Harms-related data are poorly reported among randomized controlled trials underpinning the American Academy of Orthopaedic Surgeons clinical practice guideline recommendations for rotator cuff injuries.

BACKGROUND: Results produced from randomized controlled trials (RCTs) help guide clinical decision making and health policy. Therefore, it is essential that RCT outcomes- including harms (eg, adverse events)-are adequately reported such that clinicians, patients, and policy makers are equipped with all necessary information to complete risk-benefit assessment of the RCT's intervention. Here, we evaluated the quality of reporting of harms (eg, adverse events) in RCTs cited as supporting evidence for recommendations in the American Academy of Orthopaedic Surgeons (AAOS) Management of Rotator Cuff Injuries clinical practice guidelines (CPGs) using the Consolidated Standards of Reporting Trials (CONSORT) Extension for Harms Checklist. METHODS: To quantify adherence to CONSORT Extension for Harms items, each RCT was screened for pertinent information satisfying each checklist item. Screening of CPG reference sections for RCTs underpinning CPG recommendations, as well as data extraction from each of the included RCTs, was performed in a blind and duplicate manner. Descriptive statistics-including frequencies, percentages, and 95% confidence intervals-were used to summarize overall percent adherence to checklist items. A linear regression model assessed the relationship of CONSORT Harms reporting over time. RESULTS: Ninety-nine RCTs were included in our final sample. Fifty-seven RCTs (of 99; 57.6%) were conducted at a single center. Common funding sources included private (nonindustry) (17/99; 17.2%), private (industry) (8/99; 8.1%), and public (7/99; 7.1%) sources. Sample size for each trial most often consisted of <50 participants (29/99; 29.3%) or 51-100 participants (50/99; 50.5%). The average number of CONSORT Extension for Harms items adequately reported across all included RCTs was 5.7 (of 18; 31.7%). None of the included trials reported all 18 items. Twenty-six RCTs (of 99; 26.3%) adequately reported ≥50% of eligible checklist items. Fifty-nine RCTs (of 99; 59.6%) adequately reported ≤33% of eligible checklist items. Items with ≥50% adherence included item 2, item 7a, and item 8a. Items with ≤20% adherence included item 3b, item 4d, and item 5. Results from our linear regression demonstrated a slight, yet nonsignificant, improvement in adherence to the Harms Extension over time (R2 = 0.009; P = .407). CONCLUSIONS: Our results illustrate the poor state of harms reporting within RCTs cited as supporting evidence for the AAOS Management of Rotator Cuff Injuries CPG. Efforts to address these gaps in reporting are warranted, as complete knowledge of potential harms is critical to patients, clinicians, and health policy makers when determining best practice decisions in orthopedic surgery.

Fat Is All My Fault: Globalized Metathemes of Body Self-blame.

Norms valorizing not-fat bodies appear to have spread around the world, combined with a globalizing belief that thinness is the result of individual management of self and hard work. We examine themes of blame and felt responsibility for weight and "fat" in four distinct geographic and cultural locations: peri-urban Georgia, United States; suburban Osaka, Japan; urban Encarnación, Paraguay; and urban Apia, Samoa. Use of a novel metatheme approach that compares and contrasts these four distinct places characterized by different population-level prevalences of obesity and by specific cultural histories relevant to body norms and ideals provides a flexible toolkit for comparative cross-cultural/multi-sited ethnographic research. We show that self-blame, marked by an articulated sense of individual responsibility for weight and a sense of failing in this responsibility, is present in every field site, but to varying degrees and expressed in different ways. [fat, obesity, metatheme, stigma, self-blame].

Tocilizumab for the management of immune mediated adverse events secondary to PD-1 blockade.

BACKGROUND: Immune checkpoint inhibitors are poised to revolutionize the management of a growing number of malignancies. Unfortunately, the management of steroid-refractory immune mediated adverse events is based on a paucity of randomized data and limited to single center experiences. Our initial experience with the IL-6 receptor antagonist tocilizumab showed clinical improvement in a wide variety of irAEs. As a result, we adopted the use of tocilizumab for the management of steroid refractory irAEs. METHODS: The character and clinical course of irAEs were abstracted from the medical record and analyzed. The dose of tocilizumab was 4 mg/kg given IV over one hour. C-reactive protein was drawn at first nivolumab infusion and at q two weeks (and with irAEs) thereafter. Clinical improvement was defined as either: documentation of resolution of symptoms or hospital discharge within seven days. RESULTS: Of the initial 87 patients that were treated with nivolumab, 34 required tocilizumab (39.1%). All patients were on corticosteroids. The majority (88.2%) were lung cancer patients. The index grade 3/4 irAE was pneumonitis in 35.3%, serum sickness/SIRS in 35.3%, cerebritis in 14.7% and one case each of hypophysitis, colitis, pancreatitis, hepatitis and immune mediated coagulopathy. Median time between first nivolumab and initiation of tocilizumab was 76 days (range 1-429). There was a statistically significant increase in C-reactive protein from a median of 23 mg/L (range 0.1-238.5) at baseline to 109.3 mg/L (21.5-350.4) at the time of index irAE, followed by a decrease to 19.2 mg/L (0.25-149) after tocilizumab ( p < 0.00001). Clinical improvement was noted in 27/34 patients (79.4%). Some patients (52.9%) required a single dose, while 38.2% required two, 8.8% required three and 1 patient required four doses. Twenty-seven doses were given in the inpatient setting (49.1%). Median time to discharge was four days (range 1-27). Seventy-four percent of patients were discharged home. For the 53 doses of tocilizumab that were delivered when infliximab was an option, there was a cost savings of $141,048.72 (WAC) during the 18 month study period. CONCLUSIONS: Tocilizumab may be a therapeutic option for the management of steroid refractory irAEs secondary to immune checkpoint blockade. However, randomized trials are needed to better elucidate the relative efficacy and safety of these agents.

Body size, body norms and some unintended consequences of obesity intervention in the Pacific islands.

BACKGROUND: Pacific Islanders have experienced over 50 years of obesity interventions-the longest of any region in the world. Yet, obesity-related non-communicable diseases (NCDs) continue to rise. 'Traditional' body norms have been cited as barriers to these interventions. AIM: In this study, we ask: 'What is the relationship between health interventions, body norms and people's experience of "fatness"? How - and why - have these changed over time?' We study two nations with high rates of obesity: Nauru and Samoa. SUBJECTS AND METHODS: Ethnographic fieldwork with people in everyday and clinical settings in Samoa (2011-2012; 2017) and Nauru (2010-2011). RESULTS: Body norms are not a single or universal set of values. Instead, multiple cultural influences-including global health, local community members and global media-interact to create a complex landscape of contradictory body norms. CONCLUSIONS: Body norms and body size interventions exist in an iterative relationship. Our findings suggest that Pacific island obesity interventions do not fail because they conflict with local body norms; rather, they fail because they powerfully re-shape body norms in ways that confuse and counteract their intended purpose. Left unacknowledged, this appears to have (unintended) consequences for the success of anti-obesity interventions.

Embedded Narratives: Metabolic Disorders and Pentecostal Conversion in Samoa.

Drawing from interviews and participant observation, this article explores the intersection of diagnosis of metabolic disorders and religious conversion among Pentecostal Christians in Samoa by analyzing what I call embedded narratives--conversion narratives embedded in illness narratives. Drawing from ethnographic data, I examine how using conversion narrative conventions enabled those living with metabolic disorders to narrate behavior change in a culturally and socially valorized way. By embedding their narratives, I suggest those living with metabolic disorders shifted the object of care from a disease process toward the creation of a religious life and in turn transformed the risks associated with metabolic disorders, including diet, exercise, and pharmaceutical use into moral risks associated with everyday religious life. In these cases, Pentecostal conversion created possible scripts for changing health practices, managing stress, and shifting resource use in the name of religious commitment, providing insights into how self-care can be an expression of religious practice.

Developing Trust in Collaborative Research: Utilizing Indigenous Pacific Methodologies to Create Dialogue Within Research Teams.

This article explores the processes involved in developing international, cross-cultural research teams. Scholarship on Indigenous and Pacific Methodologies demonstrate the importance of employing methodologies that center Indigenous approaches to research and relationships. This article explores using these methodologies within research teams as a preliminary step in developing sustainable and impactful international, cross-cultural research teams. Although this is not a formal study, the article reports that the importance of building trust within research teams as an essential step in addition to building trust with communities.

Event-based internet biosurveillance: relation to epidemiological observation.

BACKGROUND: The World Health Organization (WHO) collects and publishes surveillance data and statistics for select diseases, but traditional methods of gathering such data are time and labor intensive. Event-based biosurveillance, which utilizes a variety of Internet sources, complements traditional surveillance. In this study we assess the reliability of Internet biosurveillance and evaluate disease-specific alert criteria against epidemiological data. METHODS: We reviewed and compared WHO epidemiological data and Argus biosurveillance system data for pandemic (H1N1) 2009 (April 2009 - January 2010) from 8 regions and 122 countries to: identify reliable alert criteria among 15 Argus-defined categories; determine the degree of data correlation for disease progression; and assess timeliness of Internet information. RESULTS: Argus generated a total of 1,580 unique alerts; 5 alert categories generated statistically significant (p < 0.05) correlations with WHO case count data; the sum of these 5 categories was highly correlated with WHO case data (r = 0.81, p < 0.0001), with expected differences observed among the 8 regions. Argus reported first confirmed cases on the same day as WHO for 21 of the first 64 countries reporting cases, and 1 to 16 days (average 1.5 days) ahead of WHO for 42 of those countries. CONCLUSION: Confirmed pandemic (H1N1) 2009 cases collected by Argus and WHO methods returned consistent results and confirmed the reliability and timeliness of Internet information. Disease-specific alert criteria provide situational awareness and may serve as proxy indicators to event progression and escalation in lieu of traditional surveillance data; alerts may identify early-warning indicators to another pandemic, preparing the public health community for disease events.

Duoethnography as Transformative Praxis: Conversations about Nourishment and Coercion in the COVID-Era Academy.

This article introduces the feminist praxis of duoethnography as a way to examine the COVID era. As a group of diverse, junior, midcareer, and senior feminist scholars, we developed a methodology to critically reflect on our positions in our institutions and social worlds. As a method, duoethnography emphasizes the dialogical intimacy that can form through anthropological work. While autoethnography draws on individual daily lives to make sense of sociopolitical dynamics, duoethnography emphasizes the relational character of research across people and practices. Taking the relational aspects of knowledge production seriously, we conceptualized this praxis as a transformative method for facilitating radical empathy, mobilizing our collective voice, and merging together our partial truths. As collective authors, interviewers, and interlocutors of this article, the anonymity of duoethnography allows us to vocalize details of the experience of living through COVID-19 that we could not have safely spoken about publicly or on our own.

On the limitations of barriers: Social visibility and weight management in Cuba and Samoa.

Obesity is an enduring global health challenge. Researchers have struggled to understand the barriers and facilitators of weight loss. Using a cross-cultural comparative approach, we move away from a barriers approach to analyze obesity and overweight through the lens of social visibility to understand the persistent failure of most obesity interventions. Drawing on ethnographic data from Cuba and Samoa collected between 2010 and 2017, we argue that social visibility is a framework for analyzing some of the reasons why people do not participate in weight management programs when they have high rates of health literacy and access to free or low-cost programming. Comparing these two places with very different histories of obesity interventions, we trace how weight management practices make people socially visible (in positive and negative ways), specifically analyzing how gender and economic inequalities shape the sociality of obesity. Our findings show that regardless of barriers and facilitators of weight loss at an individual and population level, the ways weight loss activities are incorporated into or conflict with the social dynamics of everyday life can have a profound effect on weight management. Employing visibility as a analytic framework de-individualizes weight responsibility, providing a contextual way to understand the difficulties people face when they manage their weight.

"Healing is a Done Deal": Temporality and Metabolic Healing Among Evangelical Christians in Samoa.

Drawing on fieldwork in independent Samoa, in this article, I analyze the temporal dimensions of evangelical Christian healing of metabolic disorders. I explore how those suffering with metabolic disorders draw from multiple time-based notions of healing, drawing attention to the limits of biomedicine in contrast with the effectiveness of Divine healing. By simultaneously engaging evangelical and biomedical temporalities, I argue that evangelical Christians create wellness despite sickness and, in turn, re-signify chronic suffering as a long-term process of Christian healing. Positioning biomedical temporality and evangelical temporality as parallel yet distinctive ways of practicing healing, therefore, influences health care choices.

Provider perspectives on electronic decision supports for obesity prevention.

Despite the availability of national evidenced-based guidelines related to pediatric obesity screening and prevention, multiple studies have shown that primary care physicians find it difficult to adhere to them or are unfamiliar with them altogether. This article presents physicians' perspectives on the use of electronic decision support tools, an alert and Smart Set, to accelerate the adoption of obesity-related recommendations into their practice. The authors interviewed providers using a test encounter walk-through technique that revealed a number of barriers to using electronic decision supports for obesity care in primary care settings. Providers' suggestions for improving their use of obesity-related decision supports are presented. Careful consideration must be given to both the development of electronic decision support tools and a multilayered educational outreach strategy if providers are going to be persuaded to use such supports to help them implement pediatric obesity prevention and management best practices.