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Nutrients Jan 2024Pressure injuries (PIs) represent a significant healthcare challenge in Singapore among the aging population. These injuries contribute to increased morbidity,...
The Clinical and Cost-Effectiveness of an Individualized Nutritional CAre (INCA) Bundle versus Standard Care for Adults with Pressure Injuries Receiving Home Nursing Services: A Protocol for a Cluster Randomized and Pragmatic Clinical Trial with an Economic Evaluation.
BACKGROUND
Pressure injuries (PIs) represent a significant healthcare challenge in Singapore among the aging population. These injuries contribute to increased morbidity, mortality, and healthcare expenditure. Existing research predominantly explores single-component interventions in hospital environments, often yielding limited success. The INCA Trial aims to address this research gap by conducting a comprehensive, cluster randomized controlled trial that integrates education, individualized nutritional support, and community nursing care. This study is designed to evaluate clinical and cost-effectiveness outcomes, focusing on PI wound area reduction and incremental costs associated with the intervention.
METHODS
The INCA Trial employs a two-group, non-blinded, cluster randomized, and pragmatic clinical trial design, recruiting 380 adult individuals (age ≥ 21 years) living in the community with stage II, III, IV, and unstageable PI(s) who are receiving home nursing service in Singapore. Cluster randomization is stratified by postal codes to minimize treatment contamination. The intervention arm will receive an individualized nutrition and nursing care bundle (dietary education with nutritional supplementation), while the control arm will receive standard care. The 90-day intervention will be followed by outcome assessments extending over one year. Primary outcomes include changes in PI wound area and the proportion of participants achieving a ≥40% area reduction. Secondary outcomes include health-related quality of life (HRQOL), nutritional status, and hospitalization rates. Data analysis will be conducted on an intention-to-treat (ITT) basis, supplemented by interim analyses for efficacy and futility and pre-specified sensitivity and subgroup analyses. The primary outcome for the cost-effectiveness analysis will be based on the change to total costs compared to the change to health benefits, as measured by quality-adjusted life years (QALYs).
DISCUSSION
The INCA Trial serves as a pioneering effort in its approach to PI management in community settings. This study uniquely emphasizes both clinical and economic outcomes and melds education, intensive dietetic support, and community nursing care for a holistic approach to enhancing PI management.
Topics: Adult; Humans; Aged; Young Adult; Cost-Benefit Analysis; Cost-Effectiveness Analysis; Patient Care Bundles; Pressure Ulcer; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 38257192
DOI: 10.3390/nu16020299 -
Obesity Surgery Mar 2024Metabolic and bariatric surgery (MBS) is the preferred method to achieve significant weight loss in patients with Obesity Class V (BMI > 60 kg/m). However, there is...
BACKGROUND
Metabolic and bariatric surgery (MBS) is the preferred method to achieve significant weight loss in patients with Obesity Class V (BMI > 60 kg/m). However, there is no consensus regarding the best procedure(s) for this population. Additionally, these patients will likely have a higher risk of complications and mortality. The aim of this study was to achieve a consensus among a global panel of expert bariatric surgeons using a modified Delphi methodology.
METHODS
A total of 36 recognized opinion-makers and highly experienced metabolic and bariatric surgeons participated in the present Delphi consensus. 81 statements on preoperative management, selection of the procedure, perioperative management, weight loss parameters, follow-up, and metabolic outcomes were voted on in two rounds. A consensus was considered reached when an agreement of ≥ 70% of experts' votes was achieved.
RESULTS
A total of 54 out of 81 statements reached consensus. Remarkably, more than 90% of the experts agreed that patients should be notified of the greater risk of complications, the possibility of modifications to the surgical procedure, and the early start of chemical thromboprophylaxis. Regarding the choice of the procedure, SADI-S, RYGB, and OAGB were the top 3 preferred operations. However, no consensus was reached on the limb length in these operations.
CONCLUSION
This study represents the first attempt to reach consensus on the choice of procedures as well as perioperative management in patients with obesity class V. Although overall consensus was reached in different areas, more research is needed to better serve this high-risk population.
Topics: Humans; Obesity, Morbid; Delphi Technique; Anticoagulants; Body Mass Index; Venous Thromboembolism; Obesity; Bariatric Surgery; Weight Loss
PubMed: 38238640
DOI: 10.1007/s11695-023-06990-9 -
Australian Health Review : a... Feb 2024Objective Fostering a research culture and enhancing research capacity within the workforce is essential for any health service aiming to provide evidence-based care....
Objective Fostering a research culture and enhancing research capacity within the workforce is essential for any health service aiming to provide evidence-based care. This study aims to explore the research culture and capacity in a community health service setting and provide a comparison to previous published research in other health service settings. Methods Participants were invited to complete a survey consisting of demographics and the Research Capacity and Culture (RCC) tool. Median and interquartile ranges were calculated for each RCC item and compared to three Australian and one international comparison. Results A total of 73 staff members from Metro North Community and Oral Health service participated. The team-level scores for the RCC were overall the lowest. Comparison to previously published research using the RCC indicated marginally higher scores for individual-level items in our study across all domains. Individual-level items were very weak to weakly correlated with the team and organisation-level RCC items. Strong to very strong correlations were found between a majority of the team and organisation-level items. Conclusions Team-level scores were substantially lower when compared to individual and organisational levels. The item 'team leaders that support research' was positively correlated with various organisation-level items, indicating that if the respondent perceived the team leader as a low supporter of research the respondent perceived several organisation items also poorly. As an important stakeholder in enabling research in a health service, organisations should investigate the challenges experienced by team leaders in facilitating research and the support or training they may need.
Topics: Humans; Australia; Carcinoma, Renal Cell; Health Services Research; Health Services; Kidney Neoplasms
PubMed: 38219279
DOI: 10.1071/AH23241 -
Environmental Science and Pollution... Feb 2024The goal of "carbon peak and carbon neutrality" is the key to coping with global warming and achieving high-quality development. Producer services and manufacturing...
The goal of "carbon peak and carbon neutrality" is the key to coping with global warming and achieving high-quality development. Producer services and manufacturing co-agglomeration (Coagglo) is an important path to achieve low-carbon development. Therefore, the relationship between industrial co-agglomeration and carbon emission efficiency (CEE) needs to be discussed. Based on the panel data of 114 cities along the eastern coast of China from 2006 to 2021, this study uses a panel quantile regression model and dynamic spatial Durbin model to evaluate the impact and spatial effect of Coagglo on CEE. The results show that there is a nonlinear relationship between Coagglo and CEE. When it exceeds the 50th quantile, the degree of influence decreases slightly, but it still shows a significant positive correlation. When considering industry heterogeneity, we find that the co-agglomeration of warehousing and postal industry (TRA) and manufacturing has the most significant impact on CEE, while the co-agglomeration of leasing and commercial service industry (LEA) and manufacturing has the least impact on CEE. Regional heterogeneity shows that the Coagglo has a greater impact on carbon emission efficiency in the northern region than in the southern region. In addition, Coagglo promotes the spillover of knowledge and technology and has a positive spatial spillover effect on CEE. This conclusion provides a theoretical reference for carbon emission reduction in eastern coastal areas of China.
Topics: Industry; Commerce; China; Carbon; Cities; Economic Development; Efficiency
PubMed: 38200197
DOI: 10.1007/s11356-023-31626-x -
Musculoskeletal Science & Practice Feb 2024The OPTimisE intervention was developed to address uncertainty regarding the most effective physiotherapy treatment strategy for people with Lateral Elbow Tendinopathy... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The OPTimisE intervention was developed to address uncertainty regarding the most effective physiotherapy treatment strategy for people with Lateral Elbow Tendinopathy (LET).
OBJECTIVES
To assess the feasibility of conducting a fully-powered randomised controlled trial (RCT) evaluating whether the OPTimisE intervention is superior to usual physiotherapy treatment for adults with LET.
DESIGN
A mixed-methods multi-centred, parallel pilot and feasibility RCT, conducted in three outpatient physiotherapy departments in the UK.
METHOD
Patients were independently randomised 1:1 in mixed blocks, stratified by site, to the OPTimisE intervention or usual care. Outcomes were assessed using pre-defined feasibility progression criteria.
RESULTS
50 patients were randomised (22 Female, 28 Male), mean age 48 years (range 27-75). Consent rate was 71% (50/70), fidelity to intervention 89% (16/18), attendance rate in the OPTimisE group 82% (55/67) vs 85% (56/66) in usual care, outcome measure completion 81% (39/48) at six-month follow-up. There were no related adverse events. Patients and physiotherapists reported that the OPTimisE intervention was acceptable but suggested improvements to the trial design. 49 patients were recruited from physiotherapy referrals vs one from primary care records. Outcome measure return rates were higher when completed online (74%) compared to postal questionnaire (50%). Exploratory analysis showed improvements in both groups over time.
CONCLUSIONS
It is methodologically feasible to conduct a fully powered RCT comparing the clinical and cost-effectiveness of the OPTimisE intervention versus usual physiotherapy treatment. Considering the similar improvements observed in both groups, careful consideration is needed regarding the priority research question to be addressed in future research.
Topics: Adult; Aged; Female; Humans; Male; Middle Aged; Elbow Tendinopathy; Feasibility Studies; Musculoskeletal Diseases; Physical Therapy Modalities; Surveys and Questionnaires; Tendinopathy; Treatment Outcome; Pilot Projects
PubMed: 38194841
DOI: 10.1016/j.msksp.2023.102905 -
Tobacco Control Jan 2024This project assesses how online vape shops (OVSs) verify buyer identification (ID) and the shipping methods used to send products within the USA.
OBJECTIVE
This project assesses how online vape shops (OVSs) verify buyer identification (ID) and the shipping methods used to send products within the USA.
METHODOLOGY
In January 2023, we conducted three online searches (eg, 'best online vape shops') from our office in Washington, District of Columbia, to identify popular OVSs. Two trained coders identified discrete features available within the site sections: 'About Us', 'Shipping Policy' and 'Frequently Asked Questions', or displayed within the site's homepage. Coders recorded OVS listed locations, shipping discounts, shipping companies used and ID verification methods. Lastly, coders indicated if the site requested ID/age verification after adding an item to the shopping cart and initiating checkout procedures.
RESULTS
We identified 64 unique OVSs; 92.2% (n=59) offered shipping and 82.8% (n=53) shipped to US buyers; 76.6% (n=49) allowed visitors to type a birthday or choose the '21 or older' option to access the site. Of the 59 sites shipping to buyers, 76.3% (n=45) offered free shipping, 21.9% (n=14) required login to purchase products, while most sites (n=45, 76.3%) allowed visitors to reach the checkout page without ID verification. The US Postal Service is the most commonly used shipping carrier (n=23), in violation of the Preventing All Cigarette Trafficking Act.
CONCLUSIONS
Most OVSs rely on age self-certification, which underage youth can easily exploit to access these products. Findings warrant that the Food and Drug Administration, state and local policymakers explore additional actions regulating online tobacco sales to address the compliance issues our data elucidate. These include enhanced surveillance, compliance checks and stricter penalties.
PubMed: 38191237
DOI: 10.1136/tc-2023-058303 -
Translational Behavioral Medicine Jun 2024Scalable models for result disclosure are needed to ensure large-scale access to genomics services. Research evaluating alternatives to genetic counseling suggests...
Scalable models for result disclosure are needed to ensure large-scale access to genomics services. Research evaluating alternatives to genetic counseling suggests effectiveness; however, it is unknown whether these findings are generalizable across populations. We assessed whether a letter is non-inferior to telephone genetic counseling to inform participants with no personal or family history of cancer of their normal results. Data were collected via self-report surveys before and after result disclosure (at 1 and 6 months) in a study sample enriched for individuals from underserved populations. Primary outcomes were subjective understanding of results (global and aggregated) and test-related feelings, ascertained via three subscales (uncertainty, negative emotions, and positive feelings) of the Feelings About genomiC Testing Results (FACToR) measure. Secondary outcomes related to satisfaction with communication. Non-inferiority tests compared outcomes among disclosure methods. Communication by letter was inferior in terms of global subjective understanding of results (at 1 month) and non-inferior to telephoned results (at 6 months). Letter was non-inferior to telephone for aggregated understanding (at 6 months). Letter was superior (at 1 month) to telephone on the uncertainty FACToR subscale. Letter was non-inferior to telephone on the positive-feelings FACToR subscale (at 6 months). Letter was non-inferior to telephone for satisfaction with mode of result delivery and genetic test results. Communication via letter was inferior to telephone in communicating the "right amount of information." The use of written communication to relay normal results to low-risk individuals is a promising strategy that may improve the efficiency of care delivery.
Topics: Humans; Female; Genetic Testing; Male; Telephone; Middle Aged; Genetic Counseling; Neoplasms; Adult; Vulnerable Populations; Disclosure; Postal Service; Aged
PubMed: 38190737
DOI: 10.1093/tbm/ibad084 -
JMIR Formative Research Jan 2024Randomized controlled trials (RCTs) with no in-person contact (ie, remote) between researchers and participants offer savings in terms of cost and time but present...
Methodological Insights on Recruitment and Retention From a Remote Randomized Controlled Trial Examining the Effectiveness of an Alcohol Reduction App: Descriptive Analysis Study.
BACKGROUND
Randomized controlled trials (RCTs) with no in-person contact (ie, remote) between researchers and participants offer savings in terms of cost and time but present unique challenges.
OBJECTIVE
The goal of this study is to examine the differences between different forms of remote recruitment (eg, National Health Service [NHS] website, social media, and radio advertising) in the proportion of participants recruited, demographic diversity, follow-up rates, and cost. We also examine the cost per participant of sequential methods of follow-up (emails, phone calls, postal surveys, and postcards). Finally, our experience with broader issues around study advertising and participant deception is discussed.
METHODS
We conducted a descriptive analysis of 5602 increasing-and-higher-risk drinkers (Alcohol Use Disorders Identification Test score ≥8), taking part in a 2-arm, parallel group, remote RCT with a 1:1 allocation, comparing the intervention (Drink Less app) with usual digital care (NHS alcohol advice web page). Participants were recruited between July 2020 and March 2022 and compensated with gift vouchers of up to £36 (a currency exchange rate of £1=US $1.26988 is applicable) for completing follow-up surveys, with 4 stages of follow-up: email reminders, phone calls, postal survey, and postcard.
RESULTS
The three main recruitment methods were advertisements on (1) social media (2483/5602, 44.32%), (2) the NHS website (1961/5602, 35.01%), and (3) radio and newspapers (745/5602, 13.3%), with the remaining methods of recruitment accounting 7.37% (413/5602) of the sample. The overall recruitment cost per participant varied from £0 to £11.01. Costs were greater when recruiting participants who were men (£0-£28.85), from an ethnic minority group (£0-£303.81), and more disadvantaged (£0-£49.12). Targeted approaches were useful for recruiting more men but less useful in achieving diversity in ethnicity and socioeconomic status. Follow-up at 6 months was 79.58% (4458/5602). Of those who responded, 92.4% (4119/4458) responded by email. Each additional stage of follow-up resulted in an additional 2-3 percentage points of the overall sample being followed up, although phone calls, postal surveys, and postcards were more resource intensive than email reminders.
CONCLUSIONS
For remote RCTs, researchers could benefit from using a range of recruitment methods and cost-targeted approaches to achieve demographic diversity. Automated emails with substantial financial incentives for prompt completion can achieve good follow-up rates, and sequential, offline follow-up options, such as phone calls and postal surveys, can further increase follow-up rates but are comparatively expensive. We also make broader recommendations focused on striking the right balance when designing remote RCTs. Careful planning, ongoing maintenance, and dynamic decision-making are required throughout a trial to balance the competing demands of participation among those eligible, deceptive participation among those who are not eligible, and ensuring no postrandomization bias is introduced by data-checking protocols.
PubMed: 38180802
DOI: 10.2196/51839 -
Journal of the American Board of Family... Jan 2024Academic detailing, patient-panel management, and mailed, stool-based testing have each been utilized to increase colorectal cancer (CRC) screening in rural clinics. The...
INTRODUCTION
Academic detailing, patient-panel management, and mailed, stool-based testing have each been utilized to increase colorectal cancer (CRC) screening in rural clinics. The effectiveness of combining these interventions to increase CRC screening during COVID-19 restrictions was unclear.
METHODS
We explored the effects of a multi-component intervention including academic detailing, active patient panel management, and mailed MT-sDNA testing on colorectal cancer screening in our rural family medicine clinic. Baseline interventions included EMR-based provider alerts and mailed patient reminders. Our intervention (March-May 2020) and follow-up periods (June-August 2020) coincided with the initial COVID-19 surge, giving us the opportunity to observe the effects of our intervention during COVID-19 restrictions.
RESULTS
A total of 407 patients were eligible and overdue for colorectal cancer screening. Our clinic's CRC screening rate increased significantly after intervention (69.7%) as compared with before (64.3%) ( = <0.01; 95%CI = 5.39-5.4). Our clinic's CRC screening rates increased significantly during the initial 3 months of the COVID-19 surge (67.8%) compared with the same period the prior year. (62.3%) ( = .003; 95%CI = 3.4-7.6). Our CRC screening rates increased after intervention (69.7%) compared with our regional health system (67%) ( = <0.01; 95%CI = 2.6-2.77). Our weekly stool-based CRC screening increased (94% increase) compared with other health systems nationally (61 to 83% decrease).
DISCUSSION
A multi-component intervention, including academic detailing, panel management, and mailed MT-sDNA testing, can lead to significant increases in CRC screening in a rural family medicine clinic, empowering providers to maintain an effective CRC screening outreach during COVID-19 related restrictions.
Topics: Humans; Early Detection of Cancer; Postal Service; Colorectal Neoplasms; Occult Blood; DNA; COVID-19; Mass Screening
PubMed: 38171582
DOI: 10.3122/jabfm.2023.230082R1 -
Respiratory Medicine Feb 2024Traditionally continuous positive airways pressure (CPAP) trials for obstructive sleep apnoea (OSA) are through face to face (F2F) set up. During Covid-19 pandemic CPAP... (Observational Study)
Observational Study
BACKGROUND
Traditionally continuous positive airways pressure (CPAP) trials for obstructive sleep apnoea (OSA) are through face to face (F2F) set up. During Covid-19 pandemic CPAP was classed as aerosol-generating hence Leeds sleep service moved to a virtual service. Patients received equipment by post followed by virtual reviews (VR). We evaluated the adherence and symptomatic benefit of postal compared to F2F method.
METHODS
Observational data were collected from databases monitoring CPAP loans. F2F patients met a sleep technician for hands on setup in 2019, and in 2020 postal patients received equipment, written guides, and links to custom made YouTube videos. All (F2F and postal) patients had a telephone and VR appointment to discuss symptoms, and CPAP machine (AirSense 10, ResMed Inc., San Diego, USA) data including data on usage and treatment apnoea-hypopnoea index (AHI). Data was analysed using unpaired T-tests, Mann-Whitney U tests, and chi-square tests to examine differences in means, medians, and proportions, respectively of the F2F and postal groups.
RESULTS
Both groups (n = 1,221, 656 F2F, 53.7%) were similar in all categories except length of CPAP trial (postal 33 vs F2F 84 days,p < 0.0001), change in AHI (postal 22.4/Hr vs F2F 25.1/Hr,p = 0.04), and trial average use (postal 4.9 vs F2F 5.2 h,p = 0.04). There was no significant difference in the proportion of patients continuing with CPAP (postal 64%, F2F 66%, p = 0.71), the improvement in Epworth Sleepiness Score (ESS) (postal 6.9/24, F2F 7.1/24, p = 0.31) or the patient's subjective rating on whether they felt much better, better, the same or worse on CPAP (p = 0.27). Logistic regression showed factors which affected odds ratios of continuing CPAP were diagnostic AHI, treatment AHI, treatment ESS and how they felt on CPAP. Trial type did not affect the odds ratios of continuing CPAP.
CONCLUSIONS
Postal CPAP trial patients had similar odds of continuing CPAP therapy compared to patients with F2F trials and achieved similar levels of ESS improvement and reporting feeling better on CPAP. This provides support for postal trials as a viable option post-pandemic.
Topics: Humans; Pandemics; Continuous Positive Airway Pressure; Sleep Apnea, Obstructive; Sleep
PubMed: 38159781
DOI: 10.1016/j.rmed.2023.107513