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Randomised controlled trial on whether advance knowledge of prostate-specific antigen testing improves participant reporting of unprotected sex.

OBJECTIVES: To determine whether the process of informing research participants that they would be tested for the presence of a biological marker of semen exposure would reduce bias in their reports of unprotected sex. METHODS: A randomised trial of 210 female sex workers from Mombasa, Kenya, was conducted, where half the group had advance knowledge (via the request for informed consent) that they would be tested for prostate-specific antigen (PSA) in their vaginal fluid before they reported on sex and condom use for the past 48 h. The other half were invited to participate (via additional in…

Lateral retinacular release: a survey of the International Patellofemoral Study Group.

PURPOSE: The purpose of this investigation was to determine current views regarding lateral release among experienced knee surgeons with a s … of arthroscopy or exploration, 74% of respondents believed that lateral release calls for specific informed consent. Strong consensus was found that objective evidence is needed to justify lateral release, but agreement was poor as to what clinical evidence provides the most appropriate indication for the procedure. CONCLUSIONS: Even among experienced knee surge …

Determinants of a subject's decision to participate in clinical anesthesia research.

BACKGROUND: A top priority for research studies is to ensure that potential participants receive adequate information to make a truly informed decision. Understanding patient experiences with the recruitment process may identify areas for improvement in the consent process. We examined which factors were associated with the decision to consent in a clinical research study. METHODS: Patients scheduled for elective surgery were asked to complete a questionnaire about the consent process, immediately after being approached to participate in an anesthesia-related research study. Sociodemographic

Investigating haemodynamic changes during vaginal delivery in low-risk pregnant women and the association between haemodynamic and adverse pregnancy outcomes: an ambispective cohort study protocol.

INTRODUCTION: The progressive adaptation of the maternal cardiovascular system throughout pregnancy is essential to maintaining adequate ute … na. A total of 2800 pregnant women will be enrolled. After hospital admission and providing written informed consent, participants will complete a demographic questionnaire. Data collection will include maternal baseline characteristics, haemodynamic parameters at multiple stages of labour and maternal and newborn outcomes. These data will allow comprehensive anal …

Ethical nursing strategies for ART in intellectual disability: tools and systemic pathways.

BackgroundThe use of assisted reproductive technology (ART) in individuals with intellectual disabilities raises significant ethical tension … ical approval was obtained, and the study adhered to strict ethical standards, including a tailored informed consent process and robust guarantees of confidentiality.FindingsThe intervention ensured informed consent completion, medication adherence without errors, and comprehensive prenatal tracking via the national maternal health system. The patient delivered a …

Prevalence of Comorbid Hyperparathyroidism and Its Association with Renal Dysfunction in Asian Patients with X-Linked Hypophosphatemic Rickets/Osteomalacia.

In patients with X-linked hypophosphatemic rickets/osteomalacia (XLH) in Asia, the current prevalence of hyperparathyroidism and its association with renal dysfunction have not been determined. We used patient data retrospectively collected up to the time of informed consent in the SUNFLOWER study, a long-term observational study, to investigate the current treatment status and prevalence of comorbid hyperparathyroidism and its association with renal dysfunction in patients with XLH in Japan and South Korea. Of 69 patients who met the eligibility criteria, 32 (46.4%) did not have hyperparathyr…

Skin Numbness after Total Knee Arthroplasty: Complication or Side-Effect?

BACKGROUND: Peri-incisional numbness occurs frequently after Total Knee Arthroplasty (TKA), yet its impact on clinical outcomes remains controversial. With some studies reporting 100% incidence and patients often perceiving it as a minor inconvenience, its categorisation as a complication is controversial. This study investigates the prevalence and temporal changes of numbness post-TKA to refine the informed consent process and improve patient satisfaction. MATERIAL AND METHODS: A convenience sample of patients who underwent primary cemented TKA was studied. Demographic data, scar length, tou…

Nutritional support and prophylaxis of azithromycin for pregnant women to improve birth outcomes in peri-urban slums of Karachi, Pakistan-a protocol of multi-arm assessor-blinded randomized controlled trial (Mumta PW trial).

BACKGROUND: Maternal undernutrition is critical in the etiology of poor perinatal outcomes and accounts for 20% of small-for-gestational-age … ered routine antenatal care (ANC) counseling and voluntary participation in the trial after written informed consent. A total number of 1836 PW will be enrolled with informed consent and randomly allocated to one of the four arms receiving: (1) ANC counseling only (control group), (2) ANC counseling plus BEP supplement (intervention arm 1), (3) ANC counseling plus …

Decision-Making Regarding Ventilator Support in Children with SMA Type 1-A Cross-Sectional Survey among Physicians.

Spinal muscular atrophy (SMA) is a neuromuscular disorder characterized by muscle atrophy and severe proximal muscle weakness. In the absenc … The survey focused on factors influencing the decision about ventilator support and the content in informed consent discussions. Additionally, physicians were asked about their general attitude towards mechanical ventilation in children with SMA type 1 and their hypothetical clinical management in emergency settings using case vignettes. Hundred and sixty-five ph …

Issues in molecular genetic testing of individuals with suspected early-onset familial Alzheimer's disease.

The identification of mutations in the amyloid precursor protein (APP) gene associated with the presence of early-onset familial Alzheimer d … otential test results as well as the competency of the individual who requested the test to provide informed consent. Informed consent includes an understanding of the foreseeable risks and benefits associated with disclosure of test results. Although molecular genetic testing in particular individuals, such as the man described herein, could be appropriate, it sh …

Translation approaches to support systemic anti-cancer therapy consent for individuals with limited English proficiency.

PurposeLimited English proficiency (LEP) is associated with poor cancer outcomes, and written information about systemic anticancer treatment (SACT) is often provided in English only. Unsupervised machine translation of medical information is common, but its effectiveness and accuracy are unclear. This study aimed to (a) compare professional and machine translation of written SACT information and (b) investigate whether providing a bilingual SACT consent form altered comprehension of key information during an interpreted SACT consent consultation.MethodsThis randomised study included healthy,

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… Sealed envelopes were given to participants following informed consent and only unsealed by participants after enrolment. … US Food and Drug Administration (FDA) (2023) Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent . Accessed 11 Nov 2025 13. …

Perceived Sensitivity of Sensor-Based Digital Health Data: Qualitative Interview Study.

BACKGROUND: Digital health tools are increasingly used in mental health care to passively collect patient data and analyze health status out … se data and expectations for data stewardship, perspectives that are critical for developing robust informed consent and data protection policies for digital health data use. OBJECTIVE: This study aimed to explore key stakeholder perspectives on the sensitivity of computer perception (CP) data, trust in existing data protections, willingness to share CP data exte …

Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial.

BACKGROUND: Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no s … inical trial. Inclusion criteria will be infants born below 28 weeks postmenstrual age and parental informed consent (unless the site is using 'opt-out' or deferred consent). Exclusion criteria will be no parental informed consent (or if 'opt-out' is used, lack of a record that clinical staff have explained the trial and the 'opt-out' consent process to parents an …

Resection of thymic carcinoma after induction therapy and reconstruction of right ventricular outflow tract with pulmonary homograft.

Treatment of malignant epithelial thymic tumours, including thymoma and thymic carcinoma, is based on surgical resection, whenever possible. Mainstay of surgical treatment is complete resection with clear margins. This may require resection of adjacent structures, even major vessels. We describe a case of resection of the main pulmonary artery trunk and reconstruction with cadaveric homograft after induction chemo-radiotherapy for a locally advanced thymic carcinoma. Written informed consent was obtained from the patient.

RETRACTED ARTICLE: Kocuria massiliensis sp. nov, a new bacterial species isolated from a patient with foot osteomyelitis.

The Editor-in-Chief has retracted this article because the authors did not obtain informed consent to publish identifying information about the patient whose treatment was presented in this case report. The content of this article is no longer available online to protect patient confidentiality. The Publisher was not able to confirm a current contact email for Mamadou Beye. The remaining authors did not respond to correspondence from the Publisher regarding this retraction.

Committee Opinion No 672: Clinical Challenges of Long-Acting Reversible Contraceptive Methods.

Long-acting reversible contraceptive methods are the most effective reversible contraceptives and have an excellent safety record. Although uncommon, possible long-acting reversible contraceptive complications should be included in the informed consent process. Obstetrician-gynecologists and other gynecologic care providers should understand the diagnosis and management of common clinical challenges. The American College of Obstetricians and Gynecologists recommends the algorithms included in this document for management of the most common clinical challenges.

Genetics-Supported Mainstream Testing Improves Access and Efficiency for Patients With Breast Cancer.

BACKGROUND: The demand for germline genetic testing in oncology is outpacing traditional genetics service capacity. Mainstream genetic testi … 59.5 days; P<.0001) and from consent to final report (28.2 vs 35.2 days; P=.039). Documentation of informed consent was >99% in both models. However, documentation of final result disclosure was significantly lower in the mainstream model (82.4% vs 100%; P<.0001). All PV carriers were successfully referred to genetic counseling. The mainstream model substantially …

Factors influencing consent to HIV testing among wives of heavy drinkers in an urban slum in India.

The study examined the influence of socio cultural factors, perception of risk and exposure to violence on consent to HIV testing among at risk women in an urban slum. Married women chosen via a multistage probability sampling in a section of Bangalore, India, between 18 and 44 years, sexually active and considered to be at risk because of their husband's hazardous drinking were recruited for the study. Written informed consent was obtained and measures of risk behavior and violence were administered. Pretest HIV counseling was then conducted and consent for HIV testing was sought. Factors inf…

The Role of Social Value in Data-Intensive Health Research.

Data-intensive health research complicates traditional requirements for informed consent, due to the amount of data contributors and data points, the open-ended nature of research questions, and repeated or secondary data use. To still enable data-intensive health research, there is a move towards other-generally lower-standards for consent such as opt-out systems, in current developments such as the European Health Data Space (EHDS). This is premised on the social value that data-intensive health research is assumed to provide through advancing research and innovation. Traditionally, social v…

Comprehension of written texts for the assessment of clinical competence and decision making in people with mild to moderate Alzheimer disease.

BACKGROUND: Clinical competence is the term used to describe an individual's capacity to express a choice regarding their participation in c … Alzheimer's disease were compared with 130 controls in a comprehension task involving a simplified informed consent form. Their performance in this task was compared with their performance with two other types of reading material (a testament and a history text). In addition, the performance of a subgroup of very mild patients in this test was compared with their …