Background Low back pain (LBP) affects nearly 4 out of 5 individuals during their lifetime and is the leading cause of disability globally. Digital therapeutics are emerging as effective treatment options for individuals experiencing LBP. Despite the growth of evidence demonstrating the benefits of these therapeutics in reducing LBP and improving functional outcomes, little data has been systematically collected on their safety profiles. Objective This study aims to evaluate the safety profile of a multidisciplinary digital therapeutic for LBP, the Kaia App, by performing a comprehensive assessment of reported adverse events (AEs) by users as captured by a standardized process for postmarket surveillance. Methods All users of a multidisciplinary digital app that includes physiotherapy, mindfulness techniques, and education for LBP (Kaia App) from 2018 to 2019 were included. Relevant messages sent by users via the app were collected according to a standard operating procedure regulating postmarket surveillance of the device. These messages were then analyzed to determine if they described an adverse event (AE). Messages describing an AE were then categorized based on the type of AE, its seriousness, and its relatedness to the app, and they were described by numerical counts. User demographics, including age and gender, and data on app use were collected and evaluated to determine if they were risk factors for increased AE reporting. Results Of the 138,337 active users of the Kaia App, 125 (0.09%) reported at least one AE. Users reported 0.00014 AEs per active day on the app. The most common nonserious AE reported was increased pain. Other nonserious AEs reported included muscle issues, unpleasant sensations, headache, dizziness, and sleep disturbances. One serious AE, a surgery, was reported. Details of the event and its connection to the intervention were not obtainable, as the user did not provide more information when asked to do so; therefore, it was considered to be possibly related to the intervention. There was no relationship between gender and AE reporting (P>.99). Users aged 25 to 34 years had reduced odds (odds ratio [OR] 0.31, 95% CI 0.08-0.95; P=.03) of reporting AEs, while users aged 55 to 65 years (OR 2.53, 95% CI 1.36-4.84, P=.002) and ≥75 years (OR 4.36, 95% CI 1.07-13.26; P=.02) had increased odds. AEs were most frequently reported by users who had 0 to 99 active days on the app, and less frequently reported by users with more active days on the app. Conclusions This study on the Kaia App provides the first comprehensive assessment of reported AEs associated with real-world use of digital therapeutics for lower back pain. The overall rate of reported AEs was very low, but significant reporting bias is likely to be present. The AEs reported were generally consistent with those described for in-person therapies for LBP.
Congenital megaprepuce (CMP) is a type of buried penis characterized by extensive redundancy and ballooning of the inner prepuce as a result of preputial stenosis and phimosis. The malformation typically presents with difficulty voiding, often requiring manual expression of stagnant urine. Multiple techniques have been reported for the treatment of CMP with varying levels of positive outcomes. The authors provide a review of published literature, in addition to describing the procedure and results of our surgical technique in three children aged eleven months, two years, and twelve years. The literature review was conducted using PubMed with keywords “congenital megaprepuce,” “megaprepuce,” “buried penis,” “CMP,” and “correction.” Results were then differentiated based on presence or absence of true congenital megaprepuce and the surgical correction thereof. Regarding our cases, all patients completed the procedure with excellent cosmesis and without complication. Our technique is shown to provide consistent, excellent esthetic outcome across a wide range of ages and may be replicated by others.
Introduction and hypothesisOveractive bladder (OAB) affects up to 43% of women. Treatment ranges from lifestyle modification to invasive therapies. Nearly 75% of patients report using the internet to gain health information creating a need for interpretable, online resources. This study is aimed at evaluating the readability of online resources for OAB treatment in the US population. Methods Google and Bing were queried regarding "sacral neuromodulation," "peripheral tibial nerve stimulation (PTNS)," and "bladder botox." The first 20 results from each search engine were assessed, representing over 90% of accessed search results. Websites were categorized as institutional/reference, commercial, nonprofit, or personal. The Gunning fog (GF), Simple Measure of Gobbledygook (SMOG), and Dale-Chall (DC) validated readability scores were used to assess results. Results Sacral neuromodulation yielded 27 eligible results. The associated mean readability scores correlated with levels of college senior (GF), high school junior (SMOG), and college level (DC). PTNS yielded 31 eligible results. The associated mean readability scores correlated with levels of college senior (GF), high school senior (SMOG), and college level (DC). Bladder botox yielded 17 eligible results. The associated mean readability scores correlated with levels of college sophomore (GF), high school junior (SMOG), and college level (DC). There was no difference between the therapies regarding readability. Sixty-one percent of websites were institutional/reference, 24% were commercial, 13% were nonprofit, and 2% were personal. Conclusions High levels of reading comprehension are required by the general US population to understand OAB information obtained through the internet. These findings highlight a need for simplification of online resources pertaining to OAB.
Background: The majority of bladder cancer patients experience recurrence. Cisplatin is the standard chemotherapy for muscle-invasive bladder cancer though adverse effects are often severe. Case Report: Intravenous (IV) dicycloplatin (DCP) sustained remission in an American bladder cancer patient for five years. A recurrent mass was observed in July 2021. The patient received DCP capsules for seven weeks with no significant side-effects. Complete blood count with differential and a basic metabolic panel showed no adverse effects of DCP capsules on the bone marrow, liver or renal parameters. Cystoscopy after oral DCP found no evident bladder tumors; cytology was negative for high-grade urothelial carcinoma. Conclusion: In this patient, DCP-capsules appeared to be as effective as DCP-IV for achieving bladder cancer remission. Both forms of DCP chemotherapy are convenient, active against several cancer types, with decreased adverse effects compared to cisplatin. Both have been available for treating cancer patients in China. A USA clinical trial of DCP in bladder and other cancers appears warranted.Bladder cancer (BC) cases steadily declined by about 1% per year from 2008 to 2017. Still, 17,200 deaths are expected in 2021. An estimated 83,730 adults in the United States will be diagnosed with BC this year. Men are about 4 times more likely than women to develop this malignancy. Among men, BC is the fourth most common cancer and the eighth most common cause of cancer death (1).The main type of BC is non-muscle invasive tumors (T1, Ta), treated with complete transurethral resection, followed by BCG (Bacillus Calmette-Guérin) intravesical immunotherapy. The vast majority of patients with high-risk BC endure recurrence, progression of disease, or die within ten years (2-7). In England, among those diagnosed with BC, 75% survive for 1 year or more, 55% for 5 years, and around 45% for 10 years after diagnosis (8-10).Recurrence and survival depend on initial tumor stage and grade, with 5-year recurrence rates in about 65% of patients with non-invasive or in situ tumors, and 73% of patients with slightly more advanced disease. Blute et al noted that the high recurrence rate in the first two years after diagnosis warrants an intense surveillance schedule (11). According to Cambier and colleagues, patients at high risk of recurrence and progression do poorly on current BCG maintenance schedules. Alternative treatments are needed (12, 13).
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We present an unusual case of a rare ossifying renal tumor of infancy. A 6-month-old male initially presented with gross hematuria and without any palpable abdominal mass. Renal ultrasound and MRI showed a right lower pole, calcified, endophytic renal mass. Laparoscopic radical nephrectomy was performed without complications. Pathology demonstrated an ossifying renal tumor of infancy. We report this case, in addition to a review of the literature for similar cases, to highlight a rare renal tumor in infancy that can be managed laparoscopically.
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