Nonrandomized Study Research Articles

The Ablate-by-LAWT multicentre prospective study: Personalized paroxysmal atrial fibrillation ablation with ablation index adapted to local left atrial wall thickness.

Personalized radiofrequency (RF) ablation for paroxysmal atrial fibrillation (PAF), adapting the ablation index (AI) to local left atrial wall thickness (LAWT), proved to be highly efficient maintaining high arrhythmia-free survival rates. However, multicentre data are lacking. This multicentre, prospective, non-randomized study was conducted at 5 tertiary hospitals and sought to assess the safety, efficacy, and reproducibility of the LAWT-guided ablation for PAF. Consecutive patients referred for first-time PAF were prospectively enrolled. The LAWT maps were obtained from preprocedural multidetector computed tomography and integrated into the navigation system. AI was titrated according to the local LAWT, and the ablation line was personalized to avoid the thickest regions while encircling the pulmonary veins (PVs). A total 109 patients (60.1 ± 9.4years, 64.2% male) were enrolled. Median procedure time was 61.7min (48.4-83.8), fluoroscopy time was 1.0min (0.4-3.3), and RF time was 13.9min (12.3-16.8). Median AI tailored to the local LAWT was 393 (374-412) for the anterior wall and 340 (315-378) for the posterior wall. Right and left PVs first-pass isolation was achieved in 89% and 91.7% of the patients, respectively. At 12-month follow-up, freedom from any atrial arrhythmia was 93.4% (95% CI 88.7-98.1), without differences across centres (P = 0.169). One patient experienced femoral artery pseudoaneurysm, with no other serious procedural-related complication. The Ablate-by-LAWT study proved that LAWT-guided PV isolation for PAF is safe, effective, and efficient in a multicentre setting. Twelve-month recurrence-free survival exceeded 90% (NCT04218604).

Impact of rehabilitation unit-based physical activity therapy versus symptomatic supportive treatment on older patients with advanced cancer: a non-randomized controlled study

ObjectivesRelatively few studies have investigated the effects of rehabilitation-based physical activity therapy as a treatment for older patients with advanced cancer. This study evaluated the effects of individualized precise and structured exercise interventions, prescribed by a rehabilitation physician, on fatigue, quality of life (QOL), and physical activity in older patients with advanced cancer.MethodsAfter admission to the rehabilitation department, older cancer patients were divided into groups receiving conventional symptomatic supportive therapy (SST) or physical activity therapy plus conventional symptomatic supportive therapy (PAT). The SST group was given symptomatic supportive treatment, exercised on their own, and were observed at home after their symptoms improved. The PAT group was required to implement physical exercise along with SST, involving 30 min of moderate-intensity exercise per day and 5 days per week, and were discharged after 4 weeks and instructed to continue to exercise outside the hospital. Cancer-related fatigue (CRF) at 4 and 8 weeks was the primary endpoint of the study, while the secondary endpoints included patients’ QOL, physical activity, and exercise adherence rate.ResultsSixty-five patients were included; 37 (56.92%) chose to enter the PAT group, and 28 (43.08%) chose to enter the SST group. After 4 and 8 weeks of treatment, CRF relief and QOL improvement were significantly better in the PAT group than in the SST group (p < 0.05), whereas global health status did not differ between the two treatment groups (T1: p = 0.84; T2: p = 0.92). Mild physical activity significantly increased for the PAT group at T1 and T2 (T1: p = 0.03; T2: p = 0.005). At the T2 time point, the PAT group exhibited a higher level of participation in moderate-intensity physical activities as well as a higher total leisure activity score (p < 0.05). Thirty-three patients (94.29%) completed the PAT exercise program during hospitalization. Only four (12.12%) patients achieved moderate-intensity exercise, while the other 29 (87.88%) patients were able to continue exercising after their exercise intensity was decreased.ConclusionsImplementation of precise and individualized exercise interventions, prescribed by the rehabilitation team, can lead to the reduction of CRF and improvement of QOL, and change in behavior related to physical activity.

Can we Predict Drug Excretion into Saliva? A Systematic Review and Analysis of Physicochemical Properties.

Saliva is a patient-friendly matrix for therapeutic drug monitoring (TDM) but is infrequently used in routine care. This is due to the uncertainty of saliva-based TDM results to inform dosing. This study aimed to retrieve data on saliva-plasma concentration and subsequently determine the physicochemical properties that influence the excretion of drugs into saliva to increase the foundational knowledge underpinning saliva-based TDM. Medline, Web of Science and Embase (1974-2023) were searched for human clinical studies, which determined drug pharmacokinetics in both saliva and plasma. Studies with at least ten subjects and five paired saliva-plasma concentrations per subject were included. For each study, the ratio of the area under the concentration-time curve between saliva and plasma was determined to assess excretion into saliva. Physicochemical properties of each drug (e.g. pKa, lipophilicity, molecular weight, polar surface area, rotatable bonds and fraction of drug unbound to plasma proteins) were obtained from PubChem and Drugbank. Drugs were categorised by their ionisability, after which saliva-to-plasma ratios were predicted with adjustment for protein binding and physiological pH via the Henderson-Hasselbalch equation. Spearman correlation analyses were performed for each drug category to identify factors predicting saliva excretion (α = 5%). Study quality was assessed by the risk of bias in non-randomised studies of interventions tool. Overall, 42 studies including 40 drugs (anti-psychotics, anti-microbials, immunosuppressants, anti-thrombotic, anti-cancer and cardiac drugs) were included. The median saliva-to-plasma ratios were similar for drugs in the amphoteric (0.59), basic (0.43) and acidic (0.41) groups and lowest for drugs in the neutral group (0.21). Higher excretion of acidic drugs (n = 5) into saliva was associated with lower ionisation and protein binding (correlation between predicted versus observed saliva-to-plasma ratios: R2 = 0.85, p = 0.02). For basic drugs (n = 21), pKa predicted saliva excretion (Spearman correlation coefficient: R = 0.53, p = 0.02). For amphoteric drugs (n = 10), hydrogen bond donor (R = - 0.76, p = 0.01) and polar surface area (R = - 0.69, p = 0.02) were predictors. For neutral drugs (n = 10), protein binding (R = 0.84, p = 0.004), lipophilicity (R = - 0.65, p = 0.04) and hydrogen bond donor count (R = - 0.68, p = 0.03) were predictors. Drugs considered potentially suitable for saliva-based TDM are phenytoin, tacrolimus, voriconazole and lamotrigine. The studies had a low-to-moderate risk of bias. Many commonly used drugs are excreted into saliva, which can be partly predicted by a drug's ionisation state, protein binding, lipophilicity, hydrogen bond donor count and polar surface area. The contribution of drug transporters and physiological factors to the excretion needs to be evaluated. Continued research on drugs potentially suitable for saliva-based TDM will aid in adopting this person-centred TDM approach to improve patient outcomes.

Pediatric dentistry systematic reviews using the GRADE approach: methodological study

BackgroundTo assess the reporting of the certainty of the evidence using the GRADE approach in systematic reviews of interventions in pediatric dentistry.MethodsThe inclusion criteria were systematic reviews of randomized clinical trials (RCTs) and non-randomized studies of interventions (NRSIs) in pediatric dentistry that reported the certainty of the evidence through the GRADE approach. Paired independent reviewers screened the studies, extracted data, and appraised the methodological quality using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR 2) tool. The certainty of the evidence was extracted for each outcome. A descriptive analysis was conducted.ResultsAround 28% of pediatric dentistry reviews of interventions used the GRADE approach (n = 24). Twenty reviews reported 112 evidence outcomes from RCTs and 13 from NRSIs using GRADE evidence profile tables. The methodological quality was high (16.7%), moderate (12.5%), low (37.5%), and critically low (33.3%), fulfilling the majority of the AMSTAR 2 criteria. The certainty of the evidence for outcomes generated from RCTs and NRSIs was very low (40.2% and 84.6%), low (33.1% and 7.7%), moderate (17.8% and 7.7%), and high (9.8% and 0.0%). The main reasons to downgrade the certainty were due to (for RCTs and NRSIs, respectively): risk of bias (68.8% and 84.6%), imprecision (67.8% and 100.0%), inconsistency (18.8% and 23.1%), indirectness (17.8% and 0.0%), and publication bias (7.1% and 0.0%).ConclusionThe proportion of systematic reviews assessing the certainty of the evidence using the GRADE approach was considered small, considering the total initial number of published pediatric dentistry reviews of intervention. The certainty of the evidence was mainly very low and low, and the main problems for downgrading the certainty of evidence were due to risk of bias and imprecision.RegistrationPROSPERO database #CRD42022365443.

Complications of Superomedial Versus Inferior Pedicle Reduction Mammaplasty: A Systematic Review and Meta-Analysis.

The superomedial pedicle reduction mammoplasty has gained popularity and is an important alternative approach for reduction mammoplasty, while the inferior pedicle reduction mammaplasty remains by far the most performed as it is considered to provide the best vascularization to the nipple-areola complex, allowing safe removal of large amount of redundant tissue. The authors conducted the first systematic review and meta-analysis in an attempt to declare the differences of the superomedial pedicle versus the inferior pedicle reduction technique by comparing the postoperative complications. PubMed, MEDLINE, and Cochrane Library for clinical studies were queried from inception to January 1, 2024. Review Manager Version 5.4 was used for this meta-analysis. A random effects model was applied to OR, and 95%CI were determined using the Mantel-Haenszel method. The I2 test was used to assess heterogeneity, and the Newcastle-Ottawa scale was used to assess the risk of bias in the nonrandomized studies. Twelve observational comparative studies were included. The superomedial pedicle technique had a statistically lower rate of overall complications (OR 0.59, 95% CI 0.47-0.75; p < 0.0001) and delayed wound healing (OR 0.46, 95% CI 0.33-0.64; p < 0.00001) than the inferior pedicle technique. No significant differences in wound dehiscence, infection, seroma, hematoma, skin necrosis, fat necrosis, NAC necrosis, nipple sensation decrease or loss, asymmetry, hypertrophic scarring, and reoperation were noted. Both two techniques are equally safe and reliable, while the superomedial pedicle technique resulted in a statistically lower rate of overall complications and delayed wound healing. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Does the Application of Topical Vancomycin Reduce Surgical Site Infections in Spine Surgery? A Meta-analysis of Randomized Controlled Trials.

Surgical site infections (SSIs) represent a major challenge in spine surgery, leading to severe morbidity, mortality, and increased costs. The local application of antibiotics, particularly vancomycin, has emerged as a potential strategy. Individual randomized controlled trials (RCTs) have disagreed about the efficacy of topical vancomycin in preventing SSIs after spine surgery, and so a meta-analysis that pools data from those RCTs might be helpful to inform clinicians' decisions on the topic. This meta-analysis of RCTs asked: Does intrawound topical vancomycin reduce the risk of (1) SSIs, (2) deep SSIs, and (3) superficial SSIs in patients undergoing spine surgery? PubMed, Cochrane, and Google Scholar (pages 1-20) were searched up through March 13, 2024 (search performed on March 13, 2024). Inclusion criteria consisted of English or non-English-language RCTs comparing the implementation of topical vancomycin in spine surgery to its nonuse and assessing its efficacy in preventing SSI, while exclusion criteria consisted of nonrandomized comparative studies, single-arm noncomparative studies, comparative studies based on national databases or from the same center as other included studies, studies posted to preprint servers, studies reporting incomplete/nonrelevant outcomes, and studies adding another SSI preventive measure. The studies were assessed using the Cochrane Risk of Bias tool. Heterogeneity was evaluated by Q tests and I2 statistics. We used a random-effects model when considerable heterogeneity was observed (all SSIs, deep SSIs); otherwise, a fixed-effects model was used (all SSIs subanalysis, superficial SSIs). Furthermore, the fragility index was calculated for each of the assessed outcomes when there was no difference between the two groups to assess how many patients were needed to experience the outcomes for a difference to become present. The studied outcomes were the risks of SSIs, deep SSIs, and superficial SSIs. Deep SSIs were defined by the included trials as SSIs underneath the fascia, otherwise they were considered superficial. Six RCTs representing a total of 2140 patients were included, with 1053 patients in the vancomycin group and 1087 in the control group. Using an alpha of 0.05, our meta-analysis had 80% power to detect a risk difference of 1.5% for the primary outcome between patients who did and did not receive vancomycin. The age of the patients in the vancomycin group ranged from 37 to 52 years, while the age in the control group ranged from 34 to 52 years. The surgical procedures consisted of both instrumented and noninstrumented spinal procedures. Overall, the risk of bias in the included studies was either low or unclear, with none of the studies having a high risk of bias in any of the assessed categories (selection bias, performance bias, detection bias, attrition bias, and reporting bias). We found no difference in the risk of SSI between the vancomycin and control groups (3.0% [32 of 1053] versus 3.9% [42 of 1087], relative risk 0.74 [95% CI 0.35 to 1.57]; p = 0.43). Ten additional patients (4.8% infection risk) in the control group would need to experience an SSI for a difference to be observed between the two groups. We found no difference in the risk of deep SSI between the vancomycin and control groups (1.8% [15 of 812] versus 2.7% [23 of 860], relative risk 0.69 [95% CI 0.24 to 2.00]; p = 0.50). Seven additional patients (3.5% infection risk) in the control group would need to experience a deep SSI for a difference to be observed between the two groups. We found no difference in the risk of superficial SSI between the vancomycin and control groups (1.0% [6 of 620] versus 1.4% [9 of 662], relative risk 0.68 [95% CI 0.25 to 1.89]; p = 0.46). Seven additional patients (2.4% infection risk) in the control group would need to experience a superficial SSI for a difference to be observed between the two groups. This meta-analysis of randomized trials examining use of topical vancomycin in spine surgery failed to show efficacy in reducing infection, and thus we do not recommend routine use of topical vancomycin for this indication. Future large-scale trials would be needed if surgeons believe that between-group differences smaller than those for which we were powered here (this meta-analysis had 80% power to detect a between-group difference of 1.5% in infection risk) are clinically important, and large database surveys may be informative in terms of assessing for postoperative adverse events associated with the use of vancomycin powder. Level I, therapeutic study.

Outcomes of a Virtual Day Treatment Program for Adults With Eating Disorders-Comparison With In-Person Day Treatment.

Previous studies have indicated that virtual treatments for eating disorders (EDs) are roughly as effective as are in-person treatments; the present nonrandomized study aimed to expand on the current body of evidence by comparing outcomes from a virtual day treatment program with those of an in-person program in an adult ED sample. Participants were 109 patients who completed at least 60% of day treatment sessions (n = 55 in-person and n = 54 virtual). Outcome measures included ED and comorbid symptoms, and motivation. Linear mixed models showed that global EDE-Q scores decreased during treatment (AIC = 376.396, F = 10.94, p = 0.002), irrespective of treatment modality (p = 0.186). BMI significantly increased over time (AIC = 389.029, F = 27.97, p < 0.001), with no effect of treatment modality (p = 0.779). Our findings suggest that the virtual delivery of day treatments produces comparable outcomes to those obtained using in-person formats, and that virtual formats may represent a pragmatic treatment option, especially in situations in which access to in-person care is limited.

Laboratory-confirmed respiratory viral infection triggers for acute myocardial infarction and stroke: Systematic review protocol.

Cardiovascular disease contributes substantially to global mortality and morbidity. Respiratory tract infections, particularly influenza, may trigger an increase in the short-term risk of acute myocardial infarction (AMI) and stroke. Recent studies have also linked this risk to other respiratory viruses, including respiratory syncytial virus (RSV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, the pathogen-specific relative contributions, the strength of their associations, and overall public health significance are poorly understood. Assuming causal links, understanding, quantifying, and comparing the effects of different pathogens as triggering factors for acute cardiovascular events is critical to guide future research and prevention. Our aim is to conduct a systematic review to examine the relative effects of laboratory-confirmed respiratory virus infections as triggers for acute myocardial infarction and stroke. We will conduct a comprehensive search of Ovid MEDLINE, PubMed, Ovid Embase, Cochrane Library Central Register of Controlled Trials, and Web of Science, from inception to the end of March 2024. Studies capturing respiratory viral infection(s) using laboratory-confirmatory methods, incidence of AMI or stroke (ischaemic or haemorrhagic), and those involving human participants in any country, will be assessed for eligibility. We will include the following analytical epidemiological study types: randomised controlled trials, cohort and case-control studies, self-controlled case series, and case-crossover designs. We will not impose restrictions on the date, language, study population, geographical region, or sample size, to minimise the risk of introducing biases. Search results will be screened for eligibility by two independent reviewers, and discrepancies resolved by consensus and/or arbitration by a third reviewer. We will assess the risk of bias among the included studies by adopting the Cochrane Collaboration tools for randomised and non-randomised studies. The overall quality of studies will be assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. We will examine sources of heterogeneity, and if studies are sufficiently homogeneous, a meta-analysis will be conducted to calculate the pooled effect sizes. Reporting will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. International Prospective Register of Systematic Reviews (PROSPERO) registration number: CRD42024494997.

Three and twelve-month analysis of the PROM-Q study: comparison of patient-reported outcome measures using the BREAST-Q questionnaire in pre- vs. sub-pectoral implant-based immediate breast reconstruction.

Implant-based breast reconstruction (IBR) is being increasingly performed with implant placed above the pectoral muscle (pre-pectoral), instead of below the pectoral muscle (sub-pectoral). Currently, there is a lack of comparative data on clinical and patient-perceived outcomes between pre- vs. sub-pectoral IBR. We investigated whether this difference in surgical approach influenced clinical or patient-perceived outcomes. This prospective non-randomised longitudinal cohort study (ClinicalTrials.gov identifier: NCT04842240) recruited patients undergoing immediate IBR at the Leeds Breast Unit (Sep 2019-Sep 2021). Data collection included patient characteristics and post-operative complications. Patient-Reported Outcome Measures were collected using the BREAST-Q questionnaire at baseline, 2 weeks, 3- and 12-months post-surgery. Seventy-eight patients underwent IBR (46 patients pre-pectoral; 59% vs. 32 patients sub-pectoral; 41%). Similar complication rates were observed (15.2% pre-pectoral vs. 9.4% sub-pectoral; p = 0.44). Overall implant loss rate was 3.8% (6.5% pre-pectoral vs. 0% sub-pectoral; p = 0.13). Respective median Breast-Q scores for pre- and sub-pectoral IBR at 3 months were: breast satisfaction (58 vs. 48; p = 0.01), psychosocial well-being (60 vs. 57; p = 0.9), physical well-being (68 vs. 76; p = 0.53), and Animation Q scores (73 vs. 76; p = 0.45). Respective Breast-Q scores at 12 months were: breast satisfaction (58 vs. 53; p = 0.3), psychosocial well-being (59 vs. 60; p = 0.9), physical well-being (68 vs. 78; p = 0.18), and Animation Q scores (69 vs. 73; p = 0.4). This study demonstrates equivalent clinical and patient-perceived outcomes between pre- and sub-pectoral IBR. The study findings can be utilised to aid informed decision making regarding either surgical option.

Three and twelve-month analysis of the PROM-Q study: comparison of patient-reported outcome measures using the BREAST-Q questionnaire in pre- vs. sub-pectoral implant-based immediate breast reconstruction.

Implant-based breast reconstruction (IBR) is being increasingly performed with implant placed above the pectoral muscle (pre-pectoral), instead of below the pectoral muscle (sub-pectoral). Currently, there is a lack of comparative data on clinical and patient-perceived outcomes between pre- vs. sub-pectoral IBR. We investigated whether this difference in surgical approach influenced clinical or patient-perceived outcomes. This prospective non-randomised longitudinal cohort study (ClinicalTrials.gov identifier: NCT04842240) recruited patients undergoing immediate IBR at the Leeds Breast Unit (Sep 2019-Sep 2021). Data collection included patient characteristics and post-operative complications. Patient-Reported Outcome Measures were collected using the BREAST-Q questionnaire at baseline, 2 weeks, 3- and 12-months post-surgery. Seventy-eight patients underwent IBR (46 patients pre-pectoral; 59% vs. 32 patients sub-pectoral; 41%). Similar complication rates were observed (15.2% pre-pectoral vs. 9.4% sub-pectoral; p = 0.44). Overall implant loss rate was 3.8% (6.5% pre-pectoral vs. 0% sub-pectoral; p = 0.13). Respective median Breast-Q scores for pre- and sub-pectoral IBR at 3 months were: breast satisfaction (58 vs. 48; p = 0.01), psychosocial well-being (60 vs. 57; p = 0.9), physical well-being (68 vs. 76; p = 0.53), and Animation Q scores (73 vs. 76; p = 0.45). Respective Breast-Q scores at 12 months were: breast satisfaction (58 vs. 53; p = 0.3), psychosocial well-being (59 vs. 60; p = 0.9), physical well-being (68 vs. 78; p = 0.18), and Animation Q scores (69 vs. 73; p = 0.4). This study demonstrates equivalent clinical and patient-perceived outcomes between pre- and sub-pectoral IBR. The study findings can be utilised to aid informed decision making regarding either surgical option.

Online vs. face-to-face interactive communication education using video materials among healthcare college students: a pilot non-randomized controlled study

BackgroundThis study aimed to examine whether online interactive communication education using video materials was as effective as face-to-face education among healthcare college students.MethodsThe participants were healthcare college students who were enrolled in study programs to obtain national medical licenses. They participated in lectures and exercises on healthcare communication, both online (n = 139) and face-to-face (n = 132). Listening skills, understanding, and confidence in healthcare communication were assessed using a self-assessed tool.ResultsFrom the two-way ANOVA result, the interaction effects between group (online, face-to-face) and time (Time 1, Time 2, Time 3) were not statistically significant. The main effect of time increased significantly from Time1 to Time 3 on understanding of communication with patients (Hedges’g = 0.51, 95%CI 0.27–0.75), confidence in communication with patients (g = 0.40, 95%CI 0.16–0.64), and confidence in clinical practice (g = 0.49, 95%CI 0.25, 0.73), while the score of listening skills had no significant change (Hedges’g = 0.09, 95%CI − 0.03 to 0.45).ConclusionsThe results show that online communication education with video materials and active exercises is as effective in improving students’ confidence as face-to-face. It will be necessary to modify the content of this educational program to improve skills as well as confidence in communication.Trial registrationNot Applicable.

Effectiveness of residential versus outpatient therapy for smoking cessation: The START randomized clinical trial.

Tobacco smoking represents a major cause for preventable death and morbidity. Results from non-randomized studies suggest that smoking cessation therapy in a residential setting might be a new viable way to facilitate smoking abstinence. We aimed to test the effects of residential multicomponent group therapy for smoking cessation compared with outpatient group therapy. Prospective parallel-group open-label randomized superiority trial, with assessments at baseline, 6 and 12 months. Recruitment throughout Germany via media advertisements. Adult smokers (≥10 cigarettes/day) randomly assigned to residential (n = 157) or outpatient (n = 158) therapy. 51.8% female; mean age 53.2 years; mean years of smoking 34.4. Residential 9-day smoking cessation group therapy comprising six daily therapy sessions and supportive interventions for cessation and daily structure embedded in the routines of a somatic rehabilitation center, compared with weekly outpatient smoking cessation group therapy (3-7weeks) provided in routine care courses close to the participants' places of residence, both including at least 9h of behavioral therapy. Co-primary outcomes were self-reported continuous 6- and 12-month abstinence (hierarchically ordered). Primary analyses were conducted in the therapy-uptake population including participants who started therapy with sensitivity analyses in the intention-to-treat population of all randomized participants. Intervention uptake rates were 87.3% (n = 137) in the residential and 60.1% (n = 95) in the outpatient group. In the therapy-uptake population, abstinence rates were 46.7% in the residential versus 26.3% in the outpatient group at 6 months (odds ratio [OR] = 2.46, 95% confidence interval [CI] = 1.39-4.33, P = 0.0019) and 39.4% versus 24.2% at 12 months (OR = 2.04, 95% CI = 1.14-3.64, P = 0.017). Biochemically validated abstinence rates at 12 months were 33.1% in the residential versus 17.4% in the outpatient group (OR = 2.35, 95% CI = 1.22-4.51, P = 0.011). In the intention-to-treat population, self-reported and biochemically validated abstinence rates at 12 months were 34.4% in the residential versus 14.6% in the outpatient group (OR = 3.08, 95% CI = 1.77-5.34, P < 0.0001) and 28.6% versus 10.3% (OR = 3.48, 95% CI = 1.85-6.52, P = 0.0001), respectively. Residential therapy exclusively for smoking cessation is feasible and effective and could be a beneficial new treatment for smokers.

Effectiveness of residential versus outpatient therapy for smoking cessation: The START randomized clinical trial.

Tobacco smoking represents a major cause for preventable death and morbidity. Results from non-randomized studies suggest that smoking cessation therapy in a residential setting might be a new viable way to facilitate smoking abstinence. We aimed to test the effects of residential multicomponent group therapy for smoking cessation compared with outpatient group therapy. Prospective parallel-group open-label randomized superiority trial, with assessments at baseline, 6 and 12 months. Recruitment throughout Germany via media advertisements. Adult smokers (≥10 cigarettes/day) randomly assigned to residential (n = 157) or outpatient (n = 158) therapy. 51.8% female; mean age 53.2 years; mean years of smoking 34.4. Residential 9-day smoking cessation group therapy comprising six daily therapy sessions and supportive interventions for cessation and daily structure embedded in the routines of a somatic rehabilitation center, compared with weekly outpatient smoking cessation group therapy (3-7weeks) provided in routine care courses close to the participants' places of residence, both including at least 9h of behavioral therapy. Co-primary outcomes were self-reported continuous 6- and 12-month abstinence (hierarchically ordered). Primary analyses were conducted in the therapy-uptake population including participants who started therapy with sensitivity analyses in the intention-to-treat population of all randomized participants. Intervention uptake rates were 87.3% (n = 137) in the residential and 60.1% (n = 95) in the outpatient group. In the therapy-uptake population, abstinence rates were 46.7% in the residential versus 26.3% in the outpatient group at 6 months (odds ratio [OR] = 2.46, 95% confidence interval [CI] = 1.39-4.33, P = 0.0019) and 39.4% versus 24.2% at 12 months (OR = 2.04, 95% CI = 1.14-3.64, P = 0.017). Biochemically validated abstinence rates at 12 months were 33.1% in the residential versus 17.4% in the outpatient group (OR = 2.35, 95% CI = 1.22-4.51, P = 0.011). In the intention-to-treat population, self-reported and biochemically validated abstinence rates at 12 months were 34.4% in the residential versus 14.6% in the outpatient group (OR = 3.08, 95% CI = 1.77-5.34, P < 0.0001) and 28.6% versus 10.3% (OR = 3.48, 95% CI = 1.85-6.52, P = 0.0001), respectively. Residential therapy exclusively for smoking cessation is feasible and effective and could be a beneficial new treatment for smokers.

Patient-Specific Factors Predicting Renal Denervation Response in Patients With Hypertension: A Systematic Review and Meta-Analysis.

The accurate selection of patients likely to respond to renal denervation (RDN) is crucial for optimizing treatment outcomes in patients with hypertension. This systematic review was designed to evaluate patient-specific factors predicting the RDN response. We focused on individuals with hypertension who underwent RDN. Patients were categorized based on their baseline characteristics. The primary outcome was blood pressure (BP) reduction after RDN. Both randomized controlled trials and nonrandomized studies were included. We assessed the risk of bias using corresponding tools and further employed the Grading of Recommendations Assessment, Development, and Evaluation approach to assess the overall quality of evidence. A total of 50 studies were ultimately included in this systematic review, among which 17 studies were for meta-analysis. Higher baseline heart rate and lower pulse wave velocity were shown to be associated with significant antihypertensive efficacy of RDN on 24-hour systolic BP reduction (weighted mean difference, -4.05 [95% CI, -7.33 to -0.77]; weighted mean difference, -7.20 [95% CI, -9.79 to -4.62], respectively). In addition, based on qualitative analysis, higher baseline BP, orthostatic hypertension, impaired baroreflex sensitivity, and several biomarkers are also reported to be associated with significant BP reduction after RDN. In patients with hypertension treated with the RDN, higher heart rate, and lower pulse wave velocity were associated with significant BP reduction after RDN. Other factors, including higher baseline BP, hypertensive patients with orthostatic hypertension, BP variability, impaired cardiac baroreflex sensitivity, and some biomarkers are also reported to be associated with a better BP response to RDN.

In-person psychoeducational intervention to reduce rehospitalizations and improve the clinical course of major depressive disorder: a non-randomized pilot study

BackgroundEmerging issues in the management of major depressive disorder (MDD) comprise a nonadherence to treatment and treatment failures, depressive recurrence and relapses, misidentification of incoming exacerbated phases and consequently, a chronification of depression. While antidepressant drugs constitute the standard of care for MDD, effective psychosocial interventions are needed to reduce rehospitalizations and other adverse events. The present study primarily investigated the effects and impact of implementing a structured psychoeducational intervention on the clinical course of MDD.MethodsA non-randomized comparative, pragmatic, pilot, single-center study of adults with nonpsychotic moderate or severe episode of MDD recently discharged from a psychiatric hospitalization. The consecutive subjects were allocated either to the intervention group (N=49) or to the attention control group (N=47), based on their preference. The psychoeducational intervention was based on a modified Munoz’s Depression Prevention Course. Subjects were followed up prospectively for two years.ResultsThe absolute changes in Beck anxiety inventory scale, Zung’s depression questionnaire, and Montgomery and Äsberg depression rating scale (MADRS) total scores at 6-month follow-up were comparable between the two groups. There were lower rates of the rehospitalization within one year (2.1% vs. 16.7%; P&amp;lt;0.001) and less rehospitalizations after one year (6.3% vs. 25%; P&amp;lt;0.001), lower rates of the ongoing sickness absence (11.5% vs. 29.2%; P&amp;lt;0.001), less persons with disability due to MDD at 1-year follow-up (1% vs. 11.5%; P=0.002), and less nonadherent subjects who self-discontinued treatment (6.3% vs. 28.1%; P&amp;lt;0.001) among participants in the intervention group compared to the control group. The disability due to MDD at 1-year follow-up was predicted by the absence of the psychoeducational intervention (P=0.002) and by the MADRS total score at 6-month follow-up (OR 1.10; 95% CI 1.003–1.195; P=0.044). Qualitative data indicated the intervention was desired and appreciated by the participants, as well as being practical to implement in Slovakian clinical settings.ConclusionThe results suggest the psychoeducational intervention based on a modified Munoz’s Depression Prevention Course has beneficial effects in adults with MDD recently discharged from a psychiatric hospitalization. The findings implicate the psychoeducational intervention may offer a new approach to the prevention of depressive relapses.

AI for detection, classification and prediction of loss of alignment of distal radius fractures; a systematic review.

Early and accurate assessment of distal radius fractures (DRFs) is crucial for optimal prognosis. Identifying fractures likely to lose threshold alignment (instability) in a cast is vital for treatment decisions, yet prediction tools' accuracy and reliability remain challenging. Artificial intelligence (AI), particularly Convolutional Neural Networks (CNNs), can evaluate radiographic images with high performance. This systematic review aims to summarize studies utilizing CNNs to detect, classify, or predict loss of threshold alignment of DRFs. A literature search was performed according to the PRISMA. Studies were eligible when the use of AI for the detection, classification, or prediction of loss of threshold alignment was analyzed. Quality assessment was done with a modified version of the methodologic index for non-randomized studies (MINORS). Of the 576 identified studies, 15 were included. On fracture detection, studies reported sensitivity and specificity ranging from 80 to 99% and 73-100%, respectively; the AUC ranged from 0.87 to 0.99; the accuracy varied from 82 to 99%. The accuracy of fracture classification ranged from 60 to 81% and the AUC from 0.59 to 0.84. No studies focused on predicting loss of thresholds alignement of DRFs. AI models for DRF detection show promising performance, indicating the potential of algorithms to assist clinicians in the assessment of radiographs. In addition, AI models showed similar performance compared to clinicians. No algorithms for predicting the loss of threshold alignment were identified in our literature search despite the clinical relevance of such algorithms.

Interactive voice response (IVR) for tobacco cessation: a systematic review

ObjectiveTo summarise the uses, outcomes and implementation of interactive voice response (IVR) as a tobacco cessation intervention.Data sourcesA systematic review was conducted. Searches were performed on 3 May 2023. The...

Effects of Immersive Technology-based Education for Undergraduate Nursing Students: A Systematic Review and Meta-Analysis using the GRADE approach.

The adoption of immersive technology in simulation-based nursing education has grown significantly, offering a solution to resource limitations and enabling safe access to clinical environments. Despite its advantages, there are still diverse reports regarding the effectiveness of immersive technology. It is crucial to verify the effectiveness of immersive technology in nursing education to inform future educational programs. This systematic review aimed to identify the contents of immersive technology-based education for undergraduate nursing students and evaluate the effectiveness of immersive technology compared to traditional teaching methods. A literature search was performed using four databases: PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase, and Web of Science, with the latest search completed on January 19, 2023. The inclusion criteria were as follows: participants were undergraduate nursing students; studies were published in Korean or English; designs included randomized controlled trials (RCTs) or non-randomized studies; and interventions involved virtual reality (VR), augmented reality (AR), mixed reality (MR), or extended reality (XR). Quality assessment was conducted using Version 2 of the Cochrane risk of bias tool (RoB 2) for RCTs and the Risk of Bias Assessment Tool for Non-Randomized Studies (RoBANS). The main outcomes of the included studies were classified according to the New World Kirkpatrick Model (NWKM), ranging from Level 1 (Reaction) to Level 4 (Results). Meta-analysis was conducted using RevMan 5.4 software, and subgroup analysis was conducted due to heterogeneity of the results of meta-analysis. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach was adopted for assessing certainty and synthesizing results of the relevant literature. A total of 23 studies were included, with participants numbers ranging from 33 to 289. Nineteen studies adopted VR to simulate various nursing scenarios, including disaster training, resuscitation, health assessments, and home healthcare. Four studies utilized AR technologies. Fifteen studies involved virtual patients in their scenarios. Based on NWKM, the main outcome variables were classified as Level 1 (usability and satisfaction), Level 2 (knowledge, motivation, confidence, performance, attitude, and self-efficacy), and Level 3 (clinical reasoning). Level 4 outcomes were not found in selected studies. Results of the subgroup analysis of meta-analysis showed that immersive technology-based nursing education was more effective than traditional education on knowledge attainment (standard mean difference (SMD)=0.59, 95% confidence interval (CI)=0.28-0.90, P<.001, I2=49%). Additionally, there were significant difference differences between the experimental groups and the control groups in confidence (SMD=0.70, 95% CI= 0.05-1.35, P=.03, I2=82%), and self-efficacy (SMD=0.86, 95% CI= 0.42-1.30; P<.001, I2=63%). These findings support the effectiveness of immersive technology-based education for undergraduate nursing students, despite heterogeneity in methods and interventions. We suggest that long-term cohort studies should be conducted to evaluate the effects of immersive technology-based nursing education on the NWKM Level 4.

Agreement and repeatability of scotopic pupil size measurement with the 2WIN-S portable refractor in Chinese adults

To assess the agreement and repeatability of scotopic pupil size measurement using 2WIN-S (Adaptica, Padova, Italy) portable refractor in Chinese adults. This prospective non-randomized open-label controlled study assessed the scotopic pupil size of 100 right eyes using OPD-Scan III (Optical path difference) (Nidek Technologies, Gamagori, Japan) and 2WIN-S. OPD-Scan III and 2WIN-S measure pupil size using infrared light and detector, while 2WIN-S measures bilateral eyes simultaneously, OPD-Scan III measures unilateral eyes individually. Participants were first measured once using OPD-Scan III and two consecutive measurements were performed using 2WIN-S after 15 min of rest interval. The primary outcome was to evaluate the agreement between 2WIN-S and OPD-Scan III, and the secondary outcome was to evaluate the repeatability of 2WIN-S. Scotopic pupil size of 100 right eyes of 100 adults (28 male and 72 female) aged 18–53 years (mean 36 ± 12 years) was assessed using OPD-Scan III and 2WIN-S, respectively. The mean scotopic pupil size of OPD-Scan III and 2WIN-S was recorded to be 6.24 ± 0.88 mm and 6.27 ± 0.81 mm, respectively. For the mean scotopic pupil size of OPD-Scan III and 2WIN-S the difference was − 0.03 mm (95%CI − 0.10 to 0.04 mm), p = 0.445, the 95% limits of agreement (LOA) was − 0.71 to 0.66 mm. ICC between the two devices was 0.92 (95% CI 0.88–0.94) (ICC > 0.9 indicates excellent consistency). Coefficients of repeatability (CoR) of 2WIN-S was 0.37, which has a high repeatability. For the mean scotopic pupil size of 2WIN-S of the repeated measurements, the difference was -0.04 mm (95%CI − 0.08 to 0.01 mm), p = 0.019, the 95% limits of agreement (LOA) was − 0.41 to 0.32 mm, with a narrow LOA. However, the majority of the variations were less than ± 0.50 mm (98% of scotopic pupil size measurements were below this threshold), within the clinically acceptable range (± 0.50 mm). Our study showed excellent agreement between 2WIN-S and OPD-Scan III (ICC > 0.9) and a good repeatability of 2WIN-S (CoR = 0.37). This study suggests a novel technique for measuring pupillary responses in low light conditions, which can be considered an alternative to OPD-Scan III in clinical settings.

Antiplatelet therapy to prevent ischemic events in giant cell arteritis: protocol for a systematic review and meta-analysis

BackgroundGiant cell arteritis (GCA) is the most common systemic vasculitis in adults. Presenting features include new-onset headaches, constitutional symptoms, jaw claudication, polymyalgia rheumatica, and visual symptoms. Arterial inflammation with subsequent stenosis and occlusion may cause tissue ischemia, leading to blindness, strokes, and myocardial infarction. Oral antiplatelet therapy has been hypothesized to reduce GCA-related ischemic events. However, previous studies have demonstrated conflicting results regarding the efficacy of antiplatelet agents in GCA. The objective of this systematic review is to assess the safety and efficacy of antiplatelet therapy for the prevention of these events in adults with giant cell arteritis.MethodsIn this systematic review, we will include randomized controlled trials (RTCs), quasi-randomized trials, non-randomized intervention studies, cohort studies, and case–control studies on patients with new-onset or relapsing GCA. The intervention of interest will be pre-existing use or initiation of an oral antiplatelet medication (aspirin, clopidogrel, prasugrel, or ticagrelor) at GCA onset or relapse. The comparator of interest will be the absence of antiplatelet therapy. Endpoints will be evaluated after 6 and 12 months of follow-up. The primary outcome will be GCA-related ischemic events, including permanent blindness, stroke, myocardial infarction, and ischemic event-related deaths. Adverse events such as major bleeding and death caused by a bleeding event will be assessed.DiscussionGCA-related ischemic events are catastrophic, sudden, often irreversible, and lead to significant morbidity. Antiplatelet agents are affordable, accessible, and could be effective for the prevention of these events. Nevertheless, the potential benefits of platelet aggregation inhibition must be weighed against their associated risk of bleeding. Assessing the efficacy and safety of antiplatelet therapy in GCA is therefore clinically important.Systematic review registrationOur systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO, registration number CRD42023441574.