Browsing by Author "Kattan, Michael W"

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Open Access
A model for predicting the risk of de novo stress urinary incontinence in women undergoing pelvic organ prolapse surgery.
(Obstetrics and gynecology, 2014-02) Jelovsek, J Eric; Chagin, Kevin; Brubaker, Linda; Rogers, Rebecca G; Richter, Holly E; Arya, Lily; Barber, Matthew D; Shepherd, Jonathan P; Nolen, Tracy L; Norton, Peggy; Sung, Vivian; Menefee, Shawn; Siddiqui, Nazema; Meikle, Susan F; Kattan, Michael W; Pelvic Floor Disorders Network
To construct and validate a prediction model for estimating the risk of de novo stress urinary incontinence (SUI) after vaginal pelvic organ prolapse (POP) surgery and compare it with predictions using preoperative urinary stress testing and expert surgeons' predictions.Using the data set (n=457) from the Outcomes Following Vaginal Prolapse Repair and Midurethral Sling trial, a model using 12 clinical preoperative predictors of de novo SUI was constructed. De novo SUI was determined by Pelvic Floor Distress Inventory responses through 12 months postoperatively. After fitting the multivariable logistic regression model using the best predictors, the model was internally validated with 1,000 bootstrap samples to obtain bias-corrected accuracy using a concordance index. The model's predictions were also externally validated by comparing findings against actual outcomes using Colpopexy and Urinary Reduction Efforts trial patients (n=316). The final model's performance was compared with experts using a test data set of 32 randomly chosen Outcomes Following Vaginal Prolapse Repair and Midurethral Sling trial patients through comparison of the model's area under the curve against: 1) 22 experts' predictions; and 2) preoperative prolapse reduction stress testing.A model containing seven predictors discriminated between de novo SUI status (concordance index 0.73, 95% confidence interval [CI] 0.65-0.80) in Outcomes Following Vaginal Prolapse Repair and Midurethral Sling participants and outperformed expert clinicians (area under the curve 0.72 compared with 0.62, P<.001) and preoperative urinary stress testing (area under the curve 0.72 compared with 0.54, P<.001). The concordance index for Colpopexy and Urinary Reduction Efforts trial participants was 0.62 (95% CI 0.56-0.69).This individualized prediction model for de novo SUI after vaginal POP surgery is valid and outperforms preoperative stress testing, prediction by experts, and preoperative reduction cough stress testing. An online calculator is provided for clinical use.III.
Open Access
Importance of prostate volume in the European Randomised Study of Screening for Prostate Cancer (ERSPC) risk calculators: results from the prostate biopsy collaborative group.
(World J Urol, 2012-04) Roobol, Monique J; Schröder, FH; Hugosson, Jonas; Jones, J Stephen; Kattan, Michael W; Klein, Eric A; Hamdy, Freddie; Neal, David; Donovan, Jenny; Parekh, Dipen J; Ankerst, Donna; Bartsch, George; Klocker, Helmut; Horninger, Wolfgang; Benchikh, Amine; Salama, Gilles; Villers, Arnauld; Freedland, Stephen J; Moreira, Daniel M; Vickers, Andrew J; Lilja, Hans; Steyerberg, Ewout W
OBJECTIVES: To compare the predictive performance and potential clinical usefulness of risk calculators of the European Randomized Study of Screening for Prostate Cancer (ERSPC RC) with and without information on prostate volume. METHODS: We studied 6 cohorts (5 European and 1 US) with a total of 15,300 men, all biopsied and with pre-biopsy TRUS measurements of prostate volume. Volume was categorized into 3 categories (25, 40, and 60 cc), to reflect use of digital rectal examination (DRE) for volume assessment. Risks of prostate cancer were calculated according to a ERSPC DRE-based RC (including PSA, DRE, prior biopsy, and prostate volume) and a PSA + DRE model (including PSA, DRE, and prior biopsy). Missing data on prostate volume were completed by single imputation. Risk predictions were evaluated with respect to calibration (graphically), discrimination (AUC curve), and clinical usefulness (net benefit, graphically assessed in decision curves). RESULTS: The AUCs of the ERSPC DRE-based RC ranged from 0.61 to 0.77 and were substantially larger than the AUCs of a model based on only PSA + DRE (ranging from 0.56 to 0.72) in each of the 6 cohorts. The ERSPC DRE-based RC provided net benefit over performing a prostate biopsy on the basis of PSA and DRE outcome in five of the six cohorts. CONCLUSIONS: Identifying men at increased risk for having a biopsy detectable prostate cancer should consider multiple factors, including an estimate of prostate volume.
Open Access
Management of prostate cancer in older men: recommendations of a working group of the International Society of Geriatric Oncology.
(BJU Int, 2010-08) Droz, Jean-Pierre; Balducci, Lodovico; Bolla, Michel; Emberton, Mark; Fitzpatrick, John M; Joniau, Steven; Kattan, Michael W; Monfardini, Silvio; Moul, Judd W; Naeim, Arash; van Poppel, Hendrik; Saad, Fred; Sternberg, Cora N
Prostate cancer is the most prevalent cancer in men and predominantly affects older men (aged >or=70 years). The median age at diagnosis is 68 years; overall, two-thirds of prostate cancer-related deaths occur in men aged >or=75 years. With the exponential ageing of the population and the increasing life-expectancy in developed countries, the burden of prostate cancer is expected to increase dramatically in the future. To date, no specific guidelines on the management of prostate cancer in older men have been published. The International Society of Geriatric Oncology (SIOG) conducted a systematic bibliographic search based on screening, diagnostic procedures and treatment options for localized and advanced prostate cancer, to develop a proposal for recommendations that should provide the highest standard of care for older men with prostate cancer. The consensus of the SIOG Prostate Cancer Task Force is that older men with prostate cancer should be managed according to their individual health status, which is mainly driven by the severity of associated comorbid conditions, and not according to chronological age. Existing international recommendations (European Association of Urology, National Comprehensive Cancer Network, and American Urological Association) are the backbone for localized and advanced prostate cancer treatment, but need to be adapted to patient health status. Based on a rapid and simple evaluation, patients can be classified into four different groups: 1, 'Healthy' patients (controlled comorbidity, fully independent in daily living activities, no malnutrition) should receive the same treatment as younger patients; 2, 'Vulnerable' patients (reversible impairment) should receive standard treatment after medical intervention; 3, 'Frail' patients (irreversible impairment) should receive adapted treatment; 4, Patients who are 'too sick' with 'terminal illness' should receive only symptomatic palliative treatment.
Open Access
Models for Predicting Recurrence, Complications, and Health Status in Women After Pelvic Organ Prolapse Surgery.
(Obstetrics and gynecology, 2018-08) Jelovsek, J Eric; Chagin, Kevin; Lukacz, Emily S; Nolen, Tracy L; Shepherd, Jonathan P; Barber, Matthew D; Sung, Vivian; Brubaker, Linda; Norton, Peggy A; Rahn, David D; Smith, Ariana L; Ballard, Alicia; Jeppson, Peter; Meikle, Susan F; Kattan, Michael W; NICHD Pelvic Floor Disorders Network
OBJECTIVE:To develop statistical models predicting recurrent pelvic organ prolapse, surgical complications, and change in health status 12 months after apical prolapse surgery. METHODS:Logistic regression models were developed using a combined cohort from three randomized trials and two prospective cohort studies from 1,301 participants enrolled in surgical studies conducted by the Pelvic Floor Disorders Network. Composite recurrent prolapse was defined as prolapse beyond the hymen; the presence of bothersome bulge symptoms; or prolapse reoperation or retreatment within 12 months after surgery. Complications were defined as any serious adverse event or Dindo grade III complication within 12 months of surgery. Significant change in health status was defined as a minimum important change of SF-6D utility score (±0.035 points) from baseline. Thirty-two candidate risk factors were considered for each model and model accuracy was measured using concordance indices. All indices were internally validated using 1,000 bootstrap resamples to correct for bias. RESULTS:The models accurately predicted composite recurrent prolapse (concordance index=0.72, 95% CI 0.69-0.76), bothersome vaginal bulge (concordance index=0.73, 95% CI 0.68-0.77), prolapse beyond the hymen (concordance index=0.74, 95% CI 0.70-0.77), serious adverse event (concordance index=0.60, 95% CI 0.56-0.64), Dindo grade III or greater complication (concordance index=0.62, 95% CI 0.58-0.66), and health status improvement (concordance index=0.64, 95% CI 0.62-0.67) or worsening (concordance index=0.63, 95% CI 0.60-0.67). Calibration curves demonstrated all models were accurate through clinically useful predicted probabilities. CONCLUSION:These prediction models are able to provide accurate and discriminating estimates of prolapse recurrence, complications, and health status 12 months after prolapse surgery.
Open Access
Predicting risk of pelvic floor disorders 12 and 20 years after delivery.
(American journal of obstetrics and gynecology, 2018-02) Jelovsek, J Eric; Chagin, Kevin; Gyhagen, Maria; Hagen, Suzanne; Wilson, Don; Kattan, Michael W; Elders, Andrew; Barber, Matthew D; Areskoug, Björn; MacArthur, Christine; Milsom, Ian
Little progress has been made in the prevention of pelvic floor disorders, despite their significant health and economic impact. The identification of women who are at risk remains a key element in targeting prevention and planning health resource allocation strategies. Although events around the time of childbirth are recognized clinically as important predictors, it is difficult to counsel women and to intervene around the time of childbirth because of an inability to convey a patient's risk accurately in the presence of multiple risk factors and the long time lapse, which is often decades, between obstetric events and the onset of pelvic floor disorders later in life. Prediction models and scoring systems have been used in other areas of medicine to identify patients who are at risk for chronic diseases. Models have been developed for use before delivery that predict short-term risk of pelvic floor disorders after childbirth, but no models that predict long-term risk exist.The purpose of this study was to use variables that are known before and during childbirth to develop and validate prognostic models that will estimate the risks of these disorders 12 and 20 years after delivery.Obstetric variables were collected from 2 cohorts: (1) women who gave birth in the United Kingdom and New Zealand (n=3763) and (2) women from the Swedish Medical Birth Register (n=4991). Pelvic floor disorders were self-reported 12 years after childbirth in the United Kingdom/New Zealand cohort and 20 years after childbirth in the Swedish Register. The cohorts were split so that data during the first half of the cohort's time period were used to fit prediction models, and validation was performed from the second half (temporal validation). Because there is currently no consensus on how to best define pelvic floor disorders from a patient's perspective, we chose to fit the data for each model using multiple outcome definitions for prolapse, urinary incontinence, fecal incontinence, ≥1 pelvic floor disorder, and ≥2 pelvic floor disorders. Model accuracy was measured in the following manner: (1) by ranking an individual's risk among all subjects in the cohort (discrimination) with the use of a concordance index and (2) by observing whether the predicted probability was too high or low (calibration) at a range of predicted probabilities with the use of visual plots.Models were able to discriminate between women who experienced bothersome symptoms or received treatment at 12 and 20 years, respectively, for pelvic organ prolapse (concordance indices, 0.570, 0.627), urinary incontinence (concordance indices, 0.653, 0.689), fecal incontinence (concordance indices, 0.618, 0.676), ≥1 pelvic floor disorders (concordance indices, 0.639, 0.675), and ≥2 pelvic floor disorders (concordance indices, 0.635, 0.619). Route of delivery and family history of each pelvic floor disorder were strong predictors in most models. Urinary incontinence before and during the index pregnancy was a strong predictor for the development of all pelvic floor disorders in most models 12 years after delivery. The 12- and 20-year bothersome symptoms or treatment for prolapse models were accurate when predictions were provided for risk from 0% to approximately 15%. The 12- and 20-year primiparous model began to over predict when risk rates reached 20%. When we predicted bothersome symptoms or treatment for urinary incontinence, the 12-year models were accurate when predictions ranged from approximately 5-60%; the 20-year primiparous models were accurate from 5% and 80%. For bothersome symptoms or treatment for fecal incontinence, the 12- and 20-year models were accurate from 1-15% risk and began to over predict at rates at >15% and 20%, respectively.Models may provide an opportunity before birth to identify women who are at low risk of the development of pelvic floor disorders and may provide institute prevention strategies such as pelvic floor muscle training, weight control, or elective cesarean section for women who are at higher risk. Models are provided at http://riskcalc.org/UR_CHOICE/.
Open Access
Predicting Risk of Urinary Incontinence and Adverse Events After Midurethral Sling Surgery in Women.
(Obstet Gynecol, 2016-02) Jelovsek, J Eric; Hill, Audra Jolyn; Chagin, Kevin M; Kattan, Michael W; Barber, Matthew D
OBJECTIVE: To construct and validate models that predict a patient's risk of developing stress and urgency urinary incontinence and adverse events 12 months after sling surgery. METHODS: This was a secondary analysis of four randomized trials. Twenty-five candidate predictors (patient characteristics and urodynamic variables) were identified from the National Institute of Diabetes and Digestive and Kidney Diseases Trial of Mid-Urethral Slings (N=597). Multiple logistic models were fit to predict four different outcomes: 1) bothersome stress urinary incontinence; 2) a positive stress test; 3) bothersome urgency urinary incontinence; and 4) any adverse event up to 12 months after sling surgery. Model discrimination was measured using a concordance index. Each model's concordance index was internally validated using 1,000 bootstrap samples and calibration curves were plotted. Final models were externally validated on a separate data set (n=902) from a combination of three different multicenter randomized trials. RESULTS: Four best models discriminated on internal validation between women with bothersome stress urinary incontinence (concordance index 0.728, 95% confidence interval [CI] 0.683-0.773), a positive stress test (concordance index 0.712, 95% CI 0.669-0.758), bothersome urgency urinary incontinence (concordance index 0.722, 95% CI 0.680-0.764), and any adverse event (concordance index 0.640, 95% CI 0.595-0.681) after sling surgery. Each model's concordance index was reduced as expected when important variables were removed for external validation, but model discrimination remained stable with bothersome stress urinary incontinence (concordance index 0.548), a positive stress test (concordance index 0.656), bothersome urgency urinary incontinence (concordance index 0.621), and any adverse event (concordance index 0.567). Predicted probabilities are closest to actual probabilities when predictions are less than 50%. CONCLUSION: Four best and modified models discriminate between women who will and will not develop urinary incontinence and adverse events 12 months after midurethral sling surgery 64-73% and 55-66% of the time, respectively.
Open Access
Prediction models for postpartum urinary and fecal incontinence in primiparous women.
(Female pelvic medicine & reconstructive surgery, 2013-03) Jelovsek, J Eric; Piccorelli, Annalisa; Barber, Matthew D; Tunitsky-Bitton, Elena; Kattan, Michael W
OBJECTIVES: This study aimed to develop and internally validate a nomogram that facilitates decision making between patient and physician by predicting a woman's individual probability of developing urinary (UI) or fecal incontinence (FI) after her first delivery. METHODS: This study used Childbirth and Pelvic Symptoms Study data, which estimated the prevalence of postpartum UI and FI in primiparous women after vaginal or cesarean delivery. Two models were developed using antepartum variables, and 2 models were developed using antepartum plus labor and delivery variables. Urinary incontinence was defined by a response of leaking urine "sometimes" or "often" using the Medical, Epidemiological, and Social Aspects of Aging Questionnaire. Fecal incontinence was defined as any involuntary leakage of mucus, liquid, or solid stool using the Fecal Incontinence Severity Index. Logistic regression models allowing nonlinear effects were used and displayed as nomograms. Overall performance was assessed using the Brier score (zero equals perfect model) and concordance index (c-statistic). RESULTS: A total of 921 women enrolled in the Childbirth and Pelvic Symptoms Study, and 759 (82%) were interviewed by telephone 6 months postpartum. Two antepartum models were generated, which discriminated between women who will and will not develop UI (Brier score = 0.19, c-statistic = 0.69) and FI (Brier score = 0.10, c-statistic = 0.67) at 6 months and 2 models were generated (Brier score = 0.18, c-statistic= 0.68 and Brier score = 0.09, c-statistic = 0.68) for predicting UI and FI, respectively, for use after labor and delivery. CONCLUSIONS: These models yielded 4 nomograms that are accurate for generating individualized prognostic estimates of postpartum UI and FI and may facilitate decision making in the prevention of incontinence.