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Biomedical subjects

J Irani

Publications and source records attributed to J Irani.

At least 19 recordsLinked to original sources

[Structure of a medical article].

The publication of medical research results requires that articles are drafted with a current well-codified structure that must be respected to convince the editorial board of a review and then its readers. The title must be short and relevant in order to best reflect the contents of the article and to allow its effective search on the Internet. The universally adopted structure is the IMRAD (Introduction Methods, Results and Discussion). The introduction is a prerequisite; it presents current knowledge on the problem studied, justifies the subject of the work and specifies its objective within this context. The "Methods" section describes the population, the type of study and its methodology, the equipment used, the primary and secondary end-points studied as well as the statistical methods used for analysis. The "Results" section describes the raw results associated with the statistical tests illustrated by relevant tables and figures. The "Discussion" section is used to underline results that are considered to be important and to compare them with those already published in the field. It may also contain comments on potential bias and suggest the impact of the results on daily practice and/or future research. A conclusion may finalize the discussion or form the subject matter for an independent section. Lastly, all articles include a relevant summary and a suitable bibliography.

Periodicals as Topic↗

[Clinical practice guidelines (CPG): are they useful? Example of the benign prostatic hyperplasia (BPH)].

Clinicians develop routine strategies with multiple and sometimes hardly relevant origins. The logical theoretical solution would be to make available systematically drafted clinical practice guidelines (CPG) with the aim of helping the physician during daily practice. These CPG summarize the best available proofs and relate each recommendation to a level of proof. However, if the CPG is not rigorously drafted, their usefulness is questionable. The AGREE scale, translated into several languages and used by several european countries, including France (ANAES), is useful for the evaluation of the quality of drafting of a CPG but also as a guide when making a CPG. The analysis of different CPG for the management of benign prostatic hyperplasia (HBP) originating from different countries and companies shows important variations which are best explained by large differences in the rigour of drafting. Besides, whatever the quality of the CPG, they too often neglect the key element which is its application in practice. A survey of the modalities of prescription of subsequent examinations in France in HBP demonstrates an important disparity between CPG and routine attitudes in clinical practice. A potential solution may require a deeper involvement of the learned urologic society in the drafting and distribution of the CPG.

Humans↗

Obesity in relation to prostate cancer risk: comparison with a population having benign prostatic hyperplasia.

OBJECTIVE: To analyse the relationship between obesity and prostate cancer, when compared with men with benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: The records were reviewed of consecutive patients with histologically confirmed prostate cancer admitted for prostate surgery between January 1993 and February 1999. Controls were selected from patients who were hospitalized at the same time for the surgical treatment of BPH. One control was matched to each case by age. Obesity was defined as a body mass index (BMI) of> 29 kg/m2. RESULTS: The study included 194 cases and 194 controls; their median (range) age at operation was 69.5 (50-88) years in both groups, and the BMI 26.1 (16.6-38.1) kg/m2 in the cancer and 25.7 (15.1-36.8) kg/m2 in the BPH group. The difference between the groups was not significant (P = 0.06). Obesity was significantly associated with prostate cancer, with an odds ratio (95% confidence interval) of 2.47 (1.41-4.34). Cases with advanced disease had a higher BMI than those with localized disease, but when age was considered the difference was not significant. CONCLUSION: In general the BMI was not significantly associated with prostate cancer when compared with men having BPH. However, obese men had 2.5 times the risk of having prostate cancer.

Aged↗

A review of guidelines on benign prostatic hyperplasia and lower urinary tract symptoms: are all guidelines the same?

OBJECTIVE: To compare overall and methodological quality with content in national and supra-national Clinical Practice Guidelines (CPGs) on benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS), as the purpose of CPGs is to reduce unwanted variation in practice and improve patient care by setting agreed standards based on the best available evidence. METHODS: An electronic search was used to identify Internet-based national and supra-national CPGs on BPH and LUTS available in 2001. Two independent assessors analysed the content and appraised the methodological quality of the CPGs using an existing and validated instrument (St. George's Hospital Medical School Health Care Evaluation Unit Appraisal Instrument) comprising 37 items grouped into three broad areas, i.e. rigour of development, context and content, and clinical application. RESULTS: Eight CPGs were suitable for appraisal; there was much variation in overall and methodological quality. There was agreement that a patient history and physical examination (including a digital rectal examination) should be used in all symptomatic men. In addition, patients' symptoms should be assessed using a validated symptom score, e.g. the International Prostate Symptom Score. There was considerable variation in the number and type of diagnostic tests recommended for routine assessment. CPGs scoring low on the appraisal instrument (indicating poor overall and methodological quality) were more likely to recommend more diagnostic tests than those scoring high. There was general agreement between the guidelines on the treatment of BPH/LUTS and the importance of the patient's involvement in making management decisions. Guideline quality was independent of local health resources and publication year. CONCLUSION: The overall and methodological quality of CPGs on BPH/LUTS varies considerably. There appears to be an inverse relationship between guideline quality and the number of diagnostic tests recommended for routine assessment. Using CPGs of high quality may prevent men with BPH/LUTS being exposed to tests of doubtful utility. Although this may reduce both resource use and exposure to potential harm, moving to a more minimalist approach to diagnosis may itself be potentially harmful to patients.

Decision Making↗

Effect of nonsteroidal anti-inflammatory agents and finasteride on prostate cancer risk.

PURPOSE: We examine the relationship of nonsteroidal anti-inflammatory drugs and finasteride on the risk of prostate cancer. MATERIALS AND METHODS: Participants in this case control study using a prospective collection of data were drawn from consecutive patients who underwent prostate biopsy at 12 different departments of urology from January 1999 to June 2000. Medication use was assessed by self-questionnaire as well as questions about dietary and lifestyle factors that might be relevant for prostate cancer risk. RESULTS: The study included 639 patients with prostate cancer and 659 cancer-free controls. Univariate analysis showed no significant impact of aspirin and finasteride on prostate cancer risk while the nonaspirin nonsteroidal anti-inflammatory drug users had a lower risk (OR 0.80, 95% CI 0.64-0.99). After adjusting for potential confounders, the protective effect of nonaspirin nonsteroidal anti-inflammatory drugs was no longer significant (OR, 0.84, 95% CI 0.66-1.07), while finasteride showed a significant protective effect (OR 0.58, 95% CI 0.37-0.92). CONCLUSIONS: The results suggest that finasteride could have a chemopreventive role in prostate cancer. While aspirin did not show any impact on prostate cancer risk, the role of nonaspirin nonsteroidal anti-inflammatory drugs warrants further studies.

Aged↗

A prospective radiological anatomical study of the variations of the position of the colon in the left pararenal space.

Percutaneous puncture of the kidney allows direct access to the pyelocalicial cavities. The posterior approach of this retroperitoneal organ can be complicated of transcolic punctures due to the postrenal position of the colon. A prospective radiological anatomical study of the relationship between the left kidney and the descending colon was undertaken. One hundred computed tomograms of adult subjects were obtained from which the anatomy of the left perirenal area was determined: the descending colon is more frequently behind the kidney in the young females. Two main factors determinants of this situation are: 1) colon ontogenesis in relation to the attachment of the primitive mesocolon, permitting a 'fixed' left colon, or 'moving' left colon at the end of a long mesocolon, allowing it to pass behind the kidney; 2) a mechanical factor whereby the accumulation of perirenal fat with increasing age may be a limiting factor in lateral displacement of the colon.

Adult↗

Tolerability of bacille Calmette-Guérin maintenance therapy for superficial bladder cancer.

OBJECTIVES: To study the influence of adverse reactions on adherence to an immunotherapy maintenance schedule and the recurrence rate of bladder cancer. Bacille Calmette-Guérin immunotherapy has documented efficacy in the management of high-risk superficial bladder cancer. However, the optimal duration of intravesical bacille Calmette-Guérin therapy and the risk/benefit ratio of maintenance therapy are controversial. METHODS: From April 1996 to April 2000, 72 patients with superficial bladder cancer were treated with Immucyst (six consecutive weekly instillations of 81 mg) and then received maintenance therapy consisting of three consecutive weekly instillations 3, 6, 12, 18, 24, 30, and 36 months later. Adverse reactions, studied during 518 instillations, were classified in four categories using a scale based on the World Health Organization recommendations, and their impact on the adherence to therapy was analyzed. RESULTS: After an average follow-up of 24 months, a durable disease-free response was observed in 84.9% of the patients; 12.5% of patients had a relapse and 2.6% had disease progression. The response rate was similar in patients with and without adverse reactions. Only 14 patients (19%) received all the scheduled maintenance instillations. The dose was reduced in 41 patients (57%), and treatment was stopped in 28 patients (39%). In multivariate analysis, an adverse event score of 1.5 or greater during induction therapy was significantly associated with cessation or modification of maintenance therapy (P = 0.01). CONCLUSIONS: The scale developed in this study to monitor the adverse reactions to bacille Calmette-Guérin and their impact on the adherence to maintenance therapy may be helpful for tailoring maintenance regimens or implementing protective measures (dose reduction or treatment postponement).

Adjuvants, Immunologic↗

Leukocyturia as a predictor of tolerance and efficacy of intravesical BCG maintenance therapy for superficial bladder cancer.

OBJECTIVES: To examine leukocyturia as a predictor of tumor recurrence and occurrence of adverse events after bacille Calmette-Guérin (BCG) immunotherapy. The use of BCG immunotherapy, a very major advance in the management of superficial bladder cancer, is limited by the frequency of adverse events. As yet, we have no way of predicting the efficacy and tolerability of BCG instillation in clinical practice. This problem is even more acute during BCG maintenance therapy. METHODS: Adverse events in 72 patients who received 518 instillations were prospectively assessed using a four-class scale based on severity and duration. Urinary leukocytes were counted 3 days after each instillation, using the KOVA-Slide 10 method. RESULTS: High leukocyturia during BCG treatment (cutoff value 1.65 x 10(5)/mL urine) correlated with recurrence-free status (P = 0.009). The degree of leukocyturia correlated with the severity/duration of adverse events (P <0.0001); the median leukocyturia values associated with class I, II, and III adverse events were 4 x 10(4)/mL, 1.5 x 10(5)/mL, and 3.5 x 10(5)/mL, respectively. No class IV events occurred. The cutoff point indicating treatment cessation for adverse events was leukocyturia of 8.6 x 10(4)/mL. CONCLUSIONS: These results suggest a link between adverse events and efficacy during BCG maintenance therapy. Leukocyturia appears to correlate with both efficacy and tolerability in this setting. Prospective randomized studies are required to evaluate leukocyturia as a basis on which to adapt the BCG instillation schedule to individual patient susceptibility.

Administration, Intravesical↗

Tumor progression and survival in patients with T1G3 bladder tumors: multicentric retrospective study comparing 94 patients treated during 17 years.

OBJECTIVES: To compare tumor recurrence, progression, and patient survival in T1G3 bladder tumors treated with transurethral resection (TUR) alone, early cystectomy, or TUR with an adjuvant 6-week course of bacille Calmette-Guérin (BCG) and followed up for a minimum of 5 years. METHODS: Between 1979 and 1996, 94 patients with T1G3 bladder tumors (lamina propria invasion) were treated at nine different centers. The time to tumor recurrence, tumor stage and grade progression, number of delayed cystectomies, and patient survival were analyzed retrospectively in relation to the initial treatment. RESULTS: The mean follow-up was 62 months. Thirty patients were treated by TUR alone (32%), 50 patients by TUR plus BCG (53%), and 14 patients by primary cystectomy (15%). The recurrence, progression, and cystectomy rates were significantly different between patients treated by TUR alone and TUR plus BCG (Fisher's exact test, P = 0.0005, P = 0.02, and P = 0.005, respectively). The disease-free survival was also significantly different when comparing TUR plus BCG with TUR alone or primary cystectomy (Kaplan-Meier analysis, log-rank test, P = 0.02). CONCLUSIONS: Endoscopic resection plus BCG treatment of pT1G3 tumors allows an 80% rate of disease-free 5-year survival with bladder preservation. This conservative option has been widely accepted as first-line treatment, offering good cancer control with excellent quality of life. Very accurate surgical and pathologic evaluations before treatment and lifelong follow-up are obviously required.

Aged↗

Renal tumor size: comparison between computed tomography and surgical measurements.

OBJECTIVE: We studied the agreement between renal tumor size as assessed on computed tomography (CT) before surgery and that measured during histopathological examination on the radical nephrectomy specimen. METHODS: We retrospectively analyzed the records of 100 consecutive patients treated with radical nephrectomy for a renal tumor. The tumor size was determined in all patients by the largest diameter shown within the month before surgery on contrast-enhanced CT and as measured postoperatively by the pathologist. A possible influence of the clinical and pathological parameters was assessed in a multivariate analysis. RESULTS: CT estimate and surgical measurement of tumor size were highly correlated (r = 0.9; p<0.001). Median (range) tumor size was 70.0 mm (13-180) and 60.0 mm (10-180) as measured, respectively, on CT and in the specimen, with a significant difference (p = 0.005). Multiple regression did not reveal any significant influence of tumor side, location, type, nuclear grade as well as patient gender, body mass index and radiological center (p>0.3 in all cases). The extent of difference between CT and surgical measurements was significantly influenced by the surgical size of the tumor (p = 0.03): the smaller the tumor, the more the CT overestimated the tumor size. If nephron-sparing surgery had been planned for tumors equal to or less than 40 mm, 24 patients would have been selected following the CT estimate, while 27 patients would have met this criterion on the surgical measurement. CONCLUSION: Renal tumors were statistically smaller than the estimate from CT, although this was not systematically the case. This should be kept in mind when issuing recommendations on the optimal cutoff size value under which nephron-sparing surgery is considered equivalent to radical nephrectomy.

Adult↗

[Tolerance and efficiency of intravesical instillation of Calmette-Guérin in the prophylactic treatment of superficial bladder tumors, using a maintenance treatment].

UNLABELLED: Maintenance treatment with complementary BCG instillations in the prevention of superficial bladder tumour could improve the results of this immunotherapy. This maintenance treatment is limited by accentuation of the adverse effects related to BCG. OBJECTIVES: To evaluate the impact of maintenance treatment on tumour recurrence and progression, and to evaluate the influence of adverse effects on maintenance treatment and the recurrence rate. MATERIAL AND METHODS: 72 patients were treated with six weekly instillations of 81 mg of BCG (Immucyst) followed by three complementary instillations 3, 6, 12, 18, 24, 30 and 36 months later. Adverse effects (AE) were classified into four classes, according to their type, severity and duration, and were recorded prospectively for 518 instillations. An adverse effect score was determined for each patient. RESULTS: 84.9% of patients did not present any recurrence, 12.5% developed recurrence and 2.6% progressed. The instillation regimen was completed by 19% of patients, the dose had to be decreased for 57% of patients and treatment had to be discontinued for 39% of patients. An initial adverse effect score (AESi) greater than 1.5 was associated with an increased risk of discontinuation of treatment or reduction of the dosage during maintenance treatment (p = 0.01). CONCLUSIONS: Maintenance treatment was associated with a very low recurrence and progression rate. We have established and validated an adverse effect severity scale and the consequences of these adverse effects on maintenance treatment. This scale could be used to prospectively define the most appropriate maintenance instillation regimen, by preventively decreasing the doses or deferring instillation.

Adjuvants, Immunologic↗

[Urinary leukocytes as a new prognostic marker of therapeutic response and of adverse effects associated with the maintenance treatment with endovesical BCG, for the prophylaxis of superficial bladder tumors].

UNLABELLED: The use of Bacillus Calmette-Guérin (BCG) vaccine as immunotherapy for superficial bladder cancer constitutes a major progress, although it remains limited by the development of adverse effects and problems related to safety. No individual tool is currently available in clinical practice to predict the efficacy or adverse effects of BCG therapy. These problems are accentuated in the case of maintenance therapy according to the protocol of D.L. Lamm. OBJECTIVES: To define whether the urinary leukocyte count observed after intravesical BCG instillation could be associated with adverse effects and efficacy of treatment. MATERIAL AND METHODS: A cohort of 72 consecutive patients (518 instillations) was studied prospectively. We defined four classes of adverse effects associated with BCG, according to their type, severity and duration. In combination with this classification, we performed systematic optical urinary leukocyte count on the third day after each instillation (KOVA-Slide 10). RESULTS: A high urinary leukocyte count (cut-off value: 165,000/ml) was correlated with absence of recurrence (p = 0.009). The adverse effect classification also demonstrated that urinary leukocyte count was related to the severity and duration of adverse effects (p < 0.0001). Median values observed for class I, II and III adverse effects were 40,000 leukocytes/ml, 150,000 leukocytes/ml and 350,000 leukocytes/ml, respectively. No class IV adverse effects were observed. The risk of developing class III adverse effects was increased when the urinary leukocyte count was greater than 86,000 leukocytes per ml. CONCLUSION: These results suggest a probable relationship between efficacy and safety of BCG, during maintenance therapy. Randomized prospective studies are necessary to evaluate urinary leukocyte count as a tool for adaptation and optimization of BCG therapy.

Adjuvants, Immunologic↗

Polyethylene stent blockage: a porcine model.

BACKGROUND: Endoscopic insertion of biliary stents is a useful treatment for obstructive jaundice resulting from unresectable tumors of the pancreas and biliary tree. The main drawback is the recurrence of jaundice due to clogging. The aim of this study was to establish an experimental model of polyethylene stent clogging in large white pigs. METHODS: A straight polyethylene stent of 5F (group I), 7F (group II) or 10F size (group III) was inserted in the common bile duct. Animals were killed at 2 months, or earlier if physical signs suggesting stent clogging occurred. Chemicophysical analysis of stent deposition combined stereomicroscopy and identification of the contents by means of Fourrier transform infrared spectroscopy. Bacteriologic analyses included identification of aerobic and anaerobic bacteria and measurement of beta-glucuronidase, lecithinase and lipase activities. RESULTS: Physical signs suggesting stent obstruction or death occurred in 8 of 8 animals in group I, 11 of 12 in group II, and 2 of 8 in group III (p < 0.001). The proportion of mucoprotein in the stent contents tended to fall with increasing stent diameter (mean 82%, 58% and 47% for 5F, 7F and 10F, respectively), whereas wheat starch and calcium bilirubinate content increased with increasing stent diameter (9% and 4%, 18% and 10%, and 29% and 23% for 5F, 7 F, and 10F, respectively), although none of these differences were statistically significant. A variety of bacteria were cultured from the stent deposits, including anaerobic strains. Clostridium species were associated with the highest enzyme activities. CONCLUSIONS: In this model the major component of early stent deposits was mucoprotein, and numerous aerobic and anaerobic bacteria were isolated. Formation of calcium bilirubinate was a late phenomenon and poorly related to bacterial enzymatic activities.

Animals↗