BACKGROUND: Accurate pedicle screw placement is a challenge with reported misplacement rates of 10% and higher. A handheld navigation device (HND) may provide accuracy equal to CT-based navigation (CT-Nav) but without the cost and complexity.
OBJECTIVE: To study the accuracy of a handheld navigation device for pedicle screw placement.
METHODS: This prospective cross-sectional study with consistently applied reference standard enrolled 20 patients undergoing 92 pedicle screw placements.
METHODS: Patients who underwent pedicle screw placement between May 2022 and September 2022.
METHODS: Pedicle screw placement accuracy per Gertzbein-Robbins.
METHODS: Once the screw pilot hole was established, the proposed trajectory of the HND was compared with that proposed by CT-Nav. Postoperatively, screw accuracy was graded according to Gertzbein-Robbins by a blinded radiologist based on CT scans. Accuracy was compared between the two systems and published control for fluoroscopy assisted and CT-Nav placement using Bayesian posterior distribution.
RESULTS: The trajectory proposed by the HND and CT-Nav were in agreement in 98.9% (95% Exact CI; 94.09%-99.97%). The HND accuracy was 98.9% with 91 screws rated \"A\" and 1 rated \"C\". Non-inferiority to fluoroscopic placement was achieved because the one-sided normal-approximation 95% CI Lower Bound (LB) of 95.3% is greater than the Performance Goal (PG) of 83.4%. Post-hoc analysis demonstrated that the probability of superiority of the HND relative to the historical accuracy rate of 91.5% for fluoroscopy assisted procedures is >0.999 and that the HND\'s accuracy rate is within 4.5% of CT-Nav of 95.5% is >0.999. No adverse events or intra-operative complications associated with HND were observed. There was 1 (1.1%) intra-operative repositioning and no re-operations for any reason.
CONCLUSIONS: The accuracy rate of the HND was 98.9%, and the proposed trajectory matched with CT-Nav in 98.9% of the time. This is superior to the historical published accuracy rate for fluoroscopy-assisted procedures and equivalent to the historical published accuracy rate for CT-Nav.
BACKGROUND: Dutch trial register NL74268.058.20.

Internet-based cognitive behavioral therapy (ICBT) is promising in alleviating loneliness in adults. Identifying individuals who benefit from ICBT for loneliness is pivotal to offering this intervention in a more targeted way and improving the intervention for those who do not benefit. This secondary analysis of a randomized controlled trial (RCT) aimed to identify predictors and moderators of outcome of an ICBT with guidance or automated messages for loneliness. In the RCT, 243 participants suffering from loneliness were randomly assigned to an ICBT with guidance (n = 98), automated messages (n = 97), or a waitlist-control condition (n = 48). In total, 180 participants completed the post-assessment (i.e., 10 weeks post-randomization). Outcomes were treatment outcome assessed with the UCLA-9 Loneliness Scale at post-assessment and treatment response, i.e., reliable improvement on the UCLA-9 from pre- to post. The relationship between a wide range of patient characteristics (grouped into socio-demographic, clinical, loneliness-specific, and treatment-related variables) and outcome was analyzed using multiple linear and logistic regressions. Feeling less burdened by loneliness resulted in higher odds of reliable improvement in guided ICBT compared to the waitlist-control condition. No treatment outcome or response moderators were identified for ICBT with automated messages compared to the waitlist-control group. Across active intervention groups, loneliness at baseline, age and fit between the tasks and goals of the intervention and participants\' need predicted treatment outcome. Predictors of treatment response for ICBT with guidance and automated messages were not identified, and no variables differentially predicted the effects of ICBT with guidance or automated messages on the outcomes. In conclusion, individuals less burdened by their feelings of loneliness benefited more from guided ICBT. Lower baseline loneliness scores, younger age, and a better match between tasks and goals of the intervention and participants\' needs also predicted a more favorable treatment outcome for both ICBT with guidance and automated messages.

The crux of building and planning standards for age-friendly built environment in all countries resides in the regulation of age-friendly built environment practices, yet there exist variations in the representation of content dimensions. The UK is distinguished by its discretionary approach to guidance, whereas China exhibits a highly controlled disposition. Control and guidance may appear to be antithetical, it is essential to recognize that the building and planning standards for age-friendly built environment in both countries never deviate from the legal constraints while providing guidance in achieving age-friendly environments, thus striking a delicate balance between control and guidance. The study examines the standard systems of national standards, local standards and organizational standards, as well as the three dimensions of foundation standards, generic standards and specialized standards. The analysis of building and planning standards for age-friendly built environment in the UK and China scrutinizes the disparities between control and guidance, identifying similarities and differences in the building and planning standard system and content dimensions of the two countries. This analysis serves as a valuable reference for the development of building and planning standards for age-friendly built environment in China.

BACKGROUND: Academic procrastination is a widespread problem among college students. It is linked to poor academic performance and increased college dropout intentions, as well as several mental health problems such as depression, anxiety, and stress. Guided web-based interventions can help reduce procrastination. However, guidance by professional clinicians draws upon valuable and limited societal resources, and a more efficient, scalable form of guidance is needed. Guidance by trained clinical psychology students has not yet been examined.
OBJECTIVE: The aim of this open trial is to examine the feasibility and acceptability of a web-based procrastination intervention for college students under the guidance of student digital coaches (e-coaches).
METHODS: We developed a single-arm trial of a guided web-based intervention targeting procrastination for the Dutch student population. Guidance is delivered by trained clinical psychology students asynchronously in the form of textual feedback on intervention progress, with the aim of supporting and motivating the participant. Participants are recruited at 7 Dutch universities. Primary outcomes are intervention satisfaction, usability, and adherence, which are assessed by the Client Satisfaction Scale (CSQ-8), System Usability Scale (SUS-10), and number of completed modules, respectively. The primary outcomes will be examined by calculating descriptive statistics. Secondary outcomes are e-coach satisfaction and changes to procrastination, depression, stress, and quality of life from pre- to posttest and follow-up.
RESULTS: The project was funded in 2019, and recruitment began in January 2021. As of May 2023, a total of 985 participants were enrolled, of which 372 had completed the posttest and 192 had completed the follow-up. The expected date of analysis and publication of the results is 2024.
CONCLUSIONS: The results are expected to contribute to the body of literature regarding eHealth in 3 ways. First, we will examine whether students who procrastinate adhere to and are satisfied with an eHealth intervention targeting this problem. Second, we will explore whether an intervention targeting procrastination can also decrease depression and stress. Lastly, we will investigate whether trained psychology students can effectively guide their peers in web-based interventions. Given the shortage of licensed psychologists, exploring alternative sources of guidance is much needed in order to provide students with the mental health support they need.
UNASSIGNED: DERR1-10.2196/44907.

Infections and deaths from the COVID-19 pandemic have disproportionately affected underserved populations. A community-engaged approach that supports decision making around safe COVID-19 practices is needed to promote equitable access to testing and treatment. You & Me: Test and Treat (YMTT) will evaluate a systematic and scalable community-engaged protocol that provides rapid access to COVID-19 at-home tests, education, guidance on next steps, and information on local resources to facilitate treatment in underserved populations.
This direct-to-participant observational study will distribute at-home, self-administered, COVID-19 testing kits to people in designated communities. YMTT features a Public Health 3.0 framework and Toolkit prescribing a tiered approach to community engagement. We will partner with two large community organizations, Merced County United Way (Merced County, CA) and Pitt County Health Department (Pitt County, NC), who will coordinate up to 20 local partners to distribute 40,000 COVID tests and support enrollment, consenting, and data collection over a 15-month period. Participants will complete baseline questions about their demographics, experience with COVID-19 infection, and satisfaction with the distribution event. Community partners will also complete engagement surveys. In addition, participants will receive guidance on COVID-19 mitigation and health-promoting resources, and accessible and affordable therapeutics if they test positive for COVID-19. Data collection will be completed using a web-based platform that enables creation and management of electronic data capture forms. Implementation measures include evaluating 1) the Toolkit as a method to form community-academic partnerships for COVID-19 test access, 2) testing results, and 3) the efficacy of a YMTT protocol coupled with local resourcing to provide information on testing, guidance, treatment, and links to resources. Findings will be used to inform innovative methods to address community needs in public health research that foster cultural relevance, improve research quality, and promote health equity.
This work will promote access to COVID-19 testing and treatment for underserved populations by leveraging a community-engaged research toolkit. Future dissemination of the toolkit can support effective community-academic partnerships for health interventions in underserved settings.
ClinicalTrials.gov Identifier: NCT05455190 . Registered 13 July 2022.

Guidance on foods to limit or avoid in pregnancy is provided on the NHS website for England. Advice on fish consumption is related to exposure to mercury, dioxins and polychlorinated biphenyls, which may have adverse effects on fetal neurodevelopment. Our aim was to provide evidence on the effectiveness of the guidance in minimising exposure to toxins while maximising nutrient intake in a mixed-methods study. An online questionnaire on fish consumption before/during pregnancy was completed by postpartum women (≤12 months) in England (n = 598). A subsample of participants was invited to take part in an interview (n = 14). Women who ate fish before pregnancy reduced their intakes of both oily and white fish during pregnancy, with some avoiding it altogether. Women did not exceed the limit on tinned tuna, but there was evidence of mis-recall on the suggested limit. Overall intakes of fish were below that recommended during pregnancy (36% compliance for pre-pregnancy consumers). Barriers to fish consumption included risk aversion, confusion over specific details of the guidance, cost, availability, family preferences and smell/taste. Clarity and simplicity of the NHS guidance, with an overall message on the number of portions of fish a week advised prominently shown, would help pregnant women to benefit from the nutrients in fish while minimising exposure to toxins. The guidance on the number of cans of tuna advised per week is poorly recalled and needs to be disseminated accurately. The guidance on shark/marlin/swordfish could receive less prominence as it is rarely eaten by pregnant women in England.

The college years can be accompanied by mental distress. Internet- and mobile-based interventions (IMIs) have the potential to improve mental health but adherence is problematic. Psychological guidance might promote adherence but is resource intensive. In this three-armed randomized controlled trial, \"guidance on demand\" (GoD) and unguided (UG) adherence-promoting versions of the seven-module IMI StudiCare Mindfulness were compared with a waitlist control group and each other. The GoD participants could ask for guidance as needed. A total of 387 students with moderate/low mindfulness were recruited. Follow-up assessments took place after 1 (t1), 2 (t2), and 6 (t3) months. Post-intervention (t2), both versions significantly improved the primary outcome of mindfulness (d = 0.91-1.06, 95% CI 0.66-1.32) and most other mental health outcomes (d = 0.25-0.69, 95% CI 0.00-0.94) compared with WL, with effects generally persisting after 6 months. Exploratory comparisons between UG and GoD were mostly non-significant. Adherence was low but significantly higher in GoD (39%) vs. UG (28%) at the 6-month follow-up. Across versions, 15% of participants experienced negative effects, which were mostly mild. Both versions effectively promoted mental health in college students. Overall, GoD was not associated with substantial gains in effectiveness or adherence compared with UG. Future studies should investigate persuasive design to improve adherence.

UNASSIGNED: Integration is a unique attribute of Mixed Methods Research (MMR). However, some MMR studies, published in the field of physiotherapy and other allied health professions, have illustrated a lack of understanding of the concept of integration.
UNASSIGNED: The purpose of this paper is to provide guidance for integrating elements of mixed methods research in order to effectively support evidence-based practice in health.
UNASSIGNED: The concept of integration of findings is explained with reference to the author\'s recent PhD study, which used a mixed methods exploratory sequential design. This article describes how the author used a narrative joint display to integrate findings from both the qualitative and survey phases of the study. Then, a step-by-step approach is introduced to guide the interpretation and integration of the findings.
UNASSIGNED: This four-step approach demonstrates integration of the two different datasets: Creating a joint display, linking activity, establishing relationships, and interpreting and reporting. Tables and Figures are used to support detailed description and illustration of the integration process.
UNASSIGNED: A joint display provides a visual representation of how the qualitative and quantitative findings in a MMR study can be integrated. In this way, interpretation of the data drawn from this process extend beyond the individual findings of each study component to facilitate a greater understanding of complex health care issues.

BACKGROUND: Evaluate whether the Breast Cancer Locator™ (BCL), a novel guidance system based on supine MRI images, can be safely and effectively deployed by several surgeons at multiple sites.
METHODS: Patients with palpable breast cancer underwent supine MRI at their local institution. A three dimensional (3D) digital image of the tumor in the breast was derived from supine MRI images and used to generate 1) an interactive 3D virtual image of the tumor in the breast (Visualizer) and 2) a plastic bra-like form that allowed the surgeon to place a central wire and bracketing wires in the breast (BCL). The primary objective was to determine the proportion of patients who had the central localization wire deployed within the cancer on specimen mammogram.
RESULTS: Fourteen patients were enrolled at 4 different sites by 6 surgeons. BCLs were successfully manufactured for all patients. The central wire was deployed within the tumor on specimen mammogram in 12 of the 13 patients who had a central wire placed (92%). The cancer was excised with negative margins in 14/14 cases (100%). No adverse events occurred.
CONCLUSIONS: Supine MRI image acquisition was accomplished successfully across multiple sites. Multiple surgeons utilized the BCL system to localize cancers accurately and safely.

Internet-delivered cognitive behavioral therapy (ICBT) for alcohol misuse has potential to radically improve access to evidence-based care, and there is a need to investigate ways to optimize its delivery in clinical settings. Guidance from a clinician has previously been shown to improve drinking outcomes in ICBT, and some studies suggest that pre-treatment assessments may contribute in initiating early change. The objective of this study was to investigate the added and combined effects of a pre-treatment assessment interview and guidance on the outcomes of ICBT for alcohol misuse delivered in an online therapy clinic.
A 2X2 factorial randomized controlled trial was conducted where participants received access to an 8-week ICBT program, and either a pre-treatment assessment interview (Factor 1), guidance (Factor 2), a combination of these, or neither of these. Participants were 270 individuals (66.8% female, mean age = 46.5) scoring 8 or more on the Alcohol Use Disorders Identification Test and consuming 14 standard drinks or more in the preceding week. Primary outcomes were number of drinks consumed and number of heavy drinking days during the preceding week, 3 months post-treatment.
Large within-group effects were found in terms of alcohol reductions (dw ≥ 0.82, p < 0.001), but neither of the factors significantly improved drinking outcomes. Guidance was associated with greater adherence (i.e. completed modules).
Neither a pre-treatment assessment interview nor guidance from a clinician appears to improve drinking outcomes resulting from internet-delivered cognitive behaviour therapy for alcohol misuse when delivered in a routine online therapy clinic.
NCT03984786. Registered 13 June 2019, https://clinicaltrials.gov/ct2/show/NCT03984786.