Effect of low-dose terazosin on arterial stiffness improvement: A pilot study.

Arterial stiffness, a prominent hallmark of ageing arteries, is a predictor of all-cause mortality. Strategies for promoting healthy vascular ageing are encouraged. Here we conducted a pilot study to evaluate the potential effects of low-dose Terazosin on arterial stiffness. We enrolled patients aged over 40 with elevated arterial stiffness, defined as a brachial-ankle pulse wave velocity (baPWV) ≥1400 cm/s, who were administered Terazosin (0.5 and 1.0 mg/day) from December 2020 to June 2023. Treatment responses were assessed every 3 months. Linear regression analysis was used to characterise the improvement. We matched cases who took Terazosin for 1 year with Terazosin-free controls using propensity score matching (PSM). Our findings demonstrate that Terazosin administration significantly affected arterial stiffness. (1) Arterial stiffness significantly improved (at least a 5% reduction in baPWV) in 50.0% of patients at 3 months, 48.6% at 6 months, 59.3% at 9 months, and 54.4% at 12 months, respectively. (2) Those with higher baseline baPWV and hypertension exhibited a significantly reduced risk of non-response. (3) Terazosin was associated with a reduction of baPWV at 1-year follow-up (linear regression: ß = -165.16, p < 0.001). This pilot study offers valuable insights into the potential significance of Terazosin in improving arterial stiffness and paves the way for future randomised clinical trials in combating vascular ageing.

Wastewater Target Pathogens of Public Health Importance for Expanded Sampling, Houston, Texas, USA.

Building on the success of initiatives put forth during the COVID-19 pandemic response, US health officials are expanding wastewater surveillance programs to track other target pathogens and diseases of public health interest. The Houston Health Department in Houston, Texas, USA, conducted a hypothesis-generating study whereby infectious disease subject matter experts suggested potential targets. This study addressed 2 criteria recommended by the National Academies of Sciences, Engineering, and Medicine for selecting wastewater targets. Results can be used as a basis of a questionnaire for a future population-based study to recommend targets of highest priority to include for expanded wastewater sampling.

Improving newborn screening test performance for metachromatic leukodystrophy: Recommendation from a pre-pilot study that identified a late-infantile case for treatment.

Metachromatic leukodystrophy (MLD) is a devastating rare neurodegenerative disease. Typically, loss of motor and cognitive skills precedes early death. The disease is characterised by deficient lysosomal arylsulphatase A (ARSA) activity and an accumulation of undegraded sulphatide due to pathogenic variants in the ARSA gene. Atidarsagene autotemcel (arsa-cel), an ex vivo haematopoietic stem cell gene therapy was approved for use in the UK in 2021 to treat early-onset forms of pre- or early-symptomatic MLD. Optimal outcomes require early diagnosis, but in the absence of family history this is difficult to achieve without newborn screening (NBS). A pre-pilot MLD NBS study was conducted as a feasibility study in Manchester UK using a two-tiered screening test algorithm. Pre-established cutoff values (COV) for the first-tier C16:0 sulphatide (C16:0-S) and the second-tier ARSA tests were evaluated. Before the pre-pilot study, initial test validation using non­neonatal diagnostic bloodspots demonstrated ARSA pseudodeficiency status was associated with normal C16:0-S results for age (n = 43) and hence not expected to cause false positive results in this first-tier test. Instability of ARSA in bloodspot required transfer of NBS bloodspots from ambient temperature to -20°C storage within 7-8 days after heel prick, the earliest possible in this UK pre-pilot study. Eleven of 3687 de-identified NBS samples in the pre-pilot were positive for C16:0-S based on the pre-established COV of ≥170 nmol/l or ≥ 1.8 multiples of median (MoM). All 11 samples were subsequently tested negative determined by the ARSA COV of <20% mean of negative controls. However, two of 20 NBS samples from MLD patients would be missed by this C16:0-S COV. A further suspected false negative case that displayed 4% mean ARSA activity by single ARSA analysis for the initial test validation was confirmed by genotyping of this NBS bloodspot, a severe late infantile MLD phenotype was predicted. This led to urgent assessment of this child by authority approval and timely commencement of arsa-cel gene therapy at 11 months old. Secondary C16:0-S analysis of this NBS bloodspot was 150 nmol/l or 1.67 MoM. This was the lowest result reported thus far, a new COV of 1.65 MoM is recommended for future pilot studies. Furthermore, preliminary data of this study showed C16:1-OH sulphatide is more specific for MLD than C16:0-S. In conclusion, this pre-pilot study adds to the international evidence that recommends newborn screening for MLD, making it possible for patients to benefit fully from treatment through early diagnosis.

A randomized feasibility trial of medium chain triglyceride-supplemented ketogenic diet in people with Parkinson's disease.

BACKGROUND: A ketogenic diet (KD) may benefit people with neurodegenerative disorders marked by mitochondrial depolarization/insufficiency, including Parkinson's disease (PD). OBJECTIVE: Evaluate whether a KD supplemented by medium chain triglyceride (MCT-KD) oil is feasible and acceptable for PD patients. Furthermore, we explored the effects of MCT-KD on blood ketone levels, metabolic parameters, levodopa absorption, mobility, nonmotor symptoms, simple motor and cognitive tests, autonomic function, and resting-state electroencephalography (rsEEG). METHODS: A one-week in-hospital, double-blind, randomized, placebo-controlled diet (MCT-KD vs. standard diet (SD)), followed by an at-home two-week open-label extension. The primary outcome was KD feasibility and acceptability. The secondary outcome was the change in Timed Up & Go (TUG) on day 7 of the diet intervention. Additional exploratory outcomes included the N-Back task, Unified Parkinson's Disease Rating Scale, Non-Motor Symptom Scale, and rsEEG connectivity. RESULTS: A total of 15/16 subjects completed the study. The mean acceptability was 2.3/3, indicating willingness to continue the KD. Day 7 TUG time was not significantly different between the SD and KD groups. The nonmotor symptom severity score was reduced at the week 3 visit and to a greater extent in the KD group. UPDRS, 3-back, and rsEEG measures were not significantly different between groups. Blood ketosis was attained by day 4 in the KD group and to a greater extent at week 3 than in the SD group. The plasma levodopa metabolites DOPAC and dopamine both showed nonsignificant increasing trends over 3 days in the KD vs. SD groups. CONCLUSIONS: An MCT-supplemented KD is feasible and acceptable to PD patients but requires further study to understand its effects on symptoms and disease. TRIAL REGISTRATION: Trial Registration Number NCT04584346, registration dates were Oct 14, 2020 - Sept 13, 2022.

Safety and feasibility pilot study of continuous low-dose maternal supplemental oxygen in fetal single ventricle heart disease.

OBJECTIVE: Fetuses with single ventricle physiology (SVP) exhibit reductions in fetal cerebral oxygenation, with associated delays in fetal brain growth and neurodevelopmental outcomes. Maternal supplemental oxygen (MSO) has been proposed to improve fetal brain growth, but current evidence on dosing, candidacy and outcomes is limited. In this pilot study, we evaluated the safety and feasibility of continuous low-dose MSO in the setting of SVP. METHODS: This single-center, open-label, pilot phase-1 safety and feasibility clinical trial included 25 pregnant individuals with a diagnosis of fetal SVP. Participants self-administered continuous MSO using medical-grade oxygen concentrators for up to 24 h per day from the second half of gestation until delivery. The primary aim was the evaluation of the safety profile and feasibility of MSO. A secondary preliminary analysis was performed to assess the impact of MSO on the fetal circulation using echocardiography and late-gestation cardiovascular magnetic resonance imaging. Early outcomes were assessed, including perinatal growth and preoperative brain injury, and neurodevelopmental outcomes were assessed at 18 months using the Bayley Scales of Infant and Toddler Development 3rd edition, and compared with those of a contemporary fetal SVP cohort (n = 217) that received the normal standard of care (SOC). RESULTS: Among the 25 participants, the median maternal age at conception was 35 years, and fetal SVP diagnoses included 16 with right ventricle dominant, eight with left ventricle dominant and one with indeterminate ventricular morphology. Participants started the trial at approximately 29 + 2 weeks' gestation and self-administered MSO for a median of 16.1 h per day for 63 days, accumulating a median of 1029 h of oxygen intake from enrolment until delivery. The only treatment-associated adverse events were nasal complications that were resolved typically by attaching a humidifier unit to the oxygen concentrator. No premature closure of the ductus arteriosus or unexpected fetal demise was observed. In the secondary analysis, MSO was not associated with any changes in fetal growth, middle cerebral artery pulsatility index, cerebroplacental ratio or head-circumference-to-abdominal-circumference ratio Z-scores over gestation compared with SOC. Although MSO was associated with changes in umbilical artery pulsatility index Z-score over the study period compared with SOC (P = 0.02), this was probably due to initial baseline differences in placental resistance. At late-gestation cardiovascular magnetic resonance imaging, MSO was not associated with an increase in fetal cerebral oxygen delivery. Similarly, no differences were observed in neonatal outcomes, including preoperative brain weight Z-score and brain injury, mortality by 18 months of age and neurodevelopmental outcomes at 18 months of age. CONCLUSIONS: This pilot phase-1 clinical trial indicates that low-dose MSO therapy is safe and well tolerated in pregnancies diagnosed with fetal SVP. However, our protocol was not associated with an increase in fetal cerebral oxygen delivery or improvements in early neurological or neurodevelopmental outcomes. © 2024 International Society of Ultrasound in Obstetrics and Gynecology.

Perioperative randomised controlled trials: to pilot or not to pilot?

The science of pilot trials is evolving, and understanding of their role in medical research is increasing. Perioperative randomised controlled trials often test interventions that are inherently multidisciplinary and complex; therefore, there might be compelling reasons to conduct pilot studies to assess feasibility and inform trial design. As pilot studies themselves require resources, investigators should not squander this opportunity; they should design them so that they properly address the sources of uncertainty regarding the success of the definitive trial.

Personalised perioperative dosing of ivabradine in noncardiac surgery: a single-centre, randomised, placebo-controlled, double-blind feasibility pilot trial.

BACKGROUND: Perioperative myocardial injury after noncardiac surgery is associated with postoperative mortality. Heart rate (HR) is an independent risk factor for perioperative myocardial injury. In this pilot trial we tested the feasibility of a randomised, placebo-controlled trial of personalised HR-targeted perioperative ivabradine. METHODS: This was a single-centre, randomised, placebo-controlled, double-blind, parallel group, feasibility pilot trial conducted at Geneva University Hospitals. We included patients ≥75 yr old or ≥45 yr old with cardiovascular risk factors planned for intermediate- or high-risk surgery. Patients were randomised to receive ivabradine (2.5, 5.0, or 7.5 mg) or placebo according to their HR, twice daily, from the morning of surgery until postoperative day 2. Primary outcomes were appropriate dosage and blinding success rates. RESULTS: Between October 2020 and January 2022, we randomised 78 patients (recruitment rate of 1.3 patients week-1). Some 439 of 444 study drug administrations were adequate (99% appropriate dosage rate). The blinding success rate was 100%. There were 137 (31%) administrations of Pill A (placebo in both groups for HR ≤70 beats min-1). Nine (11.5%) patients had a high-sensitive cardiac troponin T elevation ≥14 ng L-1 between any two measurements. The number of bradycardia episodes was eight in the placebo group and nine in the ivabradine group. CONCLUSIONS: This pilot study demonstrates the feasibility of, and provides guidance for, a future trial testing the efficacy of personalised perioperative ivabradine. Future studies should include patients at higher risk of cardiac complications. CLINICAL TRIAL REGISTRATION: NCT04436016.

Online Compassion Focused Therapy for overeating: Feasibility and acceptability pilot study.

OBJECTIVE: This pilot study aims to investigate the feasibility, acceptability, and potential effectiveness of online Compassion Focused Therapy for overeating (CFT-OE). METHOD: Eighteen Portuguese women seeking treatment for overeating were enrolled in this study, and 15 participants completed the CFT-OE. This was a single-arm study. Participants were assessed at pre- and post-intervention and 3-month follow-up. All participants completed measures assessing binge eating, cognitive restraint, uncontrolled eating, emotional eating, general eating psychopathology, general and body shame, self-criticism, self-compassion, and fears of self-compassion. RESULTS: The treatment attrition rate was 16.7%, which is relatively low compared to other similar online interventions. Participants gave positive feedback on the program and indicated they would recommend it to people with similar difficulties. CFT-OE improved self-compassion and reduced eating psychopathology symptoms, general and body shame, self-criticism, and fears of self-compassion. Clinical significance analysis showed that the majority of participants were classified as in recovery in all measures at post-intervention and 3-month follow-up. DISCUSSION: Preliminary results suggest that the online CFT-OE program is an acceptable and feasible intervention. Results also suggest that CFT-OE is beneficial for the treatment of women with difficulties with overeating. A future randomized controlled trial is necessary to establish the effectiveness of the CFT-OE. PUBLIC SIGNIFICANCE: This study indicates that online CFT-OE is a feasible and adequate intervention for women who struggle with overeating. This therapy showed promising results in reducing eating disorder symptoms, shame, and self-criticism and improving self-compassion. As an online intervention, CFT-OE may be more accessible and offer an alternative to in-person therapy.

Getting a "SMART START" to gestational diabetes mellitus education: a mixed-methods pilot evaluation of a knowledge translation tool in primary care.

BACKGROUND: South Asian people living in Canada face higher rates of gestational diabetes mellitus (GDM) compared to national trends. The objective of this study was to design and pilot test a knowledge translation (KT) tool to support GDM prevention counselling in primary care. METHODS: This study is a mixed-methods pilot evaluation of the "SMART START" KT tool involving 2 family physicians in separate practices and 20 pregnant South Asians in Ontario, Canada. We conducted the quantitative and qualitative components in parallel, developing a joint display to illustrate the converging and diverging elements. RESULTS: Between January and July 2020, 20 South Asian pregnant people were enrolled in this study. A high level of acceptability was received from patients and practitioners for timing, content, format, language, and interest in the interventions delivered. Quantitative findings revealed gaps in patient knowledge and behaviour in the following areas: GDM risk factors, the impact of GDM on the unborn baby, weight gain recommendations, diet, physical activity practices, and tracking of weight gain. From the qualitative component, we found that physicians valued and were keen to engage in GDM prevention counselling. Patients also expressed personal perceptions of healthy active living during pregnancy, experiences, and preferences with gathering and searching for information, and key preventative behaviours. CONCLUSIONS: Building on this knowledge can contribute to the design and implementation of other research opportunities or test new hypotheses as they relate to GDM prevention among South Asian communities.

Retinal integrity in human babesiosis: a pilot study.

BACKGROUND: Prior case reports and animal studies have reported on potential ophthalmologic complications of babesiosis, but this issue has not previously been addressed in a cohort of patients with babesiosis. This cross-sectional descriptive pilot study evaluated the retinas of patients with acute babesiosis to determine if retinal abnormalities are a feature of the disease. METHODS: We screened all patients admitted to Yale New Haven Hospital with laboratory confirmed babesiosis during the summer of 2023 and obtained informed consent. Patients were interviewed and underwent pupil dilation and a retinal examination using an indirect ophthalmoscope. Demographic and clinical information were obtained by questionnaire and through chart review. RESULTS: Ten patients underwent retinal eye exams with results that were generally unremarkable. No study patients showed any signs of retinal inflammation, infection, retinal bleeding, retinal tears, or abnormal vessel formation that could be attributed to infection. CONCLUSION: This small study did not find evidence of retinopathy in patients with babesiosis. Further studies with larger populations, repeated exams, and long term follow up will further elucidate the potential small vessel complications of human babesiosis.

Artificial Intelligence Smartphone Application for Detection of Simulated Skin Changes: An In Vivo Pilot Study.

BACKGROUND: The development of artificial intelligence (AI) is rapidly expanding, showing promise in the dermatological field. Skin checks are a resource-heavy challenge that could potentially benefit from AI-tool assistance, particularly if provided in widely available AI solutions. A novel smartphone application(app)-based AI system, "SCAI," was developed and trained to recognize spots in paired images of skin, pursuing identification of new skin lesions. This pilot study aimed to investigate the feasibility of the SCAI-app to identify simulated skin changes in vivo. MATERIALS AND METHODS: The study was conducted in a controlled setting with healthy volunteers and standardized, simulated skin changes (test spots), consisting of customized 3-mm adhesive spots in three colors (black, brown, and red). Each volunteer had a total of eight test spots adhered to four areas on back and legs. The SCAI-app collected smartphone- and template-guided standardized images before and after test spot application, using its backend AI algorithms to identify changes between the paired images. RESULTS: Twenty-four volunteers were included, amounting to a total of 192 test spots. Overall, the detection algorithms identified test spots with a sensitivity of 92.0% (CI: 88.1-95.9) and a specificity of 95.5% (CI: 95.0-96.0). The SCAI-app's positive predictive value was 38.0% (CI: 31.0-44.9), while the negative predictive value was 99.7% (CI: 99.0-100). CONCLUSION: This pilot study showed that SCAI-app could detect simulated skin changes in a controlled in vivo setting. The app's feasibility in a clinical setting with real-life skin lesions remains to be investigated, where the challenge with false positives in particular needs to be addressed.

Digital music and movement intervention to improve health and wellbeing in older adults in care homes: a pilot mixed methods study.

BACKGROUND: Low physical activity among older adults is related to adverse health outcomes such as depression and loneliness, poor physical function and increased risk of falls. This study was designed to increase physical activity through a digital, group-based, physical activity and music intervention and to examine its effectiveness on social, mental and physical health outcomes. METHODS: Participants were 34 older adults (65 years +) recruited across four care homes in Scotland to a pilot study. Surveys were administered at baseline and post-intervention, comprising measures of fear of falling, depression and anxiety, loneliness, sleep satisfaction and quality of life. A battery of physical function tests and saliva sampling for cortisol and dehydroepiandrosterone hormone analysis were also conducted at each time point. Additionally, process evaluation measures (recruitment, intervention fidelity, attendance, retention rates and safety) were monitored. The intervention comprised 12 weeks of three prescribed digital sessions per week: movement and music (n = 2) and music-only (n = 1), delivered by an activity coordinator in the care home. Post-intervention interviews with staff and participants were conducted to gain qualitative data on the acceptability of the intervention. RESULTS: An average of 88% of prescribed sessions were delivered. Pre- to post-intervention intention-to-treat analysis across all participants revealed significant improvements in anxiety, salivary DHEA, fear of falling and loneliness. There were no significant improvements in health-related quality of life, perceived stress, sleep satisfaction or physical function tests, including handgrip strength. Qualitative analysis highlighted benefits of and barriers to the programme. CONCLUSIONS: The digital movement and music intervention was deemed acceptable and delivered with moderate fidelity, justifying progression to a full-scale trial. Although a proper control group would have yielded more confident causal relationships, preliminary psychosocial and biological effects were evident from this trial. To show significant improvements in physical function, it is likely that a bigger sample size providing sufficient power to detect significant changes, greater adherence, longer intervention and/or higher exercise volume may be necessary. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov, number NCT05601102 on 01/11/2022.

An educative nutritional intervention supporting older hospital patients to eat sufficiently using eHealth: a mixed methods feasibility and pilot study.

BACKGROUND: Insufficient food intake is common in older hospital patients and increases the risk of readmission, mortality, and decline in functional status. To improve food intake in older patients, an eHealth solution (Food'n'Go) enabling them to participate in their own nutritional care was implemented in a hospital unit. We developed an educative nutritional intervention (ENI) to support hospitalized older adults (aged ≥ 65 years) to participate in their own nutritional care using Food'n'Go. In this study, we evaluate the feasibility of the ENI and its potential to improve nutritional intake. METHODS: Feasibility was evaluated using process evaluation, and nutritional intake was examined by using a pre- and post-test design. Assessment of feasibility: Contextual factors (availability of Food'n'Go and prevalence of counseling by a dietitian); Intervention fidelity (whether patients were informed of nutrition and Food'n'Go, and whether their needs for support were assessed); and Mechanism of impact (patients' knowledge and skills related to nutrition and the use of Food'n'Go and their acceptance of the ENI). Assessment of nutritional intake: Patients' intake of protein and energy based on one-day observations before implementation of the ENI (pre-test; n = 65) and after a three-month intervention (post-test; n = 65). RESULTS: Feasibility: Food'n'Go was available for more patients after the intervention (85 vs. 64%, p = .004). Most patients managed the use of Food'n'Go and were involved in ordering their food, but only a few monitored their food intake. Information on nutrition was not provided sufficiently to all patients. In general, the ENI had high acceptability among the patients. Nutritional intake: Compared to patients in the pre-test, patients in the post-test had a higher daily mean intake of energy (kJ) (6712 (SD: 2964) vs. 5660 (SD: 2432); difference 1052 (95% CI 111-1993)), and of protein (g) (60 (SD: 28) vs. 43 (SD: 19); difference 17 (95% CI 9-26)). Likewise, there was an increase in the mean attainment of protein requirements: 73% (SD: 34) vs. 59% (SD: 29) (p = .013). CONCLUSION: The ENI is feasible for supporting hospitalized older adults to participate in their own nutrition using eHealth and preliminary results indicate that it may lead to an increasing energy and protein intake.

A comparison of surgical scar treatment using various combinations of autologous fat, hyaluronic acid and resurfacing with the 1540 nm non-ablative Erbium laser - a prospective pilot study.

Scars can cause aesthetic or functional disturbance. Several interventions had been described to improve their appearance. We propose that the combination of some of those treatments can synergize their effects on the scar. We designed a prospective pilot study with ten patients using the patient as their own control to compare different interventions. In each patient, the scar was divided into four parts treated differently: 1. No treatment (control), 2. Fat grafting only, 3. Fat grafting and Hyaluronic Acid (HA), 4. Fat grafting, HA and with a non-fractional laser. Each part of the scar was evaluated by the Patient and Observer Scar Assessment Scale (POSAS). Treatment of the scar with the combination of the three modalities showed better results in the observer scale. In addition, a combination of fat injection, HA, and subsequent skin resurfacing with non-ablative laser showed better outcomes for all parameters on the Observer Scale except vascularity, while on the Patient Scale thickness, relief, pliability, surface area, and overall measurement were better. The combination of all three treatments tends to improve scarring results and appears to be safe and effective. However, further studies with larger samples are needed to explore the potential use of this combined treatment.

"Being an informal caregiver - strengthening resources": mixed methods evaluation of a psychoeducational intervention supporting informal caregivers in palliative care.

BACKGROUND: Informal caregivers are key support for patients with progressive incurable diseases. However, their own needs often remain unmet. Therefore, we developed, manualised and implemented the intervention "Being an informal caregiver - strengthening resources" aiming to support and empower informal caregivers by addressing relevant information-related, physical, psychological and social needs. METHODS: In this pilot study, we evaluated the acceptance and experiences with this psychoeducational intervention. The study was conducted over two years (2019-2021). Informal caregivers were recruited from the University Medical Centre Hamburg-Eppendorf and the metropolitan region of Hamburg, Germany. The intervention was aimed at adult persons who identified themselves as an informal caregiver to an adult patient with a progressive incurable cancer and non-cancer disease. For the evaluation we used a mixed methods approach, combining a longitudinal questionnaire survey (pre-intervention, after each module, 3-months follow-up) and semi-structured interviews post-intervention. Quantitative data were analysed using descriptive statistics and a paired t-Test, interviews were analysed based on the qualitative content analysis according to Mayring. Results were triangulated using a convergent triangulation design. RESULTS: Of 31 informal caregivers who received the intervention, 25 returned the follow-up questionnaire and 20 informal caregivers were interviewed. Triangulated results showed a high satisfaction with the implementation of the intervention. Of a broad range of subjective benefits, gaining knowledge, self-awareness and self-efficacy were most apparent. Informal caregivers reported improved preparedness, awareness of own needs as well as confidence regarding handling own emotions and interacting with the ill person. However, implementing the learned skills into daily life can be challenging due to internal and external factors. Motivations and challenges for participating as well as potential for improvement were identified. CONCLUSIONS: This pilot study showed an overall positive evaluation and several subjective benefits of the psychoeducational intervention "Being an informal caregiver - strengthening resources". Further research is needed to measure the efficacy of this intervention on informal caregivers' outcomes. Therefore, a multicentre randomized prospective study is planned.

Assessing the Response Results of an mHealth-Based Patient Experience Survey Among People Receiving HIV Care in Lusaka, Zambia: Cohort Study.

BACKGROUND: This pilot study evaluates the effectiveness of mobile talk-time incentives in maintaining participation in a longitudinal mobile health (mHealth) data collection program among people living with HIV in Lusaka, Zambia. While mHealth tools, such as mobile phone surveys, provide vital health feedback, optimal incentive strategies to ensure long-term engagement remain limited. This study explores how different incentive levels affect response rates in multiple survey rounds, providing insights into effective methods for encouraging ongoing participation, especially in the context of Zambia's prepaid mobile system and multi-SIM usage, a common practice in sub-Saharan Africa. OBJECTIVE: This study aimed to assess the response rate success across multiple invitations to participate in a care experience survey using a mobile phone short codes and unstructured supplementary service data (USSD) model among individuals in an HIV care setting in the Lusaka, Zambia. METHODS: Participants were recruited from 2 study clinics-1 in a periurban setting and 1 in an urban setting. A total of 2 rounds of survey invitations were sent to study participants on a 3-month interval between November 1, 2018, and September 23, 2019. Overall, 3 incentive levels were randomly assigned by participant and survey round: (1) no incentive, (2) 2 Zambian Kwacha (ZMW; US $0.16), and (3) 5 ZMW (US $0.42). Survey response rates were analyzed using mixed-effects Poisson regression, adjusting for individual- and facility-level factors. Probability plots for survey completion were generated based on language, incentive level, and survey round. We projected the cost per additional response for different incentive levels. RESULTS: A total of 1006 participants were enrolled, with 72.3% (727/1006) from the urban HIV care facility and 62.4% (628/1006) requesting the survey in English. We sent a total of 1992 survey invitations for both rounds. Overall, survey completion across both surveys was 32.1% (637/1992), with significantly different survey completion between the first (40.5%, 95% CI 37.4-43.6%) and second (23.7%, 95% CI 21.1-26.4) invitations. Implementing a 5 ZMW (US $0.42) incentive significantly increased the adjusted prevalence ratio (aPR) for survey completion compared with those that received no incentive (aPR 1.35, 95% CI 1.11-1.63). The cost per additional response was highest at 5 ZMW, equivalent to US $0.42 (72.8 ZMW [US $5.82] per 1% increase in response). CONCLUSIONS: We observed a sharp decline of almost 50% in survey completion success from the initial invitation to follow-up survey administered 3 months later. This substantial decrease suggests that longitudinal data collection potential for a care experience survey may be limited without additional sensitization and, potentially, added survey reminders. Implementing a moderate incentive increased response rates to our health care experience survey. Tailoring survey strategies to accommodate language preferences and providing moderate incentives can optimize response rates in Zambia. TRIAL REGISTRATION: Pan African Clinical Trial Registry PACTR202101847907585; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=14613.

Mandibular overdenture with a single implant in the canine region (c-SIMO): a feasibility study.

OBJECTIVES: The aim of this multi-center pilot study was to assess the viability and feasibility of a novel treatment concept - the canine-positioned single implant mandibular overdenture (c-SIMO), with the single implant placed on the patient's preferred chewing side instead of the midline. MATERIALS AND METHODS: Participants received a single implant in the canine region of their preferred chewing side, based on an Asymmetry Index observed during mastication. The pre-existing mandibular denture was transformed into a c-SIMO on a spherical attachment. The primary outcome was oral health-related quality of life (OHRQoL), measured with GOHAI and OHIP-EDENT. Secondary outcomes included denture satisfaction index (DSI), chewing efficiency (CE), maximum bite force (MBF), implant survival and success, and prosthetic maintenance. Data analysis included descriptive statistics and bivariate comparison tests. RESULTS: Fifteen participants received the c-SIMO treatment (mean age: 69.9 ± 7.0). Implant success and survival rates were 100% at 1 year. Patient-reported outcome measures improved significantly compared to pre-treatment values (OHIP-EDENT: p = 0.001; DSI: p = 0.001; GOHAI: p = 0.002). Masticatory outcomes also improved significantly (CE: p = 0.001; overall MBF: p = 0.005). Post-implant, MBF was significantly higher in the ipsilateral side compared to the contralateral side at 2 weeks (p = 0.019) and 3 months (p = 0.015), but no longer at T3 (p = 0.730). Common prosthodontic events included denture base adjustments (n = 17) and matrix activation (n = 9). CONCLUSIONS: This pilot study concludes that c-SIMO is a promising treatment option, and a potential alternative to the single midline implant overdenture. CLINICAL RELEVANCE: The novel treatment concept of a canine-positioned single implant mandibular overdenture could be a viable treatment alternative to the midline positioning.

Examining gaze behavior in undergraduate students and educators during the evaluation of tooth preparation: an eye-tracking study.

BACKGROUND: Gaze behavior can serve as an objective tool in undergraduate pre-clinical dental education, helping to identify key areas of interest and common pitfalls in the routine evaluation of tooth preparations. Therefore, this study aimed to investigate the gaze behavior of undergraduate dental students and dental educators while evaluating a single crown tooth preparation. METHODS: Thirty-five participants volunteered to participate in the study and were divided into a novice group (dental students, n = 18) and an expert group (dental educators, n = 17). Each participant wore a binocular eye-tracking device, and the total duration of fixation was evaluated as a metric to study the gaze behavior. Sixty photographs of twenty different tooth preparations in three different views (buccal, lingual, and occlusal) were prepared and displayed during the experimental session. The participants were asked to rate the tooth preparations on a 100 mm visual analog rating scale and were also asked to determine whether each tooth preparation was ready to make an impression. Each view was divided into different areas of interest. Statistical analysis was performed with a three-way analysis of the variance model with repeated measures. RESULTS: Based on the participants' mean rates, the "best" and the "worst" tooth preparations were selected for analysis. The results showed a significantly longer time to decision in the novices compared to the experts (P = 0.003) and a significantly longer time to decision for both the groups in the best tooth preparation compared to the worst tooth preparation (P = 0.002). Statistical analysis also showed a significantly longer total duration of fixations in the margin compared to all other conditions for both the buccal (P < 0.012) and lingual (P < 0.001) views. CONCLUSIONS: The current study showed distinct differences in gaze behavior between the novices and the experts during the evaluation of single crown tooth preparation. Understanding differences in gaze behavior between undergraduate dental students and dental educators could help improve tooth preparation skills and provide constructive customized feedback.

A concentrated approach for treating OCD: a pilot study examining the feasibility and potential effectiveness of the Bergen Four Day Treatment in the U.S.

The Bergen Four Day Treatment (B4DT) is a concentrated treatment for OCD that has demonstrated promising effectiveness in Nordic country samples. The B4DT is delivered over four days and provides individual treatment in a group context. The effectiveness of the B4DT for OCD has not been tested outside Nordic countries. The current pilot study evaluated the feasibility and the potential effectiveness of B4DT in a different culture and health-care system in the United States. Findings from 48 adults with OCD who completed the B4DT indicated that OCD, anxiety, and depression symptom severity significantly decreased from pre- to post-treatment, and gains were maintained at six month follow-up. The Yale-Brown Obsessive Compulsive Scale scores were reduced from moderate to subclinical; specifically, the average scores of 27.0 (pre-treatment) fell to 11.7 (post-treatment), 12.7 (3-month follow-up), and 13.7 (6-month follow-up). The B4DT was rated as highly acceptable by the US patients. Over 95% of the patients stated that they would recommend the treatment to a friend. These findings provide the first preliminary evidence for the generalizability of the B4DT to patients outside Nordic countries. Cultural and context-dependent issues that affected this dissemination pilot study are discussed in addition to future clinical and research directions.

Effectiveness of a kinesio-taping-based treatment in stage IV sacral pressure ulcers in older patients: a pilot study.

OBJECTIVE: As reduced tissue vascularity is one of the mechanisms that prevent skin ulcers from healing, treatments that can improve local circulation could accelerate their clinical resolution. Given that kinesio-taping (KT) can improve tissue blood circulation and lymphatic drainage, we aimed to determine whether applying KT close to stage IV pressure ulcers (PUs) could improve their healing. METHOD: Older patients with stage IV sacral PUs, and impaired mobility and functional dependency who were consecutively admitted in a six-month period to the Home Care service of Galliera Hospital (Genoa, Italy) were screened for participation in this pilot clinical trial. Patients' PUs were divided into two treatment areas-in the experimental intervention, KT was applied close to a portion of the PU, while the contralateral portion of the same lesion was treated according to the standard protocol ('control'). The surface reduction of both portions was measured every four days, for a total of five examinations (timepoints (T2-T6) after the baseline evaluation (T1). RESULTS: A total of 12 patients (male=5, female=7; mean age 78.83±8.94 years) fulfilled the inclusion criteria and were enrolled in the study. At all timepoints (T2-T6), the mean percentage reduction was significantly greater in KT-treated areas than in control areas: T2=20.66% versus 6.17%, respectively; p<0.001; T3=37.33% versus 17.31%, respectively; p<0.001; T4=57.01% versus 30.06%, respectively; p<0.001; T5=69.04% versus 40.55%, respectively; p<0.001; and T6=80.34% versus 51.91%, respectively; p<0.001. Furthermore, from T3 onwards, a significantly higher number of KT-treated areas than control areas had halved in size, the maximum difference being recorded at T5 (10 versus two, respectively; p=0.002). CONCLUSION: From the findings of this pilot study, KT would seem to be an effective, rapid, low-cost therapy for advanced sacral PUs in older patients with impaired mobility and functional dependency. Declaration of interest: The authors have no conflicts of interest to declare.