Watchful Waiting Group Research Articles

Health-Related Quality of Life of Patients Diagnosed with Indolent Lymphoma.

Background Numerous treatment options are available for patients with indolent lymphoma (IL), including active treatment and active observation without initiation of therapy, watchful waiting; each is associated with unique, longer term therapeutic and health-related quality of life (HRQL) consequences. We sought to identify key HRQL domains of importance to patients with indolent lymphoma and whether HRQL varies by treatment.Methods Five focus groups (n=33), supplemented by in-depth one-on-one telephone interviews (n=19) were conducted with IL patients across the US. Patients completed a questionnaire composed of five standard validated instruments related to physical well-being, social/family well-being, emotional well-being, functional well-being (FACT-G), additional concerns (FACT-Lym), physical appearance, psychosocial adaptation to illness (PAIS), and mental health (MHI-5). Questionnaire domains were scored on a 0–100 scale where higher scores indicate better functioning.Results A total of 52 IL patients (65% female; mean age 53 years) completed the questionnaire. Participants belonged to one of the following treatment categories: Active Treatment (n=18), Previous Treatment (n=25) and Watchful Waiting (n=9). Similarities in FACT scores were found between the Previous Treatment and Watchful Waiting groups. The Watchful Waiting group scored the lowest on both the MHI-5 and the PAIS. Differences were found in Physical Well-Being between the Active Treatment and Previous Treatment groups (67.06 vs. 81.10, respectively, p=0.029). Differences were observed for the PAIS between the Active Treatment and Watchful Waiting groups (83.82 vs. 65.63, respectively, p=0.021) and between the Previous Treatment and Watchful Waiting groups (85.00 vs. 65.63, respectively, p=0.010).Conclusions Preliminary findings suggest that differences were observed between patients on active treatment, those who have previously been treated and patients who have never been treated, watchful waiting. Further elucidation of these issues is needed to facilitate HRQL evaluation in future studies and more importantly better inform patients and providers of treatment decisions.Table 1Mean (Standard Deviation) HRQL Scores of all Patients and by Treatment CategoriesDomainsAll Patients (N=52)Active Treatment (N=18)Previous Treatment (N=25)Watchful Waiting (N=9)FACT-G73.01 (15.56)67.41 (15.82)76.21 (14.12)75.67 (17.30)FACT-Lym71.35 (15.25)67.63 (16.09)73.11 (12.39)75.02 (18.58)Physical Appearance76.85 (29.36)65.00 (31.62)82.69 (27.74)87.50 (25.00)PAIS81.50 (18.77)83.82 (16.40)85.00 (18.40)65.63 (18.60)MHI-569.08 (18.00)69.33 (15.22)71.36 (18.46)62.22 (21.92)

Long-term effects of pediatric adenotonsillectomy on serum immunoglobulin levels: results of a randomized controlled trial

It remains controversial whether pediatric adenotonsillectomy ultimately results in decreased serum immunoglobulin levels and if so whether such a decrease is associated with increased susceptibility to upper respiratory tract infections (URIs). To evaluate changes in serum immunoglobulin levels in relation to occurrence of URIs in children participating in a randomized controlled trial on the effectiveness of adenotonsillectomy. A total of 300 children aged 2 to 8 years, with symptoms of recurrent throat infections or tonsillar hypertrophy, were randomly assigned to either adenotonsillectomy or watchful waiting (WW). Serum samples were collected at baseline and at 1-year follow-up. Occurrence of throat infections and other URIs during first-year follow-up was recorded in a diary by the child's parents. Paired serum samples were available for 123 children (63 in the adenotonsillectomy group and 60 in the WW group). IgG1 and IgG2 levels decreased but remained within the reference range for age in both study arms. IgM and IgA levels decreased as well but remained elevated. The IgA level in the adenotonsillectomy group decreased in significantly greater degree compared with the WW group, but this difference disappeared in cases where children experienced frequent URIs. In general, no relation between immunoglobulin levels and the number of throat infections or URIs at 1-year follow-up was found. Immunoglobulin levels of children undergoing adenotonsillectomy decreased from elevated to slightly elevated or reference values for age during 1-year follow-up irrespective of treatment (adenotonsillectomy or WW). IgA showed a greater decrease in the adenotonsillectomy group but rose to levels comparable with the WW group in cases of frequent URIs. This finding indicates that the remaining mucosa-associated lymphoid tissue can compensate for the loss of tonsil and adenoid tissue.

PSA velocity in conservatively managed BPH: Can it predict the need for BPH-related invasive therapy?

To study the value of PSA velocity (PSAV) to predict benign prostatic hyperplasia (BPH) progression in patients managed with alpha(1)-blockers or watchful waiting (WW). Nine hundred and forty two BPH patients treated with alpha(1)-blocker or WW were reviewed. PSAV was defined as: (PSA(t)-PSA(b))/(t/12); where PSA(t) = PSA at time of follow-up (t, in months), PSA(b) = PSA at baseline. PSA(t) was taken from the 1 year follow-up visit or, if not present, from the next available visit with a maximum of 24 months. Five hundred and ninety five patients (234 alpha(1)-blocker, 361 WW) were included in the analyses. PSAV range was -5.24 to 43.06 ng/ml/year in alpha(1)-blocker patients and -6.11 to 19.55 ng/ml/year in WW patients (median: 0.01 ng/ml/year). PSAV was stratified into tertiles (Stable/Decrease/Increase). There were no significant differences in retreatment-free survival and the risk of BPH-related invasive therapy between the tertiles in both treatment groups. PSAV did not predict BPH progression in either alpha(1)-blocker treated patients or WW group.

Análisis crítico de un artículo: Cáncer de próstata inicial ¿operar o esperar?

Background In 2002, we reported the initial results of a trial comparing radical prostatectomy with watchful waiting in the management of early prostate cancer. After three more years of follow-up, we report estimated 10-year results. Methods: From October 1989 through February 1999, 695 men with early prostate cancer (mean age, 64.7 years) were randomly assigned to radical prostatectomy (347 men) or watchful waiting (348 men). The follow-up was complete through 2003, with blinded evaluation of the causes of death. The primary end point was death due to prostate cancer; thesecondary end points were death from any cause, metastasis, and local progression. Results: During a median of 8.2 years of follow-up, 83 men in the surgery group and 106 men in the watchful-waiting group died (P=0.04). In 30 of the 347 men assigned to surgery (8.6 percent) and 50 of the 348 men assigned to watchful waiting (14.4 percent), death was due to prostate cancer. The difference in the cumulative incidence of death due to prostate cancer increased from 2.0 percentage points after 5 years to 5.3 percentage points after 10 years, for a relative risk of 0.56 (95 percent confidence interval, 0.36 to 0.88; P=0.01 by Gray's test). For distant metastasis, the corresponding increase was from 1.7 to 10.2 percentage points, for a relative risk in the surgery group of 0.60 (95 percent confidence interval, 0.42 to 0.86; P=0.004 by Gray's test), and for local progression, the increase was from 19.1 to 25.1 percentage points, for a relative risk of 0.33 (95 percent confidence interval, 0.25 to 0.44; P<0.001 by Gray's test). Conclusions: Radical prostatectomy reduces disease-specific mortality, overall mortality, and the risks of metastasis and local progression. The absolute reduction in the risk of death after 10 years is small, but the reductions in the risks of metastasis and local tumor progression are substantial

Radical prostatectomy versus watchful waiting in early prostate cancer: Bill-Axelson A, Holmberg L, Ruutu M, Haggman M, Andersson SO, Bratell S, Spangberg A, Busch C, Nordling S, Garmo H, Palmgren J, Adami HO, Norlen BJ, Johansson JE, Scandinavian Prostate Cancer Group Study No. 4, Department of Urology, University Hospital, Uppsala, Sweden

In 2002, we reported the initial results of a trial comparing radical prostatectomy with watchful waiting in the management of early prostate cancer. After three more years of follow-up, we report estimated 10-year results. From October 1989 through February 1999, 695 men with early prostate cancer (mean age, 64.7 years) were randomly assigned to radical prostatectomy (347 men) or watchful waiting (348 men). The follow-up was complete through 2003, with blinded evaluation of the causes of death. The primary end point was death due to prostate cancer; the secondary end points were death from any cause, metastasis, and local progression. During a median of 8.2 years of follow-up, 83 men in the surgery group and 106 men in the watchful-waiting group died ( P = 0.04). In 30 of the 347 men assigned to surgery (8.6 percent) and 50 of the 348 men assigned to watchful waiting (14.4 percent), death was due to prostate cancer. The difference in the cumulative incidence of death due to prostate cancer increased from 2.0 percentage points after 5 years to 5.3 percentage points after 10 years, for a relative risk of 0.56 (95 percent confidence interval, 0.36 to 0.88; P = 0.01 by Gray’s test). For distant metastasis, the corresponding increase was from 1.7 to 10.2 percentage points, for a relative risk in the surgery group of 0.60 (95 percent confidence interval, 0.42 to 0.86; P = 0.004 by Gray’s test), and for local progression, the increase was from 19.1 to 25.1 percentage points, for a relative risk of 0.33 (95 percent confidence interval, 0.25 to 0.44; P < 0.001 by Gray’s test). Radical prostatectomy reduces disease-specific mortality, overall mortality, and the risks of metastasis and local progression. The absolute reduction in the risk of death after 10 years is small, but the reductions in the risks of metastasis and local tumor progression are substantial.

Radical Prostatectomy versus Watchful Waiting in Early Prostate Cancer

In 2002, we reported the initial results of a trial comparing radical prostatectomy with watchful waiting in the management of early prostate cancer. After three more years of follow-up, we report estimated 10-year results. From October 1989 through February 1999, 695 men with early prostate cancer (mean age, 64.7 years) were randomly assigned to radical prostatectomy (347 men) or watchful waiting (348 men). The follow-up was complete through 2003, with blinded evaluation of the causes of death. The primary end point was death due to prostate cancer; the secondary end points were death from any cause, metastasis, and local progression. During a median of 8.2 years of follow-up, 83 men in the surgery group and 106 men in the watchful-waiting group died (P=0.04). In 30 of the 347 men assigned to surgery (8.6 percent) and 50 of the 348 men assigned to watchful waiting (14.4 percent), death was due to prostate cancer. The difference in the cumulative incidence of death due to prostate cancer increased from 2.0 percentage points after 5 years to 5.3 percentage points after 10 years, for a relative risk of 0.56 (95 percent confidence interval, 0.36 to 0.88; P=0.01 by Gray's test). For distant metastasis, the corresponding increase was from 1.7 to 10.2 percentage points, for a relative risk in the surgery group of 0.60 (95 percent confidence interval, 0.42 to 0.86; P=0.004 by Gray's test), and for local progression, the increase was from 19.1 to 25.1 percentage points, for a relative risk of 0.33 (95 percent confidence interval, 0.25 to 0.44; P<0.001 by Gray's test). Radical prostatectomy reduces disease-specific mortality, overall mortality, and the risks of metastasis and local progression. The absolute reduction in the risk of death after 10 years is small, but the reductions in the risks of metastasis and local tumor progression are substantial.

Incidence and follow‐up of patients with focal prostate carcinoma in 2 screening rounds after an interval of 4 years

Focal carcinoma detected by needle biopsy has been a common finding since prostate-specific antigen (PSA)-based screening was introduced. Clinicopathologic features in patients with focal prostate carcinoma who underwent radical prostatectomy (RP) or who were treated with watchful waiting (WW) were analyzed to detect clinical predictors for disease progression during follow-up. Patients were selected from the European Randomized Screening study for Prostate Cancer. Focal carcinoma on sextant biopsy was defined as <or=3.0 mm involvement by tumor in 1 biopsy core lacking Gleason pattern 4 or 5. PSA doubling time was used in the WW group as a marker of disease progression. The proportion of patients with focal prostate carcinoma increased significantly from 16% in the first screening round to 29% in the second screening round. One hundred eighteen men underwent RP, and 108 men were treated with WW. The median tumor volume was 0.13 mL. PSA level and prostate volume were predictive for tumor volume in a multivariate regression analysis. A PSA density cut-off level of <or=0.1 ng/mL/cm3 predicted organ-confined tumor (<0.5 mL) in 94% of patients. Positive surgical margins were predictive for PSA recurrence. Four patients in the RP group had PSA recurrence at follow-up. PSA doubling times <2 years, <3 years, and <4 years were noted in 4.9%, 14.6%, and 22.0% of patients in the WW group, respectively. The median tumor volume was small (0.13 mL). A comparison between PSA recurrence in the RP group and PSA doubling time in the WW group showed a significantly more favorable outcome after RP if a PSA doubling time of <3 years or <4 years was chosen as a marker for disease progression in the WW group. A WW policy with delayed curative intent may be recommended in patients ages 55-75 years with focal carcinoma and PSA density <0.1 ng/mL/cm3.

Prognostic role of prostate-specific antigen and prostate volume for the risk of invasive therapy in patients with benign prostatic hyperplasia initially managed with alpha1-blockers and watchful waiting

To investigate the prognostic role of prostate-specific antigen (PSA) level and prostate volume (PV) for the need for benign prostatic hyperplasia (BPH)-related invasive therapy among patients initially treated with an alpha1-blocker or watchful waiting (WW) in real-life clinical practice. Data were collected from 2264 consecutive patients with clinical BPH. Patients initially treated with an alpha1-blocker or WW were included in this study. They were stratified by baseline PSA level (less than 1.5, 1.5 to less than 3.0, 3.0 to 10.0 ng/mL) and PV (less than 30 and 30 to 200 cm3), and analyzed for the time to BPH-related invasive therapy. Of the 2264 patients, 389 treated with alpha1-blockers and 553 who chose WW were included. Across the PSA and PV strata, the alpha1-blocker group had worse symptoms, peak flow, postvoid residual urine volumes, and obstruction than did the WW group. Increasing PSA levels produced an increase in the 5-year cumulative risk of invasive treatment: 20%, 34%, and 44% in the alpha1-blocker and 8%, 9%, and 15% in the WW group for a PSA level of less than 1.5, 1.5 to less than 3.0, and 3.0 to 10.0 ng/mL, respectively. The hazard ratio for the highest compared with the lowest PSA strata was 2.8 for alpha1-blocker and 2.7 for WW patients. An increasing PV increased the 5-year cumulative risk from 21% to 35% in the alpha1-blocker group and 8% to 11% in the WW group. The hazard ratio for the large versus small prostates in the alpha1-blocker group was 1.8 and in the WW group was 1.0. A higher PSA level and larger PV resulted in a greater risk of BPH-related invasive therapy that was more pronounced in the alpha1-blocker than in the WW patients. However, symptom severity, flow parameters, and obstruction grade may have contributed to the difference in risk between the two treatment groups.

Clinical and Pressure-Flow Changes after Long-Term Treatment with Alfuzosin SR

Objectives: The aim of our study was to evaluate the symptomatic and urodynamic changes after 1–5 years of treatment with alfuzosin in patients with benign prostatic hyperplasia. Methods: Out of 255 patients with lower urinary tract symptoms observed from 1992 to 1997, who completed the International Prostatic Symptom Score (I-PSS) and underwent full urodynamic investigation, 161 were found to be obstructed (Schäfer classes 2–6). One hundred and two subsequently consented to a second clinical and urodynamic evaluation. Out of these, 46 underwent surgical treatment, 20 were elected for watchful waiting (WW) and 36 received a medical treatment. Twenty out of these, with a mean age of 65 years, a mean prostatic volume of 44 ml (20–70) a median Schäfer’s obstruction class of 3 (range 2–5) were treated with slow release alfuzosin 5 mg twice a day. We re-evaluated these 20 patients with a second I-PSS and pressure-flow study after 1–5 years (mean: 2 years) of treatment. The patients in the WW group with comparable baseline characteristics were considered as controls. The Wilcoxon matched-pairs signed rank test and the Kruskal-Wallis test were used for statistical analysis. Results: In the group treated with alfuzosin, no differences were noted for I-PSS (14.9 ± 6,8; 13.3 ± 5); maximum flow (124 ± 6; 14 ± 6) and projected isometric pressure (105 ± 36; 105 ± 26). Statistically significant differences were noted for residual urine (103 ± 100; 33 ± 38, p = 0.02); detrusor pressure at maximum flow (64.4 ± 23; 53 ± 12, p = 0.04), minimum urethral opening pressure (36.5 ± 9; 31 ± 9, p = 0.02), Schäfer class (2.7 ± 0.7; 2 ± 0.8, p = 0.04); urethral resistance algorithm (34.7 ± 11; 27 ± 7, p = 0.02). Statistically significant differences between baseline and follow-up were noted for none of the clinical and urodynamic parameters in the WW group. Conclusions: Patients with bladder outlet obstruction seem to remain clinically stable and to improve urodynamically when treated with alfuzosin for a long period of time.

Early surgery compared with watchful waiting for glue ear and effect on language development in preschool children: a randomised trial

Otitis media with effusion (OME) is the most common cause of hearing loss in children and is generally treated by elective surgery. We compared in children with persistent OME the effect on speech and language development of immediate surgery (ventilation-tube insertion) and watchful waiting before surgery. We did a randomised controlled trial with masked outcome assessment in Bristol Children's Hospital, Bristol, UK. We included 186 children born between April 1, 1991, and Dec 31, 1992, who had confirmed bilateral OME and bilateral hearing impairment of 25-70 dB of at least 3 months' duration. Children were randomly assigned surgery within 6 weeks (n=92), or 9 months of watchful waiting (n=90), after which bilateral tube insertion was done if required. We assessed hearing loss, expressive language, and verbal comprehension at 9 months and 18 months. At 9 months, standardised scores for expressive language and verbal comprehension differed between groups with marginal significance after adjustment for baseline differences (p=0.04 and p=0.028, respectively). At 9 months, verbal comprehension and expressive language skills in the watchful-waiting group were 3.24 months behind those in the early-surgery group. The watchful-waiting group was delayed on these two measures compared with their age-expected levels. 18 months after randomisation, 85% of children in the watchful-waiting group had received surgery and groups did not differ significantly. There is some benefit from ventilation-tube insertion for expressive language and verbal comprehension but the timing of surgery is not critical.

A Comparison of Transurethral Surgery with Watchful Waiting for Moderate Symptoms of Benign Prostatic Hyperplasia

Transurethral resection of the prostate is the most common surgical treatment for benign prostatic hyperplasia. We conducted a multicenter randomized trial to compare this surgery with watchful waiting in men with moderate symptoms of benign prostatic hyperplasia. Of 800 men over the age of 54 years who were screened between July 1986 and July 1989, 556 (mean [+/- SD] age, 66 +/- 5 years) were studied (280 in the surgery group and 276 in the watchful-waiting group). Patients' symptoms and the degree to which they were bothered by urinary difficulties were measured with standardized questionnaires and medical evaluations. The primary outcome measure was treatment failure, which was defined as the occurrence of any of the following: death, repeated or intractable urinary retention, a residual urinary volume over 350 ml, the development of bladder calculus, new and persistent incontinence, a high symptom score, or a doubling of the serum creatinine concentration. Patients were followed for three years. Of the men randomly assigned to the surgery group, 249 underwent surgery within two weeks after the assignment. Surgery was not associated with impotence or urinary incontinence. The average follow-up period was 2.8 years. In an intention-to-treat analysis, there were 23 treatment failures in the surgery group, as compared with 47 in the watchful-waiting group (relative risk, 0.48; 95 percent confidence interval, 0.30 to 0.77). Of the men assigned to the watchful-waiting group, 65 (24 percent) underwent surgery within three years after the assignment. Surgery was associated with improvement in symptoms and in scores for urinary difficulties and interference with activities of daily living (P < 0.001 for all comparisons). The outcomes of surgery were best for the men who were most bothered by urinary symptoms at base line. For men with moderate symptoms of benign prostatic hyperplasia, surgery is more effective than watchful waiting in reducing the rate of treatment failure and improving genitourinary symptoms. Watchful waiting is usually a safe alternative for men who are less bothered by urinary difficulty or who wish to delay surgery.