Patient-centered Outcomes Research Articles

Improving Family Medicine Residents' Provision of Gender-Affirming Care.

Family physicians are uniquely poised to provide gender-affirming care (GAC) to transgender and nonbinary patients, but current undergraduate and graduate medical education in this field is lacking. Little is known about the impact of various GAC curricula on the clinical care provided by resident physicians. We aimed to assess the efficacy of a multimodal educational framework on the quality of GAC provided by residents at a large academic family medicine program. This pilot study used chart review to assess the impact of a multifaceted educational intervention around GAC in an academic family medicine practice. Components included faculty-specific didactics, resident feedback and didactics, standardized note templates, and compiled resources. We completed pre- and postintervention analysis of resident-led GAC encounters using a novel rubric based on standards of care and compared these results using descriptive statistics. Following a multimodal educational intervention, residents demonstrated improvement in multiple domains of gender-affirming care, including documenting informed consent, counseling on pregnancy and contraception, and laboratory monitoring for patients initiating gender-affirming hormone therapy. This widespread improvement suggested that a multimodal approach to resident and faculty education may help enhance the quality of GAC provided by family medicine residents. Chart review offers a feasible and effective method for identifying gaps in resident knowledge and documentation in GAC. Further research should specifically explore faculty development in this area and expanded patient-centered quality metrics and outcomes that encompass GAC.

Assessing Patient-Centered Clinical Outcomes in a Virtual Randomized Controlled Trial of the AsthmaXcel Mobile Platform

Assessing Patient-Centered Clinical Outcomes in a Virtual Randomized Controlled Trial of the AsthmaXcel Mobile Platform

Social Determinants of Health in Family Medicine Residency: A National Survey of Program Directors.

Social factors account for most health outcomes, underscoring the need to address social determinants of health (SDH) to eliminate health disparities. Our objectives are (1) to describe the scope of formal SDH curricula in family medicine residency, (2) to identify residency program characteristics associated with integrated core curriculum components to teach SDH, and (3) to identify barriers to addressing SDH in residency. We distributed a cross-sectional survey to all family medicine residency program directors (PDs) accredited by the Accreditation Council for Graduate Medical Education as identified by the Association of Family Medicine Residency Directors. Of 624 eligible program directors, 279 completed the survey (45% response rate). Overall, 41.2% of respondents reported significant formal SDH training in their program. Though a majority (93.9%) agreed that screening for social needs should be a standard of care, most (58.9%) did not use standardized screening tools. The most common barriers to addressing SDH were lack of clinical resources (eg, social workers, legal advocates), lack of community resources (eg, food banks, substance use disorder treatment), and inadequate screening instruments or integration into the electronic medical record system. Availability of referral resources was associated with PDs' increased perception of resident SDH competency. Nearly all respondents agreed that screening for social needs should be a standard part of care; however, this vision is not yet realized. To better train the next generation of physicians to identify and meaningfully address social needs, additional research is needed. This research might include mixed-methods approaches that incorporate qualitative assessments to define best practices and patient-centered outcomes related to identifying and responding to SDH.

The frequency of use and enrollment impact of patient-centered outcomes in prostate cancer clinical trials.

115 Background: Cancer treatments should help patients live either longer or better by improving patient quantity or quality of life. However, some trial endpoints do not correlate with overall survival, and are not noticeable to patients. Selecting endpoints for clinical trials that reflect these goals could improve the discovery process by ensuring trial results are of direct interest to patients, and perhaps by improving enrollment rates to trials. However, how frequently prostate cancer clinical trials use patient-centered outcomes, and how outcome type impacts trial enrollment, is unknown. Methods: On October 23, 2022, we queried ClinicalTrials.gov for full text records of phase 2-3 prostate cancer trials started after January 1, 2007. We extracted primary outcomes and other trial characteristics using a custom Python script. Two reviewers categorized each outcome into categories (e.g., overall survival, response rate, patient reported measure). As previously studied, the only valid surrogate for overall survival is metastasis-free survival. We considered these two outcomes or any outcome directly noticeable to a patient to be a patient-centered outcome. For completed or terminated trials, we defined ‘sufficient accrual’ as attaining 85% of a trial’s goal enrollment. We identified associations between trial outcome types and sufficient trial enrollment with chi-square tests and logistic regression. Results: Of 1,717 prostate cancer trials, only 37% used a patient-centered outcome, with 6% using overall or metastasis-free survival. Among 318 Phase 3 trials, 49% used a patient-centered outcome and 26% used overall or metastasis-free survival. Of 731 completed or terminated prostate cancer trials, 55% of trials and 68% of phase 3 trials reached sufficient enrollment (85% of enrollment goal). On multivariable analysis, trials with an overall survival endpoint had higher odds of sufficient enrollment (OR 8.0 [95% CI 2.2-33.5], p < 0.01), but trials with any patient-centered outcome had lower odds of sufficient enrollment (OR 0.25 [95% CI 0.11-0.54], p < 0.01). Conclusions: Less than half of prostate cancer trials use an outcome that is clearly patient-centered (i.e., affecting overall survival or an outcome noticeable to a patient). Further work is needed to clarify the use, understanding, and effect of outcome selection in cancer trials. Realigning trial efforts with patient-centered goals could improve the efficiency, productivity, and applicability of clinical trials.

Building Statewide Quality Improvement Capacity to Improve Cardiovascular Care and Health Equity: Lessons from the Tennessee Heart Health Network

Many states with high rates of cardiovascular disease (CVD) lack statewide quality improvement (QI) infrastructure (for example, resources, leadership, community) to address relevant health needs of the population. Academic health centers are well positioned to play a central role in addressing this deficiency. This article describes early experience and lessons learned in building statewide QI infrastructure through the Tennessee Heart Health Network (Network). A statewide, multistakeholder network composed of primary care practices (PCPs), health systems, health plans, QI organizations, patients, and academic institutions was led by the University of Tennessee Health Science Center (UTHSC), an academic health center, to improve cardiovascular health by supporting dissemination and implementation of patient-centered outcomes research (PCOR) evidence-based interventions in primary care. PCPs were required to select and implement at least one of three interventions (health coaching, tailored health-related text messaging, and pharmacist-physician collaboration). Thirty statewide organizational partners joined the Network in year one, including 18 health systems representing 77 PCPs (30.0% of 257 potentially eligible PCPs identified) with approximately 300,000 patients. The organizational partners share EHRs for the ongoing tracking and reporting of key health metrics, including hypertension control and delivery of tobacco cessation counseling. Of the 77 PCPs, 62 continue participation after year two (80.5% retention). Main barriers to participation and reasons for discontinuing participation included reluctance to share data and changes in leadership at the health system level. These 62 PCPs selected the following interventions to implement: health coaching (41.9%), tailored health-related text messages (48.4%), and pharmacist-physician collaboration (40.3%). Academic health centers have broad reach and high acceptability by diverse stakeholders. Tennessee's experience illustrates how academic health centers can serve as platforms for building a statewide infrastructure for disseminating, implementing, and sustaining QI interventions at the practice level. Assessment of Network impact is ongoing.

Advanced and alternative research methods for the acute care surgeon scientist

Clinical research has evolved significantly over the last few decades to include many advanced and alternative study designs to answer unique questions. Recognizing a potential knowledge gap, the AAST Associate...

Skin Antisepsis before Surgical Fixation of Extremity Fractures

BackgroundStudies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture).MethodsIn a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications.ResultsA total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P=0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P=0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups.ConclusionsAmong patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.)

Lessons from the COVID-19 pandemic in paediatric post-discharge care

The COVID-19 pandemic dictated rapid reform in outpatient paediatric services. To reduce ward footfall and its associated infection risk, a trainee-led outpatient clinic was established with the aim to provide...

Association of patient-reported outcome measures with lung function and mortality in fibrotic interstitial lung disease: a prospective cohort study.

Patient-reported outcome measures (PROMs) may provide clinicians and researchers with direct insights into disease impact and patient well-being. We assessed whether selected PROMs and their domains are associated with baseline and longitudinal changes in lung function and can predict mortality in patients with fibrotic interstitial lung disease (f-ILD). A single-centre prospective study of adult patients with f-ILD enrolled over 3 years was conducted assessing baseline and short-term changes in PROMs. Three questionnaires, the modified Medical Research Council dyspnoea scale (mMRC), Chronic Respiratory Questionnaire (CRQ) and Self-Management Ability Scale (SMAS-30) were administered at planned intervals and assessed for their association with baseline clinical findings, change in lung function (% predicted forced vital capacity (FVC%) and diffusion capacity of the lung for carbon monoxide (DLCO%)) and all-cause mortality. 199 patients were enrolled with a mean PROM follow-up of 9.6 months. When stratified by FVC% quartiles at presentation, lower mMRC (less dyspnoea), higher CRQ Physical and Emotional domain (better health-related quality of life) and higher total SMAS-30 scores (better self-management ability) were associated with higher FVC%. Short-term changes in all three PROMs appeared to be associated with changes in FVC% and DLCO%. Adjusted and unadjusted baseline and serial PROM changes were also predictive of mortality. Baseline and serial assessments of PROMs were associated with changes in lung function and predicted death in patients with f-ILD. PROMs may strengthen comprehensive assessments of disease impact in clinical practice as well as support patient-centred outcomes in research.

Call to Action: A Faculty Survey to Inform Future Efforts at Student-Run Clinics.

Existing literature about student-run clinics (SRCs) often focuses on student rather than patient experiences. To begin to gather data on norms and practices at SRCs nationally, this pilot study surveyed faculty leaders from SRCs around the country about metrics such as clinic organization, patient demographics, and care services. A 38-question survey was distributed via email to members of the Student Run Free Clinic Faculty Association (SRFCFA) in October 2021. All responses were collected electronically via Qualtrics survey software. Most SRCs are held at least once weekly in variable physical locations. All SRCs surveyed use an electronic medical record. Student leadership typically rotates annually. Preceptors skew towards generalists rather than specialists. Clinics have variable patient volumes but see majority uninsured and non-English-speaking patient populations. Responses about consistency of result communication, follow-up visits, referrals to specialty care, and management of high-risk patients were mixed. The majority of respondents did not feel that learner experience was prioritized over patient care. The design and operations of SRCs nationwide is variable and not standardized. There remains a limited understanding of patient experiences and patient-centered outcomes at SRCs, and thus it is difficult to guide best practices. Future efforts to collect patient perspectives and outcomes should be emphasized given the vulnerable populations these clinics serve.

Patient Outcomes After Peripheral Nerve Injury Depend on Bimanual Dexterity and Preserved Use of the Affected Hand

Background Little is known about how peripheral nerve injury affects human performance, behavior, and life. Hand use choices are important for rehabilitation after unilateral impairment, but rarely measured, and are not changed by the normal course of rehabilitation and daily life. Objective To identify the relationship between hand use (L/R choices), motor performance, and patient-centered outcomes. Methods Participants (n = 48) with unilateral peripheral nerve injury were assessed for hand use via Block Building Task, Motor Activity Log, and Edinburgh Handedness Inventory; dexterity (separately for each hand) via Nine-Hole Peg Test, Jebsen Taylor Hand Function Test, and a precision drawing task; patient-centered outcomes via surveys of disability, activity participation, and health-related quality of life; and injury-related factors including injury cause and affected nerve. Factor Analysis of Mixed Data was used to explore relationships between these variables. The data were analyzed under 2 approaches: comparing dominant hand (DH) versus non-dominant hand (NH), or affected versus unaffected hand. Results The data were best explained by 5 dimensions. Good patient outcomes were associated with NH performance, DH performance (separately and secondarily to NH performance), and preserved function and use of the affected hand; whereas poor patient outcomes were associated with preserved but unused function of the affected hand. Conclusion After unilateral peripheral nerve injury, hand function, hand usage, and patient life arise from a complex interaction of many factors. To optimize rehabilitation after unilateral impairment, new rehabilitation methods are needed to promote performance and use with the NH, as well as the injured hand.

Precision Versus Practicality: A Comprehensive Analysis of Robotic Right Colectomy Versus Laparoscopic Right Colectomy, Future Directions, Biases, Research Gaps, and Their Implications.

Colorectal cancer is the third most commonly diagnosed cancer in the world and second in cancer-related mortality. It is most prevalent in the developed world and is often associated with lifestyle factors along with age and genetics. The inclusion criteria comprised high-level evidence, such as randomized clinical trials, meta-analyses, and systematic reviews, conducted between 2012 and 2023, that directly compared the two approaches. The reviewreveals mixed outcomes between robotic right colectomy (RRC) and laparoscopic right colectomy (LRC). The robotic approach was associated with longer operative duration and higher costs but with decreased blood loss and quicker recovery compared to laparoscopy. On the other hand, no major differences were observed regarding lymph node retrieval, duration of hospitalization, and surgical complications. Regarding future directions, it is evident that the focus needs to shift beyond the operative parameters and to patient-centered outcomes, which are underreported. Also, more randomized clinical trials are required, focusing on safety, efficacy, and long-term quality of life. Costs-benefit analyses are required to weigh the benefits of robotic surgery against the implementation and practice costs. Additionally, improvements in surgeons' training may be necessary to reduce the operative duration and potentially decrease operational costs. Finally, standardization of research protocols may be necessary to reduce biases.

The Translation and Validation of Patient-Centered Outcomes Questionnaire Into Arabic: A Chronic Periodontitis Patient-Based Study.

Background The patient-centered outcomes questionnaire (PCOQ) is a self-report questionnaire that aims to assess four fundamental domains (pain, fatigue, distress, and interference) on an 11-point numerical rating scale from 0 to 10 in chronic diseases. The implementation of this tool will help assess chronic diseases; hence, this study aimed to translate the PCOQ to a sample of periodontitis patients. Methodology This study went through the content validity index. Arabic PCOQ used Cronbach's alpha for reliability with 300 participants. From July to August 2023, patients with periodontitis visiting an outpatient dental center in Riyadhwere invited to participate in the study. The language, content, and structure of the questionnaire were appropriate, and with forward and backward translation, external entity translation was implemented. Results Regarding the participants' gender, the number of males was higher at 61%. Regarding age distribution, 50.7% of the participants were between 30 and 50 years old. A clarity score of 95.2% and a representativeness score of 97.3% were reported in the content validity analysis. The Cronbach's alpha of the Arabic PCOQ questionnaire was 0.85, and the subscales ranged between 0.68 and 0.93. Conclusions The translated version of the Arabic PCOQ is a valid tool to be used in Arab countries. Nonetheless, this instrument can provide insights for healthcare professionals, policymakers, and managers to improve patient satisfaction and healthcare system delivery.

Provider Perceptions Regarding Cardiopulmonary Resuscitation in Surgical Patients with Frailty.

To characterize the perceptions of surgeons, anesthesiologists, and geriatricians regarding perioperative CPR in surgical patients with frailty. The population of patients undergoing surgery is growing older and more frail. Despite a growing focus on goal-concordant care, frailty assessment, and debate regarding the appropriateness of cardiopulmonary resuscitation (CPR) in patients with frailty, providers' views regarding frailty and perioperative CPR are unknown. We performed qualitative thematic analysis of transcripts from semi-structured interviews of anesthesiologists (8), surgeons (10), and geriatricians (9) who care for high-risk surgical patients at two academic medical centers in Boston, MA. The interview guide elicited clinicians' understanding of frailty, approach to decision-making regarding perioperative CPR, and perceptions of perioperative CPR in frail surgical patients. We identified 5 themes: perceptions of perioperative CPR in patients with frailty vary by provider specialty; judgments regarding appropriateness of CPR in surgical patients with frailty are typically multifactorial and include patient goals, age, comorbidities, and arrest etiology; resuscitation in patients with frailty is sometimes associated with moral distress; biases such as ableism and ageism may skew clinicians' perceptions of appropriateness of perioperative CPR in patients with frailty; and evidence to guide risk stratification for patients with frailty undergoing perioperative CPR is inadequate. Anesthesiologists, surgeons, and geriatricians offer different accounts of frailty's relevance to judgments regarding CPR in surgical patients. Divergent views regarding frailty and perioperative CPR may impede efforts to deliver goal-concordant care and suggest a need for research to inform risk stratification, predict patient-centered outcomes, and understand the role of potential biases such as ageism and ableism.

Days at home alive after major surgery in patients with and without diabetes: an observational cohort study.

We hypothesized that days at home alive up to 30days after surgery (DAH30), a novel patient-centered outcome metric, as well as long-term mortality, would be impaired in patients with type 1 or 2 diabetes mellitus (DM) undergoing major surgery. This cohort study investigated patients > 18years with and without DM presenting for major non-cardiovascular, non-ambulatory surgical procedures at 23 hospitals in Sweden between 2007 and 2014. We identified 290,306 patients. Data were matched with various quality registers. The primary outcome was the composite score, DAH30. The secondary outcome was mortality from 31 to 365days. Using multivariable logistic regression, significant independent risk factors influencing the primary and secondary outcomes were identified, and their adjusted odds ratios were calculated. Patients with DM type 1 and 2 had significantly lower DAH30 as compared to non-diabetics. Patients with DM were older, had higher co-morbid burden, and needed more emergency surgery. After adjustment for illness severity and age, the odds of having a DAH30 less than 15, indicating death and/or complications, were significantly increased for both type 1 and type 2 diabetes. In the year after surgery, DM patients had a higher mortality as compared to those without diabetes. The results of this large cohort study are likely broadly generalizable. To optimize patient and societal outcomes, specific perioperative care pathways for patients with diabetes should be evaluated.

The impact of a pancreatic cancer multi-disciplinary clinic on patient-centric outcomes.

641 Background: A one-day multi-disciplinary clinic allows for a comprehensive evaluation of patients in a single-visit format. This study aims to evaluate the impact of a one-day pancreatic cancer multi-disciplinary clinic (PMDC) on patient-centric outcomes. Methods: Patients with pancreatic cancer who were seen at The Ohio State University PMDC from January 2021 to March 2023 were identified. Patient-centric outcomes were evaluated including time from diagnosis to first evaluation and treatment, number of supportive care referrals completed, and number of physical trips to the medical center leading up to the first treatment. Outcomes were compared to pancreatic cancer patients seen in the year prior to the opening of the PMDC (non-PMDC). Results: Among the 139 PMDC and 141 non-PMDC patients, the median number of days between referral and treatment initiation was similar (PMDC: 33 days (IQR: 22, 44) vs. non-PMDC: 32 days (IQR: 23, 42); p >0.9). The median time between diagnosis and treatment initiation was also similar (PMDC: 28 days (IQR: 19, 37) vs. non-PMDC: 30 days (IQR: 21, 37); p=0.4). Of note, PMDC patients received more supportive care visits within 30 days of diagnosis (PMDC: 2 (IQR: 1, 2) vs. non-PMDC: 0 (IQR: 0, 1) ; p <0.001) and completed more visits with cancer providers (PMDC: 7 (IQR: 6, 8) vs. non-PMDC: 5 (IQR: 4, 7); p <0.001) compared with non-PMDC patients. In addition, PMDC patients also required fewer physical trips to the medical center (PMDC: 4 (IQR: 3, 5) vs. non-PMDC: 4 (IQR: 3, 6); p <0.001). Conclusions: Pancreatic cancer patients seen in a one-day multi-disciplinary clinic attend a greater number of coordinated appointments and receive more supportive care services with fewer physical trips to the medical center compared with patients not seen in a PMDC clinic. Future studies should focus on the long-term patient-centric benefits of a multi-disciplinary approach for cancer patients.

Making progress against rare cancers: A case study on neuroendocrine tumors.

In April 2023, the National Cancer Institute offered a roadmap for cancer research to achieve Cancer Moonshot goals. To reach these goals requires making progress for all cancers, not just those that are most common. Achieving progress against rare cancers, as well as common cancers, requires involvement of large clinical research networks. In 2020, the Patient-Centered Outcomes Research Institute (PCORI) launched an initiative on Conducting Rare Disease Research using PCORnet, the National Patient-Centered Clinical Research Network. The purpose of this commentary is to introduce the broader community of cancer researchers to the PCORnet NET-PRO study (comparing the effects of different treatment approaches for neuroendocrine tumors on patient-reported outcomes) thereby demonstrating how researchers can use the PCORnet infrastructure to conduct large-scale patient-centered studies of rare cancers.

Automated Electronic Alert for the Care and Outcomes of Adults With Acute Kidney Injury

Despite the expansion of published electronic alerts for acute kidney injury (AKI), there are still concerns regarding their effect on the clinical outcomes of patients. To evaluate the effect of the AKI alert combined with a care bundle on the care and clinical outcomes of patients with hospital-acquired AKI. This single-center, double-blind, parallel-group randomized clinical trial was conducted in a tertiary teaching hospital in Nanjing, China, from August 1, 2019, to December 31, 2021. The inclusion criteria were inpatient adults aged 18 years or older with AKI, which was defined using the Kidney Disease: Improving Global Outcomes creatinine criteria. Participants were randomized 1:1 to either the alert group or the usual care group, which were stratified by medical vs surgical ward and by intensive care unit (ICU) vs non-ICU setting. Analyses were conducted on the modified intention-to-treat population. A programmatic AKI alert system generated randomization automatically and sent messages to the mobile telephones of clinicians (alert group) or did not send messages (usual care group). A care bundle accompanied the AKI alert and consisted of general, nonindividualized, and nonmandatory AKI management measures. The primary outcome was maximum change in estimated glomerular filtration rate (eGFR) within 7 days after randomization. Secondary patient-centered outcomes included death, dialysis, AKI progression, and AKI recovery. Care-centered outcomes included diagnostic and therapeutic interventions for AKI. A total of 2208 patients (median [IQR] age, 65 [54-72] years; 1560 males [70.7%]) were randomized to the alert group (n = 1123) or the usual care group (n = 1085) and analyzed. Within 7 days of randomization, median (IQR) maximum absolute changes in eGFR were 3.7 (-6.4 to 19.3) mL/min/1.73 m2 in the alert group and 2.9 (-9.2 to 16.9) mL/min/1.73 m2 in the usual care group (P = .24). This result was robust in all subgroups in an exploratory analysis. For care-centered outcomes, patients in the alert group had more intravenous fluids (927 [82.6%] vs 670 [61.8%]; P < .001), less exposure to nonsteroidal anti-inflammatory drugs (56 [5.0%] vs 119 [11.0%]; P < .001), and more AKI documentation at discharge (560 [49.9%] vs 296 [27.3%]; P < .001) than patients in the usual care group. No differences were observed in patient-centered secondary outcomes between the 2 groups. Results of this randomized clinical trial showed that the electronic AKI alert did not improve kidney function or other patient-centered outcomes but changed patient care behaviors. The findings warrant the use of a combination of high-quality interventions and AKI alert in future clinical practice. ClinicalTrials.gov Identifier: NCT03736304.

The impact of obesity in hospitalized patients with COVID-19: a retrospective cohort study

BackgroundObesity is believed to be a risk factor for COVID-19 and unfavorable outcomes, although data on this remains to be better elucidated.ObjectiveTo evaluate the impact of obesity on the endpoints of patients hospitalized due to SARS-CoV-2.MethodsThis retrospective cohort study evaluated patients hospitalized at a tertiary hospital (Hospital das Clínicas da Faculdade de Medicina da USP) from March to December 2020. Only patients positive for COVID-19 (real-time PCR or serology) were included. Data were collected from medical records and included clinical and demographic information, weight and height, SAPS-3 score, comorbidities, and patient-centered outcomes (mortality, and need for mechanical ventilation, renal replacement therapy, or vasoactive drugs). Patients were divided into categories according to their BMI (underweight, eutrophic, overweight and obesity) for comparison porpoise.ResultsA total of 2547 patients were included. The mean age was 60.3 years, 56.2% were men, 65.2% were white and the mean BMI was 28.1 kg/m2. SAPS-3 score was a risk factor for all patient-centered outcomes (HR 1.032 for mortality, OR 1.03 for dialysis, OR 1.07 for vasoactive drug use, and OR 1.08 for intubation, p < 0.05). Male sex increased the risk of death (HR 1.175, p = 0.027) and dialysis (OR 1.64, p < 0.001), and underweight was protective for vasoactive drug use (OR 0.45, p = 0.027) and intubation (OR 0.31, p < 0.003).ConclusionObesity itself was not an independent factor for worse patient-centered outcomes. Critical clinical state (indirectly evaluated by SAPS-3) appears to be the most important variable related to hard outcomes in patients infected with COVID-19.

The impacts of migraine on functioning: Results from two qualitative studies of people living with migraine.

To describe the impact of migraine on functioning based on comprehensive data collection, analysis, and reporting of patients' experiences. Qualitative research conducted to understand patients' perspectives on living with migraine has often focused on narrow topics or specific groups of patients or has been selectively reported. Qualitative interviews with 71 participants were conducted during two concept elicitation studies as part of the Migraine Clinical Outcome Assessment System (MiCOAS) project, an FDA grant-funded program designed to develop a core set of patient-centered outcome measures for migraine clinical trials. Participants self-reported being diagnosed with migraine by a healthcare professional and participated in semi-structured qualitative interviews about their experiences with the symptoms and impacts of migraine. Interview transcripts were coded to identify and define concepts, which were then grouped into broad domains based on conceptual similarities. A total of 66 concepts were identified: 12 for physical functioning, 16 for cognitive functioning, 10 for social role functioning, 19 for emotional and psychological functioning, and 9 related to migraine management. Participants described a complex and varied relationship between migraine attack symptoms and impacts on functioning. Impacts from migraine were further influenced by numerous contextual factors, such as people's individual social environments and the level of day-to-day demand for functioning they face. Findings showed that migraine impacted individual functioning in multiple ways and the nature of these impacts was dependent on social-contextual factors. The results are being used in the development of core measures designed to improve our understanding of the burden of migraine and the efficacy of migraine therapies. The results also offer new insights and raise new questions about migraine experience that can be used to guide future research.