Development of a core outcome set for venous leg ulceration (CoreVen) research evaluations (protocol)

BackgroundA venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines.AimThe aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration.MethodsThrough a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports.     

The impact of a total knee arthroplasty on jaw movements,upper body posture,plantar pressure distribution,and postural control

ABSTRACT

Objective: The purpose of this study was to examine the influence of a total knee arthroplasty (TKA) on linked cranial and caudal structures.

Methods: Thirty-five (14f/21m) subjects participated in this study: 15 subjects (9f, 6m) pre- and post- TKA and a control group of 20 subjects (5f, 15m). The measurements included: jaw condyle position and movement, back scan, plantar pressure distribution, and body sway.

Results: There were no significant differences in electronic position analysis of the jaw; however, the protrusion of the TKA group improved (p = 0.001). The test group had a more anteriorly inclined thoracic spine and a less pronounced lumbar lordosis. Before and after surgery, the body sway in the test group was larger.

Conclusion: The TKA affected most prominently the static mechanisms of the postural control and the spine position. The trajectories of the mandible during protrusion also changed slightly.     

Mechanisms of repigmentation induced by photobiomodulation therapy in vitiligo

Photobiomodulation (PBM) therapy is based on the exposure of biological tissues to low‐level laser light (coherent light) or light‐emitting diodes (LEDs; noncoherent light), leading to the modulation of cellular functions, such as proliferation and migration, which result in tissue regeneration. PBM therapy has important clinical applications in regenerative medicine. Vitiligo is an acquired depigmentary disorder resulting from disappearance of functional melanocytes in the involved skin. Vitiligo repigmentation depends on available melanocytes derived from (a) melanocyte stem cells located in the bulge area of hair follicles and (b) the epidermis at the lesional borders, which contains a pool of functional melanocytes. Since follicular melanoblasts (MBs) are derived from the melanocyte stem cells residing at the bulge area of hair follicle, the process of vitiligo repigmentation presents a research model for studying the regenerative effect of PBM therapy. Previous reports have shown favourable response for treatment of vitiligo with a low‐energy helium‐neon (He‐Ne) laser. This review focuses on the molecular events that took place during the repigmentation process of vitiligo triggered by He‐Ne laser (632.8 nm, red light). Monochromatic radiation in the visible and infrared A (IRA) range sustains matrix metalloproteinase (MMP), improves mitochondrial function, and increases adenosine triphosphate (ATP) synthesis and O₂ consumption, which lead to cellular regenerative pathways. Cytochrome c oxidase in the mitochondria was reported to be the photoacceptor upon which He‐Ne laser exerts its effects. Mitochondrial retrograde signalling is responsible for the cellular events by red light. This review shows that He‐Ne laser initiated mitochondrial retrograde signalling via a Ca²⁺‐dependent cascade. The impact on cytochrome c oxidase within the mitochondria, an event that results in activation of CREB (cyclic‐AMP response element binding protein)‐related cascade, is responsible for the He‐Ne laser promoting functional development at different stages of MBs and boosting functional melanocytes. He‐Ne laser irradiation induced (a) melanocyte stem cell differentiation; (b) immature outer root sheath MB migration; (c) differentiated outer root sheath MB melanogenesis and migration; and (d) perilesional melanocyte migration and proliferation. These photobiomodulation effects result in perifollocular and marginal repigmentation in vitiligo.     

FOLFCIS Treatment and Genomic Correlates of Response in Advanced Anal Squamous Cell Cancer

Background

Treatment of advanced anal squamous cell cancer (SCC) is usually with the combination of cisplatin and 5-fluorouracil, which is associated with heterogeneous responses across patients and significant toxicity. We examined the safety and efficacy of a modified schedule, FOLFCIS (leucovorin, fluorouracil, and cisplatin), and performed an integrated clinical and genomic analysis of anal SCC.

Oral beta2-agonist use by preschool children with asthma in East and Central Harlem, New York.

Although studies have documented underuse of controller medications and overuse of short-acting inhaled ss(2)-agonist among children with persistent asthma in disadvantaged communities, the persistence of oral ss(2)-agonist use in pediatric practice has not been studied since inhaled short-acting ss(2)-agonists became widespread. We describe medications used to treat asthma among children 3 to 5 years of age at 10 Head Start and other subsidized preschool centers in East and Central Harlem, New York City. We interviewed 149 parents/guardians of children who were identified as having probable asthma based on physician's diagnosis, persistent symptoms, hospitalization, and medication use. We classified 86 of the 149 children (58%) as having current persistent asthma. Only 15 of them (17%) were reported to have used controller medications at least 5 days/week in the last 4 weeks-only 2 of whom used inhaled corticosteroids. By contrast, 53 children (62%) used oral ss(2)-agonist in the last 4 weeks, often (72%) in conjunction with nebulized or inhaled short-acting ss(2)-agonist. Use of oral ss(2)-agonist was associated with more severe symptoms. This study documents the continued widespread use of oral ss(2)-agonist for treatment of children in a low-income community with high prevalence of asthma.     

Intraoperative radiotherapy in stage I and II lung cancer

Lung cancer is the leading cause of cancer deaths in both men and women in the United States. Treatment depends on the type and stage of lung cancer. For stage I and II cancer, surgery is usually the treatment of choice. Radiation therapy is used in patients who are considered poor risks for surgical resection. Intraoperative brachytherapy is an effective alternative to external irradiation in this group of patients. From 1958 to 1984, 55 patients with non-small-cell lung cancer were explored at Memorial Sloan Kettering Cancer Center and found to have surgical stage I or II tumors, which were considered to be unresectable mainly because of severe obstructive pulmonary disease precluding adequate resection. All these patients were treated with intraoperative brachytherapy at the time of the thoracotomy. Forty-four percent of these patients received in addition external irradiation, mainly to the mediastinum. The overall 5-year survival calculated by the Kaplan-Meier Method was 32%, and the local disease-free survival was 63%. Cox regression multivariant analysis demonstrated that there is a distinct subgroup with a better prognosis based on tumor site and patient's age--ie, patients who were younger than 58 years of age and had right-side lesions.     

Tuberculosis of the upper limb joints

Summary Seventy-four cases of tuberculosis of the upper limb joints (sterno-clavicular 1; shoulder 12; elbow 42; wrist 10 and fingers 9), treated by two of the authors, were reviewed. Eighty-seven percent presented at an advanced stage of destruction. The diagnosis was proved in 71 out of 74 cases. In most, the treatment was 6–12 months of chemotherapy, plaster immobilization (in order to prevent or correct deformity) and functional rehabilitation whenever possible. The sterno-clavicular and finger joints were not immobilized. Response to chemotherapy was favourable in 66 of the patients followed up. One relapse occurred at the 18th month.The affected shoulder joints healed with loss of movement, but were not painful. At the elbow, ten patients developed spontaneous bony fusion in the right-angle position, 27 had a useful range of motion and 19 had more than 70° of flexion-extension movement. One patient had an arthrodesis. At the wrist, two patients healed with painful stiffness and an arthrodesis was performed. All the finger lesions healed with painless stiffness which did not interfere much with function because rehabilitation had been started early. The authors believe that conservative management usually gives better results than arthrodesis or excision of the joint.

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Résumé Les auteurs rapportent les résultats de leur expérience dans 74 cas d'ostéo-arthrite tuberculeuse du membre supérieur: 1 sterno-claviculaire, 12 scapulo-humérales, 42 coudes, 10 poignets et 9 articulations des doigts, toutes traitées personnellement par les deux auteurs principaux. Sur le plan diagnostique, 87% des patients se présentaient à un stade de destruction avancée. Le diagnostic de certitude fut obtenu dans 71 cas sur 74. Dans la majorité des cas, le traitement a été standardisé: chimiothérapie de 6 à 12 mois, immobilisation plâtrée pour prévenir ou corriger les déformations, suivie de reéducation chaque fois que possible. Les lésions de la sterno-claviculaire et des doigts ne furent pas immobilisées. Les résultats ont été bons en ce qui concerne la chimiothérapie: 66 réponses favorables chez 66 patients suivis. Il y a eu une rechute au 18éme mois. Du point de vue orthopédique, les lésions scapulo-humérales ont guéri avec une raideur de l'épaule toujours importante mais indolore. Au niveau du coude, 10 patients évoluèrent vers la fusion osseuse précoce spontanée, qui se fit à 90° de flexion grâce à l'immobilisation plâtrée; 27 guérirent avec une conservation variable des mouvements du coude dans un secteur fonctionnel et 19 d'entre eux présentaient plus de 70° d'étendue de flexion; 1 patient fut arthrodésé. Au niveau du poignet, 2 patients guérirent avec une raideur douloureuse qui nécessita une arthrodèse. Les lésions des doigts guérirent avec une raideur plus ou moins marquée, bien compensée par la mobilité des autres articulations, conservée intacte par la reéducation. Les auteurs concluent à la meilleure qualité des résultats du traitement conservateur que des classiques interventions d'arthrodèse ou de résection articulaire.

     

Mebendazole retention enema for severe Trichuris trichiura (whipworm) infection: a case report

The authors report a case of massive Trichuris trichiura infection, resulting in severe anaemia and congestive cardiac failure in a 9-year-old Iban boy, who was resistant to the usual oral anthelmintic treatment, but promptly responded to mebendazole retention enema. This patient also had an associated Entamoeba histolytica infection.