Impact of opioid-free analgesia on pain severity and patient satisfaction after discharge from surgery: multispecialty, prospective cohort study in 25 countries

Background: Balancing opioid stewardship and the need for adequate analgesia following discharge after surgery is challenging. This study aimed to compare the outcomes for patients discharged with opioid versus opioid-free analgesia after common surgical procedures.Methods: This international, multicentre, prospective cohort study collected data from patients undergoing common acute and elective general surgical, urological, gynaecological, and orthopaedic procedures. The primary outcomes were patient-reported time in severe pain measured on a numerical analogue scale from 0 to 100% and patient-reported satisfaction with pain relief during the first week following discharge. Data were collected by in-hospital chart review and patient telephone interview 1 week after discharge.Results: The study recruited 4273 patients from 144 centres in 25 countries; 1311 patients (30.7%) were prescribed opioid analgesia at discharge. Patients reported being in severe pain for 10 (i.q.r. 1-30)% of the first week after discharge and rated satisfaction with analgesia as 90 (i.q.r. 80-100) of 100. After adjustment for confounders, opioid analgesia on discharge was independently associated with increased pain severity (risk ratio 1.52, 95% c.i. 1.31 to 1.76; P < 0.001) and re-presentation to healthcare providers owing to side-effects of medication (OR 2.38, 95% c.i. 1.36 to 4.17; P = 0.004), but not with satisfaction with analgesia (beta coefficient 0.92, 95% c.i. -1.52 to 3.36; P = 0.468) compared with opioid-free analgesia. Although opioid prescribing varied greatly between high-income and low- and middle-income countries, patient-reported outcomes did not.Conclusion: Opioid analgesia prescription on surgical discharge is associated with a higher risk of re-presentation owing to side-effects of medication and increased patient-reported pain, but not with changes in patient-reported satisfaction. Opioid-free discharge analgesia should be adopted routinely

Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial

Background Previous evidence indicates that adjuvant, short-course androgen deprivation therapy (ADT) improves metastasis-free survival when given with primary radiotherapy for intermediate-risk and high-risk localised prostate cancer. However, the value of ADT with postoperative radiotherapy after radical prostatectomy is unclear. Methods RADICALS-HD was an international randomised controlled trial to test the efficacy of ADT used in combination with postoperative radiotherapy for prostate cancer. Key eligibility criteria were indication for radiotherapy after radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to radiotherapy alone (no ADT) or radiotherapy with 6 months of ADT (short-course ADT), using monthly subcutaneous gonadotropin-releasing hormone analogue injections, daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as distant metastasis arising from prostate cancer or death from any cause. Standard survival analysis methods were used, accounting for randomisation stratification factors. The trial had 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 80% to 86% (hazard ratio [HR] 0·67). Analyses followed the intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047. Findings Between Nov 22, 2007, and June 29, 2015, 1480 patients (median age 66 years [IQR 61–69]) were randomly assigned to receive no ADT (n=737) or short-course ADT (n=743) in addition to postoperative radiotherapy at 121 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 9·0 years (IQR 7·1–10·1), metastasis-free survival events were reported for 268 participants (142 in the no ADT group and 126 in the short-course ADT group; HR 0·886 [95% CI 0·688–1·140], p=0·35). 10-year metastasis-free survival was 79·2% (95% CI 75·4–82·5) in the no ADT group and 80·4% (76·6–83·6) in the short-course ADT group. Toxicity of grade 3 or higher was reported for 121 (17%) of 737 participants in the no ADT group and 100 (14%) of 743 in the short-course ADT group (p=0·15), with no treatment-related deaths. Interpretation Metastatic disease is uncommon following postoperative bed radiotherapy after radical prostatectomy. Adding 6 months of ADT to this radiotherapy did not improve metastasis-free survival compared with no ADT. These findings do not support the use of short-course ADT with postoperative radiotherapy in this patient population

Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial

Background Previous evidence supports androgen deprivation therapy (ADT) with primary radiotherapy as initial treatment for intermediate-risk and high-risk localised prostate cancer. However, the use and optimal duration of ADT with postoperative radiotherapy after radical prostatectomy remains uncertain. Methods RADICALS-HD was a randomised controlled trial of ADT duration within the RADICALS protocol. Here, we report on the comparison of short-course versus long-course ADT. Key eligibility criteria were indication for radiotherapy after previous radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to add 6 months of ADT (short-course ADT) or 24 months of ADT (long-course ADT) to radiotherapy, using subcutaneous gonadotrophin-releasing hormone analogue (monthly in the short-course ADT group and 3-monthly in the long-course ADT group), daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as metastasis arising from prostate cancer or death from any cause. The comparison had more than 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 75% to 81% (hazard ratio [HR] 0·72). Standard time-to-event analyses were used. Analyses followed intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov , NCT00541047 . Findings Between Jan 30, 2008, and July 7, 2015, 1523 patients (median age 65 years, IQR 60–69) were randomly assigned to receive short-course ADT (n=761) or long-course ADT (n=762) in addition to postoperative radiotherapy at 138 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 8·9 years (7·0–10·0), 313 metastasis-free survival events were reported overall (174 in the short-course ADT group and 139 in the long-course ADT group; HR 0·773 [95% CI 0·612–0·975]; p=0·029). 10-year metastasis-free survival was 71·9% (95% CI 67·6–75·7) in the short-course ADT group and 78·1% (74·2–81·5) in the long-course ADT group. Toxicity of grade 3 or higher was reported for 105 (14%) of 753 participants in the short-course ADT group and 142 (19%) of 757 participants in the long-course ADT group (p=0·025), with no treatment-related deaths. Interpretation Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy. For individuals who can accept the additional duration of adverse effects, long-course ADT should be offered with postoperative radiotherapy. Funding Cancer Research UK, UK Research and Innovation (formerly Medical Research Council), and Canadian Cancer Society

Rethinking Data Privacy: Examining Innovative Policy Solutions and Private Sector Mechanisms for Consumer Data Privacy in the United States

This thesis focuses on rethinking the approach to addressing data privacy in America. It examines and proposes the use of innovative policy solutions and private sector mechanisms to address the consumer data privacy concerns of citizens that are at the heart of the issue. It proposes a new framework for analyzing the issue at hand and argues that a hybrid of improved private and public sector mechanisms must be in place in order to safeguard privacy in America. The analysis and arguments in this paper stem from a non-technical perspective on the issue of data privacy, and therefore it is important to acknowledge the limitations in the consideration of the technical implications of some of the policy recommendations presented in this paper. Before diving into policy recommendations and potential solutions, Chapter 1 first defines data privacy as a concept and emphasizes the importance of the topic as an area for research and analysis given recent developments. Using data from the Pew Research Center and other sources, Chapter 1 substantiates the three largest concerns that need to be addressed as being: lack of transparency, lack of control, and lack of choice. In order to ensure data privacy, this paper argues that users must be empowered with end-to-end transparency on their data, along with the autonomy to control its collection and use. In Chapter 2, this paper presents a case study of Facebook in order to highlight many of these issues and concerns in practice at one of the largest and ubiquitous technology companies in the world. Later, Chapter 3 examines the existing data privacy regulatory approaches of the European Union and the United States by focusing on the two preeminent legislations with the General Data Protection Regulation and the California Consumer Privacy Act. After understanding and analyzing the issues and concerns at hand along with the current regulatory approach in Europe and the United States, the key research takeaways and ensuing recommendations are presented in Chapter 4 and a reimagined American federal regulatory framework for data privacy is proposed. While government policies such as the GDPR and CCPA are on the path towards an adequate regulatory framework, there is much room for improvement and growth. The larger themes captured within these recommendations include creating a new data protection and privacy authority, increasing private and public sector collaboration, exploring ways to implement the notice and choice model, and incorporating digital literacy into policy. However, Chapter 5 highlight that while policy-making plays an important role in addressing the data privacy concerns consumers have, it is not the complete solution and only works to a certain extent, as many gaps remain. Therefore, in Chapter 6, this paper present how private sector mechanisms can fill the remaining gaps in addressing lack of transparency, lack of control, and lack of choice through a variety of technologies and solutions. Afterwards, Chapter 7 highlights remaining considerations that should be included in the conversation of data privacy, from the concept of privacy for the privileged to the privacy implications of Covid-19. Lastly, this thesis concludes with a synthesis of the analysis and an outlook on the path forward

Rethinking Data Privacy: Examining Innovative Policy Solutions and Private Sector Mechanisms for Consumer Data Privacy in the United States

This thesis focuses on rethinking the approach to addressing data privacy in America. It examines and proposes the use of innovative policy solutions and private sector mechanisms to address the consumer data privacy concerns of citizens that are at the heart of the issue. It proposes a new framework for analyzing the issue at hand and argues that a hybrid of improved private and public sector mechanisms must be in place in order to safeguard privacy in America. The analysis and arguments in this paper stem from a non-technical perspective on the issue of data privacy, and therefore it is important to acknowledge the limitations in the consideration of the technical implications of some of the policy recommendations presented in this paper. Before diving into policy recommendations and potential solutions, Chapter 1 first defines data privacy as a concept and emphasizes the importance of the topic as an area for research and analysis given recent developments. Using data from the Pew Research Center and other sources, Chapter 1 substantiates the three largest concerns that need to be addressed as being: lack of transparency, lack of control, and lack of choice. In order to ensure data privacy, this paper argues that users must be empowered with end-to-end transparency on their data, along with the autonomy to control its collection and use. In Chapter 2, this paper presents a case study of Facebook in order to highlight many of these issues and concerns in practice at one of the largest and ubiquitous technology companies in the world. Later, Chapter 3 examines the existing data privacy regulatory approaches of the European Union and the United States by focusing on the two preeminent legislations with the General Data Protection Regulation and the California Consumer Privacy Act. After understanding and analyzing the issues and concerns at hand along with the current regulatory approach in Europe and the United States, the key research takeaways and ensuing recommendations are presented in Chapter 4 and a reimagined American federal regulatory framework for data privacy is proposed. While government policies such as the GDPR and CCPA are on the path towards an adequate regulatory framework, there is much room for improvement and growth. The larger themes captured within these recommendations include creating a new data protection and privacy authority, increasing private and public sector collaboration, exploring ways to implement the notice and choice model, and incorporating digital literacy into policy. However, Chapter 5 highlight that while policy-making plays an important role in addressing the data privacy concerns consumers have, it is not the complete solution and only works to a certain extent, as many gaps remain. Therefore, in Chapter 6, this paper present how private sector mechanisms can fill the remaining gaps in addressing lack of transparency, lack of control, and lack of choice through a variety of technologies and solutions. Afterwards, Chapter 7 highlights remaining considerations that should be included in the conversation of data privacy, from the concept of privacy for the privileged to the privacy implications of Covid-19. Lastly, this thesis concludes with a synthesis of the analysis and an outlook on the path forward

Rethinking Data Privacy: Examining Innovative Policy Solutions and Private Sector Mechanisms for Consumer Data Privacy in the United States

This thesis focuses on rethinking the approach to addressing data privacy in America. It examines and proposes the use of innovative policy solutions and private sector mechanisms to address the consumer data privacy concerns of citizens that are at the heart of the issue. It proposes a new framework for analyzing the issue at hand and argues that a hybrid of improved private and public sector mechanisms must be in place in order to safeguard privacy in America. The analysis and arguments in this paper stem from a non-technical perspective on the issue of data privacy, and therefore it is important to acknowledge the limitations in the consideration of the technical implications of some of the policy recommendations presented in this paper. Before diving into policy recommendations and potential solutions, Chapter 1 first defines data privacy as a concept and emphasizes the importance of the topic as an area for research and analysis given recent developments. Using data from the Pew Research Center and other sources, Chapter 1 substantiates the three largest concerns that need to be addressed as being: lack of transparency, lack of control, and lack of choice. In order to ensure data privacy, this paper argues that users must be empowered with end-to-end transparency on their data, along with the autonomy to control its collection and use. In Chapter 2, this paper presents a case study of Facebook in order to highlight many of these issues and concerns in practice at one of the largest and ubiquitous technology companies in the world. Later, Chapter 3 examines the existing data privacy regulatory approaches of the European Union and the United States by focusing on the two preeminent legislations with the General Data Protection Regulation and the California Consumer Privacy Act. After understanding and analyzing the issues and concerns at hand along with the current regulatory approach in Europe and the United States, the key research takeaways and ensuing recommendations are presented in Chapter 4 and a reimagined American federal regulatory framework for data privacy is proposed. While government policies such as the GDPR and CCPA are on the path towards an adequate regulatory framework, there is much room for improvement and growth. The larger themes captured within these recommendations include creating a new data protection and privacy authority, increasing private and public sector collaboration, exploring ways to implement the notice and choice model, and incorporating digital literacy into policy. However, Chapter 5 highlight that while policy-making plays an important role in addressing the data privacy concerns consumers have, it is not the complete solution and only works to a certain extent, as many gaps remain. Therefore, in Chapter 6, this paper present how private sector mechanisms can fill the remaining gaps in addressing lack of transparency, lack of control, and lack of choice through a variety of technologies and solutions. Afterwards, Chapter 7 highlights remaining considerations that should be included in the conversation of data privacy, from the concept of privacy for the privileged to the privacy implications of Covid-19. Lastly, this thesis concludes with a synthesis of the analysis and an outlook on the path forward