Tag: nevin manimala

BMJ Open. 2021 Dec 3;11(12):e052528. doi: 10.1136/bmjopen-2021-052528.

ABSTRACT

INTRODUCTION: To date, there has been a lack of knowledge about the status, reporting completeness and methodological quality of pilot trials in the acupuncture field. Thus, this systematic review protocol aims to: (1) investigate publication trends and aspects of feasibility evaluated in acupuncture pilot trials; (2) identify the proportion of acupuncture pilot trials that lead to definitive trials and (3) assess the reporting completeness and methodological quality of pilot trials in acupuncture.

METHODS AND ANALYSIS: Studies of acupuncture pilot randomised controlled trials published from 2011 to 2021 will be retrieved in seven databases in January 2022, including PubMed, Web of Science, EMBASE, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang Database and Chinese Biomedical Literature Database. The methodological quality and reporting completeness of all included studies will be assessed using the risk of bias 2.0 tool (RoB 2) and the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials, respectively. For the primary analysis, publication trends, aspects of feasibility and the proportion of pilot trials that lead to definitive trials will be analysed. A quantitative analysis of the methodological quality and reporting completeness of the included trials will be implemented by calculating the percentage of items reported in each domain of RoB 2 and CONSORT. The secondary analysis will adopt a regression analysis to identify factors associated with the reporting completeness.

ETHICS AND DISSEMINATION: Ethical approval is not required for this study. This study is planned to be submitted to a peer-reviewed academic journal.

PMID:34862291 | DOI:10.1136/bmjopen-2021-052528

BMJ Open. 2021 Dec 3;11(12):e053980. doi: 10.1136/bmjopen-2021-053980.

ABSTRACT

INTRODUCTION: Epilepsy is a chronic condition requiring consistent follow-up aimed at seizure control, and monitoring of anti-seizure medication (ASM) levels and side effects. Telemedicine (TM) offers invaluable support to patient follow-up, guaranteeing the prompt availability of a team of experts for persons with epilepsy (PWE) widely distributed across the country. Although many health institutions have endorsed the use of TM, robust data on effectiveness, safety and costs of TM applied to epilepsy are lacking. TELEmedicine for EPIlepsy Care (TELE-EPIC) will evaluate the effectiveness of video consultation (VC) via TM compared with usual care (UC) for the monitoring of PWE (TELE-EPIC_RCT). Moreover, TELE-EPIC will apply an innovative Volumetric Absorptive Microsampling (VAMS) device for quantitation of ASM through finger prick blood sampling as an alternative to venipuncture sampling (TELE-EPIC_VAMS).

METHODS AND ANALYSIS: TELE-EPIC_RCT is a multicentre, open, pragmatic two-arm randomised controlled trial prospectively including adult and paediatric outpatients with established diagnosis of epilepsy consecutively attending the Epilepsy Centres of Bologna and Rome, respectively. The primary outcome is the non-inferiority of VC on seizure control compared with UC after an 18-month follow-up. Secondary outcomes are adherence to treatment, ASM-related adverse events, quality of life, mood disorders, patient and caregiver satisfaction, safety and costs. TELE-EPIC_VAMS is a cross-validation study for blood ASM quantitation through a novel, VAMS-based device, comparing (1) VAMS versus plasma samples (reference standard method); and (2) nurse-collected versus self-collected blood by VAMS device.

ETHICS AND DISSEMINATION: The study has been approved by the local ethics committee (349-2019-SPER-AUSLBO). Complete information about the state of project, relevant events and results will be regularly updated on the project’s webpage on ClinicalTrials.gov. The project’s results and data on the potential impact of TM in epilepsy will be disseminated on social media. A closeout meeting will be convened for the communication and dissemination of the project, highlighting its main achievements and impacts.

TRIAL REGISTRATION NUMBER: NCT04496310.

PMID:34862297 | DOI:10.1136/bmjopen-2021-053980

BMJ Open. 2021 Dec 3;11(12):e049662. doi: 10.1136/bmjopen-2021-049662.

ABSTRACT

INTRODUCTION: Dyslipidaemia is one of the established risk factors for cardiovascular disease. Evidence from large-scale trials showed that effective treatment of dyslipidaemia can reduce all-cause and coronary mortality. To date, there is no published systematic review on the worldwide prevalence of dyslipidaemia in adults. We propose to perform a systematic review on the global prevalence of dyslipidaemia in adults 18 years and older.

METHODS AND ANALYSIS: We will identify observational studies through comprehensive literature searches. We will search: MEDLINE, Cochrane Central Register of Controlled Trials for published studies and trial registries including the WHO International Trial Registry Platform and ClinicalTrials.gov. Two reviewers will independently screen the titles and abstracts, attain full text of eligible articles, extract data, and appraise the quality and bias of the included studies. Disagreement among the authors will be resolved by discussion leading to a consensus. Next, we will perform a narrative synthesis of the study results. Study heterogeneity will be assessed using I² statistics. If I² is high (≥75%), and plausible heterogeneity contributors are found, we will divide the studies into appropriate subgroups for pooling of results or assess the association of plausible covariates and the prevalence estimates using meta-regression. If I²<75%, we will undertake meta-analysis using the random-effects model and transform all prevalence estimates using the Freeman-Tukey transformation for pooling, to obtain a synthesised point estimate of prevalence with its 95% confidence. We will then back-transform the point estimate, and report our results using the back-transformed figures.

ETHICS AND DISSEMINATION: Ethics approval is not a requirement as this study is based on available published data. Results of this systematic review will be presented at conferences, shared with relevant health authorities, and published in a peer-reviewed journal. These results may help quantify the magnitude of dyslipidaemia globally, and guide preventative and therapeutic interventions.

PROSPERO REGISTRATION NUMBER: CRD42020200281.

PMID:34862282 | DOI:10.1136/bmjopen-2021-049662

BMJ Open. 2021 Dec 3;11(12):e051702. doi: 10.1136/bmjopen-2021-051702.

ABSTRACT

OBJECTIVE: Medicines with limited evidence of effectiveness are prime candidates for disinvestment. However, investment in further research may be preferable to deimplementation, given that the absence of evidence is not evidence of absence, and research can inform formulary decisions. A case in point is liothyronine, which is sometimes prescribed to levothyroxine-treated patients who continue to experience hypothyroid symptoms. It is a putative low value medicine, associated with uncertainties in both clinical and cost-effectiveness. The aim was to assess the cost-effectiveness of liothyronine in this context, and estimate the value of conducting further research.

DESIGN: Cost utility and value of information analyses.

SETTING: Primary care within the National Health Service in the UK.

PARTICIPANTS: Fifty-four levothyroxine-treated patients with persistent symptoms of hypothyroidism.

INTERVENTIONS: Liothyronine plus levothyroxine versus levothyroxine alone.

PRIMARY AND SECONDARY OUTCOME MEASURES: Incremental cost per quality-adjusted life year (QALY) gained, and the expected monetary value of sample information.

RESULTS: 20/54 (37%) of patients who responded to the survey reported severe problems in carrying out usual activities of everyday living and 12/54 (22%) reported severe anxiety or depression symptoms. Mean (SD) utility was 0.53 (0.23). The differences in expected total, 10-year costs and QALYs between a treatment strategy of liothyronine/levothyroxine combination therapy, and levothyroxine alone, was £12 053 and 1.014, respectively. The incremental cost-effectiveness ratio of £11 881 per QALY gained was sensitive to the price of liothyronine. The probability of liothyronine/levothyroxine combination therapy being cost effective at a threshold of £20 000 per QALY was 0.56. The value of reducing uncertainty in the efficacy of treatment was £3.64 m per year in the UK.

CONCLUSIONS: A definitive clinical trial to confirm clinical effectiveness may be preferable to immediate disinvestment, and would be justified given the value of the information gained far exceeds the cost.

PMID:34862288 | DOI:10.1136/bmjopen-2021-051702

BMJ Open. 2021 Dec 3;11(12):e048830. doi: 10.1136/bmjopen-2021-048830.

ABSTRACT

INTRODUCTION: Approximately 38% of haemodialysis patients carry Staphylococcus aureus in their noses, and carriers have a nearly four-fold increased risk of S. aureus access-related bloodstream infections (BSIs) compared with non-carriers. Our objective is to determine the clinical efficacy and effectiveness of a novel intervention using nasal povidone-iodine (PVI) to prevent BSIs among patients in haemodialysis units. We will survey patients and conduct qualitative interviews with healthcare workers to identify barriers and facilitators to implementing the intervention.

METHODS AND ANALYSIS: We will perform an open-label, stepped-wedge cluster randomised trial to assess the effectiveness of nasal PVI compared with standard care. Sixteen outpatient haemodialysis units will participate in the study. The 3-year trial period will be divided into a 4-month baseline period and eight additional 4-month time blocks. The primary outcome of the study will be S. aureus BSI, defined as a S. aureus positive blood culture collected in the outpatient setting or within one calendar day after a hospital admission. The study team will evaluate characteristics of individual patients and the clusters by exposure status (control or intervention) to assess the balance between groups, and calculate descriptive statistics such as average responses separately for control and intervention survey questions.

ETHICS AND DISSEMINATION: This study has received IRB approval from all study sites. A Data Safety and Monitoring Board will monitor this multicentre clinical trial. We will present our results at international meetings. The study team will publish findings in peer-reviewed journals and make each accepted peer-reviewed manuscript publicly available.

TRIAL REGISTRATION NUMBER: NCT04210505.

PMID:34862278 | DOI:10.1136/bmjopen-2021-048830

Clin Med (Lond). 2021 Nov;21(6):e639-e644. doi: 10.7861/clinmed.2021-0325.

ABSTRACT

BACKGROUND: The decision to admit patients to hospital in low-resource settings have been poorly investigated.

AIM: We aimed to determine the association of a disposition score determined on arrival with the decision subsequently made to admit or discharge the patient. The score awarded one point for altered mental status, one point for impaired mobility and one point for low oxygen saturation.

METHODS: The mental status, mobility and oxygen saturation on arrival of 5,334 consecutive patients attending a combined emergency and outpatient department in a low-resource Ugandan hospital were recorded. Admission decisions were subsequently made independently by clinicians unaware to the score.

RESULTS: Most patients (n=3,876; 73%) had a disposition score of zero and only 25 of these patients (0.6%) were subsequently admitted. A total of 646 (12.1%) patients were admitted. Only 301 (5.6%) patients had a score of 3 points and 263 (87.4%) of these were admitted. The C statistic for the discrimination of the score for admission was 0.953 (95% confidence interval 0.941-0.964).

CONCLUSION: In a low-resource setting, a simple score based on mental status, mobility and oxygen saturation identified outpatient and emergency department patients most and least likely to be subsequently admitted to hospital with a high degree of discrimination.

PMID:34862225 | DOI:10.7861/clinmed.2021-0325

Clin Cancer Res. 2021 Dec 3:clincanres.3231.2021. doi: 10.1158/1078-0432.CCR-21-3231. Online ahead of print.

ABSTRACT

PURPOSE: Accurate response assessment during neoadjuvant systemic treatment (NST) poses a clinical challenge. Therefore, a minimally-invasive assessment of tumor response based on cell-free circulating tumor DNA (ctDNA) may be beneficial to guide treatment decisions.

EXPERIMENTAL DESIGN: We profiled 93 genes in tissue from 193 early breast cancer patients. Patient-specific assays were designed for 145 patients to track ctDNA during NST in plasma. ctDNA presence and levels were correlated with complete pathological response (pCR), residual cancer burden (RCB) as well as clinicopathologic characteristics of the tumor to identify potential proxies for ctDNA release.

RESULTS: At baseline, ctDNA could be detected in 63/145 (43.4%) patients and persisted in 25/63 (39.7%) patients at mid-therapy (MT) and 15/63 (23.8%) patients at the end of treatment. ctDNA detection at MT was significantly associated with higher RCB (OR 0.062, 95% CI 0.01-0.48, P=0.0077).Out of 31 patients with detectable ctDNA at MT, 30 patients (96.8%) were non-responders (RCB II, n=8; RCB III, n=22) and only one patient responded to the treatment (RCB I). Considering all 145 patients with baseline (BL) plasma, none of the patients with RCB 0 and only 6.7% of patients with RCB I had ctDNA detectable at MT, while 30.6% and 29.6% of patients with RCB II/III, respectively, had a positive ctDNA result.

CONCLUSION: Overall, our results demonstrate that the detection and persistence of ctDNA at MT may have the potential to negatively predict response to neoadjuvant treatment and identify patients who will not achieve pCR or be classified with RCB II/III.

PMID:34862246 | DOI:10.1158/1078-0432.CCR-21-3231

Clin Med (Lond). 2021 Nov;21(6):e629-e632. doi: 10.7861/clinmed.2021-0462.

ABSTRACT

BACKGROUND: Long COVID is a common occurrence following COVID-19 infection. The most common symptom reported is fatigue. Limited interventional treatment options exist. We report the first evaluation of hyperbaric oxygen therapy (HBOT) for long COVID treatment.

METHODS: A total of 10 consecutive patients received 10 sessions of HBOT to 2.4 atmospheres over 12 days. Each treatment session lasted 105 minutes, consisting of three 30-minute exposures to 100% oxygen, interspersed with 5-minute air breaks. Validated fatigue and cognitive scoring assessments were performed at day 1 and 10. Statistical analysis was with Wilcoxon signed-rank testing reported alongside effect sizes.

RESULTS: HBOT yielded a statistically significant improvement in the Chalder fatigue scale (p=0.0059; d=1.75 (very large)), global cognition (p=0.0137; d=-1.07 (large)), executive function (p=0.0039; d=-1.06 (large)), attention (p=0.0020; d=-1.2 (very large)), information processing (p=0.0059; d=-1.25 (very large)) and verbal function (p=0.0098; d=-0.92 (large)).

CONCLUSION: Long COVID-related fatigue can be debilitating, and may affect young people who were previously in economic employment. The results presented here suggest potential benefits of HBOT, with statistically significant results following 10 sessions.

PMID:34862223 | DOI:10.7861/clinmed.2021-0462

Clin Med (Lond). 2021 Nov;21(6):e633-e638. doi: 10.7861/clinmed.2021-0420.

ABSTRACT

OBJECTIVES: Reactive axillary lymph nodes (ALN) may occur post-COVID-19 vaccination. This may be confused with malignant nodal metastases on oncological imaging. We aimed to determine the reactive ALN incidence and duration on ¹⁸F-fluorodeoxyglucose positron emission tomography – computed tomography (¹⁸F-FDG PET-CT), and its relationship with gender, age and vaccine type.

METHODS: A retrospective study was performed. Two-hundred and four eligible patients had ¹⁸F-FDG PET-CT between 01 January 2021 and 31 March 2021, post-vaccination with Pfizer-BioNTech or Oxford-AstraZeneca vaccine. Image analysis was performed on dedicated workstations. SPSS was used for statistical analysis.

RESULTS: Thirty-six per cent of patients had reactive ALN until 10 weeks post-vaccination; reducing in frequency and intensity with time. Women were more likely to have reactive ALN compared with men. The frequency and intensity were higher in patients aged <65 years compared with those aged ≥65 years. However, no difference was found between both vaccine types in our study cohort.

CONCLUSIONS: Physicians’ awareness of COVID-19 vaccine-related reactive ALN on ¹⁸F-FDG PET-CT is important to avoid inappropriate upstaging of cancers.

PMID:34862224 | DOI:10.7861/clinmed.2021-0420

J Surg Educ. 2021 Nov 30:S1931-7204(21)00312-3. doi: 10.1016/j.jsurg.2021.10.012. Online ahead of print.

ABSTRACT

PURPOSE: Application inflation in the current residency application process leads to congestion, inefficiency, and perceptions of inequity. The authors aimed to assess the interest of key stakeholders on the topic of capping applications and interviews, and their perceptions regarding equity of the process.

METHODS: An anonymous survey was electronically distributed in March 2021 to Obstetrics and Gynecology (OBGYN) residency applicants, clerkship directors, program directors, and student affairs deans after the submission of the rank order list for the 2021 application cycle and prior to the release of final Match results. Participants answered questions regarding the perceived equity of the current process (no limits on applications submitted or interviews completed) compared with limiting the number of applications and interviews students could submit or complete. Respondents supporting caps reported the number they considered a reasonable cap for applications and interviews. Associations between the profiles of applicants and program directors and their interest in application and interview caps were explored using chi-squared tests for non-parametric statistics and t-tests for normally distributed interval data. The University of Michigan determined the study exempt from IRB review.

RESULTS: The overall response rate was 36.0% (1167/3243), including 34.0% of applicants (879/2579), 50.3% of program directors (143/284), 41.8% of clerkship directors (94/225) and 32.9% of student affairs deans (51/155). All groups reported application caps for either all applicants or the most competitive applicants to be more equitable than the current process, and suggested a median application cap ranging from 25 (clerkship directors and program directors) to 40 (applicants). All groups also believed interview caps to be more equitable than the current process, and suggested a median interview cap ranging from 12 (clerkship directors) to 15 (applicants, program directors, and student affairs deans).

CONCLUSIONS: Stakeholders in the OBGYN application process consider caps to applications and interviews a promising means to improve equity in the Match.

PMID:34862152 | DOI:10.1016/j.jsurg.2021.10.012