Tag: pubmed

Jpn J Radiol. 2022 May 19. doi: 10.1007/s11604-022-01290-1. Online ahead of print.

ABSTRACT

BACKGROUND: The aim of the study was to evaluate whether ultra-low-dose computed tomography (ULD-CT) could replace conventional-dose CT (CD-CT) for diagnosis of acute wrist, ankle, knee, and shoulder fractures in emergency departments (ED).

METHODS: We developed CD-CT and ULD-CT scanning schemes for the various joints of the four limbs and scanned emergency patients prospectively. When performing CD-CT, a conventional bone reconstruction algorithm was used, while ULD-CT used both soft tissue and bone algorithms. A five-point scale was used to evaluate whether ULD-CT image quality affected surgical planning. The image quality and diagnostic performance of different types of scanned and reconstructed images for diagnosing fractures were evaluated and compared. Effective radiation dose of each group was calculated.

RESULTS: Our study included 56 normal cases and 185 fracture cases. The combination of bone and soft tissue algorithms on ULD-CT can improve diagnostic performance, such that on ULD-CT, the sensitivity improved from 96.7% to 98.9%, specificity from 98.2% to 100%, positive predictive value from 99.4% to 100%, negative predictive value from 90.2% to 96.6% and diagnostic accuracy ranged from 97.5% to 99.1%. There were no statistically significant differences between ULD-CT and CD-CT on diagnostic performance (p values, 0.40-1.00). The radiation doses for ULD-CT protocols were only 3.0-7.7% of those for CD-CT protocols (all p < 0.01).

CONCLUSIONS: In the emergency department, the 320-row detector ULD-CT could replace CD-CT in the diagnosis of limb joint fractures. The combination of bone algorithm with soft tissue algorithm reconstruction can further improve the image quality and diagnostic performance.

PMID:35588348 | DOI:10.1007/s11604-022-01290-1

Pharmaceut Med. 2022 May 19. doi: 10.1007/s40290-022-00427-x. Online ahead of print.

ABSTRACT

BACKGROUND: In 2007, the priority review voucher (PRV) was implemented in the US to incentivize research and development (R&D) for tropical diseases. The PRV is issued by the US FDA and grants a quicker review to manufacturers upon successful development of a product for a disease eligible for the program.

OBJECTIVE: The objective of this analysis was to assess whether the PRV has incentivized R&D (measured as clinical trial activity) for the intended tropical diseases.

METHOD: We used a difference-in-difference-in-differences (DDD) strategy by exploiting variation in its implementation across diseases and registries around the world. Clinical trials were retrieved from the World Health Organization International Clinical Trials Registry Platform for the years 2005-2019.

RESULTS: We found a positive, but not statistically significant, effect of the PRV on stimulating R&D activity. Delayed effects of the policy could not be found.

CONCLUSION: Our findings, which were robust across a series of robustness tests, suggest that the PRV program is not associated with a trigger in innovation for neglected diseases and therefore should not be considered as a stand-alone solution. It should be supplemented with other government measures to incentivize R&D activity. To increase the value of the program, we recommend that the PRV only be awarded to novel products and not to products that have already been licensed outside the US. Doing so would restrict the number of vouchers awarded and slow down their ongoing market depreciation. Finally, we propose that product sponsors be required to submit an access plan for PRV-awarded products.

PMID:35588350 | DOI:10.1007/s40290-022-00427-x

Tech Coloproctol. 2022 May 19. doi: 10.1007/s10151-022-02633-w. Online ahead of print.

ABSTRACT

BACKGROUND: The effectiveness of laparoscopic ventral mesh rectopexy (LVMR) in patients with defecatory disorders secondary to internal rectal prolapse is poorly evidenced. A UK-based multicenter randomized controlled trial was designed to determine the clinical efficacy of LVMR compared to controls at medium-term follow-up.

METHODS: The randomized controlled trial was conducted from March 1, 2015 TO January 31, 2019. A stepped-wedge RCT design permitted observer-masked data comparisons between patients awaiting LVMR (controls) with those who had undergone surgery. Adult participants with radiologically confirmed IRP refractory to conservative treatment were randomized to three arms with different delays before surgery. Efficacy outcome data were collected at equally stepped time points (12, 24, 36, 48, 60, and 72 weeks). Clinical efficacy of LVMR compared to controls was defined as ≥ 1.0-point reduction in Patient Assessment of Constipation-Quality of Life and/or Symptoms (PAC-QOL and/or PAC-SYM) scores at 24 weeks. Secondary outcome measures included 14-day diary data, the Generalized Anxiety Disorder scale (GAD-7), the Patient Health Questionnaire-9 (PHQ-9), St Marks incontinence score, the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), the chronic constipation Behavioral Response to Illness Questionnaire (CC-BRQ), and the Brief Illness Perception Questionnaire (BIPQ).

RESULTS: Of a calculated sample size of 114, only 28 patients (100% female) were randomized from 6 institutions (due mainly to national pause on mesh-related surgery). Nine were assigned to the T0 arm, 10 to T12, and 9 to T24. There were no substantial differences in baseline characteristics between the three arms. Compared to baseline, significant reduction (improvement) in PAC-QOL and PAC-SYM scores were observed at 24 weeks post-surgery (- 1.09 [95% CI – 1.76, – 0.41], p = 0.0019, and – 0.92 [- 1.52, – 0.32], p = 0.0029, respectively) in the 19 patients available for analysis (9 were excluded for dropout [n = 2] or missing primary outcome [n = 7]). There was a clinically significant long-term reduction in PAC-QOL scores (- 1.38 [- 2.94, 0.19], p = 0.0840 at 72 weeks). Statistically significant improvements in PAC-SYM scores persisted to 72 weeks (- 1.51 [- 2.87, – 0.16], p = 0.0289). Compared to baseline, no differences were found in secondary outcomes, except for significant improvements at 24 and 48 weeks on CC-BRQ avoidance behavior (- 14.3 [95% CI – 23.3, – 5.4], and – 0.92 [- 1.52, – 0.32], respectively), CC-BRQ safety behavior (- 13.7 [95% CI – 20.5, – 7.0], and – 13.0 [- 19.8, – 6.1], respectively), and BIPQ negative perceptions (- 16.3 [95% CI – 23.5, – 9.0], and – 10.5 [- 17.9, – 3.2], respectively).

CONCLUSIONS: With the caveat of under-powering due to poor recruitment, the study presents the first randomized trial evidence of short-term benefit of LVMR for internal rectal prolapse.

TRIAL REGISTRATION: ISRCTN Registry (ISRCTN11747152).

PMID:35588336 | DOI:10.1007/s10151-022-02633-w

Graefes Arch Clin Exp Ophthalmol. 2022 May 19. doi: 10.1007/s00417-022-05692-9. Online ahead of print.

ABSTRACT

PURPOSE: This study aimed to investigate the clinical characteristics of patients with recurrent intraocular lens (IOL) dislocation after scleral-fixated sutured IOL implantation and evaluate the long-term outcomes of scleral re-fixation of IOL.

METHODS: The medical records of patients who underwent surgery for IOL dislocation between January 2011 and January 2021 were reviewed. The study included 164 patients (male: 131, female: 33) (176 eyes). Patient demographics, preoperative, intraoperative and postoperative data, and the ocular and systemic conditions associated with IOL re-dislocation were analyzed.

RESULTS: The study included 176 consecutive cases of scleral-fixated sutured IOL. Twenty-six eyes (14.8%) showed re-dislocation of IOL after the initial IOL scleral fixation and underwent reoperation (mean 75.5 ± 62.5 months after the first surgery); three (11.5%) of them required a third surgery. Younger adults (aged less than 40 years), and patients who underwent IOL scleral fixation in complicated cataract surgery or aphakic state had a higher risk of re-dislocation. Diabetes mellitus (DM) was the only statistically significantly higher risk factor in the re-dislocated group (p = 0.041). The complication rate with scleral re-fixation was higher than that in the non-re-dislocated group. No statistically significant differences were observed, except for vitreous hemorrhage (p = 0.024).

CONCLUSIONS: Caution should be exercised when performing sutured scleral fixation of IOL in younger patients, cases of complicated cataract surgery and aphakia, and patients with DM to prevent IOL re-dislocation. Scleral-fixated sutured IOL in eyes with recurrent IOL dislocation seems to be a safe and effective procedure with a relatively low complication rate.

PMID:35588329 | DOI:10.1007/s00417-022-05692-9

Int Urogynecol J. 2022 May 19. doi: 10.1007/s00192-022-05228-z. Online ahead of print.

ABSTRACT

INTRODUCTION AND HYPOTHESIS: Overactive bladder (OAB) and urinary incontinence (UI) are prevalent in older women. We investigated relations of toileting behaviors and urinary urge cues to OAB and UI in women ≥ 65 years. We tested mediation hypotheses that toileting behaviors lead to higher sensitivity to urinary urge cues (the mediator), which leads to both OAB and UI.

METHODS: An e-panel was recruited to respond to an electronic survey that included demographic information, Urinary Cues Scale version 2, Toileting Behaviors-Women’s Elimination Behaviors (TB-WEB) scale, and the International Consultation on Incontinence Questionnaire Short Forms for Urinary Incontinence (ICIQ-SF-UI) and Overactive Bladder (ICIQ-SF-OAB). Descriptive statistics were conducted; correlation matrices were created to explore relationships among major variables. Regression analyses were conducted to test our mediation hypotheses.

RESULTS: There were 338 respondents with average age 70.9 (SD + 5.55) years. Most were white, overweight or obese, and had UI. Urinary urge cues fully mediated the relationship of TB-WEB with OAB. Urinary urge cues partially mediated the relationship of TB-WEB with UI; the direct effect of toileting behaviors on UI remained significant. Age and body mass index had significant partial correlations with UI but not with OAB.

DISCUSSION: Toileting behaviors appear to contribute to sensitivity to urinary cues, which are related to both OAB and UI. Toileting behaviors have indirect effects on OAB and both indirect and direct effects on UI. Interventions to change toileting behaviors and extinguish urinary cues are needed.

CONCLUSIONS: Behavioral and conditioning factors contribute to UI in older women.

PMID:35588320 | DOI:10.1007/s00192-022-05228-z

Biomark Med. 2022 May 19. doi: 10.2217/bmm-2021-1014. Online ahead of print.

ABSTRACT

Aims: To evaluate BRAK and APRIL in serum samples from healthy patients and an ovarian tumor group and analyze their effective value as biomarkers. Materials & methods: BRAK and APRIL were measured in 197 serum samples including 34 healthy controls, 48 patients with benign ovarian cysts and 115 patients with ovarian cancer, and the best statistical cutoff values were calculated. Then, the sensitivity, specificity, accuracy, positive predictive value and negative predictive value for selected cutoff points were assessed. Results: The healthy control group had statistically significant higher BRAK and lower APRIL than the ovarian tumor group. BRAK was excellent for differentiating healthy patients from patients with ovarian tumors, showing area under the receiver operating characteristic curve 0.983, 98.16% sensitivity and 100% specificity. When BRAK was combined with APRIL and CA-125, it also played a role in distinguishing benign cysts from malignancies with area under the curve 0.864, 81.74% sensitivity and 79.17% specificity. Conclusions: BRAK and APRIL are good candidates for ovarian tumor biomarkers.

PMID:35588310 | DOI:10.2217/bmm-2021-1014

Transfusion. 2022 May 19. doi: 10.1111/trf.16934. Online ahead of print.

ABSTRACT

BACKGROUND: The therapeutic benefit of convalescent plasma (CP) therapy to treat COVID-19 may derive from neutralising antibodies (nAbs) to SARS-CoV-2. To investigate effects of antigenic variation on neutralisation potency of CP, we compared nAb titres against prototype and recently emerging strains of SARS-CoV-2, including Delta and Omicron, in CP donors previously infected with SARS-CoV-2 before and after immunisation.

METHODS AND MATERIALS: Samples were assayed from previously SARS-CoV-2 infected donors before (n=17) and after one (n=43) or two (n=71) doses of Astra-Zeneca or Pfizer vaccinations. Ab titres against Wuhan/wild type (WT), Alpha, Beta and Delta SARS-CoV-2 strains were determined by live virus microneutralization assay while titres to Omicron used a focus reduction neutralisation test. Anti-spike antibody was assayed by Elecsys anti-SARS-CoV-2 quantitative spike assay (Roche).

RESULTS: Unvaccinated donors showed a geometric mean titre (GMT) of 148 against WT, 80 against Alpha but mostly failed to neutralise Beta, Delta and Omicron strains. Contrastingly, high GMTs were observed in vaccinated donors against all SARS-CoV-2 strains after one vaccine dose (WT:703; Alpha:692; Beta:187; Delta:215; Omicron:434). By ROC analysis, reactivity in the Roche quantitative Elecsys spike assay of 20,000 U/ml was highly predictive of donations with nAb titres of ≥1:640 against Delta (90% sensitivity; 97% specificity) and ≥1:320 against Omicron (89% sensitivity; 81% specifciity) DISCUSSION: Vaccination of previously infected CP donors induced high levels of broadly neutralising antibodies against circulating antigenic variants of SARS-CoV-2. High titre donations could be reliably identified by automated quantitative anti-spike antibody assay, enabling large-scale pre- selection of high-titre convalescent plasma.

PMID:35588314 | DOI:10.1111/trf.16934

J Med Virol. 2022 May 19. doi: 10.1002/jmv.27871. Online ahead of print.

ABSTRACT

OBJECTIVE: To provide a comparative meta-analysis and systematic review of the risk and clinical outcomes of COVID-19 infection between fully vaccinated and unvaccinated groups.

METHODS: Eighteen studies of COVID-19 infections in fully vaccinated (“breakthrough infections”) and unvaccinated individuals were reviewed from Medline/PubMed, Scopus, Embase, and Web of Science databases. The meta-analysis examined the summary effects and between-study heterogeneity regarding differences in the risk of infection, hospitalization, treatments, and mortality between vaccinated and unvaccinated individuals.

RESULTS: The overall risk of infection was lower for the fully vaccinated compared to that of the unvaccinated (relative risk[RR] 0.20, 95% CI 0.19-0.21), especially for variants other than Delta (Delta: RR 0.29, 95% CI 0.13-0.65; other variants: RR 0.06, 95% CI 0.04-0.08). The risk of asymptomatic infection was not statistically significantly different between fully vaccinated and unvaccinated (RR 0.56, 95% CI 0.27-1.19). There were neither statistically significant differences in risk of hospitalization (RR 1.06, 95% CI 0.38-2.93), invasive mechanical ventilation (RR 1.65 ,95% CI 0.90-3.06), or mortality (RR 1.19, 95% CI 0.79-1.78). Conversely, the risk of supplemental oxygen during hospitalization was significantly higher for the unvaccinated (RR 1.40, 95% CI 1.08-1.82).

CONCLUSIONS: Unvaccinated people were more vulnerable to COVID-19 infection than fully vaccinated for all variants. Once infected, there were no statistically significant differences in the risk of hospitalization, invasive mechanical ventilation, or mortality. Still, unvaccinated showed an increased need for oxygen supplementation. Further prospective analysis, including patients’ risk factors, COVID-19 variants, and the utilized treatment strategies, would be warranted. This article is protected by copyright. All rights reserved.

PMID:35588301 | DOI:10.1002/jmv.27871

JMIR Form Res. 2022 May 19;6(5):e34906. doi: 10.2196/34906.

ABSTRACT

BACKGROUND: Innovative digital technology systems that support and monitor real-time medication intake are now available commercially; however, there is limited knowledge of the use of such technology in patients’ homes. One such smart medication dispenser, spencer, provides alerts to patients to take their medications and allows for tracking and reporting real-time medication adherence data.

OBJECTIVE: The objectives of this study were to examine the use of a smart medication dispenser as a medication adherence and self-management support tool for community dwelling adults over a 6-month period, in addition to usability, usefulness, satisfaction, and impact on caregiver support.

METHODS: This prospective, observational study invited community-dwelling adults aged 45 years and older taking at least one chronic medication and their caregivers to use this smart medication dispenser for their medication administration for 6 months. Adherence was defined as a dose intake within 2 hours post scheduled time. Real-time adherence data were collected using the smart medication dispenser and the AdhereNet platform. Usability, usefulness, and satisfaction were measured using the System Usability Scale and the Usefulness, Satisfaction, and Ease of Use questionnaire, respectively. Caregiver burden was measured on a visual analog scale at baseline and at the end of the 6-month study period.

RESULTS: A total of 58 participants were recruited, of which 55% (32/58) were female with a mean age of 66.36 (SD 11.28; range 48-90) years. Eleven caregiver participants were recruited, of whom 91% (10/11) were female. The average monthly adherence over 6 months was 98% (SD 3.1%; range 76.5%-100%). The average System Usability score was 85.74 (n=47; SD 12.7; range 47.5-100). Of the 46 participants who provided data, 44 (96%) rated the product as easy, 43 (93%) as simple to use, and 43 (93%) were satisfied with the product. Caregiver burden prior to and following smart medication dispenser use for 6 months was found to be statistically significantly different (P<.001; CI 2.11-5.98).

CONCLUSIONS: Smart medication adherence products such as spencer, when connected and clinically monitored, can be a useful solution for medication management and have the potential to improve caregiver burden.

PMID:35587371 | DOI:10.2196/34906

J Med Internet Res. 2022 May 19;24(5):e36431. doi: 10.2196/36431.

ABSTRACT

BACKGROUND: Exposure and response prevention, a type of cognitive-behavioral therapy, is an effective first-line treatment for obsessive-compulsive disorder (OCD). Despite extensive evidence of the efficacy of exposure and response prevention (ERP) from clinical studies and in real-world samples, it is still underused as a treatment. This is likely due to the limits to access to care that include the availability of adequately trained therapists, as well as geographical location, time, and cost barriers. To address these, NOCD created a digital behavioral health treatment for OCD using ERP delivered via video teletherapy and with technology-assisted elements including app-based therapy tools and between-session therapist messaging.

OBJECTIVE: We examined treatment outcomes in a large naturalistic sample of 3552 adults with a primary OCD diagnosis who received NOCD treatment.

METHODS: The treatment model consisted of twice-weekly, live, face-to-face video teletherapy ERP for 3 weeks, followed by 6 weeks of once-weekly brief video teletherapy check-ins for 30 minutes. Assessments were conducted at baseline, at midpoint after completion of 3 weeks of twice-weekly sessions, and at the end of 6 weeks of brief check-ins (endpoint). Longitudinal assessments were also obtained at 3, 6, 9, and 12 months after endpoint.

RESULTS: Treatment resulted in clinically and statistically significant improvements, with a 43.4% mean reduction in obsessive-compulsive symptoms (g=1.0; 95% CI 0.93 to 1.03) and a 62.9% response rate. Treatment also resulted in a 44.2% mean reduction in depression, a 47.8% mean reduction in anxiety, and a 37.3% mean reduction in stress symptoms. Quality of life improved by a mean of 22.7%. Reduction in OCD symptoms and response rates were similar for those with mild, moderate, or severe symptoms. The mean duration of treatment was 11.5 (SD 4.0) weeks, and the mean total therapist time was 10.6 (SD 1.1) hours. Improvements were maintained at 3, 6, 9, and 12 months.

CONCLUSIONS: In this sample, representing the largest reported treated cohort of patients with OCD to date, video teletherapy treatment demonstrated effectiveness in reducing obsessive-compulsive and comorbid symptoms and improved quality of life. Further, it achieved meaningful results in less than half the total therapist time compared with standard once-weekly outpatient treatment, an efficiency that represents substantial monetary and time savings. The effect size was large and similar to studies of in-person ERP. This technology-assisted remote treatment is readily accessible for patients, offering an advancement in the field in the dissemination of effective evidence-based care for OCD.

PMID:35587365 | DOI:10.2196/36431