Clinician Reports Research Articles

Association Between Parent Comfort With English and Adverse Events Among Hospitalized Children

Children of parents expressing limited comfort with English (LCE) or limited English proficiency may be at increased risk of adverse events (harms due to medical care). No prior studies have examined, in a multicenter fashion, the association between language comfort or language proficiency and systematically, actively collected adverse events that include family safety reporting. To examine the association between parent LCE and adverse events in a cohort of hospitalized children. This multicenter prospective cohort study was conducted from December 2014 to January 2017, concurrent with data collection from the Patient and Family Centered I-PASS Study, a clinician-family communication and patient safety intervention study. The study included 1666 Arabic-, Chinese-, English-, and Spanish-speaking parents of general pediatric and subspecialty patients 17 years and younger in the pediatric units of 7 North American hospitals. Data were analyzed from January 2018 to May 2020. Language-comfort data were collected through parent self-reporting. LCE was defined as reporting any language besides English as the language in which parents were most comfortable speaking to physicians or nurses. The primary outcome was adverse events; the secondary outcome was preventable adverse events. Adverse events were collected using a systematic 2-step methodology. First, clinician abstractors reviewed patient medical records, solicited clinician reports, hospital incident reports, and family safety interviews. Then, review and consensus classification were completed by physician pairs. To examine the association of LCE with adverse events, a multivariable logistic regression was conducted with random intercepts to adjust for clustering by site. Of 1666 parents providing language-comfort data, 1341 (80.5%) were female, and the mean (SD) age of parents was 35.4 (10.0) years. A total of 147 parents (8.8%) expressed LCE, most of whom (105 [71.4%]) preferred Spanish. Children of parents who expressed LCE had higher odds of having 1 or more adverse events compared with children whose parents expressed comfort with English (26 of 147 [17.7%] vs 146 of 1519 [9.6%]; adjusted odds ratio, 2.1; 95% CI, 1.2-3.7), after adjustment for parent race and education, complex chronic conditions, length of stay, site, and the intervention period. Similarly, children whose parents expressed LCE were more likely to experience 1 or more preventable adverse events (adjusted odds ratio, 2.3; 95% CI, 1.2-4.2). Hospitalized children of parents expressing LCE were twice as likely to experience harms due to medical care. Targeted strategies are needed to improve communication and safety for this vulnerable group of children.

Development and Validation Clinician and Patient Reported Photonumeric Scales to Assess Buttocks Cellulite Severity.

The Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported PCSS (PR-PCSS) are newly developed tools for assessing cellulite severity. To report on the reliability, validity, and ability to detect a change in cellulite severity on the buttocks of adult women with the CR-PCSS and PR-PCSS. Content validity of both scales was established through concept elicitation and cognitive interviews. Test-retest reliability was evaluated, and intra-rater (both scales) and inter-rater (CR-PCSS only) reliability were estimated using intraclass correlation coefficients (ICCs) for agreement and consistency. Ability to detect a change was determined using the Subject-Global Aesthetic Improvement Scale (GAIS) or Investigator-GAIS as anchors. For the CR-PCSS (n = 6) at baseline and Day 2, the mean interrater ICCs were ≥0.70 and mean intrarater ICCs (95% confidence interval [CI]) were ≥0.81 (0.72-0.90) for both buttocks. For the PR-PCSS (n = 99) at baseline and Day 14, the mean test-retest reliability ICCs (95% CI) were ≥0.86 (0.79-0.91) for both buttocks. A clinically meaningful change was 1.0 point on the PR-PCSS and 1.0 on the CR-PCSS. The CR-PCSS and PR-PCSS reliably assess cellulite severity of the buttocks and can detect a clinically meaningful change after treatment for cellulite.

A Program to Provide Clinicians with Feedback on Their Diagnostic Performance in a Learning Health System

Reducing diagnostic errors requires improving both systems and individual clinical reasoning. One strategy to achieve diagnostic excellence is learning from feedback. However, clinicians remain uncomfortable receiving feedback on their diagnostic performance. Thus, a team of researchers and clinical leaders aimed to develop and implement a diagnostic performance feedback program for learning that mitigates potential clinician discomfort. The program was developed as part of a larger project to create a learning health system around diagnostic safety at Geisinger, a large, integrated health care system in rural Pennsylvania. Steps included identifying potential missed opportunities in diagnosis (MODs) from various sources (for example, risk management, clinician reports, patient complaints); confirming MODs through chart review; and having trained facilitators provide feedback to clinicians about MODs as learning opportunities. The team developed a guide for facilitators to conduct effective diagnostic feedback sessions and surveyed facilitators and recipients about their experiences and perceptions of the feedback sessions. 28 feedback sessions occurred from January 2019 to June 2020, involving MODs from emergency medicine, primary care, and hospital medicine. Most facilitators (90.6% [29/32]) reported that recipients were receptive to learning and discussing MODs. Most recipients reported that conversations were constructive and nonpunitive (83.3% [25/30]) and allowed them to take concrete steps toward improving diagnosis (76.7% [23/30]). Both groups believed discussions would improve future diagnostic safety (93.8% [30/32] and 70.0% [21/30], respectively). An institutional program was developed and implemented to deliver diagnostic performance feedback. Such a program may facilitate learning and improvement to reduce MODs. Future efforts should assess long-term effects on diagnostic performance and patient outcomes.

Clinician-judged hearing impairment and associations with neuropathologic burden.

To examine whether neuropathologic burden is associated with hearing impairment. We studied 2,755 autopsied participants ≥55 years of age from the National Alzheimer's Coordinating Center database. Participants had at least 1 clinical evaluation at US National Institute on Aging-funded Alzheimer's Disease Center no more than 2 years before death. Patients were classified as hearing impaired by clinician report at baseline. Common dementia neuropathologies included Alzheimer disease pathologic change (Consortium to Establish a Registry for Alzheimer's Disease neuritic plaque density, neurofibrillary degeneration Braak stage), Lewy body disease, gross infarcts, and microinfarcts. Logistic regression models predicted impaired hearing with adjustment for age at death, sex, race, education, center, and follow-up time. Relative risks were calculated with the use of marginal standardization. Impaired hearing was common (32%). In participants who were cognitively normal at baseline (n = 580), impaired hearing was associated with higher Braak stage (relative risk [RR] 1.33 per 2-stage increase, 95% confidence interval [CI] 1.06-1.66) but not other pathologies. In participants with dementia (n = 2,175), impaired hearing was positively associated with microinfarcts (RR 1.18, 95% CI 1.00-1.39) and inversely associated with neuritic plaque density (RR 0.91 per score increase, 95% CI 0.85-0.99). Development of impaired hearing in those with cognitive impairment was associated with neocortical Lewy bodies (1.26, 95% CI 1.02-1.55). Impaired hearing, reported before the onset of cognitive impairment, was associated with increased neurofibrillary tangle burden. Impaired hearing in those with cognitive impairment was associated with microinfarcts and neocortical Lewy bodies but not typical Alzheimer disease pathologic change. Functional hearing problems may be a preclinical marker of neurofibrillary neurodegeneration, although replication is needed.

Effect of Family Caregiver Need for Training on Medicare Home Health Care

Research ObjectiveTo assess whether and how family caregiver need for training affects the number and type of visits received during a Medicare home health episode, an issue of policy relevance due to a new mandate requiring Medicare‐funded home health providers to train family caregivers.Study DesignCross‐sectional analysis of linked nationally representative survey data from the National Health and Aging Trends Study (NHATS), home health patient assessment data, Medicare claims data, and Medicare Provider of Services file. Multivariable logistic and negative binomial models were used to model the effect of family caregiver need for training on specific caregiving activities on the number and type of visits received during a Medicare home health episode. Family caregiver need for training was drawn from home health clinician reports included in the patient assessment; home health visit type/number was drawn from Medicare claims. Analyses were limited to home health patients receiving family caregiver assistance with each specific caregiving activity.Multivariable logistic regressions were used to model the odds of receiving any nursing, therapy, aide, or training visits during a Medicare home health episode, and multivariable negative binomial regressions were used to model the expected number of total, nursing, therapy, aide, or training visits during a Medicare home health episode. Propensity score adjustment was used to produce causal estimates. All models adjusted for patient sociodemographic characteristics and health and functional status during home health, as well as home health provider characteristics. All models were weighted to account for complex survey design and to produce nationally representative estimates.Population Studied1217 (weighted n = 5 870 905) community‐dwelling older adults who participated in the NHATS from 2011‐2015 and received Medicare‐funded home health within one year of NHATS interview.Principal FindingsAmong patients receiving self‐care help from a family caregiver, the odds of any therapy visits are 71% greater (P = .04) and the odds of any aide visits are 213% greater (P = .02) if the family caregiver was identified as needing training. Among patients receiving medication management help from a family caregiver, the odds of any nursing visits are 302% greater (P = .04) and, among those who receive nursing visits, there are an expected additional 1.04 nursing visits (P = .03) if the family caregiver was identified as needing training. Family caregiver need for task‐specific training did not significantly predict the odds of any training visit nor the expected number of training visits received.ConclusionsFamily caregivers’ need for training on specific caregiving tasks was associated with greater resource utilization (home health visits) during Medicare home health episodes. This relationship was amplified for caregiver tasks and home health visits that address similar care needs (eg, caregiver need for training on self‐care and home health personal care aide visits).Implications for Policy or PracticeFindings support the call from advocates and researchers for greater support of family caregivers relating to increased access to training resources. Additionally, as home health providers comply with the recent CMS mandate to offer training to family caregivers, they should consider prioritizing training interventions which focus on caregiving tasks most closely tied to resource utilization: self‐care and medication management.Primary Funding SourceNational Institutes of Health.

ASPEN Report on Nutrition Support Practice Processes With COVID-19: The First Response.

Coronavirus disease 2019 (COVID‐19) has changed nutrition care processes in hospitals and in the home setting. This paper summarizes clinician reports on these changed processes, including overall nutrition care, nutrition assessment, enteral nutrition and parenteral nutrition care steps, and food and oral supplement delivery. Also included are teaching, logistics, and personnel issues around changes in the work environment. Use of safe, standardized, evidence‐based processes in the face of altered care patterns is critical.

Development and reliability of the AOSpine CROST (Clinician Reported Outcome Spine Trauma): a tool to evaluate and predict outcomes from clinician\u2019s perspective

PurposeTo report on the development of AOSpine CROST (Clinician Reported Outcome Spine Trauma) and results of an initial reliability study.MethodsThe AOSpine CROST was developed using an iterative approach of multiple cycles of development, review, and revision including an expert clinician panel. Subsequently, a reliability study was performed among an expert panel who were provided with 20 spine trauma cases, administered twice with 4-week interval. The results of the developmental process were analyzed using descriptive statistics, the reliability per parameter using Kappa statistics, inter-rater rater agreement using intraclass correlation coefficient (ICC), and internal consistency using Cronbach’s α.ResultsThe AOSpine CROST was developed and consisted of 10 parameters, 2 of which are only applicable for surgically treated patents (‘Wound healing’ and ‘Implants’). A dichotomous scoring system (‘yes’ or ‘no’ response) was incorporated to express expected problems for the short term and long term. In the reliability study, 16 (84.2%) participated in the first round and 14 (73.7%) in the second. Intra-rater reliability was fair to good for both time points (κ = 0.40–0.80 and κ = 0.31–0.67). Results of inter-rater reliability were lower (κ = 0.18–0.60 and κ = 0.16–0.46). Inter-rater agreement for total scores showed moderate results (ICC = 0.52–0.60), and the internal consistency was acceptable (α = 0.76–0.82).ConclusionsThe AOSpine CROST, an outcome tool for the surgeons, was developed using an iterative process. An initial reliability analysis showed fair to moderate results and acceptable internal consistency. Further clinical validation studies will be performed to further validate the tool.

Human Taeniases in Slovakia (2010-2019): Genetic Analysis of Taenia saginata Isolates.

Taenia saginata and Taenia solium, known as beef and pork tapeworm, are foodborne pathogens of global importance having a substantial impact on human health and economy. The study aimed to summarize the occurrence of human Taenia spp. infection in past 10 years in Slovakia based on reports of clinicians and diagnostic laboratories to Public Health Authority of the Slovak Republic. Altogether, 19 human cases were reported in Slovakia in 2010-2019, with the incidence of infection ranging from 0.00 to 0.12/100,000 inhabitants per year. In two patients T. saginata infection was confirmed molecularly. Nucleotide sequences of the analyzed nad1 gene fragments derived from both patients were identical and in a phylogenetic tree clustered together with T. saginata Tsa isolate (AM503345), as well as with a homologous sequence of the completely sequenced mitochondrial genome of T. saginata. Similarly, cox1 nucleotide sequences derived from one of the patients and isolates from Asia and/or Europe were identical. A cluster for cox1 partial gene sequence was placed separately from closely related Taenia asiatica and/or T. solium isolates in the phylogenetic tree.

Patient-reported and clinician-rated performance status and general health among women with gynecologic cancers on palliative chemotherapy.

e24128 Background: Oncologists’ perceptions of patients’ performance status (PS) and general health are key determinants of eligibility for chemotherapy and clinical trials. We sought to examine correlations between patient-reported and clinician-rated Eastern Clinical Oncology Group PS (ECOG-PS) and general health status (EQ5D) in women with incurable recurrent gynecologic cancers, as well as step counts from accelerometry as a proxy for objective PS. Methods: We used baseline data from a randomized trial evaluating a mobile health intervention that collects patient-reported outcomes and passive smartphone data and provides tailored symptom management advice. Half of participants also received a wearable accelerometer. We calculated Pearson correlations to determine agreement between ECOG-PS and EQ-5D assessments in patient-clinician dyads. We also calculated the median (IQR) step counts among a subset of women with ≥7 days of ≥8 hours wear time. Results: Data from 78 patient-clinician dyads demonstrated a moderate correlation between patient-reported and clinician-rated ECOG-PS (r = .47; P< .000). Among dyads, 38 (49%) had perfect agreement; 36 (46%) had higher patient-reported ECOG-PS, indicating more patient-reported functional limitations, compared with clinician reports; and 4 (5%) had lower patient-reported ECOG-PS. Comparisons between patient-clinician ratings of EQ-5D subscales indicated moderate agreement for mobility (r = 0.44; P< .001), pain/discomfort (r = 0.45; P< .001), and usual activities (r = 0.36; P= .002); and weak or no agreement for anxiety/depression (r = 0.31; P= .007) and self-care (r = 0.02; P> .05). Participants’ daily step counts varied widely (median = 5,511 steps, IQR = 3,784, range 1,736-13,961) and were not associated with patients’ or clinicians’ ECOG-PS estimates (r = -.12; P= 0.44 and r = -0.03; P= 0.84) or patient-reported mobility (r = -0.10; P =0.51). Conclusions: Among women with incurable gynecologic cancers, patients’ and clinicians’ perceptions of patients’ ECOG-PS were moderately correlated, although 46% of clinician ratings were more optimistic than patients’ ratings. There was also moderate agreement between dyads for mobility and pain/discomfort. Patients’ step counts were not correlated with ECOG-PS or patient-reported mobility. Future studies should examine these measures longitudinally to determine which is the most sensitive predictor of clinical outcomes. Clinical trial information: NCT03022032 .

Early discontinuation to adjuvant endocrine therapy in the ECOG-ACRIN TAILORx Trial.

7004 Background: The TAILORx study demonstrated women with an intermediate Oncotype DX score receive the same benefit with endocrine therapy (ET) compared to chemoendocrine therapy (CET). However, early discontinuation of adjuvant ET is problematic among breast cancer survivors, with previous studies suggesting that up to 50% of women do not adhere to the full 5 years of recommended ET treatment. The aim of this study was to identify patient-level risk factors associated with early discontinuation of ET in the TAILORx study. Methods: TAILORx was coordinated by the ECOG-ACRIN Cancer Research Group. Participants were a subgroup of 954 women who completed additional measures on health-related quality of life (HRQoL) including endocrine symptoms (ES) physical well-being (PWB) and social well-being (SWB) prior to initiating ET, which categorized into three groups by tertile for analysis. All participants were diagnosed with hormone-receptor–positive, human epidermal growth factor receptor 2–negative, axillary node–negative breast cancer who started ET within a year of study entry. Early discontinuation of ET, defined as discontinuation less than 4 years from initiation for reasons other than death or recurrence, was assessed by clinician report. Rate of discontinuation was calculated using Kaplan-Meier estimates, and Cox-proportional hazards joint models were used to analyze the association between rates of adherence to ET with patient-level factors. Results: In a joint model, receipt of CET therapy (vs receipt of ET only; HR = .59, 95% CI .38-.94, p = .02) and age above 40 (versus age < = 40; HR = .30, 95% CI .14-.66, p = .003) were associated with a lower probability of early discontinuation of ET. Adjusted for these factors, a history of depression compared to no history of depression (HR 1.82, 95% CI 1.19-2.77, p = 0.005), worse ES compared to better ES (HR 1.70, 95% CI 1.06-2.74, p = 0.03), worse PWB compared to better PWB (HR 2.12, 95% CI 1.30-3.45,p = 0.003), and worse SWB compared to better SWB (HR 1.94, 95% CI 1.20-3.13, p = 0.007) were individually and significantly associated with a higher probability of early discontinuation of ET, although none reached statistical significance when all were included in a joint model. Conclusions: Younger women are at risk for early discontinuation and modifiable characteristics such as HRQoL and history of depression are potential risk factors for early discontinuation of ET. These results support systematic screening for HRQoL and depressive symptoms to identify women at risk for discontinuation of ET. Clinical trial information: NCT00310180 .

Critical Care Clinician Reports on Coronavirus Disease 2019: Results From a National Survey of 4,875 ICU Providers.

Importance:Global cases of coronavirus disease 2019 infection continue to increase, and significant numbers of patients are critically ill, placing an immense burden on ICU resources. Understanding baseline resource needs and surge capacity in the ICU will be essential to meet current and projected healthcare needs. Continued appraisal of the state of readiness for healthcare systems at individual, regional and national levels will be paramount to ensure we are poised to continue the fight against coronavirus disease 2019.Objectives:This study queried U.S. ICU clinician perspectives on ICU preparedness and concerns regarding delivering coronavirus disease 2019 patient care.Design, Setting, and Participants:An anonymous web-based survey administered from March 18, 2020, to March 25, 2020 (email and newsletter) used survey methodology to query members of U.S. national critical care organizations.Main Outcomes and Measures:Through a 12-item descriptive questionnaire, ICU clinicians were assessed regarding preparedness, techniques employed to augment critical care capacity, and concerns related to caring for coronavirus disease 2019 patients.Results:A total of 4,875 ICU clinicians responded to the survey. Respondents included ICU nurses (n = 3,470, 71.3%), physicians (n = 664, 13.6%), advanced practice providers (nurse practitioners and physician assistants; n = 334, 6.9%), respiratory therapists (n = 236, 4.9%), and pharmacists (n = 79, 1.6%). Over half (n = 2,552, 52.5%) reported having cared for a presumed or confirmed coronavirus disease 2019 patient. The majority (n = 4,010, 82.9%) identified that their hospital was employing techniques to augment critical care capacity. However, 64.5% (n = 3,125) believed that their ICU facility and team were inadequately prepared to treat coronavirus disease 2019 patients. The majority (n = 4,547, 93.9%) anticipated ICU personal protective equipment shortages based upon their current use profile. The chief reported concerns include ICU resource shortages such as supplies, medications, beds, ICU staffing shortages, and patient surge leading to overcrowding.Conclusions and Relevance:This national ICU clinician survey indicates that hospitals are expanding ICU bed capacity to prepare for coronavirus disease 2019 patient surge. Importantly, amid this preparation, ICU clinicians harbor concerns regarding preparedness, staffing, and common use resources that merit specific education as well as resource allocation and utilization planning.

Reliability and Validity of the English Version of the AOSpine PROST (Patient Reported Outcome Spine Trauma).

Multicenter validation study. The aim of this study was to translate and adapt the AOSpine PROST (Patient Reported Outcome Spine Trauma) into English, and test its psychometric properties among North-American spine trauma patients. In the absence of an outcome instrument specifically designed and validated for traumatic spinal column injury patients, it is difficult to measure the effect size of various treatment options. The AOSpine Knowledge Forum Trauma initiated a project and developed the AOSpine PROST consisting of 19 items. Patients were recruited from two level-1 North-American trauma centers. For concurrent validity, next to AOSpine PROST also 36-item Short-Form Health Survey (SF-36) was filled out by patients. Patient characteristics were analyzed using descriptive statistics. Floor and ceiling effects as well as the number of inapplicable and missing questions were analyzed for content validity. Cronbach α and item-total correlation coefficients (ITCCs) were calculated for internal consistency. Spearman correlation tests were performed within AOSpine PROST items and in correlation to SF-36. Test-retest reliability was assessed using intraclass correlation coefficients (ICCs). Factor analysis was performed to explore any dimensions within AOSpine PROST. The AOSpine PROST was translated adapted into English using established guidelines. Of 196 enrolled patients, 162 (82.7%) met the inclusion criteria and provided sufficient data. Content validity showed good results, and no floor and ceiling effects were seen. The internal consistency was excellent (Cronbach α = 0.97; ITCC 0.50-0.90) as well as test-retest reliability (ICC = 0.97). Spearman correlations were good (0.29-0.85). The strongest correlations of AOSpine PROST with SF-36 were seen with the physical components (0.69-0.82; P < 0.001). Factor analysis revealed two possible dimensions (Eigen values >1), explaining 75.7% of variance. The English version of AOSpine PROST showed very good validity and reliability. It is considered as a valuable tool, and has the potential to contribute to the reduction of ongoing controversies in spine trauma care. 2.

Congruence of patient- and clinician-reported toxicity in women receiving chemotherapy for early breast cancer.

The National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, collected alongside the clinician-reported Common Terminology Criteria for Adverse Events, enables comparisons of patient and clinician reports on treatment toxicity. In a multisite study of women receiving chemotherapy for early-stage breast cancer, symptom reports were collected on the same day from patients and their clinicians for 17 symptoms; their data were not shared with each other. The proportions of moderate, severe, or very severe patient-reported symptom severity were compared with the proportions of clinician-rated grade 2, 3, or 4 toxicity. Patient-clinician agreement was assessed via κ statistics. Chi-square tests investigated whether patient characteristics were associated with patient-clinician agreement. Among 267 women, the median age was 58years (range, 24-83years), and 26% were nonwhite. There was moderate scoring agreement (κ=0.413-0.570) for 53% of symptoms, fair agreement for 41% (κ=0.220-0.378), and slight agreement for 6% (κ=0.188). For example, patient-reported and clinician-rated percentages were 22% and 8% for severe or very severe fatigue, 41% and 46% for moderate fatigue, 32% and 39% for mild fatigue, and 6% and 7% for none. Clinician severity scores were lower for nonwhite patients in comparison with white patients for peripheral neuropathy, nausea, arthralgia, and dyspnea. Although clinician reporting of symptoms is common practice in oncology, there is suboptimal agreement with the gold standard of patient self-reporting. These data provide further evidence supporting the integration of patient-reported outcomes into oncological clinical research and clinical practice to improve monitoring of symptoms as well as timely interventions for symptoms.

Estimation of equable scale scores and treatment outcomes from patient- and clinician-reported PTSD measures using item response theory calibration.

Across multiple RCTs, discrepancies between patient and clinician reports of PTSD symptoms are at least a partial contributing factor to large discrepancies between treatment outcome effect sizes from self-report and clinician reports within the same patients. Using secondary data from the NIDA-funded Women and Trauma Study, we demonstrated Common Persons Item Response Theory (IRT) Calibration for calibrating self-reported and clinician-reported PTSD severity scores in a manner similar to the process used to produce equated scores across multiple forms of standardized tests (e.g., SAT, GRE). Under IRT calibration, treatment effect sizes between the CAPS and MPSS-SR did not differ, while with the noncalibrated measures, the CAPS effect size was 85% larger than the MPSS-SR. Further, across the range of a combined CAPS/MPSS-SR gold standard, IRT-calibrated CAPS and MPSS-SR individual scores did not differ; for uncalibrated individual scores, MPSS scores were higher than CAPS scores at higher levels of PTSD severity while the reverse was true at lower levels of severity. The use of IRT calibration approaches for calibrating self-report and clinical interview measures of PTSD will allow treatment researchers to reflect the treatment effect on PTSD as a construct (regardless of reporter) as opposed to being limited to reporting treatment effects that may be discrepant within patients and specific to the particular assessment measure being employed. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Do We Need a Measure of Vocal Effort? Clinician's report of vocal effort in voice patients.

Vocal effort has been of increasing interest to voice clinicians and researchers. However, little is known about the prevalence of vocal effort in voice patients presenting to voice clinics. The purpose of this study was to better understand how vocal effort is perceived and used in a clinical setting, including the current opinions on this symptom and experiences of voice clinicians regarding vocal effort measurement and management. Speech language pathologists who regularly treat voice patients were queried about their years of voice experience, number of voice patients treated yearly, percentage of voice patients who complain of vocal effort, methods of clinically measuring vocal effort, and treatment strategies that address vocal effort in therapy. Survey results revealed that vocal effort is a commonly presented complaint in the voice clinic with over two-thirds of clinicians reporting that the majority of their patients complain of vocal effort and approximately 25% of clinicians reporting that vocal effort is the main complaint in their patients. Although most clinicians measure vocal effort in the clinic, very few use a dedicated vocal effort measure. About half of the clinicians reported that they specifically address vocal effort reduction as a therapy goal. Despite the high prevalence of observed vocal effort complaints in patients and the focus of vocal effort reduction in therapy, there is no standardized measure of vocal effort widely utilized in the clinic. Future research should address clinically tractable methods to measure vocal effort validly and reliably.

Clinical assessment of acellular dermal matrix (AlloDerm©) as an option in the replacement of the temporomandibular joint disc: A pilot study

BackgroundThere is limited data available in the literature describing the utility of acellular dermal matrix (AlloDerm©) in the replacement of the temporomandibular joint disc. Few reports of clinicians using implantable AlloDerm to replace the disc do exist, however, this has been described for reconstruction after surgical resection of the entire temporomandibular joint complex to treat pathology, as opposed to isolated articular disc disorders. Moreover, there is a lack of description in the literature regarding associated perioperative outcomes after such a procedure. We sought to assess the immediate perioperative outcomes in the form of a pilot study, to determine whether this technique warrants further investigation in the form of prospective clinical studies. MethodsThe study team conducted a retrospective review of medical records for patients who underwent temporomandibular joint discectomy and replacement with AlloDerm© at a single tertiary care center, from 2011 to 2016. Perioperative outcomes of interest including pain levels and range of motion were recorded and descriptive statistics were utilized for statistical analysis. Results15 patients met the inclusion criteria, of which 87% were females and 13% males. The mean age was 47.27±15.93 years. Preoperatively, 74% of the patients reported severe pain (VAS scores of 7–10); in contrast, 73% of the patients reported only mild pain (VAS scores of 1–3) during the postoperative visits, suggesting an overall reduction in pain intensity. Range of motion also improved from an average of 27.73±13.04mm, to an average of 38.60±6.08mm (P<0.01). ConclusionsBased on our preliminary data, patients with advanced TMJ articular disc disorders showed clinical improvement from discectomy and replacement with acellular dermal matrix (AlloDerm©). Further longitudinal studies evaluating long-term outcomes need to be conducted to validate this technique, in the form of larger sample sizes with a control group, as well as radiographic assessment of long-term clinical outcomes.

Clinician vs Patient Reporting of Baseline and Postbaseline Symptoms for Adverse Event Assessment in Cancer Clinical Trials

Clinician vs Patient Reporting of Baseline and Postbaseline Symptoms for Adverse Event Assessment in Cancer Clinical Trials

Clinician vs Patient Reporting of Baseline and Postbaseline Symptoms for Adverse Event Assessment in Cancer Clinical Trials

This retrospective analysis of clinical trials compares clinician reporting of adverse events and patient reporting of analogous symptoms.

Clinician Report of Oral Oncolytic Symptoms and Adherence Obtained via a Patient-Reported Outcome Measure (PROM).

Patient-reported outcome measures (PROMs) for symptom monitoring during cancer therapy have been shown to have a positive impact on outcomes. These findings have primarily been shown for patients receiving intravenous chemotherapy. In addition, there is known discordance between physician reporting of symptoms and patient self-report. This initiative sought to describe patient-reported symptom burden and medication adherence and to indicate the degree of PROM results being discussed with the provider as indicated by documentation in the medical record for patients taking oral oncolytic therapy. The Michigan Oncology Quality Consortium (MOQC) PROM, which included symptom ratings, medication adherence, and patient confidence in self-management, was completed during outpatient visits and compared with corresponding data documented in the electronic medical record (EMR). There were 82 completed PROMs. Approximately half included at least one symptom rated as severe (46%). Sixty-five percent of reported severe symptoms were documented in the EMR. Patient-reported moderate-to-severe pain was most likely to be documented in the EMR (100%), whereas patient-reported moderate-to-severe depression and anxiety were least likely to be documented (21%). Of the total symptoms documented, grading of symptom severity matched that of the patients' own report for 11% of severe symptoms. Adherence to oral oncolytics was excellent for 63% of patients, and patient adherence was documented in 7% of provider notes. Patients frequently reported moderate-to-severe symptoms, and approximately 40% of patients reported nonadherence. Clinician report (documented in the EMR) of the patient symptom burden, symptom severity, and adherence to oral oncolytic therapy was not consistent with the patients' self-report. Use of a PROM for patients taking oral oncolytics has the opportunity to improve symptom management and medication adherence.

Reinterpretation, reclassification, and its downstream effects: challenges for clinical laboratory geneticists

BackgroundIn recent years, the amount of genomic data produced in clinical genetics services has increased significantly due to the advent of next-generation sequencing. This influx of genomic information leads to continuous changes in knowledge on how genetic variants relate to hereditary disease. These changes can have important consequences for patients who have had genetic testing in the past, as new information may affect their clinical management. When and how patients should be recontacted after new genetic information becomes available has been investigated extensively. However, the issue of how to handle the changing nature of genetic information remains underexplored in a laboratory setting, despite it being the first stage at which changes in genetic data are identified and managed.MethodsThe authors organized a 7-day online focus group discussion. Fifteen clinical laboratory geneticists took part. All (nine) Dutch clinical molecular genetics diagnostic laboratories were represented.ResultsLaboratories in our study reinterpret genetic variants reactively, e.g. at the request of a clinician or following identification of a previously classified variant in a new patient. Participants currently deemed active, periodic reinterpretation to be unfeasible and opinions differed on whether it is desirable, particularly regarding patient autonomy and the main responsibilities of the laboratory. The efficacy of reinterpretation was questioned in the presence of other strategies, such as reanalysis and resequencing of DNA. Despite absence of formal policy regarding when to issue a new report for clinicians due to reclassified genetic data, participants indicated similar practice across all laboratories. However, practice differed significantly between laboratory geneticists regarding the reporting of VUS reclassifications.ConclusionBased on the results, the authors formulated five challenges needing to be addressed in future laboratory guidelines: 1. Should active reinterpretation of variants be conducted by the laboratory as a routine practice? 2. How does reinterpretation initiated by the laboratory relate to patient expectations and consent? 3. When should reinterpreted data be considered clinically significant and communicated from laboratory to clinician? 4. Should reinterpretation, reanalysis or a new test be conducted? 5. How are reclassifications perceived and how might this affect laboratory practice?