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Showing papers by "Timothy J Wilt published in 2007"


Journal ArticleDOI
TL;DR: Increased RN staffing was associated with lower hospital related mortality in intensive care units (ICUs) and lower odds of hospitalrelated mortality and adverse patient events and patient and hospital characteristics, including hospitals’ commitment to quality of medical care, likely contribute to the actual causal pathway.
Abstract: (OR, 0.49; 95% CI, 0.36‐0.67), respiratory failure (OR, 0.40; 95% CI, 0.27‐0.59), and cardiac arrest (OR, 0.72; 95% CI, 0.62‐0.84) in ICUs, with a lower risk of failure to rescue (OR, 0.84; 95% CI, 0.79‐0.90) in surgical patients. Length of stay was shorter by 24% in ICUs (OR, 0.76; 95% CI, 0.62‐0.94) and by 31% in surgical patients (OR, 0.69; 95% CI, 0.55‐0.86). Conclusions: Studies with different design show associations between increased RN staffing and lower odds of hospital related mortality and adverse patient events. Patient and hospital characteristics, including hospitals’ commitment to quality of medical care, likely contribute to the actual causal pathway.

1,091 citations


Journal ArticleDOI
TL;DR: This guideline grades the evidence and recommendations by using the American College of Physicians' clinical practice guidelines grading system adopted from the classification developed by the Grading of Recommendations, Assessment, Development, and Evaluation workgroup.
Abstract: Recommendation 1: In patients with respiratory symptoms, particularly dyspnea, spirometry should be performed to diagnose airflow obstruction. Spirometry should not be used to screen for airflow obstruction in asymptomatic individuals. (Grade: strong recommendation, moderate-quality evidence.)

429 citations


01 Mar 2007
TL;DR: Increased nursing staffing in hospitals was associated with lower hospital-related mortality, failure to rescue, and other patient outcomes, but the association is not necessarily causal.
Abstract: OBJECTIVES To assess how nurse to patient ratios and nurse work hours were associated with patient outcomes in acute care hospitals, factors that influence nurse staffing policies, and nurse staffing strategies that improved patient outcomes.

274 citations


Journal ArticleDOI
01 Jul 2007-BJUI
TL;DR: To evaluate the effectiveness of pelvic floor muscle training (PFMT) for treating urinary incontinence after radical prostatectomy (RP) by reviewing evidence from randomized trials.
Abstract: OBJECTIVE To evaluate the effectiveness of pelvic floor muscle training (PFMT) for treating urinary incontinence (UI) after radical prostatectomy (RP) by reviewing evidence from randomized trials. METHODS Randomized trials published in English were included if they involved men with UI after RP and compared PFMT with a control group. Data were abstracted onto a standardized form using a prospectively developed protocol. RESULTS Eleven trials randomizing 1028 men (mean age 64 years) met the inclusion criteria; the duration of the trials was 3–12 months. One trial of 300 men found that those assigned to PFMT achieved continence more quickly (after 1, 3 and 6 months) than men not assigned to PFMT. Men receiving biofeedback-enhanced PFMT were more likely to achieve continence or have no continual leakage than those with no training within 1–2 months after RP (relative benefit increase 1.54; 95% confidence interval 1.01–2.34; four trials reporting). The relative benefit increase (1.19, 0.82–1.72; five studies) was no longer significant after 3–4 months. Biofeedback-enhanced PFMT was comparable to written/verbal PFMT instruction. Extracorporeal magnetic innervation (ExMI) and electrical stimulation (ES) were found to be initially (within 1–2 months) more effective than PFMT in one trial, but there were no significant differences between groups at ≥ 3 months. CONCLUSION Based on available evidence, PFMT with or without biofeedback enhancement hastens the return to continence more than no PFMT in men with UI after RP. Additional trials are needed to confirm whether ExMI and ES are effective conservative treatment options.

119 citations


Journal ArticleDOI
TL;DR: This review extends the search related to COPD therapies through March 2007 by using search terms used in a 2003 review by Sin and colleagues to identify randomized, controlled trials (RCTs), controlled clinical trials, meta-analyses, and reviews published since the completion of their search in 2002.
Abstract: This systematic review evaluated the effectiveness of COPD management strategies. Long-acting inhaled therapies, supplemental oxygen, and pulmonary rehabilitation are beneficial in adults with both...

112 citations


01 Dec 2007
TL;DR: Egiologic surveys to detect persons at risk and patients with undiagnosed UI have the same diagnostic value and less cost compared to professional examinations and diagnostic tests and self-reported questionnaires have unsatisfactory validity to diagnose FI.
Abstract: Objectives To assess the prevalence of and risk factors for urinary (UI) and fecal (FI) incontinence in adults in long-term care (LTC) settings and in the community, the effectiveness of diagnostic methods to identify adults at risk and patients with incontinence, and to review the effectiveness of clinical interventions to reduce the risk of incontinence. Data sources MEDLINE (PubMed), CINAHL, and Cochrane Databases. Review methods Observational studies were reviewed to examine the prevalence and incidence of UI and FI and the association with risk factors. The effects of treatments on patient outcomes were analyzed from randomized controlled and multicenter clinical trials. The diagnostic values of the tests were compared from the original epidemiologic studies of different designs. Of the 6,097 articles identified, 1,077 articles were eligible for analysis. Results The prevalence of UI, FI, and combined incontinence increased with age and functional dependency. Cognitive impairment, limitations in daily activities, and prolonged institutionalization in nursing homes were associated with a higher risk of incontinence. Stroke, diabetes, obesity, poor general health, and comorbidities were associated with UI and FI in community dwelling adults. Parity, anal trauma, and vaginal prolapse in women and urological surgery and radiation for prostate cancer in men are risk factors for UI and FI. Intensive individualized management and rehabilitation programs improved continence status in nursing home residents and adults after stroke. Self-administered behavioral interventions including pelvic floor muscle training with biofeedback and bladder training resolved UI in incontinent women. Electrical stimulation and sacral neuromodulation improved urge UI, but improvement for FI was inconsistent. Tension-free vaginal tape procedures and modified surgical techniques for prolapse to support the bladder neck resolved stress UI in the majority of treated women. Behavioral treatments of FI resulted in small improvements in severity and quality of life related to incontinence. The effects on FI of surgical techniques for hemorrhoids, rectal prolapse, rectal cancer, and anal fissures are not consistent across studies. Surgical interventions in patients with ulcerative colitis resulted in the same rates of fecal continence when compared to each other. The few clinical interventions to treat FI that were tested in well-designed trials had no clear evidence of better effects of the compared treatments. Instrumental outcomes to evaluate the effectiveness of treatments did not correlate with patient outcomes. Epidemiologic surveys to detect persons at risk and patients with undiagnosed UI have the same diagnostic value and less cost compared to professional examinations and diagnostic tests. Self-reported questionnaires and scales have unsatisfactory validity to diagnose FI. Conclusions Epidemiologic surveys are cost-effective ways to estimate the prevalence of UI in large nationally representative population groups. Routine clinical evaluation should include an assessment of the risk factors, symptoms, and signs of incontinence. Pregnant or menopausal women, women with vaginal prolapse, males treated for prostate disease, patients with rectal prolapse, and frail elderly and nursing home residents are high risk groups. Individualized management programs can improve continence in LTC facilities but are hard to sustain. Regular monitoring and documentation of the continence status in relation to implemented continence services should be quality of care indicators for nursing homes. Pelvic floor muscle trainings with biofeedback can resolve incontinence and improve quality of life. Surgery is effective in curing stress UI in females. Clinical interventions for UI in males and for FI in adults need future investigation. A list of research recommendations is offered.

111 citations


Journal ArticleDOI
TL;DR: The comparative effectiveness of treatment options, including active surveillance, open repair, and endovascular repair, for unruptured AAAs was sought, and all-cause mortality was calculated for all randomly assigned patients.
Abstract: The authors performed a systematic review of randomized trials that compared open or endovascular repair of abdominal aortic aneurysms (AAAs) with another treatment to compare the effectiveness of ...

107 citations


Journal ArticleDOI
TL;DR: There is insufficient evidence to either support or refute the routine use of screening compared to no screening for reducing prostate cancer mortality and no robust evidence from randomised controlled trials is available regarding the impact of screening on quality of life, harms of screening, or its economic value.
Abstract: The objective of this systematic review was to determine whether screening for prostate cancer reduces prostate cancer mortality. A systematic search for randomised controlled trials was conducted through electronic scientific databases and a specialist register of the Cochrane Prostatic Diseases and Urologic Cancers Group. Manual searching of specific journals was also conducted. Two authors independently reviewed studies that met the inclusion criteria. Studies were independently assessed for quality. Data from included studies was also extracted independently. Two randomised controlled trials were included however, both trials had methodological weaknesses. Re-analysis of the reported data using intention-to-screen and meta-analysis indicated no statistically significant difference in prostate cancer mortality between men randomized for prostate cancer screening and controls (RR 1.01, 95% CI: 0.80–1.29). Given that only two randomised controlled trials were included, and the high risk of bias of both trials, there is insufficient evidence to either support or refute the routine use of screening compared to no screening for reducing prostate cancer mortality. Currently, no robust evidence from randomised controlled trials is available regarding the impact of screening on quality of life, harms of screening, or its economic value. Results from two ongoing large scale multi-center randomised controlled trials, which will be available in the upcoming few years, will assist patients and health professionals in making an evidence-based decision regarding the effectiveness of screening for prostate cancer

82 citations


Journal ArticleDOI
TL;DR: Available evidence is insufficient to determine whether obtaining spirometric values and providing that information to patients improves smoking cessation compared with other smoking cessation methods, and Spirometric values are of limited benefit as a predictor of smoking cessation or as a tool to "customize" smoking cessation strategies.
Abstract: Obtaining spirometric testing and providing those results to individuals who smoke has been advocated as a motivational tool to improve smoking cessation. However, its effectiveness is not known. We conducted a systematic review to determine if this approach improves rates of smoking cessation. Data sources included MEDLINE (1966 to October 2005), the Cochrane Library, and experts in the field. Eligible randomized controlled trials (RCTs) enrolled at least 25 smokers per arm, evaluated spirometry with associated counseling or in combination with other treatments, followed subjects at least 6 months, and provided smoking abstinence rates. Results from nonrandomized studies also were summarized. The primary outcome was patient-reported long-term (at least 6 months) sustained abstinence with biological validation. Additional outcomes included self-reported abstinence and point-prevalence abstinence. Seven RCTs (N = 6,052 subjects) met eligibility criteria. Follow-up duration ranged from 9 to 36 months. In six trials, the intervention group received concomitant treatments previously demonstrated to increase cessation independently. The range of abstinence was 3%-14% for control subjects and 7%-39% among intervention groups, statistically significantly in favor of intervention in four studies. The only RCT that assessed the independent contribution of spirometry in combination with counseling demonstrated a nonsignificant 1% improvement in patient-reported point-prevalence abstinence at 12 months in the group that received spirometry plus counseling versus counseling alone (6.5% versus 5.5%). Findings from observational studies were mixed, and the lack of controls makes interpretation problematic. Available evidence is insufficient to determine whether obtaining spirometric values and providing that information to patients improves smoking cessation compared with other smoking cessation methods. Spirometric values are of limited benefit as a predictor of smoking cessation or as a tool to "customize" smoking cessation strategies.

62 citations


Journal ArticleDOI
TL;DR: The relative clinical and economic benefits of cryotherapy compared to standard therapies for the primary treatment of localised prostate cancer are evaluated.
Abstract: BACKGROUND Prostate cancer is a common cancer in elderly men and in some will prove fatal. Standard treatments for localised disease include surgery ( radical prostatectomy), radiotherapy and active monitoring. New emerging therapies are being evaluated with the aim of reducing the complication rate associated with standard therapies, as well as developing an effective treatment. One such modality is cryotherapy, a procedure that introduces probes directly into the prostate tumour and kills the malignant cells by a freezing process. OBJECTIVES This review aims to evaluate the relative clinical and economic benefits of cryotherapy compared to standard therapies for the primary treatment of localised prostate cancer. SEARCH STRATEGY Our search strategy included an electronic search of MEDLINE from 1996 to December 2006, plus EMBASE (Excerpta Medica Database), the Cochrane library, ISI Science Citation Index, Database of Abstracts and Reviews of Effectiveness (DARE), and LILACS to identify all relevant published randomised trials of cryotherapy for localised prostate cancer. Cancerlit and HealthSTAR databases were searched to their final date. Handsearching of relevant journals was undertaken. SELECTION CRITERIA Only published randomised trials comparing the effectiveness of cryotherapy with radical prostatectomy, radiotherapy or active monitoring for the primary treatment of men with localised prostate cancer were eligible for inclusion in this review. DATA COLLECTION AND ANALYSIS Data were extracted from eligible studies, and included study design, participants, interventions and outcomes. Primary outcome measures were biochemical disease-free survival, disease-free survival and treatment-induced complications. Secondary outcomes included disease-specific survival, overall survival, quality-of-life outcome measures and economic impact measures. MAIN RESULTS There were no randomised trials found comparing cryotherapy with other therapies for the primary treatment of localised prostate cancer. All studies identified were case series. To indicate the level of the available evidence, studies that evaluated cryotherapy as a primary therapy, using transrectal ultrasound guidance and urethral warming in at least 50 patients with localised prostate cancer, and a minimum of one year follow up, were reviewed. Eight case series were identified that complied with these criteria; two were retrospective. The patients recruited (n = 1483) had an age range from 41 to 84 years, stages T1 = 0 to 43%, T2 = 24 to 88%, T3 = 1 to 41%, and T4 = 0 to 14%. The mean preoperative PSA level ranged from 9.7 to 39 ng/mL, with Gleason scores < 7 and ranging from 6 to 37%. One additional study that compared cryotherapy (total cryotherapy and standard cryotherapy with urethral preservation) with radical prostatectomy was also identified and reviewed. In this study the success rates, defined as a post-treatment PSA of 0.2 ng/mL or less, were reported as 96% for total cryotherapy, 49% for standard cryotherapy and 73% for radical prostatectomy. Four studies did not monitor the temperature of the cyro-procedure and reported 17 to 28% of patients had a positive biopsy following cryotherapy with a mean PSA nadir of 0.55 to 1.75 ng/mL (median 0.4 to 1.85 ng/mL). The other four studies used thermocouples to monitor the temperature of the cryo-procedure and reported progression-free survival rates of 71 to 89% with 1.4 to 13% of patients having a positive biopsy post-cryotherapy. At 5 years, overall survival was reported as 89 to 92% in two studies, and disease-specific survival as 94% in one study. The major complications observed in all studies included impotence (47 to 100%), incontinence (1.3 to 19%), and urethral sloughing (3.9 to 85%), with less common complications of fistula (0 to 2%), bladder-neck obstruction (2 to 55%), stricture (2.2 to 17%) and pain (0.4 to 3.1%). Most patients were sent home the following day (range 1 to 4 days). AUTHORS' CONCLUSIONS Cryotherapy offers a potential alternative to standard therapies for the primary treatment of localised prostate cancer. However, the poor quality of the available studies makes it difficult to determine the relative benefits of this modality. Randomised trials are needed to fully evaluate the full potential of cryotherapy in men with this disease. Patients selecting cryotherapy as their therapeutic option should be made fully aware of the reported efficacy, complications and the low-grade evidence from which these data are derived.

60 citations


Journal ArticleDOI
TL;DR: Information suggests IAS may have slightly reduced adverse events, and intermittent androgen suppression was also as effective as CAS for potency, but was superior during the interval of cycles.
Abstract: Background After lung cancer, prostate cancer is the most common cause of death among males. The aim of treatment is to prevent disease-related morbidity and mortality while minimizing intervention-related adverse events. Androgen suppression therapy (AST) to reduce circulating serum testosterone and disease progression is considered a mainstay of treatment for men with advanced prostate cancer. It has been increasingly utilized for early stage disease despite a lack of evidence of effectiveness. Objectives Evaluate the effectiveness and safety of intermittent androgen suppression (IAS) compared to continuous androgen suppression for treating prostatic cancer. Search methods The following databases were searched to identify randomised or quasi-randomised, controlled trials comparing intermittent and continuous androgen suppression in the treatment of any stage of prostate cancer: the Cochrane Central Register of Controlled Trials; EMBASE and LILACS. Selection criteria Studies were included if they were randomised or quasi-randomized, and compare the effects of IAS versus CAS. Data collection and analysis Two reviewers selected relevant trials, assessed methodological quality and extracted data. Main results Five randomized studies involving 1382 patients were included in this review. All the included studies involved advanced (T3 or T4) prostate cancer, had relatively small populations, and were of short duration. Few events were reported and did not assess disease-specific survival or metastatic disease. Only one study (N = 77) evaluated biochemical outcomes. A subgroup analysis found no significant differences in biochemical progression (defined by the authors as PSA ≥ 10 ng/mL) between IAS and CAS for Gleason scores 4 - 6, 7, and 8 - 10. For patients with a Gleason score > 6, reduction in biochemical progression favoured the IAS group (RR 0.10, 95% CI 0.01 to 0.67, P = 0.02). Studies primarily reported on adverse events. One trial (N = 43) found no difference in adverse effects (gastrointestinal, gynecomastia and asthenia) between IAS ( two events) and CAS (five events), with the exception of impotence, which was significantly lower in the IAS group (RR 0.72, 95% CI 0.56 to 0.92, P = 0.008). Authors' conclusions Data from RCTs comparing IAS to CAS are limited by small sample size and short duration. There are no data for the relative effectiveness of IAS versus CAS for overall survival, prostate cancer-specific survival, or disease progression. Limited information suggests IAS may have slightly reduced adverse events. Overall, IAS was also as effective as CAS for potency, but was superior during the interval of cycles (96%).

Journal ArticleDOI
TL;DR: Endovascular repair is not currently cost-effective for patients with large AAA regardless of medical fitness, and conclusions regarding the cost-effectiveness of AAA treatment options are time dependent and vary by institutional perspective.
Abstract: Objectives: A systematic review of the cost-effectiveness of abdominal aortic aneurysm (AAA) repair was conducted. Although open surgery has been considered the gold standard for prevention of AAA rupture, emerging less-invasive endovascular treatments have led to increased interest in evaluating the cost and cost-effectiveness of treatment options.Methods: A systematic review of studies published in MEDLINE between 1999 and 2005 reporting the cost and/or cost-effectiveness of endovascular and/or open surgical repair of nonruptured AAAs was conducted. Case series studies with less than fifty patients per treatment were excluded.Results: Of twenty eligible articles, three were randomized controlled trials, twelve case series, four Markov models, and one systematic review. Regardless of time frame, all studies found that endovascular repair costs more than open surgery. Although the high cost of the endovascular prosthesis was partially offset by reduced intensive care, hospital length of stay, operating time, blood transfusions, and perioperative complications, hospital costs were still greater for endovascular than open surgical repair. For patients medically fit for open surgery, mid-term costs were greater for endovascular repair with no difference in overall survival or quality of life. For patients medically unfit for open surgery, endovascular repair costs more than no intervention with no difference in survival.Conclusions: Although conclusions regarding the cost-effectiveness of AAA treatment options are time dependent and vary by institutional perspective, from a societal perspective, endovascular repair is not currently cost-effective for patients with large AAA regardless of medical fitness.


Journal ArticleDOI
TL;DR: BTX may improve UI for subjects with refractory DO and the preferred dose and type of BTX is not known, but long-term efficacy and safety remain unclear and require conduct of larger RCT using standardized and validated clinical outcomes measures.
Abstract: Systematic review. To evaluate effectiveness and adverse effects of botulinum toxin (BTX) for treatment of urinary incontinence (UI) due to detrusor overactivity (DO). Randomized controlled trials published in English before November 2006 were included if they enrolled subjects with UI caused by DO and reported incontinence outcomes. Three trials totaling 104 subjects with DO refractory to antimuscarinic treatment were included. Two BTX-A trials enrolled primarily patients with NDO secondary to spinal cord injury (SCI) (93%). BTX-A decreased daily UI episodes compared to placebo but the reductions were only significantly different at a few of the time intervals during 24 weeks of follow-up. BTX-A was superior in reducing daily UI episodes in SCI subjects compared to intravesical resiniferatoxin at 12 and 18 months after injections. A small crossover study found BTX-B significantly more effective than placebo in reducing weekly UI episodes in subjects with predominately idiopathic DO. Adverse events (AEs) in BTX-A-treated subjects included urinary tract infection, pain at the injection site, hematuria and autonomic dysreflexia. Four subjects treated with BTX-B reported autonomic AEs. BTX may improve UI for subjects with refractory DO. The preferred dose and type of BTX is not known. Long-term efficacy and safety remain unclear and require conduct of larger RCT using standardized and validated clinical outcomes measures.


Journal ArticleDOI
TL;DR: Despite prior beliefs, a standardized quality assurance tool do not enhance informed consent in actual clinical trials and future research is needed to rigorously evaluate proposed methods to enhanceinformed consent prior to widespread introduction.
Abstract: Background The informed consent process for research warrants improvement but approaches designed to enhance informed consent need testing in the context of actual clinical research.Purpose Test the cumulative effect of a retrospective quality assurance questionnaire intended to enhance awareness in the person obtaining informed consent on the quality of the informed consent in clinical trials.Methods In the Veterans Affairs Cooperative Study `Enhancing the Quality of Informed Consent- Self Monitoring', 30 study sites are randomly assigned from five clinical trials to either use a new quality assurance questionnaire after each informed consent encounter or the standard process of obtaining informed consent. The quality of informed consent is evaluated using independent telephone interviews of 836 subjects who had given consent to participate in the clinical trials and the authors' study. The main outcome measures are two previously validated scores derived from an independent telephone interview, measurin...

01 Jan 2007
TL;DR: A comparison between AMS 700TM CX and ColoplastTM Titan inflatable penile prosthesis for Peyronie’s disease treatment and remodeling: clinical outcomes and patient satisfaction and low testosterone has a similar prevalence among men with sexual dysfunction due to either Peyronsie's disease or erectile dysfunction.
Abstract: Male sexual health has taken on increased importance as the United States population ages, develops coexisting medical conditions, and undergoes interventions that can affect sexual health.