The level of association between functional performance status measures and patient-reported outcomes in cancer patients: a systematic review

The process of assessing patient symptoms and functionality using patient-reported outcomes (PROs) and functional performance status (FPS) is an essential aspect of patient-centered oncology research and care. However, PRO and FPS measures are often employed separately or inconsistently combined. Thus, the purpose of this study was to conduct a systematic review of the level of association between PRO and FPS measures to determine their differential or combined utility

Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple treatments in patients hospitalised for COVID-19 (NCT04381936, ISRCTN50189673). In this assessment of DMF performed at 27 UK hospitals, adults were randomly allocated (1:1) to either usual standard of care alone or usual standard of care plus DMF. The primary outcome was clinical status on day 5 measured on a seven-point ordinal scale. Secondary outcomes were time to sustained improvement in clinical status, time to discharge, day 5 peripheral blood oxygenation, day 5 C-reactive protein, and improvement in day 10 clinical status. Between 2 March 2021 and 18 November 2021, 713 patients were enroled in the DMF evaluation, of whom 356 were randomly allocated to receive usual care plus DMF, and 357 to usual care alone. 95% of patients received corticosteroids as part of routine care. There was no evidence of a beneficial effect of DMF on clinical status at day 5 (common odds ratio of unfavourable outcome 1.12; 95% CI 0.86-1.47; p = 0.40). There was no significant effect of DMF on any secondary outcome

Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple treatments in patients hospitalised for COVID-19 (NCT04381936, ISRCTN50189673). In this assessment of DMF performed at 27 UK hospitals, adults were randomly allocated (1:1) to either usual standard of care alone or usual standard of care plus DMF. The primary outcome was clinical status on day 5 measured on a seven-point ordinal scale. Secondary outcomes were time to sustained improvement in clinical status, time to discharge, day 5 peripheral blood oxygenation, day 5 C-reactive protein, and improvement in day 10 clinical status. Between 2 March 2021 and 18 November 2021, 713 patients were enroled in the DMF evaluation, of whom 356 were randomly allocated to receive usual care plus DMF, and 357 to usual care alone. 95% of patients received corticosteroids as part of routine care. There was no evidence of a beneficial effect of DMF on clinical status at day 5 (common odds ratio of unfavourable outcome 1.12; 95% CI 0.86-1.47; p = 0.40). There was no significant effect of DMF on any secondary outcome

LGBTQIA+ inclusion in the global health policy agenda: A critical discourse analysis of the Lancet Commission report archive

LGBTQIA+ people worldwide experience discrimination, violence, and stigma that lead to poor health outcomes. Policy plays a crucial role in ensuring health equity and safety for LGBTQIA+ communities. Given Lancet Commissions' substantial impact on health policy across domains, we aimed to determine how LGBTQIA+ communities and their care needs are incorporated throughout Lancet Commission reports and recommendations.CONTEXTLGBTQIA+ people worldwide experience discrimination, violence, and stigma that lead to poor health outcomes. Policy plays a crucial role in ensuring health equity and safety for LGBTQIA+ communities. Given Lancet Commissions' substantial impact on health policy across domains, we aimed to determine how LGBTQIA+ communities and their care needs are incorporated throughout Lancet Commission reports and recommendations.Using critical discourse analysis, we analyzed 102 Commissions for inclusion of and reference to LGBTQIA+ communities using 36 key terms. Three levels of analysis were conducted: 1) micro-level (overview of terminology use); 2) meso-level (visibility and placement of LGBTQIA+ references); and 3) macro-level (outlining characterizations and framing of references with consideration of broader social discourses).METHODSUsing critical discourse analysis, we analyzed 102 Commissions for inclusion of and reference to LGBTQIA+ communities using 36 key terms. Three levels of analysis were conducted: 1) micro-level (overview of terminology use); 2) meso-level (visibility and placement of LGBTQIA+ references); and 3) macro-level (outlining characterizations and framing of references with consideration of broader social discourses).36 of 102 (35%) Commissions referenced LGBTQIA+ communities with 801 mentions in total. There were minimal (9/36) references made in the "Executive Summary," "Recommendations," and/or "Key Messages" sections of reports. LGBTQIA+ communities were most frequently discussed in reports related to HIV/AIDS and sexual and reproductive health. Few Commissions related to public health, or chronic conditions (9/60) referenced LGBTQIA+ communities. Some reports made non-specific or unexplained references; many discussed the LGBTQIA+ population without specific reference to sub-groups. LGBTQIA+ communities were often listed alongside other marginalized groups without rationale or a description of shared needs or experiences. We identified framings (legal, vulnerability, risk) and characterizations (as victims, as blameworthy, as a problem) of LGBTQIA+ communities that contribute to problematizing discourse.FINDINGS36 of 102 (35%) Commissions referenced LGBTQIA+ communities with 801 mentions in total. There were minimal (9/36) references made in the "Executive Summary," "Recommendations," and/or "Key Messages" sections of reports. LGBTQIA+ communities were most frequently discussed in reports related to HIV/AIDS and sexual and reproductive health. Few Commissions related to public health, or chronic conditions (9/60) referenced LGBTQIA+ communities. Some reports made non-specific or unexplained references; many discussed the LGBTQIA+ population without specific reference to sub-groups. LGBTQIA+ communities were often listed alongside other marginalized groups without rationale or a description of shared needs or experiences. We identified framings (legal, vulnerability, risk) and characterizations (as victims, as blameworthy, as a problem) of LGBTQIA+ communities that contribute to problematizing discourse.LGBTQIA+ people were rarely included in the Commissions, resulting in an inadvertent marginalization of their health needs. Policy initiatives must consider LGBTQIA+ groups from a strengths-based rather than problematizing perspective, integrating evidence-based approaches alongside community-based stakeholder engagement to mitigate inequities and promote inclusive care and policymaking.CONCLUSIONSLGBTQIA+ people were rarely included in the Commissions, resulting in an inadvertent marginalization of their health needs. Policy initiatives must consider LGBTQIA+ groups from a strengths-based rather than problematizing perspective, integrating evidence-based approaches alongside community-based stakeholder engagement to mitigate inequities and promote inclusive care and policymaking

EMPOWER: A Multi-Site Pilot Trial to Reduce Distress in Surrogate Decision-Makers in the ICU

CONTEXT: Efforts to reduce the psychological distress of surrogate decision-makers of critically ill patients have had limited success, and some have even exacerbated distress. OBJECTIVES: The aim of this study was to determine the feasibility, acceptability, and preliminary efficacy of EMPOWER (Enhancing and Mobilizing the POtential for Wellness and Resilience), an ultra-brief (∼2-hour), 6-module manualized psychological intervention for surrogates. METHODS: Surrogates who reported significant anxiety and/or an emotionally close relationship with the patient (n=60) were randomized to receive EMPOWER or enhanced usual care (EUC) at one of three metropolitan hospitals. Participants completed an assessment of EMPOWER's acceptability, measures of psychological distress pre-intervention, immediately post-intervention, and at 1- and 3-month follow-up assessments. RESULTS: Delivery of EMPOWER appeared feasible, with 89% of participants completing all 6 modules, and acceptable, with high ratings of satisfaction (mean=4.5/5, SD=0.90). Compared to EUC, intent-to-treat analyses showed EMPOWER was superior at reducing peritraumatic distress (Cohen's d=-0.21, small effect) immediately post-intervention and grief intensity (d=-0.70, medium-large effect), posttraumatic stress (d=-0.74, medium-large effect), experiential avoidance (d=-0.46, medium effect), and depression (d=-0.34, small effect) 3 months post-intervention. Surrogate satisfaction with overall critical care (d=0.27, small effect) was higher among surrogates randomized to EMPOWER. CONCLUSIONS: EMPOWER appeared feasible and acceptable, increased surrogates' satisfaction with critical care, and prevented escalation of posttraumatic stress, grief, and depression 3 months later

The level of association between functional performance status measures and patient-reported outcomes in cancer patients: a systematic review

PURPOSE: The process of assessing patient symptoms and functionality using patient-reported outcomes (PROs) and functional performance status (FPS) is an essential aspect of patient-centered oncology research and care. However, PRO and FPS measures are often employed separately or inconsistently combined. Thus, the purpose of this study was to conduct a systematic review of the level of association between PRO and FPS measures to determine their differential or combined utility. METHODS: A systematic search was conducted using five databases (1966 to February 2014) to identify studies that described an association between PRO and FPS. Studies were excluded if they were non-cancer specific, did not include adults aged 18 or older, or were review articles. Publications were selected for review by consensus among two authors, with a third author arbitrating as needed. RESULTS: A total of 18 studies met inclusion criteria. FPS was primarily assessed by clinicians using the ECOG Performance Status or Karnofsky Performance Status measures. PROs were captured using a variety of measures, with numerous domains assessed (e.g., pain, fatigue, and general health status). Concordance between PROs and FPS measures was widely variable, falling in the low to moderate range (0.09–0.72). CONCLUSIONS: Despite consistency in the method of capture of PROs or FPS, domain capture varied considerably across reviewed studies. Irrespective of the method of capturing PROs or FPS, the quantified level of association between these two areas was moderate at best, providing evidence that FPS and PRO assessments offer unique information to assist clinicians in their decision-making