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Transoral tongue base mucosectomy for the identification of the primary site in the work-up of cancers of unknown origin: Systematic review and meta-analysis.
No full textBACKGROUND
The use of transoral robotic surgery (TORS) and laser microsurgery (TLM) in the diagnosis and identification of the site of the unknown primary has become increasingly common. This systematic review and meta-analysis aims to assess the use and efficacy of TORS and TLM for this indication.
METHOD
Systematic review and meta-analysis of studies employing TORS or TLM in diagnosis of the unknown primary tumor site in patients with cervical nodal metastases of squamous cell origin. MEDLINE, EMBASE and CINHAL were searched from inception to July 2018 for all studies that used TORS and or TLM in identifying the unknown primary.
RESULTS
251 studies were identified, of which 21 were eligible for inclusion. The primary tumour was identified by TORS/TLM in 78% of patients (433 out of 556). Tongue base mucosectomy (TBM) identified the primary in 222 of 427 cases (53%). In patients with negative physical examination, diagnostic imaging and PETCT, TBM identified the primary in 64% (95% CI 50, 79) cases. In patients who had negative CT/MRI imaging, negative PETCT and negative EUA and tonsillectomy, TBM identified a tongue base primary in 78% (95% CI 41, 92) cases. Haemorrhage, the commonest complication, was reported in 4.9% cases. Mean length of stay varied between 1.4 and 6.3 days.
CONCLUSION
Tongue base mucosectomy, performed by TORS or TLM, is highly efficacious in identifying the unknown primary in the head and neck region
Phalangeal fracture leading to digital amputation, sustained during manipulation for Dupuytren's disease as part of clostridial collagenase treatment.
No full textCollagenase injection was approved in Europe for use in the treatment of Dupuytren's disease in 2011. Reported adverse effects include skin tears, swelling, pain and complex regional pain syndrome. Here, we present a case of a rare complication of phalangeal fracture following treatment with collagenase clostridium and the resultant digital amputation. An 81-year-old man was treated for a 25-year history of progressively disabling Dupuytren's disease of his left middle and ring fingers. Nine days post-manipulation he presented with persistent pain and swelling and was diagnosed with a displaced fracture of the proximal phalanx of his ring finger. Following discussion of surgical options and potential outcome, he elected to undergo amputation of the digit. He has experienced good treatment results in his middle finger and has no significant functional impairment as a result of this complication. Those offering collagenase injection in the management of Dupuytren's disease should be aware of this potential complication and it should be included in the consent process
Patient-Reported Outcome Results From the Open-Label, Randomized Phase III Myeloma X Trial Evaluating Salvage Autologous Stem-Cell Transplantation in Relapsed Multiple Myeloma.
No full textPURPOSE
Salvage autologous stem-cell transplantation (sASCT) in patients with multiple myeloma (MM) relapsing after a prior autologous stem-cell transplantation leads to increased remission duration and overall survival. We report a comprehensive study on patient-reported outcomes, including quality of life (QoL) and pain in sASCT.
METHODS
Patients were randomly assigned to either sASCT or nontransplantation consolidation (NTC). Pain and QoL were assessed as secondary outcomes using validated QoL instruments (European Organisation for Research and Treatment of Cancer QLQ-C30 and myeloma-specific module, QLQ-MY20; the Brief Pain Inventory [Short Form]; and the Leeds Assessment of Neuropathic Symptoms and Signs [Self-Assessment] scale).
RESULTS
A total of 288 patients (> 96%) consented to the QoL substudy. The median follow-up was 52 months. The European Organisation for Research and Treatment of Cancer QLQ-C30 Global health status scores were higher (better) in the NTC group at 100 days after random assignment ( P = .0496), but not at later time points. Pain interference was higher (worse) in the sASCT group than in the NTC group at 6 months after random assignment ( P = .0267), with patients with sASCT reporting higher scores for Pain interference with daily living for up to 2 years after random assignment. Patients reporting lower concerns about adverse effects of treatment after sASCT had a time to progression advantage.
CONCLUSION
Patients with sASCT with relapsed MM demonstrated a comparative reduction in QoL and greater impact of treatment adverse effects lasting for 6 months and up to 2 years for pain, after which patients who had received sASCT reported better outcomes. Patients who experienced lower adverse effects after sASCT had longer time to progression and overall survival, showing the need to improve symptom management peritransplantation. To our knowledge, this study provides the most comprehensive picture of QoL before and after sASCT in patients with relapsed MM
Systematic evaluation of Patient-Reported Outcome protocol content and reporting in cancer trials.
No full textBACKGROUND
Patient-Reported Outcomes (PROs) are captured within cancer trials to help future patients and their clinicians make more informed treatment decisions. However, variability in standards of PRO trial design and reporting threaten the validity of these endpoints for application in clinical practice.
METHODS
We systematically investigated a cohort of randomized controlled cancer trials which included a primary or secondary PRO. For each trial, an evaluation of protocol and reporting quality was undertaken using standard checklists. General patterns of reporting where also explored.
RESULTS
Protocols (101 sourced, 44.3%) included a mean of 10/33 (range = 2-19, SD = 4) PRO protocol checklist items. Recommended items frequently omitted included: the rationale and objectives underpinning PRO collection and approaches to minimise/address missing PRO data. Of 160 trials with published results, 61 (38.1%, 95% CI = 30.6% to 45.7%) failed to include their PRO findings in any publication (mean 6.43-year follow-up); these trials included 49,568 participants. Although two-thirds of included trials published PRO findings, reporting standards were often inadequate according to international guidelines (mean inclusion of 3/14 (range = 0-11, SD = 3) CONSORT PRO Extension checklist items). Over half of trials publishing PRO results in a secondary publication (12/22, 54.5%) took 4 or more years to do so following trial closure, with 8 (36.4%) taking 5-8 years and one trial publishing after 14 years.
CONCLUSIONS
PRO protocol content is frequently inadequate, and non-reporting of PRO findings is widespread, meaning patient-important information may not be available to benefit patients, clinicians and regulators. Even where PRO data are published, there is often considerable delay and reporting quality is suboptimal. This study presents key recommendations to enhance the likelihood of successful delivery of PROs in the future
Adenovirus-associated antibodies in UK cohort of hemophilia patients: A seroprevalence study of the presence of adenovirus-associated virus vector-serotypes AAV5 and AAV8 neutralizing activity and antibodies in patients with hemophilia A.
No full textBackground
Current treatment for severe hemophilia A is replacement of deficient factor. Although replacement therapy has improved life expectancy and quality, limitations include frequent infusions and high costs. Gene therapy is a potential alternative that utilizes an adeno-associated virus (AAV) vector containing the human genetic code for factor 8 (FVIII) that transduces the liver, enabling endogenous production of FVIII. Individuals with preexisting immunity to AAV serotypes may be less likely to benefit from this treatment.
Objectives
This study measured seroprevalence of antibodies to AAV5 and 8 in an UK adult hemophilia A cohort.
Patients/Methods
Patients were recruited from seven hemophilia centres in the UK. Citrated plasma samples from 100 patients were tested for preexisting activities against AAV5 and 8 using AAV transduction inhibition and total antibodies assays.
Results
Twent-one percent of patients had antibodies against AAV5 and 23% had antibodies against AAV8. Twenty-five percent and 38% of patients exhibited inhibitors of AAV5 or AAV8 cellular transduction respectively. Overall seroprevalence using either assay against AAV5 was 30% and against AAV8 was 40% in this cohort of hemophilia A patients. Seropositivity for both AAV5 and AAV8 was seen in 24% of participants.
Conclusions
Screening for preexisting immunity may be important in identifying patients most likely to benefit from gene therapy. Clinical studies may be needed to evaluate the impact of preexisting immunity on the safety and efficacy of AAV mediated gene therapy
Adherence to least injurious tidal volume ventilation in thoracic trauma: A tertiary trauma centre retrospective cohort analysis.
No full textThe Use of Patient-Reported Outcomes in Patients Treated With Maintenance Hemodialysis: A Perspective.
No full textThere is increasing interest in the integration of patient-reported outcomes (PROs) into health care research and clinical practice for the benefit of patients with end-stage kidney disease receiving hemodialysis. In a research setting, PROs can be used as a patient-centered primary or secondary outcome in clinical studies. In routine care, PRO data may be used to support service delivery through benchmarking and audit or inform and enhance the care of the individual patient by improving patient-clinician communication. Despite evidence demonstrating the potential benefits of PROs and prioritization of these outcomes by patients, their use in kidney disease remains limited. Although there are significant methodological and operational challenges for the widespread integration of PROs, there is now consensus that this area should be at the forefront of clinical research and implementation science. We discuss the current use of PROs for patients with end-stage kidney disease receiving hemodialysis and identify a roadmap for increasing the evidence base and introducing PROs into mainstream clinical practice
White Matter Microstructure in Youths With Conduct Disorder: Effects of Sex and Variation in Callous Traits.
No full textOBJECTIVE
Studies using diffusion tensor imaging (DTI) to investigate white matter (WM) microstructure in youths with conduct disorder (CD) have reported disparate findings. We investigated WM alterations in a large sample of youths with CD, and examined the influence of sex and callous-unemotional (CU) traits.
METHOD
DTI-data were acquired from 124 youths with CD (59 female youth) and 174 typically-developing (TD) youths (103 female youth) aged 9-18 years. Tract-based spatial statistics tested for effects of diagnosis and sex-by-diagnosis interactions. Associations with CD symptoms, CU traits, a task measuring impulsivity, and the impact of comorbidity and age- and puberty-related effects were examined.
RESULTS
Youths with CD exhibited higher axial-diffusivity in the corpus callosum and lower radial-diffusivity and mean-diffusivity in the anterior thalamic radiation relative to TD youths. Female and male youth with CD exhibited opposite changes within the internal capsule, fornix, posterior thalamic radiation and uncinate fasciculus. Within the CD group, CD symptoms and callous traits exerted opposing influences on corpus callosum axial-diffusivity, with callous traits identified as the unique clinical feature predicting higher axial-diffusivity and lower radial-diffusivity within the corpus callosum and anterior thalamic radiation, respectively. In an exploratory analysis, corpus callosum axial-diffusivity partially mediated the association between callous traits and impulsive responses to emotional faces. Results were not influenced by symptoms of comorbid disorders and no age- or puberty-related interactions were observed.
CONCLUSION
WM alterations within the corpus callosum represent a reliable neuroimaging marker of CD. Sex and callous traits are important factors to consider when examining WM in CD
Utilization of volumetric magnetic resonance imaging for baseline and surveillance imaging in Neuro-oncology.
No full textThe acquisition of volumetric post-contrast MRI has clear advantages in the interpretation of neuro-oncology studies but has yet to find its way into routine clinical practice beyond planning scans for surgery and radiotherapy. This commentary briefly highlights the benefits of these techniques whilst dispelling some of the perceived disadvantages