Readiness, acceptance and use of digital patient reported outcome in an outpatient clinic.

Use of digital patient-reported outcomes is being introduced in care of chronic conditions, including Inflammatory Bowel Disease. The aim is to supplement face-to-face follow-up sessions through symptom screening, and to inform follow-up through questions about mental health and quality of life. However, little is known about who is using this as intended. This study aimed to map differences between users and non-users among people with IBD and explore the mechanisms behind. We administered a questionnaire including the Readiness and Enablement Index for Health Technology (ReadHy) and the Service User Technology Acceptability Questionnaire (SUTAQ) to all people with IBD registered at Silkeborg Regional Hospital. Comparison between users and non-users and cluster analysis was conducted. Effect size (Cohen's d) was used to estimate magnitude of difference between groups. The user and non-user groups differed most strongly by level of emotional distress (d = 0.45). Cluster analysis of the ReadHy scales showed profiles have different sets of difficulties and reservations towards digital solutions. These difficulties correlated moderately with SUTAQ dissatisfaction and low acceptability. The dimensions of ReadHy may help to better understand particular needs of people with IBD when accessing digital PROs, which may lead to higher acceptability and improved quality of care.

Digital patient-reported outcomes in inflammatory bowel disease routine clinical practice: the clinician perspective.

BACKGROUND: Use of digital health services, such as digital patient-reported outcomes, depends on many different human factors as well as digital design solutions. One factor is clinicians' attitude towards the system, their reasoning behind the using system and their perceptions of patients' ability to engage with digital health systems. This study aimed to explore hospital clinicians' attitudes towards digital patient-reported outcomes used in the routine care and treatment of inflammatory bowel disease, and to explore the potential role of clinicians' attitudes in influencing patients' use of digital patient-reported outcomes. RESULTS: Twelve clinicians using digital patient-reported outcome assessments in the care of inflammatory bowel disease were interviewed about their experiences of, and perspectives on, using this service. Most participants supported the use of digital patient-reported outcome assessments in the care of most patients. Participants reported that most patients found the digital solution easy to use. They perceived digital patient-reported outcomes to have three main purposes: prioritising resources; improving patients' quality of life; and improving quality of care. The patient-clinician relationship was of great importance to participants. Participants varied in their intention to use digital PRO, as some viewed the system as a positive but optional add-on for patients, whilst others intended to use the system with all eligible patients. CONCLUSION: Clinicians' general support of using digital patient-reported outcomes might facilitate their use among patients with inflammatory bowel disease. The participants saw benefits in doing so for patients, clinicians and the wider health service. Clinicians' attitudes towards the use of digital PRO in the care of their patients may influence patients' uptake of health service.

Implanted Peroneal Nerve Stimulator Treatment for Drop Foot Caused by Central Nervous System Lesion: A Twelve-Month Follow-up of 21 Patients.

OBJECTIVE: Drop foot is a common impairment following stroke or other causes of central pathology. We report data on patient self-perceived performance, satisfaction with performance, walking ability, and adverse effects after surgical implantation of the ActiGait® drop foot stimulator. DESIGN: Prospective case study with a 12-month follow-up. SUBJECTS: Twenty-one participants with drop foot caused by central nervous system lesion. METHODS: The patients' self-perceived performance and satisfaction with performance were evaluated using the Canadian Occupational Performance Measure (COPM). Walking ability was assessed using a 10-m walk test and a 6-min walk. Nerve conduction of the peroneal nerve was examined in 10 patients. RESULTS: At follow-up, COPM self-percieved performance from 3.2 to 6.7 points, the median increase being 2.8 (interquartile range (IQR) 2.2-5.0), p < 0.001. Likewise, the COPM satisfaction with performance increased from 2.6 to 6.9 points, the median increase being 4.2 (IQR 2.8-5.8), p < 0.001. Walking velocity increased 0.1 m/s from a baseline measurement of 0.73 m/s (95% confidence interval (95% CI) 0.03-0.2), n = 21, p < 0.01, and walking distance increased by 33 m, from a baseline measurement of 236 m (95% CI 15-51), n = 21, p < 0.001. CONCLUSION: Stimulation of the peroneal nerve by an implantable stimulator increases self-perceived performance, satisfaction with performance, and ambulation in patients with long-lasting drop foot caused by a central nervous system lesion.

Telemedicine based on patient-reported outcomes in management of patients with inflammatory bowel disease in a real-life setting - a before and after cohort study.

BACKGROUND: Avoidable appointments and increasing incidence of inflammatory bowel disease (IBD) call for alternative ways of organizing outpatient visits. In controlled studies, telemedicine including patient reported outcome (PRO) has shown to improve outcomes in IBD and reduce health care utilization. However, we lack studies of telemedicine implemented in everyday practice. We therefore described use of a PRO-based telemedicine follow-up (AmbuIBD) in a real-life setting and investigated the effect on outpatient visits and hospital admissions. METHODS: We conducted a cohort study including patients with IBD in an outpatient clinic at a Danish regional hospital August 2018. Data included extracts from the Patient Administration System and the AmbuFlex system between 2017 and August 2018, plus questionnaire data from clinicians. Descriptive statistics were used to describe use of AmbuIBD and differences between before and after results were tested with Wilcoxon's signed-rank test. RESULTS: Of 848 patients in outpatient care, 77% were included in AmbuIBD. Most patients were set to answer a PRO questionnaire once a year (n = 407, 62%), and 66% of 1913 answered questionnaires were handled with no further contact. AmbuIBD was well accepted by clinicians. Outpatient visits the year after AmbuIBD compared to the year before were reduced with 14% (p ≤ .001). The largest reduction was for patients with mild or no disease activity (45%, p ≤ .001). No difference was found for hospital admissions. CONCLUSIONS: AmbuIBD is feasible and well accepted when implemented in an outpatient clinic. More than half of patients are only followed by questionnaire, and we found a reduction in outpatient visits.

Patient perspectives on digital patient reported outcomes in routine care of inflammatory bowel disease.

BACKGROUND: Digital patient reported outcomes are used increasingly in daily care and treatment of inflammatory bowel disease. Their purpose includes increased focus on patient wellbeing, reduction in avoidable follow-up consultations and increased patient self-management. However, implementation issues occur and studies indicate patients may have concerns, particularly regarding having fewer face-to-face consultations. This study aims to explore patients' perspectives of use and non-use of digital patient reported outcomes and to understand the mechanisms underpinning patient reluctance to engage with this health technology. RESULTS: Sixteen patients with inflammatory bowel disease at a regional hospital in Denmark were interviewed about their experiences of, and perspectives on, digital patient reported outcomes. A certain level of eHealth literacy was found to be a fundamental condition for use, while other factors were barriers or facilitators for use of digital PROs. Patients' main concerns were about potential consequences for their care and relationship with the clinic. Most patients in stable remission were satisfied with the hospital being a "life-line" if their symptoms worsened, and perceived digital patient reported outcomes to be an efficient tool to establish that "life-line". Patients with severe symptoms and a high degree of emotional distress related to their disease valued the potential for digital patient reported outcomes to increase their clinicians' focus on mental health and extra-intestinal symptoms. CONCLUSION: This study found that if patients had sufficient digital literacy, they perceived digital patient reported outcomes to be a useful replacement for face-to-face consultations. However, they were concerned about digital patient reported outcomes' effect on the patient-clinician relationship and its ability to detect worsening of symptoms. These concerns may be mitigated by good patient-clinician relationships, and the option for patients to maintain direct telephone contact with their gastroenterology specialist.

'Digital patient reported outcomes' refer to systems by which health professionals collect health information from patients between consultations, mostly via self-completed online questionnaires. This approach aims to support treatment and disease management, and reduce avoidable face-to-face consultations between doctor and patient. However, patients may have concerns about using digital systems to communicate with their clinicians, particularly regarding having fewer face-to-face consultations. To find out more, we interviewed sixteen patients at an Inflammatory Bowel Disease outpatient clinic in Denmark, where digital Patient Reported Outcomes have been used since 2017. We found out that patients needed to have enough familiarity with technology to be able to use these online systems. Patients were worried about how this new way of communicating with the clinic affected their care and their relationship with their doctors and nurses. People with Inflammatory Bowel Disease can have long periods of time with very little disease activity, and in these stable periods, a lot of patients found that a digital Patient Reported Outcomes system was a good way to stay in touch with the clinic and keep reporting their symptoms online­ as long as they still had the possibility of contacting the clinic by telephone if needed. During disease flare-ups, patients believed that digital patient reported outcomes' could be used to give broader insight into their health situation, and trusted their clinicians to use their self-reported data to improve their care.

Translation and cultural adaptation of the Pregnancy Physical Activity Questionnaire into Danish using the dual-panel approach: comparison with outcomes from an alternative translation approach.

OBJECTIVE: Physical activity reduces the risk of pregnancy-related complications. However, pregnant women often reduce their physical activity levels and do not follow the WHO's physical activity recommendations during pregnancy. To support pregnant women in monitoring physical activity, the self-administered Pregnancy Physical Activity Questionnaire was developed in the US. We translated and cross-cultural adapted the questionnaire using the dual approach method. Meanwhile, and without knowing this, another Danish group simultaneously translated the questionnaire using the method described by Beaton et al. The aim is to present our data and discuss the unplanned purpose of comparing the results from using two different translation methods. RESULTS: We translated and cross-culturally adapted the Pregnancy Physical Activity Questionnaire to Danish with the following findings. Two additional items for cycling were included. Three items about spending time on a computer, reading, writing or talking on the phone were not feasible in terms of differentiating between them and these were merged into one item. The item 'Taking care of an older adult' was found to be irrelevant in a Danish setting and was removed. Adaptions were similar comparing the two methods. Consequently, using the dual-panel and the methods suggested by Beaton et al. yield similar results when translating and cultural adapting the PPAQ.

Measurement latency significantly contributes to reduced heart rate measurement accuracy in wearable devices.

The purpose of this study was to determine the extent to which measurement latency has significance for the accuracy of heart rate (HR) measured by wearable devices during physical activities. Thirty participants (15 female) aged 18-50 years (mean 24.8, 6.3 SD years) with weight ranging from 53-87 kg (mean 70.5, 9.4 SD kg) participated in this cross-sectional study. Participants completed three submaximal exercise conditions; cycling, treadmill walking/running and rapid arm movements. During the exercises, HR was concurrently measured using the Polar H10 (PL), the Apple Watch 2 (AW) and the Garmin Forerunner 235 (GF). Measurement latency significantly affected the discrepancy in HR measures and measurement latency accounted for 15% (GF) and 2% (AW) of the explained discrepancy in HR between the criterion measure PL and the GF and AW. However, the findings also showed that the magnitude of HR measurement latency differed notably among the two wearable devices and measurement latency was greatly influenced not only by type but also by the intensity of exercise. These findings contribute to our understanding of wearable device HR measures discrepancy and this knowledge may be of assistance when electing to use wearable devices to monitor physical exertion in different contexts.

Giardia and Cryptosporidium infections in Danish cats: risk factors and zoonotic potential.

Giardia and Cryptosporidium infections are common in cats, but knowledge is limited about their clinical importance, risk factors, and the role of cats as a reservoir for human infections. Here, we collected faeces and questionnaire data from 284 cats from shelters and veterinary clinics in the Copenhagen Metropolitan Region (= study population). Additionally, 33 samples were analysed separately from catteries with gastrointestinal clinical signs (= cases). (Oo-)cysts were quantified by immunofluorescence microscopy. All Giardia (n = 34) and Cryptosporidium (n = 29) positive samples were analysed by sequencing of the 18S rRNA, gdh and hsp70 loci, and co-infections were detected by McMaster/inverted microscopy. In the study population, 7.0% and 6.7% were positive for Giardia and Cryptosporidium respectively; 48.5% and 36.4% of the breeder cats (cases) were infected. Increased odds of diarrhoea were demonstrated in Giardia (p = 0.0008) and Cryptosporidium (p = 0.034) positive cats. For Giardia, the odds were positively correlated with infection intensity. Co-infection with Cryptosporidium (OR 12.79; p < 0.001), parasitic co-infections other than Cryptosporidium (OR 5.22; p = 0.009), no deworming (OR 4.67; p = 0.035), and male sex (OR 3.63; p = 0.025) were risk factors for Giardia. For Cryptosporidium, co-infection with Giardia was the only risk factor (OR 11.93; p < 0.0001). Genotyping revealed G. duodenalis assemblages A and F, and C. felis, all of them previously detected in humans. In conclusion, excretion of Giardia and Cryptosporidium was associated with clinical disease. Although a public health risk is likely, studies including larger sample sizes, more discriminatory markers and samples from other animals and humans are needed to reveal the full zoonotic potential.

Accuracy of the wearable activity tracker Garmin Forerunner 235 for the assessment of heart rate during rest and activity.

Accurate measures of heart rate (HR) during rehabilitation and sporting activities are important for precise exercise prescription to maintain or increase capacity. Wrist-worn activity monitors utilizing photoplethysmography technology (PPG) to configure HR show discrepant findings regarding validity depending on the type and intensity of exercises measured, and no previous study has yet investigated the accuracy during running at speeds exceeding 9.6 km/h. The purpose of the study was to assess the accuracy of the Garmin Forerunner 235 (GF), at different exercises at various intensities. Twenty-nine participants participated in the study. HR was measured with the (GF) during rest and three submaximal exercise conditions; cycling, treadmill walking, running and rapid arm movements. The GF had high agreement with the PL during rest (r = 0.997) cycling at 150 W (Rho = 0.889), treadmill running at 8.7 km/h (r = 0.906) and 12.1 km/h (r = 0.845) and rapid arm movements (r = 0.928, r = 0.745) but a low agreement during cycling at 50 W (Rho = 0.269) and 100W (Rho = 0.462) and treadmill walking at 4.8 km/h (r = 0.481). The results varied across exercise conditions and intensities and although the GF provided accurate measurements of HR during rest, cycling at 150W, treadmill running, and rapid arm movement measurement latency may potentially affect application.

A novel tool for measuring ankle dorsiflexion: A study of its reliability in patients following ankle fractures.

BACKGROUND: Assessment of ankle joint movement in a weight bearing position has important clinical implications. The lunge ankle dorsiflexion measurement device (LAD) has been developed with the aim of facilitating ease of and standardisation of the measurement of ankle joint movement. The literature lacks studies evaluating the reliability of weight bearing measurements of the ankle joint in study groups with ankle disabilities. The objective of this study was to examine the intra- and inter-tester reliability of ankle dorsiflexion measured with the novel LAD in patients following a fracture of the ankle. METHOD: This study was a randomized intra- and inter-tester reliability study with blinding of testers and participants. All participants were tested twice by each tester, with the order of testers randomized. The intra- and inter-tester reliability was assessed by the calculation of interclass correlation coefficients (ICC). RESULTS: The study sample consisted of 24 patients: 15 females and nine males post-immobilisation following surgery for ankle fractures. The mean age was 51.0 years, ranging from 22 to 92 years. All patients had sustained an AO classification 44- fracture of the ankle. The mean follow-up time was 9.3 months (16.2 SD) after the time of fracture. The inter-tester reliability was high, with an ICC of 0.984 (95%CI: 0.963-0.993) and SEmeas of 0.14cm. The ICC for Tester A was 0.989 (95%CI: 0.974-0.995) and SEmeas 0.10cm. The ICC for Tester B was 0.990 (95%CI: 0.977-0.996) and SEmeas 0.09cm. CONCLUSION: This study shows a high inter- and intra-tester reliability for measuring ankle dorsiflexion with the LAD following a fracture of the ankle.

Black or white coffee before anaesthesia?: A randomised crossover trial.

BACKGROUND: In current preoperative fasting guidelines, coffee with milk is still regarded by many as solid food. Evidence on the consequences for gastric volume of adding milk to coffee 2 h before anaesthesia is still weak. OBJECTIVES: The aim of this study was to compare the gastric volume by MRI in healthy volunteers after drinking coffee with and without added milk. DESIGN: A randomised crossover trial where all participants were exposed to three coffee and milk mixtures performed as a noninferiority study with a predefined noninferiority limit of 12 ml. SETTING: Department of Day Surgery and Department of Radiology, Aarhus University Hospital, Aarhus, Denmark. The study was conducted between August 2013 and February 2014. PARTICIPANTS: Total 32 healthy volunteers, aged 18 to 71 years. INTERVENTIONS: The participants fasted for 6 h for solid food, and 2 h before the MRI examination of gastric volume, each participant ingested one of three coffee mixtures: 175 ml coffee, including either 0 or 20 or 50% full fat milk. Each participant was studied by MRI three times separated by a minimum time interval of 2 days. The order of coffee mixture ingested was determined by random allocation. MAIN OUTCOME MEASURE: Gastric volume as measured by MRI. RESULTS: The mean gastric volume for black coffee was 27.8 ml, for coffee with 20% milk 17.9 ml and for coffee with 50% milk 20.6 ml. Compared to black coffee, the gastric volume for 20% milk was significantly decreased with a difference of -10.0 ml (95% confidence interval, -18.2, -1.8), and for 50% milk it was insignificantly decreased, -7.2 ml (95% confidence interval, -17.4, +2.9). The upper confidence interval for the difference in gastric volume between the 'no milk added' group and each 'milk added' group did not reach the noninferiority limit of 12 ml. CONCLUSION: The study provides evidence that adding up to 50% full fat milk to coffee leads to no or only a minimal increase of the gastric volume 2 h later. The results support a liberalisation of policy on the addition of milk to hot drinks before planned anaesthesia. TRIAL REGISTRATION: www.Clinicaltrials.gov identifier: NCT02361632.

Detection of electroporation-induced membrane permeabilization states in the brain using diffusion-weighted MRI.

BACKGROUND: Tissue permeabilization by electroporation (EP) is a promising technique to treat certain cancers. Non-invasive methods for verification of induced permeabilization are important, especially in deep-seated cancers. In this study we evaluated diffusion-weighted magnetic resonance imaging (DW-MRI) as a quantitative method for detecting EP-induced membrane permeabilization of brain tissue using a rat brain model. MATERIAL AND METHODS: Fifty-four anesthetized Sprague-Dawley male rats were electroporated in the right hemisphere, using different voltage levels to induce no permeabilization (NP), transient membrane permeabilization (TMP), and permanent membrane permeabilization (PMP), respectively. DW-MRI was acquired 5 minutes, 2 hours, 24 hours and 48 hours after EP. Histology was performed for validation of the permeabilization states. Tissue content of water, Na+, K+, Ca2+, and extracellular volume were determined. The Kruskal-Wallis test was used to compare the DW-MRI parameters, apparent diffusion coefficient (ADC) and kurtosis, at different voltage levels. The two-sample Mann- Whitney test with Holm's Bonferroni correction was used to identify pairs of significantly different groups. The study was approved by the Danish Animal Experiments Inspectorate. RESULTS AND CONCLUSION: Results showed significant difference in the ADC between TMP and PMP at 2 hours (p<0.001) and 24 hours (p<0.05) after EP. Kurtosis was significantly increased both at TMP (p<0.05) and PMP (p<0.001) 5 minutes after EP, compared to NP. Kurtosis was also significantly higher at 24 hours (p<0.05) and 48 hours (p<0.05) at PMP compared to NP. Physiological parameters indicated correlation with the permeabilization states, supporting the DW-MRI findings. We conclude that DW-MRI is capable of detecting EP-induced permeabilization of brain tissue and to some extent of differentiating NP, TMP and PMP using appropriate scan timing.

Preclinical validation of electrochemotherapy as an effective treatment for brain tumors.

Electrochemotherapy represents a strategy to enhance chemotherapeutic drug uptake by delivering electrical pulses which exceed the dielectric strength of the cell membrane, causing transient formation of structures that enhance permeabilization. Here we show that brain tumors in a rat model can be eliminated by electrochemotherapy with a novel electrode device developed for use in the brain. By using this method, the cytotoxicity of bleomycin can be augmented more than 300-fold because of increased permeabilization and more direct passage of drug to the cytosol, enabling highly efficient local tumor treatment. Bleomycin was injected intracranially into male rats inoculated with rat glia-derived tumor cells 2 weeks before the application of the electrical field (32 pulses, 100 V, 0.1 ms, and 1 Hz). In this model, where presence of tumor was confirmed by magnetic resonance imaging (MRI) before treatment, we found that 9 of 13 rats (69%) receiving electrochemotherapy displayed a complete elimination of tumor, in contrast to control rats treated with bleomycin only, pulses only, or untreated where tumor progression occurred in each case. Necrosis induced by electrochemotherapy was restricted to the treated area, which MRI and histology showed to contain a fluid-filled cavity. In a long-range survival study, treatment side effects seemed to be minimal, with normal rat behavior observed after electrochemotherapy. Our findings suggest that electrochemotherapy may offer a safe and effective new tool to treat primary brain tumors and brain metastases.

Diffusion-weighted MRI for verification of electroporation-based treatments.

Clinical electroporation (EP) is a rapidly advancing treatment modality that uses electric pulses to introduce drugs or genes into, e.g., cancer cells. The indication of successful EP is an instant plasma membrane permeabilization in the treated tissue. A noninvasive means of monitoring such a tissue reaction represents a great clinical benefit since, in case of target miss, retreatment can be performed immediately. We propose diffusion-weighted magnetic resonance imaging (DW-MRI) as a method to monitor EP tissue, using the concept of the apparent diffusion coefficient (ADC). We hypothesize that the plasma membrane permeabilization induced by EP changes the ADC, suggesting that DW-MRI constitutes a noninvasive and quick means of EP verification. In this study we performed in vivo EP in rat brains, followed by DW-MRI using a clinical MRI scanner. We found a pulse amplitude-dependent increase in the ADC following EP, indicating that (1) DW-MRI is sensitive to the EP-induced changes and (2) the observed changes in ADC are indeed due to the applied electric field.

Efficiency of cellular delivery of antisense peptide nucleic acid by electroporation depends on charge and electroporation geometry.

Electroporation is potentially a very powerful technique for both in vitro cellular and in vivo drug delivery, particularly relating to oligonucleotides and their analogs for genetic therapy. Using a sensitive and quantitative HeLa cell luciferase RNA interference mRNA splice correction assay with a functional luciferase readout, we demonstrate that parameters such as peptide nucleic acid (PNA) charge and the method of electroporation have dramatic influence on the efficiency of productive delivery. In a suspended cell electroporation system (cuvettes), a positively charged PNA (+8) was most efficiently transferred, whereas charge neutral PNA was more effective in a microtiter plate electrotransfer system for monolayer cells. Surprisingly, a negatively charged (-23) PNA did not show appreciable activity in either system. Findings from the functional assay were corroborated by pulse parameter variations, polymerase chain reaction, and confocal microscopy. In conclusion, we have found that the charge of PNA and electroporation system combination greatly influences the transfer efficiency, thereby illustrating the complexity of the electroporation mechanism.

Methods for gait event detection and analysis in ambulatory systems.

After stroke, hemiparesis is a common problem resulting in very individual needs for walking assistance. Often patients suffer from foot drop, i.e. inability to lift the foot from the ground during the swing phase of walking. Functional electrical stimulation is commonly used to correct foot drop. For all supporting stimulation devices, it is vital to adequately detect the gait events, which is traditionally obtained by a foot switch placed under the heel. To investigate present methods of gait analysis and detection for use in ambulatory rehabilitation systems, we carried out a meta-analysis on research studies. We found various sensors and sensor combinations capable of analyzing gait in ambulatory settings, ranging form simple force based binary switches to complex setups involving multiple inertial sensors and advanced algorithms. However additional effort is needed to minimize donning/doffing efforts, to overcome cosmetical aspects, and to implement those systems into closed loop ambulatory devices.

[Positioning injuries among patients undergoing spine surgery]. / Lejringsskader hos rygopererede patienter.

INTRODUCTION: The aim of this study was to answer the questions: Which kind of positioning injuries occurred in anaesthetized orthopaedic patients undergoing spine surgery who were prone-positioned for more than two hours? What was the incidence of positioning injuries? Which patients were at particular risk of developing positioning-related injuries? MATERIAL AND METHODS: Follow-up study comprising 299 patients. A patient record followed the patient from the day of surgery until discharge. Selected pre-disposing factors related to positioning injuries as well as positioning-related injuries were registered. One year after surgery, localisation, duration and treatment of positioning-related injuries were registered. A total of 299 patients were included. Among these, 60 patients died within the first year, and 52 could not be reached. The remaining 187 patients were interviewed by telephone one year after surgery using a structured guide RESULTS: In all, 33 patients had nerve injuries one year after surgery, among these 18 patients had nerve injuries located to the upper extremities. CONCLUSION: A possible association between the duration of the prone position and positioning injuries emerged, but there was no connection between nerve injuries located to the upper extremities and the predisposing factors. Nerve injuries in arms/hands influence daily living. Future studies are needed to investigate predisposing factors such as high body mass index and body build, and guidelines for positioning are recommended.

Angiotensinogen and ACE gene polymorphisms and risk of atrial fibrillation in the general population.

OBJECTIVES: The renin-angiotensin system may play a role in the pathogenesis of atrial fibrillation, and renin-angiotensin system blockers reduce the risk of atrial fibrillation. We hypothesized that polymorphisms in the angiotensinogen and angiotensin-converting enzyme (ACE) genes encoding proteins in this system predict risk of atrial fibrillation. METHODS AND RESULTS: We genotyped 9235 individuals from the Danish general population, The Copenhagen City Heart Study, for the a-20c, g-6a, T174M, and M235T polymorphisms in the angiotensinogen gene and the insertion/deletion (I/D) polymorphism in the ACE gene; rare allele frequencies were 0.16, 0.40, 0.12, 0.41, and 0.49, respectively. Participants had sinus rhythm at inclusion. During 26 years of follow-up, 968 individuals developed atrial fibrillation. Multifactorially adjusted hazard ratios for atrial fibrillation for a-20c ac and cc versus aa genotype were 1.1(95% confidence interval: 1.0-1.3; P=0.05) and 1.5(1.1-2.1; P=0.01). Compared with double noncarriers (angiotensinogen -20aa and ACE II), double heterozygotes (ac-I/D genotype), and double homozygotes (cc-DD) had hazard ratios for atrial fibrillation of 1.2(0.9-1.6; P=0.06) and 2.4(1.4-4.1; P=0.001). a-20c cc homozygotes above 70 years of age who were overweight, severely hypertensive, and had heart failure, had an absolute 10-year risk of atrial fibrillation of 61%. CONCLUSION: Angiotensinogen a-20c genotype alone and in combination with ACE I/D genotype predicts an increased risk of atrial fibrillation. Therefore, genetic variation in the renin-angiotensin system may influence effect of renin-angiotensin system blockers on atrial fibrillation.

Patients' perceptions of the benefits and problems of using the ActiGait implanted drop-foot stimulator.

OBJECTIVE: To evaluate patients' perceptions of the benefits and problems associated with using the ActiGait implanted drop-foot stimulator. METHOD: Thirteen participants who had suffered a stroke at least 6 months prior to recruitment, had a drop-foot that affected walking and had taken part in a trial in which an ActiGait drop-foot stimulator had been implanted, completed a postal questionnaire. RESULTS: Users agreed that the ActiGait had a positive effect on walking; they used it regularly and had little difficulty with putting it on and taking it off. Reliability was a greater problem at 90 days than at the final assessment. Ten of the 13 responders either agreed or strongly agreed with the statement that the ActiGait improved their quality of life at 90 days and 9 out of 12 at the final assessment: 11 of the 12 respondents would recommend the ActiGait to others. DISCUSSION AND CONCLUSION: From the users' perspective the ActiGait improved walking, it was reported to be used regularly and it appeared to be easier to use than a surface system. Users were equivocal about the reliability of the system at 90 days, but at the final assessment reliability had improved.

Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia.

OBJECTIVE: To evaluate a selective implantable drop foot stimulator (ActiGait) in terms of effect on walking and safety. DESIGN: A phase II trial in which a consecutive sample of participants acted as their own controls. SUBJECTS: People who had suffered a stroke at least 6 months prior to recruitment and had a drop-foot that affected walking were recruited from 3 rehabilitation centres in Denmark. METHODS: Stimulators were implanted into all participants. Outcome measures were range of ankle dorsiflexion with stimulation and maximum walking speed and distance walked in 4 minutes. Measurements were applied before implantation, at 90 days and at a long-term follow-up assessment. Changes over time and with and without stimulation are reported. Safety was evaluated by nerve conduction velocity and adverse events. RESULTS: Fifteen participants were implanted and 13 completed the trial. Long-term improvements were detected in walking speed and distance walked in 4 minutes when stimulated, and the orthotic effect of stimulation showed statistically significant improvement. The device did not compromise nerve conduction velocity and no serious device-related adverse events were reported. Technical problems were resolved by the long-term follow-up assessment at which further improvement in walking was observed. CONCLUSION: This trial has evaluated the safety and performance of the device, which was well accepted by patients and did not compromise safety.