Cutting back on low-value health care practices supports sustainable kidney care.

July 2023 marked the hottest month on record, underscoring the urgent need for action on climate change. The imperative to reduce carbon emissions extends to all sectors, including health care, with it being responsible for 5.5% of global emissions. In decarbonizing health care, although much attention has focused on greening health care infrastructure and procurement, less attention has focused on reducing emissions through demand-side management. An important key element of this is reducing low-value care, given that ≈20% of global health care expenditure is considered low value. "Value" in health care, however, is subjective and dependent on how health outcomes are regarded. This review, therefore, examines the 3 main value perspectives specific to health care. Clinical effectiveness defines low-value care as interventions that offer little to no benefit or have a risk of harm exceeding benefits. Cost-effectiveness compares health outcomes versus costs compared with an alternative treatment. In this case, low-value care is care greater than a societal willingness to pay for an additional unit of health (quality-adjusted life year). Last, community perspectives emphasize the value of shared decision-making and patient-centered care. These values sit within broader societal values of ethics and equity. Any reduction in low-value care should, therefore, also consider patient autonomy, societal value perspectives and opportunity costs, and equity. Deimplementing entrenched low-value care practices without unnecessarily compromising ethics and equity will require tailored strategies, education, and transparency.

Assessing the clinical and cost-effectiveness of inpatient mental health rehabilitation services provided by the NHS and independent sector (ACER): protocol.

BACKGROUND: Mental health rehabilitation services provide specialist treatment to people with particularly severe and complex problems. In 2018, the Care Quality Commission reported that over half the 4,400 mental health inpatient rehabilitation beds in England were provided by the independent sector. They raised concerns that the length of stay and cost of independent sector care was double that of the NHS and that their services tended to be provided much further from people's homes. However, there has been no research comparing the two sectors and we therefore do not know if these concerns are justified. The ACER Study (Assessing the Clinical and cost-Effectiveness of inpatient mental health Rehabilitation services provided by the NHS and independent sector) is a national programme of research in England, funded from 2021 to 2026, that aims to investigate differences in inpatient mental health rehabilitation provided by the NHS and independent sector in terms of: patient characteristics; service quality; patient, carer and staff experiences; clinical and cost effectiveness. METHODS: ACER comprises a:1) detailed survey of NHS and independent sector inpatient mental health rehabilitation services across England; 2) qualitative investigation of patient, family, staff and commissioners' experiences of the two sectors; 3) cohort study comparing clinical outcomes in the two sectors over 18 months; 4) comprehensive national comparison of inpatient service use in the two sectors, using instrumental variable analysis of routinely collected healthcare data over 18 months; 5) health economic evaluation of the relative cost-effectiveness of the two sectors. In Components 3 and 4, our primary outcome is 'successful rehabilitation' defined as a) being discharged from the inpatient rehabilitation unit without readmission and b) inpatient service use over the 18 months. DISCUSSION: The ACER study will deliver the first empirical comparison of the clinical and cost-effectiveness of NHS and independent sector inpatient mental health rehabilitation services. TRIAL REGISTRATION: ISRCTN17381762 retrospectively registered.

Study on medical dispute prediction model and its clinical-application effectiveness based on machine learning.

BACKGROUND: Medical dispute is a global public health issue, which has been garnering increasing attention. In this study, we used machine learning (ML) method to establish a dispute prediction model and explored the clinical-application efficiency of this model in effectively reducing the occurrence of medical disputes. METHODS: Retrospective study of All disputes filed by Gansu Medical Mediation Committee from 2019 to 2021 and patients with the same hospital level as that of the dispute group and hospitalization year were randomly selected as the control group in 1:1 ratio. SPSS software was used for univariate feature selection of the 14 factors that may cause disputes, and factors with statistical differences were selected. The data were divided into training and test sets in a 7:3 ratio. Six ML models were selected, and Python was used to establish a dispute prediction model. The area under the curve (AUC) of the receiver operating characteristic curve (ROC), sensitivity, specificity, accuracy, precision, average precision (AP), and F1 score were used to characterize the fitting and accuracy of the models, while decision curve analysis (DCA) was used to evaluate their clinical utility. RESULTS: A total of 1189 patients in the dispute and control groups were extracted. Following 11 influencing factors were selected: the inpatient department, doctor title, patient age, patient gender, patient occupation, payment method, hospitalization days, hospitalization times, discharge method, blood transfusion volume, and hospitalization espenses. Compared to other models, the AUC (0.945, 95% CI 0.913-0.981), Sensitivity (0.887), Accuracy (0.887), AP (0.834), and F1 score (0.880) of the random forest model were higher than those of other models, while the DCA curve indicated its high clinical benefits. CONCLUSIONS: Inpatient department, hospitalization expenses, and discharge type are the primary influencing factors of dispute. Random forest exhibited high dispute prediction and clinical-application value and is expected to be promoted for offline dispute prediction.

Shedding new light for nurses: Enhancing pressure injury prevention across skin tones with sub-epidermal moisture assessment technology.

AIM(S): To assess the effectiveness of sub-epidermal moisture (SEM) assessment technology in the detection of early-stage pressure damage in a critical care unit (CCU) and dark skin tone patients and its impact on hospital-acquired pressure injury (HAPI) incidence. DESIGN: Quality improvement study employing Kurt Lewin's change model emphasizing planning, implementation, evaluation and sustainable change. METHODS: The study evaluated 140 adult patients admitted to the CCU over a 24-week period, from July to December 2022. Retrospective analysis of standard PI care pathways was performed in 90 patients admitted during a 12-week pre-implementation period. Fifty patients were admitted through the subsequent 12-week implementation period. SEM assessments were performed daily at the sacrum and heels and interventions were applied based on SEM assessments; SEM delta ≥0.6 indicating localized oedema or persistent focal oedema. Statistical analyses were performed on anonymized data. RESULTS: Pre-implementation HAPI incidence was 8.9% (N = 8/90). All eight patients were African American with varying skin tones. A 100% reduction in HAPI incidence was achieved in the implementation period which included 35 African American patients. The relative risk of HAPI incidence was 1.6 times higher in the pre-implementation group. CONCLUSION: Implementing SEM assessment technology enabled equitable PI care for all population types and resulted in a 100% reduction of PIs in our CCU. Objective SEM assessments detected early-stage PIs, regardless of skin tone and enabled providing interventions to specific anatomies developing tissue damage as opposed to universal preventive interventions. IMPLICATIONS: PI care pathways relying on visual and tactile skin assessments are inherently biased in providing equitable care for dark skin tone patients. Implementing SEM assessments empowers healthcare practitioners in driving objective clinical interventions, eliminates bias and enables positive PI health outcomes. IMPACT: Implementing SEM assessment technology had three main effects: it detected early tissue damage regardless of skin tone (detection effect), enabled anatomy-specific interventions (treatment effect) and prevented PIs across all population types (prevention effect). The authors have adhered to the Standards for Quality Improvement Reporting Excellence (SQUIRE) 2.0 guidelines. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution. What does this paper contribute to the wider global clinical community? Addressing health inequities in pressure injury prevention; Demonstrated effectiveness across patient populations; Resource optimization and enhanced patient safety.

Systematic review and quality assessment of clinical and economic evidence for superabsorbent wound dressings in a population with chronic ulcers.

Effective exudate management is key for optimal ulcer healing. Superabsorbent dressings are designed to have high fluid handling capacity, reduced risk of exudate leakage, fluid retention under compression, and to sequester harmful exudate components. This study aimed to systematically identify existing evidence for the clinical efficacy and cost-effectiveness of superabsorbent dressings for the treatment of moderate-to-highly exudating chronic ulcers of various etiologies. The aim is focused on examining the 'class' effect of all superabsorbers, not any particular dressing. Clinical and cost effectiveness systematic reviews were conducted, searching Embase, MEDLINE, the Cochrane Library, and the Cumulative Index to Nursing and Allied Health Literature. The Cost Effectiveness Analysis Registry and Econ papers were also searched for the economic review. Outcomes of interest included ulcer closure, dressing properties, hospital- and infection-related outcomes, safety, and economic outcomes. Fourteen studies were included in the clinical systematic review. Eleven were case series, with one randomised controlled trial, one retrospective matched observational study, and one retrospective cohort study. The studies investigated eight superabsorbent dressings and were heterogeneous in their patient population and outcomes. Superabsorbent dressings may result in favourable outcomes, including reductions in frequency of dressing change and pain scores. As most studies were case series, drawing firm conclusions was difficult due to absence of a comparator arm. The economic systematic review identified seven studies, five of which were cost-utility analyses. These suggested superabsorbent dressings are a more cost-effective option for the treatment of chronic ulcers compared with standard dressings. However, the small number and low quality of studies identified in both reviews highlights the need for future research.

Clinical Effectiveness and Safety Comparison between Reduced Rivaroxaban Dose and Dual Antiplatelet Therapy for Nonvalvular Atrial Fibrillation Patients Following Percutaneous Left Atrial Appendage Closure: A Prospective Observational Study.

Background: Device-related thrombosis (DRT) after successful closure implantation on left atrial appendage (LAA) was considered as a major challenge and optimal strategy on antithrombotic therapy remains to be solved. This study was performed to compare the clinical effectiveness and safety of reduced rivaroxaban dose (RRD) and dual antiplatelet therapy (DAPT) after left atrial appendage closure (LAAC) implantation with the Watchman device. Methods: After successful LAAC, consecutive participants were medicated with a standard DAPT or RRD. The primary endpoints included DRT, thrombosis events (TE), and bleeding events that were documented during a 12-month follow-up period. Results: 767 patients (DAPT: n = 140; RRD: n = 627) were initially included. After propensity score matching (PSM), 140 patients treated with DAPT and 280 patients with RRD were included in each group with similar baseline information, thromboembolic and bleeding risk factors, cardiovascular risk factors and concomitant medication. In the RRD group, 193 patients were on rivaroxaban 15 mg ( R 15 ) and 47 received rivaroxaban 10 mg ( R 10 ). The incidence of DRT was documented in 12 (9.3%) patients in the DAPT group and 3 (6.3%) in R 10 and 7 (3.0%) in R 15 (log-rank p = 0.050). DAPT subgroups were more likely to experience shorter time to DRT as compared to R 15 ( R 15 vs. DAPT hazard ratio (HR) = 0.334, p = 0.015, 95% CI: 0.131-0.850). The median length of DRT in the R 15 group was significantly lower than that of the DAPT group (1.721 [1.610-1.818] mm vs. 1.820 [1.725-1.925] mm, p = 0.029). Compared with the unadjusted estimated rates of ischemic events for patients with similar congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category ( CHA 2 DS 2 - VAS c ) scores, a significant decrease of 68.6% in ischemic stroke rates was noted in the R 15 group, which contributed to a 54.9% reduction of overall thromboembolic events. The overall minor bleeding was not significantly different amongst the three groups (p = 0.944). Procedural bleeding was more common in the DAPT group, as compared with the R 10 and R 15 groups. Conclusions: After successful closure implantation, long-term RRD significantly reduced the DRT and TE occurrence compared with DAPT.

Real-World Experience of PD-1 Inhibitors for Relapsed and Refractory Hodgkin Lymphoma: A Multicenter Retrospective Analysis of Patients in China.

INTRODUCTION: Despite the promising clinical trial data regarding programmed death 1 (PD-1) inhibitors in relapsed/refractory classical Hodgkin lymphoma (R/R cHL), there remains a paucity of studies describing the outcomes of patients in a real-world setting, especially for Asian cohort. METHODS: We present a multicenter retrospective analysis of patients with R/R cHL who had failed ≥2 prior lines of therapies and received sintilimab or tislelizumab developed in China (sintilimab or tislelizumab monotherapy) at 3 medical centers from January 2019 to September 2021. Efficacy was evaluated with progression-free survival (PFS), overall survival, duration of response (DOR), best overall response (BOR) including objective response rate (ORR), complete response rate (CRR). Safety data were also recorded. RESULTS: 74 patients were reviewed. The median age was 38 years (range, 14-85 years). The ORR, CRR, and disease control rate were 78.3%, 52.7%, and 91.9%, respectively. The median duration of follow-up was 22 (4-36) months. Four patients (5.4%) died of disease progression. The median PFS and DOR was 22.1 and 23.5 months. BOR as a new emergent endpoint was found to be the only independent prognostic factor for PFS in our study (HR = 6.234, p = 0.005), suggesting this endpoint carries stronger prognostic value over traditional endpoints in the immunotherapy era. 66 (89.2%) patients reported adverse event (AE) with any grade, with the majority of AEs being grade 1 or 2. CONCLUSION: We presented a unique real-life experience and conducted a relatively long follow-up of PD-1 antibodies developed in China for R/R HL patients which confirmed their promising effectiveness and manageable side effects given in real world in an Asian cohort. Even for those who would usually be excluded in most of clinical trials such as elderly or minor patients, anti-PD-1 monotherapy also showed a significant improvement of outcomes. Furthermore, the depth of response seemed to be a more powerful predictive tool in new era, which might serve as a basis for future immune risk-adapted strategies.

The effect of an integrated palliative care intervention on quality of life and acute healthcare use in patients with COPD: Results of the COMPASSION cluster randomized controlled trial.

BACKGROUND: COPD causes high morbidity and mortality, emphasizing the need for palliative care. AIM: To assess the effectiveness of palliative care in patients with COPD. DESIGN: Cluster randomized controlled trial (COMPASSION study; Netherlands Trial Register (NTR): NL7644, 07-04-2019). Healthcare providers within the intervention group were trained to implement palliative care components into routine COPD care. Patients completed questionnaires at baseline, after 3 and 6 months; medical records were assessed after 12 months. The primary outcome was quality of life (FACIT-Pal). Secondary outcomes were anxiety, depression, spiritual well-being, satisfaction with care, acute healthcare use, documentation of life-sustaining treatment preferences and place of death. Generalized linear mixed modelling was used for analyses. SETTING: Eight hospital regions in the Netherlands. PARTICIPANTS: Patients hospitalized for an acute exacerbation of COPD and positive ProPal-COPD score. RESULTS: Of 222 patients included, 106 responded to the questionnaire at 6 months. Thirty-six of 98 intervention patients (36.7%) received the intervention. Intention-to-treat-analysis showed no effect on the primary outcome (adjusted difference: 1.09; 95% confidence interval: -5.44 to 7.60). In the intervention group, fewer intensive care admissions for COPD took place (adjusted odds ratio: 0.21; 95% confidence interval: 0.03-0.81) and strong indications were found for fewer hospitalizations (adjusted incidence rate ratio: 0.69; 95% confidence interval: 0.46-1.03). CONCLUSIONS: We found no evidence that palliative care improves quality of life in patients with COPD. However, it can potentially reduce acute healthcare use. The consequences of the COVID-19 pandemic led to suboptimal implementation and insufficient power, and may have affected some of our findings.

Effect of a novel interocclusal recording method on occlusal accuracy of implant-supported fixed prostheses: A randomized clinical trial.

OBJECTIVES: To investigate the effect of a novel interocclusal recording method on the occlusal accuracy of implant-supported fixed prostheses for partially dentate patients with distal extension. MATERIALS AND METHODS: Twenty patients with two or more adjacent teeth missing in the distal extension and scheduled to receive implant-supported fixed prostheses were enrolled. Two interocclusal recording methods were used: placing polyvinyl siloxane (PVS) on the interocclusal recording caps (test), and placing PVS on healing abutments (control). The intraoral occlusal contacts in maximal intercuspal position (MIP) were compared with those in the mounted casts to calculate sensitivity and positive predictive value (PPV). Then, patients were randomly allocated into two groups to determine which interocclusal record would be used. The implant prostheses' evaluations mainly included occlusal adjustment height, volume, and time, occlusal contact score based on articulating paper examination. Paired-samples t-test, Mann-Whitney U test, and least squares regression analyzed the statistic differences. RESULTS: The test method had higher sensitivity to detect intraoral occlusal contacts than the control method (p = .002), but similar PPV (p = .10). During the prostheses' evaluations, the occlusal adjustment height in the test group was significantly lower than that in the control group [99.4 (53.2, 134.2) vs. 159.0 (82.3, 247.8) µm, p = .03], while the occlusal contact score before adjustment was higher (p = .006). The groups had similar occlusal adjustment volume and time. CONCLUSIONS: The novel interocclusal recording method for implant-supported fixed prostheses was more accurate and could reduce the occlusal adjustment.

An alarm device for mechanical compression device displacement at femoral artery puncture sites.

OBJECTIVE: To develop an alarm device for the mechanical compression device displacement (MCD), and further evaluate its effectiveness in clinical use. MATERIAL AND METHODS: The alarm device is mainly composed of buzzer, indicator light, magnetic sheet. This is a prospective randomized and controlled study. Four hundred patients who met the inclusion/exclusion criteria were included and randomly assigned to two groups (MCD group vs alarm + MCD group). The primary outcome measures were the sensitivity and specificity of the alarm device to detect MCD displacement, time to hemostasis (TTH), time to ambulation (TTA), time to hospital discharge (TTHD), hospital costs (HC), complication rates, and patient satisfaction. RESULTS: The sensitivity and specificity of the alarm device in detecting MCD displacement were 94.44% and 88.46%, respectively. The study group achieved shorter TTH (p = .034), shorter TTA (p = .021), lower complication rates (p = .025), and better patients' satisfaction (p < .001) compared to the control group. However, no significant difference was observed in TTHD (p = .361) and HC (p = .583). CONCLUSION: The alarm device is highly sensitive in detecting MCD displacement, while achieving better clinical outcomes compared with artificial monitoring.

Tigecycline antibacterial activity, clinical effectiveness, and mechanisms and epidemiology of resistance: narrative review.

Tigecycline is unique glycylcycline class of semisynthetic antimicrobial agents developed for the treatment of polymicrobial infections caused by multidrug-resistant Gram-positive and Gram-negative pathogens. Tigecycline evades the main tetracycline resistance genetic mechanisms, such as tetracycline-specific efflux pump acquisition and ribosomal protection, via the addition of a glycyclamide moiety to the 9-position of minocycline. The use of the parenteral form of tigecycline is approved for complicated skin and skin structure infections (excluding diabetes foot infection), complicated intra-abdominal infections, and community-acquired bacterial pneumonia in adults. New evidence also suggests the effectiveness of tigecycline for the treatment of severe Clostridioides difficile infections. Tigecycline showed in vitro susceptibility to Coxiella spp., Rickettsia spp., and multidrug-resistant Neisseria gonnorrhoeae strains which indicate the possible use of tigecycline in the treatment of infections caused by these pathogens. Except for intrinsic, or often reported resistance in some Gram-negatives, tigecycline is effective against a wide range of multidrug-resistant nosocomial pathogens. Herein, we summarize the currently available data on tigecycline pharmacokinetics and pharmacodynamics, its mechanism of action, the epidemiology of tigecycline resistance, and its clinical effectiveness.

Impact of Gd-153 scanning line source attenuation correction on downstream invasive testing.

BACKGROUND: Attenuation correction (AC) using hardware and software solutions has been shown to increase the specificity of SPECT MPI by decreasing false positive results and improving prognostic ability. Theoretically this should reduce downstream testing and unnecessary costs. We sought to assess the consequences of the use of Gd-153 scanning line source attenuation correction during SPECT myocardial perfusion imaging (MPI) on downstream invasive testing. METHODS: All patients who underwent a clinically indicated Tc-99m stress SPECT MPI study from 2013 to 2015 at five hospitals (2 with AC and 3 without) were retrospectively reviewed. Patient demographics, results of testing, subsequent coronary angiography within 3 months, and revascularization were recorded. The results of the MPI studies, downstream angiogram utilization, and results of angiography were compared and a propensity matched subgroup analysis was performed. RESULTS: A total of 9968 patients underwent SPECT MPI during the study time period (6106 performed with AC and 3862 without). Out of 3928 patients included in the propensity matched cohort, there was no difference in the proportion of abnormal MPI results between the two groups (31.5% vs 30.4%, P = 0.47), however, more patients underwent coronary angiography within 90 days in the AC group (10.6% vs 8.7%, P = 0.05). There was no significant difference in the proportion of patients with angiographically significant obstructive disease (53.4% vs 56.1%, P = 0.19), however, fewer patients in the AC group with obstructive coronary disease were revascularized (36.1% vs 46.8%, P = 0.04). The findings remained consistent after sub-group analysis in patients without known coronary disease. CONCLUSION: The use of scanning line source AC did not meaningfully influence the rate of abnormal MPI results or downstream invasive testing in this cohort. The clinical utility of scanning line source AC may be limited to facilitating stress-first imaging protocols.

Antidepressants Trial in Parkinson's Disease (ADepT-PD): protocol for a randomised placebo-controlled trial on the effectiveness of escitalopram and nortriptyline on depressive symptoms in Parkinson's disease.

BACKGROUND: Depressive symptoms are common in patients with Parkinson's disease and depression is a significant predictor of functional impairment, reduced quality of life and general well-being in Parkinson's disease. Despite the high prevalence of depression, evidence on the effectiveness and tolerability of antidepressants in this population is limited. The primary aim of this trial is to establish the clinical and cost effectiveness of escitalopram and nortriptyline for the treatment of depression in Parkinson's disease. METHODS: This is a multi-centre, double-blind, randomised placebo-controlled trial in 408 people with Parkinson's disease with subsyndromal depression, major depressive disorder or persistent depressive disorder and a Beck Depression Inventory-II (BDI-II) score of 14 or above. Participants will be randomised into one of three groups, receiving either escitalopram, nortriptyline or placebo for 12 months. Trial participation is face-to-face, hybrid or remote. The primary outcome measure is the BDI-II score following 8 weeks of treatment. Secondary outcomes will be collected at baseline, 8, 26 and 52 weeks and following withdrawal, including severity of anxiety and depression scores as well as Parkinson's disease motor severity, and ratings of non-motor symptoms, cognitive function, health-related quality of life, levodopa-equivalence dose, changes in medication, overall clinical effectiveness, capability, health and social care resource use, carer health-related quality of life, adverse effects and number of dropouts. DISCUSSION: This trial aims to determine the effectiveness of escitalopram and nortriptyline for reducing depressive symptoms in Parkinson's disease over 8 weeks, to provide information on the effect of these medications on anxiety and other non-motor symptoms in PD and on impact on patients and caregivers, and to examine their effect on change in motor severity. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03652870 Date of registration - 29th August 2018.

Coronavirus disease 2019 vaccination is protective of clinical disease in solid organ transplant recipients.

BACKGROUND: Clinical effectiveness of coronavirus disease 2019 (COVID-19) vaccination in solid organ transplant recipients (SOTRs) is not well documented despite multiple studies demonstrating sub-optimal immunogenicity. METHODS: We reviewed medical records of eligible SOTRs at a single center to assess vaccination status and identify cases of symptomatic COVID-19 from January 1 to August 12, 2021. We developed a Cox proportional hazards model using the date of vaccination and time since transplantation as a time-varying covariate with age and gender as potential time-invariant confounders. Survival curves were created using the parameters estimated from the Cox model. RESULTS: Among 1904 SOTRs, 1362 were fully vaccinated (96% received mRNA vaccines) and 542 were either unvaccinated (n = 470) or partially vaccinated (n = 72). There were 115 cases of COVID-19, of which 12 occurred in fully vaccinated individuals. Cox regression with the date of vaccination and time since transplantation as the time-varying co-variates showed that after baseline adjustment for age and sex, being fully vaccinated had a significantly lower hazard for COVID-19, hazard ratio (HR) = 0.29 and 95% confidence interval ([CI] 0.09, 0.91). CONCLUSION: We found that 2-dose mRNA COVID-19 vaccination was protective of symptomatic COVID-19 in vaccinated versus unvaccinated SOTRs. TWEET: COVID-19 vaccination was associated with a significantly lower hazard for symptomatic COVID-19 (HR 0.29; 95% CI 0.09, 0.91) among 1904 SOT recipients at a single center from January 1 to August 12, 2021.

Acceptability of and Willingness to Take Digital Pills by Patients, the Public, and Health Care Professionals: Qualitative Content Analysis of a Large Online Survey.

BACKGROUND: Digital pills are pills combined with a sensor, which sends a signal to a patch connected to a smartphone when the pills are ingested. Health care professionals can access patient data from digital pills online via their own interface, thus allowing them to check whether a patient took the drug. Digital pills were developed for the stated goal of improving treatment adherence. The US Food and Drug Administration approved the first digital pills in November 2017, but the manufacturer withdrew its application to the European Medicines Agency in July 2020 because of insufficient evaluation. OBJECTIVE: As recommended for the evaluation of health technologies, this study assesses the prospective acceptability of and willingness to take digital pills among patients, the public, and health care professionals. METHODS: Participants were patients who were receiving long-term treatment for a chronic condition, public participants (both groups recruited from a representative sample), and health care professionals. Participants answered 5 open-ended questions regarding the acceptability of digital pills and 1 close-ended question regarding the willingness to take digital pills, which were developed in a preliminary qualitative study. We explored the 5 theoretical dimensions of acceptability by performing an abductive qualitative content analysis of all free-text responses. We assessed data saturation with mathematical models. We fitted a multivariate logistic regression model to identify the sociodemographic and health characteristics associated with the willingness to take digital pills. RESULTS: Between January 29, 2020, and April 18, 2020, 767 patients, 1238 public participants, and 246 health care professionals provided 11,451 free-text responses. We identified 98 codes related to the acceptability of digital pills: 29 codes on perceived clinical effectiveness (eg, sensor safety cited by 66/2251 participants, 29.5%), 6 on perceived burden (eg, increased doctors' workload, 164/2251 participants, 7.3%), 25 on perceived ethicality (eg, policing, 345/2251 participants, 15.3%), 30 codes on perceived opportunity (eg, exclusively negative perception, 690/2251 participants, 30.7%), and 8 on affective attitude (eg, anger, 541/2251, 24%). Overall, 271/767 (35.3%) patients, 376/1238 (30.4%) public participants, and 39/246 (15.8%) health care professionals reported willingness to take digital pills. This willingness was associated with male sex (odds ratio 1.98, 95% CI 1.62-2.43) and current use of a connected device to record health settings (with a dose-response relationship). CONCLUSIONS: The prospective acceptability of and willingness to take digital pills were limited by clinical and ethical concerns both at the individual and societal level. Our results suggest that digital pills should not be considered a mere change in the form of drug administration but a complex intervention requiring specific evaluation before extended use in clinical routine practice as well as an ethical and legal framework to ensure safe and ethical collection and use of health data through a patient-centered approach.

Effectiveness of telemedicine psychoeducational interventions for adults with non-oncological chronic disease: A systematic review.

AIM: To evaluate the effectiveness of telemedicine psychoeducational interventions (PIs) in adult patients on the clinical management of chronic non-oncological diseases compared with another therapeutic option or no treatment. DESIGN: Systematic review of randomized controlled trials. DATA SOURCES: Six databases were searched between January 2011 and August 2021. REVIEW METHODS: A systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Study selection, quality appraisal and data extraction were conducted independently by two reviewers. A third arbiter was available if discrepancies. RESULTS: A total of 719 articles were reviewed and 17 studies met the inclusion and quality criteria. The included studies related to smoking, chronic pain, obesity and mental illness. Most interventions were based on cognitive behavioural theory. Most of the included studies (12/17, 70.5%) showed improvements in health and significant reductions in anxiety, pain and depression with variable effect sizes. Patients reported a high satisfaction rate and indicated lectures or self-report writings as helpful in their recovery compared with more interactive items. Only financial incentives demonstrated greater adherence. A specific intervention format or complementary professional support was not associated with health outcomes. CONCLUSIONS: Telemedicine PIs are a safe and effective option for the clinical management of adults with chronic diseases. Future longitudinal studies are needed to assess the impact of these interventions on chronic physical and mental disease, evaluating the quality of life, morbidity and mortality. IMPACT: The results reinforce the telemedicine PIs with effects on clinical management similar to those of the face-to-face modality and can be carried out in a safe environment for patients at a lower cost to the health system. These conditions make them suitable for comprehensive care in the epidemiological COVID-19 context with the highest safety conditions for the patients and professionals.

A Lower Level of Post-Vaccinal Antibody Titer against Influenza Virus A H1N1 May Protect Patients with Autoimmune Rheumatic Diseases from Respiratory Viral Infections.

Background and Objectives: The concentration of antibodies against virus influenza A H1N1 in the titer (≥1:32) positively correlates with resistance to flu in healthy persons. In elderly and immune-compromised patients, an influenza vaccine may be less immunogenic. Hypothesis: A lower post-vaccinal antibody titer (≥1:16) may be sero-protective against respiratory viral infections in patients with autoimmune rheumatic diseases. Materials and Methods: Fifty patients with autoimmune rheumatic diseases (Systemic Lupus Erythematosus-24; Rheumatoid Arthritis-15; and Sjögren's Syndrome-11), who were at least 65 years old or whose relative disease duration (disease duration/age) was greater than 1/8, were examined. Thirty-four of them were vaccinated with a trivalent inactivated non-adjuvant influenza vaccine. The antibody concentration against influenza virus A H1N1 was measured using the standardized hemagglutination inhibition test and patients who got any respiratory viral infection were registered. To test the hypothesis, a correlative analysis was applied, followed by a binary logistic regression that included potential confounding variables, such as age, disease duration and therapy (personal/health-related conditions). Results: Vaccinated patients were significantly less affected by respiratory viral infections (21% vs. 75%). The lower titer considered (≥1:16) was significantly present more often among vaccinated patients (68% vs. 6%). The correlation between its presence/absence and that of respiratory viral infections was -0.34 (p < 0.05). The binary logistic regression evidenced the relevance of this correlation, confirming the hypothesis. Vaccination was associated with the 87.3% reduction in the likelihood of getting respiratory viral infections, whereas the lower antibody titer (≥1:16) was associated with the 77.6% reduction in the likelihood of getting respiratory viral infections. The vaccine was well tolerated by all patients and after vaccination no exacerbation of the underlying disease was observed. Conclusions: A lower antibody titer (≥1:16) against influenza virus A H1N1 could be protective against respiratory viral infections for certain autoimmune rheumatic diseases patients, which confirms the clinical effectiveness of influenza vaccination.

Target-Based Care: An Intervention to Reduce Variation in Postoperative Length of Stay.

OBJECTIVES: To derive care targets and evaluate the impact of displaying them at the point of care on postoperative length of stay (LOS). STUDY DESIGN: A prospective cohort study using 2 years of historical controls within a freestanding, academic children's hospital. Patients undergoing benchmark cardiac surgery between May 4, 2014, and August 15, 2016 (preintervention) and September 6, 2016, to September 30, 2018 (postintervention) were included. The intervention consisted of displaying at the point of care targets for the timing of extubation, transfer from the intensive care unit (ICU), and hospital discharge. Family satisfaction, reintubation, and readmission rates were tracked. RESULTS: The postintervention cohort consisted of 219 consecutive patients. There was a reduction in variation for ICU (difference in SD -2.56, P < .01) and total LOS (difference in SD -2.84, P < .001). Patients stayed on average 0.97 fewer days (P < .001) in the ICU (median -1.01 [IQR -2.15, -0.39]), 0.7 fewer days (P < .001) on mechanical ventilation (median -0.54 [IQR -0.77, -0.50]), and 1.18 fewer days (P < .001) for the total LOS (median -2.25 [IQR -3.69, -0.15]). Log-transformed multivariable linear regression demonstrated the intervention to be associated with shorter ICU LOS (ß coefficient -0.19, SE 0.059, P < .001), total postoperative LOS (ß coefficient -0.12, SE 0.052, P = .02), and ventilator duration (ß coefficient -0.21, SE 0.048, P < .001). Balancing metrics did not differ after the intervention. CONCLUSIONS: Target-based care is a simple, novel intervention associated with reduced variation in LOS and absolute LOS across a diverse spectrum of complex cardiac surgeries.

Clinical effectiveness of golimumab in ulcerative colitis: a prospective multicentre study based on the Swedish IBD Quality Register, SWIBREG.

OBJECTIVES: Clinical trials demonstrated that golimumab is effective in anti-TNF naïve patients with ulcerative colitis. We aimed to assess the clinical effectiveness of golimumab in a real-world setting. MATERIALS AND METHODS: This was a prospective cohort study, conducted at 16 Swedish hospitals. Data were collected using an electronic case report form. Patients with active ulcerative colitis, defined as Mayo endoscopic subscore ≥2 were eligible for inclusion. The primary outcomes were clinical effectiveness at 12 weeks and 52 weeks, i.e. response (defined as a decrease in Mayo score by ≥3 points or 30% from baseline) and remission (defined as a Mayo score of ≤2 with no individual subscores >1). RESULTS: Fifty patients were included. At study entry, 70% were previously exposed to anti-TNF, 16% to vedolizumab, and 96% to immunomodulators. The 12 and 52-week drug continuation rates were 37/50 (74%) and 23/50 (46%), respectively. The 12-week response rate was 14/50 (28%), the remission rate, 8/50 (16%) and the corresponding figures at week 52 were 13/50 (26%) and 10/50 (20%). Among patients who continued golimumab, the median Mayo score decreased from 7 (6-9) at baseline to 1 (0-5) at 52 weeks (p < .01) and the faecal calprotectin decreased from 862 (335-1759) µg/g to 90 (34-169) µg/g (p < .01). Clinical response at week 12 was highly predictive of clinical remission at week 52 (adjusted OR: 73.1; 95% CI: 4.5‒1188.9). CONCLUSIONS: The majority of golimumab treated patients represented a treatment refractory patient-group. Despite this, our results confirm that golimumab is an effective therapy in ulcerative colitis.

Clinical effectiveness of gasless laparoscopic surgery for abdominal conditions: systematic review and meta-analysis.

BACKGROUND: In high-income countries, laparoscopic surgery is the preferred approach for many abdominal conditions. Conventional laparoscopy is a complex intervention that is challenging to adopt and implement in low resource settings. This systematic review and meta-analysis evaluate the clinical effectiveness of gasless laparoscopy compared to conventional laparoscopy with CO2 pneumoperitoneum and open surgery for general surgery and gynaecological procedures. METHODS: A search of the MEDLINE, EMBASE, Global Health, AJOL databases and Cochrane Library was performed from inception to January 2021. All randomised (RCTs) and comparative cohort (non-RCTs) studies comparing gasless laparoscopy with open surgery or conventional laparoscopy were included. The primary outcomes were mortality, conversion rates and intraoperative complications. SECONDARY OUTCOMES: operative times and length of stay. The inverse variance random-effects model was used to synthesise data. RESULTS: 63 studies were included: 41 RCTs and 22 non-RCTs (3,620 patients). No procedure-related deaths were reported in the studies. For gasless vs conventional laparoscopy there was no difference in intraoperative complications for general RR 1.04 [CI 0.45-2.40] or gynaecological surgery RR 0.66 [0.14-3.13]. In the gasless laparoscopy group, the conversion rates for gynaecological surgery were high RR 11.72 [CI 2.26-60.87] when compared to conventional laparoscopy. For gasless vs open surgery, the operative times were longer for gasless surgery in general surgery RCT group MD (mean difference) 10 [CI 0.64, 19.36], but significantly shorter in the gynaecology RCT group MD - 18.74 [CI - 29.23, - 8.26]. For gasless laparoscopy vs open surgery non-RCT, the length of stay was shorter for gasless laparoscopy in general surgery MD - 3.94 [CI - 5.93, - 1.95] and gynaecology MD - 1.75 [CI - 2.64, - 0.86]. Overall GRADE assessment for RCTs and Non-RCTs was very low. CONCLUSION: Gasless laparoscopy has advantages for selective general and gynaecological procedures and may have a vital role to play in low resource settings.