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Randomized controlled trials (RCTs) are the gold standard for evaluating clinical interventions, but their limitations—particularly in settings where strong patient preferences exist—can impair recruitment, compliance, and external validity. In cardiovascular research, these challenges are pronounced in trials comparing treatments that differ substantially in invasiveness, burden, or delivery mode. We describe how patient preference-controlled designs can enhance trial efficiency and generalizability by engaging patients as active participants in the allocation process. Although nonrandom allocation introduces potential for confounding, we argue that these trials can produce valid and robust treatment effect estimates when key confounding influences—such as physician bias, functional status, and health beliefs—are prospectively measured and controlled. Preference, under appropriate design conditions, may function as a valid instrumental variable. Furthermore, we introduce a hybrid trial design that incorporates both randomized and preference-based cohorts. This approach allows for separate and combined effect estimates, preserving the internal validity of randomization while expanding recruitment and improving external validity. Bayesian modeling frameworks can be used to integrate treatment effect estimates across cohorts while adjusting for differences in preference strength and confounding structure. In summary, patient preference-controlled trials represent a rigorous, underutilized methodology in cardiovascular research. By prospectively addressing and quantifying bias, they offer a practical solution to the limitations of both traditional RCTs and retrospective observational studies. We advocate for the development of formal design and reporting guidelines and encourage their consideration in trials where patient empowerment and generalizability are critical. •Randomization can hinder enrollment and compliance due to ignored patient preferences.•Preference-controlled trials may improve engagement, representativeness, and power.•Prospective, preference-based designs remain underused in cardiovascular research.•These designs require careful bias control and confounder adjustment to be valid.•Hybrid preference and randomization trials can enhance power and external validity.

To review the literature and obtain preferences and perceptions from experts regarding the role of randomized studies (RSs) and nonrandomized studies (NRSs) in systematic reviews of intervention effects. Scoping review and survey of experts. Using levels of certainty developed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group, experts expressed their preferences about the use of RS and NRS in health syntheses. Of 189 respondents, 123 had the expertise required to answer the questionnaire; 116 provided their extent of agreement with approaches to use NRS with RS. Most respondents would include NRS when RS was unfeasible (83.6%) or unethical (71.5%) and a majority to maximize the body of evidence (66.3%), compare results in NRS and RS (53.5%) and to identify subgroups (51.7%). Sizable minorities would include NRS and RS to address the effect of randomization (29.5%) or because the question being addressed was a public-health intervention (36.5%). In summary of findings tables, most respondents would include both bodies of evidence–in two rows in the same table—when RS provided moderate, low, or very-low certainty evidence; even when RS provided high certainty evidence, a sizable minority (25%) would still present results from both bodies of evidence. Very few (3.6%) would, under realistic circumstances, pool RS and NRS results. Most experts would include both RS and NRS in the same review under a wide variety of circumstances, but almost all would present results of two bodies of evidence separately.

Background: The major component of a systematic review is assessment of the methodologic quality and bias of randomized and nonrandomized trials. While there are multiple instruments available to assess the methodologic quality and bias for randomized controlled trials (RCTs), there is a lack of extensively utilized instruments for observational studies, specifically for interventional pain management (IPM) techniques. Even Cochrane review criteria for randomized trials is considered not to be a “gold standard,” but merely an indication of the current state of the art review methodology. Recently a specific instrument to assess the methodologic quality of randomized trials has been developed for interventional techniques. Objectives: Our objective was to develop an IPM specific instrument to assess the methodological quality of nonrandomized trials or observational studies of interventional techniques. Methods: The item generation for the instrument was based on a definition of quality, to the extent to which the design and conduct of the trial were congruent with the objectives of the study. Applicability was defined as the extent to which procedures produced by the study could be applied using contemporary IPM techniques. Multiple items based on Cochrane review criteria and Interventional Pain Management Techniques – Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR) were utilized. Results: A total of 16 items were developed which formed the IPM-QRBNR tool. The assessment was performed in multiple stages. The final assessment was 4 nonrandomized studies. The inter-rater agreement was moderate to good for IPM-QRBNR criteria. Limitations: Limited validity or accuracy assessment of the instrument and the large number of items to be scored were limitations. Conclusion: We have developed a new comprehensive instrument to assess the methodological quality of nonrandomized studies of interventional techniques. This instrument provides extensive information specific to interventional techniques is useful in assessing the methodological quality and bias of observational studies of interventional techniques. Key words: Methodological quality assessment, evidence-based medicine, comparative effectiveness research, Cochrane Reviews, interventional techniques, risk of bias assessment, nonrandomized trials, observational studies

Background Amputation is the standard of care even for early-stage subungual melanomas (SUMs), known as nail apparatus melanoma, because the nail bed and nail matrix are close to the distal phalanx. However, a recent study demonstrated that not all patients with SUMs had histologic invasion of the underlying distal phalanx. As most SUMs occur in the thumb or big toe, amputation of either the thumb or big toe substantially interferes with activities of daily living, including poor cosmesis, loss of function, and phantom pain. Non-amputative digit preservation surgery can thus be applied in such cases without compromising patient prognosis. Methods We are conducting a multi-institutional single-arm trial to confirm the safety and efficacy of non-amputative digit preservation surgery. We will compare our results with those reported in the Japanese Melanoma Study, in which patients underwent amputation for SUMs as a traditional standard of care. Patients aged between 20 and 80 years with stage I, II, or III without evidence of tumor invasion to the underlying distal phalanx on preoperative radiograph are included in the study. The primary endpoint is major relapse-free survival (major RFS), which does not include local recurrence as an event; secondary endpoints include overall survival, digit-preservation survival, relapse-free survival, local relapse-free survival, partial relapse-free survival, and incidence of adverse events. A total of 85 patients from 21 Japanese institutions will be recruited within 5.5 years, and the follow-up period will last at least 5 years. The Japan Clinical Oncology Group Protocol Review Committee approved this study protocol in August 2017, and patient enrollment began in November 2017. Ethical approval was obtained from each institution’s Institutional Review Board prior to patient enrollment. Discussion This is the first prospective trial to confirm the safety and efficacy of non-amputative digit preservation surgery for SUM without distant metastasis or bony invasion. The results of this trial could provide evidence to support this less-invasive surgery as a new standard of care to preserve adequately functioning digits. Trial registration Registry number: UMIN000029997 . Date of Registration: 16/Nov/2017. Date of First Participant Enrollment: 12/Dec/2017.

Cancer is the leading cause of death in Canada, responsible for 28.2% of all deaths. Based on surgical candidacy and disease status, both lung and esophageal cancer are treated through surgical resection by a thoracic surgeon. Although surgery contributes to improved outcomes, the 30-day postoperative mortality risks are as high as 10% and 2.8%, respectively. Evidence has shown that prehabilitation is a way in which patients can have improved postoperative outcomes. Prehabilitation is multimodal, often including some form of movement, nutrition, stress management, and smoking cessation. Given the complexity of the health care system, pragmatic trials are important methodological tools to assess internal validity and improve current practice under real-world conditions. Concurrently, using community resources is imperative to keep people active in their community and create sustainable programming. The Boosting Recovery and Activity Through Early Wellness (BREATHE WELL) study aims to explore the feasibility, implementation, and preliminary effectiveness of a clinically integrated, community-based, prehabilitation health coaching program. This includes nutrition, smoking cessation, sleep hygiene, and movement for individuals scheduled to undergo surgery for lung or esophageal cancer. This is a pilot, nonrandomized, pragmatic, repeated measures, mixed methods trial. We will recruit 32 participants diagnosed with lung or esophageal cancer and are scheduled to undergo surgical resection into the prehabilitation program, with 32 additional participants who decline participation to act as a control group. Participants who agree will then go through an 8-week tailored prehabilitation program (in person or virtual), covering movement, nutrition, stress management, nutrition, goal setting, and smoking cessation. They will complete 6 sessions prior to surgery and then have 4 sessions, 1×/week following surgery. Following the completion of the program, they will have 3 booster sessions via phone or Zoom (Zoom Video Communications). The primary outcome is feasibility: (1) recruitment feasibility-recruitment rate (the number of participants referred per month), enrollment rate (the number of enrolled participants divided by the number of referred participants), reasons for declining, and prehabilitation window (time between consent and surgery); and (2) intervention feasibility-adherence to the movement intervention, attrition, safety, study completion rate, and adverse events. Secondary outcomes include measures of preliminary effectiveness including patient-reported outcomes, such as well-being, fatigue, and functional measures. All measures will be assessed before, during, and after the prehabilitation program. Enrollment has begun in January 2025, with 2 participants enrolled in the health coaching program. The full study is expected to be completed in approximately 3 years and be published in winter 2027. This study will inform the feasibility, implementation, and preliminary effectiveness of a clinically integrated, community-based, prehabilitation program in Nova Scotia, Canada, for people scheduled to undergo curative intent surgery for lung and esophageal cancer. ClinicalTrials.gov NCT06354959; https://clinicaltrials.gov/study/NCT06354959. PRR1-10.2196/60791.

Despite the acceptability and efficacy of e-patient-reported outcome (ePRO) systems, implementation in routine clinical care remains challenging. This pragmatic trial implemented the PROMPT-Care (Patient Reported Outcome Measures for Personalized Treatment and Care) web-based system into existing clinical workflows and evaluated its effectiveness among a diverse population of patients with cancer. Adult patients with solid tumors receiving active treatment or follow-up care in four cancer centers were enrolled. The PROMPT-Care intervention supported patient management through (1) monthly off-site electronic PRO physical symptom and psychosocial well-being assessments, (2) automated electronic clinical alerts notifying the care team of unresolved clinical issues following two consecutive assessments, and (3) tailored online patient self-management resources. Propensity score matching was used to match controls with intervention patients in a 4:1 ratio for patient age, sex, and treatment status. The primary outcome was a reduction in emergency department presentations. Secondary outcomes were time spent on chemotherapy and the number of allied health service referrals. From April 2016 to October 2018, 328 patients from four public hospitals received the intervention. Matched controls (n=1312) comprised the general population of patients with cancer, seen at the participating hospitals during the study period. Emergency department visits were significantly reduced by 33% (P=.02) among patients receiving the intervention compared with patients in the matched controls. No significant associations were found in allied health referrals or time to end of chemotherapy. At baseline, the most common patient reported outcomes (above-threshold) were fatigue (39%), tiredness (38.4%), worry (32.9%), general wellbeing (32.9%), and sleep (24.1%), aligning with the most frequently accessed self-management domain pages of physical well-being (36%) and emotional well-being (23%). The majority of clinical feedback reports were reviewed by nursing staff (729/893, 82%), largely in response to the automated clinical alerts (n=877). Algorithm-supported web-based systems utilizing patient reported outcomes in clinical practice reduced emergency department presentations among a diverse population of patients with cancer. This study also highlighted the importance of (1) automated triggers for reviewing above-threshold results in patient reports, rather than passive manual review of patient records; (2) the instrumental role nurses play in managing alerts; and (3) providing patients with resources to support guided self-management, where appropriate. Together, these factors will inform the integration of web-based PRO systems into future models of routine cancer care. Australian New Zealand Clinical Trials Registry ACTRN12616000615482; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370633. RR2-10.1186/s12885-018-4729-3.

Designers and architects created the rule ‘form follows function (FFF)’ for their own profession. Our paper demonstrates that this FFF rule applies equally well to the designers of clinical studies. Four examples present are as follows: disregarding this FFF rule causes an inconsistent terminology to differentiate between efficacy and effectiveness, inconsistent differentiation of efficacy and effectiveness interferes with the consistent interpretation of the results of clinical studies, inconsistent interpretation of clinical studies results in an unexpectedly variance of recommendations in clinical guidelines and the fusion of the FFF designer rule and of the demands of Cochrane and Bradford Hill (‘can it work?’, ‘does it work?’ and ‘is it worth it?’) avoids the terminology problem and its misleading consequences. This strategy is presented.

Medical interviewing is a critical skill in clinical practice, yet opportunities for practical training are limited in Japanese medical schools, necessitating urgent measures. Given advancements in artificial intelligence (AI) technology, its application in the medical field is expanding. However, reports on its application in medical interviews in medical education are scarce. This study aimed to investigate whether medical students' interview skills could be improved by engaging with AI-simulated patients using large language models, including the provision of feedback. This nonrandomized controlled trial was conducted with fourth-year medical students in Japan. A simulation program using large language models was provided to 35 students in the intervention group in 2023, while 110 students from 2022 who did not participate in the intervention were selected as the control group. The primary outcome was the score on the Pre-Clinical Clerkship Objective Structured Clinical Examination (pre-CC OSCE), a national standardized clinical skills examination, in medical interviewing. Secondary outcomes included surveys such as the Simulation-Based Training Quality Assurance Tool (SBT-QA10), administered at the start and end of the study. The AI intervention group showed significantly higher scores on medical interviews than the control group (AI group vs control group: mean 28.1, SD 1.6 vs 27.1, SD 2.2; P=.01). There was a trend of inverse correlation between the SBT-QA10 and pre-CC OSCE scores (regression coefficient -2.0 to -2.1). No significant safety concerns were observed. Education through medical interviews using AI-simulated patients has demonstrated safety and a certain level of educational effectiveness. However, at present, the educational effects of this platform on nonverbal communication skills are limited, suggesting that it should be used as a supplementary tool to traditional simulation education.

To assess the effect of the COVID-19 pandemic on performance indicators in the population-based breast cancer screening program of Parc de Salut Mar (PSMAR), Barcelona, Spain. We conducted a before-and-after, study to evaluate participation, recall, false positives, the cancer detection rate, and cancer characteristics in our screening population from March 2020 to March 2021 compared with the four previous rounds (2012-2019). Using multilevel logistic regression models, we estimated the adjusted odds ratios (aORs) of each of the performance indicators for the COVID-19 period, controlling by type of screening (prevalent or incident), socioeconomic index, family history of breast cancer, and menopausal status. We analyzed 144,779 invitations from 47,571women. During the COVID-19 period, the odds of participation were lower in first-time invitees (aOR = 0.90 [95% CI = 0.84-0.96]) and in those who had previously participated regularly and irregularly (aOR = 0.63 [95% CI = 0.59-0.67] and aOR = 0.95 [95% CI = 0.86-1.05], respectively). Participation showed a modest increase in women not attending any of the previous rounds (aOR = 1.10 [95% CI = 1.01-1.20]). The recall rate decreased in both prevalent and incident screening (aOR = 0.74 [95% CI = 0.56-0.99] and aOR = 0.80 [95% CI = 0.68-0.95], respectively). False positives also decreased in both groups (prevalent aOR = 0.92 [95% CI = 0.66-1.28] and incident aOR = 0.72 [95% CI = 0.59-0.88]). No significant differences were observed in compliance with recall (OR = 1.26, 95% CI = 0.76-2.23), cancer detection rate (aOR = 0.91 [95% CI = 0.69-1.18]), or cancer stages. The COVID-19 pandemic negatively affected screening attendance, especially in previous participants and newcomers. We found a reduction in recall and false positives and no marked differences in cancer detection, indicating the robustness of the program. There is a need for further evaluations of interval cancers and potential diagnostic delays. This study has received funding by grants PI19/00007 and PI21/00058, funded by Instituto de Salud Carlos III (ISCIII) and cofunded by the European Union and Grant RD21/0016/0020 funded by Instituto de Salud Carlos III and by the European Union NextGenerationEU, Mecanismo para la Recuperación y la Resiliencia (MRR).

Background and Aim: Treatment of palmoplantar warts is a challenge for dermatologists. We aimed to study the efficacy and safety of Falknor's needling method in palmoplantar warts. Methods: In an open, nonrandomized study, the index wart of eligible patients was punctured several times with a 26-gauge needle to produce a \"beefy\" red wound. Patients were followed up to 6 months. Results: Out of 82 patients, complete resolution occurred in 58 (70.7%) and partial response in 5 (6.1%) patients. Nine (10.9%) patients developed secondary infection. Limitations: Small sample size, No comparison group. Conclusion: Falknor's needling method provides a high rate of complete resolution after a single treatment session. It is easy to perform and is cost effective.