Usual Care Group Research Articles

Effect of Combination of Point-of-Care C-Reactive Protein Testing and General Practitioner Education and Long-Term Effect of Education on Reducing Antibiotic Prescribing for Children Presenting with Acute Infections in General Practice in Latvia: A Randomized Controlled Intervention Study.

Antibiotics are often overprescribed in children in general practice. We investigated whether the availability of C-reactive protein point-of-care testing (CRP POCT) in daily practice and general practitioner (GP) education reduces antibiotic prescribing for children with acute infections and whether GP education has a long-term effect on antibiotic prescribing. This was a randomized controlled intervention study with randomization at the GP practice level. Eligible patients were children aged 1 month to 17 years presenting to general practice with an acute infection. In the first study period, one GP group received combined interventions (CRP POCT was provided for daily use in combination with a live educational session), while the second GP group continued usual care. During the second study period, the GP groups were switched. During this period, the long-term education effect was evaluated in the GP group, which had previously received both interventions: the CRP POCT was no longer available in their practices in accordance with the study protocol, but education could have a lasting effect. Antibiotic prescribing at index consultation. GP with combined intervention enrolled 1784 patients, GP with usual care enrolled 886 patients, and GP with long-term education effect enrolled 647 patients. Most of the patients had upper (76.8%) and lower (18.8%) respiratory infections. In total, 29.3% of the study patients received antibiotic prescriptions. Adjusted binary logistic regression analysis showed no differences for the primary outcome between GPs with usual care and GPs with combined intervention (aOR 0.89 (0.74-1.07), p = 0.20), but significantly lower antibiotic prescribing was observed for GPs with long-term education in comparison with GPs with usual care (aOR 0.75 (0.59-0.96), p = 0.02); however, after multilevel analyses, any differences in the antibiotic prescription between intervention groups became non-significant. GPs widely used CRP POCT when it was available in practice (for 69.1% of patients in the combined intervention group), but rarely measured CRP in the laboratory in the usual care group (8.8% (n = 78)) or long-term education group (14.8% (n = 98)). The majority of the tested patients had low CRP levels (below 20 mg/L); despite this, up to 35.4% of them received antibiotic prescriptions. Our results show that the availability of CRP POCT and educational training for GPs together did not reduce antibiotic prescribing, and one-time education did not have a long-term effect on antibiotic prescribing.

Effect of Hospital-to-Home Transitional Care for COPD on Patient-Centered Outcomes.

Appropriate hospital-to-home transitional care has been recognized for its positive impact on health care usage and health outcomes in patients with COPD. However, there is limited research assessing its effects on patient-centered outcomes, focusing on patient symptoms and experiences. This single-blind randomized controlled trial included subjects diagnosed with COPD at one of 2 university hospitals in South Korea. The study included 179 subjects (transitional care group [transitional care], 87; usual care group [usual care], 92). The transitional care received transitional care comprising post-discharge care planning, personalized education, breathing exercises, telephone counseling, home visits, and referral to social services. We analyzed the effects of these interventions by comparing breathing symptoms and various patient-centered outcomes between the 2 groups. The Modified Medical Research Council scores (mean [SD], transitional care 1.3 [1.06], usual care 1.82 [1.1], P = .002) and COPD Assessment Test scores (transitional care 6.32 [5.5], usual care 9.43 [7.16], P = .001) in the intervention group demonstrated more significant improvement than did those in the usual care. Following intervention, the subjects exhibited enhanced awareness of their disease, an increased frequency of inhaler use (transitional care 49.69 [1.67], usual care 46.86 [7.92], P = .002), and lower depression and anxiety scores. Additionally, the transitional care outperformed the usual care in the domain of subject experience during hospitalization (transitional care 39.34 [6.14], usual care 37.5 [5.61], P = .036), preparedness before discharge (transitional care 34.54 [4.96], usual care 32.3 [5.09], P = .003), and post-discharge management (transitional care 34.72 [4.36], usual care 30.29 [4.26], P = .003). Evidence-based transitional care services can exert positive effects on patient-centered indices. Our findings can be used as evidence of the need to establish patient-centered transitional care as a form of universal care for patients with COPD.

An audit of perioperative speech pathology intervention on improving enhanced recovery after surgery in oesophagectomy patients

Purpose To evaluate the impact of a speech-language pathology (SLP) pathway on recovery following oesophagectomy. Method An audit was conducted at a single metropolitan public hospital in Sydney, Australia. Patients between 2014–2021 undergoing a three-stage oesophagectomy (n = 41) were included in the study. The sample was divided into two groups, those who received usual care (2014–2019) and those who received perioperative SLP assessment and intervention (2020–2021), with data collected across swallowing and health outcomes. Patient demographics and outcomes between the two groups were compared. Result Patients who received perioperative SLP intervention commenced oral intake faster postoperatively (SLP intervention group Mdn = 6.50 days, IQR = 6.00–7.00; usual care group Mdn = 9.00 days, IQR = 7.00–13.25; p = 0.001). There was no statistically significant difference between groups in rates of aspiration on the postoperative leak test (p = 0.32). No statistically significant differences were found between the two groups in length of hospital stay or number of swallowing-related medical images completed during their admission. Conclusion Perioperative SLP intervention has a positive impact on commencing oral intake following a three-stage oesophagectomy, however, it does not have a significant impact on rates of aspiration postoperatively. This pathway may contribute to enhanced recovery after oesophagectomy.

Sodium–glucose co-transporter-2 inhibitors for hospitalised patients with COVID-19: a prospective meta-analysis of randomised trials

Sodium-glucose co-transporter-2 (SGLT2) inhibitors have been proposed as a potential treatment for adults hospitalised with COVID-19, due to their potential anti-inflammatory and endothelial protective effects. Published evidence from randomised control trials (RCTs) does not provide evidence of benefit. We aimed to estimate the effect of oral administration of SGLT2 inhibitors compared with usual care or placebo in adults hospitalised with COVID-19. Eligible RCTs that estimated the effect of oral administration of SGLT2 inhibitors compared with usual care or placebo on 28-day all-cause mortality (primary outcome) were included in this prospective meta-analysis. The primary safety outcome was ketoacidosis by 28 days. Trials were identified through systematic searches of ClinicalTrials.gov, EudraCT, and the WHO ISRCTN registry between Nov 1, 2022 and Jan 31, 2023. The search terms were "random*" AND "COVID" AND each SGLT2i, not restricted by trial status or language. Individual searches were then combined. Prespecified summary outcome data, overall and within subgroups of interest, were provided by each trial. The primary analyses were inverse variance weighted meta-analysis of odds ratios (ORs). Risk of bias was assessed using the Cochrane Risk of Bias tool. This study was registered with PROSPERO, CRD42023406442. Three eligible trials randomly assigned 6096 participants (3025 to the SGLT2 inhibitor group and 3071 to the usual care or placebo group). 2381 (39%) patients were women and 1547 (25%) had type 2 diabetes at randomisation. By 28 days, there were 351 deaths in the SGLT2 inhibitor group and 382 deaths in the usual care or placebo group (summary OR 0·93 [95% CI 0·79-1·08]; p=0·33, I2 for inconsistency across trials 0%). The risk of bias was assessed as being low. Ketoacidosis was observed in seven participants in the SGLT2 inhibitor group and two patients in the usual care or placebo group. Although administration of SGLT2 inhibitor was safe, we found no clear evidence that adding SGLT2 inhibitor therapy improved outcomes in patients hospitalised with COVID-19 compared with usual care or placebo. These data do not support the use of SGLT2 inhibitors as standard treatment in adults hospitalised for COVID-19. None.

Effectiveness of whole-body electromyostimulation on knee pain and physical function in knee osteoarthritis: a randomized controlled trial

In a randomized, controlled study, whole-body electromyostimulation (WB-EMS) was investigated as a promising alternative treatment technique compared to conventional strength training for the management of knee osteoarthritis (OA). Seventy-two overweight participants with symptomatic knee OA were randomly assigned to WB-EMS (n = 36) or a usual care group (UCG, n = 36). For seven months, the WB-EMS group received three times per fortnight a WB-EMS training, while the UCG was prescribed six-times physiotherapeutic treatments. We observed significant effects for the primary outcome “pain”, as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS), with more favourable changes in the WB-EMS group vs UCG (between-group difference 9.0 points, 95%CI 2.9–15.1, p = 0.004). Secondary outcomes, including the other KOOS subscales (symptoms, function in daily living, function in sports/recreational activities and quality of life), 7 day pain diary, hip/leg extensor strength and lower limb function (30s sit-to-stand test), were also statistically significant in favour of the WB-EMS group. Overall, WB-EMS was found to be effective in relieving knee pain symptoms and improving physical function in individuals with symptomatic knee OA compared to usual care treatment. WB-EMS could be used as an alternative therapy in the management of knee OA; particularly for patients that cannot be motivated for conventional training.

Efficacy of Teleconsultation Versus Usual Care in Improving Quality of Life Among Geriatric Patients Aged 60 and Above: A Randomized Controlled Trial.

Introduction The geriatric population, aged 60 years and older, is rapidly growing worldwide. This demographic shift has led to a higher prevalence of chronic diseases, comorbidities, and functional impairments, placing immense pressure on healthcare systems. Teleconsultation, which uses telecommunication technologies to deliver healthcare services remotely, offers a potential solution. This study aimed to assess the efficacy of teleconsultation versus usual care in improving the quality of life among the geriatric population aged 60 years and older. Methods A parallel, randomized controlled trial with a 1:1 allocation ratio was conducted. Eligible participants, aged 60 and above, were recruited at the triage emergency department (ED) following a baseline eligibility assessment. Inclusion criteria included the ability to communicate in English or Hindi, possession of International Organization for Standardization (ISO-certified) instruments for self-monitoring, and willingness to comply with study procedures and provide written consent. Participants were randomly assigned to experimental and control arms using a computer-generated sequence, with allocation concealment achieved through sequentially numbered opaque sealed envelopes (SNOSEs), which were opened in front of participants after obtaining baseline data. A total of 2,000 participants (1,000 per arm) were enrolled and randomly assigned to either the teleconsultation or usual care group. Results In the teleconsultation group (n=1,000), 36.5% of participants (365) were female and 63.5% of participants (635) were male. Similarly, in the usual care group (n=1,000), 37.1% of participants (371) were female and 62.9% of participants (629) were male. The teleconsultation group significantly outperformed the usual care group in several domains pre-intervention, with higher mean scores in the physical health domain (11.16 vs. 10.96, P = 0.009), psychological domain (11.74 vs. 11.62, P = 0.020), and environment domain (12.44 vs. 12.26, P = 0.0001). No significant difference was observed in the social relationships domain (P = 0.452). The teleconsultation group significantly outperformed the usual care group in all domains post-intervention, with higher mean scores in the physical health domain (14.49 vs. 12.74), psychological domain (13.75 vs. 12.35), social relationships domain (14.05 vs. 12.90), and environment domain (13.91 vs. 12.94) (P < 0.001 for all). Conclusion These findings suggest that teleconsultation significantly improves the quality of life for elderly patients by providing a more accessible and convenient means of healthcare delivery and addressing the physical, emotional, and social challenges associated with chronic illnesses.

Effect of depression treatment on health behaviors and cardiovascular risk factors in primary care patients with depression and elevated cardiovascular risk: data from the eIMPACT trial.

Depression is an independent risk factor for cardiovascular disease (CVD), but it is unknown if successful depression treatment reduces CVD risk. Using eIMPACT trial data, we examined the effect of modernized collaborative care for depression on indicators of CVD risk. A total of 216 primary care patients with depression and elevated CVD risk were randomized to 12 months of the eIMPACT intervention (internet cognitive-behavioral therapy [CBT], telephonic CBT, and select antidepressant medications) or usual primary care. CVD-relevant health behaviors (self-reported CVD prevention medication adherence, sedentary behavior, and sleep quality) and traditional CVD risk factors (blood pressure and lipid fractions) were assessed over 12 months. Incident CVD events were tracked over four years using a statewide health information exchange. The intervention group exhibited greater improvement in depressive symptoms (p < 0.01) and sleep quality (p < 0.01) than the usual care group, but there was no intervention effect on systolic blood pressure (p = 0.36), low-density lipoprotein cholesterol (p = 0.38), high-density lipoprotein cholesterol (p = 0.79), triglycerides (p = 0.76), CVD prevention medication adherence (p = 0.64), or sedentary behavior (p = 0.57). There was an intervention effect on diastolic blood pressure that favored the usual care group (p = 0.02). The likelihood of an incident CVD event did not differ between the intervention (13/107, 12.1%) and usual care (9/109, 8.3%) groups (p = 0.39). Successful depression treatment alone is not sufficient to lower the heightened CVD risk of people with depression. Alternative approaches are needed. ClinicalTrials.gov Identifier: NCT02458690.

A risk-differentiated, community-led intervention to strengthen uptake and engagement with HIV prevention and care cascades among female sex workers in Zimbabwe (AMETHIST): a cluster randomised trial

Female sex workers remain disproportionately affected by HIV. The aim of this study was to determine the effect of risk-differentiated, peer-led support for female sex workers in Zimbabwe on the risk of HIV acquisition and HIV transmission from sex among female sex workers. In this cluster randomised, open-label, controlled study, 22 clinics dedicated to female sex workers co-located in government health facilities throughout Zimbabwe were allocated (1:1, through restricted randomisation) to usual care or AMETHIST intervention. Usual care comprised HIV testing, pre-exposure prophylaxis (PrEP), referral to government antiretroviral therapy (ART) services, contraception, condoms, syndromic management of sexually transmitted infections, health education, legal advice, and peer support. AMETHIST added peer-led microplanning tailored to individuals' risk and participatory self-help groups. All cisgender women (aged >18 years) who had sold sex within the past 30 days and lived or worked within trial cluster areas were eligible. Intervention status was not masked to programme implementers but was masked to survey teams and laboratory staff. After 28 months, a respondent-driven sampling (RDS) survey was done in the female sex worker population around each clinic, which measured the primary outcome, the combined proportion of female sex workers in the surveyed population at risk of transmitting HIV (ie, were HIV positive, not virally suppressed, and not consistently using condoms) or at risk of acquiring HIV (ie, were HIV negative and not consistently using condoms or PrEP). We report prespecified analyses of the disaggregated proportions of female sex workers in the surveyed population at risk of either transmission or acquisition of HIV. Analyses were prespecified, RDS-weighted, and age-adjusted. This trial is registered with the Pan African Clinical Trials Registry, PACTR202007818077777. The AMETHIST intervention was started on May 15, 2019, and data were collected from June 1, 2019, until Dec 13, 2021. The RDS survey was done from Oct 18 to Dec 13, 2021, with 2137 women included in the usual care group (11 clusters) and 2131 in the AMETHIST intervention group (11 clusters) after excluding survey seeds (n=132) and women with missing key data (n=44). 1973 (46·2%) of the 4268 female sex workers surveyed were living with HIV; of these, 863 (93·5%; RDS-adjusted) of 931 women in the intervention group and 927 (88·8%) of 1042 in the usual care group were virologically suppressed. 287 (22·4%) of 1200 HIV-negative women in the intervention group and 194 (15·7%) of 1096 in the usual care group reported currently taking PrEP, of whom only two (0·4%) of 569 had protective tenofovir diphosphate concentrations in dried blood spots (>700 fmol/dried blood punch). There was no effect of the intervention on the primary endpoint of risk of both HIV transmission and acquisition (intervention group n=1156/2131, RDS-adjusted proportion 55·3%; usual care group n=1104/2137, RDS-adjusted proportion 52·7%; age-adjusted risk difference -0·9%, 95% CI -5·7% to 3·9%, p=0·70). For the secondary outcomes, the proportion of women living with HIV at risk of transmission was low and significantly reduced in the intervention group (n=63/931, RDS-adjusted proportion 5·8%) compared with the usual care group (103/1041, 10·4%), with an age-adjusted risk difference of -5·5% (95% CI -8·2% to -2·9%, p=0·0003). Risk of acquisition among HIV-negative women was similar in the intervention (n=1093/1200, RDS-adjusted proportion 92·1%) and the usual care group (1001/1096, 92·2%), with an age-adjusted risk difference of -0·6% (95% CI -4·6 to 3·4, p=0·74). There was no overall benefit of the intervention on combined risk of transmission or acquisition. Viral load suppression in women living with HIV was high and appeared to be further improved by AMETHIST, suggesting potential for impressive uptake and adherence to ART in vulnerable and mobile populations. Sustaining treatment and reinvigorating prevention remain crucial. The Wellcome Trust and the Bill & Melinda Gates Foundation. For the Shona and Ndebele translations of the abstract see Supplementary Materials section.

Health outcomes 3 months and 6 months after molnupiravir treatment for COVID-19 for people at higher risk in the community (PANORAMIC): a randomised controlled trial.

No randomised controlled trials have yet reported on the effectiveness of molnupiravir on longer term outcomes for COVID-19. The PANORAMIC trial found molnupiravir reduced time to recovery in acute COVID-19 over 28 days. We aimed to report the effect of molnupiravir treatment for COVID-19 on wellbeing, severe and persistent symptoms, new infections, health care and social service use, medication use, and time off work at 3 months and 6 months post-randomisation. This study is a follow-up to the main analysis, which was based on the first 28 days of follow-up and has been previously reported. For this multicentre, primary care, open-label, multi-arm, prospective randomised controlled trial conducted in the UK, participants were eligible if aged at least 50 years, or at least 18 years with a comorbidity, and unwell 5 days or less with confirmed COVID-19 in the community. Participants were randomly assigned to the usual care group or molnupiravir group plus usual care (800 mg twice a day for 5 days), which was stratified by age (<50 years or ≥50 years) and vaccination status (at least one dose: yes or no). The primary outcome was hospitalisation or death (or both) at 28 days; all longer term outcomes were considered to be secondary outcomes and included self-reported ratings of wellness (on a scale of 0-10), experiencing any symptom (fever, cough, shortness of breath, fatigue, muscle ache, nausea and vomiting, diarrhoea, loss of smell or taste, headache, dizziness, abdominal pain, and generally feeling unwell) rated as severe (moderately bad or major problem) or persistent, any health and social care use, health-related quality of life (measured by the EQ-5D-5L), time off work or school, new infections, and hospitalisation. Between Dec 8, 2021, and April 27, 2022, 25 783 participants were randomly assigned to the molnupiravir plus usual care group (n=12 821) or usual care group (n=12 962). Long-term follow-up data were available for 23 008 (89·2%) of 25 784 participants with 11 778 (91·9%) of 12 821 participants in the molnupiravir plus usual care group and 11 230 (86·6%) of 12 963 in the usual care group. 22 806 (99·1%) of 23 008 had at least one previous dose of a SARS-CoV-2 vaccine. Any severe (3 months: adjusted risk difference -1·6% [-2·6% to -0·6%]; probability superiority [p(sup)]>0·99; number needed to treat [NNT] 62·5; 6 months: -1·9% [-2·9% to -0·9%]; p(sup)>0·99, NNT 52·6) or persistent symptoms (3 months: adjusted risk difference -2·1% [-2·9% to -1·5%]; p(sup)>0·99; NNT 47·6; 6 months: -2·5% [-3·3% to -1·6%]; p(sup)>0·99; NNT 40) were reduced in severity, and health-related quality of life (measured by the EQ-5D-5L) improved in the molnupiravir plus usual care group at 3 months and 6 months (3 months: adjusted mean difference 1·08 [0·65 to 1·53]; p(sup)>0·99; 6 months: 1·09 [0·63 to 1·55]; p(sup)>0·99). Ratings of wellness (3 months: adjusted mean difference 0·15 (0·11 to 0·19); p(sup)>0·99; 6 months: 0·12 (0·07 to 0·16); p(sup)>0·99), experiencing any more severe symptom (3 months; adjusted risk difference -1·6% [-2·6% to -0·6%]; p(sup)=0·99; 6 months: -1·9% [-2·9% to -0·9%]; p(sup)>0·99), and health-care use (3 months: adjusted risk difference -1·4% [-2·3% to -0·4%]; p(sup)>0·99; NNT 71·4; 6 months: -0·5% [-1·5% to 0·4%]; p(sup)>0·99; NNT 200) had high probabilities of superiority with molnupiravir treatment. There were significant differences in persistence of any symptom (910 [8·9%] of 10 190 vs 1027 [11%] of 9332, NNT 67) at 6 months, and reported time off work at 3 months (2017 [17·9%] of 11 274 vs 2385 [22·4%] of 10 628) and 6 months (460 [4·4%] of 10 562 vs 527 [5·4%] of 9846; NNT 100). There were no differences in hospitalisations at long-term follow-up. In a vaccinated population, people treated with molnupiravir for acute COVID-19 felt better, experienced fewer and less severe COVID-19 associated symptoms, accessed health care less often, and took less time off work at 6 months. However, the absolute differences in this open-label design are small with high numbers needed to treat. UK Research and Innovation and National Institute for Health and Care Research.

Effect of Screening for Undiagnosed Atrial Fibrillation on Stroke Prevention

BackgroundAtrial fibrillation (AF) often remains undiagnosed, and it independently raises the risk of ischemic stroke, which is largely reversible by oral anticoagulation. Although randomized trials using longer term screening approaches increase identification of AF, no studies have established that AF screening lowers stroke rates. ObjectivesTo address this knowledge gap, the GUARD-AF (Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals) trial screened participants in primary care practices using a 14-day continuous electrocardiographic monitor to determine whether screening for AF coupled with physician/patient decision-making to use oral anticoagulation reduces stroke and provides a net clinical benefit compared with usual care. MethodsGUARD-AF was a prospective, parallel-group, randomized controlled trial designed to test whether screening for AF in people aged ≥70 years using a 14-day single-lead continuous electrocardiographic patch monitor could identify patients with undiagnosed AF and reduce stroke. Participants were randomized 1:1 to screening or usual care. The primary efficacy and safety outcomes were hospitalization due to all-cause stroke and bleeding, respectively. Analyses used the intention-to-treat population. ResultsEnrollment began on December 17, 2019, and involved 149 primary care sites across the United States. The COVID-19 pandemic led to premature termination of enrollment, with 11,905 participants in the intention-to-treat population. Median follow-up was 15.3 months (Q1-Q3: 13.8-17.6 months). Median age was 75 years (Q1-Q3: 72-79 years), and 56.6% were female. The risk of stroke in the screening group was 0.7% vs 0.6% in the usual care group (HR: 1.10; 95% CI: 0.69-1.75). The risk of bleeding was 1.0% in the screening group vs 1.1% in the usual care group (HR: 0.87; 95% CI: 0.60-1.26). Diagnosis of AF was 5% in the screening group and 3.3% in the usual care group, and initiation of oral anticoagulation after randomization was 4.2% and 2.8%, respectively. ConclusionsIn this trial, there was no evidence that screening for AF using a 14-day continuous electrocardiographic monitor in people ≥70 years of age seen in primary care practice reduces stroke hospitalizations. Event rates were low, however, and the trial did not enroll the planned sample size.(Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals [GUARD-AF]; NCT04126486)

Evaluation of Virtual Care in Kidney Transplant Recipients in the Early Posttransplant Period.

Though virtual care was widely adopted during the COVID-19 pandemic, evidence to support its use in kidney transplant recipients early after transplantation is limited. We conducted a retrospective cohort study comparing post kidney transplant outcomes in patients who received in-person transplant care before the COVID-19 pandemic with those who received mainly virtual transplant care during the COVID-19 pandemic. The usual-care group included 69 patients who received a kidney transplant from March 1, 2019 to September 1, 2019, and the virtual-care group included 64 patients who received a kidney transplant from September 1, 2020 to March 1, 2021. At 6 months, five patients in the usual-care group and three patients in the virtual-care group died. There was one graft loss and one episode of acute rejection in the usual-care group, and two episodes of acute rejection in the virtual-care group (p = 0.60). Estimated glomerular filtration rate was higher for patients in the virtual-care group (59mL/min/1.73m2 vs. 52mL/min/1.73m2, p = 0.046) and serum creatinine was not different (138 µmol/L vs. 127µmol/L, p = 0.27). There was no difference in mean blood pressure or hospitalizations. Outcomes were similar among recipients of a kidney transplant prior to the COVID-19 pandemic when care was mainly in person and during the pandemic when care was mainly virtual, without a signal of harm. Patient and donor selection may have led to unmeasured differences between groups.

Panniculus Retractor Use for Visualization of Fetal Anatomy: A Randomized Controlled Trial.

To evaluate whether use of a panniculus retractor device for pregnant patients with body mass index (BMI) 40 or higher and a panniculus improves the completion rate of the fetal anatomic examination. This was a randomized trial in which eligible patients with BMI 40 or higher and a panniculus were randomized to undergo their detailed fetal anatomic examination with a panniculus retractor device in place compared with usual care. The primary outcome was the completion rate of 16 prespecified views from the anatomic examination. Secondary outcomes included completion rate of all 64 views from our institution's detailed anatomic examination, duration of examination, major fetal anomaly detection rate, depth from the skin to amniotic cavity before and after retractor placement, patient and ultrasonographer satisfaction, and prespecified adverse events. We assumed a baseline completion rate of 23% for the primary outcome and targeted a twofold improvement with 80% power and two-sided α of 0.05, which resulted in a sample size of 132 participants. The goal enrollment was increased to 150 participants to account for potential dropout. Statistical tests included the Student's t test, χ 2 , and relative risks (RRs) as appropriate. From March to July of 2023, 150 participants completed the study: 74 in the retractor group and 76 in the usual care group. Baseline characteristics were similar between groups except for panniculus grade. The completion rate of 16 prespecified views was 25.7% (19/74) in the retractor group and 31.6% (24/76) in the control group (RR 0.81, 95% CI, 0.49-1.35). There were no significant differences between groups for any of the secondary outcomes. Patient satisfaction and ultrasonographer satisfaction were similar between groups. Use of a panniculus retractor device during the fetal anatomic examination for patients with BMI 40 or higher and a panniculus was well tolerated by patients and ultrasonographers but did not improve the completion rate of 16 prespecified fetal anatomic views. ClinicalTrials.gov , NCT05764408.

Abstract 27: A Randomized Clinical Trial for Asymptomatic Elevated Blood Pressure in Patients Discharged from Emergency Department

Introduction: Hypertension is a prevalent condition that is often asymptomatic. Emergency Department (ED) patients commonly present with underlying and undiagnosed hypertension. As EDs serve as critical access points for healthcare, they present a unique opportunity for hypertension screening and intervention, and ED-based interventions could target patients who are often missed in other healthcare settings. Hypothesis: We hypothesize that an Education and mHealth Empowerment intervention would be effective when compared to standard discharge instructions in reducing systolic blood pressure by 6-month follow-up among patients with asymptomatic elevated blood pressure discharged from the ED. Methods: A randomized clinical trial was designed to enroll patients with asymptomatic elevated blood pressure (&gt; 140/90 mm Hg and ≤ 180/110 mm Hg) discharged from an urban academic ED that predominantly serves patients from minoritized racial and ethnic groups. Patients were randomized to either usual care (standard discharge with outpatient follow-up referral) or the intervention arm (education and mHealth Empowerment intervention at discharge – the intervention included a consultation with a clinical pharmacist or an advanced practice nurse, and use of mHealth to educate on and facilitate self-monitoring and behavior change along with a primary care referral, and follow-up visits at 3 and 6 months). Results: Of the 574 enrolled, 289 were randomized to the intervention group. The mean age of the sample was 51.1 (±12.5) years, and 57% were female, 72% were Black, and 20% Hispanic. There were no statistically significant differences between the two arms by demographics or mean blood pressure at baseline. At 6 months follow up, the intervention arm showed a greater reduction in systolic blood pressure compared to the usual care group, and the difference was statistically significant (mean difference: 4.9 mm Hg, 95% CI [0.8, 9.0], p=0.02). Conclusions: The Education and mHealth Empowerment intervention was more effective than standard discharge instructions in reducing systolic blood pressure in a predominantly Black and Latino patient population with elevated blood pressure discharged from the ED. This intervention, and other similar ED-based interventions could be a viable and scalable strategy for blood pressure control in asymptomatic patients for preventing secondary cardiovascular complications due to uncontrolled hypertension.

Effects of the teach-back method on the health status of patients with chronic obstructive pulmonary disease: a real-world community-based cluster-randomized controlled trial.

The teach-back method (TBM), also known as the "show-me" method, is a technique for verifying patients' understanding of health-related information that has been recommended for improving health literacy. However, the research on TBM effect on the outcomes of chronic obstructive pulmonary disease (COPD) patients is limited. Therefore, the aim of this study was to examine the effect of a TBM intervention on the health status of COPD patients. This real-world community-based cluster-randomized controlled trial enrolled 1,688 patients with COPD from 18 communities in China. Participants received either TBM plus usual care (UC) or UC only. General practitioners were trained in TBM before the intervention. The primary outcomes were depression and anxiety symptoms, as measured by the Hospital Anxiety and Depression Scale (HADS). The secondary outcomes were health-related quality of life and dyspnea, as measured by the COPD Assessment Test (CAT). Dyspnea was assessed using the modified Medical Research Council (mMRC) dyspnea scale. Data on acute exacerbations and deaths were extracted from medical records. Lung function was expressed as the forced expiratory volume in 1 second as a percentage of the predicted value [FEV1 (% pred)]. In total, 336 of the 853 COPD patients in the intervention group (TBM plus UC) had comorbid depression, compared with 329 of the 835 in the control group (UC only). The TBM group showed a significantly greater improvement in HADS depression and anxiety subscale scores (HADS-D and HADS-A, respectively) than the UC group at12 months (t =8.34, P<0.001; t=12.18, P<0.001). The CAT and mMRC scores were significantly lower in the TBM than UC group at 12 months (t=8.43, P<0.001; t=7.23, P<0.001). The numbers of acute exacerbations and deaths were significantly lower in the TBM than UC group at 12 months (mean MCF values were 0.35 and 0.56, respectively [difference of 0.22; 95% confidence interval (CI): -0.41, -0.02; χ2=9.63, P<0.001]. The FEV1 (% pred) was significantly higher in the TBM than UC group at 12 months (t=7.45, P<0.001). General practitioners can use TBM interventions to effectively reduce anxiety, depression, and dyspnea symptoms, decrease the frequency of exacerbations and likelihood of death, and improve health-related quality of life and pulmonary function in patients with COPD. The trial was registered on the Chinese Clinical Trials Registry (reference: ChiCTR-TRC-12001958).

Identifying a Heterogeneous Effect of Atrial Fibrillation Screening in Older Adults: A Secondary Analysis of the VITAL-AF Trial.

One-time atrial fibrillation (AF) screening trials have produced mixed results; however, it is unclear if there is a subset for whom screening is effective. Identifying such a subgroup would support targeted screening. We conducted a secondary analysis of VITAL-AF, a randomized trial of one-time, single-lead ECG screening during primary care visits. We tested two approaches to identify a subgroup where screening is effective. First, we developed an effect-based model using a T-learner. Specifically, we separately predicted the likelihood of AF diagnosis under screening and usual care conditions; the difference in probabilities was the predicted screening effect. Second, we used a validated AF risk model to test for a heterogeneous screening effect. We used interaction testing to determine if observed AF diagnosis rates in the screening and usual care groups differed when stratified by decile of the predicted screening effect and predicted AF risk. Baseline characteristics were similar between the screening (n=15187) and usual care (n=15078) groups (mean age 74 years, 59% female). In the effect-based analysis, in the highest decile of predicted screening effectiveness (n=3026), AF diagnosis rates were higher in the screening group (6.50 vs. 3.06 per 100 person-years, rate difference 3.45, 95%CI 1.62 to 5.28). In this group, the mean age was 84 years and 68% were female. The risk-based analysis did not identify a subgroup where screening was more effective. Predicted screening effectiveness and predicted baseline AF risk were poorly correlated (Spearman coefficient 0.13). In a secondary analysis of the VITAL-AF trial, we identified a small subgroup where one-time screening was associated with increased AF diagnoses using an effect-based approach. In this study, predicted AF risk was a poor proxy for predicted screening effectiveness. These data caution against the assumption that high AF risk is necessarily correlated with high screening effectiveness.

Potential harms resulting from patient–clinician real-time clinical encounters using video-based telehealth: A making healthcare safer rapid evidence review

Objectives To review the evidence on harms associated with patient–clinician real-time encounters using video-based telehealth and determine the effectiveness of any related patient safety practices (PSPs), which are interventions, strategies, or approaches intended to prevent or mitigate unintended consequences of healthcare delivery and improve patient safety. Methods We searched PubMed, EMBASE, and Cochrane to identify eligible studies published from 2012 to 2022, supplemented by grey literature search. Outcomes of interest included adverse events and other specified harms (i.e., preventable hospitalizations, inappropriate treatment, missed or delayed diagnoses, duplication of services, privacy breaches). Findings Our search retrieved 7155 citations, of which 23 studies (including six randomized controlled trials [RCTs]) were eligible for review. Fourteen studies reported on adverse events or unintended effects of telehealth conducted in diverse settings. Adverse events such as death, reoperation, infection, or major complications were infrequent in both telehealth and usual care groups. Thirteen studies examined preventable hospitalizations or emergency department (ED) visits and reported mixed findings. Of the six RCTs, three showed no difference in risk of hospitalization or ED visits for telehealth compared to usual care and three showed reduced risk for patients receiving telehealth. We found no studies on the effectiveness of PSPs in reducing harms associated with real-time telehealth. Conclusions Telehealth was not inferior to usual care in terms of hospitalizations or ED visits. No studies evaluated a specific PSP. More research is needed to improve understanding of harms associated with real-time use of telehealth and how to prevent or mitigate those harms.

Integrating transcriptomics and proteomics to analyze the immune microenvironment of cytomegalovirus associated ulcerative colitis and identify relevant biomarkers

BackgroundIn recent years, significant morbidity and mortality in patients with severe inflammatory bowel disease (IBD) and cytomegalovirus (CMV) have drawn considerable attention to the status of CMV infection in the intestinal mucosa of IBD patients and its role in disease progression. However, there is currently no high-throughput sequencing data for ulcerative colitis patients with CMV infection (CMV + UC), and the immune microenvironment in CMV + UC patients have yet to be explored.MethodThe xCell algorithm was used for evaluate the immune microenvironment of CMV + UC patients. Then, WGCNA analysis was explored to obtain the co-expression modules between abnormal immune cells and gene level or protein level. Next, three machine learning approach include Random Forest, SVM-rfe, and Lasso were used to filter candidate biomarkers. Finally, Best Subset Selection algorithms was performed to construct the diagnostic model.ResultsIn this study, we performed transcriptomic and proteomic sequencing on CMV + UC patients to establish a comprehensive immune microenvironment profile and found 11 specific abnormal immune cells in CMV + UC group. After using multi-omics integration algorithms, we identified seven co-expression gene modules and five co-expression protein modules. Subsequently, we utilized various machine learning algorithms to identify key biomarkers with diagnostic efficacy and constructed an early diagnostic model. We identified a total of eight biomarkers (PPP1R12B, CIRBP, CSNK2A2, DNAJB11, PIK3R4, RRBP1, STX5, TMEM214) that play crucial roles in the immune microenvironment of CMV + UC and exhibit superior diagnostic performance for CMV + UC.ConclusionThis 8 biomarkers model offers a new paradigm for the diagnosis and treatment of IBD patients post-CMV infection. Further research into this model will be significant for understanding the changes in the host immune microenvironment following CMV infection.

Early comprehensive pulmonary rehabilitation for hospitalized patients with acute ex-acerbation of chronic obstructive pulmonary disease: a randomized controlled trial.

To investigate whether an early comprehensive pulmonary rehabilitation intervention initiated during hospital admission is safe and effective for patients with acute exacerbation of chronic obstructive pulmonary disease. Prospective randomized controlled study. Patients with acute exacerbation of chronic obstructive pulmonary disease. In total, 108 patients were randomized to the early comprehensive pulmonary rehabilitation and usual care groups within 48 hours. The 6-min walking distance, quality of life, breathlessness, and inspiratory muscle strength were measured on admission and discharge. Any adverse events of pulmonary rehabilitation were recorded. On discharge, the patients in the early comprehensive pulmonary rehabilitation group had a more significant improvement in the 6-min walking distance (47.5 vs 23.0, p = 0.04). There was no significant difference in quality of life and breathlessness between the 2 groups. In the early comprehensive pulmonary rehabilitation group, inspiratory muscle strength and peak inspiratory flow were significantly improved, and the changes were much more pronounced than in the usual care group. There were no adverse events. Early comprehensive pulmonary rehabilitation is safe and effective for hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease, and should be performed during the early stage of hospitalization.

A new approach in insulin pump education improves glycemic outcomes: a randomized controlled trial.

To address the scarcity of continued education for insulin pump users, we developed and evaluated a new program (NP) for individuals transitioning to a different insulin pump. In a randomized, controlled 3-month study, adults with type 1 diabetes and suboptimal HbA1c received either NP or usual care program (UC). The NP was designed in collaboration with representatives of the target group and incorporated technical training, case-based learning, and peer experience sharing - encompassing two group sessions, and two follow-up telephone calls. The UC included a single training session led by the pump company with hotline assistance (clinic) but no structured follow-up. The primary endpoint was the difference in time in range (TIR) (70-180mg/dL (3.9-10.0 mmol/L)), measured by continuous glucose monitoring from baseline to 3 months post-course. Psychosocial self-efficacy was measured by the Diabetes Empowerment Scale (DES-SF). Thirty-nine participants (median age 43, 74% female) were included. Mean TIR increased significantly in the NP group and remained unchanged in the UC group (between-group difference in change was 13.5% [95% CI: 4.0 to 22.9], p = 0.0064). Psychosocial self-efficacy improved and HbA1c decreased only significantly in the NP group. Applying a novel education program at pump transition significantly improved glycemic outcomes and self-efficacy.

Restrictive Strategy vs Usual Care for Cholecystectomy in Patients With Abdominal Pain and Gallstones

The 1-year results of the SECURE trial, a randomized trial comparing a restrictive strategy vs usual care for select patients with symptomatic cholelithiasis for cholecystectomy, resulted in a significantly lower operation rate after restrictive strategy. However, a restrictive strategy did not result in more pain-free patients at 1 year. To gauge pain level and determine the proportion of pain-free patients, operation rate, and biliary and surgical complications at the 5-year follow-up. This randomized clinical trial was a multicenter, parallel-arm, noninferiority, prospective study. Between February 2014 and April 2017, patients from 24 hospitals with symptomatic, uncomplicated cholelithiasis were included. Uncomplicated cholelithiasis was defined as gallstone disease without signs of complicated cholelithiasis, ie, biliary pancreatitis, cholangitis, common bile duct stones, or cholecystitis. Follow-up data for this analysis were collected by telephone from July 11, 2019, to September 23, 2023. Patients were randomized (1:1) to receive usual care or a restrictive strategy with stepwise selection for cholecystectomy. The primary, noninferiority end point was proportion of patients who were pain free as evaluated by Izbicki pain score at the 5-year follow-up. A 5% noninferiority margin was chosen. The secondary end points included cholecystectomy rates, biliary and surgical complications, and patient satisfaction. Among 1067 patients, the median (IQR) age was 49.0 years (38.0-59.0 years); 786 (73.7%) were female, and 281 (26.3%) were male. At the 5-year follow-up, 228 of 363 patients (62.8%) were pain free in the usual care group, compared with 216 of 353 patients (61.2%) in restrictive strategy group (difference, 1.6%; 1-sided 95% lower confidence limit, -7.6%; noninferiority P = .18). After cholecystectomy, 187 of 294 patients (63.6%) in the usual care group and 160 of 254 patients (63.0%) in the restrictive strategy group were pain free, respectively (P = .88). The restrictive care strategy was associated with 387 of 529 cholecystectomies (73.2%) compared with 437 of 536 in the usual care group (81.5%; 8.3% difference; P = .001). No differences between groups were observed in biliary and surgical complications or in patient satisfaction. In the long-term, a restrictive strategy results in a significant but small reduction in operation rate compared with usual care and is not associated with increased biliary and surgical complications. However, regardless of the strategy, only two-third of patients were pain free. Further criteria for selecting patients with uncomplicated cholelithiasis for cholecystectomy and rethinking laparoscopic cholecystectomy as treatment is needed to improve patient-reported outcomes. CCMO Identifier: NTR4022.