Timely publication of preregistered study outcomes is not self-evident. Discrepancies can lead to significant research waste.

To assess timely (within 7 years) and consistent publication of preregistered primary outcomes and associated factors of total knee arthroplasty (TKA) studies registered between 2000 and 2017 over time.

An observational study.

ClinicalTrials.Gov, MEDLINE, Embase, Cochrane Library, Web of Science, PubMed and Google Scholar.

Registered TKA trials at ClinicalTrials.Gov between 2000 and 2017.

ClinicalTrials.Gov’s required and optional data elements for registering a study and the preregistered and published primary outcome, defined as the outcome stated in the primary outcome field on ClinicalTrials.Gov. We used descriptive statistics, Kaplan-Meier curves and Cox regression analyses.

1352 registered TKA (1072 interventional; 280 observational) studies were included, with 967 (811 interventional; 156 observational) unique references. Regarding the publication of preregistered primary outcomes within 7 years, the results for interventional trials were 0% (2000), which increased to 59.6% (2017). Observational studies were timely published in 0% (2000) and 37.5% (2017). Interventional trials and observational studies not funded by industry were more likely to have timely and consistent publication of their primary outcomes. Drug intervention trials were more likely to be timely and consistently published than procedure-focused trials. Phase 3 interventional trials were more likely, while phase 1 trials were less likely to be consistently published on time.

Despite ongoing efforts to improve publication rates, over a third of interventional trials remain unpublished within 7 years. For observational studies, the rate is even lower, with only two-fifths published on time, contributing to significant research waste.

CRD42021246599.

Transoral robotic surgery (TORS) is a minimally invasive technique for surgical removal of tumours of the tonsil and lateral oropharynx. Surgical defects after TORS lateral oropharyngectomy are traditionally left open to heal by secondary intention, resulting in significant postoperative pain and secondarily resulting in delayed swallowing and discharge. Although multimodal analgesia can improve postoperative pain control, no studies to date have assessed the impact of adjunct surgical interventions for reducing postoperative pain after TORS. Buccal fat rotation flap is a regional reconstruction option after TORS lateral oropharyngectomy and provides immediate coverage of the open surgical wound. However, the impact of buccal fat rotation flap reconstruction on postoperative pain and swallowing remains unclear. This trial aims to compare postoperative pain outcomes in patients who undergo TORS lateral oropharyngectomy with and without buccal fat rotation reconstruction.

This protocol outlines a single centre, parallel, unblinded, phase II, randomised control trial. Inclusion criteria include adult patient (≥18 years) undergoing TORS lateral oropharyngectomy for early to intermediate stage tonsillar squamous cell carcinoma (T1-2N0-1 p16+/–) or early to intermediate stage salivary gland tumours of the palatine tonsils. Exclusion criteria include a history of prior head and neck squamous cell carcinoma, prior head and neck radiotherapy, retropharyngeal lymphadenopathy, bilateral lymphadenopathy, need for bilateral neck dissection, baseline trismus, opioid use or drug addiction, need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap, and pregnancy. All patients are planned for a TORS lateral oropharyngectomy. The intervention group will have a buccal fat rotation flap reconstruction, and the control group will be allowed to heal via secondary intention. The allocation sequence will be created using a computer-generated random sequence with a permuted block strategy. The allocation sequence will be concealed until the time of assignment. The primary outcome is postoperative pain intensity during rest and swallowing using the visualised analogue scale. Secondary outcomes include postoperative complications, other adverse events, patient-reported speech and swallowing, opioid usage, length of hospital stay, feeding tube dependence and blood glucose levels. The trial has a target sample size of 40 patients. Statistical analysis of the primary outcome will be analysed in an intention to treat analysis using a linear mixed effects model.

The study was approved by the University Health Network Coordinated Approval Process for Clinical Research. Study number CAPCR ID: 24-5894. All participants will be required to provide written informed consent to participate. Findings will be presented at national conferences and published in medical journals.

NCT06965738.

To explore and understand the disease priorities and preferences for rapid diagnostic testings (RDTs) among community members and stakeholders.

Qualitative study using focused group discussions and in-depth interviews. Thematic analysis was applied to identify themes of disease priorities and RDT preferences.

uMsunduzi Municipality, KwaZulu-Natal, South Africa.

49 community members and five community stakeholders were recruited through a combination of convenience and purposeful sampling using community events and meetings.

Participants prioritised both communicable diseases (HIV, tuberculosis) and non-communicable diseases (diabetes, cardiovascular disease, hypertension and cancer), aligning with national health priorities. They supported RDTs for early diagnosis and home-based testing to mitigate barriers to accessing diagnostic care. A need for post-test support, such as digital support tools, was also highlighted.

Community perspectives highlighted a demand for accessible, rapid and decentralised diagnostic tools for high-burden diseases in KwaZulu-Natal. RDTs have the potential to improve health outcomes and reduce health disparities through improved access to diagnostic healthcare services. The community members are potential end users of RDTs, especially in resource-constrained settings. Therefore, their perspectives should be considered in the development and implementation of RDTs to enhance acceptability and public health impact.

Data quality in epidemiological studies is a basic requirement for good scientific research. The aim of this study was to examine an important indicator of data quality, data completeness, by investigating predictors of missing data.

Baseline data of a cohort study, the population-based Hamburg City Health Study, were used. Missingness was investigated at the levels of a whole research unit, on the two segments of health service utilisation and psychosocial variables, and two sensitive items (income and number of sexual partners). Predictors for missingness were sociodemographic variables, cognitive abilities and the mode of data collection. Associations were estimated using binary and multinomial logistic regression models.

Of 10 000 participants (mean age=62.4 years; 51.1% women), 32.9% had complete data at the unit level, 66.8% had partially missing data and 0.3% missed all items. The highest proportions of missing values were found for income (27.8%) and the number of sexual partners (36.7%). At both the unit, segment and item level, older age, female sex, low education, a foreign mother language and cognitive impairment were significant predictors for missingness.

For analysing population-based data, dealing with missingness is equally important at all levels of analysis. During the design and conduct of the study, the identified groups may be targeted to reach higher levels of data completeness.

Early-life exposures, such as nutritional deficiencies, stress, smoking, toxins, medications, diseases, infections and inflammation may affect multiple physiological and metabolic systems in the offspring, including hormonal regulation, bone metabolism and mineralisation, and body composition. Moreover, the effect of these early-life exposures on later health may potentially be mediated through adverse neonatal epigenetic reprogramming of bone-related genes affecting health later in life, especially skeletal development and bone density. Thus, to advance this research further, the overall aim of the project is to investigate if (a) neonatal epigenetic and genetic signature; (b) maternal risk factors during preconception and pregnancy, such as medicine use, diseases, socioeconomic status, major life events, weight, growth and lifestyle; (c) risk factors at birth, such as instrumental delivery, mode of delivery, medicine use, injuries, diseases, weight, size for gestational age, ponderal index, gestational age; and (d) childhood risk factors, such as diseases, medicine use, major life events, weight, growth and lifestyle are associated with hormonal status, lipids, bone turnover markers, bone mineral density, fat mass and lean body mass at age 18–19 years.

Population-based, nationwide, cross-sectional clinical study with potential for longitudinal reassessment. Danish women and men aged 18–19 years old will be selected at random from the Danish National Population Registry and invited if they have available neonatal dried blood spot cards. A total of 2000 individuals will be enrolled. The study combines register data, and neonatal epigenetic and genetic analyses from stored blood with clinical and survey data. Body composition will be measured using dual-energy X-ray absorptiometry. Adult blood and hair samples will be obtained to assess hormonal status, lipids and bone turnover markers. Height, weight, waist and hip circumference, and blood pressure will be measured. Questionnaires on well-being, sleep patterns, dietary and exercise habits, onset of puberty, use of cannabis, nicotine, alcohol and pain medication will be included. Information on medicine use, diseases, socioeconomic status, major life events, weight, growth and lifestyle will be obtained from the national administrative and health registers at the time of conception and during pregnancy for the parents, as well as from the participants throughout their lifetime. Health registries include the Danish Medical Birth Register, the National Patient Register, the Danish National Prescription Register, the National Child Health Register and Statistics Denmark. Multivariate regression analyses will be performed.

This nationwide study has been approved by the Regional Committees on Health Research Ethics for Southern Denmark (S-20230105). The study participants will be enrolled in the study following their informed written consent. Results will be submitted for publication. The Strengthening the Reporting of Observational Studies in Epidemiology Statement guidelines will be used for reporting.

NCT06509776.

To evaluate staffing conditions, patient outcomes, quality of care, patient safety and nurse job outcomes in British Columbia (BC), Canada hospitals.

Cross-sectional study of 58 hospitals in BC with surveys of nurses and independent measures of patient outcomes.

58 hospitals in BC.

6685 hospital-based nurses working in a direct patient care role.

Hospital-wide and unit-specific patient-to-nurse staffing ratios derived from registered nurse reports of how many patients and how many nurses were on their unit during their last shift worked.

Objective patient outcome measures included the Hospital Standardized Mortality Ratio (HSMR) and 30-day Readmission Rate, from 2022 to 2023 Canadian Institute for Health Information data. Nurses4All@BC provided data from 2024 using validated items on multiple measures (eg, nurse burnout, missed health breaks, intentions to leave, quality and safety measures such as culture of patient safety, quality of nursing care, missed nursing care).

Burnout (59.4%), missed health breaks (41.7%), job dissatisfaction (36.0%), intentions to leave (19.3%) and patient outcomes (HSMR mean 95.4, median 96.0, range 26–180; readmission rate mean 10.0%, median 9.5%, range 7.9%–13.8%) were high and varied across hospitals. 68.3% of nurses reported there were not enough staff, and 77.3% reported their workloads were unsafe for patients. 60.6% of nurses gave their hospital an unfavourable patient safety rating. More patients per nurse were associated with poorer hospital mortality and readmission rates, poorer job outcomes for nurses, more adverse events for patients, less favourable ratings of quality of care and patient safety, more missed nursing care and poorer ratings of staffing adequacy and management.

Given the variability in staffing, quality and patient outcomes across BC hospitals, the implementation of a minimum nurse-to-patient ratio policy has the potential to improve patient care safety and retention of nurses.