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This study explored illness experiences and decision-making among patients with epilepsy who underwent two different types of surgical interventions: resection versus implantation of the NeuroPace Responsive Neurostimulation System (RNS). We recruited 31 participants from a level four epilepsy center in an academic medical institution. We observed 22 patient clinic visits (resection: n = 10, RNS: n = 12) and conducted 18 in-depth patient interviews (resection: n = seven, RNS: n = 11); most visits and interviews included patient caregivers. Using an applied ethnographic approach, we identified three major themes in the experiences of resection versus RNS patients. First, for patients in both cohorts, the therapeutic journey was circuitous in ways that defied standardized first-, second-, and third- line of care models. Second, in conceptualizing risk, resection patients emphasized the permanent loss of taking out brain tissue whereas RNS patients highlighted the reversibility of putting in a device. Lastly, in considering benefit, resection patients perceived their surgery as potentially curative while RNS patients understood implantation as primarily palliative with possible additional diagnostic benefit from chronic electrocorticography. Insight into the perspectives of patients and caregivers may help identify key topics for counseling and exploration by clinicians.

ObjectivesTo explore the context in which older men navigate treatment for stress urinary incontinence (SUI) following prostate surgery by characterizing lived experience of men with symptomatic SUI.Subjects/patients and methodsMixed method study using surveys and semistructured interviews to examine a cohort of men who underwent evaluation for treatment of postprostatectomy SUI.ResultsThirty-six men were interviewed after consultation for SUI and 31 had complete quantitative clinical data. Twenty-six underwent surgery and 10 chose no surgical intervention. In qualitative interviews, respondents experienced substantial decline in quality of life due to incontinence citing concerns associated with use of pads and worrying about incontinence. Most patients reported "workarounds"-efforts to mitigate or manage incontinence including Kegels, physical therapy, and garments. Participants also reported lifestyle changes including less strenuous physical activity, less sexual activity, and/or fewer social gatherings. Patients then described a "breaking point" where incontinence workarounds were no longer sufficient. After seeking evaluation, men described challenges in exploring treatment for SUI, including access to care and provider knowledge of treatment options.ConclusionIn a novel study of patients living with SUI a predictable lived experience was observed that culminated in a desire for change or "breaking point." In all men, this led to treatment-seeking behaviors and for many it led to SUI intervention. Despite effective treatments, patients continue to meet barriers gaining access to SUI evaluation and treatment.

OBJECTIVES: An estimated 14-23% of patients with traumatic brain injury (TBI) incur multiple lifetime TBIs. The relationship between prior TBI and outcomes in patients with moderate to severe TBI (msTBI) is not well delineated. We examined the associations between prior TBI, in-hospital mortality, and outcomes up to 12 months after injury in a prospective US msTBI cohort. METHODS: Data from hospitalized subjects with Glasgow Coma Scale score of 3-12 were extracted from the Transforming Research and Clinical Knowledge in Traumatic Brain Injury Study (enrollment period: 2014-2019). Prior TBI with amnesia or alteration of consciousness was assessed using the Ohio State University TBI Identification Method. Competing risk regressions adjusting for age, sex, psychiatric history, cranial injury and extracranial injury severity examined the associations between prior TBI and in-hospital mortality, with hospital discharged alive as the competing risk. Adjusted HRs (aHR (95% CI)) were reported. Multivariable logistic regressions assessed the associations between prior TBI, mortality, and unfavorable outcome (Glasgow Outcome Scale-Extended score 1-3 (vs. 4-8)) at 3, 6, and 12 months after injury. RESULTS: Of 405 acute msTBI subjects, 21.5% had prior TBI, which was associated with male sex (87.4% vs. 77.0%, p=0.037) and psychiatric history (34.5% vs. 20.7%, p=0.010). In-hospital mortality was 10.1% (prior TBI: 17.2%, no prior TBI: 8.2%, p=0.025). Competing risk regressions indicated that prior TBI was associated with likelihood of in-hospital mortality (aHR=2.06 (1.01-4.22)), but not with hospital discharged alive. Prior TBI was not associated with mortality or unfavorable outcomes at 3, 6, and 12 months. CONCLUSIONS: After acute msTBI, prior TBI history is independently associated with in-hospital mortality but not with mortality or unfavorable outcomes within 12 months after injury. This selective association underscores the importance of collecting standardized prior TBI history data early after acute hospitalization to inform risk stratification. Prospective validation studies are needed. LEVEL OF EVIDENCE: IV. TRIAL REGISTRATION NUMBER: NCT02119182.

A growing body of research has documented disrespectful, abusive, and neglectful treatment of women in facilities during childbirth, as well as the drivers of such mistreatment. Yet, little research exists on effective interventions to improve Person-Centred Maternal Care (PCMC)-care that is respectful and responsive to individual women's preferences, needs, and values. We sought to extend knowledge on interventions to improve PCMC, with a focus on two factors - provider stress and implicit bias - that are driving poor PCMC and contributing to disparities in PCMC. In this paper we describe the process towards the development of the intervention. The intervention design was an iterative process informed by existing literature, behaviour change theory, formative research, and continuous feedback in consultation with key stakeholders. The intervention strategies were informed by the Social Cognitive Theory, Trauma Informed System framework, and the Ecological Perspective. This process resulted in the 'Caring for Providers to Improve Patient Experience (CPIPE)' intervention, which has 5 components: provider training, peer support, mentorship, embedded champions, and leadership engagement. The training includes didactic and interactive content on PCMC, stress, burnout, dealing with difficult situations, and bias, with some content integrated into emergency obstetric and neonatal care (EmONC) simulations to enable providers apply concepts in the context of managing an emergency. The other components create an enabling environment for ongoing individual behavior and facility culture change. The pilot study is being implemented in Migori County, Kenya. The CPIPE intervention is an innovative theory and evidence-based intervention that addresses key drivers of poor PCMC and centers the unique needs of vulnerable women as well as that of providers. This intervention will advance the evidence base for interventions to improve PCMC and has great potential to improve equity in PCMC and maternal and neonatal health.

PURPOSE: To evaluate the accuracy of a point-of-view cataract surgery simulation video in representing different subjective experiences of patients undergoing the procedure. METHODS: One hundred consecutive post-cataract-surgery patients were shown a short simulation video of the surgery obtained through a porcine eye model during the first postoperative week. Patients then answered a multiple-choice questionnaire regarding their visual and tactile intraoperative experiences and how those experiences matched the simulation. RESULTS: Of the patients surveyed (n = 100), 78% (n = 78) recalled visual experiences during surgery, 11% recalled pain (n = 11), and 6.4% (n = 5) recalled frightening experiences. Thirty-six percent of patients (n = 36) were interviewed after their second cataract surgery; there was no statistically significant difference between anxiety scores reported before the first eye surgery and second eye surgery (p = 0.147). Among all patients who recalled visual experiences (n = 78), nearly half (47.4%) reported that the video was the same/similar to their experience. Forty-eight percent of the patients recommended future patients to watch the video before their procedures, and more than a third (36%) agreed that watching the video before surgery would have helped them to relax. CONCLUSIONS: Our model reflects the wide range of subjective patient experiences during and after surgery. The high percentage of patients who found the video accurate in different ways suggests that, with more development, point-of-view cataract simulation videos could prove useful for educational or clinical use. Further research may be done to confirm the simulations utility, by screening the video for subjects before operations.

Providers disrespect and abuse of patients is a recognized but understudied issue affecting quality of care and likely affecting healthcare utilization. Little research has examined this issue among people living with HIV (PWH) who inject drugs, despite high stigmatization of this population. No research has examined this issue in the context of Russia. This study assesses patients reports of disrespect and abuse from providers as a barrier to healthcare and examines the association between these reports and HIV care outcomes.We conducted a cross-sectional analysis of the associations between disrespect/abuse from health providers as a barrier to care and the following HIV care outcomes: (i) anti-retroviral treatment (ART) uptake ever, (ii) past 6-month visit to HIV provider, and (iii) CD4 count. Participants (N = 221) were people living with HIV who injected drugs and were not on ART at enrollment.Two in five participants (42%) reported a history disrespect/abuse from a healthcare provider that they cited as a barrier to care. Those reporting this concern had lower odds of ever use of ART (adjusted odds ratio 0.46 [95% CI 0.22, 0.95]); we found no significant associations for the other HIV outcomes. We additionally found higher representation of women among those reporting prevalence of disrespect/abuse from provider as a barrier to care compared to those not reporting this barrier (58.1% versus 27.3%).Almost half of this sample of PWH who inject drugs report disrespect/abuse from a provider as a barrier to healthcare, and this is associated with lower odds of receipt of ART but not with other HIV outcomes studied. There is need for improved focus on quality of respectful and dignified care from providers for PWH who inject drugs, and such focus may improve ART uptake in Russia.

BACKGROUND: Existing data and clinical trials could not determine whether faster intravenous thrombolytic therapy (IVT) translates into better long-term functional outcomes after acute ischemic stroke among those treated with endovascular thrombectomy (EVT). Patient-level national data can provide the required large population to study the associations between earlier IVT, versus later, with longitudinal functional outcomes and mortality in patients receiving IVT+EVT combined treatment. METHODS: This cohort study included older US patients (age ≥65 years) who received IVT within 4.5 hours or EVT within 7 hours after acute ischemic stroke using the linked 2015 to 2018 Get With The Guidelines-Stroke and Medicare database (38 913 treated with IVT only and 3946 with IVT+EVT). Primary outcome was home time, a patient-prioritized functional outcome. Secondary outcomes included all-cause mortality in 1 year. Multivariate logistic regression and Cox proportional hazards models were used to evaluate the associations between door-to-needle (DTN) times and outcomes. RESULTS: Among patients treated with IVT+EVT, after adjusting for patient and hospital factors, including onset-to-EVT times, each 15-minute increase in DTN times for IVT was associated with significantly higher odds of zero home time in a year (never discharged to home) (adjusted odds ratio, 1.12 [95% CI, 1.06-1.19]), less home time among those discharged to home (adjusted odds ratio, 0.93 per 1% of 365 days [95% CI, 0.89-0.98]), and higher all-cause mortality (adjusted hazard ratio, 1.07 [95% CI, 1.02-1.11]). These associations were also statistically significant among patients treated with IVT but at a modest degree (adjusted odds ratio, 1.04 for zero home time, 0.96 per 1% home time for those discharged to home, and adjusted hazard ratio 1.03 for mortality). In the secondary analysis where the IVT+EVT group was compared with 3704 patients treated with EVT only, shorter DTN times (≤60, 45, and 30 minutes) achieved incrementally more home time in a year, and more modified Rankin Scale 0 to 2 at discharge (22.3%, 23.4%, and 25.0%, respectively) versus EVT only (16.4%, P60 minutes. CONCLUSIONS: Among older patients with stroke treated with either IVT only or IVT+EVT, shorter DTN times are associated with better long-term functional outcomes and lower mortality. These findings support further efforts to accelerate thrombolytic administration in all eligible patients, including EVT candidates.

BackgroundOver one-third of multiple sclerosis (MS) patients are post-menopausal women, the primary demographic affected by breast cancer. After breast cancer diagnosis, there is little information about patients' clinical experiences with both diseases.ObjectiveUtilize a case series of MS patients diagnosed with breast cancer to characterize oncologic and MS trajectories, and generate novel insights about clinical considerations using qualitative analysis.MethodsA single-center retrospective review was performed on medical record data of patients with MS and breast cancer. Thematic analysis was used to characterize experiences with the concurrent diagnoses.ResultsFor the 43 patients identified, mean age was 56.7 years at cancer diagnosis and MS duration was 16.5 years. Approximately half were treated with MS disease modifying therapy at cancer diagnosis, and half of these subsequently discontinued or changed therapy. Altogether 14% experienced MS relapse(s) during follow-up (with 2 relapses in the first 2 years), with mean annualized relapse rate of 0.03. Cohort Expanded Disability Status Scale (EDSS) scores remained stable during follow-up. Qualitative insights unique to this population were identified regarding immunosuppression use and neurologic symptoms.ConclusionsMS relapses were infrequent, and there was modest progression during breast cancer treatment. Oncologic outcomes were comparable to non-MS patients with similarly staged cancer.

IntroductionNeuroworsening may be a sign of progressive brain injury and is a factor for treatment of traumatic brain injury (TBI) in intensive care settings. The implications of neuroworsening for clinical management and long-term sequelae of TBI in the emergency department (ED) require characterization.MethodsAdult TBI subjects from the prospective Transforming Research and Clinical Knowledge in Traumatic Brain Injury Pilot Study with ED admission and disposition Glasgow Coma Scale (GCS) scores were extracted. All patients received head computed tomography (CT) scan

Background and objectivesPrevious studies have demonstrated associations between patient experience scores and physician's demographic characteristics such as gender and race. There is a paucity of data, however, on the effect of broader pediatrician characteristics on caregivers' experience of their children's care. This study assessed pediatric caregiver experience of care ratings within a children's hospital and examined the effects of pediatricians' interpersonal and personality traits on caregiver experience ratings.MethodsThis cross-sectional study included caregivers of children under 18 years old (n = 26,703) and physicians within children's hospital system (n = 65). Caregivers of children who received care from 2017 to 2019 provided their rating (0-10) of care experience via the standardized National Research Corporation Health Survey. Top box provider ratings were used for analyses. Physician's interpersonal and personality data were collected. Multilevel logistic regression analyses were used to examine the effects of physician interpersonal characteristics (empathy, compassion) and personality (perfectionism, Big Five personality traits [openness, conscientiousness, extraversion, agreeableness, neuroticism]) on experience of care rating.ResultsThe odds of caregivers of Spanish-speaking children to provide a high physician rating were 75% higher than the odds for non-Spanish-speaking patients. At the physician level, lower agreeableness (odds ratio [OR] = 0.63, P = .002), and lower narcissistic perfectionism (OR = 0.98, P = .016) were associated with an increased likelihood of a high care experience rating. The odds of nonemergency medicine pediatricians receiving high ratings were approximately 4.17 times higher than that of EM pediatricians.ConclusionsCurrent results may inform future interventions that address pediatrician personality characteristics associated with caregivers of children experience outcomes.

BackgroundData from surveys of patient care experiences are a cornerstone of public reporting and pay-for-performance initiatives. Recently, increasing concerns have been raised about survey response rates and how to promote equity by ensuring that responses represent the perspectives of all patients.ObjectiveReview evidence on survey administration strategies to improve response rates and representativeness of patient surveys.Research designSystematic review adhering to the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines.Study selectionForty peer-reviewed randomized experiments of administration protocols for patient experience surveys.ResultsMail administration with telephone follow-up provides a median response rate benefit of 13% compared with mail-only or telephone-only. While surveys administered only by web typically result in lower response rates than those administered by mail or telephone (median difference in response rate: -21%, range: -44%, 0%), the limited evidence for a sequential web-mail-telephone mode suggests a potential response rate benefit over sequential mail-telephone (median: 4%, range: 2%, 5%). Telephone-only and sequential mixed modes including telephone may yield better representation across patient subgroups by age, insurance type, and race/ethnicity. Monetary incentives are associated with large increases in response rates (median increase: 12%, range: 7%, 20%).ConclusionsSequential mixed-mode administration yields higher patient survey response rates than a single mode. Including telephone in sequential mixed-mode administration improves response among those with historically lower response rates; including web in mixed-mode administration may increase response at lower cost. Other promising strategies to improve response rates include in-person survey administration during hospital discharge, incentives, minimizing survey language complexity, and prenotification before survey administration.

ObjectiveCancer patients in Zimbabwe typically access health services with advanced disease, limiting treatment choices and lessening the likelihood of positive treatment outcomes. We outline experiences of patients with advanced cancer prior to interaction with palliative care services to identify targets for future intervention development to enhance care delivery in Zimbabwe.MethodsParticipants were purposively sampled adult patients with advanced cancer. We adopted a thematic approach to guide a qualitative secondary data analysis exploring factors influencing support sought by participants, external factors influencing decision making across the disease trajectory and the process for seeking and accessing palliative care.ResultsParticipants reported fragmented and uncoordinated care, from initial symptom experience and throughout disease progression. A recurring notion of disjuncture was present through participants' experiences of gaps, breaks and discontinuity across the disease trajectory. Each step had a beginning and end without clear routes for transition with movement between steps as a result of happenstance or informal encounters.ConclusionTargets for intervention development at the patient and family level exist that may reduce the disjuncture currently experienced between need and care provision. A holistic response that incorporates engagement with policy actors is critical to addressing prominent financial constraints for patients.

This study examines Patient-Reported Outcome Measurement Information System (PROMIS®)-29 v1.0 outcomes of chiropractic care in a multi-site, pragmatic clinical trial and compares the PROMIS measures to: 1) worst pain intensity from a numerical pain rating 0-10 scale, 2) 24-item Roland-Morris Disability Questionnaire (RMDQ); and 3) global improvement (modified visual analog scale). A pragmatic, prospective, multisite, parallel-group comparative effectiveness clinical trial comparing usual medical care (UMC) with UMC plus chiropractic care (UMC+CC). Three military treatment facilities. 750 active-duty military personnel with low back pain. Linear mixed effects regression models estimated the treatment group differences. Coefficient of repeatability to estimate significant individual change. We found statistically significant mean group differences favoring UMC+CC for all PROMIS®-29 scales and the RMDQ score. Area under the curve estimates for global improvement for the PROMIS®-29 scales and the RMDQ, ranged from 0.79 to 0.83. Findings from this pre-planned secondary analysis demonstrate that chiropractic care impacts health-related quality of life beyond pain and pain-related disability. Further, comparable findings were found between the 24-item RMDQ and the PROMIS®-29 v1.0 briefer scales.

BackgroundThe Agency for Healthcare Research and Quality held a research meeting on using Consumer Assessment of Healthcare Providers and Systems (CAHPS®) data for quality improvement (QI) and evaluating such efforts.Topics covered.Meeting addressed: 1)What has been learned about organizational factors/environment needed to improve patient experience? 2)How have organizations used data to improve patient experience? 3)What can evaluations using CAHPS data teach us about implementing successful programs to improve patient experience?Key themesProviders and stakeholders need to be engaged early and often, standardize QI processes, complement CAHPS data with other data, and compile dashboards of CAHPS scores to identify and track improvement. Rigorous study designs are valuable, but much can be learned and accomplished through practical organization-level studies.

Continuous subcutaneous insulin infusion (CSII) therapy is becoming increasingly popular. CSII provides convenient insulin delivery, precise dosing, easy adjustments for physical activity, stress, or illness, and integration with continuous glucose monitors in hybrid or other closed-loop systems. However, even as insulin pump hardware and software have advanced, technology for insulin infusion sets (IISs) has stayed relatively stagnant over time and is often referred to as the "Achilles heel" of CSII. To discuss barriers to insulin pump therapy and present information about advancements in, and results from clinical trials of extended wear IISs, Diabetes Technology Society virtually hosted the "Improving the Patient Experience with Longer Wear Infusion Sets Symposium" on December 1, 2021. The symposium featured experts in the field of IISs, including representatives from Steno Diabetes Center Copenhagen, University of California San Francisco, Stanford University, Medtronic Diabetes, and Science Consulting in Diabetes. The webinar's seven speakers covered (1) advancements in insulin pump therapy, (2) efficacy of longer wear infusion sets, and (3) innovations to reduce plastics and insulin waste.

BackgroundInformation about telehealth versus in-office visits and how patient experience before compared to during the COVID-19 pandemic is important for healthcare planning.ObjectiveTo compare patient experience by visit type and before and during the pandemic.DesignSurvey of patients assessing ambulatory care before and during the pandemic.ParticipantsA total of 58,500 adult patients (13,928 primary care and 44,581 specialty physician visits) at a large integrated health system with 197 clinics on the west coast of the United States. The majority were female (59%), 55 or older (65%), and non-Hispanic White (55%), and had an in-office visit (87%) while 10% had a tele-video and 3% a phone visit.Main measuresConsumer Assessment of Healthcare Providers and Systems (CAHPS®) Survey 3.0 doctor communication, care coordination, access, and office staff composites; an overall rating of the doctor; and whether the patient would recommend the doctor to family and friends.Key resultsPatient experience with telehealth visits was as positive as or more positive than that with traditional office-based visits. Doctor communication on tele-video visits was viewed as slightly more positive than that of in-office or phone visits. Tele-video visits were also slightly more positive than in-office visits for care coordination, overall rating of the doctor, and willingness to recommend to family and friends. Office staff were viewed less positively on the phone than tele-video or in-office visits. Patient experience was similar before and during the COVID-19 pandemic (e.g., on a 0-100 possible range with a higher score being better, doctor communication was 94.4 before and 94.9 during).ConclusionsThe positive experiences with telehealth, especially tele-video, may be due to patient appreciation of efforts made to maintain access, the focused nature of telehealth visits, and help by staff for navigation technical issues. Lessons learned about delivering responsive telehealth care can be used to ensure high-quality care after the pandemic.

ObjectivesTo (1) develop a survey to assess the patient experience of care in hospital-based emergency departments (ED) and (2) evaluate the reliability and validity of composite measures of patient experience using data collected through the experimental implementation of the newly developed Emergency Department Patient Experience of Care (EDPEC) Discharged to Community (DTC) Survey.Data source4893 adult patients were treated in the ED of 16 hospitals across the United States in 2018.Study designThe study utilized a cross-sectional survey.Data collectionSurvey development activities included a literature review, focus groups, and cognitive interviews with recently discharged ED patients, technical expert panels, and multiple field experiments. Survey development resulted in a 34-item instrument; the analysis reported here focuses on 18 items on patient experience of care. Using data from the EDPEC DTC Survey in the 2018 Feasibility Test, we performed confirmatory factor analysis to group 15 evaluative survey items into composite measures. We examined internal consistency reliability, interunit reliability, and associations between each composite measure and patients' overall rating and willingness to recommend the ED.Principal findingsAnalyses of 15 evaluative items identified four composite measures: Getting Timely Care, How Well Doctors and Nurses Communicate, Communication about Medications, and Communication about Follow-up. Patient-level internal consistency reliability exceeded 0.75 for two of four composites; ED-level internal consistency reliability exceeded 0.83 for all four composites. Interunit reliability estimates indicated that 450 survey completes per ED results in at least 0.70 reliability for all composites. Higher scores on each composite were associated with higher overall ratings and willingness to recommend the ED.ConclusionsThe composite measures derived from the EDPEC DTC Survey are statistically reliable and valid. These results provide guidance for EDPEC DTC Survey adopters on how to construct meaningful and psychometrically-sound composite measures for monitoring the quality of care they provide.

ObjectivesThe Anal Cancer High-grade squamous intraepithelial lesions (HSIL) Outcomes Research (ANCHOR) Health-Related Symptom Index (A-HRSI) is a 25-item measure that assesses physical symptoms and impacts, and psychological symptoms. To promote generalizability and equity in the capture of these concepts in Spanish-speaking participants, we linguistically validated a Spanish version of A-HRSI.MethodsFollowing independent forward translation and reconciliation of A-HRSI from English to Spanish, two rounds of cognitive interviews were completed with ANCHOR participants who had been diagnosed with anal HSIL in the prior nine months and preferred delivery of their healthcare in Spanish. Interviews were coded to highlight any items and concepts that were reported as being difficult for any reason by ≥ 3 participants, with such items revised during a research team panel discussion and tested in a second round of interviews if applicable.ResultsSeventeen participants representing 8 nationalities were enrolled (Round 1 n=10, Round 2 n=7); 7 participants reported not completing high school (41.2%). No difficulties were reported with respect to the theoretical concepts measured by A-HRSI. We made modifications to the Spanish translation of eight items and two response option terms in cases where participants had difficulty understanding a term, experienced problems in discriminating between terms, or preferred the use of an alternative term to represent the concept(s).ConclusionThe Spanish version of A-HRSI is a linguistically valid tool that can be used to assess physical symptoms, impacts, and psychological symptoms related to anal HSIL. Language is a tremendous barrier to enrolling patients to clinical trials. The anal cancer high-grade squamous intraepithelial lesions (HSIL) outcomes research [ANCHOR] trial is a randomized clinical trial that recently established that the treatment of anal HSIL, versus active monitoring, is effective in reducing incidence of anal cancer in persons living with HIV (PLWH). The ANCHOR Health-Related Symptom Index (A-HRSI) is a 25-item patient-reported outcomes measure that was developed to assess physical symptoms, physical impacts, and psychological symptoms related to anal HSIL. As approximately 10% of ANCHOR participants preferred the delivery of their healthcare in Spanish, the purpose of the present study was to linguistically validate a Spanish version of A-HRSI. Based on feedback from interviews with 17 participants from the ANCHOR trial who had been diagnosed with anal HSIL in the prior nine months and preferred delivery of their healthcare in Spanish, we made modifications to the Spanish translation of eight items and two response option terms in cases where participants had difficulty understanding a term, experienced problems in discriminating between terms, or preferred the use of an alternative term to represent the concept(s). The Spanish version of A-HRSI is a linguistically valid tool that can be used to assess physical symptoms, impacts, and psychological symptoms related to anal HSIL as part of clinical trials or routine care.

BackgroundGiven persistent gaps in coordination of care for medically complex primary care patients, efficient strategies are needed to promote better care coordination.ObjectiveThe Coordination Toolkit and Coaching project compared two toolkit-based strategies of differing intensity to improve care coordination at VA primary care clinics.DesignMulti-site, cluster-randomized QI initiative.ParticipantsTwelve VA primary care clinics matched in 6 pairs.InterventionsWe used a computer-generated allocation sequence to randomize clinics within each pair to two implementation strategies. Active control clinics received an online toolkit with evidence-based tools and QI coaching manual. Intervention clinics received the online toolkit plus weekly assistance from a distance coach for 12 months.Main measuresWe quantified patient experience of general care coordination using the Health Care System Hassles Scale (primary outcome) mailed at baseline and 12-month follow-up to serial cross-sectional patient samples. We measured the difference-in-difference (DiD) in clinic-level-predicted mean counts of hassles between coached and non-coached clinics, adjusting for clustering and patient characteristics using zero-inflated negative binomial regression and bootstrapping to obtain 95% confidence intervals. Other measures included care coordination QI projects attempted, tools adopted, and patient-reported exposure to projects.Key resultsN = 2,484 (49%) patients completed baseline surveys and 2,481 (48%) completed follow-ups. Six coached clinics versus five non-coached clinics attempted QI projects. All coached clinics versus two non-coached clinics attempted more than one project or projects that were multifaceted (i.e., involving multiple components addressing a common goal). Five coached versus three non-coached clinics used 1-2 toolkit tools. Both the coached and non-coached clinics experienced pre-post reductions in hassle counts over the study period (- 0.42 (- 0.76, - 0.08) non-coached; - 0.40 (- 0.75, - 0.06) coached). However, the DiD (0.02 (- 0.47, 0.50)) was not statistically significant; coaching did not improve patient experience of care coordination relative to the toolkit alone.ConclusionAlthough coached clinics attempted more or more complex QI projects and used more tools than non-coached clinics, coaching provided no additional benefit versus the online toolkit alone in patient-reported outcomes.Trial registrationClinicalTrials.gov identifier: NCT03063294.

ObjectivesDamage control laparotomy (DCL) remains an important tool in the trauma surgeon's armamentarium. Inconsistency in reporting standards have hindered careful scrutiny of DCL outcomes. We sought to develop a core outcome set (COS) for DCL clinical studies to facilitate future pooling of data via meta-analysis and Bayesian statistics while minimizing reporting bias.MethodsA modified Delphi study was performed using DCL content experts identified through Eastern Association for the Surgery of Trauma (EAST) 'landmark' DCL papers and EAST ad hoc COS task force consensus.ResultsOf 28 content experts identified, 20 (71%) participated in round 1, 20/20 (100%) in round 2, and 19/20 (95%) in round 3. Round 1 identified 36 potential COS. Round 2 achieved consensus on 10 core outcomes: mortality, 30-day mortality, fascial closure, days to fascial closure, abdominal complications, major complications requiring reoperation or unplanned re-exploration following closure, gastrointestinal anastomotic leak, secondary intra-abdominal sepsis (including anastomotic leak), enterocutaneous fistula, and 12-month functional outcome. Despite feedback provided between rounds, round 3 achieved no further consensus.ConclusionsThrough an electronic survey-based consensus method, content experts agreed on a core outcome set for damage control laparotomy, which is recommended for future trials in DCL clinical research. Further work is necessary to delineate specific tools and methods for measuring specific outcomes.Level of evidenceV, criteria.

BackgroundAccurate self-reported symptomatic toxicity documentation via the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is essential throughout cancer treatment to ensure safety and understand therapeutic efficacy. However, the capture of accurate toxicities from patients undergoing radiation therapy is challenging because this is generally provided only at the time of scheduled visits.ObjectiveThis study seeks to establish the usability and feasibility of a mobile PRO-CTCAE Administration System (mPROS) to capture toxicities related to radiation therapy.MethodsEnglish-speaking adult patients who were undergoing radiation therapy for cancer were enrolled and given a brief demonstration of the Say All Your Symptoms (SAYS) and Symptom Tracking Entry Program (STEP) interfaces of the mPROS app, followed by a patient-use phase where patient actions were observed as they navigated mPROS to enter toxicities. Patient feedback was captured via a semistructured interview and brief questionnaire.ResultsWe enrolled 25 patients (age: mean 60.7 years; females: n=13, 52%; White patients: n=13; 52%; non-Hispanic patients: n=19, 76%; college graduates: n=17, 68%). Patients almost equally preferred the SAYS (n=14, 56%) or STEP (n=11, 44%) interfaces, with 21 patients (84%) agreeing that they would use mPROS to report their symptoms to their health care team and 19 patients (76%) agreeing that they would recommend mPROS to others.ConclusionsThe mPROS app is usable and feasible for facilitating the patient reporting of radiation therapy-related symptomatic toxicities. A revised version of mPROS that incorporates patient input and includes electronic health record integration is being developed and validated as part of a multicenter trial.

Background: The coronavirus disease (COVID-19) pandemic has impacted patients receiving methadone maintenance treatment (MMT) through opioid treatment programs (OTPs), especially because of the unique challenges of the care delivery model. Previously, documentation of patient experiences during emergencies often comes years after the fact, in part because there is a substantial data void in real-time. Methods: We extracted 308 posts that mention COVID-19 keywords on r/methadone, an online community for patients receiving MMT to share information, on Reddit occurring between January 31, 2020 and September 30, 2020. 215 of these posts self-report an impact to their MMT. Using qualitative content analysis, we characterized the impacts described in these posts and identified four emergent themes describing patients' experience of impacts to MMT during COVID-19. Results: The themes included (1) 54.4% of posts reporting impediments to accessing their methadone, (2) 28.4% reporting impediments to accessing physicial OTPs, (3) 19.5% reporting having to self-manage their care, and (4) 4.7% reporting impediments to accessing OTP providers and staff. Conclusions: Patients described unanticipated consequences to one-size-fits-all policies that are unevenly applied resulting in suboptimal dosing, increased perceived risk of acquiring COVID-19 at OTPs, and reduced interaction with OTP providers and staff. While preliminary, these results are formative for follow-up surveillance metrics for patients of OTPs as well as digitally-mediated resource needs for this online community. This study serves as a model of how social media can be employed during and after emergencies to hear the lived experiences of patients for informed emergency preparedness and response.

BACKGROUND: Mental health specialists and care managers facilitate comprehensive care provision within medical homes. Despite implementation challenges, mental health integration is thought to improve patient-centered primary care. OBJECTIVES: To examine the relationship between primary care patient experience and mental health integration. RESEARCH DESIGN: Cross-sectional surveys from 168 primary care clinicians (PCPs) (n = 226) matched with assigned patients surveys (n = 1734) in one Veterans Health Administration (VA) region, fiscal years 2012-2013. Multilevel regression models examined patient experience and mental health integration, adjusting for patient and PCP characteristics. MEASURES: Patient experience outcomes were (1) experience with PCP and (2) receipt of comprehensive care, such as talked about stress. Independent variables represented mental health integration- (1) PCP-rated communication with mental health and (2) proportion of clinic patients who saw integrated specialists. RESULTS: 50% and 43% of patients rated their PCPs 10/10 and reported receiving comprehensive care, respectively. Neither patient experience or receipt of comprehensive care was significantly associated with PCPs ratings of communication with mental health, nor with proportion of clinic patients who saw integrated specialists. Among a subsample of patients who rated their mental health as poor/fair, however, we detected an association between proportion of clinic patients who saw integrated specialists and patient experience (odds ratio = 1.05, 95% confidence interval = 1.01-1.09, p = .01). CONCLUSIONS: No association was observed between mental health integration and primary care patients reported care experiences, but a significant association existed among patients who reported poor/fair mental health. More research is needed to understand patient experiences with regard to care model implementation.

BackgroundHealth care organizations strive to improve patient care experiences. Some use one-on-one provider counseling (shadow coaching) to identify and target modifiable provider behaviors.ObjectiveWe examined whether shadow coaching improves patient experience across 44 primary care practices in a large urban Federally Qualified Health Center.Research designSeventy-four providers with "medium" (ie, slightly below average) overall provider ratings received coaching and were compared with 246 uncoached providers. We fit mixed-effects regression models with random effects for provider (level of treatment assignment) and fixed effects for time (linear spline with a knot and "jump" at coaching date), patient characteristics and site indicators. By design, coached providers performed worse at selection; models account for the very small (0.2 point) regression-to-the-mean effects. We assessed differential effects by coach.SubjectsA total of 46,452 patients (from 320 providers) who completed the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Visit Survey 2.0.MeasuresCAHPS overall provider rating and provider communication composite (scaled 0-100).ResultsProviders not chosen for coaching had a nonsignificant change in performance during the period when selected providers were coached. We observed a statistically significant 2-point (small-to-medium) jump among coached providers after coaching on the CAHPS overall provider rating and provider communication score. However, these gains disappeared after 2.5 years; effects differed by coach.ConclusionsShadow coaching improved providers' overall performance and communication immediately after being coached. Regularly planned shadow coaching "booster" sessions might maintain or even increase the improvement gained in patient experience scores, but research examining additional coaching and optimal implementation is needed.

ProblemThe utility of the polymerase chain reaction (PCR) cycle threshold (Ct ) values in the management of patients with coronavirus disease 2019 (COVID-19) remains controversial.MethodsWe assessed the correlation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Ct values in nasopharyngeal swab samples with the oxygen requirements at the time of sample collection. Specimens were tested with the Simplexa PCR platform, which targets the SARS-CoV-2 ORF1ab and S genes.ResultsWe identified 23 COVID-19 patients with 49 Ct values available. While Ct values from ORF1ab and S genes were highly correlated for a given specimen, there was no correlation between Ct values for any of these target genes and the oxygen requirements of the patient at the time of sample collection. We found no differences in the initial nor the nadir Ct values between survivors and non-survivors or mild/moderate versus severe/critical illness at the maximum point of illness.ConclusionSARS-CoV-2 Ct values have limited value in the management of COVID-19.

ObjectivesTo examine how primary care practices use the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey and its patient-centered medical home (PCMH) items during their PCMH transition.Study designQualitative study of practices' use of patient experience data during PCMH transformation, based on a random sample of primary care practices engaged in PCMH transformation, stratified by region, practice size, PCMH recognition history, and use of the CAHPS PCMH survey.MethodsWe interviewed 105 practice leaders from 294 sampled practices (36% response rate) and used content analysis to identify themes about uses of patient experience data for practice improvement during PCMH transformation.ResultsPatient experience data were used primarily to assess and track improvements toward PCMH goals and as quality improvement (QI) metrics. CAHPS measures were used most often to discuss best practices, share data with patient advisory councils, and improve provider performance. The CAHPS PCMH survey helped practices improve patient-centeredness, particularly in coordinating care and supporting patient self-management and communication. The CAHPS PCMH items that assisted practices most were about patient self-management and provider referrals. Most practice leaders using the CAHPS PCMH survey felt that its items were actionable for standardizing PCMH changes or making structural changes. Practices administering CAHPS surveys focused on a more diverse set of QI areas.ConclusionsCAHPS surveys were considered actionable for PCMH transformation and used in standardizing and coordinating care. The CAHPS PCMH items were considered integral to the continuous QI needed for moving beyond formal PCMH recognition and maximizing transformation. This supports the National Committee for Quality Assurance's recommendation to administer the CAHPS or CAHPS PCMH survey for PCMH transformation.

BACKGROUND: Stakeholder involvement in health care research has been shown to improve research development, processes, and dissemination. The literature is developing on stakeholder engagement methods and preliminarily validated tools for evaluating stakeholder level of engagement have been proposed for specific stakeholder groups and settings. OBJECTIVES: This paper describes the methodology for engaging a Study Advisory Committee (SAC) in research and reports on the use of a stakeholder engagement survey for measuring level of engagement. METHODS: Stakeholders with previous research connections were recruited to the SAC during the planning process for a multicenter randomized control clinical trial, which is ongoing at the time of this writing. All SAC meetings undergo qualitative analysis, while the Stakeholder Engagement Survey instrument developed by the Patient-Centered Outcomes Research Institute (PCORI) is distributed annually for quantitative evaluation. RESULTS: The trials SAC is composed of 18 members from 3 stakeholder groups: patients and their caregivers; patient advocacy organizations; and health care payers. After an initial in-person meeting, the SAC meets quarterly by telephone and annually in-person. The SAC monitors research progress and provides feedback on all study processes. The stakeholder engagement survey reveals improved engagement over time as well as continued challenges. CONCLUSIONS: Stakeholder engagement in the research process has meaningfully contributed to the study design, patient recruitment, and preliminary analysis of findings.

BackgroundSocial isolation is a known predictor of mortality that disproportionately affects vulnerable populations in the USA. Although experts began to recognize it as a public health crisis prior to 2020, the novel coronavirus pandemic has accelerated recognition of social isolation as a serious threat to health and well-being.ObjectiveExamine patient experiences with screening and assistance for social isolation in primary care settings, and whether patient experiences with these activities are associated with the severity of reported social isolation.DesignCross-sectional survey conducted in 2018.ParticipantsAdults (N = 251) were recruited from 3 primary care clinics in Boston, Chicago, and San Francisco.Main measuresA modified version of the Berkman-Syme Social Network Index (SNI), endorsed by the National Academies of Sciences, Engineering, and Medicine; items to assess for prior experiences with screening and assistance for social isolation.Key resultsIn the sample population, 12.4% reported the highest levels of social isolation (SNI = 0/1), compared to 36.7%, 34.7%, and 16.3% (SNI = 2-4, respectively). Most patients had not been asked about social isolation in a healthcare setting (87.3%), despite reporting no discomfort with social isolation screening (93.9%). Neither discomfort with nor participation in prior screening for social isolation was associated with social isolation levels. Desire for assistance with social isolation (3.2%) was associated with a higher level of social isolation (AOR = 6.0, 95% CI, 1.3-28.8), as well as poor or fair health status (AOR = 9.1; 95% CI, 1.3-64.1).ConclusionsIn this study, few patients reported being screened previously for social isolation in a primary care setting, despite low levels of discomfort with screening. Providers should consider broadening social isolation screening and referral practices in healthcare settings, especially among sicker and more isolated patients who express higher levels of interest in assistance with social isolation.

Background/objectivesEvaluations of complex models of care for older adults may benefit from simultaneous assessment of intervention implementation. The STRIDE (Strategies To Reduce Injuries and Develop confidence in Elders) pragmatic trial evaluated the effectiveness of a multifactorial intervention to reduce serious fall injuries in older adults. We conducted multi-level stakeholder interviews to identify barriers to STRIDE intervention implementation and understand efforts taken to mitigate these barriers.DesignQualitative interviews with key informants.SettingTen clinical trial sites affiliated with practices that provided primary care for persons at increased risk for fall injuries.ParticipantsSpecially trained registered nurses working as Falls Care Managers (FCMs) who delivered the intervention (n = 13 individual interviews), Research Staff who supervised trial implementation locally (n = 10 group interviews, 23 included individuals), and members of Central Project Management and the National Patient Stakeholder Council who oversaw national implementation (n = 2 group interviews, six included individuals).MeasurementsA semi-structured interview guide derived from the consolidated framework for implementation research (CFIR).ResultsWe identified eight key barriers to STRIDE intervention implementation. FCMs navigated complex relationships with patients and families while working with Research Staff to implement the intervention in primary care practices with limited clinical space, variable provider buy-in, and significant primary care practice staff and provider turnover. The costs of the intervention to individual patients and medical practices amplified these barriers. Efforts to mitigate these barriers varied depending on the needs and opportunities of each primary care setting.ConclusionThe many barriers to implementation and the variability in how stakeholders addressed these locally may have affected the overall STRIDE intervention's effectiveness. Future pragmatic trials should incorporate simultaneous implementation aims to better understand how research interventions translate into clinical care that improves the lives of older adults.

BACKGROUND: Oncology settings increasingly use patient experience data to evaluate clinical performance. Given that older patients with hematologic malignancies are a high-risk population, this study examined factors associated with patient-reported health care experiences during the first year of their cancer diagnosis. METHODS: Cross-sectional study using the 2000-2015 SEER-CAHPS® data to examine patient experiences of Medicare enrollees with a primary diagnosis of leukemia or lymphoma. The primary outcomes were three CAHPS assessments: overall care, personal doctor, and health plan overall. We estimated case-mix adjusted and fully adjusted associations between factors (i.e., clinical and sociodemographic) and the CAHPS outcomes using bivariate statistical tests and multiple linear regression. RESULTS: The final sample included 1,151 patients, with 431 diagnosed with leukemia and 720 diagnosed with lymphoma (median time from diagnosis to survey 6 months). Patients who completed the survey further apart from the diagnosis date reported significantly higher adjusted ratings of care overall (β .39, p = .008) than those closer to diagnosis. American Indian/Alaska Native, Asian, and Pacific Islander patients had lower adjusted ratings of care overall (β - .73, p = .003) than Non-Hispanic white patients. Multimorbidity was significantly associated with higher adjusted personal doctor ratings (β .26, p = .003). CONCLUSIONS: Unfavorable patient experiences among older adults diagnosed with hematologic malignancies warrant targeted efforts to measure and improve care quality. Future measurement of experiences of cancer care soon after diagnosis, coupled with careful sampling of high-priority populations, will inform oncology leaders and clinicians on strategies to improve care for high-risk, high-cost populations.

Acute flaccid myelitis (AFM) is a disabling, polio-like illness mainly affecting children. Outbreaks of AFM have occurred across multiple global regions since 2012, and the disease appears to be caused by non-polio enterovirus infection, posing a major public health challenge. The clinical presentation of flaccid and often profound muscle weakness (which can invoke respiratory failure and other critical complications) can mimic several other acute neurological illnesses. There is no single sensitive and specific test for AFM, and the diagnosis relies on identification of several important clinical, neuroimaging, and cerebrospinal fluid characteristics. Following the acute phase of AFM, patients typically have substantial residual disability and unique long-term rehabilitation needs. In this Review we describe the epidemiology, clinical features, course, and outcomes of AFM to help to guide diagnosis, management, and rehabilitation. Future research directions include further studies evaluating host and pathogen factors, including investigations into genetic, viral, and immunological features of affected patients, host-virus interactions, and investigations of targeted therapeutic approaches to improve the long-term outcomes in this population.

The C-X-C motif chemokine ligand 17 (CXCL17) is chemotactic for myeloid cells, exhibits bactericidal activity, and exerts anti-viral functions. This chemokine is constitutively expressed in the respiratory tract, suggesting a role in lung defenses. However, little is known about the participation of CXCL17 against relevant respiratory pathogens in humans. Here, we evaluated the serum levels and lung tissue expression pattern of CXCL17 in a cohort of patients with severe pandemic influenza A(H1N1) from Mexico City. Peripheral blood samples obtained on admission and seven days after hospitalization were processed for determinations of serum CXCL17 levels by enzyme-linked immunosorbent assay (ELISA). The expression of CXCL17 was assessed by immunohistochemistry (IHQ) in lung autopsy specimens from patients that succumbed to the disease. Serum CXCL17 levels were also analyzed in two additional comparative cohorts of coronavirus disease 2019 (COVID-19) and pulmonary tuberculosis (TB) patients. Additionally, the expression of CXCL17 was tested in lung autopsy specimens from COVID-19 patients. A total of 122 patients were enrolled in the study, from which 68 had pandemic influenza A(H1N1), 24 had COVID-19, and 30 with PTB. CXCL17 was detected in post-mortem lung specimens from patients that died of pandemic influenza A(H1N1) and COVID-19. Interestingly, serum levels of CXCL17 were increased only in patients with pandemic influenza A(H1N1), but not COVID-19 and PTB. CXCL17 not only differentiated pandemic influenza A(H1N1) from other respiratory infections but showed prognostic value for influenza-associated mortality and renal failure in machine-learning algorithms and regression analyses. Using cell culture assays, we also identified that human alveolar A549 cells and peripheral blood monocyte-derived macrophages increase their CXCL17 production capacity after influenza A(H1N1) pdm09 virus infection. Our results for the first time demonstrate an induction of CXCL17 specifically during pandemic influenza A(H1N1), but not COVID-19 and PTB in humans. These findings could be of great utility to differentiate influenza and COVID-19 and to predict poor prognosis specially at settings of high incidence of pandemic A(H1N1). Future studies on the role of CXCL17 not only in severe pandemic influenza, but also in seasonal influenza, COVID-19, and PTB are required to validate our results.

ObjectiveThere are few standardized neonatal neurobehavioral instruments available for longitudinal child development research. We adapted an established clinical tool, the Newborn Behavioral Observations (NBO) system, for research by standardizing the administration protocol and expanding the 3-point coding scale to 5 points.MethodsWe administered the 5-point NBO to 144 racially/ethnically diverse late preterm or term infants born to low-income women (average age 5 weeks). Cronbach's alphas were calculated to determine internal consistency reliability of Autonomic, Motor, Organization of State, and Responsivity subscales. We examined concurrent validity using subscale associations with infant salivary cortisol reactivity to the NBO and maternally reported infant temperament.ResultsTwo of the 4 NBO subscales, Organization of State and Responsivity, had excellent (0.91) and good (0.76) reliability, respectively, and were retained for further analyses. Infants with higher Organization of State scores (more optimal regulation) demonstrated lower cortisol reactivity (r = -0.30, p < 0.01) and temperamental negativity (r = -0.16, p < 0.05). Responsivity was unrelated to cortisol reactivity or temperament.ConclusionsState regulation, as measured by the 5-point NBO, was associated with a biologic marker of infant stress response to the NBO administration and reported temperament. Poor reliability of the NBO's 3-item Autonomic and 7-item Motor subscales suggests that further psychometric research in other samples and likely refinement are needed. Given the paucity of neurobehavioral assessment tools for infants, these findings justify such research as next steps in the incremental progression toward the development of a practical, reliable, and predictive measure of early neurobehavioral development.

BackgroundDespite increased utilization of hepatitis C virus-infected (HCV+) organs for transplantation into HCV-uninfected recipients, there is lack of standardization in HCV-related patient education/consent and limited data on financial and social impact on patients.MethodsWe conducted a survey on patients with donor-derived HCV infection at our center transplanted between 4/1/2017 and 11/1/2019 to assess: why patients chose to accept HCV+ organ(s), the adequacy of their pre-transplant HCV education and informed consent process, financial issues related to copays after discharge, and social challenges they faced.ResultsAmong 49 patients surveyed, transplanted organs included heart (n = 19), lung (n = 9), kidney (n = 11), liver (n = 4), heart/kidney (n = 4), and liver/kidney (n = 2). Many recipients accepted an HCV-viremic (HCV-V) organ due to perceived reduction in waitlist time (n = 33) and/or trust in their physician's recommendation (n = 29). Almost all (n = 47) felt that pre-transplant education and consent was appropriate. Thirty patients had no copay for direct-acting antivirals (DAA) for HCV, including 21 with household income $1000. Two patients reported feeling isolated due to HCV infection and eight reported higher than anticipated medication costs. Patients' biggest concern was potential HCV transmission to partners (n = 18) and family/friends (n = 15). Overall almost all (n = 47) patients reported a positive experience with HCV-V organ transplantation.ConclusionWe demonstrate that real-world patient experiences surrounding HCV-V organ transplantation have been favorable. Almost all patients report comprehensive HCV-related pre-transplant consent and education. Additionally, medication costs and social isolation/exclusion were not barriers to the use of these organs.

ObjectiveTo compare health care system problems or "hassles" experienced by Veterans receiving VA health care only versus those receiving dual care from both VA and non-VA community providers.Data sourcesWe collected survey data in 2017-2018 from 2444 randomly selected Veterans with four or more primary care visits in the prior year at one of 12 VA primary care clinics located in four geographically diverse regions of the United States.Study designWe used baseline surveys from the Coordination Toolkit and Coaching quality improvement project to explore Veterans' experience of hassles (dependent variable), source of health care, self-rated physical and mental health, and sociodemographics.Data collectionParticipants responded to mailed surveys by mail, telephone, or online.Principal findingsThe number of reported hassles ranged from 0 to 16; 79 percent of Veterans reported experiencing one or more hassles. Controlling for sociodemographic characteristics and self-rated physical and mental health, zero-inflated negative binominal regression indicated that dual care users experienced more hassles than VA-only users (adjusted predicted average 5.5 [CI: 5.2, 5.8] vs 4.3 [CI: 4.1, 4.6] hassles [P

Clinical research is necessary for an effective response to an emerging infectious disease outbreak. However, research efforts are often hastily organised and done using various research tools, with the result that pooling data across studies is challenging. In response to the needs of the rapidly evolving COVID-19 outbreak, the Clinical Characterisation and Management Working Group of the WHO Research and Development Blueprint programme, the International Forum for Acute Care Trialists, and the International Severe Acute Respiratory and Emerging Infections Consortium have developed a minimum set of common outcome measures for studies of COVID-19. This set includes three elements: a measure of viral burden (quantitative PCR or cycle threshold), a measure of patient survival (mortality at hospital discharge or at 60 days), and a measure of patient progression through the health-care system by use of the WHO Clinical Progression Scale, which reflects patient trajectory and resource use over the course of clinical illness. We urge investigators to include these key data elements in ongoing and future studies to expedite the pooling of data during this immediate threat, and to hone a tool for future needs.

PurposeA stringent outcome assessment is a key aspect for establishing evidence-based clinical guidelines for anterior cruciate ligament (ACL) injury treatment. The aim of this consensus statement was to establish what data should be reported when conducting an ACL outcome study, what specific outcome measurements should be used and at what follow-up time those outcomes should be assessed.MethodsTo establish a standardized approach to assessment of clinical outcome after ACL treatment, a consensus meeting including a multidisciplinary group of ACL experts was held at the ACL Consensus Meeting Panther Symposium, Pittsburgh, PA; USA, in June 2019. The group reached consensus on nine statements by using a modified Delphi method.ResultsIn general, outcomes after ACL treatment can be divided into four robust categories-early adverse events, patient-reported outcomes, ACL graft failure/recurrent ligament disruption and clinical measures of knee function and structure. A comprehensive assessment following ACL treatment should aim to provide a complete overview of the treatment result, optimally including the various aspects of outcome categories. For most research questions, a minimum follow-up of 2 years with an optimal follow-up rate of 80% is necessary to achieve a comprehensive assessment. This should include clinical examination, any sustained re-injuries, validated knee-specific PROs and Health-Related Quality of Life questionnaires. In the mid- to long-term follow-up, the presence of osteoarthritis should be evaluated.ConclusionThis consensus paper provides practical guidelines for how the aforementioned entities of outcomes should be reported and suggests the preferred tools for a reliable and valid assessment of outcome after ACL treatment.Level of evidenceV.

ContextAchieving high-quality patient-centered care requires assessing patient and family experiences to identify opportunities for improvement. With the Child Hospital Consumer Assessment of Healthcare Providers and Systems Survey, hospitals can assess performance and make national comparisons of inpatient pediatric experiences. However, using patient and family experience data to improve care remains a challenge.ObjectiveWe reviewed the literature on best practices for monitoring performance and undertaking activities aimed at improving pediatric patient and family experiences of inpatient care.Data sourcesWe searched PubMed, Cumulative Index to Nursing and Allied Health Literature, and PsychINFO.Study selectionWe included (1) English-language peer-reviewed articles published from January 2000 to April 2019; (2) articles based in the United States, United Kingdom, or Canada; (3) articles focused on pediatric inpatient care; (4) articles describing pediatric patient and family experiences; and (5) articles including content on activities aimed at improving patient and family experiences. Our review included 25 articles.Data extractionTwo researchers reviewed the full article and abstracted specific information: country, study aims, setting, design, methods, results, Quality Improvement (QI) initiatives performed, internal reporting description, best practices, lessons learned, barriers, facilitators and study implications for clinical practice, patient-experience data collection, and QI activities. We noted themes across samples and care settings.ResultsWe identified 10 themes of best practice. The 4 most common were (1) use evidence-based approaches, (2) maintain an internal system that communicates information and performance on patient and family experiences to staff and hospital leadership, (3) use experience survey data to initiate and/or evaluate QI interventions, and (4) identify optimal times (eg, discharge) and modes (eg, print) for obtaining patient and family feedback. These correspond to adult inpatient best practices.ConclusionsBoth pediatric and adult inpatient best practices rely on common principles of culture change (such as evidence-based clinical practice), collaborative learning, multidisciplinary teamwork, and building and/or supporting a QI infrastructure that requires time, money, collaboration, data tracking, and monitoring. QI best practices in both pediatric and adult inpatient settings commonly rely on identifying drivers of overall ratings of care, rewarding staff for successful implementation, and creating easy-to-use and easy-to-access planning and QI tools for staff.

BackgroundThe optimal level of care for hemodynamically stable patients with isolated blunt hepatic, renal, or splenic injuries (solid organ injuries [SOIs]) is unknown. We sought to characterize interhospital variability in intensive care unit (ICU) admission of such patients and to determine whether greater hospital-level ICU use would be associated with improved outcomes.MethodsWe conducted a retrospective cohort study using the 2015 and 2016 National Trauma Data Bank. We included adult patients with blunt trauma with SOIs with an Abbreviated Injury Scale score of 2 to 4. We excluded patients with other significant injuries, hypotension, or another indication for ICU admission, and hospitals with less than 10 eligible patients. We categorized hospitals into quartiles based on the proportion of eligible patients admitted to an ICU. The primary outcome was a composite of organ failure (cardiac arrest, acute lung injury/acute respiratory failure, or acute kidney injury), infection (sepsis, pneumonia, or catheter-related blood stream infection), or death during hospitalization.ResultsAmong 14,312 patients at 444 facilities, 7,225 (50%), 5,050 (35%), and 3,499 (24%) had splenic, hepatic, and renal injuries, respectively. The median proportion of ICU use was 44% (interquartile range, 27-59%, range 0-95%). The composite outcome occurred in 180 patients (1.3%), with death in 76 (0.5%), organ failure in 97 (0.7%), and infection in 53 (0.4%). Relative to hospitals with the lowest ICU use (quartile 1), greater hospital-level ICU use was not associated with decreased likelihood of the composite outcome (adjusted odds ratios, 1.31; 95% confidence interval [95% CI], 0.88-1.95; 0.81; 95% CI, 0.52-1.26; and 0.94; 95% CI, 0.62-1.43 for quartiles 2-4, respectively) or its components. Unplanned ICU transfer was no more likely with lower hospital-level ICU use.ConclusionAdmission location of stable patients with isolated mild to moderate abdominal SOIs is variable across hospitals, but hospitalization at a facility with greater ICU use is not associated with substantially improved outcomes.Level of evidenceTherapeutic/care management, Level IV.

PurposeThis systematic review and meta-analysis evaluated the effectiveness of diabetes self-management education (DSME) in reducing glycosylated hemoglobin (A1C) levels in adult Latinos with type 2 diabetes (T2DM).MethodsFive databases were searched for DSME randomized controlled trials or quasi-experimental trials published between January 1997 and March 2019. A random effects model was utilized to calculate combined effect sizes. Subgroup analyses were performed to explore possible sources of heterogeneity between studies.ResultsTwenty-three unique studies met criteria for this systematic review and of these, 18 were included in the meta-analysis. Pooled estimate effect of DSME on A1C from the random effect model was -0.240 (95% confidence interval = -0.345, -0.135, p 8.0 [69 mmol/mol], and team-based approach.ConclusionsMeta-analysis results showed that culturally tailored DSME interventions significantly reduce AIC in Latinos with T2DM despite the heterogeneity across the studies.ImplicationsThe heterogeneity in the study methodologies reinforce the need for additional studies to better understand DSME interventions to reduce disparities in Latino adults with T2DM.

ObjectiveTo construct a Frailty Index (FI) as a measure of vulnerability to adverse outcomes among patients with systemic lupus erythematosus (SLE), using data from the Systemic Lupus International Collaborating Clinics (SLICC) inception cohort.MethodsThe SLICC inception cohort consists of recently diagnosed patients with SLE followed annually with clinical and laboratory assessments. For this analysis, the baseline visit was defined as the first study visit at which sufficient information was available for construction of an FI. Following a standard procedure, variables from the SLICC database were evaluated as potential health deficits. Selected health deficits were then used to generate a SLICC-FI. The prevalence of frailty in the baseline dataset was evaluated using established cutpoints for FI values.ResultsThe 1683 patients with SLE (92.1% of the overall cohort) eligible for inclusion in the baseline dataset were mostly female (89%) with mean (SD) age 35.7 (13.4) years and mean (SD) disease duration 18.8 (15.7) months at baseline. Of 222 variables, 48 met criteria for inclusion in the SLICC-FI. Mean (SD) SLICC-FI was 0.17 (0.08) with a range from 0 to 0.51. At baseline, 27.1% (95% CI 25.0-29.2) of patients were classified as frail, based on SLICC-FI values > 0.21.ConclusionThe SLICC inception cohort permits feasible construction of an FI for use in patients with SLE. Even in a relatively young cohort of patients with SLE, frailty was common. The SLICC-FI may be a useful tool for identifying patients with SLE who are most vulnerable to adverse outcomes, but validation of this index is required prior to its use.

PurposeAnal cancer risk is substantially higher among HIV-infected men who have sex with men (MSM) as compared with other reproductive-age adults, but screening is rare across sub-Saharan Africa. We report the use of high-resolution anoscopy (HRA) as a first-line screening tool and the resulting early outcomes among MSM in Abuja, Nigeria.MethodsFrom August 2016 to August 2017, 424 MSM enrolled in an anal cancer screening substudy of TRUST/RV368, a combined HIV prevention and treatment cohort. HRA-directed biopsies were diagnosed by histology, and ablative treatment was offered for high-grade squamous intraepithelial lesions (HSIL). HRA proficiency was assessed by evaluating the detection of squamous intraepithelial lesions (SIL) over time and the proportion biopsied. Prevalence estimates of low-grade squamous intraepithelial lesions and HSIL with 95% CIs were calculated. Multinomial logistic regression was used to identify those at the highest risk of SIL.ResultsMedian age was 25 years (interquartile range [IQR], 22-29), median time since sexual debut was 8 years (IQR, 4-12), and 59% (95% CI, 54.2% to 63.6%) were HIV infected. Rate of detection of any SIL stabilized after 200 screenings, and less than 20% had two or more biopsies. Preliminary prevalence estimates of low-grade squamous intraepithelial lesions and HSIL were 50.0% (95% CI, 44.7% to 55.3%) and 6.3% (95% CI, 4.0% to 9.3%). HIV infection, at least 8 years since anal coital debut, concurrency, and external warts were independently statistically associated with SIL.ConclusionProficiency with HRA increased with experience over time. However, HSIL detection rates were low, potentially affected by obstructed views from internal warts and low biopsy rates, highlighting the need for ongoing evaluation and mentoring to validate this finding. HRA is a feasible first-line screening tool at an MSM-friendly health care facility. Years since anal coital debut and external warts could prioritize screening.

Hematopoietic cell transplantation (HCT) is potentially curative for patients with hematologic disorders, but carries significant risks of infection-related morbidity and mortality. Infectious diseases are the second most common cause of death in HCT recipients, surpassed only by progression of underlying disease. Many infectious diseases are difficult to diagnose and treat, and may only be first identified by autopsy. However, autopsy rates are decreasing despite their value. The clinical and autopsy records of adult HCT recipients at our center who underwent autopsy between 1 January 2000 and 31 December 2017 were reviewed. Discrepancies between premortem clinical diagnoses and postmortem autopsy diagnoses were evaluated. Of 185 patients who underwent autopsy, 35 patients (18.8%) had a total of 41 missed infections. Five patients (2.7%) had >1 missed infection. Of the 41 missed infections, 18 (43.9%) were viral, 16 (39.0%) were fungal, 5 (12.2%) were bacterial, and 2 (4.9%) were parasitic. According to the Goldman criteria, 31 discrepancies (75.6%) were class I, 5 (12.2%) were class II, 1 (2.4%) was class III, and 4 (9.8%) were class IV. Autopsies of HCT recipients frequently identify clinically significant infectious diseases that were not suspected premortem. Had these infections been suspected, a change in management might have improved patient survival in many of these cases. Autopsy is underutilized and should be performed regularly to help improve infection-related morbidity and mortality. Illustrative cases are presented and the lessons learned from them are also discussed.

OBJECTIVE: The Functional Status Examination (FSE) is a comprehensive measure of functional status post-traumatic brain injury (TBI) that has primarily been used in studies of moderate-to-severe TBI. The present observational study examines functional status using the FSE among patients who sustained mild TBIs (mTBIs; defined as Glasgow Coma Scale [GCS] = 13-15 at admission) seen in a Level 1 trauma center. Study aims included examining the course of functional status following mTBI, as well as exploring relationships of the FSE and other relevant constructs among those with GCS = 13-15. METHOD: Participants were assessed at 2 weeks (n = 112), 3 months (n = 113), 6 months (n = 106), and 12 months (n = 88) post-injury for changes in functional status resulting both (a) from all injuries and (b) from TBI only. RESULTS: Among seven domains of day-to-day functioning, participants generally experienced the greatest disruption in their primary activity (work or school) and in leisure and recreation. Subjects overall functional status tended to improve over time, with sharpest increases in functionality occurring in the first 3 months post-injury. However, some subjects continued to report functional limitations even at 12 months post-injury. Functional status was largely unrelated to neurocognitive functioning, but related strongly to post-traumatic symptoms, life satisfaction, and emotional well-being, particularly at 3 months post-injury and beyond. CONCLUSION: Findings indicate that functional impairments related to mTBI may be more likely to persist than widely believed, with those who experience lingering functional deficits at particular risk for emotional health difficulties.

BACKGROUND:As a dominant seasonal influenza virus, H3N2 virus rapidly evolves in humans and is a constant threat to public health. Despite sustained research efforts, the efficacy of H3N2 vaccine has decreased rapidly. Even though antigenic drift and passage adaptation (substitutions accumulated during vaccine production in embryonated eggs) have been implicated in reduced vaccine efficacy (VE), their respective contributions to the phenomenon remain controversial. METHODS:We utilized mutational mapping, a powerful probabilistic method for studying sequence evolution, to analyze patterns of substitutions in different passage conditions for an unprecedented amount of H3N2 hemagglutinin sequences (n = 32 278). RESULTS:We found that passage adaptation in embryonated eggs is driven by repeated convergent evolution over 12 codons. Based on substitution patterns at these sites, we developed a metric, adaptive distance (AD), to quantify the strength of passage adaptation and subsequently identified a strong negative correlation between AD and VE. CONCLUSIONS:The high correlation between AD and VE implies that passage adaptation in embryonated eggs may be a strong contributor to the recent reduction in H3N2 VE. We developed a computational package called MADE (Measuring Adaptive Distance and vaccine Efficacy based on allelic barcodes) to measure the strength of passage adaptation and predict the efficacy of a candidate vaccine strain. Our findings shed light on strategies for reducing Darwinian evolution within the passaging medium in order to potentially restore an effective vaccine program in the future.

Metabolomics is an emerging science that can inform pathogenic mechanisms behind clinical phenotypes in COPD. We aimed to understand disturbances in the serum metabolome associated with respiratory outcomes in ever-smokers from the SPIROMICS cohort. We measured 27 serum metabolites, mostly amino acids, by 1H-nuclear magnetic resonance spectroscopy in 157 white ever-smokers with and without COPD. We tested the association between log-transformed metabolite concentrations and one-year incidence of respiratory exacerbations after adjusting for age, sex, current smoking, body mass index, diabetes, inhaled or oral corticosteroid use, study site and clinical predictors of exacerbations, including FEV1% predicted and history of exacerbations. The mean age of participants was 53.7 years and 58% had COPD. Lower concentrations of serum amino acids were independently associated with 1-year incidence of respiratory exacerbations, including tryptophan (β = -4.1, 95% CI [-7.0; -1.1], p = 0.007) and the branched-chain amino acids (leucine: β = -6.0, 95% CI [-9.5; -2.4], p = 0.001; isoleucine: β = -5.2, 95% CI [-8.6; -1.8], p = 0.003; valine: β = -4.1, 95% CI [-6.9; -1.4], p = 0.003). Tryptophan concentration was inversely associated with the blood neutrophil-to-lymphocyte ratio (p = 0.03) and the BODE index (p = 0.03). Reduced serum amino acid concentrations in ever-smokers with and without COPD are associated with an increased incidence of respiratory exacerbations.

AIMS:To compare long-term criminal justice outcomes among opioid-dependent individuals randomized to receive buprenorphine or methadone. DESIGN, SETTING AND PARTICIPANTS:A 5-year follow-up was conducted in 2011-14 of 303 opioid-dependent participants entering three opioid treatment programs in California, USA in 2006-09 and randomized to receive either buprenorphine/naloxone or methadone. INTERVENTION AND COMPARATOR:Participants received buprenorphine/naloxone (BUP; n = 179) or methadone (MET; n = 124) for 24 weeks and then were tapered off their treatment over ≤ 8 weeks or referred for ongoing clinical treatment. Midway through the study, the randomization scheme was switched from 1 : 1 BUP : MET to 2 : 1 because of higher dropout in the BUP arm. MEASUREMENTS:Study outcomes included arrests and self-reported incarceration. Predictors included randomization condition (buprenorphine versus methadone), age, gender, race/ethnicity, use of cocaine, drug injection in the 30 days prior to baseline and study site. Treatment status (buprenorphine, methadone, none) during follow-up was included as a time-varying covariate. FINDINGS:There was no significant difference by randomization condition in the proportion arrested (buprenorphine: 55.3%, methadone: 54.0%) or incarcerated (40.9%, 47.3%) during follow-up. Among methadone-randomized individuals, arrest was less likely with methadone treatment (0.50, 0.35-0.72) during follow-up (relative to no treatment) and switching to buprenorphine had a lower likelihood of arrest than those receiving no treatment (0.39, 0.18-0.87). Among buprenorphine-randomized individuals, arrest was less likely with receipt of buprenorphine (0.49, 0.33-0.75) during follow-up and switching to methadone had a similar likelihood of arrest as methadone-randomized individuals receiving no treatment. Likelihood of arrest was also negatively associated with older age (0.98, 0.96-1.00); it was positively associated with Hispanic ethnicity (1.63, 1.04-2.56), cocaine use (2.00, 1.33-3.03), injection drug use (2.19, 1.26-3.83), and study site. CONCLUSIONS:In a US sample of people treated for opioid use disorder, continued treatment with either buprenorphine or methadone was associated with a reduction in arrests relative to no treatment. Cocaine use, injection drug use, Hispanic ethnicity and younger age were associated with higher likelihood of arrest.