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Current Urology Reports Oct 2023Many prostate cancer active surveillance protocols mandate serial monitoring at defined intervals, including but certainly not limited to serum PSA (often every... (Review)
Review
PURPOSE OF REVIEW
Many prostate cancer active surveillance protocols mandate serial monitoring at defined intervals, including but certainly not limited to serum PSA (often every 6 months), clinic visits, prostate multiparametric MRI, and repeat prostate biopsies. The purpose of this article is to evaluate whether current protocols result in excessive testing of patients on active surveillance.
RECENT FINDINGS
Multiple studies have been published in the past several years evaluating the utility of multiparametric MRI, serum biomarkers, and serial prostate biopsy for men on active surveillance. While MRI and serum biomarkers have promise with risk stratification, no studies have demonstrated that periodic prostate biopsy can be safely omitted in active surveillance. Active surveillance for prostate cancer is too active for some men with seemingly low-risk cancer. The use of multiple prostate MRIs or additional biomarkers do not always add to the prediction of higher-grade disease on surveillance biopsy.
Topics: Male; Humans; Prostate-Specific Antigen; Watchful Waiting; Prostatic Neoplasms; Biopsy; Prostate; Magnetic Resonance Imaging
PubMed: 37436691
DOI: 10.1007/s11934-023-01177-2 -
BMJ (Clinical Research Ed.) Dec 2010To compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term. (Comparative Study)
Comparative Study Randomized Controlled Trial
OBJECTIVE
To compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term.
DESIGN
Multicentre randomised equivalence trial (the Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT)).
SETTING
Eight academic and 44 non-academic hospitals in the Netherlands between November 2004 and November 2008.
PARTICIPANTS
Pregnant women who had a singleton pregnancy beyond 36+0 weeks' gestation with suspected intrauterine growth restriction.
INTERVENTIONS
Induction of labour or expectant monitoring.
MAIN OUTCOME MEASURES
The primary outcome was a composite measure of adverse neonatal outcome, defined as death before hospital discharge, five minute Apgar score of less than 7, umbilical artery pH of less than 7.05, or admission to the intensive care unit. Operative delivery (vaginal instrumental delivery or caesarean section) was a secondary outcome. Analysis was by intention to treat, with confidence intervals calculated for the differences in percentages or means.
RESULTS
321 pregnant women were randomly allocated to induction and 329 to expectant monitoring. Induction group infants were delivered 10 days earlier (mean difference -9.9 days, 95% CI -11.3 to -8.6) and weighed 130 g less (mean difference -130 g, 95% CI -188 g to -71 g) than babies in the expectant monitoring group. A total of 17 (5.3%) infants in the induction group experienced the composite adverse neonatal outcome, compared with 20 (6.1%) in the expectant monitoring group (difference -0.8%, 95% CI -4.3% to 3.2%). Caesarean sections were performed on 45 (14.0%) mothers in the induction group and 45 (13.7%) in the expectant monitoring group (difference 0.3%, 95% CI -5.0% to 5.6%).
CONCLUSIONS
In women with suspected intrauterine growth restriction at term, we found no important differences in adverse outcomes between induction of labour and expectant monitoring. Patients who are keen on non-intervention can safely choose expectant management with intensive maternal and fetal monitoring; however, it is rational to choose induction to prevent possible neonatal morbidity and stillbirth.
TRIAL REGISTRATION
International Standard Randomised Controlled Trial number ISRCTN10363217.
Topics: Adult; Female; Fetal Growth Retardation; Gestational Age; Humans; Labor Onset; Labor, Induced; Length of Stay; Pregnancy; Pregnancy Outcome; Watchful Waiting; Young Adult
PubMed: 21177352
DOI: 10.1136/bmj.c7087 -
Journal of Advanced Nursing Feb 2003Observation is used in research in two ways - structured and unstructured. Which of these methods to choose depends on the research question but will be defined... (Review)
Review
BACKGROUND
Observation is used in research in two ways - structured and unstructured. Which of these methods to choose depends on the research question but will be defined predominantly by the paradigm underlying each study. Positivistic research generally uses structured observation and interpretist/naturalistic paradigms use unstructured observation. This paper is concerned with unstructured observation.
AIM
To discuss the importance of unstructured observation as a research method and to examine critically the problems associated with both access and field notes.
APPLICATION TO NURSING
Although unstructured observation has been used in nursing research, it is less favoured than the interview. Furthermore, although some of the dilemmas concerned with observation such as the role of the researcher, covert research and informed consent have received attention in the nursing literature, other aspects remain relatively unexplored. In particular little has been written concerning access to the field and field notes. Both of these aspects have practical and theoretical considerations that require the attention of the researcher. This omission may partly explain nurses' apparent reluctance to use unstructured observation in their studies. This paper seeks to redress this situation.
Topics: Data Collection; Nursing Research; Observation; Research Design; Writing
PubMed: 12581118
DOI: 10.1046/j.1365-2648.2003.02514.x -
Recent Patents on Inflammation &... May 2011Alopecia aerata (AA) is an autoimmune disease that presents as well defined patches of nonscarring hair loss with no overt epidermal changes. The life-time risk of AA in... (Review)
Review
Alopecia aerata (AA) is an autoimmune disease that presents as well defined patches of nonscarring hair loss with no overt epidermal changes. The life-time risk of AA in the general population is approximately 1.7%. As many as 60% of patients with AA have disease onset before 20 years of age. AA most commonly manifests as sudden loss of hair in well demarcated, localized area in the scalp. The hair loss is usually limited to a single patch. The lesion is usually round or oval. "Exclamation point hairs" are frequently seen at the periphery of the lesion. Because of the high rate of spontaneous recovery especially in those with small areas of hair loss or with a recent onset, not all patients require pharmacological treatment. A "watch-and-wait" approach is often recommended. Psychological support may be offered if necessary. For patients who actively desire treatment, topical corticosteroids and/or minoxidil are the treatment of choice. Interleukin (IL)-31 antibodies and 308-nm Excimer laser as novel treatment modalities appear promising in the armamentarium against this distressing disease. The review also outlined recent patents on the treatment of alopecia.
Topics: Adrenal Cortex Hormones; Alopecia Areata; Animals; Antibodies; Humans; Immunotherapy; Interleukins; Lasers, Excimer; Minoxidil; Remission, Spontaneous; Risk Factors; Treatment Outcome; Watchful Waiting
PubMed: 21453266
DOI: 10.2174/187221311795399291 -
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 -
World Journal of Urology Jan 2022In the past two decades, new biomarkers for prostate cancer detection and risk prediction have become available for clinical use. While tissue-based gene expression... (Review)
Review
PURPOSE
In the past two decades, new biomarkers for prostate cancer detection and risk prediction have become available for clinical use. While tissue-based gene expression assays offer molecular risk assessment after diagnoses, several serum- and urine-based 'liquid' biomarkers are available for the pre-biopsy setting which may also play a role for active surveillance (AS).
METHODS
The medical literature was queried utilizing PubMed (pubmed.ncbi.nlm.nih.gov) for all relevant original publications describing prostate cancer biomarkers that can be identified in the blood, urine, or semen. Referenced studies must have defined patient inclusion criteria and descriptions of the biomarkers. Included studies investigated the utility of liquid biomarkers for selection or monitoring of men with prostate cancer for active surveillance.
RESULTS
PSA is the most common and readily available biomarker for prostate cancer diagnosis and treatment. Contemporary AS guidelines consider diagnostic PSA level in addition to other clinical factors when selecting men for this approach, with most recommending that initial PSA should be under 10 ng/ml. Serum PSA changes are associated with outcomes on AS but are not adequately sensitive so drive men to secondary treatment in isolation. PSA derivates including the Prostate Health Index (phi) and the 4K Score can predict higher grade cancer and may help tailor repeat prostate biopsy strategies, but further data are needed prior to routine clinic use. Several urine-based biomarkers including PCA3 and TMPRSS2:ERG levels have also been studied in the AS setting.
CONCLUSIONS
Multiple serum- and urine-based liquid biomarkers are available for use in men with prostate cancer. For AS, serum PSA is utilized in part for patient selection as well as to monitor disease over time. Models that incorporate PSA kinetics with other clinical characteristics may help tailor surveillance strategies to reduce disease burden and health care costs over time. Several novel liquid biomarkers demonstrate promise and may eventually have applications for prostate cancer surveillance as well.
Topics: Biomarkers, Tumor; Humans; Male; Prostatic Neoplasms; Semen; Watchful Waiting
PubMed: 33590279
DOI: 10.1007/s00345-021-03609-5 -
Human Reproduction (Oxford, England) Apr 2021Does septum resection improve reproductive outcomes in women with a septate uterus? (Randomized Controlled Trial)
Randomized Controlled Trial
STUDY QUESTION
Does septum resection improve reproductive outcomes in women with a septate uterus?
SUMMARY ANSWER
Hysteroscopic septum resection does not improve reproductive outcomes in women with a septate uterus.
WHAT IS KNOWN ALREADY
A septate uterus is a congenital uterine anomaly. Women with a septate uterus are at increased risk of subfertility, pregnancy loss and preterm birth. Hysteroscopic resection of a septum may improve the chance of a live birth in affected women, but this has never been evaluated in randomized clinical trials. We assessed whether septum resection improves reproductive outcomes in women with a septate uterus, wanting to become pregnant.
STUDY DESIGN, SIZE, DURATION
We performed an international, multicentre, open-label, randomized controlled trial in 10 centres in The Netherlands, UK, USA and Iran between October 2010 and September 2018.
PARTICIPANTS/MATERIALS, SETTING, METHODS
Women with a septate uterus and a history of subfertility, pregnancy loss or preterm birth were randomly allocated to septum resection or expectant management. The primary outcome was conception leading to live birth within 12 months after randomization, defined as the birth of a living foetus beyond 24 weeks of gestational age. We analysed the data on an intention-to-treat basis and calculated relative risks with 95% CI.
MAIN RESULTS AND THE ROLE OF CHANCE
We randomly assigned 80 women with a septate uterus to septum resection (n = 40) or expectant management (n = 40). We excluded one woman who underwent septum resection from the intention-to-treat analysis, because she withdrew informed consent for the study shortly after randomization. Live birth occurred in 12 of 39 women allocated to septum resection (31%) and in 14 of 40 women allocated to expectant management (35%) (relative risk (RR) 0.88 (95% CI 0.47 to 1.65)). There was one uterine perforation which occurred during surgery (1/39 = 2.6%).
LIMITATIONS, REASONS FOR CAUTION
Although this was a major international trial, the sample size was still limited and recruitment took a long period. Since surgical techniques did not fundamentally change over time, we consider the latter of limited clinical significance.
WIDER IMPLICATIONS OF THE FINDINGS
The trial generated high-level evidence in addition to evidence from a recently published large cohort study. Both studies unequivocally do not reveal any improvements in reproductive outcomes, thereby questioning any rationale behind surgery.
STUDY FUNDING/COMPETING INTEREST(S)
There was no study funding. M.H.E. reports a patent on a surgical endoscopic cutting device and process for the removal of tissue from a body cavity licensed to Medtronic, outside the scope of the submitted work. H.A.v.V. reports personal fees from Medtronic, outside the submitted work. B.W.J.M. reports grants from NHMRC, personal fees from ObsEva, personal fees from Merck Merck KGaA, personal fees from Guerbet, personal fees from iGenomix, outside the submitted work. M.G. reports several research and educational grants from Guerbet, Merck and Ferring (location VUMC) outside the scope of the submitted work. The remaining authors have nothing to declare.
TRIAL REGISTRATION NUMBER
Dutch trial registry: NTR 1676.
TRIAL REGISTRATION DATE
18 February 2009.
DATE OF FIRST PATIENT’S ENROLMENT
20 October 2010.
Topics: Cohort Studies; Female; Humans; Infant, Newborn; Iran; Netherlands; Pregnancy; Premature Birth; Uterus; Watchful Waiting
PubMed: 33793794
DOI: 10.1093/humrep/deab037 -
Journal of Internal Medicine Jul 2020Aortic pathologies such as aneurysm, dissection and trauma are relatively common and potentially fatal diseases. Over the past two decades, we have experienced... (Review)
Review
Aortic pathologies such as aneurysm, dissection and trauma are relatively common and potentially fatal diseases. Over the past two decades, we have experienced unprecedented technical and medical developments in the field. Despite this, there is a great need, and great opportunities, to further explore the area. In this review, we have identified important areas that need to be further studied and selected priority aortic disease trials. There is a pressing need to update the AAA natural history and the role for endovascular AAA repair as well as to define biomarkers and genetic risk factors as well as influence of gender for development and progression of aortic disease. A key limitation of contemporary treatment strategies of AAA is the lack of therapy directed at small AAA, to prevent AAA expansion and need for surgical repair, as well as to reduce the risk for aortic rupture. Currently, the most promising potential drug candidate to slow AAA growth is metformin, and RCTs to verify or reject this hypothesis are warranted. In addition, the role of endovascular treatment for ascending pathologies and for uncomplicated type B aortic dissection needs to be clarified.
Topics: Aortic Dissection; Aorta; Aortic Aneurysm, Abdominal; Balloon Occlusion; Biomarkers; Clinical Trials as Topic; Disease Progression; Endovascular Procedures; Humans; Hypoglycemic Agents; Metformin; Sex Factors; Stents; Vascular Surgical Procedures; Watchful Waiting
PubMed: 32187752
DOI: 10.1111/joim.13042 -
Current Opinion in Pulmonary Medicine Jul 2018Ground glass nodules (GGNs) represent an indolent subset of lung nodules including preinvasive nonsmall-cell lung cancer associated with a favorable prognosis and low... (Review)
Review
PURPOSE OF REVIEW
Ground glass nodules (GGNs) represent an indolent subset of lung nodules including preinvasive nonsmall-cell lung cancer associated with a favorable prognosis and low risk for progression. Increased performance of screening cat-scan (CT) for high-risk patients has identified an increasing number of GGNs. The management of these nodules is founded mostly on single institution data and currently no universally accepted recommendations help guide clinicians managing these patients.
RECENT FINDINGS
The solid component within a GGN is the key determinant of prognosis and is best defined by evaluating nodule density on mediastinal windows of a chest CT. When a GGN is small (<3 cm), associated with minimal change in size (<25% growth per year), and there is no demonstration of a significant solid component on mediastinal windows (<2 mm in diameter), patients can be safely observed with serially imaging. These imaging features also help distinguish patients that may harbor early-stage lung cancers that benefit from local treatment options.
SUMMARY
The majority of GGNs do not undergo significant progression during surveillance. Evidence of nodule progression on interval imaging may be a trigger for consideration of a local treatment option such as surgical resection. Large prospective studies are needed in the United States to validate the more robust data derived from Asian studies to help formulate formal recommendations for surveillance and treatment. Future improvements in imaging and the molecular characterization of these GGNs may further refine which patients are at risk for progression.
Topics: Diagnosis, Differential; Disease Progression; Humans; Lung Neoplasms; Solitary Pulmonary Nodule; Tomography, X-Ray Computed; Tumor Burden; Watchful Waiting
PubMed: 29634577
DOI: 10.1097/MCP.0000000000000492 -
Clinical Obstetrics and Gynecology Mar 2015With the advent of routine obstetrical ultrasound, the diagnosis of an adnexal mass in pregnancy has become increasingly common. Although the reported incidence and... (Review)
Review
With the advent of routine obstetrical ultrasound, the diagnosis of an adnexal mass in pregnancy has become increasingly common. Although the reported incidence and expected clinical course varies based on the gestational age at the time of diagnosis and the criteria used to define an adnexal mass, the majority of adnexal masses diagnosed in pregnancy are benign and are likely to resolve without complication or intervention. This review will discuss the epidemiology of adnexal masses in pregnancy, diagnostic tools, potential complications, and management options during pregnancy.
Topics: Adnexal Diseases; Biomarkers, Tumor; Female; Humans; Laparoscopy; Magnetic Resonance Imaging; Ovarian Cysts; Pregnancy; Pregnancy Complications; Pregnancy Complications, Neoplastic; Torsion Abnormality; Ultrasonography; Watchful Waiting
PubMed: 25551696
DOI: 10.1097/GRF.0000000000000088