Michaela Strobelberger

Sentinel lymph node dissection only versus complete axillary lymph node dissection in early invasive breast cancer: A systematic review and meta-analysis

BACKGROUND The Z0011-study, a landmark randomised controlled trial (RCT) challenged the benefits of complete axillary lymph node dissection (ALND) compared with sentinel lymph node dissection only (SLND) in breast cancer patients with positive sentinel nodes. The study, however, has been criticised for lack of power and low applicability. The aim of this review was to systematically assess the evidence on the comparative benefits and harms of ALND versus SLND for sentinel node positive breast cancer patients. METHODS We systematically searched PubMed, Embase, the Cochrane Library, and reference lists of pertinent review articles from January 2006 to August 2011. We dually reviewed the literature and rated the risk of bias of each study. For effectiveness, we included RCTs and observational studies of at least 1 year follow-up. In addition, we considered studies conducted in sentinel node-negative women to assess the risk of harms. If data were sufficient, we conducted random effects meta-analysis of outcomes of interest. RESULTS Meta-analysis of three studies with 50,120 patients indicated similar 5-year survival and regional recurrence rates between patients treated with ALND or SLND, although prognostic tumour characteristics varied among the 3 study-populations. Results from 6 studies on more than 11,500 patients reported a higher risk for harms for ALND than SLND. Long-term evidence on pertinent health outcomes is missing. CONCLUSION The available evidence indicates that for some women with early invasive breast cancer SLND appears to be a justifiable alternative to ALND. Surgeons need to discuss advantages and disadvantages of both approaches with their patients.

Differences in Efficacy and Safety of Pharmaceutical Treatments between Men and Women: An Umbrella Review

Being male or female is an important determinant of risks for certain diseases, patterns of illness and life expectancy. Although differences in risks for and prognoses of several diseases have been well documented, sex-based differences in responses to pharmaceutical treatments and accompanying risks of adverse events are less clear. The objective of this umbrella review was to determine whether clinically relevant differences in efficacy and safety of commonly prescribed medications exist between men and women. We retrieved all available systematic reviews of the Oregon Drug Effectiveness Review Project published before January 2010. Two persons independently reviewed each report to identify relevant studies. We dually abstracted data from the original publications into standardized forms. We synthesized the available evidence for each drug class and rated its quality applying the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Findings, based on 59 studies and data of more than 250,000 patients suggested that for the majority of drugs no substantial differences in efficacy and safety exist between men and women. Some clinically important exceptions, however, were apparent: women experienced substantially lower response rates with newer antiemetics than men (45% vs. 58%; relative risk 1.49, 95% confidence interval 1.35–1.64); men had higher rates of sexual dysfunction than women while on paroxetine for major depressive disorder; women discontinued lovastatin more frequently than men because of adverse events. Overall, for the majority of drugs sex does not appear to be a factor that has to be taken into consideration when choosing a drug treatment. The available body of evidence, however, was limited in quality and quantity, confining the range and certainty of our conclusions.

Extended-release opioids in the management of cancer pain: a systematic review of efficacy and safety.

Despite the increased availability of strong analgesics and evidence‐based recommendations for pain management, under‐treatment of cancer‐related pain is still common. Extended‐release (ER) opioids, in contrast to immediate‐release opioids, provide prolonged analgesia. In this review, we aimed to compare the efficacy and safety of ER opioid analgesics in managing moderate‐to‐severe pain in patients with cancer. We identified randomized controlled trials (RCTs) and controlled observational studies that compared ER opioids in cancer pain by searching several databases, including MEDLINE, EMBASE and the Cochrane Library. Two independent reviewers screened and evaluated retrieved records to select relevant studies. We dually assessed the risk of bias for included studies and evaluated the overall strength of evidence for six critical outcomes using Grading of Recommendations Assessment, Development and Evaluation level of evidence. A total of three double‐blind RCTs (comparative efficacy and adverse events), two non‐blinded RCTs and four observational studies (comparative adverse events) were included in this review. All randomized trials and one observational study were of high risk of bias, and three observational studies of unclear risk of bias. The level of evidence for the selected efficacy and safety outcomes was low and very low. We synthesized the findings qualitatively because of the paucity of relevant studies as well as variable study design and quality. This systematic review indicates no substantial differences in efficacy and frequent adverse events among ER opioids for cancer pain. The body of evidence, however, is limited to few comparisons and fraught with methodological shortcomings.

Österreichische Patienteninformationsmaterialien zu PSA-Screening entsprechen nicht internationalen evidenzbasierten Standards

SummaryBACKGROUND: Currently, the available evidence regarding the net benefits of prostate cancer screening with PSA (prostate-specific antigen) tests is unclear. Therefore, international guidelines do not recommend PSA-screening on a regular basis for men. Because of the unclear evidence, guidelines emphasize the importance of shared decision-making. Shared decision-making, however, requires that balanced and evidence-based information is available for those who take PSA-screening into consideration. The aim of this paper was to evaluate all in Austria available patient information materials on PSA-screening with regard to their evidence-based content and their potential to facilitate informed decision-making. METHODS: To get information materials, we contacted a wide variety of public, industry, and academic institutions, professional organisations, patient advocacy groups, and other organisations that are concerned with prostate cancer screening in Austria. Two persons independently evaluated the quality of each information product based on adapted criteria of the UK (United Kingdom) General Medical Council. RESULTS: We evaluated a total of 17 information leaflets. Not a single brochure fulfilled all of the criteria necessary for informed decision-making. More than half fulfilled less than 50% of the recommended criteria. All of the analysed leaflets provided information about the benefits of screening, while only 35% mentioned the possibility of harms caused by screening. CONCLUSIONS: To date, Austrian patient information materials on PSA-screening do not meet international standards. Therefore, they cannot serve as a balanced and objective information base for informed decision-making.ZusammenfassungGRUNDLAGEN: Aufgrund der wissenschaftlich unklaren Studienlage wird PSA(Prostata-spezifisches Antigen)-Screening von den meisten internationalen Leitlinien nicht als Routineuntersuchung zur Früherkennung von Prostatakarzinomen empfohlen. PSA-Screening sollte erst nach genauer Diskussion der Vor- und Nachteile mit Männern, die diese Art der Krebsfrüherkennung in Erwägung ziehen, durchgeführt werden. Um eine solche informierte Entscheidung erreichen zu können, ist es daher wichtig, dass ausgewogene und evidenzbasierte Information über Vor- und Nachteile von PSA-Screening zur Verfügung steht. Ziel unserer Studie war es, alle in Österreich zur Verfügung stehenden Patienten-Informationssmaterialien über PSA-Screening auf ihren evidenzbasierten Inhalt, sowie ihre Eignung, eine Grundlage für informierte Entscheidungen zu bieten, zu prüfen. METHODIK: Um möglichst alle in Österreich verfügbaren Patienten-Informationsmaterialien zu PSA-Screening zu erhalten, kontaktierten wir universitäre Institutionen, öffentliche Einrichtungen, Selbsthilfeorganisationen, Standesvertretungen und industrielle Unternehmen, die sich in Österreich mit PSA-Screening beschäftigen oder dieses anbieten. Zusätzlich führten wir gezielte Suchen in Google durch. Zwei Personen evaluierten unabhängig voneinander die Qualität der erhaltenen Materialien nach adaptierten Kriterien des UK (United Kingdom) General Medical Councils. ERGEBNISSE: Insgesamt wurden 17 Informationsmaterialien evaluiert. Keines der untersuchten Materialien erfüllte alle für eine informierte Entscheidungsfindung notwendigen Kriterien. Die inhaltlich beste Informationsbroschüre entsprach nur 57 % der untersuchten Qualitätskriterien. Mehr als die Hälfte der untersuchten Informationsbroschüren erfüllten weniger als 50 % der Qualitätskriterien. Alle untersuchten Broschüren betonten den potentiellen Nutzen von PSA-Screening, nur 35 % berichteten jedoch auch über den möglichen Schaden. SCHLUSSFOLGERUNGEN: Die derzeit in Österreich vorhandenen Informationsmaterialien zu PSA-Screening sind einseitig und entsprechen nicht internationalen Standards. Sie können daher keine ausreichende Basis für eine informierte Entscheidungsfindung über PSA-Screening bieten.BACKGROUND Currently, the available evidence regarding the net benefits of prostate cancer screening with PSA (prostate-specific antigen) tests is unclear. Therefore, international guidelines do not recommend PSA-screening on a regular basis for men. Because of the unclear evidence, guidelines emphasize the importance of shared decision-making. Shared decision-making, however, requires that balanced and evidence-based information is available for those who take PSA-screening into consideration. The aim of this paper was to evaluate all in Austria available patient information materials on PSA-screening with regard to their evidence-based content and their potential to facilitate informed decision-making. METHODS To get information materials, we contacted a wide variety of public, industry, and academic institutions, professional organisations, patient advocacy groups, and other organisations that are concerned with prostate cancer screening in Austria. Two persons independently evaluated the quality of each information product based on adapted criteria of the UK (United Kingdom) General Medical Council. RESULTS We evaluated a total of 17 information leaflets. Not a single brochure fulfilled all of the criteria necessary for informed decision-making. More than half fulfilled less than 50% of the recommended criteria. All of the analysed leaflets provided information about the benefits of screening, while only 35% mentioned the possibility of harms caused by screening. CONCLUSIONS To date, Austrian patient information materials on PSA-screening do not meet international standards. Therefore, they cannot serve as a balanced and objective information base for informed decision-making.

Austrian patient information materials on PSA-screening do not meet international evidence-based standards:

SummaryBACKGROUND: Currently, the available evidence regarding the net benefits of prostate cancer screening with PSA (prostate-specific antigen) tests is unclear. Therefore, international guidelines do not recommend PSA-screening on a regular basis for men. Because of the unclear evidence, guidelines emphasize the importance of shared decision-making. Shared decision-making, however, requires that balanced and evidence-based information is available for those who take PSA-screening into consideration. The aim of this paper was to evaluate all in Austria available patient information materials on PSA-screening with regard to their evidence-based content and their potential to facilitate informed decision-making. METHODS: To get information materials, we contacted a wide variety of public, industry, and academic institutions, professional organisations, patient advocacy groups, and other organisations that are concerned with prostate cancer screening in Austria. Two persons independently evaluated the quality of each information product based on adapted criteria of the UK (United Kingdom) General Medical Council. RESULTS: We evaluated a total of 17 information leaflets. Not a single brochure fulfilled all of the criteria necessary for informed decision-making. More than half fulfilled less than 50% of the recommended criteria. All of the analysed leaflets provided information about the benefits of screening, while only 35% mentioned the possibility of harms caused by screening. CONCLUSIONS: To date, Austrian patient information materials on PSA-screening do not meet international standards. Therefore, they cannot serve as a balanced and objective information base for informed decision-making.ZusammenfassungGRUNDLAGEN: Aufgrund der wissenschaftlich unklaren Studienlage wird PSA(Prostata-spezifisches Antigen)-Screening von den meisten internationalen Leitlinien nicht als Routineuntersuchung zur Früherkennung von Prostatakarzinomen empfohlen. PSA-Screening sollte erst nach genauer Diskussion der Vor- und Nachteile mit Männern, die diese Art der Krebsfrüherkennung in Erwägung ziehen, durchgeführt werden. Um eine solche informierte Entscheidung erreichen zu können, ist es daher wichtig, dass ausgewogene und evidenzbasierte Information über Vor- und Nachteile von PSA-Screening zur Verfügung steht. Ziel unserer Studie war es, alle in Österreich zur Verfügung stehenden Patienten-Informationssmaterialien über PSA-Screening auf ihren evidenzbasierten Inhalt, sowie ihre Eignung, eine Grundlage für informierte Entscheidungen zu bieten, zu prüfen. METHODIK: Um möglichst alle in Österreich verfügbaren Patienten-Informationsmaterialien zu PSA-Screening zu erhalten, kontaktierten wir universitäre Institutionen, öffentliche Einrichtungen, Selbsthilfeorganisationen, Standesvertretungen und industrielle Unternehmen, die sich in Österreich mit PSA-Screening beschäftigen oder dieses anbieten. Zusätzlich führten wir gezielte Suchen in Google durch. Zwei Personen evaluierten unabhängig voneinander die Qualität der erhaltenen Materialien nach adaptierten Kriterien des UK (United Kingdom) General Medical Councils. ERGEBNISSE: Insgesamt wurden 17 Informationsmaterialien evaluiert. Keines der untersuchten Materialien erfüllte alle für eine informierte Entscheidungsfindung notwendigen Kriterien. Die inhaltlich beste Informationsbroschüre entsprach nur 57 % der untersuchten Qualitätskriterien. Mehr als die Hälfte der untersuchten Informationsbroschüren erfüllten weniger als 50 % der Qualitätskriterien. Alle untersuchten Broschüren betonten den potentiellen Nutzen von PSA-Screening, nur 35 % berichteten jedoch auch über den möglichen Schaden. SCHLUSSFOLGERUNGEN: Die derzeit in Österreich vorhandenen Informationsmaterialien zu PSA-Screening sind einseitig und entsprechen nicht internationalen Standards. Sie können daher keine ausreichende Basis für eine informierte Entscheidungsfindung über PSA-Screening bieten.BACKGROUND Currently, the available evidence regarding the net benefits of prostate cancer screening with PSA (prostate-specific antigen) tests is unclear. Therefore, international guidelines do not recommend PSA-screening on a regular basis for men. Because of the unclear evidence, guidelines emphasize the importance of shared decision-making. Shared decision-making, however, requires that balanced and evidence-based information is available for those who take PSA-screening into consideration. The aim of this paper was to evaluate all in Austria available patient information materials on PSA-screening with regard to their evidence-based content and their potential to facilitate informed decision-making. METHODS To get information materials, we contacted a wide variety of public, industry, and academic institutions, professional organisations, patient advocacy groups, and other organisations that are concerned with prostate cancer screening in Austria. Two persons independently evaluated the quality of each information product based on adapted criteria of the UK (United Kingdom) General Medical Council. RESULTS We evaluated a total of 17 information leaflets. Not a single brochure fulfilled all of the criteria necessary for informed decision-making. More than half fulfilled less than 50% of the recommended criteria. All of the analysed leaflets provided information about the benefits of screening, while only 35% mentioned the possibility of harms caused by screening. CONCLUSIONS To date, Austrian patient information materials on PSA-screening do not meet international standards. Therefore, they cannot serve as a balanced and objective information base for informed decision-making.

P03-120 - Immediate-release and extended-release formulations of second-generation antidepressants for the treatment of major depressive disorder in adults

Introduction Extended-release formulations of antidepressants have been marketed as a strategy to increase patient adherence. Changes in the formulation of drugs, however, could be related to changes in efficacy and tolerability. Among second-generation antidepressants bupropion, fluoxetine, mirtazapine, paroxetine, and venlafaxine are available in immediate- and extended-release formulations. Objectives To compare the efficacy, tolerability, and adherence of immediate- versus extended-release formulations of second-generation antidepressants for the treatment of major depressive disorder (MDD) in adults. Aim To provide an evidence base for clinicians when choosing immediate- or extended-release formulations for the treatment of MDD. Methods We conducted a comparative effectiveness review for the U.S. Agency for Healthcare Research and Quality searching PubMed, EMBASE, the Cochrane Library, PsycINFO, and International Pharmaceutical Abstracts up to January 2011. Two persons independently reviewed the literature, abstracted data, and rated the risk of bias. Results Six RCTs and one retrospective cohort study provided evidence about the comparative efficacy, tolerability, and adherence of bupropion XL (extended release) versus bupropion SR (sustained release), fluoxetine daily versus fluoxetine weekly, paroxetine IR (immediate release) versus paroxetine CR (continuous release), and venlafaxine IR versus venlafaxine XR (extended release). Overall, no substantial differences in efficacy and safety could be detected. Open-label and observational evidence indicated better adherence for bupropion XL and fluoxetine weekly than for immediate-release medications. No differences in adherence could be detected between paroxetine IR and paroxetine CR. Conclusions Our findings indicate similar efficacy and tolerability between immediate- and extended-release formulations. Whether extended-release formulations lead to better adherence remains unclear.

Österreichische Patienteninformationsmaterialien zu PSA-Screening entsprechen nicht internationalen evidenzbasierten Standards@@@Austrian patient information materials on PSA-screening do not meet international evidence-based standards

SummaryBACKGROUND: Currently, the available evidence regarding the net benefits of prostate cancer screening with PSA (prostate-specific antigen) tests is unclear. Therefore, international guidelines do not recommend PSA-screening on a regular basis for men. Because of the unclear evidence, guidelines emphasize the importance of shared decision-making. Shared decision-making, however, requires that balanced and evidence-based information is available for those who take PSA-screening into consideration. The aim of this paper was to evaluate all in Austria available patient information materials on PSA-screening with regard to their evidence-based content and their potential to facilitate informed decision-making. METHODS: To get information materials, we contacted a wide variety of public, industry, and academic institutions, professional organisations, patient advocacy groups, and other organisations that are concerned with prostate cancer screening in Austria. Two persons independently evaluated the quality of each information product based on adapted criteria of the UK (United Kingdom) General Medical Council. RESULTS: We evaluated a total of 17 information leaflets. Not a single brochure fulfilled all of the criteria necessary for informed decision-making. More than half fulfilled less than 50% of the recommended criteria. All of the analysed leaflets provided information about the benefits of screening, while only 35% mentioned the possibility of harms caused by screening. CONCLUSIONS: To date, Austrian patient information materials on PSA-screening do not meet international standards. Therefore, they cannot serve as a balanced and objective information base for informed decision-making.ZusammenfassungGRUNDLAGEN: Aufgrund der wissenschaftlich unklaren Studienlage wird PSA(Prostata-spezifisches Antigen)-Screening von den meisten internationalen Leitlinien nicht als Routineuntersuchung zur Früherkennung von Prostatakarzinomen empfohlen. PSA-Screening sollte erst nach genauer Diskussion der Vor- und Nachteile mit Männern, die diese Art der Krebsfrüherkennung in Erwägung ziehen, durchgeführt werden. Um eine solche informierte Entscheidung erreichen zu können, ist es daher wichtig, dass ausgewogene und evidenzbasierte Information über Vor- und Nachteile von PSA-Screening zur Verfügung steht. Ziel unserer Studie war es, alle in Österreich zur Verfügung stehenden Patienten-Informationssmaterialien über PSA-Screening auf ihren evidenzbasierten Inhalt, sowie ihre Eignung, eine Grundlage für informierte Entscheidungen zu bieten, zu prüfen. METHODIK: Um möglichst alle in Österreich verfügbaren Patienten-Informationsmaterialien zu PSA-Screening zu erhalten, kontaktierten wir universitäre Institutionen, öffentliche Einrichtungen, Selbsthilfeorganisationen, Standesvertretungen und industrielle Unternehmen, die sich in Österreich mit PSA-Screening beschäftigen oder dieses anbieten. Zusätzlich führten wir gezielte Suchen in Google durch. Zwei Personen evaluierten unabhängig voneinander die Qualität der erhaltenen Materialien nach adaptierten Kriterien des UK (United Kingdom) General Medical Councils. ERGEBNISSE: Insgesamt wurden 17 Informationsmaterialien evaluiert. Keines der untersuchten Materialien erfüllte alle für eine informierte Entscheidungsfindung notwendigen Kriterien. Die inhaltlich beste Informationsbroschüre entsprach nur 57 % der untersuchten Qualitätskriterien. Mehr als die Hälfte der untersuchten Informationsbroschüren erfüllten weniger als 50 % der Qualitätskriterien. Alle untersuchten Broschüren betonten den potentiellen Nutzen von PSA-Screening, nur 35 % berichteten jedoch auch über den möglichen Schaden. SCHLUSSFOLGERUNGEN: Die derzeit in Österreich vorhandenen Informationsmaterialien zu PSA-Screening sind einseitig und entsprechen nicht internationalen Standards. Sie können daher keine ausreichende Basis für eine informierte Entscheidungsfindung über PSA-Screening bieten.BACKGROUND Currently, the available evidence regarding the net benefits of prostate cancer screening with PSA (prostate-specific antigen) tests is unclear. Therefore, international guidelines do not recommend PSA-screening on a regular basis for men. Because of the unclear evidence, guidelines emphasize the importance of shared decision-making. Shared decision-making, however, requires that balanced and evidence-based information is available for those who take PSA-screening into consideration. The aim of this paper was to evaluate all in Austria available patient information materials on PSA-screening with regard to their evidence-based content and their potential to facilitate informed decision-making. METHODS To get information materials, we contacted a wide variety of public, industry, and academic institutions, professional organisations, patient advocacy groups, and other organisations that are concerned with prostate cancer screening in Austria. Two persons independently evaluated the quality of each information product based on adapted criteria of the UK (United Kingdom) General Medical Council. RESULTS We evaluated a total of 17 information leaflets. Not a single brochure fulfilled all of the criteria necessary for informed decision-making. More than half fulfilled less than 50% of the recommended criteria. All of the analysed leaflets provided information about the benefits of screening, while only 35% mentioned the possibility of harms caused by screening. CONCLUSIONS To date, Austrian patient information materials on PSA-screening do not meet international standards. Therefore, they cannot serve as a balanced and objective information base for informed decision-making.