Understanding results.

Purpose: Properly conducted clinical trials provide essential evidence about the benefits and harms of a therapeutic intervention. To ensure accurate interpretation of study findings urologists should understand measures of effect and their precision. In this segment of the Users' Guide to the Urological Literature series we provide guidance on how measures of effect and precision should be interpreted and used in the evidence-based practice of urology.

Evaluating the evidence: the methodological and reporting quality of comparative observational studies of surgical interventions in urological publications.

Objective: To develop and apply a standardized evaluation form for assessing the methodological and reporting quality of observational studies of surgical interventions in urology.

Methods: An evaluation standard was developed using the Consolidated Standards for Reporting Trials statement and previously reported surgical reporting quality instruments. Consensus scoring among three reviewers was developed using two distinct sets of studies.

Renal sarcoma and associated malignant pulmonary embolism: a report of 2 cases.

Renal sarcoma with venous tumour thrombus is usually an aggressive malignancy that necessitates complete surgical extirpation to achieve cure. Due to the rarity of these tumours, clinicians rely on case reports to better understand and treat patients with this disease. We recently encountered 2 patients with renal sarcoma who developed malignant pulmonary embolus.

Preservation of renal function following partial or radical nephrectomy using 24-hour creatinine clearance.

Objective: To compare the effect on renal function of partial and radical nephrectomy using creatinine clearance measurements from 24-hr urine collection.

Methods: All patients with a solid enhancing renal mass suspicious for renal cell carcinoma, a normal contralateral kidney, and not dialysis dependent were enrolled in this prospective cohort study. Patients were treated with partial or radical nephrectomy by one urologist.

Surgical wound complications after intensive chemoradiotherapy for advanced squamous cell carcinoma of the head and neck.

Objective: To define the rate of complications from surgery following intensive chemoradiotherapy in patients with advanced squamous cell carcinoma of the head and neck.

Design: The medical records of 131 consecutive patients treated with a combination of chemotherapy and radiation therapy for head and neck squamous cell carcinoma from 1995 through 2002 were reviewed. Thirty-eight patients underwent 50 surgical procedures.

Inadequate statistical power of negative clinical trials in urological literature.

Purpose: Negative studies provide valuable information. However, conducting studies with inadequate power is unethical and an inefficient use of resources. The purpose of this study was to determine the prevalence of negative studies with inadequate power in urological literature.

Spread of prostate carcinoma to the perirectal lymph node basin: analysis of 112 rectal resections over a 10-year span for primary rectal adenocarcinoma.

We recently identified metastatic prostate carcinoma (PCA) within perirectal lymph nodes (PLNs) from 2 patients undergoing abdominoperineal resection (APR) for rectal adenocarcinoma (RA). As this phenomenon has not been addressed by any studies in the literature and because these positive PLNs had the potential to be mistakenly diagnosed as metastatic RA, we were prompted to undertake a retrospective study of rectal resections for RA to determine the frequency of PCA metastasizing to the PLNs in this patient population. The laboratory information system of the Department of Pathology, Capital Health, Halifax, Nova Scotia was searched for lymph node (LN)-positive RAs resected by low anterior resection or APR in male patients between January 1, 1992 and December 31, 2002.

Intensive chemoradiotherapy as a primary treatment for organ preservation in patients with advanced cancer of the head and neck: efficacy, toxic effects, and limitations.

Objectives: To evaluate the efficacy and toxic effects of intensive chemoradiotherapy as a primary modality for organ preservation in patients with advanced squamous cell carcinoma of the head and neck (SCCHN) and to define the patterns of treatment failure associated with this therapy.

Design: Retrospective review.

Setting: Tertiary care referral center.

Preferential expression of hPGFS in primary SCCHN and tumour cell lines derived from respiratory and digestive organs.

Identifying overexpressed genes in tumours is a critical step for tumour diagnosis, prognosis, and treatment. Using differential display polymerase chain reaction, sequence analysis, and gene Blast searches, we discovered that human prostaglandin F synthase (hPGFS) was upregulated in squamous cell carcinoma of the head and neck (SCCHN). Northern blot analysis indicated that up to a 16-fold increase in the level of hPGFS expression was detected in 40.

Assessing self-help issues for patients with prostate cancer, interstitial cystitis, erectile dysfunction and urinary diversion.

Objective: To determine the prevalence of self-help (which is widely available and can assist clinicians to educate and empower patients) for several urological diseases.

Patients And Methods: Using a structured interview, the prevalence of self-help use and awareness was assessed in patients with prostate cancer, interstitial cystitis, erectile dysfunction and urinary diversion. Patients were also asked to report levels of support and information they required and to specify how well these needs were being met.

The role of self-help groups in educating and supporting patients with prostate cancer and interstitial cystitis.

Objectives: To identify and compare the needs of patients with prostate cancer or interstitial cystitis (IC), and to evaluate the role of self-help groups (SHGs) in meeting those needs, as SHGs are thought to be an important source of information and social support for such patients.

Methods: The authors attended SHG meetings for prostate cancer and IC from September 2000 to May 2001. Issues related to SHGs were addressed by combining their experiences with those published previously.

Cancer of the external auditory canal and temporal bone.

Malignant neoplasms involving the temporal bone are a relatively rare and often misdiagnosed disease. Staging of temporal bone cancer has proven difficult because of the small number of patients with this condition, the various histopathologic and histologic findings reported, and a lack of randomized trials. Of the various staging systems that have been proposed, the Pittsburgh classification appears to be the most widely accepted.

Optimal prevention and management of proximal ureteral stent migration and remigration.

Purpose: We evaluated issues associated with proximal ureteral stent migration and remigration, including causes and management, and the predictability of ureteral length.

Materials And Methods: All proximal ureteral stent migrations that occurred from January 1997 to March 2000 were reviewed. Characteristics and treatment of the 33 patients with proximal ureteral stent migration were compared with those of 66 randomly selected controls who did not have stent migration.

Lingual thyroid: iodine 131: a viable treatment modality revisited.

Purpose: Lingual thyroid has a reported incidence between 1:10 and 1:100,000. When symptomatic, patients may present with dysphagia, choking, and/or dyspnea. Current surgical treatment options range from tumor extirpation or transposition to excision and reimplantation.

Intramuscular electroporation delivery of IL-12 gene for treatment of squamous cell carcinoma located at distant site.

Gene therapy with IL-12 has been shown to elicit potent systemic antitumor response in a variety of tumors. Although direct intratumoral injection is the most commonly used delivery route for gene therapy of solid tumors, the skeletal muscle has been shown to be an ideal tissue for gene delivery to produce systemic gene expression. We have previously demonstrated that electroporation delivery of a reporter gene to muscle enhances the transfection efficiency and the level of gene expression by two to three logs.

Intramuscular electroporation delivery of IFN-alpha gene therapy for inhibition of tumor growth located at a distant site.

Although electroporation has been shown in recent years to be a powerful method for delivering genes to muscle, no gene therapy via electro-injection has been studied for the treatment of tumors. In an immunocompetent tumor-bearing murine model, we have found that delivery of a low dose of reporter gene DNA (10 microg) to muscle via electroporation under specific pulse conditions (two 25-ms pulses of 375 V/cm) increased the level of gene expression by two logs of magnitude. Moreover, administration of 10 microg of interferon (IFN)-alpha DNA plasmid using these parameters once a week for 3 weeks increased the survival time and reduced squamous cell carcinoma (SCC) growth at a distant site in the C3H/HeJ-immunocompetent mouse.

A novel alternative approach for prediction of radiation response of squamous cell carcinoma of head and neck.

Accurate prediction of human tumor response to radiation therapy and concomitant chemoradiation would be an important tool to assist the physician in making recommendations for tumor treatment. Most of the studies that define the molecular markers for prediction of radiation response are based on the observation of gene expression using immunostaining, Northern blot, or Western blot analysis of a single or several genes. The results vary among different studies, and some results are contradictory.

Telomerase activity in head and neck tumors after introduction of wild-type p53, p21, p16, and E2F-1 genes by means of recombinant adenovirus.

Background: Telomerase (reverse transcriptase) has been shown to play a role in the process of cellular immortalization.

Methods: Telomerase activity was determined in 11 head and neck squamous cell carcinoma (SCCHN) cell lines. The effects of wild-type p16, p21, E2F-1, and p53 genes on telomerase activity were examined by introducing the wild-type genes into two SCCHN cell lines by means of a recombinant adenovirus.

Apoptosis induction by E2F-1 via adenoviral-mediated gene transfer results in growth suppression of head and neck squamous cell carcinoma cell lines.

E2F-1, a transcription factor by discovery, is thought to play a crucial role in regulating G1/S cell cycle progression. Its activity is modulated by complex formation with the retinoblastoma protein and related proteins. Overexpression of E2F-1 has been shown to induce apoptosis in quiescent fibroblasts.

Management of the N(0) neck.

Paramount among the challenges and controversies among the head and neck surgeon is the proper treatment of the N0 neck. Therapeutic intervention for the N0 neck usually involves any of two treatment modalities alone or in combination: surgery or radiation therapy. This article discusses the potential treatment strategies for possible subclinical neck metastasis and the rationale for their use on a site by site basis for head and neck primary tumors.