Cybermedlife - Therapeutic Actions Watchful Waiting

Risk factors for persistent cervical intraepithelial neoplasia grades 1 and 2: managed by watchful waiting. 📎

Abstract Title: Risk factors for persistent cervical intraepithelial neoplasia grades 1 and 2: managed by watchful waiting. Abstract Source: J Low Genit Tract Dis. 2011 Oct ;15(4):268-75. PMID: 21811178 Abstract Author(s): Gloria Y F Ho, Mark H Einstein, Seymour L Romney, Anna S Kadish, Maria Abadi, Magdy Mikhail, Jayasri Basu, Benjamin Thysen, Laura Reimers, Prabhudas R Palan, Shelly Trim, Nafisseh Soroudi, Robert D Burk, Article Affiliation: Departments of Epidemiology&Population Health, Albert Einstein College of Medicine, NY, USA. This email address is being protected from spambots. You need JavaScript enabled to view it. Abstract: OBJECTIVE: : This study examines risk factors for persistent cervical intraepithelial neoplasia (CIN) and examines whether human papillomavirus (HPV) testing predicts persistent lesions. MATERIALS AND METHODS: : Women with histologically diagnosed CIN 1 or CIN 2 (n = 206) were followed up every 3 months without treatment. Human papillomavirus genotyping, plasma levels of ascorbic acid, and red blood cell folate levels were obtained. Cervical biopsy at 12 months determined the presence of CIN. Relative risk (RR) was estimated by log-linked binomial regression models. RESULTS: : At 12 months, 70% of CIN 1 versus 54% of CIN 2 lesions spontaneously regressed (p<.001). Levels of folate or ascorbic acid were not associated with persistent CIN at 12 months. Compared with HPV-negative women, those with multiple HPV types (RRs ranged from 1.68 to 2.17 at each follow-up visit) or high-risk types (RRs range = 1.74-2.09) were at increased risk for persistent CIN; women with HPV-16/18 had the highest risk (RRs range = 1.91-2.21). Persistent infection with a high-risk type was also associated with persistent CIN (RRs range = 1.50-2.35). Typing for high-risk HPVs at 6 months only had a sensitivity of 46% in predicting persistence of any lesions at 12 months. CONCLUSIONS: : Spontaneous regression of CIN 1 and 2 occurs frequently within 12 months. Human papillomavirus infection is the major risk factor for persistent CIN. However, HPV testing cannot reliably predict persistence of any lesion. Article Published Date : Sep 30, 2011

Natural history of gallstone disease: Expectant management or active treatment? Results from a population-based cohort study.

Abstract Title: Natural history of gallstone disease: Expectant management or active treatment? Results from a population-based cohort study. Abstract Source: J Gastroenterol Hepatol. 2010 Apr;25(4):719-24. PMID: 20492328 Abstract Author(s): Davide Festi, Maria Letizia Bacchi Reggiani, Adolfo F Attili, Paola Loria, Paolo Pazzi, Eleonora Scaioli, Simona Capodicasa, Ferdinando Romano, Enrico Roda, Antonio Colecchia Article Affiliation: Department of Clinical Medicine, University of Bologna, Bologna, Italy. This email address is being protected from spambots. You need JavaScript enabled to view it. Abstract: BACKGROUND AND AIMS: The knowledge of natural history is essential for disease management. We evaluated the natural history (e.g. frequency and characteristics of symptoms and clinical outcome) of gallstones (GS) in a population-based cohort study. METHODS: A total of 11 229 subjects (6610 men, 4619 women, age-range: 29-69 years, mean age: 48 years) were studied. At ultrasonography, GS were present in 856 subjects (338 men, 455 women) (7.1%). GS were followed by means of a questionnaire inquiring about the characteristics of specific biliary symptoms. RESULTS: At enrollment, 580 (73.1%) patients were asymptomatic, 94 (11.8%) had mild symptoms and 119 (15.1%) had severe symptoms. GS patients were followed up for a mean period of 8.7 years; 63 subjects (7.3%) were lost to follow up. At the end of the follow up, of the asymptomatic subjects, 453 (78.1%) remained asymptomatic; 61 (10.5%) developed mild symptoms and 66 (11.4%) developed severe symptoms. In subjects with mild symptoms, the symptoms disappeared in 55 (58.5%), became severe in 23 (24.5%), remained stable in 16 (17%); in subjects with severe symptoms, the symptoms disappeared in 62 (52.1%), became mild in 20 (16.8%) and remained stable in 37 (31.1%). A total of 189 cholecystectomies were performed: 41.3% on asymptomatic patients, 17.4% on patients with mild symptoms and 41.3% on patients with severe symptoms. CONCLUSIONS: This study indicates that: (i) asymptomatic and symptomatic GS patients have a benign natural history; (ii) the majority of GS patients with severe or mild symptoms will no longer experience biliary pain; and (iii) a significant proportion of cholecystectomies are performed in asymptomatic patients. Expectant management still represents a valid therapeutic approach in the majority of patients. Article Published Date : Apr 01, 2010

Spontaneous partial regression of hepatocellular carcinoma in a cirrhotic patient.

Abstract Title: Spontaneous partial regression of hepatocellular carcinoma in a cirrhotic patient. Abstract Source: Ann Hepatol. 2007 Jan-Mar;6(1):66-9. PMID: 17297433 Abstract Author(s): Judith Meza-Junco, Aldo J Montaño-Loza, Braulio Martinez-Benítez, Tatiana Cabrera-Aleksandrova Article Affiliation: Department of Oncology, Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán, Mexico City. This email address is being protected from spambots. You need JavaScript enabled to view it. Abstract: Spontaneous regression of a malignant tumor is an exceptional phenomenon. A 56-year-old woman with liver cirrhosis related to chronic hepatitis C presented with a liver tumor. Partial regression of a hepatocellular carcinoma was diagnosed by imaging studies that showed progressive diminution of the size of the tumor and changes in the tumor markers. However, because of the persistence of the tumor and uncertainty in the diagnosis we recommended surgery. A hepatectomy was performed and a hepatocellular carcinoma moderately differentiated was found. The patient is now doing well and without any evidence of recurrence at 25 months after surgery. We found 61 case reports that have been published from 1982 to September 2006, with apparently spontaneous regression of hepatocellular carcinoma. The precise mechanism regarding the spontaneous regression of this tumor is not fully understood, either ischemia due to rapid growth of the neoplasia or particular inflammatory and immunologic mechanisms may be involved in the regression of the hepatocellular carcinoma. Article Published Date : Jan 01, 2007

Nonsevere acute otitis media: a clinical trial comparing outcomes of watchful waiting versus immediate antibiotic treatment.

Abstract Title: Nonsevere acute otitis media: a clinical trial comparing outcomes of watchful waiting versus immediate antibiotic treatment. Abstract Source: Pediatrics. 2005 Jun;115(6):1455-65. PMID: 15930204 Abstract Author(s): David P McCormick, Tasnee Chonmaitree, Carmen Pittman, Kokab Saeed, Norman R Friedman, Tatsuo Uchida, Constance D Baldwin Article Affiliation: Division of General Academic Pediatrics, University of Texas Medical Branch, 301 University Blvd, Galveston, TX 77555-1119, USA. This email address is being protected from spambots. You need JavaScript enabled to view it. Abstract: OBJECTIVE: The widespread use of antibiotics for treatment of acute otitis media (AOM) has resulted in the emergence of multidrug-resistant pathogens that are difficult to treat. However, it has been shown that most children with nonsevere AOM recover without ABX. The objective of this study was to evaluate the safety, efficacy, acceptability, and costs of a non-ABX intervention for children with nonsevere AOM. METHODOLOGY: Children 6 months to 12 years old with AOM were screened by using a novel AOM-severity screening index. Parents of children with nonsevere AOM received an educational intervention, and their children were randomized to receive either immediate antibiotics (ABX; amoxicillin plus symptom medication) or watchful waiting (WW; symptom medication only). The investigators, but not the parents, were blinded to enrollment status. Primary outcomes included parent satisfaction with AOM care, resolution of symptoms, AOM failure/recurrence, and nasopharyngeal carriage of Streptococcus pneumoniae strains resistant to ABX. Secondary outcomes included medication-related adverse events, serious adverse events, unanticipated AOM-related office and emergency department visits and telephone calls, the child's absence from day care or school resulting from AOM, the parent's absence from school or work because of their child's AOM, and costs of treatment. Subjects were defined as failing (days 0-12) or recurring (days 13-30) if they experienced a higher AOM-severity score on reexamination. RESULTS: A total of 223 subjects were recruited: 73% were nonwhite, 57% were<2 years old, 47% attended day care, 82% had experienced prior AOM, and 83% had not been fully immunized with heptavalent pneumococcal vaccine. One hundred twelve were randomized to ABX, and 111 were randomized to WW. Ninety-four percent of the subjects were followed to the 30-day end point. Parent satisfaction with AOM care was not different between the 2 treatment groups at either day 12 or 30. Compared with WW, symptom scores on days 1 to 10 resolved faster in subjects treated with immediate ABX. At day 12, among the immediate-ABX group, 69% of tympanic membranes and 25% of tympanograms were normal, compared with 51% of normal tympanic membranes and 10% of normal tympanograms in the WW group. Parents of children in the ABX group gave their children fewer doses of pain medication than did parents of children in the WW group. Subjects in the ABX group experienced 16% fewer failures than subjects in the WW group. Of the children in the WW group, 66% completed the study without needing ABX. Immediate ABX resulted in eradication of S pneumoniae carriage in the majority of children, but S pneumoniae strains cultured from children in the ABX group at day 12 were more likely to be multidrug-resistant than strains from children in the WW group. More ABX-related adverse events were noted in the ABX group, compared with the WW group. No serious AOM-related adverse events were observed in either group. Office and emergency department visits, phone calls, and days of work/school missed were not different between groups. Prescriptions for ABX were reduced by 73% in the WW group compared with the ABX group. Costs of ABX averaged $47.41 per subject in the ABX group and $11.43 in the WW group. CONCLUSIONS: Sixty-six percent of subjects in the WW group completed the study without ABX. Parent satisfaction was the same between groups regardless of treatment. Compared with WW, immediate ABX treatment was associated with decreased numbers of treatment failures and improved symptom control but increased ABX-related adverse events and a higher percent carriage of multidrug-resistant S pneumoniae strains in the nasopharynx at the day-12 visit. Key factors in implementing a WW strategy were (a) a method to classify AOM severity; (b) parent education; (c) management of AOM symptoms; (d) access to follow-up care; and (e) use of an effective ABX regimen, when needed. When these caveats are observed, WW may be an acceptable alternative to immediate ABX for some children with nonsevere AOM. Article Published Date : Jun 01, 2005
Therapeutic Actions Watchful Waiting

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Older Age Predicts Biopsy and Radical Prostatectomy Grade Reclassification to Aggressive Prostate Cancer in Men on Active Surveillance.

Related Articles Older Age Predicts Biopsy and Radical Prostatectomy Grade Reclassification to Aggressive Prostate Cancer in Men on Active Surveillance. J Urol. 2018 Aug 13;: Authors: Druskin SC, Mamawala M, Tosoian JJ, Epstein JI, Pavlovich CP, Carter HB, Trock BJ Abstract PURPOSE: Age at prostate cancer (PCa) diagnosis has been positively associated with PCa-specific mortality, and for men on active surveillance (AS), a higher risk of biopsy grade reclassification (BGR) to Gleason score ≥3+4 (grade group [GG]≥2); however, the association between age and BGR to an aggressive phenotype (Gleason score ≥4+3 [GG≥3]) has not been explored. MATERIALS & METHODS: From 1995-2016, 1625 men aged 41-81y with NCCN very-low (68%) or low (32%) risk PCa were followed on AS. We determined rates of BGR to GG≥3. Competing risk analysis was used to evaluate the association between age at enrollment and risk of BGR. Additionally, in men who underwent radical prostatectomy (RP) after BGR, we assessed rates of RP grade reclassification (RPGR; i.e. RP GG>biopsy GG). RESULTS: The 5-year incidence of BGR to GG≥3 was 4%, 7% and 14% in men <60y, 60-69y and ≥70y, respectively (p<0.001). In univariate analysis, older age was associated with BGR to GG≥3 (HR=2.43 per 10-year increase, p<0.001). In multivariable analysis adjusting for year of diagnosis, race, PSA density and cancer volume at diagnosis, older age remained associated with BGR to GG≥3 (HR=2.19 per 10-year increase; p<0.001). In men who underwent RP after BGR, older men had higher rates of RPGR (p<0.05). CONCLUSIONS: For men on AS, older age at time of diagnosis was positively associated with BGR to GG≥3, and RPGR. These observations imply that for many older men, AS (as opposed to watchful waiting) remains a more appropriate management strategy. PMID: 30114397 [PubMed - as supplied by publisher]

Labor Induction versus Expectant Management in Low-Risk Nulliparous Women.

Related Articles Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 08 09;379(6):513-523 Authors: Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA, Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network Abstract BACKGROUND: The perinatal and maternal consequences of induction of labor at 39 weeks among low-risk nulliparous women are uncertain. METHODS: In this multicenter trial, we randomly assigned low-risk nulliparous women who were at 38 weeks 0 days to 38 weeks 6 days of gestation to labor induction at 39 weeks 0 days to 39 weeks 4 days or to expectant management. The primary outcome was a composite of perinatal death or severe neonatal complications; the principal secondary outcome was cesarean delivery. RESULTS: A total of 3062 women were assigned to labor induction, and 3044 were assigned to expectant management. The primary outcome occurred in 4.3% of neonates in the induction group and in 5.4% in the expectant-management group (relative risk, 0.80; 95% confidence interval [CI], 0.64 to 1.00). The frequency of cesarean delivery was significantly lower in the induction group than in the expectant-management group (18.6% vs. 22.2%; relative risk, 0.84; 95% CI, 0.76 to 0.93). CONCLUSIONS: Induction of labor at 39 weeks in low-risk nulliparous women did not result in a significantly lower frequency of a composite adverse perinatal outcome, but it did result in a significantly lower frequency of cesarean delivery. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ARRIVE ClinicalTrials.gov number, NCT01990612 .). PMID: 30089070 [PubMed - indexed for MEDLINE]

Prostate cancer: Basics on clinical appearance, diagnostics and treatment.

Related Articles Prostate cancer: Basics on clinical appearance, diagnostics and treatment. Med Monatsschr Pharm. 2017 May;40(5):192-201 Authors: Groeben C, Wirth MP Abstract With an incidence of approximately 60,000 per year prostate cancer is the most common malignant neoplasm in men with a relatively low mortality rate and a high mean age of primary diagnosis of about 70 years. The disease remains usually clinically occult over a long period of time and generally manifests primarily in a locally advanced or metastasized stage. Due to screening using the PSA level (prostate specific antigen) in blood serum, diagnosis and therapy nowadays are oftentimes possible at an early stage. The prostate carcinoma is classified using risk groups based on the level of PSA, the local tumor spread and the histological degree of differentiation (Gleason score). If no metastases are detected during staging a local curative therapy is indicated, provided that the patient is eligible for this due to age, comorbidity and life expectancy. Depending on the risk group of the patient, radical prostatectomy, percutaneous radiotherapy, brachytherapy or active surveillance are available as curative therapy concepts. Focal therapies such as HIFU, electrovaporization or cryotherapy are currently considered to be experimental. If metastases are already present at primary diagnosis, palliative, systemic therapy can be performed with an androgen deprivation therapy and chemotherapy. At an advanced and hormone refractory stage, treatment with an osteotropic radiotracer or palliative radiotherapy can reduce bone metastases and alleviate respective symptoms. PMID: 29950285 [PubMed - indexed for MEDLINE]

Spontaneous Pneumothorax in Children: National Management Strategies and Outcomes.

Related Articles Spontaneous Pneumothorax in Children: National Management Strategies and Outcomes. J Laparoendosc Adv Surg Tech A. 2018 Feb;28(2):218-222 Authors: Williams K, Oyetunji TA, Hsuing G, Hendrickson RJ, Lautz TB Abstract INTRODUCTION: The timing of surgical intervention in the management of spontaneous pneumothorax remains controversial. The aim of this multicenter review was to compare management strategies and outcomes in children with spontaneous pneumothorax. METHODS: We retrospectively reviewed patients 10-19 years old in the Pediatric Health Information System admitted for spontaneous pneumothorax from 2010 to 2014. Three treatment groups were identified based on initial hospital management-no intervention, initial chest tube placement, and operation; and outcomes were compared. RESULTS: A total of 1040 patients were included. The majority were male (82.1%) and White (71.1%). The mean age at first encounter was 15.7 ± 1.7 years. Initial treatment included no intervention in 336 (32.3%), chest tube in 497 (47.8%), and video-assisted thoracoscopic surgery (VATS) in 207 (19.9%). Ultimately, 417 (40.1%) patients underwent VATS during the initial admission and 559 (53.8%) during the initial admission or a subsequent encounter. Aggregate length of stay (LOS) was highest for those treated initially with chest tube alone (P < .001). For patients managed initially with chest tube, the probability of requiring surgery increased with each day of hospitalization. Initial operation was associated with a decreased risk of readmission (OR 0.67, 95% CI 0.50-0.90). Estimated adjusted hospital costs, aggregated across all encounters, were highest for chest tube alone (P < .001). CONCLUSION: Early VATS is associated with decreased hospital LOS, charges, and readmissions. For those managed initially with chest tube alone, the likelihood of requiring operation increases with each day hospitalized, and early conversion to operative management should be considered in patients with persistent pneumothorax or air leak. PMID: 29237135 [PubMed - indexed for MEDLINE]

Rectal sparing approach after preoperative radio- and/or chemotherapy (RESARCH) in patients with rectal cancer: a multicentre observational study.

Related Articles Rectal sparing approach after preoperative radio- and/or chemotherapy (RESARCH) in patients with rectal cancer: a multicentre observational study. Tech Coloproctol. 2017 Aug;21(8):633-640 Authors: Barina A, De Paoli A, Delrio P, Guerrieri M, Muratore A, Bianco F, Vespa D, Asteria C, Morpurgo E, Restivo A, Coco C, Pace U, Belluco C, Aschele C, Lonardi S, Valentini V, Mantello G, Maretto I, Del Bianco P, Perin A, Pucciarelli S Abstract BACKGROUND: Rectum-sparing approaches appear to be appropriate in rectal cancer patients with a major (mCR) or complete clinical response (cCR) after neoadjuvant therapy. The aim of the present study is to evaluate the effectiveness of rectum-sparing approaches at 2 years after the completion of neoadjuvant treatment. STUDY DESIGN: Patients with rectal adenocarcinoma eligible to receive neoadjuvant therapy will be prospectively enrolled. Patients will be restaged 7-8 weeks after the completion of neoadjuvant therapy and those with mCR (defined as absence of mass, small mucosal irregularity no more than 2 cm in diameter at endoscopy and no metastatic nodes at MRI) or cCR will be enrolled in the trial. Patients with mCR will undergo local excision, while patients with cCR will either undergo local excision or watch and wait policy. The main end point of the study is to determine the percentage of rectum preservation at 2 years in the enrolled patients. CONCLUSION: This protocol is the first prospective trial that investigates the role of both local excision and watch and wait approaches in patients treated with neoadjuvant therapy for rectal cancer. The trial is registered at clinicaltrials.gov (NCT02710812). PMID: 28755256 [PubMed - indexed for MEDLINE]

Caesarean section rates and adverse neonatal outcomes after induction of labour versus expectant management in women with an unripe cervix: a secondary analysis of the HYPITAT and DIGITAT trials.

Related Articles Caesarean section rates and adverse neonatal outcomes after induction of labour versus expectant management in women with an unripe cervix: a secondary analysis of the HYPITAT and DIGITAT trials. BJOG. 2016 Aug;123(9):1501-8 Authors: Bernardes TP, Broekhuijsen K, Koopmans CM, Boers KE, van Wyk L, Tajik P, van Pampus MG, Scherjon SA, Mol BW, Franssen MT, van den Berg PP, Groen H Abstract OBJECTIVE: To evaluate caesarean section and adverse neonatal outcome rates after induction of labour or expectant management in women with an unripe cervix at or near term. DESIGN: Secondary analysis of data from two randomised clinical trials. SETTING: Data were collected in two nationwide Dutch trials. POPULATION: Women with hypertensive disease (HYPITAT trial) or suspected fetal growth restriction (DIGITAT trial) and a Bishop score ≤6. METHODS: Comparison of outcomes after induction of labour and expectant management. MAIN OUTCOME MEASURES: Rates of caesarean section and adverse neonatal outcome, defined as 5-minute Apgar score ≤6 and/or arterial umbilical cord pH <7.05 and/or neonatal intensive care unit admission and/or seizures and/or perinatal death. RESULTS: Of 1172 included women with an unripe cervix, 572 had induction of labour and 600 had expectant management. We found no significant difference in the overall caesarean rate (difference -1.1%, 95% CI -5.4 to 3.2). Induction of labour did not increase caesarean rates in women with Bishop scores from 3 to 6 (difference -2.7%, 95% CI -7.6 to 2.2) or adverse neonatal outcome rates (difference -1.5%, 95% CI -4.3 to 1.3). However, there was a significant difference in the rates of arterial umbilical cord pH <7.05 favouring induction (difference -3.2%, 95% CI -5.6 to -0.9). The number needed to treat to prevent one case of umbilical arterial pH <7.05 was 32. CONCLUSIONS: We found no evidence that induction of labour increases the caesarean rate or compromises neonatal outcome as compared with expectant management. Concerns over increased risk of failed induction in women with a Bishop score from 3 to 6 seem unwarranted. TWEETABLE ABSTRACT: Induction of labour at low Bishop scores does not increase caesarean section rate or poor neonatal outcome. PMID: 27173131 [PubMed - indexed for MEDLINE]