Multinational survey of chiropractic patients: reasons for seeking care

This is the publisher's version, copyright by the Canadian Chiropractic Association.This study explores the extent to which consumers seek wellness care when choosing chiropractors whose practice methods are known to include periodic evaluative and interventional methods to maintain wellness and prevent illness. Methods: Using an international convenience sample of Sacro-Occipital Technique (SOT) practitioners, 1316 consecutive patients attending 27 different chiropractic clinics in the USA, Europe and Australia completed a one-page survey on intake to assess reason for seeking care. A forced choice response was obtained characterizing the patient’s reason for seeking chiropractic care. Results: More than 40% of chiropractic patient visits were initiated for the purposes of health enhancement and/or disease prevention. Conclusion: Although prudence dictates great caution when generalizing from this study, if confirmed by subsequent research among other similar cohorts, the present results may lend support to continued arguments of consumer demand for a more comprehensive paradigm of chiropractic care, beyond routine musculoskeletal complaints, that conceptualizes the systemic, nonspecific effects of the chiropractic encounter in much broader terms

Development and validation of the Ulcerative Colitis patient-reported outcomes signs and symptoms (UC-pro/SS) diary

Abstract Background The clinical course of ulcerative colitis (UC) and the effects of treatment are assessed through patient-reported signs and symptoms (S&S), and endoscopic evidence of inflammation. The Ulcerative Colitis Patient-Reported Outcomes Signs and Symptoms (UC-PRO/SS) measure was developed to standardize the quantification of gastrointestinal S&S of UC in clinical trials through direct report from patient ratings. Design The UC-PRO/SS was developed by collecting data from concept elicitation (focus groups, and individual interviews), then refined through a process of cognitive interviews of 57 UC patients. Measurement properties, including item-level statistics, scaling structure, reliability, and validity, were evaluated in an observational, four-week study of adults with mild to severe UC (N = 200). Results Findings from qualitative focus groups and interviews identified nine symptom items covering bowel and abdominal symptoms. The final UC-PRO/SS daily diary includes two scales: Bowel S&S (six items) and Abdominal Symptoms (three items), each scored separately. Each scale showed evidence of adequate reliability (α = 80 and 0.66, respectively); reproducibility (intraclass correlation coefficient = 0.81, 0.71) and validity, including moderate-to-high correlations with the Partial Mayo Score (0.79; 0.45) and Inflammatory Bowel Disease Questionnaire (IBDQ) total score (− 0.70; − 0.61). Scores discriminated by level of disease severity, as defined by the Partial Mayo Score, Patient Global Rating, and Clinician Global Rating (p < 0.0001). Conclusions Results suggest that the UC-PRO/SS is a reliable and valid measure of gastrointestinal symptom severity in UC patients. Additional longitudinal data are needed to evaluate the ability of the UC-PRO/SS scores to detect responsiveness and inform the selection of responder definitions.https://deepblue.lib.umich.edu/bitstream/2027.42/143869/1/41687_2018_Article_49.pd

Effects of omecamtiv mecarbil on symptoms and health-related quality of life in patients with chronic heart failure: results from the COSMIC-HF study

Background: Chronic HF with reduced ejection fraction (HFrEF) impairs health related quality of life (HRQL). Omecamtiv mecarbil, a novel activator of cardiac myosin, improves left ventricular systolic function and remodeling and reduces natriuretic peptides. We sought to evaluate the effect of omecamtiv mecarbil on symptoms and HRQL in patients with chronic HFrEF and elevated natriuretic peptides enrolled in the COSMIC-HF trial. Methods: Patients (n = 448) were randomized 1:1:1 to placebo, 25 mg of omecamtiv mecarbil twice daily (OM 25 mg), or to pharmacokinetically-guided dose titration (OM-PK) for 20 weeks. The Kansas City Cardiomyopathy Questionnaire (KCCQ) was administered to assess HRQL at baseline, 16 weeks, and 20 weeks. The primary scores of interest were the Total Symptom Score (TSS), Physical Limitation Scale (PLS), and Clinical Summary Score (CSS). Results: Mean change in score from baseline to 20 weeks for the TSS was 5.0 (95%CI: 1.8-8.1) for placebo, 6.6(95%CI: 3.4-9.8) for OM 25 mg (p = 0.32 vs placebo), and 9.9 (95%CI: 6.7-13.0) for OM-PK (p = 0.03 vs placebo); for the PLS, it was 3.1 for placebo (95%CI: -0.3-6.6), 6.0 (95%CI: 3.1-8.9) for OM 25 mg (p=0.12), and 4.3 (95%CI: 0.7-7.9) for OM-PK (p=0.42); for the CSS, it was 4.1 (95%CI: 1.4-6.9) for placebo, 6.3 (95%CI: 3.6-9.0) for OM 25 mg (p=0.19), and 7.0 (95%CI: 4.1-10.0) for OM-PK (p=0.14). Differences between omecamtiv mecarbil and placebo were greater in patients who were more symptomatic at baseline. Conclusions: HRQL as measured by the TSS improved in patients with HFrEF assigned to omecamtiv mecarbil (OM-PK group) relative to placebo. Ongoing trials are prospectively testing whether omecamtiv mecarbil improves symptoms and HRQL in HFrEF

Development and validation of the Crohn’s disease patient-reported outcomes signs and symptoms (CD-PRO/SS) diary

Abstract Background The clinical course of Crohn’s disease (CD) and the effect of its treatment are monitored through patient-reported signs and symptoms (S&S), and endoscopic evidence of inflammation. The Crohn’s Disease Patient-reported Outcomes Signs and Symptoms (CD-PRO/SS) measure was developed to standardize the quantification of gastrointestinal S&S of CD through direct report from patient ratings. Methods The CD-PRO/SS was developed based on data from concept elicitation (focus groups, interviews; n = 29), then refined through cognitive interviews of CD patients (n = 20). Measurement properties, including item-level statistics, scaling structure, reliability, and validity, were examined using secondary analyses of baseline and two-week clinical trial data of adults with moderate-to-severe CD (n = 238). Results Findings from qualitative interviews identified nine S&S items covering bowel and abdominal symptoms. The final CD-PRO/SS daily diary includes two scales: Bowel S&S (three items) and Abdominal Symptoms (three items), each scored separately. Each scale showed evidence of adequate reliability (α = 0.74 and 0.67, respectively); reproducibility (intraclass correlation coefficient > 0.80), and validity, with the last including moderate correlations with the Inflammatory Bowel Disease Questionnaire bowel symptom score and select items (ranging from r = 0.43–0.54). Scores distinguished patients categorized by patient global ratings of disease severity (p < 0.0001). Conclusions Results suggest the CD-PRO/SS is a reliable and valid measure of gastrointestinal symptom severity in CD patients. Additional longitudinal data are needed to evaluate the ability of the CD-PRO/SS scores to detect responsiveness and inform the selection of responder definitions.https://deepblue.lib.umich.edu/bitstream/2027.42/143542/1/41687_2018_Article_44.pd

Development of the chronic obstructive pulmonary disease morning symptom diary (COPD-MSD).

BACKGROUND: The morning tends to be the most difficult time of day for many patients with chronic obstructive pulmonary disease (COPD) when symptoms can limit one's ability to perform even simple activities. Morning symptoms have been linked to higher levels of work absenteeism, thereby increasing the already substantial economic burden associated with COPD. A validated patient-reported outcome (PRO) instrument designed to capture morning symptoms will allow for a more comprehensive approach to the evaluation of treatment benefit in COPD clinical trials. METHODS: A qualitative interview study was conducted among a sample of symptomatic adults with COPD. Concept elicitation interviews (n = 35) were conducted to identify COPD morning symptoms, followed by cognitive interviews (n = 21) to ensure patient comprehension of the items, instructions and response options of the draft COPD Morning Symptom Diary (COPD-MSD). All interview transcript data were coded using ATLAS.ti software for content analysis. RESULTS: Mean age of the concept elicitation and cognitive interview sample was 65.0 years (±7.5) and 62.3 years (±8.3), respectively. The study sample represented the full range of COPD severity (Global Initiative for Chronic Lung Disease [GOLD] classifications I-IV) and included a mix of racial backgrounds, employment status and educational achievement. During the concept elicitation interviews, the three most frequently reported morning symptoms were shortness of breath (n = 35/35; 100 %), phlegm/mucus (n = 31/35; 88.6 %), and cough (n = 30/35; 85.7 %). A group of clinical and instrument development experts convened to review the concept elicitation data and develop the initial 32-item draft COPD-MSD. Cognitive interviews indicated subjects found the draft COPD-MSD to be comprehensive, clear, and easy to understand. The COPD-MSD underwent minor editorial revisions and streamlining based on cognitive interviews and input from the experts to yield the final 19-item daily diary. CONCLUSIONS: This study supports the content validity of the new COPD-MSD and positions the diary for quantitative psychometric testing

Is the EQ-5D fit for purpose in asthma? Acceptability and content validity from the patient perspective

Background The increasing emphasis on patient-reported outcomes in health care decision making has prompted greater rigor in the evidence to support the instruments used. Acceptability and content validity are important properties of any measure to ensure it assesses the relevant aspects of the target concept. The purpose of this study was to evaluate the acceptability and content validity of the EQ-5D 5-Level (EQ-5D-5L) to assess the impact of asthma on patients’ lives. Methods Qualitative interviews were conducted with 40 adults with asthma in the United Kingdom. The first 25 interviews used cognitive-debriefing methods to assess the relevance and acceptability of the EQ-5D-5L and two asthma-specific measures for comparison: an asthma-specific, preference-based measure (the Asthma Quality of Life Utility Index–5 Dimensions) and an Asthma Symptom Diary. The final 15 interviews combined concept elicitation to identify patient-perceived asthma impact, and cognitive debriefing to assess relevance and acceptability of the EQ-5D-5L and the Asthma Symptom Diary. Cognitive-debriefing feedback on the content of the measures was collated and summarized descriptively. The concept-elicitation data were analyzed thematically. Results Participants were aged 20 to 57 years and 62.5% were female. Although some participants expressed positive opinions on aspects of the EQ-5D-5L, only the usual activities dimension was consistently considered relevant to participants’ asthma experiences. The mobility and self-care dimensions prompted strong negative reactions from some participants. Variations in interpretation of the mobility dimension and difficulties with multiple concepts in the pain/discomfort and anxiety/depression dimensions also were noted. Concepts reported by participants as missing included environmental triggers, asthma symptoms, emotions, and sleep. The EQ-5D-5L was the least preferred measure to describe the impact of asthma on participants’ lives. Participants reported shortness of breath and impact on activities as especially salient issues. Conclusions The content of the EQ-5D-5L was poorly aligned with the patient-perceived impact of asthma, and the measure failed to meet basic standards for acceptability and content validity as a measure to assess the impact of asthma from the patient perspective. The shortcomings identified raise concerns regarding the appropriateness of the EQ-5D in asthma and further evaluation is warranted

Multinational survey of chiropractic patients: reasons for seeking care

This is the publisher's version, copyright by the Canadian Chiropractic Association.This study explores the extent to which consumers seek wellness care when choosing chiropractors whose practice methods are known to include periodic evaluative and interventional methods to maintain wellness and prevent illness. Methods: Using an international convenience sample of Sacro-Occipital Technique (SOT) practitioners, 1316 consecutive patients attending 27 different chiropractic clinics in the USA, Europe and Australia completed a one-page survey on intake to assess reason for seeking care. A forced choice response was obtained characterizing the patient’s reason for seeking chiropractic care. Results: More than 40% of chiropractic patient visits were initiated for the purposes of health enhancement and/or disease prevention. Conclusion: Although prudence dictates great caution when generalizing from this study, if confirmed by subsequent research among other similar cohorts, the present results may lend support to continued arguments of consumer demand for a more comprehensive paradigm of chiropractic care, beyond routine musculoskeletal complaints, that conceptualizes the systemic, nonspecific effects of the chiropractic encounter in much broader terms

Estimating asthma control questionnaire (ACQ) scores from claims data

Background: Asthma control is the main focus of treatment guidelines. Valid instruments such as the Asthma Control Questionnaire (ACQ) require prospective survey. These surveys may be challenging for large population health applications. Objective: To develop an algorithm for estimating ACQ-5 scores from commonly available claims data. Methods: Data was derived from four prospective surveys including the ACQ-5 combined with retrospective claims of Kaiser Permanente of Colorado (KPCO) patients. The statistical approach consisted of derivation and validation of a prediction algorithm including medical and pharmacy claims data using stepwise regression elimination. Validation was conducted by estimating mean squared error (MSE) and mean absolute error (MAE) in one hundred split-sample iterations. Ordinary least squares (OLS), Tobit and Median regression were used. Results: There were 2,657 individuals with valid ACQ-5 scores, claims and eligibility at baseline. The following had statistically significant associations with ACQ-5 scores: gender, use of oral corticosteroids and short-acting beta agonists, the number of asthma drug classes, and emergency and outpatient visits. Average MSE and MAE were similar for the estimation and validation samples. Conclusion: This research provides preliminary results of the feasibility of predicting ACQ-5 scores using commonly available medical and pharmacy claims data. The resulting algorithm may facilitate public health and population level analyses of asthma control. Future studies in different populations will be important to validate the algorithm

Asthma in USA: Its impact on health-related quality of life

Objectives: Given the growing prevalence of asthma in USA, it is important to understand its national burden from the patient\u27s perspective. The objective of this research is to examine the national burden of asthma and poor asthma control on health function, health perception and preference-based health-related quality of life (HRQL). Methods: The Medical Expenditure Panel Survey (MEPS), a nationally representative survey, was used to estimate the impact of asthma and indicators of poor asthma control on health function, self-rated health perception and preference-based HRQL using multivariate regression methods controlling for socioeconomic, clinical and demographic characteristics. Two HRQL instruments were used: SF-12v2 Physical Component Scale (PCS-12) and Mental Component Scale (MCS-12); EQ-5D-3L index and visual analogue scale (VAS). Two multivariate regression methods were used, Censored Least Absolute Deviation [EQ-5D-3L and VAS (due to censoring)] and Ordinary Least Squares (OLS) (PCS-12 and MCS-12). Results: After controlling for covariates, asthma resulted in a statistically significant reduction in preference-based HRQL, health perception and physical and mental function (EQ-5D -0.023; VAS -2.21; PCS-12 -2.36; MCS-12 -0.96). Likewise, experiencing an exacerbation in the previous year and using more than three canisters of quick-relief medication in the previous 3 months were both associated with a statistically significant and clinically meaningful reduction in all four measures. Conclusions: Asthma itself and especially indicators of poor asthma control were associated with a deleterious effect on health function, preference-based HRQL and self-perceived health status. Given the prevalence of asthma, poorly controlled asthma constitutes a significant national burden in USA. © 2013 Informa Healthcare USA, Inc