V3+ extends the V3 framework to ensure user-centricity and scalability of sensor-based digital health technologies.

We propose the addition of usability validation to the extended V3 framework, now "V3+", and describe a pragmatic approach to ensuring that sensor-based digital health technologies can be used optimally at scale by diverse users. Alongside the original V3 components (verification; analytical validation; clinical validation), usability validation will ensure user-centricity of digital measurement tools, paving the way for more inclusive, reliable, and trustworthy digital measures within clinical research and clinical care.

Lower risk of revision in fixed-bearing compared to mobile-bearing total ankle arthroplasties: A register based evaluation of 1246 patients in the Netherlands.

Background: Total ankle arthroplasty (TAA) has been developed as treatment for disabling tibiotalar osteoarthritis. TAAs are divided into mobile- and fixed-bearings. The aim was to determine the incidence and trends of fixed- and mobile bearings over time and investigate the association of bearing type and risk of revision after primary TAA in the Netherlands.

Assessing the net financial benefits of employing digital endpoints in clinical trials.

In the last few decades, developers of new drugs, biologics, and devices have increasingly leveraged digital health technologies (DHTs) to assess clinical trial digital endpoints. To our knowledge, a comprehensive assessment of the financial net benefits of digital endpoints in clinical trials has not been conducted. We obtained data from the Digital Medicine Society (DiMe) Library of Digital Endpoints and the US clinical trials registry, ClinicalTrials.

Unlocking the full potential of digital endpoints for decision making: a novel modular evidence concept enabling re-use and advancing collaboration.

Introduction: Over the last decade increasing examples indicate opportunities to measure patient functioning and its relevance for clinical and regulatory decision making via endpoints collected through digital health technologies. More recently, we have seen such measures support primary study endpoints and enable smaller trials. The field is advancing fast: validation requirements have been proposed in the literature and regulators are releasing new guidances to review these endpoints.

Digital Health Technologies in Clinical Trials: An Ontology-Driven Analysis to Inform Digital Sustainability Policies.

Background: Digital health technologies (DHTs) can facilitate the execution of de-centralized trials that can offer opportunities to reduce the burden on participants, collect outcome data in a real-world setting, and potentially make trial populations more diverse and inclusive. However, DHTs can also be a significant source of electronic waste (e-waste). In recognition of the potential health and environmental impact from DHT use in trials, private and public institutions have recently launched initiatives to help measure and manage this e-waste.

User experience with a voice-enabled smartphone app to collect patient-reported outcomes in rheumatoid arthritis.

Objectives: Rheumatoid arthritis (RA) is a chronic disease, requiring frequent patient-provider interaction and self-monitoring. We developed a novel mobile health smartphone app with a voice-enabled feature to help patients virtually track disease activity and ask general questions about RA.

Methods: With a user-centered design (UCD) approach, we developed a voice-enabled app (VEA) which was then tested in two focus groups of patients (n=8) and one with providers (n=4).

The Different Immune Profiles of Normal Colonic Mucosa in Cancer-Free Lynch Syndrome Carriers and Lynch Syndrome Colorectal Cancer Patients.

Background & Aims: Owing to the high load of immunogenic frameshift neoantigens, tumors arising in individuals with Lynch syndrome (LS), the most common inherited colorectal cancer (CRC) syndrome, are characterized by a pronounced immune infiltration. However, the immune status of normal colorectal mucosa in LS is not well characterized. We assessed the immune infiltrate in tumor-distant normal colorectal mucosa from LS CRC patients, sporadic microsatellite-unstable (MSI) and microsatellite-stable (MSS) CRC patients, and cancer-free LS carriers.

Harnessing Real-World Evidence for the Development of Novel Cancer Therapies.

Resourcing real-world evidence (RWE) is becoming an increasingly important asset in developing novel therapies for cancer. In this article, an overview of the benefits and challenges of using these data is provided. Through several case examples we highlight future applications and potential.

[A woman with a painless swelling on her shoulder].

A 84-year-old woman presented with a swelling located over the acromioclavicular joint, known as a Geyser sign. A Geyser sign occurs in the presence of full-thickness rotator cuff tears. Fluid exudes through the AC-joint creating a cyst.

Child with serogroup W135 primary meningococcal septic arthritis.

Over the last decade, there has been a concerning increase in the number of invasive meningococcal serotype W infections in Europe. Although sepsis and meningitis are the most feared complications, focal complications of systemic disease such as pneumonia, pericarditis and arthritis can also occur. We present a rare case of isolated meningococcal W135 arthritis of the hip without invasive meningococcal disease in a 6-year-old patient.

Effect of femoral head size and surgical approach on risk of revision for dislocation after total hip arthroplasty.

Background and purpose - Recurrent dislocation is the commonest cause of early revision of a total hip arthropasty (THA). We examined the effect of femoral head size and surgical approach on revision rate for dislocation, and for other reasons, after total hip arthroplasty (THA). Patients and methods - We analyzed data on 166,231 primary THAs and 3,754 subsequent revision THAs performed between 2007 and 2015, registered in the Dutch Arthroplasty Register (LROI).

Low density of FOXP3-positive T cells in normal colonic mucosa is related to the presence of beta2-microglobulin mutations in Lynch syndrome-associated colorectal cancer.

Microsatellite instability (MSI-H) is caused by DNA mismatch repair deficiency and occurs in 15% of colorectal cancers. MSI-H cancers generate highly immunogenic frameshift peptide (FSP) antigens, which elicit pronounced local immune responses. A subset of MSI-H colorectal cancers develops in frame of Lynch syndrome, which represents an ideal human model for studying the concept of immunoediting.

Endometrial effects of a single early luteal dose of the selective progesterone receptor modulator CDB-2914.

Objective: To test potential contraceptive mechanisms of the selective P receptor modulator CDB-2914 in the early luteal phase.

Design: Prospective randomized clinical trial.

Setting: Clinical research center.

Expression of the alphav integrin adhesion molecule during development of preimplantation human embryos.

Objective: To investigate the expression of alphav integrin in developing human embryos.

Design: Observational study.

Setting: University medical center.

A single mid-follicular dose of CDB-2914, a new antiprogestin, inhibits folliculogenesis and endometrial differentiation in normally cycling women.

Previous studies in women have shown that the antiprogestin mifepristone delays or inhibits folliculogenesis. The purpose of this study was to explore whether a new analogue, CDB-2914, has similar effects on folliculogenesis, ovulation, or on subsequent luteal phase endometrial maturation. Forty-four normally cycling, healthy women recorded urine LH and vaginal bleeding during pre-treatment, treatment, and post-treatment cycles.

Is blastocyst transfer useful as an alternative treatment for patients with multiple in vitro fertilization failures?

Objective: To determine whether blastocyst transfer is of benefit to patients with multiple IVF failures.

Design: Retrospective cohort study.

Setting: The George Washington University Medical Center.

Efficacy of sinus irrigation versus sinus irrigation followed by functional endoscopic sinus surgery.

Sinus irrigation is the traditional treatment for chronic maxillary sinusitis. Functional endoscopic sinus surgery (FESS) restores aeration and allows secretions to be removed from an infected sinus. This study compares the efficacy of sinus irrigation with that of sinus irrigation followed by FESS in 89 patients.

Value of sinus radiographs in the diagnosis of maxillary sinus disease: interobserver agreement on sinus radiographs by otolaryngologists and radiologists.

Variability between observers and specificity of sinus radiographic findings are subject to discussion. The aim of this study was to assess interobserver variability, between four physicians, two otolaryngologists and two radiologists, in the evaluation of 100 maxillary sinus radiographs. Equal agreement was found within the specialties when rating radiographs as normal or abnormal (80%).

Microbiology of chronic maxillary sinusitis in adults: isolated aerobic and anaerobic bacteria and their susceptibility to twenty antibiotics.

In a comparative study on the efficacy of two surgical treatment procedures, 90 patients diagnosed with chronic maxillary sinusitis received antimicrobial prophylaxis. Maxillary sinus fluid samples were taken from these 90 patients before the initiation of antimicrobial prophylaxis, and were cultured for aerobic and anaerobic bacteria. In 81% of all samples, bacterial growth was present.

[The microbiological status of dry sausage in East Netherlands].

Dry fermented sausage (dfs) was the food most suspected in a number of outbreaks of salmonellosis and staphylococcal enterotoxaemia. Data on formulation and processing showed that over 75 per cent of 76 producers still manufactured dfs in a traditional manner: fermentation and drying at ambient temperature for ten days on an average, green room facilities not present. 'Modern' processes were characterised by fermentation in green rooms at elevated temperatures, thus limiting production time to six days on an average.

Effects of D,L-buthionine-S,R-sulfoximine on cellular thiol levels and the oxygen effect in Chinese hamster V79 cells.

The role of glutathione (GSH) and total non-protein thiols (NPSH) in repairing radiation-induced free radical damage incurred under aerated and hypoxic conditions was investigated using Chinese hamster V79 cells cultured in vitro. GSH and NPSH levels were depleted in V79 cells of varying cell densities using the gamma-glutamyl-cysteine-synthetase inhibitor, D,L-Buthionine-S,R-sulfoximine (BSO). A small change in hypoxic cell radiosensitivity could be attributed to the loss of GSH while depletion of thiols to lower levels affected both aerated and hypoxic cell radiosensitivity, resulting in no change in the OER.