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Watchful waiting or watchful progression?: Prostate specific antigen doubling times and clinical behavior in patients with early untreated prostate carcinoma.

BACKGROUND: Prostate specific antigen doubling time (PSAdt) is a dynamic model of prostate tumor biology. It predicts aggressive disease and subsequent clinical recurrence after radical treatment. However, as yet there is only limited evidence for its validity in the watchful waiting population. METHODS: One hundred and thirteen previously untreated patients with adenocarcinoma of the prostate who were referred to the British Columbia Cancer Agency for a management opinion subsequently were placed into a prospective watchful waiting program. The reasons for watchful waiting, previous medical history, serial PSA, and histopathologic data were recorded. RESULTS: The median age of patients was 75 years (range, 49-85 years). The median follow-up from the time of the first appointment was 14 months (range, 0-58 months). The reasons for watchful waiting were correlated highly with T classification (P = 0.003) and past medical history (P = 0.002). Approximately 40% of T1 patients and 51% of T2 patients had clinical progression by 2 years, increasing to 60% at 3 years. On multivariate analysis PSAdt strongly correlated with clinical progression (P < 0.0001), stage progression (P = 0.01), and time to treatment (P = 0.0001); tumor grade and initial stage were not found to be predictive for any of the endpoints studied. Initial PSA only was significant in predicting for time to treatment (P = 0.03). Approximately 50% of patients with a PSAdt of <18 months progressed within 6 months. At last follow-up, no deaths from prostate carcinoma had been recorded. Overall survival at 2 and 5 years was 92% and 68%, respectively. CONCLUSIONS: Using digital rectal examination, the findings of this study demonstrated high rates of clinical tumor progression within the watchful waiting population. PSAdt rather than standard histopathologic criteria was found to be the most powerful indicator of disease activity.

Adenocarcinoma↗

A new look at an old option in the treatment of early-stage prostate cancer: hormone therapy as an alternative to watchful waiting.

Watchful waiting is an attractive option in the management of early-stage, low-grade prostate cancer because of the high financial costs and complication risks associated with surgery and radiotherapy. Despite the drawbacks of current local therapy, neither treatment can demonstrate a discernible survival benefit over observation alone. Even the slowest progressing disease, however, can potentially develop into a deadly medical problem. As a result, physicians and patients frequently have difficulty accepting untreated cancer. Therefore, we propose that another option be considered in cases of prostate cancer that would otherwise qualify for observation alone: the use of two oral hormonal agents, flutamide and finasteride, to achieve complete androgen blockade. Some evidence exists which suggests that such therapy may improve symptom-free survival, and perhaps overall survival as well. This 'aggressive' form of 'conservative' therapy may satisfy patient concerns that are not adequately addressed by current forms of therapy.

5-alpha Reductase Inhibitors↗

5-year outcome of surgical resection and watchful waiting for men with moderately symptomatic benign prostatic hyperplasia: a Department of Veterans Affairs cooperative study.

PURPOSE: We determine outcomes after 5 years of followup for men who were randomized to receive transurethral resection or watchful waiting for moderate symptoms of benign prostatic hyperplasia. MATERIALS AND METHODS: A total of 556 patients were evaluated up to 60 months after randomization providing 966 patient-years of followup for transurethral prostatic resection and 990 for watchful waiting. Patients randomized to watchful waiting were evaluated according to whether they remained on treatment or crossed over to surgery. Outcomes included treatment failure, a genitourinary symptom score, peak flow rate, post-void residual urine volume and the degree of bother from genitourinary symptoms. RESULTS: All outcomes were significantly better for transurethral prostatic resection than for watchful waiting. Treatment failure rates were 10% for transurethral prostatic resection versus 21% for watchful waiting (p = 0.0004). The crossover rate at 5 years was 36% and was positively associated with the degree of bother. Men with low pretreatment peak flow rates who were randomized to transurethral prostatic resection had 85% greater improvement in peak flow rate than comparable men who were randomized to watchful waiting and eventually crossed over to resection. However, after crossover, bother from genitourinary symptoms was similar to that of the resection group. CONCLUSIONS: For men with moderate symptoms of benign prostatic hyperplasia transurethral prostatic resection has more favorable outcomes up to 5 years of followup compared to watchful waiting. While many men do well on watchful waiting, those who undergo transurethral prostatic resection after a trial of watchful waiting have less improvement in measures of bladder function than men randomized to resection, although there is no difference in serious adverse outcomes or bother from genitourinary symptoms.

Follow-Up Studies↗

Do GPs have the techniques for 'watchful waiting' in glue ear?

'Watchful waiting' for glue ear in children within primary care as a precursor or alternative to surgery is one of the increasing pressures on general practitioners (GPs) to limit outpatient referrals. An equipment survey questions whether primary care is properly equipped to 'watch', given the limited access to audiological equipment that might objectively underpin a decision on when 'waiting' should end.

Audiometry↗

An analysis of watchful waiting for clinically localized prostate cancer.

PURPOSE: We reviewed recent series of watchful waiting for prostate cancer to place this management strategy in appropriate perspective MATERIALS AND METHODS: We reviewed the literature and analyzed the 9 articles on watchful waiting published in leading medical journals in the last decade. RESULTS: Watchful waiting is probably the best treatment option for men with well and perhaps moderately differentiated, low volume prostate cancer who have a life expectancy of less than 10 years. However, the conclusions derived from watchful waiting studies of older men cannot and should not be applied to younger, healthier men or to those with more advanced or aggressive disease. If treated ineffectively, many of these men will die of prostate cancer. CONCLUSIONS: Most men with prostate cancer who have a life expectancy greater than 10 to 15 years should be treated with curative intent.

Age Factors↗

Is 'watchful waiting' a real choice for men with prostate cancer? A qualitative study.

OBJECTIVE: To understand what leads men to choose 'watchful waiting' rather than active treatment for cancer of the prostate. PATIENTS AND METHODS: Fifty men with confirmed prostate cancer in England, Wales and Scotland were interviewed about all aspects of their illness, for a Database of Individual Patients' Experience of illness. The sample included men at different stages of diagnosis and with experience of a wide range of treatments. We report here only what men said about their choice of treatment and the decision-making process. RESULTS: Watchful waiting would have been clinically inappropriate for almost half of the men (those with serious urinary symptoms and those with metastatic disease). However, few of the men who might have chosen watchful-waiting remembered this being presented as a serious option. Most in this group chose radical prostatectomy, radiotherapy, brachytherapy or cryosurgery. The few who chose watchful waiting had found doctors who supported their decision, had assessed the evidence from Internet sites, and were concerned about the side-effects and uncertain outcome of treatment. Men who chose watchful waiting, as well as those who opted for treatment, described considerable pressure from family members, doctors or support groups, to seek active treatment. CONCLUSION: This study helps to explain why some men will not contemplate watchful waiting, and why others may find it difficult to pursue that option. Understanding men's concerns may help clinicians to support men's treatment decisions. Treatment for prostate cancer is highly controversial because no randomized, controlled trials have shown whether or not active intervention increases survival. If trials are not completed it cannot be determined whether active treatments are the best course of action for men with prostate cancer.

Aged↗

Watchful waiting in cases of small abdominal aortic aneurysms- appropriate for all patients?

OBJECTIVE: The purpose of this study was to determine the effect of patient compliance on a program of watchful waiting in cases of small abdominal aortic aneurysms and to document the proportion of patients who become prohibitive operative risks during follow-up. STUDY DESIGN: A retrospective review was conducted at a regional military veterans medical center. The subjects were 101 male military veterans with abdominal aortic aneurysms measuring less than 5 cm who did not have medical contraindications to operative repair. The main outcome measures were (1) the proportion of patients who missed three scheduled radiologic tests in a row despite written notifications mailed to their homes and (2) the proportion of compliant patients who had medical illnesses and became prohibitive operative risks during follow-up. RESULTS: During a follow-up (mean +/- SEM) of 34 +/- 2 months, 69 patients (69%) were fully compliant with the watchful waiting program and underwent a mean of 4.5 +/- 0.3 radiologic tests. There were no abdominal aortic aneurysm ruptures in this subgroup. Twenty-five patients (36%) had indications for abdominal aortic aneurysm repair, and 28 (41%) have not met the criteria for repair. Sixteen (23%) of the 69 compliant patients developed prohibitive medical risks during follow-up; eight (50%) of these 16 patients died, all of the causes unrelated to their abdominal aortic aneurysms. Thirty-two (32%) of the 101 study subjects were noncompliant with the watchful waiting program. Twenty-seven (84%) of the noncompliant patients did not keep any scheduled appointments, and five (16%) were lost after one or two examinations. Three of the noncompliant patients experienced documented abdominal aortic aneurysm rupture, and it is suspected in a fourth. Direct contact was made with 28 (88%) of these patients or their families; all acknowledged having received written notifications regarding their watchful waiting program tests and had decided not to continue with surveillance for a variety of socioeconomic reasons. Between the 69 compliant patients and the 32 noncompliant patients, there were no differences with respect to mean age (70 +/- 1 years vs 73 +/- 2 years), distance from home of record to the hospital (62 +/- 14 miles vs 73 +/- 23 miles), or abdominal aortic aneurysm size at initial detection (3.75 +/- 0.5 cm vs 3.8 +/- 0.5 cm). CONCLUSIONS: Watchful waiting programs are imperfect and highly reliant on the motivation levels and means of the individual patients. Watchful waiting is reasonable among compliant patients with abdominal aortic aneurysms, inasmuch as fewer than half will meet the criteria for intervention within a mean of 3 years. Approximately one fourth of these patients will have medical contraindications to abdominal aortic aneurysm repair during follow-up, and many of these will die of causes other than abdominal aortic aneurysm rupture. In our experience, one third of candidates for watchful waiting programs are unable to participate and are at risk of rupture. These patients need special attention so that the reasons for their noncompliance can be determined, and they may be candidates for earlier intervention.

Aged↗

A comparison of transurethral surgery with watchful waiting for moderate symptoms of benign prostatic hyperplasia. The Veterans Affairs Cooperative Study Group on Transurethral Resection of the Prostate.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Aged↗

Management of small abdominal aortic aneurysms. Early surgery vs watchful waiting.

OBJECTIVE: To compare two clinical strategies for the management of small abdominal aortic aneurysms (AAAs) less than 5 cm in diameter: early surgery (repair small AAAs when diagnosed) and watchful waiting (measure AAA size every 6 months and repair when the diameter reaches 5 cm). DATA SOURCES: We reviewed data from an earlier longitudinal study of patients with small AAAs to estimate incidence rates of rupture or acute expansion. Estimates for other parameters in the model were obtained by searching the medical literature (MEDLINE, 1966 to present). DATA SYNTHESIS: We constructed a Markov decision tree to compare early surgery with watchful waiting in patients with asymptomatic AAAs less than 5 cm in diameter, with respect to long-term survival in quality-adjusted life years. The average annual rates of rupture or acute expansion for AAAs with a maximal transverse diameter of less than 4.0, 4.0 to 4.9, and at least 5.0 cm, are 0, 3.3, and 14.4 events per 100 patient-years of observation, respectively. At an average rupture rate of 3.3 events per 100 patient-years and an average operative risk for elective surgery (4.6%, 30-day mortality), our model predicts that early surgery improves survival in patients who present with a 4-cm AAA. The benefit of early surgery decreases with increased age at presentation. If the average rupture rate for AAAs less than 5 cm is assumed to be low (eg, 0.4 event per 100 patient-years), watchful waiting if favored, particularly as operative risk increases. The decision in this subgroup, however, is sensitive to possible future increases in operative risk. CONCLUSIONS: In the majority of scenarios that we examined, early surgery is preferred to watchful waiting for patients with AAAs less than 5 cm in diameter. Watchful waiting is generally favored, however, for patients with a low risk of AAA rupture or acute expansion, including those patients who present with very small AAAs (eg, < 4 cm). More accurate data concerning the rupture risk of AAAs less than 5 cm would improve clinical decision making.

Aortic Aneurysm, Abdominal↗

A randomized trial comparing radical prostatectomy with watchful waiting in early prostate cancer.

BACKGROUND: Radical prostatectomy is widely used in the treatment of early prostate cancer. The possible survival benefit of this treatment, however, is unclear. We conducted a randomized trial to address this question. METHODS: From October 1989 through February 1999, 695 men with newly diagnosed prostate cancer in International Union against Cancer clinical stage T1b, T1c, or T2 were randomly assigned to watchful waiting or radical prostatectomy. We achieved complete follow-up through the year 2000 with blinded evaluation of causes of death. The primary end point was death due to prostate cancer, and the secondary end points were overall mortality, metastasis-free survival, and local progression. RESULTS: During a median of 6.2 years of follow-up, 62 men in the watchful-waiting group and 53 in the radical-prostatectomy group died (P=0.31). Death due to prostate cancer occurred in 31 of 348 of those assigned to watchful waiting (8.9 percent) and in 16 of 347 of those assigned to radical prostatectomy (4.6 percent) (relative hazard, 0.50; 95 percent confidence interval, 0.27 to 0.91; P=0.02). Death due to other causes occurred in 31 of 348 men in the watchful-waiting group (8.9 percent) and in 37 of 347 men in the radical-prostatectomy group (10.6 percent). The men assigned to surgery had a lower relative risk of distant metastases than the men assigned to watchful waiting (relative hazard, 0.63; 95 percent confidence interval, 0.41 to 0.96). CONCLUSIONS: In this randomized trial, radical prostatectomy significantly reduced disease-specific mortality, but there was no significant difference between surgery and watchful waiting in terms of overall survival.

Aged↗

Randomised controlled trial of early surgery versus watchful waiting for glue ear: the effect on behavioural problems in pre-school children.

This trial was designed to compare early surgery with watchful waiting for persistent bilateral otitis media with effusion (OME) in terms of hearing loss and behavioural problems in pre-school children. A randomised controlled trial compared the effects of early treatment with ventilation tubes versus watchful waiting for 9 months. Results were analysed by intention-to-treat. One hundred and eighty-two pre-school children (date of birth between 1 April 1991 and 31 December 1992), mean age of 2.9 years (SD 0.85) with at least a 3-month history of bilateral OME and hearing loss of greater than 25 dB were treated in Bristol Children's Hospital between November 1993 and January 1996. Bilateral ventilation tubes were inserted within 6 weeks of randomisation or within 6 weeks of reassessment after 9 months of watchful waiting, with a final assessment at 18 months. The main outcome measures were behavioural problems, measured by the Richman Behaviour Checklist, and hearing loss at 4000 Hz in the better hearing ear. Early surgical intervention significantly reduced behavioural problems by 17% (95% CI, 2% - 33%). This difference was largely mediated by concurrent hearing loss. After 18 months, there was no longer a significant difference (95% Cl, -19% to +10%). However, the majority (85%) of the Watchful Waiting group had required surgery and 22% of all children still had behavioural problems.

Child Behavior Disorders↗

The cost-effectiveness of early surgery versus watchful waiting in the management of small abdominal aortic aneurysms.

PURPOSE: The purpose of this study was to compare the relative cost-effectiveness of two clinical strategies for managing 4 to 5 cm diameter abdominal aortic aneurysms (AAAs): early surgery (repair 4 cm AAA when diagnosed) versus watchful waiting (monitor AAA with ultrasound size measurements every 6 months and repair if the diameter reaches 5 cm). METHODS: We used a Markov decision tree to compute the expected survival in quality-adjusted life years (QALYs) for each strategy, based on literature-derived estimates for the probabilities of different outcomes in this model. We determined hospital costs for patients undergoing elective and emergency AAA repair at our center. With standard methods of cost accounting, we then calculated the additional cost per year of life saved by early surgery compared with watchful waiting (cost-effectiveness ratio, dollars/QALY). RESULTS: Mean hospital costs for elective and emergency AAA repair were $24,020 and $43,208, respectively (1992 dollars). For our base-case analysis (60-year-old men with 4 cm diameter AAAs, with 5% elective operative mortality rate and 3.3% annual rupture rate), early surgery improved survival by 0.34 QALYs compared with watchful waiting, at an incremental cost of $17,404/QALY. Increased elective surgical mortality rate, decreased AAA rupture risk, and increased patient age all reduced the cost-effectiveness of early surgery. Future increases in elective operative risk, noncompliance with ultrasound follow-up and increased threshold size for elective AAA repair during watchful waiting all improved the cost-effectiveness of early surgery. Future increases in elective operative risk, noncompliance with ultrasound follow-up and increased threshold size for elective AAA repair during watchful waiting all improved the cost-effectiveness of early surgery. CONCLUSIONS: The cost effectiveness of early surgery for 4 cm diameter AAAs in carefully selected patients compares favorably with that of other commonly accepted preventive interventions such as hypertension screening and treatment. With an upper limit of $40,000/QALY as an "acceptable" cost-effectiveness ratio, early surgery appears to be justified for patients 70 years old or younger, if the AAA rupture risk is 3%/year or more and the elective operative mortality rate is 5% or less. Although not a substitute for clinical judgment, this cost-effectiveness analysis delineates the essential tradeoffs and uncertainties in treating patients with small AAAs.

Aged↗

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

BACKGROUND: 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. METHODS: 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. FINDINGS: 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. INTERPRETATION: There is some benefit from ventilation-tube insertion for expressive language and verbal comprehension but the timing of surgery is not critical.

Acoustic Impedance Tests↗

The role of watchful waiting in the management of localized prostate cancer.

The management of localized prostate cancer remains controversial. Watchful waiting or conservative management is frequently criticized as a poor option for this disease. However, studies have shown that a high percentage of men are free of metastases at 10 years provided they have well or moderately differentiated prostate cancer. Watchful waiting, like radiation or radical prostatectomy, has a set of advantages and disadvantages that must be compared by each patient when choosing therapy. The best approach may be to have patients select a therapy after being well informed of the outcome for each option. Watchful waiting is a valid option for all men regardless of age or health status. However, radical prostatectomy still offers the best opportunity to cure the disease.

Age Factors↗

The development of a clinical trial to determine if watchful waiting is an acceptable alternative to routine herniorrhaphy for patients with minimal or no hernia symptoms.

BACKGROUND: This article describes the development and implementation of a randomized clinical trial designed to answer the question: Is watchful waiting an acceptable alternative to operation for men with asymptomatic or minimally symptomatic inguinal hernias? STUDY DESIGN: A clinical trial has been designed to compare watchful waiting and operation for men with an asymptomatic or a relatively asymptomatic inguinal hernia. Men are randomized to watchful waiting or a standard open operation, the Lichtenstein tension-free hernia repair, and are followed for a minimum of 2 years. The target sample size of 753 patients was chosen so that the trial would have power sufficiently high to detect a clinically meaningful difference between treatment groups in either of the two primary outcomes as measured at 2 years: pain or discomfort interfering with normal activities and the physical component summary score of the SF-36 health-related quality-of-life survey. The study was begun in five centers located in both community and academic environments. At 18 months, a sixth site was added and at 28 months, after enrollment of 145 patients, one of the centers was terminated for reasons related to inadequate followup; all data from this center were deleted. As a routine measure, an independent experienced trial manager audited all clinical sites. RESULTS: Enrollment of patients began in January 2000 and will end on December 31, 2002. As of November 1, 2002, 637 patients had been randomized, 85% of the target enrollment. An additional 2,115 patients were screened but not randomized, yielding a recruitment rate of 23.1%. Analysis and publication of the results of the study will take place on completion of the minimum 2-year followup period for all patients. CONCLUSIONS: A trial to compare the outcomes of watchful waiting and operation for management of inguinal hernias in men is needed to provide data to surgeons and to patients that can aid in choice of treatment. A description of the design of such a trial is presented.

Follow-Up Studies↗

Comparison of percent free prostate-specific antigen levels in men with benign prostatic hyperplasia treated with finasteride, terazosin, or watchful waiting.

OBJECTIVES: Finasteride is known to lower total serum prostate-specific antigen (PSA) levels by approximately 50%. Terazosin is thought to have little or no effect on serum PSA concentration. The objective of our study was to determine the effect of finasteride and terazosin on serum total and serum free PSA levels and the ratio of free to total PSA. METHODS: We identified 69 men with symptomatic benign prostatic hyperplasia (BPH) who had been receiving 5 mg/day (n = 33) of finasteride or 2 to 5 mg/day (n = 14) of terazosin or no therapy ("watchful waiting") (n = 22). The three groups were compared with respect to pretreatment total serum PSA levels and post-treatment total, free, and percent free serum PSA levels. RESULTS: Median (+/- semi-interquartile range [SIR]) pretreatment total serum PSA levels (ng/mL) were not significantly different in men taking finasteride (2.8 +/- 1.9), terazosin (2.2 +/- 2.5), or undergoing watchful waiting (5.5 +/- 1.4) (P = 0.12). The median (+/- SIR) post-treatment total serum PSA levels (ng/mL) were significantly lower in the finasteride group (1.1 +/- 1) when compared with the terazosin (2.5 +/- 1.5) or watchful waiting (4.3 +/- 2.8) groups (P = 0.016). Only the finasteride group had significantly lower post-treatment total serum PSA levels compared with pretreatment levels. The median (+/- SIR) post-treatment free PSA levels were significantly lower in the finasteride group (0.26 +/- 0.16) compared with the terazosin (0.54 +/- 0.5) and watchful waiting (0.85 +/- 0.5) groups (P = 0.0015). However, the median (+/- SIR) percent free PSA was not significantly different in the finasteride (23 +/- 6), terazosin (22 +/- 4), and watchful waiting (25 +/- 5) groups (P = 0.66). CONCLUSIONS: Finasteride appears to lower total and free PSA levels equally in men with BPH and does not appear to change the ratio of free to total serum PSA. Terazosin does not appear to alter total or free serum PSA levels in men with BPH. The percent free PSA could potentially be used to screen for prostate cancer in men taking finasteride. Prospective studies are needed to further evaluate this issue.

Adrenergic alpha-Antagonists↗

Uncertainty and quality of life of older men who undergo watchful waiting for prostate cancer.

PURPOSE/OBJECTIVES: To explore uncertainty, anxiety, and the personal manner in which uncertainty is understood, and explain the health-related and affective quality of life (QOL) of men who undergo watchful waiting for prostate cancer. DESIGN: Descriptive, quantitative, survey approach. SETTING: United States. SAMPLE: A national sample of 21 men diagnosed with prostate cancer (mean age = 76 years) who had elected to receive no treatment for their disease. METHODS: 19 subjects who met the criteria contacted the researcher and completed the mailed questionnaire. MAIN RESEARCH VARIABLES: Uncertainty and QOL. FINDINGS: Moderate yet significant relationships were found between each of the independent variables. Significant relationships were found among uncertainty, anxiety, and the perception of danger (a dimension of QOL). Using hierarchical multiple regression, a model was built to explain 60% of the variance in this QOL dimension. CONCLUSIONS: This study supports that men who undergo watchful waiting are uncertain and that this uncertainty results in their perception of danger and influences their affective health-functioning QOL. This study lends further support for the Uncertainty in Illness Model in the watchful waiting population. IMPLICATIONS FOR NURSING: The findings of this study imply that increased teaching and patient care management regarding watchful waiting are needed both before and after the treatment decision has been made. This study provides the framework for further study on interventions to improve the QOL of this population.

Aged↗

Oral erythromycin prophylaxis vs watchful waiting in caring for newborns exposed to Chlamydia trachomatis.

BACKGROUND: Chlamydia trachomatis exposure at birth may cause conjunctivitis or pneumonia. Until recently, a course of oral erythromycin prophylaxis was recommended for C trachomatis-exposed neonates. However, recognition of an association between erythromycin and pyloric stenosis prompted a change to a watchful waiting recommendation under which only infants who develop symptomatic C trachomatis infection are treated with oral erythromycin. OBJECTIVE: To compare erythromycin prophylaxis with watchful waiting for a hypothetical cohort of 100 000 neonates exposed to C trachomatis. METHODS: In a decision tree, potential outcomes were C trachomatis conjunctivitis, C trachomatis pneumonia (which could require inpatient or outpatient therapy), no clinical disease, and pyloric stenosis. Published data were reviewed to derive probability point estimates and ranges. Estimated charges served as outcome measures. RESULTS: Watchful waiting is less expensive than erythromycin prophylaxis ($15.1 million vs $28.3 million); prophylaxis prevents 5986 cases of C trachomatis pneumonia, including 1197 hospital admissions, but causes 3284 pyloric stenosis cases. (For every 30 infants given oral erythromycin prophylaxis, one additional case of pyloric stenosis would be expected to occur, and approximately 1.8 cases of C trachomatis pneumonia would be prevented.) In sensitivity analyses, if more than 3.4% of exposed neonates are hospitalized for C trachomatis pneumonia, prophylaxis becomes favored. CONCLUSIONS: This study supports the watchful waiting recommendation for asymptomatic C trachomatis-exposed neonates. However, there are wide plausible ranges for pyloric stenosis risk after erythromycin administration and for the incidence of C trachomatis pneumonia severe enough to require hospitalization; under some combinations of these rates, prophylaxis could be favored.

Anti-Bacterial Agents↗