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3. The GIN-McMaster guideline tool extension for the integration of quality improvement and quality assurance in guidelines: a description of the methods for its development

Author

Piggott, Thomas, Langendam, Miranda W., Parmelli, Elena, Adolfsson, Jan, Akl, Elie A., Armstrong, David, Braithwaite, Jeffrey, Brignardello-Petersen, Romina, Brozek, Jan, Follmann, Markus, Kopp, Ina, Meerpohl, Joerg J., Neamtiu, Luciana, Nothacker, Monika, Qaseem, Amir, Rossi, Paolo Giorgi, Saz-Parkinson, Zuleika, van der Wees, Philip J., and Schünemann, Holger J.

Published
2023
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6. Prostate-Specific Antigen Screening and 15-Year Prostate Cancer Mortality: A Secondary Analysis of the CAP Randomized Clinical Trial.

Author

Martin, Richard M., Turner, Emma L., Young, Grace J., Metcalfe, Chris, Walsh, Eleanor I., Lane, J. Athene, Sterne, Jonathan A. C., Noble, Sian, Holding, Peter, Ben-Shlomo, Yoav, Williams, Naomi J., Pashayan, Nora, Bui, Mai Ngoc, Albertsen, Peter C., Seibert, Tyler M., Zietman, Anthony L., Oxley, Jon, Adolfsson, Jan, Mason, Malcolm D., and Davey Smith, George

Abstract

This secondary analysis of a randomized clinical trial assesses whether screening for prostate-specific antigen reduces prostate cancer mortality at 15-year follow-up. Key Points: Question: In men aged 50 to 69 years, does a single invitation for a prostate-specific antigen (PSA) screening test reduce prostate cancer mortality at 15-year follow-up compared with no invitation for testing? Findings: In this secondary analysis of a randomized clinical trial of 415 357 men aged 50 to 69 years randomized to a single invitation for PSA screening (n = 195 912) or a control group without PSA screening (n = 219 445) and followed up for a median of 15 years, risk of death from prostate cancer was lower in the group invited to screening (0.69% vs 0.78%; mean difference, 0.09%) compared with the control group. Meaning: Compared with no invitation for routine PSA testing, a single invitation for a PSA screening test reduced prostate cancer mortality at a median follow-up of 15 years, but the absolute mortality benefit was small. Importance: The Cluster Randomized Trial of PSA Testing for Prostate Cancer (CAP) reported no effect of prostate-specific antigen (PSA) screening on prostate cancer mortality at a median 10-year follow-up (primary outcome), but the long-term effects of PSA screening on prostate cancer mortality remain unclear. Objective: To evaluate the effect of a single invitation for PSA screening on prostate cancer–specific mortality at a median 15-year follow-up compared with no invitation for screening. Design, Setting, and Participants: This secondary analysis of the CAP randomized clinical trial included men aged 50 to 69 years identified at 573 primary care practices in England and Wales. Primary care practices were randomized between September 25, 2001, and August 24, 2007, and men were enrolled between January 8, 2002, and January 20, 2009. Follow-up was completed on March 31, 2021. Intervention: Men received a single invitation for a PSA screening test with subsequent diagnostic tests if the PSA level was 3.0 ng/mL or higher. The control group received standard practice (no invitation). Main Outcomes and Measures: The primary outcome was reported previously. Of 8 prespecified secondary outcomes, results of 4 were reported previously. The 4 remaining prespecified secondary outcomes at 15-year follow-up were prostate cancer–specific mortality, all-cause mortality, and prostate cancer stage and Gleason grade at diagnosis. Results: Of 415 357 eligible men (mean [SD] age, 59.0 [5.6] years), 98% were included in these analyses. Overall, 12 013 and 12 958 men with a prostate cancer diagnosis were in the intervention and control groups, respectively (15-year cumulative risk, 7.08% [95% CI, 6.95%-7.21%] and 6.94% [95% CI, 6.82%-7.06%], respectively). At a median 15-year follow-up, 1199 men in the intervention group (0.69% [95% CI, 0.65%-0.73%]) and 1451 men in the control group (0.78% [95% CI, 0.73%-0.82%]) died of prostate cancer (rate ratio [RR], 0.92 [95% CI, 0.85-0.99]; P =.03). Compared with the control, the PSA screening intervention increased detection of low-grade (Gleason score [GS] ≤6: 2.2% vs 1.6%; P <.001) and localized (T1/T2: 3.6% vs 3.1%; P <.001) disease but not intermediate (GS of 7), high-grade (GS ≥8), locally advanced (T3), or distally advanced (T4/N1/M1) tumors. There were 45 084 all-cause deaths in the intervention group (23.2% [95% CI, 23.0%-23.4%]) and 50 336 deaths in the control group (23.3% [95% CI, 23.1%-23.5%]) (RR, 0.97 [95% CI, 0.94-1.01]; P =.11). Eight of the prostate cancer deaths in the intervention group (0.7%) and 7 deaths in the control group (0.5%) were related to a diagnostic biopsy or prostate cancer treatment. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial, a single invitation for PSA screening compared with standard practice without routine screening reduced prostate cancer deaths at a median follow-up of 15 years. However, the absolute reduction in deaths was small. Trial Registration: isrctn.org Identifier: ISRCTN92187251 [ABSTRACT FROM AUTHOR]

Published
2024
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7. Bringing two worlds closer together: a critical analysis of an integrated approach to guideline development and quality assurance schemes

Author

Piggott, Thomas, Langendam, Miranda, Parmelli, Elena, Adolfsson, Jan, Akl, Elie A., Armstrong, David, Braithwaite, Jeffrey, Brignardello-Petersen, Romina, Brozek, Jan, Gore-Booth, Jolanta, Follmann, Markus, Leś, Zbigniew, Meerpohl, Joerg J, Neamţiu, Luciana, Nothacker, Monika, Qaseem, Amir, Giorgi Rossi, Paolo, Saz-Parkinson, Zuleika, van der Wees, Philip, and Schünemann, Holger J.

Published
2021
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14. PD38-11 THE STOCKHOLM3 PROSTATE CANCER SCREENING TRIAL (STHLM3): AN INTERIM ANALYSIS OF MORTALITY RESULTS AFTER 6.5 YEARS OF FOLLOW-UP

Author

Micoli, Chiara, primary, Crippa, Alessio, additional, Discacciati, Andrea, additional, Palsdottir, Thorgerdur, additional, Vigneswaran, Hari, additional, Aly, Markus, additional, Adolfsson, Jan, additional, Lindberg, Johan, additional, Wiklund, Peter, additional, Thompson, James, additional, Brandberg, Yvonne, additional, Clements, Mark, additional, Egevad, Lars, additional, Grönberg, Henrik, additional, Nordström, Tobias, additional, and Eklund, Martin, additional

Published
2023
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30. Time to castration-resistant prostate cancer and prostate cancer death according to PSA response in men with non-metastatic prostate cancer treated with gonadotropin releasing hormone agonists

Author

Bonde, Tiago M., primary, Westerberg, Marcus, additional, Aly, Markus, additional, Eklund, Martin, additional, Adolfsson, Jan, additional, Bill-Axelson, Anna, additional, Garmo, Hans, additional, Stattin, Pär, additional, and Robinson, David, additional

Published
2022
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31. Integrating Quality Assurance and Quality Improvement With Guidelines: Systematic Stakeholder-Driven Development of an Extension of the Guidelines International Network–McMaster Guideline Development Checklist

Author

Piggott, Thomas, primary, Langendam, Miranda W., additional, Parmelli, Elena, additional, Adolfsson, Jan, additional, Akl, Elie A., additional, Armstrong, David, additional, Braithwaite, Jeffrey, additional, Brignardello-Petersen, Romina, additional, Brozek, Jan, additional, Follmann, Markus, additional, Kopp, Ina, additional, Meerpohl, Joerg J., additional, Neamtiu, Luciana, additional, Nothacker, Monika, additional, Qaseem, Amir, additional, Rossi, Paolo Giorgi, additional, Saz-Parkinson, Zuleika, additional, van der Wees, Philip J., additional, and Schünemann, Holger J., additional

Published
2022
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