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PloS One 2021Management of multidrug-resistant tuberculosis (MDR-TB) is a significant challenge to the global healthcare system due to the complexity and long duration of the MDR-TB... (Observational Study)
Observational Study
OBJECTIVE
Management of multidrug-resistant tuberculosis (MDR-TB) is a significant challenge to the global healthcare system due to the complexity and long duration of the MDR-TB treatment. This study analyzed the safety of patients on longer injectable-based MDR-TB treatment regimens using active pharmacovigilance data.
METHOD
We conducted an observational, prospective study based on active pharmacovigilance within the national TB program. A total of 659 MDR-TB patients were enrolled and followed up at 9 TB- hospitals in 9 provinces of all 3 regions in Vietnam between 2014 and 2016. Patients received a treatment regimen (standardized or individualized) based on their drug susceptibility test result and their treatment history. Baseline and follow-up information was collected at the start and during treatment. Adverse events (AE) were defined and classified as serious adverse events (SAEs) or otherwise. Multivariate Cox regression following the Iterative Bayesian Model Averaging algorithm was performed to identify factors associated with AE occurrence.
RESULTS
Out of 659 patients assessed, 71.3% experienced at least one AE, and 17.5% suffered at least one SAE. The most common AEs were gastrointestinal disorders (38.5%), arthralgia (34.7%), and psychiatric disorders (30.0%). The proportion of patients with nephrotoxicity and hearing loss or vestibular disorders were 7.4% and 15.2%, respectively. 13.1% of patients required modifications or interruption of one or more drugs. In 77.7% of patients, treatment was completed successfully, while 9.3% lost to follow-up, in 3.0% treatment failed, and 7.4% died. Some significant risk factors for nephrotoxicity included diabetes mellitus (HR = 8.46 [1.91-37.42]), renal dysfunction (HR = 8.46 [1.91-37.42]), alcoholism (HR = 13.28 [5.04-34.99]), and a higher average daily dose of injectable drugs (HR = 1.28 [1.14-1.43]).
CONCLUSION
While a majority of patients on the longer injectable-based regimens experienced non-serious AEs during MDR-TB treatment, one in six patients experienced at least an SAE. Active TB drug-safety monitoring is useful to understand the safety of MDR-TB treatment and explore the risk factors for toxicity. All-oral, shorter MDR-TB regimens might be able to reduce the inconvenience, discomfort, and toxicity of such regimens and increase adherence and likelihood of successful completion.
Topics: Adult; Antitubercular Agents; Bayes Theorem; Diagnostic Tests, Routine; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Kidney; Male; Middle Aged; Prospective Studies; Tuberculosis, Multidrug-Resistant; Vietnam; Watchful Waiting
PubMed: 34492031
DOI: 10.1371/journal.pone.0255357 -
Current Opinion in Urology Sep 2022This review aims to analyze the current place of active surveillance (AS) in non-muscle-invasive bladder cancer (NMIBC). (Review)
Review
PURPOSE OF REVIEW
This review aims to analyze the current place of active surveillance (AS) in non-muscle-invasive bladder cancer (NMIBC).
RECENT FINDINGS
A growing body of evidence suggests that AS protocols for pTa low-grade (TaLG) NMIBC are safe and feasible. However, current guidelines have not implemented AS due to a lack of high-quality data. Available studies included pTa tumors, with only one study excluding pT1-NMIBC. Inclusion/exclusion criteria were heterogeneously defined based on tumor volume, number of tumors, carcinoma in situ (CIS), or high-grade (HG) NMIBC. Tumor volume <10 mm and <5 lesions were used as cut-offs. Positive urinary cytology (UC) or cancer-related symptoms precluded inclusion. Surveillance within the first year consisted of quarterly cystoscopy. AS stopped upon the presence of cancer-related symptoms, change in tumor morphology, positive UC, or patient's request. With a median time on AS of 16 months, two-thirds of the patients failed AS. Progression to muscle-invasive bladder cancer (MIBC) was rare and occurred only in patients with pT1-NIMBC at inclusion.
SUMMARY
AS in NMIBC is an attractive concept in the era of personalized medicine, but strong evidence is still awaited. A more precise definition of patient inclusion, follow-up, and failure criteria is required to improve its implementation in daily clinical practice.
Topics: Carcinoma in Situ; Cystoscopy; Humans; Neoplasm Invasiveness; Urinary Bladder Neoplasms; Watchful Waiting
PubMed: 35869738
DOI: 10.1097/MOU.0000000000001028 -
Der Chirurg; Zeitschrift Fur Alle... Feb 2022For (locally advanced) rectal cancer, a multimodal therapy concept comprising neoadjuvant radiotherapy/chemoradiotherapy, radical surgical resection with... (Review)
Review
For (locally advanced) rectal cancer, a multimodal therapy concept comprising neoadjuvant radiotherapy/chemoradiotherapy, radical surgical resection with partial/complete mesorectal excision and subsequent adjuvant chemotherapy represents the current international standard of care. Further developments in neoadjuvant therapy concepts, such as the principle of total neoadjuvant therapy, lead to an increasing number of patients who show a complete clinical response in restaging after neoadjuvant therapy without clinically detectable residual tumor. In view of the risk associated with radical surgical resection in terms of perioperative morbidity and a potentially non-continence-preserving procedure, the question of the oncological justifiability of an organ-preserving procedure in the case of a complete clinical response under neoadjuvant therapy is increasingly being raised. The therapeutic principle of watch and wait, defined by refraining from immediate radical surgical resection and inclusion in a close-meshed, structured follow-up program, currently appears to be oncologically justifiable based on the current study situation; however, for the initial evaluation of the extent of the clinical response and for the structuring of the close-meshed follow-up program, further optimization and standardization based on broadly designed studies appear necessary in order to be able to provide this concept to a clearly defined patient collective as an oncologically equivalent therapy principle also outside specialized centers.
Topics: Chemoradiotherapy; Humans; Neoadjuvant Therapy; Neoplasm Recurrence, Local; Rectal Neoplasms; Treatment Outcome; Watchful Waiting
PubMed: 34878582
DOI: 10.1007/s00104-021-01540-4 -
Current Opinion in Urology Sep 2015Metastatic renal cell carcinoma (mRCC) is a diagnosis with wide variation in outcome; prognostic categories of favourable, intermediate and poor risk based on clinical... (Review)
Review
PURPOSE OF REVIEW
Metastatic renal cell carcinoma (mRCC) is a diagnosis with wide variation in outcome; prognostic categories of favourable, intermediate and poor risk based on clinical criteria are widely used in routine clinical practice. The observation that a subgroup of patients has indolent disease associated with prolonged survival was recognized before the introduction of novel targeted agents. This led to interest in a strategy of deferring systemic therapy in selected patients. This review will consider data that have evaluated the safety and acceptability of such a strategy in the era of effective systemic therapies for mRCC.
RECENT FINDINGS
Data from five retrospective studies, one prospective cohort and a subgroup of a randomized phase III trial lend support to the strategy of deferral of systemic therapy for carefully selected patients with mRCC. Prospectively collected data also indicate that this approach is acceptable to patients and does not induce anxiety or impair quality of life.
SUMMARY
Patients with asymptomatic, low-volume metastatic disease may benefit from a period of observation free from the toxicity of systemic therapy without compromising survival. Further prospective studies with biomarker validation are required to define the patients most likely to benefit from this approach.
Topics: Carcinoma, Renal Cell; Humans; Kidney Neoplasms; Patient Selection; Prognosis; Risk Assessment; Risk Factors; Time Factors; Watchful Waiting
PubMed: 26075569
DOI: 10.1097/MOU.0000000000000193 -
The Canadian Journal of Urology Feb 2017There are numerous standard treatment options for men diagnosed with localized prostate cancer. Multidisciplinary consultation before decision-making is a consensus- and...
INTRODUCTION
There are numerous standard treatment options for men diagnosed with localized prostate cancer. Multidisciplinary consultation before decision-making is a consensus- and quality-based objective in Ontario. With the goals of working together more collaboratively and to provide higher quality information for patients at the time of decision-making, a prostate cancer community partnership consensus (PCPC) panel was formed among six partnering centers in the Greater Toronto Area.
MATERIALS AND METHODS
Five iterative meetings were held among 40 prostate cancer specialists (32 urologists and 8 radiation oncologists) who participate in multidisciplinary clinics. The meetings defined the goals of the partnership as well as the topics and questions the group would address together. Answers to these questions were developed by formal consensus: >= 75% of participants had to agree with wording based on secret ballots to achieve consensus.
RESULTS
All six groups wanted to participate to improve patient care/decision-making. Forty-one questions addressing 30 issues were derived from the literature and the group's collective experience. These issues were cross-tabbed against five management options: active surveillance, radical prostatectomy, low dose rate brachytherapy, high dose rate brachytherapy boost and external beam radiation. Answers common to all modalities were coalesced. Eighty-six issues were subjected to formal consensus. After three rounds of secret ballots, consensus was achieved for the answers to all issues.
CONCLUSIONS
A formal consensus-based partnership between urology and radiation oncology to support newly diagnosed prostate cancer patients was feasible and resulted in a patient information guide which may improve decision-making.
Topics: Brachytherapy; Decision Making; Humans; Interdisciplinary Communication; Male; Patient Education as Topic; Prostatic Neoplasms; Radiation Oncology; Urology; Watchful Waiting
PubMed: 28263130
DOI: No ID Found -
Ultrasound in Obstetrics & Gynecology :... Nov 2023To assess whether coexisting fetal growth restriction (FGR) influences pregnancy latency among women with preterm pre-eclampsia undergoing expectant management....
OBJECTIVES
To assess whether coexisting fetal growth restriction (FGR) influences pregnancy latency among women with preterm pre-eclampsia undergoing expectant management. Secondary outcomes assessed were indication for delivery, mode of delivery and rate of serious adverse maternal and perinatal outcomes.
METHODS
We conducted a secondary analysis of the Pre-eclampsia Intervention (PIE) and the Pre-eclampsia Intervention 2 (PI2) trial data. These randomized controlled trials evaluated whether esomeprazole and metformin could prolong gestation of women diagnosed with pre-eclampsia between 26 and 32 weeks of gestation undergoing expectant management. Delivery indications were deteriorating maternal or fetal status, or reaching 34 weeks' gestation. FGR (defined by Delphi consensus) at the time of pre-eclampsia diagnosis was examined as a predictor of outcome. Only placebo data from PI2 were included, as the trial showed that metformin use was associated with prolonged gestation. All outcome data were collected prospectively from diagnosis of pre-eclampsia to 6 weeks after the expected due date.
RESULTS
Of the 202 women included, 92 (45.5%) had FGR at the time of pre-eclampsia diagnosis. Median pregnancy latency was 6.8 days in the FGR group and 15.3 days in the control group (difference 8.5 days; adjusted 0.49-fold change (95% CI, 0.33-0.74); P < 0.001). FGR pregnancies were less likely to reach 34 weeks' gestation (12.0% vs 30.9%; adjusted relative risk (aRR), 0.44 (95% CI, 0.23-0.83)) and more likely to be delivered for suspected fetal compromise (64.1% vs 36.4%; aRR, 1.84 (95% CI, 1.36-2.47)). More women with FGR underwent a prelabor emergency Cesarean section (66.3% vs 43.6%; aRR, 1.56 (95% CI, 1.20-2.03)) and were less likely to have a successful induction of labor (4.3% vs 14.5%; aRR, 0.32 (95% CI, 0.10-1.00)), compared to those without FGR. The rate of maternal complications did not differ significantly between the two groups. FGR was associated with a higher rate of infant death (14.1% vs 4.5%; aRR, 3.26 (95% CI, 1.08-9.81)) and need for intubation and mechanical ventilation (15.2% vs 5.5%; aRR, 2.97 (95% CI, 1.11-7.90)).
CONCLUSION
FGR is commonly present in women with early preterm pre-eclampsia and outcome is poorer. FGR is associated with shorter pregnancy latency, more emergency Cesarean deliveries, fewer successful inductions and increased rates of neonatal morbidity and mortality. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
Topics: Infant, Newborn; Infant; Pregnancy; Female; Humans; Pregnancy Outcome; Cesarean Section; Pre-Eclampsia; Fetal Growth Retardation; Watchful Waiting; Metformin
PubMed: 37289938
DOI: 10.1002/uog.26282 -
Seminars in Reproductive Medicine Jan 2020Unexplained infertility represents up to 30% of all cases of infertility. It is a diagnosis of exclusion, where no cause for infertility may be identified in the...
Unexplained infertility represents up to 30% of all cases of infertility. It is a diagnosis of exclusion, where no cause for infertility may be identified in the investigation of the couple, be it anovulation, fallopian tube blockage, or severe male factor. Unexplained infertility therefore cannot be considered a diagnosis to which a specific treatment is directed, rather that it indicates a failure to reach a diagnosis of the true cause of infertility. In this review, we explore the evidence base and potential limitations of the current routine infertility assessment. We also aim to highlight the importance of considering the prognosis of each individual couple through the process of assessment and propose a reconsidered approach to treatment, targeted to the prognosis rather than the diagnosis. Ultimately, a better understanding of the mechanisms of infertility will reduce the number of couples diagnosed with "unexplained" infertility.
Topics: Female; Humans; Infertility; Male; Pregnancy; Prognosis; Reproductive Techniques, Assisted; Watchful Waiting
PubMed: 33058088
DOI: 10.1055/s-0040-1718709 -
Archives of Gynecology and Obstetrics Oct 2022Both expectant and interventional managements are acceptable in selected cases, when heterotopic pregnancy is diagnosed, with high ongoing intra-uterine pregnancy rate...
KEY MESSAGE
Both expectant and interventional managements are acceptable in selected cases, when heterotopic pregnancy is diagnosed, with high ongoing intra-uterine pregnancy rate and term deliveries.
PURPOSE
Heterotopic pregnancy, though relatively rare, is potentially a life-threatening condition. The aim of the study is to compare expectant versus interventional management of heterotopic pregnancies.
METHODS
This is a retrospective cohort study including all women diagnosed with heterotopic pregnancy on ultrasound from March 2011 to December 2020 in a single medical center. Expectant and interventional management outcomes were compared. Primary outcome was defined as live birth.
RESULTS
Forty-one women were diagnosed with heterotopic pregnancy during the study period. Management was expectant in 10 (24.4%) and interventional in 31 (75.6%) of the women. Expectant management was considered when the patient was stable, and the attending physician decided that the ectopic pregnancy did not continue to develop. Interventions included laparoscopic salpingectomy (n = 26), laparoscopic cornual resection (n = 2), laparotomic cornual resection (n = 1) and gestational sac aspiration (n = 2). The intra-uterine pregnancy continued to develop in 6 (60.0%) and 22 (81.5%) of the women in the expectant and interventional groups, respectively (p = 0.52). All women managed expectantly reached term delivery, as opposed to 17/22 (77.3%) in the intervention management group (p = 0.60). Multivariate analysis found serum β-hCG level as the only independent parameter associated with ongoing pregnancy rate (B = 0.001, p = 0.04).
CONCLUSIONS
Both expectant and interventional management were found to be acceptable when heterotopic pregnancy was diagnosed, with high ongoing intra-uterine pregnancy rate and term deliveries.
Topics: Female; Humans; Live Birth; Pregnancy; Pregnancy, Heterotopic; Retrospective Studies; Salpingectomy; Watchful Waiting
PubMed: 35648227
DOI: 10.1007/s00404-022-06628-8 -
Current Urology Reports Nov 2019Advancements in the care of patients affected by myelomeningocele have flourished in recent years especially with respect to renal preservation and continence.... (Review)
Review
PURPOSE OF REVIEW
Advancements in the care of patients affected by myelomeningocele have flourished in recent years especially with respect to renal preservation and continence. Involvement of urologists both prenatally and early in life has driven many developments in preventative care and early intervention. As of yet, however, the ideal management algorithm that offers these patients the least invasive diagnostic testing and interventions while still preserving renal and bladder function remains ill defined.
RECENT FINDINGS
In a shift from prior years where the use of surgical intervention and intermittent catheterization were more liberally employed, some providers have more recently advocated for monitoring patients in a more conservative manner with a variety of diagnostic tests until radiographic or clinical changes are discovered. The criteria used to define the need for catheterization and the timing to initiate CIC or more invasive interventions is disparate across pediatric urology and there is published data to support several approaches. This review presents some of these criteria for use of CIC and some newer evidence to support different approaches along with supporting the trend toward individualized medicine and use of risk stratification in developing clinical treatment algorithms.
Topics: Humans; Intermittent Urethral Catheterization; Kidney; Risk Assessment; Spinal Dysraphism; Urinary Bladder, Neurogenic; Watchful Waiting
PubMed: 31734847
DOI: 10.1007/s11934-019-0943-z -
European Journal of Surgical Oncology :... Mar 2018Papillary microcarcinoma (PMC) of the thyroid is defined as papillary thyroid carcinoma (PTC) measuring ≤1 cm. Many autopsy studies on subjects who died of... (Review)
Review
Papillary microcarcinoma (PMC) of the thyroid is defined as papillary thyroid carcinoma (PTC) measuring ≤1 cm. Many autopsy studies on subjects who died of non-thyroidal diseases reported latent small thyroid carcinoma in up to 5.2% of the subjects. A mass screening study for thyroid cancer in Japanese adult women detected small thyroid cancer in 3.5% of the examinees. This incidence was close to the incidence of latent thyroid cancer and more than 1000 times the prevalence of clinical thyroid cancer in Japanese women reported at that time. The question of whether it was correct to treat such PMCs surgically then arose. In 1993, according to Dr. Miyauchi's proposal, Kuma Hospital initiated an active surveillance trial for low-risk PMC as defined in the text. In 1995, Cancer Institute Hospital in Tokyo, Japan, started a similar observation trial. The accumulated data from the trials at these two institutions strongly suggest that active surveillance (i.e., observation without immediate surgery) can be the first-line management for low-risk PMC. Although our data showed that young age and pregnancy might be risk factors of disease progression, we think that these patients can also be candidates for active surveillance, because all of the patients who showed progression signs were treated successfully with a rescue surgery, and none of them died of PTC. In this review, we summarize the data regarding the active surveillance of low-risk PMC as support for physicians and institutions that are considering adopting this strategy.
Topics: Carcinoma, Papillary; Clinical Trials as Topic; Disease Progression; Humans; Incidence; Population Surveillance; Prognosis; Risk Assessment; Risk Factors; Survival Rate; Thyroid Neoplasms; Thyroidectomy; Watchful Waiting
PubMed: 28343733
DOI: 10.1016/j.ejso.2017.03.004