Secondary outcome analysis for data from an outcome-dependent sampling design.

PubMed

Pan, Yinghao; Cai, Jianwen; Longnecker, Matthew P; Zhou, Haibo

2018-04-22

Outcome-dependent sampling (ODS) scheme is a cost-effective way to conduct a study. For a study with continuous primary outcome, an ODS scheme can be implemented where the expensive exposure is only measured on a simple random sample and supplemental samples selected from 2 tails of the primary outcome variable. With the tremendous cost invested in collecting the primary exposure information, investigators often would like to use the available data to study the relationship between a secondary outcome and the obtained exposure variable. This is referred as secondary analysis. Secondary analysis in ODS designs can be tricky, as the ODS sample is not a random sample from the general population. In this article, we use the inverse probability weighted and augmented inverse probability weighted estimating equations to analyze the secondary outcome for data obtained from the ODS design. We do not make any parametric assumptions on the primary and secondary outcome and only specify the form of the regression mean models, thus allow an arbitrary error distribution. Our approach is robust to second- and higher-order moment misspecification. It also leads to more precise estimates of the parameters by effectively using all the available participants. Through simulation studies, we show that the proposed estimator is consistent and asymptotically normal. Data from the Collaborative Perinatal Project are analyzed to illustrate our method. Copyright © 2018 John Wiley & Sons, Ltd.

Agreement in reporting between trial publications and current clinical trial registry in high impact journals: A methodological review.

PubMed

Kosa, Sarah Daisy; Mbuagbaw, Lawrence; Borg Debono, Victoria; Bhandari, Mohit; Dennis, Brittany B; Ene, Gabrielle; Leenus, Alvin; Shi, Daniel; Thabane, Michael; Valvasori, Sara; Vanniyasingam, Thuva; Ye, Chenglin; Yranon, Elgene; Zhang, Shiyuan; Thabane, Lehana

2018-02-01

The primary objective of this systematic survey was to examine the percentage of studies in which there was agreement in the reporting of the primary outcome between the currently updated version of the clinical trial registry and the published paper. We also investigated the factors associated with agreement in reporting of the primary outcome. We searched PubMed for all randomized control trials (RCT)s published in 2012-2015 in the top five general medicine journals (based on the 2014 impact factor). Two hundred abstracts (50 from each year) were randomly selected for data extraction. Agreement in reporting of 11 key study conduct items (e.g., sample size) and study characteristics (e.g., funding, number of sites) were extracted by two independent reviewers. Descriptive analyses were conducted to determine the proportion of studies on which there was agreement in reporting of key study conduct items. Generalized estimating equations were used to explore factors associated with agreement in reporting of the primary outcome. Of the 200 included studies, 87% had agreement in reporting of the primary outcome. After adjusting for other covariates, having greater than 50 sites was associated with an increased likelihood of agreement in reporting of the primary outcome (odds ratio=7.1, 95% confidence interval=1.39, 36.27, p=0.018). We identified substantive disagreement in reporting between publications and current clinical trial registry, which were associated with several study characteristics. Further measures are needed to improve reporting given the potential threats to the quality and integrity of scientific research. Copyright © 2017 Elsevier Inc. All rights reserved.

Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology

PubMed Central

Azar, Marleine; Riehm, Kira E.; McKay, Dean; Thombs, Brett D.

2015-01-01

Background Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Methods Eligible RCTs were published in JCCP in 2013–2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Results Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). Conclusions The quality of published outcome analysis definitions and trial registrations in JCCP is suboptimal. Greater attention to proper trial registration and outcome analysis definition in published reports is needed. PMID:26581079

Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

PubMed

Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D

2015-01-01

Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is suboptimal. Greater attention to proper trial registration and outcome analysis definition in published reports is needed.

Evidence of selective reporting bias in hematology journals: A systematic review

PubMed Central

Scheckel, Caleb; Hicks, Chandler; Nissen, Timothy; Leduc, Linda; Som, Mousumi; Vassar, Matt

2017-01-01

Introduction Selective reporting bias occurs when chance or selective outcome reporting rather than the intervention contributes to group differences. The prevailing concern about selective reporting bias is the possibility of results being modified towards specific conclusions. In this study, we evaluate randomized controlled trials (RCTs) published in hematology journals, a group in which selective outcome reporting has not yet been explored. Methods Our primary goal was to examine discrepancies between the reported primary and secondary outcomes in registered and published RCTs concerning hematological malignancies reported in hematology journals with a high impact factor. The secondary goals were to address whether outcome reporting discrepancies favored statistically significant outcomes, whether a pattern existed between the funding source and likelihood of outcome reporting bias, and whether temporal trends were present in outcome reporting bias. For trials with major outcome discrepancies, we contacted trialists to determine reasons for these discrepancies. Trials published between January 1, 2010 and December 31, 2015 in Blood; British Journal of Haematology; American Journal of Hematology; Leukemia; and Haematologica were included. Results Of 499 RCTs screened, 109 RCTs were included. Our analysis revealed 118 major discrepancies and 629 total discrepancies. Among the 118 discrepancies, 30 (25.4%) primary outcomes were demoted, 47 (39.8%) primary outcomes were omitted, and 30 (25.4%) primary outcomes were added. Three (2.5%) secondary outcomes were upgraded to a primary outcome. The timing of assessment for a primary outcome changed eight (6.8%) times. Thirty-one major discrepancies were published with a P-value and twenty-five (80.6%) favored statistical significance. A majority of authors whom we contacted cited a pre-planned subgroup analysis as a reason for outcome changes. Conclusion Our results suggest that outcome changes occur frequently in hematology trials. Because RCTs ultimately underpin clinical judgment and guide policy implementation, selective reporting could pose a threat to medical decision making. PMID:28570573

The association between the supply of primary care physicians and population health outcomes in Korea.

PubMed

Lee, Juhyun; Park, Sangmin; Choi, Kyunghyun; Kwon, Soon-Man

2010-10-01

Several studies reported that primary care improves health outcomes for populations. The objective of this study was to examine the relationship between the supply of primary care physicians and population health outcomes in Korea. Data were extracted from the 2007 report of the Health Insurance Review, the 2005 report from the Korean National Statistical Office, and the 2008 Korean Community Health Survey. The dependent variables were age-adjusted all-cause and disease-specific mortality rates, and independent variables were the supply of primary care physicians, the ratio of primary care physicians to specialists, the number of beds, socioeconomic factors (unemployment rate, local tax, education), population (population size, proportion of the elderly over age 65), and health behaviors (smoking, exercise, using seat belts rates). We used multivariate linear regression as well as ANOVA and t tests. A higher number of primary care physicians was associated with lower all-cause mortality, cancer mortality, and cardiovascular mortality. However, the ratio of primary care physicians to specialists was not related to all-cause mortality. In addition, the relationship between socioeconomic variables and mortality rates was similar in strength to the relationship between the supply of primary care physicians and mortality rates. Accident mortality, suicide mortality, infection mortality, and perinatal mortality were not related to the supply of primary care physicians. The supply of primary care physicians is associated with improved health outcomes, especially in chronic diseases and cancer. However, other variables such as the socioeconomic factors and population factors seem to have a more significant influence on these outcomes.

Systematic review of knowledge translation strategies in the allied health professions.

PubMed

Scott, Shannon D; Albrecht, Lauren; O'Leary, Kathy; Ball, Geoff D C; Hartling, Lisa; Hofmeyer, Anne; Jones, C Allyson; Klassen, Terry P; Kovacs Burns, Katharina; Newton, Amanda S; Thompson, David; Dryden, Donna M

2012-07-25

Knowledge translation (KT) aims to close the research-practice gap in order to realize and maximize the benefits of research within the practice setting. Previous studies have investigated KT strategies in nursing and medicine; however, the present study is the first systematic review of the effectiveness of a variety of KT interventions in five allied health disciplines: dietetics, occupational therapy, pharmacy, physiotherapy, and speech-language pathology. A health research librarian developed and implemented search strategies in eight electronic databases (MEDLINE, CINAHL, ERIC, PASCAL, EMBASE, IPA, Scopus, CENTRAL) using language (English) and date restrictions (1985 to March 2010). Other relevant sources were manually searched. Two reviewers independently screened the titles and abstracts, reviewed full-text articles, performed data extraction, and performed quality assessment. Within each profession, evidence tables were created, grouping and analyzing data by research design, KT strategy, targeted behaviour, and primary outcome. The published descriptions of the KT interventions were compared to the Workgroup for Intervention Development and Evaluation Research (WIDER) Recommendations to Improve the Reporting of the Content of Behaviour Change Interventions. A total of 2,638 articles were located and the titles and abstracts were screened. Of those, 1,172 full-text articles were reviewed and subsequently 32 studies were included in the systematic review. A variety of single (n = 15) and multiple (n = 17) KT interventions were identified, with educational meetings being the predominant KT strategy (n = 11). The majority of primary outcomes were identified as professional/process outcomes (n = 25); however, patient outcomes (n = 4), economic outcomes (n = 2), and multiple primary outcomes (n = 1) were also represented. Generally, the studies were of low methodological quality. Outcome reporting bias was common and precluded clear determination of intervention effectiveness. In the majority of studies, the interventions demonstrated mixed effects on primary outcomes, and only four studies demonstrated statistically significant, positive effects on primary outcomes. None of the studies satisfied the four WIDER Recommendations. Across five allied health professions, equivocal results, low methodological quality, and outcome reporting bias limited our ability to recommend one KT strategy over another. Further research employing the WIDER Recommendations is needed to inform the development and implementation of effective KT interventions in allied health.

A systematic review of chronic disease management interventions in primary care.

PubMed

Reynolds, Rebecca; Dennis, Sarah; Hasan, Iqbal; Slewa, Jan; Chen, Winnie; Tian, David; Bobba, Sangeetha; Zwar, Nicholas

2018-01-09

Primary and community care are key settings for the effective management of long term conditions. We aimed to evaluate the pattern of health outcomes in chronic disease management interventions for adults with physical health problems implemented in primary or community care settings. The methods were based on our previous review published in 2006. We performed database searches for articles published from 2006 to 2014 and conducted a systematic review with narrative synthesis using the Cochrane Effective Practice and Organisation of Care taxonomy to classify interventions and outcomes. The interventions were mapped to Chronic Care Model elements. The pattern of outcomes related to interventions was summarized by frequency of statistically significant improvements in health care provision and patient outcomes. A total of 9589 journal articles were retrieved from database searches and snowballing. After screening and verification, 165 articles that detailed 157 studies were included. There were few studies with Health Care Organization (1.9% of studies) or Community Resources (0.6% of studies) as the primary intervention element. Self-Management Support interventions (45.8% of studies) most frequently resulted in improvements in patient-level outcomes. Delivery System Design interventions (22.6% of studies) showed benefits in both professional and patient-level outcomes for a narrow range of conditions. Decision Support interventions (21.3% of studies) had impact limited to professional-level outcomes, in particular use of medications. The small number of studies of Clinical Information System interventions (8.9%) showed benefits for both professional- and patient-level outcomes. The published literature has expanded substantially since 2006. This review confirms that Self-Management Support is the most frequent Chronic Care Model intervention that is associated with statistically significant improvements, predominately for diabetes and hypertension.

Specialist outreach clinics in primary care and rural hospital settings.

PubMed

Gruen, R L; Weeramanthri, T S; Knight, S E; Bailie, R S

2004-01-01

Specialist medical practitioners have conducted clinics in primary care and rural hospital settings for a variety of reasons in many different countries. Such clinics have been regarded as an important policy option for increasing the accessibility and effectiveness of specialist services and their integration with primary care services. To undertake a descriptive overview of studies of specialist outreach clinics and to assess the effectiveness of specialist outreach clinics on access, quality, health outcomes, patient satisfaction, use of services, and costs. We searched the Cochrane Effective Practice and Organisation of Care (EPOC) specialised register (March 2002), the Cochrane Controlled Trials Register (CCTR) (Cochrane Library Issue 1, 2002), MEDLINE (including HealthStar) (1966 to May 2002), EMBASE (1988 to March 2002), CINAHL (1982 to March 2002), the Primary-Secondary Care Database previously maintained by the Centre for Primary Care Research in the Department of General Practice at the University of Manchester, a collection of studies from the UK collated in "Specialist Outreach Clinics in General Practice" (Roland 1998), and the reference lists of all retrieved articles. Randomised trials, controlled before and after studies and interrupted time series analyses of visiting specialist outreach clinics in primary care or rural hospital settings, either providing simple consultations or as part of complex multifaceted interventions. The participants were patients, specialists, and primary care providers. The outcomes included objective measures of access, quality, health outcomes, satisfaction, service use, and cost. Four reviewers working in pairs independently extracted data and assessed study quality. 73 outreach interventions were identified covering many specialties, countries and settings. Nine studies met the inclusion criteria. Most comparative studies came from urban non-disadvantaged populations in developed countries. Simple 'shifted outpatients' styles of specialist outreach were shown to improve access, but there was no evidence of impact on health outcomes. Specialist outreach as part of more complex multifaceted interventions involving collaboration with primary care, education or other services was associated with improved health outcomes, more efficient and guideline-consistent care, and less use of inpatient services. The additional costs of outreach may be balanced by improved health outcomes. This review supports the hypothesis that specialist outreach can improve access, outcomes and service use, especially when delivered as part of a multifaceted intervention. The benefits of simple outreach models in urban non-disadvantaged settings seem small. There is a need for good comparative studies of outreach in rural and disadvantaged settings where outreach may confer most benefit to access and health outcomes.

The Effects of Career Calling and Perceived Overqualification on Work Outcomes for Primary and Secondary School Teachers

ERIC Educational Resources Information Center

Lobene, Eleni V.; Meade, Adam W.

2013-01-01

While perceived overqualification (POQ) has received increased research attention in recent years, the identification of variables that moderate POQ-outcome relationships is critical to our understanding of how the construct affects career outcomes. This study, involving 170 full-time primary and secondary school educators in a suburban…

Outcome-Reporting Bias in Education Research

ERIC Educational Resources Information Center

Pigott, Therese D.; Valentine, Jeffrey C.; Polanin, Joshua R.; Williams, Ryan T.; Canada, Dericka D.

2013-01-01

Outcome-reporting bias occurs when primary studies do not include information about all outcomes measured in a study. When studies omit findings on important measures, efforts to synthesize the research using systematic review techniques will be biased and interpretations of individual studies will be incomplete. Outcome-reporting bias has been…

Direct observation of weight-related communication in primary care: a systematic review.

PubMed

McHale, Calum T; Laidlaw, Anita H; Cecil, Joanne E

2016-08-01

Primary care is ideally placed to play an effective role in patient weight management; however, patient weight is seldom discussed in this context. A synthesis of studies that directly observe weight discussion in primary care is required to more comprehensively understand and improve primary care weight-related communication. To systematically identify and examine primary care observational research that investigates weight-related communication and its relationship to patient weight outcomes. A systematic review of literature published up to August 2015, using seven electronic databases (including MEDLINE, Scopus and PsycINFO), was conducted using search terms such as overweight, obese and/or doctor-patient communication. Twenty papers were included in the final review. Communication analysis focused predominantly on 'practitioner' use of specific patient-centred communication. Practitioner use of motivational interviewing was associated with improved patient weight-related outcomes, including patient weight loss and increased patient readiness to lose weight; however, few studies measured patient weight-related outcomes. Studies directly observing weight-related communication in primary care are scarce and limited by a lack of focus on patient communication and patient weight-related outcomes. Future research should measure practitioner and patient communications during weight discussion and their impact on patient weight-related outcomes. This knowledge may inform the development of a communication intervention to assist practitioners to more effectively discuss weight with their overweight and/or obese patients. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Physician-patient communication in the primary care office: a systematic review.

PubMed

Beck, Rainer S; Daughtridge, Rebecca; Sloane, Philip D

2002-01-01

The physician-patient interview is the key component of all health care, particularly of primary medical care. This review sought to evaluate existing primary-care-based research studies to determine which verbal and nonverbal behaviors on the part of the physician during the medical encounter have been linked in empirical studies with favorable patient outcomes. We reviewed the literature from 1975 to 2000 for studies of office interactions between primary care physicians and patients that evaluated these interactions empirically using neutral observers who coded observed encounters, videotapes, or audiotapes. Each study was reviewed for the quality of the methods and to find statistically significant relations between specific physician behaviors and patient outcomes. In examining nonverbal behaviors, because of a paucity of clinical outcome studies, outcomes were expanded to include associations with patient characteristics or subjective ratings of the interaction by observers. We found 14 studies of verbal communication and 8 studies of nonverbal communication that met inclusion criteria. Verbal behaviors positively associated with health outcomes included empathy, reassurance and support, various patient-centered questioning techniques, encounter length, history taking, explanations, both dominant and passive physician styles, positive reinforcement, humor, psychosocial talk, time in health education and information sharing, friendliness, courtesy, orienting the patient during examination, and summarization and clarification. Nonverbal behaviors positively associated with outcomes included head nodding, forward lean, direct body orientation, uncrossed legs and arms, arm symmetry, and less mutual gaze. Existing research is limited because of lack of consensus of what to measure, conflicting findings, and relative lack of empirical studies (especially of nonverbal behavior). Nonetheless, medical educators should focus on teaching and reinforcing behaviors known to be facilitative, and to continue to understand further how physician behavior can enhance favorable patient outcomes, such as understanding and adherence to medical regimens and overall satisfaction.

Clinical outcomes of HIV care delivery models in the US: a systematic review.

PubMed

Kimmel, April D; Martin, Erika G; Galadima, Hadiza; Bono, Rose S; Tehrani, Ali Bonakdar; Cyrus, John W; Henderson, Margaret; Freedberg, Kenneth A; Krist, Alexander H

2016-10-01

With over 1 million people living with HIV, the US faces national challenges in HIV care delivery due to an inadequate HIV specialist workforce and the increasing role of non-communicable chronic diseases in driving morbidity and mortality in HIV-infected patients. Alternative HIV care delivery models, which include substantial roles for advanced practitioners and/or coordination between specialty and primary care settings in managing HIV-infected patients, may address these needs. We aimed to systematically review the evidence on patient-level HIV-specific and primary care health outcomes for HIV-infected adults receiving outpatient care across HIV care delivery models. We identified randomized trials and observational studies from bibliographic and other databases through March 2016. Eligible studies met pre-specified eligibility criteria including on care delivery models and patient-level health outcomes. We considered all available evidence, including non-experimental studies, and evaluated studies for risk of bias. We identified 3605 studies, of which 13 met eligibility criteria. Of the 13 eligible studies, the majority evaluated specialty-based care (9 studies). Across all studies and care delivery models, eligible studies primarily reported mortality and antiretroviral use, with specialty-based care associated with mortality reductions at the clinician and practice levels and with increased antiretroviral initiation or use at the clinician level but not the practice level. Limited and heterogeneous outcomes were reported for other patient-level HIV-specific outcomes (e.g., viral suppression) as well as for primary care health outcomes across all care delivery models. No studies addressed chronic care outcomes related to aging. Limited evidence was available across geographic settings and key populations. As re-design of care delivery in the US continues to evolve, better understanding of patient-level HIV-related and primary care health outcomes, especially across different staffing models and among different patient populations and geographic locations, is urgently needed to improve HIV disease management.

Considering disparities: How do nurse practitioner regulatory policies, access to care, and health outcomes vary across four states?

PubMed

Sonenberg, Andréa; Knepper, Hillary J

Health disparities persist among morbidity and mortality rates in the United States. Contributing significantly to these disparities are the ability to pay for health care (largely, access to health insurance) and access to, and capacity of, the primary care health workforce. This article examines key determinants of health (DOH) including demographics, public and regulatory policies, health workforce capacity, and primary health outcomes of four states of the United States. The context of this study is the potential association among health care disparities and myriad DOH, among them, the restrictive nurse practitioner (NP) scope of practice (SOP) regulatory environment, which are documented to influence access to care and health outcomes. This descriptive study explores current NP SOP regulations, access to primary care, and health outcomes of key chronic disease indicators-diabetes, hypertension, and obesity in Alabama, Colorado, Mississippi, and Utah. These states represent both the greatest disparity in chronic disease health outcomes (obesity, diabetes, and hypertension) and the greatest difference in modernization of their NP SOP laws. The Affordable Care Act has greatly expanded access to health care. However, it is estimated that 23 million Americans, 7% of its total population, will remain uninsured by 2019. Restrictive and inconsistent NP SOP policies may continue to contribute to health workforce capacity and population health disparities across the country, with particular concern for primary care indicators. The study findings bring into question whether states with more restrictive NP SOP regulations impact access to primary care, which may in turn influence population health outcomes. These findings suggest the need for further research. NPs are essential for meeting the increasing demands of primary care in the United States, and quality-of-care indicator research supports their use. Copyright © 2016 Elsevier Inc. All rights reserved.

Systematic review of knowledge translation strategies in the allied health professions

PubMed Central

2012-01-01

Background Knowledge translation (KT) aims to close the research-practice gap in order to realize and maximize the benefits of research within the practice setting. Previous studies have investigated KT strategies in nursing and medicine; however, the present study is the first systematic review of the effectiveness of a variety of KT interventions in five allied health disciplines: dietetics, occupational therapy, pharmacy, physiotherapy, and speech-language pathology. Methods A health research librarian developed and implemented search strategies in eight electronic databases (MEDLINE, CINAHL, ERIC, PASCAL, EMBASE, IPA, Scopus, CENTRAL) using language (English) and date restrictions (1985 to March 2010). Other relevant sources were manually searched. Two reviewers independently screened the titles and abstracts, reviewed full-text articles, performed data extraction, and performed quality assessment. Within each profession, evidence tables were created, grouping and analyzing data by research design, KT strategy, targeted behaviour, and primary outcome. The published descriptions of the KT interventions were compared to the Workgroup for Intervention Development and Evaluation Research (WIDER) Recommendations to Improve the Reporting of the Content of Behaviour Change Interventions. Results A total of 2,638 articles were located and the titles and abstracts were screened. Of those, 1,172 full-text articles were reviewed and subsequently 32 studies were included in the systematic review. A variety of single (n = 15) and multiple (n = 17) KT interventions were identified, with educational meetings being the predominant KT strategy (n = 11). The majority of primary outcomes were identified as professional/process outcomes (n = 25); however, patient outcomes (n = 4), economic outcomes (n = 2), and multiple primary outcomes (n = 1) were also represented. Generally, the studies were of low methodological quality. Outcome reporting bias was common and precluded clear determination of intervention effectiveness. In the majority of studies, the interventions demonstrated mixed effects on primary outcomes, and only four studies demonstrated statistically significant, positive effects on primary outcomes. None of the studies satisfied the four WIDER Recommendations. Conclusions Across five allied health professions, equivocal results, low methodological quality, and outcome reporting bias limited our ability to recommend one KT strategy over another. Further research employing the WIDER Recommendations is needed to inform the development and implementation of effective KT interventions in allied health. PMID:22831550

Effects of Sand Harvesting on Environment and Educational Outcomes in Public Primary Schools in Kathiani Sub-County, Machakos County, Kenya

ERIC Educational Resources Information Center

Nthambi, Mutiso Veronicah; Orodho, John Aluko

2015-01-01

The purpose of this study was to examine the effects of sand harvesting on environment and educational outcomes in public primary schools in Kathiani Sub-County, Machakos County, Kenya. This study was premised on treadmill theory of production proposed by Schnaiberg (1980). The study adopted a survey design. Combinations of purposive and…

The effect of care pathways for hip fractures: a systematic review.

PubMed

Leigheb, Fabrizio; Vanhaecht, Kris; Sermeus, Walter; Lodewijckx, Cathy; Deneckere, Svin; Boonen, Steven; Boto, Paulo Alexandre Faria; Mendes, Rita Veloso; Panella, Massimiliano

2012-07-01

We performed a systematic review for primary studies on care pathways (CPs) for hip fracture (HF). The online databases MEDLINE-PubMed, Ovid-EMBASE, CINAHL-EBSCO host, and The Cochrane Library (Cochrane Central Register of Clinical Trials, Health Technology Assessment Database, NHS Economic Evaluation Database) were searched. Two researchers reviewed the literature independently. Primary studies that met predefined inclusion criteria were assessed for their methodological quality. A total of 15 publications were included: 15 primary studies corresponding with 12 main investigations. Primary studies were evaluated for clinical outcomes, process outcomes, and economic outcomes. The studies assessed a wide range of outcome measures. While a number of divergent clinical outcomes were reported, most studies showed positive results of process management and health-services utilization. In terms of mortality, the results provided evidence for a positive impact of CPs on in-hospital mortality. Most studies also showed a significantly reduced risk of complications, including medical complications, wound infections, and pressure sores. Moreover, time-span process measures showed that an improvement in the organization of care was achieved through the use of CPs. Conflicting results were observed with regard to functional recovery and mobility between patients treated with CPs compared to usual care. Although our review suggests that CPs can have positive effects in patients with HF, the available evidence is insufficient for formal recommendations. There is a need for more research on CPs with selected process and outcome indicators, for in-hospital and postdischarge management of HF, with an emphasis on well-designed randomized trials.

Study protocol of EMPOWER participatory action research (EMPOWER-PAR): a pragmatic cluster randomised controlled trial of multifaceted chronic disease management strategies to improve diabetes and hypertension outcomes in primary care.

PubMed

Ramli, Anis S; Lakshmanan, Sharmila; Haniff, Jamaiyah; Selvarajah, Sharmini; Tong, Seng F; Bujang, Mohamad-Adam; Abdul-Razak, Suraya; Shafie, Asrul A; Lee, Verna K M; Abdul-Rahman, Thuhairah H; Daud, Maryam H; Ng, Kien K; Ariffin, Farnaza; Abdul-Hamid, Hasidah; Mazapuspavina, Md-Yasin; Mat-Nasir, Nafiza; Miskan, Maizatullifah; Stanley-Ponniah, Jaya P; Ismail, Mastura; Chan, Chun W; Abdul-Rahman, Yong R; Chew, Boon-How; Low, Wilson H H

2014-09-13

Chronic disease management presents enormous challenges to the primary care workforce because of the rising epidemic of cardiovascular risk factors. The chronic care model was proven effective in improving chronic disease outcomes in developed countries, but there is little evidence of its effectiveness in developing countries. The aim of this study was to evaluate the effectiveness of the EMPOWER-PAR intervention (multifaceted chronic disease management strategies based on the chronic care model) in improving outcomes for type 2 diabetes mellitus and hypertension using readily available resources in the Malaysian public primary care setting. This paper presents the study protocol. A pragmatic cluster randomised controlled trial using participatory action research is underway in 10 public primary care clinics in Selangor and Kuala Lumpur, Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Each clinic consecutively recruits type 2 diabetes mellitus and hypertension patients fulfilling the inclusion and exclusion criteria over a 2-week period. The EMPOWER-PAR intervention consists of creating/strengthening a multidisciplinary chronic disease management team, training the team to use the Global Cardiovascular Risks Self-Management Booklet to support patient care and reinforcing the use of relevant clinical practice guidelines for management and prescribing. For type 2 diabetes mellitus, the primary outcome is the change in the proportion of patients achieving HbA1c < 6.5%. For hypertension without type 2 diabetes mellitus, the primary outcome is the change in the proportion of patients achieving blood pressure < 140/90 mmHg. Secondary outcomes include the proportion of patients achieving targets for serum lipid profile, body mass index and waist circumference. Other outcome measures include medication adherence levels, process of care and prescribing patterns. Patients' assessment of their chronic disease care and providers' perceptions, attitudes and perceived barriers in care delivery and cost-effectiveness of the intervention are also evaluated. Results from this study will provide objective evidence of the effectiveness and cost-effectiveness of a multifaceted intervention based on the chronic care model in resource-constrained public primary care settings. The evidence should instigate crucial primary care system change in Malaysia. ClinicalTrials.gov NCT01545401.

Serum Hepatocyte Growth Factor Is Probably Associated With 3-Month Prognosis of Acute Ischemic Stroke.

PubMed

Zhu, Zhengbao; Xu, Tan; Guo, Daoxia; Huangfu, Xinfeng; Zhong, Chongke; Yang, Jingyuan; Wang, Aili; Chen, Chung-Shiuan; Peng, Yanbo; Xu, Tian; Wang, Jinchao; Sun, Yingxian; Peng, Hao; Li, Qunwei; Ju, Zhong; Geng, Deqin; Chen, Jing; Zhang, Yonghong; He, Jiang

2018-02-01

Serum hepatocyte growth factor (HGF) is positively associated with poor prognosis of heart failure and myocardial infarction, and it can also predict the risk of ischemic stroke in population. The goal of this study was to investigate the association between serum HGF and prognosis of ischemic stroke. A total of 3027 acute ischemic stroke patients were included in this post hoc analysis of the CATIS (China Antihypertensive Trial in Acute Ischemic Stroke). The primary outcome was composite outcome of death or major disability (modified Rankin Scale score ≥3) within 3 months. After multivariate adjustment, elevated HGF levels were associated with an increased risk of primary outcome (odds ratio, 1.50; 95% confidence interval, 1.10-2.03; P trend =0.015) when 2 extreme quartiles were compared. Each SD increase of log-transformed HGF was associated with 14% (95% confidence interval, 2%-27%) increased risk of primary outcome. Adding HGF quartiles to a model containing conventional risk factors improved the predictive power for primary outcome (net reclassification improvement: 17.50%, P <0.001; integrated discrimination index: 0.23%, P =0.022). The association between serum HGF and primary outcome could be modified by heparin pre-treatment ( P interaction =0.001), and a positive linear dose-response relationship between HGF and primary outcome was observed in patients without heparin pre-treatment ( P linearity <0.001) but not in those with heparin pre-treatment. Serum HGF levels were higher in the more severe stroke at baseline, and elevated HGF levels were probably associated with 3-month poor prognosis independently of stroke severity among ischemic stroke patients, especially in those without heparin pre-treatment. Further studies from other samples of ischemic stroke patients are needed to validate our findings. © 2018 American Heart Association, Inc.

Variations in institutional infrastructure, physician specialization and experience, and outcome in ovarian cancer: a systematic review.

PubMed

du Bois, Andreas; Rochon, Justine; Pfisterer, Jacobus; Hoskins, William J

2009-02-01

Ovarian cancer outcome varies among different institutions, regions, and countries. This systematic review summarizes the available data evaluating the impact of different physician and hospital characteristics on outcome in ovarian cancer patients. A MEDLINE database search for pertinent publications was conducted and reference lists of each relevant article were screened. Experts in the field were contacted. Selected studies assessed the relationship between physician and/or hospital specialty or volume and at least one of the outcomes of interest. The primary outcome was survival. Additional parameters included surgical outcome (debulking), completeness of staging, and quality of chemotherapy. The authors independently reviewed each article and applied the inclusion/exclusion criteria. The quality of each study was assessed by focusing on strategies to control for important prognostic factors. Forty-four articles met inclusion criteria. Discipline and sub-specialization of the primary treating physician were identified as the most important variable associated with superior outcome. Evidence showing a beneficial impact of institutional factors was weaker, but followed the same trend. Hospital volume was hardly related to any outcome parameter. The limited evidence available showed considerable heterogeneity and has to be interpreted cautiously. Better utilization of knowledge about institutional factors and well-established board certifications may improve outcome in ovarian cancer. Patients and primary-care physicians should select gynecologic oncologists for primary treatment in countries with established sub-specialty training. Policymakers, insurance companies, and lay organizations should support development of respective programs.

Impact of age, sex, therapeutic intent, race and severity of advanced heart failure on short-term principal outcomes in the MOMENTUM 3 trial.

PubMed

Goldstein, Daniel J; Mehra, Mandeep R; Naka, Yoshifumi; Salerno, Christopher; Uriel, Nir; Dean, David; Itoh, Akinobu; Pagani, Francis D; Skipper, Eric R; Bhat, Geetha; Raval, Nirav; Bruckner, Brian A; Estep, Jerry D; Cogswell, Rebecca; Milano, Carmelo; Fendelander, Lahn; O'Connell, John B; Cleveland, Joseph

2018-01-01

Primary outcomes analysis of the Multicenter Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3 (MOMENTUM 3) trial short-term cohort demonstrated a higher survival rate free of debilitating stroke and reoperation to replace/remove the device (primary end-point) in patients receiving the HeartMate 3 (HM3) compared with the HeartMate (HMII). In this study we sought to evaluate the individual and interactive effects of pre-specified patient subgroups (age, sex, race, therapeutic intent [bridge to transplant/bridge to candidacy/destination therapy] and severity of illness) on primary end-point outcomes in MOMENTUM 3 patients implanted with HM3 and HMII devices. Cox proportional hazard models were used to analyze patients enrolled in the "as-treated cohort" (n = 289) of the MOMENTUM 3 trial to: (1) determine interaction of various subgroups on primary end-point outcomes; and (2) identify independent variables associated with primary end-point success. Baseline characteristics were well balanced among HM3 (n = 151) and HMII (n = 138) cohorts. No significant interaction between the sub-groups on primary end-point outcomes was observed. Cox multivariable modeling identified age (≤65 years vs >65 years, hazard ratio 0.42 [95% confidence interval 0.22 to 0.78], p = 0.006]) and pump type (HM3 vs HMII, hazard ratio 0.53 [95% confidence interval 0.30 to 0.96], p = 0.034) to be independent predictors of primary outcomes success. After adjusting for age, no significant impact of sex, race, therapeutic intent and INTERMACS profiles on primary outcomes were observed. This analysis of MOMENTUM 3 suggests that younger age (≤65 years) at implant and pump choice are associated with a greater likelihood of primary end-point success. These findings further suggest that characterization of therapeutic intent into discrete bridge-to-transplant and destination therapy categories offers no clear clinical advantage, and should ideally be abandoned. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Primary percutaneous coronary intervention for acute ST elevation myocardial infarction: Outcomes and determinants of outcomes: A tertiary care center study from North India.

PubMed

Dubey, Gajendra; Verma, Sunil Kumar; Bahl, Vinay Kumar

Primary percutaneous coronary intervention (PCI) is the current standard of care for acute ST elevation myocardial infarction (STEMI). Most of the data on primary PCI in acute STEMI is from western countries. We studied the outcomes of primary PCI for acute STEMI at a tertiary care center in North India. Consecutive patients undergoing primary PCI for STEMI were prospectively studied during the period from February 2103 to May 2015. The outcomes assessed were all cause in hospital mortality, factors associated with mortality, major adverse cardiac and cerebrovascular event rate (composite of all cause in hospital mortality, non-fatal re infarction and stroke) and procedural complications. 371 patients underwent primary PCI during the study period. The mean age was 54 years and 82.7% were males. The mean total ischemia time and door to balloon times were 6.8h and 51min respectively. 96.4% patients underwent successful primary PCI. The total in hospital mortality was 12.9%. Mortality with cardiogenic shock at presentation was 66.7% while non-shock mortality was 2.6%. In hospital MACCE rate was 13.5%. Factors significantly associated with mortality were KILLIP class (OR: 8.4), door to balloon time (OR 1.02), final TIMI flow (OR 0.44) and severe LV dysfunction (OR 22.0). Procedure related adverse events were rare and there was no non-CABG associated major TIMI bleeding. Primary PCI for acute STEMI is feasible in our setup and associated with high success rate, low mortality in non-shock patients and low complication rates. Copyright © 2016. Published by Elsevier B.V.

Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A systematic review.

PubMed

Milette, Katherine; Roseman, Michelle; Thombs, Brett D

2011-03-01

The most reliable evidence for evaluating healthcare interventions comes from well-designed and conducted randomized controlled trials (RCTs). The extent to which published RCTs reflect the efficacy of interventions, however, depends on the completeness and accuracy of published results. The Consolidated Standards of Reporting Trials statement, initially developed in 1996, provides guidelines intended to improve the transparency of published RCT reports. A policy of the International Committee of Medical Journal Editors, initiated in 2005, requires clinical trials published in member journals to be registered in publicly accessible registries prior to patient enrollment. The objective of this study was to assess the clarity of outcome reporting, proportion of registered trials, and adequacy of outcome registration in RCTs published in top behavioral health journals. Eligible studies were primary or secondary reports of RCTs published in Annals of Behavioral Medicine, Health Psychology, Journal of Psychosomatic Research, and Psychosomatic Medicine from January 2008 to September 2009. Data were extracted for each study on adequacy of outcome reporting and registration. Of 63 articles reviewed, only 25 (39.7%) had adequately declared primary or secondary outcomes, whereas 38 (60.3%) had multiple primary outcomes or did not define outcomes. Only 13 studies (20.6%) were registered. Only 1 study registered sufficiently precise outcome information to compare with published outcomes, and registered and published outcomes were discrepant in that study. Greater attention to outcome reporting and trial registration by researchers, peer reviewers, and journal editors will increase the likelihood that effective behavioral health interventions are readily identified and made available to patients. Copyright © 2011 Elsevier Inc. All rights reserved.

Inadvertent P-hacking among trials and systematic reviews of the effect of progestogens in pregnancy? A systematic review and meta-analysis.

PubMed

Prior, M; Hibberd, R; Asemota, N; Thornton, J G

2017-06-01

Progestogens have been evaluated in numerous trials and meta-analyses, many of which concluded they were effective. However, two large trials PROMISE and OPPTIMUM have recently concluded that progesterone was ineffective. This raises the possibility that earlier studies and reviews had been biased by either selective publication or selective choice of outcomes, so called "P-hacking". To compare the findings all progestogen trials and systematic reviews with those of trials with pre-registered primary outcomes which avoided selective outcome reporting. Search of PubMed, the Cochrane Library and trial registries. Registration PROSPERO CRD42016035303. Systematic reviews of randomised trials comparing progestogen with placebo in pregnancy and the individual trials included in those reviews. The subset of trials reporting a pre-registered primary outcome were compared with the totality of trials and reviews. For reviews all outcomes were included. For individual trials all outcomes reported in the systematic reviews were included. For the comparison group we recorded the registered primary outcome from trials that were either registered before they started, or registered during the recruitment phase and also double blind. Nineteen of twenty-nine meta-analyses concluded that progestogens were effective. Twenty-two trials reported their pre-registered primary outcomes. There was no effect of progesterone on primary registered dichotomous outcome RR 1.00 (95% CI 0.94-1.07). Only one of the 22 showed a nominally statistically significant benefit. When evaluated in registered double-blind trials with analysis restricted to predefined primary outcomes, progestational agents in pregnancy are ineffective. Progestogens to prevent pregnancy loss, an example of P-hacking. © 2017 Royal College of Obstetricians and Gynaecologists.

Assessing the Impact of Free Primary Education Using Retrospective and Prospective Data: Lessons from the Nairobi Case Study

ERIC Educational Resources Information Center

Ngware, Moses Waithanji; Oketch, Moses; Ezeh, Alex Chika; Mutisya, Maurice; Ejakait, Charles Epari

2012-01-01

This paper describes the design and methodology used to assess the impact of free primary education (FPE) policy in Nairobi, Kenya. The key outcome of the study was to assess the impact of FPE on schooling outcomes among the urban poor. The study assesses the impact of FPE by examining how two non-comparable groups responded to the introduction of…

The Chronic Care Model and Diabetes Management in US Primary Care Settings: A Systematic Review

PubMed Central

Stellefson, Michael; Stopka, Christine

2013-01-01

Introduction The Chronic Care Model (CCM) uses a systematic approach to restructuring medical care to create partnerships between health systems and communities. The objective of this study was to describe how researchers have applied CCM in US primary care settings to provide care for people who have diabetes and to describe outcomes of CCM implementation. Methods We conducted a literature review by using the Cochrane database of systematic reviews, CINAHL, and Health Source: Nursing/Academic Edition and the following search terms: “chronic care model” (and) “diabet*.” We included articles published between January 1999 and October 2011. We summarized details on CCM application and health outcomes for 16 studies. Results The 16 studies included various study designs, including 9 randomized controlled trials, and settings, including academic-affiliated primary care practices and private practices. We found evidence that CCM approaches have been effective in managing diabetes in US primary care settings. Organizational leaders in health care systems initiated system-level reorganizations that improved the coordination of diabetes care. Disease registries and electronic medical records were used to establish patient-centered goals, monitor patient progress, and identify lapses in care. Primary care physicians (PCPs) were trained to deliver evidence-based care, and PCP office–based diabetes self-management education improved patient outcomes. Only 7 studies described strategies for addressing community resources and policies. Conclusion CCM is being used for diabetes care in US primary care settings, and positive outcomes have been reported. Future research on integration of CCM into primary care settings for diabetes management should measure diabetes process indicators, such as self-efficacy for disease management and clinical decision making. PMID:23428085

Primary Care Outcomes Questionnaire: psychometric testing of a new instrument.

PubMed

Murphy, Mairead; Hollinghurst, Sandra; Cowlishaw, Sean; Salisbury, Chris

2018-06-01

Patients attend primary care for many reasons and to achieve a range of possible outcomes. There is currently no Patient Reported Outcome Measure (PROM) designed to capture these diverse outcomes, and trials of interventions in primary care may thus fail to detect beneficial effects. This study describes the psychometric testing of the Primary Care Outcomes Questionnaire (PCOQ), which was designed to capture a broad range of outcomes relevant to primary care. Questionnaires were administered in primary care in South West England. Patients completed the PCOQ in GP waiting rooms before a consultation, and a second questionnaire, including the PCOQ and seven comparator PROMs, after 1 week. Psychometric testing included exploratory factor analysis on the PCOQ, internal consistency, correlation coefficients between domain scores and comparator measures, and repeated measures effect sizes indicating change across 1 week. In total, 602 patients completed the PCOQ at baseline, and 264 (44%) returned the follow-up questionnaire. Exploratory factor analysis suggested four dimensions underlying the PCOQ items: health and wellbeing, health knowledge and self-care, confidence in health provision, and confidence in health plan. Each dimension was internally consistent and correlated as expected with comparator PROMs, providing evidence of construct validity. Patients reporting an improvement in their main problem exhibited small to moderate improvements in relevant domain scores on the PCOQ. The PCOQ was acceptable, feasible, showed strong psychometric properties, and was responsive to change. It is a promising new tool for assessment of outcomes of primary care interventions from a patient perspective. © British Journal of General Practice 2018.

Strategies facilitating practice change in pediatric cancer: a systematic review.

PubMed

Robinson, Paula D; Dupuis, Lee L; Tomlinson, George; Phillips, Bob; Greenberg, Mark; Sung, Lillian

2016-09-01

By conducting a systematic review, we describe strategies to actively disseminate knowledge or facilitate practice change among healthcare providers caring for children with cancer and we evaluate the effectiveness of these strategies. We searched Ovid Medline, EMBASE and PsychINFO. Fully published primary studies were included if they evaluated one or more professional intervention strategies to actively disseminate knowledge or facilitate practice change in pediatric cancer or hematopoietic stem cell transplantation. Data extracted included study characteristics and strategies evaluated. In studies with a quantitative analysis of patient outcomes, the relationship between study-level characteristics and statistically significant primary analyses was evaluated. Of 20 644 titles and abstracts screened, 146 studies were retrieved in full and 60 were included. In 20 studies, quantitative evaluation of patient outcomes was examined and a primary outcome was stated. Eighteen studies were 'before and after' design; there were no randomized studies. All studies were at risk for bias. Interrupted time series was never the primary analytic approach. No specific strategy type was successful at improving patient outcomes. Literature describing strategies to facilitate practice change in pediatric cancer is emerging. However, major methodological limitations exist. Studies with robust designs are required to identify effective strategies to effect practice change. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

A survivorship care plan for breast cancer survivors: extended results of a randomized clinical trial.

PubMed

Boekhout, Annelies H; Maunsell, Elizabeth; Pond, Gregory R; Julian, Jim A; Coyle, Doug; Levine, Mark N; Grunfeld, Eva

2015-12-01

Prevailing wisdom suggests that implementation of a survivorship care plan (SCP) will address deficits in survivorship care planning and delivery for cancer patients. Here, we present 24-month results of a randomized clinical trial on health service and patient-reported outcomes among breast cancer patients transferred to their primary care physician for follow-up care. The 24-month assessments represent the long-term benefit and sustainability of the implantation of a SCP. In all, 408 patients with early-stage breast cancer were randomized to the SCP or control group. Patient self-completed questionnaires, supplemented with telephone interviews, during the 24-month study period assessed health service and patient-reported outcomes. The primary outcome was cancer-specific distress. Secondary outcomes included health-related quality of life, patient satisfaction, continuity and coordination of care, and health service outcomes such as adherence to guidelines. Over the course of 24 months, there were no differences between both groups in health service and patient-reported outcomes. Women from Quebec compared to those from Western Canada (p < 0.001), women within 2 years of completion of primary treatment compared to a longer period (p = 0.013), and those with a higher SF-36 mental component score compared to a lower score (p = 0.044) were positively associated with adherence to guidelines. The implementation of a SCP in the transition of survivorship care from cancer center to primary care did not contribute to improved health service or patient-reported outcomes in this study population. Therefore, additional research is needed before widespread implementation of a SCP in clinical practice. The transition of survivorship care from cancer center to the primary care setting showed no negative effect on health service and patient-reported outcomes.

Prognostic factors for extracorporeal cardiopulmonary resuscitation recipients following out-of-hospital refractory cardiac arrest. A systematic review and meta-analysis.

PubMed

Debaty, Guillaume; Babaz, Valentin; Durand, Michel; Gaide-Chevronnay, Lucie; Fournel, Emmanuel; Blancher, Marc; Bouvaist, Hélène; Chavanon, Olivier; Maignan, Maxime; Bouzat, Pierre; Albaladejo, Pierre; Labarère, José

2017-03-01

Association estimates between baseline characteristics and outcomes are imprecise and inconsistent among extracorporeal cardiopulmonary resuscitation (ECPR) recipients following refractory out-of-hospital cardiac arrest (OHCA). This systematic review and meta-analysis aimed to investigate the prognostic significance of pre-specified characteristics for OHCA treated with ECPR. The Medline electronic database was searched via PubMed for articles published from January 2000 to September 2016. The electronic search was supplemented by scanning the reference lists of retrieved articles and contacting field experts. Eligible studies were historical and prospective cohort studies of adult patients undergoing ECPR following OHCA. Fifteen primary studies were included, totaling 841 participants. The median prevalence of the primary outcome (i.e., short- or long-term survival for five studies and cerebral performance for ten studies) was 15% (range, 0-50%). The primary outcome was associated with an increased odds ratio of initial shockable cardiac rhythm (2.20; 95% confidence interval [CI], 1.30-3.72; P=0.003), shorter low-flow duration (geometric mean ratio, 0.90; 95% CI, 0.81-0.99; P=0.04), higher arterial pH value (difference, 0.12; 95% CI, 0.03-0.22; P=0.01) and lower serum lactate concentration (difference, -3.52mmol/L; 95% CI, -5.05 to -1.99; P<0.001). No significant association was found between the primary outcome and patient age (the odds of female gender and bystander CPR attempt. Observational evidence from published primary studies indicates that shorter low-flow duration, shockable cardiac rhythm, higher arterial pH value and lower serum lactate concentration on hospital admission are associated with better outcomes for ECPR recipients after OHCA. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Systematic review of the effectiveness of primary care nursing.

PubMed

Keleher, Helen; Parker, Rhian; Abdulwadud, Omar; Francis, Karen

2009-02-01

This paper reports on a systematic review that sought to answer the research question: What is the impact of the primary and community care nurse on patient health outcomes compared with usual doctor-led care in primary care settings? A range of pertinent text-words with medical subject headings were combined and electronic databases were searched. Because of the volume of published articles, the search was restricted to studies with high-level evidence. Overall, 31 relevant studies were identified and included in the review. We found modest international evidence that nurses in primary care settings can provide effective care and achieve positive health outcomes for patients similar to that provided by doctors. Nurses are effective in care management and achieve good patient compliance. Nurses are also effective in a more diverse range of roles including chronic disease management, illness prevention and health promotion. Nevertheless, there is insufficient evidence about primary care nurses' roles and impact on patient health outcomes.

Why did an effective Dutch complex psycho-social intervention for people with dementia not work in the German healthcare context? Lessons learnt from a process evaluation alongside a multicentre RCT.

PubMed

Voigt-Radloff, Sebastian; Graff, Maud; Leonhart, Rainer; Hüll, Michael; Rikkert, Marcel Olde; Vernooij-Dassen, Myrra

2011-08-09

Background The positive effects of the Dutch Community Occupational Therapy in Dementia programme on patients' daily functioning were not found in a multicentre randomised controlled trial (RCT) in Germany. Objectives To evaluate possible effect modification on the primary outcome within the German RCT with regard to (1) participant characteristics, (2) treatment performance and (3) healthcare service utilisation; and (4) to compare the design and primary outcome between the German and the original Dutch study. Methods (1) The impact of participant baseline data on the primary outcome was analysed in exploratory ANCOVA and regression analyses. (2) Therapists completed questionnaires on context and performance problems. The main problems were identified by a qualitative content analysis and focus-group discussion. Associations of the primary outcome with scores of participant adherence and treatment performance were evaluated by regression analysis. (3) Utilisation rates of healthcare services were controlled for significant group differences. (4) Differences in the Dutch and German study design were identified, and the primary outcome was contrasted at the item level. Results (1) Participant characteristics could not explain more than 5% of outcome variance. (2) The treatment performance of some active intervention components was poor but not significantly associated with the primary outcome. (3) There were no significant group differences in the utilisation of healthcare resources. (4) In contrast to the Dutch waiting-control group, the active intervention in the German control group may have reduced group differences in the current RCT. The German patients demonstrated a higher independence at baseline and less improvement in instrumental activities of daily living. Conclusion The differences in outcome may be explained by a more active control treatment, partially poor experimental treatment and less room for improvement in the German sample. Future cross-national transfers should be prepared by pilot studies assessing the applicability of the intervention and patient needs specific to the target country. Trial registration International Clinical Trials Registry Platform, DRKS00000053.

The quality of Australian Indigenous primary health care research focusing on social and emotional wellbeing: a systematic review.

PubMed

Farnbach, Sara; Eades, Anne-Maree; Fernando, Jamie K; Gwynn, Josephine D; Glozier, Nick; Hackett, Maree L

2017-10-11

Objectives and importance of the study: Primary health care research focused on Aboriginal and Torres Strait Islander (Indigenous) people is needed to ensure that key frontline services provide evidence based and culturally appropriate care. We systematically reviewed the published primary health care literature to identify research designs, processes and outcomes, and assess the scientific quality of research focused on social and emotional wellbeing. This will inform future research to improve evidence based, culturally appropriate primary health care. Systematic review in accordance with PRISMA and MOOSE guidelines. Four databases and one Indigenous-specific project website were searched for qualitative, quantitative and mixed-method published research. Studies that were conducted in primary health care services and focused on the social and emotional wellbeing of Indigenous people were included. Scientific quality was assessed using risk-of-bias assessment tools that were modified to meet our aims. We assessed community acceptance by identifying the involvement of community governance structures and representation during research development, conduct and reporting. Data were extracted using standard forms developed for this review. We included 32 articles, which reported on 25 studies. Qualitative and mixed methods were used in 18 studies. Twelve articles were judged as high or unclear risk of bias, four as moderate and five as low risk of bias. Another four studies were not able to be assessed as they did not align with the risk-of-bias tools. Of the five articles judged as low risk of bias, two also had high community acceptance and both of these were qualitative. One used a phenomenological approach and the other combined participatory action research with a social-ecological perspective and incorporated 'two-way learning' principles. Of the 16 studies where a primary outcome was identified, eight aimed to identify perceptions or experiences. The remaining studies assessed resources, or evaluated services, interventions, programs or policies. We were unable to identify primary outcomes in eight studies. Conducting Indigenous-focused primary health care research that is scientifically robust, culturally appropriate and produces community-level outcomes is challenging. We suggest that research teams use participatory, culturally sensitive approaches and collaborate closely to plan and implement high-quality research that incorporates local perspectives. Research should result in beneficial outcomes for the communities involved.

Sport-specific outcomes after anterior cruciate ligament reconstruction.

PubMed

Warner, Stephen J; Smith, Matthew V; Wright, Rick W; Matava, Matthew J; Brophy, Robert H

2011-08-01

Although anterior cruciate ligament (ACL) reconstruction has been studied extensively in the literature, sport-specific outcomes have not been well-documented. The purpose of this systematic review was to assess sport-specific outcomes after ACL reconstruction in the literature. We performed a systematic review of the literature to identify studies reporting sport-specific outcomes after primary ACL reconstruction. Included studies were required to have reported standardized outcomes after primary ACL reconstruction for a single sport or comparing between different sports. In total 8 studies conformed to all inclusion criteria: 2 Level II studies, 1 Level III study, and 5 Level IV case series. Only 1 study reported comparisons of standardized outcomes between different sports, whereas 7 studies reported standardized outcomes in a single sport. Return to activity was the most common sport-specific outcome reported and varied from 19% (soccer) to 100% (bicycling and rugby), although the methods of measuring this outcome differed. Whereas return to activity after ACL reconstruction appears more likely for bicycling and jogging than for cutting and pivoting sports such as soccer and football, the literature on sport-specific outcomes from ACL reconstruction is limited with minimal data. Further studies are needed to report sport-specific outcomes and return to play after ACL reconstruction. Level IV, systematic review of Level II, III, and IV studies. Copyright © 2011 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Assessment of the Incorporation of Patient-Centric Outcomes in Studies of Minimally Invasive Glaucoma Surgical Devices

PubMed Central

Le, Jimmy T.; Viswanathan, Shilpa; Tarver, Michelle E.; Eydelman, Malvina; Li, Tianjing

2017-01-01

IMPORTANCE Minimally invasive glaucoma surgical (MIGS) devices are one option for lowering intraocular pressure in patients with glaucoma. OBJECTIVE To examine how often existing clinical studies of MIGS devices registered on ClinicalTrials.gov measure patient-centric outcomes that patients value directly. DESIGN, SETTING, AND PARTICIPANTS We searched ClinicalTrials.gov, a registry of publicly and privately supported clinical studies, on February 20, 2015, for records of MIGS device studies involving patients with glaucoma. Two investigators independently abstracted study design and outcome details from eligible records. We classified outcomes as patient-centric or not patient-centric using a prespecified definition. MAIN OUTCOMES AND MEASURES Proportion of patient-centric and nonpatient-centric outcomes registered on ClinicalTrials.gov. RESULTS We identified 51 eligible studies specifying 127 outcomes. Reduction in intraocular pressure was the most frequent outcome specified (78/127; 61%) and a primary outcome in 41 studies. Patient-centric outcomes—such as adverse events (n = 19; 15%), topical medication use (n = 16; 13%), visual acuity (n = 4; 3%), and health-related quality of life (n = 1; 1%)—were less frequently specified (n = 40; 32%) and a primary outcome in only 12 studies. CONCLUSION AND RELEVANCE Patient-centric outcomes that provide insight into the relative desirability and acceptability of the benefits and risks of MIGS devices are not well represented in current clinical studies. PMID:27389667

Physical Education in Primary Schools: Classroom Teachers' Perceptions of Benefits and Outcomes

ERIC Educational Resources Information Center

Morgan, Philip J.; Hansen, Vibeke

2008-01-01

Objective: The aim of the current study was to examine the perceptions of classroom teachers regarding the benefits and outcomes of their PE programs. Design: Cross-sectional. Setting: Thirty eight randomly selected primary schools in New South Wales (NSW), Australia. Method: A mixed-mode methodology was utilized, incorporating semi-structured…

Which features of primary care affect unscheduled secondary care use? A systematic review

PubMed Central

Huntley, Alyson; Lasserson, Daniel; Wye, Lesley; Morris, Richard; Checkland, Kath; England, Helen; Salisbury, Chris; Purdy, Sarah

2014-01-01

Objectives To conduct a systematic review to identify studies that describe factors and interventions at primary care practice level that impact on levels of utilisation of unscheduled secondary care. Setting Observational studies at primary care practice level. Participants Studies included people of any age of either sex living in Organisation for Economic Co-operation and Development (OECD) countries with any health condition. Primary and secondary outcome measures The primary outcome measure was unscheduled secondary care as measured by emergency department attendance and emergency hospital admissions. Results 48 papers were identified describing potential influencing features on emergency department visits (n=24 studies) and emergency admissions (n=22 studies). Patient factors associated with both outcomes were increased age, reduced socioeconomic status, lower educational attainment, chronic disease and multimorbidity. Features of primary care affecting unscheduled secondary care were more complex. Being able to see the same healthcare professional reduced unscheduled secondary care. Generally, better access was associated with reduced unscheduled care in the USA. Proximity to healthcare provision influenced patterns of use. Evidence relating to quality of care was limited and mixed. Conclusions The majority of research was from different healthcare systems and limited in the extent to which it can inform policy. However, there is evidence that continuity of care is associated with reduced emergency department attendance and emergency hospital admissions. PMID:24860000

Effective strategies for scaling up evidence-based practices in primary care: a systematic review.

PubMed

Ben Charif, Ali; Zomahoun, Hervé Tchala Vignon; LeBlanc, Annie; Langlois, Léa; Wolfenden, Luke; Yoong, Sze Lin; Williams, Christopher M; Lépine, Roxanne; Légaré, France

2017-11-22

While an extensive array of existing evidence-based practices (EBPs) have the potential to improve patient outcomes, little is known about how to implement EBPs on a larger scale. Therefore, we sought to identify effective strategies for scaling up EBPs in primary care. We conducted a systematic review with the following inclusion criteria: (i) study design: randomized and non-randomized controlled trials, before-and-after (with/without control), and interrupted time series; (ii) participants: primary care-related units (e.g., clinical sites, patients); (iii) intervention: any strategy used to scale up an EBP; (iv) comparator: no restrictions; and (v) outcomes: no restrictions. We searched MEDLINE, Embase, PsycINFO, Web of Science, CINAHL, and the Cochrane Library from database inception to August 2016 and consulted clinical trial registries and gray literature. Two reviewers independently selected eligible studies, then extracted and analyzed data following the Cochrane methodology. We extracted components of scaling-up strategies and classified them into five categories: infrastructure, policy/regulation, financial, human resources-related, and patient involvement. We extracted scaling-up process outcomes, such as coverage, and provider/patient outcomes. We validated data extraction with study authors. We included 14 studies. They were published since 2003 and primarily conducted in low-/middle-income countries (n = 11). Most were funded by governmental organizations (n = 8). The clinical area most represented was infectious diseases (HIV, tuberculosis, and malaria, n = 8), followed by newborn/child care (n = 4), depression (n = 1), and preventing seniors' falls (n = 1). Study designs were mostly before-and-after (without control, n = 8). The most frequently targeted unit of scaling up was the clinical site (n = 11). The component of a scaling-up strategy most frequently mentioned was human resource-related (n = 12). All studies reported patient/provider outcomes. Three studies reported scaling-up coverage, but no study quantitatively reported achieving a coverage of 80% in combination with a favorable impact. We found few studies assessing strategies for scaling up EBPs in primary care settings. It is uncertain whether any strategies were effective as most studies focused more on patient/provider outcomes and less on scaling-up process outcomes. Minimal consensus on the metrics of scaling up are needed for assessing the scaling up of EBPs in primary care. This review is registered as PROSPERO CRD42016041461 .

Relationship of Kidney Injury Biomarkers with Long-Term Cardiovascular Outcomes after Cardiac Surgery.

PubMed

Parikh, Chirag R; Puthumana, Jeremy; Shlipak, Michael G; Koyner, Jay L; Thiessen-Philbrook, Heather; McArthur, Eric; Kerr, Kathleen; Kavsak, Peter; Whitlock, Richard P; Garg, Amit X; Coca, Steven G

2017-12-01

Clinical AKI, measured by serum creatinine elevation, is associated with long-term risks of adverse cardiovascular (CV) events and mortality in patients after cardiac surgery. To evaluate the relative contributions of urine kidney injury biomarkers and plasma cardiac injury biomarkers in adverse events, we conducted a multicenter prospective cohort study of 968 adults undergoing cardiac surgery. On postoperative days 1-3, we measured five urine biomarkers of kidney injury (IL-18, NGAL, KIM-1, L-FABP, and albumin) and five plasma biomarkers of cardiac injury (NT-proBNP, H-FABP, hs-cTnT, cTnI, and CK-MB). The primary outcome was a composite of long-term CV events or death, which was assessed via national health care databases. During a median 3.8 years of follow-up, 219 (22.6%) patients experienced the primary outcome (136 CV events and 83 additional deaths). Compared with patients without postsurgical AKI, patients who experienced AKI Network stage 2 or 3 had an adjusted hazard ratio for the primary composite outcome of 3.52 (95% confidence interval, 2.17 to 5.71). However, none of the five urinary kidney injury biomarkers were significantly associated with the primary outcome. In contrast, four out of five postoperative cardiac injury biomarkers (NT-proBNP, H-FABP, hs-cTnT, and cTnI) strongly associated with the primary outcome. Mediation analyses demonstrated that cardiac biomarkers explained 49% (95% confidence interval, 1% to 97%) of the association between AKI and the primary outcome. These results suggest that clinical AKI at the time of cardiac surgery is indicative of concurrent CV stress rather than an independent renal pathway for long-term adverse CV outcomes. Copyright © 2017 by the American Society of Nephrology.

Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.

PubMed

Shepshelovich, D; Goldvaser, H; Wang, L; Abdul Razak, A R; Bedard, P L

2017-12-01

Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (p<0.001), multicenter trials (p<0.001) and publication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.

Short-Term Outcomes of Simultaneous Laparoscopic Colectomy and Hepatectomy for Primary Colorectal Cancer With Synchronous Liver Metastases

PubMed Central

Inoue, Akira; Uemura, Mamoru; Yamamoto, Hirofumi; Hiraki, Masayuki; Naito, Atsushi; Ogino, Takayuki; Nonaka, Ryoji; Nishimura, Junichi; Wada, Hiroshi; Hata, Taishi; Takemasa, Ichiro; Eguchi, Hidetoshi; Mizushima, Tsunekazu; Nagano, Hiroaki; Doki, Yuichiro; Mori, Masaki

2014-01-01

Although simultaneous resection of primary colorectal cancer and synchronous liver metastases is reported to be safe and effective, the feasibility of a laparoscopic approach remains controversial. This study evaluated the safety, feasibility, and short-term outcomes of simultaneous laparoscopic surgery for primary colorectal cancer with synchronous liver metastases. From September 2008 to December 2013, 10 patients underwent simultaneous laparoscopic resection of primary colorectal cancer and synchronous liver metastases with curative intent at our institute. The median operative time was 452 minutes, and the median estimated blood loss was 245 mL. Median times to discharge from the hospital and adjuvant chemotherapy were 13.5 and 44 postoperative days, respectively. Negative resection margins were achieved in all cases, with no postoperative mortality or major morbidity. Simultaneous laparoscopic colectomy and hepatectomy for primary colorectal cancer with synchronous liver metastases appears feasible with low morbidity and favorable outcomes. PMID:25058762

The Empirical Foundations of Telemedicine Interventions in Primary Care.

PubMed

Bashshur, Rashid L; Howell, Joel D; Krupinski, Elizabeth A; Harms, Kathryn M; Bashshur, Noura; Doarn, Charles R

2016-05-01

This article presents the scientific evidence for the merits of telemedicine interventions in primary care. Although there is no uniform and consistent definition of primary care, most agree that it occupies a central role in the healthcare system as first contact for patients seeking care, as well as gatekeeper and coordinator of care. It enables and supports patient-centered care, the medical home, managed care, accountable care, and population health. Increasing concerns about sustainability and the anticipated shortages of primary care physicians have sparked interest in exploring the potential of telemedicine in addressing many of the challenges facing primary care in the United States and the world. The findings are based on a systematic review of scientific studies published from 2005 through 2015. The initial search yielded 2,308 articles, with 86 meeting the inclusion criteria. Evidence is organized and evaluated according to feasibility/acceptance, intermediate outcomes, health outcomes, and cost. The majority of studies support the feasibility/acceptance of telemedicine for use in primary care, although it varies significantly by demographic variables, such as gender, age, and socioeconomic status, and telemedicine has often been found more acceptable by patients than healthcare providers. Outcomes data are limited but overall suggest that telemedicine interventions are generally at least as effective as traditional care. Cost analyses vary, but telemedicine in primary care is increasingly demonstrated to be cost-effective. Telemedicine has significant potential to address many of the challenges facing primary care in today's healthcare environment. Challenges still remain in validating its impact on clinical outcomes with scientific rigor, as well as in standardizing methods to assess cost, but patient and provider acceptance is increasingly making telemedicine a viable and integral component of primary care around the world.

The Empirical Foundations of Telemedicine Interventions in Primary Care

PubMed Central

Howell, Joel D.; Krupinski, Elizabeth A.; Harms, Kathryn M.; Bashshur, Noura; Doarn, Charles R.

2016-01-01

Abstract Introduction: This article presents the scientific evidence for the merits of telemedicine interventions in primary care. Although there is no uniform and consistent definition of primary care, most agree that it occupies a central role in the healthcare system as first contact for patients seeking care, as well as gatekeeper and coordinator of care. It enables and supports patient-centered care, the medical home, managed care, accountable care, and population health. Increasing concerns about sustainability and the anticipated shortages of primary care physicians have sparked interest in exploring the potential of telemedicine in addressing many of the challenges facing primary care in the United States and the world. Materials and Methods: The findings are based on a systematic review of scientific studies published from 2005 through 2015. The initial search yielded 2,308 articles, with 86 meeting the inclusion criteria. Evidence is organized and evaluated according to feasibility/acceptance, intermediate outcomes, health outcomes, and cost. Results: The majority of studies support the feasibility/acceptance of telemedicine for use in primary care, although it varies significantly by demographic variables, such as gender, age, and socioeconomic status, and telemedicine has often been found more acceptable by patients than healthcare providers. Outcomes data are limited but overall suggest that telemedicine interventions are generally at least as effective as traditional care. Cost analyses vary, but telemedicine in primary care is increasingly demonstrated to be cost-effective. Conclusions: Telemedicine has significant potential to address many of the challenges facing primary care in today's healthcare environment. Challenges still remain in validating its impact on clinical outcomes with scientific rigor, as well as in standardizing methods to assess cost, but patient and provider acceptance is increasingly making telemedicine a viable and integral component of primary care around the world. PMID:27128779

Quality of registration for clinical trials published in emergency medicine journals.

PubMed

Jones, Christopher W; Platts-Mills, Timothy F

2012-10-01

In 2005, the International Committee of Medical Journal Editors established clinical trial registration as a requirement for articles submitted to member journals, with the goal of improving the transparency of clinical research. The objective of this study is to characterize the registration of clinical trials published in emergency medicine journals. Randomized trials involving human subjects and published between June 1, 2008, and May 31, 2011 in the 5 emergency medicine journals with the highest impact factors were included. We assessed the clarity of registered primary outcomes, timing of registration relative to patient enrollment, and consistency between registered and published outcomes. Of the 123 trials included, registry entries were identified for 57 (46%). Of the 57 registered studies, 45 (79%) were registered after the initiation of subject enrollment, 9 (16%) had registered outcomes that were unclear, and 26 (46%) had discrepancies between registered and published outcomes. Only 5 studies were registered before patient enrollment with a clear primary outcome that was consistent with the published primary outcome. Annals of Emergency Medicine was the only journal in which the majority of trials were registered. Current compliance with clinical trial registration guidelines is poor among trials published in emergency medicine journals. Copyright © 2012. Published by Mosby, Inc.

Health-related quality of life, satisfaction, and economic outcome measures in studies of prostate cancer screening and treatment, 1990-2000.

PubMed

McNaughton-Collins, Mary; Walker-Corkery, Elizabeth; Barry, Michael J

2004-01-01

Prostate cancer outcomes research incorporates a broad spectrum of endpoints, from clinical or intermediate endpoints, such as tumor shrinkage or patient compliance, to final endpoints, such as survival or disease-free survival. Three types of nontraditional endpoints that are of growing interest-health-related quality of life (QOL), satisfaction with care, and economic cost impact-hold the promise of improving our ability to understand the full burden of prostate cancer screening and treatment. In this article we review the last decade's published literature regarding the health-related QOL, satisfaction, and economic outcomes of prostate cancer screening and treatment to determine the "state of the science" of outcomes measurement. The focus is the enumeration of the types of outcome measurement used in the studies not the determination of the results of the studies. Studies were identified by searching Medline (1990-2000). Articles were included if they presented original data on any patient-centered outcome (including costs or survival alone) for men screened and treated for prostate cancer. Review papers were excluded unless they were quantitative syntheses of the results of other primary studies. Economic and decision analytic papers were included if they presented information on outcomes of real or hypothetical patient cohorts. Each retrieved article was reviewed by one of the authors. Included papers were assigned one primary, mutually exclusive study design. For the "primary data" studies, information was abstracted on care setting, dates of the study, sample size, racial distribution, age, tumor differentiation, tumor stage, survival, statistical power, and types of outcomes measures (QOL-generic, QOL-cancer specific, QOL-prostate cancer specific, satisfaction, costs, utilities, and other). For the "economic and decision analytic" papers, information was abstracted on stage of disease, age range, outcomes, costs, and whether utilities were measured. Of the 198 included papers, there were 161 primary data papers categorized as follows: randomized trial (n = 28), nonrandomized trial (n = 13), prospective or retrospective cohort study (n = 55), case-control study (n = 0), cross-sectional study (n = 63), and meta-analysis (n = 2). The remaining 37 papers were economic and decision analytic papers. Among the 149 primary data papers that contained patient outcome data, there were 42 standard instruments used, accounting for 44% (179 of 410) of the measures overall. Almost three-quarters (71%) of papers included one, two, or three outcomes measures of all types (standard and nonstandard); three papers included seven outcomes measures, and one paper included nine. Over the 11-year time period, there was a nonstatistically significant trend toward more frequent use of standardized QOL instruments and a statistically significant trend toward increased reporting of race (P = .003). Standardization of measurement of health-related QOL, satisfaction with care, and economic cost effect among men screened and treated for prostate cancer is needed. A core set of similar questions, both generic and disease-specific, should ideally be asked in every study, although investigators should be encouraged to include additional question sets as appropriate to individual studies to get a more complete picture of how patients screened and treated for this condition are doing over time.

Establishment and outcomes of a model primary care pharmacy service system.

PubMed

Carmichael, Jannet M; Alvarez, Autumn; Chaput, Ryan; DiMaggio, Jennifer; Magallon, Heather; Mambourg, Scott

2004-03-01

The establishment and outcomes of a model primary care pharmacy service system are described. A primary care pharmacy practice model was established at a government health care facility in March 1996. The original objective was to establish a primary pharmacy practice model that would demonstrate improved patient outcomes and maximize the pharmacist's contributions to drug therapy. Since its inception, many improvements have been realized and supported by advanced computer and automated systems, expanded disease state management practices, and unique practitioner and administrative support. Many outcomes studies have been performed on the pharmacist-initiated and -managed clinics, leading to improved patient care and conveying the quality-conscious and cost-effective role pharmacists can play as independent practitioners in this environment. These activities demonstrate cutting-edge leadership in health-system pharmacy. Redesign has been used to improve consistent access to a medication expert and has significantly improved the quality of patient care while easing physicians' workload without increasing health care costs. A system using pharmacists as independent practitioners to promote primary care has achieved high-quality and cost-effective patient care.

Health benefits of primary care social work for adults with complex health and social needs: a systematic review.

PubMed

McGregor, Jules; Mercer, Stewart W; Harris, Fiona M

2018-01-01

The prevalence of complex health and social needs in primary care patients is growing. Furthermore, recent research suggests that the impact of psychosocial distress on the significantly poorer health outcomes in this population may have been underestimated. The potential of social work in primary care settings has been extensively discussed in both health and social work literature and there is evidence that social work interventions in other settings are particularly effective in addressing psychosocial needs. However, the evidence base for specific improved health outcomes related to primary care social work is minimal. This review aimed to identify and synthesise the available evidence on the health benefits of social work interventions in primary care settings. Nine electronic databases were searched from 1990 to 2015 and seven primary research studies were retrieved. Due to the heterogeneity of studies, a narrative synthesis was conducted. Although there is no definitive evidence for effectiveness, results suggest a promising role for primary care social work interventions in improving health outcomes. These include subjective health measures and self-management of long-term conditions, reducing psychosocial morbidity and barriers to treatment and health maintenance. Although few rigorous study designs were found, the contextual detail and clinical settings of studies provide evidence of the practice applicability of social work intervention. Emerging policy on the integration of health and social care may provide an opportunity to develop this model of care. © 2016 John Wiley & Sons Ltd.

Monthly oral methylprednisolone pulse treatment in progressive multiple sclerosis.

PubMed

Ratzer, Rikke; Iversen, Pernille; Börnsen, Lars; Dyrby, Tim B; Romme Christensen, Jeppe; Ammitzbøll, Cecilie; Madsen, Camilla Gøbel; Garde, Ellen; Lyksborg, Mark; Andersen, Birgit; Hyldstrup, Lars; Sørensen, Per Soelberg; Siebner, Hartwig R; Sellebjerg, Finn

2016-06-01

There is a large unmet need for treatments for patients with progressive multiple sclerosis (MS). Phase 2 studies with cerebrospinal fluid (CSF) biomarker outcomes may be well suited for the initial evaluation of efficacious treatments. To evaluate the effect of monthly oral methylprednisolone pulse treatment on intrathecal inflammation in progressive MS. In this open-label phase 2A study, 15 primary progressive and 15 secondary progressive MS patients received oral methylprednisolone pulse treatment for 60 weeks. Primary outcome was changes in CSF concentrations of osteopontin. Secondary outcomes were other CSF biomarkers of inflammation, axonal damage and demyelination; clinical scores; magnetic resonance imaging measures of disease activity, magnetization transfer ratio (MTR) and diffusion tensor imaging (DTI); motor evoked potentials; and bone density scans. We found no change in the CSF concentration of osteopontin, but we observed significant improvement in clinical scores, MTR, DTI and some secondary CSF outcome measures. Adverse events were well-known side effects to methylprednisolone. Monthly methylprednisolone pulse treatment was safe, but had no effect on the primary outcome. However, improvements in secondary clinical and MRI outcome measures suggest that this treatment regimen may have a beneficial effect in progressive MS. © The Author(s), 2015.

Maternal nutrition and birth outcomes.

PubMed

Abu-Saad, Kathleen; Fraser, Drora

2010-01-01

In this review, the authors summarize current knowledge on maternal nutritional requirements during pregnancy, with a focus on the nutrients that have been most commonly investigated in association with birth outcomes. Data sourcing and extraction included searches of the primary resources establishing maternal nutrient requirements during pregnancy (e.g., Dietary Reference Intakes), and searches of Medline for "maternal nutrition"/[specific nutrient of interest] and "birth/pregnancy outcomes," focusing mainly on the less extensively reviewed evidence from observational studies of maternal dietary intake and birth outcomes. The authors used a conceptual framework which took both primary and secondary factors (e.g., baseline maternal nutritional status, socioeconomic status of the study populations, timing and methods of assessing maternal nutritional variables) into account when interpreting study findings. The authors conclude that maternal nutrition is a modifiable risk factor of public health importance that can be integrated into efforts to prevent adverse birth outcomes, particularly among economically developing/low-income populations.

The efficacy of computer-enabled discharge communication interventions: a systematic review.

PubMed

Motamedi, Soror Mona; Posadas-Calleja, Juan; Straus, Sharon; Bates, David W; Lorenzetti, Diane L; Baylis, Barry; Gilmour, Janet; Kimpton, Shandra; Ghali, William A

2011-05-01

Traditional manual/dictated discharge summaries are inaccurate, inconsistent and untimely. Computer-enabled discharge communications may improve information transfer by providing a standardised document that immediately links acute and community healthcare providers. To conduct a systematic review evaluating the efficacy of computer-enabled discharge communication compared with traditional communication for patients discharged from acute care hospitals. MEDLINE, EMBASE, Cochrane CENTRAL Register of Controlled Trials and MEDLINE In-Process. Keywords from three themes were combined: discharge communication, electronic/online/web-based and controlled interventional studies. Study types included: clinical trials, quasiexperimental studies with concurrent controls and controlled before--after studies. Interventions included: (1) automatic population of a discharge document by computer database(s); (2) transmission of discharge information via computer technology; or (3) computer technology providing a 'platform' for dynamic discharge communication. Controls included: no intervention or traditional manual/dictated discharge summaries. Primary outcomes included: mortality, readmission and adverse events/near misses. Secondary outcomes included: timeliness, accuracy, quality/completeness and physician/patient satisfaction. Description of interventions and study outcomes were extracted by two independent reviewers. 12 unique studies were identified: eight randomised controlled trials and four quasi-experimental studies. Pooling/meta-analysis was not possible, given the heterogeneity of measures and outcomes reported. The primary outcomes of mortality and readmission were inconsistently reported. There was no significant difference in mortality, and one study reported reduced long-term readmission. Intervention groups experienced reductions in perceived medical errors/adverse events, and improvements in timeliness and physician/patient satisfaction. Computer-enabled discharge communications appear beneficial with respect to a number of important secondary outcomes. Primary outcomes of mortality and readmission are less commonly reported in this literature and require further study.

Prognostic indicators of poor short-term outcome of physiotherapy intervention in women with stress urinary incontinence.

PubMed

Hendriks, Erik J M; Kessels, Alfons G H; de Vet, Henrica C W; Bernards, Arnold T M; de Bie, Rob A

2010-03-01

To identify prognostic indicators independently associated with poor outcome of physiotherapy intervention in women with primary or recurrent stress urinary incontinence (stress UI). A prospective cohort study was performed in physiotherapy practices in primary care to identify prognostic indicators 12 weeks after initiation of physiotherapy intervention. Patients were referred by general practitioners or urogynecologists. Risk factors for stress UI were examined as potential prognostic indicators of poor outcome. The primary outcomes were defined as poor outcome on the binary Leakage Severity scale (LS scale) and the binary global perceived effectiveness (GPE) score. Two hundred sixty-seven women, with a mean age of 47.7 (SD = 8.3), with stress UI for at least 6 months were included. At 12 weeks, 43% and 59% of the women were considered recovered on the binary LS scale and the binary GPE score, respectively. Prognostic indicators associated with poor outcome included 11 indicators based on the binary LS scale and 8 based on the binary GPE score. The prognostic indicators shared by both models show that poor recovery was associated with women with severe stress UI, POP-Q stage > II, poor outcome of physiotherapy intervention for a previous UI episode, prolonged second stage of labor, BMI > 30, high psychological distress, and poor physical health. This study provides robust evidence of clinically meaningful prognostic indicators of poor short-term outcome. These findings need to be confirmed by replication studies. (c) 2009 Wiley-Liss, Inc.

Primary Multiple Simultaneous Intracerebral Hemorrhages between 1950 and 2013: Analysis of Data on Age, Sex and Outcome.

PubMed

Laiwattana, Denchai; Sangsawang, Bussara; Sangsawang, Nucharee

2014-01-01

Primary multiple simultaneous intracerebral hemorrhages (MSICHs) are quite rare. Although occasional reports have been found, there have been no systematic reviews. The published case reports and case series contain overlapping data, leading to erroneous information about MSICHs. This is the first extensive review of accessible studies published in English on MSICHs. Our primary objective was to analyze the demographic data on age, sex, outcome and prognosis with regard to primary MSICHs. A PubMed search without language restriction for articles with results from human studies and registered between January 1950 and September 2013 yielded 677 articles. The following inclusion criteria were applied: (1) reported case(s) or case series on primary MSICHs; (2) text partly or fully in English, and (3) text contains identifiable data on age, sex and outcome of patients. A total of 24 articles met all the inclusion criteria. The reference lists of these 24 articles were inspected for additional relevant articles, which yielded another 20 articles. In all, 248 cases were identified; 143 cases were excluded for various reasons: 52 duplicate cases, 18 cases of multiple nonsimultaneous intracerebral hemorrhages, 25 cases of secondary MSICHs, and 48 cases with incomplete data on age, sex and outcome. The remaining 105 cases were analyzed. MSICHs were found to be more common in bilateral cases (53.33%): there were bilateral basal ganglia hemorrhages (33.33%), bilateral thalamic hemorrhages (18.10%), bilateral lobar hemorrhages (0.95%) and bilateral cerebellar hemorrhages (0.95%). Nonbilateral MSICHs were found in 46.67% of the cases. The hematomas were commonly distributed in the basal ganglia (45.83%), thalamus (30.56%) and cerebellum (10.19%). MSICHs were more frequently encountered in males (60.95%; average age: 59.13 ± 12.49 years). The average age of the female patients was higher (63.89 ± 13.11 years). Patients with primary MSICHs had a survival rate of 56.20%. There was a favorable outcome of primary MSICHs in 18.10% of all the cases, the highest proportion of which was in the nonbilateral MSICH group. The remaining 38.10% had unfavorable outcomes. Death occurred in 43.80% of all cases, the highest proportion being found in the bilateral basal ganglia hemorrhage group. Primary MSICHs share features with solitary intracerebral hemorrhage regarding age, sex, and the location and distribution of hematomas, but they have a poorer outcome (p < 0.05). Primary MSICHs are rare and share features with solitary intracerebral hemorrhage regarding age and the location and distribution of hematomas. Patients have a poorer prognosis but higher favorable outcome rates in case of survival. This information adds to the awareness of clinicians that higher rates of favorable outcomes can be achieved for MSICHs.

Comparison of Registered and Reported Outcomes in Randomized Clinical Trials Published in Anesthesiology Journals.

PubMed

Jones, Philip M; Chow, Jeffrey T Y; Arango, Miguel F; Fridfinnson, Jason A; Gai, Nan; Lam, Kevin; Turkstra, Timothy P

2017-10-01

Randomized clinical trials (RCTs) provide high-quality evidence for clinical decision-making. Trial registration is one of the many tools used to improve the reporting of RCTs by reducing publication bias and selective outcome reporting bias. The purpose of our study is to examine whether RCTs published in the top 6 general anesthesiology journals were adequately registered and whether the reported primary and secondary outcomes corresponded to the originally registered outcomes. Following a prespecified protocol, an electronic database was used to systematically screen and extract data from RCTs published in the top 6 general anesthesiology journals by impact factor (Anaesthesia, Anesthesia & Analgesia, Anesthesiology, British Journal of Anaesthesia, Canadian Journal of Anesthesia, and European Journal of Anaesthesiology) during the years 2007, 2010, 2013, and 2015. A manual search of each journal's Table of Contents was performed (in duplicate) to identify eligible RCTs. An adequately registered trial was defined as being registered in a publicly available trials registry before the first patient being enrolled with an unambiguously defined primary outcome. For adequately registered trials, the outcomes registered in the trial registry were compared with the outcomes reported in the article, with outcome discrepancies documented and analyzed by the type of discrepancy. During the 4 years studied, there were 860 RCTs identified, with 102 RCTs determined to be adequately registered (12%). The proportion of adequately registered trials increased over time, with 38% of RCTs being adequately registered in 2015. The most common reason in 2015 for inadequate registration was registering the RCT after the first patient had already been enrolled. Among adequately registered trials, 92% had at least 1 primary or secondary outcome discrepancy. In 2015, 42% of RCTs had at least 1 primary outcome discrepancy, while 90% of RCTs had at least 1 secondary outcome discrepancy. Despite trial registration being an accepted best practice, RCTs published in anesthesiology journals have a high rate of inadequate registration. While mandating trial registration has increased the proportion of adequately registered trials over time, there is still an unacceptably high proportion of inadequately registered RCTs. Among adequately registered trials, there are high rates of discrepancies between registered and reported outcomes, suggesting a need to compare a published RCT with its trial registry entry to be able to fully assess the quality of the study. If clinicians base their decisions on evidence distorted by primary outcome switching, patient care could be negatively affected.

Effectiveness of shared care across the interface between primary and specialty care in chronic disease management.

PubMed

Smith, S M; Allwright, S; O'Dowd, T

2007-07-18

Shared care has been used in the management of many chronic conditions with the assumption that it delivers better care than either primary or specialty care alone. It has been defined as the joint participation of primary care physicians and specialty care physicians in the planned delivery of care, informed by an enhanced information exchange over and above routine discharge and referral notices. It has the potential to offer improved quality and coordination of care delivery across the primary-specialty care interface and to improve outcomes for patients. To determine the effectiveness of shared-care health service interventions designed to improve the management of chronic disease across the primary-specialty care interface. We searched the Cochrane Effective Practice and Organisation of Care Group (EPOC) Specialised Register (and the database of studies awaiting assessment); Cochrane Central Register of Controlled Trials (CENTRAL); Database of Abstracts of Reviews of Effects (DARE); MEDLINE (from 1966); EMBASE (from 1980) and CINAHL (from 1982). We also searched the reference lists of included studies. Randomised controlled trials, controlled before and after studies and interrupted time series analyses of shared-care interventions for chronic disease management. The participants were primary care providers, specialty care providers and patients. The outcomes included physical health outcomes, mental health outcomes, and psychosocial health outcomes, treatment satisfaction, measures of care delivery including participation in services, delivery of care and prescribing of appropriate medications, and costs of shared care. Three review authors independently assessed studies for eligibility, extracted data and assessed study quality. Twenty studies of shared care interventions for chronic disease management were identified, 19 of which were randomised controlled trials. The majority of studies examined complex multifaceted interventions and were of relatively short duration. The results were mixed. Overall there were no consistent improvements in physical or mental health outcomes, psychosocial outcomes, psychosocial measures including measures of disability and functioning, hospital admissions, default or participation rates, recording of risk factors and satisfaction with treatment. However, there were clear improvements in prescribing in the studies that considered this outcome. The methodological quality of studies varied considerably with only a minority of studies of high-quality design. Cost data were limited and difficult to interpret across studies. This review indicates that there is, at present, insufficient evidence to demonstrate significant benefits from shared care apart from improved prescribing. Methodological shortcomings, particularly inadequate length of follow-up, may partially account for this lack of evidence. This review indicates that there is no evidence to support the widespread introduction of shared care services at present. Future shared-care interventions should only be developed within research settings and with account taken of the complexity of such interventions and the need to carry out longer studies to test the effectiveness and sustainability of shared care over time.

Turkish Preservice Primary School Teachers' Science Teaching Efficacy Beliefs and Attitudes toward Science: The Effect of a Primary Teacher Education Program

ERIC Educational Resources Information Center

Bayraktar, Sule

2011-01-01

The main purpose of this study was to investigate the effectiveness of a primary teacher education program in improving science teaching efficacy beliefs (personal science teaching efficacy beliefs and outcome expectancy beliefs) of preservice primary school teachers. The study also investigated whether the program has an effect on student…

Arthroscopic Hip Revision Surgery for Residual Femoroacetabular Impingement (FAI): Surgical Outcomes Compared With a Matched Cohort After Primary Arthroscopic FAI Correction.

PubMed

Larson, Christopher M; Giveans, M Russell; Samuelson, Kathryn M; Stone, Rebecca M; Bedi, Asheesh

2014-08-01

There are limited data reporting outcomes after revision arthroscopic surgery for residual femoroacetabular impingement (FAI). (1) Revision arthroscopic FAI correction results in improved outcomes, but they are inferior to those of primary arthroscopic FAI correction. (2) Improved postrevision radiographic parameters are predictive of better outcomes. Cohort study; Level of evidence, 3. Patients who underwent arthroscopic hip revision for residual FAI were reviewed. Pathomorphological findings, intraoperative findings, and preoperative and postoperative modified Harris Hip Score (MHHS), Short Form-12 (SF-12), and pain on a visual analog scale (VAS) values were evaluated. Outcomes after revision arthroscopic FAI correction were compared with outcomes of a matched cohort who underwent primary arthroscopic FAI correction. A total of 79 patients (85 hips) with a mean age of 29.5 years underwent arthroscopic revision FAI correction (mean follow-up, 26 months). The labrum was debrided (27 hips), repaired (49 hips), or reconstructed (7 hips). Two labrums were stable and required no treatment. The results of revision arthroscopic FAI correction were compared with those of 220 age- and sex-matched patients (237 hips) who underwent primary arthroscopic FAI correction (mean follow-up, 23 months). The mean improvement in outcome scores after revision FAI correction was 17.8 (MHHS), 12.5 (SF-12), and 1.4 (VAS) points compared with 23.4 (MHHS), 19.7 (SF-12), and 4.6 (VAS) points after primary arthroscopic FAI correction. The mean improvement was significantly better in the primary cohort compared with the revision cohort (P < .01 for MHHS, SF-12, and VAS values). Good/excellent results were achieved in 81.7% of the primary cohort and 62.7% of the revision cohort (P < .01). Greater postoperative head-neck offset (P = .024), subspine/anterior inferior iliac spine (AIIS) decompression (P = .014), labral repair/reconstruction (P = .009), and capsular plication (P = .032) were significant predictors for better outcomes after revision surgery. Arthroscopic hip revision surgery for residual FAI yielded significantly improved outcome measures, but these were inferior to those after primary arthroscopic FAI corrective surgery. Improved femoral head-neck offset after cam decompression, identification and treatment of subspine/AIIS impingement, labral preservation/reconstruction, and capsular preservation/plication may be paramount to achieve satisfactory outcomes. © 2014 The Author(s).

The degree of integration of non-dispensing pharmacists in primary care practice and the impact on health outcomes: A systematic review.

PubMed

Hazen, Ankie C M; de Bont, Antoinette A; Boelman, Lia; Zwart, Dorien L M; de Gier, Johan J; de Wit, Niek J; Bouvy, Marcel L

2018-03-01

A non-dispensing pharmacist conducts clinical pharmacy services aimed at optimizing patients individual pharmacotherapy. Embedding a non-dispensing pharmacist in primary care practice enables collaboration, probably enhancing patient care. The degree of integration of non-dispensing pharmacists into multidisciplinary health care teams varies strongly between settings. The degree of integration may be a determinant for its success. This study investigates how the degree of integration of a non-dispensing pharmacist impacts medication related health outcomes in primary care. In this literature review we searched two electronic databases and the reference list of published literature reviews for studies about clinical pharmacy services performed by non-dispensing pharmacists physically co-located in primary care practice. We assessed the degree of integration via key dimensions of integration based on the conceptual framework of Walshe and Smith. We included English language studies of any design that had a control group or baseline comparison published from 1966 to June 2016. Descriptive statistics were used to correlate the degree of integration to health outcomes. The analysis was stratified for disease-specific and patient-centered clinical pharmacy services. Eighty-nine health outcomes in 60 comparative studies contributed to the analysis. The accumulated evidence from these studies shows no impact of the degree of integration of non-dispensing pharmacists on health outcomes. For disease specific clinical pharmacy services the percentage of improved health outcomes for none, partial and fully integrated NDPs is respectively 75%, 63% and 59%. For patient-centered clinical pharmacy services the percentage of improved health outcomes for none, partial and fully integrated NDPs is respectively 55%, 57% and 70%. Full integration adds value to patient-centered clinical pharmacy services, but not to disease-specific clinical pharmacy services. To obtain maximum benefits of clinical pharmacy services for patients with multiple medications and comorbidities, full integration of non-dispensing pharmacists should be promoted. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

The effect of platelet-rich plasma on arthroscopic double-row rotator cuff repair: a clinical study with 12-month follow-up.

PubMed

Zhang, Zhenxiang; Wang, Yong; Sun, Junying

2016-01-01

The aim of the study was to assess the effect of platelet-rich plasma on arthroscopic double-row rotator cuff repair. The study included 60 patients with arthroscopic rotator cuff repair. Thirthy patients (mean age: 57.2±7.4; 16 males and 14 females) underwent arthroscopic double-row repair alone (Group 1), another 30 (mean age: 56.9±6.0; 15 males and 15 females) had an injection of platelet-rich plasma (PRP) (Group 2). The groups were compared with DASH as a primary outcome score and Constant-Murley score, visual analog scale, measurement of active forward flexion, and external and internal rotation as secondary outcome measures. Magnetic resonance imaging was used to assess the integrity of the repair at 12 months postoperatively. Primary and secondary outcome measures statistically improved in both groups postoperatively (p<0.05). Overall mean primary and secondary postoperative outcome measures were not significantly different between the 2 groups. A retear was seen in 9 subjects (30%) in Group 1 and 4 subjects (14%) in Group 2 (p<0.05). The local injection of PRP into a primary arthroscopic double-row cuff repair resulted in lower recurrence rates than repairs without the novel biological augmentation material.

Multidisciplinary care planning in the primary care management of completed stroke: a systematic review

PubMed Central

Mitchell, Geoffrey K; Brown, Robyn M; Erikssen, Lars; Tieman, Jennifer J

2008-01-01

Background Chronic disease management requires input from multiple health professionals, both specialist and primary care providers. This study sought to assess the impact of co-ordinated multidisciplinary care in primary care, represented by the delivery of formal care planning by primary care teams or shared across primary-secondary teams, on outcomes in stroke, relative to usual care. Methods A Systematic review of Medline, EMBASE, CINAHL (all 1990–2006), Cochrane Library (Issue 1 2006), and grey literature from web based searching of web sites listed in the CCOHA Health Technology Assessment List Analysis used narrative analysis of findings of randomised and non-randomised trials, and observational and qualitative studies of patients with completed stroke in the primary care setting where care planning was undertaken by 1) a multi-disciplinary primary care team or 2) through shared care by primary and secondary providers. Results One thousand and forty-five citations were retrieved. Eighteen papers were included for analysis. Most care planning took part in the context of multidisciplinary team care based in hospitals with outreach to community patients. Mortality rates are not impacted by multidisciplinary care planning. Functional outcomes of the studies were inconsistent. It is uncertain whether the active engagement of GPs and other primary care professionals in the multidisciplinary care planning contributed to the outcomes in the studies showing a positive effect. There may be process benefits from multidisciplinary care planning that includes primary care professionals and GPs. Few studies actually described the tasks and roles GPs fulfilled and whether this matched what was presumed to be provided. Conclusion While multidisciplinary care planning may not unequivocally improve the care of patients with completed stroke, there may be process benefits such as improved task allocation between providers. Further study on the impact of active GP involvement in multidisciplinary care planning is warranted. PMID:18681977

Does the extended Glasgow Outcome Scale add value to the conventional Glasgow Outcome Scale?

PubMed

Weir, James; Steyerberg, Ewout W; Butcher, Isabella; Lu, Juan; Lingsma, Hester F; McHugh, Gillian S; Roozenbeek, Bob; Maas, Andrew I R; Murray, Gordon D

2012-01-01

The Glasgow Outcome Scale (GOS) is firmly established as the primary outcome measure for use in Phase III trials of interventions in traumatic brain injury (TBI). However, the GOS has been criticized for its lack of sensitivity to detect small but clinically relevant changes in outcome. The Glasgow Outcome Scale-Extended (GOSE) potentially addresses this criticism, and in this study we estimate the efficiency gain associated with using the GOSE in place of the GOS in ordinal analysis of 6-month outcome. The study uses both simulation and the reanalysis of existing data from two completed TBI studies, one an observational cohort study and the other a randomized controlled trial. As expected, the results show that using an ordinal technique to analyze the GOS gives a substantial gain in efficiency relative to the conventional analysis, which collapses the GOS onto a binary scale (favorable versus unfavorable outcome). We also found that using the GOSE gave a modest but consistent increase in efficiency relative to the GOS in both studies, corresponding to a reduction in the required sample size of the order of 3-5%. We recommend that the GOSE be used in place of the GOS as the primary outcome measure in trials of TBI, with an appropriate ordinal approach being taken to the statistical analysis.

Trauma-Informed Medical Care: Patient Response to a Primary Care Provider Communication Training

PubMed Central

Green, Bonnie L.; Saunders, Pamela A.; Power, Elizabeth; Dass-Brailsford, Priscilla; Schelbert, Kavitha Bhat; Giller, Esther; Wissow, Larry; Hurtado de Mendoza, Alejandra; Mete, Mihriye

2016-01-01

Trauma exposure predicts mental disorders and health outcomes; yet there is little training of primary care providers about trauma’s effects, and how to better interact with trauma survivors. This study adapted a theory-based approach to working with trauma survivors, Risking Connection, into a 6-hour CME course, Trauma-Informed Medical Care (TI-Med), to evaluate its feasibility and preliminary efficacy. We randomized four primary care sites to training or wait-list conditions; PCPs at wait-list sites were trained after reassessment. Primary care providers (PCPs) were Family Medicine residents (n = 17; 2 sites) or community physicians (n = 13; 2 sites). Outcomes reported here comprised a survey of 400 actual patients seen by the PCPs in the study. Patients, mostly minority, completed surveys before or after their provider received training. Patients rated PCPs significantly higher after training on a scale encompassing partnership issues. Breakdowns showed lower partnership scores for those with trauma or posttraumatic stress symptoms. Future studies will need to include more specific trauma-related outcomes. Nevertheless, this training is a promising initial approach to teaching trauma-informed communication skills to PCPs. PMID:27721673

Outcomes for Young Children's Social Status from Playing Group Games: Experiences from a Primary School in Hong Kong

ERIC Educational Resources Information Center

Liu, Sylvia; Yuen, Mantak; Rao, Nirmala

2015-01-01

This exploratory study involved a structured group-games intervention to develop first-grade students' social competence. The effects were evaluated by assessing possible outcomes for the children's social status. A sample of 119 first-grade, mixed-ability students from a Hong Kong primary school participated in the sessions (63 boys, 56 girls:…

Students Creating Digital Video in the Primary Classroom: Student Autonomy, Learning Outcomes, and Professional Learning Communities

ERIC Educational Resources Information Center

Henderson, Michael; Auld, Glenn; Holkner, Bernard; Russell, Glenn; Seah, Wee Tiong; Fernando, Anthony; Romeo, Geoff

2010-01-01

This research is a part of a national project to identify effective sustainable and embedded use of ICTs leading to improved educational outcomes. The project identified six schools and conducted a qualitative case study analysis out of which eleven successful strategies were reported. One of these strategies was observed at a primary school and…

Therapeutic alliance and obesity management in primary care - a cross-sectional pilot using the Working Alliance Inventory.

PubMed

Sturgiss, E A; Sargent, G M; Haesler, E; Rieger, E; Douglas, K

2016-12-01

Therapeutic alliance is a well-recognized predictor of patient outcomes within psychological therapy. It has not been applied to obesity interventions, and Bordin's theoretical framework shows particular relevance to the management of obesity in primary health care. This cross-sectional study of a weight management programme in general practice aimed to determine if therapeutic alliance was associated with patient outcomes. The Working Alliance Inventory short revised version (WAI-SR) was administered to 23 patients and 11 general practitioners (GPs) at the end of a 6-month weight management programme. Use of the WAI-SR indicated that the strength of therapeutic alliance varied between different patient-GP relationships in this pilot intervention. A robust therapeutic alliance was strongly associated with patient engagement in the weight management programme indicated by number of appointments. It was also associated with some general health and quality of life outcomes. These are promising results that require confirmation with larger studies in primary health care. The measurement of therapeutic alliance using the WAI-SR may predict patient attendance and outcomes in obesity interventions in primary healthcare settings. © 2016 World Obesity Federation.

The impact of the Brazilian family health on selected primary care sensitive conditions: A systematic review

PubMed Central

Menzies, Dick; Hone, Thomas; Dehghani, Kianoush; Trajman, Anete

2017-01-01

Background Brazil has the largest public health-system in the world, with 120 million people covered by its free primary care services. The Family Health Strategy (FHS) is the main primary care model, but there is no consensus on its impact on health outcomes. We systematically reviewed published evidence regarding the impact of the Brazilian FHS on selective primary care sensitive conditions (PCSC). Methods We searched Medline, Web of Science and Lilacs in May 2016 using key words in Portuguese and English, without language restriction. We included studies if intervention was the FHS; comparison was either different levels of FHS coverage or other primary health care service models; outcomes were the selected PCSC; and results were adjusted for relevant sanitary and socioeconomic variables, including the national conditional cash transfer program (Bolsa Familia). Due to differences in methods and outcomes reported, pooling of results was not possible. Results Of 1831 records found, 31 met our inclusion criteria. Of these, 25 were ecological studies. Twenty-one employed longitudinal quasi-experimental methods, 27 compared different levels the FHS coverage, whilst four compared the FHS versus other models of primary care. Fourteen studies found an association between higher FHS coverage and lower post-neonatal and child mortality. When the effect of Bolsa Familia was accounted for, the effect of the FHS on child mortality was greater. In 13 studies about hospitalizations due to PCSC, no clear pattern of association was found. In four studies, there was no effect on child and elderly vaccination or low-birth weight. No included studies addressed breast-feeding, dengue, HIV/AIDS and other neglected infectious diseases. Conclusions Among these ecological studies with limited quality evidence, increasing coverage by the FHS was consistently associated with improvements in child mortality. Scarce evidence on other health outcomes, hospitalization and synergies with cash transfer was found. PMID:28786997

Severe hyponatraemia in foals: clinical findings, primary diagnosis and outcome.

PubMed

Collins, N M; Axon, J E; Carrick, J B; Russell, C M; Palmer, J E

2016-06-01

To evaluate severe hyponatraemia in foals presenting as medical emergencies to an intensive care unit (ICU) in order to determine the prevalence, clinical findings, primary diagnosis and outcome. Retrospective case study of records from Thoroughbred foals aged less than 3 months presenting to an ICU as medical emergencies in 2002-12; foals with severe hyponatraemia (serum sodium <122 mmol/L) on admission laboratory data were identified. Data retrieved included signalment, clinical findings, laboratory results, primary diagnosis, treatment and outcome. Severe hyponatraemia was identified in 69/1718 Thoroughbred foals (4%) presenting to the ICU during the study period. Of the 69 foals, 11 (15.9%) presented with neurological signs attributable to hyponatraemic encephalopathy and 7 of these foals had seizures; other neurological signs included obtundation, ataxia and apparent blindness. The three most common primary diagnoses of the 69 foals with severe hyponatraemia were renal disease (18/69, 26.1%), enterocolitis (16/69, 23.2%) and uroperitoneum (15/69, 21.7%). Treatment was directed at the primary disease and correction of the hyponatraemia. A total of 50 of the 69 foals (72.5%) with severe hyponatraemia survived to hospital discharge and 38 of them (76%) survived at least 12 months following discharge. The prevalence of severe hyponatraemia in this study population was 4%. The majority of foals with severe hyponatraemia did not demonstrate direct clinical manifestations as a result of the low serum sodium concentration. The outcome of foals with severe hyponatraemia was mostly favourable. © 2016 Australian Veterinary Association.

Do patients׳ illness beliefs predict depression measures at six months in primary care; a longitudinal study.

PubMed

Lynch, Jeannette; Moore, Michael; Moss-Morris, Rona; Kendrick, Tony

2015-03-15

Depressive disorders are prevalent and costly but there is a lack of evidence on how best to select treatments for mild to moderate depression in primary care. Illness beliefs have been shown to affect the outcome from physical illness, but there is limited information on the beliefs of patients who are depressed. To measure patients׳ beliefs about depression at baseline and determine whether these relate to depression severity at six months. Primary care patients with a recently diagnosed episode of depression completed the Beliefs about Depression Questionnaire and depression severity scores at baseline. The primary outcome was the change in depression severity score on the Hospital Anxiety and Depression Scale after six months. 227/292 (78%) participants completed follow-up questionnaires. Initial severity of depression at baseline, and particular beliefs about the causes, consequences and timeline of depression predicted poorer outcomes, whereas a belief in using exercise or keeping busy to treat depression predicted improved outcomes. Prescription of antidepressants did not appear to mediate these relationships. This was an initial study using a new validated questionnaire and it cannot be predicted whether these results are representative or would be reproduced in other populations. Although participants were primary care patients whose GP (General Practitioner) had coded as having a new incident episode of depression in the preceding six months, 43% of participants stated they had been depressed for more than a year. Sufficient participants were recruited to ensure the study was adequately powered but participation rate was 30%, raising the possibility of response bias. Illness beliefs may help to predict outcomes in depression and therefore assessing and addressing patients׳ beliefs about their depression may enhance treatment. Crown Copyright © 2015. Published by Elsevier B.V. All rights reserved.

Body mass index is not a clinically meaningful predictor of patient reported outcomes of primary hip replacement surgery: prospective cohort study.

PubMed

Judge, A; Batra, R N; Thomas, G E; Beard, D; Javaid, M K; Murray, D W; Dieppe, P A; Dreinhoefer, K E; Peter-Guenther, K; Field, R; Cooper, C; Arden, N K

2014-03-01

To describe whether body mass index (BMI) is a clinically meaningful predictor of patient reported outcomes following primary total hip replacement (THR) surgery. Combined data from prospective cohort studies. We obtained information from four cohorts of patients receiving primary THR for osteoarthritis: Exeter Primary Outcomes Study (EPOS) (n = 1431); EUROHIP (n = 1327); Elective Orthopaedic Centre (n = 2832); and St. Helier (n = 787). The exposure of interest was pre-operative BMI. Confounding variables included: age, sex, SF-36 mental health, comorbidities, fixed flexion, analgesic use, college education, OA in other joints, expectation of less pain, radiographic K&L grade, ASA grade, years of hip pain. The primary outcome was the Oxford Hip Score (OHS). Regression models describe the association of BMI on outcome adjusting for all confounders. For a 5-unit increase in BMI, the attained 12-month OHS decreases by 0.78 points 95%CI (0.27-1.28), P-value 0.001. Compared to people of normal BMI (20-25), those in the obese class II (BMI 35-40) would have a 12-month OHS that is 2.34 points lower. Although statistically significant this effect is small and not clinically meaningful in contrast to the substantial change in OHS seen across all BMI groupings. In obese class II patients achieved a 22.2 point change in OHS following surgery. Patients achieved substantial change in OHS after THR across all BMI categories, which greatly outweighs the small difference in attained post-operative score. The findings suggest BMI should not present a barrier to access THR in terms of PROMs. Copyright © 2014 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Body mass index is not a clinically meaningful predictor of patient reported outcomes of primary hip replacement surgery: prospective cohort study

PubMed Central

Judge, Andy; Batra, Rajbir N; Thomas, Geraint; Beard, David; Javaid, M Kassim; Murray, David; Dieppe, Paul A; Dreinhoefer, Karsten; Peter-Guenther, Klaus; Field, Richard; Cooper, Cyrus; Arden, Nigel K

2014-01-01

Objectives To describe whether body mass index (BMI) is a clinically meaningful predictor of patient reported outcomes following primary total hip replacement (THR) surgery Design Combined data from prospective cohort studies. We obtained information from four cohorts of patients receiving primary THR for osteoarthritis: Exeter Primary Outcomes Study (n=1431); EUROHIP (n=1327); Elective Orthopaedic Centre (n=2832); and St. Helier (n=787). The exposure of interest was pre-operative BMI. Confounding variables included: age, sex, SF-36 mental health, comorbidities, fixed flexion, analgesic use, college education, OA in other joints, expectation of less pain, radiographic K&L grade, ASA grade, years of hip pain. The primary outcome was the Oxford Hip Score (OHS). Regression models describe the association of BMI on outcome adjusting for all confounders. Results For a 5-unit increase in BMI, the attained 12-month OHS decreases by 0.78 points 95%CI (0.27 to 1.28), p-value 0.001. Compared to people of normal BMI (20 to 25), those in the obese class II (BMI 35 to 40) would have a 12-month OHS that is 2.34 points lower. Although statistically significant this effect is small and not clinically meaningful in contrast to the substantial change in OHS seen across all BMI groupings. In obese class II patients achieved a 22.2 point change in OHS following surgery. Conclusions Patients achieved substantial change in OHS after THR across all BMI categories, which greatly outweighs the small difference in attained post-operative score. The findings suggest BMI should not present a barrier to access THR in terms of PROMs. PMID:24418679

Robust estimation of the proportion of treatment effect explained by surrogate marker information.

PubMed

Parast, Layla; McDermott, Mary M; Tian, Lu

2016-05-10

In randomized treatment studies where the primary outcome requires long follow-up of patients and/or expensive or invasive obtainment procedures, the availability of a surrogate marker that could be used to estimate the treatment effect and could potentially be observed earlier than the primary outcome would allow researchers to make conclusions regarding the treatment effect with less required follow-up time and resources. The Prentice criterion for a valid surrogate marker requires that a test for treatment effect on the surrogate marker also be a valid test for treatment effect on the primary outcome of interest. Based on this criterion, methods have been developed to define and estimate the proportion of treatment effect on the primary outcome that is explained by the treatment effect on the surrogate marker. These methods aim to identify useful statistical surrogates that capture a large proportion of the treatment effect. However, current methods to estimate this proportion usually require restrictive model assumptions that may not hold in practice and thus may lead to biased estimates of this quantity. In this paper, we propose a nonparametric procedure to estimate the proportion of treatment effect on the primary outcome that is explained by the treatment effect on a potential surrogate marker and extend this procedure to a setting with multiple surrogate markers. We compare our approach with previously proposed model-based approaches and propose a variance estimation procedure based on a perturbation-resampling method. Simulation studies demonstrate that the procedure performs well in finite samples and outperforms model-based procedures when the specified models are not correct. We illustrate our proposed procedure using a data set from a randomized study investigating a group-mediated cognitive behavioral intervention for peripheral artery disease participants. Copyright © 2015 John Wiley & Sons, Ltd.

Exercise for improving balance in older people.

PubMed

Howe, Tracey E; Rochester, Lynn; Neil, Fiona; Skelton, Dawn A; Ballinger, Claire

2011-11-09

In older adults, diminished balance is associated with reduced physical functioning and an increased risk of falling. This is an update of a Cochrane review first published in 2007. To examine the effects of exercise interventions on balance in older people, aged 60 and over, living in the community or in institutional care. We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, CENTRAL (The Cochrane Library 2011, Issue 1), MEDLINE and EMBASE (to February 2011). Randomised controlled studies testing the effects of exercise interventions on balance in older people. The primary outcomes of the review were clinical measures of balance. Pairs of review authors independently assessed risk of bias and extracted data from studies. Data were pooled where appropriate. This update included 94 studies (62 new) with 9,917 participants. Most participants were women living in their own home.Most trials were judged at unclear risk of selection bias, generally reflecting inadequate reporting of the randomisation methods, but at high risk of performance bias relating to lack of participant blinding, which is largely unavoidable for these trials. Most studies only reported outcome up to the end of the exercise programme.There were eight categories of exercise programmes. These are listed below together with primary measures of balance for which there was some evidence of a statistically significant effect at the end of the exercise programme. Some trials tested more than one type of exercise. Crucially, the evidence for each outcome was generally from only a few of the trials for each exercise category. 1. Gait, balance, co-ordination and functional tasks (19 studies of which 10 provided primary outcome data): Timed Up & Go test (mean difference (MD) -0.82 s; 95% CI -1.56 to -0.08 s, 114 participants, 4 studies); walking speed (standardised mean difference (SMD) 0.43; 95% CI 0.11 to 0.75, 156 participants, 4 studies), and the Berg Balance Scale (MD 3.48 points; 95% CI 2.01 to 4.95 points, 145 participants, 4 studies).2. Strengthening exercise (including resistance or power training) (21 studies of which 11 provided primary outcome data): Timed Up & Go Test (MD -4.30 s; 95% CI -7.60 to -1.00 s, 71 participants, 3 studies); standing on one leg for as long as possible with eyes closed (MD 1.64 s; 95% CI 0.97 to 2.31 s, 120 participants, 3 studies); and walking speed (SMD 0.25; 95% CI 0.05 to 0.46, 375 participants, 8 studies).3. 3D (3 dimensional) exercise (including Tai Chi, qi gong, dance, yoga) (15 studies of which seven provided primary outcome data): Timed Up & Go Test (MD -1.30 s; 95% CI -2.40 to -0.20 s, 44 participants, 1 study); standing on one leg for as long as possible with eyes open (MD 9.60 s; 95% CI 6.64 to 12.56 s, 47 participants, 1 study), and with eyes closed (MD 2.21 s; 95% CI 0.69 to 3.73 s, 48 participants, 1 study); and the Berg Balance Scale (MD 1.06 points; 95% CI 0.37 to 1.76 points, 150 participants, 2 studies).4. General physical activity (walking) (seven studies of which five provided primary outcome data). 5. General physical activity (cycling) (one study which provided data for walking speed). 6. Computerised balance training using visual feedback (two studies, neither of which provided primary outcome data). 7. Vibration platform used as intervention (three studies of which one provided primary outcome data).8. Multiple exercise types (combinations of the above) (43 studies of which 29 provided data for one or more primary outcomes): Timed Up & Go Test (MD -1.63 s; 95% CI -2.28 to -0.98 s, 635 participants, 12 studies); standing on one leg for as long as possible with eyes open (MD 5.03 s; 95% CI 1.19 to 8.87 s, 545 participants, 9 studies), and with eyes closed ((MD 1.60 s; 95% CI -0.01 to 3.20 s, 176 participants, 2 studies); walking speed (SMD 0.04; 95% CI -0.10 to 0.17, 818 participants, 15 studies); and the Berg Balance Scale ((MD 1.84 points; 95% CI 0.71 to 2.97 points, 80 participants, 2 studies).Few adverse events were reported but most studies did not monitor or report adverse events.In general, the more effective programmes ran three times a week for three months and involved dynamic exercise in standing. There is weak evidence that some types of exercise (gait, balance, co-ordination and functional tasks; strengthening exercise; 3D exercise and multiple exercise types) are moderately effective, immediately post intervention, in improving clinical balance outcomes in older people. Such interventions are probably safe. There is either no or insufficient evidence to draw any conclusions for general physical activity (walking or cycling) and exercise involving computerised balance programmes or vibration plates. Further high methodological quality research using core outcome measures and adequate surveillance is required.

Primary Prevention: Reducing Institutional Racism/Sexism Through Consultation. Case Study.

ERIC Educational Resources Information Center

O'Neil, James M.; Conyne, Robert

This paper presents a two-year primary prevention intervention aimed at reducing institutional racism and sexism at a large midwestern university. A case study format is used to describe the history, process, and outcomes of the consultation that resulted in proactive change in the institution. Definitions of primary prevention are given and the…

National socioeconomic indicators are associated with outcomes after aneurysmal subarachnoid hemorrhage: a hierarchical mixed-effects analysis.

PubMed

Guha, Daipayan; Ibrahim, George M; Kertzer, Joshua D; Macdonald, R Loch

2014-11-01

Although heterogeneity exists in patient outcomes following subarachnoid hemorrhage (SAH) across different centers and countries, it is unclear which factors contribute to such disparities. In this study, the authors performed a post hoc analysis of a large international database to evaluate the association between a country's socioeconomic indicators and patient outcome following aneurysmal SAH. An analysis was performed on a database of 3552 patients enrolled in studies of tirilazad mesylate for aneurysmal SAH from 1991 to 1997, which included 162 neurosurgical centers in North and Central America, Australia, Europe, and Africa. Two primary outcomes were assessed at 3 months after SAH: mortality and Glasgow Outcome Scale (GOS) score. The association between these outcomes, nation-level socioeconomic indicators (percapita gross domestic product [GDP], population-to-neurosurgeon ratio, and health care funding model), and patientlevel covariates were assessed using a hierarchical mixed-effects logistic regression analysis. Multiple previously identified patient-level covariates were significantly associated with increased mortality and worse neurological outcome, including age, intraventricular hemorrhage, and initial neurological grade. Among national-level covariates, higher per-capita GDP (p < 0.05) was associated with both reduced mortality and improved neurological outcome. A higher population-to-neurosurgeon ratio (p < 0.01), as well as fewer neurosurgical centers per population (p < 0.001), was also associated with better neurological outcome (p < 0.01). Health care funding model was not a significant predictor of either primary outcome. Higher per-capita gross GDP and population-to-neurosurgeon ratio were associated with improved outcome after aneurysmal SAH. The former result may speak to the availability of resources, while the latter may be a reflection of better outcomes with centralized care. Although patient clinical and radiographic phenotypes remain the primary predictors of outcome, this study shows that national socioeconomic disparities also explain heterogeneity in outcomes following SAH.

Return to Sports and Physical Activities After Primary Partial Arthrodesis for Lisfranc Injuries in Young Patients.

PubMed

MacMahon, Aoife; Kim, Paul; Levine, David S; Burket, Jayme; Roberts, Matthew M; Drakos, Mark C; Deland, Jonathan T; Elliott, Andrew J; Ellis, Scott J

2016-04-01

Research regarding outcomes in sports and physical activities after primary partial arthrodesis for Lisfranc injuries has been sparse. The purposes of this study were to assess various sports and physical activities in young patients following primary partial arthrodesis for Lisfranc injuries and to compare these with clinical outcomes. Patients who underwent primary partial arthrodesis for a Lisfranc injury were identified by a retrospective registry review. Thirty-eight of 46 eligible patients (83%) responded for follow-up at a mean of 5.2 (range, 1.0 to 9.3) years with a mean age at surgery of 31.8 (range, 16.8 to 50.3) years. Physical activity participation was assessed with a new sports-specific, patient-administered questionnaire. Clinical outcomes were assessed with the Foot and Ankle Outcome Score (FAOS). Patients participated in 29 different and 155 total physical activities preoperatively, and 27 different and 145 total physical activities postoperatively. Preoperatively, 47.1% were high impact, and postoperatively, 44.8% were high impact. The most common activities were walking, bicycling, running, and weightlifting. Compared to preoperatively, difficulty was the same in 66% and increased in 34% of physical activities. Participation levels were improved in 11%, the same in 64%, and impaired in 25% of physical activities. Patients spent on average 4.2 (range, 0.0 to 19.8) hours per week exercising postoperatively. In regard to return to physical activity, 97% of respondents were satisfied with their operative outcome. Mean postoperative FAOS subscores were significantly worse for patients who had increased physical activity difficulty. Most patients were able to return to their previous physical activities following primary partial arthrodesis for a Lisfranc injury, many of which were high-impact. However, the decreased participation or increase in difficulty of some activities suggests that some patients experienced postoperative limitations in exercise. Future studies could compare sports outcomes between primary partial arthrodesis and open reduction internal fixation for Lisfranc injuries. Level IV, retrospective case series. © The Author(s) 2015.

Using perinatal morbidity scoring tools as a primary study outcome.

PubMed

Hutcheon, Jennifer A; Bodnar, Lisa M; Platt, Robert W

2017-11-01

Perinatal morbidity scores are tools that score or weight different adverse events according to their relative severity. Perinatal morbidity scores are appealing for maternal-infant health researchers because they provide a way to capture a broad range of adverse events to mother and newborn while recognising that some events are considered more serious than others. However, they have proved difficult to implement as a primary outcome in applied research studies because of challenges in testing if the scores are significantly different between two or more study groups. We outline these challenges and describe a solution, based on Poisson regression, that allows differences in perinatal morbidity scores to be formally evaluated. The approach is illustrated using an existing maternal-neonatal scoring tool, the Adverse Outcome Index, to evaluate the safety of labour and delivery before and after the closure of obstetrical services in small rural communities. Applying the proposed Poisson regression to the case study showed a protective risk ratio for adverse outcome following closures as compared with the original analysis, where no difference was found. This approach opens the door for considerably broader use of perinatal morbidity scoring tools as a primary outcome in applied population and clinical maternal-infant health research studies. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

CONTROL FUNCTION ASSISTED IPW ESTIMATION WITH A SECONDARY OUTCOME IN CASE-CONTROL STUDIES.

PubMed

Sofer, Tamar; Cornelis, Marilyn C; Kraft, Peter; Tchetgen Tchetgen, Eric J

2017-04-01

Case-control studies are designed towards studying associations between risk factors and a single, primary outcome. Information about additional, secondary outcomes is also collected, but association studies targeting such secondary outcomes should account for the case-control sampling scheme, or otherwise results may be biased. Often, one uses inverse probability weighted (IPW) estimators to estimate population effects in such studies. IPW estimators are robust, as they only require correct specification of the mean regression model of the secondary outcome on covariates, and knowledge of the disease prevalence. However, IPW estimators are inefficient relative to estimators that make additional assumptions about the data generating mechanism. We propose a class of estimators for the effect of risk factors on a secondary outcome in case-control studies that combine IPW with an additional modeling assumption: specification of the disease outcome probability model. We incorporate this model via a mean zero control function. We derive the class of all regular and asymptotically linear estimators corresponding to our modeling assumption, when the secondary outcome mean is modeled using either the identity or the log link. We find the efficient estimator in our class of estimators and show that it reduces to standard IPW when the model for the primary disease outcome is unrestricted, and is more efficient than standard IPW when the model is either parametric or semiparametric.

Revision Ligament Reconstruction Tendon Interposition for Trapeziometacarpal Arthritis: A Case-Control Investigation

PubMed Central

Sadhu, Anita; Calfee, Ryan P.; Guthrie, Andre; Wall, Lindley B.

2016-01-01

Purpose To test the null hypothesis that there is no difference in patient-reported and objective outcomes of revision ligament reconstruction and tendon interposition (LRTI) compared to primary LRTI. Methods This case-control investigation enrolled 10 patients who had undergone revision LRTI at a tertiary care center. All patients had previously undergone primary trapeziectomy with LRTI. Patients with a minimum of two years of follow-up were eligible. All patients completed an in-office study evaluation. Controls (treated only with primary LRTI) were matched from our practice to reach a 1:2 case to control ratio. Outcome measures included Michigan Hand Questionnaire (primary outcome), Quick Disability of the Arm, Hand, and Shoulder (QuickDASH) Questionnaire, VAS for pain and improvement, and physical examination. Statistical analyses were conducted to compare the patient groups. Results Revision LRTI patients reported significantly worse outcomes on all measured standardized questionnaires compared with primary patients. The Michigan Hand Questionnaire indicated worse overall outcomes (54 versus 79) as well as worse pain, appearance, and ability to complete activities of daily living. Revision LRTI patients also reported more impairment (QuickDASH 47 versus 23), greater pain (VAS pain 6.3 versus 1), and less improvement after surgery (VAS improvement 2.7 versus 7.9). There was also a significantly higher rate of patient-reported depression in the revision LRTI group (50% versus 10% of primary LRTI patients). We did not find a significant difference in objective outcomes of pinch strength, grip strength, and thumb palmar abduction between the two groups. Conclusion Following revision LRTI patient-reported outcomes indicate worse perceived function and greater pain than expected following primary LRTI despite similar motion and strength. Revision surgery can be offered in the setting of persistent or recurrent symptoms, but patients should be counseled that improvement of symptoms is unpredictable. PMID:27751779

A systematic review and meta-analysis of pharmacist-led fee-for-services medication review

PubMed Central

Hatah, Ernieda; Braund, Rhiannon; Tordoff, June; Duffull, Stephen B

2014-01-01

Aim The aim was to examine the impact of fee-for-service pharmacist-led medication review on patient outcomes and quantify this according to the type of review undertaken, e.g. adherence support and clinical medication review. Methods Relevant published studies were identified from Medline, Embase and International Pharmaceutical Abstract databases (from inception to February 2011). Study inclusion criteria were fee-for-service medication review, presence of a control group and pre-specified patient outcomes. Outcomes were grouped into primary (changes in biomarkers, hospitalization, and mortality) and secondary outcomes (medication adherence, economic implications and quality of life). Meta-analyses for primary outcomes were conducted using random effects models and secondary outcomes were summarized using descriptive statistics. Results Of the 135 relevant articles located, 21 studies met the inclusion criteria for primary outcomes and 32 for secondary outcomes. Significant results favouring pharmacists' intervention were found for blood pressure (OR 3.50, 95% CI 1.58, 7.75, P = 0.002) and low density lipoprotein (OR 2.35, 95% CI 1.17, 4.72, P = 0.02). Outcomes on hospitalization (OR 0.69, 95% CI 0.39, 1.21, P = 0.19) and mortality (OR 1.50, 95% CI 0.65 to 3.46, P = 0.34) indicated no differences between the groups. On subgroup analysis, clinical medication review (OR 0.46, 95% CI 0.26, 0.83, P = 0.01) but not adherence support review (OR 0.88, 95% CI 0.59, 1.32, P = 0.54) reduced hospitalization. Conclusions The majority of the studies (57.9%) showed improvement in medication adherence. Fee-for-service pharmacist-led medication reviews showed positive benefits on patient outcomes. Interventions that include a clinical review had a significant impact on patient outcomes by attainment of target clinical biomarkers and reduced hospitalization. PMID:23594037

A comparison of time taken to return to baseline erectile function following focal and whole gland ablative therapies for localized prostate cancer: A systematic review.

PubMed

Faure Walker, Nicholas A; Norris, Joseph M; Shah, Taimur T; Yap, Tet; Cathcart, Paul; Moore, Caroline M; Ahmed, Hashim U; Emberton, Mark; Minhas, Suks

2018-02-01

To systematically review erectile function (EF) outcomes following primary whole gland (WG) and focal ablative therapies for localized prostate cancer to ascertain whether the treatment modality or intended treatment volume affects the time taken to recover baseline EF. A systematic review was performed according to the preferred reporting items for systematic review and meta-analysis statement. Inclusion criteria were men with localized prostate cancer treated with primary, ablative therapy. Primary outcome was the return to baseline EF measured with objective, validated symptoms scores. Secondary outcome was use of phosphodiesterase inhibitors or erectile aids. Meta-analysis was not performed owing to heterogenous outcome measures. Of 222 articles identified in February 2017, 55 studies which reported EF after ablative therapy were identified but only 17 used validated outcome measures and met inclusion criteria. WG cryotherapy was used in 2 studies, WG high-intensity focused ultrasound (HIFU) in 5, focal cryotherapy in 2, focal HIFU in 3, focal phototherapy or laser therapy in 4, vascular-targeted photodynamic therapy in 3, and irreversible electroporation in 2. WG cryotherapy was associated with a significant decline in EF at 6 months with minimal improvement at 36 months. Baseline IIEF-15 of patients undergoing focal HIFU fell 30 points at 1 month but returned to baseline by 6 months. The remaining focal therapies demonstrated minimal or no effect on EF, but the men in these studies had small foci of disease. The review is limited by lack of randomized studies and heterogenous outcome measures. Most studies assessing the outcomes of focal therapy on sexual function were not of high quality, used heterogenous outcomes, and had relatively short follow up, highlighting the need for more robustly designed studies using validated patient reported outcome measures  for comparison. However, FT in general resulted in less effect on EF than WG ablation. Copyright © 2018 Elsevier Inc. All rights reserved.

Hemoglobin A1c and short-term outcomes in patients with acute myocardial infarction undergoing primary angioplasty: an observational multicenter study.

PubMed

Tian, Li; Zhu, Jun; Liu, Lisheng; Liang, Yan; Li, Jiandong; Yang, Yanmin

2013-01-01

Several studies to date have examined whether admission levels of hemoglobin A1c (HbA1c) correlate with short-term and long-term outcomes in patients with acute myocardial infarction treated with primary percutaneous coronary intervention (PCI). However, the results have been ambiguous. We speculated that admission levels of HbA1c correlate with short-term outcomes of patients with ST-elevation myocardial infarction (STEMI) undergoing primary PCI. In this observational multicenter study, 608 patients with STEMI who underwent primary PCI between June 2001 and July 2004 were enrolled. Blood samples were collected upon admission to hospital for HbA1c measurement. Follow-up was carried out at 7 and 30 days after hospital admission. According to the new American Diabetes Association criteria, patients were stratified into three groups: I, HbA1c 5.6% or less (n=262); II, HbA1c 5.7-6.4% (n=182); and III, HbA1c at least 6.5% (n=164). The primary outcomes were all-cause mortality and major adverse cardiac events at follow-up. The 7-day mortality was similar (P=0.179) between groups I (1.9%), II (2.2%), and III (0.0%); the 30-day mortality was also similar (P=0.241) between groups I (3.8%), II (2.2%), and III (1.2%). MACE at the 7- day and 30-day follow-up were not significantly different between the three groups either (P>0.05). Rates of target vessel revascularization and rehospitalization, and MACE-free survival curves, at the 30-day follow-up were also similar among the three groups. After adjusting the baseline characteristics, HbA1c was not an independent predictor of short-term outcomes (hazards ratio: 0.431; 95% confidence interval: 0.175-1.061, P=0.067). Admission levels of HbA1c are not an independent prognostic marker for short-term outcomes in STEMI patients treated with primary PCI.

A pragmatic group sequential, placebo-controlled, randomised trial to determine the effectiveness of glyceryl trinitrate for retained placenta (GOT-IT): a study protocol

PubMed Central

Norrie, John; Lawton, Julia; Norman, Jane E; Scotland, Graham; McPherson, Gladys C; McDonald, Alison; Forrest, Mark; Hudson, Jemma; Brewin, Jane; Peace, Mathilde; Clarkson, Cynthia; Brook-Smith, Sheonagh; Morrow, Susan; Hallowell, Nina; Hodges, Laura; Carruthers, Kathryn F

2017-01-01

Introduction A retained placenta is diagnosed when the placenta is not delivered following delivery of the baby. It is a major cause of postpartum haemorrhage and treated by the operative procedure of manual removal of placenta (MROP). Methods and analysis The aim of this pragmatic, randomised, placebo-controlled, double-blind UK-wide trial, with an internal pilot and nested qualitative research to adjust strategies to refine delivery of the main trial, is to determine whether sublingual glyceryl trinitrate (GTN) is (or is not) clinically and cost-effective for (medical) management of retained placenta. The primary clinical outcome is need for MROP, defined as the placenta remaining undelivered 15 min poststudy treatment and/or being required within 15 min of treatment due to safety concerns. The primary safety outcome is measured blood loss between administration of treatment and transfer to the postnatal ward or other clinical area. The primary patient-sided outcome is satisfaction with treatment and a side effect profile. The primary economic outcome is net incremental costs (or cost savings) to the National Health Service of using GTN versus standard practice. Secondary outcomes are being measured over a range of clinical and economic domains. The primary outcomes will be analysed using linear models appropriate to the distribution of each outcome. Health service costs will be compared with multiple trial outcomes in a cost-consequence analysis of GTN versus standard practice. Ethics and dissemination Ethical approval has been obtained from the North-East Newcastle & North Tyneside 2 Research Ethics Committee (13/NE/0339). Dissemination plans for the trial include the Health Technology Assessment Monograph, presentation at international scientific meetings and publication in high-impact, peer-reviewed journals. Trial registration number ISCRTN88609453; Pre-results. PMID:28928192

Association of the Magnitude of Weight Loss and Physical Fitness Change on Long-term CVD outcomes: The Look AHEAD Study

PubMed Central

2016-01-01

Background The Look AHEAD Study found no significant reduction in cardiovascular disease (CVD) incidence among adults with diabetes enrolled in an intensive weight loss intervention (ILI) compared to those randomized to diabetes support and education (DSE). We examined whether CVD incidence in Look AHEAD varied by weight or fitness change. Methods Among overweight or obese adults people aged 45–76 with type 2 diabetes in the Look AHEAD study, this observational analysis examined the association of magnitude of weight loss (N=4834) and fitness change (N=4406) over the first year with CVD incidence over a median 10.2 years of follow-up. The primary outcome was a composite of CVD death, myocardial infarction, stroke, or angina hospitalization; the secondary outcome included the same indices plus coronary–artery bypass grafting, carotid endartectomy, percutaneous coronary intervention, hospitalization for congestive heart failure, peripheral vascular disease, or total mortality. Analyses adjusted for baseline differences in weight or fitness, demographics and CVD risk factors. Findings In analyses of the full cohort combining ILI and DSE, persons who lost > 10% body weight in the first year had 21% lower risk of the primary outcome (HR=0.79, 95% CI, 0.64 to 0.98) and a 24% reduced risk of the secondary outcome (HR=0.76, 95% CI, 0.63 to 0.91) relative to those with stable weight/weight gain. Achieving a > 2 MET fitness change was associated with a significant reduction in the secondary outcome (HR=0.77, 95% CI, 0.61 – 0.96) but not the primary outcome (HR=0.78, 0.60 – 1.03). In analyses treating the DSE as the referent group, ILI participants with > 10% weight losses had a 20% lower risk of the primary outcome (HR=0.80 (95% CI, 0.65 – 0.99) and a 21% reduced risk of the secondary outcome (0.79 (95% CI, 0.66 – 0.95); fitness change was not significantly associated with either outcome. Interpretation This secondary analysis of Look AHEAD suggests an association between the magnitude of intentional weight loss and CVD incidence. PMID:27595918

Cue-elicited food seeking is eliminated with aversive outcomes following outcome devaluation.

PubMed

Eder, Andreas B; Dignath, David

2016-01-01

In outcome-selective Pavlovian-to-instrumental transfer (PIT), stimuli that are predictive of specific outcomes prime instrumental responses that are associated with these outcomes. Previous human studies yielded mixed evidence in respect to whether the PIT effect is affected by a posttraining devaluation of an outcome, with the PIT effect being preserved after a devaluation of a primary reinforcer (food, drugs) but not following the devaluation of a secondary reinforcer (money). The present research examined whether outcome-selective transfer is eliminated when the devaluation of a primary (liquid) reinforcer is strong and aversive. Experiment 1 confirmed these expectations following a devaluation with bad tasting Tween 20. However, outcome-selective transfer was still observed when the earned (devalued) outcome was not consumed immediately after each test (Experiment 2). These results suggest that the capacity of a Pavlovian cue to motivate a specific response is affected by the incentive value of the shared outcome only when the devaluation yields an aversive outcome that is consumed immediately.

Limited evidence to assess the impact of primary health care system or service level attributes on health outcomes of Indigenous people with type 2 diabetes: a systematic review.

PubMed

Gibson, Odette R; Segal, Leonie

2015-04-11

To describe reported studies of the impact on HbA1C levels, diabetes-related hospitalisations, and other primary care health endpoints of initiatives aimed at improving the management of diabetes in Indigenous adult populations of Australia, Canada, New Zealand and the United States. Systematic literature review using data sources of MEDLINE, Embase, the Cochrane Library, CINHAL and PsycInfo from January 1985 to March 2012. Inclusion criteria were a clearly described primary care intervention, model of care or service, delivered to Indigenous adults with type 2 diabetes reporting a program impact on at least one quantitative diabetes-related health outcome, and where results were reported separately for Indigenous persons. Joanna Briggs Institute critical appraisal tools were used to assess the study quality. PRISMA guidelines were used for reporting. The search strategy retrieved 2714 articles. Of these, 13 studies met the review inclusion criteria. Three levels of primary care initiatives were identified: 1) addition of a single service component to the existing service, 2) system-level improvement processes to enhance the quality of diabetes care, 3) change in primary health funding to support better access to care. Initiatives included in the review were diverse and included comprehensive multi-disciplinary diabetes care, specific workforce development, systematic foot care and intensive individual hypertension management. Twelve studies reported HbA1C, of those one also reported hospitalisations and one reported the incidence of lower limb amputation. The methodological quality of the four comparable cohort and seven observational studies was good, and moderate for the two randomised control trials. The current literature provides an inadequate evidence base for making important policy and practice decisions in relation to primary care initiatives for Indigenous persons with type 2 diabetes. This reflects a very small number of published studies, the general reliance on intermediate health outcomes and the predominance of observational studies. Additional studies of the impacts of primary care need to consider carefully research design and the reporting of hospital outcomes or other primary end points. This is an important question for policy makers and further high quality research is needed to contribute to an evidence-base to inform decision making.

Team functioning as a predictor of patient outcomes in early medical home implementation.

PubMed

Wu, Frances M; Rubenstein, Lisa V; Yoon, Jean

New models of patient-centered primary care such as the patient-centered medical home (PCMH) depend on high levels of interdisciplinary primary care team functioning to achieve improved outcomes. A few studies have qualitatively assessed barriers and facilitators to optimal team functioning; however, we know of no prior study that assesses PCMH team functioning in relationship to patient health outcomes. The aim of the study was to assess the relationships between primary care team functioning, patients' use of acute care, and mortality. Retrospective longitudinal cohort analysis of patient outcomes measured at two time points (2012 and 2013) after PCMH implementation began in Veterans Health Administration practices. Multilevel models examined practice-level measures of team functioning in relationship to patient outcomes (all-cause and ambulatory care-sensitive condition-related hospitalizations, emergency department visits, and mortality). We controlled for practice-level factors likely to affect team functioning, including leadership support, provider and staff burnout, and staffing sufficiency, as well as for individual patient characteristics. We also tested the model among a subgroup of vulnerable patients (homeless, mentally ill, or with dementia). In adjusted analyses, higher team functioning was associated with lower mortality (OR = 0.92, p = .04) among all patients and with fewer all-cause admissions (incidence rate ratio [IRR] = 0.90, p < 0.01), ambulatory care-sensitive condition-related admissions (IRR = 0.91, p = .04), and emergency department visits (IRR = 0.91, p = .03) in the vulnerable patient subgroup. These early findings give support for the importance of team functioning within PCMH models for achieving improved patient outcomes. A focus on team functioning is important especially in the early implementation of team-based primary care models.

Preoperative physiotherapy and short-term functional outcomes of primary total knee arthroplasty.

PubMed

Mat Eil Ismail, Mohd Shukry; Sharifudin, Mohd Ariff; Shokri, Amran Ahmed; Ab Rahman, Shaifuzain

2016-03-01

Physiotherapy is an important part of rehabilitation following arthroplasty, but the impact of preoperative physiotherapy on functional outcomes is still being studied. This randomised controlled trial evaluated the effect of preoperative physiotherapy on the short-term functional outcomes of primary total knee arthroplasty (TKA). 50 patients with primary knee osteoarthritis who underwent unilateral primary TKA were randomised into two groups: the physiotherapy group (n = 24), whose patients performed physical exercises for six weeks immediately prior to surgery, and the nonphysiotherapy group (n = 26). All patients went through a similar physiotherapy regime in the postoperative rehabilitation period. Functional outcome assessment using the algofunctional Knee Injury and Osteoarthritis Outcome Score (KOOS) scale and range of motion (ROM) evaluation was performed preoperatively, and postoperatively at six weeks and three months. Both groups showed a significant difference in all algofunctional KOOS subscales (p < 0.001). The mean score difference at six weeks and three months was not significant in the sports and recreational activities subscale for both groups (p > 0.05). Significant differences were observed in the time-versus-treatment analysis between groups for the symptoms (p = 0.003) and activities of daily living (p = 0.025) subscales. No significant difference in ROM was found when comparing preoperative measurements and those at three months following surgery, as well as in time-versus-treatment analysis (p = 0.928). Six-week preoperative physiotherapy showed no significant impact on short-term functional outcomes (KOOS subscales) and ROM of the knee following primary TKA. Copyright: © Singapore Medical Association.

Perinatal and maternal outcomes by planned place of birth for healthy women with low risk pregnancies: the Birthplace in England national prospective cohort study.

PubMed

Brocklehurst, Peter; Hardy, Pollyanna; Hollowell, Jennifer; Linsell, Louise; Macfarlane, Alison; McCourt, Christine; Marlow, Neil; Miller, Alison; Newburn, Mary; Petrou, Stavros; Puddicombe, David; Redshaw, Maggie; Rowe, Rachel; Sandall, Jane; Silverton, Louise; Stewart, Mary

2011-11-23

To compare perinatal outcomes, maternal outcomes, and interventions in labour by planned place of birth at the start of care in labour for women with low risk pregnancies. Prospective cohort study. England: all NHS trusts providing intrapartum care at home, all freestanding midwifery units, all alongside midwifery units (midwife led units on a hospital site with an obstetric unit), and a stratified random sample of obstetric units. 64,538 eligible women with a singleton, term (≥37 weeks gestation), and "booked" pregnancy who gave birth between April 2008 and April 2010. Planned caesarean sections and caesarean sections before the onset of labour and unplanned home births were excluded. A composite primary outcome of perinatal mortality and intrapartum related neonatal morbidities (stillbirth after start of care in labour, early neonatal death, neonatal encephalopathy, meconium aspiration syndrome, brachial plexus injury, fractured humerus, or fractured clavicle) was used to compare outcomes by planned place of birth at the start of care in labour (at home, freestanding midwifery units, alongside midwifery units, and obstetric units). There were 250 primary outcome events and an overall weighted incidence of 4.3 per 1000 births (95% CI 3.3 to 5.5). Overall, there were no significant differences in the adjusted odds of the primary outcome for any of the non-obstetric unit settings compared with obstetric units. For nulliparous women, the odds of the primary outcome were higher for planned home births (adjusted odds ratio 1.75, 95% CI 1.07 to 2.86) but not for either midwifery unit setting. For multiparous women, there were no significant differences in the incidence of the primary outcome by planned place of birth. Interventions during labour were substantially lower in all non-obstetric unit settings. Transfers from non-obstetric unit settings were more frequent for nulliparous women (36% to 45%) than for multiparous women (9% to 13%). The results support a policy of offering healthy women with low risk pregnancies a choice of birth setting. Women planning birth in a midwifery unit and multiparous women planning birth at home experience fewer interventions than those planning birth in an obstetric unit with no impact on perinatal outcomes. For nulliparous women, planned home births also have fewer interventions but have poorer perinatal outcomes.

Integrating Telehealth Technology into a Clinical Pharmacy Telephonic Diabetes Management Program

PubMed Central

Klug, Cindy; Bonin, Kerry; Bultemeier, Nanette; Rozenfeld, Yelena; Stuckman Vasquez, Rebecca; Johnson, Mark; Cherry, Julie Cheitlin

2011-01-01

Background Use of home monitoring technologies can enhance care coordination and improve clinical outcomes in patients with diabetes and other chronic diseases. This study was designed to explore the feasibility of incorporating a telehealth system into an existing telephonic diabetes management program utilizing clinical pharmacists. Methods This observational study was conducted at three Providence Medical Group primary care clinics. Adults with a diagnosis of diabetes and a recent hemoglobin A1c (HbA1c) >8% were referred by their primary care provider to participate in the study. Participants utilized the telehealth system developed by Intel Corporation and were followed by clinical pharmacists who provide telephonic diabetes management. The primary clinical outcome measure was change in mean HbA1c. Secondary outcomes included blood glucose levels, participant self-management knowledge, and the degree of participant engagement. Results Mean HbA1c level decreased by 1.3% at the study end (p = .001). Based on participant satisfaction surveys and qualitative responses, participants were satisfied with the telehealth system. Mean blood glucose values decreased significantly over the 16-week study period from 178 mg/dl [standard deviation (SD) 67] at week 1 to 163 mg/dl (SD 64) at week 16 (p = .0002). Participants entered the study with moderate to good knowledge about managing their diabetes based on three questions, and no statistically significant improvement in knowledge was found post-study. Conclusion Telehealth technology can be a positive adjunct to the primary care team in managing diabetes or other chronic conditions to improve clinical outcomes. PMID:22027325

Impact of Interventions to Increase the Proportion of Medical Students Choosing a Primary Care Career: A Systematic Review.

PubMed

Pfarrwaller, Eva; Sommer, Johanna; Chung, Christopher; Maisonneuve, Hubert; Nendaz, Mathieu; Junod Perron, Noëlle; Haller, Dagmar M

2015-09-01

Increasing the attractiveness of primary care careers is a key step in addressing the growing shortage of primary care physicians. The purpose of this review was to (1) identify interventions aimed at increasing the proportion of undergraduate medical students choosing a primary care specialty, (2) describe the characteristics of these interventions, (3) assess the quality of the studies, and (4) compare the findings to those of a previous literature review within a global context. We searched MEDLINE, EMBASE, ERIC, CINAHL, PsycINFO, The Cochrane Library, and Dissertations & Theses A&I for articles published between 1993 and February 20, 2015. We included quantitative and qualitative studies reporting on primary care specialty choice outcomes of interventions in the undergraduate medical curriculum, without geographic restrictions. Data extracted included study characteristics, intervention details, and relevant outcomes. Studies were assessed for quality and strength of findings using a five-point scale. The review included 72 articles reporting on 66 different interventions. Longitudinal programs were the only intervention consistently associated with an increased proportion of students choosing primary care. Successful interventions were characterized by diverse teaching formats, student selection, and good-quality teaching. Study quality had not improved since recommendations were published in 1995. Many studies used cross-sectional designs and non-validated surveys, did not include control groups, and were not based on a theory or conceptual framework. Our review supports the value of longitudinal, multifaceted, primary care programs to increase the proportion of students choosing primary care specialties. Isolated modules or clerkships did not appear to be effective. Our results are in line with the conclusions from previous reviews and add an international perspective, but the evidence is limited by the overall low methodological quality of the included studies. Future research should use more rigorous evaluation methods and include long-term outcomes.

Does the Extended Glasgow Outcome Scale Add Value to the Conventional Glasgow Outcome Scale?

PubMed Central

Weir, James; Steyerberg, Ewout W.; Butcher, Isabella; Lu, Juan; Lingsma, Hester F.; McHugh, Gillian S.; Roozenbeek, Bob; Maas, Andrew I.R.

2012-01-01

Abstract The Glasgow Outcome Scale (GOS) is firmly established as the primary outcome measure for use in Phase III trials of interventions in traumatic brain injury (TBI). However, the GOS has been criticized for its lack of sensitivity to detect small but clinically relevant changes in outcome. The Glasgow Outcome Scale-Extended (GOSE) potentially addresses this criticism, and in this study we estimate the efficiency gain associated with using the GOSE in place of the GOS in ordinal analysis of 6-month outcome. The study uses both simulation and the reanalysis of existing data from two completed TBI studies, one an observational cohort study and the other a randomized controlled trial. As expected, the results show that using an ordinal technique to analyze the GOS gives a substantial gain in efficiency relative to the conventional analysis, which collapses the GOS onto a binary scale (favorable versus unfavorable outcome). We also found that using the GOSE gave a modest but consistent increase in efficiency relative to the GOS in both studies, corresponding to a reduction in the required sample size of the order of 3–5%. We recommend that the GOSE be used in place of the GOS as the primary outcome measure in trials of TBI, with an appropriate ordinal approach being taken to the statistical analysis. PMID:22026476

Shaping dental contract reform: a clinical and cost-effective analysis of incentive-driven commissioning for improved oral health in primary dental care

PubMed Central

Hulme, C; Robinson, P G; Saloniki, E C; Vinall-Collier, K; Baxter, P D; Douglas, G; Gibson, B; Godson, J H; Meads, D; Pavitt, S H

2016-01-01

Objective To evaluate the clinical and cost-effectiveness of a new blended dental contract incentivising improved oral health compared with a traditional dental contract based on units of dental activity (UDAs). Design Non-randomised controlled study. Setting Six UK primary care dental practices, three working under a new blended dental contract; three matched practices under a traditional contract. Participants 550 new adult patients. Interventions A new blended/incentive-driven primary care dentistry contract and service delivery model versus the traditional contract based on UDAs. Main outcome measures Primary outcome was as follows: percentage of sites with gingival bleeding on probing. Secondary outcomes were as follows: extracted and filled teeth (%), caries (International Caries Detection and Assessment System (ICDAS)), oral health-related quality of life (Oral Health Impact Profile-14 (OHIP-14)). Incremental cost-effective ratios used OHIP-14 and quality adjusted life years (QALYs) derived from the EQ-5D-3L. Results At 24 months, 291/550 (53%) patients returned for final assessment; those lost to follow-up attended 6.46 appointments on average (SD 4.80). The primary outcome favoured patients in the blended contract group. Extractions and fillings were more frequent in this group. Blended contracts were financially attractive for the dental provider but carried a higher cost for the service commissioner. Differences in generic health-related quality of life were negligible. Positive changes over time in oral health-related quality of life in both groups were statistically significant. Conclusions This is the first UK study to assess the clinical and cost-effectiveness of a blended contract in primary care dentistry. Although the primary outcome favoured the blended contract, the results are limited because 47% patients did not attend at 24 months. This is consistent with 39% of adults not being regular attenders and 27% only visiting their dentist when they have a problem. Promotion of appropriate attendance, especially among those with high need, necessitates being factored into recruitment strategies of future studies. PMID:27609858

Interprofessional online learning for primary healthcare: findings from a scoping review

PubMed Central

Reeves, Scott; Fletcher, Simon; McLoughlin, Clodagh; Yim, Alastair; Patel, Kunal D

2017-01-01

Objectives This article presents the findings from a scoping review which explored the nature of interprofessional online learning in primary healthcare. The review was informed by the following questions: What is the nature of evidence on online postgraduate education for primary healthcare interprofessional teams? What learning approaches and study methods are used in this context? What is the range of reported outcomes for primary healthcare learners, their organisations and the care they deliver to patients/clients? Setting The review explored the global literature on interprofessional online learning in primary healthcare settings. Results The review found that the 23 included studies employed a range of different e-learning methods with contrasting course durations, use of theory, participant mix, approaches to accreditation and assessment of learning. Most of the included studies reported outcomes associated with learner reactions and positive changes in participant attitudes/perceptions and improvement in knowledge/skills as a result of engagement in an e-learning course. In contrast, fewer studies reported changes in participant behaviours, changes in organisational practice and improvements to patients/clients. Conclusions A number of educational, methodological and outcome implications are be offered. E-learning can enhance an education experience, support development, ease time constraints, overcome geographic limitations and can offer greater flexibility. However, it can also contribute to the isolation of learners and its benefits can be negated by technical problems. PMID:28780560

The impact of transmural multiprofessional simulation-based obstetric team training on perinatal outcome and quality of care in the Netherlands

PubMed Central

2014-01-01

Background Perinatal mortality and morbidity in the Netherlands is relatively high compared to other European countries. Our country has a unique system with an independent primary care providing care to low-risk pregnancies and a secondary/tertiary care responsible for high-risk pregnancies. About 65% of pregnant women in the Netherlands will be referred from primary to secondary care implicating multiple medical handovers. Dutch audits concluded that in the entire obstetric collaborative network process parameters could be improved. Studies have shown that obstetric team training improves perinatal outcome and that simulation-based obstetric team training implementing crew resource management (CRM) improves team performance. In addition, deliberate practice (DP) improves medical skills. The aim of this study is to analyse whether transmural multiprofessional simulation-based obstetric team training improves perinatal outcome. Methods/Design The study will be implemented in the south-eastern part of the Netherlands with an annual delivery rate of over 9,000. In this area secondary care is provided by four hospitals. Each hospital with referring primary care practices will form a cluster (study group). Within each cluster, teams will be formed of different care providers representing the obstetric collaborative network. CRM and elements of DP will be implemented in the training. To analyse the quality of care as perceived by patients, the Pregnancy and Childbirth Questionnaire (PCQ) will be used. Furthermore, self-reported collaboration between care providers will be assessed. Team performance will be measured by the Clinical Teamwork Scale (CTS). We employ a stepped-wedge trial design with a sequential roll-out of the trainings for the different study groups. Primary outcome will be perinatal mortality and/or admission to a NICU. Secondary outcome will be team performance, quality of care as perceived by patients, and collaboration among care providers. Conclusion The effect of transmural multiprofessional simulation-based obstetric team training on perinatal outcome has never been studied. We hypothesise that this training will improve perinatal outcome, team performance, and quality of care as perceived by patients and care providers. Trial registration The Netherlands National Trial Register, http://www.trialregister.nl/NTR4576, registered June 1, 2014 PMID:25145317

Neutrophil-to-lymphocyte ratio as a predictor of worsening renal function in diabetic patients (3-year follow-up study).

PubMed

Azab, Basem; Daoud, Jacques; Naeem, Fahad Ben; Nasr, Rabih; Ross, Jennifer; Ghimire, Pratima; Siddiqui, Ayesha; Azzi, Nadine; Rihana, Nancy; Abdallah, Marie; Azzi, Nassif; Patel, Parishram; Kleiner, Morton; El-Sayegh, Suzanne

2012-01-01

Previous studies have demonstrated the role of inflammation in diabetic nephropathy (DN). Neutrophil to lymphocyte ratio (NLR) rather than other white cell parameters was found to be a useful inflammatory marker to predict adverse outcomes in medical and surgical conditions. Nevertheless, the value of NLR in predicting DN has not been elucidated. An observational study included 338 diabetic patients, who were followed at our clinic between 2007 and 2009. We arranged our patients into tertiles according to their 2007 NLR. The primary outcome was continuous decrease of GFR >12 mL/min between 2007 and 2009 with the last GFR <60 mL/min. The lowest NLR tertile had fewer patients (2.7%) with primary outcome (i.e., worsening renal function) compared with middle and highest NLR tertiles, which had more patients with primary outcomes (8.7% and 11.5%, respectively) with a significant p-value 0.0164. When other potential confounders were individually analyzed with NLR tertile, the NLR tertiles remained a significant predictor of poor GFR outcome in the presence of other variables (hemoglobin A1C, systolic blood pressure, diastolic blood pressure, age, and congestive heart failure with p-values 0.018, 0.019, 0.017, 0.033, and 0.022, respectively). NLR predicted the worsening of the renal function in diabetic patients. Further studies are needed to confirm this result.

Surgical Outcomes of Primary Versus Post-Neoadjuvant Chemotherapy Breast Conservation Surgery: A Comparative Study from a Developing Country.

PubMed

Agarwal, Gaurav; Sonthineni, Chaitra; Mayilvaganan, Sabaretnam; Mishra, Anjali; Lal, Punita; Agrawal, Vinita

2018-05-01

In India and other developing countries, breast conservation surgery (BCS) rates in breast cancer patients are low due to advanced disease at presentation and misconceptions about BCS outcomes. Many patients presenting with large or locally advanced breast cancers (LABC) can be offered post-neoadjuvant chemotherapy (NACT) BCS, safety of which is not as well established as that of primary BCS. This retrospective study compared pathological and surgical outcome parameters in patients undergoing primary and post-NACT BCS. All non-metastatic breast cancer patients undergoing BCS during 2011-2015 with 1-year follow-up were included. Outcome parameters in form of margin infiltration, ipsilateral breast tumor recurrence (IBTR) rates and IBTR-free survival were compared between primary and post-NACT BCS patients groups. One hundred and twenty-nine patients underwent BCS; 95 underwent primary and 34 post-NACT BCS. Patients in both groups underwent similar multimodality treatment as per institutional protocols. Post-NACT patients more frequently required oncoplastic volume displacement or replacement surgery (p = 0.002). Re-excision of infiltrated margins was needed more frequently in primary BCS compared with post-NACT BCS group (14.4 vs. 8.8%; p = 0.40). IBTR (Mean follow-up = 30.7 months) was seen in 8.8% post-NACT patients compared with 2.1% primary BCS (p = 0.114). IBTR-free survival did not differ significantly between the groups in stage-wise comparison. Post-NACT BCS is safe even in large tumors and LABC, though many require oncoplastic procedures for satisfactory cosmesis. In a developing country where many patients present with large breast cancers or LABC, the benefits of BCS can be offered to a majority with the help of NACT, without compromising the chances of cure.

Advancing primary care to promote equitable health: implications for China

PubMed Central

2012-01-01

China is a country with vast regional differences and uneven economic development, which have led to widening gaps between the rich and poor in terms of access to healthcare, quality of care, and health outcomes. China's healthcare reform efforts must be tailored to the needs and resources of each region and community. Building and strengthening primary care within the Chinese health care system is one way to effectively address health challenges. This paper begins by outlining the concept of primary care, including key definitions and measurements. Next, results from a number of studies will demonstrate that primary care characteristics are associated with savings in medical costs, improvements in health outcomes and reductions in health disparities. This paper concludes with recommendations for China on successfully incorporating a primary care model into its national health policy, including bolstering the primary care workforce, addressing medical financing structures, recognizing the importance of evidence-based medicine, and looking to case studies from countries that have successfully implemented health reform. PMID:22264309

Impact of primary care depression intervention on employment and workplace conflict outcomes: is value added?

PubMed

Smith, Jeffrey L; Rost, Kathryn M; Nutting, Paul A; Libby, Anne M; Elliott, Carl E; Pyne, Jeffrey M

2002-03-01

Depression causes significant functional impairment in sufferers and often leads to adverse employment outcomes for working individuals. Recovery from depression has been associated with better employment outcomes at one year. The study s goals were to assess a primary care depression intervention s impact on subsequent employment and workplace conflict outcomes in employed patients with depression. In 1996-1997, the study enrolled 262 employed patients with depression from twelve primary care practices located across ten U.S. states; 219 (84%) of the patients were followed at one year. Intent-to-treat analyses assessing intervention effects on subsequent employment and workplace conflict were conducted using logistic regression models controlling for individual clinical and sociodemographic characteristics, job classification and local employment conditions. To meet criteria for subsequent employment, persons working full-time at baseline had to report they were working full-time at follow-up and persons working part-time at baseline had to report working part-/full-time at follow-up. Workplace conflict was measured by asking patients employed at follow-up whether, in the past year, they had arguments or other difficulties with people at work . Findings showed that 92.1% of intervention patients met criteria for subsequent employment at one year, versus 82.0% of usual care patients (c2=4.42, p=.04). Intervention patients were less likely than usual care patients to report workplace conflict in the year following baseline (8.1% vs. 18.9%, respectively; c2=4.11; p=.04). The intervention s effect on subsequent employment was not mediated by its effect on workplace conflict. The intervention significantly improved employment outcomes and reduced workplace conflict in depressed, employed persons at one year. Economic implications for employers related to reduced turnover costs, for workers related to retained earnings, and for governments related to reduced unemployment expenditures and increased tax receipts may be considerable. Although similar primary care depression interventions have been shown to produce comparable effects on subsequent employment at one year, replications in larger samples of depressed, employed patients in different economic climates may be necessary to increase the generalizability and precision of estimates. Primary care interventions that enhance depression treatment and improve clinical outcomes can contribute meaningful added value to society by improving employment and workplace outcomes. Federal/state governments may realize economic benefits from reduced unemployment expenditures and increased tax receipts should primary care depression interventions that improve employment outcomes be broadly disseminated. Policy initiatives to increase the dissemination of such interventions may be an innovative approach for improving labor force participation by depressed individuals. Formal cost-benefit analyses are needed to explore whether economic benefits to societal stakeholders from these and other labor outcomes equal or exceed the incremental costs of disseminating similar primary care interventions nationally. Researchers in other nations may wish to consider investigating the impact primary care depression interventions might have on employment and workplace outcomes in their countries.

Spontaneous hypothermia on intensive care unit admission is a predictor of unfavorable neurological outcome in patients after resuscitation: an observational cohort study.

PubMed

den Hartog, Alexander W; de Pont, Anne-Cornélie J M; Robillard, Laure B M; Binnekade, Jan M; Schultz, Marcus J; Horn, Janneke

2010-01-01

A large number of patients resuscitated for primary cardiac arrest arrive in the intensive care unit (ICU) with a body temperature < 35.0 degrees C. The aim of this observational cohort study was to determine the association between ICU admission temperature and neurological outcome in this patient group. Demographics and parameters influencing neurological outcome were retrieved from the charts of all patients resuscitated for primary cardiac arrest and treated with induced mild hypothermia in our ICU from January 2006 until January 2008. Patients were divided into two groups according to their body temperature on ICU admission: a hypothermia group (< 35.0 degrees C) and a non-hypothermia group (>or=35.0 degrees C). Neurological outcome after six months was assessed by means of the Glasgow Outcome Score (GOS), with GOS 1 to 3 defined as unfavorable and GOS 4 to 5 as favorable. A logistic regression model was used to analyze the influence of the different parameters on neurological outcome. The data of 105 consecutive patients resuscitated for primary cardiac arrest and treated with induced mild hypothermia were analyzed. Median ICU admission temperature was 35.1 degrees C (interquartile range (IQR) 34.3 to 35.7). After six months, 61% of the patients had an unfavorable outcome (59% died and 2% were severely disabled), whereas 39% had a favorable outcome (moderate disability or good recovery). Among patients with spontaneous hypothermia on ICU admission, the percentage with unfavorable outcome was higher (69% versus 50%, P = 0.05). Logistic regression showed that age, acute physiology and chronic health evaluation (APACHE) II and sequential organ failure assessment (SOFA) scores and spontaneous hypothermia on ICU admission all had an increased odds ratio (OR) for an unfavorable outcome after six months. Spontaneous hypothermia had the strongest association with unfavorable outcome (OR 2.6, 95% CI (confidence interval) 1.1 to 5.9), which became even stronger after adjustment for age, presenting heart rhythm, APACHE II and SOFA scores (OR 3.8, CI 1.3 to 11.0). In this observational cohort study, spontaneous hypothermia on ICU admission was the strongest predictor of an unfavorable neurological outcome in patients resuscitated for primary cardiac arrest.

Pregnancy outcomes in women with type 1 and type 2 diabetes mellitus in a retrospective multi-institutional study in Japan.

PubMed

Sato, Takahiro; Sugiyama, Takashi; Kurakata, Michiyo; Saito, Masatoshi; Sugawara, Junichi; Yaegashi, Nobuo; Sagawa, Norimasa; Sanaka, Mayumi; Akazawa, Shoichi; Anazawa, Sonoko; Waguri, Masako; Sameshima, Hiroshi; Hiramatsu, Yuji; Toyoda, Nagayasu

2014-01-01

The present study was performed to evaluate pregnancy outcomes in women with type 1 and type 2 diabetes mellitus (DM) in Japan. This multi-institutional retrospective study was conducted in 40 general hospitals in Japan during 2003-2009. We evaluated 369 and 579 pregnant women with type 1 and type 2 DM, respectively, and compared pregnancy outcomes between the two groups. Glycosylated hemoglobin levels in the first trimester did not differ significantly between the studied groups. Gestational weight gain was lower in type 2 DM than in type 1 DM. Although there were no significant differences in perinatal outcomes between the groups, the primary cesarean section rate was higher in type 2 DM than in type 1 DM. Multiple logistic regression analysis revealed that primigravida status, pre-gestational body mass index (BMI), gestational weight gain, chronic hypertension, and microvascular disease including diabetic retinopathy or nephropathy were associated with onset of pregnancy-induced hypertension. Further, pre-gestational BMI was associated with the need for primary cesarean section. This study demonstrated that no differences were observed in the rates of perinatal mortality and congenital malformation between pregnant women with type 1 DM and type 2 DM; however, women with type 2 DM displayed a higher risk of primary cesarean section.

Outcomes Definitions and Statistical Tests in Oncology Studies: A Systematic Review of the Reporting Consistency.

PubMed

Rivoirard, Romain; Duplay, Vianney; Oriol, Mathieu; Tinquaut, Fabien; Chauvin, Franck; Magne, Nicolas; Bourmaud, Aurelie

2016-01-01

Quality of reporting for Randomized Clinical Trials (RCTs) in oncology was analyzed in several systematic reviews, but, in this setting, there is paucity of data for the outcomes definitions and consistency of reporting for statistical tests in RCTs and Observational Studies (OBS). The objective of this review was to describe those two reporting aspects, for OBS and RCTs in oncology. From a list of 19 medical journals, three were retained for analysis, after a random selection: British Medical Journal (BMJ), Annals of Oncology (AoO) and British Journal of Cancer (BJC). All original articles published between March 2009 and March 2014 were screened. Only studies whose main outcome was accompanied by a corresponding statistical test were included in the analysis. Studies based on censored data were excluded. Primary outcome was to assess quality of reporting for description of primary outcome measure in RCTs and of variables of interest in OBS. A logistic regression was performed to identify covariates of studies potentially associated with concordance of tests between Methods and Results parts. 826 studies were included in the review, and 698 were OBS. Variables were described in Methods section for all OBS studies and primary endpoint was clearly detailed in Methods section for 109 RCTs (85.2%). 295 OBS (42.2%) and 43 RCTs (33.6%) had perfect agreement for reported statistical test between Methods and Results parts. In multivariable analysis, variable "number of included patients in study" was associated with test consistency: aOR (adjusted Odds Ratio) for third group compared to first group was equal to: aOR Grp3 = 0.52 [0.31-0.89] (P value = 0.009). Variables in OBS and primary endpoint in RCTs are reported and described with a high frequency. However, statistical tests consistency between methods and Results sections of OBS is not always noted. Therefore, we encourage authors and peer reviewers to verify consistency of statistical tests in oncology studies.

Outcomes Definitions and Statistical Tests in Oncology Studies: A Systematic Review of the Reporting Consistency

PubMed Central

Rivoirard, Romain; Duplay, Vianney; Oriol, Mathieu; Tinquaut, Fabien; Chauvin, Franck; Magne, Nicolas; Bourmaud, Aurelie

2016-01-01

Background Quality of reporting for Randomized Clinical Trials (RCTs) in oncology was analyzed in several systematic reviews, but, in this setting, there is paucity of data for the outcomes definitions and consistency of reporting for statistical tests in RCTs and Observational Studies (OBS). The objective of this review was to describe those two reporting aspects, for OBS and RCTs in oncology. Methods From a list of 19 medical journals, three were retained for analysis, after a random selection: British Medical Journal (BMJ), Annals of Oncology (AoO) and British Journal of Cancer (BJC). All original articles published between March 2009 and March 2014 were screened. Only studies whose main outcome was accompanied by a corresponding statistical test were included in the analysis. Studies based on censored data were excluded. Primary outcome was to assess quality of reporting for description of primary outcome measure in RCTs and of variables of interest in OBS. A logistic regression was performed to identify covariates of studies potentially associated with concordance of tests between Methods and Results parts. Results 826 studies were included in the review, and 698 were OBS. Variables were described in Methods section for all OBS studies and primary endpoint was clearly detailed in Methods section for 109 RCTs (85.2%). 295 OBS (42.2%) and 43 RCTs (33.6%) had perfect agreement for reported statistical test between Methods and Results parts. In multivariable analysis, variable "number of included patients in study" was associated with test consistency: aOR (adjusted Odds Ratio) for third group compared to first group was equal to: aOR Grp3 = 0.52 [0.31–0.89] (P value = 0.009). Conclusion Variables in OBS and primary endpoint in RCTs are reported and described with a high frequency. However, statistical tests consistency between methods and Results sections of OBS is not always noted. Therefore, we encourage authors and peer reviewers to verify consistency of statistical tests in oncology studies. PMID:27716793

Computerized clinical decision support systems for primary preventive care: a decision-maker-researcher partnership systematic review of effects on process of care and patient outcomes.

PubMed

Souza, Nathan M; Sebaldt, Rolf J; Mackay, Jean A; Prorok, Jeanette C; Weise-Kelly, Lorraine; Navarro, Tamara; Wilczynski, Nancy L; Haynes, R Brian

2011-08-03

Computerized clinical decision support systems (CCDSSs) are claimed to improve processes and outcomes of primary preventive care (PPC), but their effects, safety, and acceptance must be confirmed. We updated our previous systematic reviews of CCDSSs and integrated a knowledge translation approach in the process. The objective was to review randomized controlled trials (RCTs) assessing the effects of CCDSSs for PPC on process of care, patient outcomes, harms, and costs. We conducted a decision-maker-researcher partnership systematic review. We searched MEDLINE, EMBASE, Ovid's EBM Reviews Database, Inspec, and other databases, as well as reference lists through January 2010. We contacted authors to confirm data or provide additional information. We included RCTs that assessed the effect of a CCDSS for PPC on process of care and patient outcomes compared to care provided without a CCDSS. A study was considered to have a positive effect (i.e., CCDSS showed improvement) if at least 50% of the relevant study outcomes were statistically significantly positive. We added 17 new RCTs to our 2005 review for a total of 41 studies. RCT quality improved over time. CCDSSs improved process of care in 25 of 40 (63%) RCTs. Cumulative scientifically strong evidence supports the effectiveness of CCDSSs for screening and management of dyslipidaemia in primary care. There is mixed evidence for effectiveness in screening for cancer and mental health conditions, multiple preventive care activities, vaccination, and other preventive care interventions. Fourteen (34%) trials assessed patient outcomes, and four (29%) reported improvements with the CCDSS. Most trials were not powered to evaluate patient-important outcomes. CCDSS costs and adverse events were reported in only six (15%) and two (5%) trials, respectively. Information on study duration was often missing, limiting our ability to assess sustainability of CCDSS effects. Evidence supports the effectiveness of CCDSSs for screening and treatment of dyslipidaemia in primary care with less consistent evidence for CCDSSs used in screening for cancer and mental health-related conditions, vaccinations, and other preventive care. CCDSS effects on patient outcomes, safety, costs of care, and provider satisfaction remain poorly supported.

Defining the Scope of Prognosis: Primary Care Clinicians' Perspectives on Predicting the Future Health of Older Adults.

PubMed

Thomas, John M; Fried, Terri R

2018-05-01

Studies examining the attitudes of clinicians toward prognostication for older adults have focused on life expectancy prediction. Little is known about whether clinicians approach prognostication in other ways. To describe how clinicians approach prognostication for older adults, defined broadly as making projections about patients' future health. In five focus groups, 30 primary care clinicians from community-based, academic-affiliated, and Veterans Affairs primary care practices were given open-ended questions about how they make projections about their patients' future health and how this informs the approach to care. Content analysis was used to organize responses into themes. Clinicians spoke about future health in terms of a variety of health outcomes in addition to life expectancy, including independence in activities and decision making, quality of life, avoiding hospitalization, and symptom burden. They described approaches in predicting these health outcomes, including making observations about the overall trajectory of patients to predict health outcomes and recognizing increased risk for adverse health outcomes. Clinicians expressed reservations about using estimates of mortality risk and life expectancy to think about and communicate patients' future health. They discussed ways in which future research might help them in thinking about and discussing patients' future health to guide care decisions, including identifying when and whether interventions might impact future health. The perspectives of primary care clinicians in this study confirm that prognostic considerations can go beyond precise estimates of mortality risk and life expectancy to include a number of outcomes and approaches to predicting those outcomes. Published by Elsevier Inc.

Patient and provider interventions for managing osteoarthritis in primary care: protocols for two randomized controlled trials

PubMed Central

2012-01-01

Background Osteoarthritis (OA) of the hip and knee are among the most common chronic conditions, resulting in substantial pain and functional limitations. Adequate management of OA requires a combination of medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and the majority of patients with hip and knee OA are overweight and physically inactive. Consequently, interventions at the provider-level and patient-level both have potential for improving outcomes. This manuscript describes two ongoing randomized clinical trials being conducted in two different health care systems, examining patient-based and provider-based interventions for managing hip and knee OA in primary care. Methods / Design One study is being conducted within the Department of Veterans Affairs (VA) health care system and will compare a Combined Patient and Provider intervention relative to usual care among n = 300 patients (10 from each of 30 primary care providers). Another study is being conducted within the Duke Primary Care Research Consortium and will compare Patient Only, Provider Only, and Combined (Patient + Provider) interventions relative to usual care among n = 560 patients across 10 clinics. Participants in these studies have clinical and / or radiographic evidence of hip or knee osteoarthritis, are overweight, and do not meet current physical activity guidelines. The 12-month, telephone-based patient intervention focuses on physical activity, weight management, and cognitive behavioral pain management. The provider intervention involves provision of patient-specific recommendations for care (e.g., referral to physical therapy, knee brace, joint injection), based on evidence-based guidelines. Outcomes are collected at baseline, 6-months, and 12-months. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function), and secondary outcomes are the Short Physical Performance Test Protocol (objective physical function) and the Patient Health Questionnaire-8 (depressive symptoms). Cost effectiveness of the interventions will also be assessed. Discussion Results of these two studies will further our understanding of the most effective strategies for improving hip and knee OA outcomes in primary care settings. Trial registration NCT01130740 (VA); NCT 01435109 (NIH) PMID:22530979

Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care: A Pragmatic Cluster Randomised Controlled Trial.

PubMed

Ramli, Anis Safura; Selvarajah, Sharmini; Daud, Maryam Hannah; Haniff, Jamaiyah; Abdul-Razak, Suraya; Tg-Abu-Bakar-Sidik, Tg Mohd Ikhwan; Bujang, Mohamad Adam; Chew, Boon How; Rahman, Thuhairah; Tong, Seng Fah; Shafie, Asrul Akmal; Lee, Verna K M; Ng, Kien Keat; Ariffin, Farnaza; Abdul-Hamid, Hasidah; Mazapuspavina, Md Yasin; Mat-Nasir, Nafiza; Chan, Chun W; Yong-Rafidah, Abdul Rahman; Ismail, Mastura; Lakshmanan, Sharmila; Low, Wilson H H

2016-11-14

The chronic care model was proven effective in improving clinical outcomes of diabetes in developed countries. However, evidence in developing countries is scarce. The objective of this study was to evaluate the effectiveness of EMPOWER-PAR intervention (based on the chronic care model) in improving clinical outcomes for type 2 diabetes mellitus using readily available resources in the Malaysian public primary care setting. This was a pragmatic, cluster-randomised, parallel, matched pair, controlled trial using participatory action research approach, conducted in 10 public primary care clinics in Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Patients who fulfilled the criteria were recruited over a 2-week period by each clinic. The obligatory intervention components were designed based on four elements of the chronic care model i.e. healthcare organisation, delivery system design, self-management support and decision support. The primary outcome was the change in the proportion of patients achieving HbA1c < 6.5%. Secondary outcomes were the change in proportion of patients achieving targets for blood pressure, lipid profile, body mass index and waist circumference. Intention to treat analysis was performed for all outcome measures. A generalised estimating equation method was used to account for baseline differences and clustering effect. A total of 888 type 2 diabetes mellitus patients were recruited at baseline (intervention: 471 vs. 417). At 1-year, 96.6 and 97.8% of patients in the intervention and control groups completed the study, respectively. The baseline demographic and clinical characteristics of both groups were comparable. The change in the proportion of patients achieving HbA1c target was significantly higher in the intervention compared to the control group (intervention: 3.0% vs. -4.1%, P < 0.002). Patients who received the EMPOWER-PAR intervention were twice more likely to achieve HbA1c target compared to those in the control group (adjusted OR 2.16, 95% CI 1.34-3.50, P < 0.002). However, there was no significant improvement found in the secondary outcomes. This study demonstrates that the EMPOWER-PAR intervention was effective in improving the primary outcome for type 2 diabetes in the Malaysian public primary care setting. Registered with: ClinicalTrials.gov.: NCT01545401 . Date of registration: 1st March 2012.

Occupational outcomes following mild traumatic brain injury in Canadian military personnel deployed in support of the mission in Afghanistan: a retrospective cohort study

PubMed Central

Garber, Bryan G; Rusu, Corneliu; Zamorski, Mark A; Boulos, David

2016-01-01

Objective Deployment-related mild traumatic brain injury (MTBI) occurs in a significant number of military personnel but its long-term impacts are unclear. This study explores the impact of deployment-related MTBI on continued fitness-for-duty, with the ultimate intent of identifying potential targets for intervention to attenuate its effects. Participants Consisted of 16 193 Canadian Armed Forces (CAF) personnel who deployed in support of the mission in Afghanistan and completed an enhanced postdeployment screening (EPDS) questionnaire over the period January 2009–July 2012. Primary outcome The primary outcome was development of permanent medical unfitness defined as a ‘career-limiting medical condition’ (CL-MC). The secondary outcome was the diagnostic categories recorded for each individual at the time a CL-MC was established. Design This study used a retrospective cohort design. Linked administrative and health data provided the primary outcome and the diagnoses responsible for it. Survival analysis was used to estimate the risk of a CL-MC and Cox regression provided adjusted HRs (aHRs) for the association between a CL-MC and MTBI, accounting for key covariates and confounders. Diagnostic categories associated with CL-MCs were identified. Results Over a median follow-up period of 3.42 years, 6.57% of the study population developed a CL-MC. MTBI was independently associated with CL-MCs (aHR=1.65, 95% CI 1.35 to 2.03). Mental disorders and musculoskeletal conditions were the primary diagnoses associated with CL-MCs (identified as the primary diagnosis in 55.4% and 25.9%, respectively), and a neurological condition was only documented in 5.8% of those with MTBI who developed a CL-MC Conclusions Deployment-related MTBI was associated with adverse occupational outcome but mental disorders and musculoskeletal conditions primarily drove subsequent medical unfitness. These findings support a diagnostic and treatment approach focusing on these comorbidities as the most promising strategy to minimise the burden of disability in MTBI-exposed military personnel. PMID:27147386

Pedagogy and Primary Sources: Outcomes of the Library of Congress' Professional Development Program, Teaching with Primary Sources at Loyola

ERIC Educational Resources Information Center

Fry, Michelle L.

2010-01-01

Until recently, few K-12 teachers outside of social studies have integrated primary sources in classroom instruction. Integrating primary sources in educational practice does require an uncommon pedagogical understanding. Addressing this K-12 educator need is the Library of Congress. Recently, the Library implemented a national educator…

Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990-2011.

PubMed

Bikdeli, Behnood; Punnanithinont, Natdanai; Akram, Yasir; Lee, Ike; Desai, Nihar R; Ross, Joseph S; Krumholz, Harlan M

2017-03-21

Surrogate endpoint trials test strategies more efficiently but are accompanied by uncertainty about the relationship between changes in surrogate markers and clinical outcomes. We identified cardiovascular trials with primary surrogate endpoints published in the New England Journal of Medicine , Lancet , and JAMA: Journal of the American Medical Association from 1990 to 2011 and determined the trends in publication of surrogate endpoint trials and the success of the trials in meeting their primary endpoints. We tracked for publication of clinical outcome trials on the interventions tested in surrogate trials. We screened 3016 articles and identified 220 surrogate endpoint trials. From the total of 220 surrogate trials, 157 (71.4%) were positive for their primary endpoint. Only 59 (26.8%) surrogate trials had a subsequent clinical outcomes trial. Among these 59 trials, 24 outcomes trial results validated the positive surrogates, whereas 20 subsequent outcome trials were negative following positive results on a surrogate. We identified only 3 examples in which the surrogate trial was negative but a subsequent outcomes trial was conducted and showed benefit. Findings were consistent in a sample cohort of 383 screened articles inclusive of 37 surrogate endpoint trials from 6 other high-impact journals. Although cardiovascular surrogate outcomes trials frequently show superiority of the tested intervention, they are infrequently followed by a prominent outcomes trial. When there was a high-profile clinical outcomes study, nearly half of the positive surrogate trials were not validated. Cardiovascular surrogate outcome trials may be more appropriate for excluding benefit from the patient perspective than for identifying it. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Design of the POINT study: Pharmacotherapy Optimisation through Integration of a Non-dispensing pharmacist in a primary care Team (POINT).

PubMed

Hazen, Ankie C M; Sloeserwij, Vivianne M; Zwart, Dorien L M; de Bont, Antoinette A; Bouvy, Marcel L; de Gier, Johan J; de Wit, Niek J; Leendertse, Anne J

2015-07-02

In the Netherlands, 5.6 % of acute hospital admissions are medication-related. Almost half of these admissions are potentially preventable. Reviewing medication in patients at risk in primary care might prevent these hospital admissions. At present, implementation of medication reviews in primary care is suboptimal: pharmacists lack access to patient information, pharmacists are short of clinical knowledge and skills, and working processes of pharmacists (focus on dispensing) and general practitioners (focus on clinical practice) match poorly. Integration of the pharmacist in the primary health care team might improve pharmaceutical care outcomes. The aim of this study is to evaluate the effect of integration of a non-dispensing pharmacist in general practice on the safety of pharmacotherapy in the Netherlands. The POINT study is a non-randomised controlled intervention study with pre-post comparison in an integrated primary care setting. We compare three different models of pharmaceutical care provision in primary care: 1) a non-dispensing pharmacist as an integral member of a primary care team, 2) a pharmacist in a community pharmacy with a predefined training in performing medication reviews and 3) a pharmacist in a community pharmacy (care as usual). In all models, GPs remain accountable for individual medication prescription. In the first model, ten non-dispensing clinical pharmacists are posted in ten primary care practices (including 5 - 10 000 patients each) for a period of 15 months. These non-dispensing pharmacists perform patient consultations, including medication reviews, and share responsibility for the pharmaceutical care provided in the practice. The two other groups consist of ten primary care practices with collaborating pharmacists. The main outcome measurement is the number of medication-related hospital admissions during follow-up. Secondary outcome measurements are potential medication errors, drug burden index and costs. Parallel to this study, a qualitative study is conducted to evaluate the feasibility of introducing a NDP in general practice. As the POINT study is a large-scale intervention study, it should provide evidence as to whether integration of a non-dispensing clinical pharmacist in primary care will result in safer pharmacotherapy. The qualitative study also generates knowledge on the optimal implementation of this model in primary care. Results are expected in 2016. NTR4389 , The Netherlands National Trial Register, 07-01-2014.

Contribution of primary care to health: an individual level analysis from Tibet, China.

PubMed

Wang, Wenhua; Shi, Leiyu; Yin, Aitian; Mao, Zongfu; Maitland, Elizabeth; Nicholas, Stephen; Liu, Xiaoyun

2015-11-30

There have been significant improvements in health outcomes in Tibet, health disparities between Tibet and the rest of China has been greatly reduced. This paper tests whether there was a positive association between good primary care and better health outcomes in Tibet. A validated Tibetan version of the Primary Care Assessment Tool (PCAT-T) was used to collect data on 1386 patients aged over 18 years old accessing primary care. Self-rated health (SRH) was employed to measure health outcomes. A multiple binary logistic regression model was used to explore the association between primary care quality and self-rated health status after controlling for socio-demographic and lifestyle variables. This study found that primary care quality had a significant positive association with self-rated health status. Among the nine domains of PCAT-T, family centeredness domain had the highest Odds Ratio (OR = 1.013) with SRH. Patients located in rural area, with higher education levels, without depression, and less frequent drinking were more likely to self-rate as "good health" compared with the reference group. In Tibet, higher quality primary care was associated with better self-rated health status. Primary care should be much strengthened in future health system reform in Tibet.

Organizational interventions improving access to community-based primary health care for vulnerable populations: a scoping review.

PubMed

Khanassov, Vladimir; Pluye, Pierre; Descoteaux, Sarah; Haggerty, Jeannie L; Russell, Grant; Gunn, Jane; Levesque, Jean-Frederic

2016-10-10

Access to community-based primary health care (hereafter, 'primary care') is a priority in many countries. Health care systems have emphasized policies that help the community 'get the right service in the right place at the right time'. However, little is known about organizational interventions in primary care that are aimed to improve access for populations in situations of vulnerability (e.g., socioeconomically disadvantaged) and how successful they are. The purpose of this scoping review was to map the existing evidence on organizational interventions that improve access to primary care services for vulnerable populations. Scoping review followed an iterative process. Eligibility criteria: organizational interventions in Organisation for Economic Cooperation and Development (OECD) countries; aiming to improve access to primary care for vulnerable populations; all study designs; published from 2000 in English or French; reporting at least one outcome (avoidable hospitalization, emergency department admission, or unmet health care needs). Main bibliographic databases (Medline, Embase, CINAHL) and team members' personal files. One researcher selected relevant abstracts and full text papers. Theory-driven synthesis: The researcher classified included studies using (i) the 'Patient Centered Access to Healthcare' conceptual framework (dimensions and outcomes of access to primary care), and (ii) the classification of interventions of the Cochrane Effective Practice and Organization of Care. Using pattern analysis, interventions were mapped in accordance with the presence/absence of 'dimension-outcome' patterns. Out of 8,694 records (title/abstract), 39 studies with varying designs were included. The analysis revealed the following pattern. Results of 10 studies on interventions classified as 'Formal integration of services' suggested that these interventions were associated with three dimensions of access (approachability, availability and affordability) and reduction of hospitalizations (four/four studies), emergency department admissions (six/six studies), and unmet healthcare needs (five/six studies). These 10 studies included seven non-randomized studies, one randomized controlled trial, one quantitative descriptive study, and one mixed methods study. Our results suggest the limited breadth of research in this area, and that it will be feasible to conduct a full systematic review of studies on the effectiveness of the formal integration of services to improve access to primary care services for vulnerable populations.

Anxiety Outcomes after Physical Activity Interventions: Meta-Analysis Findings

PubMed Central

Conn, Vicki S.

2011-01-01

Background Although numerous primary studies have documented the mental health benefits of physical activity (PA), no previous quantitative synthesis has examined anxiety outcomes of interventions to increase PA. Objectives This meta-analysis integrates extant research about anxiety outcomes from interventions to increase PA among healthy adults. Method Extensive literature searching located published and unpublished PA intervention studies with anxiety outcomes. Eligible studies reported findings from interventions designed to increase PA delivered to healthy adults without anxiety disorders. Data were coded from primary studies. Random-effects meta-analytic procedures were completed. Exploratory moderator analyses using meta-analysis ANOVA and regression analogues were conducted to determine if report, methods, sample, or intervention characteristics were associated with differences in anxiety outcomes. Results Data were synthesized across 3,289 subjects from 19 eligible reports. The overall mean anxiety effect size (d-index) for two-group comparisons was 0.22 with significant heterogeneity (Q = 32.15). Exploratory moderator analyses found larger anxiety improvement effect sizes among studies that included larger samples, used random allocation of subjects to treatment and control conditions, targeted only PA behavior instead of multiple health behaviors, included supervised exercise (vs. home-based PA), used moderate or high-intensity instead of low-intensity PA, and suggested subjects exercise at a fitness facility (vs. home) following interventions. Discussion These findings document that some interventions can decrease anxiety symptoms among healthy adults. Exploratory moderator analyses suggest possible directions for future primary research to compare interventions in randomized trials to confirm causal relationships. PMID:20410849

Clostridium difficile Infection in Older Adults: Systematic Review of Efforts to Reduce Occurrence and Improve Outcomes.

PubMed

Marshall, Leisa L; Peasah, Samuel; Stevens, Gregg A

2017-01-01

Provide a systematic review of the primary literature on efforts to reduce Clostridium difficile infection (CDI) occurrence and improve outcomes in older adults. PubMed and CINAHL databases were searched for research studies using search terms CDI, CDI prevention, reduction, control, management, geriatric, elderly, adults 65 years of age and older. The MeSH categories Aged and Aged, 80 and older, were used. A second search of PubMed, CINAHL, National Guideline Clearinghouse, and TRIP databases was conducted for primary, secondary, and tertiary literature for CDI epidemiology, burden, and management in adults of all ages, and prevention and management guidelines. Of the 2,263 articles located, 105 were selected for full review: 55 primary and 50 secondary, tertiary. Primary literature selected for full review included studies of interventions to prevent, reduce occurrence, control, manage, or improve outcomes in adults 65 years of age and older. Patient settings included the community, assisted living, nursing facility, subacute care, or hospital. The main outcome measures for research studies were whether the studied intervention prevented, reduced occurrence, controlled, managed, or improved outcomes. Studies were conducted in acute or long-term hospitals, with a few in nursing facilities. Interventions that prevented or reduced CDI included antibiotic policy changes, education, procedure changes, infection control, and multi-intervention approaches. There were few management studies for adults 65 years of age and older or for all adults with results stratified by age. Treatments studied included efficacy of fidaxomicin, metronidazole, vancomycin, and fecal microbiota transplant. Though clinical outcomes were slightly less robust in those 65 years of age and older, age was not an independent predictor of success or failure. The current prevention and management guidelines for adults of all ages, as well as special considerations in skilled nursing facilities, extracted from the secondary/tertiary literature selected, are summarized. There are a limited number of studies designed for older adults. Our findings suggest that guideline recommendations for adults are adequate and appropriate for older adults. Exposure to antibiotics and Clostridium difficile remain the two major risk factors for CDI, reinforcing the importance of antibiotic stewardship and infection control.

Missing data frequency and correlates in two randomized surgical trials for urinary incontinence in women.

PubMed

Brubaker, Linda; Litman, Heather J; Kim, Hae-Young; Zimmern, Philippe; Dyer, Keisha; Kusek, John W; Richter, Holly E; Stoddard, Anne

2015-08-01

Missing data is frequently observed in clinical trials; high rates of missing data may jeopardize trial outcome validity. We determined the rates of missing data over time, by type of data collected and compared demographic and clinical factors associated with missing data among women who participated in two large randomized clinical trials of surgery for stress urinary incontinence, the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) and the Trial of Midurethral Sling (TOMUS). The proportions of subjects who attended and missed each follow-up visit were calculated. The chi-squared test, Fisher's exact test and t test were used to compare women with and without missing data, as well as the completeness of the data for each component of the composite primary outcome. Data completeness for the primary outcome computation in the TOMUS trial (62.3%) was nearly double that in the SISTEr trial (35.7%). The follow-up visit attendance rate decreased over time. A higher proportion of subjects attended all follow-up visits in the TOMUS trial and overall there were fewer missing data for the period that included the primary outcome assessment at 12 months. The highest levels of complete data for the composite outcome variables were for the symptoms questionnaire (SISTEr 100 %, TOMUS 99.8%) and the urinary stress test (SISTEr 96.1%, TOMUS 96.7%). In both studies, the pad test was associated with the lowest levels of complete data (SISTEr 85.1%, TOMUS 88.3%) and approximately one in ten subjects had incomplete voiding diaries at the time of primary outcome assessment. Generally, in both studies, a higher proportion of younger subjects had missing data. This analysis lacked a patient perspective as to the reasons for missing data that could have provided additional information on subject burden, motivations for adherence and study design. In addition, we were unable to compare the effects of the different primary outcome assessment time-points in an identically designed trial. Missing visits and data increased with time. Questionnaire data and physical outcome data (urinary stress test) that could be assessed during a visit were least prone to missing data, whereas data for variables that required subject effort while away from the research team (pad test, voiding diary) were more likely to be missing. Older subjects were more likely to provide complete data.

Primary care practices' perceived constraints to engaging in research: the importance of context and 'Flow'.

PubMed

Michalec, Barret; Fagan, Heather Bittner; Rahmer, Brian

2014-01-01

The primary purpose of this study is to understand primary care practices' perceived constraints to engaging in research from micro-, meso-, and macro-level perspectives. Past research has spotlighted various barriers and hurdles that primary care practices face when attempting to engage in research efforts; yet a majority of this research has focused exclusively on micro- (physician-specific) and meso-level (practice-specific) factors. Minimal attention has been paid to the context - the more macro-level issues such as how these barriers relate to primary care practices' role within the dominant payment/reimbursement model of U.S. health-care system. Semi-structured focus groups were conducted in five U.S. practices, all owned by an independent academic medical center. Each had participated in at least one research study but were not part of a practice-based research network or affiliated with a medical school. Data were analyzed using NVIVO-9 by using a multistep coding process. Findings The perceived constraints offered by the participants echoed those featured in previous studies. Secondary analyses of the interconnected nature of these factors highlighted a valuable and sensitive 'Flow' that is evident at the individual, interaction, and organizational levels of primary care practice. Engaging in research appears to pose a significant threat to the outcomes of Flow (i.e., revenue, patient health outcomes, and the overall well-being of the practice). It is posited that the risk of not meeting expected productivity-based outcomes, which appear to be dictated by current dominant reimbursement models, frames the overall process of research-related decision making in primary care. Within the funding/reimbursement models of the US health-care system, engaging in research does not appear to be advantageous for primary care practices.

Hidden Treasures and Secret Pitfalls: Application of the Capability Approach to ParkinsonNet.

PubMed

Canoy, Marcel; Faber, Marjan J; Munneke, Marten; Oortwijn, Wija; Nijkrake, Maarten J; Bloem, Bastiaan R

2015-01-01

In the Netherlands, the largest health technology assessment (HTA) program funds mainly (cost-)effectiveness studies and implementation research. The cost-effectiveness studies are usually controlled clinical trials which simultaneously collect cost data. The success of a clinical trial typically depends on the effect size for the primary outcome, such as health gains or mortality rates. A drawback is that in case of a negative primary outcome, relevant other (and perhaps more implicit) benefits might be missed. Conversely, positive trials can contain adverse outcomes that may also remain hidden. The capability approach (developed by Nobel Prize winner and philosopher Sen) is an instrument that may reveal such "hidden treasures and secret pitfalls" that lie embedded within clinical trials, beyond the more traditional outcomes. Here, we exemplify the possible merits of the capability approach using a large clinical trial (funded by the HTA program in the Netherlands) that aimed to evaluate the ParkinsonNet concept, an innovative network approach for Parkinson patients. This trial showed no effects for the primary outcome, but the ParkinsonNet concept tested in this study was nevertheless met with great enthusiasm and was rapidly implemented throughout an entire country, and meanwhile also internationally. We applied the capability approach to the ParkinsonNet concept, and this analysis yielded additional benefits within several capability domains. These findings seems to substantiate the claim that richer policy debates may ensue by applying the capability approach to clinical trial data, in addition to traditional outcomes.

Palliative care in the home: a scoping review of study quality, primary outcomes, and thematic component analysis.

PubMed

Hofmeister, Mark; Memedovich, Ally; Dowsett, Laura E; Sevick, Laura; McCarron, Tamara; Spackman, Eldon; Stafinski, Tania; Menon, Devidas; Noseworthy, Tom; Clement, Fiona

2018-03-07

The aim of palliative care is to improve the quality of life of patients and families through the prevention and relief of suffering. Frequently, patients may choose to receive palliative care in the home. The objective of this paper is to summarize the quality and primary outcomes measured within the palliative care in the home literature. This will synthesize the current state of the literature and inform future work. A scoping review was completed using PRISMA guidelines. PubMed, Embase, CINAHL, Web of Science, Cochrane Library, EconLit, PsycINFO, Centre for Reviews and Dissemination, Database of Abstracts of Reviews of Effects, and National Health Service Economic Evaluation Database were searched from inception to August 2016. Inclusion criteria included: 1) care was provided in the "home of the patient" as defined by the study, 2) outcomes were reported, and 3) reported original data. Thematic component analysis was completed to categorize interventions. Fifty-three studies formed the final data set. The literature varied extensively. Five themes were identified: accessibility of healthcare, caregiver support, individualized patient centered care, multidisciplinary care provision, and quality improvement. Primary outcomes were resource use, symptom burden, quality of life, satisfaction, caregiver distress, place of death, cost analysis, or described experiences. The majority of studies were of moderate or unclear quality. There is robust literature of varying quality, assessing different components of palliative care in the home interventions, and measuring different outcomes. To be meaningful to patients, these interventions need to be consistently evaluated with outcomes that matter to patients. Future research could focus on reaching a consensus for outcomes to evaluate palliative care in the home interventions.

The impact of depression and antidepressant usage on primary biliary cholangitis clinical outcomes

PubMed Central

Kaplan, Gilaad G.; Almishri, Wagdi; Vallerand, Isabelle; Frolkis, Alexandra D.; Patten, Scott; Swain, Mark G.

2018-01-01

Background Depression is prevalent in primary biliary cholangitis (PBC) patients. Our aims were to examine the effects of depression and antidepressants on hepatic outcomes of PBC patients. Methods We used the UK Health Improvement Network database to identify PBC patients between 1974 and 2007. Our primary outcome was one of three clinical events: decompensated cirrhosis, liver transplantation and death. We assessed depression and each class of antidepressant medication in adjusted multivariate Cox proportional hazards models to identify independent predictors of outcomes. In a sensitivity analysis, the study population was restricted to PBC patients using ursodeoxycholic acid (UDCA). Results We identified 1,177 PBC patients during our study period. In our cohort, 86 patients (7.3%) had a depression diagnosis prior to PBC diagnosis, while 79 patients (6.7%) had a depression diagnosis after PBC diagnosis. Ten-year incidence of mortality, decompensated cirrhosis, and liver transplantation were 13.4%, 6.6%, and 2.0%, respectively. In our adjusted models, depression status was not a predictor of poor outcomes. After studying all classes of antidepressants, using the atypical antidepressant mirtazapine after PBC diagnosis was significantly protective (Adjusted HR 0.23: 95% CI 0.07–0.72) against poor liver outcomes (decompensation, liver transplant, mortality), which remained statistically significant in patients using UCDA (HR 0.21: 95% CI 0.05–0.83). Conclusions In our study, depression was not associated with poor clinical outcomes. However, using the antidepressant mirtazapine was associated with decreased mortality, decompensated cirrhosis and liver transplantation in PBC patients. These findings support further assessment of mirtazapine as a potential treatment for PBC patients. PMID:29617396

Safety and Efficacy of a Pharmacoinvasive Strategy in ST-Segment Elevation Myocardial Infarction: A Patient Population Study Comparing a Pharmacoinvasive Strategy With a Primary Percutaneous Coronary Intervention Strategy Within a Regional System.

PubMed

Rashid, Mohammed K; Guron, Nita; Bernick, Jordan; Wells, George A; Blondeau, Melissa; Chong, Aun-Yeong; Dick, Alexander; Froeschl, Michael P V; Glover, Chris A; Hibbert, Benjamin; Labinaz, Marino; Marquis, Jean-François; Osborne, Christina; So, Derek Y; Le May, Michel R

2016-10-10

This study investigated the safety and efficacy of a pharmacoinvasive strategy compared with a primary percutaneous coronary intervention (PCI) strategy for ST-segment elevation myocardial infarction (STEMI) in the context of a real-world system. Primary PCI continues to be the optimal reperfusion therapy; however, in areas where PCI centers are not readily available, a pharmacoinvasive strategy has been proposed. The University of Ottawa Heart Institute regional STEMI system provides a primary PCI strategy for patients presenting within a 90-km radius from the PCI center, and a pharmacoinvasive strategy for patients outside this limit. We included all confirmed STEMI patients between April 2009 and May 2011. The primary efficacy outcome was a composite of mortality, reinfarction, or stroke and the primary safety outcome was major bleeding. We identified 236 and 980 consecutive patients enrolled in pharmacoinvasive and primary PCI strategies, respectively. The median door-to-needle time was 31 min in the pharmacoinvasive group and the median door-to-balloon time was 95 min in the primary PCI group. In a multivariable model, there was no significant difference in the primary efficacy outcome (odds ratio: 1.54; p = 0.21); however, the propensity for more bleeding with a pharmacoinvasive strategy approached statistical significance (odds ratio: 2.02; p = 0.08). Within the context of a STEMI system, a pharmacoinvasive strategy was associated with similar rates of the composite of mortality, reinfarction, or stroke as compared with a primary PCI strategy; however, there was a propensity for more bleeding with a pharmacoinvasive strategy. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Adult Outcomes, Reported Self-Aptitude, and Perceived Training: A Follow-Up Study of Individuals with Visual Impairment

ERIC Educational Resources Information Center

Lawson, Holly Michelle

2010-01-01

The purpose of this study was to examine factors that relate to successful adult outcomes for 28 individuals with visual impairment ages 23-30. The primary dependent variable was current employment. Independent living and completion of postsecondary educational program were secondary, related outcome measures. A secondary goal of this research was…

Elevated Patient Body Mass Index Does Not Negatively Affect Self-Reported Outcomes of Thoracolumbar Surgery: Results of a Comparative Observational Study with Minimum 1-Year Follow-Up

PubMed Central

Manson, Neil A.; Green, Alana J.; Abraham, Edward P.

2015-01-01

Study Design Retrospective study. Objective Quantify the effect of obesity on elective thoracolumbar spine surgery patients. Methods Five hundred consecutive adult patients undergoing thoracolumbar spine surgery to treat degenerative pathologies with minimum follow-up of at least 1 year were included. Primary outcome measures included Numerical Rating Scales for back and leg pain, the Short Form 36 Physical Component Summary and Mental Component Summary, the modified Oswestry Disability Index, and patient satisfaction scores collected preoperatively and at 3, 6, 12, and 24 months postoperatively. Secondary outcome measures included perioperative and postoperative adverse events, postoperative emergency department presentation, hospital readmission, and revision surgeries. Patients were grouped according to World Health Organization body mass index (BMI) guidelines to isolate the effect of obesity on primary and secondary outcome measures. Results Mean BMI was 30 kg/m2, reflecting a significantly overweight population. Each BMI group reported statistically significant improvement on all self-reported outcome measures. Contrary to our hypothesis, however, there was no association between BMI group and primary outcome measures. Patients with BMI of 35 to 39.99 visited the emergency department with complaints of pain significantly more often than the other groups. Otherwise, we did not detect any differences in the secondary outcome measures between BMI groups. Conclusions Patients of all levels of obesity experienced significant improvement following elective thoracolumbar spine surgery. These outcomes were achieved without increased risk of postoperative complications such as infection and reoperation. A risk–benefit algorithm to assist with surgical decision making for obese patients would be valuable to surgeons and patients alike. PMID:26933611

Early Outcomes of Primary Total Hip Arthroplasty After Prior Lumbar Spinal Fusion.

PubMed

Barry, Jeffrey J; Sing, David C; Vail, Thomas P; Hansen, Erik N

2017-02-01

The coexistence of degenerative hip disease and spinal pathology is not uncommon with the number of surgical treatments performed for each condition increasing annually. The limited research available suggests spinal pathology portends less pain relief and worse outcomes after total hip arthroplasty (THA). We hypothesize that primary THA patients with preexisting lumbar spinal fusions (LSF) experience worse early postoperative outcomes. This study is a retrospective matched cohort study. Primary THA patients at 1 institution who had undergone prior LSF (spine arthrodesis-hip arthroplasty [SAHA]) were identified and matched to controls of primary THA without LSF. Early outcomes (<90 days) were compared. From 2012 to 2014, 35 SAHA patients were compared to 70 matched controls. Patients were similar in age, sex, American Society of Anesthesiologist score, body mass index, and Charlson Comorbidity Index. SAHA patients had higher rates of complications (31.4% vs 8.6%, P = .008), reoperation (14.3% vs 2.9%, P = .040), and general anesthesia (54.3% vs 5.7%, P = .0001). Bivariate analysis demonstrated SAHA to predict reoperation (odds ratio, 5.67; P = .045) and complications (odds ratio, 4.89; P = .005). With the numbers available, dislocations (0% vs 2.8%), infections (0% vs 8.6%), readmissions, postoperative walking distance, and disposition only trended to favor controls (P > .05). Comparing controls to SAHA patients with <3 or ≥3 levels fused, longer fusions had increased cumulative postoperative narcotic consumption (mean morphine equivalents, 44.3 vs 46.9 vs 169.4; P = .001). Patients with preexisting LSF experience worse early outcomes after primary THA including higher rates of complications and reoperation. Lower rates of neuraxial anesthesia and increased narcotic usage represent potential contributors. The complex interplay between the lumbar spine and hip warrants attention and further investigation. Copyright © 2016 Elsevier Inc. All rights reserved.

Medication safety programs in primary care: a scoping review.

PubMed

Khalil, Hanan; Shahid, Monica; Roughead, Libby

2017-10-01

Medication safety plays an essential role in all healthcare organizations; improving this area is paramount to quality and safety of any wider healthcare program. While several medication safety programs in the hospital setting have been described and the associated impact on patient safety evaluated, no systematic reviews have described the impact of medication safety programs in the primary care setting. A preliminary search of the literature demonstrated that no systematic reviews, meta-analysis or scoping reviews have reported on medication safety programs in primary care; instead they have focused on specific interventions such as medication reconciliation or computerized physician order entry. This scoping review sought to map the current medication safety programs used in primary care. The current scoping review sought to examine the characteristics of medication safety programs in the primary care setting and to map evidence on the outcome measures used to assess the effectiveness of medication safety programs in improving patient safety. The current review considered participants of any age and any condition using care obtained from any primary care services. We considered studies that focussed on the characteristics of medication safety programs and the outcome measures used to measure the effectiveness of these programs on patient safety in the primary care setting. The context of this review was primary care settings, primary healthcare organizations, general practitioner clinics, outpatient clinics and any other clinics that do not classify patients as inpatients. We considered all quantitative studied published in English. A three-step search strategy was utilized in this review. Data were extracted from the included studies to address the review question. The data extracted included type of medication safety program, author, country of origin, aims and purpose of the study, study population, method, comparator, context, main findings and outcome measures. The objectives, inclusion criteria and methods for this scoping review were specified in advance and documented in a protocol that was previously published. This scoping review included nine studies published over an eight-year period that investigated or described the effects of medication safety programs in primary care settings. We classified each of the nine included studies into three main sections according to whether they included an organizational, professional or patient component. The organizational component is aimed at changing the structure of the organization to implement the intervention, the professional component is aimed at the healthcare professionals involved in implementing the interventions, and the patient component is aimed at counseling and education of the patient. All of the included studies had different types of medication safety programs. The programs ranged from complex interventions including pharmacists and teams of healthcare professionals to educational packages for patients and computerized system interventions. The outcome measures described in the included studies were medication error incidence, adverse events and number of drug-related problems. Multi-faceted medication safety programs are likely to vary in characteristics. They include educational training, quality improvement tools, informatics, patient education and feedback provision. The most likely outcome measure for these programs is the incidence of medication errors and reported adverse events or drug-related problems.

Primary repair of penetrating colon injuries: a systematic review.

PubMed

Singer, Marc A; Nelson, Richard L

2002-12-01

Primary repair of penetrating colon injuries is an appealing management option; however, uncertainty about its safety persists. This study was conducted to compare the morbidity and mortality of primary repair with fecal diversion in the management of penetrating colon injuries by use of a meta-analysis of randomized, prospective trials. We searched for prospective, randomized trials in MEDLINE (1966 to November 2001), the Cochrane Library, and EMBase using the terms colon, penetrating, injury, colostomy, prospective, and randomized. Studies were included if they were randomized, controlled trials that compared the outcomes of primary repair with fecal diversion in the management of penetrating colon injuries. Five studies were included. Reviewers performed data extraction independently. Outcomes evaluated from each trial included mortality, total complications, infectious complications, intra-abdominal infections, wound complications, penetrating abdominal trauma index, and length of stay. Peto odds ratios for combined effect were calculated with a 95 percent confidence interval for each outcome. Heterogeneity was also assessed for each outcome. The penetrating abdominal trauma index of included subjects did not differ significantly between studies. Mortality was not significantly different between groups (odds ratio, 1.70; 95 percent confidence interval, 0.51-5.66). However, total complications (odds ratio, 0.28; 95 percent confidence interval, 0.18-0.42), total infectious complications (odds ratio, 0.41; 95 percent confidence interval, 0.27-0.63), abdominal infections including dehiscence (odds ratio, 0.59; 95 percent confidence interval, 0.38-0.94), abdominal infections excluding dehiscence (odds ratio, 0.52; 95 percent confidence interval, 0.31-0.86), wound complications including dehiscence (odds ratio, 0.55; 95 percent confidence interval, 0.34-0.89), and wound complications excluding dehiscence (odds ratio, 0.43; 95 percent confidence interval, 0.25-0.76) all significantly favored primary repair. Meta-analysis of currently published randomized, controlled trials favors primary repair over fecal diversion for penetrating colon injuries.

Comparison of Ferric Sulfate Combined Mineral Trioxide Aggregate Pulpotomy and Zinc Oxide Eugenol Pulpectomy of Primary Maxillary Incisors: An 18-month Randomized, Controlled Trial.

PubMed

Nguyen, Trang D; Judd, Peter L; Barrett, Edward J; Sidhu, Nicole; Casas, Michael J

2017-01-15

The purpose of this study was to compare outcomes and survival of ferric sulfate with mineral trioxide aggregate (FS+MTA) pulpotomy and root canal therapy (RCT) in carious vital primary maxillary incisors. In this parallel group noninferiority trial, asymptomatic carious vital primary incisors with pulp exposure in healthy 18- to 46-month-olds were allocated randomly to receive FS+MTA pulpotomy or RCT between September 2010 and September 2012. Each incisor was classified into one of the following radiographic outcomes: N (incisor without pathologic change); Po (pathologic change present, follow-up recommended); Px (pathologic change present, extract.) Clinical findings and incisor survival were secondary outcomes. Seventy subjects were enrolled with a total of 172 incisors. Twelve- and 18-month radiographic outcomes demonstrated no statistical difference between FS+MTA pulpotomy and RCT incisors for Px outcomes (P=0.38; odds ratio equals 0.60; 95 percent confidence interval equals 0.19 to 1.89; chi-square test). There was no statistical differences in clinical outcomes for FS+MTA pulpotomy and RCT at 12 and 18 months (P=0.51; Fisher's exact test) or survival for FS+MTA pulpotomy and RCT incisors (P=0.11; log-rank test). Ferric Sulfate with Mineral Trioxide Aggregate (FS+MTA) is an alternative to RCT for vital primary incisors.

Severity of illness and outcome in adult patients with primary varicella pneumonia.

PubMed

Gregorakos, Leonidas; Myrianthefs, Pavlos; Markou, Nikolaos; Chroni, Despina; Sakagianni, Ekaterini

2002-01-01

Varicella pneumonia is a serious complication of primary varicella infection in adults that often results in respiratory failure and death. To analyze the clinical and laboratory manifestations of primary varicella pneumonia in patients admitted to our intensive care unit (ICU). Retrospective study on patients treated in our ICU with a diagnosis of primary varicella pneumonia during a period of 15 years. We recorded age, gender, smoking habits, clinical and laboratory findings, arterial blood gases, chest radiograph, illness severity (SAPS II), length of stay, necessity for mechanical ventilation, complications, therapy and survival. We examined the influence of the duration of respiratory symptoms and rash prior to admission, and the influence of illness severity on outcome. There was a statistically significant difference in duration of respiratory symptoms, duration of rash and SAPS II on admission between: (a) mechanically ventilated patients vs. spontaneously breathing patients (p < 0.007, p < 0.00, p < 0.00), (b) patients who survived vs. patients with poor outcome (p < 0.001, p < 0.000, p < 0.000), and (c) mechanically ventilated patients with poor outcome vs. mechanically ventilated patients who survived (p < 0.001, p < 0.00, p < 0.000). Overall mortality was 13.6%; death occurred only in mechanically ventilated patients (mortality 33.3%). Primary varicella pneumonia remains a critical problem with significant mortality. When recognized before respiratory failure ensues and mechanical ventilation becomes mandatory, patients could have an excellent outcome. Adult patients who delay asking for medical support, the disease may lead to the need for mechanical ventilation and severe complications with a fatal outcome. Copyright 2002 S. Karger AG, Basel

Preoperative physiotherapy and short-term functional outcomes of primary total knee arthroplasty

PubMed Central

Ismail, Mohd Shukry Mat Eil @; Sharifudin, Mohd Ariff; Shokri, Amran Ahmed; Rahman, Shaifuzain Ab

2016-01-01

INTRODUCTION Physiotherapy is an important part of rehabilitation following arthroplasty, but the impact of preoperative physiotherapy on functional outcomes is still being studied. This randomised controlled trial evaluated the effect of preoperative physiotherapy on the short-term functional outcomes of primary total knee arthroplasty (TKA). METHODS 50 patients with primary knee osteoarthritis who underwent unilateral primary TKA were randomised into two groups: the physiotherapy group (n = 24), whose patients performed physical exercises for six weeks immediately prior to surgery, and the nonphysiotherapy group (n = 26). All patients went through a similar physiotherapy regime in the postoperative rehabilitation period. Functional outcome assessment using the algofunctional Knee Injury and Osteoarthritis Outcome Score (KOOS) scale and range of motion (ROM) evaluation was performed preoperatively, and postoperatively at six weeks and three months. RESULTS Both groups showed a significant difference in all algofunctional KOOS subscales (p < 0.001). The mean score difference at six weeks and three months was not significant in the sports and recreational activities subscale for both groups (p > 0.05). Significant differences were observed in the time-versus-treatment analysis between groups for the symptoms (p = 0.003) and activities of daily living (p = 0.025) subscales. No significant difference in ROM was found when comparing preoperative measurements and those at three months following surgery, as well as in time-versus-treatment analysis (p = 0.928). CONCLUSION Six-week preoperative physiotherapy showed no significant impact on short-term functional outcomes (KOOS subscales) and ROM of the knee following primary TKA. PMID:26996450

Bias due to selective inclusion and reporting of outcomes and analyses in systematic reviews of randomised trials of healthcare interventions.

PubMed

Page, Matthew J; McKenzie, Joanne E; Kirkham, Jamie; Dwan, Kerry; Kramer, Sharon; Green, Sally; Forbes, Andrew

2014-10-01

Systematic reviews may be compromised by selective inclusion and reporting of outcomes and analyses. Selective inclusion occurs when there are multiple effect estimates in a trial report that could be included in a particular meta-analysis (e.g. from multiple measurement scales and time points) and the choice of effect estimate to include in the meta-analysis is based on the results (e.g. statistical significance, magnitude or direction of effect). Selective reporting occurs when the reporting of a subset of outcomes and analyses in the systematic review is based on the results (e.g. a protocol-defined outcome is omitted from the published systematic review). To summarise the characteristics and synthesise the results of empirical studies that have investigated the prevalence of selective inclusion or reporting in systematic reviews of randomised controlled trials (RCTs), investigated the factors (e.g. statistical significance or direction of effect) associated with the prevalence and quantified the bias. We searched the Cochrane Methodology Register (to July 2012), Ovid MEDLINE, Ovid EMBASE, Ovid PsycINFO and ISI Web of Science (each up to May 2013), and the US Agency for Healthcare Research and Quality (AHRQ) Effective Healthcare Program's Scientific Resource Center (SRC) Methods Library (to June 2013). We also searched the abstract books of the 2011 and 2012 Cochrane Colloquia and the article alerts for methodological work in research synthesis published from 2009 to 2011 and compiled in Research Synthesis Methods. We included both published and unpublished empirical studies that investigated the prevalence and factors associated with selective inclusion or reporting, or both, in systematic reviews of RCTs of healthcare interventions. We included empirical studies assessing any type of selective inclusion or reporting, such as investigations of how frequently RCT outcome data is selectively included in systematic reviews based on the results, outcomes and analyses are discrepant between protocol and published review or non-significant outcomes are partially reported in the full text or summary within systematic reviews. Two review authors independently selected empirical studies for inclusion, extracted the data and performed a risk of bias assessment. A third review author resolved any disagreements about inclusion or exclusion of empirical studies, data extraction and risk of bias. We contacted authors of included studies for additional unpublished data. Primary outcomes included overall prevalence of selective inclusion or reporting, association between selective inclusion or reporting and the statistical significance of the effect estimate, and association between selective inclusion or reporting and the direction of the effect estimate. We combined prevalence estimates and risk ratios (RRs) using a random-effects meta-analysis model. Seven studies met the inclusion criteria. No studies had investigated selective inclusion of results in systematic reviews, or discrepancies in outcomes and analyses between systematic review registry entries and published systematic reviews. Based on a meta-analysis of four studies (including 485 Cochrane Reviews), 38% (95% confidence interval (CI) 23% to 54%) of systematic reviews added, omitted, upgraded or downgraded at least one outcome between the protocol and published systematic review. The association between statistical significance and discrepant outcome reporting between protocol and published systematic review was uncertain. The meta-analytic estimate suggested an increased risk of adding or upgrading (i.e. changing a secondary outcome to primary) when the outcome was statistically significant, although the 95% CI included no association and a decreased risk as plausible estimates (RR 1.43, 95% CI 0.71 to 2.85; two studies, n = 552 meta-analyses). Also, the meta-analytic estimate suggested an increased risk of downgrading (i.e. changing a primary outcome to secondary) when the outcome was statistically significant, although the 95% CI included no association and a decreased risk as plausible estimates (RR 1.26, 95% CI 0.60 to 2.62; two studies, n = 484 meta-analyses). None of the included studies had investigated whether the association between statistical significance and adding, upgrading or downgrading of outcomes was modified by the type of comparison, direction of effect or type of outcome; or whether there is an association between direction of the effect estimate and discrepant outcome reporting.Several secondary outcomes were reported in the included studies. Two studies found that reasons for discrepant outcome reporting were infrequently reported in published systematic reviews (6% in one study and 22% in the other). One study (including 62 Cochrane Reviews) found that 32% (95% CI 21% to 45%) of systematic reviews did not report all primary outcomes in the abstract. Another study (including 64 Cochrane and 118 non-Cochrane reviews) found that statistically significant primary outcomes were more likely to be completely reported in the systematic review abstract than non-significant primary outcomes (RR 2.66, 95% CI 1.81 to 3.90). None of the studies included systematic reviews published after 2009 when reporting standards for systematic reviews (Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) Statement, and Methodological Expectations of Cochrane Intervention Reviews (MECIR)) were disseminated, so the results might not be generalisable to more recent systematic reviews. Discrepant outcome reporting between the protocol and published systematic review is fairly common, although the association between statistical significance and discrepant outcome reporting is uncertain. Complete reporting of outcomes in systematic review abstracts is associated with statistical significance of the results for those outcomes. Systematic review outcomes and analysis plans should be specified prior to seeing the results of included studies to minimise post-hoc decisions that may be based on the observed results. Modifications that occur once the review has commenced, along with their justification, should be clearly reported. Effect estimates and CIs should be reported for all systematic review outcomes regardless of the results. The lack of research on selective inclusion of results in systematic reviews needs to be addressed and studies that avoid the methodological weaknesses of existing research are also needed.

The Boston Rehabilitative Impairment Study of the Elderly: A description of methods

PubMed Central

Holt, Nicole E.; Percac-Lima, Sanja; Kurlinski, Laura A.; Thomas, Julia C.; Landry, Paige M.; Campbell, Braidie; Latham, Nancy; Ni, Pengsheng; Jette, Alan; Leveille, Suzanne G.; Bean, Jonathan F.

2012-01-01

Objective To describe the methods of a longitudinal cohort study among older adults with preclinical disability. The study aims to address the lack of evidence guiding mobility rehabilitation for older adults by identifying those impairments and impairment combinations that are most responsible for mobility decline and disability progression over 2 years of follow up. Design Longitudinal cohort study Setting Metropolitan based healthcare system in the US Participants Community dwelling primary care patients ≥ 65 years (N=430), with self-reported modification of mobility tasks due to underlying health conditions. Interventions: Not Applicable Main Outcome Measures Late Life Function and Disability Instrument (LLFDI) (primary outcome), Short Physical Performance Battery (SPPB) and 400 meter walk test (secondary outcomes) Results Among 7403 primary care patients identified as being potentially eligible for participation, 430 were enrolled. Participants have a mean age of 76.5 years, are 68% women and have on average 4.2 chronic conditions. Mean LLFDI scores are 55.5 for Function and 68.9 and 52.3 for the Disability Limitation and Frequency domains, respectively. Conclusions Completion of our study aims will inform development of primary care-based rehabilitative strategies to prevent disability. Additionally, data generated in this investigation can also serve as a vital resource for ancillary studies addressing important questions in rehabilitative science relevant to geriatric care. PMID:22989700

The impact of mentor mother programs on PMTCT service uptake and retention-in-care at primary health care facilities in Nigeria: a prospective cohort study (MoMent Nigeria).

PubMed

Sam-Agudu, Nadia A; Cornelius, Llewellyn J; Okundaye, Joshua N; Adeyemi, Olusegun A; Isah, Haroun O; Wiwa, Owens M; Adejuyigbe, Ebun; Galadanci, Hadiza; Afe, Abayomi J; Jolaoso, Ibidun; Bassey, Emem; Charurat, Manhattan E

2014-11-01

Nigeria is a key target country in the global effort toward elimination of mother-to-child transmission of HIV. Low coverage of prevention of mother-to-child transmission (PMTCT) interventions, adherence, and retention-in-care rates in HIV-positive pregnant women are contributing factors to high mother-to-child transmission of HIV (MTCT) rates. In Nigeria, rural areas, served largely by primary health care facilities, have particularly poor indicators of PMTCT coverage. Mentor Mothers are HIV-positive women who serve as peer counselors for PMTCT clients, provide guidance, and support in keeping appointments and promoting antiretroviral adherence and retention-in-care. The Mother Mentor (MoMent) study aims to investigate the impact of structured Mentor Mother programs on PMTCT outcomes in rural Nigeria. A prospective cohort study will compare rates of retention-in-care among PMTCT clients who are supported by formally-trained supervised Mentor Mothers versus clients who receive standard-of-care, informal peer support. Study sites are 20 primary health care centers (10 intervention, 10 control) in rural North-Central Nigeria. The study population is HIV-positive mothers and exposed infant pairs (MIPs) (N = 480; 240 MIPs per study arm). Primary outcome measures are the proportion of exposed infants receiving early HIV testing by age 2 months, and the proportion of MIPs retained in care at 6 months postpartum. Secondary outcome measures examine antiretroviral adherence, 12-month postpartum MIP retention, and MTCT rates. This article presents details of the study design, the structured Mentor Mother programs, and how their impact on PMTCT outcomes will be assessed.

Automated Communication Tools and Computer-Based Medication Reconciliation to Decrease Hospital Discharge Medication Errors.

PubMed

Smith, Kenneth J; Handler, Steven M; Kapoor, Wishwa N; Martich, G Daniel; Reddy, Vivek K; Clark, Sunday

2016-07-01

This study sought to determine the effects of automated primary care physician (PCP) communication and patient safety tools, including computerized discharge medication reconciliation, on discharge medication errors and posthospitalization patient outcomes, using a pre-post quasi-experimental study design, in hospitalized medical patients with ≥2 comorbidities and ≥5 chronic medications, at a single center. The primary outcome was discharge medication errors, compared before and after rollout of these tools. Secondary outcomes were 30-day rehospitalization, emergency department visit, and PCP follow-up visit rates. This study found that discharge medication errors were lower post intervention (odds ratio = 0.57; 95% confidence interval = 0.44-0.74; P < .001). Clinically important errors, with the potential for serious or life-threatening harm, and 30-day patient outcomes were not significantly different between study periods. Thus, automated health system-based communication and patient safety tools, including computerized discharge medication reconciliation, decreased hospital discharge medication errors in medically complex patients. © The Author(s) 2015.

ISCHEMIC CENTRAL RETINAL VEIN OCCLUSION IN THE ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR ERA.

PubMed

Tam, Emily K; Golchet, Pamela; Yung, Madeline; DeCroos, Francis C; Spirn, Marc; Lehmann-Clarke, Lydia; Ambresin, Aude; Tsui, Irena

2018-02-01

Anti-vascular endothelial growth factor therapy has improved the prognosis for patients with central retinal vein occlusion (CRVO). However, most studies published to date exclude ischemic CRVO. The purpose of this study was to describe the outcome in eyes with ischemic CRVO treated with anti-vascular endothelial growth factor therapy. Thirty-seven patients with ischemic CRVO from 3 centers were followed for at least 6 months. Data on patient demographic, vision status, and anti-vascular endothelial growth factor treatments were collected. Average number of injections during the study period was 5. Younger age was associated with improved vision (P = 0.006). Patients with improved visual outcomes tended to have macular edema as the primary indication for treatment, whereas patients with worse outcomes tended to have neovascularization as the primary indication for treatment. This study highlights significant variability in the use of anti-vascular endothelial growth factor therapy for ischemic CRVO and underscores that eyes with neovascularization tend to have worse visual outcomes.

Moderators of remission with interpersonal counselling or drug treatment in primary care patients with depression: randomised controlled trial.

PubMed

Menchetti, Marco; Rucci, Paola; Bortolotti, Biancamaria; Bombi, Annarosa; Scocco, Paolo; Kraemer, Helena Chmura; Berardi, Domenico

2014-02-01

Despite depressive disorders being very common there has been little research to guide primary care physicians on the choice of treatment for patients with mild to moderate depression. To evaluate the efficacy of interpersonal counselling compared with selective serotonin reuptake inhibitors (SSRIs), in primary care attenders with major depression and to identify moderators of treatment outcome. A randomised controlled trial in nine centres (DEPICS, Australian New Zealand Clinical Trials Registry number: ACTRN12608000479303). The primary outcome was remission of the depressive episode (defined as a Hamilton Rating Scale for Depression score ≤7 at 2 months). Daily functioning was assessed using the Work and Social Adjustment Scale. Logistic regression models were used to identify moderators of treatment outcome. The percentage of patients who achieved remission at 2 months was significantly higher in the interpersonal counselling group compared with the SSRI group (58.7% v. 45.1%, P = 0.021). Five moderators of treatment outcome were found: depression severity, functional impairment, anxiety comorbidity, previous depressive episodes and smoking habit. We identified some patient characteristics predicting a differential outcome with pharmacological and psychological interventions. Should our results be confirmed in future studies, these characteristics will help clinicians to define criteria for first-line treatment of depression targeted to patients' characteristics.

Examining the Effect of Automatic Promotion on Students' Learning Achievements in Uganda's Primary Education

ERIC Educational Resources Information Center

Okurut, Jeje Moses

2015-01-01

This study employed a difference-in-differences analysis technique to estimate the average treatment effect of automatic promotion on students' cognitive learning outcomes in Uganda's primary education. Regression results indicate a positive policy effect on learning achievements in literacy and numeracy at primary three (P3) and primary six (P6).…

Brief cognitive behavioral therapy in primary care: a hybrid type 2 patient-randomized effectiveness-implementation design.

PubMed

Cully, Jeffrey A; Armento, Maria E A; Mott, Juliette; Nadorff, Michael R; Naik, Aanand D; Stanley, Melinda A; Sorocco, Kristen H; Kunik, Mark E; Petersen, Nancy J; Kauth, Michael R

2012-07-11

Despite the availability of evidence-based psychotherapies for depression and anxiety, they are underused in non-mental health specialty settings such as primary care. Hybrid effectiveness-implementation designs have the potential to evaluate clinical and implementation outcomes of evidence-based psychotherapies to improve their translation into routine clinical care practices. This protocol article discusses the study methodology and implementation strategies employed in an ongoing, hybrid, type 2 randomized controlled trial with two primary aims: (1) to determine whether a brief, manualized cognitive behavioral therapy administered by Veterans Affairs Primary Care Mental Health Integration program clinicians is effective in treating depression and anxiety in a sample of medically ill (chronic cardiopulmonary diseases) primary care patients and (2) to examine the acceptability, feasibility, and preliminary outcomes of a focused implementation strategy on improving adoption and fidelity of brief cognitive behavioral therapy at two Primary Care-Mental Health Integration clinics. The study uses a hybrid type 2 effectiveness/implementation design to simultaneously test clinical effectiveness and to collect pilot data on a multifaceted implementation strategy that includes an online training program, audit and feedback of session content, and internal and external facilitation. Additionally, the study engages the participation of an advisory council consisting of stakeholders from Primary Care-Mental Health Integration, as well as regional and national mental health leaders within the Veterans Administration. It targets recruitment of 320 participants randomized to brief cognitive behavioral therapy (n = 200) or usual care (n = 120). Both effectiveness and implementation outcomes are being assessed using mixed methods, including quantitative evaluation (e.g., intent-to-treat analyses across multiple time points) and qualitative methods (e.g., focus interviews and surveys from patients and providers). Patient-effectiveness outcomes include measures of depression, anxiety, and physical health functioning using blinded independent evaluators. Implementation outcomes include patient engagement and adherence and clinician brief cognitive behavioral therapy adoption and fidelity. Hybrid designs are needed to advance clinical effectiveness and implementation knowledge to improve healthcare practices. The current article describes the rationale and challenges associated with the use of a hybrid design for the study of brief cognitive behavioral therapy in primary care. Although trade-offs exist between scientific control and external validity, hybrid designs are part of an emerging approach that has the potential to rapidly advance both science and practice. NCT01149772 at http://www.clinicaltrials.gov/ct2/show/NCT01149772.

How best to structure interdisciplinary primary care teams: the study protocol for a systematic review with narrative framework synthesis.

PubMed

Wranik, W Dominika; Hayden, Jill A; Price, Sheri; Parker, Robin M N; Haydt, Susan M; Edwards, Jeanette M; Suter, Esther; Katz, Alan; Gambold, Liesl L; Levy, Adrian R

2016-10-04

Western publicly funded health care systems increasingly rely on interdisciplinary teams to support primary care delivery and management of chronic conditions. This knowledge synthesis focuses on what is known in the academic and grey literature about optimal structural characteristics of teams. Its goal is to assess which factors contribute to the effective functioning of interdisciplinary primary care teams and improved health system outcomes, with specific focus on (i) team structure contribution to team process, (ii) team process contribution to primary care goals, and (iii) team structure contribution to primary care goals. The systematic search of academic literature focuses on four chronic conditions and co-morbidities. Within this scope, qualitative and quantitative studies that assess the effects of team characteristics (funding, governance, organization) on care process and patient outcomes will be searched. Electronic databases (Ovid MEDLINE, Embase, CINAHL, PAIS, Web of Science) will be searched systematically. Online web-based searches will be supported by the Grey Matters Tool. Studies will be included, if they report on interdisciplinary primary care in publicly funded Western health systems, and address the relationships between team structure, process, and/or patient outcomes. Studies will be selected in a three-stage screening process (title/abstract/full text) by two independent reviewers in each stage. Study quality will be assessed using the Mixed Methods Assessment Tool. An a priori framework will be applied to data extraction, and a narrative framework approach is used for the synthesis. Using an integrated knowledge translation approach, an electronic decision support tool will be developed for decision makers. It will be searchable along two axes of inquiry: (i) what primary care goals are supported by specific team characteristics and (ii) how should teams be structured to support specific primary care goals? The results of this evidence review will contribute directly to the design of interdisciplinary primary care teams. The optimized design will support the goals of primary care, contributing to the improved health of populations. PROSPERO CRD42016041884.

The Association between Outpatient Buprenorphine Detoxification Duration and Clinical Treatment Outcomes: A Review

PubMed Central

Sigmon, Stacey C.; Strain, Eric C.; Heil, Sarah H.; Higgins, Stephen T.

2011-01-01

Background The association between buprenorphine taper duration and treatment outcomes is not well understood. This review evaluated whether duration of outpatient buprenorphine taper is significantly associated with treatment outcomes. Methods Studies that were published in peer-reviewed journals, administered buprenorphine as an outpatient taper to opioid-dependent participants, and provided data on at least one of three primary treatment outcome measures (opioid abstinence, retention, peak withdrawal severity) were reviewed. Primary treatment outcomes were evaluated as a function of taper duration using hierarchical linear regressions using pre-taper maintenance as a cofactor. Results Twenty-eight studies were reviewed. Taper duration significantly predicted percent of opioid-negative samples provided during treatment, however pre-taper maintenance period predicted percent participants abstinent on the final day of treatment. High rates of relapse were reported. No significant association between taper duration and retention in treatment or peak withdrawal severity was observed. Conclusion The data reviewed here suggest taper duration is associated with opioid abstinence achieved during detoxification but not with other markers of treatment outcome. The reviewed studies varied widely on several parameters (e.g., frequency of urinalysis testing, provision of ancillary medications) that may influence treatment outcome and thus could have interfered with the ability to identify relationships between taper duration and outcomes. Future studies evaluating opioid detoxification should utilize rigorous experimental methods and report a wider range of outcome measures in order to help advance our understanding of the association between taper duration and treatment outcomes. PMID:21741781

Terminated Trials in the ClinicalTrials.gov Results Database: Evaluation of Availability of Primary Outcome Data and Reasons for Termination

PubMed Central

Williams, Rebecca J.; Tse, Tony; DiPiazza, Katelyn; Zarin, Deborah A.

2015-01-01

Background Clinical trials that end prematurely (or “terminate”) raise financial, ethical, and scientific concerns. The extent to which the results of such trials are disseminated and the reasons for termination have not been well characterized. Methods and Findings A cross-sectional, descriptive study of terminated clinical trials posted on the ClinicalTrials.gov results database as of February 2013 was conducted. The main outcomes were to characterize the availability of primary outcome data on ClinicalTrials.gov and in the published literature and to identify the reasons for trial termination. Approximately 12% of trials with results posted on the ClinicalTrials.gov results database (905/7,646) were terminated. Most trials were terminated for reasons other than accumulated data from the trial (68%; 619/905), with an insufficient rate of accrual being the lead reason for termination among these trials (57%; 350/619). Of the remaining trials, 21% (193/905) were terminated based on data from the trial (findings of efficacy or toxicity) and 10% (93/905) did not specify a reason. Overall, data for a primary outcome measure were available on ClinicalTrials.gov and in the published literature for 72% (648/905) and 22% (198/905) of trials, respectively. Primary outcome data were reported on the ClinicalTrials.gov results database and in the published literature more frequently (91% and 46%, respectively) when the decision to terminate was based on data from the trial. Conclusions Trials terminate for a variety of reasons, not all of which reflect failures in the process or an inability to achieve the intended goals. Primary outcome data were reported most often when termination was based on data from the trial. Further research is needed to identify best practices for disseminating the experience and data resulting from terminated trials in order to help ensure maximal societal benefit from the investments of trial participants and others involved with the study. PMID:26011295

Terminated Trials in the ClinicalTrials.gov Results Database: Evaluation of Availability of Primary Outcome Data and Reasons for Termination.

PubMed

Williams, Rebecca J; Tse, Tony; DiPiazza, Katelyn; Zarin, Deborah A

2015-01-01

Clinical trials that end prematurely (or "terminate") raise financial, ethical, and scientific concerns. The extent to which the results of such trials are disseminated and the reasons for termination have not been well characterized. A cross-sectional, descriptive study of terminated clinical trials posted on the ClinicalTrials.gov results database as of February 2013 was conducted. The main outcomes were to characterize the availability of primary outcome data on ClinicalTrials.gov and in the published literature and to identify the reasons for trial termination. Approximately 12% of trials with results posted on the ClinicalTrials.gov results database (905/7,646) were terminated. Most trials were terminated for reasons other than accumulated data from the trial (68%; 619/905), with an insufficient rate of accrual being the lead reason for termination among these trials (57%; 350/619). Of the remaining trials, 21% (193/905) were terminated based on data from the trial (findings of efficacy or toxicity) and 10% (93/905) did not specify a reason. Overall, data for a primary outcome measure were available on ClinicalTrials.gov and in the published literature for 72% (648/905) and 22% (198/905) of trials, respectively. Primary outcome data were reported on the ClinicalTrials.gov results database and in the published literature more frequently (91% and 46%, respectively) when the decision to terminate was based on data from the trial. Trials terminate for a variety of reasons, not all of which reflect failures in the process or an inability to achieve the intended goals. Primary outcome data were reported most often when termination was based on data from the trial. Further research is needed to identify best practices for disseminating the experience and data resulting from terminated trials in order to help ensure maximal societal benefit from the investments of trial participants and others involved with the study.

The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial

PubMed Central

Abdel-Fattah, Mohamed; MacLennan, Graeme; Kilonzo, Mary; Assassa, R Phil; McCormick, Kirsty; Davidson, Tracey; McDonald, Alison; N’Dow, James; Wardle, Judith; Norrie, John

2017-01-01

Introduction Single-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up. Methods and analysis A pragmatic, multicentre, non-inferiority randomised controlled trial. Primary outcome measure The primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months. Secondary outcome measures The secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit. Statistical analysis The statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly. Ethics and dissemination The North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations. Trial registration number ISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020. PMID:28801396

Primary repair of the anterior cruciate ligament: A paradigm shift.

PubMed

van der List, Jelle P; DiFelice, Gregory S

2017-06-01

Over the last century, many surgical treatments have been developed in the orthopedic field, including treatments of anterior cruciate ligament (ACL) injuries. These treatments ideally evolve in a process of trial and error with prospective comparison of new treatments to the current treatment standard. However, these evolutions are sometimes not linear and periodically undergo paradigm shifts. In this article, we review the evolution of ACL treatment and explain how it underwent a paradigm shift. Open primary ACL repair was the most common treatment in the 1970s and 1980s, but because multiple studies noted deterioration of outcomes at mid-term follow-up, in addition to several randomized clinical trials (RCTs) that noted better outcomes following ACL reconstruction, the open primary repair technique was abandoned. At the end of the primary repair era, however, several studies showed that outcomes of open primary repair were good to excellent and did not deteriorate when this technique was selectively performed in patients with proximal ACL tears, whereas primary repair led to disappointing and unpredictable results in patients with mid-substance tears. Unfortunately, enrollment of patients in the aforementioned RCTs was already finished, ultimately leading to abandoning of open primary repair, despite the advantages of ligament preservation. In this review, we discuss (I) why the evolution of ACL treatment underwent a paradigm shift, (II) which factors may have played a role in this and (III) what the future role of arthroscopic primary ACL repair is in the evolution of ACL treatments. Copyright © 2016. Published by Elsevier Ltd.

A systematic review of the effect of different models of after-hours primary medical care services on clinical outcome, medical workload, and patient and GP satisfaction.

PubMed

Leibowitz, Ruth; Day, Susan; Dunt, David

2003-06-01

The organization of after-hours primary medical care services is changing in many countries. Increasing demand, economic considerations and changes in doctors' attitudes are fueling these changes. Information for policy makers in this field is needed. However, a comprehensive review of the international literature that compares the effects of one model of after-hours care with another is lacking. The aim of this study was to carry out a systematic review of the international literature to determine what evidence exists about the effect of different models of out-of-hours primary medical care service on outcome. Original studies and systematic reviews written since 1976 on the subject of 'after-hours primary medical care services' were identified. Databases searched were Medline/Premedline, CINAHL, HealthSTAR, Current Contents, Cochrane Reviews, DARE, EBM Reviews and EconLit. For each paper where the optimal design would have been an interventional study, the 'level' of evidence was assessed as described in the National Health and Medical Research Council Handbook. 'Comparative' studies (levels I, II, III and IV pre-/post-test studies) were included in this review. Six main models of after-hours primary care services (not mutually exclusive) were identified: practice-based services, deputizing services, emergency departments, co-operatives, primary care centres, and telephone triage and advice services. Outcomes were divided into the following categories: clinical outcomes, medical workload, and patient and GP satisfaction. The results indicate that the introduction of a telephone triage and advice service for after-hours primary medical care may reduce the immediate medical workload. Deputizing services increase immediate medical workload because of the low use of telephone advice and the high home visiting rate. Co-operatives, which use telephone triage and primary care centres and have a low home visiting rate, reduce immediate medical workload. There is little evidence on the effect of different service models on subsequent medical workload apart from the finding that GPs working in emergency departments may reduce the subsequent medical workload. There was very little evidence about the advantages of one service model compared with another in relation to clinical outcome. Studies consistently showed patient dissatisfaction with telephone consultations. The rapid growth in telephone triage and advice services appears to have the advantage of reducing immediate medical workload through the substitution of telephone consultations for in-person consultations, and this has the potential to reduce costs. However, this has to be balanced with the finding of reduced patient satisfaction when in-person consultations are replaced by telephone consultations. These findings should be borne in mind by policy makers deciding on the shape of future services.

Interprofessional online learning for primary healthcare: findings from a scoping review.

PubMed

Reeves, Scott; Fletcher, Simon; McLoughlin, Clodagh; Yim, Alastair; Patel, Kunal D

2017-08-04

This article presents the findings from a scoping review which explored the nature of interprofessional online learning in primary healthcare. The review was informed by the following questions: What is the nature of evidence on online postgraduate education for primary healthcare interprofessional teams? What learning approaches and study methods are used in this context? What is the range of reported outcomes for primary healthcare learners, their organisations and the care they deliver to patients/clients? The review explored the global literature on interprofessional online learning in primary healthcare settings. The review found that the 23 included studies employed a range of different e-learning methods with contrasting course durations, use of theory, participant mix, approaches to accreditation and assessment of learning. Most of the included studies reported outcomes associated with learner reactions and positive changes in participant attitudes/perceptions and improvement in knowledge/skills as a result of engagement in an e-learning course. In contrast, fewer studies reported changes in participant behaviours, changes in organisational practice and improvements to patients/clients. A number of educational, methodological and outcome implications are be offered. E-learning can enhance an education experience, support development, ease time constraints, overcome geographic limitations and can offer greater flexibility. However, it can also contribute to the isolation of learners and its benefits can be negated by technical problems. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

[Withdrawal of a specialised diabetes education program in primary care: long term impact on the metabolic control outcomes].

PubMed

Jurado Campos, Jerónimo; Caula Ros, Jacint A; Hernández Anguera, Josep M; Juvinyà Canal, Dolors; Pou Torelló, José M

2009-12-01

To evaluate the possible relationships between a health policy decision, in relation to the diabetes education strategies and the metabolic control outcomes. Longitudinal prospective cohort study. A random cohort sample of 276 type II diabetes mellitus subjects. All primary care centres in three regions of Catalonia. Patients were classified as specialised (n=59) or non-specialised (n=217) groups, as regards whether having received previous diabetes education before the start of the study. HbA1c values were evaluated in all subjects at baseline and after 5 years after receiving only conventional education. Baseline evaluation showed a better metabolic control in the specialised group (P=0.009). The final evaluation showed no significant differences in outcomes between the two groups (P=0.679). When baseline and outcomes values were compared, significant differences were observed in all subjects (P=0.001), the specialised group showed significantly poorer metabolic control (P<0.001), but in the group with previous conventional education no significant differences were observed (P=0.058). Our results suggest that the withdrawal of higher levels of diabetes education may play a major role in poor metabolic control, and that conventional diabetes education does not improve outcomes. Health policy in Primary Care should consider improving the level of diabetes education.

Does the Rotator Cuff Tear Pattern Influence Clinical Outcomes After Surgical Repair?

PubMed Central

Watson, Scott; Allen, Benjamin; Robbins, Chris; Bedi, Asheesh; Gagnier, Joel J.; Miller, Bruce

2018-01-01

Background: Limited literature exists regarding the influence of rotator cuff tear morphology on patient outcomes. Purpose: To determine the effect of rotator cuff tear pattern (crescent, U-shape, L-shape) on patient-reported outcomes after rotator cuff repair. Study Design: Cohort study; Level of evidence, 3. Methods: Patients undergoing arthroscopic repair of known full-thickness rotator cuff tears were observed prospectively at regular intervals from baseline to 1 year. The tear pattern was classified at the time of surgery as crescent, U-shaped, or L-shaped. Primary outcome measures were the Western Ontario Rotator Cuff Index (WORC), the American Shoulder and Elbow Surgeons (ASES), and a visual analog scale (VAS) for pain. The tear pattern was evaluated as the primary predictor while controlling for variables known to affect rotator cuff outcomes. Mixed-methods regression and analysis of variance (ANOVA) were used to examine the effects of tear morphology on patient-reported outcomes after surgical repair from baseline to 1 year. Results: A total of 82 patients were included in the study (53 male, 29 female; mean age, 58 years [range, 41-75 years]). A crescent shape was the most common tear pattern (54%), followed by U-shaped (25%) and L-shaped tears (21%). There were no significant differences in outcome scores between the 3 groups at baseline. All 3 groups showed statistically significant improvement from baseline to 1 year, but analysis failed to show any predictive effect in the change in outcome scores from baseline to 1 year for the WORC, ASES, or VAS when tear pattern was the primary predictor. Further ANOVA also failed to show any significant difference in the change in outcome scores from baseline to 1 year for the WORC (P = .96), ASES (P = .71), or VAS (P = .86). Conclusion: Rotator cuff tear pattern is not a predictor of functional outcomes after arthroscopic rotator cuff repair. PMID:29623283

Primary closure versus non-closure of dog bite wounds. a randomised controlled trial.

PubMed

Paschos, Nikolaos K; Makris, Eleftherios A; Gantsos, Apostolos; Georgoulis, Anastasios D

2014-01-01

Dog bite wounds represent a major health problem. Despite their importance, their management and especially the role of primary closure remain controversial. In this randomised controlled trial, the outcome between primary suturing and non-closure was compared. 168 consecutive patients with dog bite injuries were included in this study. The wounds were allocated randomly in two treatment approaches: Group 1, consisting of eighty-two patients, had their wound sutured, whilst Group 2, consisting of eighty-six patients, did not have their wounds sutured. All wounds were cleansed using high-pressure irrigation and povidone iodine. All patients received the same type of antibiotic treatment. Our measured outcomes included presence of infection and cosmetic appearance. Cosmetic outcome was evaluated using the Vancouver Scar Scale (VSS). Wound and patient characteristics, such as time of management, wound location and size, and patient age, were recorded and analysed for their potential role in the resulting outcome. The overall infection rate was 8.3%. No difference in the infection rate between primary suturing and non-suturing group was detected in the present study. The cosmetic appearance of the sutured wounds was significantly better (mean score 1.74) compared to the wounds that were left open (mean score 3.05) (p=0.0001). The infection rate was comparable among all age groups. Wounds treated within 8h of injury demonstrated an infection rate of 4.5%, which is lower compared to the 22.2% rate observed in wounds treated later than 8h. The wounds located at the head and neck exhibited better results in both infection rate and cosmetic outcome. Additionally, wounds >3 cm negatively affected the cosmetic appearance of the outcome. Primary suturing of wounds caused by dog bites resulted in similar infection rate compared to non-suturing. However, primary suturing exhibited improved cosmetic appearance. Time of management appeared to be critical, as early treatment resulted in lower infection rate and improved cosmetic appearance regardless suturing or not. Furthermore, wounds located at the head and face demonstrated better results. Copyright © 2013 Elsevier Ltd. All rights reserved.

Impact of peer review on reports of randomised trials published in open peer review journals: retrospective before and after study

PubMed Central

Collins, Gary S; Boutron, Isabelle; Yu, Ly-Mee; Cook, Jonathan; Shanyinde, Milensu; Wharton, Rose; Shamseer, Larissa; Altman, Douglas G

2014-01-01

Objective To investigate the effectiveness of open peer review as a mechanism to improve the reporting of randomised trials published in biomedical journals. Design Retrospective before and after study. Setting BioMed Central series medical journals. Sample 93 primary reports of randomised trials published in BMC-series medical journals in 2012. Main outcome measures Changes to the reporting of methodological aspects of randomised trials in manuscripts after peer review, based on the CONSORT checklist, corresponding peer reviewer reports, the type of changes requested, and the extent to which authors adhered to these requests. Results Of the 93 trial reports, 38% (n=35) did not describe the method of random sequence generation, 54% (n=50) concealment of allocation sequence, 50% (n=46) whether the study was blinded, 34% (n=32) the sample size calculation, 35% (n=33) specification of primary and secondary outcomes, 55% (n=51) results for the primary outcome, and 90% (n=84) details of the trial protocol. The number of changes between manuscript versions was relatively small; most involved adding new information or altering existing information. Most changes requested by peer reviewers had a positive impact on the reporting of the final manuscript—for example, adding or clarifying randomisation and blinding (n=27), sample size (n=15), primary and secondary outcomes (n=16), results for primary or secondary outcomes (n=14), and toning down conclusions to reflect the results (n=27). Some changes requested by peer reviewers, however, had a negative impact, such as adding additional unplanned analyses (n=15). Conclusion Peer reviewers fail to detect important deficiencies in reporting of the methods and results of randomised trials. The number of these changes requested by peer reviewers was relatively small. Although most had a positive impact, some were inappropriate and could have a negative impact on reporting in the final publication. PMID:24986891

Race and Gender Differences in One-Year Outcomes for Community-Dwelling Stroke Survivors with Family Caregivers

PubMed Central

Roth, David L.; Haley, William E.; Clay, Olivio J.; Perkins, Martinique; Grant, Joan S.; Rhodes, J. David; Wadley, Virginia G.; Kissela, Brett; Howard, George

2011-01-01

Background and Purpose Previous research has reported worse outcomes after stroke for women and for African Americans, but few prospective, population-based studies have systematically examined demographic differences on long-term stroke outcomes. Race and gender differences on one-year stroke outcomes were examined using an epidemiologically-derived sample of first-time stroke survivors from the national REasons for Geographic and Racial Differences in Stroke (REGARDS) study. Methods Participants of REGARDS who reported a first-time stroke event during regular surveillance calls were interviewed by telephone and then completed an in-home evaluation approximately one year after the verified first-time stroke event (N = 112). A primary family caregiver was also enrolled and interviewed for each stroke survivor. Measures from the in-home evaluation included previously validated stroke outcomes assessments of neurological deficits, functional impairments, and patient-reported effects of stroke in multiple domains. Results African American stroke survivors were less likely to be living with their primary family caregivers than White participants. Analyses that controlled for age, education, and whether the stroke survivors lived with their primary family caregivers indicated that African Americans and women showed significantly greater deficits on multiple one-year outcome measures compared to Whites and men, respectively. Conclusions Among community-dwelling stroke survivors with family caregivers, women and African Americans are at heightened risk for poor long-term outcomes one year after first-time stroke events. Rehabilitation services and public health policies aimed at enhancing stroke recovery rates should address these disparities in post-stroke outcomes. PMID:21257820

Does sensory relearning improve tactile function after carpal tunnel decompression? A pragmatic, assessor-blinded, randomized clinical trial

PubMed Central

Jerosch-Herold, C.; Houghton, J.; Miller, L.; Shepstone, L.

2016-01-01

Despite surgery for carpal tunnel syndrome being effective in 80%–90% of cases, chronic numbness and hand disability can occur. The aim of this study was to investigate whether sensory relearning improves tactile discrimination and hand function after decompression. In a multi-centre, pragmatic, randomized, controlled trial, 104 patients were randomized to a sensory relearning (n = 52) or control (n = 52) group. A total of 93 patients completed a 12-week follow-up. Primary outcome was the shape-texture identification test at 6 weeks. Secondary outcomes were touch threshold, touch localization, dexterity and self-reported hand function. No significant group differences were seen for the primary outcome (Shape-Texture Identification) at 6 weeks or 12 weeks. Similarly, no significant group differences were observed on secondary outcomes, with the exception of self-reported hand function. A secondary complier-averaged-causal-effects analysis showed no statistically significant treatment effect on the primary outcome. Sensory relearning for tactile sensory and functional deficits after carpal tunnel decompression is not effective. Level of Evidence: II PMID:27402282

What Happens After Health Coaching? Observational Study 1 Year Following a Randomized Controlled Trial

PubMed Central

Sharma, Anjana E.; Willard-Grace, Rachel; Hessler, Danielle; Bodenheimer, Thomas; Thom, David H.

2016-01-01

PURPOSE Health coaching is effective for chronic disease self-management in the primary care safety-net setting, but little is known about the persistence of its benefits. We conducted an observational study evaluating the maintenance of improved cardiovascular risk factors following a health coaching intervention. METHODS We performed a naturalistic follow-up to the Health Coaching in Primary Care Study, a 12-month randomized controlled trial (RCT) comparing health coaching to usual care for patients with uncontrolled diabetes, hypertension, or hyperlipidemia. Participants were followed up 24 months from RCT baseline. The primary outcome was the proportion at goal for at least 1 measure (hemoglobin A1c, systolic blood pressure, or LDL cholesterol) that had been above goal at enrollment; secondary outcomes included each individual clinical goal. Chi-square tests and paired t-tests compared dichotomous and continuous measures. RESULTS 290 of 441 participants (65.8%) participated at both 12 and 24 months. The proportion of patients in the coaching arm of the RCT who achieved the primary outcome dropped only slightly from 47.1% at 12 to 45.9% at 24 months (P = .80). The proportion at goal for hemoglobin A1c dropped from 53.4% to 36.2% (P = .03). All other clinical metrics had small, nonsignificant changes between 12 and 24 months. CONCLUSIONS Results support the conclusion that most improved clinical outcomes persisted 1 year after the completion of the health coaching intervention. PMID:27184989

What Happens After Health Coaching? Observational Study 1 Year Following a Randomized Controlled Trial.

PubMed

Sharma, Anjana E; Willard-Grace, Rachel; Hessler, Danielle; Bodenheimer, Thomas; Thom, David H

2016-05-01

Health coaching is effective for chronic disease self-management in the primary care safety-net setting, but little is known about the persistence of its benefits. We conducted an observational study evaluating the maintenance of improved cardiovascular risk factors following a health coaching intervention. We performed a naturalistic follow-up to the Health Coaching in Primary Care Study, a 12-month randomized controlled trial (RCT) comparing health coaching to usual care for patients with uncontrolled diabetes, hypertension, or hyperlipidemia. Participants were followed up 24 months from RCT baseline. The primary outcome was the proportion at goal for at least 1 measure (hemoglobin A1c, systolic blood pressure, or LDL cholesterol) that had been above goal at enrollment; secondary outcomes included each individual clinical goal. Chi-square tests and paired t-tests compared dichotomous and continuous measures. 290 of 441 participants (65.8%) participated at both 12 and 24 months. The proportion of patients in the coaching arm of the RCT who achieved the primary outcome dropped only slightly from 47.1% at 12 to 45.9% at 24 months (P = .80). The proportion at goal for hemoglobin A1c dropped from 53.4% to 36.2% (P = .03). All other clinical metrics had small, nonsignificant changes between 12 and 24 months. Results support the conclusion that most improved clinical outcomes persisted 1 year after the completion of the health coaching intervention. © 2016 Annals of Family Medicine, Inc.

Investigating the effect of independent, blinded digital image assessment on the STOP GAP trial.

PubMed

Patsko, Emily; Godolphin, Peter J; Thomas, Kim S; Hepburn, Trish; Mitchell, Eleanor J; Craig, Fiona E; Bath, Philip M; Montgomery, Alan A

2017-02-02

Blinding is the process of keeping treatment assignment hidden and is used to minimise the possibility of bias. Trials at high risk of bias have been shown to report larger treatment effects than low-risk studies. In dermatology, one popular method of blinding is to have independent outcome assessors who are unaware of treatment allocation assessing the endpoint using digital photographs. However, this can be complex, expensive and time-consuming. The objective of this study was to compare the effect of blinded and unblinded outcome assessment on the results of the STOP GAP trial. The STOP GAP trial compared prednisolone to ciclosporin in treating pyoderma gangrenosum. Participants' lesions were measured at baseline and at 6 weeks to calculate the primary outcome, speed of healing. Independent blinded assessors obtained measurements from digital photographs using specialist software. In addition, unblinded treating clinicians estimated lesion area by measuring length and width. The primary outcome was determined using blinded measurements where available, otherwise unblinded measurements were used (method referred to as trial measurements). In this study, agreement between the trial and unblinded measurements was determined using the intraclass correlation coefficient (ICC). The STOP GAP trial's primary analysis was repeated using unblinded measurements only. We introduced differential and nondifferential error in unblinded measurements and investigated the effect on the STOP GAP trial's primary analysis. Eighty-six (80%) of the 108 patients were assessed using digital images. Agreement between trial and unblinded measurements was excellent (ICC = 0.92 at baseline; 0.83 at 6 weeks). There was no evidence that the results of the trial primary analysis differed according to how the primary outcome was assessed (p value for homogeneity = 1.00). Blinded digital image assessment in the STOP GAP trial did not meaningfully alter trial conclusions compared with unblinded assessment. However, as the process brought added accuracy and credibility to the trial it was considered worthwhile. These findings question the usefulness of digital image assessment in a trial with an objective outcome and where bias is not expected to be excessive. Further research should investigate if there are alternative, less complex ways of incorporating blinding in clinical trials. Current Controlled Trials, www.isrctn.com ISRCTN35898459. Registered on 26 May 2009.

A single-centre cohort study of National Early Warning Score (NEWS) and near patient testing in acute medical admissions.

PubMed

Abbott, Tom E F; Torrance, Hew D T; Cron, Nicholas; Vaid, Nidhi; Emmanuel, Julian

2016-11-01

The utility of an early warning score may be improved when used with near patient testing. However, this has not yet been investigated for National Early Warning Score (NEWS). We hypothesised that the combination of NEWS and blood gas variables (lactate, glucose or base-excess) was more strongly associated with clinical outcome compared to NEWS alone. This was a prospective cohort study of adult medical admissions to a single-centre over 20days. Blood gas results and physiological observations were recorded at admission. NEWS was calculated retrospectively and combined with the biomarkers in multivariable logistic regression models. The primary outcome was a composite of mortality or critical care escalation within 2days of hospital admission. The secondary outcome was hospital length of stay. After accounting for missing data, 15 patients out of 322 (4.7%) died or were escalated to the critical care unit. The median length of stay was 4 (IQR 7) days. When combined with lactate or base excess, NEWS was associated with the primary outcome (OR 1.18, p=0.01 and OR 1.13, p=0.03). However, NEWS alone was more strongly associated with the primary outcome measure (OR 1.46, p<0.01). The combination of NEWS with glucose was not associated with the primary outcome. Neither NEWS nor any combination of NEWS and a biomarker were associated with hospital length of stay. Admission NEWS is more strongly associated with death or critical care unit admission within 2days of hospital admission, compared to combinations of NEWS and blood-gas derived biomarkers. Copyright © 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

A systematic review of evidence on the links between patient experience and clinical safety and effectiveness

PubMed Central

Doyle, Cathal; Lennox, Laura; Bell, Derek

2013-01-01

Objective To explore evidence on the links between patient experience and clinical safety and effectiveness outcomes. Design Systematic review. Setting A wide range of settings within primary and secondary care including hospitals and primary care centres. Participants A wide range of demographic groups and age groups. Primary and secondary outcome measures A broad range of patient safety and clinical effectiveness outcomes including mortality, physical symptoms, length of stay and adherence to treatment. Results This study, summarising evidence from 55 studies, indicates consistent positive associations between patient experience, patient safety and clinical effectiveness for a wide range of disease areas, settings, outcome measures and study designs. It demonstrates positive associations between patient experience and self-rated and objectively measured health outcomes; adherence to recommended clinical practice and medication; preventive care (such as health-promoting behaviour, use of screening services and immunisation); and resource use (such as hospitalisation, length of stay and primary-care visits). There is some evidence of positive associations between patient experience and measures of the technical quality of care and adverse events. Overall, it was more common to find positive associations between patient experience and patient safety and clinical effectiveness than no associations. Conclusions The data presented display that patient experience is positively associated with clinical effectiveness and patient safety, and support the case for the inclusion of patient experience as one of the central pillars of quality in healthcare. It supports the argument that the three dimensions of quality should be looked at as a group and not in isolation. Clinicians should resist sidelining patient experience as too subjective or mood-oriented, divorced from the ‘real’ clinical work of measuring safety and effectiveness. PMID:23293244

Data sharing and reanalysis of randomized controlled trials in leading biomedical journals with a full data sharing policy: survey of studies published in The BMJ and PLOS Medicine

PubMed Central

Naudet, Florian; Sakarovitch, Charlotte; Janiaud, Perrine; Cristea, Ioana; Fanelli, Daniele; Moher, David

2018-01-01

Abstract Objectives To explore the effectiveness of data sharing by randomized controlled trials (RCTs) in journals with a full data sharing policy and to describe potential difficulties encountered in the process of performing reanalyses of the primary outcomes. Design Survey of published RCTs. Setting PubMed/Medline. Eligibility criteria RCTs that had been submitted and published by The BMJ and PLOS Medicine subsequent to the adoption of data sharing policies by these journals. Main outcome measure The primary outcome was data availability, defined as the eventual receipt of complete data with clear labelling. Primary outcomes were reanalyzed to assess to what extent studies were reproduced. Difficulties encountered were described. Results 37 RCTs (21 from The BMJ and 16 from PLOS Medicine) published between 2013 and 2016 met the eligibility criteria. 17/37 (46%, 95% confidence interval 30% to 62%) satisfied the definition of data availability and 14 of the 17 (82%, 59% to 94%) were fully reproduced on all their primary outcomes. Of the remaining RCTs, errors were identified in two but reached similar conclusions and one paper did not provide enough information in the Methods section to reproduce the analyses. Difficulties identified included problems in contacting corresponding authors and lack of resources on their behalf in preparing the datasets. In addition, there was a range of different data sharing practices across study groups. Conclusions Data availability was not optimal in two journals with a strong policy for data sharing. When investigators shared data, most reanalyses largely reproduced the original results. Data sharing practices need to become more widespread and streamlined to allow meaningful reanalyses and reuse of data. Trial registration Open Science Framework osf.io/c4zke. PMID:29440066

The economic impact of stroke in The Netherlands: the €-restore4stroke study

PubMed Central

2012-01-01

Background Stroke has a considerable socio-economic impact worldwide and is the leading cause of disabilities in the Western world. Economic studies of stroke focus merely on physical aspects and clinical interventions. To our current knowledge there is no comprehensive economic study investigating the economic impact of stroke including psychological and social aspects. The €-Restore4Stroke project, part of a large comprehensive research programme Restore4Stroke, aims to investigate the total economic impact of stroke in the Netherlands. Methods Two trial-based economic evaluation studies will be conducted within the €-Restore4Stroke project: one focussing on a self-management intervention and one on an augmented cognitive behavioural therapy intervention. Both include cost-effectiveness analyses and cost-utility analyses as primary research methods. Furthermore, a cost-of-illness study investigating costs after stroke attached to a cohort study and a record linkage study in which four databases are linked to investigate patterns of health care consumption before and after stroke, are embedded in €-Restore4Stroke. All studies will be performed from a societal perspective. The primary outcome measure for the cost-effectiveness analysis is the increase in health status on the primary outcome scales. Within the cost-utility analysis, the primary outcome measure is quality-adjusted life years (QALYs) for which an indirect preference-based technique will be used. In the self-management study we will also look at the estimation of health effects on informal caregivers. Cost outcomes in the cost-of-illness study will be computed with a cost questionnaire and linkage of several databases will be used to derive outcomes in the record linkage study, Discussion €-Restore4Stroke will provide new insights and evidence for the economic impact of psychosocial consequences after stroke. Besides being innovative in various ways (i.e. focussing on the chronic phase after stroke and including personal factors as possible determinants of long-term re-integration including quality of life in a prospective longitudinal design), a major strength of €-Restore4Stroke is that we include impact on informal caregivers. The outcomes of this study will provide health care decision makers with valuable and necessary information regarding stroke care related decisions. Trial registration NTR3051 (RCT Self-management), NTR2999 (RCT Augmented Cognitive Behavioural Therapy) PMID:22329910

The Patient-Centered Medical Home (PCMH) Framing Typology for Understanding the Structure, Function, and Outcomes of PCMHs.

PubMed

Kieber-Emmons, Autumn M; Miller, William L

2017-01-01

Patient-centered medical homes (PCHMs) aspire to transform today's challenged primary care services. However, it is unclear which PCMH characteristics produce specific outcomes of interest for care delivery. This study tested a novel typology of PCMH practice transformation, the PCMH framing typology, and evaluated measurable outcomes by each type. Using the Patient-Centered Primary Care Collaborative 2012 to 2013 Annual Review, this secondary analysis of the published PCMH literature extracted data from publications of 59 PCMHs. Each of the 59 sites was categorized as 1 of 4 PCMH types: add-on, renovated, hybrid, or integrated. Six outcome measures (cost reductions, decreased emergency department/hospital utilization, improved quality, improved access, increased preventive services, and improved patient satisfaction) were independently coded for each site. Practices were combined based on type, and mean outcomes scores for each measure were displayed on radar graphs for comparison. While each type showed a characteristic pattern of success, only the integrated type improved in all 6 outcomes. No type achieved high success in all measures. There seem to be 4 types of PCMH, each of which shows a distinctive outcomes profile. Within the PCMH framing typology, direction is emerging for how best to transform primary care to achieve the greatest success. © Copyright 2017 by the American Board of Family Medicine.

Improving diabetes care among patients overdue for recommended testing: a randomized controlled trial of automated telephone outreach.

PubMed

Simon, Steven R; Trinacty, Connie Mah; Soumerai, Stephen B; Piette, John D; Meigs, James B; Shi, Ping; Ensroth, Arthur; Ross-Degnan, Dennis

2010-07-01

The study's objective was to assess the effects of automated telephone outreach with speech recognition (ATO-SR) on diabetes-related testing. We identified 1,200 health plan members who were overdue for diabetes-related testing and randomly allocated 600 to ATO-SR and 600 to usual care (no intervention). The intervention included three interactive calls encouraging recommended testing. The primary outcome was retinopathy testing, since this was the health plan's principal goal. Tests for glycemia, hyperlipidemia, and nephropathy were secondary outcomes. In total, 232 participants (39%) verbally responded to the calls. There was no difference between the intervention and the usual care groups in the primary outcome (adjusted hazard ratio 0.93 [95% CI 0.71-1.22]) and no effect of the intervention on any of the secondary outcomes. Fewer than 40% of the patients randomized to ATO-SR interacted verbally with the system. The intervention had no effect on the study's outcomes.

Multiprofessional Primary Care Units: What Affects the Clinical Performance of Italian General Practitioners?

PubMed

Armeni, Patrizio; Compagni, Amelia; Longo, Francesco

2014-08-01

Multiprofessional primary care models promise to deliver better care and reduce waste. This study evaluates the impact of such a model, the primary care unit (PCU), on three outcomes. A multilevel analysis within a "pre- and post-PCU" study design and a cross-sectional analysis were conducted on 215 PCUs located in the Emilia-Romagna region in Italy. Seven dimensions captured a set of processes and services characterizing a well-functioning PCU, or its degree of vitality. The impact of each dimension on outcomes was evaluated. The analyses show that certain dimensions of PCU vitality (i.e., the possibility for general practitioners to meet and share patients) can lead to better outcomes. However, dimensions related to the interaction and the joint works of general practitioners with other professionals tend not to have a significant or positive impact. This suggests that more effort needs to be invested to realize all the potential benefits of the PCU's multiprofessional approach to care. © The Author(s) 2014.

Survival of primary condylar-constrained total knee arthroplasty at a minimum of 7 years.

PubMed

Maynard, Lance M; Sauber, Timothy J; Kostopoulos, Vasileios K; Lavigne, Gregory S; Sewecke, Jeffrey J; Sotereanos, Nicholas G

2014-06-01

The purpose of the present study is to retrospectively analyze clinical and radiographic outcomes in primary constrained condylar knee arthroplasty at a minimum follow-up of 7 years. Given the concern for early aseptic loosening in constrained implants, we focused on this outcome. Our cohort consists of 127 constrained condylar knees. The mean age of patients in the study was 68.3 years, with a mean follow-up of 110.7 months. The diagnosis was primary osteoarthritis in 92%. There were four periprosthetic distal femur fractures, with a rate of revision of 0.8%. No implants were revised for aseptic loosening. Kaplan-Meier survivorship analysis with removal of any component as the end point revealed that the 10-year rate of survival of the primary CCK was 97.6% (95% CI, 94%-100%). Copyright © 2014. Published by Elsevier Inc.

A pragmatic group sequential, placebo-controlled, randomised trial to determine the effectiveness of glyceryl trinitrate for retained placenta (GOT-IT): a study protocol.

PubMed

Denison, Fiona C; Norrie, John; Lawton, Julia; Norman, Jane E; Scotland, Graham; McPherson, Gladys C; McDonald, Alison; Forrest, Mark; Hudson, Jemma; Brewin, Jane; Peace, Mathilde; Clarkson, Cynthia; Brook-Smith, Sheonagh; Morrow, Susan; Hallowell, Nina; Hodges, Laura; Carruthers, Kathryn F

2017-09-18

A retained placenta is diagnosed when the placenta is not delivered following delivery of the baby. It is a major cause of postpartum haemorrhage and treated by the operative procedure of manual removal of placenta (MROP). The aim of this pragmatic, randomised, placebo-controlled, double-blind UK-wide trial, with an internal pilot and nested qualitative research to adjust strategies to refine delivery of the main trial, is to determine whether sublingual glyceryl trinitrate (GTN) is (or is not) clinically and cost-effective for (medical) management of retained placenta. The primary clinical outcome is need for MROP, defined as the placenta remaining undelivered 15 min poststudy treatment and/or being required within 15 min of treatment due to safety concerns. The primary safety outcome is measured blood loss between administration of treatment and transfer to the postnatal ward or other clinical area. The primary patient-sided outcome is satisfaction with treatment and a side effect profile. The primary economic outcome is net incremental costs (or cost savings) to the National Health Service of using GTN versus standard practice. Secondary outcomes are being measured over a range of clinical and economic domains. The primary outcomes will be analysed using linear models appropriate to the distribution of each outcome. Health service costs will be compared with multiple trial outcomes in a cost-consequence analysis of GTN versus standard practice. Ethical approval has been obtained from the North-East Newcastle & North Tyneside 2 Research Ethics Committee (13/NE/0339). Dissemination plans for the trial include the Health Technology Assessment Monograph, presentation at international scientific meetings and publication in high-impact, peer-reviewed journals. ISCRTN88609453; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Factors influencing clinical outcome in patients with primary hyperoxaluria type 1.

PubMed

Fargue, Sonia

2014-12-01

The renal outcome in patients with primary hyperoxaluria type 1 is partly determined by AGXT mutations, including but not limited to the p.Gly170Arg mutation. The study by Mandrile et al. reports on the largest cohort of patients genotyped yet, with long-term renal survival and medical treatment by pyridoxine. In addition to the common p.Gly170Arg mutation, three other mutations were shown to be potentially associated with slower evolution.

Assessment of complete unilateral cleft lip and palate treatment outcome using EUROCRAN index and associated factors.

PubMed

Arshad, Anas Imran; Alam, Mohammad Khursheed; Khamis, Mohd Fadhli

2017-09-01

Assessment of treatment outcome is the only non-invasive approach to identify the effects of cleft lip and palate repair and modify management accordingly. Here the aim is to assess the outcome of complete unilateral cleft lip and palate (CUCLP) patients using EUROCRAN index and to check whether there are any factors associated with the treatment outcome. It is a retrospective cross sectional study. Dental models were collected from archives of two cleft referral centers in Pakistan. Five blinded examiners scored 101 models twice at two week interval. The primary outcome was mean EUROCRAN scores based on dental arch relationships and palatal surface morphology. A mean(SD) score of 2.72 (0.76) and 2.20 (0.73) was determined based on dental arch relationships and palatal surface morphology, respectively. According to the final logistic regression model, modified Millard technique (cheiloplasty) and Veau-Wardill-Kilners' method (palatoplasty) had higher odds of producing unfavorable treatment outcome. Present study determined a fair and a fair to poor treatment outcome based on dental arch relationships and palatal surface morphology, respectively. Our study suggests a significant association between treatment outcome and primary surgical techniques for lip and palate. These findings could warrant a modification of management protocols to ensure improvement in future cleft outcomes. Copyright © 2017 Elsevier B.V. All rights reserved.

Respiratory outcomes study (RESPOS) for preterm infants at primary school age.

PubMed

Astle, Valerie; Broom, Margaret; Todd, David A; Charles, Blessy; Ringland, Cathy; Ciszek, Karen; Shadbolt, Bruce

2015-02-01

Pulmonary function abnormalities and hospital re-admissions in survivors of neonatal lung disease remain highly prevalent. The respiratory outcomes study (RESPOS) aimed to investigate the respiratory and associated atopy outcomes in preterm infants <30 weeks gestational age (GA) and/or birth-weight (BWt) <1000 g at primary school age, and to compare these outcomes between infants with and without chronic lung disease (CLD). In the RESPOS 92 parents of preterm infants admitted to the Neonatal unit in Canberra Hospital between 1/1/2001 and 31/12/2003 were sent a questionnaire regarding their respiratory, atopy management and follow-up. Fifty-three parents responded, including 28 preterm infants who had CLD and 25 who had no CLD. The gestational age was significantly lower in the CLD group compared to the non-CLD group [26.9 (26.3-27.5) CLD and 28.6 (28.3-29.0) non-CLD] [weeks [95% confidence interval (CI)

Immunocompromised patients with metastatic cutaneous nodal squamous cell carcinoma of the head and neck: Poor outcome unrelated to the index lesion.

PubMed

Lam, Johnson K S; Sundaresan, Puma; Gebski, Val; Veness, Michael J

2018-05-01

Immunocompromised patients with metastatic cutaneous nodal head and neck squamous cell carcinoma (HNSCC) have worse outcomes compared to the immunocompetent. The purpose of this study was to investigate the characteristics of the primary cutaneous squamous cell carcinoma (SCC), nodal pathology, and outcome between these 2 groups. Analysis of a prospective database was performed. A 2:1 pooled analysis selected 46 immunocompetent patients matched with 23 immunocompromised patients. Overall survival (OS) and relapse-free survival (RFS) were calculated using the Kaplan-Meier method. No significant difference was found in the primary tumor characteristics between the 2 groups. In the immunocompromised group, RFS (hazard ratio [HR] 2.70; P = .01) and OS (HR 2.32; P = .04) were significantly worse. Extracapsular spread was present in 100% of the immunocompromised patients. No significant difference was identified in the primary cutaneous SCC between the immunocompetent and immunocompromised patients. Immunosuppression predicted worse outcome. © 2018 Wiley Periodicals, Inc.

Clinical course and prognosis of musculoskeletal pain in patients referred for physiotherapy: does pain site matter?

PubMed

de Vos Andersen, Nils-Bo; Kent, Peter; Hjort, Jakob; Christiansen, David Høyrup

2017-03-29

Danish patients with musculoskeletal disorders are commonly referred for primary care physiotherapy treatment but little is known about their general health status, pain diagnoses, clinical course and prognosis. The objectives of this study were to 1) describe the clinical course of patients with musculoskeletal disorders referred to physiotherapy, 2) identify predictors associated with a satisfactory outcome, and 3) determine the influence of the primary pain site diagnosis relative to those predictors. This was a prospective cohort study of patients (n = 2,706) newly referred because of musculoskeletal pain to 30 physiotherapy practices from January 2012 to May 2012. Data were collected via a web-based questionnaire 1-2 days prior to the first physiotherapy consultation and at 6 weeks, 3 and 6 months, from clinical records (including primary musculoskeletal symptom diagnosis based on the ICPC-2 classification system), and from national registry data. The main outcome was the Patient Acceptable Symptom State. Potential predictors were analysed using backwards step-wise selection during longitudinal Generalised Estimating Equation regression modelling. To assess the influence of pain site on these associations, primary pain site diagnosis was added to the model. Of the patients included, 66% were female and the mean age was 48 (SD 15). The percentage of patients reporting their symptoms as acceptable was 32% at 6 weeks, 43% at 3 months and 52% at 6 months. A higher probability of satisfactory outcome was associated with place of residence, being retired, no compensation claim, less frequent pain, shorter duration of pain, lower levels of disability and fear avoidance, better mental health and being a non-smoker. Primary pain site diagnosis had little influence on these associations, and was not predictive of a satisfactory outcome. Only half of the patients rated their symptoms as acceptable at 6 months. Although satisfactory outcome was difficult to predict at an individual patient level, there were a number of prognostic factors that were associated with this outcome. These factors should be considered when developing generic prediction tools to assess the probability of satisfactory outcome in musculoskeletal physiotherapy patients, because the site of pain did not affect that prognostic association.

Primary perivascular epithelioid cell tumors of the liver: CT/MRI findings and clinical outcomes.

PubMed

O'Malley, Martin E; Chawla, Tanya P; Lavelle, Lisa P; Cleary, Sean; Fischer, Sandra

2017-06-01

The purpose of our study was to describe the CT and MRI features of primary PEComas of the liver and to document the associated clinical outcomes. Retrospective study included 20 patients with primary hepatic perivascular epithelioid cell tumors (PEComa) with pathology and clinical outcomes for correlation. Study group included 20 patients: 16 women, 4 men; mean age 53 (range 35-77) years. Initial pathology diagnoses were classic angiomyolipoma (AML) (n = 11), epithelioid AML (n = 7), and PEComa not otherwise specified (n = 2). Mean tumor size was 5.1 (range 1.3-15.0) cm. CT/MRI features included well-defined margins 20/20 (100%), arterial enhancement 18/19 (95%), subcapsular location 17/20 (85%), heterogeneous 16/20 (80%), dysmorphic vessels 14/20 (70%), fat 13/20 (65%), hemorrhage 4/20 (20%), cystic components 4/20 (20%), and calcification 1/20 (5%). At the time of discovery, 18 patients were asymptomatic and their tumors were incidentally detected on imaging, and 2 patients were symptomatic. Ultimately, 18 tumors were benign and 2 developed metastases. On CT/MRI, most primary hepatic PEComas were well-defined, arterial enhancing, subcapsular, heterogeneous masses that often had dysmorphic vessels and contained fat. Most tumors were benign but complications included local symptoms, bleeding, and malignant change.

The Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS): Unifying Efforts to Inform Practice and Improve Global Outcomes in Peritoneal Dialysis

PubMed Central

Perl, Jeffrey; Davies, Simon J.; Lambie, Mark; Pisoni, Ronald L.; McCullough, Keith; Johnson, David W.; Sloand, James A.; Prichard, Sarah; Kawanishi, Hideki; Tentori, Francesca; Robinson, Bruce M.

2016-01-01

♦ Background: Extending technique survival on peritoneal dialysis (PD) remains a major challenge in optimizing outcomes for PD patients while increasing PD utilization. The primary objective of the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) is to identify modifiable practices associated with improvements in PD technique and patient survival. In collaboration with the International Society for Peritoneal Dialysis (ISPD), PDOPPS seeks to standardize PD-related data definitions and provide a forum for effective international collaborative clinical research in PD. ♦ Methods: The PDOPPS is an international prospective cohort study in Australia, Canada, Japan, the United Kingdom (UK), and the United States (US). Each country is enrolling a random sample of incident and prevalent patients from national samples of 20 to 80 sites with at least 20 patients on PD. Enrolled patients will be followed over an initial 3-year study period. Demographic, comorbidity, and treatment-related variables, and patient-reported data, will be collected over the study course. The primary outcome will be all-cause PD technique failure or death; other outcomes will include cause-specific technique failure, hospitalizations, and patient-reported outcomes. ♦ Results: A high proportion of the targeted number of study sites has been recruited to date in each country. Several ancillary studies have been funded with high momentum toward expansion to new countries and additional participation. ♦ Conclusion: The PDOPPS is the first large, international study to follow PD patients longitudinally to capture clinical practice. With data collected, the study will serve as an invaluable resource and research platform for the international PD community, and provide a means to understand variation in PD practices and outcomes, to identify optimal practices, and to ultimately improve outcomes for PD patients. PMID:26526049

The Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS): Unifying Efforts to Inform Practice and Improve Global Outcomes in Peritoneal Dialysis.

PubMed

Perl, Jeffrey; Davies, Simon J; Lambie, Mark; Pisoni, Ronald L; McCullough, Keith; Johnson, David W; Sloand, James A; Prichard, Sarah; Kawanishi, Hideki; Tentori, Francesca; Robinson, Bruce M

2016-01-01

♦ Extending technique survival on peritoneal dialysis (PD) remains a major challenge in optimizing outcomes for PD patients while increasing PD utilization. The primary objective of the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) is to identify modifiable practices associated with improvements in PD technique and patient survival. In collaboration with the International Society for Peritoneal Dialysis (ISPD), PDOPPS seeks to standardize PD-related data definitions and provide a forum for effective international collaborative clinical research in PD. ♦ The PDOPPS is an international prospective cohort study in Australia, Canada, Japan, the United Kingdom (UK), and the United States (US). Each country is enrolling a random sample of incident and prevalent patients from national samples of 20 to 80 sites with at least 20 patients on PD. Enrolled patients will be followed over an initial 3-year study period. Demographic, comorbidity, and treatment-related variables, and patient-reported data, will be collected over the study course. The primary outcome will be all-cause PD technique failure or death; other outcomes will include cause-specific technique failure, hospitalizations, and patient-reported outcomes. ♦ A high proportion of the targeted number of study sites has been recruited to date in each country. Several ancillary studies have been funded with high momentum toward expansion to new countries and additional participation. ♦ The PDOPPS is the first large, international study to follow PD patients longitudinally to capture clinical practice. With data collected, the study will serve as an invaluable resource and research platform for the international PD community, and provide a means to understand variation in PD practices and outcomes, to identify optimal practices, and to ultimately improve outcomes for PD patients. Copyright © 2016 International Society for Peritoneal Dialysis.

Dimensional personality traits and alcohol treatment outcome: a systematic review and meta-analysis.

PubMed

Foulds, James; Newton-Howes, Giles; Guy, Nicola H; Boden, Joseph M; Mulder, Roger T

2017-08-01

To identify dimensional personality traits associated with treatment outcome for patients with an alcohol use disorder (AUD). Systematic review and meta-analysis of clinical trials and longitudinal studies of ≥ 8 weeks in patients receiving treatment for AUD, in which the association between personality dimensions and treatment outcome was reported. Primary outcomes were relapse and alcohol consumption measures. Treatment retention was a secondary outcome. Eighteen studies, including 4783 subjects, were identified. Twelve studies used Cloninger's Temperament and Personality Questionnaire (TPQ) or Temperament and Character Inventory (TCI). Remaining studies used a broad range of other personality measures. Compared with non-relapsers, patients who relapsed had higher novelty-seeking [standardized mean difference in novelty-seeking score 0.28; 95% confidence interval (CI) = 0.12, 0.44], lower persistence (-0.30, 95% = CI -0.48, -0.12), lower reward dependence (-0.16, 95% CI = -0.31, -0.01) and lower cooperativeness (-0.23, 95% CI = -0.41, -0.04). Few studies reported on alcohol consumption outcomes, therefore findings for those outcomes were inconclusive. Lower novelty-seeking predicted better retention in treatment in two of three studies. Most studies reported findings only for those retained in treatment, and did not attempt to account for missing data; therefore, findings for the primary outcomes cannot be generalized to patients who dropped out of treatment. Studies using personality instruments other than the TCI or TPQ reported no consistent findings on the association between personality variables and treatment outcome. Among patients receiving treatment for an alcohol use disorder, those who relapse during follow-up have higher novelty-seeking, lower persistence, lower reward dependence and lower cooperativeness than those who do not relapse. © 2017 Society for the Study of Addiction.

Primary Care Interventions for Dementia Caregivers: 2-Year Outcomes from the REACH Study

ERIC Educational Resources Information Center

Burns, Robert; Nichols, Linda O.; Martindale-Adams, Jennifer; Graney, Marshall J.; Lummus, Allan

2003-01-01

Purpose: This study developed and tested two 24-month primary care interventions to alleviate the psychological distress suffered by the caregivers of those with Alzheimer's disease. The interventions, using targeted educational materials, were patient behavior management only, and patient behavior management plus caregiver stress-coping…

Effects of substituting nurse practitioners, physician assistants or nurses for physicians concerning healthcare for the ageing population: a systematic literature review.

PubMed

Lovink, Marleen H; Persoon, Anke; Koopmans, Raymond T C M; Van Vught, Anneke J A H; Schoonhoven, Lisette; Laurant, Miranda G H

2017-09-01

To evaluate the effects of substituting nurse practitioners, physician assistants or nurses for physicians in long-term care facilities and primary healthcare for the ageing population (primary aim) and to describe what influences the implementation (secondary aim). Healthcare for the ageing population is undergoing major changes and physicians face heavy workloads. A solution to guarantee quality and contain costs might be to substitute nurse practitioners, physician assistants or nurses for physicians. A systematic literature review. PubMed, EMBASE, CINAHL, PsycINFO, CENTRAL, Web of Science; searched January 1995-August 2015. Study selection, data extraction and quality appraisal were conducted independently by two reviewers. Outcomes collected: patient outcomes, care provider outcomes, process of care outcomes, resource use outcomes, costs and descriptions of the implementation. Data synthesis consisted of a narrative summary. Two studies used a randomized design and eight studies used other comparative designs. The evidence of the two randomized controlled trials showed no effect on approximately half of the outcomes and a positive effect on the other half of the outcomes. Results of eight other comparative study designs point towards the same direction. The implementation was influenced by factors on a social, organizational and individual level. Physician substitution in healthcare for the ageing population may achieve at least as good patient outcomes and process of care outcomes compared with care provided by physicians. Evidence about resource use and costs is too limited to draw conclusions. © 2017 John Wiley & Sons Ltd.

Reproductive outcome after IVF following hysteroscopic division of incomplete uterine septum/arcuate uterine anomaly in women with primary infertility

PubMed Central

Abuzeid, M.; Ghourab, G.; Abuzeid, O.; Mitwally, M.; Ashraf, M.; Diamond, M.

2014-01-01

Objective: To determine reproductive outcome after in-vitro fertilization/embryo transfer (IVF-ET) in women with primary infertility following hysteroscopic septoplasty of incomplete uterine septum or arcuate uterine anomaly. Methods: This is a historical cohort study. The study group consisted of 156 consecutive patients who underwent a total of 221 cycles of IVF/ET following hysteroscopic septoplasty of an incomplete uterine septum or arcuate anomaly (Group 1). The control group included 196 consecutive patients with normal endometrial cavity on hysteroscopy who underwent a total of 369 cycles of IVF/ET (Group 2). The reproductive outcome after the first cycle of IVF-ET and the best reproductive outcome of all the cycles the patient underwent were calculated. In addition, we compared the reproductive outcome in the study group based on the type of the anomalies (septum versus arcuate). Results: In the first fresh cycle, following septoplasty, there were significantly higher clinical pregnancy and delivery rates in Group 1 (60.3% and 51.3% respectively) compared to Group 2 (38.8% and 33.2% respectively). However, there was no significant difference between the two groups in the clinical pregnancy (74.4% vs. 67.3%) or in the delivery (65.4% vs. 60.2%) rates per patient, respectively. There was no significant difference in the reproductive outcome after IVF-ET between patients who previously had arcuate uterine anomaly versus incomplete uterine septum. Conclusion: Reproductive outcome of IVF-ET after hysteroscopic correction of incomplete uterine septum/arcuate uterine anomaly in women with primary infertility is no different from women with normal uterine cavity. PMID:25593694

Arthroscopic Debridement for Primary Degenerative Osteoarthritis of the Elbow Leads to Significant Improvement in Range of Motion and Clinical Outcomes: A Systematic Review.

PubMed

Sochacki, Kyle R; Jack, Robert A; Hirase, Takashi; McCulloch, Patrick C; Lintner, David M; Liberman, Shari R; Harris, Joshua D

2017-12-01

The purpose of this investigation was to determine whether arthroscopic debridement of primary elbow osteoarthritis results in statistically significant and clinically relevant improvement in (1) elbow range of motion and (2) clinical outcomes with (3) low complication and reoperation rates. A systematic review was registered with PROSPERO and performed using PRISMA guidelines. Databases were searched for studies that investigated the outcomes of arthroscopic debridement for the treatment of primary osteoarthritis of the elbow in adult human patients. Study methodological quality was analyzed. Studies that included post-traumatic arthritis were excluded. Elbow motion and all elbow-specific patient-reported outcome scores were eligible for analysis. Comparisons between preoperative and postoperative values from each study were made using 2-sample Z-tests (http://in-silico.net/tools/statistics/ztest) using a P value < .05. Nine articles (209 subjects, 213 elbows, 187 males, 22 females, mean age 45.7 ± 7.1 years, mean follow-up 41.7 ± 16.3. months; 75% right, 25% left; 79% dominant elbow, 21% nondominant) were analyzed. Elbow extension (23.4°-10.7°, Δ 12.7°), flexion (115.9°-128.7°, Δ 12.8°), and global arc of motion (94.5°-117.6°, Δ 23.1°) had statistically significant and clinically relevant improvement following arthroscopic debridement (P < .0001 for all). There was also a statistically significant (P < .0001) and clinically relevant improvement in the Mayo Elbow Performance Score (60.7-84.6, Δ 23.9) postoperatively. Six patients (2.8%) had postoperative complications. Nine (4.2%) underwent reoperation. Elbow arthroscopic debridement for primary degenerative osteoarthritis results in statistically significant and clinically relevant improvement in elbow range of motion and clinical outcomes with low complication and reoperation rates. Systematic review of level IV studies. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

International practice settings, interventions and outcomes of nurse practitioners in geriatric care: A scoping review.

PubMed

Chavez, Krista S; Dwyer, Andrew A; Ramelet, Anne-Sylvie

2018-02-01

To identify and summarize the common clinical settings, interventions, and outcomes of nurse practitioner care specific to older people. Scoping review of the international published and grey literature. A structured literature search was conducted of CINAHL, EMBASE, MEDLINE, Google Scholar, and Cochrane Collaboration and Joanna Briggs Institute databases. Following the Arksey and O'Malley framework, randomized controlled and quasi-experimental studies of Masters-prepared nurse practitioners providing care for patients over 65 years were included. Studies were reviewed independently by two investigators. Data were extracted, collated by setting, summarized in tables and synthesized for analysis. In total, 56 primary research studies from four countries and 23 systematic reviews were identified. Primary studies were conducted in primary care (n=13), home care (n=14), long-term care (n=10), acute/hospital care (n=9), and transitional care (n=10). Nurse practitioner interventions included substitutive as well as a supplementation NP role elements to meet specific unmet patient care needs. Studies examined six main outcome measures: service utilization (n=41), cost (n=24), length of stay (n=14), health indices (n=44), satisfaction (n=14) and quality of life (n=7). Cumulatively, nurse practitioners demonstrated enhanced results in 83/144 (58%) of outcomes compared to physician-only or usual care. The most commonly measured financial-related outcome was service utilization (n=41) and benefits were frequently reported in home care (8/9, 89%) and long-term care (7/10, 70%) settings. Among patient and care-related outcomes health indices were most frequently measured (n=44). Primary care most frequently reported improved health indices (11/13, 85%). Transitional care reported improved outcomes across all measures, except for service utilization. This review demonstrates improved or non-inferiority results of nurse practitioner care in older people across settings. More well-designed, rigorous studies are needed particularly in relation to costs. The results of this review could be used for future systemic review of effectiveness of NP care specific to older people. Despite the demonstrated NP role value, barriers to implementing the nurse practitioner role persist internationally and more work is needed to develop and promote these roles. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Differences in clinical characteristics between patients assessed for NHS specialist psychotherapy and primary care counselling.

PubMed

Chiesa, Marco; Fonagy, Peter; Bateman, Anthony W

2007-12-01

Although several studies have described patient populations in primary care counselling settings and NHS (National Health Service) specialist psychotherapy settings, there is a paucity of studies specifically comparing differences in clinical characteristics between the two groups of patients. The aim of this study is to ascertain if specialist psychotherapy referrals represent a more challenging client group than primary care counselling patients. We compare the socio-demographic features and severity of presentation in the symptomatic, interpersonal problems and global adjustment dimensions of a sample of patients (N=384) assessed by a primary care counselling service located in North London and a sample of patients (N=853) assessed in eight NHS psychotherapy centres located within urban settings in England. Both the groups completed the Brief Symptom Inventory, the Inventory of Interpersonal Problems and Clinical Outcomes in Routine Evaluation Outcome Measure. Patients referred for specialist psychotherapy services were more dysfunctional than those referred for primary care counselling. The linear function constructed to discriminate the groups showed that a combination of more psychotic symptoms, social inhibitions and higher risk of self-harm effectively identified those referred to psychotherapy services, while patients exhibiting greater levels of somatic and anxiety symptoms and non-assertiveness were more likely to be seen in primary care settings. However, similarities between the two samples were also marked, as shown by the overlap in the distribution of clinical outcomes in routine evaluation clinical scores in the two samples. The findings are discussed in terms of their implications for policy and service delivery of these two types of psychological therapy services.

Do project management and network governance contribute to inter-organisational collaboration in primary care? A mixed methods study.

PubMed

Schepman, Sanneke; Valentijn, Pim; Bruijnzeels, Marc; Maaijen, Marlies; de Bakker, Dinny; Batenburg, Ronald; de Bont, Antoinette

2018-06-07

The need for organisational development in primary care has increased as it is accepted as a means of curbing rising costs and responding to demographic transitions. It is only within such inter-organisational networks that small-scale practices can offer treatment to complex patients and continuity of care. The aim of this paper is to explore, through the experience of professionals and patients, whether, and how, project management and network governance can improve the outcomes of projects which promote inter-organisational collaboration in primary care. This paper describes a study of projects aimed at improving inter-organisational collaboration in Dutch primary care. The projects' success in project management and network governance was monitored by interviewing project leaders and board members on the one hand, and improvement in the collaboration by surveying professionals and patients on the other. Both qualitative and quantitative methods were applied to assess the projects. These were analysed, finally, using multi-level models in order to account for the variation in the projects, professionals and patients. Successful network governance was associated positively with the professionals' satisfaction with the collaboration; but not with improvements in the quality of care as experienced by patients. Neither patients nor professionals perceived successful project management as associated with the outcomes of the collaboration projects. This study shows that network governance in particular makes a difference to the outcomes of inter-organisational collaboration in primary care. However, project management is not a predictor for successful inter-organisational collaboration in primary care.

Outcome of prosthesis matched and unmatched patella components in primary and revision total knee replacement.

PubMed

Lewis, Peter L; Gamboa, Ai E; Campbell, David G; Lorimer, Michelle

2017-10-01

Although knee replacements have specifically designed patella prostheses that correspond to the geometry of their femoral components, a patella prosthesis that is unmatched to the femoral component may occasionally be inserted. In revision total knee arthroplasty (TKA), an originally resurfaced patella may be left, but the femoral component revised to one that does not match the patella. Few studies have compared the outcome of matched and unmatched patella components in TKA. This study compared the primary or revision TKA outcome of procedures where patella components matched to their femoral counterparts were inserted, with procedures using patella and femoral components that were unmatched. Data on all primary and revision TKA procedures without a patella component or a matched or an unmatched patella component were obtained from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Revision surgery was the outcome measure. Cumulative percent revised (CPR) were calculated and Hazard ratios with p values were used to test statistical significance. In primary TKA, there were higher rates of revision where unmatched patella components were used, regardless of implant design. There was no difference in the second revision rates of unmatched versus matched patella component groups. This was evident where delayed resurfacing was carried out, and where the patella prosthesis was left alone but the femoral component was changed. All primary TKA procedures require a patella component corresponding to the femoral component if the patella is resurfaced. Conversely, revision knee arthroplasties are not affected by the use of dissimilar patella and femoral components. Copyright © 2017 Elsevier B.V. All rights reserved.

Octanoic acid in alcohol-responsive essential tremor

PubMed Central

McCrossin, Gayle; Lungu, Codrin; Considine, Elaine; Toro, Camilo; Nahab, Fatta B.; Auh, Sungyoung; Buchwald, Peter; Grimes, George J.; Starling, Judith; Potti, Gopal; Scheider, Linda; Kalowitz, Daniel; Bowen, Daniel; Carnie, Andrea; Hallett, Mark

2013-01-01

Objective: To assess safety and efficacy of an oral, single, low dose of octanoic acid (OA) in subjects with alcohol-responsive essential tremor (ET). Methods: We conducted a double-blind, placebo-controlled, crossover, phase I/II clinical trial evaluating the effect of 4 mg/kg OA in 19 subjects with ET. The primary outcome was accelerometric postural tremor power of the dominant hand 80 minutes after administration. Secondary outcomes included digital spiral analysis, pharmacokinetic sampling, as well as safety measures. Results: OA was safe and well tolerated. Nonserious adverse events were mild (Common Terminology Criteria for Adverse Events grade 1) and equally present after OA and placebo. At the primary outcome, OA effects were not different from placebo. Secondary outcome analyses of digital spiral analysis, comparison across the entire time course in weighted and nonweighted accelerometry, as well as nondominant hand tremor power did not show a benefit of OA over placebo. The analysis of individual time points showed that OA improved tremor at 300 minutes (dominant hand, F1,16 = 5.49, p = 0.032 vs placebo), with a maximum benefit at 180 minutes after OA (both hands, F1,16 = 6.1, p = 0.025). Conclusions: Although the effects of OA and placebo at the primary outcome were not different, secondary outcome measures suggest superiority of OA in reducing tremor at later time points, warranting further trials at higher dose levels. Classification of evidence: This study provides Class I evidence that a single 4-mg/kg dose of OA is not effective in reducing postural tremor in patients with ET at a primary outcome of 80 minutes, but is effective for a secondary outcome after 180 minutes. PMID:23408867

Shoulder dystocia in primary midwifery care in the Netherlands.

PubMed

Kallianidis, Athanasios F; Smit, Marrit; Van Roosmalen, Jos

2016-02-01

In the Netherlands, low-risk pregnancies are managed by midwives in primary care. Despite strict definitions of low risk, obstetric complications can occur. Midwives seldom encounter uncommon labour complications, but are sufficiently trained to manage these. We assessed neonatal and maternal outcome after management of shoulder dystocia in primary midwifery care. In this 2-year prospective cohort study from April 2008 to April 2010, primary-care midwives, who participated in an obstetric emergency course, reported all obstetric complications. Main outcome was neonatal and maternal outcome. In sixty-four cases of shoulder dystocia McRoberts was the first maneuver in 42/64 (65.6%) cases with a success rate of 23.8%. All-fours maneuver was most frequently used as the second maneuver (24/45; 53.3%). No neonatal mortality occurred, none of the infants suffered from hypoxic ischemic injury, two (3.1%) had transient brachial plexus injuries, two (3.1%) had fractured clavicles and one (1.6%) had a fractured humerus. Eight (12.5%) neonates were successfully resuscitated because of birth asphyxia. All infants fully recovered. In neonates with immediate adverse outcome significantly more maneuvers were used compared with those without adverse neonatal outcome (p = 0.02). Postpartum hemorrhage occurred in 2/64 (3.1%) women, deep vaginal lacerations in 2/64 (3.1%), perineal tears in 23/64 (35.9%). No anal sphincter injuries occurred. McRoberts and all-fours maneuvers are widely used by primary-care midwives in the management of shoulder dystocia. Low rates of adverse neonatal and maternal outcomes were observed in cases of shoulder dystocia up to 6 weeks postpartum. © 2015 Nordic Federation of Societies of Obstetrics and Gynecology.

Effect of renal function status on the prognostic value of heart rate in acute ischemic stroke patients.

PubMed

Zhu, Zhengbao; Zhong, Chongke; Xu, Tian; Wang, Aili; Peng, Yanbo; Xu, Tan; Peng, Hao; Chen, Chung-Shiuan; Wang, Jinchao; Ju, Zhong; Li, Qunwei; Geng, Deqin; Sun, Yingxian; Du, Qingjuan; Li, Yongqiu; Chen, Jing; Zhang, Yonghong; He, Jiang

2017-08-01

The association between heart rate and prognosis of ischemic stroke remains debatable, and whether renal function status influences the relationship between them is still not elucidated. A total of 3923 ischemic stroke patients were included in this prospective multicenter study from the China Antihypertensive Trial in Acute Ischemic Stroke (CATIS). The primary outcome was a combination of death and major disability (modified Rankin Scale score ≥3) at 3 months after stroke. Secondary outcomes were, separately, death and major disability. The association between heart rate tertiles and primary outcome was appreciably modified by renal function status (p interaction  = 0.037). After multivariate adjustment, high heart rate was associated with increased risk of primary outcome in patients with abnormal renal function (odds ratio, 1.61; 95% confidence interval, 1.02-2.54; p trend  = 0.039) but not in patients with normal renal function (odds ratio, 0.96; 95% confidence interval, 0.75-1.23; p trend  = 0.741), when two extreme tertiles were compared. Each 10 bpm increase of heart rate was associated with 21% (95% CI: 1%-44%) increased risk of primary outcome, and a linear association between heart rate and risk of primary outcome was observed among patients with abnormal renal function (p for linearity = 0.002). High heart rate may be merely a strong predictor of poor prognosis in acute ischemic stroke patients with abnormal renal function, suggesting that heart rate reduction should be applied to ischemic stroke patients with abnormal renal function to improve their prognosis. Copyright © 2017 Elsevier B.V. All rights reserved.

Patient or treatment centre? Where are efforts invested to improve cancer patients' psychosocial outcomes?

PubMed Central

Carey, ML; Clinton-McHarg, T; Sanson-Fisher, RW; Campbell, S; Douglas, HE

2011-01-01

The psychosocial outcomes of cancer patients may be influenced by individual-level, social and treatment centre predictors. This paper aimed to examine the extent to which individual, social and treatment centre variables have been examined as predictors or targets of intervention for psychosocial outcomes of cancer patients. Medline was searched to find studies in which the psychological outcomes of cancer patient were primary variables. Papers published in English between 1999 and 2009 that reported primary data relevant to psychosocial outcomes for cancer patients were included, with 20% randomly selected for further coding. Descriptive studies were coded for inclusion of individual, social or treatment centre variables. Intervention studies were coded to determine if the unit of intervention was the individual patient, social unit or treatment centre. After random sampling, 412 publications meeting the inclusion criteria were identified, 169 were descriptive and 243 interventions. Of the descriptive papers 95.0% included individual predictors, and 5.0% social predictors. None of the descriptive papers examined treatment centre variables as predictors of psychosocial outcomes. Similarly, none of the interventions evaluated the effectiveness of treatment centre interventions for improving psychosocial outcomes. Potential reasons for the overwhelming dominance of individual predictors and individual-focused interventions in psychosocial literature are discussed. PMID:20646035

Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study.

PubMed

Wareham, K J; Hyde, R M; Grindlay, D; Brennan, M L; Dean, R S

2017-10-04

Randomised controlled trials (RCTs) are a key component of the veterinary evidence base. Sample sizes and defined outcome measures are crucial components of RCTs. To describe the sample size and number of outcome measures of veterinary RCTs either funded by the pharmaceutical industry or not, published in 2011. A structured search of PubMed identified RCTs examining the efficacy of pharmaceutical interventions. Number of outcome measures, number of animals enrolled per trial, whether a primary outcome was identified, and the presence of a sample size calculation were extracted from the RCTs. The source of funding was identified for each trial and groups compared on the above parameters. Literature searches returned 972 papers; 86 papers comprising 126 individual trials were analysed. The median number of outcomes per trial was 5.0; there were no significant differences across funding groups (p = 0.133). The median number of animals enrolled per trial was 30.0; this was similar across funding groups (p = 0.302). A primary outcome was identified in 40.5% of trials and was significantly more likely to be stated in trials funded by a pharmaceutical company. A very low percentage of trials reported a sample size calculation (14.3%). Failure to report primary outcomes, justify sample sizes and the reporting of multiple outcome measures was a common feature in all of the clinical trials examined in this study. It is possible some of these factors may be affected by the source of funding of the studies, but the influence of funding needs to be explored with a larger number of trials. Some veterinary RCTs provide a weak evidence base and targeted strategies are required to improve the quality of veterinary RCTs to ensure there is reliable evidence on which to base clinical decisions.

Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design.

PubMed

Cho, Alex H; Killeya-Jones, Ley A; O'Daniel, Julianne M; Kawamoto, Kensaku; Gallagher, Patrick; Haga, Susanne; Lucas, Joseph E; Trujillo, Gloria M; Joy, Scott V; Ginsburg, Geoffrey S

2012-01-18

Type 2 diabetes is a prevalent chronic condition globally that results in extensive morbidity, decreased quality of life, and increased health services utilization. Lifestyle changes can prevent the development of diabetes, but require patient engagement. Genetic risk testing might represent a new tool to increase patients' motivation for lifestyle changes. Here we describe the rationale, development, and design of a randomized controlled trial (RCT) assessing the clinical and personal utility of incorporating type 2 diabetes genetic risk testing into comprehensive diabetes risk assessments performed in a primary care setting. Patients are recruited in the laboratory waiting areas of two primary care clinics and enrolled into one of three study arms. Those interested in genetic risk testing are randomized to receive either a standard risk assessment (SRA) for type 2 diabetes incorporating conventional risk factors plus upfront disclosure of the results of genetic risk testing ("SRA+G" arm), or the SRA alone ("SRA" arm). Participants not interested in genetic risk testing will not receive the test, but will receive SRA (forming a third, "no-test" arm). Risk counseling is provided by clinic staff (not study staff external to the clinic). Fasting plasma glucose, insulin levels, body mass index (BMI), and waist circumference are measured at baseline and 12 months, as are patients' self-reported behavioral and emotional responses to diabetes risk information. Primary outcomes are changes in insulin resistance and BMI after 12 months; secondary outcomes include changes in diet patterns, physical activity, waist circumference, and perceived risk of developing diabetes. The utility, feasibility, and efficacy of providing patients with genetic risk information for common chronic diseases in primary care remain unknown. The study described here will help to establish whether providing type 2 diabetes genetic risk information in a primary care setting can help improve patients' clinical outcomes, risk perceptions, and/or their engagement in healthy behavior change. In addition, study design features such as the use of existing clinic personnel for risk counseling could inform the future development and implementation of care models for the use of individual genetic risk information in primary care. ClinicalTrials.gov: NCT00849563.

Behavior modification techniques used to prevent gestational diabetes: a systematic review of the literature.

PubMed

Skouteris, Helen; Morris, Heather; Nagle, Cate; Nankervis, Alison

2014-04-01

The prevalence of gestational diabetes mellitus (GDM) and obesity is increasing in developed countries, presenting significant challenges to acute care and public health. The aim of this study is to systematically review published controlled trials evaluating behavior modification interventions to prevent the development of GDM. Nine studies were identified involving such techniques as repetition of information, use of verbal and written educational information, goal setting, and planning, in addition to group and individual counseling sessions. Of the 3 trials with GDM incidence as a primary outcome, only 1 showed a significant reduction. GDM was a secondary outcome in 6 studies where the prevention of excessive gestational weight gain was the primary outcome and only 1 trial study determined an effective intervention. The small number of effective interventions highlights a significant gap in evidence to inform maternity health policy and practice.

Heart failure and the discrepancy between trials of intensive blood pressure management: an analysis of individual patient data.

PubMed

Aggarwal, Rahul; Mirzan, Haares; Chiu, Nicholas; Steinkamp, Jackson

2018-02-26

ACCORD and SPRINT are the best randomized controlled trial data evaluating the effects of blood pressure targets below 140 mmHg. These trials had contradictory results regarding the benefits of intensive antihypertensive therapy. We investigate if this discordance was driven by SPRINT's inclusion of Heart Failure in its primary outcome, as this is a parameter not included in ACCORD's original primary outcome. This analysis helps to resolve a significant area of contention. Individual patient data from 4733 participants in ACCORD were analyzed from time of randomization. All participants were diabetic and at increased cardiovascular risk. Participants were assigned to their original intervention, a standard blood pressure target of less than 140 mmHg or an intensive target of less than 120 mmHg. Primary composite outcome was defined as in SPRINT: a composite of first occurrence of myocardial infarction, stroke, heart failure, death from cardiovascular causes, and other acute coronary syndromes. Primary outcome was not significantly different between standard and intensive groups [HR: 0.89; 95% CI: (0.76-1.03); p = 0.108]. The primary composite outcome occurred in 370 participants in the standard group (15.6%) and 324 participants in the intensive group (13.7%), with an event rate of 3.38% per year for the standard group and 3.01% per year for the intensive group. Differing results between ACCORD and SPRINT are not attributable to ACCORD's exclusion of Heart Failure from its original primary outcome measurement. No significant differences in primary outcome were observed between intensive and standard blood pressure groups in the ACCORD patients under the SPRINT primary outcome definition. Caution should be taken in extrapolating the intensive blood pressure control benefits of SPRINT to the diabetic population.

Measures of quality, costs and equity in primary health care instruments developed to analyse and compare primary care in 35 countries.

PubMed

Schäfer, Willemijn L A; Boerma, Wienke G W; Kringos, Dionne S; De Ryck, Evelyne; Greß, Stefan; Heinemann, Stephanie; Murante, Anna Maria; Rotar-Pavlic, Danica; Schellevis, François G; Seghieri, Chiara; Van den Berg, Michael J; Westert, Gert P; Willems, Sara; Groenewegen, Peter P

2013-01-01

The Quality and Costs of Primary Care in Europe (QUALICOPC) study aims to analyse and compare how primary health care systems in 35 countries perform in terms of quality, costs and equity. This article answers the question 'How can the organisation and delivery of primary health care and its outcomes be measured through surveys of general practitioners (GPs) and patients?' It will also deal with the process of pooling questions and the subsequent development and application of exclusion criteria to arrive at a set of appropriate questions for a broad international comparative study. The development of the questionnaires consisted of four phases: a search for existing validated questionnaires, the classification and selection of relevant questions, shortening of the questionnaires in three consensus rounds and the pilot survey. Consensus was reached on the basis of exclusion criteria (e.g. the applicability for international comparison). Based on the pilot survey, comprehensibility increased and the number of questions was further restricted, as the questionnaires were too long. Four questionnaires were developed: one for GPs, one for patients about their experiences with their GP, another for patients about what they consider important, and a practice questionnaire. The GP questionnaire mainly focused on the structural aspects (e.g. economic conditions) and care processes (e.g. comprehensiveness of services of primary care). The patient experiences questionnaire focused on the care processes and outcomes (e.g. how do patients experience access to care?). The questionnaire about what patients consider important was complementary to the experiences questionnaire, as it enabled weighing the answers from the latter. Finally, the practice questionnaire included questions on practice characteristics. The QUALICOPC researchers have developed four questionnaires to characterise the organisation and delivery of primary health care and to compare and analyse the outcomes. Data collected with these instruments will allow us not only to show in detail the variation in process and outcomes of primary health care, but also to explain the differences from features of the (primary) health care system.

Does preoperative mental health affect length of hospital stay and functional outcomes following arthroplasty surgery? A registry-based cohort study.

PubMed

Singleton, Neal; Poutawera, Vaughan

2017-01-01

It has been reported in the literature that patients with poor preoperative mental health are more likely to have worse functional outcomes following primary total hip and knee arthroplasty. We could find no studies investigating whether preoperative mental health also affects length of hospital stay following surgery. The aim of this study was to determine whether preoperative mental health affects length of hospital stay and long-term functional outcomes following primary total hip and knee arthroplasty. We also aimed to determine whether mental health scores improve after arthroplasty surgery and, finally, we looked specifically at a subgroup of patients with diagnosed mental illness to determine whether this affects length of hospital stay and functional outcomes after surgery. Through a review of prospectively collected regional joint registry data, we compared preoperative mental health scores (SF-12 MH) with length of hospital stay and post-operative (1 and 5 years) functional outcome scores (Oxford and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)) in 2279 primary total hip and knee arthroplasty surgeries performed in the Bay of Plenty District Health Board between 2006 and 2010. Based on Pearson product-moment correlation coefficients, there was a significant correlation between preoperative mental health scores and post-operative Oxford scores at 1 year as well as post-operative WOMAC scores at both 1 and 5 years. There was no significant correlation between preoperative mental health and length of hospital stay. Mental health scores improved significantly after arthroplasty surgery. Those patients with a formally diagnosed mental illness had significantly worse preoperative mental health and function scores. Following surgery, they had longer hospital stays although their improvement in function was not significantly different to those without mental illness. The results of this study support reports in the literature that there is a correlation between preoperative mental health and long-term functional outcomes following primary total hip and knee arthroplasty. Patients with poor preoperative mental health are more likely to have worse functional outcomes at 1 and 5 years following surgery. No correlation between preoperative mental health and length of hospital stay was identified. Mental health scores improved significantly after surgery. Patients with mental illness had longer hospital stays and despite worse preoperative mental health and function had equal improvements in functional outcomes.

Teaching approaches and strategies that promote healthy eating in primary school children: a systematic review and meta-analysis.

PubMed

Dudley, Dean A; Cotton, Wayne G; Peralta, Louisa R

2015-02-25

Healthy eating by primary school-aged children is important for good health and development. Schools can play an important role in the education and promotion of healthy eating among children. The aim of this review was to: 1) perform a systematic review of randomised controlled, quasi-experimental and cluster controlled trials examining the school-based teaching interventions that improve the eating habits of primary school children; and 2) perform a meta-analysis to determine the effect of those interventions. The systematic review was limited to four healthy eating outcomes: reduced food consumption or energy intake; increased fruit and vegetable consumption or preference; reduced sugar consumption or preference (not from whole fruit); increased nutritional knowledge. In March 2014, we searched seven electronic databases using predefined keywords for intervention studies that were conducted in primary schools which focused on the four healthy eating outcomes. Targeted internet searching using Google Scholar was also used. In excess of 200,000 possible citations were identified. Abstracts and full text of articles of potentially relevant papers were screened to determine eligibility. Data pertaining to teaching strategies that reported on healthy eating outcomes for primary school children was extracted from the 49 eligible papers. Experiential learning strategies were associated with the largest effects across the reduced food consumption or energy intake; increased fruit and vegetable consumption or preference; and increased nutritional knowledge outcomes. Reducing sugar consumption and preference was most influenced by cross-curricular approaches embedded in the interventions. As with most educational interventions, most of the teaching strategies extracted from the intervention studies led to positive changes in primary school children's healthy eating behaviours. However, given the finite resources, increased overcrowding of school curriculum and capacity of teachers in primary schools, a meta-analysis of this scope is able to provide stakeholders with the best evidence of where these resources should be focused.

Short- and long-term outcomes of 1000 adult lung transplant recipients at a single center.

PubMed

Kreisel, Daniel; Krupnick, Alexander S; Puri, Varun; Guthrie, Tracey J; Trulock, Elbert P; Meyers, Bryan F; Patterson, G Alexander

2011-01-01

Lung transplantation has become accepted therapy for end-stage pulmonary disease. The objective of this study was to review a single-institution experience of adult lung transplants. We reviewed 1000 adult lung transplants that were performed at Washington University between July 1988 and January 2009. Transplants were performed for emphysema (52%), cystic fibrosis (18.2%), pulmonary fibrosis (16.1%), and pulmonary vascular disease (7.2%). Overall recipient age was 48 ± 13 years with an increase from 43 ± 12 years (July 1988-November 1993) to 50 ± 14 years (June 2005-January 2009). Overall incidence of primary graft dysfunction was 22.1%. Hospital mortality was higher for patients who had primary graft dysfunction (primary graft dysfunction, 13.6%; no primary graft dysfunction, 4%; P < .001). Freedom from bronchiolitis obliterans syndrome was 84% at 1 year, 38.2% at 5 years, and 12.2% at 10 years. Survival at 1, 5, 10, and 15 years was 84%, 56.4%, 32.2%, and 17.8%, respectively. Five-year survival improved from 49.6% (July 1988-November 1993) to 62.1% (October 2001-June 2005). Primary graft dysfunction was associated with lower survival at 1, 5, and 10 years (primary graft dysfunction: 72.8%, 43.9%, and 18.7%, respectively; no primary graft dysfunction: 87.1%, 59.8%, and 35.7%, respectively, P < .001) and lower rates of freedom from bronchiolitis obliterans syndrome (primary graft dysfunction: 78%, 27.5%, and 8.5%, respectively; no primary graft dysfunction: 85.4%, 40.7%, and 13.1%, respectively, P = .007). Five-year survival has improved over the study period, but long-term outcomes are limited by bronchiolitis obliterans syndrome. Primary graft dysfunction is associated with higher rates of bronchiolitis obliterans syndrome and impaired short- and long-term survival. A better understanding of primary graft dysfunction and bronchiolitis obliterans syndrome is critical to improve outcomes. Copyright © 2011 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Blood product transfusion in emergency department patients: a case-control study of practice patterns and impact on outcome.

PubMed

Beyer, Alexander; Rees, Ryan; Palmer, Christopher; Wessman, Brian T; Fuller, Brian M

2017-12-01

Blood product transfusion occurs in a significant percentage of intensive care unit (ICU) patients. Pulmonary complications, such as acute respiratory distress syndrome (ARDS), occurring in the setting of transfusion, are associated with increased morbidity and mortality. Contrary to the ICU setting, there is little evidence describing the epidemiology of transfusion in the emergency department (ED) or its potential impact on outcome. The objectives of this study were to: (1) characterize transfusion practices in the ED with respect to patient characteristics and pre-transfusion laboratory values; and (2) investigate the effect of ED blood product transfusion on the incidence of pulmonary complications after admission. We hypothesized that blood product transfusion would increase the event rate for pulmonary complications, and have a negative impact on other clinically significant outcomes. This was a retrospective case-control study with one-one matching of 204 transfused ED patients to 204 non-transfused controls. The primary outcome was a composite pulmonary outcome that included: acute respiratory failure, new need for ICU admission, and ARDS. Multivariable logistic regression was used to evaluate the primary outcome as a function of transfusion. One-hundred twenty four (60.8%) patients were transfused packed red blood cells (PRBC) in the ED. The mean pre-transfusion hemoglobin level was 8.5 g/dl. There were 73 patients with a hemoglobin value ≥10 g/dl; 19 (26.0%) received a PRBC transfusion. A total of 54 (26.5%) patients were transfused platelets. The main indications were thrombocytopenia (27.8%) and neurologic injury (24.1%). Ten patients had a platelet level <10,000 (guideline recommended threshold for transfusion to prevent spontaneous hemorrhage). The mean platelet count for neurologic injury patients was 197,000 prior to transfusion. The primary outcome occurred in 26 control patients (12.7%), as compared with 28 cases (13.7%). In multivariable logistic regression analysis, ED transfusion was not associated with an increased odds of primary outcome [adjusted OR 0.91 (0.48-1.72), P = 0.77]. The mortality rate was 10.8% in the cases and 8.8% in the controls, P = 0.51. A significant percentage of ED blood product transfusions are discordant with guideline recommendations. However, there was no association with ED transfusion and worse clinical outcome.

Making the transition from video-assisted thoracoscopic surgery to chest tube with fibrinolytics for empyema in children: Any change in outcomes?

PubMed Central

Livingston, Michael H.; Colozza, Sara; Vogt, Kelly N.; Merritt, Neil; Bütter, Andreana

2016-01-01

Background There is ongoing variation in the use of video-assisted thoracoscopic surgery (VATS) and chest tube with fibrinolytics (CTWF) for empyema in children. Our objective was to report outcomes from a centre that recently made the transition from VATS to CTWF as the primary treatment modality. Methods We conducted a historical cohort study of children with empyema treated with either primary VATS (between 2005 and 2009) or CTWF (between 2009 and 2013). Results Sixty-seven children underwent pleural drainage for empyema during the study period: 28 (42%) were treated with primary VATS, and 39 (58%) underwent CTWF. There were no significant differences between the VATS and CTWF groups for length of stay (8 v. 9 d, p = 0.61) or need for additional procedures (4% v. 13%, p = 0.19). Length of stay varied widely for both VATS (4–53 d) and CTWF (5–46 d). Primary VATS failed in 1 (4%) patient, who required an additional chest tube, and CTWF failed in 5 (13%) patients. Additional procedures included 3 rescue VATS, 2 additional chest tubes and 1 thoracotomy. All patients recovered and were discharged home. Conclusion Primary VATS and CTWF were associated with similar outcomes in children with empyema. There appears to be a subset of children at risk for treatment failure with CTWF. Further research is needed to determine if these patients would benefit from primary VATS. PMID:26999475

A Comparative Study of Strategic HRD Approaches for Workforce Planning in the Tourism Industry

ERIC Educational Resources Information Center

Bartlett, Kenneth; Johnson, Karen; Schneider, Ingrid E.

2006-01-01

This study compares the outcomes of two often used approaches for strategic HRD planning. Using methods framed within a strategic HRD planning framework the outcomes of a qualitative primary data approach are examined against quantitative labor market projections in a study of the future Minnesota tourism workforce. Results show each planning…

The Development of Vocational Calling, Identity, and Faith in College Students: A Preliminary Study of the Impact of Study Abroad

ERIC Educational Resources Information Center

Miller-Perrin, Cindy; Thompson, Don

2010-01-01

Living and learning in another country, primary conditions of the study abroad experience, are commonly associated with two fundamental outcomes. The first outcome is an increase in "external" connections, manifested through an increased ability to converse in another language and an increased understanding and sensitivity to another…

Predictors of treatment outcome in an effectiveness trial of cognitive behavioral therapy for children with anxiety disorders.

PubMed

Wergeland, Gro Janne H; Fjermestad, Krister W; Marin, Carla E; Bjelland, Ingvar; Haugland, Bente Storm Mowatt; Silverman, Wendy K; Öst, Lars-Göran; Bjaastad, Jon Fauskanger; Oeding, Kristin; Havik, Odd E; Heiervang, Einar R

2016-01-01

A substantial number of children with anxiety disorders do not improve following cognitive behavioral therapy (CBT). Recent effectiveness studies have found poorer outcome for CBT programs than what is typically found in efficacy studies. The present study examined predictors of treatment outcome among 181 children (aged 8-15 years), with separation anxiety, social phobia, or generalized anxiety disorder, who participated in a randomized, controlled effectiveness trial of a 10-session CBT program in community clinics. Potential predictors included baseline demographic, child, and parent factors. Outcomes were as follows: a) remission from all inclusion anxiety disorders; b) remission from the primary anxiety disorder; and c) child- and parent-rated reduction of anxiety symptoms at post-treatment and at 1-year follow-up. The most consistent findings across outcome measures and informants were that child-rated anxiety symptoms, functional impairment, a primary diagnosis of social phobia or separation anxiety disorder, and parent internalizing symptoms predicted poorer outcome at post-treatment. Child-rated anxiety symptoms, lower family social class, lower pretreatment child motivation, and parent internalizing symptoms predicted poorer outcome at 1-year follow-up. These results suggest that anxious children with more severe problems, and children of parents with elevated internalizing symptom levels, may be in need of modified, additional, or alternative interventions to achieve a positive treatment outcome. Copyright © 2015 Elsevier Ltd. All rights reserved.

Size and consistency of problem-solving consultation outcomes: an empirical analysis.

PubMed

Hurwitz, Jason T; Kratochwill, Thomas R; Serlin, Ronald C

2015-04-01

In this study, we analyzed extant data to evaluate the variability and magnitude of students' behavior change outcomes (academic, social, and behavioral) produced by consultants through problem-solving consultation with teachers. Research questions were twofold: (a) Do consultants produce consistent and sizeable positive student outcomes across their cases as measured through direct and frequent assessment? and (b) What proportion of variability in student outcomes is attributable to consultants? Analyses of extant data collected from problem-solving consultation outcome studies that used single-case, time-series AB designs with multiple participants were analyzed. Four such studies ultimately met the inclusion criteria for the extant data, comprising 124 consultants who worked with 302 school teachers regarding 453 individual students. Consultants constituted the independent variable, while the primary dependent variable was a descriptive effect size based on student behavior change as measured by (a) curriculum-based measures, (b) permanent products, or (c) direct observations. Primary analyses involved visual and statistical evaluation of effect size magnitude and variability observed within and between consultants and studies. Given the nested nature of the data, multilevel analyses were used to assess consultant effects on student outcomes. Results suggest that consultants consistently produced positive effect sizes on average across their cases, but outcomes varied between consultants. Findings also indicated that consultants, teachers, and the corresponding studies accounted for a significant proportion of variability in student outcomes. This investigation advances the use of multilevel and integrative data analyses to evaluate consultation outcomes and extends research on problem-solving consultation, consultant effects, and meta-analysis of case study AB designs. Practical implications for evaluating consultation service delivery in school settings are also discussed. Copyright © 2015 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.

Reduced Stress in Medical Education: An Outcome of Altered Learning Environment.

ERIC Educational Resources Information Center

Moore-West, Maggi; And Others

1983-01-01

An experimental curricular track (Primary Care Curriculum) was instituted at the University of New Mexico School of Medicine to educate more students to enter rural primary care and to better develop skills in life-long, self-motivated learning. A study comparing characteristics and results of the Primary Care Curriculum and of a conventional…

Long-term evidence for the effect of pay-for-performance in primary care on mortality in the UK: a population study.

PubMed

Ryan, Andrew M; Krinsky, Sam; Kontopantelis, Evangelos; Doran, Tim

2016-07-16

Introduced in 2004, the UK's Quality and Outcomes Framework (QOF) is the world's largest primary care pay-for-performance programme. We tested whether the QOF was associated with reduced population mortality. We used population-level mortality statistics between 1994 and 2010 for the UK and other high-income countries that were not exposed to pay-for-performance. The primary outcome was age-adjusted and sex-adjusted mortality per 100,000 people for a composite outcome of chronic disorders that were targeted by the QOF. Secondary outcomes were age-adjusted and sex-adjusted mortality for ischaemic heart disease, cancer, and a composite of all non-targeted conditions. For each study outcome, we created a so-called synthetic UK as a weighted combination of comparison countries. We then estimated difference-in-differences models to test whether mortality fell more in the UK than in the synthetic UK after the QOF. Introduction of the QOF was not significantly associated with changes in population mortality for the composite outcome (-3.68 per 100,000 population [95% CI -8.16 to 0.80]; p=0.107), ischaemic heart disease (-2.21 per 100,000 [-6.86 to 2.44]; p=0.357), cancer (0.28 per 100,000 [-0.99 to 1.55]; p=0.679), or all non-targeted conditions (11.60 per 100,000 [-3.91 to 27.11]; p=0.143). Although we noted small mortality reductions for a composite outcome of targeted disorders, the QOF was not associated with significant changes in mortality. Our findings have implications for the probable effects of similar programmes on population health outcomes. The relation between incentives and mortality needs to be assessed in specific disease domains. None. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effectiveness of implementation interventions in improving physician adherence to guideline recommendations in heart failure: a systematic review

PubMed Central

Shanbhag, Deepti; Graham, Ian D; Harlos, Karen; Haynes, R. Brian; Gabizon, Itzhak; Connolly, Stuart J; Van Spall, Harriette Gillian Christine

2018-01-01

Background The uptake of guideline recommendations that improve heart failure (HF) outcomes remains suboptimal. We reviewed implementation interventions that improve physician adherence to these recommendations, and identified contextual factors associated with implementation success. Methods We searched databases from January 1990 to November 2017 for studies testing interventions to improve uptake of class I HF guidelines. We used the Cochrane Effective Practice and Organisation of Care and Process Redesign frameworks for data extraction. Primary outcomes included: proportion of eligible patients offered guideline-recommended pharmacotherapy, self-care education, left ventricular function assessment and/or intracardiac devices. We reported clinical outcomes when available. Results We included 38 studies. Provider-level interventions (n=13 studies) included audit and feedback, reminders and education. Organisation-level interventions (n=18) included medical records system changes, multidisciplinary teams, clinical pathways and continuity of care. System-level interventions (n=3) included provider/institutional incentives. Four studies assessed multi-level interventions. We could not perform meta-analyses due to statistical/conceptual heterogeneity. Thirty-two studies reported significant improvements in at least one primary outcome. Clinical pathways, multidisciplinary teams and multifaceted interventions were most consistently successful in increasing physician uptake of guidelines. Among randomised controlled trials (RCT) (n=10), pharmacist and nurse-led interventions improved target dose prescriptions. Eleven studies reported clinical outcomes; significant improvements were reported in three, including a clinical pathway, a multidisciplinary team and a multifaceted intervention. Baseline assessment of barriers, staff training, iterative intervention development, leadership commitment and policy/financial incentives were associated with intervention effectiveness. Most studies (n=20) had medium risk of bias; nine RCTs had low risk of bias. Conclusion Our study is limited by the quality and heterogeneity of the primary studies. Clinical pathways, multidisciplinary teams and multifaceted interventions appear to be most consistent in increasing guideline uptake. However, improvements in process outcomes were rarely accompanied by improvements in clinical outcomes. Our work highlights the need for improved research methodology to reliably assess the effectiveness of implementation interventions. PMID:29511005

Effectiveness of implementation interventions in improving physician adherence to guideline recommendations in heart failure: a systematic review.

PubMed

Shanbhag, Deepti; Graham, Ian D; Harlos, Karen; Haynes, R Brian; Gabizon, Itzhak; Connolly, Stuart J; Van Spall, Harriette Gillian Christine

2018-03-06

The uptake of guideline recommendations that improve heart failure (HF) outcomes remains suboptimal. We reviewed implementation interventions that improve physician adherence to these recommendations, and identified contextual factors associated with implementation success. We searched databases from January 1990 to November 2017 for studies testing interventions to improve uptake of class I HF guidelines. We used the Cochrane Effective Practice and Organisation of Care and Process Redesign frameworks for data extraction. Primary outcomes included: proportion of eligible patients offered guideline-recommended pharmacotherapy, self-care education, left ventricular function assessment and/or intracardiac devices. We reported clinical outcomes when available. We included 38 studies. Provider-level interventions (n=13 studies) included audit and feedback, reminders and education. Organisation-level interventions (n=18) included medical records system changes, multidisciplinary teams, clinical pathways and continuity of care. System-level interventions (n=3) included provider/institutional incentives. Four studies assessed multi-level interventions. We could not perform meta-analyses due to statistical/conceptual heterogeneity. Thirty-two studies reported significant improvements in at least one primary outcome. Clinical pathways, multidisciplinary teams and multifaceted interventions were most consistently successful in increasing physician uptake of guidelines. Among randomised controlled trials (RCT) (n=10), pharmacist and nurse-led interventions improved target dose prescriptions. Eleven studies reported clinical outcomes; significant improvements were reported in three, including a clinical pathway, a multidisciplinary team and a multifaceted intervention. Baseline assessment of barriers, staff training, iterative intervention development, leadership commitment and policy/financial incentives were associated with intervention effectiveness. Most studies (n=20) had medium risk of bias; nine RCTs had low risk of bias. Our study is limited by the quality and heterogeneity of the primary studies. Clinical pathways, multidisciplinary teams and multifaceted interventions appear to be most consistent in increasing guideline uptake. However, improvements in process outcomes were rarely accompanied by improvements in clinical outcomes. Our work highlights the need for improved research methodology to reliably assess the effectiveness of implementation interventions. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Shaping dental contract reform: a clinical and cost-effective analysis of incentive-driven commissioning for improved oral health in primary dental care.

PubMed

Hulme, C; Robinson, P G; Saloniki, E C; Vinall-Collier, K; Baxter, P D; Douglas, G; Gibson, B; Godson, J H; Meads, D; Pavitt, S H

2016-09-08

To evaluate the clinical and cost-effectiveness of a new blended dental contract incentivising improved oral health compared with a traditional dental contract based on units of dental activity (UDAs). Non-randomised controlled study. Six UK primary care dental practices, three working under a new blended dental contract; three matched practices under a traditional contract. 550 new adult patients. A new blended/incentive-driven primary care dentistry contract and service delivery model versus the traditional contract based on UDAs. Primary outcome was as follows: percentage of sites with gingival bleeding on probing. Secondary outcomes were as follows: extracted and filled teeth (%), caries (International Caries Detection and Assessment System (ICDAS)), oral health-related quality of life (Oral Health Impact Profile-14 (OHIP-14)). Incremental cost-effective ratios used OHIP-14 and quality adjusted life years (QALYs) derived from the EQ-5D-3L. At 24 months, 291/550 (53%) patients returned for final assessment; those lost to follow-up attended 6.46 appointments on average (SD 4.80). The primary outcome favoured patients in the blended contract group. Extractions and fillings were more frequent in this group. Blended contracts were financially attractive for the dental provider but carried a higher cost for the service commissioner. Differences in generic health-related quality of life were negligible. Positive changes over time in oral health-related quality of life in both groups were statistically significant. This is the first UK study to assess the clinical and cost-effectiveness of a blended contract in primary care dentistry. Although the primary outcome favoured the blended contract, the results are limited because 47% patients did not attend at 24 months. This is consistent with 39% of adults not being regular attenders and 27% only visiting their dentist when they have a problem. Promotion of appropriate attendance, especially among those with high need, necessitates being factored into recruitment strategies of future studies. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Comparison of survival in adult antiretroviral treatment naïve patients treated in primary health care centers versus those treated in hospitals: retrospective cohort study; Oromia region, Ethiopia.

PubMed

Megerso, Abebe; Garoma, Sileshi

2016-10-18

Antiretroviral treatment (ART) service scaling up has been practiced in the Ethiopia since 2006. Regardless of increasing number of primary health care centers providing the service, the existing hospitals are still overcrowded with ART service seeking patients may be because of the common belief that treatment outcome is better for hospital patients than those treated at the primary health centers. However, documented evidence comparing the treatment outcome for the two categories of health facilities is scarce in the study setting. The purpose of the current study was to compare major treatment outcomes among new patients treated at the two health facility categories. Retrospective cohort study was implemented using secondary data from medical records collected between October 2010 and January 2014 in the selected health facilities. All patients (1895) who started the treatment in the facilities during the period were included in the study. Univariate analyses were made using descriptive methods such as frequency distributions and measures of central tendency. Bivariate and multivariate analyses were made using Kaplan Meier and Cox regression models respectively to compare the mean survival time between the two facility categories. P-value less than 0.05 was considered as statistically significant. A total of 1895 patient records were followed for 27,990 person-months. Risks of unwanted treatment outcomes (death and lose-to-follow-up) were the same for both categories of patients. The median survival probability was similar to the facility categories (P-value = 0.11). Baseline performance scale III/IV (AHR, 2.4; 95 % CI: 2.0, 3.0), baseline WHO clinical stages III/IV (AHR, 2.8; 95 % CI: 2.3, 3.4), and low adherence (<95 %) to ART drugs (AHR, 3.4; 95 % CI: 2.8, 5.2) were the independent predictors of the unwanted treatment outcomes. Antiretroviral treatment service delivery at primary health care facilities did not compromise the treatment outcomes among adult ART naïve patients. This implies that, ART services decentralization can result in acceptable treatment outcome in less developed settings. Therefore, treatment requiring patients should be encouraged to start the treatment in either of the health facilities as early as possible.

The impact of poverty reduction and development interventions on non-communicable diseases and their behavioural risk factors in low and lower-middle income countries: A systematic review

PubMed Central

Pullar, Jessie; Allen, Luke; Townsend, Nick; Williams, Julianne; Foster, Charlie; Roberts, Nia; Rayner, Mike; Mikkelsen, Bente; Branca, Francesco

2018-01-01

Introduction Non-communicable diseases (NCDs) disproportionately affect low- and lower-middle income countries (LLMICs) where 80% of global NCD related deaths occur. LLMICs are the primary focus of interventions to address development and poverty indicators. We aimed to synthesise the evidence of these interventions' impact on the four primary NCDs (cardiovascular disease, diabetes, chronic respiratory disease and cancer) and their common behavioural risk factors (unhealthy diets, physical inactivity, tobacco and alcohol use). Methods We systematically searched four online databases (Medline, Embase, Web of Science and Global Health) for primary research conducted in LLMICS, published between January 1st 1990 and February 15th 2016. Studies involved development or poverty interventions which reported on outcomes relating to NCDs. We extracted summary level data on study design, population, health outcomes and potential confounders. Results From 6383 search results, 29 studies from 24 LLMICs published between 1999 and 2015 met our inclusion criteria. The quality of included studies was limited and heterogeneity of outcome measures required narrative synthesis. One study measured impact on NCD prevalence, one physical activity and 27 dietary components. The majority of papers (23), involved agricultural interventions. Primary outcome measures tended to focus on undernutrition. Intensive agricultural interventions were associated with improved calorie, vitamin, fruit and vegetable intake. However, positive impacts were reliant on participant's land ownership, infection status and limited in generalisability. Just three studies measured adult obesity; two indicated increased income and consequential food affordability had the potential to increase obesity. Overall, there was poor alignment between included studies outcome measures and the key policy options and objectives of the Global Action Plan on NCDs. Conclusions Though many interventions addressing poverty and development have great potential to impact on NCD prevalence and risk, most fail to measure or report these outcomes. Current evidence is limited to behavioural risk factors, namely diet and suggests a positive impact of agricultural-based food security programmes on dietary indicators. However, studies investigating the impact of improved income on obesity tend to show an increased risk. Embedding NCD impact evaluation into development programmes is crucial in the context of the Sustainable Development Goals and the rapid epidemiological transitions facing LLMICs. PMID:29474454

The impact of poverty reduction and development interventions on non-communicable diseases and their behavioural risk factors in low and lower-middle income countries: A systematic review.

PubMed

Pullar, Jessie; Allen, Luke; Townsend, Nick; Williams, Julianne; Foster, Charlie; Roberts, Nia; Rayner, Mike; Mikkelsen, Bente; Branca, Francesco; Wickramasinghe, Kremlin

2018-01-01

Non-communicable diseases (NCDs) disproportionately affect low- and lower-middle income countries (LLMICs) where 80% of global NCD related deaths occur. LLMICs are the primary focus of interventions to address development and poverty indicators. We aimed to synthesise the evidence of these interventions' impact on the four primary NCDs (cardiovascular disease, diabetes, chronic respiratory disease and cancer) and their common behavioural risk factors (unhealthy diets, physical inactivity, tobacco and alcohol use). We systematically searched four online databases (Medline, Embase, Web of Science and Global Health) for primary research conducted in LLMICS, published between January 1st 1990 and February 15th 2016. Studies involved development or poverty interventions which reported on outcomes relating to NCDs. We extracted summary level data on study design, population, health outcomes and potential confounders. From 6383 search results, 29 studies from 24 LLMICs published between 1999 and 2015 met our inclusion criteria. The quality of included studies was limited and heterogeneity of outcome measures required narrative synthesis. One study measured impact on NCD prevalence, one physical activity and 27 dietary components. The majority of papers (23), involved agricultural interventions. Primary outcome measures tended to focus on undernutrition. Intensive agricultural interventions were associated with improved calorie, vitamin, fruit and vegetable intake. However, positive impacts were reliant on participant's land ownership, infection status and limited in generalisability. Just three studies measured adult obesity; two indicated increased income and consequential food affordability had the potential to increase obesity. Overall, there was poor alignment between included studies outcome measures and the key policy options and objectives of the Global Action Plan on NCDs. Though many interventions addressing poverty and development have great potential to impact on NCD prevalence and risk, most fail to measure or report these outcomes. Current evidence is limited to behavioural risk factors, namely diet and suggests a positive impact of agricultural-based food security programmes on dietary indicators. However, studies investigating the impact of improved income on obesity tend to show an increased risk. Embedding NCD impact evaluation into development programmes is crucial in the context of the Sustainable Development Goals and the rapid epidemiological transitions facing LLMICs.

Influence of peer review on the reporting of primary outcome(s) and statistical analyses of randomised trials.

PubMed

Hopewell, Sally; Witt, Claudia M; Linde, Klaus; Icke, Katja; Adedire, Olubusola; Kirtley, Shona; Altman, Douglas G

2018-01-11

Selective reporting of outcomes in clinical trials is a serious problem. We aimed to investigate the influence of the peer review process within biomedical journals on reporting of primary outcome(s) and statistical analyses within reports of randomised trials. Each month, PubMed (May 2014 to April 2015) was searched to identify primary reports of randomised trials published in six high-impact general and 12 high-impact specialty journals. The corresponding author of each trial was invited to complete an online survey asking authors about changes made to their manuscript as part of the peer review process. Our main outcomes were to assess: (1) the nature and extent of changes as part of the peer review process, in relation to reporting of the primary outcome(s) and/or primary statistical analysis; (2) how often authors followed these requests; and (3) whether this was related to specific journal or trial characteristics. Of 893 corresponding authors who were invited to take part in the online survey 258 (29%) responded. The majority of trials were multicentre (n = 191; 74%); median sample size 325 (IQR 138 to 1010). The primary outcome was clearly defined in 92% (n = 238), of which the direction of treatment effect was statistically significant in 49%. The majority responded (1-10 Likert scale) they were satisfied with the overall handling (mean 8.6, SD 1.5) and quality of peer review (mean 8.5, SD 1.5) of their manuscript. Only 3% (n = 8) said that the editor or peer reviewers had asked them to change or clarify the trial's primary outcome. However, 27% (n = 69) reported they were asked to change or clarify the statistical analysis of the primary outcome; most had fulfilled the request, the main motivation being to improve the statistical methods (n = 38; 55%) or avoid rejection (n = 30; 44%). Overall, there was little association between authors being asked to make this change and the type of journal, intervention, significance of the primary outcome, or funding source. Thirty-six percent (n = 94) of authors had been asked to include additional analyses that had not been included in the original manuscript; in 77% (n = 72) these were not pre-specified in the protocol. Twenty-three percent (n = 60) had been asked to modify their overall conclusion, usually (n = 53; 88%) to provide a more cautious conclusion. Overall, most changes, as a result of the peer review process, resulted in improvements to the published manuscript; there was little evidence of a negative impact in terms of post hoc changes of the primary outcome. However, some suggested changes might be considered inappropriate, such as unplanned additional analyses, and should be discouraged.

A descriptive feast but an evaluative famine: systematic review of published articles on primary care computing during 1980-97

PubMed Central

Mitchell, Elizabeth; Sullivan, Frank

2001-01-01

Objectives To appraise findings from studies examining the impact of computers on primary care consultations. Design Systematic review of world literature from 1980 to 1997. Data sources 5475 references were identified from electronic databases (Medline, Science Citation Index, Social Sciences Citation Index, Index of Scientific and Technical Proceedings, Embase, OCLC FirstSearch Proceedings), bibliographies, books, identified articles, and by authors active in the field. 1892 eligible abstracts were independently rated, and 89 studies met the inclusion criteria. Main outcome measures Effect on doctors' performance and patient outcomes; attitudes towards computerisation. Results 61 studies examined effects of computers on practitioners' performance, 17 evaluated their impact on patient outcome, and 20 studied practitioners' or patients' attitudes. Computer use during consultations lengthened the consultation. Reminder systems for preventive tasks and disease management improved process rates, although some returned to pre-intervention levels when reminders were stopped. Use of computers for issuing prescriptions increased prescribing of generic drugs, and use of computers for test ordering led to cost savings and fewer unnecessary tests. There were no negative effects on those patient outcomes evaluated. Doctors and patients were generally positive about use of computers, but issues of concern included their impact on privacy, the doctor-patient relationship, cost, time, and training needs. Conclusions Primary care computing systems can improve practitioner performance, particularly for health promotion interventions. This may be at the expense of patient initiated activities, making many practitioners suspicious of the negative impact on relationships with patients. There remains a dearth of evidence evaluating effects on patient outcomes. PMID:11157532

Primary radical ablative surgery and fibula free-flap reconstruction for T4 oral cavity squamous cell carcinoma with mandibular invasion: oncologic and functional results and their predictive factors.

PubMed

Camuzard, Olivier; Dassonville, Olivier; Ettaiche, Marc; Chamorey, Emmanuel; Poissonnet, Gilles; Berguiga, Riadh; Leysalle, Axel; Benezery, Karen; Peyrade, Frédéric; Saada, Esma; Hechema, Raphael; Sudaka, Anne; Haudebourg, Juliette; Demard, François; Santini, José; Bozec, Alexandre

2017-01-01

The aims of this study were to evaluate clinical outcomes and to determine their predictive factors in patients with oral cavity squamous cell carcinoma (OCSCC) invading the mandibular bone (T4) who underwent primary radical surgery and fibula free-flap reconstruction. Between 2001 and 2013, all patients who underwent primary surgery and mandibular fibula free-flap reconstruction for OCSCC were enrolled in this retrospective study. Predictive factors of oncologic and functional outcomes were assessed in univariate and multivariate analysis. 77 patients (55 men and 22 women, mean age 62 ± 10.6 years) were enrolled in this study. Free-flap failure and local and general complication rates were 9, 31, and 22 %, respectively. In multivariate analysis, ASA score (p = 0.002), pathologic N-stage (p = 0.01), and close surgical margins (p = 0.03) were independent predictors of overall survival. Six months after therapy, oral diet, speech intelligibility, and mouth opening functions were normal or slightly impaired in, respectively, 79, 88, and 83 % of patients. 6.5 % of patients remaining dependent on enteral nutrition 6 months after therapy. With acceptable postoperative outcomes and satisfactory oncologic and functional results, segmental mandibulectomy with fibula free-flap reconstruction should be considered the gold standard primary treatment for patients with OCSCC invading mandible bone. Oncologic outcomes are dependent on three main factors: ASA score, pathologic N-stage, and surgical margin status.

Practical health co-operation - the impact of a referral template on quality of care and health care co-operation: study protocol for a cluster randomized controlled trial.

PubMed

Wåhlberg, Henrik; Valle, Per Christian; Malm, Siri; Broderstad, Ann Ragnhild

2013-01-07

The referral letter plays a key role both in the communication between primary and secondary care, and in the quality of the health care process. Many studies have attempted to evaluate and improve the quality of these referral letters, but few have assessed the impact of their quality on the health care delivered to each patient. A cluster randomized trial, with the general practitioner office as the unit of randomization, has been designed to evaluate the effect of a referral intervention on the quality of health care delivered. Referral templates have been developed covering four diagnostic groups: dyspepsia, suspected colonic malignancy, chest pain, and chronic obstructive pulmonary disease. Of the 14 general practitioner offices primarily served by University Hospital of North Norway Harstad, seven were randomized to the intervention group. The primary outcome is a collated quality indicator score developed for each diagnostic group. Secondary outcomes include: quality of the referral, health process outcome such as waiting times, and adequacy of prioritization. In addition, information on patient satisfaction will be collected using self-report questionnaires. Outcome data will be collected on the individual level and analyzed by random effects linear regression. Poor communication between primary and secondary care can lead to inappropriate investigations and erroneous prioritization. This study's primary hypothesis is that the use of a referral template in this communication will lead to a measurable increase in the quality of health care delivered. This trial has been registered at ClinicalTrials.gov. The trial registration number is NCT01470963.

Thinking Styles of Primary School Teachers in Beijing, China

ERIC Educational Resources Information Center

Wang, Ying; Pang, Nicholas Sun-Keung

2013-01-01

Previous studies on teachers' thinking have usually related to teaching and learning, and concentrated on classroom-level outcomes. In this study, an organizational and administrative perspective was adopted in examining teachers' thinking style. Data collected were from a sample of 268 in-service teachers from 6 primary schools in Beijing, China.…

Is the quality of brief motivational interventions for drug use in primary care associated with subsequent drug use?

PubMed

Palfai, Tibor P; Cheng, Debbie M; Bernstein, Judith A; Palmisano, Joseph; Lloyd-Travaglini, Christine A; Goodness, Tracie; Saitz, Richard

2016-05-01

Although a number of brief intervention approaches for drug use are based on motivational interviewing (MI), relatively little is known about whether the quality of motivational interviewing skills is associated with intervention outcomes. The current study examined whether indices of motivational interviewing skill were associated with subsequent drug use outcomes following two different MI-based brief interventions delivered in primary care; a 15 min Brief Negotiated Interview (BNI) and a 45 min adaptation of motivational interviewing (MOTIV). Audio recordings from 351 participants in a randomized controlled trial for drug use in primary care were coded using the Motivational Interviewing Treatment Integrity Scale, (MITI Version 3.1.1). Separate negative binomial regression analyses, stratified by intervention condition, were used to examine the associations between six MITI skill variables and the number of days that the participant used his/her main drug 6 weeks after study entry. Only one of the MITI variables (% reflections to questions) was significantly associated with the frequency of drug use in the MOTIV condition and this was opposite to the hypothesized direction (global p=0.01, adjusted IRR 1.50, 95%CI: 1.03-2.20 for middle vs. lowest tertile [higher skill, more drug use]. None were significantly associated with drug use in the BNI condition. Secondary analyses similarly failed to find consistent predictors of better drug outcomes. Overall, this study provides little evidence to suggest that the level of MI intervention skills are linked with better drug use outcomes among people who use drugs and receive brief interventions in primary care. Findings should be considered in light of the fact that data from the study are from negative trial of SBI and was limited to primary care patients. Future work should consider alternative ways of examining these process variables (i.e., comparing thresholds of proficient versus non-proficient skills) or considering alternative methods of coding intervention skills. Copyright © 2016 Elsevier Ltd. All rights reserved.

Treatment of Advanced Glaucoma Study: a multicentre randomised controlled trial comparing primary medical treatment with primary trabeculectomy for people with newly diagnosed advanced glaucoma-study protocol.

PubMed

King, Anthony J; Fernie, Gordon; Azuara-Blanco, Augusto; Burr, Jennifer M; Garway-Heath, Ted; Sparrow, John M; Vale, Luke; Hudson, Jemma; MacLennan, Graeme; McDonald, Alison; Barton, Keith; Norrie, John

2017-10-26

Presentation with advanced glaucoma is the major risk factor for lifetime blindness. Effective intervention at diagnosis is expected to minimise risk of further visual loss in this group of patients. To compare clinical and cost-effectiveness of primary medical management compared with primary surgery for people presenting with advanced open-angle glaucoma (OAG). Design : A prospective, pragmatic multicentre randomised controlled trial (RCT). Twenty-seven UK hospital eye services. Four hundred and forty patients presenting with advanced OAG, according to the Hodapp-Parish-Anderson classification of visual field loss. Participants will be randomised to medical treatment or augmented trabeculectomy (1:1 allocation minimised by centre and presence of advanced disease in both eyes). The primary outcome is vision-related quality of life measured by the National Eye Institute-Visual Function Questionnaire-25 at 24 months. Secondary outcomes include generic EQ-5D-5L, Health Utility Index-3 and glaucoma-related health status (Glaucoma Utility Index), patient experience, visual field measured by mean deviation value, logarithm of the mean angle of resolution visual acuity, intraocular pressure, adverse events, standards for driving and eligibility for blind certification. Incremental cost per quality-adjusted life-year (QALY) based on EQ-5D-5L and glaucoma profile instrument will be estimated. The study will report the comparative effectiveness and cost-effectiveness of medical treatment against augmented trabeculectomy in patients presenting with advanced glaucoma in terms of patient-reported health and visual function, clinical outcomes and incremental cost per QALY at 2 years. Treatment of Advanced Glaucoma Study will be the first RCT reporting outcomes from the perspective of those with advanced glaucoma. ISRCTN56878850, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Measures of Social Deprivation That Predict Health Care Access and Need within a Rational Area of Primary Care Service Delivery

PubMed Central

Butler, Danielle C; Petterson, Stephen; Phillips, Robert L; Bazemore, Andrew W

2013-01-01

Objective To develop a measure of social deprivation that is associated with health care access and health outcomes at a novel geographic level, primary care service area. Data Sources/Study Setting Secondary analysis of data from the Dartmouth Atlas, AMA Masterfile, National Provider Identifier data, Small Area Health Insurance Estimates, American Community Survey, Area Resource File, and Behavioural Risk Factor Surveillance System. Data were aggregated to primary care service areas (PCSAs). Study Design Social deprivation variables were selected from literature review and international examples. Factor analysis was used. Correlation and multivariate analyses were conducted between index, health outcomes, and measures of health care access. The derived index was compared with poverty as a predictor of health outcomes. Data Collection/Extraction Methods Variables not available at the PCSA level were estimated at block level, then aggregated to PCSA level. Principal Findings Our social deprivation index is positively associated with poor access and poor health outcomes. This pattern holds in multivariate analyses controlling for other measures of access. A multidimensional measure of deprivation is more strongly associated with health outcomes than a measure of poverty alone. Conclusions This geographic index has utility for identifying areas in need of assistance and is timely for revision of 35-year-old provider shortage and geographic underservice designation criteria used to allocate federal resources. PMID:22816561

Understanding the Stress Process of Chinese- and Korean-American Breast Cancer Survivors.

PubMed

Paek, Min-So; Lim, Jung-Won

2016-10-01

Guided by the stress process model (SPM), this study investigated the direct and indirect pathways of primary (negative self-image and life stress), secondary stressors (family communication strain) and family coping (external and internal) on mental health outcomes among Chinese- and Korean-American breast cancer survivors (BCS). A total of 156 Chinese- and Korean-American BCS were surveyed. Results showed primary and secondary stressors had a negative effect on better mental health outcomes. External coping was associated with better mental health. Family communication strain mediated the relationship between life stress and mental health outcomes. External coping mediated the relationship between family communication strain and mental health outcomes. Multi-group analysis revealed the stress process did not differ across ethnic groups. Findings suggest the SPM may be applicable to understand the stress process of Chinese- and Korean-American BCS and provide valuable insight into the role of family communication and external coping on mental health outcomes.

Are dental researchers asking patient-important questions? A scoping review.

PubMed

Fleming, Padhraig S; Koletsi, Despina; O'Brien, Kevin; Tsichlaki, Aliki; Pandis, Nikolaos

2016-06-01

There is an increasing recognition that research outcomes should resonate with patients rather than fixating on technical aspects of interventions. We aimed to assess the nature of outcomes within a representative subset of clinical trials published in leading dental journals. Randomized controlled trials published over a 3-year period up to December 31st, 2015 were identified in eight leading general and specialty dental journals: Journal of Dental Research, Journal of Dentistry, American Journal of Orthodontics and Dentofacial Orthopedics, Pediatric Dentistry, International Journal of Prosthodontics, Journal of Endodontics, International Journal of Oral and Maxillofacial Surgery and Journal of Clinical Periodontology. The number and nature of outcomes considered within these trials were assessed. Overall 220 RCTs involving 409 outcomes (257 primary and 152 secondary) were identified. Measures of disease activity were most commonly assessed as both primary (n=91, 35%) and secondary outcomes (n=59, 39%). Quality of life and functional measures were rarely considered as primary outcome domains. Overall, 182 (44%) outcomes were primarily clinician-focused, 140 (34%) were patient-centered, while 22% (n=87) were both patient- and clinician- focused. There is an undue emphasis on technical, clinician-centered outcomes within dental research common to all specialty areas. Development and adoption of core outcome sets representing the minimum set of data that should be obtained within a dental clinical trial would assist in addressing this issue. There is an acceptance that research outcomes should ultimately be of relevance and benefit to patients rather than focusing on technical aspects of interventions. This study points to an undue emphasis on technical, clinician-centered outcomes within dental research common to all specialty areas. Development and adoption of agreed dental core outcome sets would help to remedy this. Copyright © 2016 Elsevier Ltd. All rights reserved.

Selective outcome reporting and sponsorship in randomized controlled trials in IVF and ICSI.

PubMed

Braakhekke, M; Scholten, I; Mol, F; Limpens, J; Mol, B W; van der Veen, F

2017-10-01

Are randomized controlled trials (RCTs) on IVF and ICSI subject to selective outcome reporting and is this related to sponsorship? There are inconsistencies, independent from sponsorship, in the reporting of primary outcome measures in the majority of IVF and ICSI trials, indicating selective outcome reporting. RCTs are subject to bias at various levels. Of these biases, selective outcome reporting is particularly relevant to IVF and ICSI trials since there is a wide variety of outcome measures to choose from. An established cause of reporting bias is sponsorship. It is, at present, unknown whether RCTs in IVF/ICSI are subject to selective outcome reporting and whether this is related with sponsorship. We systematically searched RCTs on IVF and ICSI published between January 2009 and March 2016 in MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the publisher subset of PubMed. We analysed 415 RCTs. Per included RCT, we extracted data on impact factor of the journal, sample size, power calculation, and trial registry and thereafter data on primary outcome measure, the direction of trial results and sponsorship. Of the 415 identified RCTs, 235 were excluded for our primary analysis, because the sponsorship was not reported. Of the 180 RCTs included in our analysis, 7 trials did not report on any primary outcome measure and 107 of the remaining 173 trials (62%) reported on surrogate primary outcome measures. Of the 114 registered trials, 21 trials (18%) provided primary outcomes in their manuscript that were different from those in the trial registry. This indicates selective outcome reporting. We found no association between selective outcome reporting and sponsorship. We ran additional analyses to include the trials that had not reported sponsorship and found no outcomes that differed from our primary analysis. Since the majority of the trials did not report on sponsorship, there is a risk on sampling bias. IVF and ICSI trials are subject, to a large extent, to selective outcome reporting. Readers should be aware of this to avoid implementation of false or misleading results in clinical practice. No funding received and there are no conflicts of interest. N/A. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Association between registered nurse staffing and management outcomes of patients with type 2 diabetes within primary care: a cross-sectional linkage study

PubMed Central

Lukewich, Julia; Edge, Dana S.; VanDenKerkhof, Elizabeth; Williamson, Tyler; Tranmer, Joan

2016-01-01

Background: As the organization of primary care continues to evolve toward more interdisciplinary team structures, demonstrating effectiveness of care delivery is becoming important, particularly for nonphysician providers. Nurses are the most common nonphysician provider within primary care. The purpose of this study was to examine the relation between primary care delivery models that incorporate registered nurses and clinical outcomes of patients with type 2 diabetes. Methods: Patient data from the Canadian Primary Care Sentinel Surveillance Network were matched with survey data from 15 Family Health Team practices in southeastern Ontario. Included patients were adults with type 2 diabetes mellitus who had at least 1 primary care encounter at a Family Health Team practice that completed the organizational survey between Apr. 1, 2013, and Mar. 31, 2014. The clinical outcomes explored included hemoglobin A1c, fasting plasma glucose, blood pressure, low-density lipoprotein cholesterol and urine albumin:creatinine ratio. Results: Of the 15 practices, 13 (86.7%) had at least 1 registered nurse. The presence of 1 or more registered nurses in the practice was associated with increased odds of patients' having their hemoglobin A1c, fasting plasma glucose, blood pressure and low-density lipoprotein cholesterol values meet recommended targets. Practices with the lowest ratios of patients with diabetes to registered nurse had a significantly greater proportion of patients with hemoglobin A1c and fasting plasma glucose values on target than did practices with the highest ratios of patients to registered nurse (p < 0.01 and p = 0.03, respectively). Interpretation: The findings suggest that registered nurse staffing within primary care practice teams contributes to better diabetic care, as measured by diabetes management indicators. This study sets the groundwork for further exploration of nursing and organizational contributions to patient care in the primary care setting. PMID:27398372

The effects of asking a fertility intention question in primary care settings: a systematic review protocol.

PubMed

Henning, Paul A; Burgess, Carolyne K; Jones, Heidi E; Norman, Wendy V

2017-01-19

Planning for pregnancy has been associated with reduced unwanted pregnancies and improved pregnancy outcomes. Despite the benefits of planned pregnancy, there are no guideline recommendations on routine counseling regarding pregnancy intention in primary care settings. The objective of the systematic review is to determine the effectiveness of incorporating questions of pregnancy intention into primary care. A systematic search of the literature will be conducted for any studies comparing questions of pregnancy intention in primary care settings with no intervention or a control intervention. Types of studies will include randomized controlled trials, non-randomized trials, and observation studies. Participants will include patients of reproductive age presenting to primary health care settings. Interventions will include any assessment of fertility intention and follow-up care compared with a control group or no intervention. Outcomes will include quantitative data with rates for contraceptive uptake, and any pregnancy related outcome. Databases (Ovid MEDLINE; Pubmed; CINAHL; EMBASE; CDR/DARE databases; Web of Science; ISRCTN registry; Clinicaltrials.gov; Cochrane Library) will be searched from the year 2000 to current. Screening of identified articles and data extraction will be conducted in duplicate by two independent reviewers. Methodological quality will be assessed using the Jadad scale. Methodological quality of observational and non-randomized trials will be assessed using the Newcastle-Ottawa scale. Discrepancies will be resolved by consensus or by consulting a third author. Meta-analyses will be performed if appropriate. Determining the effect of including questions of pregnancy intention into primary care can provide evidence for the development of clinical practice guidelines and inform primary care providers if this simple and low-cost intervention should be routinely employed. This review will also identify any gaps in the current literature on this topic and provide direction for future research in this area of study. Systematic Review Registration: PROSPERO CRD42015019726.

Design of the Intravenous Magnesium Efficacy in Acute Stroke (IMAGES) trial.

PubMed

Bradford, Andrew; Lees, Kennedy

2000-01-01

The Intravenous Magnesium Efficacy in Acute Stroke (IMAGES) trial is a multicentre,randomised, placebo-controlled trial of magnesium sulphate (MgSO4) funded by the UK Medical Research Council. When complete, it will be the largest single neuroprotective study undertaken to date. Conscious patients presenting within 12 h of acute stroke with limb weakness are eligible. The primary outcome measure is combined death and disability as measured using the Barthel Index at 90-day follow up. By randomizing 2700 patients, the study will have 84% power to detect a 5.5% absolute reduction in the primary end-point. By April 2000, 86 centres were participating, with representation in Canada, USA, Europe, South America, Singapore and Australia. So far, 1206 patients have been randomised, of whom 37% were treated within 6 h. Overall 3-month mortality was 20% and the primary outcome event rate was 43%. The study is ongoing and centres worldwide are encouraged to participate.

Insecticide treated bednet strategy in rural settings: can we exploit women's decision making power?

PubMed

Tilak, Rina; Tilak, V W; Bhalwar, R

2007-01-01

Use of insecticide treated bednets in prevention of malaria is a widely propagated global strategy, however, its use has been reported to be influenced and limited by many variables especially gender bias. A cross sectional field epidemiological study was conducted in a rural setting with two outcome variables, 'Bednet use'(primary outcome variable) and 'Women's Decision Making Power' which were studied in reference to various predictor variables. Analysis reveals a significant effect on the primary outcome variable 'Bednet use' of the predictor variables- age, occupation, bednet purchase decision, women's decision making power, husband's education and knowledge about malaria and its prevention. The study recommends IEC on treated bednets to be disseminated through TV targeting the elderly women who have better decision making power and mobilizing younger women who were found to prefer bednets for prevention of mosquito bites for optimizing the use of treated bednets in similar settings.

NAITRE study on the impact of conditional cash transfer on poor pregnancy outcomes in underprivileged women: protocol for a nationwide pragmatic cluster-randomised superiority clinical trial in France

PubMed Central

Bardou, Marc; Crépon, Bruno; Bertaux, Anne-Claire; Godard-Marceaux, Aurélie; Eckman-Lacroix, Astrid; Thellier, Elise; Falchier, Frédérique; Deruelle, Philippe; Doret, Muriel; Carcopino-Tusoli, Xavier; Schmitz, Thomas; Barjat, Thiphaine; Morin, Mathieu; Perrotin, Franck; Hatem, Ghada; Deneux-Tharaux, Catherine; Fournel, Isabelle; Laforet, Laurent; Meunier-Beillard, Nicolas; Duflo, Esther; Le Ray, Isabelle

2017-01-01

Introduction Prenatal care is recommended during pregnancy to improve neonatal and maternal outcomes. Women of lower socioeconomic status (SES) are less compliant to recommended prenatal care and suffer a higher risk of adverse perinatal outcomes. Several attempts to encourage optimal pregnancy follow-up have shown controversial results, particularly in high-income countries. Few studies have assessed financial incentives to encourage prenatal care, and none reported materno-fetal events as the primary outcome. Our study aims to determine whether financial incentives could improve pregnancy outcomes in women with low SES in a high-income country. Methods and analysis This pragmatic cluster-randomised clinical trial includes pregnant women with the following criteria: (1) age above 18 years, (2) first pregnancy visit before 26 weeks of gestation and (3) belonging to a socioeconomically disadvantaged group. The intervention consists in offering financial incentives conditional on attending scheduled pregnancy follow-up consultations. Clusters are 2-month periods with random turnover across centres. A composite outcome of maternal and neonatal morbidity and mortality is the primary endpoint. Secondary endpoints include maternal or neonatal outcomes assessed separately, qualitative assessment of the perception of the intervention and cost-effectiveness analysis for which children will be followed to the end of their first year through the French health insurance database. The study started in June 2016, and based on an expected decrease in the primary endpoint from 18% to 14% in the intervention group, we plan to include 2000 women in each group. Ethics and dissemination Ethics approval was first gained on 28 September 2014. An independent data security and monitoring committee has been established. Results of the main trial and each of the secondary analyses will be submitted for publication in a peer-reviewed journal. Trial registration number NCT02402855; pre-results. PMID:29084796

NAITRE study on the impact of conditional cash transfer on poor pregnancy outcomes in underprivileged women: protocol for a nationwide pragmatic cluster-randomised superiority clinical trial in France.

PubMed

Bardou, Marc; Crépon, Bruno; Bertaux, Anne-Claire; Godard-Marceaux, Aurélie; Eckman-Lacroix, Astrid; Thellier, Elise; Falchier, Frédérique; Deruelle, Philippe; Doret, Muriel; Carcopino-Tusoli, Xavier; Schmitz, Thomas; Barjat, Thiphaine; Morin, Mathieu; Perrotin, Franck; Hatem, Ghada; Deneux-Tharaux, Catherine; Fournel, Isabelle; Laforet, Laurent; Meunier-Beillard, Nicolas; Duflo, Esther; Le Ray, Isabelle

2017-10-30

Prenatal care is recommended during pregnancy to improve neonatal and maternal outcomes. Women of lower socioeconomic status (SES) are less compliant to recommended prenatal care and suffer a higher risk of adverse perinatal outcomes. Several attempts to encourage optimal pregnancy follow-up have shown controversial results, particularly in high-income countries. Few studies have assessed financial incentives to encourage prenatal care, and none reported materno-fetal events as the primary outcome. Our study aims to determine whether financial incentives could improve pregnancy outcomes in women with low SES in a high-income country. This pragmatic cluster-randomised clinical trial includes pregnant women with the following criteria: (1) age above 18 years, (2) first pregnancy visit before 26 weeks of gestation and (3) belonging to a socioeconomically disadvantaged group. The intervention consists in offering financial incentives conditional on attending scheduled pregnancy follow-up consultations. Clusters are 2-month periods with random turnover across centres. A composite outcome of maternal and neonatal morbidity and mortality is the primary endpoint. Secondary endpoints include maternal or neonatal outcomes assessed separately, qualitative assessment of the perception of the intervention and cost-effectiveness analysis for which children will be followed to the end of their first year through the French health insurance database. The study started in June 2016, and based on an expected decrease in the primary endpoint from 18% to 14% in the intervention group, we plan to include 2000 women in each group. Ethics approval was first gained on 28 September 2014. An independent data security and monitoring committee has been established. Results of the main trial and each of the secondary analyses will be submitted for publication in a peer-reviewed journal. NCT02402855; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Does the Rotator Cuff Tear Pattern Influence Clinical Outcomes After Surgical Repair?

PubMed

Watson, Scott; Allen, Benjamin; Robbins, Chris; Bedi, Asheesh; Gagnier, Joel J; Miller, Bruce

2018-03-01

Limited literature exists regarding the influence of rotator cuff tear morphology on patient outcomes. To determine the effect of rotator cuff tear pattern (crescent, U-shape, L-shape) on patient-reported outcomes after rotator cuff repair. Cohort study; Level of evidence, 3. Patients undergoing arthroscopic repair of known full-thickness rotator cuff tears were observed prospectively at regular intervals from baseline to 1 year. The tear pattern was classified at the time of surgery as crescent, U-shaped, or L-shaped. Primary outcome measures were the Western Ontario Rotator Cuff Index (WORC), the American Shoulder and Elbow Surgeons (ASES), and a visual analog scale (VAS) for pain. The tear pattern was evaluated as the primary predictor while controlling for variables known to affect rotator cuff outcomes. Mixed-methods regression and analysis of variance (ANOVA) were used to examine the effects of tear morphology on patient-reported outcomes after surgical repair from baseline to 1 year. A total of 82 patients were included in the study (53 male, 29 female; mean age, 58 years [range, 41-75 years]). A crescent shape was the most common tear pattern (54%), followed by U-shaped (25%) and L-shaped tears (21%). There were no significant differences in outcome scores between the 3 groups at baseline. All 3 groups showed statistically significant improvement from baseline to 1 year, but analysis failed to show any predictive effect in the change in outcome scores from baseline to 1 year for the WORC, ASES, or VAS when tear pattern was the primary predictor. Further ANOVA also failed to show any significant difference in the change in outcome scores from baseline to 1 year for the WORC ( P = .96), ASES ( P = .71), or VAS ( P = .86). Rotator cuff tear pattern is not a predictor of functional outcomes after arthroscopic rotator cuff repair.

A comparison of oncological outcomes between transoral surgical and non-surgical treatment protocols in the management of oropharyngeal squamous cell carcinoma.

PubMed

Kao, S S; Micklem, J; Ofo, E; Edwards, S; Dhatrak, D; Foreman, A; Krishnan, S; Hodge, J-C

2018-04-01

The incidence of oropharyngeal squamous cell carcinoma in the Western world is increasing, with the human papillomavirus epidemic implicated in this observed trend. The optimal treatment modality is yet undetermined regarding oncological outcomes. This study comprised 98 patients with oropharyngeal squamous cell carcinoma, treated with either primary transoral surgery with adjuvant therapy or primary chemoradiotherapy with curative intent, between 2008 and 2012. Clinicopathological characteristics including tumour-node-metastasis stage, human papillomavirus status, treatment modality, recurrence and overall survival were collated. Five per cent of primary surgical patients had locoregional recurrences compared with 25 per cent of primary chemoradiotherapy patients. A lower rate of locoregional recurrence was observed in the human papillomavirus positive group. This paper reports higher rates of overall survival and local control for oropharyngeal squamous cell carcinoma treated with primary surgery compared with primary chemoradiotherapy. This reflects overall lower tumour stage and higher human papillomavirus status in this group.

Primary care physician assistant and advance practice nurses roles: Patient healthcare utilization, unmet need, and satisfaction.

PubMed

Everett, Christine M; Morgan, Perri; Jackson, George L

2016-12-01

Team-based care involving physician assistants (PAs) and advance practice nurses (APNs) is one strategy for improving access and quality of care. PA/APNs perform a variety of roles on primary care teams. However, limited research describes the relationship between PA/APN role and patient outcomes. We examined multiple outcomes associated with primary care PA/APN roles. In this cross-sectional survey analysis, we studied adult respondents to the 2010 Health Tracking Household Survey. Outcomes included primary care and emergency department visits, hospitalizations, unmet need, and satisfaction. PA/APN role was categorized as physician only (no PA/APN visits; reference), usual provider (PA/APN provide majority of primary care visits) or supplemental provider (physician as usual provider, PA/APN provide a subset of visits). Multivariable logistic and multinomial logistic regressions were performed. Compared to people with physician only care, patients with PA/APNs as usual providers [5-9 visits RRR=2.4 (CI 1.8-3.4), 10+ visits RRR=3.0 (CI 2.0-4.5): reference 2-4 visits] and supplemental providers had increased risk of having 5 or more primary care visits [5-9 visits RRR=1.3 (CI 1.0-1.6)]. Patients reporting PA/APN as supplemental providers had increased risk of emergency department utilization [2+ visits: RRR 1.8 (CI 1.3, 2.5)], and lower satisfaction [very dissatisfied: RRR 1.8 (CI 1.03-3.0)]. No differences were seen for hospitalizations or unmet need. Healthcare utilization patterns and satisfaction varied between adults with PA/APN in different roles, but reported unmet need did not. These findings suggest a wide range of outcomes should be considered when identifying the best PA/APN role on primary care teams. Copyright © 2016 Elsevier Inc. All rights reserved.

Effectiveness of a Geriatric Care Model for frail older adults in primary care: Results from a stepped wedge cluster randomized trial.

PubMed

Hoogendijk, Emiel O; van der Horst, Henriëtte E; van de Ven, Peter M; Twisk, Jos W R; Deeg, Dorly J H; Frijters, Dinnus H M; van Leeuwen, Karen M; van Campen, Jos P C M; Nijpels, Giel; Jansen, Aaltje P D; van Hout, Hein P J

2016-03-01

Primary care-based comprehensive care programs have the potential to improve outcomes in frail older adults. We evaluated the impact of the Geriatric Care Model (GCM) on the quality of life of community-dwelling frail older adults. A 24-month stepped wedge cluster randomized controlled trial was conducted between May 2010 and March 2013 in 35 primary care practices in the Netherlands, and included 1147 frail older adults. The intervention consisted of a geriatric in-home assessment by a practice nurse, followed by a tailored care plan. Reassessment occurred every six months. Nurses worked together with primary care physicians and were supervised and trained by geriatric expert teams. Complex patients were reviewed in multidisciplinary consultations. The primary outcome was quality of life (SF-12). Secondary outcomes were health-related quality of life, functional limitations, self-rated health, psychological wellbeing, social functioning and hospitalizations. Intention-to-treat analyses based on multilevel modeling showed no significant differences between the intervention group and usual care regarding SF-12 and most secondary outcomes. Only for IADL limitations we found a small intervention effect in patients who received the intervention for 18months (B=-0.25, 95%CI=-0.43 to -0.06, p=0.007), but this effect was not statistically significant after correction for multiple comparisons. The GCM did not show beneficial effects on quality of life in frail older adults in primary care, compared to usual care. This study strengthens the idea that comprehensive care programs add very little to usual primary care for this population. The Netherlands National Trial Register NTR2160. Copyright © 2015 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Impact of weather and climate scenarios on conservation assessment outcomes

USDA-ARS?s Scientific Manuscript database

This paper reviews selected watershed studies of the Conservation Effects Assessment Project (CEAP) and interprets findings from the perspective of potential climate change impacts on conservation outcomes. Primary foci are runoff, soil erosion, sediment transport, watershed sediment yield, and asso...

Current management and prognostic factors in physiotherapy practice for patients with shoulder pain: design of a prospective cohort study.

PubMed

Karel, Yasmaine H J M; Scholten-Peeters, Wendy G M; Thoomes-de Graaf, Marloes; Duijn, Edwin; Ottenheijm, Ramon P G; van den Borne, Maaike P J; Koes, Bart W; Verhagen, Arianne P; Dinant, Geert-Jan; Tetteroo, Eric; Beumer, Annechien; van Broekhoven, Joost B; Heijmans, Marcel

2013-02-11

Shoulder pain is disabling and has a considerable socio-economic impact. Over 50% of patients presenting in primary care still have symptoms after 6 months; moreover, prognostic factors such as pain intensity, age, disability level and duration of complaints are associated with poor outcome. Most shoulder complaints in this group are categorized as non-specific. Musculoskeletal ultrasound might be a useful imaging method to detect subgroups of patients with subacromial disorders.This article describes the design of a prospective cohort study evaluating the influence of known prognostic and possible prognostic factors, such as findings from musculoskeletal ultrasound outcome and working alliance, on the recovery of shoulder pain. Also, to assess the usual physiotherapy care for shoulder pain and examine the inter-rater reliability of musculoskeletal ultrasound between radiologists and physiotherapists for patients with shoulder pain. A prospective cohort study including an inter-rater reliability study. Patients presenting in primary care physiotherapy practice with shoulder pain are enrolled. At baseline validated questionnaires are used to measure patient characteristics, disease-specific characteristics and social factors. Physical examination is performed according to the expertise of the physiotherapists. Follow-up measurements will be performed 6, 12 and 26 weeks after inclusion. Primary outcome measure is perceived recovery, measured on a 7-point Likert scale. Logistic regression analysis will be used to evaluate the association between prognostic factors and recovery. The ShoCoDiP (Shoulder Complaints and using Diagnostic ultrasound in Physiotherapy practice) cohort study will provide information on current management of patients with shoulder pain in primary care, provide data to develop a prediction model for shoulder pain in primary care and to evaluate whether musculoskeletal ultrasound can improve prognosis.

A comparison of outcomes involving highly cohesive, form-stable breast implants from two manufacturers in patients undergoing primary breast augmentation.

PubMed

Jewell, Mark L; Jewell, James L

2010-01-01

Although there have been reports of single-surgeon outcomes with highly cohesive, form-stable silicone gel implants in women undergoing primary breast augmentation, there has been only one study published that compares the outcomes between the Allergan 410 and the Mentor CPG devices. The goal of the study is to compare outcomes in each cohort and to determine if quality systems and processes would have an impact on lowering the surgical revision rate, as compared to published reports for round gel implants and form-stable implants. Patients selected for the study were required to meet predefined inclusion criteria and general indications for breast augmentation. All subjects were treated uniformly with extensive informed consent prior to surgery. The entire process of breast augmentation (patient assessment, informed consent, the surgical procedure itself and postoperative instructions) was identical between the two groups. Patients were not randomized, as the studies did not start at the same time. The process for management of each patient was based on adaptation of the Toyota Production System and Lean Manufacturing, with emphasis on achieving operational excellence in the use of planning templates for surgery, including accurate management of patient expectations regarding size outcome. Outcomes data included physical breast measurements, quality of life metrics, and patient/surgeon satisfaction assessment. Adverse events were compared against published data for breast implants. Follow-up ranged between 20-77 months (Allergan 410) and 16-77 months (Mentor CPG). The outcome data indicate that these devices produce natural-appearing breasts with extremely low aggregate reoperation rate (4.2%). Only 0.8% of the reoperations were attributable to surgeon-related factors. There were no reoperations to correct mismanaged size expectations during the course of each study. There were 13 pregnancies and no difficulties with lactation were reported. Rippling (lateral/medial, palpable and/or visible) was encountered in both cohorts. The Mentor CPG cohort had a fivefold greater incidence of rippling (37.3% versus 7.6% in Allergan 410 cohort). This was highly statistically significant (P < .001). Provided that there is adherence to core principles and avoidance of errors in planning, patient expectations, and surgery, highly cohesive, form-stable breast implants can deliver excellent long term outcomes in primary breast augmentation in a diverse patient population. The impact of quality processes such as Toyota Production System and Lean Manufacturing was substantive in delivering operational excellence in primary breast augmentation.

FGF-23 as a Predictor of Renal Outcome in Diabetic Nephropathy

PubMed Central

Zatz, Roberto; Graciolli, Fabiana G.; dos Reis, Luciene M.; Barros, Rui T.; Jorgetti, Vanda; Moysés, Rosa M.A.

2011-01-01

Summary Background and objectives Fibroblast growth factor 23 (FGF-23) has emerged as a new factor in mineral metabolism in chronic kidney disease (CKD). An important regulator of phosphorus homeostasis, FGF-23 has been shown to independently predict CKD progression in nondiabetic renal disease. We analyzed the relation between FGF-23 and renal outcome in diabetic nephropathy (DN). Design, setting, participants, & measurements DN patients participating in a clinical trial (enalapril+placebo versus enalapril+losartan) had baseline data collected and were followed until June 2009 or until the primary outcome was reached. Four patients were lost to follow-up. The composite primary outcome was defined as death, doubling of serum creatinine, and/or dialysis need. Results At baseline, serum FGF-23 showed a significant association with serum creatinine, intact parathyroid hormone, proteinuria, urinary fractional excretion of phosphate, male sex, and race. Interestingly, FGF-23 was not related to calcium, phosphorus, 25OH-vitamin D, or 24-hour urinary phosphorus. Mean follow-up time was 30.7 ± 10 months. Cox regression showed that FGF-23 was an independent predictor of the primary outcome, even after adjustment for creatinine clearance and intact parathyroid hormone (10 pg/ml FGF-23 increase = hazard ratio, 1.09; 95% CI, 1.01 to 1.16, P = 0.02). Finally, Kaplan-Meier analysis showed a significantly higher risk of the primary outcome in patients with FGF-23 values of >70 pg/ml. Conclusions FGF-23 is a significant independent predictor of renal outcome in patients with macroalbuminuric DN. Further studies should clarify whether this relation is causal and whether FGF-23 should be a new therapeutic target for CKD prevention. PMID:20966122

Global measures of outcome in a controlled comparison of pharmacological and psychological treatment of panic disorder and agoraphobia in primary care.

PubMed Central

Sharp, D M; Power, K G; Simpson, R J; Swanson, V; Anstee, J A

1997-01-01

BACKGROUND: Panic disorder, with and without agoraphobia, is a prevalent condition which presents primarily in general practice. Previous clinical outcome studies have been conducted mainly in specialist university departments or hospital settings, and have tended to employ complex rating scales that are not well suited for use as outcome measures in primary care. AIM: To evaluate the outcome, in a primary care setting, of fluvoxamine versus cognitive behaviour therapy, each used alone and in combination in a double-blind placebo-controlled framework, balanced for therapist contact. METHOD: A total of 149 patients satisfying DSMIII-R criteria for panic disorder were randomly allocated to receive one of the following: fluvoxamine, placebo, fluvoxamine plus cognitive behaviour therapy, placebo plus cognitive behaviour therapy, and cognitive behaviour therapy alone. These five treatment groups represent the minimum number acceptable for such a comparison to be made. All patients received an identical schedule of contact over 13 weeks. Measures of symptom severity, general health and social disruption were taken at entry point and end point; measures of change in symptoms were taken at end point only. Outcome was reported in terms of brief global ratings of severity of illness and change in symptoms, and of ratings of general health and social disruption that are suitable for use in general practice. RESULTS: All active treatment groups showed statistically significant advantages over placebo over a range of outcome ratings. The groups employing cognitive behaviour therapy showed the most robust and consistent response. CONCLUSION: The brief global measures reported here proved adequate to the task of assessing treatment outcome. Results indicate that treatments including cognitive behaviour therapy can be effective in the treatment of panic disorder and agoraphobia in primary care. PMID:9167318

The Comparison of the Outcomes between Primary PCI, Fibrinolysis, and No Reperfusion in Patients ≥ 75 Years Old with ST-Segment Elevation Myocardial Infarction: Results from the Chinese Acute Myocardial Infarction (CAMI) Registry.

PubMed

Peiyuan, He; Jingang, Yang; Haiyan, Xu; Xiaojin, Gao; Ying, Xian; Yuan, Wu; Wei, Li; Yang, Wang; Xinran, Tang; Ruohua, Yan; Chen, Jin; Lei, Song; Xuan, Zhang; Rui, Fu; Yunqing, Ye; Qiuting, Dong; Hui, Sun; Xinxin, Yan; Runlin, Gao; Yuejin, Yang

2016-01-01

Only a few randomized trials have analyzed the clinical outcomes of elderly ST-segment elevation myocardial infarction (STEMI) patients (≥ 75 years old). Therefore, the best reperfusion strategy has not been well established. An observational study focused on clinical outcomes was performed in this population. Based on the national registry on STEMI patients, the in-hospital outcomes of elderly patients with different reperfusion strategies were compared. The primary endpoint was defined as death. Secondary endpoints included recurrent myocardial infarction, ischemia driven revascularization, myocardial infarction related complications, and major bleeding. Multivariable regression analysis was performed to adjust for the baseline disparities between the groups. Patients who had primary percutaneous coronary intervention (PCI) or fibrinolysis were relatively younger. They came to hospital earlier, and had lower risk of death compared with patients who had no reperfusion. The guideline recommended medications were more frequently used in patients with primary PCI during the hospitalization and at discharge. The rates of death were 7.7%, 15.0%, and 19.9% respectively, with primary PCI, fibrinolysis, and no reperfusion (P < 0.001). Patients having primary PCI also had lower rates of heart failure, mechanical complications, and cardiac arrest compared with fibrinolysis and no reperfusion (P < 0.05). The rates of hemorrhage stroke (0.3%, 0.6%, and 0.1%) and other major bleeding (3.0%, 5.0%, and 3.1%) were similar in the primary PCI, fibrinolysis, and no reperfusion group (P > 0.05). In the multivariable regression analysis, primary PCI outweighs no reperfusion in predicting the in-hospital death in patients ≥ 75 years old. However, fibrinolysis does not. Early reperfusion, especially primary PCI was safe and effective with absolute reduction of mortality compared with no reperfusion. However, certain randomized trials were encouraged to support the conclusion.

Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults.

PubMed

Hall, Deborah A; Haider, Haula; Szczepek, Agnieszka J; Lau, Pia; Rabau, Sarah; Jones-Diette, Julie; Londero, Alain; Edvall, Niklas K; Cederroth, Christopher R; Mielczarek, Marzena; Fuller, Thomas; Batuecas-Caletrio, Angel; Brueggemen, Petra; Thompson, Dean M; Norena, Arnaud; Cima, Rilana F F; Mehta, Rajnikant L; Mazurek, Birgit

2016-06-01

There is no evidence-based guidance to facilitate design decisions for confirmatory trials or systematic reviews investigating treatment efficacy for adults with tinnitus. This systematic review therefore seeks to ascertain the current status of trial designs by identifying and evaluating the reporting of outcome domains and instruments in the treatment of adults with tinnitus. Records were identified by searching PubMed, EMBASE CINAHL, EBSCO, and CENTRAL clinical trial registries (ClinicalTrials.gov, ISRCTN, ICTRP) and the Cochrane Database of Systematic Reviews. Eligible records were those published from 1 July 2006 to 12 March 2015. Included studies were those reporting adults aged 18 years or older who reported tinnitus as a primary complaint, and who were enrolled into a randomised controlled trial, a before and after study, a non-randomised controlled trial, a case-controlled study or a cohort study, and written in English. Studies with fewer than 20 participants were excluded. Two hundred and twenty-eight studies were included. Thirty-five different primary outcome domains were identified spanning seven categories (tinnitus percept, impact of tinnitus, co-occurring complaints, quality of life, body structures and function, treatment-related outcomes and unclear or not specified). Over half the studies (55 %) did not clearly define the complaint of interest. Tinnitus loudness was the domain most often reported (14 %), followed by tinnitus distress (7 %). Seventy-eight different primary outcome instruments were identified. Instruments assessing multiple attributes of the impact of tinnitus were most common (34 %). Overall, 24 different patient-reported tools were used, predominantly the Tinnitus Handicap Inventory (15 %). Loudness was measured in diverse ways including a numerical rating scale (8 %), loudness matching (4 %), minimum masking level (1 %) and loudness discomfort level (1 %). Ten percent of studies did not clearly report the instrument used. Our findings indicate poor appreciation of the basic principles of good trial design, particularly the importance of specifying what aspect of therapeutic benefit is the main outcome. No single outcome was reported in all studies and there was a broad diversity of outcome instruments. The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525 . Registered on 12 March 2015 revised on 15 March 2016.

Early results of Latitude primary total elbow replacement with a minimum follow-up of 2 years.

PubMed

Mehta, Saurabh S; Watts, Adam C; Talwalkar, Sumedh C; Birch, Ann; Nuttall, David; Trail, Ian A

2017-10-01

The aim of this study was to present outcomes of primary Latitude total elbow replacement (TER) with a minimum follow-up of 2 years. A retrospective cohort study was undertaken with prospective outcome data collection for the latest outcome. Included were 63 consecutive primary Latitude TERs in 58 patients performed during a period of 5 years at a specialist orthopedic hospital. The mean age of the patients was 62 years (33-85 years). Five primary TERs (4 patients) were lost to follow-up. The primary diagnosis was rheumatoid arthritis in 49, osteoarthritis in 8, and trauma in 6 elbows. The mean flexion-extension arc was 75° preoperatively and 97° postoperatively. Mean postoperative Elbex pain score was 19/100, and function score was 37/100. Mean postoperative scores were 42/100 for the Quick Disabilities of the Arm, Shoulder, and Hand and 38/50 for the elbow-specific American Shoulder and Elbow Surgeons assessment. Four patients died of unrelated causes, and 8 of 63 underwent further surgical intervention, including explantation and conversion from unlinked to linked implant. On radiographic review of 41 surviving TERs, aseptic radiologic loosening was observed of the humeral component in 4 elbows and of the ulnar component in 9. Seven elbows had no radial component, and of the remaining 34 elbows, 16 (47%) had signs of loosening of the radial implant. Complications included 1 heterotopic ossification, 1 olecranon fracture, and 3 further procedures for ulnar nerve entrapment. The results indicate that the early outcome of Latitude TER is comparable to that of other prostheses. There is concern about early radiologic loosening of the radial component. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

Primary treatment regimen and diabetes insipidus as predictors of health outcomes in adults with childhood-onset craniopharyngioma.

PubMed

Yuen, Kevin C J; Kołtowska-Häggström, Maria; Cook, David M; Fox, Janet L; Jönsson, Peter J; Geffner, Mitchell E; Abs, Roger

2014-04-01

Craniopharyngiomas are often associated with significant morbidity due to their location and treatment effects. Little is known of the effects of primary treatment regimen and diabetes insipidus (DI), a clinical surrogate of hypothalamic obesity, on health outcomes in adults with childhood-onset craniopharyngioma (COCP). The objective of the study was to examine health outcomes of adults with COCP based on primary treatment regimens and the presence of DI. This study included a retrospective KIMS (Pfizer International Metabolic Database) data analysis of 180 adults with COCP according to the primary treatment regimen [one surgery (1Surg) vs complex treatment regimen (CTrR) of more than 1Surg and/or radiotherapy] and the presence of DI. The majority of COCP patients underwent transcranial surgery (77%) without receiving radiotherapy (84%). Compared with the 1Surg group, more CTrR patients developed visual field defects and ophthalmoplegia (all P < .01). Compared with patients without DI, those with DI had higher rates of anterior pituitary hormone deficits, body mass index, and fat mass (all P < .01). By contrast, fasting glucose, hemoglobin A1c, lipid panel, and quality of life were comparable among 1Surg vs CTrR patients, and patients with vs without DI. Regardless of primary treatment received, the presence of DI in either group was associated with higher rates of anterior pituitary hormone deficits and obesity. CTrR and DI predicted health outcomes differently. CTrR predisposed to the development of visual dysfunction, whereas DI was associated with higher rates of anterior pituitary dysfunction and weight gain. Higher body mass index and fat mass in patients with DI further implicate the role of hypothalamic damage as an important causal factor of obesity in these patients.

Added value of delayed computed tomography angiography in primary intracranial hemorrhage and hematoma size for predicting spot sign.

PubMed

Wu, Te Chang; Chen, Tai Yuan; Shiue, Yow Ling; Chen, Jeon Hor; Hsieh, Tsyh-Jyi; Ko, Ching Chung; Lin, Ching Po

2018-04-01

Background The computed tomography angiography (CTA) spot sign represents active contrast extravasation within acute primary intracerebral hemorrhage (ICH) and is an independent predictor of hematoma expansion (HE) and poor clinical outcomes. The spot sign could be detected on first-pass CTA (fpCTA) or delayed CTA (dCTA). Purpose To investigate the additional benefits of dCTA spot sign in primary ICH and hematoma size for predicting spot sign. Material and Methods This is a retrospective study of 100 patients who underwent non-contrast CT (NCCT) and CTA within 24 h of onset of primary ICH. The presence of spot sign on fpCTA or dCTA, and hematoma size on NCCT were recorded. The spot sign on fpCTA or dCTA for predicting significant HE, in-hospital mortality, and poor clinical outcomes (mRS ≥ 4) are calculated. The hematoma size for prediction of CTA spot sign was also analyzed. Results Only the spot sign on dCTA could predict high risk of significant HE and poor clinical outcomes as on fpCTA ( P < 0.05). With dCTA, there is increased sensitivity and negative predictive value (NPV) for predicting significant HE, in-hospital mortality, and poor clinical outcomes. The XY value (product of the two maximum perpendicular axial dimensions) is the best predictor (area under the curve [AUC] = 0.82) for predicting spot sign on fpCTA or dCTA in the absence of intraventricular and subarachnoid hemorrhage. Conclusion This study clarifies that dCTA imaging could improve predictive performance of CTA in primary ICH. Furthermore, the XY value is the best predictor for CTA spot sign.

Pain control after primary total knee replacement. A prospective randomised controlled trial of local infiltration versus single shot femoral nerve block.

PubMed

Ashraf, Anam; Raut, Videsh V; Canty, Stephen J; McLauchlan, George J

2013-10-01

We report a prospective blinded randomised trial of local infiltration versus femoral nerve block in patients undergoing primary total knee replacement (TKR), in accordance with the CONSORT statement 2010. Fifty patients in a teaching hospital were consented for the study. The study arms were intraoperative local anaesthesia (150ml 0.2% ropivacaine/1ml 1:1000 adrenaline/30mg ketolorac) and femoral nerve block (30ml 0.2% ropivacaine) with a primary outcome of pain score at 4h post operatively. Secondary outcomes were pain at 2h, pain scores before and after physiotherapy on day one, total opiate administered, time to physiotherapy goals and length of stay. Randomisation was by sealed envelope. The assessor was blinded and the patients partially blinded to the intervention. Ten patients were excluded, eight before randomisation. The trial is complete. Forty patients were analysed for the primary outcome measure. The local infiltration group had significantly lower pain scores at 4h post-operatively; mean [SD] score 2.1 [2.6] versus 6.8 [3.2], p<0.00001 and on post-operative day one prior to physiotherapy; mean score 2.4 [2.3] versus 4.4 [2.3], p<0.05. Total opiate use was also significantly lower in the local infiltration group; mean total 115 [50.3]mg versus 176.5 [103.5]mg, p<0.01. There was no difference in any other outcome. There were no harms as a result of either intervention. Intraoperative local infiltration gives superior pain relief compared to single shot femoral nerve block over the first 24h following primary TKR and minimises post-operative opiate use. Copyright © 2013 Elsevier B.V. All rights reserved.

Dismantling multicomponent behavioral treatment for insomnia in older adults: a randomized controlled trial.

PubMed

Epstein, Dana R; Sidani, Souraya; Bootzin, Richard R; Belyea, Michael J

2012-06-01

Recently, the use of multicomponent insomnia treatment has increased. This study compares the effect of single component and multicomponent behavioral treatments for insomnia in older adults after intervention and at 3 months and 1 yr posttreatment. A randomized, controlled study. Veterans Affairs medical center. 179 older adults (mean age, 68.9 yr ± 8.0; 115 women [64.2%]) with chronic primary insomnia. Participants were randomly assigned to 6 wk of stimulus control therapy (SCT), sleep restriction therapy (SRT), the 2 therapies combined into a multicomponent intervention (MCI), or a wait-list control group. Primary outcomes were subjective (daily sleep diary) and objective (actigraphy) measures of sleep-onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), and sleep efficiency (SE). Secondary outcomes were clinical measures including response and remission rates. There were no differences between the single and multicomponent interventions on primary sleep outcomes measured by diary and actigraphy. All treatments produced significant improvement in diary-reported sleep in comparison with the control group. Effect sizes for sleep diary outcomes were medium to large. Treatment gains were maintained at follow-up for diary and actigraph measured SOL, WASO, and SE. The MCI group had the largest proportion of treatment remitters. For older adults with chronic primary insomnia, the findings provide initial evidence that SCT, SRT, and MCI are equally efficacious and produce sustainable treatment gains on diary, actigraphy, and clinical outcomes. From a clinical perspective, MCI may be a preferred treatment due to its higher remission rate. Behavioral Intervention for Insomnia in Older Adults. NCT01154023. URL: http://clinicaltrials.gov/ct2/show/NCT01154023?term=Behavioral+Intervention+for+Insomnia+in+Older+Adults&rank=1.

Intralesional cryotherapy versus excision and corticosteroids or brachytherapy for keloid treatment: study protocol for a randomised controlled trial

PubMed Central

2013-01-01

Background Keloids are a burden for patients due to physical, aesthetic and social complaints and treatment remains a challenge because of therapy resistance and high recurrence rates. The main goal of treatment is to improve the quality of life (QoL); this implies that, apart from surgical outcomes, patient-reported outcome measures (PROMs) need to be taken into account. Decision making in keloid treatment is difficult due to heterogeneity of the condition and the lack of comparative studies. Methods/Design This is a multicentre, randomised controlled open trial that compares 1) intralesional cryotherapy versus excision and corticosteroids for primary keloids, and 2) intralesional cryotherapy versus excision and brachytherapy for therapy-resistant keloids. The primary outcome is the Patient and Observer Scar Assessment Scale (POSAS), a 12-item scale (with score 12 indicating the best and 120 indicating the worst scar imaginable). A difference of six points on the total score is considered to be of clinical importance. Secondary outcomes are recurrence rates, volume reduction, Skindex-29 scores, SF-36 scores and complication rates. Primary and secondary outcome measurements are taken at baseline, and at 2, 12, 26 and 52 weeks postoperatively. For analysis, a linear mixed model is used. A total of 176 patients will be included over a period of 2.5 years. The protocol is approved by the Medical Ethics Committee of the Erasmus University Medical Centre Rotterdam and follows good clinical practice guidelines. Discussion The outcomes of this study will improve evidence-based decision making for the treatment of keloids, as well as patient education. Trial registration Dutch Trial Register NTR4151. PMID:24354714

Do the EULAR Sjögren's syndrome outcome measures correlate with health status in primary Sjögren's syndrome?

PubMed

Lendrem, Dennis; Mitchell, Sheryl; McMeekin, Peter; Gompels, Luke; Hackett, Katie; Bowman, Simon; Price, Elizabeth; Pease, Colin T; Emery, Paul; Andrews, Jacqueline; Lanyon, Peter; Hunter, John; Gupta, Monica; Bombardieri, Michele; Sutcliffe, Nurhan; Pitzalis, Costantino; McLaren, John; Cooper, Annie; Regan, Marian; Giles, Ian; Isenberg, David; Saravanan, Vadivelu; Coady, David; Dasgupta, Bhaskar; McHugh, Neil; Young-Min, Steven; Moots, Robert; Gendi, Nagui; Akil, Mohammed; Griffiths, Bridget; Ng, Wan-Fai

2015-04-01

This study sets out to investigate the relationship between health status [EuroQol five-dimensions questionnaire (EQ-5D)] in primary SS and three of the European League Against Rheumatism (EULAR) SS outcome measures-the disease activity index (ESSDAI), the patient reported index (ESSPRI) and the sicca score. In particular, the goal was to establish whether there is a relationship between the EULAR outcome measures and quality of life. Health status was evaluated using a standardized measure developed by the EuroQol Group-the EQ5D. This permits calculation of two measures of health status: time trade-off (TTO) values and the EQ-5D visual analogue scale (VAS) scores. We used Spearman's rank correlation analysis to investigate the strength of association between health status and three EULAR measures of physician- and patient-reported disease activity in 639 patients from the UK primary SS registry (UKPSSR) cohort. This study demonstrates that the EULAR SS disease-specific outcome measures are significantly correlated with health outcome values (P < 0.001). Higher scores on the ESSDAI, EULAR sicca score and ESSPRI are associated with poorer health states-i.e. lower TTO values and lower VAS scores. While all three are significantly correlated with TTO values and EQ-5D VAS scores, the effect is strongest for the ESSPRI. This study provides further evidence supporting the use of ESSDAI, EULAR sicca score and ESSPRI measures in the clinic. We also discuss the need for disease-specific measures of health status and their comparison with standardized health outcome measures. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Out of School Activities during Primary School and KS2 Attainment. Centre for Longitudinal Studies Working Paper 2016/1

ERIC Educational Resources Information Center

Chanfreau, Jenny; Tanner, Emily; Callanan, Meg; Laing, Karen; Skipp, Amy; Todd, Liz

2016-01-01

The aims of this working paper were to investigate whether taking part in out of school activities during primary school is linked with end of primary school attainment and social, emotional and behavioural outcomes, for all children and specifically for children from economically disadvantaged backgrounds. The analysis is based on the Millennium…

The Impacts of Retention, Expenditures, and Class Size on Primary School Completion in Sub-Saharan Africa: A Cross-National Analysis

ERIC Educational Resources Information Center

Ruff, Ryan Richard

2016-01-01

Education in Sub-Saharan Africa is increasingly viewed as a means of emancipation and a transformative project for social mobility. Developing nations have pursued policies such as universal or free primary education to increase access to education and improve student outcomes. In this study, direct and indirect precursors to primary school…

What? Me? Teach Dance? Background and Confidence of Primary Preservice Teachers in Dance Education across Five Countries

ERIC Educational Resources Information Center

Russell-Bowie, Deirdre E.

2013-01-01

In primary schools across many countries, dance is now included within the arts key learning area with its own outcomes and content. But as future teachers of dance and other art forms, how do preservice generalist primary teachers perceive their background and confidence in relation to dance and dance education? This study investigates the…

Correlation of Cognitive and Social Outcomes among Children with Autism Spectrum Disorder in a Randomized Trial of Behavioral Intervention

ERIC Educational Resources Information Center

Locke, Jill; Rotheram-Fuller, Erin; Xie, Ming; Harker, Colleen; Mandell, David

2014-01-01

Although social impairments are considered the hallmark deficit of autism, many behavioral intervention studies rely on cognitive functioning as a primary outcome. Fewer studies have examined whether changes in cognition are associated with changes in social functioning. This study examined whether cognitive gains among 192 students from 47…

Endoscopic versus surgical treatment of ampullary adenomas: a systematic review and meta-analysis

PubMed Central

Mendonça, Ernesto Quaresma; Bernardo, Wanderley Marques; de Moura, Eduardo Guimarães Hourneaux; Chaves, Dalton Marques; Kondo, André; Pu, Leonardo Zorrón Cheng Tao; Baracat, Felipe Iankelevich

2016-01-01

The aim of this study is to address the outcomes of endoscopic resection compared with surgery in the treatment of ampullary adenomas. A systematic review and meta-analysis were performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations. For this purpose, the Medline, Embase, Cochrane, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), Scopus and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases were scanned. Studies included patients with ampullary adenomas and data considering endoscopic treatment compared with surgery. The entire analysis was based on a fixed-effects model. Five retrospective cohort studies were selected (466 patients). All five studies (466 patients) had complete primary resection data available and showed a difference that favored surgical treatment (risk difference [RD] = -0.24, 95% confidence interval [CI] = -0.44 to -0.04). Primary success data were identified in all five studies as well. Analysis showed that the surgical approach outperformed endoscopic treatment for this outcome (RD = -0.37, 95% CI = -0.50 to -0.24). Recurrence data were found in all studies (466 patients), with a benefit indicated for surgical treatment (RD = 0.10, 95% CI = -0.01 to 0.19). Three studies (252 patients) presented complication data, but analysis showed no difference between the approaches for this parameter (RD = -0.15, 95% CI = -0.53 to 0.23). Considering complete primary resection, primary success and recurrence outcomes, the surgical approach achieves significantly better results. Regarding complication data, this systematic review concludes that rates are not significantly different. PMID:26872081

Measuring the prevalence and impact of poor menstrual hygiene management: a quantitative survey of schoolgirls in rural Uganda

PubMed Central

Hennegan, Julie; Wu, Maryalice; Scott, Linda; Montgomery, Paul

2016-01-01

Objectives The primary objective was to describe Ugandan schoolgirls’ menstrual hygiene management (MHM) practices and estimate the prevalence of inadequate MHM. Second, to assess the relative contribution of aspects of MHM to health, education and psychosocial outcomes. Design Secondary analysis of survey data collected as part of the final follow-up from a controlled trial of reusable sanitary pad and puberty education provision was used to provide a cross-sectional description of girls’ MHM practices and assess relationships with outcomes. Setting Rural primary schools in the Kamuli district, Uganda. Participants Participants were 205 menstruating schoolgirls (10–19 years) from the eight study sites. Primary and secondary outcome measures The prevalence of adequate MHM, consistent with the concept definition, was estimated using dimensions of absorbent used, frequency of absorbent change, washing and drying procedures and privacy. Self-reported health, education (school attendance and engagement) and psychosocial (shame, insecurity, embarrassment) outcomes hypothesised to result from poor MHM were assessed as primary outcomes. Outcomes were measured through English surveys loaded on iPads and administered verbally in the local language. Results 90.5% (95% CI 85.6% to 93.9%) of girls failed to meet available criteria for adequate MHM, with no significant difference between those using reusable sanitary pads (88.9%, 95% CI 79.0% to 94.4%) and those using existing methods, predominantly cloth (91.5%, 95% CI 85.1% to 95.3%; χ2 (1)=0.12, p=0.729). Aspects of MHM predicted some consequences including shame, not standing in class to answer questions and concerns about odour. Conclusions This study was the first to assess the prevalence of MHM consistent with the concept definition. Results suggest that when all aspects of menstrual hygiene are considered together, the prevalence is much higher than has previously been reported based on absorbents alone. The work demonstrates an urgent need for improved assessment and reporting of MHM, and for primary research testing the links between menstrual management and health, education and psychosocial consequences. PMID:28039290

Mental health nurses in primary care: qualitative outcomes of the Mental Health Nurse Incentive Program.

PubMed

Lakeman, Richard

2013-10-01

The Mental Health Nurse Incentive Program (MHNIP) is a government-funded programme, which, since 2007, has enabled mental health nurses to work in primary care settings in Australia in collaboration with general practitioners (GPs) or private psychiatrists. To date, small-scale qualitative studies have explored outcomes of the programme from the point of view of nurses, consumers, and the perceptions of GPs. This study reports on an on-line survey of credentialed mental health nurses perceptions of outcomes of the MHNIP. Two hundred and twenty five nurses who worked in MHNIP provided detailed narrative responses that were examined using thematic content analysis. The most commonly-cited outcomes were reductions in symptoms or improved coping, improved relationships, and enhanced community participation. Other reported outcomes included reduced hospitalization or use of state-funded mental health services, better use of health services, the continuation or establishment of meaningful occupation, improved physical health and medication management, less use of coercive interventions, and greater independence. © 2013 The Author; International Journal of Mental Health Nursing © 2013 Australian College of Mental Health Nurses Inc.

Dissemination of Cognitive Therapy for Panic Disorder in Primary Care

PubMed Central

Grey, Nick; Salkovskis, Paul; Quigley, Alexandra; Clark, David M.; Ehlers, Anke

2011-01-01

This study investigated whether brief training in cognitive therapy for panic disorder (Clark et al., 1994) can improve the outcomes that primary care therapists obtain with their patients. Seven primary care therapists treated 36 patients meeting DSM-IV (APA, 1994) criteria for panic disorder with or without agoraphobia in general practice surgeries. Outcomes for the cohort of patients whom the therapists treated with their usual methods (treatment-as-usual) before the training (N = 12) were compared with those obtained with similar patients treated by the same therapists after brief training and ongoing supervision in cognitive therapy (CT) for panic disorder (N = 24). Treatment-as-usual led to significant improvements in panic severity, general anxiety, and depression. However, only a small proportion (17% of the intent-to-treat sample) became panic free and there was no improvement in agoraphobic avoidance. Patients treated with CT achieved significantly better outcomes on all measures of panic attacks, including panic-free rate (54%, intent-to-treat), and showed significantly greater improvements in agoraphobic avoidance and patient-rated general anxiety. In conclusion, cognitive therapy for panic disorder can be successfully disseminated in primary care with a brief therapist training and supervision programme that leads to significant improvements in patient outcomes. PMID:22661906

Outcomes of Subsyndromal Depression in Older Primary Care Patients

PubMed Central

Grabovich, Andrew; Lu, Naiji; Tang, Wan; Tu, Xin; Lyness, Jeffrey M.

2010-01-01

Objectives Most older persons in primary care suffering clinically significant depressive symptoms do not meet criteria for major or minor depression. We tested the hypothesis that patients with subsyndromal depression (SSD) would have poorer psychiatric, medical, and functional outcomes at follow-up than non-depressed patients, but not as poor as those with minor or major depression. We also explored the relative outcomes of three definitions of SSD to determine their relative prognostic value. Design Prospective observational cohort study. Setting Primary care practices in Monroe County, NY. Participants 481 primary care patients age ≥65 years who completed research assessments at intake and at least one year of follow-up evaluation. Measurements Depression diagnoses and three definitions of SSD were determined by the Structured Clinical Interview for DSM-IV and the 24-item Hamilton Depression Rating Scale. Other validated measures assessed anxiety, cognition, medical burden, and functional status. Results Patients with SSD had poorer 1-year lagged outcomes than non-depressed subjects in terms of psychiatric symptoms and functional status, often not significantly different than major or minor depression. Two of the SSD definitions identified subjects with poorer psychiatric and functional outcomes than the third SSD definition. Conclusions Clinicians should be vigilant in caring for patients with SSD, monitoring for persistent or worsening depressive symptoms including suicidality, anxiety, cognitive impairment, and functional decline. Researchers may use particular SSD definitions to identify individuals at higher risk of poor outcomes, to better understand the relationships of SSD to functional disability and to test innovative preventive and therapeutic interventions. PMID:20173424

A Review of Preventative Methods against Human Leishmaniasis Infection

PubMed Central

Stockdale, Lisa; Newton, Robert

2013-01-01

Background Leishmaniasis is an intracellular parasitic infection transmitted to humans via the sandfly. Approximately 350 million people are at risk of contracting the disease and an estimated 1.6 million new cases occur annually. Of the two main forms, visceral and cutaneous, the visceral form is fatal in 85–90% of untreated cases. Aims This literature review aims to identify and evaluate the current evidence base for the use of various preventative methods against human leishmaniasis. Methods A literature search was performed of the relevant database repositories for primary research conforming to a priori inclusion and exclusion criteria. Results A total of 84 controlled studies investigating 12 outcome measures were identified, implementing four broad categories of preventative interventions: animal reservoir control, vector population control, human reservoir control and a category for multiple concurrently implemented interventions. The primary studies investigated a heterogeneous mix of outcome measures using a range of different methods. Conclusions This review highlights an absence of research measuring human-specific outcomes (35% of the total) across all intervention categories. The apparent inability of study findings to be generalizable across different geographic locations, points towards gaps in knowledge regarding the biology of transmission of Leishmania in different settings. More research is needed which investigates human infection as the primary outcome measure as opposed to intermediate surrogate markers, with a focus on developing a human vaccine. PMID:23818997

Employment Outcomes of Transition-Aged Adults with Autism Spectrum Disorders: A State of the States Report

ERIC Educational Resources Information Center

Burgess, Sloane; Cimera, Robert E.

2014-01-01

The primary purpose of this study was to evaluate the employment outcomes of transition-aged adults with autism spectrum disorders (ASD) served by vocational rehabilitation services (VR) over the last 10 years by state. A secondary purpose was to compare employment outcomes of individuals with ASD to those of the overall transition-aged population…

Some Learning Outcomes from a Science Programme for Pre-service Primary Teachers Undertaken in the Context of a Developing Country.

ERIC Educational Resources Information Center

Taylor, Neil; Lucas, Keith B.

2001-01-01

Studied the learning outcomes of a science teaching program for preservice teachers in Fiji using quantitative and qualitative techniques. Results for 24 teachers show that students involved in the constructivist pedagogy generally developed a deeper conceptual understanding of the topic, and in some cases these learning outcomes could be linked…

Parent and Teacher Perceptions of Participation and Outcomes in an Intensive Communication Intervention for Children with Pragmatic Language Impairment

ERIC Educational Resources Information Center

Baxendale, Janet; Lockton, Elaine; Adams, Catherine; Gaile, Jacqueline

2013-01-01

Background: Treatment trials that enquire into parents' and teachers' views on speech-language interventions and outcomes for primary school-age children are relatively rare. The current study sought perceptions of the process of intervention and value placed on outcomes resulting from a trial of intervention, the Social Communication Intervention…

A multicentre randomised controlled trial of levetiracetam versus phenytoin for convulsive status epilepticus in children (protocol): Convulsive Status Epilepticus Paediatric Trial (ConSEPT) - a PREDICT study.

PubMed

Dalziel, Stuart R; Furyk, Jeremy; Bonisch, Megan; Oakley, Ed; Borland, Meredith; Neutze, Jocelyn; Donath, Susan; Sharpe, Cynthia; Harvey, Simon; Davidson, Andrew; Craig, Simon; Phillips, Natalie; George, Shane; Rao, Arjun; Cheng, Nicholas; Zhang, Michael; Sinn, Kam; Kochar, Amit; Brabyn, Christine; Babl, Franz E

2017-06-22

Convulsive status epilepticus (CSE) is the most common life-threatening childhood neurological emergency. Despite this, there is a lack of high quality evidence supporting medication use after first line benzodiazepines, with current treatment protocols based solely on non-experimental evidence and expert opinion. The current standard of care, phenytoin, is only 60% effective, and associated with considerable adverse effects. A newer anti-convulsant, levetiracetam, can be given faster, is potentially more efficacious, with a more tolerable side effect profile. The primary aim of the study presented in this protocol is to determine whether intravenous (IV) levetiracetam or IV phenytoin is the better second line treatment for the emergency management of CSE in children. 200 children aged between 3 months and 16 years presenting to 13 emergency departments in Australia and New Zealand with CSE, that has failed to stop with first line benzodiazepines, will be enrolled into this multicentre open randomised controlled trial. Participants will be randomised to 40 mg/kg IV levetiracetam infusion over 5 min or 20 mg/kg IV phenytoin infusion over 20 min. The primary outcome for the study is clinical cessation of seizure activity five minutes following the completion of the infusion of the study medication. Blinded confirmation of the primary outcome will occur with the primary outcome assessment being video recorded and assessed by a primary outcome assessment team blinded to treatment allocation. Secondary outcomes include: Clinical cessation of seizure activity at two hours; Time to clinical seizure cessation; Need for rapid sequence induction; Intensive care unit (ICU) admission; Serious adverse events; Length of Hospital/ICU stay; Health care costs; Seizure status/death at one-month post discharge. This paper presents the background, rationale, and design for a randomised controlled trial comparing levetiracetam to phenytoin in children presenting with CSE in whom benzodiazepines have failed. This study will provide the first high quality evidence for management of paediatric CSE post first-line benzodiazepines. Prospectively registered with the Australian and New Zealand Clinical Trial Registry (ANZCTR): ACTRN12615000129583 (11/2/2015). UTN U1111-1144-5272. ConSEPT protocol version 4 (12/12/2014).

Laparoscopic versus open 1-stage resection of synchronous liver metastases and primary colorectal cancer

PubMed Central

Yazici, Pinar; Onder, Akin; Benlice, Cigdem; Yigitbas, Hakan; Kahramangil, Bora; Tasci, Yunus; Aksoy, Erol; Aucejo, Federico; Quintini, Cristiano; Miller, Charles; Berber, Eren

2017-01-01

Background The aim of this study is to compare the perioperative and oncologic outcomes of open and laparoscopic approaches for concomitant resection of synchronous colorectal cancer and liver metastases. Methods Between 2006 and 2015, all patients undergoing combined resection of primary colorectal cancer and liver metastases were included in the study (n=43). Laparoscopic and open groups were compared regarding clinical, perioperative and oncologic outcomes. Results There were 29 patients in the open group and 14 patients in the laparoscopic group. The groups were similar regarding demographics, comorbidities, histopathological characteristics of the primary tumor and liver metastases. Postoperative complication rate (44.8% vs. 7.1%, P=0.016) was higher, and hospital stay (10 vs. 6.4 days, P=0.001) longer in the open compared to the laparoscopic group. Overall survival (OS) was comparable between the groups (P=0.10); whereas, disease-free survival (DFS) was longer in laparoscopic group (P=0.02). Conclusions According to the results, in patients, whose primary colorectal cancer and metastatic liver disease was amenable to a minimally invasive resection, a concomitant laparoscopic approach resulted in less morbidity without compromising oncologic outcomes. This suggests that a laparoscopic approach may be considered in appropriate patients by surgeons with experience in both advanced laparoscopic liver and colorectal techniques. PMID:28861371

Laparoscopic versus open 1-stage resection of synchronous liver metastases and primary colorectal cancer.

PubMed

Gorgun, Emre; Yazici, Pinar; Onder, Akin; Benlice, Cigdem; Yigitbas, Hakan; Kahramangil, Bora; Tasci, Yunus; Aksoy, Erol; Aucejo, Federico; Quintini, Cristiano; Miller, Charles; Berber, Eren

2017-08-01

The aim of this study is to compare the perioperative and oncologic outcomes of open and laparoscopic approaches for concomitant resection of synchronous colorectal cancer and liver metastases. Between 2006 and 2015, all patients undergoing combined resection of primary colorectal cancer and liver metastases were included in the study (n=43). Laparoscopic and open groups were compared regarding clinical, perioperative and oncologic outcomes. There were 29 patients in the open group and 14 patients in the laparoscopic group. The groups were similar regarding demographics, comorbidities, histopathological characteristics of the primary tumor and liver metastases. Postoperative complication rate (44.8% vs . 7.1%, P=0.016) was higher, and hospital stay (10 vs . 6.4 days, P=0.001) longer in the open compared to the laparoscopic group. Overall survival (OS) was comparable between the groups (P=0.10); whereas, disease-free survival (DFS) was longer in laparoscopic group (P=0.02). According to the results, in patients, whose primary colorectal cancer and metastatic liver disease was amenable to a minimally invasive resection, a concomitant laparoscopic approach resulted in less morbidity without compromising oncologic outcomes. This suggests that a laparoscopic approach may be considered in appropriate patients by surgeons with experience in both advanced laparoscopic liver and colorectal techniques.

Integrated Approach to Reduce Perinatal Adverse Events: Standardized Processes, Interdisciplinary Teamwork Training, and Performance Feedback.

PubMed

Riley, William; Begun, James W; Meredith, Les; Miller, Kristi K; Connolly, Kathy; Price, Rebecca; Muri, Janet H; McCullough, Mac; Davis, Stanley

2016-12-01

To improve safety practices and reduce adverse events in perinatal units of acute care hospitals. Primary data collected from perinatal units of 14 hospitals participating in the intervention between 2008 and 2012. Baseline secondary data collected from the same hospitals between 2006 and 2007. A prospective study involving 342,754 deliveries was conducted using a quality improvement collaborative that supported three primary interventions. Primary measures include adoption of three standardized care processes and four measures of outcomes. Chart audits were conducted to measure the implementation of standardized care processes. Outcome measures were collected and validated by the National Perinatal Information Center. The hospital perinatal units increased use of all three care processes, raising consolidated overall use from 38 to 81 percent between 2008 and 2012. The harms measured by the Adverse Outcome Index decreased 14 percent, and a run chart analysis revealed two special causes associated with the interventions. This study demonstrates the ability of hospital perinatal staff to implement efforts to reduce perinatal harm using a quality improvement collaborative. Findings help inform the relationship between the use of standardized care processes, teamwork training, and improved perinatal outcomes, and suggest that a multiplicity of integrated strategies, rather than a single intervention, may be essential to achieve high reliability. © Health Research and Educational Trust.

Impact of study outcome on submission and acceptance metrics for peer reviewed medical journals: six year retrospective review of all completed GlaxoSmithKline human drug research studies.

PubMed

Evoniuk, Gary; Mansi, Bernadette; DeCastro, Barbara; Sykes, Jennie

2017-04-21

Objectives  To determine whether the outcome of drug studies influenced submission and/or acceptance rates for publication in peer reviewed medical journals. Design  A six year retrospective review of publication status by study outcome for all human drug research studies conducted by a single industry sponsor (GlaxoSmithKline) that completed from 1 January 2009 to 30 June 2014 and were therefore due for manuscript submission (per the sponsor's policy) to peer reviewed journals within 18 months of study completion-that is, 31 December 2015. In addition, manuscripts from studies completing after 30 June 2014 were included irrespective of outcome if they were submitted before 31 December 2015. Setting  Studies conducted by a single industry sponsor (GlaxoSmithKline) Studies reviewed  1064 human drug research studies. Main outcome measures  All studies were assigned a publication status at 26 February 2016 including (as applicable): study completion date, date of first primary manuscript submission, number of submissions, journal decision(s), and publication date. All studies were also classified with assessors blinded to publication status as "positive" (perceived favorable outcome for the drug under study), "negative" (perceived unfavorable outcome for the drug under study), mixed, or non-comparative based on the presence and outcome of the primary outcome measure(s) for each study. "Negative" studies included safety studies in which the primary outcome was achieved but was adverse for the drug under study. For the total cohort and each of the four study outcomes, measures included descriptive statistics for study phase, time from study completion to submission and publication, and number and outcome (accepted/rejected) of publication submissions. Results  Of the 1064 studies (phase I-IV, interventional and non-interventional) included, 321 had study outcomes classified as positive, 155 as negative, 52 as mixed, and 536 as non-comparative. At the time of publication cut-off date (26 February 2016), 904 (85%) studies had been submitted for publication as full manuscripts and 751 (71%) had been successfully published or accepted, with 100 (9%) still under journal review. An additional 77 (7%) studies were conference abstracts and were not included in submission or publication rates. Submission rates by study outcome were 79% for the 321 studies with positive outcomes, 92% for the 155 with negative outcomes, 94% for the 52 with mixed outcomes, and 85% for the 536 non-comparative studies; while rates of publication at the cut-off date were 66%, 77%, 77%, and 71%, respectively. Median time from study completion to submission was 537 days (interquartile range 396-638 days) and 823 days (650-1063 days) from completion to publication, with similar times observed across study outcomes. First time acceptance rates were 56% for studies with positive outcomes and 48% for studies with negative outcomes. Over 10% of studies across all categories required three or more submissions to achieve successful publication. At the time of analysis, 83 studies had not been submitted for publication, including 49 bioequivalence studies with positive outcomes and 33 non-comparative studies. Most studies (98%, 1041/1064) had results posted to one or more public registers, including all studies subject to FDAAA (Food and Drug Administration Amendments Act) requirements for posting to www.clinicaltrials.gov Conclusions  Over the period studied, there was no evidence of submission or publication bias: 92% of studies with negative outcomes were submitted for publication by the cut-off date versus 79% of those with positive outcomes. Publication rates were slightly higher for studies with a negative (that is, unfavorable) outcome compared with a positive outcome, despite a slightly lower rate of acceptance at first submission. Many studies required multiple submission attempts before they were accepted for publication. Analyses focusing solely on publication rates do not take into account unsuccessful efforts to publish. Sponsors and journal editors should share similar information to contribute to better understanding of issues and barriers to full transparency. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Variation among cleft centres in the use of secondary surgery for children with cleft palate: a retrospective cohort study

PubMed Central

Sitzman, Thomas J; Hossain, Monir; Carle, Adam C; Heaton, Pamela C; Britto, Maria T

2017-01-01

Objectives To test whether cleft centres vary in their use of secondary cleft palate surgery, also known as revision palate surgery, and if so to identify modifiable hospital factors and surgeon factors that are associated with use of secondary surgery. Design Retrospective cohort study. Setting Forty-three paediatric hospitals across the USA. Patients Children with cleft lip and palate who underwent primary cleft palate repair from 1999 to 2013. Main outcome measures Time from primary cleft palate repair to secondary palate surgery. Results We identified 4939 children who underwent primary cleft palate repair. At 10 years after primary palate repair, 44% of children had undergone secondary palate surgery. Significant variation existed among hospitals (p<0.001); the proportion of children undergoing secondary surgery by 10 years ranged from 9% to 77% across hospitals. After adjusting for patient demographics, primary palate repair before 9 months of age was associated with an increased hazard of secondary palate surgery (initial HR 6.74, 95% CI 5.30 to 8.73). Postoperative antibiotics, surgeon procedure volume and hospital procedure volume were not associated with time to secondary surgery (p>0.05). Of the outcome variation attributable to hospitals and surgeons, between-hospital differences accounted for 59% (p<0.001), while between-surgeon differences accounted for 41% (p<0.001). Conclusions Substantial variation in the hazard of secondary palate surgery exists depending on a child’s age at primary palate repair and the hospital and surgeon performing their repair. Performing primary palate repair before 9 months of age substantially increases the hazard of secondary surgery. Further research is needed to identify other factors contributing to variation in palate surgery outcomes among hospitals and surgeons. PMID:29479567

Psychiatrist Availability, Social Disintegration, and Suicide Deaths in U.S. Counties, 1990-1995

ERIC Educational Resources Information Center

Kposowa, Augustine J.

2009-01-01

Previous studies have found that primary care resources are associated with various health outcomes. The primary purpose of the study was to test for associations between psychiatrist availability, social disintegration and suicide rates. Data utilized were from the 2002 Area Resource File on U.S. counties (N=3080). Suicide rates were averaged…

Top studies relevant to primary care practice.

PubMed

Perry, Danielle; Kolber, Michael R; Korownyk, Christina; Lindblad, Adrienne J; Ramji, Jamil; Ton, Joey; Allan, G Michael

2018-04-01

To summarize 10 high-quality studies from 2017 that have strong relevance to primary care practice. Study selection involved routine literature surveillance by a group of primary care health professionals. This included screening abstracts of important journals and Evidence Alerts, as well as searching the American College of Physicians Journal Club. Topics of the 2017 articles include whether treating subclinical hypothyroidism improves outcomes or symptoms; whether evolocumab reduces cardiovascular disease as well as low-density lipoprotein levels; whether lifestyle interventions reduce medication use in patients with diabetes; whether vitamin D prevents cardiovascular disease, cancer, or upper respiratory tract infections; whether canagliflozin reduces clinical events in patients with diabetes; how corticosteroid injections affect knee osteoarthritis; whether drained abscesses benefit from antibiotic treatment; whether patients with diabetes benefit from bariatric surgery; whether exenatide reduces clinical events in patients with diabetes; and whether tympanostomy tubes affect outcomes in recurrent acute otitis media or chronic otitis media. We provide brief summaries, context where needed, and final recommendations for 10 studies with potential effects on primary care. We also briefly review 5 "runner-up" studies. Research from 2017 produced several high-quality studies in diabetes management. These have demonstrated benefit for alternative therapies and offered evidence not previously available. This year's selection of studies also provided information on a variety of conditions and therapies that are, or might become, more common in primary care settings. Copyright© the College of Family Physicians of Canada.

Prospective research on infants with mild encephalopathy: the PRIME study.

PubMed

Prempunpong, C; Chalak, L F; Garfinkle, J; Shah, B; Kalra, V; Rollins, N; Boyle, R; Nguyen, K-A; Mir, I; Pappas, A; Montaldo, P; Thayyil, S; Sánchez, P J; Shankaran, S; Laptook, A R; Sant'Anna, G

2018-01-01

To determine short-term outcomes of infants with evidence of hypoxia-ischemia at birth and classified as mild neonatal encephalopathy (NE) at <6 h of age. Prospective multicenter study. Mild NE was defined as ⩾1 abnormal category in modified Sarnat score. Primary outcome was any abnormality on early amplitude integrated electroencephalogram (aEEG) or seizures, abnormal brain magnetic resonance imaging (MRI) or neurological exam at discharge. A total of 54/63 (86%) of enrolled infants had data on components of the primary outcome, which was abnormal in 28/54 (52%): discontinuous aEEG (n=4), MRI (n=9) and discharge exam (n=22). Abnormal tone and/or incomplete Moro were the most common findings. MRI abnormalities were confined to cerebral cortex but two infants had basal ganglia and/or thalamus involvement. The 18 to 24 months follow-up is ongoing. A larger than expected proportion of mild NE infants with abnormal outcomes was observed. Future research should evaluate safety and efficacy of neuroprotection for mild NE.

[TECOS: confirmation of the cardiovascular safety of sitaliptin].

PubMed

Scheen, A J; Paquot, N

2015-10-01

The cardiovascular safety of sitagliptin has been evaluated in TECOS ("Trial Evaluating Cardiovascular Outcomes with Sitagliptin"). TECOS recruited patients with type 2 diabetes and a history of cardiovascular disease who received, as add-on to their usual therapy, either sitagliptin (n = 7.257) or placebo (n = 7.266), with a median follow-up of 3 years. The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome (hazard ratio, 0.98; 95% confidence interval, 0.88 to 1.09; P<0.001). Rates of hospitalization for heart failure did not differ between the two groups (hazard ratio, 1.00; 95% CI, 0.83 to 1.20; P=0.98). The cardiovascular safety of sitagliptin, which was already shown in meta-analyses of phase II-III randomised controlled trials and in observational cohort studies in real life, is now confirmed in the landmark prospective cardiovascular outcome study TECOS.

Service Use and Satisfaction Following Acquired Brain Injury: A Preliminary Analysis of Family Caregiver Outcomes

ERIC Educational Resources Information Center

Degeneffe, Charles Edmund; Green, Richard; Jones, Clair

2016-01-01

Purpose: The study aimed to understand how use and satisfaction with services following discharge from an acquired brain injury (ABI) acute-care facility related to family caregiver outcomes. Methods: A correlational and descriptive study design was used. Nineteen primary family caregivers of persons recently discharged from an ABI acute-care…

Textbook Pages to Salary Wages: An Examination of the Relationship between Cooperative Education and Early Employment Outcomes

ERIC Educational Resources Information Center

Grover-Bisker, Edna M.

2011-01-01

This study examined the relationship between cooperative education (co-op) and the early career outcomes of graduates at Missouri University of Science and Technology, a science and technological research university in the Midwest. The study's primary purpose was to provide university leadership with a quantitative evaluation of the university's…

Students' Conceptions of and Approaches to Knowledge Building and Its Relationship to Learning Outcomes

ERIC Educational Resources Information Center

Tsai, Pei-Shan; Chai, Ching Sing; Hong, Huang-Yao; Koh, Joyce Hwee Ling

2017-01-01

The purpose of this study is to investigate the relationships among students' conceptions of knowledge building, approaches to knowledge building, knowledge-building behaviors and learning outcomes. A total of 48 primary school students (from grades 3 and 4) who had experienced knowledge-building activities participated in the present study. After…

Adolescent Risk Screening Instruments for Primary Care: An Integrative Review Utilizing the Donabedian Framework.

PubMed

Hiott, Deanna B; Phillips, Shannon; Amella, Elaine

2017-07-31

Adolescent risk-taking behavior choices can affect future health outcomes. The purpose of this integrative literature review is to evaluate adolescent risk screening instruments available to primary care providers in the United States using the Donabedian Framework of structure, process, and outcome. To examine the literature concerning multidimensional adolescent risk screening instruments available in the United States for use in the primary care setting, library searches, ancestry searches, and Internet searches were conducted. Library searches included a systematic search of the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Academic Search Premier, Health Source Nursing Academic Ed, Medline, PsycINFO, the Psychology and Behavioral Sciences Collection, and PubMed databases with CINAHL headings using the following Boolean search terms: "primary care" and screening and pediatric. Criteria for inclusion consisted of studies conducted in the United States that involved broad multidimensional adolescent risk screening instruments for use in the pediatric primary care setting. Instruments that focused solely on one unhealthy behavior were excluded, as were developmental screens and screens not validated or designed for all ages of adolescents. In all 25 manuscripts reviewed, 16 screens met the inclusion criteria and were included in the study. These 16 screens were examined for factors associated with the Donabedian structure-process-outcome model. This review revealed that many screens contain structural issues related to cost and length that inhibit provider implementation in the primary care setting. Process limitations regarding the report method and administration format were also identified. The Pediatric Symptom Checklist was identified as a free, short tool that is valid and reliable.

A systematic review of lifestyle counseling for diverse patients in primary care.

PubMed

Melvin, Cathy L; Jefferson, Melanie S; Rice, LaShanta J; Nemeth, Lynne S; Wessell, Andrea M; Nietert, Paul J; Hughes-Halbert, Chanita

2017-07-01

Prior research and systematic reviews have examined strategies related to weight management, less is known about lifestyle and behavioral counseling interventions optimally suited for implementation in primary care practices generally, and among racial and ethnic patient populations. Primary care practitioners may find it difficult to access and use available research findings on effective behavioral and lifestyle counseling strategies and to assess their effects on health behaviors among their patients. This systematic review compiled existing evidence from randomized trials to inform primary care providers about which lifestyle and behavioral change interventions are shown to be effective for changing patients' diet, physical activity and weight outcomes. Searches identified 444 abstracts from all sources (01/01/2004-05/15/2014). Duplicate abstracts were removed, selection criteria applied and dual abstractions conducted for 106 full text articles. As of June 12, 2015, 29 articles were retained for inclusion in the body of evidence. Randomized trials tested heterogeneous multi-component behavioral interventions for an equally wide array of outcomes in three population groups: diverse patient populations (23 studies), African American patients only (4 studies), and Hispanic/Mexican American/Latino patients only (2 studies). Significant and consistent findings among diverse populations showed that weight and physical activity related outcomes were more amenable to change via lifestyle and behavioral counseling interventions than those associated with diet modification. Evidence to support specific interventions for racial and ethnic minorities was promising, but insufficient based on the small number of studies. Copyright © 2017. Published by Elsevier Inc.

Accounting for competing risks in randomized controlled trials: a review and recommendations for improvement.

PubMed

Austin, Peter C; Fine, Jason P

2017-04-15

In studies with survival or time-to-event outcomes, a competing risk is an event whose occurrence precludes the occurrence of the primary event of interest. Specialized statistical methods must be used to analyze survival data in the presence of competing risks. We conducted a review of randomized controlled trials with survival outcomes that were published in high-impact general medical journals. Of 40 studies that we identified, 31 (77.5%) were potentially susceptible to competing risks. However, in the majority of these studies, the potential presence of competing risks was not accounted for in the statistical analyses that were described. Of the 31 studies potentially susceptible to competing risks, 24 (77.4%) reported the results of a Kaplan-Meier survival analysis, while only five (16.1%) reported using cumulative incidence functions to estimate the incidence of the outcome over time in the presence of competing risks. The former approach will tend to result in an overestimate of the incidence of the outcome over time, while the latter approach will result in unbiased estimation of the incidence of the primary outcome over time. We provide recommendations on the analysis and reporting of randomized controlled trials with survival outcomes in the presence of competing risks. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.

Accounting for competing risks in randomized controlled trials: a review and recommendations for improvement

PubMed Central

Fine, Jason P.

2017-01-01

In studies with survival or time‐to‐event outcomes, a competing risk is an event whose occurrence precludes the occurrence of the primary event of interest. Specialized statistical methods must be used to analyze survival data in the presence of competing risks. We conducted a review of randomized controlled trials with survival outcomes that were published in high‐impact general medical journals. Of 40 studies that we identified, 31 (77.5%) were potentially susceptible to competing risks. However, in the majority of these studies, the potential presence of competing risks was not accounted for in the statistical analyses that were described. Of the 31 studies potentially susceptible to competing risks, 24 (77.4%) reported the results of a Kaplan–Meier survival analysis, while only five (16.1%) reported using cumulative incidence functions to estimate the incidence of the outcome over time in the presence of competing risks. The former approach will tend to result in an overestimate of the incidence of the outcome over time, while the latter approach will result in unbiased estimation of the incidence of the primary outcome over time. We provide recommendations on the analysis and reporting of randomized controlled trials with survival outcomes in the presence of competing risks. © 2017 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. PMID:28102550

Transfer from primary maternity unit to tertiary hospital in New Zealand - timing, frequency, reasons, urgency and outcomes: Part of the Evaluating Maternity Units study.

PubMed

Grigg, Celia P; Tracy, Sally K; Tracy, Mark; Schmied, Virginia; Monk, Amy

2015-09-01

to examine the transfers from primary maternity units to a tertiary hospital in New Zealand by describing the frequency, timing, reasons and outcomes of those who had antenatal or pre-admission birthplace plan changes, and transfers in labour or postnatally. mixed methods prospective (concurrent) cohort study, which analysed transfer and clinical outcome data (407 primary unit cohort, 285 tertiary hospital cohort), and data from the six week postpartum survey (571 respondents). well, pregnant women booked to give birth in a tertiary maternity hospital or primary maternity unit in one region in New Zealand (2010-2012). All women received midwifery continuity of care, regardless of their intended or actual birthplace. fewer than half of the women who planned a primary unit birth gave birth there (191 or 46.9%). A change of plan may have been made either antenatally or before admission in labour; and transfers were made after admission to the primary unit in labour or during the postnatal stay (about 48 hours). Of the 117 (28.5%) planning a primary unit birth who changed their planned birthplace type antenatally 73 (62.4%) were due to a clinical indication. Earthquakes accounted for 28.1% of birthplace change (during the research period major earthquakes occurred in the study region). Most (73.8%) labour changes occurred before admission in labour to the primary unit. For the 76 women who changed plan at this stage the most common reasons to do so were a rapid labour (25.0%) or prolonged rupture of membranes (23.7%). Transfers in labour from primary unit to tertiary hospital occurred for 27 women (12.6%) of whom 26 (96.3%) were having their first baby. "Slow progress" of labour accounted for 21 (77.8%) of these and 17 (62.9%) were classified as 'non-emergency'. The average transfer time for 'emergency' transfers was 58 minutes. The average time for all labour transfers from specialist consultation to birth was 4.5 hours. Nine postnatal transfers (maternal or neonatal) from a primary unit occurred (4.7%), making a total post-admission transfer rate of 17.3% for the primary unit cohort. birthplace changes were not uncommon, with many women changing their birthplace plan antenatally or prior to admission in labour and some transferring between facilities during or soon after birth. Most changes were due to the development of complications or 'risk factors'. Most transfers were not urgent and took approximately one hour from the decision to arrival at the tertiary hospital. Despite the transfers the neonatal clinical outcomes were comparable between both primary and tertiary cohorts, and there was higher maternal morbidity in the tertiary cohort. although the study size is relatively small, its comprehensive documentation of transfers has the potential to inform future research and the birthplace decision-making of childbearing women and midwives. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Stepped Care to Optimize Pain care Effectiveness (SCOPE) trial study design and sample characteristics.

PubMed

Kroenke, Kurt; Krebs, Erin; Wu, Jingwei; Bair, Matthew J; Damush, Teresa; Chumbler, Neale; York, Tish; Weitlauf, Sharon; McCalley, Stephanie; Evans, Erica; Barnd, Jeffrey; Yu, Zhangsheng

2013-03-01

Pain is the most common physical symptom in primary care, accounting for an enormous burden in terms of patient suffering, quality of life, work and social disability, and health care and societal costs. Although collaborative care interventions are well-established for conditions such as depression, fewer systems-based interventions have been tested for chronic pain. This paper describes the study design and baseline characteristics of the enrolled sample for the Stepped Care to Optimize Pain care Effectiveness (SCOPE) study, a randomized clinical effectiveness trial conducted in five primary care clinics. SCOPE has enrolled 250 primary care veterans with persistent (3 months or longer) musculoskeletal pain of moderate severity and randomized them to either the stepped care intervention or usual care control group. Using a telemedicine collaborative care approach, the intervention couples automated symptom monitoring with a telephone-based, nurse care manager/physician pain specialist team to treat pain. The goal is to optimize analgesic management using a stepped care approach to drug selection, symptom monitoring, dose adjustment, and switching or adding medications. All subjects undergo comprehensive outcome assessments at baseline, 1, 3, 6 and 12 months by interviewers blinded to treatment group. The primary outcome is pain severity/disability, and secondary outcomes include pain beliefs and behaviors, psychological functioning, health-related quality of life and treatment satisfaction. Innovations of SCOPE include optimized analgesic management (including a stepped care approach, opioid risk stratification, and criteria-based medication adjustment), automated monitoring, and centralized care management that can cover multiple primary care practices. Published by Elsevier Inc.

Primary cutaneous melanoma of the scalp: Patterns of recurrence.

PubMed

Sparks, David S; Read, Tavis; Lonne, Michael; Barbour, Andrew P; Wagels, Michael; Bayley, Gerard J; Smithers, B Mark

2017-03-01

Patients with primary melanoma of the scalp have been reported to have worse disease-related outcomes compared with other anatomical regions. There are few studies in the literature specifically addressing recurrence patterns and treatment outcomes for primary scalp melanoma as a discrete anatomical sub-region. We sought to identify key features adversely influencing disease control and survival and to clarify the role of resection plane, margin, and method of reconstruction in the management of this disease process. A retrospective clinical study of medical records was performed evaluating all patients with primary melanoma of the scalp treated at two hospitals in southeast Queensland between 2004 and 2014. A total of 107 patients were eligible for analysis. There were 46 recurrences in 38 patients in the cohort accounting for a recurrence rate of 35.5%. The local recurrence rate was 15.9% with 12 in-transit metastases after diagnosis. Regional and distant recurrence rates were 12.1% and 15%, respectively. At a median follow up of 30.5 months, disease-free survival was 47% and overall survival was also 47%. On multi-variate analysis, the deeper resection plane (sub-galeal) had a lower disease-free survival rate compared with the supra-galeal resection plane (P = 0.032). Our results support the hypothesis that primary scalp melanoma represents a unique aggressive subcategory with high rates of in-transit disease and poor disease-related and survival outcomes. There is a need for robust prospective comparative studies to address the significance of resection plane in the management of patients with scalp melanoma. © 2016 Wiley Periodicals, Inc.

Team-based versus traditional primary care models and short-term outcomes after hospital discharge.

PubMed

Riverin, Bruno D; Li, Patricia; Naimi, Ashley I; Strumpf, Erin

2017-04-24

Strategies to reduce hospital readmission have been studied mainly at the local level. We assessed associations between population-wide policies supporting team-based primary care delivery models and short-term outcomes after hospital discharge. We extracted claims data on hospital admissions for any cause from 2002 to 2009 in the province of Quebec. We included older or chronically ill patients enrolled in team-based or traditional primary care practices. Outcomes were rates of readmission, emergency department visits and mortality in the 90 days following hospital discharge. We used inverse probability weighting to balance exposure groups on covariates and used marginal structural survival models to estimate rate differences and hazard ratios. We included 620 656 index admissions involving 312 377 patients. Readmission rates at any point in the 90-day post-discharge period were similar between primary care models. Patients enrolled in team-based primary care practices had lower 30-day rates of emergency department visits not associated with readmission (adjusted difference 7.5 per 1000 discharges, 95% confidence interval [CI] 4.2 to 10.8) and lower 30-day mortality (adjusted difference 3.8 deaths per 1000 discharges, 95% CI 1.7 to 5.9). The 30-day difference for mortality differed according to morbidity level (moderate morbidity: 1.0 fewer deaths per 1000 discharges in team-based practices, 95% CI 0.3 more to 2.3 fewer deaths; very high morbidity: 4.2 fewer deaths per 1000 discharges, 95% CI 3.0 to 5.3; p < 0.001). Our study showed that enrolment in the newer team-based primary care practices was associated with lower rates of postdischarge emergency department visits and death. We did not observe differences in readmission rates, which suggests that more targeted or intensive efforts may be needed to affect this outcome. © 2017 Canadian Medical Association or its licensors.

A trans-disciplinary approach to the evaluation of social determinants of health in a Hispanic population.

PubMed

Dulin, Michael F; Tapp, Hazel; Smith, Heather A; de Hernandez, Brisa Urquieta; Coffman, Maren J; Ludden, Tom; Sorensen, Janni; Furuseth, Owen J

2012-09-11

Individual and community health are adversely impacted by disparities in health outcomes among disadvantaged and vulnerable populations. Understanding the underlying causes for variations in health outcomes is an essential step towards developing effective interventions to ameliorate inequalities and subsequently improve overall community health. Working at the neighborhood scale, this study examines multiple social determinates that can cause health disparities including low neighborhood wealth, weak social networks, inadequate public infrastructure, the presence of hazardous materials in or near a neighborhood, and the lack of access to primary care services. The goal of this research is to develop innovative and replicable strategies to improve community health in disadvantaged communities such as newly arrived Hispanic immigrants. This project is taking place within a primary care practice-based research network (PBRN) using key principles of community-based participatory research (CBPR). Associations between social determinants and rates of hospitalizations, emergency department (ED) use, and ED use for primary care treatable or preventable conditions are being examined. Geospatial models are in development using both hospital and community level data to identify local areas where interventions to improve disparities would have the greatest impact. The developed associations between social determinants and health outcomes as well as the geospatial models will be validated using community surveys and qualitative methods. A rapidly growing and underserved Hispanic immigrant population will be the target of an intervention informed by the research process to impact utilization of primary care services and designed, deployed, and evaluated using the geospatial tools and qualitative research findings. The purpose of this intervention will be to reduce health disparities by improving access to, and utilization of, primary care and preventative services. The results of this study will demonstrate the importance of several novel approaches to ameliorating health disparities, including the use of CBPR, the effectiveness of community-based interventions to influence health outcomes by leveraging social networks, and the importance of primary care access in ameliorating health disparities.

Effect of primary empty sella syndrome on pituitary surgery for Cushing's disease.

PubMed

Mehta, Gautam U; Bakhtian, Kamran D; Oldfield, Edward H

2014-09-01

Primary empty sella syndrome (ESS) results from herniation of arachnoid mater into the pituitary fossa. It has been suggested to have a negative effect on pituitary surgery; however, outcomes in this cohort have not been defined. This study was performed to determine the effect of ESS on immediate and long-term biochemical outcome after pituitary surgery for Cushing's disease (CD). Using a matched cohort study design, the authors followed patients treated with pituitary surgery for CD with and without ESS. Complete ESS was defined as pituitary gland height ≤ 2 mm, whereas partial ESS was defined as pituitary gland height > 2 mm but less than three-quarters of the total sellar depth. The primary end points were immediate and long-term biochemical outcome. Cerebrospinal fluid leaks were recorded as a secondary end point. Seventy-eight patients with CD and primary ESS were identified and matched with 78 patients with CD without ESS. After surgical management, immediate biochemical remission was achieved in 69 patients (88%) with ESS and 75 controls (96%, p = 0.10). Long-term remission was achieved in most patients in both groups (5-year cure: 85% vs 92%, p = 0.10). Among patients with ESS, the presence of complete ESS predicted a worse long-term outcome (p = 0.04). Intraoperative CSF leaks were significantly more frequent with ESS (54% vs 24%, p < 0.001), and despite sellar floor repair, the rate of postoperative CSF leaks was also increased (6% vs 3%, p = 0.27). Biochemical outcome after pituitary surgery for CD was worse in patients with complete ESS, and the risk of a CSF leak was increased with both partial and complete ESS. However, as outcome remains superior to those following alternative therapies and the biology of these tumors is unchanged in the setting of ESS, pituitary surgery should remain the initial treatment of choice.

Arthroscopic Surgical Procedures Versus Sham Surgery for Patients With Femoroacetabular Impingement and/or Labral Tears: Study Protocol for a Randomized Controlled Trial (HIPARTI) and a Prospective Cohort Study (HARP).

PubMed

Risberg, May Arna; Ageberg, Eva; Nilstad, Agnethe; Lund, Bent; Nordsletten, Lars; Løken, Sverre; Ludvigsen, Tom; Kierkegaard, Signe; Carsen, Sasha; Kostogiannis, Ioannis; Crossley, Kay M; Glyn-Jones, Sion; Kemp, Joanne L

2018-04-01

Study Design Study protocol for a randomized controlled trial and a prospective cohort. Background The number of arthroscopic surgical procedures for patients with femoroacetabular impingement syndrome (FAIS) has significantly increased worldwide, but high-quality evidence of the effect of such interventions is lacking. Objectives The primary objective will be to determine the efficacy of hip arthroscopic procedures compared to sham surgery on patient-reported outcomes for patients with FAIS (HIP ARThroscopy International [HIPARTI] Study). The secondary objective will be to evaluate prognostic factors for long-term outcome after arthroscopic surgical interventions in patients with FAIS (Hip ARthroscopy Prospective [HARP] Study). Methods The HIPARTI Study will include 140 patients and the HARP Study will include 100 patients. The international Hip Outcome Tool-33 will be the primary outcome measure at 1 year. Secondary outcome measures will be the Hip disability and Osteoarthritis Outcome Score, Arthritis Self-Efficacy Scale, fear of movement (Tampa Scale of Kinesiophobia), Patient-Specific Functional Scale, global rating of change score, and expectations. Other outcomes will include active hip range of motion, hip muscle strength tests, functional performance tests, as well as radiological assessments using radiographs and magnetic resonance imaging. Conclusion To determine the true effect of surgery, beyond that of placebo, double-blinded placebo-controlled trials including sham surgery are needed. The HIPARTI Study will direct future evidence-based treatment of FAIS. Predictors for long-term development and progression of degenerative changes in the hip are also needed for this young patient group with FAIS; hence, responders and nonresponders to treatment could be determined. J Orthop Sports Phys Ther 2018;48(4):325-335. doi:10.2519/jospt.2018.7931.

Atherectomy offers no benefits over balloon angioplasty in tibial interventions for critical limb ischemia.

PubMed

Todd, Kevin E; Ahanchi, Sadaf S; Maurer, Christian A; Kim, Jung H; Chipman, Candice R; Panneton, Jean M

2013-10-01

Endovascular adjuncts, like atherectomy, were developed to improve outcomes of endovascular arterial interventions. The true impact of atherectomy on endovascular outcomes remains to be determined, and little data exist on the influence of atherectomy on tibial interventions. Our study compares early and late outcomes of tibial intervention with angioplasty vs atherectomy-assisted interventions. We completed a retrospective review of all tibial interventions between 2008 and 2010. Outcomes were analyzed using single and multivariate analysis, Cox regression, and Kaplan-Meier curves. Primary outcomes were primary, primary assisted, and secondary patency rates, as well as limb salvage and survival rates. Over a 2-year period, 480 tibial interventions were completed for 421 patients. Eighty-seven percent (n = 418) of interventions were performed for critical limb ischemia (CLI) and 13% (n = 62) for claudication. The CLI cohort of 418 interventions was analyzed. These patients had a mean age of 71 years with a mean follow-up time of 16 ± 15 months (range, 0-59 months). Of the 418 interventions, 339 underwent percutaneous transluminal angioplasty (PTA): 333 PTA alone, six PTA + stent. The remaining 79 interventions received atherectomy: 33 laser, 13 directional, and 33 orbital either alone or in conjunction with PTA (11 atherectomy only, 68 atherectomy + PTA). The groups did not differ significantly in terms of demographics, risk factors, or technical success. The atherectomy group had more TASC B lesions (54% vs 38%; P = .013), while the PTA-alone group had more TASC D lesions (25% vs 13%; P = .004). TASC A and C lesions did not differ significantly between the groups. No significant differences existed with respect to the early (30-day) outcomes of loss of patency (11% vs 13%; P = .699), complications (8% vs 13%; P = .292), or major amputation (17% vs 13%; P = .344) in the PTA-alone group vs the atherectomy-assisted group. Kaplan-Meier analysis revealed no difference for all primary outcomes of PTA alone vs the atherectomy-assisted group at 12 and 36 months: primary patency (69%, 55% vs 61%, 46%; P = .158), primary assisted patency (83%, 71% vs 85%, 67%; P = .801), secondary patency (94%, 89% vs 95%, 89%; P = .892), limb salvage (79%, 70% vs 81%, 77%; P = .485), or survival (77%, 56% vs 80%, 50%; P = .944). The adjunctive use of atherectomy offered no improvement in primary outcomes over PTA alone in either early or late outcomes in CLI patients who underwent endovascular tibial interventions. Considering the additional cost and increased procedural time, these findings put into question the routine use of adjunctive atherectomy. Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

Developing a core outcome set for infant colic for primary, secondary and tertiary care settings: a prospective study.

PubMed

Steutel, Nina F; Benninga, Marc A; Langendam, Miranda W; Korterink, Judith J; Indrio, Flavia; Szajewska, Hania; Tabbers, Merit M

2017-05-29

Infant colic (IC) is defined as recurrent and prolonged crying without an obvious cause or evidence of failure to thrive or illness. It is a common problem with a prevalence of 5%-25%. The unknown aetiology results in a wide variety in interventions and use of heterogeneous outcome measures across therapeutic trials. Our aim was to develop a core outcome set (COS) for IC to facilitate and improve evidence synthesis. Prospective study design; primary, secondary and tertiary care. The COS was developed using a modified Delphi technique. First, healthcare professionals (HCPs) and parents of infants with IC were asked to list up to five outcomes they considered relevant in the treatment of IC. Outcomes mentioned by >10% of participants were forwarded to a shortlist. In the second round, outcomes on this shortlist were rated and prioritised. The final COS was defined in a face-to-face expert meeting of paediatricians. F of invited stakeholders (133 HCPs and 55 parents of infants with IC) completed both Delphi rounds. Duration of crying, family stress, sleeping time of infant, quality of life (of family), discomfort of infant and hospital admission/duration were rated as most important outcomes in IC, framing the final COS. The use of this COS should serve as a minimum of outcomes to be measured and reported. This will benefit evidence synthesis, by enhancing homogeneity of outcomes, and enable evaluation of success in therapeutic trials on IC. Researchers are strongly encouraged to use this COS when setting up a clinical trial in primary, secondary and/or tertiary care or performing a systematic review on IC. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Using an internet intervention to support self-management of low back pain in primary care: findings from a randomised controlled feasibility trial (SupportBack)

PubMed Central

Geraghty, Adam W A; Stanford, Rosie; Stuart, Beth; Little, Paul; Roberts, Lisa C; Foster, Nadine E; Hill, Jonathan C; Hay, Elaine M; Turner, David; Malakan, Wansida; Leigh, Linda; Yardley, Lucy

2018-01-01

Objective To determine the feasibility of a randomised controlled trial of an internet intervention for low back pain (LBP) using three arms: (1) usual care, (2) usual care plus an internet intervention or (3) usual care plus an internet intervention with additional physiotherapist telephone support. Design and setting A three-armed randomised controlled feasibility trial conducted in 12 general practices in England. Participants Primary care patients aged over 18 years, with current LBP, access to the internet and without indicators of serious spinal pathology or systemic illness. Interventions The ‘SupportBack’ internet intervention delivers a 6-week, tailored programme, focused on graded goal setting, self-monitoring and provision of tailored feedback to encourage physical activity. Additional physiotherapist telephone support consisted of three brief telephone calls over a 4-week period, to address any concerns and provide reassurance. Outcomes The primary outcomes were the feasibility of the trial design including recruitment, adherence and retention at follow-up. Secondary descriptive and exploratory analyses were conducted on clinical outcomes including LBP-related disability at 3 months follow-up. Results Primary outcomes: 87 patients with LBP were recruited (target 60–90) over 6 months, and there were 3 withdrawals. Adherence to the intervention was higher in the physiotherapist-supported arm, compared with the stand-alone internet intervention. Trial physiotherapists adhered to the support protocol. Overall follow-up rate on key clinical outcomes at 3 months follow-up was 84%. Conclusions This study demonstrated the feasibility of a future definitive randomised controlled trial to determine the clinical and cost-effectiveness of the SupportBack intervention in primary care patients with LBP. Trial registration number ISRCTN31034004; Results. PMID:29525768

Dimensions of socioeconomic status and clinical outcome after primary percutaneous coronary intervention.

PubMed

Jakobsen, Lars; Niemann, Troels; Thorsgaard, Niels; Thuesen, Leif; Lassen, Jens F; Jensen, Lisette O; Thayssen, Per; Ravkilde, Jan; Tilsted, Hans H; Mehnert, Frank; Johnsen, Søren P

2012-10-01

The association between low socioeconomic status (SES) and high mortality from coronary heart disease is well-known. However, the role of SES in relation to the clinical outcome after primary percutaneous coronary intervention remains poorly understood. We studied 7385 patients treated with primary percutaneous coronary intervention. Participants were divided into high-SES and low-SES groups according to income, education, and employment status. The primary outcome was major adverse cardiac events (cardiac death, recurrent myocardial infarction, and target vessel revascularization) at maximum follow-up (mean, 3.7 years). Low-SES patients had more adverse baseline risk profiles than high-SES patients. The cumulative risk of major adverse cardiac events after maximum follow-up was higher among low-income patients and unemployed patients compared with their counterparts (income: hazard ratio, 1.68; 95% CI, 1.47-1.92; employment status: hazard ratio, 1.75; 95% CI, 1.46-2.10). After adjustment for patient characteristics, these differences were substantially attenuated (income: hazard ratio, 1.12; 95% CI, 0.93-1.33; employment status: hazard ratio, 1.27; 95% CI, 1.03-1.56). Further adjustment for admission findings, procedure-related data, and medical treatment during follow-up did not significantly affect the associations. With education as the SES indicator, no between-group differences were observed in the risk of the composite end point. Even in a tax-financed healthcare system, low-SES patients treated with primary percutaneous coronary intervention face a worse prognosis than high-SES patients. The poor outcome seems to be largely explained by differences in baseline patient characteristics. Employment status and income (but not education level) were associated with clinical outcomes.

Lipid Profiles, Inflammatory Markers, and Insulin Therapy in Youth with Type 2 Diabetes.

PubMed

Levitt Katz, Lorraine E; Bacha, Fida; Gidding, Samuel S; Weinstock, Ruth S; El Ghormli, Laure; Libman, Ingrid; Nadeau, Kristen J; Porter, Kristin; Marcovina, Santica

2018-05-01

Data regarding atherogenic dyslipidemia and the inflammation profile in youth with type 2 diabetes is limited and the effect of insulin therapy on these variables has not previously been studied in youth. We determined the impact of insulin therapy on lipid and inflammatory markers in youth with poorly controlled type 2 diabetes. In the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) multicenter trial, 285 participants failed to sustain glycemic control on randomized treatment (primary outcome, glycated hemoglobin A1c [HbA1c] at ≥8% for 6 months); 363 maintained glycemic control (never reached primary outcome). Statins were used for a low-density lipoprotein cholesterol of ≥130 mg/dL. Upon reaching the primary outcome, insulin was started. Changes in lipids and inflammatory markers (slopes over time) were examined. Progression of dyslipidemia was related to glycemic control. In those with the primary outcome, insulin therapy impacted HbA1c modestly, and dampened the increase in total cholesterol, low-density lipoprotein cholesterol, and total apolipoprotein B, although statin use increased from 8.6% to 22% year after the primary outcome. The increase in triglycerides and plasma nonesterified fatty acids stabilized after insulin was started, independent of HbA1c. There was an increase in high-sensitivity C-reactive protein that continued after insulin initiation, related to HbA1c and percent overweight. Worsening dyslipidemia and inflammation over time raise concern regarding premature development of atherosclerosis in youth with type 2 diabetes. Insulin therapy has a limited benefit in the absence of glycemic control. Strategies to achieve better glycemic control are needed. ClinicalTrials.gov: NCT00081328. Copyright © 2017 Elsevier Inc. All rights reserved.

Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months.

PubMed

Rundback, John H; Peeters, Patrick; George, Jon C; Jaff, Michael R; Faries, Peter L

2017-06-01

To evaluate the safety and effectiveness of primary stenting of the common (CIA) or external iliac artery (EIA) using the Visi-Pro Balloon-Expandable Peripheral Stent System for treatment of stenotic, restenotic, or occluded lesions. Between 2011 and 2012, 75 patients (mean age 64.2±8.9 years; 46 men) with Rutherford category 2-4 ischemia and atherosclerotic lesions ≤10 cm in length underwent iliac artery stenting at 17 centers in the United States and Europe. The primary outcome of the study was the major adverse event (MAE) rate at 9 months postprocedure [composite of periprocedural death, in-hospital myocardial infarction, clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb]. Secondary outcomes included 30-day MAE rate, 9-month primary patency, changes in ankle-brachial index (ABI) and the Walking Impairment Questionnaire at 30 days and 9 months postprocedure, device success, and clinically driven target vessel revascularization (CD-TVR) at 30 days and 9 months. Outcomes in specific patient cohorts (ie, gender, stent location, calcification severity, and lesion grade) were analyzed. Eighty-one stents were implanted in 61 CIA and 15 EIA lesions (41 with moderate/severe calcification). The mean lesion treated length was 29.3±13.9 mm. All devices were successfully deployed. MAE occurred in 3 (4.0%) of 75 subjects at 9 months. Primary patency and freedom from CD-TVR at 9 months were both 95.8%. ABI improved from 0.67±0.14 at baseline to 0.94±0.14 and 0.96±0.16 at 30 days and 9-month follow-up, respectively (p<0.001 for both). There were no differences with respect to any of the analyzed patient characteristics, including gender. Nine-month results of the VISIBILITY Iliac stent study ( ClinicalTrials.gov identifier NCT01402700) demonstrated safety and effectiveness for the treatment of atherosclerotic CIA and EIA lesions with the Visi-Pro stent across all treated cohorts.

Management of advanced ovarian cancer in South West Wales - a comparison between primary debulking surgery and primary chemotherapy treatment strategies in an unselected, consecutive patient cohort.

PubMed

Drews, F; Bertelli, G; Lutchman-Singh, K

2017-08-01

This study represents the first reported outcomes for patients with advanced ovarian cancer (AOC) in South-West Wales undergoing treatment with primary debulking surgery or primary chemotherapy respectively. This is a retrospective study of consecutive, unselected patients with advanced ovarian, fallopian tube or primary peritoneal cancer (FIGO III/IV) presenting to a regional cancer centre between October 2007 and October 2014. Patients were identified from Welsh Cancer Services records and relevant data was extracted from electronic National Health Service (NHS) databases. Main outcome measures were median overall survival (OS), progression free survival (PFS) and perioperative adverse events. Hazard ratio estimation was carried out with Cox Regression analysis and survival determined by Kaplan-Meier plots. Of 220 women with AOC, 32.3% underwent primary debulking surgery (PDS) and 67.7% primary chemotherapy and interval debulking (PCT-IDS). Patients were often elderly (median age 67 years) with a poor performance status (26.5% PS >1). Complete cytoreduction (0cm residual) was achieved in 32.4% of patients in the PDS group and in 50.0% of patients undergoing IDS. Median OS for all patients was 21.9 months (PDS: 27.0 and PCT-IDS: 19.2 months; p >0.05) and median PFS was 13.1 months (PDS: 14.3 months and PCT-IDS: 13.0 months; p >0.05). Median overall and progression free survival for patients achieving complete cytoreduction were 48.0 and 23.2 months respectively in the PDS group and 35.4 months and 18.6 months in the IDS group (p >0.05). This retrospective study of an unselected, consecutive cohort of women with AOC in South West Wales shows comparable survival outcomes with recently published trials, despite the relatively advanced age and poor performance status of our patient cohort. Over the seven-year study period, our data also demonstrated a non-significant trend towards improved survival following primary surgery in patients who achieved maximal cytoreduction. Our future aim therefore is to examine and develop the role of extended surgery in these patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

Primary care interventions and current service innovations in modifying long-term outcomes after stroke: a protocol for a scoping review

PubMed Central

Pindus, Dominika M; Lim, Lisa; Rundell, A Viona; Hobbs, Victoria; Aziz, Noorazah Abd; Mullis, Ricky; Mant, Jonathan

2016-01-01

Introduction Interventions delivered by primary and/or community care have the potential to reach the majority of stroke survivors and carers and offer ongoing support. However, an integrative account emerging from the reviews of interventions addressing specific long-term outcomes after stroke is lacking. The aims of the proposed scoping review are to provide an overview of: (1) primary care and community healthcare interventions by generalist healthcare professionals to stroke survivors and/or their informal carers to address long-term outcomes after stroke, (2) the scope and characteristics of interventions which were successful in addressing long-term outcomes, and (3) developments in current clinical practice. Methods and analysis Studies that focused on adult community dwelling stroke survivors and informal carers were included. Academic electronic databases will be searched to identify reviews of randomised controlled trials (RCTs) and controlled trials, trials from the past 5 years; reviews of observational studies. Practice exemplars from grey literature will be identified through advanced Google search. Reports, guidelines and other documents of major health organisations, clinical professional bodies, and stroke charities in the UK and internationally will be included. Two reviewers will independently screen titles, abstracts and full texts for inclusion of published literature. One reviewer will screen search results from the grey literature and identify relevant documents for inclusion. Data synthesis will include analysis of the number, type of studies, year and country of publication, a summary of intervention components/service or practice, outcomes addressed, main results (an indicator of effectiveness) and a description of included interventions. Ethics and dissemination The review will help identify components of care and care pathways for primary care services for stroke. By comparing the results with stroke survivors' and carers' needs identified in the literature, the review will highlight potential gaps in research and practice relevant to long-term care after stroke. PMID:27798023

Dismantling Multicomponent Behavioral Treatment for Insomnia in Older Adults: A Randomized Controlled Trial

PubMed Central

Epstein, Dana R.; Sidani, Souraya; Bootzin, Richard R.; Belyea, Michael J.

2012-01-01

Study Objective: Recently, the use of multicomponent insomnia treatment has increased. This study compares the effect of single component and multicomponent behavioral treatments for insomnia in older adults after intervention and at 3 months and 1 yr posttreatment. Design: A randomized, controlled study. Setting: Veterans Affairs medical center. Participants: 179 older adults (mean age, 68.9 yr ± 8.0; 115 women [64.2%]) with chronic primary insomnia. Interventions: Participants were randomly assigned to 6 wk of stimulus control therapy (SCT), sleep restriction therapy (SRT), the 2 therapies combined into a multicomponent intervention (MCI), or a wait-list control group. Measurements and Results: Primary outcomes were subjective (daily sleep diary) and objective (actigraphy) measures of sleep-onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), and sleep efficiency (SE). Secondary outcomes were clinical measures including response and remission rates. There were no differences between the single and multicomponent interventions on primary sleep outcomes measured by diary and actigraphy. All treatments produced significant improvement in diary-reported sleep in comparison with the control group. Effect sizes for sleep diary outcomes were medium to large. Treatment gains were maintained at follow-up for diary and actigraph measured SOL, WASO, and SE. The MCI group had the largest proportion of treatment remitters. Conclusions: For older adults with chronic primary insomnia, the findings provide initial evidence that SCT, SRT, and MCI are equally efficacious and produce sustainable treatment gains on diary, actigraphy, and clinical outcomes. From a clinical perspective, MCI may be a preferred treatment due to its higher remission rate. Clinical Trial Information: Behavioral Intervention for Insomnia in Older Adults. NCT01154023. URL: http://clinicaltrials.gov/ct2/show/NCT01154023?term=Behavioral+Intervention+for+Insomnia+in+Older+Adults&rank=1. Citation: Epstein DR; Sidani S; Bootzin RR; Belyea MJ. Dismantling multicomponent behavioral treatment for insomnia in older adults: a randomized controlled trial. SLEEP 2012;35(6):797-805. PMID:22654199

Depression Treatment Preferences in Older Primary Care Patients

ERIC Educational Resources Information Center

Gum, Amber M.; Arean, Patricia A.; Hunkeler, Enid; Tang, Lingqi; Katon, Wayne; Hitchcock, Polly; Steffens, David C.; Dickens, Jeanne; Unutzer, Jurgen

2006-01-01

Purpose: For depressed older primary care patients, this study aimed to examine (a) characteristics associated with depression treatment preferences; (b) predictors of receiving preferred treatment; and (c) whether receiving preferred treatment predicted satisfaction and depression outcomes. Design and Methods: Data are from 1,602 depressed older…

A clinical return-to-work rule for patients with back pain.

PubMed

Dionne, Clermont E; Bourbonnais, Renée; Frémont, Pierre; Rossignol, Michel; Stock, Susan R; Larocque, Isabelle

2005-06-07

Tools for early identification of workers with back pain who are at high risk of adverse occupational outcome would help concentrate clinical attention on the patients who need it most, while helping reduce unnecessary interventions (and costs) among the others. This study was conducted to develop and validate clinical rules to predict the 2-year work disability status of people consulting for nonspecific back pain in primary care settings. This was a 2-year prospective cohort study conducted in 7 primary care settings in the Quebec City area. The study enrolled 1007 workers (participation, 68.4% of potential participants expected to be eligible) aged 18-64 years who consulted for nonspecific back pain associated with at least 1 day's absence from work. The majority (86%) completed 5 telephone interviews documenting a large array of variables. Clinical information was abstracted from the medical files. The outcome measure was "return to work in good health" at 2 years, a variable that combined patients' occupational status, functional limitations and recurrences of work absence. Predictive models of 2-year outcome were developed with a recursive partitioning approach on a 40% random sample of our study subjects, then validated on the rest. The best predictive model included 7 baseline variables (patient's recovery expectations, radiating pain, previous back surgery, pain intensity, frequent change of position because of back pain, irritability and bad temper, and difficulty sleeping) and was particularly efficient at identifying patients with no adverse occupational outcome (negative predictive value 78%- 94%). A clinical prediction rule accurately identified a large proportion of workers with back pain consulting in a primary care setting who were at a low risk of an adverse occupational outcome.

Incidence, demographics and surgical outcomes of cutaneous squamous cell carcinoma diagnosed in Northland, New Zealand.

PubMed

Elliott, Brodie M; Douglass, Benjamin R; McConnell, Daniel; Johnson, Blair; Harmston, Christopher

2018-05-18

Non-melanoma skin cancer (NMSC) is the most commonly diagnosed and most costly cancer in Australasia. Cutaneous squamous cell carcinoma (cSCC) accounts for approximately 25% of NMSC. Despite this, reporting of cSCC is not mandatory in Australasia. This creates difficulties in planning, resourcing and improving outcomes in cSCC. Previous studies in New Zealand have lacked data on ethnicity. The aim of this study was to define the incidence and demographics of cSCC diagnosed in Northland, New Zealand, including data on ethnicity. A 12-month retrospective study was carried out of all primary cSCC histologically diagnosed in Northland for one year. The cohort was identified by searching the Northland District Health Board pathology database. Data on outcomes and ethnicity were obtained from the hospital results system. Primary outcome of interest was the incidence of cSCC in Northland. Secondary outcomes of interest were lesion characteristics and positive margin rate. 1,040 cSCC were identified in 890 patients. Mean age of patients was 75. Crude incidence of primary cSCC was 668/100,000 patient years. Age standardised incidence was 305/100,000 patient years. An estimate of New Zealand incidence adjusted for age and ethnicity is 580/100,000 patient years. Overall positive margin rate in excised lesions was 9.5%. This study has defined the rate of cSCC in a large, well defined New Zealand population, and estimated age and ethnicity adjusted incidence in New Zealand. It has demonstrated the highest incidence of cSCC in the world outside Australia. Overall positive margin rate of excised lesions was acceptable.

A clinical return-to-work rule for patients with back pain

PubMed Central

Dionne, Clermont E.; Bourbonnais, Renée; Frémont, Pierre; Rossignol, Michel; Stock, Susan R.; Larocque, Isabelle

2005-01-01

Background Tools for early identification of workers with back pain who are at high risk of adverse occupational outcome would help concentrate clinical attention on the patients who need it most, while helping reduce unnecessary interventions (and costs) among the others. This study was conducted to develop and validate clinical rules to predict the 2-year work disability status of people consulting for nonspecific back pain in primary care settings. Methods This was a 2-year prospective cohort study conducted in 7 primary care settings in the Quebec City area. The study enrolled 1007 workers (participation, 68.4% of potential participants expected to be eligible) aged 18–64 years who consulted for nonspecific back pain associated with at least 1 day's absence from work. The majority (86%) completed 5 telephone interviews documenting a large array of variables. Clinical information was abstracted from the medical files. The outcome measure was “return to work in good health” at 2 years, a variable that combined patients' occupational status, functional limitations and recurrences of work absence. Predictive models of 2-year outcome were developed with a recursive partitioning approach on a 40% random sample of our study subjects, then validated on the rest. Results The best predictive model included 7 baseline variables (patient's recovery expectations, radiating pain, previous back surgery, pain intensity, frequent change of position because of back pain, irritability and bad temper, and difficulty sleeping) and was particularly efficient at identifying patients with no adverse occupational outcome (negative predictive value 78%– 94%). Interpretation A clinical prediction rule accurately identified a large proportion of workers with back pain consulting in a primary care setting who were at a low risk of an adverse occupational outcome. PMID:15939915

Patient reported outcome measures (PROMs) for goalsetting and outcome measurement in primary care physiotherapy, an explorative field study.

PubMed

van Dulmen, Simone A; van der Wees, Philip J; Bart Staal, J; Braspenning, J C C; Nijhuis-van der Sanden, Maria W G

2017-03-01

Routine use of patient reported outcome measures (PROMs) may provide an effective way of monitoring patient valued outcomes. In this study we explored (1) the current use of PROMs; (2) to what extent the goals correspond with the selected PROMs; (3) the health outcomes based on PROMs. Observational clinical cohort study. Dutch primary care physiotherapy practices (n=43). Patients (n=299) with neck pain or low back pain. The number of PROMs used per patient were calculated. The International Classification of Functioning, Disability and Health was used to map the patients' goals and the percentages of PROMS selected that match the domains of the goals were calculated. Health outcomes were assessed using two approaches for estimating the minimal clinically important difference (MCID). Repeated measurements with the Visual Analogue Scale, the Patient Specific Complaints questionnaire, the Quebec Back Pain Disability Scale, or the Neck Disability Index were completed by more than 60% of the patients. The PROMs used matched in 46% of the cases with goals for pain improvement, and in 43% with goals set at activity/participation level. The mean differences between baseline and follow up scores for all PROMs were statistically significant. Improvements of patients based on MCID varied from 57% to 90%. PROMs were used in the majority of the patients, showed improved health outcomes and fitted moderately with goals. The results of this study can be used for future research assessing the routine use of outcome measurements with PROMs. Copyright © 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Predictive Value of Pulse Pressure in Acute Ischemic Stroke for Future Major Vascular Events.

PubMed

Lee, Keon-Joo; Kim, Beom Joon; Han, Moon-Ku; Kim, Joon-Tae; Cho, Ki-Hyun; Shin, Dong-Ick; Yeo, Min-Ju; Cha, Jae-Kwan; Kim, Dae-Hyun; Nah, Hyun-Wook; Kim, Dong-Eog; Ryu, Wi-Sun; Park, Jong-Moo; Kang, Kyusik; Lee, Soo Joo; Oh, Mi-Sun; Yu, Kyung-Ho; Lee, Byung-Chul; Hong, Keun-Sik; Cho, Yong-Jin; Choi, Jay Chol; Sohn, Sung Il; Hong, Jeong-Ho; Park, Tai Hwan; Park, Sang-Soon; Kwon, Jee-Hyun; Kim, Wook-Joo; Lee, Jun; Lee, Ji Sung; Lee, Juneyoung; Gorelick, Philip B; Bae, Hee-Joon

2018-01-01

This study aimed to investigate whether pulse pressure (PP) obtained during the acute stage of ischemic stroke can be used as a predictor for future major vascular events. Using a multicenter prospective stroke registry database, patients who were hospitalized for ischemic stroke within 48 hours of onset were enrolled in this study. We analyzed blood pressure (BP) data measured during the first 3 days from onset. Primary and secondary outcomes were time to a composite of stroke recurrence, myocardial infarction, all-cause death, and time to stroke recurrence, respectively. Of 9840 patients, 4.3% experienced stroke recurrence, 0.2% myocardial infarction, and 7.3% death during a 1-year follow-up period. In Cox proportional hazards models including both linear and quadratic terms of PP, PP had a nonlinear J-shaped relationship with primary (for a quadratic term of PP, P =0.004) and secondary ( P <0.001) outcomes. The overall effects of PP and other BP parameters on primary and secondary outcomes were also significant ( P <0.05). When predictive power of BP parameters was compared using a statistic of -2 log-likelihood differences, PP was a stronger predictor than systolic BP (8.49 versus 5.91; 6.32 versus 4.56), diastolic BP (11.42 versus 11.05; 10.07 versus 4.56), and mean atrial pressure (8.75 versus 5.91; 7.03 versus 4.56) for the primary and secondary outcomes, respectively. Our study shows that PP when measured in the acute period of ischemic stroke has nonlinear J-shaped relationships with major vascular events and stroke recurrence, and may have a stronger predictive power than other commonly used BP parameters. © 2017 American Heart Association, Inc.

Overlooked and underestimated? Problematic alcohol use in clients recovering from drug dependence.

PubMed

Staiger, Petra K; Richardson, Ben; Long, Caroline M; Carr, Victoria; Marlatt, G Alan

2013-07-01

Despite recognition of the harms related to alcohol misuse and its potential to interfere substantially with sustained recovery from drug dependency, research evaluating drug treatment outcomes has not addressed the issue comprehensively. It has been overlooked possibly because treatment research has been framed according to the primary drug of choice, rather than investigating the interactions between different combinations of drugs and/or alcohol use. This paper reports on a systematic review investigating whether concurrent alcohol use could impede recovery from illicit drug use in two potential ways: first, alcohol could become a substitute addiction and/or secondly, alcohol misuse post-treatment may place an individual at risk for relapse to their primary drug problem. A systematic search of four relevant databases was undertaken to identify peer-reviewed, quantitative drug treatment outcome studies that reported alcohol use pre-, post-treatment and follow-up. The search revealed 567 papers, of which 13 were assessed as fulfilling the key inclusion criteria.The review indicated inconsistent and therefore inconclusive support for the substitution hypothesis. However, the data revealed consistent support for the hypothesis that alcohol use increases relapse to drug use. (i) The potential negative impact of alcohol misuse on drug treatment outcomes remains under-researched and overlooked; (ii) alcohol consumption post-drug treatment may increase the likelihood that an individual will relapse to their primary drug; (ii) existing evidence regarding the substitution hypothesis is inconclusive, although there was an indication that a subgroup of participants will be vulnerable to alcohol becoming the primary addiction instead of drugs. We argue that future drug treatment outcome studies need to include detailed analysis of the influence of alcohol use pre- and post-drug treatment. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.

Revision of Unicondylar to Total Knee Arthroplasty: A Systematic Review

PubMed Central

Siddiqui, Nashat A; Ahmad, Zafar M

2012-01-01

Isolated unicompartmental osteoarthritis in the young patient is a difficult problem to treat; they may be too young to consider total knee arthroplasty due to difficulties with inevitable future revision. Unicompartmental knee arthroplasty is one possible solution as it is perceived by some as being a smaller surgical insult than total knee arthroplasty, with easier revision to total knee arthroplasty than a revision total knee arthroplasty. A total knee arthroplasty performed as a revision unicondylar knee arthroplasty is thought by some authors to have equivalent functional outcomes to a primary total knee replacement. However, there have been several studies suggesting that revision is not as simple as suggested, and that function is not as good as primary total knee arthroplasty. We performed a systematic review of the literature regarding outcomes after revision of a unicondylar knee arthroplasty. Although there are many studies proposing selective use of the unicondylar knee arthroplasty, there are a number of studies highlighting difficulties with revision and poorer outcomes, and, therefore, the unicondylar knee arthroplasty cannot be considered a small procedure that will 'buy time' for the patient, and have results equal to a primary knee arthroplasty when revised. Further controlled studies, ideally randomised, are required before final conclusions can be drawn. PMID:22905072

Implementation of an integrated primary care cardiometabolic risk prevention and management network in Montréal: does greater coordination of care with primary care physicians have an impact on health outcomes?

PubMed

Provost, Sylvie; Pineault, Raynald; Grimard, Dominique; Pérez, José; Fournier, Michel; Lévesque, Yves; Desforges, Johanne; Tousignant, Pierre; Borgès Da Silva, Roxane

2017-04-01

Chronic disease management requires substantial services integration. A cardiometabolic risk management program inspired by the Chronic Care Model was implemented in Montréal for patients with diabetes or hypertension. One of this study's objectives was to assess the impact of care coordination between the interdisciplinary teams and physicians on patient participation in the program, lifestyle improvements and disease control. We obtained data on health outcomes from a register of clinical data, questionnaires completed by patients upon entry into the program and at the 12-month mark, and we drew information on the program's characteristics from the implementation analysis. We conducted multiple regression analyses, controlling for patient sociodemographic and health characteristics, to measure the association between interdisciplinary team coordination with primary care physicians and various health outcomes. A total of 1689 patients took part in the study (60.1% participation rate). Approximately 40% of patients withdrew from the program during the first year. At the 12-month follow-up (n = 992), we observed a significant increase in the proportion of patients achieving the various clinical targets. The perception by the interdisciplinary team of greater care coordination with primary care physicians was associated with increased participation in the program and the achievement of better clinical results. Greater coordination of patient services between interdisciplinary teams and primary care physicians translates into benefits for patients.

Continuing care and long-term substance use outcomes in managed care: early evidence for a primary care-based model.

PubMed

Chi, Felicia W; Parthasarathy, Sujaya; Mertens, Jennifer R; Weisner, Constance M

2011-10-01

How best to provide ongoing services to patients with substance use disorders to sustain long-term recovery is a significant clinical and policy question that has not been adequately addressed. Analyzing nine years of prospective data for 991 adults who entered substance abuse treatment in a private, nonprofit managed care health plan, this study aimed to examine the components of a continuing care model (primary care, specialty substance abuse treatment, and psychiatric services) and their combined effect on outcomes over nine years after treatment entry. In a longitudinal observational study, follow-up measures included self-reported alcohol and drug use, Addiction Severity Index scores, and service utilization data extracted from the health plan databases. Remission, defined as abstinence or nonproblematic use, was the outcome measure. A mixed-effects logistic random intercept model controlling for time and other covariates found that yearly primary care, and specialty care based on need as measured at the prior time point, were positively associated with remission over time. Persons receiving continuing care (defined as having yearly primary care and specialty substance abuse treatment and psychiatric services when needed) had twice the odds of achieving remission at follow-ups (p<.001) as those without. Continuing care that included both primary care and specialty care management to support ongoing monitoring, self-care, and treatment as needed was important for long-term recovery of patients with substance use disorders.

Overvaluation of shape and weight in adolescents with anorexia nervosa: does shape concern or weight concern matter more for treatment outcome?

PubMed

Byrne, Catherine E; Kass, Andrea E; Accurso, Erin C; Fischer, Sarah; O'Brien, Setareh; Goodyear, Alexandria; Lock, James; Le Grange, Daniel

2015-01-01

Overvaluation of shape and weight is a key diagnostic feature of anorexia nervosa (AN); however, limited research has evaluated the clinical utility of differentiating between weight versus shape concerns. Understanding differences in these constructs may have important implications for AN treatment given the focus on weight regain. This study examined differences in treatment outcome between individuals whose primary concern was weight versus those whose primary concern was shape in a randomized controlled trial of treatment for adolescent AN. Data were drawn from a two-site randomized controlled trial that compared family-based treatment and adolescent focused therapy for AN. Chi-square tests and logistic regression analyses were conducted. Thirty percent of participants presented with primary weight concern (n = 36; defined as endorsing higher Eating Disorder Examination (EDE) Weight Concern than Shape Concern subscale scores); 60 % presented with primary shape concern (n = 72; defined as endorsing higher EDE Shape Concern than Weight Concern scores). There were no significant differences between the two groups in remission status at the end of treatment. Treatment did not moderate the effect of group status on achieving remission. Results suggest that treatment outcomes are comparable between adolescents who enter treatment for AN with greater weight concerns and those who enter treatment with greater shape concerns. Therefore, treatment need not be adjusted based on primary weight or primary shape concerns.

Optimizing early child development for young children with non-anemic iron deficiency in the primary care practice setting (OptEC): study protocol for a randomized controlled trial.

PubMed

Abdullah, Kawsari; Thorpe, Kevin E; Mamak, Eva; Maguire, Jonathon L; Birken, Catherine S; Fehlings, Darcy; Hanley, Anthony J; Macarthur, Colin; Zlotkin, Stanley H; Parkin, Patricia C

2015-04-02

Three decades of research suggests that prevention of iron deficiency anemia (IDA) in the primary care setting may be an unrealized and unique opportunity to prevent poor developmental outcomes in children. A longitudinal study of infants with IDA showed that the developmental disadvantage persists long term despite iron therapy. Early stages of iron deficiency, termed non-anemic iron deficiency (NAID), provide an opportunity for early detection and treatment before progression to IDA. There is little research regarding NAID, which may be associated with delayed development in young children. The aim of this study is to compare the effectiveness of four months of oral iron treatment plus dietary advice, with placebo plus dietary advice, in improving developmental outcomes in children with NAID and to conduct an internal pilot study. From a screening cohort, those identified with NAID (hemoglobin ≥110 g/L and serum ferritin <14 μg/L) are invited to participate in a pragmatic, multi-site, placebo controlled, blinded, parallel group, superiority randomized trial. Participating physicians are part of a primary healthcare research network called TARGet Kids! Children between 12 and 40 months of age and identified with NAID are randomized to receive four months of oral iron treatment at 6 mg/kg/day plus dietary advice, or placebo plus dietary advice (75 per group). The primary outcome, child developmental score, is assessed using the Mullen Scales of Early Learning at baseline and at four months after randomization. Secondary outcomes include an age appropriate behavior measure (Children's Behavior Questionnaire) and two laboratory measures (hemoglobin and serum ferritin levels). Change in developmental and laboratory measures from baseline to the end of the four-month follow-up period will be analyzed using linear regression (analysis of covariance method). This trial will provide evidence regarding the association between child development and NAID, and the effectiveness of oral iron to improve developmental outcomes in children with NAID. The sample size of the trial will be recalculated using estimates taken from an internal pilot study. This trial was registered with Clinicaltrials.gov (identifier: NCT01481766 ) on 22 November 2011.

Surgical outcomes analysis of pediatric peritoneal dialysis catheter function in a rural region.

PubMed

Stone, Matthew L; LaPar, Damien J; Barcia, John P; Norwood, Victoria F; Mulloy, Daniel P; McGahren, Eugene D; Rodgers, Bradley M; Kane, Bartholomew J

2013-07-01

The purpose of this study was to analyze the experience with peritoneal dialysis (PD) at a high-volume, single center institution that supports a rural population. From 2000 to 2010, 88 children (median age: 1.98 years, [range: 2 days-20.2 years]) received 134 PD catheters for the management of acute and chronic renal failure. The primary outcome of interest was the incidence of primary PD catheter failure (replacement or revision within 60 days). Operative technique, longitudinal outcomes, and time intervals to transplantation were analyzed. Median time to transplant from the institution of dialysis was 1.4 years [range: 0.3-6.4 years]. Primary catheter failure occurred in 24.6% of cases. Infants less than 6 months of age demonstrated an increased incidence of primary catheter failure (p = 0.02). The operative technique for catheter placement was not associated with the incidence of primary failure. Postoperative complications included peritonitis (22.7%), omental plugging (11.9%), pericatheter drainage (9.0%), and exit site infection (3.0%). Peritoneal dialysis provides a safe and effective renal replacement therapy for regional pediatric centers that serve a rural population. However, primary catheter failure rates remain high at 24.6%. The surgical technique for placement had no effect on this failure rate in our patient population. Infants less than 6 months of age are at increased risk for primary catheter failure and warrant intensive surveillance. Copyright © 2013. Published by Elsevier Inc.

Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the ALL-HEART study.

PubMed

Mackenzie, Isla S; Ford, Ian; Walker, Andrew; Hawkey, Chris; Begg, Alan; Avery, Anthony; Taggar, Jaspal; Wei, Li; Struthers, Allan D; MacDonald, Thomas M

2016-09-08

Ischaemic heart disease (IHD) is one of the most common causes of death in the UK and treatment of patients with IHD costs the National Health System (NHS) billions of pounds each year. Allopurinol is a xanthine oxidase inhibitor used to prevent gout that also has several positive effects on the cardiovascular system. The ALL-HEART study aims to determine whether allopurinol improves cardiovascular outcomes in patients with IHD. The ALL-HEART study is a multicentre, controlled, prospective, randomised, open-label blinded end point (PROBE) trial of allopurinol (up to 600 mg daily) versus no treatment in a 1:1 ratio, added to usual care, in 5215 patients aged 60 years and over with IHD. Patients are followed up by electronic record linkage and annual questionnaires for an average of 4 years. The primary outcome is the composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. Secondary outcomes include all-cause mortality, quality of life and cost-effectiveness of allopurinol. The study will end when 631 adjudicated primary outcomes have occurred. The study is powered at 80% to detect a 20% reduction in the primary end point for the intervention. Patient recruitment to the ALL-HEART study started in February 2014. The study received ethical approval from the East of Scotland Research Ethics Service (EoSRES) REC 2 (13/ES/0104). The study is event-driven and results are expected after 2019. Results will be reported in peer-reviewed journals and at scientific meetings. Results will also be disseminated to guideline committees, NHS organisations and patient groups. 32017426, pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Violence and Disorder, School Climate, and PBIS: The Relationship among School Climate, Student Outcomes, and the Use of Positive Behavioral Interventions and Supports

ERIC Educational Resources Information Center

Eacho, Thomas Christopher

2013-01-01

The primary purpose of this study was to examine the relationship between school climate and student outcome variables. The secondary purpose was to examine the relationship between the use of Positive Behavioral Interventions and Supports (PBIS) and the same student outcome variables. Variables depicting student perceptions of school climate,…

Homeopathic and conventional treatment for acute respiratory and ear complaints: A comparative study on outcome in the primary care setting

PubMed Central

Haidvogl, Max; Riley, David S; Heger, Marianne; Brien, Sara; Jong, Miek; Fischer, Michael; Lewith, George T; Jansen, Gerard; Thurneysen, André E

2007-01-01

Background The aim of this study was to assess the effectiveness of homeopathy compared to conventional treatment in acute respiratory and ear complaints in a primary care setting. Methods The study was designed as an international, multi-centre, comparative cohort study of non-randomised design. Patients, presenting themselves with at least one chief complaint: acute (≤ 7 days) runny nose, sore throat, ear pain, sinus pain or cough, were recruited at 57 primary care practices in Austria (8), Germany (8), the Netherlands (7), Russia (6), Spain (6), Ukraine (4), United Kingdom (10) and the USA (8) and given either homeopathic or conventional treatment. Therapy outcome was measured by using the response rate, defined as the proportion of patients experiencing 'complete recovery' or 'major improvement' in each treatment group. The primary outcome criterion was the response rate after 14 days of therapy. Results Data of 1,577 patients were evaluated in the full analysis set of which 857 received homeopathic (H) and 720 conventional (C) treatment. The majority of patients in both groups reported their outcome after 14 days of treatment as complete recovery or major improvement (H: 86.9%; C: 86.0%; p = 0.0003 for non-inferiority testing). In the per-protocol set (H: 576 and C: 540 patients) similar results were obtained (H: 87.7%; C: 86.9%; p = 0.0019). Further subgroup analysis of the full analysis set showed no differences of response rates after 14 days in children (H: 88.5%; C: 84.5%) and adults (H: 85.6%; C: 86.6%). The unadjusted odds ratio (OR) of the primary outcome criterion was 1.40 (0.89–2.22) in children and 0.92 (0.63–1.34) in adults. Adjustments for demographic differences at baseline did not significantly alter the OR. The response rates after 7 and 28 days also showed no significant differences between both treatment groups. However, onset of improvement within the first 7 days after treatment was significantly faster upon homeopathic treatment both in children (p = 0.0488) and adults (p = 0.0001). Adverse drug reactions occurred more frequently in adults of the conventional group than in the homeopathic group (C: 7.6%; H: 3.1%, p = 0.0032), whereas in children the occurrence of adverse drug reactions was not significantly different (H: 2.0%; C: 2.4%, p = 0.7838). Conclusion In primary care, homeopathic treatment for acute respiratory and ear complaints was not inferior to conventional treatment. PMID:17335565

Study protocol: intervention in maternal perception of preschoolers' weight among Mexican and Mexican-American mothers.

PubMed

Flores-Peña, Yolanda; He, Meizi; Sosa, Erica T; Avila-Alpirez, Hermelinda; Trejo-Ortiz, Perla M

2018-05-30

Childhood obesity is a public health issue negatively affecting children's physical and psychosocial health. Mothers are children's primary caregivers, thus key players in childhood obesity prevention. Studies have indicated that mothers underestimate their children's weight. If mothers are unaware of their children's weight problem, they are less likely to participate in activities preventing and treating excess weight. The "Healthy Change" intervention is designed to change maternal perception of child's weight (MPCW) through peer-led group health education in childcare settings. The "Healthy Change" is a multicenter two-arm randomized trial in four centers. Three centers are in Mexican States (Nuevo Leon, Tamaulipas, and Zacatecas). The fourth center is in San Antonio, Texas, USA. A total of 360 mother-child pairs (90 pairs per center) are to be randomly and evenly allocated to either the intervention or the control group. Intervention group will receive four-session group obesity prevention education. Control group will receive a four-session personal and food hygiene education. The education is delivered by trained peer-mother promotoras. Data will be collected using questionnaires and focus groups. The primary outcome is a change in proportion of mothers with accurate MPCW. Secondary outcomes include change in maternal feeding styles and practices, maternal self-efficacy and actions for managing child excessive weight gain. McNemar's Test will be used to test the primary outcome. The GLM Univariate procedure will be used to determine intervention effects on secondary outcomes. The models will include the secondary outcome measures as the dependent variables, treatment condition (intervention/control) as the fixed factor, and confounding factors (e.g., mother's education, children's gender and age) as covariates. Sub-analyses will be performed to compare intervention effects on primary and secondary outcomes between the samples from Mexico and Texas, USA. Qualitative data will be analyzed through analysis of inductive content. A combined coding model will be developed and used to code transcripts using the NVivo software. Healthy Change intervention could help change MPCW, an initial step for obesity prevention among preschoolers. This study presents a first of its kind intervention available in Spanish and English targeting Mexican and Mexican-American mothers in Mexico and USA. ISRCTN12281648.

Outcomes that matter: A qualitative study with persons with schizophrenia and their primary caregivers in India

PubMed Central

Balaji, Madhumitha; Chatterjee, Sudipto; Brennan, Beth; Rangaswamy, Thara; Thornicroft, Graham; Patel, Vikram

2012-01-01

Background Involving persons with schizophrenia and their families in designing, implementing and evaluating mental health services is increasingly emphasised. However, there is little information on desired outcomes from the perspectives of these stakeholders from low and middle income countries (LMIC). Aims To explore and define outcomes desired by persons with schizophrenia and their primary caregivers from their perspectives. Method In-depth interviews were held with 32 persons with schizophrenia and 38 primary caregivers presenting for care at one rural and one semi-urban site in India. Participants were asked what changes they desired in the lives of persons affected by the illness and benefits they expected from treatment. Data was analysed using thematic and content analysis. Results Eleven outcomes were desired by both groups: symptom control; employment/education; social functioning; activity; fulfilment of duties and responsibilities; independent functioning; cognitive ability; management without medication; reduced side-effects; self-care; and self-determination. Social functioning, employment/education and activity were the most important outcomes for both groups; symptom control and cognitive ability were more important to persons with schizophrenia while independent functioning and fulfilment of duties were more important to caregivers. Conclusions Interventions for schizophrenia in India should target both clinical and functional outcomes, addressing the priorities of both affected persons and their caregivers. Their effectiveness needs to be evaluated independently from both perspectives. PMID:22981055

[Interventions to improve the management of diabetes mellitus in primary health care and outpatient community settings].

PubMed

Hansen, Lars Jørgen; Drivsholm, Thomas B

2002-01-28

This review should be cited as: Renders CM, Valk GD, Griffin S. Wagner EH, Eijk JThM van, Assendelft WJJ. Interventions to improve the management of diabetes mellitus in primary care, outpatient and community settings (Cochrane Review). In: The Cochrane Library, Issue 2, 2001. Oxford: Update Software. A substantive amendment to this systematic review was last made on 29 June 2000. Cochrane reviews are regularly checked and updated if necessary. Diabetes is a common chronic disease that is increasingly managed in primary care. Different systems have been proposed to manage diabetes care. To assess the effects of different interventions, targeted at health professionals or the structure in which they deliver care, on the management of patients with diabetes in primary care, outpatient and community settings. We searched the Cochrane Effective Practice and Organisation of Care Group specialised register, the Cochrane Controlled Trials Register (Issue 4 1999), MEDLINE (1966-1999), EMBASE (1980-1999), Cinahl (1982-1999), and reference lists of articles. Randomised trials (RCTs), controlled clinical trials (CCTs), controlled before and after studies (CBAs) and interrupted time series (ITS) analyses of professional, financial and organisational strategies aimed at improving care for people with Type 1 or Type 2 diabetes. The participants were health care professionals, including physicians, nurses and pharmacists. The outcomes included objectively measured health professional performance or patient outcomes, and self-report measures with known validity and reliability. Two reviewers independently extracted data and assessed study quality. Forty-one studies were included involving more than 200 practices and 48,000 patients. Twenty-seven studies were RCTs, 12 were CBAs, and two were ITS. The studies were heterogeneous in terms of interventions, participants, settings and outcomes. The methodological quality of the studies was often poor. In all studies the intervention strategy was multifaceted. In 12 studies the interventions were targeted at health professionals, in nine they were targeted at the organization of care, and 20 studies targeted both. In 15 studies patient education was added to the professional and organisational interventions. A combination of professional interventions improved process outcomes. The effect on patient outcomes remained less clear as these were rarely assessed. Arrangements for follow-up (organisational intervention) also showed a favourable effect on process outcomes. Multiple interventions in which patient education was added or in which the role of the nurse was enhanced also reported favourable effects on patients' health outcomes. REVIEWERS' CONCLUSION: Multifaceted professional interventions can enhance the performance of health professionals in managing patients with diabetes. Organisational interventions that improve regular prompted recall and review of patients (central computerised tracking systems or nurses who regularly contact the patient) can also improve diabetes management. The addition of patient-oriented interventions can lead to improved patient health outcomes. Nurses can play an important role in patient-oriented interventions, through patient education or facilitating adherence to treatment.

Brief interventions to reduce Ecstasy use: a multi-site randomized controlled trial.

PubMed

Norberg, Melissa M; Hides, Leanne; Olivier, Jake; Khawar, Laila; McKetin, Rebecca; Copeland, Jan

2014-11-01

Studies examining the ability of motivational enhancement therapy (MET) to augment education provision among ecstasy users have produced mixed results and none have examined whether treatment fidelity was related to ecstasy use outcomes. The primary objectives of this multi-site, parallel, two-group randomized controlled trial were to determine if a single-session of MET could instill greater commitment to change and reduce ecstasy use and related problems more so than an education-only intervention and whether MET sessions delivered with higher treatment fidelity are associated with better outcomes. The secondary objective was to assess participants' satisfaction with their assigned interventions. Participants (N=174; Mage=23.62) at two Australian universities were allocated randomly to receive a 15-minute educational session on ecstasy use (n=85) or a 50-minute session of MET that included an educational component (n=89). Primary outcomes were assessed at baseline, and then at 4-, 16-, and 24-weeks postbaseline, while the secondary outcome measure was assessed 4-weeks postbaseline by researchers blind to treatment allocation. Overall, the treatment fidelity was acceptable to good in the MET condition. There were no statistical differences at follow-up between the groups on the primary outcomes of ecstasy use, ecstasy-related problems, and commitment to change. Both intervention groups reported a 50% reduction in their ecstasy use and a 20% reduction in the severity of their ecstasy-related problems at the 24-week follow up. Commitment to change slightly improved for both groups (9%-17%). Despite the lack of between-group statistical differences on primary outcomes, participants who received a single session of MET were slightly more satisfied with their intervention than those who received education only. MI fidelity was not associated with ecstasy use outcomes. Given these findings, future research should focus on examining mechanisms of change. Such work may suggest new methods for enhancing outcomes. Australia and New Zealand Clinical Trial Registry: ACTRN12611000136909. Copyright © 2014. Published by Elsevier Ltd.

Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes.

PubMed

Zinman, Bernard; Wanner, Christoph; Lachin, John M; Fitchett, David; Bluhmki, Erich; Hantel, Stefan; Mattheus, Michaela; Devins, Theresa; Johansen, Odd Erik; Woerle, Hans J; Broedl, Uli C; Inzucchi, Silvio E

2015-11-26

The effects of empagliflozin, an inhibitor of sodium-glucose cotransporter 2, in addition to standard care, on cardiovascular morbidity and mortality in patients with type 2 diabetes at high cardiovascular risk are not known. We randomly assigned patients to receive 10 mg or 25 mg of empagliflozin or placebo once daily. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, as analyzed in the pooled empagliflozin group versus the placebo group. The key secondary composite outcome was the primary outcome plus hospitalization for unstable angina. A total of 7020 patients were treated (median observation time, 3.1 years). The primary outcome occurred in 490 of 4687 patients (10.5%) in the pooled empagliflozin group and in 282 of 2333 patients (12.1%) in the placebo group (hazard ratio in the empagliflozin group, 0.86; 95.02% confidence interval, 0.74 to 0.99; P=0.04 for superiority). There were no significant between-group differences in the rates of myocardial infarction or stroke, but in the empagliflozin group there were significantly lower rates of death from cardiovascular causes (3.7%, vs. 5.9% in the placebo group; 38% relative risk reduction), hospitalization for heart failure (2.7% and 4.1%, respectively; 35% relative risk reduction), and death from any cause (5.7% and 8.3%, respectively; 32% relative risk reduction). There was no significant between-group difference in the key secondary outcome (P=0.08 for superiority). Among patients receiving empagliflozin, there was an increased rate of genital infection but no increase in other adverse events. Patients with type 2 diabetes at high risk for cardiovascular events who received empagliflozin, as compared with placebo, had a lower rate of the primary composite cardiovascular outcome and of death from any cause when the study drug was added to standard care. (Funded by Boehringer Ingelheim and Eli Lilly; EMPA-REG OUTCOME ClinicalTrials.gov number, NCT01131676.).

Outcomes of Medically Indicated Preterm Births Differ by Indication.

PubMed

Wang, Michelle J; Kuper, Spencer G; Steele, Robin; Sievert, Rachel A; Tita, Alan T; Harper, Lorie M

2018-07-01

 We aim to examine whether outcomes of preterm birth (PTB) are further modified by the indication for delivery.  We performed a retrospective cohort study of all singletons delivered at 23 to 34 weeks from 2011 to 2014. Women were classified by their primary indication for delivery: maternal (preeclampsia) or fetal/obstetric (growth restriction, nonreassuring fetal status, and vaginal bleeding). The primary neonatal outcome was a composite of neonatal death, cord pH <7 or base excess < - 12, 5-minute Apgar ≤3, C-reactive protein during resuscitation, culture-proven sepsis, intraventricular hemorrhage, and necrotizing enterocolitis. Secondary outcomes included the individual components of the primary outcome. Groups were compared using Student's t -test and chi-squared tests. Logistic regression was used to adjust for confounding variables.  Of 528 women, 395 (74.8%) were delivered for maternal and 133 (25.2%) for fetal/obstetric indications. Compared with those delivered for a maternal indication, those with a fetal/obstetric indication for delivery had an increased risk of the composite neonatal outcome (adjusted odds ratio [AOR]: 1.9, 95% confidence interval [CI]: 1.13-3.21) and acidemia at birth (AOR: 4.2, 95% CI: 1.89-9.55).  Preterm infants delivered for fetal/obstetric indications have worsened outcomes compared with those delivered for maternal indications. Additional research is needed to further tailor counseling specific to the indication for delivery. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

A dose-effect analysis of children's exposure to dental amalgam and neuropsychological function: the New England Children's Amalgam Trial.

PubMed

Bellinger, David C; Trachtenberg, Felicia; Daniel, David; Zhang, Annie; Tavares, Mary A; McKinlay, Sonja

2007-09-01

The New England Children's Amalgam Trial (NECAT) was a five-year randomized trial of 534 6- to 10-year-old children that compared the neuropsychological outcomes of those whose caries were restored using dental amalgam with the outcomes of those those whose caries were restored using mercury-free resin-based composite. The primary intention-to-treat analyses did not reveal significant differences between the treatment groups on the primary or secondary outcomes of the administered psychological tests: Full-Scale IQ score on the Wechsler Intelligence Scale for Children-Third Edition, General Memory Index of the Wide Range Assessment of Memory and Learning, and Visual-Motor Composite of the Wide Range Assessment of Visual Motor Abilities. To determine whether treatment group assignment, a dichotomous measure of exposure, was sufficiently sensitive to detect associations between mercury exposure and these outcomes, the authors conducted analyses to evaluate the associations between the primary and secondary outcomes and two continuously distributed indexes of potential exposure, surface-years of amalgam and urinary mercury excretion. Neither index of mercury exposure was significantly associated with any of the three outcomes. The authors found no evidence that exposure to mercury from dental amalgam was associated with any adverse neuropsychological effects over the five-year period after placement of amalgam restorations. Analyses of the outcomes of the NECAT study indicate that use of dental amalgam was not associated with an increase in children's risk of experiencing neuropsychological dysfunction.

Drooling in Parkinson's disease: A randomized controlled trial of incobotulinum toxin A and meta-analysis of Botulinum toxins.

PubMed

Narayanaswami, Pushpa; Geisbush, Thomas; Tarulli, Andrew; Raynor, Elizabeth; Gautam, Shiva; Tarsy, Daniel; Gronseth, Gary

2016-09-01

Botulinum toxins are a therapeutic option for drooling in Parkinson's Disease (PD). The aims of this study were to: 1. evaluate the efficacy of incobotulinum toxin A for drooling in PD. 2. Perform a meta-analysis of studies of Botulinum toxins for drooling in PD. 1. Primary study: Randomized, double blind, placebo controlled, cross over trial. Incobotulinum toxin (100 units) or saline was injected into the parotid (20 units) and submandibular (30 units) glands. Subjects returned monthly for three evaluations after each injection. Outcome measures were saliva weight and Drooling Frequency and Severity Scale. 2. Systematic review of literature, followed by inverse variance meta-analyses using random effects models. 1. Primary Study: Nine of 10 subjects completed both arms. There was no significant change in the primary outcome of saliva weight one month after injection in the treatment period compared to placebo period (mean difference, gm ± SD: -0.194 ± 0.61, range: -1.28 to 0.97, 95% CI -0.71 to 0.32). Secondary outcomes also did not change. 2. Meta-analysis of six studies demonstrated significant benefit of Botulinum toxin on functional outcomes (effect size, Cohen's d: -1.32, CI -1.86 to -0.78). The other studies used a higher dose of Botulinum toxin A into the parotid glands. This study did not demonstrate efficacy of incobotulinum toxin A for drooling in PD, but lacked precision to exclude moderate benefit. The parotid/submandibular dose-ratio may have influenced results. Studies evaluating higher doses of incobotulinum toxin A into the parotid glands may be useful. Copyright © 2016 Elsevier Ltd. All rights reserved.

Improved outcomes in the non-operative management of liver injuries

PubMed Central

Saltzherr, Teun Peter; van der Vlies, Cees H; van Lienden, Krijn P; Beenen, Ludo F M; Ponsen, Kees Jan; van Gulik, Thomas M; Goslings, J Carel

2011-01-01

Objectives Non-operative management has become the treatment of choice in the majority of liver injuries. The aim of this study was to assess the changes in primary treatment and outcomes in a single Dutch Level 1 trauma centre with wide experience in angio-embolisation (AE). Methods The prospective trauma registry was retrospectively analysed for 7-year periods before (Period 1) and after (Period 2) the introduction of AE. The primary outcome was the failure rate of primary treatment defined as liver injury-related death or re-bleeding requiring radiologic or operative (re)interventions. Secondary outcomes were liver injury-related intra-abdominal complications. Results Despite an increase in high-grade liver injuries, the incidence of primary non-operative management more than doubled over the two periods, from 33% (20 of 61 cases) in Period 1 to 72% (84 of 116 cases) in Period 2 (P < 0.001). The failure rate of primary treatment in Period 1 was 18% (11/61), compared with 11% (13/116) in Period 2 (P = 0.21). Complication rates were 23% (14/61) and 16% (18/116) in Periods 1 and 2, respectively (P = 0.22). Liver-related mortality rates were 10% (6/61) and 3% (4/116) in Periods 1 and 2, respectively (P = 0.095). The increase in the frequency of non-operative management was even higher in high-grade injuries, in which outcomes were improved. In high-grade injuries in Periods 1 and 2, failure rates decreased from 45% (9/20) to 20% (11/55) (P = 0.041), liver-related mortality decreased from 30% (6/20) to 7% (4/55) (P = 0.019) and complication rates fell from 60% (12/20) to 27% (15/55) (P = 0.014). Liver infarction or necrosis and abscess formation seemed to occur more frequently with AE. Conclusions Overall, liver-related mortality, treatment failure and complication rates remained constant despite an increase in non-operative management. However, in high-grade injuries outcomes improved after the introduction of AE. PMID:21492335

Pharmacist intervention in primary care to improve outcomes in patients with left ventricular systolic dysfunction.

PubMed

Lowrie, Richard; Mair, Frances S; Greenlaw, Nicola; Forsyth, Paul; Jhund, Pardeep S; McConnachie, Alex; Rae, Brian; McMurray, John J V

2012-02-01

Meta-analysis of small trials suggests that pharmacist-led collaborative review and revision of medical treatment may improve outcomes in heart failure. We studied patients with left ventricular systolic dysfunction in a cluster-randomized controlled, event driven, trial in primary care. We allocated 87 practices (1090 patients) to pharmacist intervention and 87 practices (1074 patients) to usual care. The intervention was delivered by non-specialist pharmacists working with family doctors to optimize medical treatment. The primary outcome was a composite of death or hospital admission for worsening heart failure. This trial is registered, number ISRCTN70118765. The median follow-up was 4.7 years. At baseline, 86% of patients in both groups were treated with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. In patients not receiving one or other of these medications, or receiving less than the recommended dose, treatment was started, or the dose increased, in 33.1% of patients in the intervention group and in 18.5% of the usual care group [odds ratio (OR) 2.26, 95% CI 1.64-3.10; P< 0.001]. At baseline, 62% of each group were treated with a β-blocker and the proportions starting or having an increase in the dose were 17.9% in the intervention group and 11.1% in the usual care group (OR 1.76, 95% CI 1.31-2.35; P< 0.001). The primary outcome occurred in 35.8% of patients in the intervention group and 35.4% in the usual care group (hazard ratio 0.97, 95% CI 0.83-1.14; P = 0.72). There was no difference in any secondary outcome. A low-intensity, pharmacist-led collaborative intervention in primary care resulted in modest improvements in prescribing of disease-modifying medications but did not improve clinical outcomes in a population that was relatively well treated at baseline.

Interventions to improve care coordination between primary healthcare and oncology care providers: a systematic review.

PubMed

Tomasone, Jennifer R; Brouwers, Melissa C; Vukmirovic, Marija; Grunfeld, Eva; O'Brien, Mary Ann; Urquhart, Robin; Walker, Melanie; Webster, Fiona; Fitch, Margaret

2016-01-01

Coordination of patient care between primary care and oncology care providers is vital to care quality and outcomes across the cancer continuum, yet it is known to be challenging. We conducted a systematic review to evaluate current or new models of care and/or interventions aimed at improving coordination between primary care and oncology care providers for patients with adult breast and/or colorectal cancer. MEDLINE, EMBASE, CINAHL, Cochrane Library Database of Systematic Reviews, and the Centre for Reviews and Dissemination were searched for existing English language studies published between January 2000 and 15 May 2015. Systematic reviews, meta-analyses, randomised controlled trials (RCTs) and non-randomised studies were included if they evaluated a specific model/intervention that was designed to improve care coordination between primary care and oncology care providers, for any stage of the cancer continuum, for patients with adult breast and/or colorectal cancer. Two reviewers extracted data and assessed risk of bias. Twenty-two studies (5 systematic reviews, 6 RCTs and 11 non-randomised studies) were included and varied with respect to the targeted phase of the cancer continuum, type of model or intervention tested, and outcome measures. The majority of studies showed no statistically significant changes in any patient, provider or system outcomes. Owing to conceptual and methodological limitations in this field, the review is unable to provide specific conclusions about the most effective or preferred model/intervention to improve care coordination. Imprecise results that lack generalisability and definitiveness provide limited evidence to base the development of future interventions and policies. CRD42015025006.

Registration status and outcome reporting of trials published in core headache medicine journals.

PubMed

Rayhill, Melissa L; Sharon, Roni; Burch, Rebecca; Loder, Elizabeth

2015-11-17

To evaluate randomized controlled trial (RCT) registration and outcome reporting compliance in core headache medicine journals. We identified RCTs published in core journals (Headache, Cephalalgia, and the Journal of Headache and Pain) from 2005 through 2014. We searched articles for trial registration numbers, which were verified in the corresponding trial registry. We categorized trial funding sources as industry, academic, government, or mixed. We contacted corresponding authors to assess reasons for nonregistration. We evaluated whether primary outcomes in trial registries matched those in corresponding publications. The journals published 225 RCTs over the study period. Fifty-eight of 225 (26%) reported a trial registration number in the article that could be linked to a corresponding registry entry. Trial registration rates increased over the 9 years of the study. Forty-six of 118 (39%) of industry-funded studies were registered compared with 27% of academic and 0% of government-funded studies. Only 5% of RCTs were prospectively registered, reported primary outcomes identical to those in the trial registry, and did not report unacknowledged post hoc outcomes. The most common reason for nonregistration was lack of awareness. Only about a quarter of the articles published in the core headache medicine journals are compliant with trial registration, but compliance has increased over time. Selective reporting of outcomes remains a problem, and very few trials met all 3 reporting standards assessed in this study. Efforts to improve the quality of trial reporting in the headache literature should continue. © 2015 American Academy of Neurology.

Designing a valid randomized pragmatic primary care implementation trial: the my own health report (MOHR) project.

PubMed

Krist, Alex H; Glenn, Beth A; Glasgow, Russell E; Balasubramanian, Bijal A; Chambers, David A; Fernandez, Maria E; Heurtin-Roberts, Suzanne; Kessler, Rodger; Ory, Marcia G; Phillips, Siobhan M; Ritzwoller, Debra P; Roby, Dylan H; Rodriguez, Hector P; Sabo, Roy T; Sheinfeld Gorin, Sherri N; Stange, Kurt C

2013-06-25

There is a pressing need for greater attention to patient-centered health behavior and psychosocial issues in primary care, and for practical tools, study designs and results of clinical and policy relevance. Our goal is to design a scientifically rigorous and valid pragmatic trial to test whether primary care practices can systematically implement the collection of patient-reported information and provide patients needed advice, goal setting, and counseling in response. This manuscript reports on the iterative design of the My Own Health Report (MOHR) study, a cluster randomized delayed intervention trial. Nine pairs of diverse primary care practices will be randomized to early or delayed intervention four months later. The intervention consists of fielding the MOHR assessment--addresses 10 domains of health behaviors and psychosocial issues--and subsequent provision of needed counseling and support for patients presenting for wellness or chronic care. As a pragmatic participatory trial, stakeholder groups including practice partners and patients have been engaged throughout the study design to account for local resources and characteristics. Participatory tasks include identifying MOHR assessment content, refining the study design, providing input on outcomes measures, and designing the implementation workflow. Study outcomes include the intervention reach (percent of patients offered and completing the MOHR assessment), effectiveness (patients reporting being asked about topics, setting change goals, and receiving assistance in early versus delayed intervention practices), contextual factors influencing outcomes, and intervention costs. The MOHR study shows how a participatory design can be used to promote the consistent collection and use of patient-reported health behavior and psychosocial assessments in a broad range of primary care settings. While pragmatic in nature, the study design will allow valid comparisons to answer the posed research question, and findings will be broadly generalizable to a range of primary care settings. Per the pragmatic explanatory continuum indicator summary (PRECIS) framework, the study design is substantially more pragmatic than other published trials. The methods and findings should be of interest to researchers, practitioners, and policy makers attempting to make healthcare more patient-centered and relevant. Clinicaltrials.gov: NCT01825746.

Strengthening health human resources and improving clinical outcomes through an integrated guideline and educational outreach in resource-poor settings: a cluster-randomized trial.

PubMed

Schull, Michael J; Banda, Hastings; Kathyola, Damson; Fairall, Lara; Martiniuk, Alexandra; Burciul, Barry; Zwarenstein, Merrick; Sodhi, Sumeet; Thompson, Sandy; Joshua, Martias; Mondiwa, Martha; Bateman, Eric

2010-12-03

In low-income countries, only about a third of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) patients eligible for anti-retroviral treatment currently receive it. Providing decentralized treatment close to where patients live is crucial to a faster scale up, however, a key obstacle is limited health system capacity due to a shortage of trained health-care workers and challenges of integrating HIV/AIDS care with other primary care services (e.g. tuberculosis, malaria, respiratory conditions). This study will test an adapted primary care health care worker training and guideline intervention, Practical Approach to Lung Health and HIV/AIDS Malawi (PALM PLUS), on staff retention and satisfaction, and quality of patient care. A cluster-randomized trial design is being used to compare usual care with a standardized clinical guideline and training intervention, PALM PLUS. The intervention targets middle-cadre health care workers (nurses, clinical officers, medical assistants) in 30 rural primary care health centres in a single district in Malawi. PALM PLUS is an integrated, symptom-based and user-friendly guideline consistent with Malawian national treatment protocols. Training is standardized and based on an educational outreach approach. Trainers will be front-line peer healthcare workers trained to provide outreach training and support to their fellow front-line healthcare workers during focused (1-2 hours), intermittent, interactive sessions on-site in health centers. Primary outcomes are health care worker retention and satisfaction. Secondary outcomes are clinical outcomes measured at the health centre level for HIV/AIDS, tuberculosis, prevention-of-mother-to-child-transmission of HIV and other primary care conditions. Effect sizes and 95% confidence intervals for outcomes will be presented. Assessment of outcomes will occur at 1 year post- implementation. The PALM PLUS trial aims to address a key problem: strengthening middle-cadre health care workers to support the broader scale up of HIV/AIDS services and their integration into primary care. The trial will test whether the PALM PLUS intervention improves staff satisfaction and retention, as well as the quality of patient care, when compared to usual practice. Controlled Clinical Trials ISRCTN47805230.

A Systematic Review of Depression Treatments in Primary Care for Latino Adults

ERIC Educational Resources Information Center

Cabassa, Leopoldo J.; Hansen, Marissa C.

2007-01-01

Objective: A systematic literature review of randomized clinical trials (RCTs) assessing depression treatments in primary care for Latinos is conducted. The authors rate the methodological quality of studies, examine cultural and linguistic adaptations, summarize clinical outcomes and cost-effectiveness findings, and draw conclusions for improving…

Parental Involvement in Primary Children's Homework in Hong Kong

ERIC Educational Resources Information Center

Tam, Vicky C.; Chan, Raymond M.

2009-01-01

This study draws upon an ecological perspective to examine parental involvement in homework and its relationship with primary school children's educational outcomes within the Chinese sociocultural context of Hong Kong. Data were collected using homework diaries and questionnaires administered to 1,309 pairs of students and parents spanning all…

Advanced training for primary care and general practice nurses: enablers and outcomes of postgraduate education.

PubMed

Hallinan, Christine M; Hegarty, Kelsey L

2016-01-01

The aims of the present study were to understand enablers to participation in postgraduate education for primary care nurses (PCNs), and to explore how postgraduate education has advanced their nursing practice. Cross-sectional questionnaires were mailed out in April 2012 to current and past students undertaking postgraduate studies in primary care nursing at The University of Melbourne, Victoria, Australia. Questionnaires were returned by 100 out of 243 nurses (response rate 41%). Ninety-one per cent (91/100) of the respondents were first registered as nurses in Australia. Fifty-seven per cent were hospital trained and 43% were university educated to attain their initial nurse qualification. The respondents reported opportunities to expand scope of practice (99%; 97/98), improve clinical practice (98%; 97/99), increase work satisfaction (93%; 91/98) and increase practice autonomy (92%; 89/97) as factors that most influenced participation in postgraduate education in primary care nursing. Major enablers for postgraduate studies were scholarship access (75%; 71/95) and access to distance education (74%; 72/98). Many respondents reported an increased scope of practice (98%; 95/97) and increased job satisfaction (71%; 70/98) as an education outcome. Only 29% (28/97) cited an increase in pay-rate as an outcome. Of the 73 PCNs currently working in general practice, many anticipated an increase in time spent on the preparation of chronic disease management plans (63%; 45/72), multidisciplinary care plans (56%; 40/72) and adult health checks (56%; 40/72) in the preceding 12 months. Recommendations emerging from findings include: (1) increased access to scholarships for nurses undertaking postgraduate education in primary care nursing is imperative; (2) alternative modes of course delivery need to be embedded in primary care nursing education; (3) the development of Australian primary care policy, including policy on funding models, needs to more accurately reflect the educational level of PCNs, PCN role expansion and the extent of interprofessional collaboration that is evident from research undertaken to date. Nurses with postgraduate education have the potential to increase their scope of practice, take on a greater teaching role and provide more preventive and chronic disease services in primary care. Policies aimed at increasing access to education for nurses working in primary care would strengthen the primary care nursing profession, and enhance the delivery of primary health care services in Australia.

Pelvic floor muscle training versus watchful waiting or pessary treatment for pelvic organ prolapse (POPPS): design and participant baseline characteristics of two parallel pragmatic randomized controlled trials in primary care.

PubMed

Wiegersma, Marian; Panman, Chantal M C R; Kollen, Boudewijn J; Vermeulen, Karin M; Schram, Aaltje J; Messelink, Embert J; Berger, Marjolein Y; Lisman-Van Leeuwen, Yvonne; Dekker, Janny H

2014-02-01

Pelvic floor muscle training (PFMT) and pessaries are commonly used in the conservative treatment of pelvic organ prolapse (POP). Because there is a lack of evidence regarding the optimal choice between these two interventions, we designed the "Pelvic Organ prolapse in primary care: effects of Pelvic floor muscle training and Pessary treatment Study" (POPPS). POPPS consists of two parallel open label randomized controlled trials performed in primary care, in women aged ≥55 years, recruited through a postal questionnaire. In POPPS trial 1, women with mild POP receive either PFMT or watchful waiting. In POPPS trial 2, women with advanced POP receive either PFMT or pessary treatment. Patient recruitment started in 2009 and was finished in December 2012. Primary outcome of both POPPS trials is improvement in POP-related symptoms. Secondary outcomes are quality of life, sexual function, POP-Q stage, pelvic floor muscle function, post-void residual volume, patients' perception of improvement, and costs. All outcomes are measured 3, 12, and 24 months after the start of treatment. Cost-effectiveness will be calculated based on societal costs, using the PFDI-20 and the EQ-5D as outcomes. In this paper the POPPS design, the encountered challenges and our solutions, and participant baseline characteristics are presented. For both trials the target numbers of patients in each treatment group are achieved, giving this study sufficient power to lead to promising results. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Examining the Job-Related, Psychological, and Physical Outcomes of Workplace Sexual Harassment: A Meta-Analytic Review

ERIC Educational Resources Information Center

Chan, Darius K-S.; Lam, Chun Bun; Chow, Suk Yee; Cheung, Shu Fai

2008-01-01

This study was designed to examine the job-related, psychological, and physical outcomes of sexual harassment in the workplace. Using a meta-analytic approach, we analyzed findings from 49 primary studies, with a total sample size of 89,382, to obtain estimates of the population mean effect size of the association between sexual harassment and…

Faculty Engagement with Learning Outcomes Assessment: A Study of Public Two-Year Colleges in Colorado

ERIC Educational Resources Information Center

Williams, Jennifer L.

2013-01-01

The problem addressed in this study was the assumption that faculty at the postsecondary level in the U. S. are not sufficiently or effectively engaged with student learning outcomes assessment (LOA) activities and/or practices. This issue emerged in two primary ways within the Scholarship of Assessment (SoA) body of literature: (1) as a…

Engagement with Young Adult Literature: Outcomes and Processes

ERIC Educational Resources Information Center

Ivey, Gay; Johnston, Peter H.

2013-01-01

This study examines students' perceptions of the outcomes and processes of engaged reading in classrooms prioritizing engagement through self-selected, self-paced reading of compelling young adult literature. The primary data were 71 end-of-year student interviews, supported by end-of-year teacher interviews, biweekly observational data,…

Do E-Textbooks Impact Learning Outcomes?

ERIC Educational Resources Information Center

Fike, David; Fike, Renea

2016-01-01

The primary focus of this study was to determine if student learning outcomes in an undergraduate Statistics course differed based upon the type of textbook used (e-textbook or hardcopy). Fifty-six students enrolled in the course were allowed to choose textbook type. After controlling for student demographics and academic preparedness, student…

Curriculum-Based Measurement of Oral Reading Fluency (CBM-R): An Objective Orientated Evaluation Study

ERIC Educational Resources Information Center

Grima-Farrell, Christine

2014-01-01

The knowledge and practices associated with improved outcomes for readers have yielded converging evidence about practices associated with improved reading outcomes for primary students. This considerable intervention knowledge can be beneficial for English teachers working with struggling secondary readers. Fluency is one critical element that…

Impact of primary care exercise referral schemes on the health of patients with obesity

PubMed Central

Parretti, Helen M; Bartington, Suzanne E; Badcock, Tim; Hughes, Lucy; Duda, Joan L; Jolly, Kate

2017-01-01

Primary care exercise referral schemes (ERSs) are a potentially useful setting to promote physical activity (PA). It is not established, however, whether interventions to increase PA, such as ERSs, have differing health outcomes according to the participants’ body mass index (BMI). This paper summarizes evidence for the impact of primary care ERSs on the health of people with obesity and reports findings of a reanalysis of the EMPOWER study, providing the first data to report differential outcomes of ERSs by BMI category. Our literature review revealed a paucity of published data. A 2011 Health Technology Assessment review and 2015 update were identified, but normal-weight participants were neither excluded nor were results stratified by weight in the included studies. A study of the effect of exercise referral in overweight women reported a significantly greater increase in PA levels in the ERS group than the control group at 3 months. Reanalysis of the EMPOWER study data showed a significant improvement in PA at 3 months in both obese and overweight/normal BMI groups, with the effect size attenuated to 6 months. There was no significant difference from baseline to 6 months in blood pressure for either BMI category. At 6 months, there was a significant decrease in weight from baseline for the obese category. Comparison of crude mean differences between BMI groups revealed a significant mean difference in PA at 3 months favoring the overweight/normal BMI group, but not at 6 months. There were no further significant differences in unadjusted or adjusted mean differences for other outcomes at follow-up. We report some evidence of a differential impact of ERS on PA by BMI category. However, the effect of ERSs in primary care for patients with obesity remains unclear due to the small number of published studies that have reported outcomes by BMI category. Further research is needed. PMID:29033627

Salvage treatment for recurrent oropharyngeal squamous cell carcinoma.

PubMed

Röösli, Christof; Studer, Gabriela; Stoeckli, Sandro J

2010-08-01

This study evaluates the oncological outcome of patients with recurrent oropharyngeal squamous cell carcinoma (OPSCC) after primary radiation therapy +/- chemotherapy, primary surgical therapy, and surgical therapy followed by radiation therapy +/- chemotherapy. A total of 156 patients (36%) of a cohort of 427 treated for OPSCC between 1990 and 2006 developed recurrent disease. Fifty-one patients (12%) qualified for salvage treatment. Study endpoints were 5-year overall survival (OS) and disease-specific survival (DSS). The 5-year OS and DSS rates after salvage treatment were 29% and 40%; after initial primary radiation therapy, 25% and 40%; after initial surgery followed by radiation therapy, 40% and 40%; and after initial surgery alone, 20% and 40%. Patients with an advanced OPSCC have a considerable risk for recurrence. Despite poor ultimate outcome, salvage treatment should be attempted in patients with resectable disease, good performance status, and absence of distant metastases. 2009 Wiley Periodicals, Inc. Head Neck, 2010.

Clinical data, clinicopathologic findings and outcome in dogs with amegakaryocytic thrombocytopenia and primary immune-mediated thrombocytopenia.

PubMed

Cooper, S A; Huang, A A; Raskin, R E; Weng, H-Y; Scott-Moncrieff, J C

2016-03-01

The aim of this study was to identify distinguishing characteristics between dogs diagnosed with amegakaryocytic thrombocytopenia and those diagnosed with presumed primary peripheral immune-mediated thrombocytopenia. Presenting clinical and clinicopathologic data and outcomes were compared between the two groups. Retrospective study performed on seven client-owned dogs diagnosed with amegakaryocytic thrombocytopenia and 34 client-owned dogs with primary peripheral immune-mediated thrombocytopenia. All dogs in the amegakaryocytic thrombocytopenia group were anaemic on presentation with a median haematocrit of 23% (range 9·4 to 36), while the primary peripheral immune-mediated thrombocytopoenia group had a median presenting haematocrit of 35% (range 10 to 53). Dogs with amegakaryocytic thrombocytopenia had a median of five (range 4 to 7) clinical signs of bleeding compared to a median of three (range 0 to 6) in the primary peripheral immune-mediated thrombocytopenia group with 86% (6 of 7) of amegakaryocytic thrombocytopenia dogs requiring a blood transfusion compared to 41% (14 of 34) of primary peripheral immune-mediated thrombocytopenia dogs. Six of the seven amegakaryocytic thrombocytopenia dogs did not survive to discharge, while only five of the 34 primary peripheral immune-mediated thrombocytopenia dogs did not survive to discharge. The clinical presentation of dogs with amegakaryocytic thrombocytopenia and primary peripheral immune-mediated thrombocytopenia is similar, but dogs with amegakaryocytic thrombocytopenia had a more severe clinical course compared to primary peripheral immune-mediated thrombocytopenia dogs. The prognosis for dogs with amegakaryocytic thrombocytopenia is poor. © 2016 British Small Animal Veterinary Association.

Impact of a low intensity and broadly inclusive ED care coordination intervention on linkage to primary care and ED utilization.

PubMed

Foster, Sean D; Hart, Kim; Lindsell, Christopher J; Miller, Christopher N; Lyons, Michael S

2018-04-05

We aim to evaluate the effectiveness of a broadly inclusive, comparatively low intensity intervention linking ED patients to a primary care home. This retrospective cohort study evaluated ED patients referred for primary care linkage in a large, urban, academic ED. A care coordination specialist performed a brief interview to gauge access barriers and provide a clinic referral with optional scheduling assistance. Data were abstracted from program records and the electronic medical record. The primary outcome was the proportion of referred individuals who attended at least one primary care appointment. Secondary outcomes included return ED encounters within one year, and factors associated with linkage outcomes. There were 2142 referrals made for 2064 patients; 1688/2142 accepted assistance. Linkage was successful for 1059/1688 (63%, CI95 60% to 65%). Among patients accepting assistance, those without successful linkage were younger (41 vs 45years, difference 3years, CI95 2 to 3), more often male (62% vs 55%,difference 7%, CI95 2% to 12%), and less likely to have a chronic medical condition (37% vs 45%, difference 8%; CI95 3% to 12%) or to have had an appointment scheduled within two weeks (26% vs 33%, difference 7%, CI95 2% to 12%). Insurance status and self-reported barriers to care were not associated with linkage success. Patterns of subsequent ED use were similar, regardless of referral status or linkage outcome. Low intensity, broadly inclusive, ED care coordination linked nearly 50% of patients referred for intervention, and two-thirds of willing participants, with a primary care home. Copyright © 2018 Elsevier Inc. All rights reserved.

The Impact of Electronic Health Records and Teamwork on Diabetes Care Quality

PubMed Central

Graetz, Ilana; Huang, Jie; Brand, Richard; Shortell, Stephen M.; Rundall, Thomas G.; Bellows, Jim; Hsu, John; Jaffe, Marc; Reed, Mary E.

2016-01-01

Objective Evidence of the impact Electronic Health Records (EHR) on clinical outcomes remains mixed. The impact EHRs likely depends on the organizational context in which they are used. We focus on one aspect of the organizational context: cohesion of primary care teams. We examined whether team cohesion among primary care team members changed the association of EHR use and changes in clinical outcomes for patients with diabetes. Study Design We combined provider-reported primary care team cohesion with lab values for patients with diabetes collected during the staggered EHR implementation (2005–2009). We used multivariate regression models with patient-level fixed effects to assess whether team cohesion levels changed the association between outpatient EHR use and clinical outcomes for patients with diabetes. Subjects 80,611 patients with diabetes mellitus. Measures Changes in hemoglobin A1c (HbA1c) and low-density lipoprotein cholesterol (LDL-C) Results For HbA1c, EHR use was associated with an average decrease of 0.11% for patients with higher cohesion primary care teams compared with a decrease of 0.08% for patients with lower cohesion teams (difference 0.02% in HbA1c, 95%CI: 0.01–0.03). For LDL-C, EHR use was associated with a decrease of 2.15 mg/dL for patients with higher cohesion primary teams compared with a decrease of 1.42 mg/dL for patients with lower cohesion teams (difference 0.73 mg/dL, 95%CI: 0.41–1.11 mg/dL). Conclusions Patients cared for by higher cohesion primary care teams experienced modest but statistically significantly greater EHR-related health outcome improvements, compared with patients cared for by providers practicing in lower cohesion teams. PMID:26671699

Provider-Related Linkages Between Primary Care Clinics and Community-Based Senior Centers Associated With Diabetes-Related Outcomes.

PubMed

Noël, Polly Hitchcock; Wang, Chen-Pin; Finley, Erin P; Espinoza, Sara E; Parchman, Michael L; Bollinger, Mary J; Hazuda, Helen P

2018-06-01

The Institute of Medicine (IOM) suggests that linkages between primary care practices and community-based resources can improve health in lower income and minority patients, but examples of these are rare. We conducted a prospective, mixed-methods observational study to identify indicators of primary care-community linkage associated with the frequency of visits to community-based senior centers and improvements in diabetes-related outcomes among 149 new senior center members (72% Hispanic). We used semistructured interviews at baseline and 9-month follow-up, obtaining visit frequency from member software and clinical assessments including hemoglobin A1c (HbA1c) from colocated primary care clinics. Members' discussion of their activities with their primary care providers (PCPs) was associated with increased visits to the senior centers, as well as diabetes-related improvements. Direct feedback from the senior centers to their PCPs was desired by the majority of members and may help to reinforce use of community resources for self-management support.

Obstetrical APS: is there a place for hydroxychloroquine to improve the pregnancy outcome?

PubMed

Mekinian, Arsene; Costedoat-Chalumeau, Nathalie; Masseau, Agathe; Tincani, Angela; De Caroli, Sara; Alijotas-Reig, Jaume; Ruffatti, Amelia; Ambrozic, Ales; Botta, Angela; Le Guern, Véronique; Fritsch-Stork, Ruth; Nicaise-Roland, Pascale; Carbonne, Bruno; Carbillon, Lionel; Fain, Olivier

2015-01-01

The use of the conventional APS treatment (the combination of low-dose aspirin and LMWH) dramatically improved the obstetrical prognosis in primary obstetrical APS (OAPS). The persistence of adverse pregnancy outcome raises the need to find other drugs to improve obstetrical outcome. Hydroxychloroquine is widely used in patients with various autoimmune diseases, particularly SLE. Antimalarials have many anti-inflammatory, anti-aggregant and immune-regulatory properties: they inhibit phospholipase activity, stabilize lysosomal membranes, block the production of several pro-inflammatory cytokines and, in addition, impair complement-dependent antigen-antibody reactions. There is ample evidence of protective effects of hydroxychloroquine in OAPS similar to the situation in SLE arising from in vitro studies of pathophysiological working mechanism of hydroxychloroquine. However, the clinical data on the use of hydroxychloroquine in primary APS are lacking and prospective studies are necessary. Copyright © 2014 Elsevier B.V. All rights reserved.

ClinicalTrials.gov and Drugs@FDA: A comparison of results reporting for new drug approval trials

PubMed Central

Schwartz, Lisa M.; Woloshin, Steven; Zheng, Eugene; Tse, Tony; Zarin, Deborah A.

2016-01-01

Background Pharmaceutical companies and other trial sponsors must submit certain trial results to ClinicalTrials.gov. The validity of these results is unclear. Purpose To validate results posted on ClinicalTrials.gov against publicly-available FDA reviews on Drugs@FDA. Data sources ClinicalTrials.gov (registry and results database) and Drugs@FDA (medical/statistical reviews). Study selection 100 parallel-group, randomized trials for new drug approvals (1/2013 – 7/2014) with results posted on ClinicalTrials.gov (3/15/2015). Data extraction Two assessors systematically extracted, and another verified, trial design, primary/secondary outcomes, adverse events, and deaths. Results The 100 trials were mostly phase 3 (90%) double-blind (92%), placebo-controlled (73%), representing 32 drugs from 24 companies. Of 137 primary outcomes from ClinicalTrials.gov, 134 (98%) had corresponding data in Drugs@FDA, 130 (95%) had concordant definitions, and 107 (78%) had concordant results; most differences were nominal (i.e. relative difference < 10%). Of 100 trials, primary outcome results in 14 could not be validated . Of 1,927 secondary outcomes from ClinicalTrials.gov, 1,061 (55%) definitions could be validated and 367 (19%) had results. Of 96 trials with ≥ 1 serious adverse event in either source, 14 could be compared and 7 were discordant. Of 62 trials with ≥ 1 death in either source, 25 could be compared and 17 were discordant. Limitations Unknown generalizability to uncontrolled or crossover trial results. Conclusion Primary outcome definitions and results were largely concordant between ClinicalTrials.gov and Drugs@FDA. Half of secondary outcomes could not be validated because Drugs@FDA only includes “key outcomes” for regulatory decision-making; nor could serious adverse events and deaths because Drugs@FDA frequently only includes results aggregated across multiple trials. PMID:27294570

Phase II Clinical Trials: D-methionine to Reduce Noise-Induced Hearing Loss

DTIC Science & Technology

2012-03-01

loss (NIHL) and tinnitus in our troops. Hypotheses: Primary Hypothesis: Administration of oral D-methionine prior to and during weapons...reduce or prevent noise-induced tinnitus . Primary outcome to test the primary hypothesis: Pure tone air-conduction thresholds. Primary outcome to...test the secondary hypothesis: Tinnitus questionnaires. Specific Aims: 1. To determine whether administering oral D-methionine (D-met) can

Association of total serum cholesterol with functional outcome following home care rehabilitation in Italian patients with stroke.

PubMed

Cataldo, Maria Concetta; Calcara, Maria Luisa; Caputo, Giuseppe; Mammina, Caterina

2012-04-01

Stroke is a disabling disease. In elderly populations, stroke is the third leading cause of death and the primary cause of reduction in or loss of functional ability and personal autonomy. Possible associations between levels of total serum cholesterol (TC) and both incidence of stroke and functional outcomes after rehabilitation are still under study. To detect positive and negative prognostic factors associated with functional outcomes in first-time stroke patients admitted to an integrated home care rehabilitative program. This study enrolled 141 patients with a first-time stroke who were admitted to a home care rehabilitation program. Primary outcome measures were the Barthel activities of daily living (ADL) and mobility indices at the beginning and end of the rehabilitative treatment. The impact of TC and other demographic and clinical variables was analyzed using bivariate and multivariate logistic regression analyses. Age and Short Portable Mental Status Questionnaire (SPMSQ) score were negatively associated with functional outcome. In contrast, elevated TC was positively associated with a better home rehabilitative treatment outcome. Barthel index score at admission was negatively associated with outcomes assessed by the Barthel ADL index and age with outcomes assessed by the Barthel mobility index. In a multivariate logistic regression analysis, SPMSQ score and elevated TC were significantly associated with outcome. Specifically, higher SPMSQ scores were negatively associated with better rehabilitative treatment outcomes, whereas elevated TC was positively associated. Elevated TC seems to be associated with better functional outcomes in patients with first-time stroke. Copyright © 2012 Elsevier Inc. All rights reserved.

Revision versus primary arthroscopic rotator cuff repair: a 2-year analysis of outcomes in 360 patients.

PubMed

Shamsudin, Aminudin; Lam, Patrick H; Peters, Karin; Rubenis, Imants; Hackett, Lisa; Murrell, George A C

2015-03-01

Symptomatic rotator cuff tears are often treated surgically. However, there is a paucity of information regarding the outcomes of revision arthroscopic rotator cuff repairs. To evaluate the outcome of revision arthroscopic rotator cuff surgery when compared with primary arthroscopic rotator cuff surgery in a large cohort of patients. Cohort study; Level of evidence, 3. A consecutive series of 50 revision arthroscopic rotator cuff repairs performed by a single surgeon, with minimum 2-year follow-up, were retrospectively reviewed using prospectively collected data. As a comparison, 3 primary arthroscopic rotator cuff repair cases (primary group; n = 310) were chosen immediately before each revision case, and 3 were chosen after. Standardized patient-ranked outcomes, examiner-determined assessments, and ultrasound-determined rotator cuff integrity were assessed preoperatively at 6 months and at a minimum of 2 years after surgery. The revision group was older (mean age, 63 years; range, 43-80 years) compared with the primary group (mean age, 60 years; range, 18-88 years) (P < .05) and had larger tear size (mean ± SEM) (4.1 ± 0.5 cm(2)) compared with the primary group (3.0 ± 0.2 cm(2)) (P < .05). Two years after surgery, the primary group reported less pain at rest (P < .02), during sleep (P < .05), and with overhead activity (P < .01) compared with the revision group. The primary group had better passive forward flexion (+13°; P < .05), abduction (+18°; P < .01), internal rotation (+2 vertebral levels; P < .001) and also significantly greater supraspinatus strength (+15 N; P < .001), lift-off strength (+9.3 N; P < .05), and adduction strength (+20 N; P < .01) compared with the revision group at 2 years. When compared with the primary group, the revision group was more satisfied with the overall shoulder function before surgery but was less satisfied with their shoulder function than the primary group at 2 years (P < .005). The retear rate for primary rotator cuff repair was 16% at 6 months and 21% at 2 years, while the retear rate for revision rotator cuff repair was 28% at 6 months and deteriorated to 40% at 2 years (P < .05). The short-term clinical outcomes of patients undergoing revision rotator cuff repair were similar to those after primary rotator cuff repair. However, these results did not persist, and by 2 years patients who had revision rotator cuff repair were twice as likely to have retorn compared with those undergoing primary repair. The increase in retear rate in the revision group at 2 years was associated with increased pain, impaired overhead function, less passive motion, weaker strength, and less overall satisfaction with shoulder function. © 2014 The Author(s).

Understanding the Stress Process of Chinese- and Korean-American Breast Cancer Survivors

PubMed Central

Lim, Jung-won

2017-01-01

Guided by the stress process model (SPM), this study investigated the direct and indirect pathways of primary (negative self-image and life stress), secondary stressors (family communication strain) and family coping (external and internal) on mental health outcomes among Chinese- and Korean-American breast cancer survivors (BCS). A total of 156 Chinese- and Korean-American BCS were surveyed. Results showed primary and secondary stressors had a negative effect on better mental health outcomes. External coping was associated with better mental health. Family communication strain mediated the relationship between life stress and mental health outcomes. External coping mediated the relationship between family communication strain and mental health outcomes. Multi-group analysis revealed the stress process did not differ across ethnic groups. Findings suggest the SPM may be applicable to understand the stress process of Chinese-and Korean-American BCS and provide valuable insight into the role of family communication and external coping on mental health outcomes. PMID:26223968

Self-declared stock ownership and association with positive trial outcome in randomized controlled trials with binary outcomes published in general medical journals: a cross-sectional study.

PubMed

Falk Delgado, Alberto; Falk Delgado, Anna

2017-07-26

Describe the prevalence and types of conflicts of interest (COI) in published randomized controlled trials (RCTs) in general medical journals with a binary primary outcome and assess the association between conflicts of interest and favorable outcome. Parallel-group RCTs with a binary primary outcome published in three general medical journals during 2013-2015 were identified. COI type, funding source, and outcome were extracted. Binomial logistic regression model was performed to assess association between COI and funding source with outcome. A total of 509 consecutive parallel-group RCTs were included in the study. COI was reported in 74% in mixed funded RCTs and in 99% in for-profit funded RCTs. Stock ownership was reported in none of the non-profit RCTs, in 7% of mixed funded RCTs, and in 50% of for-profit funded RCTs. Mixed-funded RCTs had employees from the funding company in 11% and for-profit RCTs in 76%. Multivariable logistic regression revealed that stock ownership in the funding company among any of the authors was associated with a favorable outcome (odds ratio = 3.53; 95% confidence interval = 1.59-7.86; p < 0.01). COI in for-profit funded RCTs is extensive, because the factors related to COI are not fully independent, a multivariable analysis should be cautiously interpreted. However, after multivariable adjustment only stock ownership from the funding company among authors is associated with a favorable outcome.

Outcome of patients after treatment for a squamous cell carcinoma of the oropharynx.

PubMed

Röösli, Christof; Tschudi, Dominique C; Studer, Gabriela; Braun, Julia; Stoeckli, Sandro J

2009-03-01

This study evaluates the oncologic outcome with regard to survival and locoregional tumor control in a cohort of patients with oropharyngeal squamous cell carcinoma (OPSCC) treated according to a uniform algorithm. Retrospective chart review. A total of 427 consecutive patients with OPSCC were treated from 1990 to 2006. Treatment modalities were surgery alone (n = 102), surgery with adjuvant radio(chemo)therapy (n = 159), and primary radio(chemo)therapy (n = 166). Study endpoints were the five-year overall survival (OS) and disease-specific survival (DSS) stratified for primary tumor subsite, stage, T and N category, and age. The five-year OS and DSS for the entire cohort were 57.9% and 68.6%, respectively. OS and DSS for surgery alone were 70.3% and 76.5%, for surgery with radiation 66.6% and 78.9%, and for primary radiation 40.8% and 52.6%, respectively. Survival was significantly better for low stages (stage I/II vs. III/IV), small tumors (T1/2 vs. T3/4), limited nodal involvement (N0/1 vs. N2/3), and younger age at diagnosis. Together with our previous study on quality of life, we were able to show that our selection process gives excellent oncologic outcome in combination with high levels of function and quality of life. Surgery alone for early OPSCC and surgery followed by radiation for advanced OPSCC remain valuable treatment options. Primary radiochemotherapy is a strong alternative for patients who are not candidates for function-preserving surgery.

Primary versus secondary tracheoesophageal puncture for voice rehabilitation in laryngectomy patients: A systematic review.

PubMed

Luu, K; Chang, B A; Valenzuela, D; Anderson, D

2018-05-16

Among voice restoration options following laryngectomy, tracheoesophageal puncture (TEP) appears to be the most common. Currently, there is no consensus that exists with regard to the timing of performing TEP and the decision to perform a primary or secondary TEP has mostly been based on physician preference and expert opinion rather than data. The objective of this study was to compare primary and secondary tracheoesophageal puncture (TEP) for voice rehabilitation in laryngectomy patients in terms of success and complication rates. A systematic review of studies in the English literature was conducted for studies that directly compared primary and secondary TEP. A comprehensive search of MEDLINE (January 1948-15 July 2016), EMBASE (January 1974-15 July 2016) and Web of Science (January 1970-15 July 2016) was performed. Two authors (KL/BAC) independently reviewed titles and abstracts, read full-text papers, extracted data and assessed quality. Disagreements were resolved via consensus. A third author (DV) resolved disagreements between reviewers when consensus was not possible. Eleven retrospective clinical cohort studies were included. No randomised controlled trials were identified. Newcastle-Ottawa score for assessment of quality ranged from 5 to 7. Success rate was defined differently across most studies. Two studies found higher success with primary TEP compared to secondary TEP; nine studies found no difference. Voice outcomes were inconsistently measured; no difference between groups was found in 4 studies. Complication rates were divided into TEP site related, infectious and stenosis. No difference between primary and secondary TEP was found in all but one study which showed a higher rate of pharyngocutaneous fistula in the primary TEP group in salvage laryngectomy patients. There is no robust evidence to suggest that primary TEP is associated with poorer outcomes compared to secondary TEP. A well-designed randomised controlled trial is required to appropriately answer this question. © 2018 John Wiley & Sons Ltd.

Systematic Review of Interventions to Improve the Provision of Information for Adults with Primary Brain Tumors and Their Caregivers

PubMed Central

Langbecker, Danette; Janda, Monika

2014-01-01

Background: Adults with primary brain tumors and their caregivers have significant information needs. This review assessed the effect of interventions to improve information provision for adult primary brain tumor patients and/or their caregivers. Methods: We included randomized or non-randomized trials testing educational interventions that had outcomes of information provision, knowledge, understanding, recall, or satisfaction with the intervention, for adults diagnosed with primary brain tumors and/or their family or caregivers. PubMed, MEDLINE, EMBASE, and Cochrane Reviews databases were searched for studies published between 1980 and June 2014. Results: Two randomized controlled, 1 non-randomized controlled, and 10 single group pre–post trials enrolled more than 411 participants. Five group, four practice/process change, and four individual interventions assessed satisfaction (12 studies), knowledge (4 studies), and information provision (2 studies). Nine studies reported high rates of satisfaction. Three studies showed statistically significant improvements over time in knowledge and two showed greater information was provided to intervention than control group participants, although statistical testing was not performed. Discussion: The trials assessed intermediate outcomes such as satisfaction, and only 4/13 reported on knowledge improvements. Few trials had a randomized controlled design and risk of bias was either evident or could not be assessed in most domains. PMID:25667919

Patient-Reported Outcomes and Return to Activity After Peroneus Brevis Repair.

PubMed

Steginsky, Brian; Riley, Aimee; Lucas, Douglas E; Philbin, Terrence M; Berlet, Gregory C

2016-02-01

There is limited data on functional outcomes after primary repair of partial peroneal tendon tears. Previous reports have been limited by small cohorts, duration of follow-up, and often included both tenodesis and primary repair. The purpose of this study was to report the functional outcomes and return to activity in the largest cohort to date with partial peroneal tendon tears treated with primary repair. A chart review identified all patients who underwent primary repair of the peroneus brevis tendon from 2008 to 2012. Demographic data, magnetic resonance imaging findings, and postoperative complications were reviewed. Patients were asked to complete a follow-up questionnaire, Foot and Ankle Ability Measure (FAAM), and Foot Function Index (FFI). There were 201 patients who underwent primary repair of the peroneus brevis tendon. The average age at time of operation was 44.3 years. Seventy-one patients returned the follow-up questionnaires with an average follow-up of 4.6 years. Fifty-two patients completed the FFI questionnaire preoperatively and postoperatively. Fifty-nine patients (83.1%) reported a return to regular exercise and sports at final follow-up. At 1 year postoperatively, 76.5% of patients returned to the same preinjury activities, and 62.3% returned to the same level of preinjury activity. Furthermore, 85.9% of patients were satisfied with their outcome, and 91.4% of patients reported they would choose to undergo the same procedure again. The mean FAAM score was 85.2 at follow-up. The mean preoperative and postoperative FFI score was 41.1 and 12.2, respectively. There was a significant improvement in the FFI score of 28.9 after primary peroneus brevis tendon repair (P < .001). Primary repair of peroneus brevis tendon provided consistent improvement in functional outcomes in the majority of patients, as measured by a validated scoring system, the FFI. FAAM scores demonstrated good function compared to historical controls. The majority of patients were able to return to preinjury activity. Level IV, retrospective case series. © The Author(s) 2015.

Delays in the delivery room of a primary maternity unit: a retrospective analysis of obstetric outcomes.

PubMed

Giannella, Luca; Mfuta, Kabala; Pedroni, Deborah; Delrio, Elisabetta; Venuta, Agnese; Bergamini, Ezio; Cerami, Lillo B

2013-04-01

To compare obstetric outcomes in women undergoing vaginal delivery with or without delay in the 2nd and 3rd stage of labour (SOL). This is an observational retrospective study including 10,416 full-term vaginal deliveries occurred at a primary obstetric unit. Our sample was divided according to the length of 2nd and 3rd SOL: >2 h vs. ≤2 h; and >1 h vs. ≤1 h, respectively. Obstetric outcomes were compared using univariate and multivariate analysis. A prolonged 2nd SOL was associated with severe perineal tears (odds ratio (OR) = 3.53), episiotomy (OR = 3.25), major post-partum hemorrhage (PPH) (OR = 2.35), operative delivery (OR = 3.54), and Asian ethnicity (OR = 12.12). Likewise, a prolonged 3rd SOL was associated with operative deliveries (OR = 10.49), labor induction (OR = 3.24), non-use of oxytocin after delivery (OR = 12.39), major PPH (OR = 46.95), retained placenta (OR = 3.57) and female fetal gender (OR = 4.07). even at a primary care setting, where there are mostly low-risk pregnancies, a prolonged 2nd and 3rd SOL may occur and lead to poor obstetric outcomes. Our findings raise a very controversial issue about the meaning of "low obstetrics risk", given the unpredictability of any labor, and the management of complications in the delivery room of primary maternity units.

Unruptured Brain Arteriovenous Malformations: Primary ONYX Embolization in ARUBA (A Randomized Trial of Unruptured Brain Arteriovenous Malformations)-Eligible Patients.

PubMed

Singfer, Uri; Hemelsoet, Dimitri; Vanlangenhove, Peter; Martens, Frederic; Verbeke, Luc; Van Roost, Dirk; Defreyne, Luc

2017-12-01

In light of evidence from ARUBA (A Randomized Trial of Unruptured Brain Arteriovenous Malformations), neurovascular specialists had to reconsider deliberate treatment of unruptured brain arteriovenous malformations (uBAVMs). Our objective was to determine the outcomes of uBAVM treated with primary embolization using ethylene vinyl alcohol (ONYX). Patients with uBAVM who met the inclusion criteria of ARUBA and were treated with primary Onyx embolization were assigned to this retrospective study. The primary outcome was the modified Rankin Scale score. Secondary outcomes were stroke or death because of uBAVM or intervention and uBAVM obliteration. Sixty-one patients (mean age, 38 years) were included. The median observation period was 60 months. Patients were treated by embolization alone (41.0%), embolization and radiosurgery (57.4%), or embolization and excision (1.6%). Occlusion was achieved in 44 of 57 patients with completed treatment (77.2%). Forty-seven patients (77.1%) had no clinical impairment at the end of observation (modified Rankin Scale score of <2). Twelve patients (19.7%) reached the outcome of stroke or death because of uBAVM or intervention. Treatment-related mortality was 6.6% (4 patients). In uBAVM, Onyx embolization alone or combined with stereotactic radiosurgery achieves a high occlusion rate. Morbidity remains a challenge, even if it seems lower than in the ARUBA trial. © 2017 American Heart Association, Inc.

Benchmarks for effective primary care-based nursing services for adults with depression: a Delphi study.

PubMed

McIlrath, Carole; Keeney, Sinead; McKenna, Hugh; McLaughlin, Derek

2010-02-01

This paper is a report of a study conducted to identify and gain consensus on appropriate benchmarks for effective primary care-based nursing services for adults with depression. Worldwide evidence suggests that between 5% and 16% of the population have a diagnosis of depression. Most of their care and treatment takes place in primary care. In recent years, primary care nurses, including community mental health nurses, have become more involved in the identification and management of patients with depression; however, there are no appropriate benchmarks to guide, develop and support their practice. In 2006, a three-round electronic Delphi survey was completed by a United Kingdom multi-professional expert panel (n = 67). Round 1 generated 1216 statements relating to structures (such as training and protocols), processes (such as access and screening) and outcomes (such as patient satisfaction and treatments). Content analysis was used to collapse statements into 140 benchmarks. Seventy-three benchmarks achieved consensus during subsequent rounds. Of these, 45 (61%) were related to structures, 18 (25%) to processes and 10 (14%) to outcomes. Multi-professional primary care staff have similar views about the appropriate benchmarks for care of adults with depression. These benchmarks could serve as a foundation for depression improvement initiatives in primary care and ongoing research into depression management by nurses.

Caregiver and patient reported outcomes after repair of cleft lip and/or palate in the Philippines.

PubMed

Sharp, Helen M; Canady, John W; Ligot, Fernando A C; Hague, Rebecca A; Gutierrez, Johcille; Gutierrez, Johnny

2008-03-01

To establish the feasibility of conducting outcomes research among patients treated during a medical mission and to identify the salient outcomes for patients and caregivers in one region of the Philippines. Prospective structured interview conducted in or near participants' homes on the island of Cebu, Philippines. Individuals who had surgery at least 6 months earlier within the study region were eligible. Recipients of surgery were located from surgical records and by word of mouth. (1) Proportion of individuals located. (2) Primary outcomes of oral cleft repair identified for the sample. Of 99 people on a surgical list, 52 (53%) were located, eight were excluded (ineligible, unavailable, or inaccessible), and 44 agreed to participate in the study. Ten participants were identified via word of mouth. Seventy-five interviews were conducted (21 caregiver-patient pairs, one adolescent, and 32 caregivers of a child <7 years). Nearly all participants (99%) would encourage others to pursue surgery. Open-ended questions were coded to identify primary outcomes: improved speech (52%), improved eating (25%), social benefits (14%), and improved appearance (6%). Caregivers (50%) and patients (68%) reported that improved speech was the most important change after surgery. Patients and caregivers ascribe positive changes related to cleft surgery. Outcomes research requires cooperation with local professionals who can communicate effectively. These data serve to demonstrate feasibility and as a model for future studies of treatment outcomes in follow-up to international medical missions.

Risk-adjusted payment and performance assessment for primary care.

PubMed

Ash, Arlene S; Ellis, Randall P

2012-08-01

Many wish to change incentives for primary care practices through bundled population-based payments and substantial performance feedback and bonus payments. Recognizing patient differences in costs and outcomes is crucial, but customized risk adjustment for such purposes is underdeveloped. Using MarketScan's claims-based data on 17.4 million commercially insured lives, we modeled bundled payment to support expected primary care activity levels (PCAL) and 9 patient outcomes for performance assessment. We evaluated models using 457,000 people assigned to 436 primary care physician panels, and among 13,000 people in a distinct multipayer medical home implementation with commercially insured, Medicare, and Medicaid patients. Each outcome is separately predicted from age, sex, and diagnoses. We define the PCAL outcome as a subset of all costs that proxies the bundled payment needed for comprehensive primary care. Other expected outcomes are used to establish targets against which actual performance can be fairly judged. We evaluate model performance using R(2)'s at patient and practice levels, and within policy-relevant subgroups. The PCAL model explains 67% of variation in its outcome, performing well across diverse patient ages, payers, plan types, and provider specialties; it explains 72% of practice-level variation. In 9 performance measures, the outcome-specific models explain 17%-86% of variation at the practice level, often substantially outperforming a generic score like the one used for full capitation payments in Medicare: for example, with grouped R(2)'s of 47% versus 5% for predicting "prescriptions for antibiotics of concern." Existing data can support the risk-adjusted bundled payment calculations and performance assessments needed to encourage desired transformations in primary care.

Randomized comparative efficacy study of parent-mediated interventions for toddlers with autism.

PubMed

Kasari, Connie; Gulsrud, Amanda; Paparella, Tanya; Hellemann, Gerhard; Berry, Kathleen

2015-06-01

This study compared effects of two parent-mediated interventions on joint engagement outcomes as augmentations of an early intervention program for toddlers with autism spectrum disorder (ASD). Participants included 86 toddlers (range 22-36 months) with ASD and their primary caregiver. Caregiver-child dyads were randomized to receive 10 weeks of hands-on parent training in a naturalistic, developmental behavioral intervention (joint attention, symbolic play, engagement and regulation-JASPER) or a parent-only psychoeducational intervention (PEI). Dose was controlled in terms of researcher-parent contact and early intervention services received by the child. Results yielded significant effects of the JASPER intervention on the primary outcome of joint engagement. The treatment effect was large (Cohen's f² = .69) and maintained over the 6-month follow-up. JASPER effects were also found on secondary outcomes of play diversity, highest play level achieved, and generalization to the child's classroom for child-initiated joint engagement. The PEI intervention was found to be effective in reducing parenting stress associated with child characteristics. All secondary effects were generally small to moderate. These data highlight the benefit of a brief, targeted, parent-mediated intervention on child outcomes. Future studies may consider the combination of JASPER and PEI treatments for optimal parent and child outcomes. Trial registry no. NCT00999778. (c) 2015 APA, all rights reserved).

Group metacognitive therapy for repetitive negative thinking in primary and non-primary generalized anxiety disorder: an effectiveness trial.

PubMed

McEvoy, Peter M; Erceg-Hurn, David M; Anderson, Rebecca A; Campbell, Bruce N C; Swan, Amanda; Saulsman, Lisa M; Summers, Mark; Nathan, Paula R

2015-04-01

Generalized anxiety disorder (GAD) is a common and highly comorbid anxiety disorder characterized by repetitive negative thinking (RNT). Treatment trials tend to exclude individuals with non-primary GAD, despite this being a common presentation in real world clinics. RNT is also associated with multiple emotional disorders, suggesting that it should be targeted regardless of the primary disorder. This study evaluated the acceptability and effectiveness of brief group metacognitive therapy (MCT) for primary or non-primary GAD within a community clinic. Patients referred to a specialist community clinic attended six, two-hour weekly sessions plus a one-month follow-up (N=52). Measures of metacognitive beliefs, RNT, symptoms, positive and negative affect, and quality of life were completed at the first, last, and follow-up sessions. Attrition was low and large intent-to-treat effects were observed on most outcomes, particularly for negative metacognitive beliefs and RNT. Treatment gains increased further to follow-up. Benchmarking comparisons demonstrated that outcomes compared favorably to longer disorder-specific protocols for primary GAD. No control group or independent assessment of protocol adherence. Brief metacognitive therapy is an acceptable and powerful treatment for patients with primary or non-primary GAD. Copyright © 2014 Elsevier B.V. All rights reserved.

Radiosensitivity Differences Between Liver Metastases Based on Primary Histology Suggest Implications for Clinical Outcomes After Stereotactic Body Radiation Therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ahmed, Kamran A.; Caudell, Jimmy J.; El-Haddad, Ghassan

Purpose/Objectives: Evidence from the management of oligometastases with stereotactic body radiation therapy (SBRT) reveals differences in outcomes based on primary histology. We have previously identified a multigene expression index for tumor radiosensitivity (RSI) with validation in multiple independent cohorts. In this study, we assessed RSI in liver metastases and assessed our clinical outcomes after SBRT based on primary histology. Methods and Materials: Patients were identified from our prospective, observational protocol. The previously tested RSI 10 gene assay was run on samples and calculated using the published algorithm. An independent cohort of 33 patients with 38 liver metastases treated with SBRTmore » was used for clinical correlation. Results: A total of 372 unique metastatic liver lesions were identified for inclusion from our prospective, institutional metadata pool. The most common primary histologies for liver metastases were colorectal adenocarcinoma (n=314, 84.4%), breast adenocarcinoma (n=12, 3.2%), and pancreas neuroendocrine (n=11, 3%). There were significant differences in RSI of liver metastases based on histology. The median RSIs for liver metastases in descending order of radioresistance were gastrointestinal stromal tumor (0.57), melanoma (0.53), colorectal neuroendocrine (0.46), pancreas neuroendocrine (0.44), colorectal adenocarcinoma (0.43), breast adenocarcinoma (0.35), lung adenocarcinoma (0.31), pancreas adenocarcinoma (0.27), anal squamous cell cancer (0.22), and small intestine neuroendocrine (0.21) (P<.0001). The 12-month and 24-month Kaplan-Meier rates of local control (LC) for colorectal lesions from the independent clinical cohort were 79% and 59%, compared with 100% for noncolorectal lesions (P=.019), respectively. Conclusions: In this analysis, we found significant differences based on primary histology. This study suggests that primary histology may be an important factor to consider in SBRT radiation dose selection.« less

Core outcome measures for opioid abuse liability laboratory assessment studies in humans: IMMPACT recommendations

PubMed Central

Comer, Sandra D.; Zacny, James P.; Dworkin, Robert H.; Turk, Dennis C.; Bigelow, George E.; Foltin, Richard W.; Jasinski, Donald R.; Sellers, Edward M.; Adams, Edgar H.; Balster, Robert; Burke, Laurie B.; Cerny, Igor; Colucci, Robert D.; Cone, Edward; Cowan, Penney; Farrar, John T.; Haddox, J. David; Haythornthwaite, Jennifer A.; Hertz, Sharon; Jay, Gary W.; Johanson, Chris-Ellyn; Junor, Roderick; Katz, Nathaniel P.; Klein, Michael; Kopecky, Ernest A.; Leiderman, Deborah B.; McDermott, Michael P.; O’Brien, Charles; O’Connor, Alec B.; Palmer, Pamela P.; Raja, Srinivasa N.; Rappaport, Bob A.; Rauschkolb, Christine; Rowbotham, Michael C.; Sampaio, Cristina; Setnik, Beatrice; Sokolowska, Marta; Stauffer, Joseph W.; Walsh, Sharon L.

2012-01-01

A critical component in development of opioid analgesics is assessment of their abuse liability (AL). Standardization of approaches and measures used in assessing AL has the potential to facilitate comparisons across studies, research laboratories, and drugs. The goal of this report is to provide consensus recommendations regarding core outcome measures for assessing abuse potential of opioid medications in humans in a controlled laboratory setting. Although many of the recommended measures are appropriate for assessing the AL of medications from other drug classes, the focus here is on opioid medications because they present unique risks from both physiological (e.g., respiratory depression, physical dependence) and public health (e.g., individuals in pain) perspectives. A brief historical perspective on AL testing is provided and then those measures that can be considered primary and secondary outcomes and possible additional outcomes in AL assessment are discussed. These outcome measures include: (1) subjective effects (some of which comprise the primary outcome measures, including drug liking); (2) physiological responses; (3) drug self-administration behavior; and (4) cognitive and psychomotor performance. Prior to presenting recommendations for standardized approaches and measures to be used in AL assessments, the appropriateness of using these measures in clinical trials with patients in pain is discussed. PMID:22998781

Examining the Starting Dose of Glyburide in Gestational Diabetes

PubMed Central

GLOVER, Angelica V.; TITA, Alan; BIGGIO, Joseph R.; HARPER, Lorie M.

2016-01-01

OBJECTIVE The aim of this study was to determine the impact of initial glyburide dosing on pregnancy outcomes. STUDY DESIGN Retrospective cohort of singleton pregnancies complicated by gestational diabetes (GDM) from 2007-2013. Women who received glyburide were compared by initial dose: 2.5mg (n=170) versus 5mg (n=154) total daily dose. The primary maternal outcome was hypoglycemia, defined as a blood glucose <60 mg/dL. The primary neonatal outcome was birth weight. Secondary maternal outcomes included time to blood glucose control, preeclampsia, and cesarean delivery. Secondary neonatal outcomes included macrosomia (>4000g), hypoglycemia (<40 mg/dL), shoulder dystocia, and preterm delivery. RESULTS The 5 mg/day glyburide dose did not increase maternal hypoglycemia (26% in the 2.5 mg/day group versus 27% in the 5 mg/day group, AOR 0.67 (CI 0.30-1.49)). An increase in macrosomia in the 5 mg/day group was not significant after adjusting for maternal obesity (AOR 2.16 (CI 0.96-4.88)). Differences in preterm birth and large for gestational age were not significant after adjusting for prior preterm birth and maternal obesity, respectively. CONCLUSIONS A higher starting dose of glyburide for the management of GDM was not associated with increased maternal hypoglycemia or decreased adverse neonatal outcomes. PMID:26368915

Systematic review of mental health and well-being outcomes following community-based obesity prevention interventions among adolescents

PubMed Central

Hoare, Erin; Fuller-Tyszkiewicz, Matthew; Skouteris, Helen; Millar, Lynne; Nichols, Melanie; Allender, Steven

2015-01-01

Objectives This paper aimed to systematically evaluate the mental health and well-being outcomes observed in previous community-based obesity prevention interventions in adolescent populations. Setting Systematic review of literature from database inception to October 2014. Articles were sourced from CINAHL, Global Health, Health Source: Nursing and Academic Edition, MEDLINE, PsycARTICLES and PsycINFO, all of which were accessed through EBSCOhost. The Cochrane Database was also searched to identify all eligible articles. PRISMA guidelines were followed and search terms and search strategy ensured all possible studies were identified for review. Participants Intervention studies were eligible for inclusion if they were: focused on overweight or obesity prevention, community-based, targeted adolescents (aged 10–19 years), reported a mental health or well-being measure, and included a comparison or control group. Studies that focused on specific adolescent groups or were treatment interventions were excluded from review. Quality of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) guidelines. Primary and secondary outcome measures Primary outcomes were measures of mental health and well-being, including diagnostic and symptomatic measures. Secondary outcomes included adiposity or weight-related measures. Results Seven studies met the inclusion criteria; one reported anxiety/depressive outcomes, two reported on self-perception well-being measures such as self-esteem and self-efficacy, and four studies reported outcomes of quality of life. Positive mental health outcomes demonstrated that following obesity prevention, interventions included a decrease in anxiety and improved health-related quality of life. Quality of evidence was graded as very low. Conclusions Although positive outcomes for mental health and well-being do exist, controlled evaluations of community-based obesity prevention interventions have not often included mental health measures (n=7). It is recommended that future interventions incorporate mental health and well-being measures to identify any potential mechanisms influencing adolescent weight-related outcomes, and equally to ensure interventions are not causing harm to adolescent mental health. PMID:25564145

Need to Recalibrate Research Outcomes in Alzheimer's Disease: Focus on Neuropsychiatric Symptoms.

PubMed

Canevelli, Marco; Cesari, Matteo; Lucchini, Flaminia; Valletta, Martina; Sabino, Michele; Lacorte, Eleonora; Vanacore, Nicola; Bruno, Giuseppe

2017-09-01

To determine whether neuropsychiatric symptoms (NPSs) are adequately considered in clinical research on Alzheimer's disease (AD). Systematic review. Randomized controlled trials (RCTs) recruiting individuals with AD and published during the last 10 years in 16 major general medicine, neurology, psychiatry, and geriatric psychiatry journals and RCTs registered on clinicaltrials.gov and currently enrolling individuals with AD. Individuals with AD. Outcome measures adopted by the included studies. Only 21.4% of the included studies identified through the bibliographic searches had measures of NPSs as a primary outcome. Only 17.7% of the studies retrieved on clinicaltrials.gov made a specific effort to test the effect of pharmacological or nonpharmacological interventions on NPSs. These findings show how rarely previous and current research on AD has considered NPSs as primary research targets. Although these symptoms are widely recognized as the most-stressful and -challenging manifestations of dementia, they are addressed much less often than other research targets. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

Occupational outcomes following mild traumatic brain injury in Canadian military personnel deployed in support of the mission in Afghanistan: a retrospective cohort study.

PubMed

Garber, Bryan G; Rusu, Corneliu; Zamorski, Mark A; Boulos, David

2016-05-04

Deployment-related mild traumatic brain injury (MTBI) occurs in a significant number of military personnel but its long-term impacts are unclear. This study explores the impact of deployment-related MTBI on continued fitness-for-duty, with the ultimate intent of identifying potential targets for intervention to attenuate its effects. Consisted of 16 193 Canadian Armed Forces (CAF) personnel who deployed in support of the mission in Afghanistan and completed an enhanced postdeployment screening (EPDS) questionnaire over the period January 2009-July 2012. The primary outcome was development of permanent medical unfitness defined as a 'career-limiting medical condition' (CL-MC). The secondary outcome was the diagnostic categories recorded for each individual at the time a CL-MC was established. This study used a retrospective cohort design. Linked administrative and health data provided the primary outcome and the diagnoses responsible for it. Survival analysis was used to estimate the risk of a CL-MC and Cox regression provided adjusted HRs (aHRs) for the association between a CL-MC and MTBI, accounting for key covariates and confounders. Diagnostic categories associated with CL-MCs were identified. Over a median follow-up period of 3.42 years, 6.57% of the study population developed a CL-MC. MTBI was independently associated with CL-MCs (aHR=1.65, 95% CI 1.35 to 2.03). Mental disorders and musculoskeletal conditions were the primary diagnoses associated with CL-MCs (identified as the primary diagnosis in 55.4% and 25.9%, respectively), and a neurological condition was only documented in 5.8% of those with MTBI who developed a CL-MC CONCLUSIONS: Deployment-related MTBI was associated with adverse occupational outcome but mental disorders and musculoskeletal conditions primarily drove subsequent medical unfitness. These findings support a diagnostic and treatment approach focusing on these comorbidities as the most promising strategy to minimise the burden of disability in MTBI-exposed military personnel. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Systematic review: Outcome reporting bias is a problem in high impact factor neurology journals

PubMed Central

Scott, Jared T.; Blubaugh, Mark; Roepke, Brie; Scheckel, Caleb; Vassar, Matt

2017-01-01

Background Selective outcome reporting is a significant methodological concern. Comparisons between the outcomes reported in clinical trial registrations and those later published allow investigators to understand the extent of selection bias among trialists. We examined the possibility of selective outcome reporting in randomized controlled trials (RCTs) published in neurology journals. Methods We searched PubMed for randomized controlled trials from Jan 1, 2010 –Dec 31, 2015 published in the top 3 impact factor neurology journals. These articles were screened according to specific inclusion criteria. Each author individually extracted data from trials following a standardized protocol. A second author verified each extracted element and discrepancies were resolved. Consistency between registered and published outcomes was evaluated and correlations between discrepancies and funding, journal, and temporal trends were examined. Results 180 trials were included for analysis. 10 (6%) primary outcomes were demoted, 38 (21%) primary outcomes were omitted from the publication, and 61 (34%) unregistered primary outcomes were added to the published report. There were 18 (10%) cases of secondary outcomes being upgraded to primary outcomes in the publication, and there were 53 (29%) changes in timing of assessment. Of 82 (46%) major discrepancies with reported p-values, 54 (66.0%) favored publication of statistically significant results. Conclusion Across trials, we found 180 major discrepancies. 66% of major discrepancies with a reported p-value (n = 82) favored statistically significant results. These results suggest a need within neurology to provide more consistent and timely registration of outcomes. PMID:28727834

Systematic review: Outcome reporting bias is a problem in high impact factor neurology journals.

PubMed

Howard, Benjamin; Scott, Jared T; Blubaugh, Mark; Roepke, Brie; Scheckel, Caleb; Vassar, Matt

2017-01-01

Selective outcome reporting is a significant methodological concern. Comparisons between the outcomes reported in clinical trial registrations and those later published allow investigators to understand the extent of selection bias among trialists. We examined the possibility of selective outcome reporting in randomized controlled trials (RCTs) published in neurology journals. We searched PubMed for randomized controlled trials from Jan 1, 2010 -Dec 31, 2015 published in the top 3 impact factor neurology journals. These articles were screened according to specific inclusion criteria. Each author individually extracted data from trials following a standardized protocol. A second author verified each extracted element and discrepancies were resolved. Consistency between registered and published outcomes was evaluated and correlations between discrepancies and funding, journal, and temporal trends were examined. 180 trials were included for analysis. 10 (6%) primary outcomes were demoted, 38 (21%) primary outcomes were omitted from the publication, and 61 (34%) unregistered primary outcomes were added to the published report. There were 18 (10%) cases of secondary outcomes being upgraded to primary outcomes in the publication, and there were 53 (29%) changes in timing of assessment. Of 82 (46%) major discrepancies with reported p-values, 54 (66.0%) favored publication of statistically significant results. Across trials, we found 180 major discrepancies. 66% of major discrepancies with a reported p-value (n = 82) favored statistically significant results. These results suggest a need within neurology to provide more consistent and timely registration of outcomes.

Implementation of a diabetes self-management education program in primary care for adults using shared medical appointments.

PubMed

Sanchez, Iris

2011-01-01

The purpose of this study was to implement diabetes self-management education in primary care using the Chronic Care Model and shared medical appointments (SMA) to provide evidence-based interventions to improve process and measure outcomes. A quality improvement project using the Plan-Do-Check-Act cycle was implemented in a primary care setting in South Texas to provide diabetes self-management education for adults. Biological measures were evaluated in 70 patients at initiation of the project and thereafter based on current practice guidelines. The results of the project were consistent with the literature regarding the benefits, sustainability, and viability of SMA. As compared with that in studies presented in the literature, the patient population who participated in SMA had similar outcomes regarding improvement in A1C, self-management skills, and satisfaction. SMA are an innovative system redesign concept with the potential to provide comprehensive and coordinated care for patients with multiple and chronic health conditions while still being an efficient, effective, financially viable, and sustainable program. As the incidence and prevalence of diabetes increase, innovative models of care can meet the growing demand for access and utilization of diabetes self-management education programs. Programs focusing on chronic conditions to improve outcomes can be replicated by health care providers in primary care settings. SMA can increase revenue and productivity, improve disease management, and increase provider and patient satisfaction.

Transcranial direct current stimulation to primary motor area improves hand dexterity and selective attention in chronic stroke.

PubMed

Au-Yeung, Stephanie S Y; Wang, Juliana; Chen, Ye; Chua, Eldrich

2014-12-01

The aim of this study was to determine whether transcranial direct current stimulation (tDCS) applied to the primary motor hand area modulates hand dexterity and selective attention after stroke. This study was a double-blind, placebo-controlled, randomized crossover trial involving subjects with chronic stroke. Ten stroke survivors with some pinch strength in the paretic hand received three different tDCS interventions assigned in random order in separate sessions-anodal tDCS targeting the primary motor area of the lesioned hemisphere (M1lesioned), cathodal tDCS applied to the contralateral hemisphere (M1nonlesioned), and sham tDCS-each for 20 mins. The primary outcome measures were Purdue pegboard test scores for hand dexterity and response time in the color-word Stroop test for selective attention. Pinch strength of the paretic hand was the secondary outcome. Cathodal tDCS to M1nonlesioned significantly improved affected hand dexterity (by 1.1 points on the Purdue pegboard unimanual test, P = 0.014) and selective attention (0.6 secs faster response time on the level 3 Stroop interference test for response inhibition, P = 0.017), but not pinch strength. The outcomes were not improved with anodal tDCS to M1lesioned or sham tDCS. Twenty minutes of cathodal tDCS to M1nonlesioned can promote both paretic hand dexterity and selective attention in people with chronic stroke.

Generic care pathway for elderly patients in need of home care services after discharge from hospital: a cluster randomised controlled trial.

PubMed

Røsstad, Tove; Salvesen, Øyvind; Steinsbekk, Aslak; Grimsmo, Anders; Sletvold, Olav; Garåsen, Helge

2017-04-17

Improved discharge arrangements and targeted post-discharge follow-up can reduce the risk of adverse events after hospital discharge for elderly patients. Although more care is to shift from specialist to primary care, there are few studies on post-discharge interventions run by primary care. A generic care pathway, Patient Trajectory for Home-dwelling elders (PaTH) including discharge arrangements and follow-up by primary care, was developed and introduced in Central Norway Region in 2009, applying checklists at defined stages in the patient trajectory. In a previous paper, we found that PaTH had potential of improving follow-up in primary care. The aim of this study was to establish the effect of PaTH-compared to usual care-for elderly in need of home care services after discharge from hospital. We did an unblinded, cluster randomised controlled trial with 12 home care clusters. Outcomes were measured at the patient level during a 12-month follow-up period for the individual patient and analysed applying linear and logistic mixed models. Primary outcomes were readmissions within 30 days and functional level assessed by Nottingham extended ADL scale. Secondary outcomes were number and length of inpatient hospital care and nursing home care, days at home, consultations with the general practitioners (GPs), mortality and health related quality of life (SF-36). One-hundred and sixty-three patients were included in the PaTH group (six clusters), and 141 patients received care as usual (six clusters). We found no statistically significant differences between the groups for primary and secondary outcomes except for more consultations with the GPs in PaTH group (p = 0.04). Adherence to the intervention was insufficient as only 36% of the patients in the intervention group were assessed by at least three of the four main checklists in PaTH, but this improved over time. Lack of adherence to PaTH rendered the study inconclusive regarding the elderly's functional level, number of readmissions after hospital discharge, and health care utilisation except for more consultations with the GPs. A targeted exploration of prerequisites for implementation is recommended in the pre-trial phase of complex intervention studies. Clinical Trials.gov NCT01107119 , retrospectively registered 2010.04.18.

Examining multi-session brief intervention for substance use in primary care: research methods of a randomized controlled trial.

PubMed

Chambers, Jaclyn E; Brooks, Adam C; Medvin, Rachel; Metzger, David S; Lauby, Jennifer; Carpenedo, Carolyn M; Favor, Kevin E; Kirby, Kimberly C

2016-04-18

Brief interventions such as Screening, a single session of Brief Intervention, and Referral to Treatment (SBIRT) have shown mixed effectiveness in primary care. However, there are indications that multi-session brief interventions may demonstrate more consistently positive outcomes, and perhaps a more intensive approach would be of benefit in addressing substance use in primary care. This study compared the effectiveness of SBIRT with a single BI session (BI/RT) to a multi-session brief-treatment intervention (BI/RT+) in primary care. We also developed easy-to-use, evidence-based materials to assist clinicians in delivering these interventions. This study was conducted in three Federally Qualified Healthcare Centers (FQHCs). A total of 10,935 patients were screened, and 600 individuals were recruited. The sample was primarily Black/African American (82 %) with a mean age of 40. Patients who attended a healthcare appointment were screened for substance use via the AUDIT and DAST. Patients were eligible for the study if they scored 8 or higher on the AUDIT, were using only marijuana and scored 2 or higher on the DAST, or were using other illicit drugs and scored 1 or higher on the DAST. Participants were randomly assigned to receive one-session BI/RT, or two to six sessions of brief intervention that incorporated elements of motivational enhancement therapy and cognitive-behavioral therapy (BI/RT+). Both interventions were delivered by behavioral health consultants at the FQHCs. Participants completed follow-up assessments every 3 months for 1 year. Primary outcome variables included substance use treatment sessions attended and days of substance use. Secondary outcomes included measures of health, employment, legal, and psychiatric functioning and HIV risk behaviors. Additionally, we will conduct an economic evaluation examining cost-effectiveness and will analyze outcomes from a process evaluation examining patient and provider experiences. The ability of brief interventions to impact substance use has great potential, but research findings have been mixed. By conducting a large-scale randomized controlled trial in real-world health centers, this study will answer important questions about the effectiveness of expanded BIs for patients who screen positive for risky substance use in primary care. Trial registration NCT01751672.

Randomized comparison of the clinical outcome of single versus multiple arterial grafts: the ROMA trial-rationale and study protocol.

PubMed

Gaudino, Mario; Alexander, John H; Bakaeen, Faisal G; Ballman, Karla; Barili, Fabio; Calafiore, Antonio Maria; Davierwala, Piroze; Goldman, Steven; Kappetein, Peter; Lorusso, Roberto; Mylotte, Darren; Pagano, Domenico; Ruel, Marc; Schwann, Thomas; Suma, Hisayoshi; Taggart, David P; Tranbaugh, Robert F; Fremes, Stephen

2017-12-01

The primary hypothesis of the ROMA trial is that in patients undergoing primary isolated non-emergent coronary artery bypass grafting, the use of 2 or more arterial grafts compared with a single arterial graft (SAG) is associated with a reduction in the composite outcome of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in these patients, the use of 2 or more arterial grafts compared with a SAG is associated with improved survival. The ROMA trial is a prospective, unblinded, randomized event-driven multicentre trial comprising at least 4300 subjects. Patients younger than 70 years with left main and/or multivessel disease will be randomized to a SAG or multiple arterial grafts to the left coronary system in a 1:1 fashion. Permuted block randomization stratified by the centre and the type of second arterial graft will be used. The primary outcome will be a composite of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization. The secondary outcome will be all-cause mortality. The primary safety outcome will be a composite of death from any cause, any stroke and any myocardial infarction. In all patients, 1 internal thoracic artery will be anastomosed to the left anterior descending coronary artery. For patients randomized to the SAG group, saphenous vein grafts will be used for all non-left anterior descending target vessels. For patients randomized to the multiple arterial graft group, the main target vessel of the lateral wall will be grafted with either a radial artery or a second internal thoracic artery. Additional grafts for the multiple arterial graft group can be saphenous veins or supplemental arterial conduits. To detect a 20% relative reduction in the primary outcome, with 90% power at 5% alpha and assuming a time-to-event analysis, the sample size must include 845 events (and 3650 patients). To detect a 20% relative reduction in the secondary outcome, with 80% power at 5% alpha, the sample size must include 631 events (and 3650 patients). To be conservative, the sample size will be set at 4300 patients. The primary outcome will be tested according to the intention-to-treat principle. The primary analysis will be a Cox proportional hazards regression model, with the treatment arm included as a covariate. If non-proportional hazards are observed, alternatives to Cox proportional hazards regression will be explored. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

A human factors systems approach to understanding team-based primary care: a qualitative analysis

PubMed Central

Mundt, Marlon P.; Swedlund, Matthew P.

2016-01-01

Background. Research shows that high-functioning teams improve patient outcomes in primary care. However, there is no consensus on a conceptual model of team-based primary care that can be used to guide measurement and performance evaluation of teams. Objective. To qualitatively understand whether the Systems Engineering Initiative for Patient Safety (SEIPS) model could serve as a framework for creating and evaluating team-based primary care. Methods. We evaluated qualitative interview data from 19 clinicians and staff members from 6 primary care clinics associated with a large Midwestern university. All health care clinicians and staff in the study clinics completed a survey of their communication connections to team members. Social network analysis identified key informants for interviews by selecting the respondents with the highest frequency of communication ties as reported by their teammates. Semi-structured interviews focused on communication patterns, team climate and teamwork. Results. Themes derived from the interviews lent support to the SEIPS model components, such as the work system (Team, Tools and Technology, Physical Environment, Tasks and Organization), team processes and team outcomes. Conclusions. Our qualitative data support the SEIPS model as a promising conceptual framework for creating and evaluating primary care teams. Future studies of team-based care may benefit from using the SEIPS model to shift clinical practice to high functioning team-based primary care. PMID:27578837

Design and methodology of the COACH-2 (Comparative study on guideline adherence and patient compliance in heart failure patients) study: HF clinics versus primary care in stable patients on optimal therapy.

PubMed

Luttik, M L A; Brons, M; Jaarsma, T; Hillege, H L; Hoes, A; de Jong, R; Linssen, G; Lok, D J; Berger, M; van Veldhuisen, D J

2012-08-01

Since the number of heart failure (HF) patients is still growing and long-term treatment of HF patients is necessary, it is important to initiate effective ways for structural involvement of primary care services in HF management programs. However, evidence on whether and when patients can be referred back to be managed in primary care is lacking. To determine whether long-term patient management in primary care, after initial optimisation of pharmacological and non-pharmacological treatment in a specialised HF clinic, is equally effective as long-term management in a specialised HF clinic in terms of guideline adherence and patient compliance. The study is designed as a randomised, controlled, non-inferiority trial. Two-hundred patients will be randomly assigned to be managed and followed in primary care or in a HFclinic. Patients are eligible to participate if they are (1) clinically stable, (2) optimally up-titrated on medication (according to ESC guidelines) and, (3) have received optimal education and counselling on pre-specified issues regarding HF and its treatment. Furthermore, close cooperation between secondary and primary care in terms of back referral to or consultation of the HF clinic will be provided.The primary outcome will be prescriber adherence and patient compliance with medication after 12 months. Secondary outcomes measures will be readmission rate, mortality, quality of life and patient compliance with other lifestyle changes. The results of the study will add to the understanding of the role of primary care and HF clinics in the long-term follow-up of HF patients.

Team dynamics, clinical work satisfaction, and patient care coordination between primary care providers: A mixed methods study.

PubMed

Song, Hummy; Ryan, Molly; Tendulkar, Shalini; Fisher, Josephine; Martin, Julia; Peters, Antoinette S; Frolkis, Joseph P; Rosenthal, Meredith B; Chien, Alyna T; Singer, Sara J

Team-based care is essential for delivering high-quality, comprehensive, and coordinated care. Despite considerable research about the effects of team-based care on patient outcomes, few studies have examined how team dynamics relate to provider outcomes. The aim of this study was to examine relationships among team dynamics, primary care provider (PCP) clinical work satisfaction, and patient care coordination between PCPs in 18 Harvard-affiliated primary care practices participating in Harvard's Academic Innovations Collaborative. First, we administered a cross-sectional survey to all 548 PCPs (267 attending clinicians, 281 resident physicians) working at participating practices; 65% responded. We assessed the relationship of team dynamics with PCPs' clinical work satisfaction and perception of patient care coordination between PCPs, respectively, and the potential mediating effect of patient care coordination on the relationship between team dynamics and work satisfaction. In addition, we embedded a qualitative evaluation within the quantitative evaluation to achieve a convergent mixed methods design to help us better understand our findings and illuminate relationships among key variables. Better team dynamics were positively associated with clinical work satisfaction and quality of patient care coordination between PCPs. Coordination partially mediated the relationship between team dynamics and satisfaction for attending clinicians, suggesting that higher satisfaction depends, in part, on better teamwork, yielding more coordinated patient care. We found no mediating effects for resident physicians. Qualitative results suggest that sources of satisfaction from positive team dynamics for PCPs may be most relevant to attending clinicians. Improving primary care team dynamics could improve clinical work satisfaction among PCPs and patient care coordination between PCPs. In addition to improving outcomes that directly concern health care providers, efforts to improve aspects of team dynamics may also help resolve critical challenges in workforce planning in primary care.

Gender and Age Differences in Short- and Long-Term Outcomes Following Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction.

PubMed

Chua, Su-Kiat; Shyu, Kou-Gi; Hung, Huei-Fong; Cheng, Jun-Jack; Lo, Huey-Ming; Liu, Shih-Chi; Chen, Lung-Ching; Chiu, Chiung-Zuan; Chang, Che-Ming; Lin, Shen-Chang; Liou, Jer-Young; Lee, Shih-Huang

2014-07-01

Studies have reported that women with ST elevation myocardial infarction (STEMI) have worse short- and long-term outcomes than men. It has not yet been confirmed whether these differences reflect differences in age between men and women. We retrospectively enrolled 1035 consecutive STEMI patients treated with primary percutaneous coronary intervention (PCI). Baseline clinical characteristics, coronary anatomy, and outcome were compared between young (< 65 years old) and older patients (≥ 65 years old) of both sexes. Younger women presented with a lower incidence of typical angina (83% vs. 93%, p = 0.03), single-vessel disease (21% vs. 35%, p = 0.03), and total occlusion of infarct-related artery (65% vs. 83%, p = 0.001) than younger men, with no gender difference noted in the older group. Younger women in the study had a higher incidence of reinfarction, heart failure requiring admission, or mortality (23% vs. 6%, p < 0.001) during follow-up, compared with younger men, with no gender difference in the older group. Using the Kaplan-Meier analysis, younger women had lower rates of event-free survival (p < 0.001 by log-rank test) than younger men, with no gender difference in the older group. In multivariate analysis, age could predict long-term outcome in men (Hazard ratio 4.43, 95% confidence interval: 2.89-6.78, p < 0.001) but not in women. In STEMI patients receiving primary PCI, sex-related long-term outcome differences were age-dependent, with younger women likely to have a worse long-term outcome when compared with younger men. Coronary heart disease; Gender; Myocardial infarction.

Rivaroxaban for Thromboprophylaxis among Patients Recently Hospitalized for Acute Infectious Diseases: A Subgroup Analysis of the MAGELLAN Study.

PubMed

Cohoon, Kevin P; De Sanctis, Yoriko; Haskell, Lloyd; McBane, Robert D; Spiro, Theodore E

2018-05-12

Despite the well-established association between infection and venous thromboembolism (VTE), there are few data specifically assessing the efficacy and safety of the VTE prophylaxis strategies for patients hospitalized for acute infectious diseases. Estimate incidence of VTE and bleeding outcomes comparing prolonged prophylaxis with rivaroxaban 10 mg daily for 35 days with enoxaparin 40 mg daily for 10 days. A subgroup analysis of patients hospitalized for acute infectious diseases in the MAGELLAN trial was performed. The primary efficacy outcome was the composite of asymptomatic proximal or symptomatic VTE at days 10 and 35. The principal safety outcome was the composite of major or clinically relevant non-major bleeding. 3173 patients with acute infectious diseases leading to hospitalization were randomized to either rivaroxaban (n=1585) or enoxaparin/placebo (n=1588) and received at least one dose of study medication. At day 10, primary composite efficacy outcomes did not differ between prophylaxis strategies (rivaroxaban 2.7% and enoxaparin 3.7%). At day 35, VTE events were lower for rivaroxaban (4.2%) compared to enoxaparin (6.6%) (Relative risk [RR] 0.64; 95%CI, 0.45, 0.92). Patients with pulmonary infections randomized to rivaroxaban had lower incidence of VTE both at 10 days (RR 0.50, 95%CI 0.28, 0.90) and 35 days (RR 0.54, 95%CI 0.33, 0.87). Primary safety outcome events were higher for those receiving rivaroxaban (RR 2.42, 95%CI 1.60, 3.66). Prolonged rivaroxaban prophylaxis reduced VTE in patients hospitalized for acute infectious diseases particularly involving the lungs. Efficacy benefits were, in part, offset by bleeding outcomes. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Anatomically Contoured Anterior Plating for Isolated Tibiotalar Arthrodesis: A Systematic Review.

PubMed

Kusnezov, Nicholas; Dunn, John C; Koehler, Logan R; Orr, Justin D

2017-08-01

We performed a systematic review of the published literature to characterize patient demographic, surgical techniques, and functional outcomes to elucidate the complication and revision rates following isolated tibiotalar arthrodesis with anatomically contoured anterior plating. A comprehensive literature search was performed. Inclusion criteria were peer-reviewed studies in English, after 1990, at least 10 patients, and reporting clinical outcomes following contoured anterior plating and with follow-up of at least 80% and 1 year. Primary outcomes were fusion rate, time to fusion, return to activities, satisfaction, and functional outcome scores. Complication rates, reoperation, and revision were also extracted. Eight primary studies with 164 patients met the inclusion criteria. The average sample size was 21 ± 10.0 patients and average age was 49.2 years with 61.6% male. Posttraumatic arthritis (49.4%) was the most common operative indication, followed by primary osteoarthrosis (18.9%). The average follow-up was 21.1 months. At this time, 97.6% of patients went on to uneventful union at a weighted average time of 18.7 weeks postoperatively. AOFAS scores improved significantly ( P < .05). 25% complication rate was reported with wound complication (7.9%) and hardware irritation (6.7%) most common. Overall, 21.3% of patients underwent reoperation; 4 for revision arthrodesis following nonunion. Isolated tibiotalar arthrodesis utilizing anatomically contoured anterior plating demonstrates excellent clinical and functional outcomes at short-term follow-up. Overall, 97.6% of patients went on to fusion and functional outcomes consistently improved following surgery. Furthermore, while one-quarter of patients experienced complications, wound complications were relatively uncommon and less than one-quarter of these required surgical intervention. Level IV: Systematic Review.

Preventing AVF thrombosis: the rationale and design of the Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study.

PubMed

Irish, Ashley; Dogra, Gursharan; Mori, Trevor; Beller, Elaine; Heritier, Stephane; Hawley, Carmel; Kerr, Peter; Robertson, Amanda; Rosman, Johan; Paul-Brent, Peta-Anne; Starfield, Melissa; Polkinghorne, Kevan; Cass, Alan

2009-01-21

Haemodialysis (HD) is critically dependent on the availability of adequate access to the systemic circulation, ideally via a native arteriovenous fistula (AVF). The Primary failure rate of an AVF ranges between 20-54%, due to thrombosis or failure of maturation. There remains limited evidence for the use of anti-platelet agents and uncertainty as to choice of agent(s) for the prevention of AVF thrombosis. We present the study protocol for a randomised, double-blind, placebo-controlled, clinical trial examining whether the use of the anti-platelet agents, aspirin and omega-3 fatty acids, either alone or in combination, will effectively reduce the risk of early thrombosis in de novo AVF. The study population is adult patients with stage IV or V chronic kidney disease (CKD) currently on HD or where HD is planned to start within 6 months in whom a planned upper or lower arm AVF is to be the primary HD access. Using a factorial-design trial, patients will be randomised to aspirin or matching placebo, and also to omega-3 fatty acids or matching placebo, resulting in four treatment groups (aspirin placebo/omega-3 fatty acid placebo, aspirin/omega-3 fatty acid placebo, aspirin placebo/omega-3 fatty acid, aspirin/omega-3 fatty acid). Randomisation will be achieved using a dynamic balancing method over the two stratification factors of study site and upper versus lower arm AVF. The medication will be commenced pre-operatively and continued for 3 months post surgery. The primary outcome is patency of the AVF at three months after randomisation. Secondary outcome measures will include functional patency at six and twelve months, primary patency time, secondary (assisted) patency time, and adverse events, particularly bleeding. This multicentre Australian and New Zealand study has been designed to determine whether the outcome of surgery to create de novo AVF can be improved by the use of aspirin and/or omega-3 fatty acids. Recently a placebo-controlled trial has shown that clopidogrel is effective in safely preventing primary AVF thrombosis, but ineffective at increasing functional patency. Our study presents significant differences in the anti-platelet agents used, the study design, and surgical and patient demographics that should contribute further evidence regarding the efficacy of anti-platelet agents. Australia & New Zealand Clinical Trials Register (ACTRN12607000569404).

Organisation and function of the primary motor cortex in chronic pain: protocol for a systematic review and meta-analysis.

PubMed

Chang, Wei-Ju; O'Connell, Neil E; Burns, Emma; Chipchase, Lucy S; Liston, Matthew B; Schabrun, Siobhan M

2015-11-30

Primary motor cortical (M1) adaptation in the form of altered organisation and function is hypothesised to underpin motor dysfunction observed in chronic pain. The aim of this review is to assess the evidence for altered M1 organisation and function in chronic pain. Systematic review and meta-analysis. We will search electronic databases with predetermined search terms to identify relevant studies and evaluate the studies for inclusion and risks of bias. Two independent reviewers will extract data. Any disagreement will be resolved through a third reviewer. Cross-sectional or prospective studies published in English before May 2015 that investigate M1 organisation and function in chronic pain will be included if they meet the eligibility criteria. Primary outcomes will include M1 cortical excitability, spatial cortical representation, the function of inhibitory and facilitatory intracortical networks, cortical reactivity and cortical glucose metabolism. Clinical measures such as pain and disability will be included where the correlation with the primary outcomes of M1 organisation and function were investigated in the included studies. This systematic review does not require ethical approval. The results of this review will be submitted for peer-reviewed publication regardless of outcome and will be presented at relevant conferences. Our systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO; registration number CRD42015014823). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Nutrition interventions for children aged less than 5 years following natural disasters: a systematic review

PubMed Central

Dhital, Rolina; Subhani, Huma

2016-01-01

Objectives The objective of this paper was to review various nutritional interventions targeted at under-five children in countries that had suffered from natural disasters and to analyse their effect on nutrition-related outcomes. Design Systematic review. Setting Countries that had suffered from natural disasters. Participants Children aged <5 years who were given any nutritional intervention to improve overall nutritional status after a natural disaster. Primary and secondary outcome measures Primary nutrition-related outcomes were stunting, wasting and underweight. The secondary nutrition-related outcome was anaemia. Results Of the 1218 studies that the reviewers agreed on, five matched the inclusion criteria and were included in this narrative synthesis. Four studies were longitudinal and one was cross-sectional in design. Food supplementation was an integral part of nutritional interventions in all the included studies. The most consistent nutritional outcome in all five included studies was reduced prevalence of wasting, followed by reduced prevalence of underweight in four, stunting in three and anaemia in one of the five included studies. The largest reduction in the prevalence of wasting and underweight was reported by the study in Sri Lanka. Overall, the quality of evidence ranged from moderate to weak. Conclusions Integrated nutrition interventions using locally available health resources yielded the best results. However, sound evidence on the most effective interventions is still lacking. Intervention studies with comparison groups are necessary to obtain more robust evidence on the effectiveness of nutrition interventions. PMID:27650759

[Nurse involvement in primary care: it is the key to improve the outcomes in primary and secondary prevention?].

PubMed

Scardi, Sabino; Gori, Pierpaolo; Umari, Paolo

2010-06-01

Difficulties in management of risk factors, lifestyle and medications adherence to achieve secondary prevention of ischemic heart disease were described. Many studies indicate that the benefit of cardiac rehabilitation therapy after acute coronary events is only partially maintained during the following year. Thereafter, new strategies of medical care are needed to improve the long-term outcomes in coronary patients. Nurse co-ordinated, multidisciplinary cardiac rehabilitative programme could help patients to improve their lifestyle, to control their risk factors and to achieve their therapeutic goals for secondary prevention of ischemic heart disease.

Systematic review of methods used in meta-analyses where a primary outcome is an adverse or unintended event

PubMed Central

2012-01-01

Background Adverse consequences of medical interventions are a source of concern, but clinical trials may lack power to detect elevated rates of such events, while observational studies have inherent limitations. Meta-analysis allows the combination of individual studies, which can increase power and provide stronger evidence relating to adverse events. However, meta-analysis of adverse events has associated methodological challenges. The aim of this study was to systematically identify and review the methodology used in meta-analyses where a primary outcome is an adverse or unintended event, following a therapeutic intervention. Methods Using a collection of reviews identified previously, 166 references including a meta-analysis were selected for review. At least one of the primary outcomes in each review was an adverse or unintended event. The nature of the intervention, source of funding, number of individual meta-analyses performed, number of primary studies included in the review, and use of meta-analytic methods were all recorded. Specific areas of interest relating to the methods used included the choice of outcome metric, methods of dealing with sparse events, heterogeneity, publication bias and use of individual patient data. Results The 166 included reviews were published between 1994 and 2006. Interventions included drugs and surgery among other interventions. Many of the references being reviewed included multiple meta-analyses with 44.6% (74/166) including more than ten. Randomised trials only were included in 42.2% of meta-analyses (70/166), observational studies only in 33.7% (56/166) and a mix of observational studies and trials in 15.7% (26/166). Sparse data, in the form of zero events in one or both arms where the outcome was a count of events, was found in 64 reviews of two-arm studies, of which 41 (64.1%) had zero events in both arms. Conclusions Meta-analyses of adverse events data are common and useful in terms of increasing the power to detect an association with an intervention, especially when the events are infrequent. However, with regard to existing meta-analyses, a wide variety of different methods have been employed, often with no evident rationale for using a particular approach. More specifically, the approach to dealing with zero events varies, and guidelines on this issue would be desirable. PMID:22553987

A descriptive feast but an evaluative famine: systematic review of published articles on primary care computing during 1980-97.

PubMed

Mitchell, E; Sullivan, F

2001-02-03

To appraise findings from studies examining the impact of computers on primary care consultations. Systematic review of world literature from 1980 to 1997. 5475 references were identified from electronic databases (Medline, Science Citation Index, Social Sciences Citation Index, Index of Scientific and Technical Proceedings, Embase, OCLC FirstSearch Proceedings), bibliographies, books, identified articles, and by authors active in the field. 1892 eligible abstracts were independently rated, and 89 studies met the inclusion criteria. Effect on doctors' performance and patient outcomes; attitudes towards computerisation. 61 studies examined effects of computers on practitioners' performance, 17 evaluated their impact on patient outcome, and 20 studied practitioners' or patients' attitudes. Computer use during consultations lengthened the consultation. Reminder systems for preventive tasks and disease management improved process rates, although some returned to pre-intervention levels when reminders were stopped. Use of computers for issuing prescriptions increased prescribing of generic drugs, and use of computers for test ordering led to cost savings and fewer unnecessary tests. There were no negative effects on those patient outcomes evaluated. Doctors and patients were generally positive about use of computers, but issues of concern included their impact on privacy, the doctor-patient relationship, cost, time, and training needs. Primary care computing systems can improve practitioner performance, particularly for health promotion interventions. This may be at the expense of patient initiated activities, making many practitioners suspicious of the negative impact on relationships with patients. There remains a dearth of evidence evaluating effects on patient outcomes.

Hyperglycaemia in early pregnancy: the Treatment of Booking Gestational diabetes Mellitus (TOBOGM) study. A randomised controlled trial.

PubMed

Simmons, David; Hague, William M; Teede, Helena J; Cheung, N Wah; Hibbert, Emily J; Nolan, Christopher J; Peek, Michael J; Girosi, Federico; Cowell, Christopher T; Wong, Vincent W-M; Flack, Jeff R; McLean, Mark; Dalal, Raiyomand; Robertson, Annette; Rajagopal, Rohit

2018-05-28

Gestational diabetes mellitus (GDM) causes adverse pregnancy outcomes that can be averted by treatment from 24-28 weeks' gestation. Assessing and treating women for overt diabetes in pregnancy (ODIP) at the first antenatal clinic booking is now recommended in international guidelines. As a consequence, women with milder hyperglycaemia are being diagnosed and treated for early GDM, but randomised controlled trial (RCTs) assessing the benefits and harms of such treatment have not been undertaken. The Treatment Of Booking Gestational diabetes Mellitus (TOBOGM) study is a multi-centre RCT examining whether diagnosing and treating GDM diagnosed at booking improves pregnancy outcomes. Methods and analysis: 4000 adult pregnant women (< 20 weeks' gestation) at risk of ODIP will be recruited from 12 hospital antenatal booking clinics and referred for an oral glucose tolerance test (OGTT). 800 women with hyperglycaemia (ie, booking GDM) according to the 2014 Australasian Diabetes-in-Pregnancy Society criteria for pregnant women at 24-28 weeks' gestation will be randomised to immediate treatment for GDM (intervention) or to no treatment (control), pending the results of a second OGTT at 24-28 weeks' gestation. Antenatal and GDM care will otherwise follow local guidelines. Randomisation will be stratified by site and OGTT glycaemic risk strata. The primary pregnancy outcome is a composite of respiratory distress, phototherapy, birth trauma, birth before 37 weeks' gestation, stillbirth or death, shoulder dystocia, and birthweight ≥ 4.5 kg. The primary neonatal outcome is neonatal lean body mass. The primary maternal outcome is pre-eclampsia. Ethics approval: South Western Sydney Local Health District Research and Ethics Office (reference, 15/LPOOL/551). Dissemination of results: Peer-reviewed publications, scientific meetings, collaboration with research groups undertaking comparable studies, discussions with guideline groups and policy makers. Australian New Zealand Clinical Trials Registry, ACTRN12616000924459.

A cluster randomised controlled trial evaluating the effectiveness and cost-effectiveness of the daily mile on childhood obesity and wellbeing; the Birmingham daily mile protocol.

PubMed

Breheny, Katie; Adab, Peymane; Passmore, Sandra; Martin, James; Lancashire, Emma; Hemming, Karla; Frew, Emma

2018-01-11

Childhood obesity prevention is a public health priority. Children spend a large proportion of their waking time in school; therefore this is an appropriate setting to implement obesity prevention initiatives. Anecdotal reports suggest that implementing The Daily Mile in schools has had positive effects on childhood obesity, academic attainment and wellbeing. This trial aims to measure the effectiveness of The Daily Mile for improving health and wellbeing. This protocol describes a cluster randomised controlled trial (RCT) in 40 primary schools located in Birmingham, UK. Eligible participants are children in years 3 (aged 7-8) and 5 (aged 9-10). The study compares The Daily Mile (intervention) to usual practice (control) in relation to health and wellbeing. The Daily Mile intervention involves an additional 15 min of running or walking integrated into the school day, throughout a 12 month study period. The primary clinical outcome is body mass index (BMI) z-scores at 12 months following introduction of the intervention. The cost per Quality Adjusted Life Year (QALY) is the primary outcome of the economic evaluation. Secondary outcomes include wellbeing, physical fitness and teacher reported academic attainment. This study is the first RCT investigating the clinical and cost-effectiveness of The Daily Mile. A range of outcomes will be measured to evaluate the broader wellbeing and academic benefits in addition to clinical outcomes typically measured in childhood obesity prevention trials. The intervention is simple and low-cost, therefore if the benefits are demonstrated it has enormous potential to influence future policy. ISRCTN: 12698269 . Date protocol registered 27th October 2016.

The Kidney Awareness Registry and Education (KARE) study: protocol of a randomized controlled trial to enhance provider and patient engagement with chronic kidney disease.

PubMed

Tuot, Delphine S; Velasquez, Alexandra; McCulloch, Charles E; Banerjee, Tanushree; Zhu, Yunnuo; Hsu, Chi-yuan; Handley, Margaret; Schillinger, Dean; Powe, Neil R

2015-10-22

Chronic kidney disease (CKD) is common and is associated with excess mortality and morbidity. Better management could slow progression of disease, prevent metabolic complications, and reduce cardiovascular outcomes. Low patient awareness of CKD and ineffective patient-provider communication can impede such efforts. We developed provider and patient-directed interventions that harness health information technology to enhance provider recognition of CKD and delivery of guideline concordant care and augment patient understanding and engagement in CKD care. We report the design and protocol of the Kidney Awareness Registry and Education (KARE) Study, a 2x2 factorial randomized controlled trial that examines the impact of a multi-level intervention on health outcomes among low-income English, Spanish and Cantonese-speaking patients with CKD in a safety net system. The intervention includes: (1) implementation of a primary care electronic CKD registry that notifies practice teams of patients' CKD status and employs a patient profile and quarterly feedback to encourage provision of guideline-concordant care at point-of-care and via outreach; and (2) a language-concordant, culturally-sensitive self-management support program that consists of automated telephone modules, provision of low-literacy written patient-educational materials and telephone health coaching. The primary outcomes of the trial are changes in systolic blood pressure (BP) and the proportion of patients with BP control (≤ 140/90 mmHg) after one year. Secondary outcomes include patient understanding of CKD, participation in healthy behaviors, and practice team delivery of guideline-concordant CKD care. Results from the KARE study will provide data on the feasibility, effectiveness, and acceptability of technology-based interventions that support primary care efforts at improving health outcomes among vulnerable patients with CKD. ClinicalTrials.gov, number: NCT01530958.

The Effects of Antenatal Corticosteroids on Short- and Long-Term Outcomes in Small-for-Gestational-Age Infants

PubMed Central

Ishikawa, Hiroshi; Miyazaki, Ken; Ikeda, Tomoaki; Murabayashi, Nao; Hayashi, Kazutoshi; Kai, Akihiko; Ishikawa, Kaoru; Miyamoto, Yoshihiro; Nishimura, Kunihiro; Kono, Yumi; Kusuda, Satoshi; Fujimura, Masanori

2015-01-01

Aim: To evaluate the effect of antenatal corticosteroids (ANS) on short- and long-term outcomes in small-for-gestational age (SGA) infants. Methods: A retrospective database analysis was performed. A total of 1,931 single infants (birth weight <1,500 g) born at a gestational age between 22 weeks and 33 weeks 6 days who were determined to be SGA registered in the Neonatal Research Network Database in Japan between 2003 and 2007 were evaluated for short-term outcome and long-term outcome. Results: ANS was administered to a total of 719 infants (37%) in the short-term outcome evaluation group and 344 infants (36%) in the long-term outcome evaluation group. There were no significant differences between the ANS group and the no-ANS group for primary short-term outcome (adjusted odds ratio (OR) 0.73; 95% confidence interval (CI) 0.45-1.20; P-value 0.22) or primary long-term outcome (adjusted OR 0.69; 95% CI 0.40-1.17; P-value 0.17). Conclusions: Our results show that ANS does not affect short- or long-term outcome in SGA infants when the birth weight is less than 1500 g. This study strongly suggests that administration of ANS resulted in few benefits for preterm FGR fetuses. PMID:25897289

The Effects of Antenatal Corticosteroids on Short- and Long-Term Outcomes in Small-for-Gestational-Age Infants.

PubMed

Ishikawa, Hiroshi; Miyazaki, Ken; Ikeda, Tomoaki; Murabayashi, Nao; Hayashi, Kazutoshi; Kai, Akihiko; Ishikawa, Kaoru; Miyamoto, Yoshihiro; Nishimura, Kunihiro; Kono, Yumi; Kusuda, Satoshi; Fujimura, Masanori

2015-01-01

To evaluate the effect of antenatal corticosteroids (ANS) on short- and long-term outcomes in small-for-gestational age (SGA) infants. A retrospective database analysis was performed. A total of 1,931 single infants (birth weight <1,500 g) born at a gestational age between 22 weeks and 33 weeks 6 days who were determined to be SGA registered in the Neonatal Research Network Database in Japan between 2003 and 2007 were evaluated for short-term outcome and long-term outcome. ANS was administered to a total of 719 infants (37%) in the short-term outcome evaluation group and 344 infants (36%) in the long-term outcome evaluation group. There were no significant differences between the ANS group and the no-ANS group for primary short-term outcome (adjusted odds ratio (OR) 0.73; 95% confidence interval (CI) 0.45-1.20; P-value 0.22) or primary long-term outcome (adjusted OR 0.69; 95% CI 0.40-1.17; P-value 0.17). Our results show that ANS does not affect short- or long-term outcome in SGA infants when the birth weight is less than 1500 g. This study strongly suggests that administration of ANS resulted in few benefits for preterm FGR fetuses.

Primary Outcomes for Resuscitation Science Studies

PubMed Central

Becker, Lance B.; Aufderheide, Tom P.; Geocadin, Romergryko G.; Callaway, Clifton W.; Lazar, Ronald M.; Donnino, Michael W.; Nadkarni, Vinay M.; Abella, Benjamin S.; Adrie, Christophe; Berg, Robert A.; Merchant, Raina M.; O'Connor, Robert E.; Meltzer, David O.; Holm, Margo B.; Longstreth, William T.; Halperin, Henry R.

2013-01-01

Background and Purpose The guidelines presented in this consensus statement are intended to serve researchers, clinicians, reviewers, and regulators in the selection of the most appropriate primary outcome for a clinical trial of cardiac arrest therapies. The American Heart Association guidelines for the treatment of cardiac arrest depend on high-quality clinical trials, which depend on the selection of a meaningful primary outcome. Because this selection process has been the subject of much controversy, a consensus conference was convened with national and international experts, the National Institutes of Health, and the US Food and Drug Administration. Methods The Research Working Group of the American Heart Association Emergency Cardiovascular Care Committee nominated subject leaders, conference attendees, and writing group members on the basis of their expertise in clinical trials and a diverse perspective of cardiovascular and neurological outcomes (see the online-only Data Supplement). Approval was obtained from the Emergency Cardiovascular Care Committee and the American Heart Association Manuscript Oversight Committee. Preconference position papers were circulated for review; the conference was held; and postconference consensus documents were circulated for review and comments were invited from experts, conference attendees, and writing group members. Discussions focused on (1) when after cardiac arrest the measurement time point should occur; (2) what cardiovascular, neurological, and other physiology should be assessed; and (3) the costs associated with various end points. The final document underwent extensive revision and peer review by the Emergency Cardiovascular Care Committee, the American Heart Association Science Advisory and Coordinating Committee, and oversight committees. Results There was consensus that no single primary outcome is appropriate for all studies of cardiac arrest. The best outcome measure is the pairing of a time point and physiological condition that will best answer the question under study. Conference participants were asked to assign an outcome to each of 4 hypothetical cases; however, there was not complete agreement on an ideal outcome measure even after extensive discussion and debate. There was general consensus that it is appropriate for earlier studies to enroll fewer patients and to use earlier time points such as return of spontaneous circulation, simple “alive versus dead,” hospital mortality, or a hemodynamic parameter. For larger studies, a longer time point after arrest should be considered because neurological assessments fluctuate for at least 90 days after arrest. For large trials designed to have a major impact on public health policy, longer-term end points such as 90 days coupled with neurocognitive and quality-of-life assessments should be considered, as should the additional costs of this approach. For studies that will require regulatory oversight, early discussions with regulatory agencies are strongly advised. For neurological assessment of post–cardiac arrest patients, researchers may wish to use the Cerebral Performance Categories or modified Rankin Scale for global outcomes. Conclusions Although there is no single recommended outcome measure for trials of cardiac arrest care, the simple Cerebral Performance Categories or modified Rankin Scale after 90 days provides a reasonable outcome parameter for many trials. The lack of an easy-to-administer neurological functional outcome measure that is well validated in post–cardiac arrest patients is a major limitation to the field and should be a high priority for future development. PMID:21969010

Primary outcomes for resuscitation science studies: a consensus statement from the American Heart Association.

PubMed

Becker, Lance B; Aufderheide, Tom P; Geocadin, Romergryko G; Callaway, Clifton W; Lazar, Ronald M; Donnino, Michael W; Nadkarni, Vinay M; Abella, Benjamin S; Adrie, Christophe; Berg, Robert A; Merchant, Raina M; O'Connor, Robert E; Meltzer, David O; Holm, Margo B; Longstreth, William T; Halperin, Henry R

2011-11-08

The guidelines presented in this consensus statement are intended to serve researchers, clinicians, reviewers, and regulators in the selection of the most appropriate primary outcome for a clinical trial of cardiac arrest therapies. The American Heart Association guidelines for the treatment of cardiac arrest depend on high-quality clinical trials, which depend on the selection of a meaningful primary outcome. Because this selection process has been the subject of much controversy, a consensus conference was convened with national and international experts, the National Institutes of Health, and the US Food and Drug Administration. The Research Working Group of the American Heart Association Emergency Cardiovascular Care Committee nominated subject leaders, conference attendees, and writing group members on the basis of their expertise in clinical trials and a diverse perspective of cardiovascular and neurological outcomes (see the online-only Data Supplement). Approval was obtained from the Emergency Cardiovascular Care Committee and the American Heart Association Manuscript Oversight Committee. Preconference position papers were circulated for review; the conference was held; and postconference consensus documents were circulated for review and comments were invited from experts, conference attendees, and writing group members. Discussions focused on (1) when after cardiac arrest the measurement time point should occur; (2) what cardiovascular, neurological, and other physiology should be assessed; and (3) the costs associated with various end points. The final document underwent extensive revision and peer review by the Emergency Cardiovascular Care Committee, the American Heart Association Science Advisory and Coordinating Committee, and oversight committees. There was consensus that no single primary outcome is appropriate for all studies of cardiac arrest. The best outcome measure is the pairing of a time point and physiological condition that will best answer the question under study. Conference participants were asked to assign an outcome to each of 4 hypothetical cases; however, there was not complete agreement on an ideal outcome measure even after extensive discussion and debate. There was general consensus that it is appropriate for earlier studies to enroll fewer patients and to use earlier time points such as return of spontaneous circulation, simple "alive versus dead," hospital mortality, or a hemodynamic parameter. For larger studies, a longer time point after arrest should be considered because neurological assessments fluctuate for at least 90 days after arrest. For large trials designed to have a major impact on public health policy, longer-term end points such as 90 days coupled with neurocognitive and quality-of-life assessments should be considered, as should the additional costs of this approach. For studies that will require regulatory oversight, early discussions with regulatory agencies are strongly advised. For neurological assessment of post-cardiac arrest patients, researchers may wish to use the Cerebral Performance Categories or modified Rankin Scale for global outcomes. Although there is no single recommended outcome measure for trials of cardiac arrest care, the simple Cerebral Performance Categories or modified Rankin Scale after 90 days provides a reasonable outcome parameter for many trials. The lack of an easy-to-administer neurological functional outcome measure that is well validated in post-cardiac arrest patients is a major limitation to the field and should be a high priority for future development.

Systematic review of the effects of chronic disease management on quality-of-life in people with chronic obstructive pulmonary disease.

PubMed

Niesink, A; Trappenburg, J C A; de Weert-van Oene, G H; Lammers, J W J; Verheij, T J M; Schrijvers, A J P

2007-11-01

Chronic disease management for patients with chronic obstructive pulmonary disease (COPD) may improve quality, outcomes and access to care. To investigate effectiveness of chronic disease management programmes on the quality-of-life of people with COPD. Medline and Embase (1995-2005) were searched for relevant articles, and reference lists and abstracts were searched for controlled trials of chronic disease management programmes for patients with COPD. Quality-of-life was assessed as an outcome parameter. Two reviewers independently reviewed each paper for methodological quality and extracted the data. We found 10 randomized-controlled trials comparing chronic disease management with routine care. Patient populations, health-care professionals, intensity, and content of the intervention were heterogeneous. Different instruments were used to assess quality of life. Five out of 10 studies showed statistically significant positive outcomes on one or more domains of the quality of life instruments. Three studies, partly located in primary care, showed positive results. All chronic disease management projects for people with COPD involving primary care improved quality of life. In most of the studies, aspects of chronic disease management were applied to a limited extent. Quality of randomized-controlled trials was not optimal. More research is needed on chronic disease management programmes in patients with COPD across primary and secondary care.

The Relationship between Organizational Climate and Quality of Chronic Disease Management

PubMed Central

Benzer, Justin K; Young, Gary; Stolzmann, Kelly; Osatuke, Katerine; Meterko, Mark; Caso, Allison; White, Bert; Mohr, David C

2011-01-01

Objective To test the utility of a two-dimensional model of organizational climate for explaining variation in diabetes care between primary care clinics. Data Sources/Study Setting Secondary data were obtained from 223 primary care clinics in the Department of Veterans Affairs health care system. Study Design Organizational climate was defined using the dimensions of task and relational climate. The association between primary care organizational climate and diabetes processes and intermediate outcomes were estimated for 4,539 patients in a cross-sectional study. Data Collection/Extraction Methods All data were collected from administrative datasets. The climate data were drawn from the 2007 VA All Employee Survey, and the outcomes data were collected as part of the VA External Peer Review Program. Climate data were aggregated to the facility level of analysis and merged with patient-level data. Principal Findings Relational climate was related to an increased likelihood of diabetes care process adherence, with significant but small effects for adherence to intermediate outcomes. Task climate was generally not shown to be related to adherence. Conclusions The role of relational climate in predicting the quality of chronic care was supported. Future research should examine the mediators and moderators of relational climate and further investigate task climate. PMID:21210799

Effect of financial incentives on ethnic disparities in smoking cessation interventions in primary care: cross-sectional study.

PubMed

Hamilton, F L; Laverty, A A; Vamos, E P; Majeed, A; Millett, C

2013-03-01

Smoking cessation interventions are underprovided in primary care. Financial incentives may help address this. However, few studies in the UK have examined their impact on disparities in the delivery of smoking cessation interventions. Cross-sectional study using 2007 data from 29 general practices in Wandsworth, London, UK. We used logistic regression to examine associations between disease group [cardiovascular disease (CVD), respiratory disease, depression or none of these diseases], ethnicity and smoking outcomes following the introduction of the Quality and Outcomes Framework in 2004. Significantly, more CVD patients had smoking status ascertained compared with those with respiratory disease (89 versus 72%), but both groups received similar levels of cessation advice (93 and 89%). Patients with depression or none of the diseases were less likely to have smoking status ascertained (60% for both groups) or to receive advice (80 and 75%). Smoking prevalence was high, especially for patients with depression (44%). White British patients had higher rates of smoking than most ethnic groups, but black Caribbean men with depression had the highest smoking prevalence (62%). Smoking rates remain high, particularly for white British and black Caribbean patients. Extending financial incentives to include recording of ethnicity and rewarding quit rates may further improve smoking cessation outcomes in primary care.

Longitudinal Analysis of Quality of Diabetes Care and Relational Climate in Primary Care.

PubMed

Soley-Bori, Marina; Benzer, Justin K; Burgess, James F

2018-04-01

To assess the influence of relational climate on quality of diabetes care. The study was conducted at the Department of Veterans Affairs (VA). The VA All Employee Survey (AES) was used to measure relational climate. Patient and facility characteristics were gathered from VA administrative datasets. Multilevel panel data (2008-2012) with patients nested into clinics. Diabetic patients were identified using ICD-9 codes and assigned to the clinic with the highest frequency of primary care visits. Multiple quality indicators were used, including an all-or-none process measure capturing guideline compliance, the actual number of tests and procedures, and three intermediate continuous outcomes (cholesterol, glycated hemoglobin, and blood pressure). The study sample included 327,805 patients, 212 primary care clinics, and 101 parent facilities in 2010. Across all study years, there were 1,568,180 observations. Clinics with the highest relational climate were 25 percent more likely to provide guideline-compliant care than those with the lowest relational climate (OR for a 1-unit increase: 1.02, p-value <.001). Among insulin-dependent diabetic veterans, this effect was twice as large. Contrary to that expected, relational climate did not influence intermediate outcomes. Relational climate is positively associated with tests and procedures provision, but not with intermediate outcomes of diabetes care. © Health Research and Educational Trust.

Geriatric neuro-oncology: from mythology to biology.

PubMed

Weller, Michael; Platten, Michael; Roth, Patrick; Wick, Wolfgang

2011-12-01

Age has remained one of the most important determinants of risk for the development of certain brain tumors, of benefit from and tolerance of brain tumor treatment, and overall outcome. Regarding these three aspects, there are major differences across the spectrum of primary brain tumors depending on specific histology. Here, we review recent advances in understanding the biological basis of the prognostic marker 'age' in neuro-oncology. Contemporary population-based studies confirm the strong prognostic impact of age in many brain tumors. Elderly patients continue to be treated less aggressively than younger patients with the same tumors. However, biological factors may contribute to the negative prognostic impact of age. For instance, among gliomas, mutations of the isocitrate dehydrogenase genes, which are prognostically favorable, are much more common in younger patients. Moreover, complete responses defined by neuroimaging were much less durable in elderly as opposed to younger patients with primary central nervous system lymphoma in the German Primary Central Nervous System Lymphoma Study Group trial. A combination of age-adapted patterns of care and treatment-independent, tumor-intrinsic factors contributes to the poorer outcome of elderly patients with brain tumors. These factors need to be better distinguished and understood in order to improve outcome in elderly brain tumor patients.

Health consequences of adverse childhood experiences: a systematic review.

PubMed

Kalmakis, Karen A; Chandler, Genevieve E

2015-08-01

Adverse childhood experiences (ACEs) have been associated with negative health outcomes, but the evidence has had limited application in primary care practice. The purpose of this study was to systematically review the research on associations between ACEs and adult health outcomes to inform nurse practitioners (NPs) in primary care practice. The databases PubMed, CINAHL, PsycINFO, and Social Abstracts were searched for articles published in English between 2008 and 2013 using the search term "adverse childhood experiences." Forty-two research articles were included in the synthesis. The evidence was synthesized and is reported following the preferred reporting items for systematic reviews and meta-analysis procedure (PRISMA). ACEs have been associated with health consequences including physical and psychological conditions, risk behaviors, developmental disruption, and increased healthcare utilization. Generalization of the results is limited by a majority of studies (41/42) measuring childhood adversity using self-report measures. NPs are encouraged to incorporate assessment of patients' childhood history in routine primary care and to consider the evidence that supports a relationship between ACEs and health. Although difficult, talking about patient's childhood experiences may positively influence health outcomes. ©2015 American Association of Nurse Practitioners.

Primary birthing attendants and birth outcomes in remote Inuit communities--a natural "experiment" in Nunavik, Canada.

PubMed

Simonet, F; Wilkins, R; Labranche, E; Smylie, J; Heaman, M; Martens, P; Fraser, W D; Minich, K; Wu, Y; Carry, C; Luo, Z-C

2009-07-01

There is a lack of data on the safety of midwife-led maternity care in remote or indigenous communities. In a de facto natural "experiment", birth outcomes were assessed by primary birthing attendant in two sets of remote Inuit communities. A geocoding-based retrospective birth cohort study in 14 Inuit communities of Nunavik, Canada, 1989-2000: primary birth attendants were Inuit midwives in the Hudson Bay (1529 Inuit births) vs western physicians in Ungava Bay communities (1197 Inuit births). The primary outcome was perinatal death. Secondary outcomes included stillbirth, neonatal death, post-neonatal death, preterm, small-for-gestational-age and low birthweight birth. Multilevel logistic regression was used to obtain the adjusted odds ratios (aOR) controlling for maternal age, marital status, parity, education, infant sex and plurality, community size and community-level random effects. The aORs (95% confidence interval) for perinatal death comparing the Hudson Bay vs Ungava Bay communities were 1.29 (0.63 to 2.64) for all Inuit births and 1.13 (0.48 to 2.47) for Inuit births at > or =28 weeks of gestation. There were no statistically significant differences in the crude or adjusted risks of any of the outcomes examined. Risks of perinatal death were somewhat but not significantly higher in the Hudson Bay communities with midwife-led maternity care compared with the Ungava Bay communities with physician-led maternity care. These findings are inconclusive, although the results excluding extremely preterm births are more reassuring concerning the safety of midwife-led maternity care in remote indigenous communities.

Manual therapy compared with physical therapy in patients with non-specific neck pain: a randomized controlled trial.

PubMed

Groeneweg, Ruud; van Assen, Luite; Kropman, Hans; Leopold, Huco; Mulder, Jan; Smits-Engelsman, Bouwien C M; Ostelo, Raymond W J G; Oostendorp, Rob A B; van Tulder, Maurits W

2017-01-01

Manual therapy according to the School of Manual Therapy Utrecht (MTU) is a specific type of passive manual joint mobilization. MTU has not yet been systematically compared to other manual therapies and physical therapy. In this study the effectiveness of MTU is compared to physical therapy, particularly active exercise therapy (PT) in patients with non-specific neck pain. Patients neck pain, aged between 18-70 years, were included in a pragmatic randomized controlled trial with a one-year follow-up. Primary outcome measures were global perceived effect and functioning (Neck Disability Index), the secondary outcome was pain intensity (Numeric Rating Scale for Pain). Outcomes were measured at 3, 7, 13, 26 and 52 weeks. Multilevel analyses (intention-to-treat) were the primary analyses for overall between-group differences. Additional to the primary and secondary outcomes the number of treatment sessions of the MTU group and PT group was analyzed. Data were collected from September 2008 to February 2011. A total of 181 patients were included. Multilevel analyses showed no statistically significant overall differences at one year between the MTU and PT groups on any of the primary and secondary outcomes. The MTU group showed significantly lower treatment sessions compared to the PT group (respectively 3.1 vs. 5.9 after 7 weeks; 6.1 vs. 10.0 after 52 weeks). Patients with neck pain improved in both groups without statistical significantly or clinically relevant differences between the MTU and PT groups during one-year follow-up. ClinicalTrials.gov Identifier: NCT00713843.

The impact of occupational therapy in Parkinson's disease: a randomized controlled feasibility study.

PubMed

Sturkenboom, Ingrid H; Graff, Maud J; Borm, George F; Veenhuizen, Yvonne; Bloem, Bastiaan R; Munneke, Marten; Nijhuis-van der Sanden, Maria W

2013-02-01

To evaluate the feasibility of a randomized controlled trial including process and potential impact of occupational therapy in Parkinson's disease. Process and outcome were quantitatively and qualitatively evaluated in an exploratory multicentre, two-armed randomized controlled trial at three months. Forty-three community-dwelling patients with Parkinson's disease and difficulties in daily activities, their primary caregivers and seven occupational therapists. Ten weeks of home-based occupational therapy according to the Dutch guidelines of occupational therapy in Parkinson's disease versus no occupational therapy in the control group. Process evaluation measured accrual, drop-out, intervention delivery and protocol adherence. Primary outcome measures of patients assessed daily functioning: Canadian Occupational Performance Measure (COPM) and Assessment of Motor and Process Skills. Primary outcome for caregivers was caregiver burden: Zarit Burden Inventory. Participants' perspectives of the intervention were explored using questionnaires and in-depth interviews. Inclusion was 23% (43/189), drop-out 7% (3/43) and unblinding of assessors 33% (13/40). Full intervention protocol adherence was 74% (20/27), but only 60% (71/119) of baseline Canadian Occupational Performance Measure priorities were addressed in the intervention. The outcome measures revealed negligible to small effects in favour of the intervention group. Almost all patients and caregivers of the intervention group were satisfied with the results. They perceived: 'more grip on the situation' and used 'practical advices that make life easier'. Therapists were satisfied, but wished for a longer intervention period. The positive perceived impact of occupational therapy warrants a large-scale trial. Adaptations in instructions and training are needed to use the Canadian Occupational Performance Measure as primary outcome measure.

Comparison of methodological quality of positive versus negative comparative studies published in Indian medical journals: a systematic review

PubMed Central

Charan, Jaykaran; Chaudhari, Mayur; Jackson, Ryan; Mhaskar, Rahul; Reljic, Tea; Kumar, Ambuj

2015-01-01

Objectives Published negative studies should have the same rigour of methodological quality as studies with positive findings. However, the methodological quality of negative versus positive studies is not known. The objective was to assess the reported methodological quality of positive versus negative studies published in Indian medical journals. Design A systematic review (SR) was performed of all comparative studies published in Indian medical journals with a clinical science focus and impact factor >1 between 2011 and 2013. The methodological quality of randomised controlled trials (RCTs) was assessed using the Cochrane risk of bias tool, and the Newcastle-Ottawa scale for observational studies. The results were considered positive if the primary outcome was statistically significant and negative otherwise. When the primary outcome was not specified, we used data on the first outcome reported in the history followed by the results section. Differences in various methodological quality domains between positive versus negative studies were assessed by Fisher's exact test. Results Seven journals with 259 comparative studies were included in this SR. 24% (63/259) were RCTs, 24% (63/259) cohort studies, and 49% (128/259) case–control studies. 53% (137/259) of studies explicitly reported the primary outcome. Five studies did not report sufficient data to enable us to determine if results were positive or negative. Statistical significance was determined by p value in 78.3% (199/254), CI in 2.8% (7/254), both p value and CI in 11.8% (30/254), and only descriptive in 6.3% (16/254) of studies. The overall methodological quality was poor and no statistically significant differences between reporting of methodological quality were detected between studies with positive versus negative findings. Conclusions There was no difference in the reported methodological quality of positive versus negative studies. However, the uneven reporting of positive versus negative studies (72% vs 28%) indicates a publication bias in Indian medical journals with an impact factor of >1. PMID:26109118

A protocol of a cross-sectional study evaluating an online tool for early career peer reviewers assessing reports of randomised controlled trials.

PubMed

Chauvin, Anthony; Moher, David; Altman, Doug; Schriger, David L; Alam, Sabina; Hopewell, Sally; Shanahan, Daniel R; Recchioni, Alessandro; Ravaud, Philippe; Boutron, Isabelle

2017-09-15

Systematic reviews evaluating the impact of interventions to improve the quality of peer review for biomedical publications highlighted that interventions were limited and have little impact. This study aims to compare the accuracy of early career peer reviewers who use an innovative online tool to the usual peer reviewer process in evaluating the completeness of reporting and switched primary outcomes in completed reports. This is a cross-sectional study of individual two-arm parallel-group randomised controlled trials (RCTs) published in the BioMed Central series medical journals, BMJ , BMJ Open and Annals of Emergency Medicine and indexed with the publication type 'Randomised Controlled Trial'. First, we will develop an online tool and training module based (a) on the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist and the Explanation and Elaboration document that would be dedicated to junior peer reviewers for assessing the completeness of reporting of key items and (b) the Centre for Evidence-Based Medicine Outcome Monitoring Project process used to identify switched outcomes in completed reports of the primary results of RCTs when initially submitted. Then, we will compare the performance of early career peer reviewers who use the online tool to the usual peer review process in identifying inadequate reporting and switched outcomes in completed reports of RCTs at initial journal submission. The primary outcome will be the mean number of items accurately classified per manuscript. The secondary outcomes will be the mean number of items accurately classified per manuscript for the CONSORT items and the sensitivity, specificity and likelihood ratio to detect the item as adequately reported and to identify a switch in outcomes. We aim to include 120 RCTs and 120 early career peer reviewers. The research protocol was approved by the ethics committee of the INSERM Institutional Review Board (21 January 2016). The study is based on voluntary participation and informed written consent. NCT03119376. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Effects on Health Outcomes of a Mediterranean Diet With No Restriction on Fat Intake: A Systematic Review and Meta-analysis.

PubMed

Bloomfield, Hanna E; Koeller, Eva; Greer, Nancy; MacDonald, Roderick; Kane, Robert; Wilt, Timothy J

2016-10-04

Mediterranean diets may be healthier than typical Western diets. To summarize the literature comparing a Mediterranean diet with unrestricted fat intake with other diets regarding their effects on health outcomes in adults. Ovid MEDLINE, CINAHL, and the Cochrane Library from 1990 through April 2016. Controlled trials of 100 or more persons followed for at least 1 year for mortality, cardiovascular, hypertension, diabetes, and adherence outcomes, as well as cohort studies for cancer outcomes. Data extracted by 1 investigator was verified by another. Two reviewers assessed risk of bias and strength of evidence. Two primary prevention trials found no difference in all-cause mortality between diet groups. One large primary prevention trial found that a Mediterranean diet resulted in a lower incidence of major cardiovascular events (hazard ratio [HR], 0.71 [95% CI, 0.56 to 0.90]), breast cancer (HR, 0.43 [CI, 0.21 to 0.88]), and diabetes (HR, 0.70 [CI, 0.54 to 0.92]). Pooled analyses of primary prevention cohort studies showed that compared with the lowest quantile, the highest quantile of adherence to a Mediterranean diet was associated with a reduction in total cancer mortality (risk ratio [RR], 0.86 [CI, 0.82 to 0.91]; 13 studies) and in the incidence of total (RR, 0.96 [CI, 0.95 to 0.97]; 3 studies) and colorectal (RR, 0.91 [CI, 0.84 to 0.98; 9 studies]) cancer. Of 3 secondary prevention studies reporting cardiovascular outcomes, 1 found a lower risk for recurrent myocardial infarction and cardiovascular death with the Mediterranean diet. There was inconsistent, minimal, or no evidence pertaining to any other outcome, including adherence, hypertension, cognitive function, kidney disease, rheumatoid arthritis, and quality of life. Few trials; medium risk-of-bias ratings for many studies; low or insufficient strength of evidence for outcomes; heterogeneous diet definitions and components. Limited evidence suggests that a Mediterranean diet with no restriction on fat intake may reduce the incidence of cardiovascular events, breast cancer, and type 2 diabetes mellitus but may not affect all-cause mortality. Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Quality Enhancement Research Initiative. (PROSPERO: CRD42015020262).

Literacy Outcomes for Primary School Children Who Are Deaf and Hard of Hearing: A Cohort Comparison Study

ERIC Educational Resources Information Center

Harris, Margaret; Terlektsi, Emmanouela; Kyle, Fiona E.

2017-01-01

Purpose: In this study, we compared the language and literacy of two cohorts of children with severe-profound hearing loss, recruited 10 years apart, to determine if outcomes had improved in line with the introduction of newborn hearing screening and access to improved hearing aid technology. Method: Forty-two children with deafness, aged 5-7…

Preschool Age Children's Views about Primary School

ERIC Educational Resources Information Center

Kocyigit, Sezai

2014-01-01

Starting primary education is one of the most important changes that children encounter in early childhood. Moreover, especially within the last twenty years, as an outcome of the idea that children are active learners, listening to children's ideas about their learning, lives, and experiences has gained importance. In this sense, this study is…

Executive Function and Academic Achievement in Primary-Grade Students with Down Syndrome

ERIC Educational Resources Information Center

Will, E.; Fidler, D. J.; Daunhauer, L.; Gerlach-McDonald, B.

2017-01-01

Background: Executive function (EF) plays a critical role in academic outcomes in typically developing children, but the contribution of EF to academic performance in Down syndrome (DS) is less well understood. This study evaluated differences in early academic foundations between primary school aged children with DS and non-verbal mental-age…

The Mathematical Needs of Urban Indigenous Primary Children: A Western Australian Snapshot

ERIC Educational Resources Information Center

Hurst, Chris; Sparrow, Len

2010-01-01

This study considered ways of improving mathematical outcomes for urban Indigenous students. It focused on three primary schools in Western Australia and identified factors that were perceived to be having an impact on student learning. These included expectations for students, attendance rates, parent involvement, student literacy levels, student…

Classroom Interaction: Potential or Problem? The Case of Karagwe

ERIC Educational Resources Information Center

Wedin, Asa

2010-01-01

This paper discusses interactional patterns in classrooms in primary school in rural Tanzania, based on an ethnographic study on literacy practices. The paper argues that the official policy of Swahili-only in primary school, together with the huge gap between high expectations on educational outcome and lack of resources, have resulted in the…

Empathy and Critical Thinking: Primary Students Solving Local Environmental Problems through Outdoor Learning

ERIC Educational Resources Information Center

Ampuero, David; Miranda, Christian E.; Delgado, Luisa E.; Goyen, Samantha; Weaver, Sean

2015-01-01

The present study explores the outcomes of teaching empathy and critical thinking to solve environmental problems. This investigation was done throughout the duration of an environmental education course within a primary school located in central Chile. A community-based research methodology was used to understand the formation of empathy and…

Comparison of Family Therapy Outcome with Alcohol-Abusing, Runaway Adolescents

ERIC Educational Resources Information Center

Slesnick, Natasha; Prestopnik, Jillian L

2009-01-01

Treatment evaluation for alcohol problem, runaway adolescents and their families is rare. This study recruited primary alcohol problem adolescents (N = 119) and their primary caretakers from two runaway shelters and assigned them to (a) home-based ecologically based family therapy (EBFT), (b) office-based functional family therapy (FFT), or (c)…

Rationale and study protocol for the supporting children’s outcomes using rewards, exercise and skills (SCORES) group randomized controlled trial: A physical activity and fundamental movement skills intervention for primary schools in low-income communities

PubMed Central

2012-01-01

Background Many Australian children are insufficiently active to accrue health benefits and physical activity (PA) levels are consistently lower among youth of low socio-economic position. PA levels decline dramatically during adolescence and evidence suggests that competency in a range of fundamental movement skills (FMS) may serve as a protective factor against this trend. Methods/design The Supporting Children’s Outcomes Using Rewards Exercise and Skills (SCORES) intervention is a multi-component PA and FMS intervention for primary schools in low-income communities, which will be evaluated using a group randomized controlled trial. The socio-ecological model provided a framework for the 12-month intervention, which includes the following components: teacher professional learning, student leadership workshops (including leadership accreditation and rewards, e.g., stickers, water bottles), PA policy review, PA equipment packs, parental engagement via newsletters, FMS homework and a parent evening, and community partnerships with local sporting organizations. Outcomes will be assessed at baseline, 6- and 12-months. The primary outcomes are PA (accelerometers), FMS (Test of Gross Motor Development II) and cardiorespiratory fitness (multi-stage fitness test). Secondary outcomes include body mass index [using weight (kg)/height (m2)], perceived competence, physical self-esteem, and resilience. Individual and environmental mediators of behavior change (e.g. social support and enjoyment) will also be assessed. The System for Observing Fitness Instruction Time will be used to assess the impact of the intervention on PA within physical education lessons. Statistical analyses will follow intention-to-treat principles and hypothesized mediators of PA behavior change will be explored. Discussion SCORES is an innovative primary school-based PA and FMS intervention designed to support students attending schools in low-income communities to be more skilled and active. The findings from the study may be used to guide teacher pre-service education, professional learning and school policy in primary schools. Trial registration Australian New Zealand Clinical Trials Registry No: ACTRN12611001080910 PMID:22691451

Rationale and study protocol for the supporting children's outcomes using rewards, exercise and skills (SCORES) group randomized controlled trial: a physical activity and fundamental movement skills intervention for primary schools in low-income communities.

PubMed

Lubans, David R; Morgan, Philip J; Weaver, Kristen; Callister, Robin; Dewar, Deborah L; Costigan, Sarah A; Finn, Tara L; Smith, Jordan; Upton, Lee; Plotnikoff, Ronald C

2012-06-12

Many Australian children are insufficiently active to accrue health benefits and physical activity (PA) levels are consistently lower among youth of low socio-economic position. PA levels decline dramatically during adolescence and evidence suggests that competency in a range of fundamental movement skills (FMS) may serve as a protective factor against this trend. The Supporting Children's Outcomes Using Rewards Exercise and Skills (SCORES) intervention is a multi-component PA and FMS intervention for primary schools in low-income communities, which will be evaluated using a group randomized controlled trial. The socio-ecological model provided a framework for the 12-month intervention, which includes the following components: teacher professional learning, student leadership workshops (including leadership accreditation and rewards, e.g., stickers, water bottles), PA policy review, PA equipment packs, parental engagement via newsletters, FMS homework and a parent evening, and community partnerships with local sporting organizations. Outcomes will be assessed at baseline, 6- and 12-months. The primary outcomes are PA (accelerometers), FMS (Test of Gross Motor Development II) and cardiorespiratory fitness (multi-stage fitness test). Secondary outcomes include body mass index [using weight (kg)/height (m2)], perceived competence, physical self-esteem, and resilience. Individual and environmental mediators of behavior change (e.g. social support and enjoyment) will also be assessed. The System for Observing Fitness Instruction Time will be used to assess the impact of the intervention on PA within physical education lessons. Statistical analyses will follow intention-to-treat principles and hypothesized mediators of PA behavior change will be explored. SCORES is an innovative primary school-based PA and FMS intervention designed to support students attending schools in low-income communities to be more skilled and active. The findings from the study may be used to guide teacher pre-service education, professional learning and school policy in primary schools. Australian New Zealand Clinical Trials Registry No: ACTRN12611001080910.

Day-Case Treatment of Peripheral Arterial Disease: Results from a Multi-Center European Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Spiliopoulos, Stavros, E-mail: stavspiliop@med.uoa.gr, E-mail: stavspiliop@upatras.gr; Karnabatidis, Dimitrios, E-mail: karnaby@med.upatras.gr; Katsanos, Konstantinos, E-mail: katsanos@med.upatras.gr

PurposeThe purpose of the study was to investigate safety and feasibility of day-case endovascular procedures for the management of peripheral arterial disease.Materials and MethodsThis was a multi-center, retrospective study including all patients treated over a 30-month period with endovascular angioplasty or stenting for intermittent claudication (IC) or critical limb ischemia (CLI) on a day-case basis, in Interventional Radiology (IR) departments of three European tertiary hospitals. Exclusion criteria were not related to the type of lesion and included unavailability of an adult able to take care of patient overnight; high bleeding risk and ASA score ≥4. Primary efficacy outcome was themore » rate of procedures performed on an outpatient basis requiring no further hospitalization and primary safety outcome was freedom from 30-day major complications’ rate.ResultsThe study included 652 patients (male 75 %; mean age 68 ± 10 years; range: 27–93), 24.6 % treated for CLI. In 53.3 % of the cases a 6Fr sheath was used. Technical success was 97.1 %. Haemostasis was obtained by manual compression in 52.4 % of the accesses. The primary efficacy outcome occurred in 95.4 % (622/652 patients) and primary safety outcome in 98.6 % (643/652 patients). Major complications included five (0.7 %) retroperitoneal hematomas requiring transfusion; one (0.1 %) common femoral artery pseudoaneurysm successfully treated with US-guided thrombin injection, two cases of intra-procedural distal embolization treated with catheter-directed local thrombolysis and one on-table cardiac arrest necessitating >24 h recovery. No major complication was noted after same-day discharge.ConclusionsDay-case endovascular procedures for the treatment of IC or CLI can be safely and efficiently performed in experienced IR departments of large tertiary hospitals.« less

The benefits of co-location in primary care practices: the perspectives of general practitioners and patients in 34 countries.

PubMed

Bonciani, M; Schäfer, W; Barsanti, S; Heinemann, S; Groenewegen, P P

2018-02-21

There is no clear evidence as to whether the co-location of primary care professionals in the same facility positively influences their way of working and the quality of healthcare as perceived by patients. The aim of this study was to identify the relationships between general practitioner (GP) co-location with other GPs and/or other professionals and the GP outcomes and patients' experiences. We wanted to test whether GP co-location is related to a broader range of services provided, the use of clinical governance tools and inter-professional collaboration, and whether the patients of co-located GPs perceive a better quality of care in terms of accessibility, comprehensiveness and continuity of care with their GPs. The source of data was the QUALICOPC study (Quality and Costs of Primary Care in Europe), which involved surveys of GPs and their patients in 34 countries, mostly in Europe. In order to study the relationships between GP co-location and both GPs' outcomes and patients' experience, multilevel linear regression analysis was carried out. The GP questionnaire was filled in by 7183 GPs and the patient experience questionnaire by 61,931 patients. Being co-located with at least one other professional is the most common situation of the GPs involved in the study. Compared with single-handed GP practices, GP co-location are positively associated with the GP outcomes. Considering the patients' perspective, comprehensiveness of care has the strongest negative relationship of GP co-location of all the dimensions of patient experiences analysed. The paper highlights that GP mono- and multi-disciplinary co-location is related to positive outcomes at a GP level, such as a broader provision of technical procedures, increased collaboration among different providers and wider coordination with secondary care. However, GP co-location, particularly in a multidisciplinary setting, is related to less positive patient experiences, especially in countries with health systems characterised by a weak primary care structure.

Happiness as a motivator: positive affect predicts primary control striving for career and educational goals.

PubMed

Haase, Claudia M; Poulin, Michael J; Heckhausen, Jutta

2012-08-01

What motivates individuals to invest time and effort and overcome obstacles (i.e., strive for primary control) when pursuing important goals? We propose that positive affect predicts primary control striving for career and educational goals, and we explore the mediating role of control beliefs. In Study 1, positive affect predicted primary control striving for career goals in a two-wave longitudinal study of a U.S. sample. In Study 2, positive affect predicted primary control striving for career and educational goals and objective career outcomes in a six-wave longitudinal study of a German sample. Control beliefs partially mediated the longitudinal associations with primary control striving. Thus, when individuals experience positive affect, they become more motivated to invest time and effort, and overcome obstacles when pursuing their goals, in part because they believe they have more control over attaining their goals.

Effective strategies for prevention, control, and treatment of obesity in primary health care setting for adolescents, adults, and elderly people: A protocol for systematic review and meta-analysis.

PubMed

Marques, Emanuele Souza; Leite, Tatiana Henriques; Azeredo, Catarina Machado; Cunha, Diana Barbosa; Verly Júnior, Eliseu

2018-06-01

It is unquestionable that obesity is a global epidemic and one of the main public health problems in the world. The management of obesity in Primary Health Care has an important role if being considered the magnitude and serious consequence of this problem. Despite this, there is no effective standard protocol for the treatment of this disease. Studies that synthesize and assess the effectiveness of strategies for prevention, control, and treatment of obesity in Primary Health Care setting are still scarce. The objective of this study is review and synthesize study evidence for obesity management strategies among adolescents, adults and elderly developed at the Primary Health Care worldwide. Seven electronic databases (Medline, Lilacs, Embase, Psycinfo, Cochrane, WHOLIS and Open Gray) will be searched with no date limit for identification of clinical trials examining the effectiveness of prevention, control and treatment of obesity in Primary Health Care. As primary outcome will be changes in body weight. As secondary outcomes will be body mass index, body adiposity, waist circumference, and waist-hip ratio. Two independent authors will perform the selection of studies, data extraction, and the assessment of risk of bias. The results will be published in a peer-reviewed journal. This systematic review will be first to synthesize scientific evidence for obesity management strategies at Primary Health Care among adolescents, adults, and elderly. The review will benefit healthcare professionals and policymakers. Ethical approval is not required in this study because the data used include peer-reviewed publications, which do not comprise any information that could identify subjects. PROSPERO (CRD42018092416).

Primary care physician workforce and Medicare beneficiaries' health outcomes.

PubMed

Chang, Chiang-Hua; Stukel, Therese A; Flood, Ann Barry; Goodman, David C

2011-05-25

Despite a widespread interest in increasing the numbers of primary care physicians to improve care and to moderate costs, the relationship of the primary care physician workforce to patient-level outcomes remains poorly understood. To measure the association between the adult primary care physician workforce and individual patient outcomes. A cross-sectional analysis of the outcomes of a 2007 20% sample of fee-for-service Medicare beneficiaries aged 65 years or older (N = 5,132,936), which used 2 measures of adult primary care physicians (general internists and family physicians) across Primary Care Service Areas (N = 6542): (1) American Medical Association (AMA) Masterfile nonfederal, office-based physicians per total population and (2) office-based primary care clinical full-time equivalents (FTEs) per Medicare beneficiary derived from Medicare claims. Annual individual-level outcomes (mortality, ambulatory care sensitive condition [ACSC] hospitalizations, and Medicare program spending), adjusted for individual patient characteristics and geographic area variables. Marked variation was observed in the primary care physician workforce across areas, but low correlation was observed between the 2 primary care workforce measures (Spearman r = 0.056; P < .001). Compared with areas with the lowest quintile of primary care physician measure using AMA Masterfile counts, beneficiaries in the highest quintile had fewer ACSC hospitalizations (74.90 vs 79.61 per 1000 beneficiaries; relative rate [RR], 0.94; 95% confidence interval [CI], 0.93-0.95), lower mortality (5.38 vs 5.47 per 100 beneficiaries; RR, 0.98; 95% CI, 0.97-0.997), and no significant difference in total Medicare spending ($8722 vs $8765 per beneficiary; RR, 1.00; 95% CI, 0.99-1.00). Beneficiaries residing in areas with the highest quintile of primary care clinician FTEs compared with those in the lowest quintile had lower mortality (5.19 vs 5.49 per 100 beneficiaries; RR, 0.95; 95% CI, 0.93-0.96), fewer ACSC hospitalizations (72.53 vs 79.48 per 1000 beneficiaries; RR, 0.91; 95% CI, 0.90-0.92), and higher overall Medicare spending ($8857 vs $8769 per beneficiary; RR, 1.01; 95% CI, 1.004-1.02). A higher level of primary care physician workforce, particularly with an FTE measure that may more accurately reflect ambulatory primary care, was generally associated with favorable patient outcomes.

Disposition and Health Outcomes among Infants Born to Mothers with No Prenatal Care

ERIC Educational Resources Information Center

Friedman, Susan Hatters; Heneghan, Amy; Rosenthal, Miriam

2009-01-01

Objective: This study assessed infant disposition and health outcomes among offspring born to mothers without prenatal care, based on maternal characteristics and the reason for lack of prenatal care (i.e., denial of pregnancy, concealment of pregnancy, primary substance use, financial barriers and multiparity). Methods: A retrospective record…

Preventing Sexually Transmitted Infections among Adolescents: An Assessment of Ecological Approaches and Study Methods

ERIC Educational Resources Information Center

Shoveller, Jean A.; Johnson, Joy L.; Savoy, Daphne M.; Pietersma, W. A. Wia

2006-01-01

Most primary prevention research has attempted to explain sexual health outcomes, such as sexually transmitted infections, by focusing on individual characteristics (e.g. age), qualities (e.g. knowledge levels), and risk behaviour (e.g. unprotected intercourse). Emerging evidence indicates that population-level health outcomes are unlikely to be…

Infant growth outcomes from birth to 12 months of age: findings from the Delta Healthy Sprouts comparative impact trial

USDA-ARS?s Scientific Manuscript database

Objective: Multicomponent lifestyle modification interventions designed for gestational and early postnatal periods may be key to preventing obesity in children. The primary objective of the study was to determine if infant growth outcomes differed between treatment arms of an 18-month, maternal, i...

Therapeutic Alliance and Treatment Adherence in Two Interventions for Bulimia Nervosa: A Study of Process and Outcome

ERIC Educational Resources Information Center

Loeb, Katharine L.; Wilson, G. Terence; Labouvie, Erich; Pratt, Elizabeth M.; Hayaki, Jumi; Walsh, B. Timothy; Agras, W. Stewart; Fairburn, Christopher G.

2005-01-01

The relationship between therapeutic alliance, therapist adherence to treatment protocol, and outcome was analyzed in a randomized trial of cognitive-behavioral therapy (CBT) and interpersonal psychotherapy for bulimia nervosa. Independent observers rated audiotapes of full-length therapy sessions. Purging frequency was the primary outcome…

Do Organizational Culture and Climate Matter for Successful Client Outcomes?

ERIC Educational Resources Information Center

Silver Wolf, David A. Patterson; Dulmus, Catherine N.; Maguin, Eugene; Cristalli, Maria

2014-01-01

Objectives: The existing literature on the impact of workplace conditions on client care suggests that good cultures and climates provide the best outcomes for clients. The primary purpose of this study was to investigate the relationship between organizational culture and climate and the proportion of children and youth successfully discharged…

Improving Kindergarten Students' Writing Outcomes Using Peer-Assisted Strategies

ERIC Educational Resources Information Center

Puranik, Cynthia S.; Petscher, Yaacov; Al Otaiba, Stephanie; Lemons, Christopher J.

2018-01-01

The primary focus of this study was to determine the feasibility of teacher implementation of peer-assisted writing strategies (PAWS) in improving the writing outcomes of kindergarten children. Six classrooms were recruited, and 3 were randomly assigned to the experimental condition. Results indicated that the content, length, and formatting of…

Children with Cochlear Implants in Australia: Educational Settings, Supports, and Outcomes

ERIC Educational Resources Information Center

Punch, Renee; Hyde, Merv

2010-01-01

This Australian study examined the communication, academic, and social outcomes of pediatric cochlear implantation from the perspectives of teachers working with children with cochlear implants. The children were aged from 1 to 18 years and attended a range of educational settings in early intervention, primary, and secondary schooling. One…

Evaluating community health centers’ adoption of a new global capitation payment (eCHANGE) study protocol

PubMed Central

Angier, H; O’Malley, JP; Marino, M; McConnell, KJ; Cottrell, E; Jacob, RL; Likumahuwa-Ackman, S; Heintzman, J; Huguet, N; Bailey, SR; DeVoe, JE

2017-01-01

Primary care patient-centered medical homes (PCMHs) are an effective healthcare delivery model. Evidence regarding the most effective payment models for increased coordination efforts is sparse. This protocol paper describes the evaluation of an Alternative Payment Methodology (APM) implemented in a subset of Oregon community health centers (CHCs), using a prospective matched observational design. The APM is a primary care payment reform intervention that changed Oregon’s Medicaid payment for several CHCs from fee-for-service reimbursement to a per-member-per-month capitated payment. We will implement a difference-in-difference analytic approach to evaluate pre-post APM changes between intervention and control groups, including: 1) clinic-level outcomes, 2) patient-level clinical outcomes, and 3) patient-level econometric outcomes. Findings from the project will be of national significance, as there is a need for evidence regarding how novel payment methods might enhance PCMH capabilities and support their capacity to produce better quality and outcomes. If this capitated payment method is proven effective, study findings will inform dissemination of similar APMs nationwide. PMID:27836506

Evaluating community health centers' adoption of a new global capitation payment (eCHANGE) study protocol.

PubMed

Angier, H; O'Malley, J P; Marino, M; McConnell, K J; Cottrell, E; Jacob, R L; Likumahuwa-Ackman, S; Heintzman, J; Huguet, N; Bailey, S R; DeVoe, J E

2017-01-01

Primary care patient-centered medical homes (PCMHs) are an effective healthcare delivery model. Evidence regarding the most effective payment models for increased coordination efforts is sparse. This protocol paper describes the evaluation of an Alternative Payment Methodology (APM) implemented in a subset of Oregon community health centers (CHCs), using a prospective matched observational design. The APM is a primary care payment reform intervention that changed Oregon's Medicaid payment for several CHCs from fee-for-service reimbursement to a per-member-per-month capitated payment. We will implement a difference-in-difference analytic approach to evaluate pre-post APM changes between intervention and control groups, including: 1) clinic-level outcomes, 2) patient-level clinical outcomes, and 3) patient-level econometric outcomes. Findings from the project will be of national significance, as there is a need for evidence regarding how novel payment methods might enhance PCMH capabilities and support their capacity to produce better quality and outcomes. If this capitated payment method is proven effective, study findings will inform dissemination of similar APMs nationwide. Copyright © 2016 Elsevier Inc. All rights reserved.

Infant feeding bottle design, growth and behaviour: results from a randomised trial

PubMed Central

2012-01-01

Background Whether the design of an anti-vacuum infant feeding bottle influences infant milk intake, growth or behavior is unknown, and was the subject of this randomized trial. Methods Subjects 63 (36 male) healthy, exclusively formula-fed term infants. Intervention Randomisation to use Bottle A (n = 31), one-way air valve: Philips Avent) versus Bottle B (n = 32), internal venting system: Dr Browns). 74 breast-fed reference infants were recruited, with randomisation (n = 24) to bottle A (n = 11) or B (n = 13) if bottle-feeding was subsequently introduced. Randomisation stratified by gender and parity; computer-based telephone randomisation by independent clinical trials unit. Setting Infant home. Primary outcome measure infant weight gain to 4 weeks. Secondary outcomes (i) milk intake (ii) infant behaviour measured at 2 weeks (validated 3-day diary); (iii) risk of infection; (iv) continuation of breastfeeding following introduction of mixed feeding. Results Number analysed for primary outcome Bottle A n = 29, Bottle B n = 25. Primary outcome There was no significant difference in weight gain between randomised groups (0-4 weeks Bottle A 0.74 (SD 1.2) SDS versus bottle B 0.51 (0.39), mean difference 0.23 (95% CI -0.31 to 0.77). Secondary outcomes Infants using bottle A had significantly less reported fussing (mean 46 versus 74 minutes/day, p < 0.05) than those using bottle B. There was no significant difference in any other outcome measure. Breast-fed reference group There were no significant differences in primary or secondary outcomes between breast-fed and formula fed infants. The likelyhood of breastfeeding at 3 months was not significantly different in infants subsequently randomised to bottle A or B. Conclusion Bottle design may have short-term effects on infant behaviour which merit further investigation. No significant effects were seen on milk intake or growth; confidence in these findings is limited by the small sample size and this needs confirmation in a larger study. Trial registration Clinical Trials.gov NCT00325208. PMID:22424116

Physiotherapy rehabilitation after total knee or hip replacement: an evidence-based analysis.

PubMed

2005-01-01

The objective of this health technology policy analysis was to determine, where, how, and when physiotherapy services are best delivered to optimize functional outcomes for patients after they undergo primary (first-time) total hip replacement or total knee replacement, and to determine the Ontario-specific economic impact of the best delivery strategy. The objectives of the systematic review were as follows: To determine the effectiveness of inpatient physiotherapy after discharge from an acute care hospital compared with outpatient physiotherapy delivered in either a clinic-based or home-based setting for primary total joint replacement patientsTo determine the effectiveness of outpatient physiotherapy delivered by a physiotherapist in either a clinic-based or home-based setting in addition to a home exercise program compared with a home exercise program alone for primary total joint replacement patientsTo determine the effectiveness of preoperative exercise for people who are scheduled to receive primary total knee or hip replacement surgery Total hip replacements and total knee replacements are among the most commonly performed surgical procedures in Ontario. Physiotherapy rehabilitation after first-time total hip or knee replacement surgery is accepted as the standard and essential treatment. The aim is to maximize a person's functionality and independence and minimize complications such as hip dislocation (for hip replacements), wound infection, deep vein thrombosis, and pulmonary embolism. THE THERAPY: The physiotherapy rehabilitation routine has 4 components: therapeutic exercise, transfer training, gait training, and instruction in the activities of daily living. Physiotherapy rehabilitation for people who have had total joint replacement surgery varies in where, how, and when it is delivered. In Ontario, after discharge from an acute care hospital, people who have had a primary total knee or hip replacement may receive inpatient or outpatient physiotherapy. Inpatient physiotherapy is delivered in a rehabilitation hospital or specialized hospital unit. Outpatient physiotherapy is done either in an outpatient clinic (clinic-based) or in the person's home (home-based). Home-based physiotherapy may include practising an exercise program at home with or without supplemental support from a physiotherapist. Finally, physiotherapy rehabilitation may be administered at several points after surgery, including immediately postoperatively (within the first 5 days) and in the early recovery period (within the first 3 months) after discharge. There is a growing interest in whether physiotherapy should start before surgery. A variety of practises exist, and evidence regarding the optimal pre- and post-acute course of rehabilitation to obtain the best outcomes is needed. The Medical Advisory Secretariat used its standard search strategy, which included searching the databases of Ovid MEDLINE, CINHAL, EMBASE, Cochrane Database of Systematic Reviews, and PEDro from 1995 to 2005. English-language articles including systematic reviews, randomized controlled trials (RCTs), non-RCTs, and studies with a sample size of greater than 10 patients were included. Studies had to include patients undergoing primary total hip or total knee replacement, aged 18 years of age or older, and they had to have investigated one of the following comparisons: inpatient rehabilitation versus outpatient (clinic- or home-based therapy) rehabilitation, land-based post-acute care physiotherapy delivered by a physiotherapist compared with patient self-administered exercise and a land-based exercise program before surgery. The primary outcome was postoperative physical functioning. Secondary outcomes included the patient's assessment of therapeutic effect (overall improvement), perceived pain intensity, health services utilization, treatment side effects, and adverse events The quality of the methods of the included studies was assessed using the criteria outlined in the Cochrane Musculoskeletal Injuries Group Quality Assessment Tool. After this, a summary of the biases threatening study validity was determined. Four methodological biases were considered: selection bias, performance bias, attrition bias, and detection bias. A meta-analysis was conducted when adequate data were available from 2 or more studies and where there was no statistical or clinical heterogeneity among studies. The GRADE system was used to summarize the overall quality of evidence. The search yielded 422 citations; of these, 12 were included in the review including 10 primary studies (9 RCTs, 1 non-RCT) and 2 systematic reviews. The Medical Advisory Secretariat review included 2 primary studies (N = 334) that examined the effectiveness of an inpatient physiotherapy rehabilitation program compared with an outpatient home-based physiotherapy program on functional outcomes after total knee or hip replacement surgery. One study, available only as an abstract, found no difference in functional outcome at 1 year after surgery (TKR or THR) between the treatments. The other study was an observational study that found that patients who are younger than 71 years of age on average, who do not live alone, and who do not have comorbid illnesses recover adequate function with outpatient home-based physiotherapy. However results were only measured up to 3 months after surgery, and the outcome measure they used is not considered the best one for physical functioning. Three primary studies (N = 360) were reviewed that tested the effectiveness of outpatient home-based or clinic-based physiotherapy in addition to a self-administered home exercise program, compared with a self-administered exercise program only or in addition to using another therapy (phone calls or continuous passive movement), on postoperative physical functioning after primary TKR surgery. Two of the studies reported no difference in change from baseline in flexion range of motion between those patients receiving outpatient or home-based physiotherapy and doing a home exercise program compared with patients who did a home exercise program only with or without continuous passive movement. The other study reported no difference in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) scores between patients receiving clinic-based physiotherapy and practising a home exercise program and those who received monitoring phone calls and did a home exercise program after TKR surgery. The Medical Advisory Secretariat reviewed two systematic reviews evaluating the effects of preoperative exercise on postoperative physical functioning. One concluded that preoperative exercise is not effective in improving functional recovery or pain after TKR and any effects after THR could not be adequately determined. The other concluded that there was inconclusive evidence to determine the benefits of preoperative exercise on functional recovery after TKR. Because 2 primary studies were added to the published literature since the publication of these systematic reviews the Medical Advisory Secretariat revisited the question of effectiveness of a preoperative exercise program for patients scheduled for TKR ad THR surgery. The Medical Advisory Secretariat also reviewed 3 primary studies (N = 184) that tested the effectiveness of preoperative exercise beginning 4-6 weeks before surgery on postoperative outcomes after primary TKR surgery. All 3 studies reported negative findings with regard to the effectiveness of preoperative exercise to improve physical functioning after TKR surgery. However, 2 failed to show an effect of the preoperative exercise program before surgery in those patients receiving preoperative exercise. The third study did not measure functional outcome immediately before surgery in the preoperative exercise treatment group; therefore the study's authors could not document an effect of the preoperative exercise program before surgery. Regarding health services utilization, 2 of the studies did not find significant differences in either the length of the acute care hospital stay or the inpatient rehabilitation care setting between patients treated with a preoperative exercise program and those not treated. The third study did not measure health services utilization. These results must be interpreted within the limitations and the biases of each study. Negative results do not necessarily support a lack of treatment effect but may be attributed to a type II statistical error. Finally, the Medical Advisory Secretariat reviewed 2 primary studies (N = 136) that examined the effectiveness of preoperative exercise on postoperative functional outcomes after primary THR surgery. One study did not support the effectiveness of an exercise program beginning 8 weeks before surgery. However, results from the other did support the effectiveness of an exercise program 8 weeks before primary THR surgery on pain and functional outcomes 1 week before and 3 weeks after surgery. Based on the evidence, the Medical Advisory Secretariat reached the following conclusions with respect to physiotherapy rehabilitation and physical functioning 1 year after primary TKR or THR surgery: There is high-quality evidence from 1 large RCT to support the use of home-based physiotherapy instead of inpatient physiotherapy after primary THR or TKR surgery.There is low-to-moderate quality evidence from 1 large RCT to support the conclusion that receiving a monitoring phone call from a physiotherapist and practising home exercises is comparable to receiving clinic-based physiotherapy and practising home exercises for people who have had primary TKR surgery. However, results may not be generalizable to those who have had THR surgery.There is moderate evidence to suggest that an exercise program beginning 4 to 6 weeks before primary TKR surgery is not effective. (ABSTRACT TRUNCATED)

International variations in primary care physician consultation time: a systematic review of 67 countries

PubMed Central

Neves, Ana Luisa; Oishi, Ai; Tagashira, Hiroko; Verho, Anistasiya; Holden, John

2017-01-01

Objective To describe the average primary care physician consultation length in economically developed and low-income/middle-income countries, and to examine the relationship between consultation length and organisational-level economic, and health outcomes. Design and outcome measures This is a systematic review of published and grey literature in English, Chinese, Japanese, Spanish, Portuguese and Russian languages from 1946 to 2016, for articles reporting on primary care physician consultation lengths. Data were extracted and analysed for quality, and linear regression models were constructed to examine the relationship between consultation length and health service outcomes. Results One hundred and seventy nine studies were identified from 111 publications covering 28 570 712 consultations in 67 countries. Average consultation length differed across the world, ranging from 48 s in Bangladesh to 22.5 min in Sweden. We found that 18 countries representing about 50% of the global population spend 5 min or less with their primary care physicians. We also found significant associations between consultation length and healthcare spending per capita, admissions to hospital with ambulatory sensitive conditions such as diabetes, primary care physician density, physician efficiency and physician satisfaction. Conclusion There are international variations in consultation length, and it is concerning that a large proportion of the global population have only a few minutes with their primary care physicians. Such a short consultation length is likely to adversely affect patient healthcare and physician workload and stress. PMID:29118053

Childhood trauma and health outcomes in adults with comorbid substance abuse and mental health disorders.

PubMed

Wu, Nancy S; Schairer, Laura C; Dellor, Elinam; Grella, Christine

2010-01-01

This study describes the prevalence of childhood traumatic events (CTEs) among adults with comorbid substance use disorders (SUDs) and mental health problems (MHPs) and assesses the relation between cumulative CTEs and adult health outcomes. Adults with SUDs/MHPs (N=402) were recruited from residential treatment programs and interviewed at treatment admission. Exposures to 9 types of adverse childhood experiences were summed and categorized into 6 ordinal levels of exposure. Descriptive analyses were conducted to assess the prevalence and range of exposure to CTEs in comparison with a sample from primary health care. Logistic regression analyses were conducted to examine the association between the cumulative exposure to CTEs and adverse health outcomes. Most of the sample reported exposure to CTEs, with higher exposure rates among the study sample compared with the primary health care sample. Greater exposure to CTEs significantly increased the odds of several adverse adult outcomes, including PTSD, alcohol dependence, injection drug use, tobacco use, sex work, medical problems, and poor quality of life. Study findings support the importance of early prevention and intervention and provision of trauma treatment for individuals with SUDs/MHPs.

A critical view of the peripheral atherectomy data in the treatment of infrainguinal arterial disease.

PubMed

Quevedo, Henry C; Arain, Salman A; Ali, Gholam; Abi Rafeh, Nidal

2014-01-01

Revascularization of the peripheral arteries remains technically challenging. By decreasing the volume of the atherosclerotic plaque, debulking procedures may confer superior primary patency after revascularization. To assess the impact of atherectomy on primary patency rates at 12 months compared to balloon angioplasty and/or stent placement alone in patients with infrainguinal arterial disease. A database search for "directional," "orbital," "rotational," and "laser atherectomy" in peripheral arterial disease (PAD) was performed. Studies were screened according to the STROBE (Strengthening the Reporting of Observational studies in Epidemiology) critical appraisal tool and summarized by population, methodology, and outcomes (primary patency and major adverse events). Only two randomized studies were found. Most of the data were obtained from single-arm studies and registries. The primary patency with directional atherectomy approaches 60% at 12 months as a stand-alone technique, whereas orbital atherectomy in conjunction with balloon angioplasty and stenting achieved primary patency rates of 90%. Laser atherectomy is universally employed with balloon angioplasty and stenting for in-stent restenosis lesions with a primary patency rate of 64%. Although there are data for the safe use of rotational atherectomy, robust data to support its effectiveness are lacking. The combination of drug-coated balloons and atherectomy for the treatment of heavily calcified lesions in patients with critical limb ischemia is under evaluation. Despite the successful procedural outcomes reported in clinical registries, the available data do not support the use of atherectomy alone in PAD. Larger randomized controlled studies are warranted to define its role in contemporary endovascular practice.

Physiotherapy program through home visits for community-dwelling elderly Japanese women with mild knee pain.

PubMed

Konishi, Isamu; Tanabe, Naohito; Seki, Nao; Suzuki, Hiroshi; Okamura, Taro; Shinoda, Kunihiko; Hoshino, Emiko

2009-10-01

Knee pain is extremely common among the elderly, particularly women. Hence, there is an urgent need for applicable community-based intervention models for halting the progression of knee pain and related disabilities in elderly women. We aimed to assess the efficacy of home-visit physiotherapy as a new intervention model. This non-randomized 5-month-long controlled trial enrolled elderly community-dwelling women (aged 60-83 years) with mild knee pain. The intervention consisted of two home visits by a physiotherapist, with instructions on routinely performing muscle-strengthening exercises at home and implementing simple environmental modifications when necessary. Outcome measures were assessed at baseline and 5 months later. The primary outcomes were measured as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and a newly devised seiza-style sitting score. People in Japan, especially elderly women, are accustomed to seiza-style sitting that involves kneeling on one's lower legs while resting the buttocks on the heels. The secondary outcomes included quadriceps isometric strength, knee alignment in the frontal and sagittal planes, and passive knee extension range. Forty-two subjects (20 in the intervention group and 22 in the control group) completed the study. At baseline, characteristics and the primary outcomes did not significantly differ between the 2 groups. At 5 months, the primary outcomes improved significantly in the intervention group. Estimated differences in the change from baseline for each outcome between the 2 groups were computed, adjusting for outcome variables imbalanced at baseline. Even after the adjustment, the home-visit physiotherapy regimen provides favorable improvement in the seiza-style sitting score.

Cervical Spondylotic Myelopathy Surgical (CSM-S) Trial: Randomized Controlled Trial Design and Rationale

PubMed Central

Ghogawala, Zoher; Benzel, Edward C.; Heary, Robert F.; Riew, K. Daniel; Albert, Todd J.; Butler, William E.; Barker, Fred G.; Heller, John G.; McCormick, Paul C.; Whitmore, Robert G.; Freund, Karen M.; Schwartz, J. Sanford

2014-01-01

Background Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction in the world. There is significant practice variation and uncertainty as to the optimal surgical approach for treating CSM. Objective The primary objective is to determine if ventral surgery is associated with superior SF-36 Physical Component Summary (PCS) outcome at one year follow-up compared to dorsal (laminectomy/fusion or laminoplasty) surgery for the treatment of CSM. The study will also investigate whether post-operative sagittal balance is an independent predictor of overall outcome and will compare health resource utilization for ventral and dorsal procedures. Methods The study is a randomized, controlled trial with a nonrandomized arm for patients who are eligible but decline randomization. Two hundred fifty patients (159 randomized) with CSM from 11 sites will be recruited over 18 months. The primary outcome is the Short Form-36 PCS score. Secondary outcomes include disease specific outcomes, overall health-related quality of life (EuroQol-5D), and health resource utilization. Expected Outcomes This will be the first randomized controlled trial to compare directly the health-related quality of life outcomes for ventral versus dorsal surgery for treating CSM. Discussion An NIH-funded (1R13AR065834-01) investigator meeting was held prior to initiating the trial in order to bring multiple stakeholders together to finalize the study protocol. Study investigators, coordinators, and major stakeholders were able to attend and discuss strengths, limitations, and concerns regarding the study. The final protocol was approved for funding by PCORI (CE-1304-6173). The RCT began enrollment on April 1, 2014. PMID:24991714

Effectiveness of a virtual intervention for primary healthcare professionals aimed at improving attitudes towards the empowerment of patients with chronic diseases: study protocol for a cluster randomized controlled trial (e-MPODERA project).

PubMed

González-González, Ana Isabel; Orrego, Carola; Perestelo-Perez, Lilisbeth; Bermejo-Caja, Carlos Jesús; Mora, Nuria; Koatz, Débora; Ballester, Marta; Del Pino, Tasmania; Pérez-Ramos, Jeannet; Toledo-Chavarri, Ana; Robles, Noemí; Pérez-Rivas, Francisco Javier; Ramírez-Puerta, Ana Belén; Canellas-Criado, Yolanda; Del Rey-Granado, Yolanda; Muñoz-Balsa, Marcos José; Becerril-Rojas, Beatriz; Rodríguez-Morales, David; Sánchez-Perruca, Luis; Vázquez, José Ramón; Aguirre, Armando

2017-10-30

Communities of practice are based on the idea that learning involves a group of people exchanging experiences and knowledge. The e-MPODERA project aims to assess the effectiveness of a virtual community of practice aimed at improving primary healthcare professional attitudes to the empowerment of patients with chronic diseases. This paper describes the protocol for a cluster randomized controlled trial. We will randomly assign 18 primary-care practices per participating region of Spain (Catalonia, Madrid and Canary Islands) to a virtual community of practice or to usual training. The primary-care practice will be the randomization unit and the primary healthcare professional will be the unit of analysis. We will need a sample of 270 primary healthcare professionals (general practitioners and nurses) and 1382 patients. We will perform randomization after professionals and patients are selected. We will ask the intervention group to participate for 12 months in a virtual community of practice based on a web 2.0 platform. We will measure the primary outcome using the Patient-Provider Orientation Scale questionnaire administered at baseline and after 12 months. Secondary outcomes will be the sociodemographic characteristics of health professionals, sociodemographic and clinical characteristics of patients, the Patient Activation Measure questionnaire for patient activation and outcomes regarding use of the virtual community of practice. We will calculate a linear mixed-effects regression to estimate the effect of participating in the virtual community of practice. This cluster randomized controlled trial will show whether a virtual intervention for primary healthcare professionals improves attitudes to the empowerment of patients with chronic diseases. ClicalTrials.gov, NCT02757781 . Registered on 25 April 2016. Protocol Version. PI15.01 22 January 2016.

Comparative gastrointestinal safety of weekly oral bisphosphonates

PubMed Central

Katz, J. N.; Brookhart, M. A.; Stürmer, T.; Stedman, M. R.; Levin, R.; Solomon, D. H.

2012-01-01

Summary Weekly bisphosphonates are the primary agents used to treat osteoporosis. Although these agents are generally well tolerated, serious gastrointestinal adverse events, including hospitalization for gastrointestinal bleed, may arise. We compared the gastrointestinal safety between weekly alendronate and weekly risedronate and found no important difference between new users of these agents. Introduction Weekly bisphosphonates are the primary agents prescribed for osteoporosis. We examined the comparative gastrointestinal safety between weekly bisphosphonates. Methods We studied new users of weekly alendronate and weekly risedronate from June 2002 to August 2005 among enrollees in a state-wide pharmaceutical benefit program for seniors. Our primary outcome was hospitalization for upper gastrointestinal bleed. Secondary outcomes included outpatient diagnoses for upper gastrointestinal disease, symptoms, endoscopic procedures, use of gastroprotective agents, and switching between therapies. We used Cox proportional hazard models to compare outcomes between agents within 120 days of treatment initiation, adjusting for propensity score quintiles. We also examined composite safety outcomes and stratified results by age and prior gastrointestinal history. Results A total of 10,420 new users were studied, mean age=79 years (SD, 6.9), and 95% women. We observed 31 hospitalizations for upper gastrointestinal bleed (0.91 per 100 person-years) within 120 days of treatment initiation. Adjusting for covariates, there was no difference in hospitalization for upper gastrointestinal bleed among those treated with risedronate compared with alendronate (HR, 1.12; 95%CI, 0.55 to 2.28). Risedronate switching rates were lower; otherwise, no differences were observed for secondary or composite outcomes. Conclusions We found no important difference in gastrointestinal safety between weekly oral bisphosphonates. PMID:19266138

Microsurgery Versus Stereotactic Radiosurgery for Brain Arteriovenous Malformations: A Matched Cohort Study.

PubMed

Chen, Ching-Jen; Ding, Dale; Wang, Tony R; Buell, Thomas J; Ilyas, Adeel; Ironside, Natasha; Lee, Cheng-Chia; Kalani, M Yashar; Park, Min S; Liu, Kenneth C; Sheehan, Jason P

2018-05-12

Microsurgery (MS) and stereotactic radiosurgery (SRS) remain the preferred interventions for the curative treatment of brain arteriovenous malformations (AVM), but their relative efficacy remains incompletely defined. To compare the outcomes of MS to SRS for AVMs through a retrospective, matched cohort study. We evaluated institutional databases of AVM patients who underwent MS and SRS. MS-treated patients were matched, in a 1:1 ratio based on patient and AVM characteristics, to SRS-treated patients. Statistical analyses were performed to compare outcomes data between the 2 cohorts. The primary outcome was defined as AVM obliteration without a new permanent neurological deficit. The matched MS and SRS cohorts were each comprised of 59 patients. Both radiological (85 vs 11 mo; P < .001) and clinical (92 vs 12 mo; P < .001) follow-up were significantly longer for the SRS cohort. The primary outcome was achieved in 69% of each cohort. The MS cohort had a significantly higher obliteration rate (98% vs 72%; P = .001), but also had a significantly higher rate of new permanent deficit (31% vs 10%; P = .011). The posttreatment hemorrhage rate was significantly higher for the SRS cohort (10% for SRS vs 0% for MS; P = .027). In subgroup analyses of ruptured and unruptured AVMs, no significant differences between the primary outcomes were observed. For patients with comparable AVMs, MS and SRS afford similar rates of deficit-free obliteration. Nidal obliteration is more frequently achieved with MS, but this intervention also incurs a greater risk of new permanent neurological deficit.

A double-blind, placebo-controlled study of edivoxetine as an adjunctive treatment for patients with major depressive disorder who are partial responders to selective serotonin reuptake inhibitor treatment.

PubMed

Ball, Susan; Dellva, Mary Anne; D'Souza, Deborah N; Marangell, Lauren B; Russell, James M; Goldberger, Celine

2014-01-01

This phase 2 study examined the efficacy and tolerability of edivoxetine, a highly selective norepinephrine reuptake inhibitor, as an adjunctive treatment for patients with major depressive disorder (MDD) who have a partial response to selective serotonin reuptake inhibitor (SSRI) treatment. Study design consisted of double-blind, 10-week therapy of adjunctive edivoxetine (6-18 mg once daily) or adjunctive placebo with SSRI. Inclusion/entry criteria included partial response to current SSRI by investigator opinion and a GRID 17-item Hamilton Rating Scale for Depression (HAMD17) total score ≥16. The primary efficacy measure was the Montgomery-Asberg Depression Rating Scale (MADRS). Safety measures included treatment-emergent adverse events (TEAE) and vital signs. For the primary evaluable population (n=63 for adjunctive edivoxetine and n=68 for adjunctive placebo), the treatment groups did not differ significantly on the primary outcome of change from baseline to week 8 in the MADRS total score; the effect size of edivoxetine treatment was 0.26. Significant treatment differences, favoring adjunctive edivoxetine (p≤.05), were shown for improvements in role functioning and the functional impact of fatigue. For the adjunctive edivoxetine randomized group (N=111), the most frequent TEAEs were hyperhidrosis (7.2%), nausea (7.2%), erectile dysfunction (6.3%) and testicular pain (6.3%). Hemodynamic changes were observed in blood pressure and pulse rate between treatment groups. Study was underpowered for an alpha 2-sided 0.05 significance level for the primary outcome. For patients with MDD who had a partial response to SSRIs, adjunctive edivoxetine treatment was not statistically superior to adjunctive placebo on the primary outcome measure. However, pending further study, improved functioning and remission rate suggest a potential role for edivoxetine for patients with depression. Copyright © 2014 Elsevier B.V. All rights reserved.

A randomised controlled trial of a lengthened and multi-disciplinary consultation model in a socially deprived community: a study protocol.

PubMed

Whitford, David L; Chan, Wai-Sun

2007-06-28

There has been little development of the general practice consultation over the years, and many aspects of the present consultation do not serve communities with multiple health and social problems well. Many of the problems presenting to general practitioners in socio-economically disadvantaged areas are not amenable to a purely medical solution, and would particularly benefit from a multidisciplinary approach. Socio-economic deprivation is also associated with those very factors (more psychosocial problems, greater need for health promotion, more chronic diseases, more need for patient enablement) that longer consultations have been shown to address. This paper describes our study protocol, which aims to evaluate whether a lengthened multidisciplinary primary care team consultation with families in a socially deprived area can improve the psychological health of mothers in the families. In a randomised controlled trial, families with a history of social problems, substance misuse or depression are randomly allocated to an intervention or control group. The study is based in three general practices in a highly deprived area of North Dublin. Primary health care teams will be trained in conducting a multidisciplinary lengthened consultation. Families in the intervention group will participate in the new style multidisciplinary consultation. Outcomes of families receiving the intervention will be compared to the control group who will receive only usual general practitioner care. The primary outcome is the psychological health of mothers of the families and secondary outcomes include general health status, quality of life measures and health service usage. The main aim of this study is to evaluate the effectiveness of a lengthened multidisciplinary team consultation in primary care. The embedded nature of this study in general practices in a highly deprived area ensures generalisability to other deprived communities, but more particularly it promises relevance to primary care. Current Controlled Trials ISRCTN70578736.

Association of troponin T, detected with highly sensitive assay, and outcomes in infective endocarditis.

PubMed

Stancoven, Amy B; Shiue, Angela B; Khera, Amit; Pinkston, Kristi; Hashim, Ibrahim A; Wang, Andrew; de Lemos, James A; Peterson, Gail E

2011-08-01

Troponin levels have been correlated with adverse outcomes in multiple disease processes, including congestive heart failure, acute coronary syndromes, sepsis, and, in a few small series, infective endocarditis. We hypothesized that a novel measurement of troponin using a highly sensitive assay would correlate with adverse outcomes when prospectively studied in patients with infective endocarditis. At a single center in the International Collaboration on Endocarditis, 42 patients met the inclusion criteria and underwent testing for cardiac troponin T (cTnT) using both a standard and a highly sensitive precommercial assay. The cTnT levels were associated with the prespecified primary composite outcome of death, central nervous system event, and cardiac abscess. Secondary outcomes included the individual components of the composite outcome and the need for cardiac surgery. A receiver operating characteristic curve was derived and used to identify the optimal cutpoint for cTnT using the highly sensitive assay. cTnT was detectable with the highly sensitive assay in 39 (93%) of 42 patients with infective endocarditis and with the standard assay in 25 (56%) of 42 (p <0.05). Of the 42 patients, 15 experienced the composite outcome, 4 died, 9 had a central nervous system event, and 5 had a cardiac abscess. With the hs-cTnT assay, the median cTnT was greater in the patients who experienced the primary outcome (0.12 vs 0.02 ng/ml, p <0.05). According to the receiver operating characteristic curve analysis (area under the curve of 0.74), cTnT levels of ≥0.08 ng/ml produced optimal specificity (78%) for the primary outcome. The patients with a cTnT level of ≥0.08 ng/ml were more likely to experience the primary outcome (odds ratio 7.0, 95% confidence interval 1.7 to 28.6, p <0.01) and a central nervous system event (odds ratio 9.3, 95% confidence interval 1.3 to 24.1, p = 0.02). In conclusion, cTnT is detectable in 93% of patients with infective endocarditis using a novel highly sensitive assay, with higher levels correlating with poor clinical outcomes. Copyright © 2011 Elsevier Inc. All rights reserved.

Understanding how pain education causes changes in pain and disability: protocol for a causal mediation analysis of the PREVENT trial.

PubMed

Lee, Hopin; Moseley, G Lorimer; Hübscher, Markus; Kamper, Steven J; Traeger, Adrian C; Skinner, Ian W; McAuley, James H

2015-07-01

Pain education is a complex intervention developed to help clinicians manage low back pain. Although complex interventions are usually evaluated by their effects on outcomes, such as pain or disability, most do not directly target these outcomes; instead, they target intermediate factors that are presumed to be associated with the outcomes. The mechanisms underlying treatment effects, or the effect of an intervention on an intermediate factor and its subsequent effect on outcome, are rarely investigated in clinical trials. This leaves a gap in the evidence for understanding how treatments exert their effects on outcomes. Mediation analysis provides a method for identifying and quantifying the mechanisms that underlie interventions. To determine whether the effect of pain education on pain and disability is mediated by changes in self-efficacy, catastrophisation and back pain beliefs. Causal mediation analysis of the PREVENT randomised controlled trial. Two hundred and two participants with acute low back pain from primary care clinics in the Sydney metropolitan area. Participants will be randomised to receive either 'pain education' (intervention group) or 'sham education' (control group). All outcome measures (including patient characteristics), primary outcome measures (pain and disability), and putative mediating variables (self-efficacy, catastrophisation and back pain beliefs) will be measured prior to randomisation. Putative mediators and primary outcome measures will be measured 1 week after the intervention, and primary outcome measures will be measured 3 months after the onset of low back pain. Causal mediation analysis under the potential outcomes framework will be used to test single and multiple mediator models. A sensitivity analysis will be conducted to evaluate the robustness of the estimated mediation effects on the influence of violating sequential ignorability--a critical assumption for causal inference. Mediation analysis of clinical trials can estimate how much the total effect of the treatment on the outcome is carried through an indirect path. Using mediation analysis to understand these mechanisms can generate evidence that can be used to tailor treatments and optimise treatment effects. In this study, the causal mediation effects of a pain education intervention for acute non-specific low back pain will be estimated. This knowledge is critical for further development and refinement of interventions for conditions such as low back pain. Copyright © 2015 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

Advances and Remaining Challenges in the Study of Influenza and Anthrax Infection in Lung Cell Culture

DOE Office of Scientific and Technical Information (OSTI.GOV)

Powell, Joshua D.; Straub, Timothy M.

For over thirty years immortalized lung cells have enabled researchers to elucidate lung-pathogen molecular interactions. However, over the last five years numerous commercial companies are now providing affordable, ready-to-use primary lung cells for use in research laboratories. Despite advances in primary cell culture, studies using immortalized lung cells still dominate the recent scientific literature. In this paper, we highlight recent influenza and anthrax studies using in vitro primary lung tissue models and how these models are providing better predictive outcomes for when extrapolated to in vivo observations.

Advances and Remaining Challenges in the Study of Influenza and Anthrax Infection in Lung Cell Culture

DOE PAGES

Powell, Joshua D.; Straub, Timothy M.

2018-01-17

For over thirty years immortalized lung cells have enabled researchers to elucidate lung-pathogen molecular interactions. However, over the last five years numerous commercial companies are now providing affordable, ready-to-use primary lung cells for use in research laboratories. Despite advances in primary cell culture, studies using immortalized lung cells still dominate the recent scientific literature. In this paper, we highlight recent influenza and anthrax studies using in vitro primary lung tissue models and how these models are providing better predictive outcomes for when extrapolated to in vivo observations.

Study protocol of the TIRED study: a randomised controlled trial comparing either graded exercise therapy for severe fatigue or cognitive behaviour therapy with usual care in patients with incurable cancer.

PubMed

Poort, Hanneke; Verhagen, Constans A H H V M; Peters, Marlies E W J; Goedendorp, Martine M; Donders, A Rogier T; Hopman, Maria T E; Nijhuis-van der Sanden, Maria W G; Berends, Thea; Bleijenberg, Gijs; Knoop, Hans

2017-01-28

Fatigue is a common and debilitating symptom for patients with incurable cancer receiving systemic treatment with palliative intent. There is evidence that non-pharmacological interventions such as graded exercise therapy (GET) or cognitive behaviour therapy (CBT) reduce cancer-related fatigue in disease-free cancer patients and in patients receiving treatment with curative intent. These interventions may also result in a reduction of fatigue in patients receiving treatment with palliative intent, by improving physical fitness (GET) or changing fatigue-related cognitions and behaviour (CBT). The primary aim of our study is to assess the efficacy of GET or CBT compared to usual care (UC) in reducing fatigue in patients with incurable cancer. The TIRED study is a multicentre three-armed randomised controlled trial (RCT) for incurable cancer patients receiving systemic treatment with palliative intent. Participants will be randomised to GET, CBT, or UC. In addition to UC, the GET group will participate in a 12-week supervised exercise programme. The CBT group will receive a 12-week CBT intervention in addition to UC. Primary and secondary outcome measures will be assessed at baseline, post-intervention (14 weeks), and at follow-up assessments (18 and 26 weeks post-randomisation). The primary outcome measure is fatigue severity (Checklist Individual Strength subscale fatigue severity). Secondary outcome measures are fatigue (EORTC-QLQ-C30 subscale fatigue), functional impairments (Sickness Impact Profile total score, EORTC-QLQ-C30 subscale emotional functioning, subscale physical functioning) and quality of life (EORTC-QLQ-C30 subscale QoL). Outcomes at 14 weeks (primary endpoint) of either treatment arm will be compared to those of UC participants. In addition, outcomes at 18 and 26 weeks (follow-up assessments) of either treatment arm will be compared to those of UC participants. To our knowledge, the TIRED study is the first RCT investigating the efficacy of GET and CBT on reducing fatigue during treatment with palliative intent in incurable cancer patients. The results of this study will provide information about the possibility and efficacy of GET and CBT for severely fatigued incurable cancer patients. NTR3812 ; date of registration: 23/01/2013.

Incidence, predictors, and outcome of difficult mask ventilation combined with difficult laryngoscopy: a report from the multicenter perioperative outcomes group.

PubMed

Kheterpal, Sachin; Healy, David; Aziz, Michael F; Shanks, Amy M; Freundlich, Robert E; Linton, Fiona; Martin, Lizabeth D; Linton, Jonathan; Epps, Jerry L; Fernandez-Bustamante, Ana; Jameson, Leslie C; Tremper, Tyler; Tremper, Kevin K

2013-12-01

Research regarding difficult mask ventilation (DMV) combined with difficult laryngoscopy (DL) is extremely limited even though each technique serves as a rescue for one another. Four tertiary care centers participating in the Multicenter Perioperative Outcomes Group used a consistent structured patient history and airway examination and airway outcome definition. DMV was defined as grade 3 or 4 mask ventilation, and DL was defined as grade 3 or 4 laryngoscopic view or four or more intubation attempts. The primary outcome was DMV combined with DL. Patients with the primary outcome were compared to those without the primary outcome to identify predictors of DMV combined with DL using a non-parsimonious logistic regression. Of 492,239 cases performed at four institutions among adult patients, 176,679 included a documented face mask ventilation and laryngoscopy attempt. Six hundred ninety-eight patients experienced the primary outcome, an overall incidence of 0.40%. One patient required an emergent cricothyrotomy, 177 were intubated using direct laryngoscopy, 284 using direct laryngoscopy with bougie introducer, 163 using videolaryngoscopy, and 73 using other techniques. Independent predictors of the primary outcome included age 46 yr or more, body mass index 30 or more, male sex, Mallampati III or IV, neck mass or radiation, limited thyromental distance, sleep apnea, presence of teeth, beard, thick neck, limited cervical spine mobility, and limited jaw protrusion (c-statistic 0.84 [95% CI, 0.82-0.87]). DMV combined with DL is an infrequent but not rare phenomenon. Most patients can be managed with the use of direct or videolaryngoscopy. An easy to use unweighted risk scale has robust discriminating capacity.

Better health outcomes at lower costs: the benefits of primary care utilisation for chronic disease management in remote Indigenous communities in Australia's Northern Territory.

PubMed

Zhao, Yuejen; Thomas, Susan L; Guthridge, Steven L; Wakerman, John

2014-10-04

Indigenous residents living in remote communities in Australia's Northern Territory experience higher rates of preventable chronic disease and have poorer access to appropriate health services compared to other Australians. This study compared health outcomes and costs at different levels of primary care utilisation to determine if primary care represents an efficient use of resources for Indigenous patients with common chronic diseases namely hypertension, diabetes, ischaemic heart disease, chronic obstructive pulmonary disease and renal disease. This was an historical cohort study involving a total of 14,184 Indigenous residents, aged 15 years and over, who lived in remote communities and used a remote clinic or public hospital from 2002 to 2011. Individual level demographic and clinical data were drawn from primary care and hospital care information systems using a unique patient identifier. A propensity score was used to improve comparability between high, medium and low primary care utilisation groups. Incremental cost-effectiveness ratios and acceptability curves were used to analyse four health outcome measures: total and, avoidable hospital admissions, deaths and years of life lost. Compared to the low utilisation group, medium and high levels of primary care utilisation were associated with decreases in total and avoidable hospitalisations, deaths and years of life lost. Higher levels of primary care utilisation for renal disease reduced avoidable hospitalisations by 82-85%, deaths 72-75%, and years of life lost 78-81%. For patients with ischaemic heart disease, the reduction in avoidable hospitalisations was 63-78%, deaths 63-66% and years of life lost 69-73%. In terms of cost-effectiveness, primary care for renal disease and diabetes ranked as more cost-effective, followed by hypertension and ischaemic heart disease. Primary care for chronic obstructive pulmonary disease was the least cost-effective of the five conditions. Primary care in remote Indigenous communities was shown to be associated with cost-savings to public hospitals and health benefits to individual patients. Investing $1 in primary care in remote Indigenous communities could save $3.95-$11.75 in hospital costs, in addition to health benefits for individual patients. These findings may have wider applicability in strengthening primary care in the face of high chronic disease prevalence globally.

Effect of Multidisciplinary Cancer Conference on Treatment Plan for Patients With Primary Rectal Cancer.

PubMed

Snelgrove, Ryan C; Subendran, Jhananiee; Jhaveri, Kartik; Thipphavong, Seng; Cummings, Bernard; Brierley, James; Kirsch, Richard; Kennedy, Erin D

2015-07-01

Although multidisciplinary cancer conferences have been reported to lead to improved patient outcomes, few studies have reported results of these for rectal cancer. The purpose of this work was to assess the quality of multidisciplinary cancer conferences, the effect of the conference on the initial treatment plan, compliance with the conference treatment recommendations, and clinical outcomes for rectal cancer. This was a prospective, longitudinal study. The study was conducted at a tertiary care academic hospital. Patients with primary rectal cancer were included in this study. The intervention was a rectal cancer-specific multidisciplinary cancer conference. The quality of the multidisciplinary cancer conference was assessed using the Cancer Care Ontario Multidisciplinary Cancer Conference standards score. A change in treatment plan was defined as a change from the initial treatment plan selected by the treating physician to an alternate treatment plan recommended at the conference. Twenty-five multidisciplinary cancer conferences were conducted over a 10-month study period. The Cancer Care Ontario Multidisciplinary Cancer Conference standards score was 7 (from a maximum score of 9). Forty-two patients with primary rectal cancer were presented, and there was a 29% (12/42) change in the initial treatment plan. A total of 42% (5/12) of these changes were attributed to reinterpretation of the MRI findings. There was 100% compliance with the conference treatment recommendations. The circumferential resection margin was positive in 5.5% (2/36). Selection bias may have led to an overestimate of effect, and there is no control group for comparison of clinical outcomes. A high-quality rectal cancer-specific multidisciplinary cancer conference led to a 29% change in the treatment plan for patients with primary rectal cancer, with almost half of these changes attributed to reinterpretation of the magnetic resonance images.

Effectiveness of computerized clinical decision support systems for asthma and chronic obstructive pulmonary disease in primary care: a systematic review.

PubMed

Fathima, Mariam; Peiris, David; Naik-Panvelkar, Pradnya; Saini, Bandana; Armour, Carol Lyn

2014-12-02

The use of computerized clinical decision support systems may improve the diagnosis and ongoing management of chronic diseases, which requires recurrent visits to multiple health professionals, disease and medication monitoring and modification of patient behavior. The aim of this review was to systematically review randomized controlled trials evaluating the effectiveness of computerized clinical decision systems (CCDSS) in the care of people with asthma and COPD. Randomized controlled trials published between 2003 and 2013 were searched using multiple electronic databases Medline, EMBASE, CINAHL, IPA, Informit, PsychINFO, Compendex, and Cochrane Clinical Controlled Trials Register databases. To be included, RCTs had to evaluate the role of the CCDSSs for asthma and/or COPD in primary care. Nineteen studies representing 16 RCTs met our inclusion criteria. The majority of the trials were conducted in patients with asthma. Study quality was generally high. Meta-analysis was not conducted because of methodological and clinical heterogeneity. The use of CCDSS improved asthma and COPD care in 14 of the 19 studies reviewed (74%). Nine of the nineteen studies showed statistically significant (p < 0.05) improvement in the primary outcomes measured. The majority of the studies evaluated health care process measures as their primary outcomes (10/19). Evidence supports the effectiveness of CCDSS in the care of people with asthma. However there is very little information of its use in COPD care. Although there is considerable improvement in the health care process measures and clinical outcomes through the use of CCDSSs, its effects on user workload and efficiency, safety, costs of care, provider and patient satisfaction remain understudied.

Implementation of the physician assistant in Dutch health care organizations: primary motives and outcomes.

PubMed

van Vught, Anneke J A H; van den Brink, Geert T W J; Wobbes, Theo

2014-01-01

Physician assistants (PAs) are trained to perform medical procedures that were traditionally performed by medical physicians. Physician assistants seem to be deployed not only to increase efficiency but also to ensure the quality of care. What is not known is the primary motive for employing PAs within Dutch health care and whether the employment of the PAs fulfills the perceived need for them. Supervising medical specialists who used PAs in their practices were interviewed about their primary motives and outcomes. The interviews were semistructured. Two scientists coded the findings with respect to motives and outcomes. In total, 55 specialists were interviewed about their motives for employing a PA, and 15 were interviewed about the outcomes of employing a PA. With respect to the primary motives for employing a PA, the most frequent motive was to increase continuity and quality of care, followed by relieving the specialist's workload, increasing efficiency of care, and substituting for medical residents. The outcomes were found to be consistent with the motives. In conclusion, the primary motive for employing a PA in Dutch health care is to increase continuity and quality of care.

Physicians' perception of alternative displays of clinical research evidence for clinical decision support - A study with case vignettes.

PubMed

Slager, Stacey L; Weir, Charlene R; Kim, Heejun; Mostafa, Javed; Del Fiol, Guilherme

2017-07-01

To design alternate information displays that present summaries of clinical trial results to clinicians to support decision-making; and to compare the displays according to efficacy and acceptability. A 6-between (information display presentation order) by 3-within (display type) factorial design. Two alternate displays were designed based on Information Foraging theory: a narrative summary that reduces the content to a few sentences; and a table format that structures the display according to the PICO (Population, Intervention, Comparison, Outcome) framework. The designs were compared with the summary display format available in PubMed. Physicians were asked to review five clinical studies retrieved for a case vignette; and were presented with the three display formats. Participants were asked to rate their experience with each of the information displays according to a Likert scale questionnaire. Twenty physicians completed the study. Overall, participants rated the table display more highly than either the text summary or PubMed's summary format (5.9vs. 5.4vs. 3.9 on a scale between 1 [strongly disagree] and 7 [strongly agree]). Usefulness ratings of seven pieces of information, i.e. patient population, patient age range, sample size, study arm, primary outcome, results of primary outcome, and conclusion, were high (average across all items=4.71 on a 1 to 5 scale, with 1=not at all useful and 5=very useful). Study arm, primary outcome, and conclusion scored the highest (4.9, 4.85, and 4.85 respectively). Participants suggested additional details such as rate of adverse effects. The table format reduced physicians' perceived cognitive effort when quickly reviewing clinical trial information and was more favorably received by physicians than the narrative summary or PubMed's summary format display. Copyright © 2017 Elsevier Inc. All rights reserved.

MRI signal intensity of anterior cruciate ligament graft after transtibial versus anteromedial portal technique (TRANSIG): design of a randomized controlled clinical trial.

PubMed

Ruiter, Simeon J S; Brouwer, Reinoud W; Meys, Tim W G M; Slump, Cornelis H; van Raay, Jos J A M

2016-08-10

There are two primary surgical techniques to reconstruct the anterior cruciate ligament (ACL), transtibial (TT) technique and anteromedial portal (AMP) technique. Currently, there is no consensus which surgical technique elicits the best clinical and functional outcomes. MRI-derived measures of the signal intensity (SI) of the ACL graft have been described as an independent predictor of graft properties. The purpose of this study is to compare the MRI derived SI measurements of the ACL graft one year after ACL reconstruction, in order to compare the outcomes of both the AMP and TT ACL reconstruction technique. Thirty-six patients will be included in a randomized controlled trial. Patients who are admitted for primary unilateral ACL reconstruction will be included in the study. Exclusion criteria are a history of previous surgery on the ipsilateral knee, re-rupture of the ipsilateral ACL graft, associated ligamentous injuries or meniscal tear of the ipsilateral knee, unhealthy contralateral knee, contra-indications for MRI and a preference for one of the two surgical techniques and/or orthopaedic surgeon. Primary outcome is MRI Signal intensity ratio (SIR) of the ACL graft. Secondary outcome measures are the International Knee Documentation Committee (IKDC) Knee Examination Form,the Knee injury and Osteoarthritis Outcome Scores (KOOS) and the Anterior Cruciate Ligament OsteoArthritis Score (ACLOAS). Differences between MRI SIR assessment with the current MRI protocol (proton density weighted imaging protocol) and the additional T2*-weighted gradient-echo protocol will be assessed. There is no consensus regarding the TT or AMP ACL reconstruction technique. SI measurements with MRI have been used in other clinical studies for evaluation of the ACL graft and maturation after ACL reconstruction compared to clinical and functional outcomes. This randomized controlled trial has been designed to compare the TT technique with the AMP technique with the use of MRI SI of the graft after ACL reconstruction. Netherlands Trial Registry NTR5410 (registered on August 24, 2015).

Post-Discharge Care of Pediatric Traumatic Brain Injury in Argentina: A Multi-Center Randomized Controlled Trial

PubMed Central

Carney, Nancy A.; Petroni, Gustavo J.; Luján, Silvia B.; Ballarini, Nicolás M.; Faguaga, Gabriela A.; du Coudray, Hugo E. M.; Huddleston, Amy E.; Baggio, Gloria M.; Becerra, Juan M.; Busso, Leonardo O.; Dikmen, Sureyya S.; Falcone, Roberto; García, Mirta E.; Carrillo, Osvaldo R. González; Medici, Paula L.; Quaglino, Marta B.; Randisi, Carina A.; Sáenz, Silvia S.; Temkin, Nancy R.; Vanella, Elida E.

2016-01-01

Objective To develop, in partnership with families of children with traumatic brain injury (TBI), a post-discharge intervention that is effective, simple and sustainable. Design Randomized Controlled Trial Setting Seven Level 1 Pediatric Trauma Centers in Argentina. Patients Persons less than 19 years of age admitted to one of the study hospitals with a diagnosis of severe, moderate, or complicated mild TBI, and were discharged alive. Interventions Patients were randomly assigned to either the Intervention or Standard Care group. A specially trained Community Resource Coordinator (CRC) was assigned to each family in the Intervention group. We hypothesized that children with severe, moderate, and complicated mild TBI who received the intervention would have significantly better functional outcomes at 6-months post-discharge than those who received standard care. We further hypothesized there would be a direct correlation between patient outcome and measures of family function. Measurements and Main Results The primary outcome measure was a composite measured at 6-months post-injury. There were 308 patients included in the study; 61% male. Forty-four percent sustained a complicated mild TBI, 18% moderate, and 38% severe. Sixty-five percent of the patients were 8 years old or younger, and over 70% were transported to the hospital without ambulance assistance. There was no significant difference between groups on the primary outcome measure. There was a statistically significant correlation between the primary outcome measure and scores on the Family Impact Module of the PedsQL (ρ= 0.57; p < 0.0001). Children with better outcomes lived with families reporting better function at 6-months post-injury. Conclusions While no significant effect of the intervention was demonstrated, this study represents the first conducted in Latin America that documents the complete course of treatment for pediatric patients with TBI spanning hospital transport through hospital care and into the post-discharge setting. PMID:27243414

The Gait Deviation Index Is Associated with Hip Muscle Strength and Patient-Reported Outcome in Patients with Severe Hip Osteoarthritis-A Cross-Sectional Study.

PubMed

Rosenlund, Signe; Holsgaard-Larsen, Anders; Overgaard, Søren; Jensen, Carsten

2016-01-01

The Gait Deviation Index summarizes overall gait 'quality', based on kinematic data from a 3-dimensional gait analysis. However, it is unknown which clinical outcomes may affect the Gait Deviation Index in patients with primary hip osteoarthritis. The aim of this study was to investigate associations between Gait Deviation Index as a measure of gait 'quality' and hip muscle strength and between Gait Deviation Index and patient-reported outcomes in patients with primary hip osteoarthritis. Forty-seven patients (34 males), aged 61.1 ± 6.7 years, with BMI 27.3 ± 3.4 (kg/m2) and with severe primary hip osteoarthritis underwent 3-dimensional gait analysis. Mean Gait Deviation Index, pain after walking and maximal isometric hip muscle strength (flexor, extensor, and abductor) were recorded. All patients completed the 'Physical Function Short-form of the Hip disability and Osteoarthritis Outcome Score (HOOS-Physical Function) and the Hip disability and Osteoarthritis Outcome Score subscales for pain (HOOS-Pain) and quality-of-life (HOOS-QOL). Mean Gait Deviation Index was positively associated with hip abduction strength (p<0.01, r = 0.40), hip flexion strength (p = 0.01, r = 0.37), HOOS-Physical Function (p<0.01, r = 0.41) HOOS-QOL (p<0.01, r = 0.41), and negatively associated with HOOS-Pain after walking (p<0.01, r = -0.45). Adjusting the analysis for walking speed did not affect the association. Patients with the strongest hip abductor and hip flexor muscles had the best gait 'quality'. Furthermore, patients with higher physical function, quality of life scores and lower pain levels demonstrated better gait 'quality'. These findings indicate that interventions aimed at improving hip muscle strength and pain management may to a moderate degree improve the overall gait 'quality' in patients with primary hip OA.

The Gait Deviation Index Is Associated with Hip Muscle Strength and Patient-Reported Outcome in Patients with Severe Hip Osteoarthritis—A Cross-Sectional Study

PubMed Central

Rosenlund, Signe; Holsgaard-Larsen, Anders; Overgaard, Søren; Jensen, Carsten

2016-01-01

Background The Gait Deviation Index summarizes overall gait ‘quality’, based on kinematic data from a 3-dimensional gait analysis. However, it is unknown which clinical outcomes may affect the Gait Deviation Index in patients with primary hip osteoarthritis. The aim of this study was to investigate associations between Gait Deviation Index as a measure of gait ‘quality’ and hip muscle strength and between Gait Deviation Index and patient-reported outcomes in patients with primary hip osteoarthritis. Method Forty-seven patients (34 males), aged 61.1 ± 6.7 years, with BMI 27.3 ± 3.4 (kg/m2) and with severe primary hip osteoarthritis underwent 3-dimensional gait analysis. Mean Gait Deviation Index, pain after walking and maximal isometric hip muscle strength (flexor, extensor, and abductor) were recorded. All patients completed the ‘Physical Function Short-form of the Hip disability and Osteoarthritis Outcome Score (HOOS-Physical Function) and the Hip disability and Osteoarthritis Outcome Score subscales for pain (HOOS-Pain) and quality-of-life (HOOS-QOL). Results Mean Gait Deviation Index was positively associated with hip abduction strength (p<0.01, r = 0.40), hip flexion strength (p = 0.01, r = 0.37), HOOS-Physical Function (p<0.01, r = 0.41) HOOS-QOL (p<0.01, r = 0.41), and negatively associated with HOOS-Pain after walking (p<0.01, r = -0.45). Adjusting the analysis for walking speed did not affect the association. Conclusion Patients with the strongest hip abductor and hip flexor muscles had the best gait ‘quality’. Furthermore, patients with higher physical function, quality of life scores and lower pain levels demonstrated better gait ‘quality’. These findings indicate that interventions aimed at improving hip muscle strength and pain management may to a moderate degree improve the overall gait ‘quality’ in patients with primary hip OA. PMID:27065007

Association of practice size and pay-for-performance incentives with the quality of diabetes management in primary care.

PubMed

Vamos, Eszter P; Pape, Utz J; Bottle, Alex; Hamilton, Fiona Louise; Curcin, Vasa; Ng, Anthea; Molokhia, Mariam; Car, Josip; Majeed, Azeem; Millett, Christopher

2011-09-06

Not enough is known about the association between practice size and clinical outcomes in primary care. We examined this association between 1997 and 2005, in addition to the impact of the Quality and Outcomes Framework, a pay-for-performance incentive scheme introduced in the United Kingdom in 2004, on diabetes management. We conducted a retrospective open-cohort study using data from the General Practice Research Database. We enrolled 422 general practices providing care for 154,945 patients with diabetes. Our primary outcome measures were the achievement of national treatment targets for blood pressure, glycated hemoglobin (HbA(1c)) levels and total cholesterol. We saw improvements in the recording of process of care measures, prescribing and achieving intermediate outcomes in all practice sizes during the study period. We saw improvement in reaching national targets after the introduction of the Quality and Outcomes Framework. These improvements significantly exceeded the underlying trends in all practice sizes for achieving targets for cholesterol level and blood pressure, but not for HbA(1c) level. In 1997 and 2005, there were no significant differences between the smallest and largest practices in achieving targets for blood pressure (1997 odds ratio [OR] 0.98, 95% confidence interval [CI] 0.82 to 1.16; 2005 OR 0.92, 95% CI 0.80 to 1.06 in 2005), cholesterol level (1997 OR 0.94, 95% CI 0.76 to 1.16; 2005 OR 1.1, 95% CI 0.97 to 1.40) and glycated hemoglobin level (1997 OR 0.79, 95% CI 0.55 to 1.14; 2005 OR 1.05, 95% CI 0.93 to 1.19). We found no evidence that size of practice is associated with the quality of diabetes management in primary care. Pay-for-performance programs appear to benefit both large and small practices to a similar extent.

Risk of Inhospital Stroke or Death Is Associated With Age But Not Sex in Patients Treated With Carotid Endarterectomy for Asymptomatic or Symptomatic Stenosis in Routine Practice: Secondary Data Analysis of the Nationwide German Statutory Quality Assurance Database From 2009 to 2014.

PubMed

Schmid, Sofie; Tsantilas, Pavlos; Knappich, Christoph; Kallmayer, Michael; König, Thomas; Breitkreuz, Thorben; Zimmermann, Alexander; Kuehnl, Andreas; Eckstein, Hans-Henning

2017-03-13

Guideline recommendations on carotid endarterectomy are based predominantly on randomized, controlled trials, in which women or elderly patients are often under-represented. This study analyzed the association of age and sex with the risk of in-hospital stroke or death following carotid endarterectomy under routine conditions in Germany. Secondary data analysis using the Statutory German Quality Assurance Database on all carotid endarterectomy procedures (n=142 074) performed between 2009 and 2014. Primary outcome was any stroke or death until discharge; secondary outcomes were any in-hospital stroke (alone), and death (alone). Descriptive statistics and multilevel multivariable regression analyses were applied. Patients were predominately male (68%), with mean age 71 years. Carotid stenosis was symptomatic in 40%. Primary outcome occurred in 1.8% of women and 1.9% of men. Multivariable regression analysis revealed that more-advanced age was associated with a higher primary outcome rate (relative risk [RR] per 10-year increase: 1.19; 95% CI, 1.14-1.24). Risk of death (alone) was associated with age (RR, 1.68; 95% CI, 1.54-1.84). Age was associated with the risk of stroke (alone; RR, 1.05; 95% CI, 1.00-1.11). Sex was not associated with primary outcome rate (1.01; 95% CI, 0.93-1.10), nor did it significantly modify the age effect. This study shows that increasing age, but not sex, is associated with a higher risk of in-hospital stroke or death following carotid endarterectomy under everyday conditions in Germany. Whereas the risk of death (alone) is significantly associated with age, the association between age and the risk of stroke (alone) can be considered of minor importance. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Long-term Effect of Losartan on Kidney Disease in American Indians With Type 2 Diabetes: A Follow-up Analysis of a Randomized Clinical Trial.

PubMed

Tanamas, Stephanie K; Saulnier, Pierre-Jean; Fufaa, Gudeta D; Wheelock, Kevin M; Weil, E Jennifer; Hanson, Robert L; Knowler, William C; Bennett, Peter H; Nelson, Robert G

2016-11-01

To determine whether early administration of losartan slows progression of diabetic kidney disease over an extended period. We conducted a 6-year clinical trial in 169 American Indians with type 2 diabetes and urine albumin/creatinine ratio <300 mg/g; 84 participants were randomly assigned to receive losartan and 85 to placebo. Primary outcome was a decline in glomerular filtration rate (GFR; iothalamate) to ≤60 mL/min or to half the baseline value in persons who entered with GFR <120 mL/min. At enrollment, GFR averaged 165 mL/min (interquartile range 49-313 mL/min). During the trial, nine persons reached the primary outcome with a hazard ratio (HR; losartan vs. placebo) of 0.50 (95% CI 0.12-1.99). Participants were then followed posttrial for up to 12 years, with treatment managed outside the study. The effect of losartan on the primary GFR outcome was then reanalyzed for the entire study period, including the clinical trial and posttrial follow-up. After completion of the clinical trial, treatment with renin-angiotensin system inhibitors was equivalent in both groups. During a median of 13.5 years following randomization, 29 participants originally assigned to losartan and 35 to placebo reached the primary GFR outcome with an HR of 0.72 (95% CI 0.44-1.18). Long-term risk of GFR decline was not significantly different between persons randomized to early treatment with losartan and those randomized to placebo. Accordingly, we found no evidence of an extended benefit of early losartan treatment on slowing GFR decline in persons with type 2 diabetes. © 2016 by the American Diabetes Association.

Primary outcome indices in illicit drug dependence treatment research: systematic approach to selection and measurement of drug use end-points in clinical trials

PubMed Central

Donovan, Dennis M.; Bigelow, George E.; Brigham, Gregory S.; Carroll, Kathleen M.; Cohen, Allan J.; Gardin, John G.; Hamilton, John A.; Huestis, Marilyn A.; Hughes, John R.; Lindblad, Robert; Marlatt, G. Alan; Preston, Kenzie L.; Selzer, Jeffrey A.; Somoza, Eugene C.; Wakim, Paul G.; Wells, Elizabeth A.

2012-01-01

Aims Clinical trials test the safety and efficacy of behavioral and pharmacological interventions in drug-dependent individuals. However, there is no consensus about the most appropriate outcome(s) to consider in determining treatment efficacy or on the most appropriate methods for assessing selected outcome(s). We summarize the discussion and recommendations of treatment and research experts, convened by the US National Institute on Drug Abuse, to select appropriate primary outcomes for drug dependence treatment clinical trials, and in particular the feasibility of selecting a common outcome to be included in all or most trials. Methods A brief history of outcomes employed in prior drug dependence treatment research, incorporating perspectives from tobacco and alcohol research, is included. The relative merits and limitations of focusing on drug-taking behavior, as measured by self-report and qualitative or quantitative biological markers, are evaluated. Results Drug-taking behavior, measured ideally by a combination of self-report and biological indicators, is seen as the most appropriate proximal primary outcome in drug dependence treatment clinical trials. Conclusions We conclude that the most appropriate outcome will vary as a function of salient variables inherent in the clinical trial, such as the type of intervention, its target, treatment goals (e.g. abstinence or reduction of use) and the perspective being taken (e.g. researcher, clinical program, patient, society). It is recommended that a decision process, based on such trial variables, be developed to guide the selection of primary and secondary outcomes as well as the methods to assess them. PMID:21781202

Implementation and evaluation of the 5As framework of obesity management in primary care: design of the 5As Team (5AsT) randomized control trial

PubMed Central

2014-01-01

Background Obesity is a pressing public health concern, which frequently presents in primary care. With the explosive obesity epidemic, there is an urgent need to maximize effective management in primary care. The 5As of Obesity Management™ (5As) are a collection of knowledge tools developed by the Canadian Obesity Network. Low rates of obesity management visits in primary care suggest provider behaviour may be an important variable. The goal of the present study is to increase frequency and quality of obesity management in primary care using the 5As Team (5AsT) intervention to change provider behaviour. Methods/design The 5AsT trial is a theoretically informed, pragmatic randomized controlled trial with mixed methods evaluation. Clinic-based multidisciplinary teams (RN/NP, mental health, dietitians) will be randomized to control or the 5AsT intervention group, to participate in biweekly learning collaborative sessions supported by internal and external practice facilitation. The learning collaborative content addresses provider-identified barriers to effective obesity management in primary care. Evidence-based shared decision making tools will be co-developed and iteratively tested by practitioners. Evaluation will be informed by the RE-AIM framework. The primary outcome measure, to which participants are blinded, is number of weight management visits/full-time equivalent (FTE) position. Patient-level outcomes will also be assessed, through a longitudinal cohort study of patients from randomized practices. Patient outcomes include clinical (e.g., body mass index [BMI], blood pressure), health-related quality of life (SF-12, EQ5D), and satisfaction with care. Qualitative data collected from providers and patients will be evaluated using thematic analysis to understand the context, implementation and effectiveness of the 5AsT program. Discussion The 5AsT trial will provide a wide range of insights into current practices, knowledge gaps and barriers that limit obesity management in primary practice. The use of existing resources, collaborative design, practice facilitation, and integrated feedback loops cultivate an applicable, adaptable and sustainable approach to increasing the quantity and quality of weight management visits in primary care. Trial registration NCT01967797. PMID:24947045

Implementation and evaluation of the 5As framework of obesity management in primary care: design of the 5As Team (5AsT) randomized control trial.

PubMed

Campbell-Scherer, Denise L; Asselin, Jodie; Osunlana, Adedayo M; Fielding, Sheri; Anderson, Robin; Rueda-Clausen, Christian F; Johnson, Jeffrey A; Ogunleye, Ayodele A; Cave, Andrew; Manca, Donna; Sharma, Arya M

2014-06-19

Obesity is a pressing public health concern, which frequently presents in primary care. With the explosive obesity epidemic, there is an urgent need to maximize effective management in primary care. The 5As of Obesity Management™ (5As) are a collection of knowledge tools developed by the Canadian Obesity Network. Low rates of obesity management visits in primary care suggest provider behaviour may be an important variable. The goal of the present study is to increase frequency and quality of obesity management in primary care using the 5As Team (5AsT) intervention to change provider behaviour. The 5AsT trial is a theoretically informed, pragmatic randomized controlled trial with mixed methods evaluation. Clinic-based multidisciplinary teams (RN/NP, mental health, dietitians) will be randomized to control or the 5AsT intervention group, to participate in biweekly learning collaborative sessions supported by internal and external practice facilitation. The learning collaborative content addresses provider-identified barriers to effective obesity management in primary care. Evidence-based shared decision making tools will be co-developed and iteratively tested by practitioners. Evaluation will be informed by the RE-AIM framework. The primary outcome measure, to which participants are blinded, is number of weight management visits/full-time equivalent (FTE) position. Patient-level outcomes will also be assessed, through a longitudinal cohort study of patients from randomized practices. Patient outcomes include clinical (e.g., body mass index [BMI], blood pressure), health-related quality of life (SF-12, EQ5D), and satisfaction with care. Qualitative data collected from providers and patients will be evaluated using thematic analysis to understand the context, implementation and effectiveness of the 5AsT program. The 5AsT trial will provide a wide range of insights into current practices, knowledge gaps and barriers that limit obesity management in primary practice. The use of existing resources, collaborative design, practice facilitation, and integrated feedback loops cultivate an applicable, adaptable and sustainable approach to increasing the quantity and quality of weight management visits in primary care. NCT01967797.

Laparoscopic Adjustable Gastric Banding Revisions in Singapore: a 10-Year Experience.

PubMed

Ngiam, Kee Yuan; Khoo, Valerie Yu Hui; Kong, Lucy; Cheng, Anton Kui Sing

2016-05-01

Bariatric surgery is increasingly being carried out and revisional procedures have also risen in concert. A review of the complications and revisions might elucidate technical and patient factors that influence the outcomes of bariatric surgeries in Asian patients. The objective of this study is to review the safety and efficacy of revisional bariatric surgery in a single center in Singapore over a 10-year period. The setting of this study is a single public hospital with a multidisciplinary bariatric service including a weight management center, specialized endocrinology services, and bariatric surgical team. Participants were selected for surgery based on body mass index (BMI) and comorbidities. All patients underwent primary laparoscopic adjustable gastric banding (LAGB). Patients were then analyzed according to the types of revisional surgeries. The primary outcome was the type of complications and revisional surgeries. Secondary outcomes include short-term excess weight loss and further complications. A total of 365 patients were analyzed. 9.6% had a secondary procedure. In particular, two groups of complications required revisional surgery: failure of sustained weight loss and complications related to the LAGB insertion and use. Revisional surgeries had equivalent major complication rates (5.7%) compared to primary bariatric surgeries (6.8%). Revisional surgeries such as revisional LAGB (4.9 ± 9.8 kg), laparoscopic sleeve gastrectomy (LSG; 6.9 ± 21.0 kg), Roux-en-Y gastric bypass (RYGB; 4.6 ± 13.0 kg), and bilio-pancreatic diversion (BPD; 3.5 ± 6.3 kg) had modest weight loss compared to primary weight loss (12.7 ± 9.5 kg). Primary LAGB had a greater percentage excess weight loss in the first and second years post-surgery compared to revisional surgeries. There was one mortality post-primary surgery and no post-revisional surgical mortalities. Revisional bariatric surgery for complications related to the primary surgery is safe but had reduced excess weight loss compared to the initial surgery.

Which features of primary care affect unscheduled secondary care use? A systematic review.

PubMed

Huntley, Alyson; Lasserson, Daniel; Wye, Lesley; Morris, Richard; Checkland, Kath; England, Helen; Salisbury, Chris; Purdy, Sarah

2014-05-23

To conduct a systematic review to identify studies that describe factors and interventions at primary care practice level that impact on levels of utilisation of unscheduled secondary care. Observational studies at primary care practice level. Studies included people of any age of either sex living in Organisation for Economic Co-operation and Development (OECD) countries with any health condition. The primary outcome measure was unscheduled secondary care as measured by emergency department attendance and emergency hospital admissions. 48 papers were identified describing potential influencing features on emergency department visits (n=24 studies) and emergency admissions (n=22 studies). Patient factors associated with both outcomes were increased age, reduced socioeconomic status, lower educational attainment, chronic disease and multimorbidity. Features of primary care affecting unscheduled secondary care were more complex. Being able to see the same healthcare professional reduced unscheduled secondary care. Generally, better access was associated with reduced unscheduled care in the USA. Proximity to healthcare provision influenced patterns of use. Evidence relating to quality of care was limited and mixed. The majority of research was from different healthcare systems and limited in the extent to which it can inform policy. However, there is evidence that continuity of care is associated with reduced emergency department attendance and emergency hospital admissions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Treatment of trauma-affected refugees with venlafaxine versus sertraline combined with psychotherapy - a randomised study.

PubMed

Sonne, Charlotte; Carlsson, Jessica; Bech, Per; Elklit, Ask; Mortensen, Erik Lykke

2016-11-08

The prevalence of trauma-related psychiatric disorders is high among refugees. Despite this, little is known about the effect of pharmacological treatment for this patient group. The objective of the present study was therefore to examine differences in the effects of venlafaxine and sertraline on Post-Traumatic Stress Disorder (PTSD), depression and functional impairment in trauma-affected refugees. The study was a randomised pragmatic trial comparing venlafaxine and sertraline in combination with psychotherapy and social counselling. PTSD symptoms were measured on the Harvard Trauma Questionnaire - part IV, which was the primary outcome measure. Other outcome measures included: Hopkins Symptom Check List-25 (depression and anxiety), Social Adjustment Scale - short version (social functioning), WHO-5 Well-being Index (quality of life), Crisis Support Scale (support from social network), Sheehan Disability Scale (disability in three areas of functioning), Hamilton Depression and Anxiety scale, the somatisation items of the Symptoms Checklist-90, Global Assessment of Functioning scales and the summarised score of pain in four body areas rated on visual analogue scales. Two hundred seven adult refugee patients were included in the trial (98 in the venlafaxine and 109 in the sertraline group). Of these, 195 patients were eligible for intention-to-treat analyses. Small but significant pre-treatment to post-treatment differences were found on the Harvard Trauma Questionnaire and a number of other ratings in both groups. On the primary outcome measure, no difference was found in treatment effect between the sertraline and venlafaxine group. A significant group difference was found in favour of sertraline on the Sheehan Disability Scale. Sertraline had a slightly better outcome than venlafaxine on some of the secondary outcome measures, but not on the primary outcome measure. Furthermore, a higher percentage of dropouts was found in the venlafaxine group compared to the sertraline group. Although this could indicate that sertraline was better tolerated, which is supported by other studies, a final conclusion on tolerability cannot be drawn from the current study due to lack of systematic reporting of side effects. ClinicalTrials.gov NCT01569685 . Registration date: 28/2/12.

Theory-driven group-based complex intervention to support self-management of osteoarthritis and low back pain in primary care physiotherapy: protocol for a cluster randomised controlled feasibility trial (SOLAS)

PubMed Central

Hurley, Deirdre A; Hall, Amanda M; Currie-Murphy, Laura; Pincus, Tamar; Kamper, Steve; Maher, Chris; McDonough, Suzanne M; Lonsdale, Chris; Walsh, Nicola E; Guerin, Suzanne; Segurado, Ricardo; Matthews, James

2016-01-01

Introduction International clinical guidelines consistently endorse the promotion of self-management (SM), including physical activity for patients with chronic low back pain (CLBP) and osteoarthritis (OA). Patients frequently receive individual treatment and advice to self-manage from physiotherapists in primary care, but the successful implementation of a clinical and cost-effective group SM programme is a key priority for health service managers in Ireland to maximise long-term outcomes and efficient use of limited and costly resources. Methods/analysis This protocol describes an assessor-blinded cluster randomised controlled feasibility trial of a group-based education and exercise intervention underpinned by self-determination theory designed to support an increase in SM behaviour in patients with CLBP and OA in primary care physiotherapy. The primary care clinic will be the unit of randomisation (cluster), with each clinic randomised to 1 of 2 groups providing the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention or usual individual physiotherapy. Patients are followed up at 6 weeks, 2 and 6 months. The primary outcomes are the (1) acceptability and demand of the intervention to patients and physiotherapists, (2) feasibility and optimal study design/procedures and sample size for a definitive trial. Secondary outcomes include exploratory analyses of: point estimates, 95% CIs, change scores and effect sizes in physical function, pain and disability outcomes; process of change in target SM behaviours and selected mediators; and the cost of the intervention to inform a definitive trial. Ethics/dissemination This feasibility trial protocol was approved by the UCD Human Research Ethics—Sciences Committee (LS-13-54 Currie-Hurley) and research access has been granted by the Health Services Executive Primary Care Research Committee in January 2014. The study findings will be disseminated to the research, clinical and health service communities through publication in peer-reviewed journals, presentation at national and international academic and clinical conferences. Trial registration number ISRCTN 49875385; Pre-results. PMID:26801470

Patient-centered professional practice models for managing low back pain in older adults: a pilot randomized controlled trial.

PubMed

Goertz, Christine M; Salsbury, Stacie A; Long, Cynthia R; Vining, Robert D; Andresen, Andrew A; Hondras, Maria A; Lyons, Kevin J; Killinger, Lisa Z; Wolinsky, Fredric D; Wallace, Robert B

2017-10-13

Low back pain is a debilitating condition for older adults, who may seek healthcare from multiple providers. Few studies have evaluated impacts of different healthcare delivery models on back pain outcomes in this population. The purpose of this study was to compare clinical outcomes of older adults receiving back pain treatment under 3 professional practice models that included primary medical care with or without chiropractic care. We conducted a pilot randomized controlled trial with 131 community-dwelling, ambulatory older adults with subacute or chronic low back pain. Participants were randomly allocated to 12 weeks of individualized primary medical care (Medical Care), concurrent medical and chiropractic care (Dual Care), or medical and chiropractic care with enhanced interprofessional collaboration (Shared Care). Primary outcomes were low back pain intensity rated on the numerical rating scale and back-related disability measured with the Roland-Morris Disability Questionnaire. Secondary outcomes included clinical measures, adverse events, and patient satisfaction. Statistical analyses included mixed-effects regression models and general estimating equations. At 12 weeks, participants in all three treatment groups reported improvements in mean average low back pain intensity [Shared Care: 1.8; 95% confidence interval (CI) 1.0 to 2.6; Dual Care: 3.0; 95% CI 2.3 to 3.8; Medical Care: 2.3; 95% CI 1.5 to 3.2)] and back-related disability (Shared Care: 2.8; 95% CI 1.6 to 4.0; Dual Care: 2.5; 95% CI 1.3 to 3.7; Medical Care: 1.5; 95% CI 0.2 to 2.8). No statistically significant differences were noted between the three groups on the primary measures. Participants in both models that included chiropractic reported significantly better perceived low back pain improvement, overall health and quality of life, and greater satisfaction with healthcare services than patients who received medical care alone. Professional practice models that included primary care and chiropractic care led to modest improvements in low back pain intensity and disability for older adults, with chiropractic-inclusive models resulting in better perceived improvement and patient satisfaction over the primary care model alone. Clinicaltrials.gov, NCT01312233 , 4 March 2011.

Clinical outcomes of Ahmed glaucoma valve implantation in pediatric glaucoma.

PubMed

Pakravan, Mohammad; Esfandiari, Hamed; Yazdani, Shahin; Doozandeh, Azadeh; Dastborhan, Zahra; Gerami, Ebrahim; Kheiri, Bahareh; Pakravan, Parastou; Yaseri, Mehdi; Hassanpour, Kiana

2018-03-01

To evaluate the outcomes of Ahmed glaucoma valve implantation in refractory primary congenital glaucoma as well as primary procedure in aphakic glaucoma. In this retrospective study, medical records of patients who underwent Ahmed glaucoma valve implantation for refractory glaucoma and aphakic glaucoma were reviewed. Primary outcome measures were the surgical success defined as intraocular pressure ≤21 mm Hg and decreased ≥20% and no secondary glaucoma surgery. Secondary outcome measures were the number of glaucoma medications, complications, best corrected visual acuity, and intraocular pressure. A total of 62 eyes of refractory primary congenital glaucoma patients (group 1) and 33 eyes of aphakic glaucoma patients (group 2) were included in our study. Mean follow-up was 51 ± 33 months in group 1 and 49 ± 41 months in group 2 (p = 0.82). The cumulative probability of success was 90% in both groups at the first year; however, the success rate was 52.5% in group 1 and 71.5% in group 2 at 5 years' follow-up visit. In group 1, the mean intraocular pressure ± standard deviation was 33.1 ± 8.6 mm Hg at the baseline and decreased to 17.1 ± 5.3 mm Hg at 1 year and 18.5 ± 6.4 at 3 years postoperatively (all p's < 0.001). Corresponding values for group 2 were 28.9 ± 6.1, 15.2 ± 4.6, and 16.0 ± 5.9 mm Hg, respectively (all p's < 0.001). The baseline number of glaucoma medications was 3 ± 0.7 that decreased to 2 ± 0.8 at final follow-up (p = 0.02). Ahmed glaucoma valve implantation has a moderate success rate in the management of refractory primary congenital glaucoma with an increased chance of tube-related complications. The surgical success rate is higher in case of primary Ahmed glaucoma valve implant for aphakic glaucoma with acceptable safety profile.

Theory-driven group-based complex intervention to support self-management of osteoarthritis and low back pain in primary care physiotherapy: protocol for a cluster randomised controlled feasibility trial (SOLAS).

PubMed

Hurley, Deirdre A; Hall, Amanda M; Currie-Murphy, Laura; Pincus, Tamar; Kamper, Steve; Maher, Chris; McDonough, Suzanne M; Lonsdale, Chris; Walsh, Nicola E; Guerin, Suzanne; Segurado, Ricardo; Matthews, James

2016-01-21

International clinical guidelines consistently endorse the promotion of self-management (SM), including physical activity for patients with chronic low back pain (CLBP) and osteoarthritis (OA). Patients frequently receive individual treatment and advice to self-manage from physiotherapists in primary care, but the successful implementation of a clinical and cost-effective group SM programme is a key priority for health service managers in Ireland to maximise long-term outcomes and efficient use of limited and costly resources. This protocol describes an assessor-blinded cluster randomised controlled feasibility trial of a group-based education and exercise intervention underpinned by self-determination theory designed to support an increase in SM behaviour in patients with CLBP and OA in primary care physiotherapy. The primary care clinic will be the unit of randomisation (cluster), with each clinic randomised to 1 of 2 groups providing the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention or usual individual physiotherapy. Patients are followed up at 6 weeks, 2 and 6 months. The primary outcomes are the (1) acceptability and demand of the intervention to patients and physiotherapists, (2) feasibility and optimal study design/procedures and sample size for a definitive trial. Secondary outcomes include exploratory analyses of: point estimates, 95% CIs, change scores and effect sizes in physical function, pain and disability outcomes; process of change in target SM behaviours and selected mediators; and the cost of the intervention to inform a definitive trial. This feasibility trial protocol was approved by the UCD Human Research Ethics-Sciences Committee (LS-13-54 Currie-Hurley) and research access has been granted by the Health Services Executive Primary Care Research Committee in January 2014. The study findings will be disseminated to the research, clinical and health service communities through publication in peer-reviewed journals, presentation at national and international academic and clinical conferences. ISRCTN 49875385; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Exploring impacts of multi-year, community-based care programs for orphans and vulnerable children: a case study from Kenya.

PubMed

Larson, Bruce A; Wambua, Nancy; Masila, Juliana; Wangai, Susan; Rohr, Julia; Brooks, Mohamad; Bryant, Malcolm

2013-01-01

The Community-Based Care for Orphans and Vulnerable Children (CBCO) program operated in Kenya during 2006-2010. In Eastern Province, the program provided support to approximately 3000 orphans and vulnerable children (OVC) living in 1500 households. A primary focus of the program was to support savings and loan associations composed of OVC caregivers (typically elderly women) to improve household and OVC welfare. Cross-sectional data were collected in 2011 from 1500 randomly selected households from 3 populations: program participants (CBCO group, n=500), households in the same villages as program participants but not in the program (the local-community-group = Group L, n=300), and households living in nearby villages where the program did not operate (the adjacent-community-group, Group A, n=700). Primary welfare outcomes evaluated are household food security, as measured by the Household Food Insecurity Access instrument, and OVC educational attainment. We compared outcomes between the CBCO and the subset of Group L not meeting program eligibility criteria (L-N) to investigate disparities within local communities. We compared outcomes between the CBCO group and the subset of Group A meeting eligibility criteria (A-E) to consider program impact. We compared outcomes between households not eligible for the program in the local and adjacent community groups (L-N and A-N) to consider if the adjacent communities are similar to the local communities. In May-June 2011, at the end of the OVC program, the majority of CBCO households continued to be severely food insecure, with rates similar to other households living in nearby communities. Participation rates in primary school are high, reflecting free primary education. Among the 18-22 year olds who were "children" during the program years, relatively few children completed secondary school across all study groups. Although the CBCO program likely provided useful services and benefits to program participants, disparities continued to exist in food security and educational outcomes between program participants and their non-OVC peers in the local community. Outcomes for CBCO households were similar to those observed for OVC households in adjacent communities.

Exploring impacts of multi-year, community-based care programs for orphans and vulnerable children: A case study from Kenya

PubMed Central

Larson, Bruce A.; Wambua, Nancy; Masila, Juliana; Wangai, Susan; Rohr, Julia; Brooks, Mohamad; Bryant, Malcolm

2013-01-01

The Community-Based Care for Orphans and Vulnerable Children (CBCO) program operated in Kenya during 2006–2010. In Eastern Province, the program provided support to approximately 3000 orphans and vulnerable children (OVC) living in 1500 households. A primary focus of the program was to support savings and loan associations composed of OVC caregivers (typically elderly women) to improve household and OVC welfare. Cross-sectional data were collected in 2011 from 1500 randomly selected households from 3 populations: program participants (CBCO group, n = 500), households in the same villages as program participants but not in the program (the local-community-group = Group L, n = 300), and households living in nearby villages where the program did not operate (the adjacent-community-group, Group A, n = 700). Primary welfare outcomes evaluated are household food security, as measured by the Household Food Insecurity Access instrument, and OVC educational attainment. We compared outcomes between the CBCO and the subset of Group L not meeting program eligibility criteria (L-N) to investigate disparities within local communities. We compared outcomes between the CBCO group and the subset of Group A meeting eligibility criteria (A-E) to consider program impact. We compared outcomes between households not eligible for the program in the local and adjacent community groups (L-N and A-N) to consider if the adjacent communities are similar to the local communities. In May-June 2011, at the end of the OVC program, the majority of CBCO households continued to be severely food insecure, with rates similar to other households living in nearby communities. Participation rates in primary school are high, reflecting free primary education. Among the 18–22 year olds who were “children” during the program years, relatively few children completed secondary school across all study groups. Although the CBCO program likely provided useful services and benefits to program participants, disparities continued to exist in food security and educational outcomes between program participants and their non-OVC peers in the local community. Outcomes for CBCO households were similar to those observed for OVC households in adjacent communities. PMID:23745629

The CHIPS Randomized Controlled Trial (Control of Hypertension in Pregnancy Study): Is Severe Hypertension Just an Elevated Blood Pressure?

PubMed

Magee, Laura A; von Dadelszen, Peter; Singer, Joel; Lee, Terry; Rey, Evelyne; Ross, Susan; Asztalos, Elizabeth; Murphy, Kellie E; Menzies, Jennifer; Sanchez, Johanna; Gafni, Amiram; Helewa, Michael; Hutton, Eileen; Koren, Gideon; Lee, Shoo K; Logan, Alexander G; Ganzevoort, Wessel; Welch, Ross; Thornton, Jim G; Moutquin, Jean-Marie

2016-11-01

To determine whether clinical outcomes differed by occurrence of severe hypertension in the international CHIPS trial (Control of Hypertension in Pregnancy Study), adjusting for the interventions of "less tight" (target diastolic blood pressure [dBP] 100 mm Hg) versus "tight" control (target dBP 85 mm Hg). In this post-hoc analysis of CHIPS data from 987 women with nonsevere nonproteinuric preexisting or gestational hypertension, mixed effects logistic regression was used to compare the following outcomes according to occurrence of severe hypertension, adjusting for allocated group and the influence of baseline factors: CHIPS primary (perinatal loss or high-level neonatal care for >48 hours) and secondary outcomes (serious maternal complications), birth weight <10th percentile, preeclampsia, delivery at <34 or <37 weeks, platelets <100×10 9 /L, elevated liver enzymes with symptoms, maternal length of stay ≥10 days, and maternal readmission before 6 weeks postpartum. Three hundred and thirty-four (34.1%) women in CHIPS developed severe hypertension that was associated with all outcomes examined except for maternal readmission (P=0.20): CHIPS primary outcome, birth weight <10th percentile, preeclampsia, preterm delivery, elevated liver enzymes (all P<0.001), platelets <100×10 9 /L (P=0.006), and prolonged hospital stay (P=0.03). The association between severe hypertension and serious maternal complications was seen only in less tight control (P=0.02). Adjustment for preeclampsia (464, 47.3%) did not negate the relationship between severe hypertension and the CHIPS primary outcome (P<0.001), birth weight <10th percentile (P=0.005), delivery at <37 (P<0.001) or <34 weeks (P<0.001), or elevated liver enzymes with symptoms (P=0.02). Severe hypertension is a risk marker for adverse maternal and perinatal outcomes, independent of BP control or preeclampsia co-occurrence. URL: http://pre-empt.cfri.ca/. Unique identifier: ISRCTN 71416914. URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01192412. © 2016 The Authors.

Surgical versus Non-Operative Treatment for Lumbar Disc Herniation: Eight-Year Results for the Spine Patient Outcomes Research Trial (SPORT)

PubMed Central

Lurie, Jon D.; Tosteson, Tor D.; Tosteson, Anna N. A.; Zhao, Wenyan; Morgan, Tamara S.; Abdu, William A.; Herkowitz, Harry; Weinstein, James N.

2014-01-01

Study Design Concurrent prospective randomized and observational cohort studies. Objective To assess the 8-year outcomes of surgery vs. non-operative care. Summary of Background Data Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical to non-operative treatment remain controversial. Methods Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting SPORT eligibility criteria enrolled into prospective randomized (501 participants) and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual non-operative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain (BP) and Physical Function (PF) scales and the modified Oswestry Disability Index (ODI - AAOS/Modems version) assessed at 6 weeks, 3 and 6 months, and annually thereafter. Results Advantages were seen for surgery in intent-to-treat analyses for the randomized cohort for all primary and secondary outcomes other than work status; however, with extensive non-adherence to treatment assignment (49% patients assigned to non-operative therapy receiving surgery versus 60% of patients assigned to surgery) these observed effects were relatively small and not statistically significant for primary outcomes (BP, PF, ODI). Importantly, the overall comparison of secondary outcomes was significantly greater with surgery in the intent-to-treat analysis (sciatica bothersomeness [p > 0.005], satisfaction with symptoms [p > 0.013], and self-rated improvement [p > 0.013]) in long-term follow-up. An as-treated analysis showed clinically meaningful surgical treatment effects for primary outcome measures (mean change Surgery vs. Non-operative; treatment effect; 95% CI): BP (45.3 vs. 34.4; 10.9; 7.7 to 14); PF (42.2 vs. 31.5; 10.6; 7.7 to 13.5) and ODI (−36.2 vs. −24.8; −11.2; −13.6 to −9.1). Conclusion Carefully selected patients who underwent surgery for a lumbar disc herniation achieved greater improvement than non-operatively treated patients; there was little to no degradation of outcomes in either group (operative and non-operative) from 4 to 8 years. PMID:24153171

A Synthesis of the Evidence for Managing Stress at Work: A Review of the Reviews Reporting on Anxiety, Depression, and Absenteeism

PubMed Central

Bhui, Kamaldeep S.; Dinos, Sokratis; Stansfeld, Stephen A.; White, Peter D.

2012-01-01

Background. Psychosocial stressors in the workplace are a cause of anxiety and depressive illnesses, suicide and family disruption. Methods. The present review synthesizes the evidence from existing systematic reviews published between 1990 and July 2011. We assessed the effectiveness of individual, organisational and mixed interventions on two outcomes: mental health and absenteeism. Results. In total, 23 systematic reviews included 499 primary studies; there were 11 meta-analyses and 12 narrative reviews. Meta-analytic studies found a greater effect size of individual interventions on individual outcomes. Organisational interventions showed mixed evidence of benefit. Organisational programmes for physical activity showed a reduction in absenteeism. The findings from the meta-analytic reviews were consistent with the findings from the narrative reviews. Specifically, cognitive-behavioural programmes produced larger effects at the individual level compared with other interventions. Some interventions appeared to lead to deterioration in mental health and absenteeism outcomes.Gaps in the literature include studies of organisational outcomes like absenteeism, the influence of specific occupations and size of organisations, and studies of the comparative effectiveness of primary, secondary and tertiary prevention. Conclusions. Individual interventions (like CBT) improve individuals' mental health. Physical activity as an organisational intervention reduces absenteeism. Research needs to target gaps in the evidence. PMID:22496705

A synthesis of the evidence for managing stress at work: a review of the reviews reporting on anxiety, depression, and absenteeism.

PubMed

Bhui, Kamaldeep S; Dinos, Sokratis; Stansfeld, Stephen A; White, Peter D

2012-01-01

Psychosocial stressors in the workplace are a cause of anxiety and depressive illnesses, suicide and family disruption. The present review synthesizes the evidence from existing systematic reviews published between 1990 and July 2011. We assessed the effectiveness of individual, organisational and mixed interventions on two outcomes: mental health and absenteeism. In total, 23 systematic reviews included 499 primary studies; there were 11 meta-analyses and 12 narrative reviews. Meta-analytic studies found a greater effect size of individual interventions on individual outcomes. Organisational interventions showed mixed evidence of benefit. Organisational programmes for physical activity showed a reduction in absenteeism. The findings from the meta-analytic reviews were consistent with the findings from the narrative reviews. Specifically, cognitive-behavioural programmes produced larger effects at the individual level compared with other interventions. Some interventions appeared to lead to deterioration in mental health and absenteeism outcomes.Gaps in the literature include studies of organisational outcomes like absenteeism, the influence of specific occupations and size of organisations, and studies of the comparative effectiveness of primary, secondary and tertiary prevention. Individual interventions (like CBT) improve individuals' mental health. Physical activity as an organisational intervention reduces absenteeism. Research needs to target gaps in the evidence.

Asthma interventions in primary schools--a review.

PubMed

Al Aloola, Noha A; Naik-Panvelkar, Pradnya; Nissen, Lisa; Saini, Bandana

2014-10-01

To explore, in depth, the literature for evidence supporting asthma interventions delivered within primary schools and to identify any "gaps" in this research area. A literature search using electronic search engines (i.e. Medline, PubMed, Education Resources Information Center (ERIC), International Pharmaceutical Abstracts (IPA), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase and Informit) and the search terms "asthma", "asthma intervention" and "school-based asthma education program" (and derivatives of these keywords) was conducted. Twenty-three articles met the inclusion criteria; of these eight were Randomised Controlled Trials. There was much variety in the type, content, delivery and outcome measures in these 23 studies. The most common intervention type was asthma education delivery. Most studies demonstrated improvement in clinical and humanistic markers, for example, asthma symptoms medication use (decrease in reliever medication use or decrease in the need for rescue oral steroid), inhaler use technique and spacer use competency, lung function and quality of life. Relatively few studies explored the effect of the intervention on academic outcomes. Most studies did not report on the sustainability or cost effectiveness of the intervention tested. Another drawback in the literature was the lack of details about the intervention and inconsistency in instruments selected for measuring outcomes. School-based asthma interventions regardless of their heterogeneity have positive clinical, humanistic, health economical and academic outcomes.

Does time-lapse imaging have favorable results for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization? A meta-analysis and systematic review of randomized controlled trials.

PubMed

Chen, Minghao; Wei, Shiyou; Hu, Junyan; Yuan, Jing; Liu, Fenghua

2017-01-01

The present study aimed to undertake a review of available evidence assessing whether time-lapse imaging (TLI) has favorable outcomes for embryo incubation and selection compared with conventional methods in clinical in vitro fertilization (IVF). Using PubMed, EMBASE, Cochrane library and ClinicalTrial.gov up to February 2017 to search for randomized controlled trials (RCTs) comparing TLI versus conventional methods. Both studies randomized women and oocytes were included. For studies randomized women, the primary outcomes were live birth and ongoing pregnancy, the secondary outcomes were clinical pregnancy and miscarriage; for studies randomized oocytes, the primary outcome was blastocyst rate, the secondary outcome was good quality embryo on Day 2/3. Subgroup analysis was conducted based on different incubation and embryo selection between groups. Ten RCTs were included, four randomized oocytes and six randomized women. For oocyte-based review, the pool-analysis observed no significant difference between TLI group and control group for blastocyst rate [relative risk (RR) 1.08, 95% CI 0.94-1.25, I2 = 0%, two studies, including 1154 embryos]. The quality of evidence was moderate for all outcomes in oocyte-based review. For woman-based review, only one study provided live birth rate (RR 1,23, 95% CI 1.06-1.44,I2 N/A, one study, including 842 women), the pooled result showed no significant difference in ongoing pregnancy rate (RR 1.04, 95% CI 0.80-1.36, I2 = 59%, four studies, including 1403 women) between two groups. The quality of the evidence was low or very low for all outcomes in woman-based review. Currently there is insufficient evidence to support that TLI is superior to conventional methods for human embryo incubation and selection. In consideration of the limitations and flaws of included studies, more well designed RCTs are still in need to comprehensively evaluate the effectiveness of clinical TLI use.

Using Meta-analyses for Comparative Effectiveness Research

PubMed Central

Ruppar, Todd M.; Phillips, Lorraine J.; Chase, Jo-Ana D.

2012-01-01

Comparative effectiveness research seeks to identify the most effective interventions for particular patient populations. Meta-analysis is an especially valuable form of comparative effectiveness research because it emphasizes the magnitude of intervention effects rather than relying on tests of statistical significance among primary studies. Overall effects can be calculated for diverse clinical and patient-centered variables to determine the outcome patterns. Moderator analyses compare intervention characteristics among primary studies by determining if effect sizes vary among studies with different intervention characteristics. Intervention effectiveness can be linked to patient characteristics to provide evidence for patient-centered care. Moderator analyses often answer questions never posed by primary studies because neither multiple intervention characteristics nor populations are compared in single primary studies. Thus meta-analyses provide unique contributions to knowledge. Although meta-analysis is a powerful comparative effectiveness strategy, methodological challenges and limitations in primary research must be acknowledged to interpret findings. PMID:22789450

Depression care management for adults older than 60 years in primary care clinics in urban China: a cluster-randomised trial.

PubMed

Chen, Shulin; Conwell, Yeates; He, Jin; Lu, Naiji; Wu, Jiayan

2015-04-01

China's national health policy classifies depression as a chronic disease that should be managed in primary care settings. In some high-income countries use of chronic disease management principles and primary care-based collaborative-care models have improved outcomes for late-life depression; however, this approach has not yet been tested in China. We aimed to assess whether use of a collaborative-care depression care management (DCM) intervention could improve outcomes for Chinese adults with depression aged 60 years and older. Between Jan 17, 2011, [corrected] and Nov 30, 2013, we did a cluster-randomised trial in patients from primary care centre clinics in Shangcheng district of Hangzhou city in eastern China. We randomly assigned (1:1) clinics to either DCM (involving training for physicians in use of treatment guidelines, training for primary care nurses to function as care managers, and consultation with psychiatrists as support) or to give enhanced care as usual to all eligible patients aged 60 years and older with major depressive disorder. Clinics were chosen randomly for inclusion from all primary care clinics in the district by computer algorithm and then randomly allocated depression care interventions remotely by computer algorithm. Physicians, study personnel, and patients were not masked to clinic assignment. Our primary outcome was difference in Hamilton Depression Rating Scale (HAMD) score using data for clusters at baseline and 3, 6, and 12 month follow-up in a mixed-effects model of the intention-to-treat population. We originally aimed to analyse outcomes at 24 months, however the difference between groups at 12 months was large and funding was insufficient to continue to 24 months, therefore we decided to end the trial at 12 months. This trial is registered with ClinicalTrials.gov, number NCT01287494. Of 34 primary care clinics in Shangcheng district, 16 were randomly chosen. We randomly assigned eight clinics to the DCM intervention (164 patients enrolled) and eight primary care clinics to enhanced care as usual (162 patients). There were no major differences in baseline demographic and clinical variables between the groups of patients for each intervention. Over the 12 months, patients in clinics assigned to DCM had a significantly greater reduction in HAMD score than did those in practices assigned to enhanced care as usual (estimated between group difference -6·5 [95% CI -7·1 to -5·9]; Cohen's d 0·8 [95% CI 0·8-0·9]; p<0·0001). The intercluster correlation for change in HAMD total score was 0·07 (95% CI 0·06-0·08). There were no study-related adverse events in either group. Clinical outcomes of Chinese adults older than 60 years who had major depression were improved when their primary care clinic used DCM. Primary care-based collaborative management of depression is promising to address this pressing public health need in China. National Institutes of Health, Program for New Century Excellent Talents in Universities of China, Ministry of Education, China. Copyright © 2015 Elsevier Ltd. All rights reserved.

REFOCUS Trial: protocol for a cluster randomised controlled trial of a pro-recovery intervention within community based mental health teams.

PubMed

Slade, Mike; Bird, Victoria; Le Boutillier, Clair; Williams, Julie; McCrone, Paul; Leamy, Mary

2011-11-23

There is a consensus about the importance of 'recovery' in mental health services, but the evidence base is limited. A two centre, cluster randomised controlled trial. Participants are community-based mental health teams, and service users aged 18-65 years with a primary clinical diagnosis of psychosis. In relation to the REFOCUS Manual researchintorecovery.com/refocus, which describes a 12-month, pro-recovery intervention based on the REFOCUS Model, the objectives are: (1) To establish the effectiveness of the intervention described in the REFOCUS Manual; (2) To validate the REFOCUS Model; (3) To establish and optimise trial parameters for the REFOCUS Manual; and (4) To understand the relationship between clinical outcomes and recovery outcomes. The hypothesis for the main study is that service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR) compared to service users receiving care from control teams. The hypothesis for the secondary study is that black service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR) and client satisfaction (as measured by the CSQ) compared to Black service users receiving care from control teams. The intervention comprises treatment as usual plus two components: recovery-promoting relationships and working practices. The control condition is treatment as usual. The primary outcme is the Process of Recovery Questionnaire (QPR). Secondary outcomes are satisfaction, Goal setting - Personal Primary Outcome, hope, well-being, empowerment, and quality of life. Primary outcomes for the secondary study will be QPR and satisfaction. Cost data will be estimated, and clinical outcomes will also be reported (symptomatology, need, social disability, functioning). 29 teams (15 intervention and 14 control) will be randomised. Within each team, 15 services users will be randomly chosen, giving a total sample of 435 service users (225 in intervention and 210 in control). Power for the main study: 336 service users will give power to detect a medium effect size of 0.4 (alpha 0.05, power = 0.8) on both QPR sub-scales. Power for the secondary study: 89 participants will give power to detect an effect size of 0.67 on both QPR sub-scales and on CSQ. A range of approaches are used to minimise bias, although service users and clinicians cannot be blinded. This cluster-RCT will evaluate a pro-recovery intervention in community mental health teams. ISRCTN: ISRCTN02507940.

REFOCUS Trial: protocol for a cluster randomised controlled trial of a pro-recovery intervention within community based mental health teams

PubMed Central

2011-01-01

Background There is a consensus about the importance of 'recovery' in mental health services, but the evidence base is limited. Methods/Design A two centre, cluster randomised controlled trial. Participants are community-based mental health teams, and service users aged 18-65 years with a primary clinical diagnosis of psychosis. In relation to the REFOCUS Manual researchintorecovery.com/refocus, which describes a 12-month, pro-recovery intervention based on the REFOCUS Model, the objectives are: (1) To establish the effectiveness of the intervention described in the REFOCUS Manual; (2) To validate the REFOCUS Model; (3) To establish and optimise trial parameters for the REFOCUS Manual; and (4) To understand the relationship between clinical outcomes and recovery outcomes. The hypothesis for the main study is that service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR) compared to service users receiving care from control teams. The hypothesis for the secondary study is that black service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR) and client satisfaction (as measured by the CSQ) compared to Black service users receiving care from control teams. The intervention comprises treatment as usual plus two components: recovery-promoting relationships and working practices. The control condition is treatment as usual. The primary outcme is the Process of Recovery Questionnaire (QPR). Secondary outcomes are satisfaction, Goal setting - Personal Primary Outcome, hope, well-being, empowerment, and quality of life. Primary outcomes for the secondary study will be QPR and satisfaction. Cost data will be estimated, and clinical outcomes will also be reported (symptomatology, need, social disability, functioning). 29 teams (15 intervention and 14 control) will be randomised. Within each team, 15 services users will be randomly chosen, giving a total sample of 435 service users (225 in intervention and 210 in control). Power for the main study: 336 service users will give power to detect a medium effect size of 0.4 (alpha 0.05, power = 0.8) on both QPR sub-scales. Power for the secondary study: 89 participants will give power to detect an effect size of 0.67 on both QPR sub-scales and on CSQ. A range of approaches are used to minimise bias, although service users and clinicians cannot be blinded. Discussion This cluster-RCT will evaluate a pro-recovery intervention in community mental health teams. Trial registration ISRCTN: ISRCTN02507940 PMID:22112008

Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months

PubMed Central

Rundback, John H.; Peeters, Patrick; George, Jon C.; Jaff, Michael R.; Faries, Peter L.

2017-01-01

Purpose: To evaluate the safety and effectiveness of primary stenting of the common (CIA) or external iliac artery (EIA) using the Visi-Pro Balloon-Expandable Peripheral Stent System for treatment of stenotic, restenotic, or occluded lesions. Methods: Between 2011 and 2012, 75 patients (mean age 64.2±8.9 years; 46 men) with Rutherford category 2–4 ischemia and atherosclerotic lesions ≤10 cm in length underwent iliac artery stenting at 17 centers in the United States and Europe. The primary outcome of the study was the major adverse event (MAE) rate at 9 months postprocedure [composite of periprocedural death, in-hospital myocardial infarction, clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb]. Secondary outcomes included 30-day MAE rate, 9-month primary patency, changes in ankle-brachial index (ABI) and the Walking Impairment Questionnaire at 30 days and 9 months postprocedure, device success, and clinically driven target vessel revascularization (CD-TVR) at 30 days and 9 months. Outcomes in specific patient cohorts (ie, gender, stent location, calcification severity, and lesion grade) were analyzed. Results: Eighty-one stents were implanted in 61 CIA and 15 EIA lesions (41 with moderate/severe calcification). The mean lesion treated length was 29.3±13.9 mm. All devices were successfully deployed. MAE occurred in 3 (4.0%) of 75 subjects at 9 months. Primary patency and freedom from CD-TVR at 9 months were both 95.8%. ABI improved from 0.67±0.14 at baseline to 0.94±0.14 and 0.96±0.16 at 30 days and 9-month follow-up, respectively (p<0.001 for both). There were no differences with respect to any of the analyzed patient characteristics, including gender. Conclusion: Nine-month results of the VISIBILITY Iliac stent study (ClinicalTrials.gov identifier NCT01402700) demonstrated safety and effectiveness for the treatment of atherosclerotic CIA and EIA lesions with the Visi-Pro stent across all treated cohorts. PMID:28351204

The impact of a physician-directed health information technology system on diabetes outcomes in primary care: a pre- and post-implementation study.

PubMed

Hunt, Jacquelyn S; Siemienczuk, Joseph; Gillanders, William; LeBlanc, Benjamin H; Rozenfeld, Yelena; Bonin, Kerry; Pape, Ginger

2009-01-01

To determine the impact of a physician-directed, multifaceted health information technology (HIT) system on diabetes outcomes. A pre/post-interventional study. The setting was Providence Primary Care Research Network in Oregon, with approximately 71 physicians caring for 117 369 patients in 13 clinic locations. The study covered Network patients with diabetes age 18 years and older. The study intervention included implementation of the CareManager HIT system which augments an electronic medical record (EMR) by automating physician driven quality improvement interventions, including point-of-care decision support and care reminders, diabetes registry with care prompts, performance feedback with benchmarking and access to published evidence and patient educational materials. The primary clinical measures included the change in mean value for low density lipoprotein (LDL) target <100 mg/dL or 2.6 mmol/l, blood pressure (BP) target <130/80 mmHg and glycated haemoglobin (HbA1c) target <7%, and the proportion of patients meeting guideline-recommended targets for those measures. All measures were analysed using closed and open cohort approaches. A total of 6072 patients were identified at baseline, 70% of whom were continuously enrolled during the 24-month study. Significant improvements were observed in all diabetes related outcomes except mean HbA1c. LDL goal attainment improved from 32% to 56% (P=0.002), while mean LDL decreased by 13 mg/dL (0.33 mmol/l, P=0.002). BP goal attainment increased significantly from 30% to 52%, with significant decreases in both mean systolic and diastolic BP. The proportion of patients with an HbA1c below 7% was higher at the end of the study (P=0.008). Mean patient satisfaction remained high, with no significant difference between baseline and follow-up. Total Relative Value Units per patient per year significantly increased as a result of an increase in the number of visits in year one and the coding complexity throughout. Implementation of a physician-directed, multifaceted HIT system in primary care was associated with significantly improved diabetes process and outcome measures.

Matched cohort study of topical tranexamic acid in cementless primary total hip replacement.

PubMed

Sanz-Reig, Javier; Mas Martinez, Jesus; Verdu Román, Carmen; Morales Santias, Manuel; Martínez Gimenez, Enrique; Bustamante Suarez de Puga, David

2018-03-29

Tranexamic acid has been shown to be effective in reducing blood loss after total hip replacement. The purpose of this study was to prospectively assess the effectiveness of topical TXA use to reduce blood loss after primary total hip replacement and to compare these outcomes with those of a matched control group from a similar cohort that did not have received tranexamic acid. This is a prospective matched control study to assess the effect of a 2 g topical tranexamic acid in 50 mL physiological saline solution in total hip replacement. Primary outcomes were hemoglobin and hematocrit drop, and total blood loss. Secondary outcomes were transfusion rates, length of hospital stay, deep vein thrombosis, and pulmonary embolism events. We could match 100 patients to a control group. There were no statistical significantly differences between the two groups. The hemoglobin and hematocrit postoperative values were significantly higher in topical tranexamic acid group than in control group (P < 0.001). The mean total blood loss was 769 in topical tranexamic acid group and 1163 in control group with significant differences (P = 0.001), which meant 34% reduction in total blood loss. Length of stay was lower in topical tranexamic acid group. The risk of deep vein thrombosis and pulmonary events did not increase. A single dose of 2 g tranexamic acid in 50 mL physiological saline solution topical administration was effective and safe in reducing bleeding in patients undergoing unilateral primary non-cemented total hip replacement compared to a matched control group.

Child Maltreatment Prevalence and Mental Disorders Outcomes among American Indian Women in Primary Care

ERIC Educational Resources Information Center

Duran, Bonnie; Malcoe, Lorraine Halinka; Sanders, Margaret; Waitzkin, Howard; Skipper, Betty; Yager, Joel

2004-01-01

Objective: To examine (1) the prevalence, types, and severity of child abuse and neglect (CAN) and (2) the relationship between CAN and lifetime psychiatric disorders among American Indian women using primary care services. Methods: A cross-sectional study was conducted among 234 American Indian women, age 18-45 who presented for outpatient…

The Friendly Schools Friendly Families Programme: Three-Year Bullying Behaviour Outcomes in Primary School Children

ERIC Educational Resources Information Center

Cross, Donna; Waters, Stacey; Pearce, Natasha; Shaw, Therese; Hall, Margaret; Erceg, Erin; Burns, Sharyn; Roberts, Clare; Hamilton, Greg

2012-01-01

Purpose: This three-year group randomized controlled trial assessed whether a multi-age, multi-level bullying prevention and intervention with staff capacity building, can reduce bullying among primary school children. Methods: This study comprised two intervention and one comparison conditions. Student self-report data were collected from 2552…

Primary care interventions and current service innovations in modifying long-term outcomes after stroke: a protocol for a scoping review.

PubMed

Pindus, Dominika M; Lim, Lisa; Rundell, A Viona; Hobbs, Victoria; Aziz, Noorazah Abd; Mullis, Ricky; Mant, Jonathan

2016-10-24

Interventions delivered by primary and/or community care have the potential to reach the majority of stroke survivors and carers and offer ongoing support. However, an integrative account emerging from the reviews of interventions addressing specific long-term outcomes after stroke is lacking. The aims of the proposed scoping review are to provide an overview of: (1) primary care and community healthcare interventions by generalist healthcare professionals to stroke survivors and/or their informal carers to address long-term outcomes after stroke, (2) the scope and characteristics of interventions which were successful in addressing long-term outcomes, and (3) developments in current clinical practice. Studies that focused on adult community dwelling stroke survivors and informal carers were included. Academic electronic databases will be searched to identify reviews of randomised controlled trials (RCTs) and controlled trials, trials from the past 5 years; reviews of observational studies. Practice exemplars from grey literature will be identified through advanced Google search. Reports, guidelines and other documents of major health organisations, clinical professional bodies, and stroke charities in the UK and internationally will be included. Two reviewers will independently screen titles, abstracts and full texts for inclusion of published literature. One reviewer will screen search results from the grey literature and identify relevant documents for inclusion. Data synthesis will include analysis of the number, type of studies, year and country of publication, a summary of intervention components/service or practice, outcomes addressed, main results (an indicator of effectiveness) and a description of included interventions. The review will help identify components of care and care pathways for primary care services for stroke. By comparing the results with stroke survivors' and carers' needs identified in the literature, the review will highlight potential gaps in research and practice relevant to long-term care after stroke. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Prior elicitation and Bayesian analysis of the Steroids for Corneal Ulcers Trial.

PubMed

See, Craig W; Srinivasan, Muthiah; Saravanan, Somu; Oldenburg, Catherine E; Esterberg, Elizabeth J; Ray, Kathryn J; Glaser, Tanya S; Tu, Elmer Y; Zegans, Michael E; McLeod, Stephen D; Acharya, Nisha R; Lietman, Thomas M

2012-12-01

To elicit expert opinion on the use of adjunctive corticosteroid therapy in bacterial corneal ulcers. To perform a Bayesian analysis of the Steroids for Corneal Ulcers Trial (SCUT), using expert opinion as a prior probability. The SCUT was a placebo-controlled trial assessing visual outcomes in patients receiving topical corticosteroids or placebo as adjunctive therapy for bacterial keratitis. Questionnaires were conducted at scientific meetings in India and North America to gauge expert consensus on the perceived benefit of corticosteroids as adjunct treatment. Bayesian analysis, using the questionnaire data as a prior probability and the primary outcome of SCUT as a likelihood, was performed. For comparison, an additional Bayesian analysis was performed using the results of the SCUT pilot study as a prior distribution. Indian respondents believed there to be a 1.21 Snellen line improvement, and North American respondents believed there to be a 1.24 line improvement with corticosteroid therapy. The SCUT primary outcome found a non-significant 0.09 Snellen line benefit with corticosteroid treatment. The results of the Bayesian analysis estimated a slightly greater benefit than did the SCUT primary analysis (0.19 lines verses 0.09 lines). Indian and North American experts had similar expectations on the effectiveness of corticosteroids in bacterial corneal ulcers; that corticosteroids would markedly improve visual outcomes. Bayesian analysis produced results very similar to those produced by the SCUT primary analysis. The similarity in result is likely due to the large sample size of SCUT and helps validate the results of SCUT.

Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial.

PubMed

Miller, Jordan; Barber, David; Donnelly, Catherine; French, Simon; Green, Michael; Hill, Jonathan; MacDermid, Joy; Marsh, Jacquelyn; Norman, Kathleen; Richardson, Julie; Taljaard, Monica; Wideman, Timothy; Cooper, Lynn; McPhee, Colleen

2017-11-09

Back pain is a leading contributor to disability, healthcare costs, and lost work. Family physicians are the most common first point of contact in the healthcare system for people with back pain, but physiotherapists (PTs) may be able to support the primary care team through evidence-based primary care. A cluster randomized trial is needed to determine the clinical, health system, and societal impact of a primary care model that integrates physiotherapists at the first visit for people with back pain. Prior to conducting a future fully powered cluster randomized trial, we need to demonstrate feasibility of the methods. Therefore, the purpose of this pilot study will be to: 1) Determine feasibility of patient recruitment, assessment procedures, and retention. 2) Determine the feasibility of training and implementation of a new PT-led primary care model for low back pain (LBP) 3) Explore the perspectives of patients and healthcare providers (HCPs) related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value, and impact on clinic processes and patient outcomes. This pilot cluster randomized controlled trial will enroll four sites and randomize them to implement a new PT-led primary care model for back pain or a usual physician-led primary care model. All adults booking a primary care visit for back pain will be invited to participate. Feasibility outcomes will include: recruitment and retention rates, completeness of assessment data, PT training participation and confidence after training, and PT treatment fidelity. Secondary outcomes will include the clinical, health system, cost, and process outcomes planned for the future fully powered cluster trial. Results will be analyzed and reported descriptively and qualitatively. To explore perspectives of both HCPs and patients, we will conduct semi-structured qualitative interviews with patients and focus groups with HCPs from participants in the PT-led primary care sites. If this pilot demonstrates feasibility, a fully powered trial will provide evidence that has the potential to transform primary care for back pain. The full trial will inform future service design, whether these models should be more widely implemented, and training agendas. ClinicalTrials.gov, NCT03320148 . Submitted for registration on 17 September 2017.

Primary care team communication networks, team climate, quality of care, and medical costs for patients with diabetes: A cross-sectional study.

PubMed

Mundt, Marlon P; Agneessens, Filip; Tuan, Wen-Jan; Zakletskaia, Larissa I; Kamnetz, Sandra A; Gilchrist, Valerie J

2016-06-01

Primary care teams play an important role in providing the best quality of care to patients with diabetes. Little evidence is available on how team communication networks and team climate contribute to high quality diabetes care. To determine whether primary care team communication and team climate are associated with health outcomes, health care utilization, and associated costs for patients with diabetes. A cross-sectional survey of primary care team members collected information on frequency of communication with other care team members about patient care and on team climate. Patient outcomes (glycemic, cholesterol, and blood pressure control, urgent care visits, emergency department visits, hospital visit days, medical costs) in the past 12 months for team diabetes patient panels were extracted from the electronic health record. The data were analyzed using nested (clinic/team/patient) generalized linear mixed modeling. 155 health professionals at 6 U.S. primary care clinics participated from May through December 2013. Primary care teams with a greater number of daily face-to-face communication ties among team members were associated with 52% (rate ratio=0.48, 95% CI: 0.22, 0.94) fewer hospital days and US$1220 (95% CI: -US$2416, -US$24) lower health-care costs per team diabetes patient in the past 12 months. In contrast, for each additional registered nurse (RN) who reported frequent daily face-to-face communication about patient care with the primary care practitioner (PCP), team diabetes patients had less-controlled HbA1c (Odds ratio=0.83, 95% CI: 0.66, 0.99), increased hospital days (RR=1.57, 95% CI: 1.10, 2.03), and higher healthcare costs (β=US$877, 95% CI: US$42, US$1713). Shared team vision, a measure of team climate, significantly mediated the relationship between team communication and patient outcomes. Primary care teams which relied on frequent daily face-to-face communication among more team members, and had a single RN communicating patient care information to the PCP, had greater shared team vision, better patient outcomes, and lower medical costs for their diabetes patient panels. Copyright © 2016 Elsevier Ltd. All rights reserved.

Primary care team communication networks, team climate, quality of care, and medical costs for patients with diabetes: A cross-sectional study

PubMed Central

Mundt, Marlon P.; Agneessens, Filip; Tuan, Wen-Jan; Zakletskaia, Larissa I.; Kamnetz, Sandra A.; Gilchrist, Valerie J.

2016-01-01

Background Primary care teams play an important role in providing the best quality of care to patients with diabetes. Little evidence is available on how team communication networks and team climate contribute to high quality diabetes care. Objective To determine whether primary care team communication and team climate are associated with health outcomes, health care utilization, and associated costs for patients with diabetes. Methods A cross-sectional survey of primary care team members collected information on frequency of communication with other care team members about patient care and on team climate. Patient outcomes (glycemic, cholesterol, and blood pressure control, urgent care visits, emergency department visits, hospital visit days, medical costs) in the past 12 months for team diabetes patient panels were extracted from the electronic health record. The data were analyzed using nested (clinic/team/patient) generalized linear mixed modeling. Participants 155 health professionals at 6 U.S. primary care clinics participated from May through December 2013. Results Primary care teams with a greater number of daily face-to-face communication ties among team members were associated with 52% (Rate Ratio=0.48, 95% CI: 0.22, 0.94) fewer hospital days and US$1220 (95% CI: -US$2416, -US$24) lower health-care costs per team diabetes patient in the past 12 months. In contrast, for each additional registered nurse (RN) who reported frequent daily face-to-face communication about patient care with the primary care practitioner (PCP), team diabetes patients had less-controlled HbA1c (Odds Ratio=0.83, 95% CI: 0.66, 0.99), increased hospital days (RR=1.57, 95% CI: 1.10, 2.03), and higher healthcare costs (β=US$877, 95% CI: US$42, US$1713). Shared team vision, a measure of team climate, significantly mediated the relationship between team communication and patient outcomes. Conclusions Primary care teams which relied on frequent daily face-to-face communication among more team members, and had a single RN communicating patient care information to the PCP, had greater shared team vision, better patient outcomes, and lower medical costs for their diabetes patient panels. PMID:27087293

The nature and influence of pharmaceutical industry involvement in asthma trials

PubMed Central

Bond, Kenneth; Spooner, Carol; Tjosvold, Lisa; Lemière, Catherine; Rowe, Brian H

2012-01-01

BACKGROUND: Pharmaceutical industry-sponsored research has been shown to be biased toward reporting positive results. Frequent industry participation in trials assessing the efficacy of inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) combination treatment makes assessing industry influence difficult and warrants an assessment of specific potential publication bias in this area. OBJECTIVE: To describe the frequency of industry involvement in ICS/LABA trials and explore associations among significant outcomes, type of industry involvement and type of primary outcome. METHODS: A systematic review of trials comparing ICS/LABA combination therapy with ICS monotherapy for asthma was conducted. Data concerning the type of industry sponsorship, primary outcome and statistical results were collected. Comparisons between type of sponsorship and significant results were analyzed using Pearson’s χ2 test and relative risk. RESULTS: Of 91 included studies (median year of publication 2005 [interquartile range 1994 to 2008]), 86 (95%) reported pharmaceutical involvement. Author affiliation was reported in 49 of 86 (57%), and 19 of 86 (22%) were industry-reported trials without full publications. The remainder were published journal articles. Studies with a first or senior author affiliated with industry were 1.5 times more likely to report statistically significant results for the primary outcome compared with studies with other types of industry involvement. Pulmonary measures were 1.5 times more likely to be statistically significant than were measures of asthma control. CONCLUSIONS: The potential biases identified were consistent with other research focused on author role and industry involvement, and suggest that degree of bias may vary with type of affiliation. PMID:22891187

Early Indicators of Later English Reading Comprehension Outcomes among Children from Spanish-Speaking Homes

ERIC Educational Resources Information Center

Mancilla-Martinez, Jeannette; Lesaux, Nonie K.

2017-01-01

In this longitudinal study, we examined the relationship between primary grade (K-2) Spanish and English language- and word-based skills and later English reading comprehension (RC) outcomes (Grades 5 and 8) among children (n = 148) from immigrant, Spanish-speaking, low-income homes in English instructional contexts since kindergarten entry. As…