometry identified that the relative proportions of the constituent compounds of the ink likely to exist in vivo are the following: carbon black pigment (89 %), carvacrol (5 %), eugenol (2 %), hexenol (3 %) and propylene glycol (1 %). Chemical compound property tables identify that changes in phase of these compounds lead to a considerable reduction in the density and thermal conductivity of the ink and an increase in its specific heat as temperature increases. These temperature-dependent values of density, thermal conductivity and specific heat are substantially different to the constant values, derived from water or graphite at a fixed temperature, which have been applied in the simulations of laser therapy as previously described in the literature. Accordingly, the thermal properties of black tattoo ink described in this study provide valuable information that may be used to improve simulations of tattoo laser therapy.

Outcomes of Rural Men with Breast Cancer: A Multicenter Population Based Retrospective Cohort Study.

BACKGROUND: Breast cancer is rare in men. This population-based study aimed to determine outcomes of male breast cancer in relation to residence and other variables. METHODS: In this retrospective cohort study, men diagnosed with breast cancer in Saskatchewan during 2000-2019 were evaluated. Cox proportional multivariable regression analyses were performed to determine the correlation between survival and clinicopathological and contextual factors. RESULTS: One hundred-eight eligible patients with a median age of 69 years were identified. Of them, 16% had WHO performance status ≥ 2 and 61% were rural residents. The stage at diagnosis was as follows: stage 0, 7%; I, 31%; II, 42%; III, 11%; IV, 8%. Ninety-eight percent had hormone receptor-positive breast cancer. The median disease-free survival of urban patients was 97 (95% CI: 50-143) vs. 64 (46-82) months of rural patients (p = 0.29). The median OS of urban patients was 127 (94-159) vs. 93 (32-153) months for rural patients (p = 0.27). On multivariable analysis, performance status ≥ 2, hazard ratio (HR) 2.82 (1.14-6.94), lack of adjuvant systemic therapy, HR 2.47 (1.03-5.92), and node-positive disease, HR 2.32 (1.22-4.40) were significantly correlated with inferior disease-free survival in early-stage invasive breast cancer. Whereas stage IV disease, HR 7.8 (3.1-19.5), performance status ≥ 2, HR 3.25 (1.57-6.71), and age ≥ 65 years, HR 2.37 (1.13-5.0) were correlated with inferior overall survival in all stages. CONCLUSIONS: Although residence was not significantly correlated with outcomes, rural men had numerically inferior survival. Poor performance status, node-positive disease, and lack of adjuvant systemic therapy were correlated with inferior disease-free survival.

The utility of wide-field optical coherence tomography angiography in diagnosis and monitoring of proliferative diabetic retinopathy in pregnancy.

PURPOSE: Diabetic retinopathy is an increasingly common complication of diabetes mellitus that benefits from early diagnosis and frequent monitoring, especially in pregnancy where there is a greater risk of progression. Fundus fluorescein angiography is currently the gold standard method of investigation for neovascularization. However, this has risks of unpleasant and potentially dangerous side effects, with an added theoretical risk to the fetus in pregnancy. Wide-field optical coherence tomography angiography (PLEX Elite 9000, Carl Zeiss Meditec, Inc. USA and DRI Swept Source OCT Triton, Topcon Medical Systems, Inc. USA) potentially offers a safer, faster and equally effective alternative method for diagnosis and monitoring of diabetic retinopathy in pregnant patients. OBSERVATIONS: In the 3 cases reviewed from our clinic, we found that wide-field optical coherence tomography angiography was successfully used as an alternative to fundus fluorescein angiography in early diagnosis and ongoing monitoring of diabetic retinopathy in pregnant patients. CONCLUSIONS AND IMPORTANCE: Wide-field optical coherence tomography angiography can be considered as a useful alternative to fundus fluorescein angiography when reviewing pregnant diabetic retinopathy patients. This allows avoidance of any unpleasant and potentially dangerous side effects associated with fluorescein injection, and appears to be just as effective in diagnosis and detecting disease progression.

Efficacy of adjuvant trastuzumab in women with HER2-positive T1a or bN0M0 breast cancer: a population-based cohort study.

Adjuvant trastuzumab has been associated with superior survival in women with ≥ T1c or node-positive HER2-positive early-stage breast cancer; however, there is a lack of phase III trials in women with T1a/bN0 disease. Our study aimed to assess the outcomes of women with HER2-positive T1a/bN0 breast cancer who received adjuvant trastuzumab in Saskatchewan, Canada. We evaluated all women diagnosed with HER2-positive T1a/bN0 breast cancer in Saskatchewan between 2008 and 2017. We performed Cox proportional multivariable analysis to determine factors correlated with survival. In addition, inverse probability treatment weighting (IPTW) using propensity score was performed to assess benefit of adjuvant trastuzumab. Ninety-one eligible women with a median age of 61 years (range 30-89) were identified. Thirty-nine (43%) women received adjuvant trastuzumab. Women who received trastuzumab were younger and had a higher rate of T1b disease. Overall, 3% of women who received trastuzumab compared to 12% of women who did not receive trastuzumab developed breast cancer recurrence (p = 0.23). Five-year disease-free survival (DFS) of women who received adjuvant trastuzumab was 94.8% compared to 82.7% of women who did not receive trastuzumab (p = 0.22). Five-year overall survival was 100% of women who received trastuzumab compared to 90.4% of women who did not receive adjuvant trastuzumab (p = 0.038). In the multivariable analysis, grade III tumors were correlated with inferior DFS (hazard ratio [HR] 5.5, 95% CI [1.7-17.7]). The propensity score using the inverse probability of treatment weighting showed that lack of adjuvant trastuzumab was correlated inferior DFS, with an HR of 4 (95% CI 1.05-15.5). Women with HER2-positive T1a/bN0 breast cancer had overall low recurrence of breast cancer. However, the results of this exploratory analysis indicate that women who received adjuvant trastuzumab had better survival.

Pan-Canadian consensus recommendations for proton beam therapy access in Canada.

PURPOSE: Proton Beam Therapy (PBT)is a treatment option for select cancer patients. It is currently not available in Canada. Assessment and referral processes for out-of-country treatment for eligible patients vary by jurisdiction, leading to variability in access to this treatment for Canadian cancer patients. The purpose of this initiative was to develop a framework document to inform consistent and equitable PBT access for appropriate patients through the creation of pan-Canadian PBT access consensus recommendations. MATERIALS AND METHODS: A modified Delphiprocess was used to develop pan-Canadian recommendations with input from 22 PBT clinical and administrative experts across all provinces, external peer-review by provincial cancer and system partners, and feedback from a targeted community consultation. This was conducted by electronic survey and live discussion. Consensus threshold was set at 70% agreement. RESULTS: Fourconsensus rounds resulted in a final set of 27 recommendations divided into three categories: patient eligibility (n = 9); program level (n = 10); and system level (n = 8). Patient eligibility included: anatomic site (n = 4), patient characteristics (n = 3), clinical efficacy (n = 2). Program level included: regulatory and staff requirements (n = 5), equipment and technologies (n = 4), quality assurance (n = 1). System level included: referral process (n = 5), costing, budget impact and quality adjusted life years (n = 2), eligible patient estimates (n = 1). Recommendations were released nationally in June 2021 and distributed to all 43 cancer programs in Canada. CONCLUSION: A pan-Canadian consensus-building approach was successful in creating an evidence-based, peer-reviewed suite of recommendations thatsupportapplication of consistent clinical criteria to inform treatment options, facility set-up and access to high quality proton therapy.

Quality of oxytocin and tranexamic acid for the prevention and treatment of postpartum hemorrhage in Kenya, Nigeria, South Africa, and Tanzania.

OBJECTIVE: To check the quality of oxytocin and tranexamic acid-two recommended products for prevention and treatment of postpartum hemorrhage (PPH)-used in facilities taking part in an implementation research project to improve PPH diagnosis and management. METHODS: Between September 2020 and August 2021, oxytocin and tranexamic acid products used in the study facilities in Kenya, Nigeria, South Africa, and Tanzania were collected and transported in cold storage for analysis. Samples were analyzed according to the International (oxytocin) and British Pharmacopeia (tranexamic acid) standards. RESULTS: Of the 17 unique oxytocin products, 33 individual measurements were made. Only six unique products had adequate content and no related substances exceeding the recommended limits. Of 14 tranexamic acid samples, 10 showed adequate content. One product in Kenya and two products in Nigeria from different manufacturers had a high content of related substances, which classified them as substandard. CONCLUSION: While we were unable to investigate the origin regarding poor manufacturing or poor storage or both, the high number of substandard oxytocin samples is of great concern. Most of the tranexamic acid samples had adequate content but the presence of impurities in multiple products is worrying and requires further study.

Efficacy of Fulvestrant in Women with Hormone-Resistant Metastatic Breast Cancer (mBC): A Canadian Province Experience.

INTRODUCTION: Fulvestrant has demonstrated efficacy in hormone receptor positive (HR+) metastatic breast cancer (mBC), both in first-and second-line settings. In clinical practice, however, fulvestrant has been used as a later-line therapy. This study assessed the efficacy of fulvestrant in women with mBC in early-versus later-line therapy. METHODS: This retrospective cohort study assessed Saskatchewan women with HR+ mBC who received fulvestrant between 2003-2019. A multivariate Cox proportional survival analysis was performed. RESULTS: One hundred and eighty-six women with a median age of 63.5 years were identified-178 (95.6%) had hormone-resistant mBC, 57.5% had visceral disease, and 43.0% had received chemotherapy before fulvestrant. 102 (54.8%) women received ≤2-line-therapy, and 84 (45.2%) received ≥3 line-therapy before fulvestrant. The median time to progression (TTP) was 12 months in the early-treatment vs. 6 months in the later-treatment group, p = 0.015. Overall survival (OS) from the start of fulvestrant was 26 months in the early-treatment group vs. 16 months in the later-treatment group, p = 0.067. On multivariate analysis, absence of visceral metastasis, HR: 0.70 (0.50-0.99), was significantly correlated with better TTP, whereas post-fulvestrant chemotherapy, HR: 0.32 (0.23-0.47), clinical benefit from fulvestrant, HR: 0.44 (0.30-0.65), and absence of visceral metastasis, HR: 0.70 (0.50-0.97), were correlated with better OS. CONCLUSIONS: Fulvestrant has demonstrated efficacy as both early-and later-line therapy in hormone-resistant mBC. Our results show that women with clinical benefit from fulvestrant, who received post-fulvestrant chemotherapy, or had non-visceral disease, had better survival.

Adverse effects following Q-switched ruby laser treatment of pigmented lesions.

A retrospective study was conducted to investigate the incidence of adverse effects following Q-switched ruby laser treatment of pigmented lesions at the Wessex Specialist Laser Centre. Sixty-one patients received a total of 151 treatments between January 2006 and January 2008. This is the largest series to date of patients on whom adverse effects have been reported following Q-switched ruby laser treatment of an assortment of pigmented lesions. Patients with traumatic or decorative tattoos were excluded from this study. Two of the treatments (1.3%) resulted in adverse effects. One patient developed hyperpigmentation and the other experienced scabbing and subsequent textural change following abrasion of the scab. No predisposing medical or other factors were observed in either patient. This low incidence of adverse effects is consistent with the highly selective absorption of ruby laser light by melanin. The presence of these adverse effects highlights the importance of test patch treatments, the necessity for patients to follow good post-treatment advice and the case for vigilance in monitoring the quality of the laser output.

Spectrophotometers for the clinical assessment of port-wine stain skin lesions: a review.

Reflectance spectrophotometry is the most established and widely used objective technique for the assessment of port-wine stain (PWS) skin, and has been applied extensively in other dermatological applications. To date, no review has been published regarding the different spectrophotometric devices used on PWS skin. This paper comprises such a review, introducing the reader to the relevant background material and then discussing scanning, narrow-band and tristimulus spectrophotometers in turn. Scanning spectrophotometry is the most versatile of the three methods but it is noted that considerable expertise is required to interpret the acquired data. Narrow-band and tristimulus devices are available at a much lower price and can be considerably simpler to use. They do, however, provide limited information that does not account for the complex effects of melanin and other chromophores within the skin. Although scanning spectrophotometers would be the preferred choice for most investigations, cheaper, simpler and equally reliable options are available and may better suit the needs of some research projects.

Temperature stability of oxytocin ampoules labelled for storage at 2°C-8°C and below 25°C: an observational assessment under controlled accelerated and temperature cycling conditions.

INTRODUCTION: Oxytocin, administered via injection, is recommended by WHO for the prevention and treatment of postpartum haemorrhage. However, the susceptibility of oxytocin injection to thermal degradation has led WHO and UNICEF to recommend cold-chain storage of all oxytocin products. Nevertheless, some oxytocin products supplied to the global market are labelled for storage at ≤25°C, often with a shorter shelf-life relative to products labelled for refrigeration. Differences in labelled storage requirements can lead to uncertainties among stakeholders around the relative stability of oxytocin products and specifically whether ≤25°C products are more resistant to degradation. Such confusion can potentially influence policies associated with procurement, distribution, storage and the use of oxytocin in resource-poor settings. OBJECTIVES: To compare the stability of oxytocin injection ampoules formulated for storage at ≤25°C with those labelled for refrigerated storage. DESIGN: Accelerated and temperature cycling stability studies were performed with oxytocin ampoules procured by the United Nations Population Fund (UNFPA) from four manufacturers. METHOD: Using oxytocin ampoules procured by UNFPA, accelerated stability (up to 120 days) and temperature cycling (up to 135 days between elevated and refrigerated temperatures) studies were performed at 30°C, 40°C and 50°C. Oxytocin content was quantified using a validated HPLC-UV method. RESULTS: All ampoules evaluated exhibited similar stability profiles under accelerated degradation conditions with the exception of one product formulated for ≤25°C storage, where the rate of degradation increased at 50°C relative to other formulations. Similar degradation trends at elevated temperatures were observed during temperature cycling, while no significant degradation was observed during refrigerated periods of the study. CONCLUSION: Oxytocin ampoules formulated for non-refrigerated storage demonstrated comparable stability to those labelled for refrigerated storage and should not be interpreted by stakeholders as offering a more stable alternative. Furthermore, these products should not be procured for use in territories with high ambient temperatures, where all oxytocin injection products should be supplied and stored under refrigerated conditions.

Reliability and sensitivity of a wrist rig to measure motor control and spasticity in poststroke hemiplegia.

BACKGROUND: Objective assessment of impairments after stroke is vital for evidence-based therapy and progress monitoring. OBJECTIVE: This study determines the utility of outcome measures obtained from an instrumented wrist rig for future rehabilitation trials. The tests undertaken were evaluated in terms of sensitivity to detect differences between normal and impaired participants, test-retest repeatability (repeatability coefficient and intraclass correlation coefficient [ICC]), and interrater agreement (Bland and Altman limits of agreement). METHODS: Twelve participants with chronic poststroke hemiparesis (mean 5.6 years); and 12 unimpaired volunteers performed a series of tasks in the rig. The hemiparetic arm (impaired group) and dominant arm (unimpaired group) were tested in 3 sessions on the same day by 2 assessors. Signals were analyzed to derive a tracking index (motor control), stretch index (spasticity), flexor modulation index (FMI) (muscle activation), force angle index (FAI) (stiffness), range of movement, and isometric force. RESULTS AND CONCLUSIONS: The means of all tests differed between impaired and unimpaired participants except for range of movement into flexion, the FAI, and the FMI. Repeatability coefficients for each test are presented as benchmark values for use in future trials in which the wrist rig tests may be used to detect change. Test-retest reliability was excellent in the impaired group (ICC = 0.88-0.98) and poor to excellent in the unimpaired group (ICC = 0.06-0.89). The Bland-Altman ranges showed no bias between assessors, and that the interassessor variability was similar to that between repeats by the same assessor for most tests.