Methodological Challenges When Studying Distance to Care as an Exposure in Health Research.
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ABSTRACT:
SUBMITTER: Caniglia EC
PROVIDER: S-EPMC6735874 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveTo examine methods for generating evidence on health outcomes in patients with rare diseases.DesignMethodological review of existing literature.SettingPubMed, Embase, and Academic Search Premier searched for articles describing innovative approaches to randomized trial design and analysis methods and methods for conducting observational research in patients with rare diseases.Main outcome measuresWe assessed information related to the proposed methods, the specific rare disease being studied, and outcomes from the application of the methods. We summarize methods with respect to their advantages in studying health outcomes in rare diseases and provide examples of their application.ResultsWe identified 46 articles that proposed or described methods for studying patient health outcomes in rare diseases. Articles covered a wide range of rare diseases and most (72%) were published in 2008 or later. We identified 16 research strategies for studying rare disease. Innovative clinical trial methods minimize sample size requirements (n=4) and maximize the proportion of patients who receive active treatment (n=2), strategies crucial to studying small populations of patients with limited treatment choices. No studies describing unique methods for conducting observational studies in patients with rare diseases were identified.ConclusionsThough numerous studies apply unique clinical trial designs and considerations to assess patient health outcomes in rare diseases, less attention has been paid to innovative methods for studying rare diseases using observational data.
| S-EPMC4242670 | biostudies-literature
Project description:BackgroundWe sought to understand poor uptake of the Primary Care Assessment and Research of a Telephone Intervention for Neuropsychiatric Conditions with Education and Resources study (PARTNERs), a pragmatic randomized controlled trial of a collaborative care intervention for people experiencing depression, anxiety or at-risk drinking. We explored primary care providers' experience with PARTNERs, and preferences regarding collaborative care models and trials.MethodsIn this qualitative study, we interviewed primary care providers across Ontario who had participated in PARTNERs, using stratified sampling to reach high-, low- and nonreferring providers in urban and rural settings. We audio-recorded, transcribed and thematically analyzed the interviews between May and December 2017, collecting and analyzing data concurrently until achieving saturation.ResultsWe interviewed 23 primary care providers. They valued the unique availability of telephone-based coaching for patients but desired greater integration of the coach into their practice. They appreciated expert psychiatric recommendations but rarely changed their practices. Sites varied in organizational adoption and implementation of the study, including whether they designated a local champion, proactively identified eligible patients, integrated the study into existing workflows and reflected on (and revised) practices. These behaviours affected continuing awareness of the study and referral rates.InterpretationStudy uptake was influenced by the limited relationship between PARTNERs coaches and primary care providers, and variable attention to leadership, training and quality improvement as vital elements of collaborative care. Study designs focusing on implementation could promote reach and penetration of novel interventions in the practice setting and more successfully advance collaborative care implementation.
| S-EPMC6579651 | biostudies-literature
Project description:Clinical and population research on dementia and related neurologic conditions, including Alzheimer's disease, faces several unique methodological challenges. Progress to identify preventive and therapeutic strategies rests on valid and rigorous analytic approaches, but the research literature reflects little consensus on "best practices." We present findings from a large scientific working group on research methods for clinical and population studies of dementia, which identified five categories of methodological challenges as follows: (1) attrition/sample selection, including selective survival; (2) measurement, including uncertainty in diagnostic criteria, measurement error in neuropsychological assessments, and practice or retest effects; (3) specification of longitudinal models when participants are followed for months, years, or even decades; (4) time-varying measurements; and (5) high-dimensional data. We explain why each challenge is important in dementia research and how it could compromise the translation of research findings into effective prevention or care strategies. We advance a checklist of potential sources of bias that should be routinely addressed when reporting dementia research.
| S-EPMC4655106 | biostudies-literature
Project description:ObjectiveTo illustrate methodological considerations when assessing the relationship between patient care experiences and mortality.Data sourceMedical Expenditure Panel Survey data (2000-2005) linked to National Health Interview Survey and National Death Index mortality data through December 31, 2006.Study designWe estimated Cox proportional hazards models with mortality as the dependent variable and patient experience measures as independent variables and assessed consistency of experiences over time.Data extraction methodsWe used data from respondents age 18 or older with at least one doctor's office or clinic visit during the year prior to the round 2 interview. We excluded subjects who died in the baseline year.Principal findingsThe association between overall care experiences and mortality was significant for deaths not amenable to medical care and all-cause mortality, but not for amenable deaths. More than half of respondents were in a different care experience quartile over a 1-year period. In the five individual experience questions we analyzed, only time spent with the patient was significantly associated with mortality.ConclusionsDeaths not amenable to medical care and the time-varying and multifaceted nature of patient care experience are important issues to consider when assessing the relationship between care experience and mortality.
| S-EPMC4545351 | biostudies-literature
Project description:BackgroundWhile tuberculosis incidence and mortality are declining in South Africa, meeting the goals of the End TB Strategy requires an invigorated programmatic response informed by accurate data. Enumerating the losses at each step in the care cascade enables appropriate targeting of interventions and resources.MethodsWe estimated the tuberculosis burden; the number and proportion of individuals with tuberculosis who accessed tests, had tuberculosis diagnosed, initiated treatment, and successfully completed treatment for all tuberculosis cases, for those with drug-susceptible tuberculosis (including human immunodeficiency virus (HIV)-coinfected cases) and rifampicin-resistant tuberculosis. Estimates were derived from national electronic tuberculosis register data, laboratory data, and published studies.ResultsThe overall tuberculosis burden was estimated to be 532005 cases (range, 333760-764480 cases), with successful completion of treatment in 53% of cases. Losses occurred at multiple steps: 5% at test access, 13% at diagnosis, 12% at treatment initiation, and 17% at successful treatment completion. Overall losses were similar among all drug-susceptible cases and those with HIV coinfection (54% and 52%, respectively, successfully completed treatment). Losses were substantially higher among rifampicin- resistant cases, with only 22% successfully completing treatment.ConclusionAlthough the vast majority of individuals with tuberculosis engaged the public health system, just over half were successfully treated. Urgent efforts are required to improve implementation of existing policies and protocols to close gaps in tuberculosis diagnosis, treatment initiation, and successful treatment completion.
| S-EPMC5853316 | biostudies-literature
Project description:ObjectiveTo determine the effect of using Euclidean measurements and zip-code centroid geo-imputation versus more precise spatial analytical techniques in health care research.Data sourcesCommercially insured members from a southeastern managed care organization.Study designDistance from admitting inpatient facility to member's home and zip-code centroid (geographic placement) was compared using Euclidean straight-line and shortest-path drive distances (measurement technique).Data collectionAdministrative claims from October 2005 to September 2006.Principal findingsMeasurement technique had a greater impact on distance values compared with geographic placement. Drive distance from the geocoded address was highly correlated (r=0.99) with the Euclidean distance from the zip-code centroid.ConclusionsActual differences were relatively small. Researchers without capabilities to produce drive distance measurements and/or address geocoding techniques could rely on simple linear regressions to estimate correction factors with a high degree of confidence.
| S-EPMC2813451 | biostudies-literature
Project description:BackgroundEnrollment challenges for critical care research are common. Contributing factors include short enrollment windows, the crisis nature of critical illness, lack of research staff, unavailable legal proxy, family dynamics, and language barriers.ObjectiveTo describe enrollment statistics for an ongoing critical care nursing trial, barriers to recruitment, and strategies to enhance enrollment.MethodsTwo years' worth of recruitment and enrollment data from an oral care intervention trial in critically ill adults receiving mechanical ventilation at 1 hospital were analyzed. Recruitment logs include number of patients screened, eligible, enrolled, and declined and patients' sex, race, and ethnicity.ResultsTarget enrollment (15.5 patients per month) was based on experience and historical data. Strategies implemented to promote enrollment included providing study personnel at least 18 hours per day for 7 days per week, regular rounds, communication with direct care staff, and Spanish consent processes. In 2 years, 6963 patients were screened; 1551 (22%) were eligible. Consent was sought from 366 (24% of eligible patients). Enrollment averaged 13.3 patients per month (86% of projected target). The main factor impeding enrollment was unavailability of a legal proxy to provide consent (88%). The refusal rates of white (11%), black (13%), and Hispanic (16%) patients did not differ significantly. However, those classified as Asian or as more than 1 race declined significantly more often (35%) than did white or black patients (P = .02).ConclusionsUnavailability of a legal proxy within a short enrollment window was the major challenge to enrollment. Various factors influenced consent decisions. Clinical study design requires more conservative estimates.
| S-EPMC6015765 | biostudies-literature
Project description:An emerging issue in occupational health and safety (OHS) is that interventions increasingly have to demonstrate that they offer sufficient value for money. To this end, the last decennia have seen more and more economic evaluation methods being employed in this field. However, several recent publications have indicated that many of the published studies suffer from important shortcomings. This paper aims to highlight difficulties in assessing the value of OHS by use of current economic evaluation methods. First, a summary framework presents an overview of the costs and benefits relevant for OHS interventions. Next, three elements from this framework are selected that are at the same time crucial to OHS value, but also challenging to measure and monetise: Effects on worker productivity, 'intangible' benefits, such as reputation effects, and the influence of the broader legal⁻fiscal context in which an intervention takes place. The following sections then discuss the following research questions for each of these elements: Why is it difficult to exclude these factors from OHS economic evaluations? Why do they pose a challenge to the quality of economic evaluations in OHS? How can they be included, and what are the known advantages and disadvantages of the methods to measure these factors? Future work should investigate (and standardise) better methods to include these elements.
| S-EPMC6265704 | biostudies-other
Project description:BACKGROUND:Monitoring financial protection against catastrophic health expenditures is important to understand how health financing arrangements in a country protect its population against high costs associated with accessing health services. While catastrophic health expenditures are generally defined to be when household expenditures for health exceed a given threshold of household resources, there is no gold standard with several methods applied to define the threshold and household resources. These different approaches to constructing the indicator might give different pictures of a country's progress towards financial protection. In order for monitoring to effectively provide policy insight, it is critical to understand the sensitivity of measurement to these choices. METHODS:This paper examines the impact of varying two methodological choices by analysing household expenditure data from a sample of 47 countries. We assess sensitivity of cross-country comparisons to a range of thresholds by testing for restricted dominance. We further assess sensitivity of comparisons to different methods for defining household resources (i.e. total expenditure, non-food expenditure and non-subsistence expenditure) by conducting correlation tests of country rankings. RESULTS:We found country rankings are robust to the choice of threshold in a tenth to a quarter of comparisons within the 5-85% threshold range and this increases to half of comparisons if the threshold is restricted to 5-40%, following those commonly used in the literature. Furthermore, correlations of country rankings using different methods to define household resources were moderate to high; thus, this choice makes less difference from a measurement perspective than from an ethical perspective as different definitions of available household resources reflect varying concerns for equity. CONCLUSIONS:Interpreting comparisons from global monitoring based on a single threshold should be done with caution as these may not provide reliable insight into relative country progress. We therefore recommend financial protection against catastrophic health expenditures be measured across a range of thresholds using a catastrophic incidence curve as shown in this paper. We further recommend evaluating financial protection in relation to a country's health financing system arrangements in order to better understand the extent of protection and better inform future policy changes.
| S-EPMC5984475 | biostudies-literature
Project description:IntroductionDespite the pressing need for primary care-based suicide prevention initiatives and growing acknowledgement of recruitment difficulties and Institutional Review Board (IRB) challenges in suicide research, we are aware of no illustrative examples describing how IRB decisions in the design of a primary care trial can compound recruitment challenges.MethodsThe CDC-funded trial (NCT02986113) of Men and Providers Preventing Suicide aimed to examine the effects of a tailored computer program encourage men with suicidal thoughts (n = 304, ages 35-64) to discuss suicide with a primary care clinician and accept treatment. Before a visit, participants viewed MAPS or a non-tailored control video. Post-visit, both arms were offered telephone collaborative care, as mandated by the institutional review board (IRB). We previously showed that exposure to MAPs led to improvements in communication about suicide in a primary care visit. In this paper, we report data on the study's primary outcome, suicide preparatory behaviors.ResultsAfter screening nearly 4100 men, 48 enrolled. Recruitment challenges, which were exacerabted by an IRB mandate narrowing post-intervention patient management differences between trial arms, limited detection of the effects of MAPS on suicide preparatory behaviors.ConclusionsWhile primary care settings are key sites for suicide prevention trials, issues such as recruitment difficulties and overly restrictive IRB requirements may limit their utility. Methodological innovation to improve recruitment and ethical guidance to inform IRB decision-making are needed.
| S-EPMC10124132 | biostudies-literature