Effectiveness of a Smartphone App-Based Intervention With Bluetooth-Connected Monitoring Devices and a Feedback System in Heart Failure (SMART-HF Trial): Randomized Controlled Trial.

BACKGROUND: Current heart failure (HF) guidelines recommend a multidisciplinary approach, discharge education, and self-management for HF. However, the recommendations are challenging to implement in real-world clinical settings. OBJECTIVE: We developed a mobile health (mHealth) platform for HF self-care to evaluate whether a smartphone app-based intervention with Bluetooth-connected monitoring devices and a feedback system can help improve HF symptoms. METHODS: In this prospective, randomized, multicenter study, we enrolled patients 20 years of age and older, hospitalized for acute HF, and who could use a smartphone from 7 tertiary hospitals in South Korea. In the intervention group (n=39), the apps were automatically paired with Bluetooth-connected monitoring devices. The patients could enter information on vital signs, HF symptoms, diet, medications, and exercise regimen into the app daily and receive feedback or alerts on their input. In the control group (n=38), patients could only enter their blood pressure, heart rate, and weight using conventional, non-Bluetooth devices and could not receive any feedback or alerts from the app. The primary end point was the change in dyspnea symptom scores from baseline to 4 weeks, assessed using a questionnaire. RESULTS: At 4 weeks, the change in dyspnea symptom score from baseline was significantly greater in the intervention group than in the control group (mean -1.3, SD 2.1 vs mean -0.3, SD 2.3; P=.048). A significant reduction was found in body water composition from baseline to the final measurement in the intervention group (baseline level mean 7.4, SD 2.5 vs final level mean 6.6, SD 2.5; P=.003). App adherence, which was assessed based on log-in or the percentage of days when symptoms were first observed, was higher in the intervention group than in the control group. Composite end points, including death, rehospitalization, and urgent HF visits, were not significantly different between the 2 groups. CONCLUSIONS: The mobile-based health platform with Bluetooth-connected monitoring devices and a feedback system demonstrated improvement in dyspnea symptoms in patients with HF. This study provides evidence and rationale for implementing mobile app-based self-care strategies and feedback for patients with HF. TRIAL REGISTRATION: ClinicalTrials.gov NCT05668000; https://clinicaltrials.gov/study/NCT05668000.

Lessons learned from the implementation of a video health coaching technology intervention to improve self-care of family caregivers of adults with heart failure.

Individuals with heart failure (HF) typically live in the community and are cared for at home by family caregivers. These caregivers often lack supportive services and the time to access those services when available. Technology can play a role in conveniently bringing needed support to these caregivers. The purpose of this article is to describe the implementation of a virtual health coaching intervention with caregivers of HF patients ("Virtual Caregiver Coach for You"-ViCCY). A randomized controlled trial is currently in progress to test the efficacy of the intervention to improve self-care. In this trial, 250 caregivers will be randomly assigned to receive health information via a tablet computer (hereafter, tablet) plus 10 live health coaching sessions delivered virtually (intervention group; n = 125) or health information via a tablet only (control group; n = 125). Each tablet has specific health information websites preloaded. To inform others embarking on similar technology projects, here we highlight the technology challenges encountered with the first 15 caregivers who received the ViCCY intervention and the solutions used to overcome those challenges. Several adaptations to the implementation of ViCCY were needed to address hardware, software, and network connectivity challenges. Even with a well-designed research implementation plan, it is important to re-examine strategies at every step to solve implementation barriers and maximize fidelity to the intervention. Researcher and interventionist flexibility in adapting to new strategies is essential when implementing a technology-based virtual health coaching intervention.

Prevention of peritoneal dialysis-related peritonitis by regular patient retraining via technique inspection or oral education: a randomized controlled trial.

BACKGROUND: There has been little research on strategies for prevention of peritoneal dialysis (PD)-related peritonitis. We explored whether regular retraining on bag exchanges (via two methods: technique inspection and oral education) every other month could help reduce the risk of peritonitis in PD patients through a randomized controlled trial (RCT). METHOD: This is an RCT conducted at Peking University First Hospital. A total of 150 incident patients receiving PD at our centre were included between December 2010 and June 2016 and followed up until June 2018. Patients were randomly assigned 1:1:1 to receive retraining on bag exchange via technique inspection, oral education or usual care. The primary outcome was time to the first peritonitis episode. Secondary outcomes were time to organism-specific peritonitis, transfer to haemodialysis and all-cause death. RESULTS: Patients in the technique inspection group, oral education group and usual care group (n = 50 for each group) were followed up for 47.5 ± 22.9 months. Time to first peritonitis was comparable between the groups. The technique inspection group showed a lower risk of first non-enteric peritonitis than the usual care group, while the oral education group did not show a significant benefit. The incidence of first non-enteric peritonitis in the usual care group (0.07/patient-year) was significantly higher than that in the technique inspection group (0.02/patient-year; P < 0.01) but was comparable with that in the oral education group (0.06/patient-year). Transfer to haemodialysis and all-cause mortality were not significantly different between the groups. CONCLUSIONS: Neither technique inspection nor oral education significantly altered the risk of all-cause peritonitis compared with usual care, despite technique inspection showing a trend towards reducing the risk of non-enteric PD-related peritonitis. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01621997).

Improving epilepsy management with EpSMon: A Templar to highlight the multifaceted challenges of incorporating digital technologies into routine clinical practice.

The digital epilepsy self-monitor (EpSMon) app was developed to address the challenge of improving risk education and management in the UK. The tool, which has emerged out of quality improvement methodology, demonstrates efficacy and has been met with peer-reviewed support and international awards. The focus of this paper is about the development and integration into care of a digital self-assessment epilepsy risk empowerment tool into the UK health system. This paper provides detail into the specific challenges of incorporating a digital epilepsy intervention into routine clinical practice. Despite a strong narrative and evidence, the engagement of commissioners, clinicians, and people with epilepsy is slow. A breakdown of the strategies used, the current governance landscape, and emerging opportunities to develop an informed implementation strategy is provided to support others who seek to create impact with digital solutions for people with epilepsy. This paper is for the Special Issue: Prevent 21: SUDEP Summit - Time to Listen".

Evaluation of the concordance in HPV type between self- and physician-collected samples using a brush-based device and a PCR-based HPV DNA test in Japanese referred patients with abnormal cytology or HPV infection.

BACKGROUND: To adopt HPV self-sampling in Japan, we assessed the concordance between self- and physician-collected human papillomavirus (HPV) samples from Japanese patients and examined the performance of HPV self-sampling for cervical intraepithelial neoplasia grade 2 or worse (CIN2+). METHODS: Patients who had previously tested negative for intraepithelial lesions or malignancy/HPV-positive, and patients with atypical squamous cells of undetermined significance or worse (ASCUS+) cytology were eligible for this cross-sectional study. Participants performed HPV self-sampling using an Evalyn brush, which was submitted at the Fukui Prefectural Health Care Association. The Evalyn brush heads were stored in ThinPrep vials. The physician, however, performed HPV and cell sampling using an endocervical brush and immediately stored the brush heads in ThinPrep vials. All participants underwent colposcopy and biopsy. Histopathological diagnoses were made by pathologists at Fukui University Hospital. HPV infection was confirmed using a PCR-based Cobas 4800 HPV DNA test. Cytological analysis was performed at Fukui Prefectural Health Care Association. RESULTS: HPV-positive rates for physician-collected samples and self-collected samples were 51 and 50%, respectively. The perfect match rate of HPV type between the groups was 88% (κ = 0.76). HPV16/18 showed higher agreement rates than other HPVs (99%, kappa 0.96 and 89% kappa 0.77, respectively). Both groups showed 100% sensitivity to CIN2+, but specificity was 57.0 and 58.1%, respectively. CONCLUSION: For HPV typing, a good concordance rate was seen between self- and physician-collected samples. Self-sampling showed high sensitivity for CIN2+. Self-sampling using the Evalyn brush and Cobas 4800 may be feasible for screening Japanese individuals.

At-Home Transvaginal Device Following Fractional Carbon Dioxide Laser Treatment for Genitourinary Syndrome of Menopause.

BACKGROUND: Device-based therapeutic approaches have been developed to treat women’s genitourinary post-menopausal symptoms. Fractional carbon dioxide laser resurfacing (FxCO2) has been demonstrated to be safe and effective in the treatment of GSM symptoms, however the results begin to wane by 12-months post-treatment. OBJECTIVE: This study aims at assessing the application of an at-home transvaginal red and infrared light device as a maintenance treatment commencing 12 months following FxCO2 laser treatment for genitourinary syndrome of menopause (GSM). STUDY DESIGN: Subjects completing 12-month follow-up after three fractional CO2 laser vulvovaginal treatments received an at-home device and monitored for GSM symptoms with long-term follow-up to 12 months (2 years post-laser). METHODS: 10 post-menopausal subjects completing 12-months follow-up after three FxCO2 vulvovaginal treatments for GSM were treated with an at-home red and infrared LED device. Treatment consisted of intravaginal application three times per week, and subjects were followed to 1, 3, 6, and 12 months. Subjects completed the vaginal assessment scale subject satisfaction, and QUID to assess for vulvovaginal and stress urinary incontinence (SUI) symptoms. RESULTS: Vulvovaginal symptoms measured by VAS were mean 89% improved at 12-month follow-up after FxCO2 and maintained at 73% improved over baseline (2 years post-laser) following an additional 12 months of at-home transvaginal light therapy (P<0.05). VAS symptoms gradually increased over the 12 months maintenance period by a mean of 17% (P<0.05). Mean subject satisfaction was 0 at baseline, 1.86 at 1 year following FxCO2, and 1.00 after an additional 1 year of at-home light therapy. SUI symptoms as measured by QUID were mean 81% improved at 12-month follow-up after FxCO2and maintained at 38% improved over baseline (2 years post-laser) following an additional 12-months of at-home light therapy (P<0.05). SUI symptoms gradually increased by a mean of 43% over the 12-month maintenance period (P<0.05). CONCLUSIONS: At-home transvaginal red and near infrared light therapy commencing at 12 months post-FxCO2 vulvovaginal treatment in a post-menopausal population maintained statistically significant improvements in vulvovaginal and SUI symptoms over the additional12-month period (2 years post-laser); however, a gradual return of symptoms suggests that laser re-treatment or combination withhormone therapy may be necessary to maintain optimal outcomes.J Drugs Dermatol. 2020;19(11):1076-1079. doi:10.36849/JDD.2020.1012.

Evaluating the effect of a smartphone app-based self-management program for people with COPD: A randomized controlled trial.

AIM: To examine the effect of a 6-month, smartphone app-based self-management program for people with chronic obstructive pulmonary disease (COPD). BACKGROUND: Technological interventions have been used for chronic disease management, but the effect of a self-management program using a smartphone app has not been evaluated in people with COPD. METHODS: For this randomized controlled trial, patients with COPD (N = 44) were recruited in pulmonary medicine outpatient clinics at two, metropolitan, tertiary care, academic hospitals. Eligible participants were randomized into two groups and received group education and exercise sessions in the first month of the 6-month intervention. Participants in the experimental group received a smartphone app-based self-management program, which included education, exercises, self-monitoring of symptoms and exercise, and social support. Participants in the control group received one call a month from the research staff. Self-care behavior was measured as a primary outcome. All measures were administered at baseline and at 6 months. RESULTS: After randomization, the experimental group numbered 22, the control group numbered 20, and 2 participants dropped out. Significant differences between groups were found in change score for self-care behavior, total activity count per wear time, and percent time spent in moderate-to-vigorous physical activity over 6 months. CONCLUSION: A self-management program, using a smartphone app, can effect behavioral change in people with COPD. This program could be a boon to patients with COPD who have limited access to a health care provider, no opportunities for pulmonary rehabilitation, and frequent exacerbations.

Epinephrine autoinjector prescription patterns for severe anaphylactic patients in Japan: A retrospective analysis of health insurance claims data.

BACKGROUND: Current guidelines recommend that any patient who has experienced anaphylaxis should be prescribed one or more epinephrine autoinjectors (EAI) for immediate self-treatment. However, the etiology of anaphylaxis and prescription patterns of EAI have not been widely examined in Japan. METHODS: This was a retrospective cohort study using a large Japanese claims database (JMDC, Tokyo, Japan). We included patients with severe anaphylaxis who received epinephrine in a hospital or outpatient clinic from 2011 to 2016. We extracted patients who were prescribed EAIs and examined the annual trend of EAI prescription rates and refill patterns. RESULTS: We identified 1255 eligible patients. Among them, 361 patients (28.8%) were prescribed EAIs within 30 days after their initial severe anaphylactic episode. In patients who were prescribed EAIs, 65.9% were prescribed EAIs from the same facility in which initial treatment was given for severe anaphylaxis. The prescription rates of EAI significantly increased from 11.1% in 2011 to 30.9% in 2016. Among patients with initial EAI prescriptions, 97.3% refilled their EAI prescriptions at least once and 40.5% refilled their prescriptions annually during the 3 year follow up period. CONCLUSIONS: EAI prescription rates were relatively low in patients who experienced severe anaphylaxis in Japan. Physicians should prescribe EAIs to all patients who were treated for anaphylaxis under their care and avoid delegating the responsibility of prescribing EAIs to other facilities. Initial prescription of EAIs can result in improved regular refill and dissemination practices.

Validation of a new HPV self-sampling device for cervical cancer screening: The Cervical and Self-Sample In Screening (CASSIS) study.

OBJECTIVE: We compared the self-sampling performance of the newly designed HerSwab™ device with a physician-collected cervical sample and another self-sample using the cobas® PCR Female swab for the detection of cervical intraepithelial neoplasia (CIN) and cancer. METHODS: Women referred for colposcopy at McGill University affiliated hospital clinics collected two consecutive self-samples, one with HerSwab™ and one with cobas® swab, after receiving instructions. The order of sampling was randomized. The colposcopist then collected a cervical sample and conducted a colposcopic examination. Samples were tested for human papillomavirus (HPV) DNA. Sensitivity and specificity to detect CIN2+ and respective 95% confidence intervals (CI) were calculated to compare sampling approaches. The HPV testing agreement between samples was measured using the Kappa statistic. RESULTS: Of 1217 women enrolled, 1076 had complete results for HPV and cytology; 148 (13.8%) had CIN1, 147 (13.7%) had CIN2/3, and 5 (0.5%) had cancer. There was very good agreement between methods for HPV detection (HerSwab™ versus physician: kappa=0.84; cobas® swabs versus physician: kappa=0.81; HerSwab™ versus cobas® swabs: kappa=0.87). The sensitivity of HPV detection for CIN2+ was 87.6% (95%CI: 79.8-93.2) with self-sampling using HerSwab™, 88.6% (95%CI: 80.9-94.0) with self-sampling using the cobas® swab, and 92.4% (95%CI: 85.5-96.7) with physician sampling. Corresponding estimates of specificity were 58.1% (95%CI: 54.1-62.1), 55.0% (95%CI: 50.9-59.0) and 58.7% (95%CI: 54.6-62.6). Cytology (ASC-US or more severe) done on the physician-collected specimen was 80.2% (95%CI: 70.8-87.6) sensitive and 61.4% (95%CI: 57.2-65.5) specific for CIN2+. CONCLUSIONS: The HerSwab™ had good agreement with physician sampling in detecting HPV, and adequate performance in detecting high-grade lesions among women referred to colposcopy for abnormal cytology.

'Self-screening' for malnutrition with an electronic version of the Malnutrition Universal Screening Tool ('MUST') in hospital outpatients: concurrent validity, preference and ease of use.

Self-screening using an electronic version of the Malnutrition Universal Screening Tool ('MUST') has been developed but its implementation requires investigation. A total of 100 outpatients (mean age 50 (sd 16) years; 57 % male) self-screened with an electronic version of 'MUST' and were then screened by a healthcare professional (HCP) to assess concurrent validity. Ease of use, time to self-screen and prevalence of malnutrition were also assessed. A further twenty outpatients (mean age 54 (sd 15) years; 55 % male) examined preference between self- screening with paper and electronic versions of 'MUST'. For the three-category classification of 'MUST' (low, medium and high risk), agreement between electronic self-screening and HCP screening was 94 % (κ=0·74, se 0·092; P<0·001). For the two-category classification (low risk; medium+high risk) agreement was 96 % (κ=0·82, se 0·085; P<0·001), comparable with the previously reported paper-based self-screening. In all, 15 % of patients categorised themselves 'at risk' of malnutrition (5 % medium, 10 % high). Electronic self-screening took 3 min (sd 1·2 min), 40 % faster than previously reported for the paper-based version. Patients found the tool easy or very easy to understand (99 %) and complete (98 %). Patients that assessed both tools found the electronic tool easier to complete (65 %) and preferred it (55 %) to the paper version. Electronic self-screening using 'MUST' in a heterogeneous group of hospital outpatients is acceptable, user-friendly and has 'substantial to almost-perfect' agreement with HCP screening. The electronic format appears to be as agreeable and often the preferred format when compared with the validated paper-based 'MUST' self-screening tool.

Effectiveness of a Self-monitoring Device for Urinary Sodium-to-Potassium Ratio on Dietary Improvement in Free-Living Adults: a Randomized Controlled Trial.

BACKGROUND: Reducing the urinary sodium-to-potassium ratio is important for reducing both blood pressure and risk of cardiovascular disease. Among free-living Japanese individuals, we carried out a randomized trial to clarify the effect of lifestyle modification for lowering urinary sodium-to-potassium ratio using a self-monitoring device. METHODS: This was an open, prospective, parallel randomized, controlled trial. Ninety-two individuals were recruited from Japanese volunteers. Participants were randomly allocated into intervention and control groups. A month-long dietary intervention on self-monitoring urinary sodium-to-potassium ratio was carried out using monitors (HEU-001F, OMRON Healthcare Co., Ltd., Kyoto, Japan). All participants had brief dietary education and received a leaflet as usual care. Monitors were handed out to the intervention group, but not to the control group. The intervention group was asked to measure at least one spot urine sodium-to-potassium ratio daily, and advised to lower their sodium-to-potassium ratio toward the target of less than 1. Outcomes included changes in 24-hour urinary sodium-to-potassium ratio, sodium excretion, potassium excretion, blood pressure, and body weight in both groups. RESULTS: Mean measurement frequency of monitoring was 2.8 times/day during the intervention. Changes in urinary sodium-to-potassium ratio were -0.55 in the intervention group and -0.06 in the control group (P = 0.088); respective sodium excretion changes were -18.5 mmol/24 hours and -8.7 mmol/24 hours (P = 0.528); and corresponding potassium excretion was 2.6 mmol/24 hours and -1.5 mmol/24 hours (P = 0.300). No significant reductions were observed in either blood pressure or body weight after the intervention. CONCLUSIONS: Providing the device to self-monitor a sodium-to-potassium ratio did not achieve the targeted reduction of the ratio in "pure self-management" settings, indicating further needs to study an effective method to enhance the synergetic effect of dietary programs and self-monitoring practice to achieve the reduction. However, we cannot deny the possibility of reducing sodium-to-potassium ratio using a self-monitoring device.

Efficacy of self-monitoring of blood glucose versus retrospective continuous glucose monitoring in improving glycaemic control in diabetic kidney disease patients.

AIMS: Patients with diabetic kidney disease (DKD) on anti-diabetic agents, are at greater risk of glycemic variations, both hypoglycemia and hyperglycemia. We aimed to compare glycemic control (using HbA1c) and hypoglycemia incidence in patients with Stage 3 DKD (eGFR 30-60 mL/min per 1.73 m2 ), receiving retrospective CGM-guided anti-diabetic therapy versus self-monitoring of blood glucose (SMBG) over 3 months. METHODS: Thirty patients with HbA1c >8% were randomized to 6-day retrospective CGM or SMBG. In the CGM group, CGM was worn at the beginning and 6 weeks. HbA1c, assessment of hypoglycaemia events (self-reported and BG < 4 mmol/L from CGM/SMBG data) and medication adjustment were performed at baseline and 3 months. All patients received education on hypoglycaemia avoidance. RESULTS: Fourteen patients were allocated to CGM and 16 to SMBG. Mean (±SD) eGFR was 42.9 ± 10.3 mL/min. Majority (86.7%) of patients had diabetes duration >10 years and on insulin therapy (90%). HbA1c improved significantly from baseline 9.9 ± 1.2 to 9.0 ± 1.5% (P < 0.001) at 3 months, with no difference between CGM (9.8 ± 1.2 to 8.8 ± 1.8%, P = 0.009) or SMBG (9.9 ± 1.3 to 9.1 ± 1.1%, P = 0.007) groups (P = 0.869 between groups). In the CGM group, percentage duration in hyperglycaemia (BG > 10 mmol/L) reduced from baseline 65.4 ± 22.4% to 54.6 ± 23.6% (P = 0.033) at 6 weeks, with a non-significant rise in percentage duration in hypoglycaemia from 1.2 ± 2.2% to 4.0 ± 7.0% (P = 0.176). There was no difference in self-reported and documented hypoglycaemia events. CONCLUSION: In a pilot study of DKD patients, short-term episodic use of CGM reduced time spent in hyperglycaemia range without significantly increasing time-exposure to hypoglycaemia. However, both CGM and SMBG were equally effective in improving glycaemic control.

Smartphone app in self-management of chronic low back pain: a randomized controlled trial.

BACKGROUND: Mobile health (mHealth) is emerging as the most convenient way to deliver rehabilitation services remotely, and collect outcomes in real time, thus contributing to disease management by transferring care from hospital to home. It facilitates accessibility to healthcare, enhances patients' understanding of their condition, and their willingness to engage in self-management, giving way to high-quality care to the satisfaction of both patients and healthcare professionals. PURPOSE: The purpose of this study was to examine the effect of using a smartphone app (called Snapcare) on pain and function in patients suffering from chronic low back pain. METHODS: Ninety-three patients with chronic low back pain were recruited and randomly allocated to either the Conventional group (n = 48) receiving a written prescription from the Physician, containing a list of prescribed medicines and dosages, and stating the recommended level of physical activity (including home exercises) or the App group (n = 45) receiving Snapcare, in addition to the written prescription. Pain and disability were assessed at baseline and after 12 weeks of treatment. RESULTS: Both the groups showed significant improvement in pain and disability (p < 0.05). The App group showed a significantly greater decline in disability (p < 0.001). CONCLUSION: Health applications are promising tools for improving outcomes in patients suffering from various chronic conditions. Snapcare facilitated increase in physical activity and brought about clinically meaningful improvements in pain and disability in patients with chronic low back pain. These slides can be retrieved under Electronic Supplementary Material.

A randomized controlled trial on a nurse-led smartphone-based self-management programme for people with poorly controlled type 2 diabetes: A study protocol.

AIM: To develop and compare a nurse-led smartphone-based self-management programme with an existing nurse-led diabetes service on health-related outcomes for people with poorly controlled type 2 diabetes in Singapore. BACKGROUND: Over the past decades, Asia has emerged as the "diabetes epicentre" in the world due to rapid economic development, urbanization and nutrition transition. There is an urgent need to develop more effective care management strategies in response to this rising diabetes epidemic. DESIGN: A randomized controlled trial with pre- and repeated posttests control group design. METHODOLOGY: A total of 128 adults with poorly controlled type 2 diabetes will be recruited from the diabetes clinic of a public acute hospital in Singapore through convenience sampling. Study participants will be randomly allocated either to the experimental group or the control group. Outcome measures will include the 10-item General Self-Efficacy Scale, 11-item Revised Summary of Diabetes Self-care Activities and 19-item Diabetes-Dependent Quality of Life. Data will be collected at three time points: baseline, 3 and 6 months from the baseline. DISCUSSION: It is expected that this programme will be an alternative offered to diabetes patients to master their self-care management skills, in addition to the existing diabetes service provided in diabetes clinics in Singapore hospitals. Furthermore, the self-supporting and less resource-intensive nature of this programme, using a smartphone application as the mode of intervention delivery, will greatly reduce nurses' direct contact time with patients and allow more time to be allocated to those who require more attention. The study has been registered with ClinicalTrials.gov. The trial registration number is NCT03088475.

Practical and clinical utility of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: a post hoc analysis of the randomized, sham-controlled, double-blind PRESTO trial.

BACKGROUND: The PRESTO study of non-invasive vagus nerve stimulation (nVNS; gammaCore®) featured key primary and secondary end points recommended by the International Headache Society to provide Class I evidence that for patients with an episodic migraine, nVNS significantly increases the probability of having mild pain or being pain-free 2 h post stimulation. Here, we examined additional data from PRESTO to provide further insights into the practical utility of nVNS by evaluating its ability to consistently deliver clinically meaningful improvements in pain intensity while reducing the need for rescue medication. METHODS: Patients recorded pain intensity for treated migraine attacks on a 4-point scale. Data were examined to compare nVNS and sham with regard to the percentage of patients who benefited by at least 1 point in pain intensity. We also assessed the percentage of attacks that required rescue medication and pain-free rates stratified by pain intensity at treatment initiation. RESULTS: A significantly higher percentage of patients who used acute nVNS treatment (n = 120) vs sham (n = 123) reported a ≥ 1-point decrease in pain intensity at 30 min (nVNS, 32.2%; sham, 18.5%; P = 0.020), 60 min (nVNS, 38.8%; sham, 24.0%; P = 0.017), and 120 min (nVNS, 46.8%; sham, 26.2%; P = 0.002) after the first attack. Similar significant results were seen when assessing the benefit in all attacks. The proportion of patients who did not require rescue medication was significantly higher with nVNS than with sham for the first attack (nVNS, 59.3%; sham, 41.9%; P = 0.013) and all attacks (nVNS, 52.3%; sham, 37.3%; P = 0.008). When initial pain intensity was mild, the percentage of patients with no pain after treatment was significantly higher with nVNS than with sham at 60 min (all attacks: nVNS, 37.0%; sham, 21.2%; P = 0.025) and 120 min (first attack: nVNS, 50.0%; sham, 25.0%; P = 0.018; all attacks: nVNS, 46.7%; sham, 30.1%; P = 0.037). CONCLUSIONS: This post hoc analysis demonstrated that acute nVNS treatment quickly and consistently reduced pain intensity while decreasing rescue medication use. These clinical benefits provide guidance in the optimal use of nVNS in everyday practice, which can potentially reduce use of acute pharmacologic medications and their associated adverse events. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02686034 .

Selecting an intermittent self-catheter: key considerations.

This article explores the factors that must be considered when assessing patients for intermittent self-catherisation (ISC). It discusses the various types of intermittent catheters and their properties. Key considerations for the health professional when making product recommendations are covered and emphasis is placed on teaching patients the ISC technique. The article also highlights what patients value in terms of product choice and the importance of ongoing support. It concludes by introducing the GentleCath Glide, a new product that incorporates FeelClean™ technology, which leaves less residue on the hands and clothes.

The use of Tiemann tip catheters for male intermittent self-catheterisation.

Male catheterisation can be difficult to perform, especially in patients with an enlarged prostate gland or other potentially obstructive conditions in the lower urinary tract. Repeated and unsuccessful catheterisations, as well as causing trauma, pain and distress, can cause other conditions such as urethral strictures and 'false passages' (when the catheter is pushed through the urethral wall instead of passing down the urethra), which then require more costly interventions to correct. With an increasingly ageing population these complications are expected to rise, putting added strain on an already stretched health service. This article discusses the use of the Coudé (or Tiemann) tip catheter in patients presenting with these challenging catheterisations and, in particular, male patients performing intermittent self-catheterisation. Device design can help overcome obstructive difficulties, making catheterisation easier, less traumatic and more comfortable for the patient. A survey of 200 nurses working in the urology and continence field was undertaken to understand their awareness and usage of Coudé/Tiemann tip catheters in practice. It was found that many nurses and doctors were unaware of this type of catheter and its advantages and therefore did not use or offer it as an alternative to the more commonly used straight-tipped catheter. In the vast majority of cases when Tiemann tip catheters were used this occurred after failure with a straight-tipped catheter, or they were used with patients with benign prostatic hyperplasia or other potentially obstructive conditions. In many cases, the catheterisation was consultant initiated, despite the fact that intermittent self-catheterisation is instigated and taught mainly by nurses. This survey highlighted the need for better education for nurses and doctors in assessing the alternative catheter tips available to ensure successful catheterisation on first attempt.

Implementation and preliminary effectiveness of a real-time pain management smartphone app for adolescents with cancer: A multicenter pilot clinical study.

BACKGROUND: Pain in adolescents with cancer (12-18 years) is common and negatively impacts health-related quality of life (HRQL). The Pain Squad+ smartphone app, which provides adolescents with real-time pain self-management support, was developed to address this issue. This study evaluated the implementation of the app to inform a future randomized controlled trial (RCT) and obtain treatment effect estimates for pain intensity, pain interference, HRQL, and self-efficacy. PROCEDURE: A one-group baseline/poststudy design with 40 adolescents recruited from two pediatric tertiary care centers was used. Baseline questionnaires were completed and adolescents used the app at least twice daily for 28 days, receiving algorithm-informed self-management advice depending on their reported pain. A nurse received alerts in response to sustained pain and contacted adolescents to assist in pain care. Poststudy questionnaires were completed. Descriptive analyses, with exploratory inferential testing conducted on health outcome data, were used to address study aims. RESULTS: Most (40/52; 77%) eligible adolescents participated. Two participants withdrew participation. Intervention fidelity was impacted by technical difficulties (occurring for 15% of participants) and a prolonged time for nurse contact in the event of sustained pain. Adherence to pain reporting was 68.8 ± 38.1%. Outcome measure completion rates were high and the intervention was acceptable to participants. Trends in improvements in pain intensity, pain interference, and HRQL were significant, with effect sizes of 0.23-0.67. CONCLUSIONS: Implementation of Pain Squad+ is feasible and the app appears to improve pain-related outcomes for adolescents with cancer. A multicenter RCT will be undertaken to examine app effectiveness.

Linking existing instruments to develop a continuum of care measure: accuracy comparison using function-related group classification.

PURPOSES: To compare measurement accuracy of test forms with varied number of items (13, 8, and 4 items) generated from the self-care physical function item bank composed of Functional Independence Measure (FIM™) and the Minimum Data Set (MDS). METHODS: Retrospective data analysis of 2499 Veterans who completed both FIM and MDS within 6 days. We compared measurement accuracy between the converted FIM (FIMc) motor score generated from the MDS and the original FIM (FIMa) motor score (13 items) at: (a) individual-level using point differences, and (b) group-level using function-related group (FRG). RESULTS: The differences of mean FIMa and FIMc scores were between 0.05 and 1.07 points for all test forms. Over 81% of FIMc from MDS_13 were within 15 points of the FIMa. 81-90% of FRGs generated by the FIM short forms was identical to those generated by the FIMa for stroke, lower limb amputation, knee and hip replacement; and 59.9-90.5% by all MDS test forms. All MDS test forms had above 74% agreement with same or adjacent FMGs (ICC 0.65-0.91). CONCLUSIONS: The accuracy is dependent on the comparison level (i.e., individual or group), length of the test and which FRG is used. Our results partially support using existing instruments-without decreasing the number of the items-to generate a continuum of care measurement.