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Meet the authors of the Diabetes and COVID-19 blog post - Elizabeth Mann, Barbora Schonfeldova, Max Quastel, Mathilde Pohin, & Athena Cavounidis
Determinants of durable humoral and T cell immunity in myeloma patients following COVID-19 vaccination.
OBJECTIVE: To describe determinants of persisting humoral and cellular immune response to the second COVID-19 vaccination among patients with myeloma. METHODS: This is a prospective, observational study utilising the RUDYstudy.org platform. Participants reported their second and third COVID-19 vaccination dates. Myeloma patients had an Anti-S antibody level sample taken at least 21 days after their second vaccination and a repeat sample before their third vaccination. RESULTS: 60 patients provided samples at least 3 weeks (median 57.5 days) after their second vaccination and before their third vaccination (median 176.0 days after second vaccine dose). Low Anti-S antibody levels (<50 IU/mL) doubled during this interval (p = .023) and, in the 47 participants with T-spot data, there was a 25% increase negative T-spot tests (p = .008). Low anti-S antibody levels prior to the third vaccination were predicted by lower Anti-S antibody level and negative T-spot status after the second vaccine. Independent determinants of a negative T-spot included increasing age, previous COVID infection, high CD4 count and lower percentage change in Anti-S antibody levels. CONCLUSIONS: Negative T-spot results predict low Anti-S antibody levels (<50 IU/mL) following a second COVID-19 vaccination and a number of biomarkers predict T cell responses in myeloma patients.
Maternal early warning scores shown to be methodologically weak and at high risk of bias.
OBJECTIVE: To systematically review and critically appraise the methodology of developing Modified Obstetric Early Warning Scores (MOEWSs). STUDY DESIGN AND SETTING: We searched Medline, CINAHL, EMBASE and the Web of Science for MOEWS studies published between 01 January 2000 and 31 December 2023. Eligible studies included models predicting maternal death, ICU admission, and/or a composite of two or more maternal morbidities occurring in a hospital setting in women of any gestational age and up to one week after the end of pregnancy. Models were critically appraised using the Prediction Model Risk of Bias Assessment Tool (PROBAST) and adherence to the Transparent Reporting of Prediction Models (TRIPOD). RESULTS: 20 studies were included: five (25%) were model development studies, five (25%) were model development and validation, and ten (50%) were validation only. Four development studies used statistical methods, and the remaining six studies used clinical consensus (i.e., expert opinion). The four data-driven model development studies did not address key statistical challenges such as repeated measures or missing data, assess the performance adequately or dataset characterises clearly. All but one study (95%) were rated at high risk of bias due to data sources, poor reporting and analysis limitations. The fifteen validation studies were poorly reported and eleven (73%) were at high risk of bias. None of the data-driven models were independently validated, a key step towards implementation. CONCLUSIONS: There is a lack of MOEWS developed using methods that followed recommended statistical guidelines. Substantial problems with the methodological quality of included studies both in development and validation, along with high risk of bias indicating published scores could perform poorly or be potentially harmful if used in clinical practice. Future work should address handling missing data and repeated measures and consider how a MOEWS will perform in different populations and key subgroups.
Exploring nutritional supplement use for countering respiratory tract infections through an X (formerly Twitter)-based survey
Background: Respiratory tract infections are a common health issue, driving interest in preventive strategies like nutritional supplements, while evidence on their usage and effectiveness remains limited. In this context, social media platforms, particularly X (formerly Twitter), provide a unique opportunity to gather large-scale public health-related data. Objectives: In this study, we aimed to survey participants’ uses and opinions on nutritional supplements in prevention or treatment of respiratory tract infections, by using X. Methods: A survey was conducted between 1st and 15th December 2022. A single open-ended question “Which are the best dietary supplements to counteract respiratory infections?“ was asked. One week after the start of the survey, a poll was posted to get more relevant information and boost the survey's reach. Total endorsements were calculated for each tweet posted as the total sum of replies, retweets, and likes. Results: The open-ended question received a total of 118 retweets, 39 quotes, and 371 likes, while the poll received 56 retweets, 13 quotes, and 67 likes. A total of 495 replies, 2,251 retweets, 5,118 likes, and 148 quotes were received for the question and its related tweets. Vitamin D (1,607 endorsements), zinc (1,347 endorsements), vitamin C (803 endorsements), magnesium (694 endorsements), and honey (661 endorsements) were the nutritional supplements that received most endorsements. Conclusion: Various foods, drinks, and natural ingredients have been suggested as potentially helpful for counteracting respiratory infections. Approximately half of respondents indicated using such supplements for themselves. The result of this study supports the idea that the X platform can be used as an effective survey tool to study global health-related behaviours and trends.
Harnessing the neuroprotective effect of oral administration of benfotiamine in MPTP induced Parkinson's disease in rats.
The study was performed to evaluate the neuroprotective effects of Benfotiamine (BFT) in 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP)-induced Parkinson's disease (PD) in rats. The rats were given daily doses of BFT (100 mg/kg, 200 mg/kg) through oral administration for 42 days. The rats were given a single bilateral dosage of MPTP (0.1 mg/nostril) intranasally once before the drug treatment to induce PD. On day 42, the animals were subjected to various behavioral paradigms. Post-treatment with BFT for 42 days significantly improved the motor and nonmotor fluctuations of MPTP. The results demonstrated that treatment with BFT ameliorated MPTP-induced disorders in behavior, body balance, and dopamine levels in the mid-brain. Among the post-treated groups, a high dose of BFT was the most effective treatment. Mean values are indicated in ±SEM, n = 5***(p
Mucoepidermoid carcinoma of the bronchus: is conservative surgery always justified?
A case of mucoepidermoid carcinoma of the bronchus in a 7-year-old boy is reported. The patient underwent right pneumonectomy. Histologically, the tumor was a low-grade muco-epidermoid carcinoma arising from the bronchus with lymph node metastasis in the drainage area. Presence of lymph node metastasis in this low-grade tumor suggests the possibility of early progression of disease in what has until now been considered a very slow growing tumor. Aggressive surgery may be necessary in these situations.
Statistics for the hand surgeon. Part 1: principles and application to hand surgery research.
Hand surgeons have the potential to improve patient care, both with their own research and by using evidenced-based practice. In this first part of a two-part article, we describe key steps for the analysis of clinical data using quantitative methodology. We aim to describe the principles of medical statistics and their relevance and use in hand surgery, with contemporaneous examples. Hand surgeons seek expertise and guidance in the clinical domain to improve their practice and patient care. Part of this process involves the critical analysis and appraisal of the research of others.
Sample size calculations in high-profile surgical trials that use patient-reported outcome measures: systematic review.
Sample size calculations from high-profile surgical RCTs that used a patient-reported outcome measure as primary outcome were reviewed systematically against Difference ELicitation in TriAls (DELTA2) standards, with a focus on target differences. In this sample of trials, there was frequent use of suboptimal methods to determine the target difference, and sample size calculations were generally not reported to DELTA2 standards. This risks over-recruitment and/or erroneous trial conclusions, which clinicians should be aware of when interpreting published trials.
Threaded rods versus arthrodesis nail as a static spacer for two-stage revision total knee arthroplasty.
INTRODUCTION: A spacer is required to maintain limb length and alignment and to provide a stable limb for mobilisation in two-stage revision total knee arthroplasty (rTKA) for periprosthetic joint infection (PJI). Static spacers are indicated in cases of massive bone loss, compromised soft tissues, and ligamentous and/or extensor mechanism insufficiency. The aim of this study was to compare the use of Ilizarov rods to arthrodesis nails for static spacer constructs in first-stage rTKA for PJI. METHODS: This was a retrospective cohort study of 40 patients who underwent two-stage rTKA for PJI between 2019 and 2022. Static spacers were used in all cases, constructed from Ilizarov rods 20 patients and nails in 20 patients. Data collected included number of previous revisions, patient age at first revision, comorbidities and identified organisms. Groups were compared based on outcome measures including complications, reoperations, length of stay and re-revision rates. RESULTS: The use of Ilizarov rods showed higher rates of intraoperative complications (5% vs. 0%), readmissions (55% vs. 5%), and interstage re-operations (50% vs. 10%). Spacer-related complications occurred in 10 of 20 cases (50%) in the Ilizarov rod group, all due to spacer fractures, compared to none in the nail group (0%) (p
Psychometric sensitivity analyses can identify bias related to measurement properties in trials that use patient-reported outcome measures: a secondary analysis of a clinical trial using the disabilities of the arm, shoulder, and hand questionnaire.
OBJECTIVES: Demonstrate psychometric sensitivity analyses for testing the stability of study findings to assumptions made about patient-reported outcome measures. STUDY DESIGN AND SETTING: We performed secondary analyses of Disability of Arm, Shoulder, and Hand (DASH) data collected within the Prevention of Shoulder Problems clinical trial, which compared upper limb function scores in women who had undergone breast cancer surgery, randomized to either an exercise program or usual care. We repeated the principal trial analyses after grouping DASH items into subscales suggested by factorial analyses in this dataset and applied item response theory to account for unequal item weighting. We checked for measurement invariance by participant age and response shift bias using established techniques. RESULTS: Our analyses suggested that the DASH measured two constructs: motor function and sensory symptoms. The majority of the six-month difference in DASH score was driven by motor function. With item response theory scoring, we found differences in both constructs at 12 months (P = 0.019 and P = 0.007), but in neither construct at 6 months, contrary to the original trial results. We found no differential item function by age or between baseline and 12-month measurements. CONCLUSIONS: Psychometric sensitivity analyses aid in the interpretation of the Prevention of Shoulder Problems trial's results.
The Use of Botulinum Toxin in the Management of Hidradenitis Suppurativa: A Systematic Review.
UNLABELLED: Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterized by suppurative infection, sinus tract, and abscess formation. International management guidelines are largely consensus-based. Botulinum toxin (BTX) has been widely used in the treatment of apocrine and eccrine gland disorders, such as hyperhidrosis, although the effectiveness of BTX in the treatment of HS remains unknown. The aim of this systematic review was to understand the published evidence of BTX safety and effectiveness in the management of HS. METHODS: We conducted a PRISMA-compliant, prospectively registered (PROSPERO, CRD42021228732), systematic review. We devised bespoke search strategy and applied it to the Cochrane Central Register of Controlled Trials, Medline, Embase, and OpenGrey up until March 2022. We included all clinical studies that reported outcomes following BTX treatment in patients diagnosed with HS (both adult and pediatric). RESULTS: A total of 4658 studies were identified, of which six met full inclusion criteria reporting data on 26 patients. The six identified studies included one randomized control trial, one case series, and four case studies. The one included randomized control trial demonstrated a significant reduction in the Dermatology Life Quality Index score at 3 months following treatment with BTX. CONCLUSIONS: The effectiveness and safety of BTX in the treatment of HS remain unknown. This systematic review identified a paucity of high-quality clinical data. Evidence of treatment effectiveness is likely to come from registry-based cohort studies using established core outcome sets in the first instance.
Computerized adaptive testing for the Oxford Hip, Knee, Shoulder, and Elbow scores : accurate measurement from fewer, and more patient-focused, questions.
AIMS: The aim of this study was to develop and evaluate machine-learning-based computerized adaptive tests (CATs) for the Oxford Hip Score (OHS), Oxford Knee Score (OKS), Oxford Shoulder Score (OSS), and the Oxford Elbow Score (OES) and its subscales. METHODS: We developed CAT algorithms for the OHS, OKS, OSS, overall OES, and each of the OES subscales, using responses to the full-length questionnaires and a machine-learning technique called regression tree learning. The algorithms were evaluated through a series of simulation studies, in which they aimed to predict respondents' full-length questionnaire scores from only a selection of their item responses. In each case, the total number of items used by the CAT algorithm was recorded and CAT scores were compared to full-length questionnaire scores by mean, SD, score distribution plots, Pearson's correlation coefficient, intraclass correlation (ICC), and the Bland-Altman method. Differences between CAT scores and full-length questionnaire scores were contextualized through comparison to the instruments' minimal clinically important difference (MCID). RESULTS: The CAT algorithms accurately estimated 12-item questionnaire scores from between four and nine items. Scores followed a very similar distribution between CAT and full-length assessments, with the mean score difference ranging from 0.03 to 0.26 out of 48 points. Pearson's correlation coefficient and ICC were 0.98 for each 12-item scale and 0.95 or higher for the OES subscales. In over 95% of cases, a patient's CAT score was within five points of the full-length questionnaire score for each 12-item questionnaire. CONCLUSION: Oxford Hip Score, Oxford Knee Score, Oxford Shoulder Score, and Oxford Elbow Score (including separate subscale scores) CATs all markedly reduce the burden of items to be completed without sacrificing score accuracy.Cite this article: Bone Jt Open 2022;3(10):786-794.
Implementation of Patient-Reported Outcome Measures for Gender-Affirming Care Worldwide: A Systematic Review.
IMPORTANCE: Gender-affirming care is a key clinical area that can benefit from implementation of patient-reported outcome measures (PROMs). Identifying barriers to and enablers of PROM implementation is needed to develop an evidence-based implementation strategy. OBJECTIVE: To identify (1) PROMs previously implemented for gender-affirming care and constructs measured, (2) how patients completed PROMs and how results were reported and used, and (3) barriers to and enablers of PROM implementation. EVIDENCE REVIEW: In this systematic review, PubMed, Embase, MEDLINE, PsycINFO, CINAHL, and Web of Science were searched from inception to October 25, 2021, and updated on December 16, 2022. Gray literature was searched through gray literature database, online search engine, and targeted website searching. Inclusion criteria were (1) original articles of (2) a formally developed PROM or ad hoc instrument administered for gender-affirming care to (3) patients accessing gender-affirming care. The Critical Appraisal Skills Programme tool was used to evaluate quality of included studies. This review was registered on PROSPERO (CRD42021233080). FINDINGS: In total, 286 studies were included, representing 85 395 transgender and nonbinary patients from more than 30 countries. A total of 205 different PROMs were used in gender-affirming care. No studies described using an implementation science theory, model, or framework to support PROM deployment. Key barriers to PROM implementation included issues with evidence strength and quality of the PROM, engaging participants, and PROM complexity. Key enablers of PROM implementation included using PROMs validated for gender-affirming care, implementing PROMs able to be deployed online or in person, implementing PROMs that are shorter and reduce patient burden, engaging key stakeholders and participants as part of developing an implementation plan, and organizational climate. CONCLUSIONS AND RELEVANCE: In this systematic review of barriers to and enablers of PROM implementation in gender-affirming care, PROM implementation was inconsistent and did not follow evidence-based approaches in implementation science. There was also a lack of patient input in creating implementation strategies, suggesting a need for patient-centered approaches to PROM implementation. Frameworks created from these results can be used to develop evidence-based PROM implementation initiatives for gender-affirming care and have potential generalizability for other clinical areas interested in implementing PROMs.
Structural validation of the Manchester-Oxford Foot Questionnaire for use in foot and ankle surgery.
AIMS: The Manchester-Oxford Foot Questionnaire (MOxFQ) is an anatomically specific patient-reported outcome measure (PROM) currently used to assess a wide variety of foot and ankle pathology. It consists of 16 items across three subscales measuring distinct but related traits: walking/standing ability, pain, and social interaction. It is the most used foot and ankle PROM in the UK. Initial MOxFQ validation involved analysis of 100 individuals undergoing hallux valgus surgery. This project aimed to establish whether an individual's response to the MOxFQ varies with anatomical region of disease (measurement invariance), and to explore structural validity of the factor structure (subscale items) of the MOxFQ. METHODS: This was a single-centre, prospective cohort study involving 6,637 patients (mean age 52 years (SD 17.79)) presenting with a wide range of foot and ankle pathologies between January 2013 and December 2021. To assess whether the MOxFQ responses vary by anatomical region of foot and ankle disease, we performed multigroup confirmatory factor analysis. To assess the structural validity of the subscale items, exploratory and confirmatory factor analyses were performed. RESULTS: Measurement invariance by pathology was confirmed, suggesting the same model can be used across all foot and ankle anatomical regions. Exploratory factor analysis demonstrated a two- to three-factor model, and suggested that item 13 (inability to carry out work/everyday activities) and item 14 (inability to undertake social/recreational activities) loaded more positively onto the "walking/standing" subscale than their original "social interaction" subscale. CONCLUSION: This large cohort study supports the current widespread use of the MOxFQ across a broad range of foot and ankle pathologies. Our analyses found indications that could support alterations to the original factor structure (items 13 and 14 might be moved from the "social interaction" to the "walking/standing" subscale). However, this requires further work to confirm.
Computerized adaptive testing for the patient evaluation measure (PEM) in patients undergoing cubital tunnel syndrome surgery.
In outcome measures, item response theory (IRT) validation can deliver interval-scaled high-quality measurement that can be harnessed using computerized adaptive tests (CATs) to pose fewer questions to patients. We aimed to develop a CAT by developing an IRT model for the Patient Evaluation Measure (PEM) for patients undergoing cubital tunnel syndrome (CuTS) surgery. Nine hundred and seventy-nine completed PEM responses of patients with CuTS in the United Kingdom Hand Registry were used to develop and calibrate the CAT. Its performance was then evaluated in a simulated cohort of 1000 patients. The CAT reduced the original PEM length from ten to a median of two questions (range two to four), while preserving a high level of precision (median standard error of measurement of 0.27). The mean error between the CAT score and full-length score was 0.08%. A Bland-Altman analysis showed good agreement with no signs of bias. The CAT version of the PEM can substantially reduce patient burden while enhancing construct validity by harnessing IRT for patients undergoing CuTS surgery.