Introducing a Remote Patient Monitoring Usability Impact Model to Overcome Challenges.

Telehealth and remote patient monitoring (RPM), in particular, have been through a massive surge of adoption since 2020. This initiative has proven potential for the patient and the healthcare provider in areas such as reductions in the cost of care. While home-use medical devices or wearables have been shown to be beneficial, a literature review illustrates challenges with the data generated, driven by limited device usability. This could lead to inaccurate data when an exam is completed without clinical supervision, with the consequence that incorrect data lead to improper treatment. Upon further analysis of the existing literature, the RPM Usability Impact model is introduced. The goal is to guide researchers and device manufacturers to increase the usability of wearable and home-use medical devices in the future. The importance of this model is highlighted when the user-centered design process is integrated, which is needed to develop these types of devices to provide the proper user experience.

Evaluation of the hydrating benefits of a cationic hyaluronic acid: From biological evaluation to consumer home use trial.

Active ingredients are often assessed based on physiological measurements, but innovative technologies to measure skin sensations can provide a holistic volunteer assessment of the use of an ingredient. In this paper, the hydrating benefits of a cationic hyaluronic acid (HA) were evaluated alongside clinical biometrics and innovative cognitive measurements to determine how biological benefits correlated with volunteers' feelings and perceptions of hydration. The results demonstrated that cationic HA provides hydrating benefits at the clinical level due to its film-forming properties. Through the use of innovative behavioural measurement tools, we were able to show that these outcomes are perceived by naïve consumers in real-life conditions. In addition, the benefits of cationic HA reported by users were in accordance with the mental representation they had related to the use of HA, thus the product achieved complete sensorial embodiment. We can conclude that the combination of clinical evaluations and home use trials consolidates product assessment when seeking to measure consumer satisfaction with proven biological benefits.

Les ingrédients actifs sont souvent évalués sur la base de mesures physiologiques, mais des technologies innovantes de mesure des sensations des consommateurs peuvent fournir une évaluation holistique de l'utilisation d'un ingrédient. Dans cet article, les avantages hydratants d'un acide hyaluronique (AH) cationique ont été évalués parallèlement par des mesures biométriques cliniques et par des mesures cognitives innovantes afin de déterminer la correlation entre l'efficacité biologique et les sensations des volontaires en matière d'hydratation. Les résultats biologiques ont démontré que l'acide hyaluronique cationique offre des avantages hydratants au niveau clinique grâce à ses propriétés filmogènes. Grâce à l'utilisation d'outils de mesure comportementale innovants, nous avons également pu montrer que ces résultats sont perçus par des consommateurs naïfs dans des conditions réelles d'utilisation. De plus, les avantages de l'AH cationique rapportés par les utilisateurs étaient conformes à la représentation mentale qu'ils avaient des propriétés de l'AH, de sorte que l'expérience produit une congruence sensorielle complète. Nous pouvons conclure que la combinaison d'évaluations cliniques et d'essais en conditions réelles d'utilisation consolide l'évaluation des produits lorsque l'on cherche à mesurer la satisfaction des consommateurs.

Caries lesions diagnosis with deep convolutional neural network in intraoral QLF images by handheld device.

OBJECTIVES: This study investigated the effectiveness of a deep convolutional neural network (CNN) in diagnosing and staging caries lesions in quantitative light-induced fluorescence (QLF) images taken by a self-manufactured handheld device. METHODS: A small toothbrush-like device consisting of a 400 nm UV light-emitting lamp with a 470 nm filter was manufactured for intraoral imaging. A total of 133 cases with 9,478 QLF images of teeth were included for caries lesion evaluation using a CNN model. The database was divided into development, validation, and testing cohorts at a 7:2:1 ratio. The accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve (AUC) were calculated for model performance. RESULTS: The overall caries prevalence was 19.59%. The CNN model achieved an AUC of 0.88, an accuracy of 0.88, a specificity of 0.94, and a sensitivity of 0.64 in the validation cohort. They achieved an overall accuracy of 0.92, a sensitivity of 0.95 and a specificity of 0.55 in the testing cohort. The model can distinguish different stages of caries well, with the best performance in detecting deep caries followed by intermediate and superficial lesions. CONCLUSIONS: Caries lesions have typical characteristics in QLF images and can be detected by CNNs. A QLF-based device with CNNs can assist in caries screening in the clinic or at home. TRIAL REGISTRATION: The clinical trial was registered in the Chinese Clinical Trial Registry (No. ChiCTR2300073487, Date: 12/07/2023).

The promise of portable remote auditory stimulation tools to enhance slow-wave sleep and prevent cognitive decline.

Dementia is the seventh leading cause of mortality, and a major source of disability and dependency in older individuals globally. Cognitive decline (and, to a lesser extent, normal ageing) are associated with sleep fragmentation and loss of slow-wave sleep. Evidence suggests a bidirectional causal link between these losses. Phase-locked auditory stimulation has emerged as a promising non-invasive tool to enhance slow-wave sleep, potentially ameliorating cognitive decline. In laboratory settings, auditory stimulation is usually supervised by trained experts. Different algorithms (simple amplitude thresholds, topographic correlation, sine-wave fitting, phase-locked loop, and phase vocoder) are used to precisely target auditory stimulation to a desired phase of the slow wave. While all algorithms work well in younger adults, the altered sleep physiology of older adults and particularly those with neurodegenerative disorders requires a tailored approach that can adapt to older adults' fragmented sleep and reduced amplitudes of slow waves. Moreover, older adults might require a continuous intervention that is not feasible in laboratory settings. Recently, several auditory stimulation-capable portable devices ('Dreem®', 'SmartSleep®' and 'SleepLoop®') have been developed. We discuss these three devices regarding their potential as tools for science, and as clinical remote-intervention tools to combat cognitive decline. Currently, SleepLoop® shows the most promise for scientific research in older adults due to high transparency and customizability but is not commercially available. Studies evaluating down-stream effects on cognitive abilities, especially in patient populations, are required before a portable auditory stimulation device can be recommended as a clinical preventative remote-intervention tool.

Effectiveness and acceptability of home use of misoprostol for medical abortion up to 10 weeks of pregnancy.

INTRODUCTION: The administration of mifepristone, followed by misoprostol, is widely used for medical abortion. Many studies have demonstrated home abortion to be safe in pregnancies up to 63 days of gestation, and recent data support its safety when extended to more advanced pregnancies. We studied the efficacy and acceptability of home use of misoprostol up to 70 days of gestation in a Swedish setting and compared the outcomes between pregnancies with a gestational age of up to 63 days and pregnancies with gestational age 64-70 days. MATERIAL AND METHODS: This prospective cohort study was performed between November 2014 and November 2021 at Södersjukhuset and Karolinska University Hospital, Stockholm, and some patients were also recruited from Sahlgrenska University Hospital, Göteborg and Helsingborg Hospital. The primary outcome was the rate of complete abortions and was defined as complete abortion without any need for surgical or medical intervention and assessed by clinical assessment, pregnancy test and/or vaginal ultrasound. Secondary objectives were assessed by daily self-reporting in a diary and included pain, bleeding, side effects and women's satisfaction and perception of home use of misoprostol. A comparison of categorical variables was made with Fisher's exact test. The significance level was set to a p-value ≤0.05. The study was registered at Clinicaltrials.gov on July 14, 2014 (NCT02191774). RESULTS: During the study period we enrolled 273 women opting for medical abortion with home use of misoprostol. In the early group, up to 63 days of gestation, 112 women were included with a mean gestational length of 45 days and in the late group, 64-70 days of gestation, 161 women with a mean gestations length of 66.3 days were included. Complete abortion occurred in 95% (95% CI 89-98) of women in the early group and in 96% (95% CI 92-99) in the late group. No differences were found regarding side effects and acceptability was similarly high in both groups. CONCLUSIONS: Our results show high efficacy and acceptability of medical abortion when misoprostol is administered at home up to 70 days of gestation. This supports previous findings about maintained safety when misoprostol is administered at home even past a very early pregnancy.

Assessment of adverse events for a home-use intense pulsed light hair removal device using postmarketing surveillance.

BACKGROUND AND OBJECTIVES: Home-use intense pulsed light (IPL) hair removal devices are convenient for consumers. Consumer safety associated with home-use IPL devices, however, remains a subject of interest. In this descriptive analysis, we assessed the most commonly reported adverse events (AEs) for a home-use IPL device from postmarketing surveillance and qualitatively compared these with AEs from clinical studies and medical device reports of home-use IPL treatments. MATERIALS AND METHODS: For this analysis of voluntary reports, we queried a distributor's postmarketing database for IPL devices for the period beginning January 1, 2016, to December 31, 2021. All sources of comments, for example, phone, e-mail, company-sponsored web sites, were included in the analysis. AE data were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology. Also, we conducted a PubMed search to identify AE profiles from existing literature on home-use IPL devices and we searched the Manufacturer and User Facility Device Experience (MAUDE) database for reports on home-use IPL devices. These results were qualitatively compared to the data in the postmarketing surveillance database. RESULTS: A total of 1692 cases involving IPL were identified from voluntary reports of AEs between 2016 and 2021. The shipment-adjusted reporting rate for AE cases (number of AE cases/100,000 shipped IPL devices) was 67/100,000 during this 6-year period. The most commonly reported AEs were pain of skin 27.8% (470/1692), "thermal burn" 18.7% (316/1692), and erythema 16.0% (271/1692). Among the top 25 AEs reported, no unexpected health events were observed. The reported AEs were qualitatively similar to the pattern seen in clinical studies and the MAUDE database associated with such home-use IPL treatments. CONCLUSION: This is the first such report documenting AEs for home-use IPL hair removal from a postmarketing surveillance program. These data are supportive of the safety of such home-use low-fluence IPL technology.

Consumer testing away from a sensory facility: Application of home-use test and no-contact home-use test.

COVID-19 pandemic-related restrictions for approximately three years have heavily influenced sensory evaluations. People have become accustomed to working remotely and communicating online. This has led to opportunities in sensory testing paired with logistics systems and information technologies, resulting in a wide application of the home-use test (HUT), wherein panelists evaluate samples from their homes or other off-site locations. This study aimed to compare three sensory evaluation conditions: a central location test (CLT, n = 104), a HUT (n = 120), and a no-contact HUT (N-HUT, n = 111). We recruited participants via the local community website, delivered samples using a delivery service, and conducted sensory testing using a smartphone for the N-HUT. Participants were requested to report the acceptance ratings, sensory profiles, and emotion responses to four coffee samples. Some differences in the acceptance ratings might be due to the different attitudes participating in the evaluation. In the sensory profiling of the samples, multi-factor analysis (MFA) revealed highly similar sensory characteristics across the three types of tests. All RV coefficients (RVs) among the test conditions were above 0.93. The emotion responses to coffee samples were similar among test conditions based on the MFA with RV values greater than 0.84. In conclusion, we found that N-HUT produced similar results regarding the descriptions of sensory profiles and emotions, indicating that N-HUT is a suitable test method for collecting sensory data and overcoming CLT and HUT's regional limitations. Modern logistics systems and information technologies make it possible to conduct nationwide sensory evaluations without in-person contact or participant attendance at sensory testing facilities.

Competitive motivation increased home use and improved prosthesis self-perception after Cybathlon 2020 for neuromusculoskeletal prosthesis user.

BACKGROUND: Assistive technologies, such as arm prostheses, are intended to improve the quality of life of individuals with physical disabilities. However, certain training and learning is usually required from the user to make these technologies more effective. Moreover, some people can be encouraged to train more through competitive motivation. METHODS: In this study, we investigated if the training for and participation in a competitive event (Cybathlon 2020) could promote behavioral changes in an individual with upper limb amputation (the pilot). We defined behavioral changes as the active time while his prosthesis was actuated, ratio of opposing and simultaneous movements, and the pilot's ability to finely modulate his movement speeds. The investigation was based on extensive home-use data from the period before, during and after the Cybathlon 2020 competition. RESULTS: Relevant behavioral changes were found from both quantitative and qualitative analyses. The pilot's home use of his prosthesis nearly doubled in the period before the Cybathlon, and remained 66% higher than baseline after the competition. Moreover, he improved his speed modulation when controlling his prosthesis, and he learned and routinely operated new movements in the prosthesis (wrist rotation) at home. Additionally, as confirmed by semi-structured interviews, his self-perception of the prosthetic arm and its functionality also improved. CONCLUSIONS: An event like the Cybathlon may indeed promote behavioral changes in how competitive individuals with amputation use their prostheses. Provided that the prosthesis is suitable in terms of form and function for both competition and at-home daily use, daily activities can become opportunities for training, which in turn can improve prosthesis function and create further opportunities for daily use. Moreover, these changes appeared to remain even well after the event, albeit relevant only for individuals who continue using the technology employed in the competition.

Sensory profiling and consumer evaluation of solar dried tomato powder in Ghana.

BACKGROUND: Tomato (Lycopersicon esculentum) is an important vegetable in Ghana, with high post-harvest losses due to absence of facilities to store, process and extend the shelf life of fresh tomatoes. Solar drying has been proven to be a more efficient and low-cost method of enhancing quality and adding value to tomato and other vegetables. However, there are concerns about sensory appeal of the dried products. In this study a natural mixed mode solar dryer was developed to dry pre-treated fresh Roma tomatoes. The sensory characteristics of the solar dried product was profiled and compared to the sensory properties of similar commercial dried tomato on the market using quantitative descriptive analysis methodology. Consumer testing using qualitative methods provided consumer feedback on the appeal of the solar dried tomatoes. RESULTS: Results showed that the solar dried tomato powder had a stronger tomato aroma intensity (scoring 127 on a 150 mm intensity scale) than the market products (0.7 on the same 150 mm intensity scale). When reconstituted, the solar dried tomato powder had a coarse appearance and texture, and a strong cooked tomato aroma compared to tomato paste. Consumers indicated that tomato powder was used as a thickener because it was highly viscous and when reconstituted imparted a desirable cooked tomato aroma and flavor. CONCLUSION: Considering the positions of the tomato products in the sensory space, although tomato powder had its own unique sensory properties, it also exhibited some sensory characteristics found in tomato paste. From this study, high-quality tomato powder has great potential for commercialization. © 2021 Society of Chemical Industry.

Comparison of autoinjector with accessorized prefilled syringe for benralizumab pharmacokinetic exposure: AMES trial results.

OBJECTIVE: We compared the pharmacokinetic exposure following a single subcutaneous dose of benralizumab 30 mg using either autoinjectors (AI) or accessorized prefilled syringes (APFS). APFS and AI functionality and reliability for at-home benralizumab delivery have been demonstrated in the GREGALE and GRECO studies, respectively. METHODS: In the open-label AMES study (NCT02968914), 180 healthy adult men and women were randomized to one of two device (AI or APFS) and three injection site (upper arm, abdomen, or thigh) combinations. Randomization was stratified by weight (<70 kg, 70-84.9 kg, and ≥85 kg). Blood eosinophil counts were measured on Days 1, 8, 29, and 57. RESULTS: Benralizumab pharmacokinetic exposure was similar between AI and APFS. Geometric mean ratios (AI/APFS) (90% CI) were 92.8% (87.4-98.6) and 94.5% (88.2-101.2) for two area under the concentration‒time curve measurements (AUClast and AUCinf). Benralizumab exposure was approximately 15-30% greater for thigh vs. abdomen or upper arm administration. Exposure was slightly greater for APFS vs. AI regardless of injection site or weight class. These differences were unlikely to be clinically relevant, as eosinophil depletion was achieved consistently with both devices at all injection sites. No device malfunctions were reported. No new or unexpected safety findings were observed. CONCLUSION: Benralizumab pharmacokinetic exposure was similar between AI and APFS, with consistent blood eosinophil count depletion observed with both devices. These results support benralizumab administration with either AI or APFS, providing patients and physicians increased choice, flexibility, and convenience for potential at-home delivery.

Supportive care of cancer patients with a self-applied photobiomodulation device: a case series.

PURPOSE: Oral mucositis (OM) and prolonged wound healing are common side-effects of cancer treatments. Photobiomodulation (PBM), previously called low-level laser, is currently part of the official guideline for OM prevention. However, all the PBM protocols relate to office-based devices, operated by professional health caregivers, requiring frequent applications. In the following case series, we present our experience with a self-applied consumer home-use PBM device for supportive care. METHODS: Five patients receiving cancer treatment presented at the clinic (female:male 3:2, 55-76 years old) with OM grade 3/4 (n=2), post-surgical non-healing wounds (n=3), and dermatitis (n=1). The PBM treatment (808 nm, 250 mW peak power, 15KHz, 5 J/min, ray size 4.5×1.0cm2) was self-applied by the patients. The protocol included extra/intra-oral applications, over the wound bed/margins and adjacent lymph nodes. RESULTS: The treatment was found effective for resolving OM with rapid pain relief and accelerated healing in post-operative wounds and dermatitis, without reported adverse events. Patients found routine easy to follow and painless, and the protocol was easily integrated as an adjuvant treatment to standard care at the clinic or home while not requiring additional time from the staff. CONCLUSIONS: Side-effects induced by cancer therapy have a detrimental effect on the patient's well-being and may delay or even prevent the patients from completing treatment regimens. PBM is already an established tool for supportive treatment in cancer patients. The advent of a self-applied personal PBM treatment with easy-to-apply protocols for a variety of side-effects makes this technology an important accessible and safe supportive care option.

Home-Use and Real-Time Sleep-Staging System Based on Eye Masks and Mobile Devices with a Deep Learning Model.

PURPOSE: Sleep is an important human activity. Comfortable sensing and accurate analysis in sleep monitoring is beneficial to many healthcare and medical applications. From 2020, owing to the COVID­19 pandemic that spreads between people when they come into close physical contact with one another, the willingness to go to hospital for receiving care has reduced; care-at-home is the trend in modern healthcare. Therefore, a home-use and real-time sleep-staging system is developed in this paper. METHODS: We developed and implemented a real-time sleep staging system that integrates a wearable eye mask for high-quality electroencephalogram/electrooculogram measurement and a mobile device with MobileNETV2 deep learning model for sleep-stage identification. In the experiments, 25 all-night recordings were acquired, 17 of which were used for training, and the remaining eight were used for testing. RESULTS: The averaged scoring agreements for the wake, light sleep, deep sleep, and rapid eye movement stages were 85.20%, 87.17%, 82.87%, and 89.30%, respectively, for our system compared with the manual scoring of PSG recordings. In addition, the mean absolute errors of four objective sleep measurements, including sleep efficiency, total sleep time, sleep onset time, and wake after sleep onset time were 1.68%, 7.56 min, 5.50 min, and 3.94 min, respectively. No significant differences were observed between the proposed system and manual PSG scoring in terms of the percentage of each stage and the objective sleep measurements. CONCLUSION: These experimental results demonstrate that our system provides high scoring agreements in sleep staging and unbiased sleep measurements owing to the use of EEG and EOG signals and powerful mobile computing based on deep learning networks. These results also suggest that our system is applicable for home-use real-time sleep monitoring.

Expanding a woman's options to include home use of misoprostol for medical abortion up until 76 days: an observational study of efficacy and safety.

INTRODUCTION: Home use of misoprostol for medical abortion is increasingly being practiced. With gestational length up to 70 days, it is considered effective, safe and acceptable by women. Knowledge of safety and efficacy with longer gestations is limited and studies are required to expand women's options to include this method of abortion. MATERIAL AND METHODS: A retrospective cohort study was designed to compare home use of misoprostol for medical abortion at gestational length 64-76 days to its use at 57-63 days. Primary outcome was success rate. Success was defined as complete uterine evacuation without the need of surgical intervention due to incomplete abortion and no failed abortion with ongoing pregnancy. Secondary outcomes were rates of unscheduled return visits, telephone consultations, admissions to hospital, infections and the need for blood transfusion. RESULTS: We included 397 women, 270 within 57-63 days of gestation and 127 within 64-76 days of gestation at abortion. Success rate was 95.6% at 57-63 days and 93.7% at 64-76 days. The difference was not statistically significant (P = .431). The rate of unscheduled return visits was high overall but not significantly different in relation to gestational length at abortion (> 63 days; 20.5% vs < 64 days; 16.3%, P = .308). CONCLUSIONS: Our study indicates that home use of misoprostol for medical abortion at 64-76 days gestation may be as safe and effective as at 57-63 days. Further studies with larger sample sizes are needed to confirm our findings and to explore the acceptance of and experiences among women performing abortion at home at greater gestational length, before further implementation in clinical practice.

Non-occupational allergic contact dermatitis caused by long-lasting nail polish kits for home use: 'the tip of the iceberg'.

BACKGROUND: Allergic contact dermatitis (ACD) from (meth)acrylates caused by long lasting nail polish (also known as "permanent", "semi-permanent" or "gel nail polish") has been described both in occupational and non-occupational settings. Inexpensive kits for home use have been available for purchase in many stores or through the Internet. OBJECTIVE: To report on several further cases of consumers sensitised to these nail products. METHODS: Patch test results and evaluation of ingredient labelling of products brought in by the patients. RESULTS: Four new cases are presented. Three of the patients reacted to 2-hydroxypropyl methacrylate, 2-hydroxyethyl methacrylate and ethyleneglycol dimethacrylate (EGDMA), and all 4 to 2-hydroxy ethylacrylate. CONCLUSIONS: Acrylates are present in a wide range of products including medical materials. Sensitization from (meth)acrylates caused by a merely aesthetic procedure might significantly impact health by jeopardizing access to several types of medical interventions. Policies should be implemented restricting the use of long-lasting nail polishes to qualified professionals and banning the indiscriminate sale of kits for home use.

Continuous Temperature-Monitoring Socks for Home Use in Patients With Diabetes: Observational Study.

BACKGROUND: Over 30 million people in the United States (over 9%) have been diagnosed with diabetes. About 25% of people with diabetes will experience a diabetic foot ulcer (DFU) in their lifetime. Unresolved DFUs may lead to sepsis and are the leading cause of lower-limb amputations. DFU rates can be reduced by screening patients with diabetes to enable risk-based interventions. Skin temperature assessment has been shown to reduce the risk of foot ulceration. While several tools have been developed to measure plantar temperatures, they only measure temperature once a day or are designed for clinic use only. In this report, wireless sensor-embedded socks designed for daily wear are introduced, which perform continuous temperature monitoring of the feet of persons with diabetes in the home environment. Combined with a mobile app, this wearable device informs the wearer about temperature increases in one foot relative to the other, to facilitate early detection of ulcers and timely intervention. OBJECTIVE: A pilot study was conducted to assess the accuracy of sensors used in daily wear socks, obtain user feedback on how comfortable sensor-embedded socks were for home use, and examine whether observed temperatures correlated with clinical observations. METHODS: Temperature accuracy of sensors was assessed both prior to incorporation in the socks, as well as in the completed design. The measured temperatures were compared to the reference standard, a high-precision thermostatic water bath in the range 20°C-40°C. A total of 35 patients, 18 years of age and older, with diabetic peripheral neuropathy were enrolled in a single-site study conducted under an Institutional Review Board-approved protocol. This study evaluated the usability of the sensor-embedded socks and correlated the observed temperatures with clinical findings. RESULTS: The temperatures measured by the stand-alone sensors were within 0.2°C of the reference standard. In the sensor-embedded socks, across multiple measurements for each of the six sensors, a high agreement (R2=1) between temperatures measured and the reference standard was observed. Patients reported that the socks were easy to use and comfortable, ranking them at a median score of 9 or 10 for comfort and ease of use on a 10-point scale. Case studies are presented showing that the temperature differences observed between the feet were consistent with clinical observations. CONCLUSIONS: We report the first use of wireless continuous temperature monitoring for daily wear and home use in patients with diabetes and neuropathy. The wearers found the socks to be no different from standard socks. The temperature studies conducted show that the sensors used in the socks are reliable and accurate at detecting temperature and the findings matched clinical observations. Continuous temperature monitoring is a promising approach as an early warning system for foot ulcers, Charcot foot, and reulceration.

Assessment of pain during medical abortion with home use of misoprostol.

OBJECTIVES: Although medical abortion with home use of misoprostol has been shown to be safe and acceptable, there are few data about the experience of pain during the procedure. The aims of this study were to assess the intensity of pain associated with home use of misoprostol for medical abortion and to identify variables associated with severe pain. METHODS: This was an observational study using an anonymous web-based questionnaire in patients having a medical abortion at home in France between 1 December 2013 and 30 April 2014. RESULTS: The questionnaire was completed by 232 women and the results of 193 were retained for analysis. The average pain score was 5.6 on a 10 point scale. A pain score ≥6 was rated as severe and was reported by 105 patients (54%). Nulliparity (odds ratio [OR] 4.10; 95% confidence interval [CI] 2.04, 8.22; p < .0001), lack of choice regarding the method of abortion (OR 2.32; 95% CI 1.13, 4.78; p = .0218) and lack of information about the level of pain associated with the procedure (OR 3.27; 95% CI 1.09, 9.74; p = .0334) were significantly correlated with severe pain. Analgesic prescriptions were very heterogeneous. CONCLUSIONS: Pain remains the main side effect of medical abortion. More studies are needed on pain assessment and the effectiveness of analgesic treatments in women using misoprostol at home for medical abortion, in order to improve their care and improve evidence-based guidelines.

[Research on Standard System of Home Use Electronic Medical Devices].

Medical device going home is an inevitable trend, however, using these devices has potential safety risks. Through introducing the home use electronic medical device products and related medical device standards, this paper provides recommendations on construction of standard system for home use electronic medical devices, to improve the advancement of existing medical device standard system and guide future medical standardization work, to fully utilize standars's guiding and security role in the scientific and technological innovation, industrial development.

Enhanced efficacy of a topical antioxidants regimen in conjunction with a home-use non-ablative fractional diode laser in photodamaged facial skin.

BACKGROUND: Photodamaged facial skin is characterized by fine lines and wrinkles, mottled pigmentation, and other changes. OBJECTIVE: To evaluate and compare the efficacy and tolerance of a home-use laser device when used alone or in combination with an antioxidant facial treatment for moderate photodamage. METHODS: This was a 49-subject, evaluator-blinded, split-face, randomized, single-center, 24-week, phase-2, study. In phase 1, all subjects were treated on one facial side with test products and a home-use laser device and the other side was treated with laser alone for 12 weeks, followed by a 2-week regression period during which they used only support materials. For phase 2, all subjects were divided into 2 independent treatment groups. For the next 10 weeks, subjects of first group treated the assigned facial side with test products and support materials and the other facial side with only support materials. Subjects in the second group treated their entire face with only support materials. Efficacy and tolerance were assessed by clinical grading, VISIA-CR imaging, and self-assessment questionnaires. RESULTS: The combination of laser and test products improved all photodamage parameters evaluated. CONCLUSION: The test products enhanced and prolonged clinical benefits obtained with the laser alone.

A 12-week clinical and instrumental study evaluating the efficacy of a multisource radiofrequency home-use device for wrinkle reduction and improvement in skin tone, skin elasticity, and dermal collagen content.

This study was performed in order to evaluate the safety and efficacy of a new handheld home-use multisource radiofrequency device on facial rejuvenation. Forty-seven male and female subjects were enrolled. All subjects received a NEWA® 3DEEP™ home-use device (EndyMed Medical, Caesarea, Israel) to be used on facial skin three times per week for the first four weeks and then reduced to two times per week for the following eight weeks. Assessments included expert clinical grading for efficacy, instrumental evaluation, image analysis, and photography. Forty-five subjects completed the study; all subjects reported the treatment to be painless with only mild erythema lasting up to 15 minutes post-treatment. No other adverse events were reported. Statistically significant improvements were noted in the appearance of marionette lines, skin brightness, elasticity, firmness, lift (facial), lift (jawline), texture/smoothness, tone, and radiance/luminosity by expert visual assessment. Statistically significant improvements in skin firmness and elasticity were found using a Cutometer MPA 580, as well as in collagen and hemoglobin content of the skin using a SIAscope. The results of this study indicate that the NEWA® multisource radiofrequency home-use device is effective in self-administered skin rejuvenation.

Women's and children's acceptance of biofortified quality protein maize for complementary feeding in rural Ethiopia.

BACKGROUND: For impact of nutritionally improved biofortified crops, consumer acceptance specifically by women and children is necessary when the target beneficiaries are young children. The objective was to assess women's and children's acceptance of a biofortified crop, quality protein maize (QPM), for complementary feeding in rural Ethiopia. RESULTS: Randomly sampled mothers (n = 61) of young children (6-24 months) evaluated flours from a QPM and a conventional maize variety for five sensory characteristics and overall acceptance by mother and child in a home use test with a double-blind, randomized controlled cross-over design. Women distinguished the varieties when used to prepare porridge, and QPM scored more favorably for texture in hand and mouth (both P < 0.05). The varieties did not differ in overall acceptance, which was, however, affected by order of presentation, mothers' number of children, and enumerators who collected data (all P < 0.05). Aroma and taste were key in mothers' acceptance, and appearance was further important for children. Women were more than twice as likely to prefer QPM over conventional maize. CONCLUSION: Consumer acceptance is unlikely to impede uptake and impact of QPM on young children's nutritional status. Home use testing proved feasible for assessing acceptance in rural areas with food insecurity and limited education. © 2015 Society of Chemical Industry.