Continuing medical education (CME) article; invitation ...

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Continuing medical education (CME) article; invitation to submit questions. Question 1. The study population is restricted to the clinical subgroup of patients with.
Continuing medical education (CME) article; invitation to submit questions

Question 1. The study population is restricted to the clinical subgroup of patients with localised prostate cancer. What is the most appropriate definition for localised prostate cancer compared to the definition of low-risk prostate cancer? a) Not locally advanced (tumor stage T1a, T1b, T1c, T2a, T2b, T2c) without regional lymph nodes involved (N0) and without distant metastases (M0) b) Tumor stage T1 to T2a and Gleason score 2 to 6 and prostate-specific antigen below 10 ng/mL c) Digital rectal examination negative and prostate-specific antigen below 4 ng/ml d) Intraprostatic disease (tumor stage T1 to T2) independent of regional lymph node involvement or distant metastases Explanation: a) is the correct answer. The text of answer a) explains sufficiently.

Question 2. Which statement about low-dose rate brachytherapy is correct? a) Brachytherapy of localised prostate cancer starts with a low-dose radiation in the first 4 weeks. After this adaption time, radiation is switched to high-dose. b) Small containers loaded with a radioactive source are planted in the prostate gland and retrieved after use. c) Usually 4 so-called pellets are placed in the 4 quadrants of the prostate gland. d) Minimally invasive procedure that can be carried out as an outpatient treatment. Explanation: d) is the correct answer. Low-dose rate brachytherapy refers to implanting low-energy radioactive sources contained in so-called seeds. Up to 100 seeds are typically inserted into the prostate and remain there permanently. The procedure can be completed in 45 to 90 minutes under spinal or general anaesthesia.

Question 3. Which statement about PRISMA is correct? a) Acronym for preferred reporting on narrative reviews. b) Checklist with 27 items to include when reporting a systematic review or metaanalysis. c) A full electronic search strategy is not required to be presented. d) Assessing risk of bias is not possible for all individual studies. Explanation: b) is the correct answer. The preferred reporting items for systematic reviews and meta-analyses statement is a guide for authors of systematic reviews and meta-analysis to check what sections and items to include to aim for quality reporting.

Question 4. Risk of bias of the included studies was assessed. Which statement about the quality of non-randomised controlled studies is correct? a) The non-randomised design is always associated with a high risk of bias because known and unknown characteristics of participants may be distributed unequally between treatment groups. b) The applicability of conclusions deduced from study participants to non-participants cannot be better with a non-randomised design than with randomisation. c) The non-randomised design has a low risk of bias comparable to that of a randomised controlled trial if an adequate control for all known confounders has been conducted. d) Multivariable regression analysis using Cox proportional hazard model is the only method to adjust results for unbalanced baseline variables. Explanation: a) is the correct answer. In a non-randomised controlled study, the observed characteristics of participants may be more similar to the real world than those of a randomised controlled trial. In contrast to non-randomised controlled studies, only randomised controlled trials are able to control for unknown confounders. Propensity scores or stratification can also be used to control for confounding.

Question 5. Which statement about clinical heterogeneity of the observed data is correct? a) Patients with advanced localised prostate cancer were excluded. b) Patients with a prostate-specific antigen level higher than 10 ng/mL were not included. c) External beam radiotherapy was conducted with different radiation doses between studies with a median total dose ranging from 68 Gy to 78 Gy. d) Radical prostatectomy was carried out with a nerve-sparing technique in all participants. Explanation: c) is the correct answer. Clinical heterogeneity was obvious for most characteristics of patients and interventions.

Question 6. Which statement about accrual of patients with prostate cancer is correct? a) Randomised controlled trials do not have accrual problems because prostate cancer is the most common cancer in men. b) Experts such as urologists or radiooncologists provide an unbiased counselling. c) Individual preferences by patients and physicians play a central role in the decision whether to treat (for example radical prostatectomy) or to pursue active surveillance. d) A preference-based design is not compatible with and cannot be included in a randomised controlled trial. Explanation: c) is the correct answer. Accrual is the main problem of lacking randomised controlled trials. Individual preferences is believed to cause persons not to participate in a study with a randomised design. A multicentre randomised controlled trial with a preferencebased design is planned to start recruitment in November 2011 in Germany.