Browsing by Subject "Outcome Assessment, Health Care"
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Item Open Access Assessing applicability when comparing medical interventions: AHRQ and the Effective Health Care Program.(Journal of clinical epidemiology, 2011-11) Atkins, David; Chang, Stephanie M; Gartlehner, Gerald; Buckley, David I; Whitlock, Evelyn P; Berliner, Elise; Matchar, DavidObjective
To describe a systematic approach for identifying, reporting, and synthesizing information to allow consistent and transparent consideration of the applicability of the evidence in a systematic review according to the Population, Intervention, Comparator, Outcome, Setting domains.Study design and setting
Comparative effectiveness reviews need to consider whether available evidence is applicable to specific clinical or policy questions to be useful to decision makers. Authors reviewed the literature and developed guidance for the Effective Health Care program.Results
Because applicability depends on the specific questions and needs of the users, it is difficult to devise a valid uniform scale for rating the overall applicability of individual studies or body of evidence. We recommend consulting stakeholders to identify the factors most relevant to applicability for their decisions. Applicability should be considered separately for benefits and harms. Observational studies can help determine whether trial populations and interventions are representative of "real world" practice. Reviewers should describe differences between available evidence and the ideally applicable evidence for the question being asked and offer a qualitative judgment about the importance and potential effect of those differences.Conclusion
Careful consideration of applicability may improve the usefulness of systematic reviews in informing practice and policy.Item Open Access Assisted ambulation to improve health outcomes for older medical inpatients (AMBULATE): study protocol for a randomized controlled trial.(Trials, 2023-07) Johnson, Joshua K; Hamilton, Aaron C; Hu, Bo; Pack, Quinn R; Lindenauer, Peter K; Fox, Robert J; Hashmi, Ardeshir; Siegmund, Lee Anne; Burchill, Christian N; Taksler, Glen B; Goto, Toyomi; Stilphen, Mary; Rothberg, Michael BBackground
Hospitalized older adults spend as much as 95% of their time in bed, which can result in adverse events and delay recovery while increasing costs. Observational studies have shown that general mobility interventions (e.g., ambulation) can mitigate adverse events and improve patients' functional status. Mobility technicians (MTs) may address the need for patients to engage in mobility interventions without overburdening nurses. There is no data, however, on the effect of MT-assisted ambulation on adverse events or functional status, or on the cost tradeoffs if a MT were employed. The AMBULATE study aims to determine whether MT-assisted ambulation improves mobility status and decreases adverse events for older medical inpatients. It will also include analyses to identify the patients that benefit most from MT-assisted mobility and assess the cost-effectiveness of employing a MT.Methods
The AMBULATE study is a multicenter, single-blind, parallel control design, individual-level randomized trial. It will include patients admitted to a medical service in five hospitals in two regions of the USA. Patients over age 65 with mild functional deficits will be randomized using a block randomization scheme. Those in the intervention group will ambulate with the MT up to three times daily, guided by the Johns Hopkins Mobility Goal Calculator. The intervention will conclude at hospital discharge, or after 10 days if the hospitalization is prolonged. The primary outcome is the Short Physical Performance Battery score at discharge. Secondary outcomes are discharge disposition, length of stay, hospital-acquired complications (falls, venous thromboembolism, pressure ulcers, and hospital-acquired pneumonia), and post-hospital functional status.Discussion
While functional decline in the hospital is multifactorial, ambulation is a modifiable factor for many patients. The AMBULATE study will be the largest randomized controlled trial to test the clinical effects of dedicating a single care team member to facilitating mobility for older hospitalized patients. It will also provide a useful estimation of cost implications to help hospital administrators assess the feasibility and utility of employing MTs.Trial registration
Registered in the United States National Library of Medicine clinicaltrials.gov (# NCT05725928). February 13, 2023.Item Open Access Association between Dysphagia and Surgical Outcomes across the Continuum of Frailty.(Journal of nutrition in gerontology and geriatrics, 2021-04) Cohen, Seth M; Porter Starr, Kathryn N; Risoli, Thomas; Lee, Hui-Jie; Misono, Stephanie; Jones, Harrison; Raman, SudhaThis study examined the relationship between dysphagia and adverse outcomes across frailty conditions among surgical patients ≥50 years of age. A retrospective cohort analysis of surgical hospitalizations in the Healthcare Cost and Utilization Project's National Inpatient Sample among patients ≥50 years of age undergoing intermediate/high risk surgery not involving the larynx, pharynx, or esophagus. Of 3,298,835 weighted surgical hospitalizations, dysphagia occurred in 1.2% of all hospitalizations and was higher in frail patients ranging from 5.4% to 11.7%. Dysphagia was associated with greater length of stay, higher total costs, increased non-routine discharges, and increased medical/surgical complications among both frail and non-frail patients. Dysphagia may be an independent risk factor for poor postoperative outcomes among surgical patients ≥50 years of age across frailty conditions and is an important consideration for providers seeking to reduce risk in vulnerable surgical populations.Item Open Access Can acute clinical outcomes predict health-related quality of life after stroke: a one-year prospective study of stroke survivors.(Health and quality of life outcomes, 2018-11-21) Yeoh, Yen Shing; Koh, Gerald Choon-Huat; Tan, Chuen Seng; Lee, Kim En; Tu, Tian Ming; Singh, Rajinder; Chang, Hui Meng; De Silva, Deidre A; Ng, Yee Sien; Ang, Yan Hoon; Yap, Philip; Chew, Effie; Merchant, Reshma Aziz; Yeo, Tseng Tsai; Chou, Ning; Venketasubramanian, N; Young, Sherry H; Hoenig, Helen; Matchar, David Bruce; Luo, NanBackground
Health-related quality of life (HRQoL) is a key metric to understand the impact of stroke from patients' perspective. Yet HRQoL is not readily measured in clinical practice. This study aims to investigate the extent to which clinical outcomes during admission predict HRQoL at 3 months and 1 year post-stroke.Methods
Stroke patients admitted to five tertiary hospitals in Singapore were assessed with Shah-modified Barthel Index (Shah-mBI), National Institute of Health Stroke Scale (NIHSS), Modified Rankin Scale (mRS), Mini-Mental State Examination (MMSE), and Frontal Assessment Battery (FAB) before discharge, and the EQ-5D questionnaire at 3 months and 12 months post-stroke. Association of clinical measures with the EQ index at both time points was examined using multiple linear regression models. Forward stepwise selection was applied and consistently significant clinical measures were analyzed for their association with individual dimensions of EQ-5D in multiple logistic regressions.Results
All five clinical measures at baseline were significant predictors of the EQ index at 3 months and 12 months, except that MMSE was not significantly associated with the EQ index at 12 months. NIHSS (3-month standardized β = - 0.111; 12-month standardized β = - 0.109) and mRS (3-month standardized β = - 0.122; 12-month standardized β = - 0.080) were shown to have a larger effect size than other measures. The contribution of NIHSS and mRS as significant predictors of HRQoL was mostly explained by their association with the mobility, self-care, and usual activities dimensions of EQ-5D.Conclusions
HRQoL at 3 months and 12 months post-stroke can be predicted by clinical outcomes in the acute phase. NIHSS and mRS are better predictors than BI, MMSE, and FAB.Item Open Access Changing CHANGE: adaptations of an evidence-based telehealth cardiovascular disease risk reduction intervention.(Translational behavioral medicine, 2018-03) Zullig, Leah L; McCant, Felicia; Silberberg, Mina; Johnson, Fred; Granger, Bradi B; Bosworth, Hayden BRelatively few successful medication adherence interventions are translated into real-world clinical settings. The Prevention of Cardiovascular Outcomes in African Americans with Diabetes (CHANGE) intervention was originally conceived as a randomized controlled trial to improve cardiovascular disease-related medication adherence and health outcomes. The purpose of the study was to describe the translation of the CHANGE trial into two community-based clinical programs. CHANGE 2 was available to Medicaid patients with diabetes and hypertension whose primary care homes were part of a care management network in the Northern Piedmont region of North Carolina. CHANGE 3 was available to low-income patients receiving care in three geographical areas with multiple chronic conditions at low or moderate risk for developing cardiovascular disease. Adaptations were made to ensure fit with available organizational resources and the patient population's health needs. Data available for evaluation are presented. For CHANGE 2, we evaluated improvement in A1c control using paired t test. For both studies, we describe feasibility measured by percentage of patients who completed the curriculum. CHANGE 2 involved 125 participants. CHANGE 3 had 127 participants. In CHANGE 2, 69 participants had A1c measurements at baseline and 12-month follow-up; A1c improved from 8.4 to 7.8 (p = .008). In CHANGE 3, interventionists completed 47% (n = 45) of calls to enroll participants at the 4-month encounter, and among those eligible for a 12-month call (n = 52), 21% of 12-month calls were completed with participants. In CHANGE 2, 40% of participants (n = 50) completed all 12 encounters. Thoughtful adaptation is critical to translate clinical trials into community-based clinic settings. Successful implementation of adapted evidence-based interventions may be feasible and can positively affect patients' disease control.Item Open Access Comparing integrative cognitive-affective therapy and guided self-help cognitive-behavioral therapy to treat binge-eating disorder using standard and naturalistic momentary outcome measures: A randomized controlled trial.(The International journal of eating disorders, 2020-09) Peterson, Carol B; Engel, Scott G; Crosby, Ross D; Strauman, Timothy; Smith, Tracey L; Klein, Marjorie; Crow, Scott J; Mitchell, James E; Erickson, Ann; Cao, Li; Bjorlie, Kayla; Wonderlich, Stephen AObjective
Innovative treatments and outcome measures are needed for binge-eating disorder (BED). This randomized controlled trial compared Integrative Cognitive-Affective Therapy (ICAT-BED), an individual psychotherapy targeting momentary behavioral and emotional precipitants of binge eating, with an established cognitive-behavioral guided self-help (CBTgsh) treatment using standard and ecological momentary assessment (EMA) outcome measures.Method
A total of 112 participants were randomized to 17 weeks of treatment (21 sessions for ICAT-BED and 10 sessions for CBTgsh). Binge-eating frequency was assessed with the Eating Disorder Examination (EDE) as well as EMA using cell phone-based real-time, naturalistic assessment at end of treatment (EOT) and 6-month follow-up. Hypothesized maintenance mechanisms were assessed using self-report questionnaires.Results
Binge-eating frequency as measured by the EDE and real-time assessment showed significant reductions at EOT and follow-up, with no significant differences between treatments. Hypothesized maintenance mechanisms, including emotion regulation, cognitive self-discrepancy, self-directed style, as well as measures of associated eating disorder psychopathology, depression, anxiety, impulsivity, and negative affect, showed similar improvement at EOT and follow-up with no differences between treatments. Abstinence rates at EOT (ICAT-BED: 57.1%; CBTgsh: 42.9%) and 6-month follow-up (ICAT-BED: 46.4%; CBTgsh: 42.9%) were not significantly different. Treatment retention was significantly higher for ICAT-BED (87.5%) than CBTgsh (71.4%).Discussion
These findings suggest that ICAT-BED and CBTgsh were associated with similar improvements in binge eating, psychopathology, and putative maintenance mechanisms as measured by traditional self-report and momentary, naturalistic assessments and that these changes were generally sustained at 6-month follow-up.Item Open Access Consistent improvement with eculizumab across muscle groups in myasthenia gravis.(Annals of clinical and translational neurology, 2020-08) Mantegazza, Renato; O'Brien, Fanny L; Yountz, Marcus; Howard, James F; REGAIN study groupObjective
To assess whether eculizumab, a terminal complement inhibitor, improves patient- and physician-reported outcomes (evaluated using the myasthenia gravis activities of daily living profile and the quantitative myasthenia gravis scale, respectively) in patients with refractory anti-acetylcholine receptor antibody-positive generalized myasthenia gravis across four domains, representing ocular, bulbar, respiratory, and limb/gross motor muscle groups.Methods
Patients with refractory anti-acetylcholine receptor antibody-positive generalized myasthenia gravis were randomized 1:1 to receive either placebo or eculizumab during the REGAIN study (NCT01997229). Patients who completed REGAIN were eligible to continue into the open-label extension trial (NCT02301624) for up to 4 years. The four domain scores of each of the myasthenia gravis activities of daily living profile and the quantitative myasthenia gravis scale recorded throughout REGAIN and through 130 weeks of the open-label extension were analyzed.Results
Of the 125 patients who participated in REGAIN, 117 enrolled in the open-label extension; 61 had received placebo and 56 had received eculizumab during REGAIN. Patients experienced rapid improvements in total scores and all four domain scores of both the myasthenia gravis activities of daily living profile and the quantitative myasthenia gravis scale with eculizumab treatment. These improvements were sustained through 130 weeks of the open-label extension.Interpretation
Eculizumab treatment elicits rapid and sustained improvements in muscle strength across ocular, bulbar, respiratory, and limb/gross motor muscle groups and in associated daily activities in patients with refractory anti-acetylcholine receptor antibody-positive generalized myasthenia gravis.Item Open Access Eating Difficulties among Older Adults with Dementia in Long-Term Care Facilities: A Scoping Review.(International journal of environmental research and public health, 2021-09) Jung, Dukyoo; Lee, Kyuri; De Gagne, Jennie C; Lee, Minkyung; Lee, Hyesoon; Yoo, Leeho; Won, Sarah; Choi, EunjuThis paper reports a scoping review of the literature on eating difficulties among older adults with dementia in long-term care facilities to identify key concepts, methods of measuring outcomes, interventions, and related factors. A scoping review was performed using the bibliographic databases PubMed, CINAHL, PsycINFO, and Cochrane Library. A combination of keywords and subject headings related to eating or feeding difficulties was used. Inclusion criteria were limited to materials published in English. A total of 1070 references were retrieved, of which 39 articles were selected after applying the inclusion and exclusion criteria. Articles that met the criteria were published between 1987 and 2020. "Eating disabilities" have been defined as problems related to choosing food and/or the ability to get food to one's mouth, chew, and swallow. Interventions for eating difficulties described in the literature include spaced retrieval training, Montessori training, and feeding skill training. Intrapersonal, interpersonal, and environmental factors related to eating difficulties were identified. This scoping review will provide direct care workers, nursing educators, and administrators with an overview of eating performance and a broad understanding of eating difficulties for older adults with dementia in long-term care facilities.Item Open Access Eculizumab improves fatigue in refractory generalized myasthenia gravis.(Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2019-08) Andersen, Henning; Mantegazza, Renato; Wang, Jing Jing; O'Brien, Fanny; Patra, Kaushik; Howard, James F; REGAIN Study GroupPURPOSE:To evaluate the effect of eculizumab on perceived fatigue in patients with anti-acetylcholine receptor antibody-positive, refractory, generalized myasthenia gravis (MG) using the Quality of Life in Neurological Disorders (Neuro-QOL) Fatigue subscale, and to evaluate correlations between improvements in Neuro-QOL Fatigue and other clinical endpoints. METHODS:Neuro-QOL Fatigue, MG Activities of Daily Living (MG-ADL), Quantitative MG (QMG), and the 15-item MG Quality of Life (MG-QOL15) scales were administered during the phase 3, randomized, placebo-controlled REGAIN study (eculizumab, n = 62; placebo, n = 63) and subsequent open-label extension (OLE). Data were analyzed using repeated-measures models. Correlations between changes in Neuro-QOL Fatigue and in MG-ADL, QMG, and MG-QOL15 scores were determined at REGAIN week 26. RESULTS:At REGAIN week 26, eculizumab-treated patients showed significantly greater improvements in Neuro-QOL Fatigue scores than placebo-treated patients (consistent with improvements in MG-ADL, QMG, and MG-QOL15 scores previously reported in REGAIN). Improvements with eculizumab were sustained through OLE week 52. Correlations between Neuro-QOL Fatigue and MG-QOL15, MG-ADL, and QMG scores were strong for eculizumab-treated patients at REGAIN week 26, and strong, moderate, and weak, respectively, for placebo-treated patients. CONCLUSIONS:Compared with placebo, eculizumab was associated with improvements in perceived fatigue that strongly correlated with improvements in MG-specific outcome measures. Trial ID Registration: NCT01997229, NCT02301624.Item Open Access Effect of type II odontoid fracture nonunion on outcome among elderly patients treated without surgery: based on the AOSpine North America geriatric odontoid fracture study.(Spine, 2013-12) Smith, Justin S; Kepler, Christopher K; Kopjar, Branko; Harrop, James S; Arnold, Paul; Chapman, Jens R; Fehlings, Michael G; Vaccaro, Alexander R; Shaffrey, Christopher IStudy design
Subgroup analysis of a prospective multicenter study.Objective
Outcome analysis of nonoperatively treated elderly patients with type II odontoid fractures, including assessment of consequence of a fracture nonunion.Summary of background data
Odontoid fractures are among the most common fractures in the elderly, and controversy exists regarding treatment.Methods
Subgroup analysis of a prospective multicenter study of elderly patients (≥65 yr) with type II odontoid fracture. Neck Disability Index and Short-Form 36 (SF-36) version 2 were collected at baseline and 6 and 12 months. Fifty-eight (36.5%) of the 159 patients were treated nonoperatively.Results
Of the 58 patients initially treated nonoperatively, 8 died within 90 days and were excluded. Of the remaining 50 patients, 11 (22.0%) developed nonunion, with 7 (63.6%) requiring surgery. Four of the 39 (10.3%) patients classified as having "successful union" required surgery due to late fracture displacement. Thus, 15 (30.0%) patients developed primary or secondary nonunion and 11 (22.0%) required surgery. The overall 12-month mortality was 14.0% (nonunion = 2, union = 5; P= 0.6407). For union and nonunion groups, Neck Disability Index and SF-36 version 2 declined significantly at 12 months compared with preinjury values (P< 0.05), except for SF-36 version 2 Physical Functioning (P= 0.1370). There were no significant differences in outcome parameters based on union status at 12 months (P> 0.05); however, it is important to emphasize that the 12-month outcomes for the nonunion patients reflect the status of the patient after delayed surgical treatment in the majority of these cases.Conclusion
Nonoperative treatment for type II odontoid fracture in the elderly has high rates of nonunion and mortality. Patients with nonunion did not report worse outcomes compared with those who achieved union at 12 months; however, the majority of patients with nonunion required delayed surgical treatment. These findings may prove useful for patients who are not surgical candidates or elect for nonoperative treatment.Level of evidence
2.Item Open Access Five insights from the Global Burden of Disease Study 2019.(Lancet (London, England), 2020-10) GBD 2019 Viewpoint CollaboratorsThe Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 provides a rules-based synthesis of the available evidence on levels and trends in health outcomes, a diverse set of risk factors, and health system responses. GBD 2019 covered 204 countries and territories, as well as first administrative level disaggregations for 22 countries, from 1990 to 2019. Because GBD is highly standardised and comprehensive, spanning both fatal and non-fatal outcomes, and uses a mutually exclusive and collectively exhaustive list of hierarchical disease and injury causes, the study provides a powerful basis for detailed and broad insights on global health trends and emerging challenges. GBD 2019 incorporates data from 281 586 sources and provides more than 3·5 billion estimates of health outcome and health system measures of interest for global, national, and subnational policy dialogue. All GBD estimates are publicly available and adhere to the Guidelines on Accurate and Transparent Health Estimate Reporting. From this vast amount of information, five key insights that are important for health, social, and economic development strategies have been distilled. These insights are subject to the many limitations outlined in each of the component GBD capstone papers.Item Open Access Fixed-dose gabapentin augmentation in the treatment of alcohol withdrawal syndrome: a retrospective, open-label study.(The American journal of drug and alcohol abuse, 2020-01) Andaluz, Alex; DeMoss, Dustin; Claassen, Cynthia; Blair, Somer; Hsu, Jennifer; Bakre, Sulaimon; Khan, Mehreen; Atem, Folefac; Rush, A JohnBackground: Lorazepam use in the treatment of alcohol withdrawal syndrome (AWS) is not without risk.Objective: This study compares AWS outcomes using a standard, symptom-triggered lorazepam dosing protocol (control group) and symptom-triggered lorazepam dosing augmented with a gabapentin loading dose and taper (GABA group).Methods: Consecutive, non-randomized adults (n = 982; 64.0% male) undergoing treatment for AWS were included in this retrospective, open-label study. Symptom-triggered lorazepam dosing was informed by scores on the Clinical Institute Withdrawal Assessment-Alcohol, revised (CIWA-Ar). Gabapentin augmentation utilized an initial loading dose (900 mg) and a three-day taper. Outcomes included average symptom severity per treatment hour and average lorazepam dose per treatment hour. Average time in the protocol by group, stratified by highest CIWA-Ar score, was examined as a secondary outcome. A priori group differences were controlled statistically.Results: GABA patients were older and exhibited somewhat more severe withdrawal symptoms than controls. After controlling for confounders, gabapentin augmentation did not significantly lower average lorazepam dosing per treatment hour or withdrawal symptom severity per treatment hour. Compared to controls, overall withdrawal symptoms diminished somewhat more rapidly for GABA patients experiencing low or moderate-level withdrawal symptoms; however, severe withdrawal symptoms remitted more slowly in the GABA group. Results should be interpreted in light of the uncontrolled nature of group assignment and other confounders.Conclusions: Compared to symptom-triggered lorazepam dosing alone, gabapentin augmentation did not produce better outcomes during treatment of acute AWS. These results do not support the use of scheduled gabapentin as an augmentation to benzodiazepines during inpatient treatment of AWS.Item Open Access Frequency of Physical Therapist Intervention Is Associated With Mobility Status and Disposition at Hospital Discharge for Patients With COVID-19.(Physical therapy, 2021-01) Johnson, Joshua K; Lapin, Brittany; Green, Karen; Stilphen, MaryObjective
For patients diagnosed with the novel coronavirus, COVID-19, evidence is needed to understand the effect of treatment by physical therapists in the acute hospital on patient outcomes. The primary aims of this study were to examine the relationship of physical therapy visit frequency and duration in the hospital with patients' mobility status at discharge and probability of discharging home.Methods
This retrospective study included patients with COVID-19 admitted to any of 11 hospitals in 1 health system. The primary outcome was mobility status at discharge, measured using the Activity Measure for Post-Acute Care 6-Clicks basic mobility (6-Clicks mobility) and the Johns Hopkins Highest Level of Mobility scales. Discharge to home versus to a facility was a secondary outcome. Associations between these outcomes and physical therapy visit frequency or mean duration were tested using multiple linear or modified Poisson regression. Potential moderation of these relationships by particular patient characteristics was examined using interaction terms in subsequent regression models.Results
For the 312 patients included, increased physical therapy visit frequency was associated with higher 6-Clicks mobility (b = 3.63; 95% CI, 1.54-5.71) and Johns Hopkins Highest Level of Mobility scores (b = 1.15; 95% CI, 0.37-1.93) at hospital discharge and with increased probability of discharging home (adjusted relative risk = 1.82; 95% CI, 1.25-2.63). Longer mean visit duration was also associated with improved mobility at discharge and the probability of discharging home, though the effects were less pronounced. Few moderation effects were observed.Conclusion
Patients with COVID-19 demonstrated improved mobility at hospital discharge and higher probability of discharging home with increased frequency and longer mean duration of physical therapy visits. These associations were not generally moderated by patient characteristics.Impact
Physical therapy should be an integral component of care for patients hospitalized due to COVID-19. Providing sufficient physical therapist interventions to improve outcomes must be balanced against protection from viral spread.Lay summary
Patients with COVID-19 can benefit from more frequent and longer physical therapy visits in the hospital.Item Open Access Health-related quality of life loss associated with first-time stroke.(PloS one, 2019-01-28) Yeoh, Yen Shing; Koh, Gerald Choon-Huat; Tan, Chuen Seng; Tu, Tian Ming; Singh, Rajinder; Chang, Hui Meng; De Silva, Deidre A; Ng, Yee Sien; Ang, Yan Hoon; Yap, Philip; Chew, Effie; Merchant, Reshma A; Yeo, Tseng Tsai; Chou, Ning; Venketasubramanian, N; Lee, Kim En; Young, Sherry H; Hoenig, Helen; Matchar, David Bruce; Luo, NanOBJECTIVES:This study aimed to quantify health-related quality of life (HRQoL) loss associated with first episode of stroke by comparing patient-reported HRQoL before and after stroke onset. The impact of stroke in local population was also evaluated by comparing the pre- and post-stroke HRQoL with that of the general population. METHODS:The HRQoL of stroke survivors was assessed with the EQ-5D-3L index score at recruitment, for recalled pre-stroke HRQoL, and at 3 and 12 month post-stroke. Change in HRQoL from pre-stroke to 3 and 12 month was self-reported by 285 and 238 patients, respectively. Mean EQ index score at each time point (baseline: 464 patients; 3 month post-stroke: 306 patients; 12 month post-stroke: 258 patients) was compared with published population norms for EQ-5D-3L. RESULTS:There was a significant decrease in HRQoL at 3 (0.25) and 12 month (0.09) post-stroke when compared to the retrospectively recalled patients' mean pre-stroke HRQoL level (0.87). The reduction at 3 month was associated with the reduction in all EQ-5D-3L health dimensions; reductions remaining at 12 month were limited to dimensions of mobility, self-care, usual activities, and anxiety/depression. Stroke patients had a lower mean EQ index than the general population by 0.07 points pre-stroke (0.87 vs. 0.94), 0.33 points at 3 month (0.61 vs. 0.94) and 0.18 points at 12 month (0.76 vs. 0.94) post-stroke. CONCLUSIONS:Stroke has a substantial impact on HRQoL in Singapore, especially in the first three months post-stroke. Compared to the general population, stroke survivors have lower HRQoL even before stroke onset. This pre-stroke deficit in HRQoL should be taken into account when quantifying health burden of stroke or setting goals for stroke rehabilitation.Item Open Access International Comparison of Poststroke Resource Use: A Longitudinal Analysis in Europe.(Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association, 2015-10) Matchar, David B; Bilger, Marcel; Do, Young K; Eom, KirstenBackground
Long-term costs often represent a large proportion of the total costs induced by stroke, but data on long-term poststroke resource use are sparse, especially regarding the trajectory of costs by severity. We used a multinational longitudinal survey to estimate patterns of poststroke resource use by degree of functional disability and to compare resource use between regions.Methods
The Survey of Health, Ageing and Retirement in Europe (SHARE) is a multinational database of adults 50 years and older, which includes demographic information about respondents, age when stroke first occurred, current activity of daily living (ADL) limitations, and health care resource use in the year before interview. We modeled resource use with a 2-part regression for number of hospital days, home nursing hours, and paid and unpaid home caregiving hours.Results
After accounting for time since stroke, number of strokes and comorbidities, age, gender, and European regions, we found that poststroke resource use was strongly associated with ADL limitations. The duration since the stroke event was significantly associated only with inpatient care, and informal help showed significant regional heterogeneity across all ADL limitation levels.Conclusions
Poststroke physical deficits appear to be a strong driver of long-term resource utilization; treatments that decrease such deficits offer substantial potential for downline cost savings. Analyzing internationally comparable panel data, such as SHARE, provide valuable insight into long-term cost of stroke. More comprehensive international comparisons will require registries with follow-up, particularly for informal and formal home-based care.Item Open Access Outcomes after laminoplasty compared with laminectomy and fusion in patients with cervical myelopathy: a systematic review.(Spine, 2013-10) Yoon, S Tim; Hashimoto, Robin E; Raich, Annie; Shaffrey, Christopher I; Rhee, John M; Riew, K DanielStudy design
Systematic review.Objective
To determine the effectiveness and safety of cervical laminoplasty versus laminectomy and fusion for the treatment of cervical myelopathy, and to identify any patient subgroups for whom one treatment may result in better outcomes than the other.Summary of background data
Cervical laminoplasty and cervical laminectomy plus fusion are both procedures that treat cervical stenosis induced myelopathy by expanding the space available for the spinal cord. Although there are strong proponents of each procedure, the effectiveness, safety, and differential effectiveness and safety of laminoplasty versus laminectomy and fusion remains unclear.Methods
A systematic search of multiple major medical reference databases was conducted to identify studies that compared laminoplasty with laminectomy and fusion. Studies could include either or both cervical myelopathic spondylosis (CSM) and ossification of the posterior longitudinal ligament. Randomized controlled trials and cohort studies were included. Case reports and studies with less than 10 patients in the comparative group were excluded. Japanese Orthopaedic Association, modified Japanese Orthopaedic Association, and Nurick scores were the primary outcomes measuring myelopathy effectiveness. Reoperation and complication rates were evaluated for safety. Clinical recommendations were made through a modified Delphi approach by applying the Grading of Recommendations Assessment, Development and Evaluation/Agency for Healthcare Research and Quality criteria.Results
The search strategy yielded 305 citations, and 4 retrospective cohort studies ultimately met our inclusion criteria. For patients with CSM, data from 3 class of evidence III retrospective cohort studies suggest that there is no difference between treatment groups in severity of myelopathy or pain: 2 studies reported no significant difference between treatment groups in severity of myelopathy, and 3 studies found no significant difference in pain outcomes between treatment groups. For patients with ossification of the posterior longitudinal ligament, one small class of evidence III retrospective cohort study reported significant improvements in myelopathy severity after laminectomy and fusion compared with laminoplasty, but no differences in long-term pain between treatment groups. The overall evidence on the comparative safety of laminoplasty compared with laminectomy and fusion is inconsistent. Reoperation rates were lower after laminoplasty in 2 of 3 studies reporting. However, the incidence of debilitating neck pain was higher after laminoplasty as reported by one study; results on neurological complications were inconclusive, with 2 studies reporting. Results on kyphotic deformity were inconsistent, with opposite results in the 2 studies reporting. After laminectomy and fusion, 1% to 38% of patients had pseudarthrosis. Infection rates were slightly lower after laminoplasty, but the results are not likely to be statistically significant.Conclusion
For patients with CSM, there is low-quality evidence that suggests that laminoplasty and laminectomy and fusion procedures are similarly effective in treating CSM. For patients with ossification of the posterior longitudinal ligament, the evidence regarding the effectiveness of these procedures is insufficient. For both patient populations, the evidence as to whether one procedure is safer than the other is insufficient. Higher-quality research is necessary to more clearly delineate when one procedure is preferred compared with the other. EVIDENCE-BASED CLINICAL RECOMMENDATIONS:Recommendation
For CSM, evidence suggests that laminoplasty and laminectomy-fusion procedures can be similarly effective. We suggest that surgeons consider each case individually and take into account their own familiarity and expertise with each procedure.Overall strength of evidence
Low.Strength of recommendation
Weak.Item Open Access Predicting health outcomes with intensive longitudinal data collected by mobile health devices: a functional principal component regression approach.(BMC medical research methodology, 2024-03) Yang, Qing; Jiang, Meilin; Li, Cai; Luo, Sheng; Crowley, Matthew J; Shaw, Ryan JBackground
Intensive longitudinal data (ILD) collected in near real time by mobile health devices provide a new opportunity for monitoring chronic diseases, early disease risk prediction, and disease prevention in health research. Functional data analysis, specifically functional principal component analysis, has great potential to abstract trends in ILD but has not been used extensively in mobile health research.Objective
To introduce functional principal component analysis (fPCA) and demonstrate its potential applicability in estimating trends in ILD collected by mobile heath devices, assessing longitudinal association between ILD and health outcomes, and predicting health outcomes.Methods
fPCA and scalar-to-function regression models were reviewed. A case study was used to illustrate the process of abstracting trends in intensively self-measured blood glucose using functional principal component analysis and then predicting future HbA1c values in patients with type 2 diabetes using a scalar-to-function regression model.Results
Based on the scalar-to-function regression model results, there was a slightly increasing trend between daily blood glucose measures and HbA1c. 61% of variation in HbA1c could be predicted by the three preceding months' blood glucose values measured before breakfast (P < 0.0001, [Formula: see text]).Conclusions
Functional data analysis, specifically fPCA, offers a unique tool to capture patterns in ILD collected by mobile health devices. It is particularly useful in assessing longitudinal dynamic association between repeated measures and outcomes, and can be easily integrated in prediction models to improve prediction precision.Item Open Access Recommendations to Improve Health Outcomes Through Recognizing and Supporting Caregivers.(Journal of general internal medicine, 2022-04) Leykum, Luci K; Penney, Lauren S; Dang, Stuti; Trivedi, Ranak B; Noël, Polly H; Pugh, Jacqueline A; Shepherd-Banigan, Megan E; Pugh, Mary Jo; Rupper, Rand; Finley, Erin; Parish-Johnson, Julie; Delgado, Roxana; Peacock, Kimberly; Kalvesmaki, Andrea; Van Houtven, Courtney HItem Open Access Secondary prevention risk interventions via telemedicine and tailored patient education (SPRITE): a randomized trial to improve postmyocardial infarction management.(Circulation. Cardiovascular quality and outcomes, 2011-03) Shah, Bimal R; Adams, Martha; Peterson, Eric D; Powers, Benjamin; Oddone, Eugene Z; Royal, Kira; McCant, Felicia; Grambow, Steven C; Lindquist, Jennifer; Bosworth, Hayden BBackground
Secondary prevention by risk factor modification improves patient outcomes, yet it is often not achieved in clinical practice. Reasons for failure stem from challenges of prioritizing risk factor reduction and engaging patients in changing their behaviors. We hypothesize that a novel telemedicine intervention with tailored patient education could improve cardiovascular risk factors.Methods
To evaluate this intervention, we propose enrolling 450 patients with a recent myocardial infarction and hypertension into a 3-arm randomized, controlled trial. The first arm (n=150) will receive home blood pressure (BP) monitors plus a nurse-delivered, telephone-based tailored patient education intervention and will be enrolled into HealthVault, a Microsoft electronic health record platform. The second arm (n=150) will also receive BP monitors plus a tailored patient education intervention and be enrolled in HeartVault. However, the patient education intervention will be delivered by a Web-based program and will cover topics identical to those in the nurse-delivered intervention. Both arms will be compared with a control group receiving standard care (n=150). All participants will have an in-person assessment at baseline and at completion of the study, including standardized measurements of BP, LDL cholesterol, and glycosylated hemoglobin (in diabetic subjects). The study design will allow assessment of a telephone-based, nurse-administered disease management program versus standard care. The main outcome of interest is the reduction in systolic BP in each intervention group compared with the control group at 12 months. Secondary outcomes assessed will include reductions in LDL cholesterol, body weight, and glycosylated hemoglobin, as well as adherence to evidence-based therapies and improvement in health behaviors.Conclusion
If successful in optimizing BP control, managing other coronary heart disease risk factors, and demonstrating a lower cost, the Web-based disease management tool has the potential to enhance coronary artery disease management, quality of care, and ultimately, patient outcomes. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00901277.Item Open Access Selective versus nonselective fusion for idiopathic scoliosis: does lumbosacral takeoff angle change?(Spine, 2011-06) Abel, Mark F; Herndon, Stephanie K; Sauer, Lindsay D; Novicoff, Wendy M; Smith, Justin S; Shaffrey, Christopher I; Spinal Deformity Study GroupStudy design
Retrospective review of a prospective, multicentered database.Objective
To determine the relationship between preoperative lumbosacral takeoff angle (LSTOA) and postoperative thoracolumbar/lumbar Cobb angle (TL/L Cobb angle) in patients undergoing selective thoracic fusionsSummary of background data
Selective fusion of the thoracic curve can improve the lumbar curve inpatients with idiopathic thoracic scoliosis and a compensatory lumbar curve. Predicting improvement is controversial and determining whether to perform a selective fusion or nonselective fusion can be difficult.Methods
Patients had undergone either nonselective or selective spinal fusion for adolescent or juvenile idiopathic scoliosis (Lenke 1B/3B/1C/3C). Outcome measures were: coronal and sagittal thoracic Cobb angle, TL/L Cobb angles, lumbar apical vertebral translation, LSTOA and coronal decompensation. Analyses compared relationships between preoperative and postoperative radiographic measures.Results
Positive, significant correlations were found between preoperative LSTOA and preoperative TL/L Cobb angle in the nonselective (r=0.7; P<0.001) and selective (r=0.5; P<0.001) fusion groups. Mean two-year postoperative coronal TL/L Cobb angles were significantly improved in nonselective and selective fusion groups (32° and 20°, respectively, P<0.001). In the nonselective fusion group, LSTOA significantly decreased by 11° (P<0.001), and in the selective group, the LSTOA had a modest but significant decrease of 2° (P<0.001). The nonselective fusion also resulted in more lordosis between T10 and L2 (7.5° of lordosis) than the selective approach (2.7° kyphosis, P<0.001). For both groups, upper thoracic kyphosis increased after surgery (P<0.001, P<0.001). For nonselective fusions, regression modeling predicted TL/L Cobb angle at two-year follow-up based on preoperative TL/L Cobb angle and preoperative LSTOA (r=0.4, P<0.001).Conclusion
Collectively, these data demonstrate the preoperative TL/L Cobb angle and LSTOA can be useful predictors of postoperative TL/L Cobb angle after a selective instrumented fusion. Analyses of distal fixation levels demonstrated that to appreciably change the LSTOA using a posterior instrumented fusion, the distal level of fixation must be beyond the lumbar apex.