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° Se han desarrollado muchos modelos de probabilidad de complicaciones en tejidos normales (PCTN) para predecir los efectos no deseados después de la radioterapia en pacientes con cáncer de cabeza y cuello, pero la mayoría de ellos no se han validado lo suficiente de forma externa, es decir, no se han analizado lo suficiente en pacientes que no participaron en el estudio original de desarrollo del modelo, para saber cómo de bien predicen realmente los efectos no deseados.
° Para los modelos analizados en dos o más estudios además de sus estudios originales de desarrollo del modelo, la calidad de las pruebas y el informe de sus resultados fue generalmente deficiente, por lo que es difícil saber su utilidad.
° Se necesitan más estudios mejor diseñados para investigar este tema en el área del cáncer de cabeza y cuello.
La probabilidad de tener efectos adversos como resultado de la radioterapia se puede calcular mediante los denominados modelos de PCTN. Los modelos de PCTN calculan el riesgo de efectos secundarios inducidos por la radiación según la información del paciente, su enfermedad y su tratamiento.
La radioterapia es la base del tratamiento de pacientes con cáncer de cabeza y cuello. Sin embargo, la radioterapia expone a radiación partes sanas, a veces esenciales, de la región de la cabeza y el cuello. Esto puede provocar daños en estos órganos normales, p. ej. alteración de la producción de saliva, que puede tener consecuencias importantes para la calidad de vida de los pacientes con cáncer de cabeza y cuello tratados con radioterapia. Los modelos de probabilidad de complicaciones en tejidos normales (PCTN) podrían ser útiles para lograr un equilibrio óptimo entre el control del tumor y prevenir los efectos secundarios inducidos por la radiación. Estos modelos predicen el riesgo de efectos secundarios inducidos por la radiación a partir de la información del paciente, su enfermedad y su tratamiento. Ha habido un número considerable de modelos de PCTN para pacientes con cáncer de cabeza y cuello. Se quería averiguar cuál es la calidad del diseño, la ejecución y el análisis de los estudios (es decir, el riesgo de sesgo) y la eficacia de estos modelos para predecir el riesgo de efectos secundarios inducidos por la radiación.
Se buscaron estudios que desarrollaran o validaran modelos de PCTN en pacientes con cáncer de cabeza y cuello.
En la mayoría de los 592 modelos desarrollados a partir de 140 767 pacientes en 143 artículos identificados, la calidad de los modelos no fue suficiente; y para el 81% de estos modelos no se ha investigado cómo de bien funcionan en otros pacientes. Del 19% restante de los modelos, se encontraron 152 validaciones externas en 34 304 pacientes de 41 artículos. Solo hubo nueve modelos con dos o más validaciones externas. Los modelos pudieron distinguir bien a los pacientes con y sin el desenlace, pero a menudo no estuvo claro si sus predicciones concordaban con lo observado, porque esto último no siempre se evaluó o se proporcionó. En general, la calidad de la mayoría de estos estudios fue baja.
La evidencia está actualizada hasta el 8 de enero de 2024.
To investigate changes in lateral hip pain following a 3-month, physiotherapist-led, education and exercise programme in patients with clinically and MRI-verified hip abductor tendon pathology.
Prospective cohort study.
Secondary care, Danish public teaching hospital.
From May 2024 to July 2025, 60 patients (100% women) with lateral hip pain duration of >6 months, aged 18–75 years (mean age 58.2), MRI-verified hip abductor tendon pathology were included; 55 patients completed the intervention.
Patient education on load management and modification of daily activity was provided through seven physiotherapist-led sessions over 3 months. Additionally, patients followed an individually progressed daily home-based exercise programme.
The primary outcome was change in the subscale pain of the revised Copenhagen Hip and Groin Outcome Score (HAGOS). Secondary outcomes included hip-related patient-reported outcomes and health-related quality of life, isometric hip muscle strength and a 30-second Chair Stand Test (30s-CST).
Adherence to the exercise protocol was 85%. The mean (95% CI) score in the revised HAGOS pain improved from 46.4 (41.5 to 51.2) to 60.1 (54.4 to 65.7) at 3 months follow-up. Clinically relevant improvements were observed in secondary hip-related patient-reported outcomes, alongside improvements in generic patient-reported outcomes. Minor strength improvements were observed, while the 30s-CST improved from 11.7 (10.6 to 12.9) to 14.2 (12.8 to 15.6) repetitions.
Following 3 months of physiotherapist-led, combined patient education and exercise therapy, patients with clinically and MRI-verified hip abductor tendon pathology, seen in secondary care, experienced clinically relevant changes in lateral hip pain measured by the revised HAGOS pain.
To estimate the carbon footprint of a vaccine trial conducted in Uganda and to identify opportunities to reduce greenhouse gas emissions in future trials.
Retrospective carbon footprint assessment of all trial-related activities conducted in Uganda (ClinicalTrials.gov ID NCT02991495), following the Greenhouse Gas Protocol and the guidance provided by the Low Carbon Clinical Trials Group.
The activities related to the yellow fever vaccine fractional dose trial implemented in Mbarara, with contributions from international collaborators.
The study assessed processes; no participants have been included.
Trial activities were retrospectively quantified and converted into a greenhouse gas estimate using publicly available emission factors. The boundaries of the study were defined to cover the set-up, implementation and close-out phases. Emissions were categorised by source, including personnel, travel, medical supply and laboratory.
The vaccine trial produced an estimated 224.66 tonnes of carbon dioxide equivalent (tCO2e). The largest emission category was related to the research centres, accounting for 78.80 tCO2e (35.07%), with the Mbarara research centre representing 75.74 tCO2e (32.38%), including commuting (21.01 tCO2e), waste disposal (19.31 tCO2e), goods and services (18.66 tCO2e) and energy (13.75 tCO2e). International travel, including air, non-air travel and accommodation accounted for 59.37 tonnes CO2e (26.43%), with the majority attributed to air travel (53.60 CO2e). Additional contributors included road travel by trial team and participants’ travel to attend trial’s visits. The storage of samples at –80°C in ultra-dry freezers was not a significant contributor due to the low volume of samples stored. However, important differences were observed in sample storage emissions between settings that relied more heavily on oil-based electricity and those with greater dependence on hydroelectric power.
This study highlights multiple opportunities to reduce the carbon emissions of clinical trials. These include already recognised actions such as higher use of solar energy and reduction of international travel. Nevertheless, to improve sustainability of trials, attention should be given to all controllable processes across the trial lifecycle and not solely to the main drivers of emissions. For this, environmental considerations should be present from the initial trial conception phase, involving for instance decisions about the number of trial visits and where these are conducted and taking rational decisions about the long-term storage of samples.
Congenital melanocytic nevi (CMN) are congenital malformations that cannot be detected by prenatal ultrasounds and may have a significant physical and psychological impact on affected individuals, particularly when they are large. Congenital anomalies are known to impair parental quality of life, which may in turn affect the child’s well-being and development. However, little is known about the feelings and lived experience of parents on the birth of a CMN-affected child.
The aim of this study is to describe the lived experience of parents of a child with a large or giant CMN, and to document the expressed needs for support (psychological, marital, parenting-related and those evolving along the care pathway)
We will conduct a qualitative study in 10 French hospitals, based on semi-structured interviews. Eligible participants will be parents of children under 18 years of age with a large or giant CMN. A maximum variation sampling strategy will be applied to ensure optimal diversity of profiles in terms of children’s age, gender and phototype and location and size of the CMN. The target sample size will be determined by theoretical saturation. Data will be analysed using an inductive thematic content analysis approach.
The study has received ethical approval from the Nancy University Hospital (NUH) Ethics Committee (Opinion No. 504) and authorisation from the French Commission Nationale de l’Informatique et des Libertés (CNIL) (Ref. 2024PI238-614). Non-opposition to participation will be documented in medical records. Findings will be presented at national and European dermatology conferences and published in peer-reviewed international journals.
To determine the prevalence and clinical characteristics associated with polyneuropathy in kidney transplant recipients (KTRs).
Cross-sectional study.
SENS study at the University Medical Center Groningen, the Netherlands, December 2021–May 2023.
KTR, participating in the ongoing TransplantLines Biobank and Cohort Study, ≥12 months post-transplantation.
Participants underwent a structured neurological assessment including history taking, neurological examination, quantitative sensory testing and nerve conduction studies. An expert panel classified participants into no/possible, probable/definite large fibre polyneuropathy or small fibre neuropathy. Large-fibre subtypes included axonal or demyelinating, pure sensory, pure motor and sensorimotor. To assess potential associations with clinical characteristics, logistic regression analysis was conducted.
We included 160 KTRs with a mean age of 59.8±11.6 years at a median of 6.1 (95% CI 3.9 to 13.1) years post-transplantation, with 16 KTRs (10%) diagnosed with polyneuropathy before study inclusion. In total, 84 KTRs (53%) were identified with large fibre polyneuropathy and 7 KTRs (4%) with small fibre neuropathy. KTRs with large fibre polyneuropathy presented with either sensor-predominant polyneuropathy (40 KTR (48%)) or sensorimotor polyneuropathy (44 KTR (52%)). We found no neurophysiological characteristics of demyelination. Overall, 18% (95% CI 11% to 27%) of KTRs with large fibre polyneuropathy were asymptomatic. Higher age (OR=1.04 (1.01 to 1.08), p=0.01), male sex (OR=2.55 (1.19 to 5.60), p=0.02), diabetes (OR=5.58 (1.36 to 38.14), p=0.03) and elevated urea levels (OR=1.12 (1.04 to 1.23), p=0.01) were significantly associated with polyneuropathy in KTR.
In contrast with previous studies, axonal sensory or sensorimotor polyneuropathy is highly prevalent and often underdiagnosed in KTR. Next to higher age and male sex, it was independently associated with diabetes and higher urea levels. Further research is needed to reveal the aetiology and course of polyneuropathy in KTRs.
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