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BackgroundDementia can impede the relationship and connection between the person with dementia (PWD) and their caregiver. Yet, caregiving in dementia also offers opportunities for connection, which has implications for caregiver and PWD well-being. In this qualitative study, we describe and characterize ways caregivers felt connected to the person with dementia they care for.MethodsWe conducted a telephone-based survey with caregivers of people with dementia. For this paper, we analyzed responses to an open-ended question focused on when caregivers feel most connected to the person they are caring for. Responses were analyzed and coded and themes were identified through an iterative process involving a multidisciplinary team of researchers and clinicians.Results437 caregivers participated in this study. We identified two domains of connection: activity-based and emotion-based connections. Within activity-based connections, the following themes emerged: everyday activities; reminiscing; activities of caregiving; novel experiences; and time with family and friends. Within emotional connections, the following themes emerged: expressions of love, appreciation, and gratitude; physical affection; sharing an emotion or emotional experience; and times when the PWD seems like "themself" again.ConclusionsFindings provide insights into ways caregivers experience a sense of connection with the person they care for. There is a call to shift away from focusing on reducing stress and toward optimizing positive experiences as a way to better support caregivers' health and well-being. Interventions that leverage these insights to foster caregiver - PWD connection could lead to better health and well-being for both members of the dyad. The amplification of a positive experience may be particularly important for caregivers who are struggling with limited support or respite. Clinicians may be interested in using a question about connection as a way to more fully understand a caregiver's current experience.

IntroductionPotentially inappropriate medications (PIMs) cause adverse events and death. We evaluate the Care Ecosystem (CE) collaborative dementia care program on medication use among community-dwelling persons living with dementia (PLWD).MethodsSecondary analysis of a randomized clinical trial (RCT) comparing CE to usual care (UC) on changes in PIMs, over 12 months between March 2015 and May 2020. Secondary outcomes included change in number of medications, clinically relevant PIMs, and anti-dementia medications.ResultsOf 804 PLWD, N = 490 had complete medication data. The CE resulted in significantly fewer PIMs compared to UC (-0.35; 95% CI, -0.49 to -0.20; P

BackgroundHealth systems are increasingly interested in collaborative dementia care. Implementation challenges include the limited dementia specialist workforce, time pressures of high-volume care, increasing use of telemedicine, and inadequate reimbursement. The Care Ecosystem is a telephone-based collaborative dementia care model designed to augment existing healthcare services and be amenable to scale. Here we present the latest evidence for the Care Ecosystem, including the effects among subpopulations at risk for health disparities (rural and Hispanic/Latino), and facilitators from the early phase of Care Ecosystem implementation at 6 diverse health systems.MethodEffectiveness was evaluated in a single-blind, randomized clinical trial (N = 804). Persons with dementia (PWD)-caregiver dyads were randomized to receive 12 months of the intervention (N = 527) or usual care (N = 277). Outcomes were measured via telephone surveys at 6 and 12 months after randomization and medical record review. Subgroup analyses were performed for the 124 dyads who identified as Hispanic/Latino, and the 66 who lived in rural Nebraska or Iowa. The intervention was primarily delivered by an unlicensed, trained care team navigator, who provided education, support and care coordination with supervision and help from a dementia specialist team (advanced practice nurse, social worker, and pharmacist). Implementation facilitators were evaluated through observation and qualitative interviews with clinical teams at 6 health systems implementing the model.ResultsThe PWD-caregiver dyads lived in California (n = 476), Nebraska (n = 286), or Iowa (n = 42). Compared with usual care, the Care Ecosystem improved PWD quality of life, reduced emergency department visits, reduced the use of potentially inappropriate medications, and decreased caregiver depression and caregiver burden. Effect sizes were similar or greater in Hispanic/Latino and rural subgroups on most outcomes. Facilitators of Care Ecosystem implementation included open-access implementation tools (online training, care protocols), the adaptability of the care model, the care team navigator role, and remote care delivery.ConclusionEffective dementia care can be delivered by care team navigators via telephone to mitigate the burdens of dementia, including for underserved PWD living in rural areas or who identify as Hispanic/Latino. Implementation is a challenge although features of the care model appear to facilitate adoption.

Presentation at the Academy Health 2021 Health Datapalooza and National Health Policy Conference

OBJECTIVES: To illustrate specific psychosocial interventions aimed at improving self-efficacy among family caregivers enrolled in the Care Ecosystem, a model of navigated care designed to support persons with dementia and their primary caregivers. Enrolled family caregivers work with unlicensed care team navigators who are trained in dementia care and provide information, linkages to community resources, and emotional support by phone and email. METHOD: We conducted focus groups and interviews with the care team navigators to identify the approaches they used to target caregiver self-efficacy. We assessed mean self-efficacy scores in a sample of 780 family caregivers and selected three exemplary cases in which the caregivers had low self-efficacy scores at baseline with significantly higher scores after six months of participation in the Care Ecosystem intervention. RESULTS: Multiple psychosocial strategies were utilized by care team navigators working with patients with dementia and their family caregivers. Using thematic coding we identified three categories of Care Team Navigator intervention: emotional, informational, and instrumental support. These are consistent with a psychosocial approach to building self-efficacy. DISCUSSION: Self-efficacy represents a family caregivers knowledge and preparedness in managing the challenges of care. Psychosocial support shows benefit in improving caregiver self-efficacy that in turn, may positively influence caregiver health and well-being. The findings in this manuscript demonstrate how a model of navigated care can positively impact self-efficacy among dementia family caregivers.

ObjectivesTo illustrate specific psychosocial interventions aimed at improving self-efficacy among family caregivers enrolled in the Care Ecosystem, a model of navigated care designed to support persons with dementia and their primary caregivers. Enrolled family caregivers work with unlicensed care team navigators who are trained in dementia care and provide information, linkages to community resources, and emotional support by phone and email.MethodWe conducted focus groups and interviews with the care team navigators to identify the approaches they used to target caregiver self-efficacy. We assessed mean self-efficacy scores in a sample of 780 family caregivers and selected three exemplary cases in which the caregivers had low self-efficacy scores at baseline with significantly higher scores after six months of participation in the Care Ecosystem intervention.ResultsMultiple psychosocial strategies were utilized by care team navigators working with patients with dementia and their family caregivers. Using thematic coding we identified three categories of Care Team Navigator intervention: emotional, informational, and instrumental support. These are consistent with a psychosocial approach to building self-efficacy.DiscussionSelf-efficacy represents a family caregiver's knowledge and preparedness in managing the challenges of care. Psychosocial support shows benefit in improving caregiver self-efficacy that in turn, may positively influence caregiver health and well-being. The findings in this manuscript demonstrate how a model of navigated care can positively impact self-efficacy among dementia family caregivers.

BackgroundOlder adults often take multiple medications, leading to a myriad of medication-related problems. Addressing these problems requires thoughtful approaches that align with patients' perspectives and experiences.ObjectiveTo (1) identify and categorize medication-related problems from the patient perspective and (2) understand patient and clinician attitudes toward these problems and experiences with addressing these problems.DesignQualitative, semi-structured interviews with patients and focus groups with physicians and pharmacists.ParticipantsTwenty older adults recruited from an academic medical center and from a community senior center; 14 primary care physicians and 6 pharmacists affiliated with an academic medical center.ApproachHybrid deductive-inductive thematic analysis.Key resultsOlder adults identified a variety of medication-related problems that could be classified into four broad categories: (1) obtaining medications (e.g., problems with cost and insurance coverage); (2) taking medications (e.g., organization and remembering to take pills); (3) medication effects, including side effects and concerns over lack of effectiveness; and (4) communication and care coordination, including information related to medications. Many of the problems described by older adults were framed within the person's socioemotional context, including the impact of medications on interpersonal relationships, emotional wellbeing, and activities that add meaning and quality to life. In contrast, clinicians almost exclusively focused on discrete medication issues without reference to this larger context and expressed relatively little interest in learning more about their patients' perspectives.ConclusionsOlder adults experience medication-related problems as inseparable from their broader life context. Incorporating the social and emotional context of medications and related communication into a problem-focused framework can guide clinicians in specific actions and interventions to address medication-related problems from the patient perspective.

IntroductionMany caregivers of people with dementia experience burden and resulting health effects due to the intensive nature of caregiving. Phone- and web-based care navigation is an innovative model of care that may be useful in addressing caregiver burden in dementia.MethodsQualitative methods (interviews, focus groups, and case study analysis) were used to identify care navigator approaches used to address caregiver burden in dementia as part of a dementia care navigation program.ResultsCare navigators targeted caregiver burden by focusing on strategies to reduce caregiver guilt and frustration, manage patient-related behavior, address caregiver depression, and improve the relationship between the caregiver and person with dementia. The case studies presented demonstrate the ways that care navigators identified patient and caregiver needs and tailored their approaches to meet the specific social, cultural, economic, and geographic contexts of the dyads with which they worked.DiscussionFindings provide insights into strategies used to address caregiver burden through care navigation. Care navigators who speak the same language as the caregivers with whom they work and who have an in-depth understanding of the symptoms of different dementia syndromes may be particularly effective.

ObjectivesCare coordination programs can improve patient outcomes and decrease healthcare expenditures; however, implementation costs are poorly understood. We evaluate the direct costs of implementing a collaborative dementia care program.DesignWe applied a micro-costing analysis to calculate operational costs per-participant-month between March 2015 and May 2017.SettingThe University of California, San Francisco (UCSF) and the University of Nebraska Medical Center (UNMC).ParticipantsParticipants diagnosed with dementia, enrolled in Medicare or Medicaid, 45 years of age or older, residents of California, Nebraska or Iowa, and having a caregiver. The sample was 272 (UCSF) and 192 (UNMC) participants.InterventionA collaborative dementia care program provided by care team navigators (CTNs), advanced practice nurses, a social worker, and a pharmacist, focusing on caregiver support and education, medications, advance care planning, and behavior symptom management.MeasurementsWe measured costs (personnel, supplies, equipment, and training costs) during three program periods, Start-up, Early Operations, and Continuing Operations, and estimated the effects of caseload variation on costs.ResultsStart-up and Early Operations costs were, respectively, $581 and $328 (California), and $501 and $219 (Nebraska) per-participant-month. Average costs decreased across phases to $241 (California) and $142 (Nebraska) per-participant-month during Continuing Operations. We estimated that costs would range between $75 (UNMC) and $92 (UCSF) per-participant-month with the highest projected caseloads (90).ConclusionWe found that CTN caseload is an important driver of service cost. We provide strategies for maximizing caseload without sacrificing quality of care. We also discuss current barriers to broad implementation that can inform new reimbursement policies. J Am Geriatr Soc 67:2628-2633, 2019.

ImportanceFew health systems have adopted effective dementia care management programs. The Care Ecosystem is a model for delivering care from centralized hubs across broad geographic areas to caregivers and persons with dementia (PWDs) independently of their health system affiliations.ObjectiveTo determine whether the Care Ecosystem is effective in improving outcomes important to PWDs, their caregivers, and payers beyond those achieved with usual care.Design, setting, and participantsA single-blind, randomized clinical trial with a pragmatic design was conducted among PWDs and their caregivers. Each PWD-caregiver dyad was enrolled for 12 months between March 20, 2015, and February 28, 2017. Data were collected until March 5, 2018. Study interventions and assessments were administered over the telephone and internet by clinical and research teams in San Francisco, California, and Omaha, Nebraska. Of 2585 referred or volunteer PWD-caregiver dyads in California, Iowa, or Nebraska, 780 met eligibility criteria and were enrolled. A total of 512 PWD-caregiver dyads were randomized to receive care through the Care Ecosystem and 268 dyads to receive usual care. All eligible PWDs had a dementia diagnosis; were enrolled or eligible for enrollment in Medicare or Medicaid; and spoke English, Spanish, or Cantonese. Analyses were intention-to-treat.InterventionTelephone-based collaborative dementia care was delivered by a trained care team navigator, who provided education, support and care coordination with a team of dementia specialists (advanced practice nurse, social worker, and pharmacist).Main outcomes and measuresPrimary outcome measure: Quality of Life in Alzheimer's Disease based on caregiver's rating of 13 aspects of PWD's well-being (including physical health, energy level, mood, living situation, memory, relationships, and finances) on a 4-point scale (poor to excellent). Secondary outcomes: frequencies of PWDs' use of emergency department, hospitalization, and ambulance services; caregiver depression (score on 9-Item Patient Health Questionnaire; higher scores indicate more severe depression); and caregiver burden (score on 12-Item Zarit Burden Interview; higher scores indicate more severe caregiver burden).ResultsThe 780 PWDs (56.3% female; mean [SD] age, 78.1 [9.9] years) and 780 caregivers (70.9% female; mean [SD] age, 64.7 [12.0] years) lived in California (n = 452), Nebraska (n = 284), or Iowa (n = 44). Of 780 dyads, 655 were still active at 12 months, and 571 completed the 12-month survey. Compared with usual care, the Care Ecosystem improved PWD quality of life (B, 0.53; 95% CI, 0.25-1.30; P = .04), reduced emergency department visits (B, -0.14; 95% CI, -0.29 to -0.01; P = .04), and decreased caregiver depression (B, -1.14; 95% CI, -2.15 to -0.13; P = .03) and caregiver burden (B, -1.90; 95% CI, -3.89 to -0.08; P = .046).Conclusions and relevanceEffective care management for dementia can be delivered from centralized hubs to supplement usual care and mitigate the growing societal and economic burdens of dementia.Trial registrationClinicalTrials.gov identifier: NCT02213458.

Abstract Background Children’s ability to engage in meaningful activities is positively influenced by their ability to move independently. Preliminary evidence in children suggests that wheelchair skills training improves wheelchair skills, which are important for independent mobility. The Wheelchair Skills Training Program is a standardized program to teach wheelchair skills. However, it is underutilized in pediatric rehabilitation settings. To increase its utilization, 3 pediatric-specific Wheelchair Skills Training Program resources related to indoor skills were developed (i.e., a storybook, four instructional posters, and a training workbook). This study aimed to describe occupational therapists’ (OTs) and pediatric manual wheelchair users’ (PMWUs) perceived satisfaction with the storybook, instructional posters and training workbook, and to explore their perceptions regarding the usability, relevance, and feasibility of these resources in pediatric rehabilitation settings. Methods A descriptive qualitative design was used. Convenience samples of OTs and PMWUs were recruited in a rehabilitation center and affiliated schools. A focus group with OTs and semi-structured interviews with PMWUs were conducted by videoconference to obtain participants’ feedback on the resource prototypes and suggestions for improvement. Data were deductively analyzed using the Framework method. Results Eight OTs and 5 PMWUs expressed general satisfaction with the resources, describing them as usable, relevant, and feasible to integrate into wheelchair skills training with novice wheelchair users and younger children. All OTs and 3 PMWUs expressed the desire to use the resources for wheelchair skills training. Two PMWUs perceived the resources were not relevant to them because they already mastered the skills. The participants suggested minor modifications for improving the resources (e.g., more action in the story, increased precision of illustrations related to the characters’ position in the wheelchair). Conclusion OTs and PMWUs were satisfied with the resources, perceiving them to be applicable for training wheelchair skills among young children and novice wheelchair users. The resources represent a concrete solution to facilitate the use of the Wheelchair Skills Training Program in pediatric rehabilitation settings. Additional resources are needed to better reach older and more experienced PMWUs (i.e., of intermediate and advanced skill levels).

ImportanceCurrent attempts to gauge the acute care needs of patients with dementia have not effectively addressed the role of caregivers, despite their extensive involvement in decisions about acute care management.ObjectiveTo determine whether caregiver depression is associated with increased use of the emergency department (ED) among patients with dementia.Design, setting, and participantsThis longitudinal cohort study used data from the Care Ecosystem study, a randomized clinical trial examining telephone-based supportive care for patients with dementia and their caregivers. Patients were 45 years or older with any type of dementia. A total of 780 caregiver-patient dyads were enrolled from March 20, 2015, until February 28, 2017, and 663 dyads contributed baseline and 6-month data and were included in the analysis.ExposuresCaregiver depression (9-item Patient Health Questionnaire score of ≥10). Secondary analyses examined caregiver burden and self-efficacy.Main outcomes and measuresThe primary outcome was the number of ED visits in a 6-month period.ResultsAmong the 663 caregivers (467 women and 196 men; mean [SD] age, 64.9 [11.8] years), 84 caregivers (12.7%) had depression at baseline. The mean incidence rate of ED visits was 0.9 per person-year. Rates of ED presentation were higher among dyads whose caregiver did vs did not have depression (1.5 vs 0.8 ED visits per person-year). In a Poisson regression model adjusting for patient age, sex, severity of dementia, number of comorbidities, and baseline ED use, as well as caregiver age and sex, caregiver depression continued to be associated with ED use, with a 73% increase in rates of ED use among dyads with caregivers with depression (adjusted incident rate ratio, 1.73; 95% CI, 1.30-2.30). Caregiver burden was associated with higher ED use in the unadjusted model, but this association did not reach statistical significance after adjustment (incident rate ratio, 1.19; 95% CI, 0.93-1.52). Caregiver self-efficacy was inversely proportional to the number of ED visits in the unadjusted and adjusted models (adjusted incident rate ratio, 0.96; 95% CI, 0.92-0.99).Conclusions and relevanceAmong patients with dementia, caregiver depression appears to be significantly associated with increased ED use, revealing a key caregiver vulnerability, which, if addressed with patient- and caregiver-centered dementia care, could improve health outcomes and lower costs for this high-risk population.

INTRODUCTION: Dementia is among the costliest of medical conditions, but it is not known how these costs vary by dementia subtype. METHODS: The effect of dementia diagnosis subtype on direct health care costs and utilization was estimated using 2015 California Medicare fee-for-service data. Potential drivers of increased costs in Lewy body dementia (LBD), in comparison to Alzheimers disease, were tested. RESULTS: 3,001,987 Medicare beneficiaries were identified, of which 8.2% had a dementia diagnosis. Unspecified dementia was the most common diagnostic category (59.6%), followed by Alzheimers disease (23.2%). LBD was the costliest subtype to Medicare, on average, followed by vascular dementia. The higher costs in LBD were explained in part by falls, urinary incontinence or infection, depression, anxiety, dehydration, and delirium. DISCUSSION: Dementia subtype is an important predictor of health care costs. Earlier identification and targeted treatment might mitigate the costs associated with co-occurring conditions in LBD.

BACKGROUND: Care navigation is an approach to personalized care management and care coordination that can help overcome barriers to care. Care navigation has not been extensively studied in dementia, where health care workforce innovations are needed as a result of increasing disease prevalence and resulting costs to the health care system. OBJECTIVE: To identify facilitators and barriers to care navigation in dementia and to assess dementia caregiver satisfaction with care navigation. METHODS: Methods include qualitative research (interviews, focus groups, observations) with Care Team Navigators (CTNs) who were part of a dementia care navigation program, the Care Ecosystem, and a quantitative survey with caregivers about their experiences with CTNs. Transcripts were analyzed to identify themes within the data. RESULTS: CTNs identified the following facilitators to care navigation in dementia: working closely with caregivers; providing emotional support; tailoring education and resources; and coordinating with a clinical team around issues ranging from clinical questions to financial and legal decision-making. The barriers CTNS identified included burn-out, the progressive nature of the disease; coordinating with primary care providers; and identifying resources for dyads who are low-income, do not speak English, or live in rural areas. Caregivers across both sites highly rated CTNs, though satisfaction was higher among those in Nebraska and Iowa. CONCLUSIONS: Innovative approaches to care delivery in dementia are crucial. Care navigation offers a feasible model to train unlicensed people to deliver care as a way to deliver larger-scale support for the growing population of adults living with dementia and their caregivers.

IntroductionValid and reliable scores from measurement tools to test competency in basic manual wheelchair-service-provision are needed to promote good practice and support capacity building. The International Society of Wheelchair Professionals' (ISWP) Basic Test Version 1 in English, launched in 2015, is the most frequently used outcome measure tool to test basic manual wheelchair-service-provision knowledge and is part of an international certification process. Despite the wide acceptance and use of the test, its psychometric properties have not yet been established. The objectives of this study were 1) to evaluate the test's psychometric properties, 2) to develop the test's Version 2, and 3) to evaluate the content validity of the new version.MethodsFor Objective 1, methods from the Classical Test Theory were used to obtain items' difficulty, item discrimination index and domains' reliability. For Objective 2, a team of experts in wheelchair service delivery and education conducted a systematic qualitative review of the questions' text and answers and updated them using evidence-based guidelines. For Objective 3, an external team reviewed the clarity, relevance and domain allocation of the developed items using a 4-point Likert scale. Descriptive statistics were used to describe and characterize the results for each objective. Item-content (I-CVI) and Scale-content (S-CVI) validity indexes were calculated to compute content validity.ResultsFor Objective 1, all domains in the test were below the threshold for acceptable internal consistency reliability; 80% of the total test pool (116 items from the total pool of 145) did not meet the thresholds for item difficulty and index of discrimination suggested in the literature. Of the items in the Test, 78% could be responded to intuitively and 66% did not distinguish between test-takers who were knowledgeable in the content area and those who were not. For Objective 2, experts found concerns such as items being grouped in the wrong domain, being repeated, not using person-first language, and using terms inconsistently. Thirty-four (23.4%) items were dropped and 111 (76.5%) were updated. In addition, 61 new items were developed. Members re-categorized the items and proposed a new classification of subdomains. For Objective 3, good agreement between subject-matter experts was found; the S-CVI calculated using the I-CVIs related to item clarity was 84% while using the I-CVIs related to item relevance was 98%. Only 7 items (4.1%) were deemed to be in the wrong domain and 4 items (2.3%) were considered irrelevant and dropped.ConclusionThe psychometric evidence in support of ISWP Basic Test Version 1 in English is suboptimal. A new set of items developed by experts in the field has shown excellent content validity. Ongoing assessments will be needed as ISWP Basic Test Version 2 is implemented and monitored.

Abstract Background Registration of clinical trials has been introduced largely to reduce bias toward statistically significant results in the trial literature. Doubts remain about whether advance registration alone is an adequate measure to reduce selective publication, selective outcome reporting, and biased design. One of the first areas of medicine in which registration was widely adopted was oncology, although the bulk of registered oncology trials remain unpublished. The net influence of registration on the literature remains untested. This study compares the prevalence of favorable results and conclusions among published reports of registered and unregistered randomized controlled trials of new oncology drugs. Methods We conducted a cross-sectional study of published original research articles reporting clinical trials evaluating the efficacy of drugs newly approved for antimalignancy indications by the United States Food and Drug Administration (FDA) from 2000 through 2005. Drugs receiving first-time approval for indications in oncology were identified using the FDA web site and Thomson Centerwatch. Relevant trial reports were identified using PubMed and the Cochrane Library. Evidence of advance trial registration was obtained by a search of clinicaltrials.gov, WHO, ISRCTN, NCI-PDQ trial databases and corporate trial registries, as well as articles themselves. Data on blinding, results for primary outcomes, and author conclusions were extracted independently by two coders. Univariate and multivariate logistic regression identified associations between favorable results and conclusions and independent variables including advance registration, study design characteristics, and industry sponsorship. Results Of 137 original research reports from 115 distinct randomized trials assessing 25 newly approved drugs for treating cancer, the 54 publications describing data from trials registered prior to publication were as likely to report statistically significant efficacy results and reach conclusions favoring the test drug (for results, OR = 1.77; 95% CI = 0.87 to 3.61) as reports of trials not registered in advance. In multivariate analysis, reports of prior registered trials were again as likely to favor the test drug (OR = 1.29; 95% CI = 0.54 to 3.08); large sample sizes and surrogate outcome measures were statistically significant predictors of favorable efficacy results at p < 0.05. Subgroup analysis of the main reports from each trial (n = 115) similarly indicated that registered trials were as likely to report results favoring the test drug as trials not registered in advance (OR = 1.11; 95% CI = 0.44 to 2.80), and also that large trials and trials with nonstringent blinding were significantly more likely to report results favoring the test drug. Conclusions Trial registration alone, without a requirement for full reporting of research results, does not appear to reduce a bias toward results and conclusions favoring new drugs in the clinical trials literature. Our findings support the inclusion of full results reporting in trial registers, as well as protocols to allow assessment of whether results have been completely reported.

BackgroundThe United States (US) Food and Drug Administration (FDA) approves new drugs based on sponsor-submitted clinical trials. The publication status of these trials in the medical literature and factors associated with publication have not been evaluated. We sought to determine the proportion of trials submitted to the FDA in support of newly approved drugs that are published in biomedical journals that a typical clinician, consumer, or policy maker living in the US would reasonably search.Methods and findingsWe conducted a cohort study of trials supporting new drugs approved between 1998 and 2000, as described in FDA medical and statistical review documents and the FDA approved drug label. We determined publication status and time from approval to full publication in the medical literature at 2 and 5 y by searching PubMed and other databases through 01 August 2006. We then evaluated trial characteristics associated with publication. We identified 909 trials supporting 90 approved drugs in the FDA reviews, of which 43% (394/909) were published. Among the subset of trials described in the FDA-approved drug label and classified as "pivotal trials" for our analysis, 76% (257/340) were published. In multivariable logistic regression for all trials 5 y postapproval, likelihood of publication correlated with statistically significant results (odds ratio [OR] 3.03, 95% confidence interval [CI] 1.78-5.17); larger sample sizes (OR 1.33 per 2-fold increase in sample size, 95% CI 1.17-1.52); and pivotal status (OR 5.31, 95% CI 3.30-8.55). In multivariable logistic regression for only the pivotal trials 5 y postapproval, likelihood of publication correlated with statistically significant results (OR 2.96, 95% CI 1.24-7.06) and larger sample sizes (OR 1.47 per 2-fold increase in sample size, 95% CI 1.15-1.88). Statistically significant results and larger sample sizes were also predictive of publication at 2 y postapproval and in multivariable Cox proportional models for all trials and the subset of pivotal trials.ConclusionsOver half of all supporting trials for FDA-approved drugs remained unpublished >/= 5 y after approval. Pivotal trials and trials with statistically significant results and larger sample sizes are more likely to be published. Selective reporting of trial results exists for commonly marketed drugs. Our data provide a baseline for evaluating publication bias as the new FDA Amendments Act comes into force mandating basic results reporting of clinical trials.

BackgroundPublished pharmaceutical industry-sponsored trials are more likely than non-industry-sponsored trials to report results and conclusions that favor drug over placebo. Little is known about potential biases in drug-drug comparisons. This study examined associations between research funding source, study design characteristics aimed at reducing bias, and other factors that potentially influence results and conclusions in randomized controlled trials (RCTs) of statin-drug comparisons.Methods and findingsThis is a cross-sectional study of 192 published RCTs comparing a statin drug to another statin drug or non-statin drug. Data on concealment of allocation, selection bias, blinding, sample size, disclosed funding source, financial ties of authors, results for primary outcomes, and author conclusions were extracted by two coders (weighted kappa 0.80 to 0.97). Univariate and multivariate logistic regression identified associations between independent variables and favorable results and conclusions. Of the RCTs, 50% (95/192) were funded by industry, and 37% (70/192) did not disclose any funding source. Looking at the totality of available evidence, we found that almost all studies (98%, 189/192) used only surrogate outcome measures. Moreover, study design weaknesses common to published statin-drug comparisons included inadequate blinding, lack of concealment of allocation, poor follow-up, and lack of intention-to-treat analyses. In multivariate analysis of the full sample, trials with adequate blinding were less likely to report results favoring the test drug, and sample size was associated with favorable conclusions when controlling for other factors. In multivariate analysis of industry-funded RCTs, funding from the test drug company was associated with results (odds ratio = 20.16 [95% confidence interval 4.37-92.98], p < 0.001) and conclusions (odds ratio = 34.55 [95% confidence interval 7.09-168.4], p < 0.001) that favor the test drug when controlling for other factors. Studies with adequate blinding were less likely to report statistically significant results favoring the test drug.ConclusionsRCTs of head-to-head comparisons of statins with other drugs are more likely to report results and conclusions favoring the sponsor's product compared to the comparator drug. This bias in drug-drug comparison trials should be considered when making decisions regarding drug choice.

Abstract Background The United Nations has called for countries to improve access to mobility devices when needed. The World Health Organization has published guidelines on the provision of manual wheelchairs in less-resourced settings. Yet little is known about the extent to which appropriate wheelchairs are available and provided according to international guidelines. This study’s purpose was to describe wheelchair users’ experiences receiving services and acquiring wheelchair skills in urban and peri-urban areas of Kenya and the Philippines. Methods Local researchers in Nairobi and Manila interviewed 48 adult basic wheelchair users, with even distribution of those who had and had not received wheelchair services along with their wheelchair. Recordings were transcribed in the local language and translated into English. The study team coded transcripts for predetermined and emergent themes, using Atlas-ti software. A qualitative content analysis approach was taken with the WHO service delivery process as an organizing framework. Results Wheelchair users frequently described past experiences with ill-fitting wheelchairs and little formal training to use wheelchairs effectively. Through exposure to multiple wheelchairs and self-advocacy, they learned to select wheelchairs suitable for their needs. Maintenance and repair services were often in short supply. Participants attributed shorter duration of wheelchair use to lack of repair. Peer support networks emerged as an important source of knowledge, resources and emotional support. Most participants acknowledged that they received wheelchairs that would have been difficult or impossible for them to pay for, and despite challenges, they were grateful to have some means of mobility. Four themes emerged as critical for understanding the implementation of wheelchair services: barriers in the physical environment, the need for having multiple chairs to improve access, perceived social stigma, and the importance of peer support. Conclusions Interventions are needed to provide wheelchairs services efficiently, at scale, in an environment facilitating physical access and peer support, and reduced social stigma. Trial registration Not applicable since this was a descriptive study.

No abstract available.

Background: The World Health Organisation recommends that services accompany wheelchair distribution. This study examined the relationship of wheelchair service provision in Kenya and the Philippines and wheelchair-use–related outcomes. Method: We surveyed 852 adult basic manual wheelchair users. Participants who had received services and those who had not were sought in equal numbers from wheelchair-distribution entities. Outcomes assessed were daily wheelchair use, falls, unassisted outdoor use and performance of activities of daily living (ADL). Descriptive, bivariate and multivariable regression model results are presented. Results: Conditions that led to the need for a basic wheelchair were mainly spinal cord injury, polio/post-polio, and congenital conditions. Most Kenyans reported high daily wheelchair use (60%) and ADL performance (80%), while these practices were less frequent in the Philippine sample (42% and 74%, respectively). Having the wheelchair fit assessed while the user propelled the wheelchair was associated with greater odds of high ADL performance in Kenya (odds ratio [OR] 2.8, 95% confidence interval [CI] 1.6, 5.1) and the Philippines (OR 2.8, 95% CI 1.8, 4.5). Wheelchair-related training was associated with high ADL performance in Kenya (OR 3.2, 95% CI 1.3, 8.4). In the Philippines, training was associated with greater odds of high versus no daily wheelchair use but also odds of serious versus no falls (OR 2.5, 95% CI 1.4, 4.5). Conclusion: Select services that were associated with some better wheelchair use outcomes and should be emphasised in service delivery. Service providers should be aware that increased mobility may lead to serious falls.

Objective: In this study, we aimed to describe the burden of family caregivers providing powered wheelchair-related and overall assistance and test the hypotheses that caregiver burden correlates with participation, wheelchair skills capacity, anxiety, depression, and social support. Methods: Cross-sectional study. Participants included 35 family caregivers of powered wheelchair users. Caregivers were assessed using the Power Mobility Caregiver Assistive Technology Outcome Measure, Late Life Disability Instrument, Wheelchair Skills Test Questionnaire for caregivers, Hospital Anxiety and Depression Scale, and Interpersonal Support Evaluation List–12. Results: The most burdensome powered wheelchair assistance items were providing verbal hints/directions, needing to be nearby, anxiety, and fear that user may be harmed. The most burdensome overall assistance item was feeling limited in recreational/leisure activities. Caregiver burden was significantly correlated with participation limitations, anxiety, depression, and social support. Discussion: Caregivers experience burden for wheelchair-related and overall help, especially psychological burden. Such results have implications for the type of resources required to support family caregivers.

To test the hypotheses that community-dwelling veterans with spinal cord injury (SCI) who receive the Wheelchair Skills Training Program (WSTP) in their own environments significantly improve their manual wheelchair-skills capacity, retain those improvements at one year and improve participation in comparison with an Educational Control (EC) group.We carried out a randomized controlled trial, studying 106 veterans with SCI from three Veterans Affairs rehabilitation centers. Each participant received either five one-on-one WSTP or EC sessions 30-45 minutes in duration. The main outcome measures were the total and subtotal percentage capacity scores from the Wheelchair Skills Test 4.1 (WST) and Craig Handicap Assessment and Reporting Technique (CHART) scores.Participants in the WSTP group improved their total and Advanced-level WST scores by 7.1% and 30.1% relative to baseline (p < 0.001) and retained their scores at one year follow-up. The success rates for individual skills were consistent with the total and subtotal WST scores. The CHART Mobility sub-score improved by 3.2% over baseline (p = 0.021).Individualized wheelchair skills training in the home environment substantially improves the advanced and total wheelchair skills capacity of experienced community-dwelling veterans with SCI but has only a small impact on participation.