Nonrandomized Study Research Articles

A randomized controlled trial on the oncologic outcomes of use of the intrauterine manipulator in the treatment of apparent uterine-confined endometrial carcinoma: the MANEC Trial

BackgroundThe intrauterine manipulator used during a hysterectomy for endometrial cancer has been suggested as a reason for worsening oncologic outcomes. However, only a few non-randomized retrospective studies have investigated this...

Rescue stenting in refractory mechanical thrombectomy: A review

Despite advancements in mechanical thrombectomy (MT) in the treatment of large vessel occlusions, failure to achieve recanalization remains a challenge in 10 – 30% of patients. Several underlying pathologies have been postulated in refractory MT, including intracranial atherosclerotic stenosis, intracranial dissection, and recalcitrant emboli. Rescue strategies to maximize recanalization rates, such as alternative access routes, local thrombolysis, stent-assisted angioplasty, and acute “rescue” stenting, have been proposed. Considered an emerging treatment strategy for refractory MT, rescue stenting (RS) has been shown in non-randomized observational studies as a safe and effective strategy for increasing reperfusion rates and consequently improving clinical outcomes. The effective use of RS approach requires consideration of patient-specific characteristics, clot characteristics, and lesion anatomy. This review provides an overview of the understanding of refractory MT, epidemiology, pathophysiology, current evidence supporting RS in the anterior and posterior circulation, stents used, endovascular techniques, patient selection criteria, antithrombotic use, risks, and complications.

High- Versus Low-Dose Paclitaxel-Coated Balloons for Femoropopliteal Disease: A systematic review and meta-analysis.

To evaluate the comparative effectiveness of high- and low doses of paclitaxel in endovascular revascularization procedures for patients with femoropopliteal disease. The databases (Embase, PubMed, Scopus, and Web of Science) were searched for studies that had compared outcomes of high-dose and low-dose paclitaxel-coated balloons (PCBs) in the treatment of patients with femoropopliteal disease. Randomized controlled trials and nonrandomized comparative studies (eg, cohort studies and case-control studies) were eligible for inclusion. The primary outcomes of interest were patency rates, risk of restenosis, and clinically-driven target lesion revascularization (CD-TLR). Pooled effect sizes were reported as relative risk (RR) with 95% confidence intervals (CI). The analysis included 7 studies. High-dose PCB use was associated with higher patency (RR, 1.10; 95% CI, 1.00-1.21), reduced risk of restenosis (RR, 0.60; 95% CI, 0.46-0.79), and reduced need for CT-TLR (RR, 0.57; 95% CI, 0.41-0.79) compared to low-dose PCB. Rates of limb salvage (RR, 1.01; 95% CI, 0.99-1.04), freedom from major adverse limb events (RR, 1.39; 95% CI, 0.79-2.42), and overall survival (RR, 1.02; 95% CI, 0.99-1.05) were comparable in the 2 groups. There was no evidence of publication bias. High-dose PCB correlates with superior outcomes in patients with femoropopliteal disease, particularly in terms of better vascular patency, reduced restenosis risk, and lower need for target lesion revascularization, compared to low-dose PCB.

Long head of biceps tendon autograft is effective in the management of large to massive rotator cuff tear: a systematic review.

The aim of this systematic review is to review the functional, clinical and radiological outcomes of patients undergoing large to massive rotator cuff repair with long head of biceps tendon (LHBT) autograft, as well as compare these to standard arthroscopic cuff repair. A review of the online Medline database was conducted on 20 October 2022 according to PRISMA guidelines and registered prospectively on the PROSPERO database. Clinical studies assessing patients with large to massive rotator cuff tears undergoing LHBT autograft repair were included. All studies reported on functional outcomes, range of movement (ROM) and radiological re-tear rates. The Methodological Index for Non-Randomised Studies (MINORS) tool was used to appraise all studies. The search strategy identified ten studies for inclusion including a total of 594 patients. Five studies were comparable (346 patients), assessing LHBT autograft repair against arthroscopic rotator cuff repair without autograft. A variety of techniques of LHBT autograft were used across all studies, including bridging and augmentation styles. Radiographic comparison showed lower re-tear rates in the LHBT autograft group with two studies demonstrating statistically significant results. Pain scores, functional outcomes and ROM were significantly improved post-operatively in all studies for LHBT autograft patients, with no significant difference when compared to standard arthroscopic repair. LHBT autograft looks to significantly improve functional scoring and range of motion in patients with large to massive rotator cuff tears. When compared to standard arthroscopic cuff repair, LHBT autograft appears to significantly reduce the re-tear rate. Further randomised studies are needed to assess the efficacy of this technique.

Assessment of fluid responsiveness after tidal volume challenge in renal transplant recipients: a nonrandomized prospective interventional study.

When applying lung-protective ventilation, fluid responsiveness cannot be predicted by pulse pressure variation (PPV) or stroke volume variation (SVV). Functional hemodynamic testing may help address this limitation. This study examined whether changes in dynamic indices such as PPV and SVV, induced by tidal volume challenge (TVC), can reliably predict fluid responsiveness in patients undergoing renal transplantation who receive lung-protective ventilation. This nonrandomized interventional study included renal transplant recipients with end-stage renal disease. Patients received ventilation with a 6 mL/kg tidal volume (TV), and the FloTrac system was attached for continuous hemodynamic monitoring. Participants were classified as responders or nonresponders based on whether fluid challenge increased the stroke volume index by more than 10%. The analysis included 36 patients, of whom 19 (52.8%) were responders and 17 (47.2%) were nonresponders. Among responders, the mean ΔPPV6-8 (calculated as PPV at a TV of 8 mL/kg predicted body weight [PBW] minus that at 6 mL/kg PBW) was 3.32±0.75 and ΔSVV6-8 was 2.58±0.77, compared to 0.82±0.53 and 0.70±0.92 for nonresponders, respectively. ΔPPV6-8 exhibited an area under the curve (AUC) of 0.97 (95% confidence interval [CI], 0.93-1.00; P≤0.001), with an optimal cutoff value of 1.5, sensitivity of 94.7%, and specificity of 94.1%. ΔSVV6-8 displayed an AUC of 0.93 (95% CI, 0.84-1.00; P≤0.001) at the same cutoff value of 1.5, with a sensitivity of 94.7% and a specificity of 76.5%. TVC-induced changes in PPV and SVV are predictive of fluid responsiveness in renal transplant recipients who receive intraoperative lung-protective ventilation.

Patient-reported outcome measures in studies on hallux valgus surgery: what should be assessed.

In recent years, there has been an increasing demand for patient-reported outcome measures (PROMs) to assess the outcome following orthopedic surgery. But, we are lacking a standard set of PROMs to assess the outcome ofhallux valgus surgery. The aim of this study was to analyze the chosen patient rated outcome scores used in studies reporting on hallux valgus surgery. The study was based on a previously published living systematic review. Included were prospective,comparative studies of different surgical procedures or the same procedure for different degrees of deformity. Four common databases were searched for the last decade. Study selection, data extraction, and risk of bias assessment were made by two independent reviewers. Data assessed were the individual PROMs used to assess the outcome of hallux valgus surgery. 46 studies (30 RCTs and 16 non-randomized prospective studies) met the inclusion criteria. The most commonly used clinical outcome measures were the AOFAS (55%) and the VAS (30%). No differences were found between frequency of the individual scores per the level of evidence or the type of osteotomy. Based on a systematic literature review, the AOFAS and VAS are the most frequently used outcome tools in studies assessing the outcome following hallux valgus surgery. Based on the literature available, the MOXFQ is a more valid alternative. Level I; systematic review of prospective comparative (level II) and randomized controlled trials (level I).

Drug Shortages and Patient Harms

What Is the Issue? Drug shortages are a global issue with complex dynamics. Shortages can occur because of disruption at any point along the drug supply chain. Several strategies are used in Canada to prevent or alleviate the effects of drug shortages, including mandatory reporting by drug manufacturers. An understanding of the amount and types of real or potential harms caused to patients can inform policy decisions around drug shortage management and prevention. What Did We Do? We searched for literature providing evidence on patient outcomes associated with supply chain disruptions of pharmaceuticals and vaccines. An information specialist conducted a search of peer-reviewed literature sources published between January 1, 2003, and September 13, 2023. Documents were excluded if the objective was to investigate the potential effects of a drug shortage in the absence of an actual drug shortage or if the outcomes were not direct patient harms. What Did We Find? One scoping review and 33 nonrandomized studies were identified that evaluated patient outcomes associated with supply chain disruptions of pharmaceuticals and vaccines. We identified a wide variety of drug classes experiencing shortages. The most frequently reported shortages were anesthetics, oncology drugs, vaccines, drugs for the treatment of COVID-19, antimicrobials, and small-volume parenteral solutions. Most of the included primary studies concluded that the replacement drug or protocol was a safe or acceptable alternative to the shortage drug. The subset of primary studies that concluded that the replacement drug or protocol was not a safe or acceptable alternative to the shortage drug reported worse outcomes in health system use (including length of hospital stay), adverse events, disease progression, and mortality. What Does This Mean? Drug shortages have the potential to cause harm to patients and some drug shortages may have a greater impact on patients than others. The ability to predict which drugs could cause the greatest harm during a supply disruption would be a great benefit for future planning. The diversity of drugs experiencing shortages and their associated harms emphasizes that decision-makers may need to take a case-by-case approach when developing policies meant to lessen the impact of drug shortages.

Evidence Following Conditional NICE Technology Appraisal Recommendations: A Critical Analysis of Methods, Quality and Risk of Bias.

The National Institute for Health and Care Excellence (NICE) may approve health technologies on condition of more evidence generated only in research (OiR) or only with research (OwR). NICE specifies the information needed to comply with its request, although it may not necessarily guarantee good quality and timely evidence for re-appraisal, before reaching a final decision. This study aimed to critically appraise the methods, quality and risk of bias of evidence generated in response to NICE OiR and OwR technology appraisal (TA) and highly specialised technologies (HSTs) recommendations. NICE TAs (between March 2000 and September 2020) and HST evaluations (to October 2023) of medicines were reviewed. Conditional recommendations were analysed to identify the evidence requested by NICE for re-appraisal. The new evidence was analysed for compliance with NICE's request and assessed using the Cochrane Collaboration's tools for risk of bias in randomised trials and the ROBINS-I tool for non-randomised evidence. NICE made 54 conditional recommendations from TAs (13 OiR and 41 OwR) and five conditional recommendations for HSTs (all OwR). Of these, 16 TAs presented additional evidence for re-appraisal (9 OiR [69%] and 7 OwR [17%]) and three HSTs (3 OwR [60%]). Two of the nine re-appraised TAs with OiR recommendation and four of the seven OwR complied fully with NICE's request for further evidence, while all three from the HSTs complied. The majority of re-appraised TAs and HSTs included evidence that was deemed to be at serious, high, moderate or unclear risk of bias. Among the 26 randomised controlled trials from TAs assessed, eight were categorised as having low risk of bias in all domains and ten had at least one domain as a high risk of bias. Reporting was unclear for the remainder. Twenty-two non-randomised studies, primarily single-arm studies, were susceptible to biases mostly due to the selection of participants and to confounding. Two HSTs provided evidence from randomised controlled trials which were classified as unclear or high risk of bias. All non-randomised evidence from HSTs were categorised as moderate or serious risk of bias. There is widespread non-compliance with agreed data requests and important variation in the quality of evidence submitted in response to NICE conditional approval recommendations. Quality standards ought to be stipulated in respect to evidence contributing to re-appraisals following NICE conditional approval recommendations.

State of the art treatment with Impella® in cardiac surgery inAustria.

Since 2022, the mechanical left ventricular support system Impella5.5® has been used in Austria for patients with cardiogenic shock, advanced heart failure, post-cardiotomy and low output syndrome. The surgical insertion of the Impella5.5 via the subclavian artery or alternatively via the ascending aorta has become an established procedure for medium-term treatment in patients with cardiogenic shock and bridging scenarios, such as bridge to recovery, bridge to left ventricular assist device (LVAD), bridge to decision, and bridge to heart transplant (HTx) in Austria. All Impella left ventricular heart pumps share the common feature of unloading the left ventricle, with the Impella5.5 achieving afull cardiac output of 5.5l/min. The stable positioning via transaxillary or transaortic insertion enables rapid extubation and mobilization of patients in the intensive care unit (ICU), leading to asignificantly shorter ICU stay. The combined support of Impella5.5 with venoarterial extracorporeal membrane oxygenation (VA-ECMO) has also proven effective in certain scenarios. Several nonrandomized studies demonstrated the effectiveness and safety of the Impella5.5 in practice, which have been included in multiple international guidelines. The advantages of the Impella5.5 in practice include the easy handling with high positional stability, and low complications rates. This article describes the significance of surgical Impella treatment in Austria from the perspective of Austrian clinical experts.

State of the art treatment with Impella® in cardiac surgery in Austria

Since 2022, the mechanical left ventricular support system Impella 5.5® has been used in Austria for patients with cardiogenic shock, advanced heart failure, post-cardiotomy and low output syndrome. The surgical insertion of the Impella 5.5 via the subclavian artery or alternatively via the ascending aorta has become an established procedure for medium-term treatment in patients with cardiogenic shock and bridging scenarios, such as bridge to recovery, bridge to left ventricular assist device (LVAD), bridge to decision, and bridge to heart transplant (HTx) in Austria. All Impella left ventricular heart pumps share the common feature of unloading the left ventricle, with the Impella 5.5 achieving a full cardiac output of 5.5l/min. The stable positioning via transaxillary or transaortic insertion enables rapid extubation and mobilization of patients in the intensive care unit (ICU), leading to a significantly shorter ICU stay. The combined support of Impella 5.5 with venoarterial extracorporeal membrane oxygenation (VA-ECMO) has also proven effective in certain scenarios. Several nonrandomized studies demonstrated the effectiveness and safety of the Impella 5.5 in practice, which have been included in multiple international guidelines. The advantages of the Impella 5.5 in practice include the easy handling with high positional stability, and low complications rates. This article describes the significance of surgical Impella treatment in Austria from the perspective of Austrian clinical experts.

Impact of maxillary expansion on the sagittal skeletal and dental parameters of growing Class II patients: A systematic review with meta-analysis.

A "spontaneous" correction of the Class II malocclusion has been described after maxillary expansion (ME) treatment. The aim of the present review was to systematically summarize changes in the sagittal dentoskeletal parameters of growing Class II patients after ME. The study protocol was developed according to the PRISMA statement and registered in PROSPERO before literature search, data extraction and analysis. The PICO model was followed in the definition of the research question, search strategies and study selection criteria. Randomized and non-randomized studies on the sagittal effects of ME published in English language without date restrictions were electronically searched across the Cochrane Library, Scopus and MEDLINE/PubMed databases. Changes in sagittal dentoskeletal cephalometric parameters were analysed. The risk of bias in randomized and nonrandomized studies was assessed using the Rob2 and ROBINS-I tools, respectively. A narrative synthesis was performed, focusing on the investigated population, intervention, comparison, and main outcomes. Pairwise meta-analyses were used to compare the outcomes assessed in subjects who underwent ME versus untreated subjects. Ten studies met the inclusion criteria, four were included in the pairwise meta-analyses due to the presence of a control group. Slight but significant improvements in OVJ (MD: -0.36; 95%; CI [-0.69 to -0.01]; p = .04) and 6/6 molar relation (MD: 1.5; 95%; CI [0.69 to 1.61]; p < .0001) were found in patients who underwent ME compared with untreated subjects, whereas no improvement in skeletal parameters was observed. However, the limitations of a small body of moderate-quality evidence and possible confounding factors should be considered. Evidence on the sagittal skeletal and dental effects of ME in Class II patients is still ambiguous, suggesting the need for more clinical trials, including appropriate control subjects, randomization and blinding during outcome assessment.

Invasive and conservative management of elderly patients presenting with acute coronary syndrome: A meta-analysis of randomized controlled trials and adjusted observational studies

BackgroundElderly patients are often under-represented in studies about coronary revascularization in acute coronary syndromes (ACS) and undertreated in clinical practice. We sought to evaluate differences in outcomes between an initial invasive or conservative strategy in this subset of patients, MethodsThe analysis was performed following PRISMA guidelines. Randomized controlled trials (RCTs) and adjusted observational studies comparing an invasive and conservative strategy in old patients with ACS were systematically identified. Random or fixed effect model was used accordingly to heterogeneity testing results. Short-term mortality was the primary outcome. 30-day and longer-term re-infarction, MACE and all-cause mortality were secondary endpoints. Sensitivity analysis including RCTs only were performed for the primary endpoint and 1 year mortality and another analysis, stratifying NSTEMI and STEMI studies, was performed for short-term mortality. ResultsInvasive management was associated with lower short and long-term mortality (30 days OR 0.64, 95 % CI 0.54–0.76, p < 0.001; 1 year HR 0.60, 95 % CI 0.52–0.78, p < 0.001; Long-term HR 0.62, 95 % CI 0.55–0.71, p < 0.001) compared to a conservative strategy. In the short-term follow-up, the benefit was preserved when differentiating for NSTEMI or STEMI studies but not when considering only RCTs. Major bleedings were more frequent in the invasive group (30 days OR 1.61, 95 % CI 1.39–1.87, p < 0.001). The mean difference in length of stay was not significantly different between the two strategies (mean difference in days 0.14, 95 % CI -0.79 to 1.06, p = 0.77). ConclusionAn initial invasive strategy might lead to reduced short and long-term mortality in elderly patients presenting with acute coronary syndrome but it is associated with increased bleeding events rate. No difference in hospital stay length was observed. Results were mainly driven by non-randomized studies.

The Effectiveness of Exercise in Reducing Cardiovascular Risk Factors Among Adults: A Systematic Review and Meta-Analysis.

Cardiovascular disease (CVD) remains one of the major causes of sickness and death in the world. However, lifestyle modifications, such as exercise, can significantly reduce the risk of this disease. This study aimed to assess the effectiveness of various forms of physical activity in reducing CVD risk factors among adults. A comprehensive search of the databases PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Central Register of Controlled Trials (CENTRAL), and Excerpta Medica Database (EMBASE) databases was conducted between January 1, 2014, and May 31, 2024, as per Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Randomized controlled trials (RCTs), cohort studies, and observational studies on the impact of aerobic, resistance, or combined training on cardiovascular risk factors in adults (≥18 years) were considered for inclusion. Data relating to primary outcomes, including stroke and myocardial infarction rates, BP, cholesterol levels, and BMIwere collected. The Cochrane risk-of-bias tool and the Methodological Index for Non-Randomized Studies (MINORS) checklist were used for quality and bias assessment. Meta-analyses were performed using the RevMan software, with heterogeneity evaluated by I² statistics; 17 studies, including 11 RCTs and six cohort studies, met the inclusion criteria. There was a significant reduction in the mean systolic BP (SBP) by 3.32 mmHg [95% confidence interval (CI): 0.85-5.78 mmHg; p<0.0001] and mean diastolic BP (DBP) by 2.99 mmHg (95% CI: 2.34-3.64 mmHg; p < 0.00001) after exercise interventions. Moreover, cholesterol levels and BMI values improved with exercise. Those who exercised had a lower risk of stroke or heart attack compared with the controls [odds ratio (OR): 0.57; 95% CI: 0.28-1.14; p >0.0001], although there was substantial heterogeneity in effect size across the studies (I² = 98%). Different types of physical activity (i.e., aerobic, resistance, or combined exercise) can effectively reduce key cardiovascular risk factors, including BP, cholesterol levels, and BMI values. Regular physical activity is still regarded as the most effective preventive measure against CVD, despite inconsistencies in research findings. Future studies should aim to identify optimal exercise programs and their long-term effects on diverse populations.

Comparison of blue laser and red light-emitting diode-mediated aminolevulinic acid-based photodynamic therapy for moderate and severe acne vulgaris: A prospective, split-face, nonrandomized controlled study

BackgroundAcne is a chronic inflammatory skin disease. Photodynamic therapy (PDT) is a highly effective and safe drug-device combination treatment, typically using red and blue light. However, direct comparisons of aminolevulinic acid (ALA)-based PDT using these two light sources are lacking. Therefore, we compared the efficacy and adverse effects of ALA-based 450 nm blue laser-mediated PDT (BL-PDT) and 630 ± 10 nm red light-emitting diode-mediated PDT (RL-PDT) in the treatment of moderate-to-severe acne vulgaris, including analyses of different lesion types. MethodsSixteen patients with moderate-to-severe acne vulgaris were recruited. All patients underwent BL-PDT on the left side of the face and RL-PDT on the right side. Treatments were administered thrice at 2-week intervals, and follow-up continued for 2 weeks after the final treatment. The average rates of improvement in inflammatory and non-inflammatory acne lesions, IGA (Investigator's Global Assessment) scales, and IGA success rates were calculated. In addition, adverse effects during and after each treatment were recorded. ResultsAt the 2-week follow-up after the final treatment, the average rates of improvement in total acne, inflammatory, and non-inflammatory lesions were 48.0 %, 63.0 %, and 30.0 % in the BL-PDT group and 42.2 %, 58.1 %, and 27.5 % in the RL-PDT group, respectively. The IGA scores for the two groups decreased by 1.8 and 1.7 points, respectively, and the IGA success rate was 53.3 % in both groups. There were no significant differences between the BL-PDT and RL-PDT groups in any measure of effectiveness. However, the BL-PDT group exhibited more severe adverse effects, especially pain and hyperpigmentation. ConclusionsBL-PDT and RL-PDT have similar efficacies in moderate-to-severe acne vulgaris and are particularly effective for inflammatory acne lesions. RL-PDT benefits from milder adverse effects than those of BL-PDT.

The role of routing in the diagnosis of acute leukemia in children: an observational retrospective non-randomized study

Introduction. Acute leukemia (AL) is the commonest malignancy of childhood. Early diagnosis of AL is difficult due to the non-specificity of primary symptoms, which are often hidden under the "masks" of other diseases. Aim. Assess the delay in diagnosis depending on the areas of residence in the Tver region and area remoteness from the Tver Regional Clinical Children's Hospital. Materials and methods. The analysis included 35 patients hospitalized in the Department of Oncology and hematology of the RCCH for the period from 2018 to 2023. The diagnoses were: ALL - 30 (86%), AML - 3 (9%), and AL of unspecified cell type (ALUCL) - 2 (5%) patients. The mean age was 61 months. Thrombocytopenia and anemia at the time of diagnosis were found in 76% and 78%, respectively. Leukocytosis 20 x 109/L was observed in 58%, leukopenia 3.5 x 109/L in 15% of patients. In 97% of cases blasts (2% to 95%) were detected in peripheral blood. In the city of Tver (group 1) and the Tver region (group 2), 16 (46%) and 19 (54%) patients were identified, respectively. The mean age of patients in group 1 is 28.6 months, and in group 2 - 72.3 months (p = 0.1). Results. In group 1 and 2, ALL was diagnosed in 14 (88%) and 16 (84%), AML in 1 (6%) and 2 (11%) and ALUCL in 1 (6%) and 1 (5%) cases, p = 0.6, 0.7 and 0.95, respectively. Delay of diagnosis in the general group (n = 35) was observed 2 weeks in 21 (60%) cases, 2-4 weeks - in 7 (20%), ≥4 - ≤ 8 weeks - in 4 (11%) and 8 weeks - in 3 (9%) cases. Delayed diagnosis among patients living in the city of Tver and Tver region was observed 2 weeks in 7 (44%) vs. 13 (68%) cases, 2-4 weeks - in 6 (38%) vs 3 (17%), ≥4 - ≤ 8 weeks - in 1 (6%) vs 1 (5%) and 8 weeks - in 2 (12%) vs 2 (10%) cases, respectively (p = 0.37). There was no significant impact of the distance of the residence place from the level 3 children's hospital providing specialized care (RCCH) on the time of diagnosis. Conclusion. The distance from the third-level hospital did not affect the period of diagnosis of AL in children.

Clinical decision support systems for maternity care: a systematic review and meta-analysis

The use of Clinical Decision Support Systems (CDSS) is increasing throughout healthcare and may be able to improve safety and outcomes in maternity care, but maternity care has key differences to other disciplines that complicate the use of CDSS. We aimed to identify evaluated CDSS and synthesise evidence of their impact on maternity care. We conducted a systematic review for articles published before 24th May 2024 that described i) CDSS that ii) investigated the impact of their use iii) in maternity settings. Medline, CINAHL, CENTRAL and HMIC were searched for articles relating to evaluations of CDSS in maternity settings, with forward- and backward-citation tracing conducted for included articles. Risk of bias was assessed using the Mixed Methods Assessment Tool, and CDSS were described according to the clinical problem, purpose, design, and technical environment. Quantitative results from articles reporting appropriate data were meta-analysed to estimate odds of a CDSS achieving its desired outcome using a multi-level random effects model, first by individual CDSS and then across all CDSS. PROSPERO ID: CRD42022348157. We screened 12,039 papers and included 87 articles describing 47 unique CDSS. 24 articles (28%) described randomised controlled trials, 30 (34%) described non-randomised interventional studies, 10 (11%) described mixed methods studies, 10 (11%) described qualitative studies, 7 (8%) described quantitative descriptive studies, and 7 (8%) described economic evaluations. 49 (56%) were in High-Income Countries and 38 (44%) in Low- and Middle-Income countries, with no CDSS trialled in both income categories. Meta-analysis of 35 included studies found an odds ratio for improved outcomes of 1.69 (95% confidence interval 1.24-2.30). There was substantial variation in effects, aims, CDSS types, context, study designs, and outcomes. Most CDSS evaluations showed improvements in outcomes, but there was heterogeneity in all aspects of design and evaluation of systems. CDSS are increasingly important in delivering healthcare, and Electronic Health Records and mHealth will increase their availability, but traditional epidemiological methods may be limited in guiding design and demonstrating effectiveness due to rapid CDSS development lifecycles and the complex systems in which they are embedded. Development methods that are attentive to context, such as Human Centred Design, will help to meet this need. None.

The Role of Sublobar Resection in Early-Stage Non-Small-Cell Lung Cancer.

The results of a prospective, multi-institutional randomized trial developed to assess the equality of sublobar resection versus standard lobectomy were first published in 1995. They concluded that, compared with lobectomy, sublobar resections did not show any significant improvement either in terms of postoperative morbidity and mortality nor in terms of late post-resectional cardiorespiratory function. Moreover, due to the higher mortality and local recurrence rate related to sublobar resection, lobectomy had to be judged as the best surgical option for patients diagnosed with peripheral early-stage non-small-cell lung cancer. Since then, lobectomy has been considered the best surgical option for fit patients suffering from early-stage non-small cell lung cancer. In 2022 and 2023, three non-inferiority randomized trials were published, comparing lobectomy with the sublobar resection in T1a N0 patients whose tumors were up to 2 cm in size. Although presenting some important differences, all three trials met their primary endpoints, disclosing the non-inferiority of sublobar resections in terms of overall and disease-free survival. This narrative review aims to compare the newly published results of these trials as well as to report results from recent non-randomized studies on this topic.

Comparative Effectiveness of Decision Aids for Cancer-Screening Decision Making: An Overview of Reviews.

Decision aids (DAs), compared to no DAs, help improve the key aspects of shared decision-making, including increased knowledge, discussion frequency, and reduction in decisional conflict. However, systematic reviews have reported varied conclusions on screening uptake, and which DAs are superior to alternative forms in shared decision-making for cancer screening has not been comprehensively reviewed. An overview of systematic reviews was performed. Multiple databases were searched up to December 31, 2023, for systematic reviews of randomized controlled trials (RCTs) and non-randomized comparative studies (NRCSs) of any size that assessed a decision aid aimed to facilitate cancer-screening decision making communications. Dual screening of abstracts and full-text reports, dual data extraction and quality assessment, and qualitative synthesis were performed. The 22 eligible publications included 24 reviews on cancer screening DAs for a single specific cancer (8, 8, 7, and 1 on prostate, breast, colorectal, and lung cancer, respectively) and three reviews on multiple aggregate cancers. Individual reviews were based on different primary study designs (92 RCTs and 37 NRCSs); each study was infrequently cited (median citation count 2; range 1-9). Although the DAs had variable formats and delivery methods, the reviews generally focused on use and non-use comparisons. DAs decreased the intention or actual uptake for prostate and breast cancer screening, but increased it for colorectal cancer screening. DAs were associated with increased knowledge, well-informed choice, and reduced decisional conflict, regardless of cancer type. Only four reviews on comparative effectiveness between alternative formats of DAs (based on 14 RCTs and 2 NRCSs) failed to conclude on the specific format that was superior to others. DAs improve cancer screening shared decision-making by boosting cancer screening knowledge and informed choice and lowering decisional conflict and may facilitate preference-based, individualized screening participation. Comparative data on different cancer screening DAs are limited. PROSPERO, CRD42021235957.

The use of air abrasion method to treat caries in autistic patients at the age of 6 years: A non-randomized controlled trial.

Autism Spectrum Disorders (ASD) encompass a range of conditions characterized by difficulties in social interaction and communication. Managing dental treatment for children with autism presents challenges due to their reluctance to interact with dentists, which can be as high as 65%. This prospective non-randomized study, conducted at the Kazakh-Russian Medical University from January 15, 2023, to June 20, 2023, aimed to assess the efficacy of air abrasion caries treatment (AAbCT) compared to the standard method. The intervention involved applying air abrasion (AAb) treatment without anesthesia using aluminum oxide powder in the AAbCT group, while the control group received cavity preparation with local anesthesia. In this study, it was noted that the AAb method of tooth preparation was not different in efficacy from the traditional method for a population of children with autism, and could be used without anesthesia. A greater willingness to cooperate was noted (p=.0372). The AAb is an effective and safe treatment for children with ASD. Further studies needed to investigate its efficacy and safety in combination with behavioral interventions.

Treatment Effects in Randomized and Nonrandomized Studies of Pharmacological Interventions

Randomized clinical trials (RCTs) are widely regarded as the methodological benchmark for assessing clinical efficacy and safety of health interventions. There is growing interest in using nonrandomized studies to assess efficacy and safety of new drugs. To determine how treatment effects for the same drug compare when evaluated in nonrandomized vs randomized studies. Meta-analyses published between 2009 and 2018 were identified in MEDLINE via PubMed and the Cochrane Database of Systematic Reviews. Data analysis was conducted from October 2019 to July 2024. Meta-analyses of pharmacological interventions were eligible for inclusion if both randomized and nonrandomized studies contributed to a single meta-analytic estimate. For this meta-analysis using a meta-epidemiological framework, separate summary effect size estimates were calculated for nonrandomized and randomized studies within each meta-analysis using a random-effects model and then these estimates were compared. The reporting of this study followed the Guidelines for Reporting Meta-Epidemiological Methodology Research and relevant portions of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guideline. The primary outcome was discrepancies in treatment effects obtained from nonrandomized and randomized studies, as measured by the proportion of meta-analyses where the 2 study types disagreed about the direction or magnitude of effect, disagreed beyond chance about the effect size estimate, and the summary ratio of odds ratios (ROR) obtained from nonrandomized vs randomized studies combined across all meta-analyses. A total of 346 meta-analyses with 2746 studies were included. Statistical conclusions about drug benefits and harms were different for 130 of 346 meta-analyses (37.6%) when focusing solely on either nonrandomized or randomized studies. Disagreements were beyond chance for 54 meta-analyses (15.6%). Across all meta-analyses, there was no strong evidence of consistent differences in treatment effects obtained from nonrandomized vs randomized studies (summary ROR, 0.95; 95% credible interval [CrI], 0.89-1.02). Compared with experimental nonrandomized studies, randomized studies produced on average a 19% smaller treatment effect (ROR, 0.81; 95% CrI, 0.68-0.97). There was increased heterogeneity in effect size estimates obtained from nonrandomized compared with randomized studies. In this meta-analysis of treatment effects of pharmacological interventions obtained from randomized and nonrandomized studies, there was no overall difference in effect size estimates between study types on average, but nonrandomized studies both overestimated and underestimated treatment effects observed in randomized studies and introduced additional uncertainty. These findings suggest that relying on nonrandomized studies as substitutes for RCTs may introduce additional uncertainty about the therapeutic effects of new drugs.