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The Cochrane Database of Systematic... Jun 2024Peripherally inserted central catheters (PICCs) facilitate diagnostic and therapeutic interventions in health care. PICCs can fail due to infective and non-infective... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Peripherally inserted central catheters (PICCs) facilitate diagnostic and therapeutic interventions in health care. PICCs can fail due to infective and non-infective complications, which PICC materials and design may contribute to, leading to negative sequelae for patients and healthcare systems.
OBJECTIVES
To assess the effectiveness of PICC material and design in reducing catheter failure and complications.
SEARCH METHODS
The University of Queensland and Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the WHO ICTRP and ClinicalTrials.gov trials registers to 16 May 2023. We aimed to identify other potentially eligible trials or ancillary publications by searching the reference lists of retrieved included trials, as well as relevant systematic reviews, meta-analyses, and health technology assessment reports. We contacted experts in the field to ascertain additional relevant information.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) evaluating PICC design and materials.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were venous thromboembolism (VTE), PICC-associated bloodstream infection (BSI), occlusion, and all-cause mortality. Secondary outcomes were catheter failure, PICC-related BSI, catheter breakage, PICC dwell time, and safety endpoints. We assessed the certainty of evidence using GRADE.
MAIN RESULTS
We included 12 RCTs involving approximately 2913 participants (one multi-arm study). All studies except one had a high risk of bias in one or more risk of bias domain. Integrated valve technology compared to no valve technology for peripherally inserted central catheter design Integrated valve technology may make little or no difference to VTE risk when compared with PICCs with no valve (risk ratio (RR) 0.71, 95% confidence interval (CI) 0.19 to 2.63; I² = 0%; 3 studies; 437 participants; low certainty evidence). We are uncertain whether integrated valve technology reduces PICC-associated BSI risk, as the certainty of the evidence is very low (RR 0.20, 95% CI 0.01 to 4.00; I² = not applicable; 2 studies (no events in 1 study); 257 participants). Integrated valve technology may make little or no difference to occlusion risk when compared with PICCs with no valve (RR 0.86, 95% CI 0.53 to 1.38; I² = 0%; 5 studies; 900 participants; low certainty evidence). We are uncertain whether use of integrated valve technology reduces all-cause mortality risk, as the certainty of evidence is very low (RR 0.85, 95% CI 0.44 to 1.64; I² = 0%; 2 studies; 473 participants). Integrated valve technology may make little or no difference to catheter failure risk when compared with PICCs with no valve (RR 0.80, 95% CI 0.62 to 1.03; I² = 0%; 4 studies; 720 participants; low certainty evidence). We are uncertain whether integrated-valve technology reduces PICC-related BSI risk (RR 0.51, 95% CI 0.19 to 1.32; I² = not applicable; 2 studies (no events in 1 study); 542 participants) or catheter breakage, as the certainty of evidence is very low (RR 1.05, 95% CI 0.22 to 5.06; I² = 20%; 4 studies; 799 participants). Anti-thrombogenic surface modification compared to no anti-thrombogenic surface modification for peripherally inserted central catheter design We are uncertain whether use of anti-thrombogenic surface modified catheters reduces risk of VTE (RR 0.67, 95% CI 0.13 to 3.54; I² = 15%; 2 studies; 257 participants) or PICC-associated BSI, as the certainty of evidence is very low (RR 0.20, 95% CI 0.01 to 4.00; I² = not applicable; 2 studies (no events in 1 study); 257 participants). We are uncertain whether use of anti-thrombogenic surface modified catheters reduces occlusion (RR 0.69, 95% CI 0.04 to 11.22; I² = 70%; 2 studies; 257 participants) or all-cause mortality risk, as the certainty of evidence is very low (RR 0.49, 95% CI 0.05 to 5.26; I² = not applicable; 1 study; 111 participants). Use of anti-thrombogenic surface modified catheters may make little or no difference to risk of catheter failure (RR 0.76, 95% CI 0.37 to 1.54; I² = 46%; 2 studies; 257 participants; low certainty evidence). No PICC-related BSIs were reported in one study (111 participants). As such, we are uncertain whether use of anti-thrombogenic surface modified catheters reduces PICC-related BSI risk (RR not estimable; I² = not applicable; very low certainty evidence). We are uncertain whether use of anti-thrombogenic surface modified catheters reduces the risk of catheter breakage, as the certainty of evidence is very low (RR 0.15, 95% CI 0.01 to 2.79; I² = not applicable; 2 studies (no events in 1 study); 257 participants). Antimicrobial impregnation compared to non-antimicrobial impregnation for peripherally inserted central catheter design We are uncertain whether use of antimicrobial-impregnated catheters reduces VTE risk (RR 0.54, 95% CI 0.05 to 5.88; I² = not applicable; 1 study; 167 participants) or PICC-associated BSI risk, as the certainty of evidence is very low (RR 2.17, 95% CI 0.20 to 23.53; I² = not applicable; 1 study; 167 participants). Antimicrobial-impregnated catheters probably make little or no difference to occlusion risk (RR 1.00, 95% CI 0.57 to 1.74; I² = 0%; 2 studies; 1025 participants; moderate certainty evidence) or all-cause mortality (RR 1.12, 95% CI 0.71 to 1.75; I² = 0%; 2 studies; 1082 participants; moderate certainty evidence). Antimicrobial-impregnated catheters may make little or no difference to risk of catheter failure (RR 1.04, 95% CI 0.82 to 1.30; I² = not applicable; 1 study; 221 participants; low certainty evidence). Antimicrobial-impregnated catheters probably make little or no difference to PICC-related BSI risk (RR 1.05, 95% CI 0.71 to 1.55; I² = not applicable; 2 studies (no events in 1 study); 1082 participants; moderate certainty evidence). Antimicrobial-impregnated catheters may make little or no difference to risk of catheter breakage (RR 0.86, 95% CI 0.19 to 3.83; I² = not applicable; 1 study; 804 participants; low certainty evidence).
AUTHORS' CONCLUSIONS
There is limited high-quality RCT evidence available to inform clinician decision-making for PICC materials and design. Limitations of the current evidence include small sample sizes, infrequent events, and risk of bias. There may be little to no difference in the risk of VTE, PICC-associated BSI, occlusion, or mortality across PICC materials and designs. Further rigorous RCTs are needed to reduce uncertainty.
Topics: Humans; Randomized Controlled Trials as Topic; Catheterization, Peripheral; Catheter-Related Infections; Equipment Failure; Equipment Design; Venous Thromboembolism; Catheter Obstruction; Central Venous Catheters; Cause of Death; Bias; Catheterization, Central Venous; Bacteremia
PubMed: 38940297
DOI: 10.1002/14651858.CD013366.pub2 -
JACC. Advances Feb 2024Antithrombotic therapy (ATT) in patients with infective endocarditis (IE) is challenging.
BACKGROUND
Antithrombotic therapy (ATT) in patients with infective endocarditis (IE) is challenging.
OBJECTIVES
The authors evaluated the impact of anticoagulant and antiplatelet therapy on clinical endpoints in IE patients.
METHODS
We performed a systematic review and meta-analysis comparing IE patients with prior and/or ongoing use of ATT vs those without any ATT during IE course. Primary outcome was reported in-hospital cerebrovascular events. Secondary outcomes were in-hospital mortality, intracranial hemorrhage (ICH), systemic thromboembolism (ST), and mortality within 6 months.
RESULTS
Twelve studies, with a total of 12,151 patients, were included. The primary endpoint was not different comparing 10,115 IE patients with or without prior anticoagulation (OR: 1.10; 95% CI: 0.56-2.17; = 0.77) or comparing 838 IE patients with or without prior antiplatelet (OR: 0.90; 95% CI: 0.61-1.33; = 0.61). In-hospital mortality was lower in IE patients with prior anticoagulation compared to those without (OR: 0.74; 95% CI: 0.57-0.96; = 0.03). There was no difference in reported ICH rates between patients with or without prior anticoagulation (OR: 0.54; 95% CI: 0.27-1.09; = 0.09) or between patients with or without prior antiplatelet (OR: 0.35; 95% CI: 0.11-1.10; = 0.07). The rate of ST was lower in IE patients with prior antiplatelet therapy compared to those without (OR: 0.53; 95% CI: 0.38-0.72; < 0.01).
CONCLUSIONS
ATT in IE patients was not associated with higher frequency of cerebrovascular events or ICH. Moreover, we found that the use of anticoagulation was associated with decreased in-hospital mortality and the use of antiplatelets was associated with decreased ST. Due to the limitations of this study, these results should be interpreted cautiously showing the necessity of a randomized setup.
PubMed: 38939390
DOI: 10.1016/j.jacadv.2023.100768 -
Andrology Jun 2024Erectile dysfunction (ED) is prevalent not only among older males but also in younger. The physical activity has been considered a potential protective factor against... (Review)
Review
BACKGROUND
Erectile dysfunction (ED) is prevalent not only among older males but also in younger. The physical activity has been considered a potential protective factor against ED. However, there is a lack of comprehensive research on the impact of exercise interventions specifically on ED patients.
OBJECTIVES
This study aimed to assess the effectiveness of the physical activity in addressing ED symptoms among adult males, without the use of the phosphodiesterase-5 inhibitors (PDE5i) therapy. Additionally, subgroup analysis was performed to evaluate the effects of different exercise modes.
METHODS
Employing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we conducted a systematic literature search. A registered protocol is available at PROSPERO (CRD42023441717). Our search spanned PubMed, Web of Science, Embase, and Cochrane Library, with data collection ending on 11 April 2024. The Cochrane Risk of Bias tool was applied by two independent authors to assess randomized controlled trial (RCT) quality. The primary endpoint was determined as the International Index of Erectile Function (IIEF) scores.
RESULTS
A total of seven RCTs were included. Utilizing a random-effects model, the estimated standardized mean difference (SMD) was 0.69 (95% confidence interval [CI] 0.37 to 1.02, p < 0.0001) for the overall impact of the physical activity. Subgroup analysis revealed SMDs of 0.81 (95% CI 0.56 to 1.06; p < 0.00001) for aerobic training alone. However, no significant improvement was observed with pelvic floor muscle training (PFMT) (SMD 0.03; 95% CI -0.68 to 0.75; p = 0.93) and a combination of aerobic and resistance training (SMD 0.84; 95% CI -0.41 to 2.09; p = 0.19) CONCLUSION: The findings of this study highlight a significant improvement in the erectile function following exercise interventions for adult men with ED, who are not receiving the PDE5i therapy, especially in conducting aerobic training alone. However, PFMT and a combination of aerobic and resistance training did not show significant improvements in erectile function from this study.
PubMed: 38937909
DOI: 10.1111/andr.13682 -
Lasers in Medical Science Jun 2024We sought to assess the efficacy and safety of endovenous laser ablation utilizing a 980 nm device versus a 1470 nm device in the treatment of lower limb venous... (Meta-Analysis)
Meta-Analysis
We sought to assess the efficacy and safety of endovenous laser ablation utilizing a 980 nm device versus a 1470 nm device in the treatment of lower limb venous insufficiency. We performed a systematic review adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement. A research on PubMed, Scopus and Web of science for articles published by January 2024 was conducted. The primary endpoint was great saphenous vein (GSV) and truncal vein occlusion. Eleven studies encompassing 3061 patients and 3193 truncal veins, were included. The 1470 nm device demonstrated superior truncal vein and GSV occlusion outcomes compared to the 980 nm device at the early, one-year, and medium to long-term follow-up intervals. Odds ratios (OR) were 2.79(95%CI:1.31-5.94), 2.22(95%CI:1.21-4.07), and 2.02(95%CI:1.24-3.29) for truncal veins and 2.54(95%CI:1.119-5.41), 2.06(95%CI:1.07-3.95) and 2.04(95%CI:1.25-3.33) for GSV, across the respective intervals. While both devices demonstrated minimal, deep vein thrombosis (DVT), endovenous heat-induced thrombosis (EHIT) ≥ 2, and burn estimates, the 1470 nm device exhibited improved paresthesia, risk ratio (RR), 0.51(95%CI:0.34-0.77) and pain outcomes, standardized mean difference (SMD), -0.62(95%CI:-0.99to-0.25). Subgroup analysis displayed enhanced occlusion outcomes with the 1470 nm device for the six-month and one-year intervals, irrespective of fiber type. Radial fibers were associated with improved paresthesia outcomes (β=-0.9520,p = 0.03). This review emphasized the enhanced efficacy of the 1470 nm device over the 980 nm device, regardless of fiber type. Radial fibers showed promise for improved paresthesia outcomes, suggesting similar safety profiles for both systems. Conclusive remarks on pain outcomes were impeded by data limitations.
Topics: Humans; Endovascular Procedures; Laser Therapy; Treatment Outcome; Venous Insufficiency
PubMed: 38935309
DOI: 10.1007/s10103-024-04112-0 -
Digestive Diseases and Sciences Jun 2024Luminal strictures, common in inflammatory bowel disease (IBD), especially Crohn's disease (CD), are typically treated with endoscopic balloon dilatation (EBD). The...
BACKGROUND AND AIM
Luminal strictures, common in inflammatory bowel disease (IBD), especially Crohn's disease (CD), are typically treated with endoscopic balloon dilatation (EBD). The newer endoscopic stricturotomy (ESt) approach shows promise, but data is limited. This systematic review and meta-analysis assess the effectiveness and safety of ESt in IBD-related strictures.
METHODS
A comprehensive literature search was conducted until November 2023 for studies assessing ESt efficacy and safety in IBD. Primary outcomes were clinical and technical success, with secondary endpoints covering adverse events, subsequent stricture surgery, additional endoscopic treatments (ESt or EBD), medication escalation, disease-related emergency department visits, and hospitalization post-ESt. Technical success was defined as passing the scope through the stricture, and clinical success was defined as symptom improvement. Single-arm meta-analysis (CMA version 3) calculated the event rate per patient with a 95% confidence interval (CI). Heterogeneity was evaluated using I.
RESULTS
Nine studies were included, involving 640 ESt procedures on 287 IBD patients (169 CD, 118 ulcerative colitis). Of these, 53.3% were men, with a mean age of 43.3 ± 14.3 years and a mean stricture length of 1.68 ± 0.84 cm. The technical success rate was 96.4% (95% CI 92.5-98.3, p-value < 0.0001), and the clinical success rate was 62% (95% CI 52.2-70.9, p-value = 0.017, I = 34.670). The bleeding rate was 10.5% per patient, and the perforation rate was 3.5%. After an average follow-up of 0.95 ± 1.1 years, 16.4% required surgery for strictures post-ESt, while 44.2% needed additional endoscopic treatment. The medication escalation rate after ESt was 14.7%. The disease-related emergency department visit rate was 14.7%, and the disease-related hospitalization rate post-procedure was 21.3%.
CONCLUSION
Our analysis shows that ESt is safe and effective for managing IBD-related strictures, making it a valuable addition to the armamentarium of endoscopists. Formal training efforts should focus on ensuring its widespread adoption.
PubMed: 38926222
DOI: 10.1007/s10620-024-08533-3 -
BMJ Open Jun 2024To assess compliance with statutory requirements to register and report outcomes in interventional trials of mesenchymal stromal cells (MSCs) for musculoskeletal...
OBJECTIVE
To assess compliance with statutory requirements to register and report outcomes in interventional trials of mesenchymal stromal cells (MSCs) for musculoskeletal disorders and to describe the trials' clinical and design characteristics.
DESIGN
A systematic review of published trials and trials submitted to public registries.
DATA SOURCES
The databases Medline, Cochrane Library and McMaster; six public clinical registries. All searches were done until 31 January 2023.
ELIGIBILITY CRITERIA
Trials submitted to registries and completed before January 2021. Prospective interventional trials published in peer-reviewed journals.
DATA EXTRACTION AND SYNTHESIS
The first author searched for trials that had (1) posted trial results in a public registry, (2) presented results in a peer-reviewed publication and (3) submitted a pretrial protocol to a registry before publication. Other extracted variables included trial design, number of participants, funding source, follow-up duration and cell type.
RESULTS
In total 124 trials were found in registries and literature databases. Knee osteoarthritis was the most common indication. Of the 100 registry trials, 52 trials with in total 2 993 participants had neither posted results in the registry nor published results. Fifty-two of the registry trials submitted a protocol retrospectively. Forty-three of the 67 published trials (64%) had registered a pretrial protocol. Funding source was not associated with compliance with reporting requirements. A discrepancy between primary endpoints in the registry and publication was found in 16 of 25 trials. In 28% of trials, the treatment groups used adjuvant therapies. Only 39% of controlled trials were double-blinded.
CONCLUSIONS
A large proportion of trials failed to comply with statutory requirements for the registration and reporting of results, thereby increasing the risk of bias in outcome assessments. To improve confidence in the role of MSCs for musculoskeletal disorders, registries and medical journals should more rigorously enforce existing requirements for registration and reporting.
Topics: Humans; Registries; Musculoskeletal Diseases; Mesenchymal Stem Cell Transplantation; Clinical Trials as Topic; Guideline Adherence; Research Design; Mesenchymal Stem Cells
PubMed: 38925685
DOI: 10.1136/bmjopen-2023-081343 -
BMC Cardiovascular Disorders Jun 2024With advancements in chronic total coronary occlusion (CTO) recanalization techniques and concepts, the success rate of recanalization has been steadily increasing.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
With advancements in chronic total coronary occlusion (CTO) recanalization techniques and concepts, the success rate of recanalization has been steadily increasing. However, the current data are too limited to draw any reliable conclusions about the efficacy and safety of drug-coated balloons (DCBs) in CTO percutaneous coronary intervention (PCI). Herein, we conducted a meta-analysis to confirm the efficacy of DCB in CTO PCI.
METHODS
We systematically searched PubMed, Web of Science and Embase from inception to July 25, 2023. The primary outcome was major advent cardiovascular events (MACE), including cardiac death, nonfatal myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR). The follow-up angiographic endpoints were late lumen enlargement (LLE), reocclusion and restenosis.
RESULTS
Five studies with a total of 511 patients were included in the meta-analysis. Across studies, patients were predominantly male (72.9-85.7%) and over fifty years old. The summary estimate rate of MACE was 13.0% (95% CI 10.1%-15.9%, I = 0%, p = 0.428). The summary estimate rates of cardiac death and MI were 2.2% (95% CI 0.7%-3.7%, I = 0%, p = 0.873) and 1.2% (95% CI -0.2-2.6%, I = 13.7%, p = 0.314), respectively. Finally, the pooled incidences of TLR and TVR were 10.1% (95% CI 5.7%-14.5%, I = 51.7%, p = 0.082) and 7.1% (95% CI 3.0%-11.2%, I = 57.6%, p = 0.070), respectively. Finally, the summary estimate rates of LLE, reocclusion and restenosis were 59.4% (95% CI 53.5-65.3%, I = 0%, p = 0.742), 3.3% (95% CI 1.1-5.4%, I = 0%, p = 0.865) and 17.5% (95% CI 12.9-22.0%, I = 0%, p = 0.623), respectively.
CONCLUSION
Accordingly, DCB has the potential to be used as a treatment for CTO in suitable patients.
Topics: Humans; Coronary Occlusion; Coated Materials, Biocompatible; Treatment Outcome; Chronic Disease; Cardiac Catheters; Angioplasty, Balloon, Coronary; Risk Factors; Aged; Female; Middle Aged; Male; Cardiovascular Agents; Aged, 80 and over; Risk Assessment; Time Factors; Equipment Design; Coronary Restenosis
PubMed: 38918738
DOI: 10.1186/s12872-024-03993-x -
Frontiers in Neurology 2024The safety and efficacy of dual antiplatelet therapy (DAPT) in ischemic stroke patients with intracranial artery stenosis (ICAS) remain contentious.
BACKGROUND
The safety and efficacy of dual antiplatelet therapy (DAPT) in ischemic stroke patients with intracranial artery stenosis (ICAS) remain contentious.
AIMS
This study evaluates DAPT's effectiveness and safety for these patients.
METHODS
This review was reported following PRISMA 2020 guidelines. A comprehensive search was conducted in PubMed, Embase, Cochrane Library, ClinicalTrials.gov, CNKI, WanFang, VIP, and SinoMed up to June 20, 2023, for randomized controlled trials comparing efficacy and safety of DAPT against single antiplatelet therapy (SAPT) in ischemic stroke patients with ICAS. The primary outcome was a composite of ischemic and bleeding events. Secondary outcomes included stroke (cerebral infarction and hemorrhage), ischemic events, and cerebral infarction. Safety outcomes assessed were bleeding events, cerebral hemorrhage, and mortality. Risk ratios (RRs) with 95% confidence intervals (CIs) were synthesized using Review Manager 5.4.
RESULTS
Analysis of 21 randomized controlled trials involving 3,591 patients revealed that DAPT significantly lowered the rate of ischemic and bleeding events (RR = 0.52; 95% CI: 0.46-0.59, < 0.001) and recurrent stroke (RR = 0.37; 95% CI: 0.30-0.44, < 0.001) compared to SAPT. There was no significant increase in bleeding events (RR = 1.34; 95% CI: 0.97-1.85, = 0.07) or cerebral hemorrhage (RR = 0.47; 95% CI: 0.17-1.31, = 0.15).
CONCLUSION
DAPT proveed to be effective and safe for ischemic stroke patients with ICAS and significantly reduced stroke and the composite endpoint of ischemic and bleeding events without elevating bleeding risks.
PubMed: 38915797
DOI: 10.3389/fneur.2024.1411669 -
Cardiovascular Endocrinology &... Sep 2024Bempedoic acid (BA) has shown varied efficacy in managing hyperlipidemia. We conducted the most extensive up-to-date meta-analysis, the first to include recent studies... (Review)
Review
Efficacy and outcomes of bempedoic acid versus placebo in patients with hypercholesterolemia: an updated systematic review and meta-analysis of randomized controlled trials.
INTRODUCTION
Bempedoic acid (BA) has shown varied efficacy in managing hyperlipidemia. We conducted the most extensive up-to-date meta-analysis, the first to include recent studies by Nissen et al., which boast the largest sample size.
METHODS
Literature search was done on Medline, EMBASE, and Cochrane Library. The primary endpoint was a change in low-density lipoprotein-cholesterol (LDL-C) levels, while secondary endpoints encompassed changes in lipid parameters, clinical endpoints, and safety endpoints. The least-square mean (LSM) percent change was utilized for lipid changes, with statistical significance set at < 0.05.
RESULTS
This analysis included 12 randomized control trials with 22,249 participants. BA exhibited a substantial reduction in LDL-C levels [LSM % change, -24.34; 95% confidence interval (CI), -27.80 to -20.88; < 0.0001], total cholesterol levels (LSM % change, -16.62; 95% CI, -21.70 to -11.54; < 0.00001) and high-density lipoprotein-cholesterol (HDL-C) levels (LSM % change, -4.22; 95% CI, -5.51 to -2.92; < 0.00001) compared to the placebo.
CONCLUSIONS
BA significantly lowers LDL-C, total cholesterol, HDL-C, non-HDL-C, high sensitivity C reactive protein, and apolipoprotein levels.
PubMed: 38911912
DOI: 10.1097/XCE.0000000000000302 -
Cureus May 2024The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative was established in 2016 to assess the... (Review)
Review
The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative was established in 2016 to assess the quality and standardization of patient-reported outcomes (PRO) data analysis in randomized controlled trials (RCTs) on advanced breast cancer. The initiative identified deficiencies in PRO data reporting, including nonstandardized methods for handling missing data. This study evaluated the reporting of health-related quality of life (HRQOL) in Japanese cancer RCTs to provide insights into the state of PRO reporting in Japan. The study reviewed PubMed articles published from 2010 to 2018. Eligible studies included Japanese cancer RCTs with ≥50 adult patients (≥50% were Japanese) with solid tumors receiving anticancer treatments. The evaluation criteria included clarity of the HRQOL hypotheses, multiplicity testing, primary analysis methods, and reporting of clinically meaningful differences. Twenty-seven HRQOL trials were identified. Only 15% provided a clear HRQOL hypothesis, and 63% examined multiple HRQOL domains without adjusting for multiplicity. Model-based methods were the most common statistical methods for the primary HRQOL analysis. Only 22% of the trials explicitly reported clinically meaningful differences in HRQOL. Baseline assessments were reported in most trials, but only 26% reported comparisons between the treatment groups. HRQOL analysis was based on the intention-to-treat population in 19% of the trials, and 74% reported compliance at follow-up; however, 41% did not specify how missing values were handled. Although the rates of reporting clinical hypotheses and clinically meaningful differences were relatively low, the current state of HRQOL evaluation in the Japanese cancer RCT appears comparable to that of previous studies.
PubMed: 38910767
DOI: 10.7759/cureus.60804