Transitions From Heart Disease to Cancer as the Leading Cause of Death in US States, 1999-2016.

INTRODUCTION: Heart disease has been the leading cause of death in the United States since 1910 and cancer the second leading cause of death since 1933. However, cancer emerged recently as the leading cause of death in many US states. The objective of this study was to provide an in-depth analysis of age-standardized annual state-specific mortality rates for heart disease and cancer. METHODS: We used population-based mortality data from 1999 through 2016 to compare 2 underlying cause-of-death categories: diseases of heart (International Classification of Diseases, 10th Revision [ICD-10] codes I00-I09, I11, I13, and I20-I51) and malignant neoplasms (ICD-10 codes C00-C97). We calculated age-standardized annual state-specific mortality rate ratios (MRRs) as heart disease mortality rate divided by cancer mortality rate. RESULTS: In 1999, age-standardized heart disease mortality exceeded that for cancer in all 50 states. Median state-specific MRR in 1999 was 1.26 (interquartile range [IQR], 1.17-1.34; range, 1.03-1.56), indicating predominance of heart disease mortality nationwide. Median state-specific MRR decreased annually through 2010, reaching a low of 1.00 (IQR, 0.95-1.07; range, 0.71-1.25), indicating that predominance of heart disease mortality prevailed in approximately half of states. Median state-specific MRR increased to 1.03 (IQR, 0.97-1.12; range, 0.77-1.31) in 2016. In 2016, age-standardized cancer mortality exceeded that for heart disease in 19 states. State-level transitions were most apparent for people aged 65 to 84 and affected men, women, and all racial/ethnic groups. CONCLUSION: State-level data indicated heterogeneity across US states in the predominance of heart disease mortality relative to cancer mortality. Timing and magnitude of transitions toward cancer mortality predominance varied by state.

The COMiT'ID Study: Developing Core Outcome Domains Sets for Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults.

Subjective tinnitus is a chronic heterogeneous condition that is typically managed using intervention approaches based on sound devices, psychologically informed therapies, or pharmaceutical products. For clinical trials, there are currently no common standards for assessing or reporting intervention efficacy. This article reports on the first of two steps to establish a common standard, which identifies what specific tinnitus-related complaints ("outcome domains") are critical and important to assess in all clinical trials to determine whether an intervention has worked. Using purposive sampling, 719 international health-care users with tinnitus, health-care professionals, clinical researchers, commercial representatives, and funders were recruited. Eligibility was primarily determined by experience of one of the three interventions of interest. Following recommended procedures for gaining consensus, three intervention-specific, three-round, Delphi surveys were delivered online. Each Delphi survey was followed by an in-person consensus meeting. Viewpoints and votes involved all stakeholder groups, with approximately a 1:1 ratio of health-care users to professionals. "Tinnitus intrusiveness" was voted in for all three interventions. For sound-based interventions, the minimum set included "ability to ignore," "concentration," "quality of sleep," and "sense of control." For psychology-based interventions, the minimum set included "acceptance of tinnitus," "mood," "negative thoughts and beliefs," and "sense of control." For pharmacology-based interventions, "tinnitus loudness" was the only additional core outcome domain. The second step will next identify how those outcome domains should best be measured. The uptake of these intervention-specific standards in clinical trials will improve research quality, enhance clinical decision-making, and facilitate meta-analysis in systematic reviews.

Defining and evaluating novel procedures for involving patients in Core Outcome Set research: creating a meaningful long list of candidate outcome domains.

PLAIN ENGLISH SUMMARY: Outcome domains are aspects of a condition that matter to patients and clinicians and can be measured to assess treatment effects. For tinnitus, examples include 'tinnitus loudness' and 'ability to concentrate'. This study focuses on the first stage of agreeing which outcome domains should be measured in all clinical trials of tinnitus. Crucially, it involves identifying outcome domains, prior to a voting process. This article describes how we effectively involved patients in that study design process, and reflects on the impact of their input.The study first compiled a long list of all possible outcome domains before asking interested parties, including patients, to vote which ones to include. Ensuring patients fully participate in this process holds unique challenges as it can be long, repetitive and its purpose far removed from their needs. These challenges may be addressed by involving patients in designing the research. There is evidence that other research teams are doing this, but its reporting is not detailed enough to guide others. Our paper seeks to address this.We describe how we involved patients (people living with tinnitus) in creating a long list of outcome domains that we included in our study. We also reflect on the benefits this brought. Two patients partnered with us in designing the survey. We also consulted an independent patient review panel. Involving patients reduced the list of domains included in the survey and made domain names and associated descriptions clearer. Our resulting survey performed well in recruiting and retaining patients as participants. ABSTRACT: Background Tinnitus is a complex audiological condition affecting many different domains of everyday life. Clinical trials of tinnitus interventions measure and report those outcome domains inconsistently and this hinders direct comparison between study findings. To address this problem, an ongoing project is developing a Core Outcome Set; an agreed list of outcome domains to be measured and reported in all future trials. Part of this project uses a consensus methodology ('Delphi' survey), whereby all relevant stakeholders identify important and critical outcome domains from a long list of candidates. This article addresses a gap in the patient involvement literature by describing and reflecting on our involvement of patients to create a meaningful long list of candidate outcome domains.Methods Two Public Research Partners with lived experience of tinnitus reviewed an initial list of 124 outcome domains over two face-to-face workshops. With the Study Management Team, they interpreted each candidate outcome domain and generated a plain language description. Following this, the domain names and descriptions underwent an additional lay review by 14 patients and 5 clinical experts, via an online survey platform.Results Insights gained from the workshops and survey feedback prompted substantial, unforeseen modifications to the long list. These included the reduction of the number of outcome domains (from 124 to 66) via the exclusion of broad concepts and consolidation of equivalent domains or domains outside the scope of the study. Reviewers also applied their lived experience of tinnitus to bring clarity and relevance to domain names and plain language descriptions. Four impacts on the Delphi survey were observed: recruitment exceeded the target by 171%, there were equivalent numbers of patient and professional participants (n = 358 and n = 312, respectively), feedback was mostly positive, and retention was high (87%).Conclusions Patient involvement was an integral and transformative step of the study design process. Patient involvement was impactful because the online Delphi survey was successful in recruiting and retaining participants, and there were many comments about a positive participatory experience. Seven general methodological features are highlighted which fit with general principles of good patient involvement. These can benefit other Core Outcome Set developers.

Core Outcome Domains for early phase clinical trials of sound-, psychology-, and pharmacology-based interventions to manage chronic subjective tinnitus in adults: the COMIT'ID study protocol for using a Delphi process and face-to-face meetings to establish consensus.

BACKGROUND: The reporting of outcomes in clinical trials of subjective tinnitus indicates that many different tinnitus-related complaints are of interest to investigators, from perceptual attributes of the sound (e.g. loudness) to psychosocial impacts (e.g. quality of life). Even when considering one type of intervention strategy for subjective tinnitus, there is no agreement about what is critically important for deciding whether a treatment is effective. The main purpose of this observational study is, therefore to, develop Core Outcome Domain Sets for the three different intervention strategies (sound, psychological, and pharmacological) for adults with chronic subjective tinnitus that should be measured and reported in every clinical trial of these interventions. Secondary objectives are to identify the strengths and limitations of our study design for recruiting and reducing attrition of participants, and to explore uptake of the core outcomes. METHODS: The 'Core Outcome Measures in Tinnitus: International Delphi' (COMIT'ID) study will use a mixed-methods approach that incorporates input from health care users at the pre-Delphi stage, a modified three-round Delphi survey and final consensus meetings (one for each intervention). The meetings will generate recommendations by stakeholder representatives on agreed Core Outcome Domain Sets specific to each intervention. A subsequent step will establish a common cross-cutting Core Outcome Domain Set by identifying the common outcome domains included in all three intervention-specific Core Outcome Domain Sets. To address the secondary objectives, we will gather feedback from participants about their experience of taking part in the Delphi process. We aspire to conduct an observational cohort study to evaluate uptake of the core outcomes in published studies at 7 years following Core Outcome Set publication. DISCUSSION: The COMIT'ID study aims to develop a Core Outcome Domain Set that is agreed as critically important for deciding whether a treatment for subjective tinnitus is effective. Such a recommendation would help to standardise future clinical trials worldwide and so we will determine if participation increases use of the Core Outcome Set in the long term. TRIAL REGISTRATION: This project has been registered (November 2014) in the database of the Core Outcome Measures in Effectiveness Trials (COMET) initiative.