The Impact of Patient Race, Patient Socioeconomic Status, and Cognitive Load of Physician Residents and Fellows on Chronic Pain Care Decisions.

Social stereotypes are more likely to influence decision-making under conditions of high cognitive load (ie, mental workload), such as in medical settings. We examined how patient race, patient socioeconomic status (SES), physician cognitive load, and physician implicit beliefs about race and SES differences in pain tolerance impacted physicians' pain treatment decisions. Physician residents and fellows (N = 120) made treatment decisions for 12 computer-simulated patients with back pain that varied by race (Black/White) and SES (low/high). Half of the physicians were randomized to be interrupted during the decision task to make hypertension medication conversion calculations (high cognitive load group), while the other half completed the task without interruptions (low cognitive load group). Both groups were given equal time to make pain care decisions (2.5 minutes/patient). Results of multilevel ordinal logistic regression analyses indicated that physicians prescribed weaker analgesics to patients with high vs. low SES (odds ratio = .68, 95% confidence interval [.48, .97], P = .03). There was also a patient SES-by-cognitive load interaction (odds ratio = .56, 95% confidence interval [.31, 1.01], P = .05) that is theoretically and potentially practically meaningful but was not statistically significant at P < .05. These findings shed light on physician cognitive load as a clinically-relevant factor in the context of pain care quality and equity. PERSPECTIVE: These findings highlight the clinical relevance of physician cognitive load (eg, mental workload) when providing pain care for diverse patients. This line of work can support the development of interventions to manage physician cognitive load and its impact on pain care, which may ultimately help reduce pain disparities.

Effectiveness of care models for chronic disease management: A scoping review of systematic reviews.

OBJECTIVE: To conduct a scoping review of models of care for chronic disease management to identify potentially effective components for management of chronic traumatic brain injury (TBI). METHODS: Information sources: Systematic searches of three databases (Ovid MEDLINE, Embase, and Cochrane Database of Systematic Reviews) from January 2010 to May 2021. ELIGIBILITY CRITERIA: Systematic reviews and meta-analyses reporting on the effectiveness of the Chronic Care Model (CCM), collaborative/integrated care, and other chronic disease management models. DATA: Target diseases, model components used (n = 11), and six outcomes (disease-specific, generic health-related quality of life and functioning, adherence, health knowledge, patient satisfaction, and cost/health care use). SYNTHESIS: Narrative synthesis, including proportion of reviews documenting outcome benefits. RESULTS: More than half (55%) of the 186 eligible reviews focused on collaborative/integrated care models, with 25% focusing on CCM and 20% focusing on other chronic disease management models. The most common health conditions were diabetes (n = 22), depression (n = 16), heart disease (n = 12), aging (n = 11), and kidney disease (n = 8). Other single medical conditions were the focus of 22 reviews, multiple medical conditions of 59 reviews, and other or mixed mental health/behavioral conditions of 20 reviews. Some type of quality rating for individual studies was conducted in 126 (68%) of the reviews. Of reviews that assessed particular outcomes, 80% reported disease-specific benefits, and 57% to 72% reported benefits for the other five types of outcomes. Outcomes did not differ by the model category, number or type of components, or target disease. CONCLUSIONS: Although there is a paucity of evidence for TBI per se, care model components proven effective for other chronic diseases may be adaptable for chronic TBI care.

Comparable Minimally Important Differences and Responsiveness of Brief Pain Inventory and PEG Pain Scales across 6 Trials.

The 3-item pain intensity (P), interference with the enjoyment of life (E), and interference with general activity (G), or PEG, has become one of the most widely used measures of pain severity and interference. The minimally important differences (MID) and responsiveness of the PEG are essential metrics for solidifying its role in research and clinical care. The current study aims to establish the MID and responsiveness of the PEG by synthesizing data from 1,710 participants across 6 controlled trials. MIDs were estimated using absolute score changes among individuals reporting their pain was "a little better" on a retrospective global change anchor as well as distribution-based estimates using standard deviation thresholds and 1 and 2 standard errors of measurement. Responsiveness was assessed using standardized response means, area under the curve, and treatment effect sizes. MID estimates for the PEG ranged from 0.60 to 1.1 when using 0.35 SD, and 0.78 to 1.22 using 1 standard error of measurement. MID estimates using the global anchor had somewhat more variability but most estimates ranged from 1.0 to 1.75. Responsiveness effect sizes were generally large (>.80) for standardized response means and moderate (>.50) for treatment effect. Similarly, the most area under the curve values demonstrated an acceptable level of scale responsiveness (≥.70). Importantly, MID estimates and responsiveness of the PEG and BPI scales were largely comparable when aggregating data across trials. Our synthesis indicates that 1 point is a reasonable MID estimate on these 0- to 10-point pain scales, with 2 points being an upper bound. PERSPECTIVE: This article synthesizes data from 6 clinical trials to establish the minimally important difference (MID) and responsiveness of the 3-item PEG pain scale. The PEG demonstrated good responsiveness, and 1 to 2 points proved to be reasonable estimates for the lower and upper bounds of the MID.

Examining the Veterans Health Administration whole health model of care within the context of posttraumatic stress disorder.

The Veterans Health Administration's Whole Health system of care focuses on offering veterans holistic health approaches and tailoring health care to individual's goals and preferences. The present study assessed factors associated with Whole Health use and its potential benefits among veterans with posttraumatic stress disorder (PTSD) receiving Veterans Health Administration care. This cohort study used retrospective electronic health records combined with survey data (baseline, 6 months) from 18 Veterans Affairs Whole Health pilot implementation sites and compared patient-reported outcomes between veterans who used Whole Health services versus those who did not, among veterans with (n = 1,326) and without (n = 3,243) PTSD. Patient-reported outcomes assessed were pain (PEG), patient-reported outcomes measurement information system physical and mental health functioning, and a one-item global meaning and purpose assessment. Veterans with PTSD were more likely to have used Whole Health (38% vs. 21%) than those without PTSD. Veterans with PTSD who used Whole Health services experienced small improvements over 6 months in physical (Cohen's d = .12) and mental (Cohen's d = .15) health functioning. Veterans without PTSD who used Whole Health services experienced small improvements in physical health (Cohen's d = .09) but not mental health (Cohen's d = .04). Veterans with PTSD were frequently connected with Whole Health services even though implementation efforts were not explicitly focused on reaching this population. Results suggest Whole Health may play an important role in how veterans with PTSD engage with health care. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Physician views of artificial intelligence in otolaryngology and rhinology: A mixed methods study.

Objective: The study aimed to investigate otolaryngologists' knowledge, trust, acceptance, and concerns with clinical applications of artificial intelligence (AI). Methods: This study used mixed methods with survey and semistructured interviews. Survey was e-mailed to American Rhinologic Society members, of which a volunteer sample of 86 members responded. Nineteen otolaryngologists were purposefully recruited and interviewed until thematic saturation was achieved. Results: Seventy-six respondents (10% response rate) completed the majority of the survey: 49% worked in academic settings and 43% completed residency 10 or fewer years ago. Of 19 interviewees, 58% worked in academic settings, and 47% completed residency 10 or fewer years ago. Familiarity: Only 8% of survey respondents reported having AI training in residency, although 72% had familiarity with general AI concepts; 0 interviewees had personal experience with AI in clinical settings. Expected uses: Of the surveyed otolaryngologists, 82% would use an AI-based clinical decision aid and 74% were comfortable with AI proposing treatment recommendations. However, only 44% of participants would trust AI to identify malignancy and 53% to interpret radiographic images. Interviewees trusted AI for simple tasks, such as labeling septal deviation, more than complex ones, such as identifying tumors. Factors influencing AI adoption: 89% of survey participants would use AI if it improved patient satisfaction, 78% would be willing to use AI if experts and studies validated the technologies, and 73% would only use AI if it increased efficiency. Sixty-one percent of survey respondents expected AI incorporation into clinical practice within 5 years. Interviewees emphasized that AI adoption depends on its similarity to their clinical judgment and to expert opinion. Concerns included nuanced or complex cases, poor design or accuracy, and the personal nature of physician-patient relationships. Conclusion: Few physicians have experience with AI technologies but expect rapid adoption in the clinic, highlighting the urgent need for clinical education and research. Otolaryngologists are most receptive to AI "augmenting" physician expertise and administrative capacity, with respect for physician autonomy and maintaining relationships with patients. Level of Evidence: Level VI, descriptive or qualitative study.

P4 suicidality screener: Literature synthesis and results from two randomized trials.

OBJECTIVE: To synthesize the literature on use of the P4 suicidality screener since its introduction in 2010 and to summarize results from 2 randomized clinical trials. METHOD: A PubMed search was conducted from 2010 to 2023 to retrieve studies reporting on use of the P4. Also, data was extracted from the CAMMPS and SCOPE trials in which the P4 was periodically administered over 12 months when the 9th item of the PHQ-9 was endorsed. RESULTS: A total of 21 research studies using the P4 were found, of which 12 provided some data on P4 findings. Additionally, another 7 protocol papers reported intended use of the P4 as a study measure. In our 2 trials, the 9th item was endorsed 259 (12.5%) times in 2068 administrations of the PHQ-9. Higher risk suicidal ideation was identified in 4.1% (12/294) of CAMMPS participants and 2.8% (7/250) of SCOPE participants. No suicide attempts occurred over the 12 months in either trial. CONCLUSIONS: The P4 has had moderate use as a brief suicidality screener and is an efficient way to identify the small proportion of depressed patients with higher risk suicidality. Studies comparing the P4 with other common suicidality screeners would further inform use.

Impact of Pain and Adverse Health Outcomes on Long-term U.S. Testicular Cancer Survivors.

PURPOSE: No study has quantified the impact of pain and other adverse health outcomes (AHOs) on global physical/mental health in long-term U.S. testicular cancer survivors (TCS) or evaluated patient-reported functional impairment due to pain. METHODS: TCS given cisplatin-based chemotherapy completed validated surveys, including PROMIS-v1.2 Global-Physical-and-Mental-Health, PROMIS pain questionnaires, and others. Multivariable linear regression examined relationships between 25 AHOs with Global-Physical (GPH) and Mental-Health (GMH) scores, and Pain-Interference Scores. AHOs with ß > 2 are clinically important and reported below. RESULTS: Among 358 TCS [median age: 46 (IQR: 38-53); median time-since-chemotherapy: 10.7 years; IQR = 7.2-16.0)], median AHO number was 5 (IQR = 3-7). 12% TCS had ≥10 AHOs, and 19% reported chemotherapy-induced neuropathic pain. Increasing AHO numbers were associated with decreases in physical and mental health (P < 0.0001 each). In multivariable analyses, chemotherapy-induced neuropathic pain (ß = -3.72; P = 0.001), diabetes (ß = -4.41; P = 0.037), obesity (ß = -2.01; P = 0.036) and fatigue (ß = -8.58; P < 0.0001) were associated with worse GMH, while being married/living-as-married benefitted GMH (ß = 3.63; P = 0.0006). Risk factors for pain-related functional-impairment included lower extremity location (ß = 2.15; P = 0.04) and concomitant peripheral artery disease (ß = 4.68; P < 0.001). GPH-score reductions were associated with diabetes (ß = -3.81; P = 0.012), balance/equilibrium problems (ß = -3.82; P = 0.003), cognitive-dysfunction (ß = -4.43; P < 0.0001), obesity (ß = -3.09; P < 0.0001), peripheral-neuropathy-score (ß = -2.12; P < 0.0001), and depression (ß = -3.17; P < 0.0001). CONCLUSIONS: TCS suffer AHOs that negatively impact long-term GMH, GPH, and pain-related functional-status. IMPLICATIONS FOR CANCER SURVIVORS: Clinically important factors associated with worse physical/mental health identify TCS requiring closer monitoring, counseling, and interventions. Chemotherapy-induced neuropathic pain must be addressed, given its detrimental impact on patient-reported functional-status and mental health 10+ years after treatment.

Validation of the German Version of the P4 Suicidality Tool.

For general practitioners (GPs), it may be challenging to assess suicidal ideation (SI) in patients. Although promising instruments exist for the use in primary care, only a few have been validated in German. The objectives of this study were to examine the validity of the brief P4 screener for assessing SI in a cross-sectional study including outpatients. Inclusion criteria were a PHQ-9 score ≥ 10 or an affirmative answer to its SI item. Construct validity of the P4 was examined by comparison with the four-item Suicide Behaviors Questionnaire-Revised (SBQ-R), the PHQ-9 (convergent), and the positive mental health (PMH) scale (divergent). The study sample included 223 patients (mean age 47.61 ± 15 years; 61.9% women) from 20 primary care practices (104 patients) and 10 psychiatric/psychotherapeutic clinics (119 patients). The first three items of the P4 correlate positively with most of the four items of the reference standard SBQ-R (convergent validity); the fourth item of the P4 (preventive factors) correlates significantly with the PMH scale. The most common preventive factor (67%) is family or friends. The German P4 screener can be used to assess SI in outpatient care. It explores preventive or protective factors of suicide, which may support the GP's decision on treatment. We recommend a further clinical interview for patients flagged by P4 assessment in order to more formally assess suicidal risk.

Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis.

Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a disabling long-term condition of unknown cause. The National Institute for Health and Care Excellence (NICE) published a guideline in 2021 that highlighted the seriousness of the condition, but also recommended that graded exercise therapy (GET) should not be used and cognitive-behavioural therapy should only be used to manage symptoms and reduce distress, not to aid recovery. This U-turn in recommendations from the previous 2007 guideline is controversial.We suggest that the controversy stems from anomalies in both processing and interpretation of the evidence by the NICE committee. The committee: (1) created a new definition of CFS/ME, which 'downgraded' the certainty of trial evidence; (2) omitted data from standard trial end points used to assess efficacy; (3) discounted trial data when assessing treatment harm in favour of lower quality surveys and qualitative studies; (4) minimised the importance of fatigue as an outcome; (5) did not use accepted practices to synthesise trial evidence adequately using GRADE (Grading of Recommendations, Assessment, Development and Evaluations trial evidence); (6) interpreted GET as mandating fixed increments of change when trials defined it as collaborative, negotiated and symptom dependent; (7) deviated from NICE recommendations of rehabilitation for related conditions, such as chronic primary pain and (8) recommended an energy management approach in the absence of supportive research evidence.We conclude that the dissonance between this and the previous guideline was the result of deviating from usual scientific standards of the NICE process. The consequences of this are that patients may be denied helpful treatments and therefore risk persistent ill health and disability.

An Umbrella Review of Self-Management Interventions for Health Conditions With Symptom Overlap With Traumatic Brain Injury.

OBJECTIVE: To synthesize evidence for the effectiveness of self-management interventions for chronic health conditions that have symptom overlap with traumatic brain injury (TBI) in order to extract recommendations for self-management intervention in persons with TBI. DESIGN: An umbrella review of existing systematic reviews and/or meta-analyses of randomized controlled trials or nonrandomized studies targeting self-management of chronic conditions and specific outcomes relevant to persons with TBI. METHOD: A comprehensive literature search of 5 databases was conducted using PRISMA guidelines. Two independent reviewers conducted screening and data extraction using the Covidence web-based review platform. Quality assessment was conducted using criteria adapted from the Assessing the Methodological Quality of Systematic Reviews-2 (AMSTAR-2). RESULTS: A total of 26 reviews met the inclusion criteria, covering a range of chronic conditions and a range of outcomes. Seven reviews were of moderate or high quality and focused on self-management in persons with stroke, chronic pain, and psychiatric disorders with psychotic features. Self-management interventions were found to have positive effects on quality of life, self-efficacy, hope, reduction of disability, pain, relapse and rehospitalization rates, psychiatric symptoms, and occupational and social functioning. CONCLUSIONS: Findings are encouraging with regard to the effectiveness of self-management interventions in patients with symptoms similar to those of TBI. However, reviews did not address adaptation of self-management interventions for those with cognitive deficits or for populations with greater vulnerabilities, such as low education and older adults. Adaptations for TBI and its intersection with these special groups may be needed.

Indiana Palliative Excellence in Alzheimer's Care Efforts (IN-PEACE): Protocol for a randomized controlled trial in persons with advanced dementia.

BACKGROUND: Dementia affects 6.5 million persons in the U.S., a number which is expected to double by 2060. More than half of persons with dementia die at home, creating an enormous burden for both patients and caregivers. However, there is a paucity of research on community-based palliative care interventions for advanced dementia. OBJECTIVES: The Indiana Palliative Excellence in Alzheimer's Care Efforts (IN-PEACE) study is a randomized trial to test the effectiveness of a collaborative predominantly telehealth home-based intervention for persons with advanced dementia residing in the community and their primary, informal caregivers. The primary aim is to determine if this palliative care focused supportive intervention is superior to usual care in reducing neuropsychiatric symptoms of dementia. Secondarily, intervention effects on other patient symptoms (e.g., pain), caregiver distress and depression, and emergency department (ED)/hospitalization events are examined. METHODS: The study population consists of participant pairs comprising a person with dementia and their primary, informal caregiver. The person with dementia must be ≥65 years old, with a clinical diagnosis of moderate to severe dementia. A total of 201 demographically and socioeconomically diverse participant pairs have been randomized to the IN-PEACE care coordination intervention (n = 99) or usual care (n = 102). Outcome assessments are conducted at baseline, and quarterly for up to 2 years (3, 6, 9, 12, 15, 18, 21, and 24 months). DISCUSSION: IN-PEACE results will inform care for the large number of individuals with advanced dementia residing in the community and enable informal caregivers to provide effective home-based care. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT03773757.

Utilization of Whole Health and Longitudinal Outcomes After Screening Positive for Possible Depression Documented in Veterans Health Administration's Electronic Health Record.

Objectives: Depression is common among Veterans. Veterans Health Administration (VHA) is transforming into a Whole Health system of care that includes holistic treatment planning, well-being programs, and health coaching. This evaluation explores the impact of Whole Health on improving symptoms of depression among Veterans who screen positive for possible depression diagnosis. Materials and Methods: We examined a cohort of Veterans who started using Whole Health after screening positive for possible depression (having a PHQ-2 score ≥3) at 18 VA Whole Health sites. We compared Whole Health users with non-Whole Health users on their follow-up PHQ-2 scores (9-36 months after baseline), using propensity score matching with multivariable regression to adjust for baseline differences. Results: Of the 13,559 Veterans screening positive for possible depression on the PHQ-2 and having a follow-up PHQ-2, 902 (7%) began using Whole Health after their initial positive PHQ-2. Whole Health users at baseline were more likely than non-Whole Health users to have posttraumatic stress disorder or acute stress (43% vs. 29%), anxiety (22% vs. 12%), ongoing opioid use (14% vs. 8%), recent severe pain scores (15% vs. 8%), or obesity (51% vs. 40%). Both groups improved at follow-up, with mean PHQ-2 scores decreasing from 4.49 to 1.77 in the Whole Health group and 4.46 to 1.46 in the conventional care group, with the Whole Health group significantly higher at follow-up. Also, the proportion continuing to screen positive at follow-up trended higher in the Whole Health group (26% and 21%, respectively). Conclusions: After screening positive for depression, Veterans with more mental and physical health conditions were more likely to subsequently use Whole Health services, suggesting that Whole Health is becoming a tool used in VHA to address the needs of complex patients. Nevertheless, the Whole Health group did not improve compared to the Conventional Care group. Results add to the growing body of literature that Whole Health services may play an important role among patients with complex symptom presentations by promoting self-management of symptoms and targeting "what matters most" to Veterans.

Prevalence, Severity, and Co-Occurrence of SPPADE Symptoms in 31,866 Patients With Cancer.

OBJECTIVES: To examine the prevalence, severity, and co-occurrence of SPPADE symptoms as well as their association with cancer type and patient characteristics. BACKGROUND: The SPPADE symptoms (sleep disturbance, pain, physical function impairment, anxiety, depression, and low energy /fatigue) are prevalent, co-occurring, and undertreated in oncology and other clinical populations. METHODS: Baseline SPPADE symptom data were analyzed from the E2C2 study, a stepped wedge pragmatic, population-level, cluster randomized clinical trial designed to evaluate a guideline-informed symptom management model targeting the six SPPADE symptoms. Symptom prevalence and severity were measured with a 0-10 numeric rating (NRS) scale for each of the six symptoms. Prevalence of severe (NRS ≥ 7) and potential clinically relevant (NRS ≥ 5) symptoms as well as co-occurrence of clinical symptoms were determined. Distribution-based methods were used to estimate the minimally important difference (MID). Associations of cancer type and patient characteristics with a SPPADE composite score were analyzed. RESULTS: A total of 31,886 patients were assessed for SPPADE symptoms prior to, during, or soon after an outpatient medical oncology encounter. The proportion of patients with a potential clinically relevant symptom ranged from 17.5% for depression to 33.4% for fatigue. Co-occurrence of symptoms was high, with the proportion of patients with three or more additional clinically relevant symptoms ranging from 45.2% for fatigue to 68.6% for depression. The summed SPPADE composite score demonstrated good internal reliability (Cronbach's alpha of 0.86), with preliminary MID estimates of 4.1-4.3. Symptom burden differed across several types of cancer but was generally similar across most sociodemographic characteristics. CONCLUSION: The high prevalence and co-occurrence of SPPADE symptoms in patients with all types of cancer warrants clinical approaches that optimize detection and management.

A patient-centered nurse-supported primary care-based collaborative care program to treat opioid use disorder and depression: Design and protocol for the MI-CARE randomized controlled trial.

BACKGROUND: Opioid use disorder (OUD) contributes to rising morbidity and mortality. Life-saving OUD treatments can be provided in primary care but most patients with OUD don't receive treatment. Comorbid depression and other conditions complicate OUD management, especially in primary care. The MI-CARE trial is a pragmatic randomized encouragement (Zelen) trial testing whether offering collaborative care (CC) to patients with OUD and clinically-significant depressive symptoms increases OUD medication treatment with buprenorphine and improves depression outcomes compared to usual care. METHODS: Adult primary care patients with OUD and depressive symptoms (n ≥ 800) from two statewide health systems: Kaiser Permanente Washington and Indiana University Health are identified with computer algorithms from electronic Health record (EHR) data and automatically enrolled. A random sub-sample (50%) of eligible patients is offered the MI-CARE intervention: a 12-month nurse-driven CC intervention that includes motivational interviewing and behavioral activation. The remaining 50% of the study cohort comprise the usual care comparison group and is never contacted. The primary outcome is days of buprenorphine treatment provided during the intervention period. The powered secondary outcome is change in Patient Health Questionnaire (PHQ)-9 depression scores. Both outcomes are obtained from secondary electronic healthcare sources and compared in "intent-to-treat" analyses. CONCLUSION: MI-CARE addresses the need for rigorous encouragement trials to evaluate benefits of offering CC to generalizable samples of patients with OUD and mental health conditions identified from EHRs, as they would be in practice, and comparing outcomes to usual primary care. We describe the design and implementation of the trial, currently underway. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05122676. Clinical trial registration date: November 17, 2021.

The use of peer support groups for emergency physicians during the COVID-19 pandemic.

Objective: To test the feasibility, receptivity, and preliminary effectiveness of peer support groups for emergency medicine physicians during the COVID-19 pandemic and gain a better understanding of their experiences with peer support. Methods: This pilot study used a quasi-experimental design to assess change in symptoms of distress, anxiety, depression and burn-out before and after participating in a virtual, group-based peer support intervention for a duration of 8 weeks. Pre-post change analyses were performed using two-sided, paired t tests. Feasibility was measured by attendance data to demonstrate the use of the intervention. Receptivity was measured using a global change rating and net promoter score at the end of each session and 8-week period, respectively. During the final session, qualitative data on physician experience was collected and then analyzed using conventional content analysis. Results: Twenty-four emergency medicine physicians participated in the pilot study. The attendance goal was met by 20 (24, 83%) physicians and 19 (22, 86%) physicians reported they would recommend peer support groups to a friend of colleague. Positive standardized response mean effect sizes indicated modest improvement in nine of 12 symptom measurements with marginal significance (p < 0.10) for improvement in guilt [20, Effect Size (ES) = 0.45] and depression (21, ES = 0.39). Qualitative findings revealed high overall benefit with few adverse impacts of participation. Conclusions: Results demonstrate high physician receptivity, feasibility, and benefit from participation in peer support groups. Promising signs of improvement in distress, anxiety, depression, and burn out symptoms warrant additional studies with larger sample sizes and more robust research designs to establish the evidence base for peer support in the physician population.

Pragmatic cluster randomized trial to evaluate effectiveness and implementation of EHR-facilitated collaborative symptom control in cancer (E2C2): addendum.

We previously described the hypotheses, outcomes, design, and analysis for E2C2, a pragmatic stepped-wedge trial to assess an intervention to improve symptom control in patients with cancer. Subsequent consideration of the design and cohort led to the addition of a second primary hypothesis. This article describes and presents the rationale for this second hypothesis. This addendum also details a revised analytic approach, necessitated by inconsistencies in the original analytic plan. The design, outcomes, and other aspects of the protocol remain unchanged.

Patient-Reported Functional Impairment Due to Hearing Loss and Tinnitus After Cisplatin-Based Chemotherapy.

PURPOSE: Cisplatin is widely used and highly ototoxic, but patient-reported functional impairment because of cisplatin-related hearing loss (HL) and tinnitus has not been comprehensively evaluated. PATIENTS AND METHODS: Testicular cancer survivors (TCS) given first-line cisplatin-based chemotherapy completed validated questionnaires, including the Hearing Handicap Inventory for Adults (HHIA) and Tinnitus Primary Function Questionnaire (TPFQ), each of which quantifies toxicity-specific functional impairment. Spearman correlations evaluated associations between HL and tinnitus severity and level of functional handicap quantified with the HHIA and TPFQ, respectively. Associations between HL or tinnitus and five prespecified adverse health outcomes (cognitive dysfunction, fatigue, depression, anxiety, and overall health) were evaluated. RESULTS: HL and tinnitus affected 137 (56.4%) and 147 (60.5%) of 243 TCS, respectively. Hearing aids were used by 10% TCS (14/137). Of TCS with HL, 35.8% reported clinically significant functional impairment. Severe HHIA-assessed functional impairment was associated with cognitive dysfunction (odds ratio [OR], 10.62; P < .001), fatigue (OR, 5.48; P = .003), and worse overall health (OR, 0.19; P = .012). Significant relationships existed between HL severity and HHIA score, and tinnitus severity and TPFQ score (P < .0001 each). TCS with either greater hearing difficulty or more severe tinnitus were more likely to report cognitive dysfunction (OR, 5.52; P = .002; and OR, 2.56; P = .05), fatigue (OR, 6.18; P < .001; and OR, 4.04; P < .001), depression (OR, 3.93; P < .01; and OR, 3.83; P < .01), and lower overall health (OR, 0.39; P = .03; and OR, 0.46; P = .02, respectively). CONCLUSION: One in three TCS with HL report clinically significant functional impairment. Follow-up of cisplatin-treated survivors should include routine assessment for HL and tinnitus. Use of the HHIA and TPFQ permit risk stratification and referral to audiologists as needed, since HL adversely affects functional status and is the single largest modifiable risk factor for cognitive decline and dementia in the general population.