Constructing comparable intimate partner violence indicators across the DHS, MICS, and PMA health surveys.

We construct comparable indicators that measure the prevalence of recent intimate partner violence (IPV) using publicly available, integrated microdata within the IPUMS data collections across many countries. The objective of this work is to increase opportunities for comparative research by leveraging vast quantities of harmonized data. We use consistent and comparable variables that measure domestic violence in international health surveys. The most consistent indicators of domestic violence measure physical, psychological, and sexual IPV in the last 12 months. We imposed a consistent reference period and restricted to a comparable subpopulation where these differed across surveys. Aggregating IPV variables across surveys, without careful attention to question wording and subpopulations, may produce inconsistent measures leading to bias, over- or under-estimation of IPV prevalence, or spurious trends and associations. Using comparable indicators in microdata and studying the level, distribution, and covariates of IPV in multiple settings over time, we can better understand these phenomena and identify effective policy interventions.

Usability validation of the Sensoready® pen in patients with relapsing multiple sclerosis.

Background: The Sensoready® pen is intended for self-administration of subcutaneous 20 mg ofatumumab at home. This human factors summative study assessed the usability of the Sensoready pen in relapsing multiple sclerosis patients. Methods: 32 patients (injection-experienced [n = 17] and injection-naive [n = 15]) across five locations in the USA were asked to complete two simulated injections using the Sensoready pen. Results: In the first and second simulated injections, 90.6 and 96.9% of patients, respectively, successfully delivered a full dose, while 81.3 and 84.4%, respectively, successfully performed the injection without any use errors. Conclusion: The Sensoready pen is safe and effective for its intended use by intended users and in the intended use environment. This pen has a low harm potential and high injection success rate in patients, even without prior training or experience.

Do clinical trials prepare to fail by failing to prepare? An examination of MS trials and recommendations for patient-reported outcome measure selection.

BACKGROUND: Many clinical trials use patient-reported outcome (PRO) measures, which can influence treatment decision-making, drug approval and label claims. Given that many PRO measure options exist, and there are conceptual and contextual complexities with PRO measurement, we aimed to evaluate how and why specific PRO measures have been selected for pivotal multiple sclerosis (MS) clinical trials. Specifically, we aimed to identify the reasons documented for PRO measure selection in contemporary phase III MS disease-modifying treatment (DMT) clinical trials. METHODS: We searched for phase III clinical trials of MS DMTs published between 2015 and 2021 and evaluated trial protocols, or primary publications where available, for PRO measure selection information. Specifically, we examined study documents for their clarification of clinical concepts measured, definitions of concepts measured, explanations of which PRO measures were considered, why specific PRO measures were chosen, and trade-offs in PRO measure selection. RESULTS: We identified 1705 abstracts containing 61 unique phase III MS DMT clinical trials. We obtained and examined 27/61 trial protocols. Six protocols were excluded: four contained no mention of PRO measures and two contained redacted sections preventing adequate assessment, leaving 21 protocols for assessment. For the remaining 34 trials (61-27), we retrieved 31 primary publications; 15 primary publications mentioned the use of a PRO measure. None of the 36 clinical trials that mentioned the use of PRO measures (21 protocols and 15 primary publications) documented clear PRO or clinical outcome assessment (COA) measurement strategies, provided clear justifications for PRO selection, or reasons why specific PRO measures were selected when alternatives existed. CONCLUSION: PRO measure selection for clinical trials is not evidence-based or underpinned by structured systematic approaches. This represents a critical area for study design improvement as PRO measure results directly affect patient care, PRO measurement has conceptual and contextual complexities, and there is a wide range of options when selecting a PRO measure. We recommend trial designers use formal approaches for PRO measure selection to ensure PRO measurement-based decisions are optimised. We provide a simple, logical, five-stage approach for PRO measure selection in clinical trials.

Measuring Fatigue in Multiple Sclerosis: There may be Trouble Ahead.

INTRODUCTION: Poorly developed patient-reported outcome measures (PROs) risk type-II errors (i.e. false negatives) in clinical trials, resulting in erroneous failure to achieve trial endpoints. Validity is a fundamental requirement of fit-for-purpose PROs, with the main determinant of validity being the PROs items, i.e. content validity. Here, we sought to identify fatigue PRO instruments used in multiple sclerosis (MS) studies and to assess the extent to which their development satisfied current content validity standards. METHODS: We searched Embase® and Medline® for MS studies using fatigue-based PROs. Abstracts were screened, PROs identified, and their relevant development papers assessed against seven Consensus Standards for Measurement Instruments (COSMIN) criteria for content development. RESULTS: From 3814 abstracts, 18 fatigue PROs met our inclusion criteria. Most PROs did not satisfy at least one COSMIN content validity standard. Frequent omissions during PRO development include: clearly defined constructs; conceptual frameworks; qualitative research in representative samples; and literature reviews. PRO development quality has improved significantly since FDA guidance was published (U = 10.0, p = 0.02). However, scatterplots and correlations between PRO COSMIN scores and citation frequency (rho = - 0.62) and clinical trials usage (rho =  + 0.18) implied that PRO quality is unrelated to choice. COSMIN scores implied that the Fatigue Symptoms and Impact Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS) and Neurological Fatigue Index-Multiple Sclerosis (NFI-MS) had the strongest evidence for adequate content validity. CONCLUSION: Most existing fatigue PROs do not meet COSMIN content validity requirements. Although two PROs scored well on aggregate (NFI-MS and FSIQ-RMS), our subsequent evaluation of the item sets that generated their scores implied that both PROs have weaker content validity than COSMIN suggests. This indicates that COSMIN criteria require further development, and raises significant concerns about how we have measured one of the most common and burdensome MS symptoms. A detailed head-to-head psychometric evaluation is needed to determine the impact of different PRO development qualities and the implications of the problems implied by our analyses, on measurement performance.

In MS clinical trials, impacts such as fatigue, walking ability, and quality of life, are measured using questionnaires­called patient-reported outcome measures­completed by people living with MS. The quality of these measures is fundamentally important. If poor quality patient-reported outcome measures are used, treatment benefits are easily missed or underestimated.We studied the quality of 18 fatigue patient-reported outcome measures previously used in MS studies. Specifically, we studied how the questionnaire questions were developed and scored them against recognised quality control standards. In general, the patient-reported outcome measures were poor. Only two scored reasonably well. One common weakness was that people living with MS were not involved during patient-reported outcome measure development. We also conducted novel examinations that went beyond the quality control standards. These test how well the questions relate back to the MS impacts they claim to measure. We found even the two best patient-reported outcome measures were poor.Our study had two findings. First, patient-reported outcome measures of MS fatigue are poor. Second, current standards for testing patient-reported outcome measure development are too easy to satisfy, overestimate patient-reported outcome measure quality, and need updating. Therefore, the ways we measure MS fatigue, one of the most common and burdensome MS symptoms, are scientifically weak. Measuring fatigue in multiple sclerosis: there may be trouble ahead­a video abstract (MP4 125165 KB).

How to Use Simplified Reproductive Calendar Data from the Demographic and Health Survey.

IPUMS Demographic and Health Surveys (IPUMS DHS), through its intuitive website (http://dhs.ipums.org/), eliminate barriers to overtime and cross-national analyses with the DHS. IPUMS DHS recently released simplified reproductive calendar data. These calendar data are harmonized across samples, distinguish "not in universe" cases from "no" responses, and do not require destringing. Variable names are hot links to important documentation, such as survey-question text and comparability concerns. Analysts can also select consistently coded variables relating to the woman, her household, and her social and environmental context without merging files.

Dance interventions for individuals post-stroke - a scoping review.

BACKGROUND: There is a growing body of literature assessing the potential benefits of dance for individuals post-stroke. OBJECTIVES: We conducted a scoping review mapping the state of the literature on feasibility, intervention procedures, and efficacy of dance to improve health-related outcomes for individuals post-stroke. ELIGIBILITY CRITERIA: Included studies were original research that described the use of a dance intervention for individuals post-stroke, included any health-related outcome, and were written in English. SOURCES OF EVIDENCE: Databases selected were Pubmed, Scopus, Google Scholar, Proquest, MedRxiv, and CINHAL. CHARTING METHODS: Two reviewers extracted relevant data and results were organized into themes and categories determined by all authors through discussion. RESULTS: We searched electronic databases were in February 2021. We included 18 publications from 14 studies. Ten were quantitative, five were qualitative, one was mixed-methods, and two were community project descriptions. Twelve publications evaluated in-person dance classes and six evaluated dance exergaming. Based on the limited studies included, evidence suggests dance is a feasible and potentially effective intervention for individuals post-stroke. Studies demonstrate dance may facilitate changes in balance and fall risk, encourage confidence, promote comfort with the changed body, increase rehabilitation motivation, and facilitate community reintegration. Evidence is limited by number of studies, design (lack of control groups and blinded assessments), intervention descriptions, and outcomes reporting. CONCLUSIONS: There is growing interest in dance for stroke interventions. Further research should focus on rigorous study design, optimal intervention timing, consistency of reporting outcomes, key elements of dance classes, and the impact of cultural dance styles.

Physical Activity Coaching via Telehealth for People With Parkinson Disease: A Cohort Study.

BACKGROUND AND PURPOSE: Physical activity (PA) has many known benefits for people with Parkinson disease (PD); however, many people do not meet recommended levels of frequency or intensity. We designed Engage-PD, a PA coaching program delivered via telehealth and grounded in self-determination theory to promote PA uptake and facilitate exercise self-efficacy in people with Parkinson disease. This study aimed to determine the feasibility and preliminary efficacy of Engage-PD, and to explore whether baseline characteristics were associated with outcomes. METHODS: A single cohort of people with PD (n = 62, Hoehn and Yahr I-III) participated in the 3-month Engage-PD program, which consisted of up to 5 telehealth coaching sessions delivered by physical therapists. Feasibility was evaluated based on recruitment and retention rates, along with participants' feedback. Planned and unplanned PA, exercise self-efficacy (ESE), and individualized goals were assessed pre- and post-intervention. Relationships between baseline characteristics and changes in planned PA and ESE were also evaluated. RESULTS: Recruitment (62%) and retention (85%) rates were high, and the intervention was well accepted and perceived by the participants. From pre- to postintervention, participants increased planned PA (d = 0.33), ESE (d = 1.20), and individualized goal performance (d = 1.63) and satisfaction (d = 1.70). Participants with lower baseline planned PA experienced greater improvements in planned PA, and those with lower baseline ESE experienced greater improvements in ESE. DISCUSSION AND CONCLUSIONS: A telehealth PA coaching program for people with PD was feasible and potentially efficacious. Physical therapist-led coaching may be an important component of a consultative model of care starting early in the disease process.Video Abstract available for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A393).

Symptom Interconnectivity in Multiple Sclerosis: A Narrative Review of Potential Underlying Biological Disease Processes.

INTRODUCTION: Fatigue, cognitive impairment, depression, and pain are highly prevalent symptoms in multiple sclerosis (MS). These often co-occur and may be explained by a common etiology. By reviewing existing literature, we aimed to identify potential underlying biological processes implicated in the interconnectivity between these symptoms. METHODS: A literature search was conducted to identify articles reporting research into the biological mechanisms responsible for the manifestation of fatigue, cognitive impairment, depression, and pain in MS. PubMed was used to search for articles published from July 2011 to July 2021. We reviewed and assessed findings from the literature to identify biological processes common to the symptoms of interest. RESULTS: Of 693 articles identified from the search, 252 were selected following screening of titles and abstracts and assessing reference lists of review articles. Four biological processes linked with two or more of the symptoms of interest were frequently identified from the literature: (1) direct neuroanatomical changes to brain regions linked with symptoms of interest (e.g., thalamic injury associated with cognitive impairment, fatigue, and depression), (2) pro-inflammatory cytokines associated with so-called 'sickness behavior,' including manifestation of fatigue, transient cognitive impairment, depression, and pain, (3) dysregulation of monoaminergic pathways leading to depressive symptoms and fatigue, and (4) hyperactivity of the hypothalamic-pituitary-adrenal (HPA) axis as a result of pro-inflammatory cytokines promoting the release of brain noradrenaline, serotonin, and tryptophan, which is associated with symptoms of depression and cognitive impairment. CONCLUSION: The co-occurrence of fatigue, cognitive impairment, depression, and pain in MS appears to be associated with a common set of etiological factors, namely neuroanatomical changes, pro-inflammatory cytokines, dysregulation of monoaminergic pathways, and a hyperactive HPA axis. This association of symptoms and biological processes has important implications for disease management strategies and, eventually, could help find a common therapeutic pathway that will impact both inflammation and neuroprotection.

Patient-reported outcome measures in MS: Do development processes and patient involvement support valid quantification of clinically important variables?

Background: Patient-reported outcomes (PROs) are widely measured in multiple sclerosis (MS) studies. However, the quality of instrument development processes varies, raising concerns about the meaningfulness of associated data. Objectives: To review the development of selected PROs commonly used in MS studies, including definitions of the concepts measured, use of conceptual frameworks, and degree of input from people living with MS (PlwMS). To gain insights and recommendations from PlwMS on their experience with these PROs. Methods: We assessed 6 PROs (FSIQ-RMS, modified-FIS, MSQoL-54, Leeds 8-item MSQoL, MSIS-29 and EQ-5D) for alignment with regulatory and scientific requirements on PRO structure/development. PlwMS evaluated the degree to which the PROs reflect disease aspects they perceive important. Results: Definitions, clarifications and conceptualisations of the measurement variables were often lacking. PlwMS were variably involved in PRO development. Ethnic diversity was rarely documented. PlwMS identified individualisation, ease of understanding, time burden, and mode of administration as factors affecting PRO usability. Conclusions: To date, the PRO development process has consistently lacked clear definitions of concepts of interest, use of conceptual frameworks and patient involvement, thereby compromising the validity of data they generate. PRO instrument development must be conducted more robustly to maximise the value of pivotal clinical trials.

Contextual Data in IPUMS DHS: Physical and Social Environment Variables linked to the Demographic and Health Surveys.

The Demographic and Health Surveys (DHS) are the most important source of comparative information on the health of women and young children in low- and middle-income countries and are well-suited for studies of the relationship between environmental factors and health. However, barriers have limited the use of the DHS for these purposes. IPUMS DHS, an online data dissemination tool, overcomes these barriers, simplifying comparative analyses with DHS. IPUMS DHS recently incorporated environmental variables that can easily be attached to individual or household records, facilitating the use of DHS data for the study of population and environment issues. We provide a brief introduction to IPUMS DHS, describe the current and anticipated environmental variables and how to use them, and provide an example of the novel research possibilities facilitated by this latest IPUMS DHS development. IPUMS-DHS is available free online at dhs.ipums.org.

Use of the integrated health interview series: trends in medical provider utilization (1972-2008).

The Integrated Health Interview Series (IHIS) is a public data repository that harmonizes four decades of the National Health Interview Survey (NHIS). The NHIS is the premier source of information on the health of the U.S. population. Since 1957 the survey has collected information on health behaviors, health conditions, and health care access. The long running time series of the NHIS is a powerful tool for health research. However, efforts to fully utilize its time span are obstructed by difficult documentation, unstable variable and coding definitions, and non-ignorable sample re-designs. To overcome these hurdles the IHIS, a freely available and web-accessible resource, provides harmonized NHIS data from 1969-2010. This paper describes the challenges of working with the NHIS and how the IHIS reduces such burdens. To demonstrate one potential use of the IHIS we examine utilization patterns in the U.S. from 1972-2008.

A Half Century of Health Data for the U.S. Population: The Integrated Health Interview Series.

The U.S. National Health Interview Survey (NHIS) is the world's longest survey time series of health data and a rich source of information on health conditions, behaviors, and care from the 1960s to the present. NHIS public-use files are difficult to use for long-term analysis, due to complex file structure, changes in questionnaire content, and evolving variable names and coding schemes. Researchers at the Minnesota Population Center have created the Integrated Health Interview Series (IHIS) to overcome these problems. IHIS provides access to thousands of consistently coded and well-documented NHIS variables on the Internet and makes it easy to analyze health trends and differentials. IHIS multiplies the value of NHIS data by allowing researchers to make consistent comparisons over half a century and thus to study U.S. health status as a dynamic process. This article describes the main features of IHIS and suggests fruitful avenues for historical research using these invaluable health data.

Big Data: Large-Scale Historical Infrastructure from the Minnesota Population Center.

The Minnesota Population Center (MPC) provides aggregate data and microdata that have been integrated and harmonized to maximize crosstemporal and cross-spatial comparability. All MPC data products are distributed free of charge through an interactive Web interface that enables users to limit the data and metadata being analyzed to samples and variables of interest to their research. In this article, the authors describe the integrated databases available from the MPC, report on recent additions and enhancements to these data sets, and summarize new online tools and resources that help users to analyze the data over time. They conclude with a description of the MPC's newest and largest infrastructure project to date: a global population and environment data network.

Four decades of population health data: the integrated health interview series as an epidemiologic resource.

The National Health Interview Survey (NHIS) is a primary source of information on the changing health of the US population over the past 4 decades. The full potential of NHIS data for analyzing long-term change, however, has rarely been exploited. Time series analysis is complicated by several factors: large numbers of data files and voluminous documentation; complexity of file structures; and changing sample designs, questionnaires, and variable-coding schemes. We describe a major data integration project that will simplify cross-temporal analysis of population health data available in the NHIS. The Integrated Health Interview Series (IHIS) is a Web-based system that provides an integrated set of data and documentation based on the NHIS public use files from 1969 to the present. The Integrated Health Interview Series enhances the value of NHIS data for researchers by allowing them to make consistent comparisons across 4 decades of dramatic changes in health status, health behavior, and healthcare.