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1.
Neurourol Urodyn ; 43(5): 1171-1178, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38511609

RESUMEN

AIMS: Women of advanced age may choose between restorative or obliterative surgery for surgical management of pelvic organ prolapse. Obliterative surgery is traditionally reserved for a subset of older women with more severe medical comorbidities, since obliterative approaches are generally considered to be less morbid and older individuals have higher rates of perioperative complications than younger cohorts. This study compared perioperative complications amongst octogenarians undergoing obliterative versus reconstructive approaches. This data will help to inform perioperative counselling as previous studies have not been powered to evaluate complications in this population. METHODS: The National Surgical Quality Improvement Program database was used to identify patients that had Pelvic organ prolapse surgery between 2012 and 2021, aged 80 years or older. Single-compartment procedures, vaginal mesh procedures, and oncologic surgery were excluded. The primary outcome was any complication within the first 30 days excluding urinary tract infection (UTI). UTI, readmission, and severe complications were secondary outcomes. RESULTS: Of the 4149 patients identified, 2514 (60.6%) underwent reconstructive surgery and 1635 (39.4%) underwent obliterative surgery. Patients undergoing reconstructive surgery were more likely to have an American Society of Anesthesiologists (ASA) class of 1 or 2 (46.1% vs. 31.3%, p = 0.002) and were less likely to be on antihypertensive medication (72.0% vs. 75.8%, p = 0.006). Further, there was an increased length of stay (1.47 ± 1.84 vs. 1.03 ± 1.31 days, p < 0.001) in hospital for reconstructive surgery which was more often performed as an inpatient (45.7% vs. 37.9%, p < 0.001). There was no difference in the primary outcome: any complication excluding UTIs. However, UTI was more common in the reconstructive group (aOR 0.48; 95% confidence interval 0.34-0.0). The rate of serious complications (Clavien-Dindo Class IV) was low overall and not different between reconstructive and obliterative approaches (1.3% vs. 1.0%, respectively). CONCLUSIONS: Both vaginal reconstructive and obliterative approaches have low complication rates in octogenarians, with only UTI rate being different between cohorts. When choosing surgical approach, we suggest a case-based, patient center discussion on the anatomic outcomes, durability and patient satisfaction.


Asunto(s)
Prolapso de Órgano Pélvico , Procedimientos de Cirugía Plástica , Complicaciones Posoperatorias , Vagina , Humanos , Prolapso de Órgano Pélvico/cirugía , Femenino , Estudios Retrospectivos , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/epidemiología , Anciano de 80 o más Años , Procedimientos de Cirugía Plástica/efectos adversos , Vagina/cirugía , Resultado del Tratamiento , Procedimientos Quirúrgicos Ginecológicos/efectos adversos , Factores de Edad , Infecciones Urinarias/etiología , Infecciones Urinarias/epidemiología
2.
Int Urogynecol J ; 34(10): 2467-2472, 2023 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-37199742

RESUMEN

INTRODUCTION AND HYPOTHESIS: Urinary incontinence (UI) is common in the postpartum period; however, most studies focus on the early postpartum period and assess prevalence at only one or two time points. We hypothesized that UI would be prevalent across the first 2 years postpartum. Our secondary objective was to evaluate risk factors for postpartum UI among a nationally representative, contemporary sample. METHODS: This cross-sectional, population-based study used National Health and Nutrition Examination Survey (2011-2018) data for parous women within 24 months following delivery. Prevalence of UI, UI subtypes, and severity were estimated. Multivariate logistic regression was used to estimate adjusted odds (aOR) of UI for exposures of interest. RESULTS: Among 560 postpartum women, prevalence of any UI was 43.5%. Stress UI was most common (28.7%), and most women (82.8%) experienced mild symptoms. There was no significant change in prevalence of UI across the 24 months following delivery (R2 = 0.004). Individuals with postpartum UI tended to be older (30.3 ± 0.5 versus 28.8 ± 0.5 years) and had higher BMI (31.1 ± 0.6 versus 28.9 ± 0.6). In multivariate analysis, odds of postpartum UI were higher for women who had had a prior vaginal delivery (aOR 2.0, 95% CI: 1.3-3.3), prior delivery of a baby weighing 9 lb (4 kg) or more (aOR 2.5, 95% CI: 1.3-4.8), or who reported current smoking (aOR 1.5, 95% CI: 1.0-2.3). CONCLUSIONS: During the first 2 years postpartum 43.5% of women report UI, with relatively stable prevalence over this period. This high prevalence supports screening for UI after delivery regardless of risk factors.

3.
Int Urogynecol J ; 34(12): 2945-2957, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37584705

RESUMEN

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the effectiveness of pharmacological hemostatic agents in the reduction of blood loss at vaginal surgery. METHODS: A systematic review of randomized control trials (RCTs) was completed. We searched PubMed (1946-2022), Embase, and CINAHL, using search terms related to vaginal hysterectomies and reconstructive surgeries combined with peri-operative use of hemostatic agents. RCTs comparing hemostatic interventions with placebo or with standard care were analyzed with the primary outcome of estimated blood loss. Secondary outcomes included peri-operative complications, length of stay, blood transfusion, and readmission. Risk of bias was assessed using the Risk of Bias 2 tool. RESULTS: Nine RCTs were included with a total of 903 participants. All trials were considered to have an overall low risk of bias. Meta-analysis of six RCTs (491 participants) favored the use of vasoconstrictive agent (vasopressin/ornipressin) at the surgical site for an overall effect estimate of decreased blood loss by 70 ml (95% CI -125, -14 ml). There was significant heterogeneity of studies with both dose and technique of vasoconstrictive agents used. Only one RCT evaluated tranexamic acid and found a benefit in the prophylactic use of intravenous tranexamic acid. CONCLUSIONS: Peri-operative use of vasoconstrictive agents slightly reduces bleeding in women undergoing elective vaginal surgery. Additional studies evaluating alternative pharmacological agents such as tranexamic acid may be of benefit.


Asunto(s)
Hemostáticos , Ácido Tranexámico , Femenino , Humanos , Ácido Tranexámico/uso terapéutico , Hemostáticos/uso terapéutico , Hemorragia , Transfusión Sanguínea , Pérdida de Sangre Quirúrgica/prevención & control
4.
Int Urogynecol J ; 34(8): 1899-1906, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-36795110

RESUMEN

INTRODUCTION AND HYPOTHESIS: Patients with vaginal pessaries can learn to care for their pessary by themselves or they can have provider-led care, which requires more frequent follow-up visits. We aimed to understand motivations for and barriers to learning self-care of a pessary to inform strategies to promote pessary self-care. METHODS: In this qualitative study, we recruited patients recently fitted with a pessary for stress incontinence or pelvic organ prolapse, and providers who perform pessary fittings. Semi-structured, one-on-one interviews were completed to data saturation. A constructivist approach to thematic analysis using the constant comparison method was used to analyze interviews. A coding frame was created following independent review of a subset of interviews by three members of the research team and this frame was used to code interviews and develop themes through interpretive engagement with the data. RESULTS: Ten pessary users and four health care providers (physicians and nurses) participated. Three major themes were identified: motivators, benefits, and barriers. There were several motivators for learning self-care, including care provider advice, personal hygiene, and ease of care. Benefits of learning self-care included autonomy, convenience, facilitation of sexual relations, avoidance of complications, and decreased burden on the health care system. Barriers to self-care included physical, structural, mental, and emotional barriers; lack of knowledge; lack of time; and social taboo. CONCLUSIONS: Promotion of pessary self-care should focus on patient education about benefits and ways of mitigating common barriers while focusing on normalizing patient engagement in pessary self-care.


Asunto(s)
Prolapso de Órgano Pélvico , Incontinencia Urinaria de Esfuerzo , Humanos , Femenino , Pesarios , Autocuidado , Prolapso de Órgano Pélvico/terapia , Prolapso de Órgano Pélvico/psicología , Actitud
5.
Int Urogynecol J ; 34(2): 445-451, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-35947188

RESUMEN

INTRODUCTION AND HYPOTHESIS: Articles are getting published on the use of tissue adhesive for vesicovaginal fistula. The objective is to carry out a systematic review on their effectiveness and complications. METHODS: A systematic review of the literature was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Two reviewers screened abstracts and full-text and extracted data independently. A narrative synthesis was conducted given the heterogeneity of studies. RESULTS: A total of 1032 studies were identified after searching the database, and 14 articles were included in this systematic review. Of the 84 women included, 12 (14.3%) presented failure or recurrence of their fistula tract. The mean time of follow-up was 11.46 months. The average size of the fistula was 1.05 (range 0.1 to 3.9) cm. Most fistulas (81) included were vesicovaginal fistulas. Nine papers reported the usage of fibrin glue in which only three (6.5%) women reported recurrence of the fistula in a delay of 2 weeks to 26 months. The other studies used cyanoacrylate (14 women) and autologous fibrin injection from the patients' blood (31 women). No significant complications were reported. Complications reported were urinary tract infections in 3 women (3.6%), hematuria in 2 women (2.4%), overactive bladder symptoms in 6 women (7.2%) and septic pelvic thrombosis in one woman (1.2%). CONCLUSIONS: Tissue adhesive appears to be a promising alternative for management of urogenital fistulas without reported important complications.


Asunto(s)
Adhesivos Tisulares , Fístula Vesicovaginal , Humanos , Femenino , Masculino , Resultado del Tratamiento , Adhesivo de Tejido de Fibrina , Fístula Vesicovaginal/etiología , Cianoacrilatos
6.
J Obstet Gynaecol Can ; 45(2): 150-159.e1, 2023 02.
Artículo en Inglés | MEDLINE | ID: mdl-36273716

RESUMEN

OBJECTIVE: The purpose of this technical update is to establish the state of the science regarding emerging and novel electronic health (eHealth) and mobile health (mHealth) solutions for urinary incontinence among women. TARGET POPULATION: Women over 18 years with urinary incontinence. OPTIONS: Websites and mobile health applications are useful in the conservative care of urinary incontinence. Relevant care providers should be familiar with such tools, particularly those that use motivational principles for behaviour change, which can be used as adjunct tools for urinary incontinence care. Telemedicine is an effect mode to provide services for the conservative care of urinary incontinence. OUTCOMES: Use of eHealth and mHealth solutions has potentially significant health outcomes for patients, providers, and global health systems. Broader use of telemedicine, in and of itself, could improve care access and reduce costs incurred by patients and the health care system. BENEFITS, HARMS, AND COSTS: Evidence for the efficacy of eHealth and mHealth technologies and applications for urinary incontinence ranges from weak to strong. However, the research landscape for many of these novel solutions is developing rapidly. Furthermore, these options have minimal or no harm and confer an established cost benefit and care access benefit. EVIDENCE: The Cochrane Library, Medline, EMBASE, CENTRAL databases (from January 2014 to April 2019) were searched to find articles related to conservative care of urinary incontinence in women (over 18 years) and studies on eHealth and mHealth interventions for urinary incontinence. Articles were appraised, and the collective evidence was graded. VALIDATION METHODS: The authors rated the quality of evidence and strength of recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. See online Appendix A (Tables A1 for definitions and A2 for interpretations of strong and conditional [weak] recommendations). INTENDED AUDIENCE: Relevant primary care providers and medical specialists, including physicians, nurses, midwives, and pelvic health physiotherapists. SUMMARY STATEMENTS: RECOMMENDATIONS.


Asunto(s)
Telemedicina , Incontinencia Urinaria , Humanos , Femenino , Terapia por Ejercicio , Incontinencia Urinaria/terapia , Diafragma Pélvico
7.
Int Urogynecol J ; 33(7): 1941-1947, 2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-34331076

RESUMEN

INTRODUCTION AND HYPOTHESIS: Accumulating evidence regarding the negative long-term consequences of transvaginal mesh-based procedures for pelvic organ prolapse has led to a sharp decline in mesh-based procedures. We aimed to evaluate the short-term complications of mesh-based procedures for carefully selected patients with pelvic organ prolapse after Food and Drug Administration warnings. METHODS: A retrospective database review of the ACS NSQIP database was completed to examine 30-day complications including re-operation, prolonged length of stay, blood transfusion, surgical site infection, urinary tract infection, readmission and wound dehiscence in mesh-augmented and native tissue-based transvaginal procedures for pelvic organ prolapse. RESULTS: A total of 36,234 patients were included in the analysis, with only 7.1% (2574 women) having mesh-augmented repair. Using a multivariable logistical regression analysis adjusting for confounders, we found that the primary composite outcome (re-operation, hospital stay, blood transfusion and surgical site infection) was less common in the mesh group compared with the native tissue repair group (adjusted OR 0.80, CI 0.67-0.95, p = 0.009). The secondary outcomes (urinary tract infection, re-admission and wound dehiscence) were not different between the group. CONCLUSION: These results suggest that in well-chosen patients, short-term complications are not increased when using transvaginal mesh for pelvic organ prolapse repair.


Asunto(s)
Prolapso de Órgano Pélvico , Mallas Quirúrgicas , Femenino , Procedimientos Quirúrgicos Ginecológicos/efectos adversos , Procedimientos Quirúrgicos Ginecológicos/métodos , Humanos , Prolapso de Órgano Pélvico/complicaciones , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugía , Reoperación , Estudios Retrospectivos , Mallas Quirúrgicas/efectos adversos , Infección de la Herida Quirúrgica/epidemiología , Infección de la Herida Quirúrgica/etiología
8.
Int Urogynecol J ; 33(12): 3473-3479, 2022 12.
Artículo en Inglés | MEDLINE | ID: mdl-36098789

RESUMEN

INTRODUCTION AND HYPOTHESIS: Identification and prompt management of postpartum urinary retention after vaginal birth is essential to minimize long-term morbidity. Obstetrical anal sphincter injuries (OASIS) have been identified as a possible risk factor for urinary retention. The objective of this study was to estimate the association between OASIS and postpartum urinary retention and compare the length of hospital stay and cost of admission between postpartum patients who experienced urinary retention and those who did not. METHODS: We conducted a population-based, retrospective cohort study of pregnant individuals delivering singleton fetuses via vaginal birth in the United States using the National Inpatient Sample (NIS) database. Multivariate logistic regression models were used to estimate the odds ratio (OR) for the association between OASIS and postpartum urinary retention. Simple linear regression was used to compare means. RESULTS: A total of 2,013,052 delivery admissions were included, which was representative of a population size of 10,065,253 utilizing the complex sampling design of the NIS database. 47,192 (2.34%) admissions sustained OASIS and 5,339 (0.27%) admissions experienced overt urinary retention. After adjusting for potential confounders, vaginal deliveries where OASIS occurred had 3.60 times the odds of postpartum urinary retention compared with vaginal deliveries where OASIS was not sustained (95% CI 3.26-3.97). Postpartum urinary retention was associated with an increased mean length of stay (2.94 vs 2.28 days, p<0.001) and 1.37 times the mean total cost of admission (US$22,946.38 vs US$16,758.85, p<0.001). CONCLUSIONS: Obstetrical anal sphincter injuries are associated with increased odds of postpartum urinary retention compared with vaginal deliveries where OASIS did not occur.


Asunto(s)
Complicaciones del Trabajo de Parto , Retención Urinaria , Embarazo , Femenino , Humanos , Canal Anal/lesiones , Estudios Retrospectivos , Estudios de Cohortes , Retención Urinaria/etiología , Retención Urinaria/complicaciones , Parto Obstétrico/efectos adversos , Periodo Posparto , Factores de Riesgo , Complicaciones del Trabajo de Parto/epidemiología , Complicaciones del Trabajo de Parto/etiología
9.
Int Urogynecol J ; 33(7): 1827-1831, 2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-33893824

RESUMEN

INTRODUCTION AND HYPOTHESIS: Preoperative anemia is a well-established risk factor for adverse perioperative outcomes in major surgery, but studies exploring complications after pelvic reconstructive surgery are limited. The objective of this study is to examine the impact of preoperative anemia on 30-day adverse outcomes in patients undergoing pelvic organ prolapse surgery. METHODS: A retrospective cohort of women undergoing pelvic organ prolapse surgery was captured from the National Surgery Quality Improvement Program database (2014-2019). The primary outcome was a composite of postoperative medical complications such as pulmonary embolism, acute renal failure, stroke, myocardial infarction, cardiac arrest, deep vein thrombosis, and sepsis. Secondary outcomes included surgical site infection, bleeding requiring blood transfusion, readmission within 7 days of surgery, and return to the operating room within 30 days. Multivariate logistic regression was used to adjust for important pre-specified potential confounders. RESULTS: A total of 50,848 women were included in the analysis and 9.9% (4,579) met the criteria for anemia (hematocrit <36%). Potentially serious medical complications were rare, occurring in only 348 women (0.7%), and were more common among anemic patients (1.1% vs 0.6%, p < 0.001). On multivariate analysis, preoperative anemia was associated with higher odds of both potentially serious medical complications (OR 1.38, 95% CI 1.01-1.88) and returning to the operating room (OR 1.55, 95% CI 1.23-1.94). Anemic patients had a four-fold increase in the odds of requiring a blood transfusion (OR 4.47, 95% CI 3.60-5.56). CONCLUSIONS: Preoperative anemia is associated with an increased risk of adverse postoperative outcomes in women having surgery for pelvic organ prolapse.


Asunto(s)
Anemia , Prolapso de Órgano Pélvico , Procedimientos de Cirugía Plástica , Anemia/complicaciones , Anemia/epidemiología , Femenino , Humanos , Prolapso de Órgano Pélvico/complicaciones , Prolapso de Órgano Pélvico/cirugía , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugía , Mejoramiento de la Calidad , Estudios Retrospectivos , Factores de Riesgo
10.
J Obstet Gynaecol Can ; 44(12): 1257-1261, 2022 12.
Artículo en Inglés | MEDLINE | ID: mdl-36368595

RESUMEN

OBJECTIVE: We aimed to compare postoperative complications for patients undergoing posterior colporrhaphy with or without sphincteroplasty. METHODS: A retrospective cohort of women undergoing posterior colporrhaphy with or without anal sphincteroplasty was completed using the National Surgery Quality Improvement Program (NSQIP) database (2012-2019). The primary outcome was a composite of important surgical complications, including wound complications, blood transfusion, hospital stay >48 hours, reoperation, readmission, and urinary tract infection. Multivariable logistic regression was used to adjust for important potential confounders, including age, BMI, diabetes, and anterior prolapse surgery. RESULTS: A total of 5079 patients were included. Of these, 82 patients underwent a concurrent sphincteroplasty. The primary composite outcome occurred in 10.4% of patients having posterior colporrhaphy versus 19.5% having posterior colporrhaphy with sphincteroplasty. On multivariable analysis there was no increased odds of complication associated with concomitant anal sphincteroplasty (1.58, 95% CI 0.89-2.90, P = 0.12). CONCLUSION: Nearly one in five women who have posterior colporrhaphy with anal sphincteroplasty had an important surgical complication. Higher complication rates may be related to patient factors, as this was not observed after adjustment for patient factors and additional surgical procedures. Sphincteroplasty may be considered with posterior colporrhaphy in select women.


Asunto(s)
Prolapso de Órgano Pélvico , Mejoramiento de la Calidad , Humanos , Femenino , Estudios Retrospectivos , Complicaciones Posoperatorias/epidemiología , Prolapso de Órgano Pélvico/cirugía
11.
J Obstet Gynaecol Can ; 44(3): 247-254, 2022 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-34648958

RESUMEN

OBJECTIVE: To investigate risk factors associated with urologic injury in women undergoing hysterectomy for benign indication. METHODS: A retrospective cohort study for the period of 2011-2018 was conducted using the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database. Women without urologic injury were compared with women with injury. A pre-specified multivariable logistic regression model, controlling for key patient demographic factors and intraoperative variables, was used to assess for surgical factors associated with urologic injury. RESULTS: Among 262 117 women who underwent hysterectomy for benign indication, 1539 (0.6%) sustained urologic injury. On average, patients with urologic injury were younger, had lower body mass index (BMI), and more frequently underwent a transabdominal surgical approach. Patients who underwent total hysterectomy had increased odds of urologic injury than those who underwent subtotal hysterectomy (adjusted OR [aOR] 1.49; 95% confidence interval [CI] 1.21-1.84). Patients with class III obesity had lower odds of injury than patients with normal BMI (aOR 0.64; 95% CI 0.51-0.80). For risk of urologic injury, an interaction was observed between surgical approach and surgical indication. Abdominal compared with laparoscopic approach was associated with urologic injury for women with endometriosis (aOR 2.98; 95% CI 1.99-4.47), pelvic pain (aOR 3.51; 95% CI 1.74-7.08), menstrual disorders (aOR 4.33; 95% CI 1.68-11.1), and fibroids (aOR 2.28; 95% CI 1.72-3.03). Vaginal compared with laparoscopic approach was associated with increased odds of injury for women with menstrual disorders (aOR 7.62; 95% CI 1.37-42.5). CONCLUSION: While the risk of urologic injury during hysterectomy for benign indication is low, the risk is dependent on patient disease factors and surgical approach.


Asunto(s)
Endometriosis , Laparoscopía , Índice de Masa Corporal , Endometriosis/cirugía , Femenino , Humanos , Histerectomía/efectos adversos , Laparoscopía/efectos adversos , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Factores de Riesgo
12.
Int Urogynecol J ; 32(4): 945-953, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32840658

RESUMEN

INTRODUCTION AND HYPOTHESIS: To define the reasons for hospital readmissions following surgery for pelvic organ prolapse by surgical approach. METHODS: Patients undergoing surgery for pelvic organ prolapse from 2012 to 2018 were identified in the American College of Surgeons National Surgical Quality Improvement Program database using Current Procedural Terminology and International Classification of Diseases codes. Hazard risks of readmission by surgical approach (vaginal, laparoscopic, abdominal, or combined) were determined by multivariable cox regression. Diagnoses and timing of readmission by surgical approach were examined. RESULTS: Of 57,233 women undergoing surgery for pelvic organ prolapse during the study period, 1073 (1.9%) were readmitted to the hospital within 30 days postoperatively. After adjusting for prespecified potential confounders, laparoscopic and abdominal surgical approaches were associated with higher risks of readmission relative to a vaginal approach (aHR 1.30, 95% CI 1.08-1.57, and 1.97, 95% CI 1.44-2.71, respectively). The most common reason for readmission was a gastrointestinal issue among those undergoing both laparoscopic (28.0%) and abdominal surgery (30.2%). Surgical site infection was the most common readmission diagnosis among women undergoing vaginal surgery (16.2%). Of the 418 women readmitted within 7 days of surgery, the most common diagnoses were gastrointestinal issues (26.6%), medical disorders (12.0%), or surgical complications (e.g., bleeding) (11.0%). CONCLUSIONS: Women undergoing laparoscopic or abdominal surgery for pelvic organ prolapse were at higher risk of readmission relative to those undergoing surgery via a vaginal approach. The reasons and timing of readmission differed based on surgical approach.


Asunto(s)
Readmisión del Paciente , Prolapso de Órgano Pélvico , Femenino , Humanos , Prolapso de Órgano Pélvico/cirugía , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Mejoramiento de la Calidad , Estudios Retrospectivos , Infección de la Herida Quirúrgica
13.
Stroke ; 51(1): 291-299, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31718504

RESUMEN

Background and Purpose- Preclinical research using animals often informs clinical trials. However, its value is dependent on its scientific validity and reproducibility, which are, in turn, dependent on rigorous study design and reporting. In 2011, Stroke introduced a Basic Science Checklist to enhance the reporting and methodology of its preclinical studies. Except for Nature and Science journals, few others have implemented similar initiatives. We sought to estimate the impact of these journal interventions on the quality of their published reports. Methods- All articles published in Stroke, Nature Medicine, and Science Translational Medicine over 9 to 18 years and in 2 control journals without analogous interventions over a corresponding 11.5 years were reviewed to identify reports of experiments in nonhuman mammals with proposed clinical relevance. The effect of journal interventions on the reporting and use of key study design elements was estimated via interrupted time-series analyses. Results- Of 33 009 articles screened, 4162 studies met inclusion criteria. In the 3.5 to 12 years preceding each journal's intervention, the proportions of studies reporting and using key study design elements were stable except for blinding in Stroke and randomization in Science Translational Medicine, which were both increasing. Post-intervention, abrupt and often marked increases were seen in the reporting of randomization status (level change: +17% to +44%, P≤0.005), blinding (level change: +20% to +40%, P≤0.008), and sample size estimation (level change: 0% to +40%, P≤0.002 in 2 journals). Significant but more modest improvements in the use of these study design elements were also observed. These improvements were not seen in control journals. Conclusions- Journal interventions such as Stroke's author submission checklist can meaningfully improve the quality of published preclinical research and should be considered to enhance study transparency and design. However, such interventions are alone insufficient to fully address widespread shortcomings in preclinical research practices.


Asunto(s)
Accidente Cerebrovascular , Investigación Biomédica Traslacional , Femenino , Humanos , Masculino , Reproducibilidad de los Resultados , Accidente Cerebrovascular/metabolismo , Accidente Cerebrovascular/patología , Accidente Cerebrovascular/fisiopatología , Accidente Cerebrovascular/terapia
14.
Int Urogynecol J ; 31(2): 319-320, 2020 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-31811358

RESUMEN

Table 3 in the originally published article contains layout error. Corrected Table 3 shown below.

15.
Int Urogynecol J ; 31(2): 311-317, 2020 02.
Artículo en Inglés | MEDLINE | ID: mdl-31346655

RESUMEN

INTRODUCTION AND HYPOTHESIS: Pooled surgical waitlists are used to maximize the use of surgical resources; however, patients' views of this strategy are poorly understood. We sought to evaluate patients' attitudes toward a pooled waitlist for urogynecology and pelvic reconstructive surgical procedures. METHODS: Patient and provider focus groups were used to inform the design of a survey that was distributed to patients at the time of consent for female pelvic reconstructive surgical procedures. All responses were collected anonymously. Patient attitudes toward surgical wait times and the potential for a pooled surgical waitlist were explored. Grouped responses by age, procedure type, and perceived disease severity were examined. RESULTS: One hundred seventy-six patients were surveyed. Thirty-four percent were amenable to the option of a pooled surgical waitlist; 86% agreed or strongly agreed that they preferred to have their surgery performed by their own care provider. Only 18% would agree to be on a pooled surgical waitlist if it shortened their wait time. Older women (≥ 65 years) were more likely to disagree or strongly disagree that they "would like the option of having surgery done by the next available skilled surgeon" (56.2% vs. 72.0%, p = 0.028). Self-perceived severe disease and mid-urethral sling surgery were not associated with a higher acceptance of pooled surgical waitlists. CONCLUSIONS: Acceptance of pooled surgical waitlists among urogynecology patients was overall low, irrespective of disease severity. Improving our understanding of urogynecology patients' concerns and potentially negative perceptions of surgical waitlists is needed to ensure patient comfort and satisfaction are not compromised if this strategy is adopted.


Asunto(s)
Procedimientos Quirúrgicos Ginecológicos/psicología , Aceptación de la Atención de Salud/psicología , Trastornos del Suelo Pélvico/psicología , Procedimientos de Cirugía Plástica/psicología , Listas de Espera , Adulto , Anciano , Actitud , Femenino , Grupos Focales , Humanos , Persona de Mediana Edad , Trastornos del Suelo Pélvico/cirugía , Encuestas y Cuestionarios
17.
Circ Res ; 120(12): 1916-1926, 2017 Jun 09.
Artículo en Inglés | MEDLINE | ID: mdl-28373349

RESUMEN

RATIONALE: Methodological sources of bias and suboptimal reporting contribute to irreproducibility in preclinical science and may negatively affect research translation. Randomization, blinding, sample size estimation, and considering sex as a biological variable are deemed crucial study design elements to maximize the quality and predictive value of preclinical experiments. OBJECTIVE: To examine the prevalence and temporal patterns of recommended study design element implementation in preclinical cardiovascular research. METHODS AND RESULTS: All articles published over a 10-year period in 5 leading cardiovascular journals were reviewed. Reports of in vivo experiments in nonhuman mammals describing pathophysiology, genetics, or therapeutic interventions relevant to specific cardiovascular disorders were identified. Data on study design and animal model use were collected. Citations at 60 months were additionally examined as a surrogate measure of research impact in a prespecified subset of studies, stratified by individual and cumulative study design elements. Of 28 636 articles screened, 3396 met inclusion criteria. Randomization was reported in 21.8%, blinding in 32.7%, and sample size estimation in 2.3%. Temporal and disease-specific analyses show that the implementation of these study design elements has overall not appreciably increased over the past decade, except in preclinical stroke research, which has uniquely demonstrated significant improvements in methodological rigor. In a subset of 1681 preclinical studies, randomization, blinding, sample size estimation, and inclusion of both sexes were not associated with increased citations at 60 months. CONCLUSIONS: Methodological shortcomings are prevalent in preclinical cardiovascular research, have not substantially improved over the past 10 years, and may be overlooked when basing subsequent studies. Resultant risks of bias and threats to study validity have the potential to hinder progress in cardiovascular medicine as preclinical research often precedes and informs clinical trials. Stroke research quality has uniquely improved in recent years, warranting a closer examination for interventions to model in other cardiovascular fields.


Asunto(s)
Enfermedades Cardiovasculares/patología , Modelos Animales de Enfermedad , Proyectos de Investigación/normas , Investigación Biomédica Traslacional/normas , Animales , Enfermedades Cardiovasculares/terapia , Evaluación Preclínica de Medicamentos/métodos , Evaluación Preclínica de Medicamentos/normas , Humanos , Reproducibilidad de los Resultados , Investigación Biomédica Traslacional/métodos
20.
Neurourol Urodyn ; 37(7): 2234-2241, 2018 09.
Artículo en Inglés | MEDLINE | ID: mdl-29635701

RESUMEN

AIMS: To compare surgical complications for patients having minimally invasive sacrocolpopexy (MISCP) with concomitant incontinence procedure, to those having MISCP alone. METHODS: Patients undergoing MISCP with and without a concomitant incontinence procedure between 2006 and 2015 were identified in the American College of Surgeons National Surgical Quality Improvement Program database using Current Procedural Terminology codes. The main outcome of interest was a composite of surgical site infection, bleeding requiring blood transfusion, return to the operating room within 30 days, and surgical stay >48 h. Log-binomial regression was used to identify independent risk factors for the outcome and to generate adjusted effect measures for variables of interest. RESULTS: Seven thousand ninety-seven women met the inclusion criteria, of which 2433 (34%) underwent a concomitant incontinence procedure. Patients having incontinence procedures were slightly older (59 ± 11 vs 58 ± 12, P < 0.0001) and had longer total operating time (225 IQR 170-267 vs 184 IQR 120-232 min, P < 0.0001). Pre-operative steroid use, wound class III/IV (vs I/II), and longer operative time were independent predictors of the composite outcome. After adjusting for baseline patient characteristics and co-morbidities, no association was observed between concomitant incontinence procedure and the composite outcome (adjusted RR 0.87, 95%CI 0.65-1.18) but there was an increased likelihood of urinary tract infection (adjusted RR 2.47 95%CI 1.89-3.27). CONCLUSIONS: Despite being associated with a longer operative time, performing an incontinence procedure at the time of MSCIP was not associated with an increased risk of clinically important surgical complications other than urinary tract infection.


Asunto(s)
Prolapso de Órgano Pélvico/cirugía , Complicaciones Posoperatorias/epidemiología , Mejoramiento de la Calidad , Infección de la Herida Quirúrgica/epidemiología , Incontinencia Urinaria/cirugía , Anciano , Transfusión Sanguínea , Bases de Datos Factuales , Femenino , Humanos , Incidencia , Persona de Mediana Edad , Tempo Operativo , Prolapso de Órgano Pélvico/complicaciones , Complicaciones Posoperatorias/etiología , Factores de Riesgo , Infección de la Herida Quirúrgica/etiología , Incontinencia Urinaria/complicaciones
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