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1.
Cont Lens Anterior Eye ; : 102156, 2024 Apr 18.
Article in English | MEDLINE | ID: mdl-38641525

ABSTRACT

It is important to be able to measure the range of clear focus in clinical practice to advise on presbyopia correction techniques and to optimise the correction power. Both subjective and objective techniques are necessary: subjective techniques (such as patient reported outcome questionnaires and defocus curves) assess the impact of presbyopia on a patient and how the combination of residual objective accommodation and their natural DoF work for them; objective techniques (such as autorefraction, corneal topography and lens imaging) allow the clinician to understand how well a technique is working optically and whether it is the right choice or how adjustments can be made to optimise performance. Techniques to assess visual performance and adverse effects must be carefully conducted to gain a reliable end-point, considering the target size, contrast and illumination. Objective techniques are generally more reliable, can help to explain unexpected subjective results and imaging can be a powerful communication tool with patients. A clear diagnosis, excluding factors such as binocular vision issues or digital eye strain that can also cause similar symptoms, is critical for the patient to understand and adapt to presbyopia. Some corrective options are more permanent, such as implanted inlays / intraocular lenses or laser refractive surgery, so the optics can be trialled with contact lenses in advance (including differences between the eyes) to better communicate with the patient how the optics will work for them so they can make an informed choice.

2.
Cont Lens Anterior Eye ; 47(2): 102105, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38216392

ABSTRACT

PURPOSE: The current multi-study analysis combined data from three studies to quantify the relationship between the initial reaction to soft multifocal contact lens (MFCL) design types at dispensing and evaluate the predictability of overall vision satisfaction (OVS) and intention to purchase (ITP) after 1 week of wear. METHOD: Three prospective studies tested MFCLs over 1-week of wear following the same protocol, using a range of potentially predictive ratings at dispensing, and both OVS and ITP at 1-week as an indicator acceptance level. In each study, two of MyDay® multifocal, clariti® 1 day multifocal, Biofinity® multifocal (worn as a daily disposable lens) or 1 DAY ACUVUE® MOIST MULTIFOCAL were dispensed for 1-week of daily wear. OVS was recorded on a 100-point VAS and ITP on a 5-point LIKERT scale. Fourteen possible predictors were entered in the statistical model, and predictability was assessed using Chi-square Automatic Interaction Detector (CHAID) statistical test. RESULTS: A total of 210 participants (152 female & 58 male; 53.9 ± 6.5 years, range 41-71 years), representing 420 MFCL fits, equally distributed between emergent n = 65, established n = 70 and advanced n = 75 presbyopes, completed the studies. OVS on dispensing was the predictor of both OVS (p < 0.001) and ITP (p < 0.001) at 1-week. For OVS predictability, 70.8 % with OVS at dispensing > 91 points reported good OVS at 1-week and 73.4 % with OVS on dispensing ≤ 80 points reported poor OVS at 1-week. For ITP predictability, 74.6 % with OVS at dispensing > 94 points reported a positive ITP at 1-week and 65.9 % with OVS on dispensing ≤ 63 points reported negative ITP at 1-week. CONCLUSION: Overall vision satisfaction at the time of dispensing MFCLs is a powerful indicator of both OVS and ITP after 1-week of wear. Initial patient subjective assessments provide a clinically useful indicator of the likeliness of success.


Subject(s)
Contact Lenses, Hydrophilic , Presbyopia , Humans , Male , Female , Visual Acuity , Prospective Studies , Vision, Ocular
3.
Am J Med Qual ; 38(4): 174-180, 2023.
Article in English | MEDLINE | ID: mdl-37314239

ABSTRACT

The current study evaluated whether total cost of care (TCOC) and target price were aligned in Oncology Care Model (OCM) hematologic malignancy episodes and identified factors associated with episodes exceeding target price. Hematologic malignancy episodes from OCM performance period 1-4 reconciliation reports were identified from a large academic medical center. Of the 516 hematologic malignancies episodes included in the analysis, 283 (54.8%) exceeded the target price. Episode characteristics found to be statistically significantly associated with exceeding target price were Medicare Part B drug use and Part D drug use, novel therapy use, home health agency, and >730 days from last chemotherapy. The mean TCOC was $85 374 (± $26 342) for the episodes that exceeded target price while the mean target price was $56 106 (±$16 309). The results found a substantial misalignment between the TCOC and target price for hematologic malignancy episodes, adding to the existing evidence on the lack of adequate adjustment to the OCM target price.


Subject(s)
Hematologic Neoplasms , Medicare , Aged , Humans , United States , Medical Oncology , Hematologic Neoplasms/drug therapy
4.
Clin Appl Thromb Hemost ; 29: 10760296231165056, 2023.
Article in English | MEDLINE | ID: mdl-36972481

ABSTRACT

Persons with bleeding disorders (PwBD) are at high risk for bleeding with invasive procedures. However, the risk of bleeding in PwBD undergoing major surgery and outcomes of patients managed perioperatively at a hemophilia treatment center (HTC) are not well described. We performed a retrospective review of surgical outcomes among PwBD undergoing major surgery between January 1st, 2017 and December 31st, 2019 at the Cardeza Foundation Hemophilia and Thrombosis Center in Philadelphia, PA. The primary outcome was postoperative bleeding, assessed according to the ISTH-SSC's 2010 definition. Secondary outcomes included use of unplanned postoperative hemostatic therapy, LOS, and 30-day readmission rate. Results were compared to non-PwBD population from a surgical database, matched for surgery, age, and sex. During the study period, 50 PwBD underwent 63 major surgeries. The most common diagnoses were VWD (64%) and hemophilia A (20.0%). The most common surgical procedure category was orthopedic (33.3%), predominantly arthroplasties. Postoperatively,4.8% of procedures were complicated by major bleeding and 1.6% by non-major bleeding. The mean LOS was 1.65 days, and 30-day readmission rate was 1.6%. In comparison to matched, non-PwBD patients in a national surgical database undergoing the same procedures, study patients had a similar rate of bleeding complications per procedure (5.0% vs 1.04% P = .071, Fisher's exact test). PwBD undergoing major surgeries have low rates of major bleeding when receiving comprehensive care at an HTC. Bleeding and hospital readmission rates were similar to non-PwBD baseline in a large database.


Subject(s)
Hemophilia A , Hemostatics , von Willebrand Diseases , Humans , Hemophilia A/complications , Hemophilia A/surgery , Hemophilia A/drug therapy , von Willebrand Diseases/complications , Postoperative Hemorrhage/etiology , Hemostatics/therapeutic use , Retrospective Studies
5.
Vet Ophthalmol ; 26(1): 19-30, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36322454

ABSTRACT

PURPOSE: To quantify the surgical blood loss during canine enucleation and to investigate the relationship between this and any patient, surgical, and anesthetic factors. METHODS: A prospective observational analysis was conducted on 121 client-owned dogs (130 eyes) undergoing enucleation at a referral ophthalmology clinic. Blood loss was estimated by the gravimetric method (weight difference between dry and blood-containing surgical materials) to provide absolute blood loss (ABL) in milliliters, expressed as a percentage of circulating blood volume, to establish relative blood loss (RBL). RESULTS: Median ABL was 12 ml (1.6-116 ml), and median RBL was 1.3% (0.1%-6.7%). A higher RBL was associated with the following: use of a bupivacaine splash block versus retrobulbar nerve block (1.9 vs. 1%; p < .001), transpalpebral versus subconjunctival approach (2.2 vs. 1.3%; p = .003), and small versus large breed dogs (1.7% vs. 1.1%; p = .001). Both ABL and RBL differed significantly between surgeons. There was no significant difference in hemorrhage associated with the presence of ocular hypertension, systemic illness, surgical time, administration of meloxicam or choice of pre-medicant (acepromazine vs medetomidine). No dog required supportive intervention in response to surgical hemorrhage. CONCLUSIONS: This study has established a surgical blood loss estimate for dogs undergoing enucleation at an ophthalmology referral centre. Subconjunctival enucleation may be preferred for patients at greater risk of haemodynamic complications.


Subject(s)
Dog Diseases , Nerve Block , Dogs , Animals , Blood Loss, Surgical/veterinary , Bupivacaine , Acepromazine , Nerve Block/veterinary , Dog Diseases/surgery
6.
Clin Optom (Auckl) ; 14: 223-235, 2022.
Article in English | MEDLINE | ID: mdl-36444271

ABSTRACT

Purpose: A large observational survey was undertaken to determine eye care professional (ECP) and patient experience of stenfilcon A multifocal soft contact lens (MyDay multifocal) when prescribed in a real-world setting. Methods: A total of 196 ECPs from eleven countries fit up to ten presbyopes with stenfilcon A multifocal. Data were collected on fit success at the initial visit, patient satisfaction with comfort, vision at distance, intermediate, and near, overall vision, overall satisfaction, and handling at the initial and follow-up visits after 1-2 weeks of wear. ECPs completed questionnaires on multifocal fitting experience and expectations before and after the fitting period. Results: A total of 196 pre-fitting and 141 post-fitting ECP surveys were collected. A total of 1505 initial fits (mean age 53.4, range 38 to 81 years, 73% female, 27% neophytes) and 1440 follow-up visits were completed. The mean distance vision contact lens prescription was -1.32DS (range -12.00DS to +8.00DS) with Add powers: Low 56%, Medium 24%, and High 21%. At the follow-up visit 77% (n=1108) of trials were successful. Mean patient satisfaction ratings (1-10 scale, where 1 is not at all satisfied, and 10 extremely satisfied) at the initial visit were higher than eight out of ten for comfort, vision, and overall satisfaction, and were not significantly different after 1-2 weeks of wear. Stenfilcon A multifocal was preferred by 66% of patients over their habitual correction. In most cases mean satisfaction scores and the proportion of patients highly satisfied were not significantly different between myopes and hyperopes, across Add range, between new and habitual wearers, and wearers of frequently replaced and 1 day contact lenses. Conclusion: ECPs in real-world clinical settings found stenfilcon A multifocal contact lenses easy to fit to a wide range of patients, with a high fit success rate and high levels of patient satisfaction for overall comfort, vision, satisfaction, and handling.

7.
Drugs Real World Outcomes ; 9(2): 307-314, 2022 Jun.
Article in English | MEDLINE | ID: mdl-35357690

ABSTRACT

BACKGROUND: Baclofen is an effective treatment for spasticity. Abrupt cessation of intrathecal (IT) or oral baclofen risks the development of withdrawal symptoms; however, the magnitude of the problem is unknown. OBJECTIVES: The aims for this study were as follows: (1) using an administrative claims database, estimate the number of patients in the United States on baclofen, and (2) estimate the annual percent hospitalized pediatric and adult populations consequently at risk for interruption of chronic baclofen therapy. METHODS: Using 2011-2014 data representing commercially insured individuals, patients were selected based on insurance coverage; evidence of a baclofen claim; and hospitalization. All patients hospitalized while receiving chronic baclofen were assumed to be at risk for baclofen discontinuation. Yearly counts were determined and then extrapolated to national estimates using census data. RESULTS: Extrapolating from the claims database, oral or IT baclofen was prescribed annually to 33,061 or 1486 patients ≤ 18 years, and 654,294 or 7084 patients 19-64 years, respectively. The estimated national mean number of at-risk hospitalizations per year for patients aged 19-64 years on chronic oral or IT baclofen was 31,116 and 3774, respectively; patients ≤ 18 years numbered 4691 and 959, respectively. The mean percent of patients hospitalized per year was 42% in those ≤ 18 years receiving IT baclofen compared with 30% in adults, and 3-10% in the populations receiving oral baclofen. CONCLUSIONS: Extrapolation from an administrative claims database was used to estimate the national number and demographics of hospitalized chronic baclofen users. Patients ≤ 18 years receiving IT baclofen were at highest risk of withdrawal due to a high occurrence of hospitalization.

8.
Vet Rec ; 190(11): e1383, 2022 06.
Article in English | MEDLINE | ID: mdl-35092709

ABSTRACT

BACKGROUND: This study aimed to describe a modification of the combined Hotz-Celsus and wedge resection technique for the treatment of lower lid entropion in dogs and evaluate its success rate. METHODS: To reduce tissue trauma, facilitate tissue handling and shorten the surgical time, shortening of the eyelid was performed by excising a rectangular piece of the eyelid margin only, in the central section, extending to but not below the first Hotz-Celsus incision. The eyelid margin surgical wound was then sutured before excision of the Hotz-Celsus crescent which had been surgically scored at the start of surgery. Records of 31 dogs were reviewed for signalment, outcome, need for further surgery, and follow up from 6 to 48 months after surgery. RESULTS: Sixty-one eyes with lower lid entropion were treated. The most common breeds were English bulldog and English cocker spaniel and the median age was 16 months. The success rate for a single entropion correction surgery was 98.4%. One eyelid required a second surgical correction and four eyelids of three large breed dogs had wound breakdown. CONCLUSIONS: This modified technique is successful at correcting lower eyelid entropion associated with overlong eyelid length in dogs while being technically easier to perform.


Subject(s)
Dog Diseases , Entropion , Surgical Wound , Animals , Dog Diseases/surgery , Dogs , Entropion/surgery , Entropion/veterinary , Eyelids/surgery , Operative Time , Ophthalmologic Surgical Procedures/methods , Ophthalmologic Surgical Procedures/veterinary , Retrospective Studies , Surgical Wound/veterinary
9.
Cont Lens Anterior Eye ; 45(2): 101515, 2022 04.
Article in English | MEDLINE | ID: mdl-34583895

ABSTRACT

Soft contact lenses that have been prescribed by eye care practitioners are sometimes substituted for alternative lenses by unqualified, unregulated and sometimes even fully regulated lens suppliers, in the mistaken belief that there is essentially no difference between different soft lens types. This review considers the implications of inappropriately substituting soft contact lens types in terms of (a) lens properties: surface treatment, internal wetting agents, material, total diameter, back optic zone radius, thickness, edge profile, back surface design, optical design, power, colour (tint) and ultraviolet protection; and (b) lens usage: wearing modality (daily versus overnight wear) and replacement frequency. Potential aspects of patient dissatisfaction and adverse events when prescribed soft lenses are substituted for lenses with different properties or intended usage are considered. Substitution of 15 of the 16 lens properties considered (i.e. except for back surface design) was found to be related to at least one - and as many as six - potential sources of patient dissatisfaction and adverse ocular events. Contact lens are medical devices which are prescribed and fitted; they should never be substituted for another lens type in the absence of a new prescription further to a full finalised fitting, for the simple reason that all soft contact lenses are not created equal. A substituted lens may have properties that results in undesirable consequences in respect of vision, ocular health, comfort and cosmetic appearance, and may be incompatible with the lifestyle of the patient.


Subject(s)
Contact Lenses, Hydrophilic , Lens, Crystalline , Humans , Prescriptions , Vision, Ocular
10.
Popul Health Manag ; 25(1): 46-56, 2022 02.
Article in English | MEDLINE | ID: mdl-34134513

ABSTRACT

Multiple sclerosis (MS) is a "3C" (complex, chronic, costly) condition that is a common and disabling neurological illness affecting approximately 1 million adults in the United States. MS has been studied at the basic science, individual, and population levels, but not at the system level to assess small-area variation effects on MS population health outcomes. System-level effects have been observed in other 3C conditions including cystic fibrosis, rheumatoid arthritis, and inflammatory bowel disease. The authors report here on system-level variation findings from the baseline period during the first year of the Multiple Sclerosis Continuous Quality Improvement (MS-CQI) study. Stepwise binary logistic regression analyses were conducted to investigate system-level (small-area variation) effects on MS relapses (exacerbations), disease-modifying therapy (DMT) utilization, and brain MRI utilization, controlling for demographics (age and sex) and other potential confounders. Significant differences were observed in people with MS (PwMS) between centers for a number of demographic and disease characteristics, including sex, age, and MS subtype. Controlling for these factors, significant system-level effects were observed on outcomes, including DMT utilization, MRI utilization, and relapses. Significant relationships also were observed between outcomes and urgent care utilization, including emergency department visits and hospitalizations. This initial study provides evidence establishing the presence of system-level variation effects on MS outcomes in a multicenter population study - where PwMS get their care can influence their outcomes. Results support continued systems-level research and improvement initiatives to optimize MS population health outcomes in this challenging and costly complex chronic condition.


Subject(s)
Multiple Sclerosis , Adult , Chronic Disease , Hospitalization , Humans , Multiple Sclerosis/epidemiology , Multiple Sclerosis/therapy , Quality Improvement , United States
11.
Clin Exp Optom ; 105(5): 459-473, 2022 07.
Article in English | MEDLINE | ID: mdl-34886744

ABSTRACT

Advances in contact lens technology over the past 50 years since the commercialisation of the first soft lenses in 1971 have been incredible, with significant changes in contact lens materials, frequency of replacement, care systems and lens designs occurring. However, despite the widespread availability of contact lenses, penetration rates for those who need vision correction remain in the low single digits and many practitioners seem to hold on to concepts around the potential value of contact lenses that appear based in the dim and distant past and are certainly no longer valid today. This review addresses 10 common 'myths and misconceptions' around soft contact lenses using an evidence-based approach that can hopefully dispel some of these incorrect assumptions.


Subject(s)
Contact Lenses, Hydrophilic , Lens, Crystalline , Optometry , Humans , Prescriptions
12.
JCO Oncol Pract ; 17(11): e1660-e1667, 2021 11.
Article in English | MEDLINE | ID: mdl-34618553

ABSTRACT

PURPOSE: To explore mean difference between Oncology Care Model (OCM) total costs and target price among breast cancer episodes by stage under the Centers for Medicare and Medicaid Services OCM payment methodology. METHODS: Breast cancer episodes from OCM performance period 1-4 reconciliation reports (July 1, 2016-July 1, 2018) were linked with health record data from a large, academic medical center. Demographics, total cost of care (TCOC), and target price were measured by stage. Adjusted differences between TCOC and target price were compared across cancer stage using multivariable linear regression. RESULTS: A total of 539 episodes were evaluated from 252 unique patients with breast cancer, of which 235 (44%) were stage I, 124 (23%) stage II, 33 (6%) stage III, and 147 (27%) stage IV. About 37% of episodes exceeded target price. Mean differences from target price were -$1,782, $2,246, -$6,032, and $11,379 all in US dollars (USD) for stages I through IV, respectively. Stage IV episodes had highest mean TCOC ($44,210 USD) and mean target price ($32,831 USD) but also had higher rates of chemotherapy, inpatient admission, and novel therapy use. After adjusting for covariates, stage IV and ≥ 65-year-old patients had the highest mean difference from target price ($17,175 USD; 95% CI, $12,452 to $21,898 USD). CONCLUSION: Breast cancer episodes in older women with distant metastases most frequently exceeded target price, suggesting that target price did not adequately account for complexity of metastatic cancers. A metastatic adjustment introduced in PP7 represents a promising advancement in the target price methodology and an impact evaluation will be needed.


Subject(s)
Breast Neoplasms , Aged , Breast Neoplasms/therapy , Female , Hospitalization , Humans , Medical Oncology , Medicare , United States
13.
Int J Pharm Compd ; 25(2): 163-168, 2021.
Article in English | MEDLINE | ID: mdl-33798116

ABSTRACT

An oral liquid formulation of nadolol, which is required for administration to patients who cannot swallow intact tablets, is not commercially available. The objective of this study was to evaluate the stability of nadolol 10 mg/mL prepared in Oral Mix vehicle and stored in amber glass, amber polyethylene terephthalate, or amber polyvinyl chloride for 91 days at 4ÆC and 25ÆC; and polypropylene oral plastic syringes at 25ÆC only. Three separate batches of nadolol suspension 10 mg/mL were prepared with Oral Mix. Of the suspension, 50-mL aliquots were stored in 100-mL bottles (amber glass, amber polyethylene terephthalate, or amber polyvinyl chloride). Half of the bottles from each container type were stored at 25ÆC and the other half at 4ÆC. On study days 0, 2, 7, 14, 21, 28, 42, 56, 72, and 91, nadolol concentration was determined using a reverse-phase, stability-indicating liquid chromatographic method from samples drawn from each type of container at each temperature. Oral syringes (3 mL), filled with 2 mL of suspension, were stored at 25ÆC and tested on days 0, 2, 7, 21, 42, and 91. The concentration of nadolol 10 mg/mL in Oral Mix in all study samples from bottles and oral syringes remained within 3.5% of the initial concentration. Based on the fastest degradation rate with 95% confidence, on day 91, between 99% to 100% and 98% to 100% remained in suspensions stored in bottles at 25ÆC and 4ÆC, respectively. Oral syringes at 25ÆC had 94% remaining on day 91. Multiple linear regression analysis demonstrated that the percent remaining was related to study day and container, but not temperature. On day 91, nadolol 10 mg/mL oral suspensions prepared with Oral Mix and stored in all bottle types at 4ÆC will retain more than 98% of the initial concentration compared to 99% at 25ÆC and only 94% when stored in oral syringes.


Subject(s)
Nadolol , Syringes , Administration, Oral , Chromatography, High Pressure Liquid , Drug Compounding , Drug Stability , Drug Storage , Humans , Plastics , Suspensions
14.
Cont Lens Anterior Eye ; 44(5): 101432, 2021 10.
Article in English | MEDLINE | ID: mdl-33678542

ABSTRACT

Reusable soft daily wear contact lenses (CLs) remain popular and were fit to just over half of all wearers in the most recent international CL prescribing survey. Unlike daily disposable CLs, reusables require cleaning and disinfecting after every use, along with storage in a CL case. These additional requirements add a number of steps to the daily wear and care routine, increasing the opportunities for CL wearers to exhibit non-compliant behaviour. The impact of non-compliance ranges from poor lens comfort through to potentially sight-threatening infective keratitis. The coronavirus pandemic has refocused the profession on the importance of hand hygiene in particular, and the need for promoting safe CL wear in general. This review summarises typical non-compliant behaviour related to reusable CLs, and examines strategies and opportunities to better support wearers. Patient education has a central role in encouraging compliant behaviour, although patient recall of information is low, and personal belief systems may result in continuation of non-compliant behaviour despite awareness of the risks. CL care solutions are required for the daily disinfection of lenses, however misuse of multipurpose solutions (MPS) and hydrogen peroxide (H2O2)-based care systems can challenge their ability to be fully efficacious. Standard efficacy testing is reviewed, with consideration of how well current protocols model real-world use of CL solutions. Although some recommendations are in place for the inclusion of additional variables such as lens cases, CL materials, organic soil and efficacy against Acanthamoeba, opportunity still exists to reevaluate global standards to ensure consistency of testing in all markets. Finally, potential future innovations are discussed which may further support increased safety in reusable lens wear through novel antimicrobial additions to both CL materials and cases.


Subject(s)
Contact Lenses, Hydrophilic , Coronavirus Infections , Contact Lens Solutions , Humans , Hydrogen Peroxide , Pandemics , Patient Compliance
15.
Cont Lens Anterior Eye ; 44(2): 368-397, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33775383

ABSTRACT

Evidence-based contact lens -->practice involves finding, appraising and applying research findings as the basis for patient management decisions. These decisions should be informed by the strength of the research study designs that address the question, as well as by the experience of the practitioner and the preferences and environment of the patient. This reports reviews and summarises the published research evidence that is available to inform soft and rigid contact lens history and symptoms taking, anterior eye health examination (including the optimised use of ophthalmic dyes, grading scales, imaging techniques and lid eversion), considerations for contact lens selection (including the ocular surface measurements required to select the most appropriate lens parameter, lens modality and material selection), evaluation of lens fit, prescribing (teaching self-application and removal, adaptation, care regimen and cleaning instructions, as well as -->minimising risks of lens wear through encouraging compliance) and an aftercare routine.


Subject(s)
Contact Lenses, Hydrophilic , Contact Lenses , Aftercare , Humans , Patient Compliance , Vision, Ocular
16.
IIC Int Rev Ind Prop Copyr Law ; 52(4): 379-416, 2021.
Article in English | MEDLINE | ID: mdl-33716312

ABSTRACT

The importance of access to intellectual property rights (IPR) protected subject-matter in two crucial areas - public health, and educational and cultural engagement - has been extensively demonstrated during the COVID-19 pandemic. Although they involve separate legal areas, patent and copyright, the common thread linking the two is intellectual property's difficult relationship with access in the public interest. This paper examines the tensions caused by access barriers, the tools used to reduce them and their effectiveness. It is clear that the access barriers magnified by COVID-19 are not restricted to narrow or specific contexts but are widespread. They are created by, and are a feature of, our existing IPR frameworks. Open movements provide limited remedies because they are not designed to, nor can adequately address the wide range of access barriers necessary to promote the public interest. Existing legislative mechanisms designed to remove access barriers similarly fail to effectively remedy access needs. These existing options are premised on the assumption that there is a singular "public" motivated by homogenous "interests", which fails to reflect the plurality and cross-border reality of the public(s) interest(s) underpinning the welfare goals of IPR. We conclude that a systemic re-evaluation is required and call for positive and equitable legal measures protective of the public(s) interest(s) to be built within IPR frameworks that also address non-IPR barriers. The current pandemic and development of a "new normal" provides a crucial opportunity to comprehensively consider the public(s) interest(s), not just during a global health crisis, but on an ongoing basis.

17.
J Oncol Pharm Pract ; 27(1): 78-87, 2021 Jan.
Article in English | MEDLINE | ID: mdl-32228132

ABSTRACT

BACKGROUND: Temozolomide oral suspension is not commercially available. OBJECTIVE: To evaluate the stability of three temozolomide 10 mg/mL suspensions prepared in Oral Mix SF® in three container types stored at 4°C and 23°C. METHODS: Using commercial capsules, three separate batches of three different temozolomide 10 mg/mL formulations (Oral Mix SF® with PK-30; PK-30 and citric acid; and neither PK-30 nor citric acid) were made and stored in three container types (amber glass bottles, amber polyethylene terephthalate bottles, and polypropylene oral syringes). The aliquots in each container type were stored protected from light, half at 25°C and half at 4°C. On study days 0, 5, 8, 14, 21, 28, 35, 42, and 56, physical properties of samples from each container type at each temperature were assessed, and the temozolomide concentration was determined using a stability-indicating method. The beyond-use-date (time to achieve 90% of initial concentration calculated using the lower limit of the 95% confidence interval of the observed degradation rate) was calculated. RESULTS: Samples stored at 25°C turned from white to orange within seven days. Temozolomide crystals were observed in all samples. Concentration changes due to study day and temperature (p < 0.001) were observed but not due to container (p = 0.991) or formulation (p = 0.987). The beyond-use-date of all formulations in all container types was 56 days at 4°C and 6 days at 23°C. CONCLUSIONS: We recommend that these temozolomide 10 mg/mL formulations be stored at 4°C and be assigned a beyond-use-date of 30 days.


Subject(s)
Antineoplastic Agents, Alkylating/chemistry , Temozolomide/chemistry , Crystallization , Drug Compounding , Drug Packaging , Drug Stability , Drug Storage , Glass , Plastics , Syringes , Temperature
18.
Perm J ; 252021 12 14.
Article in English | MEDLINE | ID: mdl-35348092

ABSTRACT

BACKGROUND: The Multiple Sclerosis Continuous Quality Improvement (MS-CQI) Collaborative is the first multicenter improvement research collaborative for multiple sclerosis (MS). The main objective of this study is to describe baseline system-level variation in disease-modifying therapy (DMT) utilization across 4 MS centers participating in MS-CQI. METHODS: Electronic health record data from the first year of the 3-year MS-CQI study were analyzed. Participants were adults ≥ 18 years with MS presenting to any of the 4 MS-CQI centers. DMT utilization was categorized into oral, infusion, and injection types. Multinomial logistic regression was used to investigate associations between centers and DMT utilization. RESULTS: Overall, 2,029 patients were included in the analysis. Of those patients, 75.1% were female, mean age was 50 years, and 87.4% had relapsing-remitting MS. Overall, 32.7% were on an oral DMT, 23.5% on an infusion DMT, and 43.9% on an injection DMT. Overall, statistically significant differences (p < 0.01) were observed across centers for proportions of patients who received oral, infusion, and no DMTs. There were also overall significant differences (p < 0.01) across MS types for proportions of encounters who received oral, infusion, injection, no DMTs, and mean age varied significantly across centers. CONCLUSION: System-level effects on MS treatment and outcomes have not been previously studied and our findings contribute initial evidence concerning system-level variation in DMT utilization. Results suggest system-level variation in DMT utilization (ie, after adjusting for individual level factors, MS center or location of care a person with MS engages in care influences DMT treatment choices), resulting in a lack of standardization in DMT management. Continued research and improvement efforts targeting system-level performance could improve outcomes for people with MS.


Subject(s)
Multiple Sclerosis , Adult , Female , Humans , Middle Aged , Multiple Sclerosis/drug therapy , Quality Improvement
19.
Eye Contact Lens ; 47(5): 277-282, 2021 May 01.
Article in English | MEDLINE | ID: mdl-33290295

ABSTRACT

OBJECTIVES: To retrospectively compare frequency of contact lens (CL) complications in soft CL users of hydrogen peroxide (H2O2) and multipurpose solutions (MPS). METHODS: This was a multicenter, retrospective chart review of CL records from each patient's three most recent eye examinations at academic and private practices. Patients must have used the same solution type for at least 3 years. Univariate analyses were conducted using t tests, and chi-square or Fisher's exact test for categorical measures. RESULTS: There were 1,137 patients included, with 670 (59%) using MPS and 467 (41%) H2O2. In total, 706 (62%) experienced at least one complication; 409 used MPS and 297 used H2O2. There was no difference in the proportion of patients experiencing at least one complication between MPS (61%) and H2O2 (64%) (P=0.38). Multipurpose solutions users were more likely to report discomfort compared with H2O2 users (P=0.04). Presumed microbial keratitis was experienced by 16 MPS and nine H2O2 users (P=0.60). CONCLUSIONS: No significant differences were found in the frequency of CL complications between MPS and H2O2. H2O2 users were less likely to report discomfort and thus switching to a H2O2 system may be an alternative in CL users with discomfort.


Subject(s)
Contact Lenses, Hydrophilic , Keratitis , Contact Lens Solutions/adverse effects , Humans , Hydrogen Peroxide/adverse effects , Retrospective Studies , United States/epidemiology
20.
Clin Exp Optom ; 103(4): 418-424, 2020 07.
Article in English | MEDLINE | ID: mdl-32406140

ABSTRACT

The ocular surface has been suggested as a site of infection with Coronavirus-2 (SARS-CoV-2) responsible for the coronavirus disease-19 (COVID-19). This review examines the evidence for this hypothesis, and its implications for clinical practice. Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), responsible for the COVID-19 pandemic, is transmitted by person-to-person contact, via airborne droplets, or through contact with contaminated surfaces. SARS-CoV-2 binds to angiotensin converting enzyme-2 (ACE2) to facilitate infection in humans. This review sets out to evaluate evidence for the ocular surface as a route of infection. A literature search in this area was conducted on 15 April 2020 using the Scopus database. In total, 287 results were returned and reviewed. There is preliminary evidence for ACE2 expression on corneal and conjunctival cells, but most of the other receptors to which coronaviruses bind appear to be found under epithelia of the ocular surface. Evidence from animal studies is limited, with a single study suggesting viral particles on the eye can travel to the lung, resulting in very mild infection. Coronavirus infection is rarely associated with conjunctivitis, with occasional cases reported in patients with confirmed COVID-19, along with isolated cases of conjunctivitis as a presenting sign. Coronaviruses have been rarely isolated from tears or conjunctival swabs. The evidence suggests coronaviruses are unlikely to bind to ocular surface cells to initiate infection. Additionally, hypotheses that the virus could travel from the nasopharynx or through the conjunctival capillaries to the ocular surface during infection are probably incorrect. Conjunctivitis and isolation of the virus from the ocular surface occur only rarely, and overwhelmingly in patients with confirmed COVID-19. Necessary precautions to prevent person-to-person transmission should be employed in clinical practice throughout the pandemic, and patients should be reminded to maintain good hygiene practices.


Subject(s)
Betacoronavirus/isolation & purification , Conjunctivitis/etiology , Coronavirus Infections/etiology , Eye/virology , Pneumonia, Viral/etiology , Angiotensin-Converting Enzyme 2 , Animals , COVID-19 , Humans , Pandemics , Peptidyl-Dipeptidase A/genetics , Peptidyl-Dipeptidase A/physiology , Receptors, Virus/physiology , SARS-CoV-2
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